MBVP NEWS

Viral Pandemic H5N1 flu threat: Baxter contaminates European labs by error

2009-03-05T13:54:00.000-05:00

http://www.lifegen.de/newsip/shownews.php4?getnews=2009-02-25-5123

It could be a Hollywood Worst Case Thriller, but it is real: According to the scientific network PROMED, Baxter International Inc. in Austria "unintentionally contaminated samples with the bird flu virus that were used in laboratories in 3 neighboring countries, raising concern about the potential spread of the deadly disease". As PROMED reports, the contamination has been discovered when ferrets at a laboratory in the Czech Republic died after being inoculated with vaccine made from the samples early this month. "The material came from Deerfield, Illinois-based Baxter, which reported the incident to the Austrian Ministry of Health, Sigrid Rosenberger, a ministry spokeswoman, said today in a telephone interview", the network-alert-system is quoting. "This was infected with a bird flu virus," Rosenberger said. "There were some people from the company who handled it." There are severe signs that the long expected pandemic avian influenza could be on its way to conquer the world - even without Baxter's error driven help.

First deaths in Asia concern little children, which from virological point of view is a rather new aspect, and could be the evidence for a new spread. While scientists expect this pandemic to happen in the near future, the new President should also stay alert: A coming influenza pandemic would deteriorate the global economy even without financial crisis, recession - or Baxter.

Evidence for the global threat comes from China, where a 2 year old girl has been confirmed to be infected with bird flu in the northern Shanxi Province, as government officials said last Saturday. The child was found ill on 7th of January in the central Hunan province - the little patient still is in critical condition. According to the test result of the Chinese Center for Disease Control and Prevention, the girl had been tested positive for the H5N1 strain of avian influenza.

On the other site of the globe, the Ministry of Health and Population of Egypt announced a new human case of avian influenza A(H5N1) virus infection last week, the case being a 21 month old girl Kerdasa District.

“Infection with the H5N1 avian influenza virus was diagnosed by PCR at the Egyptian Central Public Health Laboratory and subsequently confirmed by the U. S. Naval Medical Research Unit No. 3 (NAMRU-3) laboratories”, reports the special wire PROMED. According to PROMED, investigations into the source of her infection indicate a recent history of contact with sick and dead poultry - 23 similar cases in Egypt have been fatal up to date.

Old Europe as leading research power?

Given such facts, Mr. Obama should follow European research policy: European research on vaccine development for pandemic influenza has been financed since 2001 by the European Union. Early projects worked to develop an egg-free vaccine, which is faster and safer to produce, along with innovative application techniques. Research is now underway with the objectives of fighting the disease at the source (infected birds) and protecting human populations through pandemic influenza vaccines. Future EU research will improve vaccine efficiency by adding adjuvants, substances that boost the body’s immune response to vaccine antigen. Additionally, research teams are currently focused on developing a universal flu vaccine that could provide a lifetime of protection from influenza.

Latest surveillance data coming through the European Centre for Disease Prevention and Control (ECDC) from virologists and clinicians indicates that the influenza A(H3N2) virus is the predominant strain in Europe so far this season (2008/2009). Based on the data published by ECDC the pharmaceutical company Roche confirms that the oral antiviral Tamiflu (oseltamivir) is fully active against influenza A(H3N2) and influenza B, which currently comprise 94 percent of circulating viruses in Europe this year. Tamiflu resistance reported in the 2008-2009 influenza seasons is confined to H1N1. No resistance has been seen with other circulating seasonal viruses - H3N2 and influenza B.

"Recent media reporting has elevated awareness of the H1N1 seasonal resistance seen this year in the United States and the Far East. However, in Europe the picture is different with H3N2 being the dominant strain so far. The circulating H3N2 viruses, which often cause a more severe illness than H1N1, are sensitive to oseltamivir, which means that oseltamivir will be active against the vast majority of influenza infections in Europe this season, if current trends continue," comments Prof Albert Osterhaus, Head of Virology, Erasmus Medical Centre, Rotterdam. "It is important that doctors understand that oseltamivir remains an effective treatment for patients across Europe."

Flu alert for the new President

However, the situation in the United States is more alerting, according to the Centers for Disease Control and Prevention (CDC). A new University of Colorado at Boulder study showed the resistance of the avian flu virus to a major class of antiviral drugs "is increasing through positive evolutionary selection, with researchers documenting the trend in more than 30 percent of the samples tested", as the scientists report. Even if the expected influenza pandemic did not start yet, there is no doubt about the comeback of the lethal virus: The first Pandemic Influenza occurred in three waves in the United States - exactly 90 years ago, between 1918 and 1919.

Inside USA's Biological Warfare Center

2009-02-18T08:43:00.002-05:00

Inside USA's Biological Warfare Center;

Q. & A. With Citizen Activist Barry Kissin

HTTP://WWW.AUSTRALIA.TO/INDEX.PHP?OPTION=COM_CONTENT&VIEW=ARTICLE&ID=5594:INSIDE-USAS-BIOLOGICAL-WARFARE-CENTER-Q-A-WITH-CITIZEN-ACTIVIST-BARRY-KISSIN&CATID=71:WORLD-NEWS&ITEMID=30

WRITTEN BY SHERWOOD ROSS

One legacy of the Bush-Cheney administration is the grandiose expansion of our germ warfare research program. This was declared to be necessary because of the September-October 2001 anthrax letters’ attacks on Congress and the media---attacks the public is now being told came not from the Middle East but from within our own government’s facilities. As a result, developmental work is going forward with deadly and loathsome pathogens capable of triggering plagues and epidemics.

Legislation to finance this expansion rolled through Congress after the anthrax attacks killed five persons, sickened 17 others, caused more than 10 million Americans to go on very strong antibiotics, and cost hundreds of millions of dollars to clean up. Laboratories at hundreds of universities and corporations have expanded into biological warfare research centers. More than $50 billion has been lavished on this effort—an effort critics charge is in violation of the existing treaty against bioweapons development ratified by the United States in 1975. So much of the nation’s resources have been shifted into germ warfare research that 750 of our most celebrated scientists signed a petition protesting the adverse effect this is having on research into combating naturally occurring diseases.

The Government’s admission the anthrax attacks came not from the Middle East but from its own biowarfare research facilities signifies the anthrax letters constituted a “false flag” operation designed to whip up public sentiment for the “War On Terror.” One man who saw the expansion of the Government’s biological warfare research hub at Ft. Detrick under President Bush as a danger to his community and to the nation was Barry Kissin, a 57-year-old Brooklyn-born attorney who moved to Frederick, Md. in 1981. Kissin and his wife, Dr. Malgorzata Schmidt, make their home just a few miles from the main gate of Ft. Detrick. Kissin has found himself devoting ever more of his time to challenging the expansion of “biodefense” as well as the underlying rationale contained in our government’s mutating story about the anthrax letters.

Over the past six years, Kissin has become a leading citizen activist in the struggle to halt the expansion of our “biodefense” program. His work evidently came to the attention of the Homeland Security division of the Maryland State Police. The Washington Post of October 12, 2008, reported that this Homeland Security division had listed Kissin and 52 others as “terrorists,” and furthermore that authorities had acknowledged their wrongdoing and had agreed to purge the files. Kissin, an unsuccessful candidate for Congress in 2006, was in good company. The activists labeled as terrorists included two nuns, a man who challenges military recruiting in high schools, and critics of the Iraq war.

Following is my Q. and A. with this passionate opponent of a new biological arms race---a race once shut down by President Richard Nixon only to be stoked anew by the Bush regime.

Q: How did you happen to get interested in Ft. Detrick?

A: I became a resident of Frederick, MD, home of Ft. Detrick, in 1981. I was aware Ft. Detrick was headquarters for our bio-warfare related programs ever since the first such program commenced in 1943. Before my move to Frederick, I was also conscious of the Silent Vigil that was maintained from July, 1959, until March, 1961, outside Detrick’s main gate that stood for the cessation of our bio-warfare program and the conversion of Detrick’s scientific facilities into a health research center. This Vigil, conceived by a Quaker named Lawrence Scott, is credited with laying the foundation for the decision by President Nixon in 1969 to terminate our offensive bio-warfare program. Two years later, Nixon came to Detrick and announced he was creating the National Cancer Institute (NCI) there which would utilize (and continues to utilize) former Army bio-warfare buildings, thus “sending a clear message that America could beat its swords into plowshares.” I might add that it has since become apparent that the CIA and its “Special Operations Division” at Detrick did not abide by the decision to terminate bio-weapons research. Various bio-warfare related programs continued to function in the 1970s, 1980s and 1990s.

During my formative years, I was very active in the movement against the Viet Nam War. Since then I have been very conscious of the terrible workings of our military-industrial-intelligence complex. Upon moving to Frederick, I quickly became aware of how the Army at Detrick manipulated the local community and local media. Ft. Detrick is the largest employer in Frederick County. Its unassailable position in the community is based on a mixture of messages about its contributions to the local economy and its patriotic role in defending against the enemy, once Communist, now terrorist.

Q: What steps did the Bush administration take to launch its biological warfare program?

A: Upon coming into power, the Bush Administration immediately exercised its strong preference for arms race over international arms control. In the realm of bio-warfare, it promptly withdrew from negotiations to strengthen the 1975 Biological Weapons Convention (BWC), the international treaty that bans the development of biological weapons. This made the United States practically the only country among 150 signatories to the Treaty opposed to a protocol for international inspections and verification. Thereafter, using the anthrax letters attacks of the fall of 2001 as a central pretext, the Bush Administration launched a massive expansion of our so-called “bio-defense” program, much of it at Ft. Detrick.

Q: Could you briefly describe the nature of the work going forward at Ft. Detrick and the names of agencies involved?

A: One of the programs at Ft. Detrick is under the auspices of the National Cancer Institute (NCI). My focus of course has been upon bio-warfare related activities, which, since termination of the overtly offensive program, have been conducted by the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID). USAMRIID is a part of the U.S. Army Medical Research and Material Command (USAMRMC) at Ft. Detrick, which also manages activities unrelated to bio-warfare, such as supplying medical materials for use by the Army.

The expansion underway at Ft. Detrick contemplates a “National Inter-agency Bio-defense Campus” (NIBC) which upon completion would occupy 200 acres there. The plan is for the NIBC to be the site of a new facility for USAMRIID, designed to measure more than one million square feet (approx. 25 acres of facility space), at a cost of $1 Billion (2005 cost estimate). Construction of two of the new NIBC facilities has already been completed (in 2008) – namely the “National Biodefense Analysis and Countermeasures Center” (NBACC) to be operated by the Department of Homeland Security (DHS), which measures 160,000 square feet, and the “Integrated Research Facility” (IRF) to be operated by the National Institute of Health (NIH), which also measures about 160,000 square feet. After the new USAMRIID facility is completed, the plan is to erect another new facility on the NIBC, to be operated by the Department of Agriculture (USDA). And the Center for Disease Control (CDC) has announced that it also wants to join this campus “confederation.”

Q: Please explain what BSL laboratories are and how they are graded. Also, could you describe some of the pathogens government scientists are working on in these labs?

A: BSL labs are biocontainment facilities designed for research, development, testing and evaluation (RDT&E) activities involving specific pathogens (germs), exposure to which would be hazardous to lab workers as well as the “outside environment.” BSL stands for Bio-Safety Level --- the higher the level, the more elaborate the safety and security measures, the more dangerous the germs. BSL-4 is for maximum containment. There are dozens of diseases viewed as potential agents for biological weapons. RDT&E upon diseases such as hepatitis A, B and C, influenza A, Lyme disease, dengue fever and salmonella takes place in BSL-2 labs. Anthrax, West Nile virus, Venezuelan equine encephalitis, Eastern equine encephalitis, SARS, tuberculosis, typhus, Coxiella burnetii, Rift Valley fever, Rocky Mountain spotted fever, and yellow fever are dealt with in BSL-3 labs. And Bolivian and Argentine hemorrhagic fevers, Marburg virus, Ebola virus, Lassa fever, and Crimean-Congo hemorrhagic fever are dealt with in BSL-4 labs.

The new DHS, NIH and Army facilities at Detrick alone will house approximately 60,000square feet of BSL-4 laboratory space, specifically designed to accommodate work with germs for which there is neither vaccine nor cure.

This amount of space is four times the total amount of BSL-4 space that existed in the entire country as of 2004.

Q: How have you attempted to slow or stop the expansion of these laboratories?

A: Since 2003, I and others in the community have been participating in proceedings under the National Environmental Protection Act (NEPA) designed to examine the environmental impacts posed by new bio-warfare related facilities at Ft. Detrick. Though NEPA treats as a priority the consideration of public input, our input has essentially been ignored as one facility after the other has been approved. I and others have also been conducting demonstrations in downtown Frederick against the expansion.

Q: In some ways the community’s activism has paid off, has it not?

A: In August, 2007, for the first time in history, an elected official, namely a Frederick County Commissioner, publicly expressed concerns about what was going on at Ft. Detrick. This opened a floodgate. Unprecedented columns and editorials in the local newspapers appeared questioning what was going on at Ft. Detrick. And in November, 2007, upon the occasion of a public meeting hosted by the County Commissioners, more than 150 members of the community filled Frederick City Hall to express their many concerns.

Under much pressure, both of Maryland’s U.S. Senators----Barbara Mikulski and Ben Cardin---got behind the demand for a review by the National Academy of Sciences (NAS) of the public health and environmental hazards posed by the new facilities being built at Ft. Detrick. Though the appropriation for this NAS review was passed by Congress in September, 2008, we continue to wait for the Army to fulfill its obligation to enter into a contract with the NAS for this review.

Q: Are you a member of any citizen groups concerned about research underway at Ft. Detrick?

A: Frederick Citizens for Bio-lab Safety; Frederick Progressive Action Coalition (FredPAC); Frederick County Peace Resource Center (PRC). There are also national organizations concerned about our national “biodefense” program, a central part of which is being implemented at Ft. Detrick. A most important example of such an organization was the “Sunshine Project” based in Austin, Texas. This non-profit organization was instrumental in procuring the Congressional hearing in October, 2007, regarding the alarming (if not reckless) proliferation of high-security bio-laboratories in the U.S. Unfortunately; the Sunshine Project has since ceased its operation for lack of funding.

Q: As I understand it, with most of the rest of the world on record as opposed to a new bioweapons arms race, the United States is setting a terrible example by its research at Ft. Detrick.

A: In 2004, Milton Leitenberg, Senior Research Scholar at the University of Maryland, James Leonard, head of the U.S. delegation that negotiated the international arms control treaty known as the Biological Weapons Convention (BWC) that bans the development of bio-weapons, and Richard Spertzel, former deputy Commander of USAMRIID and Senior Biologist on the United Nations inspection team in Iraq, co-authored a commentary containing the following statements:
“The rapidity of elaboration of American biodefense programs, their ambition and administrative aggressiveness, and the degree to which they push against the prohibitions of the Biological Weapons Convention (BWC), are startling. . . . [The Deputy Director of DHS’s NBACC himself] noted that one NBACC objective, the creation of genetically engineered agents, might raise BWC compliance questions. . . Reportedly, the US intelligence community is under orders to carry out studies. . . . Surely, the ‘intelligence community’ is the least appropriate place in the US government to ‘carry out’ such work — and the most likely to lack adequate oversight.”

Q: According to some critics, “biodefense” activity at Ft. Detrick will violate Federal criminal law, is that correct?

A: In 2007, International Law Professor Francis Boyle, who drafted the “Biological Weapons Anti-Terrorism Act of 1989” that criminalizes violations of the BWC, stated:

“The proposed construction and operation of new facilities at Fort Detrick is an integral part of the program that is referred to as ‘Biodefense for the 21st Century’ in Homeland Security Presidential Directive - HSPD-10, released on April 28, 2004. In my expert opinion, said program constitutes clear violations of the [BWC]. . . . [This] so-called ‘biodefense’ program . . . [has the] unmistakable hallmarks of an offensive weapons program. . . . In my expert opinion, participants in this so-called ‘biodefense’ program are subject to criminal liability [under the Act that I drafted.]”

Q: Have you been inside Ft. Detrick?

A: Numerous times. As an attorney, I have represented before the Magistrate’s Court at Ft. Detrick individuals charged with misdemeanors committed on post. More to the point, I have attended various “community meetings” on post hosted by the Army for the purpose of answering questions about the expansion. Furthermore, on March 5, 2008, I personally was given a three-hour-long tour of the USAMRIID facility by then USAMRIID Commander Colonel George W. Korch, which included an inspection (through windows) of the “biological containment” laboratories [like the ones portrayed in the Dustin Hoffman film, “Outbreak” (1995)].

Q: How many acres does Ft. Detrick cover and what’s it like?

A: Ft. Detrick comprises 1200 acres, (about 10% of the total land area of the City of Frederick, population 60,000). “Area A” contains all of the buildings for the activities summarized above, as well as a substantial number of recently-constructed single-family homes for Army families, a very large gymnasium, commissary, etc. (Though remarkably it still has places in it that would be easy to penetrate), the perimeter fencing has recently been bolstered, which critics describe as contributing to a militaristic presence in the middle of a densely populated community.

Q: What is going on in “Area B?”

A: “Area B” is about 400 acres and is separated from “Area A,” and has livestock on it used in testing by USAMRIID. Area B was a landfill site. Though questions were raised beginning in the 1970’s about possible leakage from Detrick dumping, it was not until the early 1990’s that monitoring wells were installed that revealed in the ground water the presence of TCE and PCE, both cancer-causing chemicals, at levels between 1,000 and 5,000 times the levels determined to be safe by the EPA. It became clear that the water supplies of nearby residents had been severely contaminated. On July 1, 2003, the local Frederick News-Post published a front-page article “Cancer questions: Residents point finger at Detrick,” based on the statements of many of Detrick’s neighbors about the high incidence of cancer in their families.

Q: How have Ft. Detrick authorities and the Army responded?

A: The clean-up has dragged along ever since the early 1990s. Two thousand metric tons of hazardous waste have been unearthed. In 2003, sanitation crews were shocked to find vials containing live germs. The discarded biological agents included anthrax, Brucella melitensis, which causes the virulent flu-like disease brucellosis, and klebsiella, a cause of pneumonia. (On May 28, 2003, The Guardian, a prominent English newspaper, published an article entitled “US finds evidence of WMD at last -- buried in a field in Maryland.”)

Q: Surely, public officials would raise questions about this situation.

A: On November 13, 2008, both of Maryland’s U.S. Senators, ordinarily quite protective with respect to Ft. Detrick, stated in a letter to then President-elect Obama: “[W]e write to draw your attention to the Department of Defense’s (DOD) position that it is not subject to the Environmental Protection Agency’s (EPA) authority to administer federal environmental protection statutes. The Department of Defense has been in flagrant and repeated violation of these statutes at installations in Maryland and around the country. . . . [A]dmitting flaws in its characterization of contamination at Ft. Detrick Maryland as well as the handling of the clean-up there, Secretary Davis promised that the Army would not oppose EPA’s decision to list Area B at Fort Detrick Maryland on the National Priorities List. Yet, we now have a clear sign that DOD appears to be shirking its responsibilities and legal obligations to protect the health and welfare of our constituents, particularly . . . neighbors outside the gate. As recently as November 3, 2008, Secretary Davis wrote to the EPA asking that the Agency refrain from placing Ft. Detrick on the Superfund list in spite of the fact that the site meets all the listing criteria.”

Q: Wow. Have there been any injuries or deaths as a result of the biological research at Ft. Detrick? I understand some of its streets are named after fallen employees.

A: In general, secrecy in the name of “national security” has concealed the consequences of biological research at Ft. Detrick.

According to the official account, three people have died as the result of contracting diseases being cultivated at Ft. Detrick, all before the overtly offensive program was terminated in 1969. A microbiologist and an electrician died from anthrax, and an animal caretaker died from the Machupo virus. The official account does not acknowledge what has come to light about one of the anthrax cases, namely that, at first, the victim was placed by his personal physician in a Frederick hospital, and that “bronchial pneumonia” was listed on his death certificate.

Q: Sounds like a cover-up.

A: One must study Pulitzer Prize-winning Seymour Hersh’s seminal work, Chemical & Biological Warfare: America’s Hidden Arsenal (Doubleday & Company, 1969) to discover the case of an enlisted laboratory technician at Detrick contracting pneumonic plague. In a memo classified as secret, Detrick officials cautioned that this lab technician was also a life guard at a public swimming pool in the community. But no attempt was made to inform Frederick residents of the danger, or to provide preventative antibiotic treatment. There was also a case of an enlisted man residing off base who contracted meningitis, which can be highly contagious. The Frederick County Health Commissioner was not informed of this case until weeks after it was discovered. Regarding the plague case, this Health Commissioner told Hersh: “I co-operated with [Ft. Detrick officials]. I had an obligation to them – I had a secret clearance. They told me not to report the case [because] we didn’t want to alarm anyone.” Referring to “funny cases” related to Ft. Detrick, this Commissioner also told Hersh about questionable incidents involving typhoid fever and tuberculosis.

Then there was the case of Frank Olson, whose death back in 1953 was attributed by officials to suicide. Largely as the result of ongoing efforts by one of Frank Olson’s sons, Eric, it has come to light that Dr. Olson was actually in charge of the CIA’s “Special Operations” at Ft. Detrick, that he was gradually becoming more and more disturbed by the CIA’s secret programs at Ft. Detrick, and that after he expressed some of his misgivings and shortly before his death, he was given LSD by CIA agents. In 1994, Dr. Olson’s son Eric retained Dr. James Starrs, a noted forensic pathologist at the George Washington University Medical Center, to assemble a team of experts to conduct an exhumation and autopsy on Frank Olson. After months of tests and investigation, Dr. Starrs concluded that the circumstances of Dr. Olson’s death had been deliberately covered up by the CIA, and that his death was the result of “homicide deft, deliberate, and diabolical.” (Dr. Olson’s son Eric has also uncovered documents that establish that Dick Cheney became personally involved in this cover-up – see Eric’s website, www.frankolsonproject.org).

Q: Are there any other examples of deaths or injuries at Ft. Detrick?

A: With regard to injuries resulting from biological research at Ft. Detrick, it is instructive to consider an article written by several medical doctors who work at USAMRIID entitled “Experience in the Medical Management of Potential Laboratory Exposures to Agents of Bioterrorism at USAMRIID” that appeared in the Journal of Occupational and Environmental Medicine: Volume 46(8), August 2004, pp. 801-811:
“The large number of exposure incidents reported . . . serves as a reminder that work in a laboratory of this type is inherently hazardous. . . . [W]e recognize that work in containment laboratories is inherently hazardous because of the need to work with sharp objects (ie, needles) and animals, which can be unpredictable. In addition, personal protective equipment may inadvertently increase the potential for incidents by limiting the field of vision, tactile sensation, and communication. . . . A laboratory worker was evaluated for a potential ocular exposure to orthopox viruses resulting from a splash of condensate. . . [A]ll 17 persons involved in the [anthrax] letter handling were considered at potentially significant risk for exposure due to the readily aerosolizable spores. . . . The route of exposure [in another case] was probably inhalational as the result of a malfunction (leak) of the filter in the bio-safety cabinet that was subsequently discovered. . . . As research on the agents of bioterrorism becomes more widespread, an increase in occupational exposures to bioterrorist agents may be expected . . .

“Much of our knowledge about biosafety has come from investigations into the mechanisms and activities that caused workers to become infected . . . However, historically the majority of individuals, over 80% in one report, diagnosed with laboratory-acquired infections, could not identify a known incident or breach in laboratory policy responsible for their infection. . . There were 77 individuals evaluated for potential exposures to 107 viral agents . . . [N]o vaccine existed for many of [these] viral agents. . . .” This Journal article also refers to instance after instance of the failure of existent vaccines to prevent infection.

The experience of one USAMRIID scientist who accidentally contracted a disease called “glanders” was described in the article as follows: “The individual, after a diagnostic liver biopsy, subsequently went into respiratory failure, necessitating intubation, [followed by] a 6-month course of treatment.” There is explicit acknowledgement in this article of “the risk of introducing communicable illnesses into the community at large.”

Also relevant to this question about death and injuries is the apparent incidence of cancer afflicting neighbors of Ft. Detrick due to water contamination, as outlined in my answer to a previous question. Also, there is the matter of the anthrax letters of 2001. It bears pointing out that according to the official account, the anthrax in the letters was developed at Ft. Detrick.

Q: Do you know what the budget is for biological research programs?

A: Spending on so-called “bio-defense” research greatly increased immediately after the anthrax letters. In the seven fiscal years following the anthrax letters, $48 billion was spent on “bio-defense.” There is another $9 billion budgeted in fiscal year 2009. Much of this is for the stockpiling of pharmaceuticals -- vaccines and remedies such as Cipro for anthrax.

The General Accounting Office and scientists like Richard Ebright of Rutgers University have suggested that the spending on research since 2001 has actually made this country less safe by vastly increasing the number of researchers and labs authorized to handle bacteria and viruses of bioterrorism concern, known as “select agents.”

Ebright estimates that the number of labs so engaged has increased 20-fold since 2001. Today, there are about 1,400 public and private labs and about 14,000 scientists known to be involved.

Q: Arms control expert Milton Leitenberg has said there is no evidence of biowarfare capability on the part of any terrorist group. What do you make of that?

A: I have read two books by Mr. Leitenberg that pertain to the bioterrorism threat, and I have spoken to him several times about his work. Mr. Leitenberg is a conservative academic. In Assessing the Biological Weapons and Bioterrorism Threat, Mr. Leitenberg demonstrates that billions of federal expenditures have been appropriated in the absence of virtually any real threat analysis, and that the risk and imminence of the use of biological agents by non-state actors/terrorist organizations has been “systematically and deliberately exaggerated” by our government. It is noteworthy that this book was published in December, 2005, by none other than the Strategic Studies Institute of the U.S. Army War College. On its title page can be found the following statement: “This publication is a work of the United States Government . . .”

Q: Turning to the anthrax letters, what is Amerithrax?

A: Amerithrax is the FBI’s name for its investigation into the anthrax letters attacks of September-October, 2001. This investigation has become a cover-up and a fraud, a systematic and deliberate fraud that now attempts to pin exclusive responsibility for the attacks upon a USAMRIID immunologist named Bruce Ivins. After months of intense harassment by the FBI, Ivins died in July, 2008, it appears by suicide.

Q: Do you believe the anthrax attacks on Congress and the media in 2001 emanated from Ft. Detrick?

A: The anthrax in the letters was of a particularly pernicious strain called the “Ames strain” of anthrax. After being discovered in a dead cow from Texas in 1981, the Ames strain made its way to Ft. Detrick, where it was originally cultivated as a potential bio-weapon. Bruce Ivins worked with the Ames strain at Ft. Detrick in the course of his efforts to derive an effective vaccine. According to the FBI’s genetic analysis, the anthrax in the letters was of a specific genotype designated RMR-1029. RMR-1029 was created by Bruce Ivins in 1997. Thereafter, Dr. Ivins was called upon to send RMR-1029 to various laboratories, including those at the Army’s Dugway Proving Ground in Utah, as well as those in Ohio owned and operated by the company named Battelle. So, it is likely that the anthrax came from Ft. Detrick. But the attacks “emanated” from either Battelle or Dugway, where the anthrax was converted from the “wet slurry” form it was in at Detrick to the powdered weaponized form found in the letters addressed to the Senators.

Since the FBI announced that Dr. Ivins was the lone culprit, two articles of mine have been published on the internet that set forth the strong evidence that the real source of the anthrax letters was one of our own secret anthrax weaponization projects being conducted by the CIA and the DIA at Battelle’s labs in Ohio and at the Army’s labs in Utah. “FBI Sweeps Anthrax Under the Rug” can be accessed at http://rockcreekfreepress.tumblr.com/post/46413512/fbi-sweeps-anthrax-under-the-rug.

“Amerithrax Hoax” can be accessed at
http://www.opednews.com/articles/AMERITHRAX-HOAX-by-Barry-Kissin-090113-263.html
or at
http://anthraxvaccine.blogspot.com/2009/01/critique-of-chemical-signature.html.

Q: The anthrax letters had “Death to Israel,” “Death to America” and “Allah is Great” printed in them. This seems like a crude propaganda plant to make the public believe the letters were sent by persons from the Middle East or their sympathizers. I’ve also heard it said the Bush Administration leaked information at the time of the anthrax attacks that the letters came from the Muslim world. What do you make of that?

A: This aspect of the anthrax letters is what makes the anthrax letters a “false flag” operation. A “false flag” operation is one wherein a country stages an attack made to look like an attack by an enemy, so as to justify an (aggressive) attack upon that enemy. Clearly, elements in the Bush administration and in the media, for as long as they could get away with it, pretended that the anthrax letters came from Iraq. This played an unmistakable role in gathering support for the invasion of Iraq.

Q: What do you believe was the motivation for the anthrax attacks?

A: The practice of inventing or exaggerating an attack or a threat in order to stimulate demand for military build-up and war has been in place forever. (The Gulf of Tonkin incident and the fabrication of Iraqi soldiers throwing Kuwaiti babies out of incubators before the first Gulf War are important, relatively recent examples.) In his 1961 Farewell Address, President Eisenhower warned about the "unwarranted influence" and “misplaced power” of the “military-industrial complex.” Before that, General Douglas MacArthur declaimed: “Our country is now geared to an arms economy bred in an artificially induced psychosis of war hysteria and an incessant propaganda of fear.” And before that, General Smedley Butler: “War is a racket. It always has been. It is possibly the oldest, easily the most profitable, surely the most vicious.” And while we are at it, let’s also heed James Madison, the primary author of our Constitution: “The means of defense against foreign danger historically have become the instruments of tyranny at home.” And: “If Tyranny and Oppression come to this land, it will be in the guise of fighting a foreign enemy.”

Q: Are you saying the motivation traces back to the profit motive of the military-industrial complex?

A: For many involved in this practice of inventing/exaggerating threat, this is part of an effort to maximize profits. Others are believers in the need for a military build-up, and justify the invention/exaggeration as necessary to establish priority among competing demands for appropriations. No matter the quality of the motivation, the practice is fraudulent, and is directly responsible for the ignored phenomenon that the U.S. spends more on its military than all of the other countries in the world combined.

Q: And is the world’s No. 1 arms merchant as well, plus the U.S. has ringed the globe with 700-800 military installations, all for “defense” of course but, taken together, giving the appearance very much of an aggressive posture, the stance of an imperialist superpower.

A: The neocons who controlled policy under Bush were of course very closely connected to the “defense” sector of our economy, and the profits made in that sector have of course skyrocketed during the past eight years. What distinguished the neocons in this context was that they did not only rely upon inventing/exaggerating threat, they also explicitly espoused “full-spectrum dominance” for the sake of the ascendance of American empire.

Q: So where do the anthrax letters fit in?

A: The anthrax letters must be viewed in this historical context. In the case of the anthrax letters, the invention/exaggeration of threat took the perverse form of an inside job. The Bush Administration has had to officially acknowledge that the anthrax letters were an inside job. But in order to minimize the implications of this fact, the official account resorts to the flimsy claim that the insider was a lone nut named Bruce Ivins, peculiarly driven to stimulate demand for his anthrax vaccine.

The obvious cover-up in Amerithrax, which depends on the complicity of not only our FBI and Department of Justice, but also of our mainstream media, demonstrates how economically and politically powerful are our military-industrial-intelligence forces. Remarkably, despite the admission of inside job, the anthrax letters continue to serve their dual purpose of generating profits and of achieving dominance in the ghastly realm of bioweapons.

Q: Thank you, Barry Kissin.

(Sherwood Ross is a Miami-based public relations consultant who formerly reported for the Chicago Daily News and wire services. He is the author of the article, “America The Beautiful’s Germ Warfare Rash” published in The Humanist magazine. Reach him at sherwoodr1@yahoo.com. Reach Kissin at barrykissin@hotmail.com.)

(Picture)
Barry Kissin leads a march in downtown Frederick to protest plans for the new “biodefense” campus at Fort Detrick. A variety of peace groups came together to express concerns that this campus will threaten local health and safety as well as international arms control.

UK Researchers Create Anthrax Vaccine Pill

2009-02-17T08:54:00.000-05:00

http://news.softpedia.com/news/UK-Researchers-Create-Anthrax-Vaccine-Pill-104738.shtml

UK Researchers Create Anthrax Vaccine Pill
Tests on mice have been very promising

Up to this point in time, administering anthrax vaccines has only been possible through needles. In other words, an eatable pill has been impossible to manufacture, simply because the acidic gastric liquids in the stomach would have disintegrated the vaccine molecules within a matter of seconds, and all its efficacy would have been lost. But now, researchers in the United Kingdom have managed to devise a new way of getting the cure through the stomach, and namely by “packing” it inside small bacteria.

These types of organisms are very common and can be found in products such as milk and cheese. Mice tests have shown minimal damage to the structure of the vaccine, meaning that, in their new “transport” vessel, the precious molecules have safely endured the hardships of the acids each human has in his or her stomach.

“Using 'food grade' lactic acid bacteria as a vehicle provides a safe way of getting the vaccine into the small intestine without losing any of the drug's efficacy,” US researcher Todd Klaenhammer, from North Carolina State University, who has been the co-author of the current study, says.

Finding a cure for anthrax is paramount, at least in America, where terrorists threats have people and authorities on their toes. The bacteria usually causes only minor skin lesions, which can be easily treated. However, if spores are inhaled, they rapidly and silently take hold of people's inner organs, and, by the time they start showing symptoms, it's usually too late for antibiotics to take effect and reverse the contamination.

The only current way to fight this pathogen is through injections, but because the vaccine is made of proteins, multiple shots must be administered, and not all have the desired effect on the body. However, the UK-US team has managed to disguise the proteins of the vaccine into regular bacteria, which can withstand the rigors of passing through a highly-acidic environment.

“Can we make these generally recognized as safe lactic bacteria into a premier delivery system for vaccines and biotherapeutics? That's the question we are now trying to answer,” Klaenhammer opines. The team is currently concentrating its efforts on finding out if other such organisms can carry other types of cures. If so, we could soon see a wide range of antibiotics delivered in the form of pills, and not through injections.

The results of the current research have been published in a recent edition of the journal Proceedings of the National Academy of Sciences. The US Army Medical Research of Infectious Diseases has also participated in the new study.

Court still undecided on report of anthrax testing on soldiers

2009-02-17T07:28:00.000-05:00

http://www.jpost.com/servlet/Satellite?cid=1233304811263&pagename=JPost%2FJPArticle%2F

NOTE:(Most vaccinated Israeli soldiers received US anthrax vaccine)

The Jerusalem Post Internet Edition

Court still undecided on report of anthrax testing on soldiers

Feb. 17, 2009
Judy Siegel-Itzkovich , THE JERUSALEM POST

The High Court of Justice once again deferred a decision Tuesday on whether to allow the publication of a report prepared by an Israel Medical Association committee investigating the giving of anthrax vaccine to over 700 soldiers who served as "guinea pigs" to determine side effects.

The story was initially disclosed by Ilana Dayan's Uvda TV program in 2007 after she received complaints from soldiers who claimed to suffer from side effects that affected various systems in their bodies.

The IDF's then-surgeon general, Dr. Chezy Levy, asked Prof. Avinoam Reches, then head of the IMA's ethics bureau, to set up a voluntary committee of experts to study the matter. Levy is today deputy director-general in charge of medical services at the Health Ministry, which has not taken any action regarding the vaccinations.

The IMA committee was chaired by Prof. Reuven Porat, chief of internal medicine at Tel Aviv Sourasky Medical Center (Ichilov). The committee members heard testimony from hundreds of soldiers who had been vaccinated, allegedly without being warned about possible side effects.

Although the report is ready for publication, the Defense Ministry's office in charge of state security petitioned the High Court to prevent its publication, arguing that its release would "endanger public security."

The IMA denied this. No one knows what is in the 100-page report (plus documents) except for the judges, IMA committee members and Reches.

On Tuesday, Justice Asher Gronis, who headed the three-judge panel, said he read the report and did not get the impression that its publication might hurt national security, but that perhaps there was a legitimate reason for the Defense Ministry's objections. He dispatched thanks (via the IMA lawyers) for working hard to prepare the report.

The court did not issue an opinion or ruling, but apparently may decide to send the report again to the Defense Ministry's office in charge of state security for an additional examination.

U.S. Army Lab Freezes Research on Dangerous Pathogens

2009-02-07T09:24:00.000-05:00

http://blogs.sciencemag.org/scienceinsider/2009/02/us-army-lab-fre-1.html
Proposed Law Would Make NIH Less "Open"

February 7, 2009

U.S. Army Lab Freezes Research on Dangerous Pathogens

The U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) has suspended research activities involving biological select agents and toxins. Army officials took the step on Friday after discovering apparent problems with the system of accounting for high-risk microbes and biomaterials at the Fort Detrick, Maryland, facility.

The lab has been under intense scrutiny since August, when the Federal Bureau of Investigation (FBI) named former USAMRIID researcher Bruce Ivins as the perpetrator of the 2001 anthrax letter attacks. Although the case never went to trial because of Ivins's suicide on 29 July 2008, FBI officials have claimed that the evidence against him is indisputable and that he carried out the mailings using anthrax stolen from a flask at USAMRIID.

Officials have begun a complete inventory of all select agents and toxins at the facility. All experiments using select agents will remain suspended until the accounting is finished, which could take several weeks. Several USAMRIID researchers have been grumbling about the decision, which seems to have caught them by surprise, according to a government official not connected to the lab.

The decision was announced by institute commander Col. John Skvorak in a 4 February memo to employees. The memo, which ScienceInsider has obtained, says the standard of accountability that USAMRIID had been applying to its select agents and toxins was not in line with the standard required by the Army and the Department of Defense. USAMRIID officials believed that a satisfactory accounting involved finding all the items listed on its database; the Army and DOD wanted the converse—that is, all select agents and toxins needed to be matched to the database.

According to the memo, any materials found without a corresponding record in the database must be reported to the Vice Chief of Staff of the Army. "I believe that the probability that there are additional vials of BSAT [biological select agents and toxins] not captured in our … database is high," Skvorak wrote.

A former USAMRIID scientist told ScienceInsider that in the past, inventorying of biological materials at the institute routinely turned up items that had not been listed on the database before. Those items would be added to the database without shutting down research.

—Yudhijit Bhattacharjee

Deadly Bio-Weaponry Build Up Comes to the Heart of the U.S.

2009-01-23T15:27:00.000-05:00

Deadly Bio-Weaponry Build Up Comes to the Heart of the U.S.
http://www.naturalnews.com/025385.html

(NaturalNews) The powers of the world are in a new arms race far more terrifying in its scope than the race for nuclear weapons. Bio-weaponry and bio-wars are now real threats to the future of the human race. What sounds like the stuff of futuristic science fiction is already a quiet reality. The recent announcement of the new site for the National Bio and Agro Defense Facility brings this reality to light, particularly as this site will house level 4 pathogens, some of which are zoonotic, meaning they can jump the species barrier and infect humans.

The new facility, to be built near Manhattan, Kansas will be classified as Biological Safety Level 4 (BSL-4), a designation that allows for the study of the most deadly, most contagious diseases known, diseases for which there are no cures. It will replace the Plum Island Animal Disease Center, located 100 miles northeast of New York City in the Long Island Sound, just six miles off the Connecticut coastline and accessible only by ferry or helicopter, a location where prevailing winds blow out to sea. That facility is closing under the rationale that it does not have the security in place for this higher level of usage. Plum Island carries a lesser BSL-3 classification.

Connecticut residents knowledgeable about what goes on at Plum objected to the creation of a new facility where the old one stands, fearing that lethal viruses could escape onto the mainland.

The Department of Agriculture ran the Plum Island lab until 2003, when it was turned over to the Homeland Security Department as part of the nation's biological defense program. The public's perception of the research at Plum Island, created by government public relations releases, has centered on its mandate to protect herds from hoof-and-mouth disease, a highly contagious virus that is deadly to animals. According to government PR, researchers at Plum work on detection of disease, epidemic control strategies, vaccines and drugs, tests of imported animals, and training of professionals.

A large body of evidence suggests there is much more than this going on at Plum. Circumstantial and factual data has presented the likelihood that Plum is responsible for a number of disease outbreaks that have proven to be national public health and agricultural nightmares. Many see Plum Island as responsible for the re-introduction of the hoof-and-mouth disease it now claims to control. Some point to bio-containment mechanisms at Plum that were allowed to deteriorate and remain non-functional for several years, and lax security that allowed accidents to happen. Others suspect more deliberate actions.

While the stated mission of the new site continues to be the control of such animal diseases, the location for the new facility in Kansas places it near 542,507 head of livestock, over three times the amount in the vicinity of other sites that were considered. An outbreak of hoof-and-mouth disease could require the destruction of tens of millions of farm animals and devastate the livestock industry.

The diseases being researched at Plum are not necessarily contained in glass viles. There are a number of infected live animals for study there with diseases having incubation periods extending for several days. This means it is very possible for a researcher to be infected on Friday, take the ferry home to Connecticut and spend the weekend spreading the infection before any signs of it are visible in him. The government maintains that there has never been a leak to the mainland, and apparently the first appearance of Lyme disease just 13 miles from the facility falls under the category of coincidence, as does the still unexplained initial U.S. appearance of West Nile virus in Long Island and New York.

Bio-weaponry in the U.S. is nothing new

The development of bio-weapons in the U.S. dates back at least to the 1930's when the U.S. Public Health Service conducted an experiment on 399 black men in the late stages of syphilis, called the Tuskegee Experiment. The experiment was designed to see how long it took for men to die from infection by the syphilis spirochete.

During the 1950s and 60s, bio-warfare attacks took place in many parts of America, the most noted being the six day attack on San Francisco during which potentially harmful bacteria were sprayed over the city. In this attack, reported in the September 17, 1979 Los Angeles Times, twelve people developed pneumonia and one man died.

In 1954, Plum scientists looked for ways to inflict bio-damage on Soviet livestock. According the Cuban government, in the 1960s and 70s bio-weapons developed at Plum were deployed against Cuban agriculture, targeting pork, tobacco and sugar cane.

During the Cold War years, thousands of U.S. citizens were used in radiation experiments conducted by the Atomic Energy Commission and other government agencies.

In 2001 the U.S. Department of Defense (DOD) issued a press release admitting it conducted over one hundred tests in which thousands of American servicemen were intentionally dosed with chemical and biological weapons during the period from 1962 to 1973. Dozens of harmful agents like VX, Sarin gas, E-coli bacteria and Bacillus globigii, a cousin to anthrax and bubonic plague, were used on completely unaware and unprotected men. The announcement by the DOD was strategically placed just two days after the mind-numbing 9/11 attacks, at a time when it was given little to no attention by the national media.

Bio-warfare development intensified in the 1970's particularly in the areas of genetic engineering. Much of it was euphemistically referred to as cancer research. During this period cancer causing viruses began to jump from one species of animal to another, a characteristic that signals the viruses are man made. New immunodeficiency diseases were then seen in lab animals.

Although generally regarded as conspiracy theory, some AIDS researchers believe the Special Virus Cancer Program and its connection to bio-warfare development spawned an immunosuppressive virus that was seeded into the gay community via the government sponsored experimental hepatitis B vaccine drive.

The Washington Times, October 19, 1998 reported bio-warfare experiments that took place at Fort Detrick between 1954 and 1973, utilizing volunteers who were exposed to germs causing tularemia, malaria, anthrax, Rocky Mountain spotted fever, encephalitis, and other diseases. Prevention, diagnosis and vaccine development were cited as the reasons for the experiments.

The Los Angeles Times, March 9, 1977, reported other experiments during which the military sprayed bacteria in New York City subways, in a Washington D.C. airport, and on highways in Pennsylvania. Military bases in Virginia, Key West, and off the coasts of Southern California and Hawaii have used live bacteria tests on U.S. civilians.

In 1992, a strike at Plum of union engineers was responsible for a loss of essential support services such as decontamination, waste-water treatment, generator maintenance, and other maintenance and safety-oriented functions. For the duration of the strike, temporary workers were brought in to replace the sentinels and technicians of the infrastructure. The water pressure fell precipitously disabling decontamination facilities and the necropsy rooms where dead animals were examined. In the fifth month of the strike a power failure occurred during which a worker called a Hillary Clinton staffer to complain that the facility was completely out of hand. Without power, the air filtration systems were inoperable, and the decontamination procedures stopped. The seals in the pressurized airlock doors deflated, and workers reportedly tried to seal them with duct tape.

In 1999, the administrator of the Agriculture Research Service persuaded President Clinton to include Plum in his expanded bio-terrorism program based on the possibility of a biological attack on the nation's agricultural base.

In 2001 it was discovered that Plum was involved in an effort to develop vaccine resistant forms of anthrax. Two years later a virologist at St. Louis University announced he was creating a more lethal form of mousepox, a relative of smallpox, and intended to extend his work to cowpox which can infect humans. The problem with research of countermeasures is that they need the lethal measure to go against. Creating deadly bio-weapons to determine how well they can be thwarted gives rise to the potential of more potent plagues. The government's budget for chemical/biological warfare has recently doubled, with $10 billion allocated to bio-weaponry projects.

These incidents are a record of what has become known in spite of all attempts to retain security and secrecy. It is obviously not the full extent of the U.S. government's bio-warfare or bio-weapon testing on its citizens. The full extent of this involvement is hidden in classified documents or is reported to be unavailable.

The increase of new bizarre diseases and organisms raises questions

The appearance in the past several years of AIDS, Legionnaire's disease, hepatitis C, mad cow, hemorrhagic viruses, Lassa fever, chronic fatigue syndrome, Persian Gulf War illness and others have made people question their sources. Older diseases such as tuberculosis, malaria and cholera have re-emerged in more virulent forms that are drug resistant. A study published in the January 6, 1999 JAMA reported infectious disease mortality in the U.S. declined during the first eight decades of the 20th century. From 1981 to 1995, there was an increase in infectious disease mortality of fifty-eight percent. The researchers concluded that recent increases emphasize the dynamic nature of infectious diseases and the need for preparedness to address them.

The official list of excuses for this rising mortality rate makes no mention of the infectious material produced for biological warfare purposes. The anthrax mailings following the attacks of 9/11 have been the only wake-up call that has reached many Americans. It raised the level of public fear enough to spark congressional increase in spending on bio-defense, but it quickly faded from the public mind.

About the same time as this funding was increased, the West Nile virus was dismissed by a government report as not being bio-warfare, a move surprising many people given the government's long and documented history of bio-warfare experimentation on its own citizens.

Bio-weaponry is for sale to the highest bidder

Killer microbes have been for sale to any person or country having the buying power. While the U.S. was still friendly with Iraq, the Education Ministry bought 70 shipments of anthrax and other disease-causing organisms from the U.S. Officials here continued to supply Iraq with bio-warfare material during the prelude to the Gulf War according to the September 24, 2002 Seattle Post Intelligencer.

Was the West Nile virus lab created?

People wonder whether the West Nile virus could be the result of animal experimentation and the laboratory manipulation of the African virus. In September, 2002, the media reported that some West Nile patients exhibited signs and symptoms of polio, although that disease is caused by a different virus. They ask if this means the virus has been laboratory altered. West Nile is generally only fatal in the old and the sick, groups being eyed by the government for their use of entitlements.

Fiction often portrays life's greatest truths

The Poison Plum (2006) is a novelized historical treatise of the Lyme disease now sweeping across the U.S. Recorded incidence of this puzzling illness without a cure shows it to be the fastest spreading disease in America today. From the politics of disease to the agenda of the powerful, the book reveals the betrayal of the nation and its people by their own most trusted institutions. It is a dark portent of the pain and suffering to come as Lyme disease and the escalation of bio-warfare continue.

The book is a testimony to the veil of secrecy surrounding Lyme, a veil that took ten years for the author to penetrate before he finally received his own Lyme diagnosis. It is a mesmerizing and powerful tale that speaks of truths that are only palatable when presented in the form of a story. The connections between Lyme and Plum are probed, as well as the involvement of government laboratories in engineering germs for use in biological warfare. Other questions raised involve the possibility of massive government cover-ups to deny the true severity of Lyme disease and the fact that there is no cure, as well as the involvement of insurance companies denying the complexity of the disease to avoid liability for costly long term treatment protocols.

Sources:

Barbara Minton, Deadly Animal Virus May Soon Come to U.S. Mainland, naturalnews.com.

Patricia Doyle, PhD., Plum Island Lab Moving to Kansas, Goes BSL-4, rense.com.

Alan Cantwell, Jr., M.D., The New West Nile Virus Epidemic: Bioterrorism? Or Mother Nature (Again)? Paranoiamagazine.com.

Patricia Doyle PhD., The Deadly Fools of Plum Island, rense.com.

Poisoned Plum, Primate Freedom, February 3, 2007.

U.S. Uses Bio-Weapons on Their Own People, americasveterans.org.

Revisiting the anthrax attacks

2009-01-22T15:24:00.000-05:00

http://www.eurekalert.org/pub_releases/2009-01/uops-rta012209.php

Contact: Clare Collins
CollCX@upmc.edu
412-647-3555
University of Pittsburgh Schools of the Health Sciences

Revisiting the anthrax attacks
PITTSBURGH, Jan. 22 – When anthrax was sent through the U.S. Postal Service in 2001, an overwhelming majority of postal workers elected not to be inoculated with the available vaccine because of confusion and distrust, according to a University of Pittsburgh Graduate School of Public Health study. Although the FBI officially closed the case on the attacks this year, lingering suspicion and uncertainty remain, say study authors, which could influence the public's reactions to future emergencies.
According to the report, reactions from postal workers were shaped partially by fears of being experimental "guinea pigs," disagreements among public health agencies about whether the vaccine should be recommended, physician advice, low perceived risk of infection and conflicting reports from national media organizations.
The study was based on interviews and focus groups conducted with 65 postal workers in Trenton, N.J., New York and Washington, and published in the December 2008 issue of Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science.
"The reaction of postal workers demonstrates the essential need to build trust and educate the public before the uncertainty, confusion and time pressures of a bioterrorism or pandemic emergency create major barriers for clear communication," said study author, Sandra Quinn, Ph.D., associate dean for Student Affairs and Education and associate professor at the University of Pittsburgh's Graduate School of Public Health. These concerns may be particularly relevant given that, in October 2008, the Department of Health and Human Services declared anthrax as a continuing bioterrorism threat through the end of 2015, she said.
During the 2001 anthrax attacks, which resulted in five deaths, 10,000 postal workers and others who were suspected or confirmed to have been exposed received a two-month dose of antibiotics. The Centers for Disease Control and Prevention (CDC) then recommended people who failed to complete the regimen or who were at high risk for exposure take antibiotics for an additional 40 days with or without a supplemental anthrax vaccine. Only 11.5 percent of postal workers who took the additional 40-day dose of antibiotics agreed to take the anthrax vaccine as a precautionary measure.
"Scientific knowledge about the effectiveness of the vaccine after exposure to anthrax was uncertain at the time, making it an almost impossible task to communicate precise and proper health information to postal workers and other affected groups, including Senate staff," said Dr. Quinn. "Given the evolving nature of the crisis, postal workers were unsure whose advice they should trust and as a result, many decided to do without the recommended vaccination," she said.
In 2004, with the passage of legislation to establish Project Bioshield, the federal government created a mechanism for declaring public health emergencies. This authority also allows the Food and Drug Administration to authorize the use of experimental or "off label" drugs to address bioterrorism or public health emergencies. According to Dr. Quinn, communication about the use of these counter measures will present significant challenges for public health authorities in the future.
To address these challenges, she suggests public health experts openly acknowledge disagreements between health agencies, develop partnerships with trusted community agencies and work with media partners to address inaccuracies, misconceptions or other issues that may arise in news reports.
"We need to engage and educate the public before an emergency occurs to prevent unnecessary risk, disease and even death. Only by doing this can individuals make informed decisions about accepting or rejecting counter measures," she said.

Litigants Argue U.S. Regulators Lacked Basis to OK Anthrax Vaccine

2009-01-16T10:53:00.003-05:00

Global Security Newswire
National Journal Group
Jan. 16, 2009

Litigants Argue U.S. Regulators Lacked Basis to OK Anthrax Vaccine

Friday, Jan. 16, 2009
By Elaine M. Grossman

Global Security Newswire

WASHINGTON -- The Food and Drug Administration violated its own regulations three years ago in approving the anthrax vaccine to prevent infection by a "weaponized" form of the disease, attorneys for eight Defense Department employees alleged in a brief filed last week at the U.S. Court of Appeals (see GSN, March 3, 2008).

(Jan. 16) - The anthrax vaccine received approval in late 2005 as a protective measure against inhaled anthrax (Emergent BioSolutions photo).

The Pentagon began a vaccination program for more than 1 million service personnel in 1998, during the Clinton administration, and continued the effort under President George W. Bush. However, compulsory shots were suspended from late 2003 through early 2007, after a federal judge found the Pentagon lacked the legal authority to
compel inoculations for an unapproved use of the vaccine.

Critics have voiced concern that it is unclear how useful anthrax vaccine is in preventing the highly lethal disease from being contracted through inhalation, and have called attention to the possible risks associated with giving the inoculations to a large population.

The U.S. government recently moved to shield itself from liability in distributing the vaccine in the event of a bio-warfare attack, just as a key advisory panel to the Centers for Disease Control and Prevention approved extending the shots to emergency first-responders nationwide (see GSN, Oct. 17, 2008, and Oct. 23, 2008).

A December 2005 FDA ruling allowed a vaccine previously labeled for use solely in inhibiting anthrax contracted through the skin or the digestive system to also be administered to prevent acquiring the disease via the lungs.

The decision paved the way for the Defense Department to resume mandatory inoculations for service members whose assignments are believed to put them at increased risk of exposure to anthrax during a potential biological attack (see GSN, Sept. 5, 2007).

However, two attorneys who succeeded in temporarily shutting down the mandatory shots program in 2003 remain dissatisfied. They alleged in a second lawsuit, filed in December 2006, that the Food and Drug Administration had not followed its own standards for reviewing a vaccine for approval in issuing its 2005 go-ahead.

The result, they are alleging, is that the vaccine has not been shown to be safe and effective for preventing inhaled anthrax.

U.S. District Judge Rosemary Collyer last year ruled against the plaintiffs, saying the court "will not substitute its own judgment when the FDA made no clear error of judgment."

Plaintiff attorneys Mark Zaid and John Michels took their case to federal appeals court, and the 73-page brief filed last week constitutes their written argument.

"There are ... internal inconsistencies in the [FDA-reviewed] record showing that nobody believed this vaccine was adequate for preventing inhalation anthrax until the DOD decided they were going to conduct this mass inoculation, " Michels said in an interview yesterday. "The FDA's failure [in its 2005 action] to explain all of these contradictory statements [in] their own documents is a violation of the Administrative Procedures Act."

The 1946 federal law controls how government agencies draft and issue regulations.

A Defense Department spokesman praised the federal judge's decision.

"We owe it to our service members to give them every possible protection," Bryan Whitman said last year. "Force protection is the No. 1 priority in the Defense Department and the anthrax inoculation program is an important force-protection measure."

In their Jan. 7 brief to the U.S. Court of Appeals, though, Michels and Zaid took issue with the notion that the vaccine has been proven to protect humans from contracting inhaled anthrax.

If the court invalidates the FDA authorization for this use, the Defense Department could be required to obtain informed consent from any personnel receiving the five-shot series (see GSN, Dec. 22, 2008).

In the case, called Rempfer vs. von Eschenbach, the two lawyers are representing Thomas Rempfer and seven other Defense Department personnel ordered to take the vaccines. Defendants are led by FDA Commissioner Andrew von Eschenbach and include the health and human services and defense secretaries.

"The regulatory history of the [anthrax vaccine] was nothing if not convoluted and contradictory, " according to the plaintiffs' new court submission. "The main basis" for Collyer's decision to dismiss the case "was the FDA's reliance on a single human test of [the anthrax vaccine] that occurred more than 50 years ago, using an admittedly different vaccine," the complainants stated.

The district court judge's Feb. 29, 2008, decision "ignored the significant disparities" in vaccine testing as well as plaintiff allegations that "undercut" the key medical study's "validity and scientific basis," the brief reads.

"We are alleging," Michels told Global Security Newswire, "the FDA has not done its job."

Agency records show a "significant failure by FDA to follow its own procedures with regard to licensing of the current version of the vaccine using data from a vaccine that was manufactured using different standards, a different anthrax strain, and different methodology, " according to the brief. "The District Court's simple acceptance of the representations made by the government was improper and factually unsupportable. "

An FDA spokeswoman today declined to offer comment on the court case.

Pending a possible extension in due date, the government has 30 days to issue its own written brief for the appeals court. After that, the plaintiffs will have an opportunity to submit their response. The appeals panel may then request to hear oral arguments on the case before issuing its decision.

AIG Plasma Donation Program

2009-01-11T09:13:00.001-05:00

http://www.cangene.com/AIGPDP.2.1.2008-1.htm?_show

By becoming a plasma donor for this program, you will help ensure that the country has an adequate supply of a drug called Anthrax Immune Globulin (AIG). Your plasma donation is needed so AIG can be available to potentially protect the safety of Americans in the event of an anthrax attack or exposure.

Regardless of whether or not you have been previously vaccinated against anthrax, you are still eligible to participate in the AIG Plasma Donation Program. At most of our plasma center locations, donors can begin anthrax immunizations or receive a booster vaccination to become eligible for plasma donation. View our Frequently Asked Questions for more detailed information on donor participation requirements or contact your nearby plasma center.

Click here to view our AIG brochure if you have been previously vaccinated against anthrax.

Click here to view our AIG brochure if you have never received an anthrax vaccination.

Top Stock Picks ‘09: Emergent BioSolutions (EBS)

2009-01-10T08:47:00.001-05:00

Top Stock Picks ‘09: Emergent BioSolutions (EBS)

http://macroaxis.com/blog/2009/01/10/top-stock-picks-09-emergent-biosolutions-ebs/

January 10th, 2009 By Steven Halpern
Filed under: Newsletters, Stocks to Buy, Best Stocks for 2009

This post is part of a special annual report -- Top Stock Picks '09 -- in which TheStockAdvisors.com asked 75 leading newsletter advisors to select their favorite investment for the new year.

"Emergent BioSolutions (NYSE: EBS) -- my top 2009 pick -- makes the only FDA-licensed vaccine for the prevention of anthrax," says Timothy Lutts in his The Cabot Stock of the Month.

"Located in Rockville, Maryland, the company is currently filling a $448 million government order for 18.75 million doses, and in October, the U.S. government contracted to purchase 14.5 million additional doses valued at up to $404 million, to add to the Strategic National Stockpile.

"The vaccine is named BioThrax, and it accounts for 97% of the revenues of Emergent BioSolutions. However, the company has a full pipeline including two 'next generation' anthrax vaccines.

"Also in development are two anthrax therapeutics (immunoglobulin and monoclonal), two botulinum vaccines and a botulinum therapeutic (botulinum is the nasty form of Botox), an oral typhoid vaccine, a next generation tuberculosis vaccine, a hepatitis B immunotherapy and a chlamydia vaccine.

Continue reading Top Stock Picks '09: Emergent BioSolutions (EBS)

Top Stock Picks '09: Emergent BioSolutions (EBS) originally appeared on BloggingStocks on Sat, 10 Jan 2009 11:00:00 EST.

Mutating Bird Flu Virus

2008-12-19T12:27:00.001-05:00

Farms may not be using 'right vaccines'
http://www.chinadaily.com.cn/china/2008-12/17/content_7311877.htm

HONG KONG - The re-emergence of bird flu in Asia and Egypt was partly because poultry farms were not using the right vaccines and that the virus is mutating, experts said on Tuesday.

Guan Yi, of the University of Hong Kong and an expert on H5N1 virus, warned that poultry farms in some parts of the world were using vaccines that did not provide full protection against the H5N1 and can't keep up with its mutation process.

"The vaccine (used in Hong Kong) was made to fight an American strain of the H5N2, and it is very different from the Guangdong strain of the H5N1 virus here," he said.

"When there were no outbreaks, we just assumed it was protective. Now that there is an outbreak (on a Hong Kong farm), we assume it is useless," he said.

Since late November, the virus has infected two children in Indonesia, killing one of them.

Earlier this week, it killed a 16-year-old girl in Egypt, too. And a youth in Cambodia tested positive for the virus after eating chicken.

"The virus is definitely mutating," Guan said, warning that authorities in some areas were using batches of vaccine that may no longer be effective.

Since 1997, when H5N1 was identified in Hong Kong, scientists have discovered 10 strains of the virus, which shows the speed and extent at which it is mutating, though it has not mutated to pass from human to human.

The strain found in Indonesia, for example, is very different from the H5N1 strain in Europe, the Middle East and Africa.

"There is a theoretical possibility that the strain being used in the vaccine is too different from the one circulating," said Albert Osterhaus, a leading virologist with Erasmus Medical Center in Rotterdam, the Netherlands.

China Daily - Agencies

Emergent BioSolutions Receives FDA approval for Supplemental Biologics License Application for BioThrax

2008-12-18T12:25:00.000-05:00

Emergent BioSolutions Receives FDA approval for Supplemental Biologics License Application for BioThrax - Quick Facts

http://www.rttnews.com/Content/QuickFacts.aspx?Node=B1&Id=807804%20&Category=Quick%20Facts

Emergent BioSolutions Inc. (EBS: News ) announced that FDA has approved its supplemental Biologics License Application or sBLA for Anthrax Vaccine Adsorbed or BioThrax to prevent disease caused by Bacillus anthracis. The approval for supplement license was based on an interim analysis of data from a large multicenter study initiated in 2002.

The company said the supplement provides for a change in the route of administration and a reduction in the total number of vaccinations. The new schedule for BioThrax is five intramuscular doses at 0, 1, 6, 12 and 18 months, compared with the former schedule of six subcutaneous doses.

Gulf War Illness and the Health of Gulf War Veterans: Scientific Findings and Recommendations

2008-11-21T07:36:00.000-05:00

Gulf War Illness and the Health of Gulf War Veterans: Scientific Findings and Recommendations

A major report on Gulf War Illness written by the VA Research Advisory Committee on Gulf War Veterans' Illnesses (RAC) was made public on November 17. This is the most important document available on Gulf War illnesses yet produced. About 1800 references are cited. The report gets it right about how many have developed the syndrome (25% of those deployed during 1990-1991) and the medical conditions they are experiencing. It emphasizes the desperate need for effective treatments to be developed and used in this population. The report also discusses a number of potential causes of the syndrome, and rules them in or out as significant factors in the report's executive summary.

This report expands on many issues discussed in my September 2007 Senate Veterans Affairs testimony on Gulf War Syndrome. I discussed a greater number of soldiers' exposures (for several of which only limited evidence is available) that were not considered in this report. Overall, my testimony and this report agree on most areas.

However, I weighed the existing evidence differently than the RAC did. Yet we both took a weight of evidence approach. How does one weigh evidence? Imho, it always involves subjectivity.

I used an approach which gave more weight to researchers whose work appeared to be of higher quality, and to evidence derived from 3 or more different groups that used different study methods but yielded the same conclusion. I gave less weight to researchers whose work received substantial criticism, was not internally consistent, or used weak methodologies. I disregarded studies whose results conflicted with those of multiple other researchers. I factored in less tangible factors as well: how politicized choices led to certain research being performed (such as a large body of research favoring psychiatric causes, which was also dismissed by the report) while other valid research was omitted or buried. With respect to anthrax vaccine, in the face of limited and contradictory data we drew very different conclusions.

From the Executive Summary: "About 150,000 Gulf War veterans are believed to have received one or two anthrax shots, most commonly troops who were in fixed support locations during the war. Although recent studies have demonstrated that the anthrax vaccine is highly reactogenic, there is no clear evidence from Gulf War studies that links the anthrax vaccine to Gulf War illness. Taken together, limited findings from Gulf War epidemiologic studies, the preferred administration to troops in support locations, and the lack of widespread multisymptom illness resulting from current deployments, combine to indicate that the anthrax vaccine is not a likely cause of Gulf War illness for most ill veterans. However, limited evidence from both animal research and Gulf War epidemiologic studies indicates that an association between Gulf War illness and receipt of a large number of vaccines cannot be ruled out.

...There is little reliable information from Gulf War studies concerning an association of DU or anthrax vaccine to Gulf War illness. The prominence of both exposures in more recent deployments, in the absence of widespread unexplained illness, suggests these exposures are unlikely to have been major causes of Gulf War illness for the majority of affected veterans."

Yet the RAC cited another study of self-reports indicating that approximately 300,000 GW veterans received anthrax vaccine. According to self-reports, the vaccine correlates highly with GWS. According to (only) DoD, most of these self-reports are wrong. But other studies indicate that self-reports in GW veterans are highly reliable. Four studies (presented by the RAC at meetings I attended) show that anthrax vaccine is correlated with GWS, with a relative risk of 1.5-1.92. A Senate report of 1995 noted that more veterans in support locations had developed GWS, a reason to suspect anthrax vaccine. Which report is correct on this point?

Why are there limited findings from epidemiologic studies? The RAND report on vaccines, first completed in 1999 and later revised, is the only one of eight RAND reports on Gulf War exposures that has never been released. The two studies billed as investigating the long-term effects of the vaccine (the Tripler and CDC studies) have so far not released the long-term safety data. The Defense Medical Surveillance System data have been hidden since 2001, despite a promise to release quarterly analyses wrt anthrax vaccine. Why have eight expert groups during the last ten years called for long-term safety studies, but none are available? The reason is political.

Due to lack of hard data, the report ignores the many soldiers since the Gulf War who received anthrax vaccine and developed an identical illness as GWS. It also seems to have ignored limited data that current OIF/OEF veterans are developing undiagnosed illnesses at a rate of 15-40%.

Without these data, the RAC has drawn at least one insupportable conclusion.

Meryl

http://anthraxvaccine.blogspot.com

Sickening results

2008-11-20T14:07:00.002-05:00

http://www.baltimoreexaminer.com/local/112008anthraxpart2.html#comments
By Deborah Rudacille
Examiner Correspondent 11/20/08

Editor’s note: This is the second of two parts.
Eddie Norman is only 43 years old, but he gets confused when he tries to remember important dates. The Fort Meade veteran walks with an old man’s shuffle and has twice experienced kidney failure. To combat this misery, he takes 13 pills a day.

“What anthrax has done to me, I can’t put a number on,” he says. “It really destroyed me.”

Norman is not a victim of the anthrax letter attacks of 2001. He is a casualty of the Army’s Anthrax Vaccine Immunization Program, instituted in 1998 to protect American troops from the threat of biological warfare. About 2.1 million troops have received the vaccine.

The number of troops who have died, been disabled or suffered chronic health problems after receiving the vaccine easily eclipses the five dead and 17 sickened by the bio-terror attack that began just a week after the Sept. 11 attacks.

Between 1998 and 2000, the first two years of the mandatory vaccination program, approximately 20,765 troops were hospitalized, according to vaccination data that the Pentagon long withheld from lawmakers. The illnesses ranged from systemic reactions such as numbness, joint pain and extreme fatigue to autoimmune diseases such as lupus, musculo-skeletal disorders and other chronic conditions.

It is impossible to say with certainty how many have fallen ill after getting the shots because no one is keeping exact count.

The Food and Drug Administration, however, has confirmed 21 deaths following anthrax vaccination, including Richard Dunn, an employee of the anthrax manufacturer — 16 more than the number of people killed in the letter attacks.

The FDA does not say the troops died because of the vaccine, only that they died after taking the shots.

A troubled program

In the summer of 2001, the Department of Defense’s Anthrax Vaccine Immunization Program was on life support, with veterans, members of Congress and even high-level staff in the newly installed Bush administration all itching to pull the plug.

Active duty military personnel risked court-martial and reservists resigned en masse rather than take the vaccine. According to a 2002 General Accounting Office study that interviewed about 1,200 troops, the reserves were bleeding air crews, as more than half of the 301st Air Squadron at Travis Air Force Base in California had quit or planned to resign rather than take the shots. An Air Guard unit in Connecticut lost a third of its pilots.

Two-thirds of the Guard and Reserve pilots in that study told the GAO they did not support the vaccination program, and as many as 85 percent of those who received the shots said they had experienced side effects. Most admitted they had not reported their symptoms to medical personnel or supervisors for fear of being grounded.

The Pentagon told the GAO that “several hundred” active duty personnel also had refused the vaccine.

In April 2001, White House Deputy Chief of Staff Karl Rove sent a memo to Deputy Secretary of Defense Paul Wolfowitz that the anthrax vaccination program was “a political problem for us.”

Four months later, Sen. Tom Daschle, D-S.D., wrote to Secretary of Defense Donald Rumsfeld challenging the program. A House of Representatives committee report already had recommended suspending the program because of its “experimental” status.

In the midst of the turmoil, the FDA shut down the vaccine’s manufacturer, BioPort Corp. of Lansing, Mich., after citing the company with 84 violations in the manufacturing process. The touted Pentagon program was on the ropes.

But by the fall of 2001, the anthrax attacks breathed new life into BioPort, as the vaccine was in demand not only by the military, but also by consumers, who suddenly were willing to roll up their sleeves. Eight years later, BioPort — now Rockville-based Emergent BioSolutions Inc. — has netted nearly $1 billion in government contracts to produce a vaccine that some biosafety experts call “antiquated.”

Emergent Biosolutions spokeswoman Tracey Schmitt rebutted the allegations made by sick veterans who took the vaccine.

“Biothrax, which is the only FDA-approved vaccine to prevent the infection of anthrax, has been studied more than just about any vaccine in the United States and has been deemed safe and effective,” said Schmitt, who noted that the Institute of Medicine of the National Academies found the vaccine safe and effective in its 2002 report.

Last month, Secretary of Health and Human Services Michael Leavitt declared a seven-year “anthrax emergency,” contracting for another 14.5 million doses of the controversial vaccine for the civilian stockpile at a cost of about $404 million. Leavitt also extended blanket immunity from legal liability for anthrax vaccine-related injuries and deaths to Emergent as well as to government officials and agencies recommending use of its vaccine.

“In the summer of 2001 we were on the verge of getting the entire program canceled,” says an Air Guard pilot whose commander forbids him from speaking publicly about the vaccine. “After the anthrax letter attacks, everyone looked the other way.”

Shot down

In 1988, Norman joined the Army and served in Operations Desert Shield and Desert Storm. He received numerous vaccinations while deployed overseas. Shortly after returning home, he got so sick that he had to be treated at the Gulf War clinic in El Paso, Texas.

Nonetheless, he advanced from private first class to staff sergeant over the next decade. “I have a folder this thick, full of awards,” he says proudly. “That’s the kind of person I was.”

After the implementation of AVIP in 1998, he underwent his second round of anthrax vaccinations and immediately experienced muscle pain and stiffness and ringing in his ears, which grew progressively worse with each shot.

After the fourth shot, Norman says, he started suffering from tremors and involuntary muscle jerks. Following the fifth shot, “I couldn’t get myself out of the bathtub. I couldn’t get in and out of a car.”

He was flown to the Walter Reed Vaccine Health Center and discharged from the Army three years later without ever returning to work. His request for a disability retirement was recently denied. “When I went into the military my goal was to retire from the military,” he says. “Anthrax stopped me. I want that on my record.”

Capt. Kelli Donley’s military career also crash landed after she received the vaccine. Donley, of Beloit, Kan., joined the Air Force in October 1998 and received the first of three anthrax shots before being deployed to South Korea in 2000. Because the vaccine supply was low in the States, due to BioPort’s difficulties with the FDA, she received the other shots overseas from stockpiled supplies.

Like many troops, Donley, a former military lawyer, had a localized reaction to the shots. “My entire right arm went numb,” she says.

“They told me that was normal and that it would go away, and it did. But soon afterward, I started getting clumsy.”

A few months after her last shot, she was gripped by an attack of vertigo and began slurring words. She sought help from a military doctor, but a thyroid test produced normal results, and no further tests were ordered.

It was only after she returned to the States in 2003 that another military doctor ordered an MRI. “It confirmed that I wasn’t making it up.

My cerebellum [that part of the brain that’s critical to coordination and motor control] had shrunk,” Donley says. A civilian neurologist diagnosed her disease as sporadic spinocerebellar ataxia, which occurs when various parts of the nervous system that control movement are damaged.

Donley won a 100 percent disability retirement in 2006, after showing up with 238 pages of evidence. “My records were tight,” she says. “How many can say that?”

Woodbridge, Va., resident Steve Fisher received shots before being deployed to the Persian Gulf in 1999. The former aircraft mechanic spent 26 years in the military and was stationed at McConnell Air Force Base in Wichita, Kan., when he was vaccinated.

“After the first [shot], I got a big lump on my arm,” Fisher said. “After the second one, it swelled again, and I started having flu symptoms. After the third one, my arm swelled up like a peach, and I started having muscular problems, ringing in my ears, vertigo. I’d be walking, and I’d just fall over.”

A base physician diagnosed chronic fatigue syndrome and fibromyalgia and sent him to be tested for allergenicity to the vaccine, he says. Without his consent, the technician, who was administering the test, gave him a fourth shot.

“Then I got really sick,” he says. “I got lesions, lost my hair, couldn’t shake hands, couldn’t walk. For a while, I was worried that I would never walk again.”

Nearly a decade after receiving his last dose of anthrax vaccine, Fisher still suffers from chronic fatigue syndrome, fibromyalgia, an eroded esophagus, asthma, tinnitus and other chronic conditions associated with the vaccine.

“I wish I was an isolated case,” he says, “but I’m not.” Of the 150 men in his unit who got the shots, he says, “seven of us were completely disabled.”

Passive surveillance

Was the Pentagon aware of the serious health risks that came with the anthrax vaccine?

“No question,” says D.A. Henderson, former dean of the Johns Hopkins School of Public Health and former chief of public health emergency preparedness. “There were a series of reports of very severe problems.”

“We used to say that if we gave 10,000 people a glass of water, some number would get a rash and a headache,” says Henderson, who headed the World Health Organization’s campaign to eradicate smallpox through a mass vaccination in the 1970s. “The problem is, how do you sort this out and figure out what is attributable to the vaccine.”

Serious reactions to any type of vaccination are supposed to be monitored through the Vaccine Adverse Events Reporting System, a “passive surveillance” system set up in 1990 to alert the Centers for Disease Control and Prevention and the FDA to potential health problems. Slightly fewer than 6,000 reports of adverse events following anthrax vaccination had been filed through July 2008, according to the FDA.

However, servicemen and women treated in military clinics say clinic staff failed to file VAERS reports. Fisher filled out his own report and faxed it to the FDA, only to be reprimanded by a clerk at the clinic where he was being treated. “She said, ‘You shouldn’t have filled out that form. We’re supposed to do that.’ ”

The same woman later admitted that she had not been sending in the forms. Fisher says she told him directly, “I was directed not to.”

For years, the Pentagon limited the recording of vaccine events to reactions leading to either hospitalization or loss of 48 hours or more of duty time. The Pentagon also rejected a GAO recommendation in 2002 that it institute an active surveillance program to identify and monitor adverse events associated with the vaccine.

Physicians at the Walter Reed Vaccine Health Center preparing letters for sick soldiers filing for disability will say only that their symptoms are “temporally related” to anthrax vaccination. Fisher, Donley and Norman all have copies.

Scientists are fond of pointing out that correlation does not prove causality, and no study has yet proven a causal relationship between the vaccine and the more than 40 side effects reported on the product’s label. That may be because none of the agencies tasked with monitoring the vaccine’s safety has conducted a large epidemiological study of vaccine recipients.

At this late date, even the mechanism by which the vaccine creates immunity is not well understood, says George Mason University professor Serguei Popov. “The vaccine is a very crude precipitate,” he says, “a kind of complex biological soup that contains some protective antigen,” together with proteins and “a certain amount of toxins.”

Popov says that he is suspicious of the vaccine not just because of the health problems reported by veterans, but because it requires so many shots to build and maintain immunity. “Six shots in a year,” he points out. “It’s ridiculous.”

Go to "Scientific impossibility: Did FBI get their man in Bruce Ivins?" for Part I of this series

Costly program with a shady past

2008-11-20T09:00:00.000-05:00

Costly program with a shady past
http://www.baltimoreexaminer.com/local/112008anthrax.html
By Deborah Rudacille
Examiner Correspondent 11/20/08

Bacillus anthracis vegetative cells and spores are pictured in this undated photomicrograph from the official U.S. Department of Defense anthrax information Web Site.

Anthrax is an infectious disease caused by the spore-forming bacteria Bacillus anthracis.

The FBI on Monday, Oct. 8, 2001, took over the investigation into the anthrax death of a Florida man after the germ was found in the nose of a co-worker and on a computer keyboard in their office.

Anthrax Vaccine Immunization Program

The Food and Drug Administration licensed Anthrax Vaccine Adsorbed in 1970, based on a 1950s study of textile mill workers who processed imported goat hair. Each year, several mill workers contracted anthrax, a disease that humans get by touching, breathing or ingesting the pathogen bacillus anthracis from infected animals.

Of the 400 vaccinated workers, three contracted anthrax, and all of them developed cutaneous anthrax, a skin infection that is rarely fatal if treated with antibiotics.

The FDA then approved AVA as safe and effective against cutaneous anthrax.

When anthrax is inhaled, however, its spores germinate in the lungs, releasing toxins that cause internal bleeding and death.

For nearly two decades, scientists studying B. anthracis in biodefense programs — like the one at Fort Detrick in Frederick — received the vaccine that the Michigan State Department of Public Health produced under contract to the Pentagon.

During the first Gulf War the fear of billowing clouds of weaponized anthrax engulfing U.S. troops led to mass immunization. About 150,000 troops received AVA in 1990-91, although the vaccine had never been licensed by the FDA for that purpose.

“There were those who were against it and who made a great fuss about this being an experimental vaccine,” says D.A. Henderson, former chief of the Office of Public Health Emergency Preparedness.

“But it was the only vaccine we had.”

In 1998, the Pentagon mandated all active duty and reserve troops to receive the shots.

That same year BioPort Corp. bought the Michigan plant and the state’s license to manufacture AVA. The newly formed company was facilitated by the late Adm. William Crowe, former chairman of the Joint Chiefs of Staff under Presidents Reagan and George H.W. Bush.

Crowe was friendly with Fuad al-Hibri, the Lebanese-German businessman who became a naturalized American citizen while bidding for the vaccine production facility.

With a limited stockpile, BioPort secured a $45.1 million contract with the Pentagon to ramp up production of a new vaccine, with $16 million upfront for renovations to the aging Michigan facility.

Despite the gush of cash, from 1999 through 2001 the company failed a series of FDA inspections and failed to ship a single dose of new vaccine. The new product also failed potency tests, but the contract signed with BioPort obliged the Pentagon to pay for the unusable product.

The cost was steep: $10.64 per dose versus the previous price of $4.36 per dose under Michigan’s ownership.

With supplies short, the government then injected troops with the old vaccine. Some troops developed symptoms similar to those of Desert Storm veterans suffering from the mysterious collection of maladies lumped together as “Gulf War syndrome.”

In April 2000, the Department of Defense assigned a team of anthrax researchers from the Army Medical Research Institute for Infectious Diseases in Frederick to work on BioPort’s vaccine. The team included Bruce E. Ivins, who, with two of his colleagues, was awarded the Decoration for Exceptional Civilian Service for the role they played in getting production moving again.

Ivins’ job was enhancing the potency of the formulation.

The FBI later accused Ivins of salvaging the program by creating “a situation, a scenario, where people all of a sudden realize the need to have this vaccine.”

That “situation” was the anthrax letter attacks of 2001, which killed five people and sickened at least 17 others.

Sen. Tom Daschle, D.-S.D., received one of the anthrax-loaded letters, nearly two months after he wrote to Secretary of Defense Donald Rumsfeld challenging the vaccination program and punishment of soldiers rejecting the anthrax vaccine.

The FBI insists Ivins sent the letter, even though several leading scientists say it would have been impossible for Ivins, who died this past July 28 after overdosing on prescription Tylenol, to have committed the crime. (Read Part I of this series at baltimoreexaminer.com.)

“The case is solved. We are 100 percent sure that Dr. Ivins was the sole perpetrator of the anthrax mailings,” said FBI spokeswoman Debbie Weierman.

While doubt about Ivins’ guilt lingers in the science community, there is strong evidence the attacks saved the program.

Three months after the attacks, the FDA relicensed BioPort’s Michigan plant, and by the end of 2003, the company (now Emergent BioSolutions Inc.) signed a new $245 million contract with the Pentagon. The next year the company built a $95 million anthrax vaccine plant in Frederick and secured a $122.7 million contract from the Department of Health and Human Services to provide five million doses of the vaccine for civilian use in the event of an emergency.

In December 2005, the FDA issued a final order declaring the vaccine (now called BioThrax) safe and effective for use against inhalation anthrax.

To date, no enemy has assaulted U.S. troops overseas with anthrax.

Anthrax vaccine timeline

» February 1998 — Michigan Biologics Products Institute halts production of anthrax vaccine to renovate facility after stockpiled vaccine fails Food and Drug Administration tests for potency and contamination.

» September 1998 — Facility and license sold to BioPort Corporation for $25 million and $7.9 million of stockpiled vaccine. BioPort signs a Pentagon contract for $45 million worth of vaccine, including $16 million in immediate cash for renovations. FDA suspends shipments from the facility because of quality-control problems.

» September 1999 — Pentagon approves a $24.1 million bailout of the new company after the facility fails FDA inspections.

» April 2000 — Bruce Ivins is appointed to the Anthrax Potency Integrated Product Team from the U.S. Army Medical Research Institute of Infectious Diseases assigned to assist BioPort.

» July 2000 — Pentagon curtails vaccine program because of supply problems. Committee on Government Reform recommends suspension of anthrax vaccination program.

» April 2001— White House Chief of Staff Karl Rove concedes to Deputy Defense Secretary Paul Wolfowitz that AVIP is a “political problem.”

» June 2001 — Sen. Tom Daschle (D-SD) and Rep. Richard Gephardt (D-Mo.) write to Defense Secretary Donald Rumsfeld challenging AVIP.

» August 2001 — Two undersecretaries of defense recommend minimizing use of the vaccine.

» September 2001 — Chairman of the Joint Chiefs of Staff Gen. Henry H. Shelton rejects the recommendation, insisting that AVIP is the centerpiece of a bio-defense program.

» September, October 2001 — Anthrax letters mailed, killing five and sickening 17. Daschle receives one of the letters.

» January 2001 — FDA approves BioPort license to manufacture and distribute anthrax vaccine under new trade name BioThrax.

» June 2002 — Pentagon restarts AVIP. All military personnel required to receive anthrax vaccinations in run-up to Iraq war.

» March 2003 — Ivins wins award for work on BioPort’s vaccine.

» November 2004 — VaxGen of San Francisco awarded a contract to produce 75 million doses of next-generation anthrax vaccine, for which Ivins holds two patents.

» October 2004 — U.S. District Judge Emmett Sullivan suspends AVIP, ruling troops cannot be forced to comply with mandatory vaccination.

» May 2005 — Pentagon appeals judge’s order, seeks to resume mandatory vaccinations.

» May 2006 — Government Accountability Office report says vaccine has not been adequately tested on humans, long-term safety has not been studied and data on short-term reactions is limited.

» October 2006 — Pentagon begins voluntary vaccination program for select personnel.

» December 2006 — VaxGen’s contract for new vaccine canceled after it misses clinical trial deadline.

» February 2007 — Pentagon resumes mandatory vaccination of select troops.

» May 5, 2008 — Emergent BioSolutions Inc. (formerly BioPort) buys rights to VaxGen vaccine.

» July 29, 2008 — Ivins commits suicide.

» August 2008 — Ivins is fingered as culprit in anthrax attacks. FBI says he was concerned that Congress would end the vaccine program.

» September 2008 — PharmaThene Inc. of Annapolis and Emergent win government vaccine contracts worth more than $1 billion; Rep. Rush Holt, D-N.J., proposes a bipartisan commission to investigate the anthrax attacks and the government's response and investigation.

» Oct. 1, 2008 — Emergent wins second order from Department of Health and Human Services for 14.5 million doses of BioThrax worth $404 million.

» Oct. 9, 2008 — Emergent shielded from lawsuits related to anthrax vaccine by Department of Health and Human Services.

Scientific impossibility: Did FBI get their man in Bruce Ivins?

2008-11-16T07:56:00.001-05:00

http://www.baltimoreexaminer.com/local/crime/Scientific_impossibility.html

Scientific impossibility: Did FBI get their man in Bruce Ivins?
By Deborah Rudacille
Examiner Correspondent 11/16/08

Bruce Ivins was a cold-blooded murderer, a deranged psycho-killer, who in the fall of 2001, cooked up a virulent batch of powdered anthrax, drove to Princeton, N.J., and mailed letters loaded with the lethal mix to five news organizations and two U.S. senators.

At least, that’s what the FBI says.

Frederick Police talk with a woman who they identified as Diane Ivins, the widow of Bruce E. Ivins, 62, who died of an apparent overdose of prescription Tylenol mixed with codeine, at their home, Friday, Aug. 1, 2008, in Frederick, Md.

The letters infected 22 people, killing five, including two Maryland postal workers.

The sixth victim of the madness was Ivins himself, a 62-year-old biodefense researcher at the U.S. Army Medical Research Institute of Infectious Diseases, who committed suicide rather than face charges.

Case closed? Neatly wrapped up? Not so fast.

Married for 33 years — and a father of two — with a 35-year career as a civilian microbiologist at Fort Detrick in Frederick, Ivins, a devout Catholic, worked as a senior research scientist and an expert in animal models of anthrax. In 2003 he received the Army’s Decoration for Exceptional Civilian Service for work on an anthrax vaccine — an assignment the FBI now says provided a motive for the attacks.

Ivins apparently was obsessed with the investigation. According to the FBI, on Sept. 7, 2007, he sent an e-mail to himself, claiming to have figured out who mailed the anthrax letters. “I should have it TOTALLY nailed down within the month,” he wrote. “I should have been a private eye.”

Ivins, who did not name anyone in the e-mail, died on July 29, 2008, at Frederick Memorial Hospital after overdosing on prescription Tylenol with codeine. The FBI says he killed himself. The presence of the drug was determined from a blood sample. No autopsy was ordered.

Before his death, he was under 24-hour police surveillance, which included interrogations about his research and work habits, searches of his home and office, and intense questioning of family members and co-workers. Friends say that the FBI offered Ivins’ son $2.5 million and a sports car to hand over evidence implicating his father in the attacks.

The month before Ivins’ death, the federal government agreed to pay $5.8 million to another former Fort Detrick researcher, Steven Hatfill, for “improperly identifying him as a suspect in the case.”

When he learned the FBI was going to charge him with the crime after clearing Hatfill, Ivins swallowed a bottle of Tylenol.

Rush to judgment

In exclusive interviews with The Examiner, two former directors of the bacteriology division at Fort Detrick challenged the science underlying the case against Ivins. They argue it would have been impossible for Ivins to have produced the powdered anthrax in the contaminated letters in the time frame proposed by the FBI — the two weeks following the attacks on the World Trade Center and Pentagon on Sept. 11, 2001

. The BSL-3 (biosafety level 3) suite where Ivins worked at the Institute was composed of a series of laboratories and an office where access was restricted to trained personnel who were required to log in and out.

“Knowing the layout of the BSL-3 suite, the implication that Bruce could have whipped out [anthrax mixture] in a couple of weeks without detection is ridiculous,” says Gerald P. Andrews, director of the bacteriology division and Ivins’ supervisor from 2000 to 2003.

The first anthrax letters were mailed to the New York offices of ABC, NBC and CBS, the New York Post and the National Inquirer in Boca Raton, Fla., on Sept. 18, 2001. The second letters were mailed to Sens. Tom Daschle (D-S.D.) and Patrick Leahy (D-Vt.) on Oct. 9.

Infectious disease specialist W. Russell Byrne, who preceded Andrews as the division’s director, said he “never believed Ivins’ could have produced the preparations used in the anthrax letters working in the bacteriology division area of Building 1425.”

Departmental policy prohibits Institute employees from speaking with the media. But one researcher, speaking anonymously, told The Examiner: “It would have been impossible for Ivins to have grown, purified and loaded the amount of material in the letters in just six days. It simply could not be done.”

Claire Fraser-Liggett, professor at the University of Maryland School of Medicine and director of the University of Maryland Institute for Genome Sciences, asked, “What would have happened in this investigation had Dr. Hatfill not been so forceful in his response to being named a person of interest. What if he, instead of fighting back, had committed suicide because of the pressure? Would that have been the end of the investigation?”

The smoking flask

Fraser-Liggett’s genetic analysis of the anthrax spores in the letters led to a flask of hybrid anthrax bacillus (known as RMR-1029) created and managed by Ivins at Fort Detrick — a preparation the Justice Department says is the murder weapon.

“The key breakthrough was the science that then focused their attention laserlike onto that flask and the person who had control of that flask and the person who made the spores in that flask,” U.S. Attorney Jeffrey Taylor claimed in laying out the evidence against Ivins on Aug. 6, 2008.

The DNA evidence linking the dry anthrax spores in the contaminated letters to the “wet” anthrax spores in the flask of RMR-1029 is not in dispute. “The part that seems still hotly debated is whether there was sufficient evidence to name Dr. Ivins as the perpetrator,” Fraser-Liggett says.

Ivins kept the one-liter flask of RMR-1029, but some 300 people within the Institute also had access to the flask, according to those familiar with operations there. Before 1999, the preparation was stored in a separate containment area, about 100 yards from the main building. At that time, “access was more vague, because the flask wasn’t under Ivins’ direct custodial control,” Andrews says.

Ivins also shared samples of RMR-1029 with researchers at other facilities.

“Another lab might take a couple of milliliters of that spore preparation and create a daughter preparation,” Andrews says. “How many [samples] Ivins gave out I have no idea, but he did it through official channels, and there is a chain of custody records that indicates which labs got RMR-1029 and how much of the material they got.”

It was those “daughter preps” that ultimately led Fraser-Liggett to Ivins’ flask. Her team at the Institute for Genomic Research began DNA sequencing of the spores in the four anthrax-loaded letters recovered after the 2001 attacks. The team spent two years analyzing 20 different samples of B. anthracis to create a group of tests capable of genetically fingering the distinctive variety of anthrax found in the letters.

They screened nearly 1,000 samples of B. anthracis collected from labs around the world. “The results identified only eight samples that contained all four of the genetic mutations,” she says. “Each of those could be traced back to this one flask at USARMRIID-RMR-1029.”

“I have complete confidence in the accuracy of our data,” Fraser-Liggett says, but she concedes it fails to prove Ivins is guilty.

One reason for doubt is the sheer volume of powdered anthrax Ivins is alleged to have grown. Nearly 1 gram per contaminated letter would have required months of intensive labor and hundreds of agar “plates,” on which the spores are grown, Byrne says.

“This number of plates is impossible to handle inconspicuously,” says George Mason University professor and former Soviet bioweapons researcher Sergei Popov.

“It would be impossible to cover up these activities.”

Prosecutors insist Ivins carried out the work secretly at night and on weekends.

That scenario is patently impossible, Andrews says. “You can’t just throw a flask up in the air and have dry weaponized spores come down. One preparation may take between three and five days — Day 1 to prepare the materials and start seed cultures, Day 2 to inoculate the spores, Day 3 to harvest, centrifuge and purify the spores. And those are the wet spores,” he says, which then need to be dried into a powder. And that would take at least another day.

“So for 10 envelopes, 100 preparations would be required to make all the mailed material at three to five days for each preparation,” he says. “Months of continuous spore preparation without doing any other work and avoiding detection? It’s ridiculous.”

Taylor also insists Ivins had access to a lyophilizer — a sophisticated machine used to dry anthrax.

Andrews mocks the suggestion that Ivins produced the fine powdered anthrax by freeze-drying the newly harvested pores in the lab’s lyophylizer. “The only lyophylizer available was a speed vac,” he says. “That’s a low-volume instrument that you can’t even fit under a hood” used to contain toxic vapors and debris.

Even with the proper equipment, mass producing a sufficient volume of spores remained dangerous. It had the potential to contaminate not only the person doing the work, but also the lab environment. “Certainly if you had makeshift equipment you wouldn’t be able to pull it off without making a mess,” Andrews says.

Popov said that the only way the FBI scenario works is if someone else provided the spores to Ivins. “What if somebody fermented the spores for him?” he asks. “What’s in favor of this hypothesis is the presence of silica in the spores. This is a signature of a large-scale fermentation process.” In other words, the evidence points to a high-volume, mechanized operation and not to a lone madman cackling over agar plates at night in an empty lab.

Lack of evidence

The anthrax-laced letters contained no traces of DNA. There is no evidence indicating Ivins visited Princeton, N.J., at the time the letters were mailed — no fingerprints or hair samples from the “smoking mailbox,” no time-stamped photos at New Jersey automated teller machines or convenience stores, no gas receipts.

Apart from the flask of RMR-1029, the case against Ivins is this: He was depressed, working long nights and weekends in September 2001, and had the time to drive to New Jersey.

Ivins’ therapist, Jean Duley, who had a history of drug and alcohol-related charges, treated him for six months. She told authorities he threatened to kill her and his co-workers after learning he faced indictment. He was committed for a few days and released five days before his death.

“Dr. Ivins had a history of mental health problems and was facing a difficult time professionally in the summer and fall of 2001 because an anthrax vaccine he was working on was failing,” Taylor said in August. “He was very concerned, according to the evidence, that the vaccination program he was working on may come to an end.”

For more than a year, Ivins and other institute researchers had been working out the kinks on a 30-year-old anthrax vaccine suspected of causing serious health problems in Gulf War vets. He also was working on a next-generation vaccine for which he already had secured two patents. But in the fall of 2001, the Pentagon’s vaccine program for 2.4 million troops faced fierce opposition by lawmakers — including Daschle, pushing to end the program.

Taylor insists Ivins was the “sole culprit” and wanted “to create a situation, where people all of a sudden realized the need to have this vaccine.”

If that was indeed the anthrax killer’s motive, it worked.

Ivins’ innocence could rest on weird science

The single most important piece of scientific evidence that raises doubt on whether Bruce Ivins was the mastermind behind the anthrax attacks could very well prove his innocence.

The high silicon content of the spores and the presence of a bacterium B. subtilis in two of the recovered letters are significant scientific factors that have yet to be satisfactorily explained.

The FBI says that the silicon in the spores accumulated naturally during the growth process — important to its case against Ivins, who co-workers say did not have knowledge of the specialized techniques used to weaponize anthrax spores by coating them in silicon.

Silicon creates an electrostatic charge between particles that helps the lethal powder disperse more readily.

“The silicon is probably the most important scientific evidence that would lead anybody to question whether Bruce was capable of making these spores,” says Gerald P. Andrews, Ivins’ former boss.

Andrews and George Mason University professor and former Soviet bioweapons researcher Sergei Popov believe the silicon was purposely added, due to unnaturally high levels of the mineral in the spores.

Also unexplained is the presence of a unique genetic strain of the bacterium B. subtilis in the anthrax letters.

“Why wasn’t this unique B. subtilis strain looked for in Bruce’s lab — or any other lab in the BSL-3 suite?” Andrews asks. “It may, in fact, serve as a marker for where those preparations were really made.”

So far, FBI scientists have failed to produce a powdered anthrax equivalent to the toxic mix that Ivins is alleged to have turned out in the course of a few late nights and weekends in the lab at Fort Detrick.

“The only opinions that I would place any confidence in would have to come from individuals who have made the stuff, in the same quantity of the letters,” said infectious disease specialist W. Russell Byrne. “And then I would ask them to go into B3 in building 1425, work there for a couple of weeks and reproduce what they say Bruce did. That’s the only way I could, in good conscience and in the spirit of objective scientific inquiry, believe them.”

Bruce Edwards Ivins
• Born: April 22, 1946 in Lebanon, Ohio.
• Died: July 29, 2008 in Frederick, Md.
• Family: Married for 33 years to Diane Ivins (homemaker, day care provider and former president of Frederick County’s Right to Life). Two grown children, Andrew and Amanda
• Work: Senior biodefense researcher at the United States Army Medical Institute of Infectious Diseases at Fort Detrick in Frederick
• Education: B.A. (1968); M.A. (1971) and Ph.D. (1976) in microbiology, University of Cincinnati
• Hobbies: Played keyboards and sang in a folk group at St. John the Evangelist Catholic Church in Frederick; founded the Frederick • Jugglers, who performed at nursing homes, schools and festivals.
• Volunteer work: Frederick County Chapter of American Red Cross
• Political party: Democrat

Vaccinations Against Bird Flu Should Happen Now, Say Experts

2008-11-05T07:29:00.000-05:00

The report says that if pre-priming with an H5N1 vaccine becomes an acceptable strategy, thought should be given to including this in the regular seasonal flu vaccines.

The experts say that although it is still unclear if a bird flu pandemic will emerge, because of the potential high death rate and huge economic cost "we simply cannot afford to ignore it as a major global threat." They point out that estimates of global deaths from bird flu have suggested that up to 350 million people could die.

The candidate vaccine contains the bird flu strain H5N1 and an adjuvant called MF59.

He added: "If governments are thinking about stockpiling vaccine, you could actually be stockpiling it in people's arms."

http://www.medicalnewstoday.com/articles/128049.php

Vaccinations Against Bird Flu Should Happen Now, Say Experts

People should be vaccinated now against bird flu rather than waiting for a global pandemic to erupt, an international panel of experts - including a leading British influenza specialist - say in a new report. 1

The influenza researchers say the World Health Organisation (WHO) and national governments should give "urgent consideration" to the idea of priming people in advance of bird flu with a preparatory vaccination.

The idea is to give people a vaccination now against bird flu to build up the immune system, while there is still plenty of time to organise the programme, then give them a booster shot when the pandemic is imminent. The primed people could be protected in a week as opposed to six weeks. 2

The experts, including Professor Karl Nicholson, from Leicester University, state: "We think that WHO and governments should give urgent consideration to the potential risks and benefits of priming people who would be at greatest risk of infection if a pandemic of H5N1 influenza were to emerge (frontline laboratory and health-care workers), with the view to cautiously introducing a programme of immunisation."

In a report in the latest edition of the journal Lancet Infectious Diseases the researchers point out that a conventional vaccination policy against bird flu requires two doses of H5N1 vaccine before people are protected "which may be logistically difficult to organise".

They say there may be no warning before a pandemic suddenly appears, as the early danger signs may be missed.

"However, pre-pandemic priming has the potential to evoke a more rapid antibody (defence cell) response that might ameliorate the disease, cutting hospital admissions, deaths, and onward transmission of the virus," say the doctors.

The report says that if pre-priming with an H5N1 vaccine becomes an acceptable strategy, thought should be given to including this in the regular seasonal flu vaccines.

The experts say that although it is still unclear if a bird flu pandemic will emerge, because of the potential high death rate and huge economic cost "we simply cannot afford to ignore it as a major global threat." They point out that estimates of global deaths from bird flu have suggested that up to 350 million people could die.

The report concludes: "The maximum benefit from using a pre-pandemic vaccine may be gained from priming populations before there is evidence of a novel virus emerging and spreading, when systematic supply, distribution and vaccination strategies can be put in place."

Just a few weeks ago a team of researchers from Leicester University, including Professor Nicholson, together with vaccination experts from the Health Protection Agency, gave details of a British study showing that pre-priming people could give protection against bird flu within a week. 2

That study, released in a letter to the New England Journal of Medicine, looked at an experimental pre-pandemic vaccine being developed by Novartis Vaccines.

The candidate vaccine contains the bird flu strain H5N1 and an adjuvant called MF59. (An adjuvant is a substance used to improve the response of the immune system to a vaccine.)

The study looked at how quickly people mounted a protective immune response against H5N1 if they had already been pre-vaccinated with a different kind of flu vaccine, using a strain known as H5N3 together with MF59.

The pre-vaccinated people received their first vaccination between 1999 and 2001 as part of earlier studies.

Two groups, involving around 60 British patients, were involved in the study - one set who had been pre-vaccinated and another set that had not.

By day seven 80% of the primed group showed a protective response after one shot of the adjuvanted vaccine compared to 20% in the un-primed group.

Study investigator Dr Iain Stephenson, from University Hospitals Leicester, said: "With the pre-priming approach you could choose certain groups in advance, for instance health care workers, and almost vaccinate at leisure. Then you would only a need a week to provide protection."

The New England Journal of Medicine study was welcomed by other flu experts.

Dr John Wood, from the National Institute for Biological Standards and Control, a government funded body which helps in the production and testing of vaccines for emerging flu strains, told the BBC: "The fact that they seem to have this protection after eight years is really interesting."

He added: "If governments are thinking about stockpiling vaccine, you could actually be stockpiling it in people's arms."

An influenza pandemic occurs when a new influenza strain emerges (one to which humans have no immunity), mutates and spreads globally as a virus. Although it is not possible to predict the actual pandemic influenza strain, global health authorities have identified H5N1 avian influenza as a strain with the greatest pandemic potential in humans. 3

H5N1 is currently circulating in birds and has caused serious illness in more than 380 people worldwide with a mortality rate, among people known to have been infected, of greater than 60 percent. 4.

The purpose of pre-pandemic vaccination is to prime the immune system to better defend against infections from an H5N1 influenza virus and is intended for use before the World Health Organization (WHO) declares an influenza pandemic.

MF59 is used in a vaccine against seasonal flu specially designed for older people who have weaker immune systems so do not respond so well to traditional vaccines, although this particular vaccine is not currently available in the UK. More than 40 million doses have been distributed worldwide since 1997. 5

References

1 Jennings LC et al. Stockpiling prepandemic influenza vaccines: a new cornerstone of pandemic preparedness plans. Lancet Infectious Diseases 2008; 8: 650-658

2. Stephenson I et al. Antigenically distinct MF59-adjuvanted vaccine to boost immunity to H5N1. New England Journal of Medicine 2008; October 9: 1631-1633

3. World Health Organization Avian influenza H5N1 infection in humans, WHO Web site: http://www.who.int/csr/don/2004_01_22/en/index.html, accessed August 22, 2008

4. World Health Organization Cumulative Number of Confirmed Human Cases of Avian Influenza, WHO Web site, accessed August 19, 2008

5. Company data on file.

Source

Zarina Baloch
Public Relations Department
Novartis Vaccines and Diagnostics UK
Frimley Business Park
Frimley, Camberley, Surrey GU16 7SR
United Kingdom
http://www.novartis.com

Panel OKs Anthrax Shots for First Responders

2008-10-31T07:58:00.000-05:00

Volume 322, Number 5902, Issue of 31 October 2008
©2008 by The American Association for the Advancement of Science.

Panel OKs Anthrax Shots for First Responders

A U.S. scientific panel thinks that police, firefighters, people who work with hazardous materials, and others running the risk of exposure to an anthrax infection may be offered the vaccine against the fatal disease. That suggestion, from an advisory panel to the U.S. Centers for Disease Control and Prevention (CDC), is a departure from current policies.

Anthrax vaccination is compulsory for military personnel serving in risk areas overseas. Although most experts believe the vaccine--six shots over a period of 18 months--is safe, some service members believe it has made them ill, and some have filed lawsuits. Relying on new safety data, CDC's Advisory Committee on Immunization Practices agreed on 22 October that first-responder agencies "may choose to offer" their staff the vaccines on a voluntary basis--but it stopped short of recommending they do so.

That caution reflects the panel's inability to assess the risk of future attacks, says the committee's chair, Dale Morse, who adds that the job site and duties affect a worker's risk of contracting anthrax as well. "We believe it's very low, but we can't say it's zero," Morse says. Meryl Nass, an internist at Mount Desert Island Hospital in Bar Harbor, Maine, who strongly opposes the military program, believes the recommendations will put more people at risk for adverse events. No first responders became infected during the 2001 anthrax letter attacks, which killed five people.

PREPA - and what this means to you

2008-10-19T08:51:00.000-05:00

October 17, 2008

The Public Readiness and Emergency Preparedness Act (PREPA) has reared its ugly head again in the wake of Mike Leavitt, Secretary of the Department of Health and Human Services (DHHS) declaring a seven-year anthrax emergency through the end of 2015.

PREPA goes beyond the anthrax vaccine and it is imperative all Americans, military or not, understand what our government has done to us. PREPA, which is completely unconstitutional, will be discussed further below.

First, let’s focus on the Anthrax vaccine.

Anthrax

A declaration of an anthrax emergency for seven years is another case by this administration of the “Boy who Cried Wolf”. The Advisory Committee on Immunization Practices (ACIP), an advisory to the CDC regarding vaccinations, are poised to meet and vote on October 22nd, 2008, to expand the anthrax vaccine to civilians.

The latest study conducted by the CDC published October 1st, 2008 and reported in a JAMA article consisted of 1,564 subjects. The report barely mentions the adverse events implying that the vaccine is safe, but in fact, 229 severe adverse events and 7 deaths occurred during this trial. For further information on serious adverse events reported following receipt of the anthrax vaccine, one need not look further than the product label, pages 5-6. http://bioport.com/pdf/emergent_biothrax_us.pdf

The declaration of an anthrax emergency, through PREPA, has been invoked as an attempt to push the anthrax vaccine on an unsuspecting public, while single-handedly perform tort reform for the anthrax vaccine in the absence of legislative approval, because the administration knows that there will be injuries. The emergency declaration for the anthrax vaccine is disastrous for Americans, but it is sure sweet for the manufacturer, Emergent Biosolutions, aka: Bioport. Mike Leavitt contracted to buy an additional $400 million worth of anthrax vaccine to add to the current $500 million currently in the nation’s stockpile. It is unclear how, or even if, the current stockpile is still valid given that the shelf-life for the vaccine has expired, but we at least know according to the GAO that 12 months ago, $100 million worth of vaccine was lost due to expiration at the taxpayer’s expense.

Interestingly enough, in the October 6th, 2008, Federal register; Mike Leavitt also gives blanket immunity for liability for use of the anthrax vaccine (and anthrax countermeasures) to not only the manufacturer, but specifically giving government officials immunity for even recommending the anthrax vaccine, should injuries or deaths result from a recipient. (http://edocket.access.gpo.gov/2008/E8-23547.htm)

"Whereas, immunity under section 319-F3(a) of the Act should be available to governmental program planners for distribution of covered countermeasures..."

Diseases/Vaccinations

PREPA (which will be addressed below) gives the Department of Health and Human Services, Secretary (currently Mike Leavitt) the authority to declare any disease an act of emergency.

The latest measles outbreak which was deemed an “epidemic” consisted of approximately 131 cases in the United States of America out of a population of more than 300,000,000. (By the way, no deaths occurred from this “epidemic”). According to PREPA, the Secretary of DHHS could have declared this to be an emergency, utilizing mass vaccinations. Unless a person who suffered an injury could have “proven” the injury resulted from the vaccination (a near impossible task), no compensation could be received and no one held accountable.

Taken in part from a news article regarding PREPA and using vaccinations/drugs on American citizens in a “state of emergency”: (it should also be noted it wouldn’t matter if these drugs/vaccines were approved by the FDA or not)

“But Sen. Edward Kennedy, D-Mass., and some other Democrats, along with consumer groups such as Public Citizen, derided the liability provision as a giveaway to the drug industry. Kennedy said the bill makes it "essentially impossible" for injured parties to sue for damages. He also argued that the measure allows the HHS secretary to use many common diseases as a reason to activate the liability shield. "Without a real compensation program, the liability protection in the defense bill provides a Christmas present to the drug industry and bag of coal to everyday Americans," stated a Dec 21
news release issued by Kennedy and Sens. Tom Harkin, D-Iowa, and Chris Dodd,
D-Conn.”

Public Readiness and Emergency Preparedness Act (PREPA)

PREPA was passed by Congress and signed into law on December 30, 2005. Probably few in Congress read it before approving it along with defense spending. You can read the bill at:
ftp://ftp.hrsa.gov/countermeasurescomp/Public_Readiness_and_Emergency_Preparedness_Act.pdf

The original bill under which Secretary Leavitt made his Declaration, the Public Readiness and Emergency Preparedness Act (PREPA, part of P.L. 109-148) gave the DHHS Secretary the right to declare any disease an emergency, triggering immunity from liability for any and all injuries due to countermeasures for that illness, unless "willful misconduct" by those who made or administered the product could be proven. The Act fails to specify any criteria for determining that an emergency exists, and fails to fund a compensation mechanism. It was tacked on to the end of the 2006 Defense Appropriations Bill during the night, after being removed from another bill due to its controversial nature.

It is unclear under PREPA should an individual refuse what that would entail. Quarantine? Maybe. Forced vaccination/drug intake with or without your consent? Maybe. It is unknown and answers have tried to be sought to no avail.
In a news release issued after the bill passed, Senator Frist, R-TN said the
measure "extends limited protections to manufacturers, distributors, and first responders, so that life-saving countermeasures, such as an H5N1 avian flu vaccine, will be developed, deployed and administered."
http://www.cidrap.umn.edu/cidrap/content/influenza/biz-lan/news/dec2805liability.html

The Democratic Senators introduced a new bill to supersede PREPA in
February 2006, http://www.fas.org/biosecurity/resource/legislation/s2291.htm, but it never passed.

Take Action Now

Such measures may be deemed acceptable if this country was an anarchy, an autocracy, an oligarchy, or a democracy. However, the United States of America is a Republic, meaning it is ruled by law, as opposed to one, the minority or majority.

It is past time the United States of America gets back to its roots. The roots are the citizens of this country, not the government, we as the people, and the government have seemed to have forgotten that.

So what do we need to do in regards to PREPA:

Four particular senators that initially tried to overturn PREPA needs to be contacted again now that the democrats are in the majority to resurrect a bill to rescind PREPA. These Senators are Senator Kennedy, (D-MA), Senator Dodd (D-CT), Senator Harkin (D-IA) and Senator Bingaman (D-NM). Their contact information is:

Senator Tom Harkins Senator Chris Dodd
Washington DC Washington DC
(202) 224-3254 Phone (202) 224-2823 Phone
(202) 224-9369 Fax (202) 224-1083 Fax

Senator Edward Kennedy Senator Jeff Bingaman
Washington DC Washington DC
(202) 224-4543 Phone (202) 224-5521 Phone
(202) 224-2417 Fax (800) 43-8658 Phone (from NM only)

Take the opportunity to not only call the above Senators expressing your concerns, call your own Senator. In each call, express what you want him or her to do. A few examples are:

1. To introduce a bill to rescind PREPA, as they tried to do in 2006.

2. Let them know the only emergency there is, is the ending of this administration, and its final opportunity to expand the anthrax vaccine market which is not acceptable. Should you be asked how you know there is no emergency to use the anthrax vaccine, have your Senator contact the Department of Homeland Security him/herself. According to Secretary Chertoff, in a September 23, 2008 memo:

“There is not currently a domestic emergency involving anthrax. Additionally, there is not currently a heightened risk of an anthrax attack. We have no credible information indicating an imminent threat of an attack involving Bacillus anthracis.”

http://74.125.45.104/search?q=cache:1CfmoQ4r6NAJ:www.dhs.gov/xlibrary/assets/ofsec_signed_determination092308.pdf+credible+information+indicating+an+imminent+threat+of+an+attack.&hl=en&ct=clnk&cd=3&gl=us

3. To promise an investigation into the “anthrax emergency” and to investigate how such a law like PREPA could have been passed in our republic, and who is responsible.

4. To act to halt CDC's plan to approve civilian anthrax vaccinations. They have the power to do this. Remind them that CDC’s latest clinical trial of anthrax vaccine resulted in 229 serious adverse events and 7 deaths, but they will not be revealed until late 2009, while CDC's plan to expand vaccinations goes through without proper attention to vaccine side effects.

5. Let them know you will not surrender your constitutional rights or that of your child’s to an appointed unelected official for any reason.

Then, call your local media and ask them to carry stories about this frightening turn of events. Only through awareness and action can change occur.

If you have any other thoughts or ideas, please share them with me, Dr. Meryl Nass (mnass@gwi.net) or Randi Airola (randiceaj@sbcglobal.net)

The time to act is now. Remember, CDC’s vote will take place around noon on Wednesday, October 22nd, 2008.

Thank you for publicizing this cynical use of "government against the people"

Meryl Nass, MD
Mount Desert Island Hospital
Bar Harbor, Maine 04609
Cell: 207 522-5229
Home: 207 244-9165
Pager: 207 818-0708
http://anthraxvaccine.blogspot.com
http://www.anthraxvaccine.org

Randi Airola
http://www.military-biodefensevaccines.org

Permission is both granted and encouraged to disseminate this letter in its entirety as written to anyone that cares about life, liberty, freedom and this great country, a republic.

Contact Your Reps: DHHS designates an anthrax emergency as a means to protect--- ITSELF!

2008-10-19T07:00:00.000-05:00

DHHS designates an anthrax emergency as a means to protect--- ITSELF!

A series of coordinated moves designed to encourage new uses for anthrax vaccine (whose safety record is terrible and effectiveness unknown)—while excluding any manufacturer liability for its use, preempting state and local laws designed to protect citizens, and extending blanket immunity to government officials who came up with the plan--- is in process.

First, DHHS Secretary Leavitt declared that the US is in an anthrax emergency. This invoked the Public Readiness and Emergency Preparedness Act, giving blanket immunity from liability to all entities involved with the manufacturer and distribution of anthrax countermeasures, including “government program planners”.

Second, Leavitt contracted to buy $400 million worth of anthrax vaccine, in addition to over $500 million currently in DHHS’ stockpile.

Third, CDC (a DHHS agency) asked its vaccine advisory committee to vote on changing its previous recommendation for anthrax vaccine on October 22, potentially expanding its use to civilian “first responders”.

Fourth, the vaccine’s manufacturer is constructing a new manufacturing plant to supply up to 30 million vaccine doses yearly.

Fifth, CDC conducted a clinical trial of anthrax vaccine in 1564 subjects, but released only partial information on the trial in a JAMA article published October 1st, implying that the vaccine is safe. Yet 229 severe adverse events and 7 deaths occurred in trial participants, but were barely mentioned in CDC’s report.

Background

The original bill under which Secretary Leavitt made his Declaration, the Public Readiness and Emergency Preparedness Act (PREPA, part of P.L. 109-148) gave the DHHS Secretary the right to declare any disease an emergency, triggering immunity from liability for any and all injuries due to countermeasures for that illness, unless “wilfull misconduct” by those who made or administered the product could be proven. The Act fails to specify any criteria for determining that an emergency exists, and fails to fund a compensation mechanism. It was tacked on to the end of the 2006 Defense Appropriations Bill during the night, after being removed from another bill due to its controversial nature. It was passed by Congress and signed into law on December 30, 2005. Probably few in Congress read it before approving it along with defense spending.
You can read the bill at: ftp://ftp.hrsa.gov/countermeasurescomp/Public_Readiness_and_Emergency_Preparedness_Act.pdf

In a news release issued after the bill passed, Senator Frist, R-TN said the measure "extends limited protections to manufacturers, distributors, and first responders, so that life-saving countermeasures, such as an H5N1 avian flu vaccine, will be developed, deployed and administered." http://www.cidrap.umn.edu/cidrap/content/influenza/biz-plan/news/dec2805liability.html

But Sen. Edward Kennedy, D-Mass., and some other Democrats, along with consumer groups such as Public Citizen, derided the liability provision as a giveaway to the drug industry. Kennedy said the bill makes it "essentially impossible" for injured parties to sue for damages. He also argued that the measure allows the HHS secretary to use many common diseases as a reason to activate the liability shield. "Without a real compensation program, the liability protection in the defense bill provides a Christmas present to the drug industry and bag of coal to everyday Americans," stated a Dec 21 news release issued by Kennedy and Sens. Tom Harkin, D-Iowa, and Chris Dodd, D-Conn.

The Democratic Senators introduced a new bill to supercede PREPA in February 2006, http://www.fas.org/biosecurity/resource/legislation/s2291.htm but it never passed.

Where is the Anthrax Emergency?

Over the past month, in the waning days of the Bush administration, and with no emergency in sight, DHHS is using PREPA against Americans to shield not only manufacturers and medical professionals, but also to immunize everyone in government who worked on the plan from any liability for problems that arise.

Yes, you heard correctly: although the media never reported on this provision when PREPA was passed, the bill specifically shields “government program planners” who deal with PREPA’s emergencies from all potential liability.

On October 1, 2008 DHHS Secretary Mike Leavitt declared an anthrax emergency under the PREPA Act, through the end of 2015. (That sounds like a very long emergency—or a very long time to enjoy liability protection.)
http://edocket.access.gpo.gov/2008/E8-23547.htm
Despite the current absence of anthrax infections in Americans, the “emergency” has been declared, and the liability shield is already in effect for anthrax vaccine and other anthrax countermeasures, including antiserum, monoclonal antibodies and multiple antibiotics.

$500 million in new anthrax vaccine spending

October 1, 2008 was a busy day in the anthrax world. DHHS announced it was going to purchase an additional 14.5 million doses of anthrax vaccine, for a cost between $364and $404 million, to add to its existing stockpile of about 25 million doses. http://www.washingtonpost.com/wp-dyn/content/article/2008/10/01/AR2008100102951.html

The manufacturer, Emergent BioSolutions, crowed about the liability protection it had just received for the purchase.
http://www.bizjournals.com/baltimore/stories/2008/10/06/daily45.html

Furthermore, on September 26, DHHS announced contracts for a total $113.6 million with Emergent BioSolutions and Pharmathene for development of “Third Generation” anthrax vaccines. These too are covered under Secretary Leavitt’s Declaration. What vaccines are these? Emergent bought its competitor VaxGen’s vaccine for $2
million, after taxpayers and investors paid over $200 million for its development. When in 2006 VaxGen failed to meet DHHS-specified milestones, its contract was cancelled and the company folded.

Pharmathene bought Avecia’s vaccine, after Avecia received a $100 million DHHS contract for early vaccine development, but failed to get a more lucrative contract later.

Bottom line: both these vaccines were rejected by DHHS during the past five years, only to suddenly arise again, and consume additional taxpayer largesse. Yet if the current vaccine were truly acceptable, a newer vaccine would be unnecessary.

Expanding the anthrax vaccine market

If DHHS simply planned to stockpile more anthrax vaccine, its purchase would just be another example case of government waste. The current stockpile is expiring at a rate of $10 million per month, as pointed out by GAO last year. http://www.washingtonpost.com/wp-dyn/content/article/2007/10/22/AR2007102202111.html

But DHHS had bigger plans than this. It eyed a new market for the vaccine, one that might double or quadruple the amount of vaccine now used by the military, justifying a new manufacturing plant that Emergent is building in Maryland. There are up to 3 million “First Responders” in the US: Police, Firefighters, Emergency Medical
Technicians and others. Maybe they could profitably use the vaccine, since they might someday face an anthrax emergency.

On October 22, the CDC ‘s Advisory Committee on Immunization Practices (ACIP) will vote on whether to overturn its anthrax vaccine recommendations of 2000 and 2002. http://www.cdc.gov/vaccines/recs/ACIP/downloads/min-jun08.pdf

Back then, ACIP stated that neither the benefit nor the risk for using anthrax vaccine could not be calculated, and therefore ACIP recommended against its use for civilians, unless they would be repeatedly exposed to anthrax spores.

2000 Recommendations: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr4915a1.htm
2002 recommendations: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5145a4.htm

Risk-Benefit Analyisis, the Basis for Public Health Policy—Except Here

But, you might argue, first responders and other citizens still cannot assess the risks and benefits of anthrax vaccination. Let that be no deterrent. As CDC’s Nancy Messonier pointed out to ACIP members in June,

“The intent of the workgroup was to open the door, knowing that the vaccine is commercially available and that first responder groups are at liberty to call the manufacturer to obtain the vaccine themselves. This is really meant to give them more impetus by saying that even if they do not have a calculated risk assessment, individuals or groups can assess their own risk, and weigh the risks and benefits of the vaccine with their occupational health and safety programs.”
http://www.cdc.gov/vaccines/recs/ACIP/downloads/min-jun08.pdf

CDC’s Messonier tossed aside the most basic public health requirement, by suggesting that first responders can weigh their own risk, even though the vaccine’s safety and efficacy remain in doubt, and the risk of anthrax is unknown! CDC doesn’t want that little omission to stand in the way of receiving the vaccine: especially when ACIP members and all CDC, FDA and DHHS employees are shielded from liability for uninformed and ill-considered recommendations. CDC seems to have accurately calculated its own risk/benefit equation.

Meryl Nass, MD
October 14, 2008

Here is an excellent discussion of the 2005 PREPA Bill:
http://www.cidrap.umn.edu/cidrap/content/influenza/biz-plan/news/dec2805liability.html

Pandemic funding, liability shield clear Congress

Dec 28, 2005 (CIDRAP News) – Before adjourning last week, the US Senate passed and sent to President Bush a bill providing $3.8 billion for pandemic influenza preparedness and a controversial liability shield for those who produce and administer drugs and vaccines used in a declared public health emergency.

The preparedness funding and liability protection were part of the fiscal year 2006 defense spending bill passed by the Senate on the evening of Dec 21. The bill had cleared the House 2 days earlier.

The $3.8 billion for pandemic preparedness is a little more than half of the $7.1 billion Bush had requested in early November. House Republican leaders said last week the measure would fund roughly the fiscal year 2006 portion of Bush's request.

As reported previously, the amount includes $350 million to improve state and local preparedness and directs the Department of Health and Human Services (HHS) to use most of the rest on "core preparedness activities," including increasing vaccine production capacity, developing vaccines, and stockpiling antiviral drugs.

The liability provision offers broad legal protection for the makers of drugs, vaccines, and other medical "countermeasures" used when the HHS secretary declares an emergency. The provision says people claiming injury from a medical countermeasure can sue only if they prove "willful misconduct" by those who made or administered it. The bill calls for Congress to set up a compensation program for injuries, but it provides no funds for that purpose.

Senate Majority Leader Bill Frist, R-Tenn., and other Republican leaders argued that the liability measure was necessary to induce biotechnology companies to develop products to counter pandemic flu and other disease threats.

In a news release issued after the bill passed, Frist said the measure "extends limited protections to manufacturers, distributors, and first responders, so that life-saving countermeasures, such as an H5N1 avian flu vaccine, will be developed, deployed and administered."

He added that the bill "strikes a reasonable balance where those who are harmed will be fairly compensated and life-saving products will be available in ample supply to protect and treat as many Americans as possible."

But Sen. Edward Kennedy, D-Mass., and some other Democrats, along with consumer groups such as Public Citizen, derided the liability provision as a giveaway to the drug industry. Kennedy said the bill makes it "essentially impossible" for injured parties to sue for damages. He also argued that the measure allows the HHS secretary to use many common diseases as a reason to activate the liability shield.

"Without a real compensation program, the liability protection in the defense bill provides a Christmas present to the drug industry and bag of coal to everyday Americans," stated a Dec 21 news release issued by Kennedy and Sens. Tom Harkin, D-Iowa, and Chris Dodd, D-Conn.

The liability protection language, called the Public Readiness and Emergency Preparedness Act, was tacked onto the end of the huge defense-spending bill (H.R. 2863).

It gives the HHS secretary authority to trigger the liability protection by declaring an emergency if he or she determines that a disease or other health threat represents an emergency or may constitute an emergency in the future. The act does not list any criteria for determining the existence of an emergency. The declaration would have to list the diseases, populations, and geographic areas covered and when the emergency would end.

Such an emergency declaration is not subject to court review, and it preempts any conflicting laws or regulations of states or local communities, the act says.

The measure says those who make and administer medical countermeasures covered by an emergency declaration are immune to lawsuits unless the plaintiff can provide clear evidence of willful misconduct that resulted in death or serious physical injury. "Willful misconduct" is ruled out if the party who administered the treatment followed HHS recommendations and notified health authorities of the relevant injury within 7 days.

In addition, the act instructs the HHS secretary to write regulations "that further restrict the scope of actions or omissions by a covered person" that constitute willful misconduct.

A party alleging "willful misconduct" can file suit only in US District Court in Washington, DC. The plaintiff must have an affidavit supporting the suit from a physician who did not treat the injured person. Before any suit can go to trial, a three-judge panel will consider any pretrial motions.

The act says that an HHS emergency declaration will trigger the establishment of a fund to provide "timely, uniform, and adequate compensation" to anyone injured by covered medical countermeasures. However, the measure does not appropriate money for the fund.

A person claiming injury from a covered treatment may not sue without first trying to collect from the compensation fund. But that requirement applies only if the compensation program has been funded. A person can sue if HHS fails to act on the request for compensation within 240 days.

If a plaintiff accepts an award from the compensation fund, he or she is barred from suing anyone, the act provides.

In arguing that the liability shield is too broad, Kennedy said in his news release, "The Bush administration could identify Vioxx as a needed countermeasure to treat the arthritis epidemic or to treat pain associated with flu, and completely immunize Merck [the manufacturer] from lawsuits currently pending against it."

Meryl Nass, MD
Mount Desert Island Hospital
Bar Harbor, Maine 04609
W 207 288-5081 ext. 1220
C 207 522-5229
H 207 244-9165
pager 207 818-0708
http://anthraxvaccine.blogspot.com
http://www.anthraxvaccine.org

Emergency declarations smooth way for vaccine makers

2008-10-18T07:43:00.000-05:00

By ALAN BAVLEY
The Kansas City Star
http://www.kansascity.com/105/story/846427.html

Sure, the economy is causing a crisis, but what about anthrax? How about smallpox?

In a little noticed move, federal officials this month have declared a series of public health emergencies relating to potential weapons of biological terror.

On Oct. 1, Health and Human Services Secretary Mike Leavitt declared an anthrax public health emergency. On Oct. 10, he declared health emergencies for smallpox, radiation sickness from the detonation of a nuclear device and poisoning from botulinum toxins, the active ingredient of Botox.

There’s no clear evidence that terrorists have managed to weaponize anthrax or stolen large caches of Botox from cosmetic surgeons in Beverly Hills.

But by declaring these public health emergencies, HHS has granted manufacturers of anti-terrorism drugs and vaccines and others involved with the products protection from lawsuits if the drugs were to cause unfortunate side effects.

In the past, drug companies have shied from vaccine development because of low profit margins and legal risks. The actions of HHS are a necessary reassurance to persuade companies to make the drugs, and doctors and other providers to administer them, federal officials and some terrorism experts say.

But consumer advocates see it as a giveaway to the drug industry that strips the public of legal protections.

“It gives the manufacturers and other people involved a ‘get out of jail free’ card,” said Joan Claybrook, president of Washington-based Public Citizen.

“These are potentially dangerous products. There could be a bad vaccine, and suppose people relied on that?” Claybrook asked. “There is no deterrent if there’s no liability.”

The emergency declarations cover a host of antibiotics to fight anthrax infection, anthrax and smallpox vaccines, and a drug to stimulate white blood cell production in people harmed by radiation.

Concerns about the safety of vaccines against potential bioweapons have been raised repeatedly in recent years. Some soldiers, for example, have balked at anthrax vaccinations. And a federal effort to inoculate 500,000 doctors, nurses and other health care workers against smallpox resulted in only about 40,000 volunteering for the vaccine.

Health and Human Services’ authority to grant drugmakers liability protection comes from a controversial measure that Senate Majority Leader Bill Frist and House Speaker Dennis Hastert added to a Defense Department appropriations bill in the waning days of 2005.

The Public Readiness and Emergency Preparedness Act targets liability protections for products used during epidemics and pandemics, or as security countermeasures.

The HHS secretary can trigger the protections by declaring that a public health emergency exists or that there’s a “credible risk” of one in the future.

And legal immunity can apply to anyone involved in the development, testing, manufacture or distribution of the drugs. Also covered is anyone who prescribes, dispenses or administers the drugs, including state and local government officials.

Public Citizen and the Consumer Federation of America were among the groups that protested the bill.

In a letter to Frist and Hastert, Sen. Ted Kennedy and 20 other members of Congress called the measure “a stealth provision to shield manufacturers from responsibility for making faulty drugs and vaccines.”

As the law was written, it could be applied to virtually any drug or vaccine, Kennedy and the others said, and not just to the medications needed to fight pandemic flu or bioterrorism.

Chertoff Memo: How to Declare an Anthrax Emergency with no basis and make liability vanish

2008-10-17T08:38:00.002-05:00

On October 1, 2008 DHHS Secretary Mike Leavitt declared an anthrax emergency, which will last through 2015. It was published in the Federal Register Volume 73, Number 194, pages 58239-58242, and can be read here:
http://edocket.access.gpo.gov/2008/E8-23547.htm

What was the basis for the emergency declaration? Nothing. A must-read (short) memo
is attached
http://www.dhs.gov/xlibrary/assets/ofsec_ signed_determination092308.pdf, in which DHS Secretary Chertoff told DHHS Secretary Leavitt the following:

"That statute authorizes the Secretary of Health and Human Services to declare an emergency on the basis of, among other things,

A determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a specified biologial, chemical, radiological or nuclear agent or agents.

There is not currently a domestic emergency involving anthrax. Additionally, there is not currently a heightened risk of an anthrax attack. We have no credible
information indicating an imminent threat of an attack involving Bacillus anthracis.

But these findings are not necessary to make a determination under 5 564(b)(l)(A). Rather, a significant potential for a future domestic emergency involving a heightened risk of attack with anthrax is a sufficient basis for such a determination. "

Here is a discussion of the Public Readiness and Emergency Preparedness Act under which the Declaration was made:
http://www.cidrap.umn.edu/cidrap/content/influenz a/biz-plan/news/dec2805liability.html

"The liability provision offers broad legal protection for the makers of drugs, vaccines, and other medical "countermeasures" used when the HHS secretary declares an emergency. The provision says people claiming injury from a medical countermeasure can sue only if they prove "willful misconduct" by those who made or administered it. The bill calls for Congress to set up a compensation program for injuries, but it provides no funds for that purpose." The bill also grants immunity specifically to "government program planners" who are involved with declared emergencies.

Here is the actual December 2005 bill:

ftp://ftp.hrsa.gov/countermeasurescomp/Public_Readiness_and_Emergency_Preparedness_Act.pdf

Here is Secretary Leavitt's October 1, 2008 Declaration:

http://edocket.access.gpo.gov/2008/E8-23547.htm

And on October 22, 2008 the CDC's Advisory Committee on Immunization Practices will vote on expanding its recommendation for anthrax vaccinations to civilian first responders, now that the threat of liability for vaccine injuries or vaccine failure is a thing of the past.
http://gsn.nti.org/gsn/ts_20081016_1491.php

Emergent Biosolutions Hits New 52-Week High On Positive Outlook

2008-10-17T07:33:00.000-05:00

http://anthraxvaccine.blogspot.com

Emergent Biosolutions Hits New 52-Week High On Positive Outlook
Mayur Pahilajani - iStockAnalyst Writer
New York, NY

Shares of Emergent Biosolutions Inc (NYSE: EBS) topped 52-week mark after the bell on Friday as investors gained confidence in the company after the Rockville-based biotech's profitable anthrax treatments won emergency protection.

On October 9, the firm announced that the vaccine Biothrax and its Anthrax Immune Globulin, both have been included as covered countermeasures to a public health emergency under the Public Readiness and Emergency Preparedness Act.

The U.S. Department of Health and Human Services (HHS) said in a declaration, which will remain in effect until December 31, 2015, that there is a credible risk that the threat of exposure to anthrax and the resulting disease constitutes a public health emergency.

"This PREP Act declaration is further evidence of the U.S. Government’s commitment to our efforts to develop a portfolio of medical countermeasures to address the threat to public health posed by the use of anthrax as a weapon of biological warfare," Daniel J. Abdun-Nabi, president of Emergent BioSolutions, said in a statement.

The measure came after the company gained a new multi-year contract with the U.S. HHS to supply additional doses of its anthrax vaccine. The contract is valued in the range of between $364 million to $404 million. Under the agreement, the company will supply HHS with the second order of 14.5 million doses of Biothrax vaccine. The first order of 19.75 million doses of the vaccine is currently being delivered, which will provide the company with $448 million...

U.S. Limits Anthrax Vaccine Liability

2008-10-17T07:21:00.002-05:00

Global Security Newswire
Elaine Grossman

WASHINGTON - The U.S. Health and Human Services Department early this month moved to shield government, industry and business officials from lawsuits filed by those who have received the anthrax vaccine (see GSN http://www.nti.org/d_newswire/issues/2007/9/5/14e90604-dd3f-42d1-9285-34ea695db21a.html, Sept. 5, 2007).

Health and Human Services Secretary Michael Leavitt established legal immunity for public and private officials who oversee the production or distribution of the anthrax vaccine by declaring a "public health emergency" due to the risk of a bioterrorism attack. He said the emergency began on Oct. 1 and would run through Dec. 31, 2015.

U.S. law provides protection from lawsuits to individuals responsible for selected countermeasures, including antibiotics, during a declared emergency. Under the Public Readiness and Emergency Preparedness Act, which President George W. Bush signed into law in December 2005, a health and human services secretary's emergency declaration can limit financial risk for government program planners and the manufacturers or distributors of pharmaceutical countermeasures. One exception to
this immunity would be willful misconduct on the part of covered individuals. The ramifications, in this instance, could be to prevent individuals who have received one or more anthrax inoculations from taking grievances to court, based on claims that the vaccine caused severe adverse reactions or did not work. The anthrax vaccine has proven particularly controversial following reports of serious adverse
events, including some deaths, among U.S. recipients
(see GSN
In addition, there are some doubts about the vaccine's efficacy in protecting people from developing anthrax after breathing in spores during a biological attack. A 2003 lawsuit - based on lapses in the Food and Drug Administration' s drug-approval process for the vaccine - temporarily shut down the Defense Department's compulsory anthrax shots program. Mandatory inoculations resumed in 2006 for personnel whose assignments are judged to put them at heightened risk of exposure to anthrax (see GSN
Leavitt's declaration
Among the activities now afforded liability protection are those "related to developing, manufacturing, distributing, prescribing, dispensing, administering and using anthrax countermeasures in preparation for, and in response to, a potential anthrax attack," the HHS news release states. "This includes entities, such as large 'big- box' retail stores, retail pharmacies, and other private sector businesses, that help to deliver and distribute medicines." Health and Human Services argued the legal shield is essential to guarantee that countermeasures are there if U.S. citizens need them. "Providing liability protection to all involved in such efforts will help ensure their full participation and bolster response efforts," according to the news release. "Preparedness is a shared responsibility that must involve all sectors of society, including the private sector, community groups, families and individuals, " Leavitt stated in the release. "We are using the authorities available to us to do all we can to support preparedness at all levels."

The move comes as a pivotal advisory group convened by the U.S. Centers for Disease Control and Prevention prepares to decide whether state and local health officials should consider giving anthrax vaccines to as many as 3 million civilian first responders nationwide (see GSN http://www.nti.org/d_newswire/issues/2008/10/16/55608b41-33c1-4553-8ce0-7a70426c4771.html, Oct. 16).

Millions of U.S. military personnel have already received the vaccines since the Pentagon's shots program began in 1997, but the law prohibits service members or their families from holding the government liable for injury or death. Now that the population of vaccine recipients could expand to include millions of civilians - who
normally do have a right to take medical injury claims to court - federal response planners and government contractors might be growing nervous about their potential legal vulnerability, according to vaccine critics. "There are people still getting ill from side effects and from the vaccine," John Michels, an attorney in litigation
targeting the Pentagon's inoculation program, told Global Security Newswire this week. "When they expand this vaccine from the military population to a civilian population, they're going to have people who sue."

Emergent BioSolutions of Rockville, Md. - the nation's only manufacturer of an FDA-approved anthrax vaccine - recently announced
Michels said commercial interests appear to be playing a role in the legal immunity issue. He questioned whether there had been any bona fide escalation in the anthrax threat sufficient to justify the declaration of an emergency. "We have no indications [now] ... that we're much more likely to be attacked by anthrax," Michels said. "But [government officials] see the writing on the wall. They see ... an erosion of [lawsuit] immunity for vaccine manufacturers as a result of widespread civilian use."

Meryl Nass, a bioterrorism expert who has been highly critical of federal handling of anthrax vaccine issues, accused Leavitt of taking more interest in protecting bureaucrats from legal action than in protecting the public from health threats. "How do you decide there is an emergency when there is no evidence of one?" she asked in e-mailed comments last week. Noting the HHS secretary's designation of
"governmental program planners" as among those afforded legal immunity by the declaration, Nass asserted that the agency "designates an emergency as a means to protect itself."

Leavitt's declaration, though, states that "targeted liability protections for anthrax countermeasures" are "based on a credible risk that the threat of exposure to [anthrax] and the resulting disease constitutes a public health emergency." The document does not offer additional details on the nature or level of threat. A request that Health and Human Services elaborate on the basis for the public health
emergency declaration went unanswered at press time.

CDC Panel May Advise Anthrax Shots for First Responders

2008-10-16T08:08:00.000-05:00

http://gsn.nti. org/gsn/ts_ 20081016_ 1491.php

CDC Panel May Advise Anthrax Shots for First Responders
Elaine Grossman
Global Security Newswire: Oct. 16, 2008

WASHINGTON - A U.S. government advisory panel next week could recommend that state and local public health officials consider administering anthrax vaccines to as many as 3 million first responders nationwide, Global Security Newswire has learned. The
panel, convened by the Centers for Disease Control and Prevention, would leave it to regional and local authorities to determine whether the risks of biological terrorism - weighed against the potential benefits of a controversial inoculation - justify vaccinating emergency personnel.

In an anthrax attack, victims could inhale tiny airborne particles capable of infecting them with a highly fatal disease. The 2001 mailings that targeted congressional and media offices, launched just days after the Sept. 11 terrorist strikes, killed five people and sickened another 17 (see GSN , Oct. 1).

The CDC panel decision, slated for release at an Oct. 22 meeting in Atlanta, could reverse a nearly 8-year-old recommendation against pre-exposure vaccinations for first responders. By contrast, U.S. military personnel operating in assignments considered at risk of exposure to anthrax attack have been subject to mandatory inoculation for several years (see GSN , Sept. 5, 2007). While the compulsory program was suspended at one point under court order, the Defense Department has administered millions of shots since the late 1990s.

The CDC Advisory Committee on Immunization Practices said in December 2000 that it could not recommend anthrax shots for civilian first responders as a matter of national policy because "the risk of exposure cannot be calculated." Even if the threat were considered higher in one city or another, the panel concluded that precautionary vaccines were unnecessary. For emergency personnel who enter an attack
site, "studies suggest an extremely low risk for exposure related to secondary aerosolization of previously settled [anthrax] spores," the group wrote at the time. If a first responder were exposed to anthrax, the "initiation of prophylaxis should be considered with antibiotics alone or in combination with vaccine," the panel concluded. Post-exposure treatment with these drugs is standard for unvaccinated
patients.

In 2002, the panel updated other aspects of its anthrax vaccine recommendations but refrained from changing its guidance for first responders. However, at a meeting in Atlanta four months ago, a working group convened by the advisory committee said the full panel should alter its 2000 statement. "Post-event vaccination in combination with antibiotics is an effective intervention following exposure to [anthrax] spores, but the workgroup felt that pre-event vaccination could offer additional protection beyond that afforded by antibiotics and post-vaccination by providing early priming of the immune system," according to a CDC summary of the review group's presentation to the panel. In addition, some first-responder organizations "have stated that their members would be more willing to respond to a bioterrorism event if they were vaccinated prior to the occurrence of the event," working group member Jennifer Gordon Wright told the committee, according to the meeting summary. "The workgroup felt that implementing a recommendation for pre-event vaccination of first responders would be difficult, but it may have a positive impact on first-responder preparedness, " she reportedly said.

If embraced by the expert panel next week, the new statement would read: "Groups for whom potential contact with aerosolized anthrax is a reasonable expectation based on occupation and duties (e.g. first responders expected to be called to the scene of a bioterrorism event) and for whom a calculable risk is not available may consider pre-event vaccination on the basis of an estimated risk benefit and in the context of an occupational health and safety program."

A Host of Challenges

Among the challenges facing any mass inoculation effort for first responders would be finding a method of tracking a complicated anthrax shot regimen for millions of personnel who might come and go from their jobs, according to the June meeting minutes. The schedule for the existing vaccine calls for six priming shots over an 18-month period, followed by annual boosters. Recent medical research suggests
that fewer shots might be needed to establish immunity, but the official regimen has not yet changed (see GSN , Oct. 1).

Another hurdle could be organizing a vaccine campaign in the absence of any single organization representing the first-responder community nationwide, according to the June meeting summary. "There are multiple types of first responders and defining this group can be difficult," Wright told the CDC panel.

Litigation pending in federal court could pose another complication for state and local officials who might contemplate setting out a requirement that their first responders take the anthrax shots. Two attorneys who in 2004 won a 16-month injunction against the Pentagon's initial mandatory vaccine effort filed a second lawsuit in late 2006, challenging the science behind a 2005 Food and Drug Administration decision allowing the drug to be used for protection against an attack (see GSN , Oct. 28, 2004). They argue that the vaccine has been proven only in the prevention of anthrax contracted through the skin or digestive system, but has not been shown to work against a more serious form of inhaled anthrax posed by biological weapons.

The second case is now on appeal following a federal judge's move to dismiss it in late February (see GSN , March 3). If the lawsuit moves forward in the U.S. Court of Appeals, "it would affect the current thinking of CDC and FDA" regarding the advisability of giving the vaccine to millions of first responders, said Mark Zaid, plaintiffs' co-counsel in both legal actions. The CDC advisory panel's working group reported in June that "available vaccine efficacy data suggested that the vaccine is effective and provides protection against inhalation anthrax." However, Zaid said state and local authorities should think twice before requiring the shots for emergency personnel, in the absence of a substantial threat. "It would be virtually unprecedented in modern times to mandate any vaccination on civilian populations without the clear existence of a current outbreak of disease," he told GSN yesterday.

Critics of the vaccine have alleged that officials at the Centers for Disease Control and Prevention - an arm of the U.S. Health and Human Services Department - have underemphasized the risk of severe adverse reactions carried by the anthrax vaccine. For example, a new CDC study of the anthrax vaccine's safety and efficacy logged 229 "serious adverse events" - including seven deaths - in 186 out of 1,563
volunteer participants receiving inoculations since May 2002. Such instances might include events that are life-threatening, require hospitalization or surgical intervention or cause significant disability or birth defects. Results were published in the Oct. 1 issue of the Journal of the American Medical Association.

However, the researchers concluded that just nine of these serious events - none resulting in death - were "possibly related" to the vaccine. Analysis of the research data will remain "double-blind" through next year, meaning the medical investigators and patients do not know which participants received anthrax inoculations and which received a placebo, according to CDC officials.

Until the serious-event data can be correlated with an understanding of which patients actually received the anthrax vaccine, an empirical analysis of the drug's safety in this study cannot be done, according to Meryl Nass, a longtime critic of the U.S. government's handling of the vaccine. An internist who has consulted with the U.S. government on bioterrorism issues, Nass questioned how CDC researchers could have concluded that just nine of the 229 serious adverse events might have
been connected to the vaccine. In e-mail comments sent to GSN last week, she accused the agency of "glossing over" the severe reactions potentially related to the vaccine and of offering few details about them.

The working group's June presentation to the CDC advisory group identified vaccine safety as a possible issue for consideration in treating first responders, but voiced confidence in the research findings. "While the workgroup [members] believe the vaccine is safe, rare adverse events do occur and a serious adverse event is not a small matter, regardless of whether it is vaccine-associated, " Wright told the panel, according to the CDC minutes.

The government advisory panel "has been given a one-sided picture from the working group at the CDC," Nass said in an interview this week. She rued the fact that few, if any, of the advisory panel's current members took part in the committee's debate nearly eight years ago, which resulted in its initial guidance against mass inoculations for first responders. This year, Nass said, the committee has heard nearly no critical perspectives about the safety and efficacy of the anthrax vaccine, and the group might similarly be unaware of skepticism about biowarfare threats facing the United States. The CDC panel has scheduled just five minutes of public comment about the issue during its upcoming meeting, she said.

A review of the committee's membership shows that none of the advisory panel's 15 voting members sat on the group in 2000, so there is little track record on which to base projections about how it will decide the issue this time. Eight liaisons from medical associations and industry organizations, "ex officio" members and others associated with the Advisory Committee on Immunization Practices served in similar roles in 2000, but none of them have a vote. Of the voting advisory panel members, several voiced support at the June meeting for making what they termed a "reasonable" change in the group's guidance regarding anthrax shots for first responders.

One of them, Jonathan Temte - a faculty member at the University of Wisconsin's School of Medicine and Public Health in Madison - said "allowing smaller [state and local] groups to consider their own risks is a very worthwhile approach," according to the CDC summary. Others expressed a degree of concern. For example, Franklyn Judson - a professor at the University of Colorado Health Sciences Center in Denver -said he would support the new statement but thought "practically it would do little at the local level," the summary states. Another, Ciro Sumaya of Texas A&M Health Center in College Station, "was uncomfortable with the wording" in the statement about assessing a risk-benefit tradeoff, adding that "there should be some type of algorithm to make risk determinations that can be useful to the practitioner and at the local level," according to the CDC minutes.

Security Problems Found at Two Biodefense Labs

2008-10-16T07:57:00.000-05:00

http://www.nti.org/d_newswire/issues/2008_10_16.html#C0381C0F

A potential terrorist would face few obstacles to infiltrating two high-security U.S. laboratories cleared to work with lethal biological agents, congressional investigators said in a report released today (see GSN, Aug. 22).

The Centers for Disease Control and Prevention endorsed the Biosafety Level 4 sites, which are not named in the Government Accountability Office report but were identified today in an Associated Press article.

The Southwest Foundation for Biomedical Research in San Antonio, Texas, was considered the most vulnerable site. Personnel at the privately operated site work with disease materials in a room that has a window directly to the outside of the building.

Investigators also described the deployment of surveillance cameras, intruder detectors and armed guards at visible entrances as inadequate. Depending on an outside contractor to watch the detection systems and notify police of security breaches could slow response times, the report says.

"We already have an initiative under way to look at perimeter security," said laboratory head Kenneth Trevett. "We're waiting for additional input but we're not waiting long. The GAO would like us to do some fairly significant things. They would like us to do it sooner rather than later."

The other vulnerable facility, an Atlanta laboratory managed by Georgia State University, was not fully walled off and had other security vulnerabilities. Congressional auditors said they watched an unknown person enter the building through its unmonitored shipping gate.

"Georgia State clearly wants its BSL-4 to be as safe as possible," university Assistant Vice President DeAnna Hines said, without acknowledging that the Georgia State site was singled out in the GAO report. "We are already taking steps that will enhance the lab's safety and security standards."

The report notes that robust security measures are in place at the three other U.S. laboratories cleared to work with the deadliest pathogens: CDC headquarters in Atlanta (see GSN, May 16); the U.S. Army Medical Research Institute of Infectious Diseases at Fort Detrick, Md.; and the University of Texas Medical Branch at Galveston (Larry Margasak, Associated Press/Google News, Oct. 16).

DHHS designates an anthrax emergency as a means to protect--- ITSELF!

2008-10-15T13:19:00.002-05:00

Excerpt:

But Sen. Edward Kennedy, D-Mass., and some other Democrats, along with consumer groups such as Public Citizen, derided the liability provision as a giveaway to the drug industry. Kennedy said the bill makes it "essentially impossible" for injured parties to sue for damages. He also argued that the measure allows the HHS secretary to use many common diseases as a reason to activate the liability shield.

ALLIANCE FOR HUMAN RESEARCH PROTECTION
Promoting Openness, Full Disclosure, and Accountability
http://www.ahrp.org and http://ahrp.blogspot.com

Despite the absence of any anthrax infections among Americans, on October 1, 2008 Mike Leavitt, Secretary of the Department of Health and Human Service (DHHS) declared a seven-year anthrax emergency through the end of 2015.

Below, AHRP board member, Meryl Nass, MD, questions the legitimacy of that declared Anthrax "emergency," noting that over the past month, in the waning days of the Bush administration, and with no emergency in sight, DHHS is using the Public Readiness and Emergency Preparedness Act against Americans (PREPA) to give "blanket immunity from liability to all entities involved with the manufacturer and distribution of anthrax countermeasures, including "government program planners."

The liability provision of PREPA offers broad legal protection for the makers of drugs, vaccines, and other medical "countermeasures" used--simply when the DHHS secretary declares an emergency.

Dr. Nass provides documented background behind this last ditch effort to expand the market for anthrax vaccine--by increasing the US stockpile of the vaccine--adding $500 million--and by unleashing the controversial vaccine on civilians--despite continued doubt about the vaccine's safety.

~~~~~~~~~~~
A series of coordinated moves designed to encourage new uses for anthrax vaccine (whose safety record is terrible and effectiveness unknown)-while excluding any manufacturer liability for its use, preempting state and local laws designed to protect citizens, and extending blanket immunity to government officials who came up with the plan--- is in process.

* First, DHHS Secretary Leavitt declared that the US is in an anthrax emergency. This invoked the Public Readiness and Emergency Preparedness Act, giving blanket immunity from liability to all entities involved with the manufacturer and distribution of anthrax countermeasures, including "government program planners"
* Second, Leavitt contracted to buy $400 million worth of anthrax vaccine, in addition to over $500 million currently in DHHS' stockpile
* Third, CDC (a DHHS agency) asked its vaccine advisory committee to vote on changing its previous recommendation for anthrax vaccine on October 22, potentially expanding its use to civilian "first responders"
* Fourth, the vaccine's manufacturer is constructing a new manufacturing plant to supply up to 30 million vaccine doses yearly.
* Fifth, CDC conducted a clinical trial of anthrax vaccine in 1564 subjects, but released only partial information on the trial in a JAMA article published October 1, implying that the vaccine is safe. Yet 229 severe adverse events and 7 deaths occurred in trial participants, but were barely mentioned in CDC's report.

Background

The original bill under which Secretary Leavitt made his Declaration, the Public Readiness and Emergency Preparedness Act (PREPA, part of P.L. 109-148) gave the DHHS Secretary the right to declare any disease an emergency, triggering immunity from liability for any and all injuries due to countermeasures for that illness, unless "willful misconduct" by those who made or administered the product could be proven. The Act fails to specify any criteria for determining that an emergency exists, and fails to fund a compensation mechanism. It was tacked on to the end of the 2006 Defense Appropriations Bill during the night, after being removed from
another bill due to its controversial nature. It was passed by Congress and signed into law on December 30, 2005. Probably few in Congress read it before approving it along with defense spending. You can read the bill at: ftp://ftp.hrsa.gov/countermeasurescomp/Public_Readiness_and_Emergency_Preparedness_Act.pdf

In a news release issued after the bill passed, Senator Frist, R-TN said the measure "extends limited protections to manufacturers, distributors, and first responders, so that life-saving countermeasures, such as an H5N1 avian flu vaccine, will be developed, deployed and administered." http://www.cidrap.umn.edu/cidrap/content/influenza/biz-plan/news/dec2805liability.html

But Sen. Edward Kennedy, D-Mass., and some other Democrats, along with consumer groups such as Public Citizen, derided the liability provision as a giveaway to the drug industry. Kennedy said the bill makes it "essentially impossible" for injured parties to sue for damages. He also argued that the measure allows the HHS secretary to use many common diseases as a reason to activate the liability shield. "Without a real compensation program, the liability protection in the defense bill provides a Christmas present to the drug industry and bag of coal to everyday Americans," stated a Dec 21 news release issued by Kennedy and Sens. Tom Harkin, D-Iowa, and Chris Dodd, D-Conn.

The Democratic Senators introduced a new bill to supersede PREPA in February 2006, http://www.fas.org/biosecurity/resource/legislation/s2291.htm
but it never passed.

Where is the Anthrax Emergency?

Over the past month, in the waning days of the Bush administration, and with no emergency in sight, DHHS is using PREPA against Americans to shield not only manufacturers and medical professionals, but also to immunize everyone in government who worked on the plan from any liability for problems that arise.

Yes, you heard correctly: although the media never reported on this provision when PREPA was passed, the bill specifically shields "government program planners" who deal with PREPA's emergencies from all potential liability.

On October 1, 2008 DHHS Secretary Mike Leavitt declared an anthrax emergency under the PREPA Act, through the end of 2015. (That sounds like a very long emergency-or a very long time to enjoy liability protection.) http://edocket.access.gpo.gov/2008/E8-23547.htm

Despite the current absence of anthrax infections in Americans, the "emergency" has been declared, and the liability shield is already in effect for anthrax vaccine and other anthrax countermeasures, including antiserum, monoclonal antibodies and
multiple antibiotics.

$500 million in new anthrax vaccine spending

October 1, 2008 was a busy day in the anthrax world. DHHS announced it was going to purchase an additional 14.5 million doses of anthrax vaccine, for a cost between $364 and $404 million, to add to its existing stockpile of about 25 million doses.
http://www.washingtonpost.com/wp-dyn/content/article/2008/10/01/AR2008100102
951.html

The manufacturer, Emergent BioSolutions, crowed about the liability protection it had just received for the purchase.
http://www.bizjournals.com/baltimore/stories/2008/10/06/daily45.html

Furthermore, on September 26, DHHS announced contracts for a total $113.6 million with Emergent BioSolutions and Pharmathene for development of "Third Generation" anthrax vaccines. These too are covered under Secretary Leavitt's Declaration. What vaccines are these? Emergent bought its competitor VaxGen's vaccine for $2 million, after taxpayers and investors paid over $200 million for its development. When in 2006 VaxGen failed to meet DHHS-specified milestones, its contract was cancelled and the company folded.

Pharmathene bought Avecia's vaccine, after Avecia received a $100 million DHHS contract for early vaccine development, but failed to get a more lucrative contract later.

Bottom line: both these vaccines were rejected by DHHS during the past five years, only to suddenly arise again, and consume additional taxpayer largesse. Yet if the current vaccine were truly acceptable, a newer vaccine would be unnecessary.

Expanding the anthrax vaccine market

If DHHS simply planned to stockpile more anthrax vaccine, its purchase would just be another example case of government waste. The current stockpile is expiring at a rate of $10 million per month, as pointed out by GAO last year.
http://www.washingtonpost.com/wp-dyn/content/article/2007/10/22/AR2007102202111.html

But DHHS had bigger plans than this. It eyed a new market for the vaccine, one that might double or quadruple the amount of vaccine now used by the military, justifying a new manufacturing plant that Emergent is building in Maryland. There are up to 3 million "First Responders" in the US: Police, Firefighters, Emergency Medical Technicians and others. Maybe they could profitably use the vaccine, since they might someday face an anthrax emergency.

On October 22, the CDC 's Advisory Committee on Immunization Practices (ACIP) will vote on whether to overturn its anthrax vaccine recommendations of 2000 and 2002.
http://www.cdc.gov/vaccines/recs/ACIP/downloads/min-jun08.pdf

Back then, ACIP stated that neither the benefit nor the risk for using anthrax vaccine could not be calculated, and therefore ACIP recommended against its use for
civilians, unless they would be repeatedly exposed to anthrax spores.

2000 Recommendations: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr4915a1.htm

2002 recommendations: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5145a4.htm

Risk-Benefit Analysis, the Basis for Public Health Policy-Except Here

But, you might argue, first responders and other citizens still cannot assess the risks and benefits of anthrax vaccination. Let that be no deterrent. As CDC's Nancy Messonier pointed out to ACIP members in June,

"The intent of the workgroup was to open the door, knowing that the vaccine is commercially available and that first responder groups are at liberty to call the manufacturer to obtain the vaccine themselves. This is really meant to give them more impetus by saying that even if they do not have a calculated risk assessment, individuals or groups can assess their own risk, and weigh the risks and benefits of the vaccine with their occupational health and safety programs."
http://www.cdc.gov/vaccines/recs/ACIP/downloads/min-jun08.pdf

CDC's Messonier tossed aside the most basic public health requirement, by suggesting that first responders can weigh their own risk, even though the vaccine's safety and efficacy remain in doubt, and the risk of anthrax is unknown! CDC doesn't want that little omission to stand in the way of receiving the vaccine: especially when ACIP members and all CDC, FDA and DHHS employees are shielded from liability for uninformed and ill-considered recommendations. CDC seems to have accurately calculated its own risk/benefit equation.

Meryl Nass, MD
October 14, 2008

Here is an excellent discussion of the 2005 PREPA Bill:

http://www.cidrap.umn.edu/cidrap/content/influenza/biz-plan/news/dec2805liability.html

Pandemic funding, liability shield clear Congress

Dec 28, 2005 (CIDRAP News) - Before adjourning last week, the US Senate
passed and sent to President Bush a bill providing $3.8 billion for pandemic
influenza preparedness and a controversial liability shield for those who
produce and administer drugs and vaccines used in a declared public health
emergency.

The preparedness funding and liability protection were part of the fiscal
year 2006 defense spending bill passed by the Senate on the evening of Dec
21. The bill had cleared the House 2 days earlier.

The $3.8 billion for pandemic preparedness is a little more than half of the
$7.1 billion Bush had requested in early November. House Republican leaders
said last week the measure would fund roughly the fiscal year 2006 portion
of Bush's request.

As reported previously, the amount includes $350 million to improve state
and local preparedness and directs the Department of Health and Human
Services (HHS) to use most of the rest on "core preparedness activities,"
including increasing vaccine production capacity, developing vaccines, and
stockpiling antiviral drugs.

The liability provision offers broad legal protection for the makers of
drugs, vaccines, and other medical "countermeasures" used when the HHS
secretary declares an emergency. The provision says people claiming injury
from a medical countermeasure can sue only if they prove "willful
misconduct" by those who made or administered it. The bill calls for
Congress to set up a compensation program for injuries, but it provides no
funds for that purpose.

Senate Majority Leader Bill Frist, R-Tenn., and other Republican leaders
argued that the liability measure was necessary to induce biotechnology
companies to develop products to counter pandemic flu and other disease
threats.

In a news release issued after the bill passed, Frist said the measure
"extends limited protections to manufacturers, distributors, and first
responders, so that life-saving countermeasures, such as an H5N1 avian flu
vaccine, will be developed, deployed and administered."
He added that the bill "strikes a reasonable balance where those who are
harmed will be fairly compensated and life-saving products will be available
in ample supply to protect and treat as many Americans as possible."

But Sen. Edward Kennedy, D-Mass., and some other Democrats, along with
consumer groups such as Public Citizen, derided the liability provision as a
giveaway to the drug industry. Kennedy said the bill makes it "essentially
impossible" for injured parties to sue for damages. He also argued that the
measure allows the HHS secretary to use many common diseases as a reason to
activate the liability shield.
"Without a real compensation program, the liability protection in the
defense bill provides a Christmas present to the drug industry and bag of
coal to everyday Americans," stated a Dec 21 news release issued by Kennedy
and Sens. Tom Harkin, D-Iowa, and Chris Dodd, D-Conn.

The liability protection language, called the Public Readiness and Emergency
Preparedness Act, was tacked onto the end of the huge defense-spending bill
(H.R. 2863).
It gives the HHS secretary authority to trigger the liability protection by
declaring an emergency if he or she determines that a disease or other
health threat represents an emergency or may constitute an emergency in the
future. The act does not list any criteria for determining the existence of
an emergency. The declaration would have to list the diseases, populations,
and geographic areas covered and when the emergency would end.

Such an emergency declaration is not subject to court review, and it
preempts any conflicting laws or regulations of states or local communities,
the act says.
The measure says those who make and administer medical countermeasures
covered by an emergency declaration are immune to lawsuits unless the
plaintiff can provide clear evidence of willful misconduct that resulted in
death or serious physical injury. "Willful misconduct" is ruled out if the
party who administered the treatment followed HHS recommendations and
notified health authorities of the relevant injury within 7 days.

In addition, the act instructs the HHS secretary to write regulations "that
further restrict the scope of actions or omissions by a covered person" that
constitute willful misconduct.
A party alleging "willful misconduct" can file suit only in US District
Court in Washington, DC. The plaintiff must have an affidavit supporting the
suit from a physician who did not treat the injured person. Before any suit
can go to trial, a three-judge panel will consider any pretrial motions.
The act says that an HHS emergency declaration will trigger the
establishment of a fund to provide "timely, uniform, and adequate
compensation" to anyone injured by covered medical countermeasures. However,
the measure does not appropriate money for the fund.

A person claiming injury from a covered treatment may not sue without first
trying to collect from the compensation fund. But that requirement applies
only if the compensation program has been funded. A person can sue if HHS
fails to act on the request for compensation within 240 days.
If a plaintiff accepts an award from the compensation fund, he or she is
barred from suing anyone, the act provides.

In arguing that the liability shield is too broad, Kennedy said in his news
release, "The Bush administration could identify Vioxx as a needed
countermeasure to treat the arthritis epidemic or to treat pain associated
with flu, and completely immunize Merck [the manufacturer] from lawsuits
currently pending against it."

Bogus Anthrax 'State of Emergency' Protects Drugmakers, Not Public

2008-10-15T13:13:00.000-05:00

http://blog.wired.com/wiredscience/2008/10/bogus-anthrax-s.html

Not a single case of human anthrax has been reported in the United States this year, but the nation is now officially in a state of anthrax emergency.

The emergency was declared earlier this month by the Department of Health and Human Services, and will last until 2015. Whether it will protect public health is debatable, but it will certainly protect makers of faulty anthrax vaccines.

Emergency exemption from legal liability is granted to vaccine manufacturers by the Public Readiness and Preparedness Act, passed in 2005 to protect against paralyzing lawsuits during outbreaks of anthrax, avian influenza or other potentially pandemic diseases.

The act is supposed to be invoked when the Secretary of Homeland Security has determined "that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a specified biological, chemical, radiological, or nuclear agent or agents."

But as Homeland Security chief Michael Chertoff explains in a letter to the DHHS, none of these conditions are met: there's neither emergency nor heightened risk of attack nor "credible information indicating an imminent threat of an attack." But that doesn't matter.

"These findings are not necessary to make a determination," Chertoff wrote. It's enough that anthrax was declared a threat four years ago, and that "were the government to determine in the future that there is a heightened risk of an anthrax attack ... that determination would almost certainly result in a domestic emergency."

In other words, there could be an emergency someday — so we might as well declare an emergency now.

Beyond the tortured logic, there's something not quite right about this. Could it have something to do with the fact that the federal government has spent nearly a billion dollars on anthrax vaccines of questionable efficacy and safety?

The CDC's vaccine committee meets next week to discuss anthrax vaccines. It will be interesting to see what they say.

Fears have led to Removal of Citizen's Protection

2008-10-10T12:19:00.000-05:00

From Dr. Meryl Nass
See my blog
http://anthraxvaccine.blogspot.com for the links:

Anthrax Letters and Pandemic Flu Fears Led to Legislation that Removed
Citizen Protections for Vaccine Injuries;
Anthrax Emergency Just Declared

The Public Readiness and Emergency Preparedness Act (PREPA), passed by the United States Congress and signed into law in December, 2005, is a controversial tort liability shield intended to protect vaccine manufacturers from financial risk in the event of a declared public health emergency. The Act does not specify any criteria for determining the existence of an emergency. PREPA removes the right to
a jury trial for persons injured by a covered vaccine, unless a plaintiff can provide clear evidence of willful misconduct that resulted in death or serious physical injury. A notice was issued regarding Potential Eligibility for Compensation in December 2007, but it applies only to avian flu vaccine, and has not been funded.

CDC has asked its Advisory Committee on Immunization Practices to vote on recommending anthrax vaccine for civilian first responders (up to three million people) on October 22, 2008. The vaccine has only been used by the Defense Department in the past, under a mandatory and controversial program. HHS announced another purchase of 14 million doses of anthrax vaccine on October 1, 2008, in addition to approximately 25 million doses already stockpiled.

DHHS issued a Declaration under the Public Readiness and Emergency Preparedness Act on October 1, 2008, declaring a public health emergency for anthrax. No discussion of why there is an emergency was provided. Not only did the declaration shield anthrax vaccine manufacturers and doctors who use the vaccine from liability for
injuries that might arise: the declaration explicitly shielded "government program planners" who might recommend anthrax vaccine or other anthrax countermeasures.

APIC seeks mandate for flu shots in health workers

2008-10-10T09:51:00.000-05:00

APIC seeks mandate for flu shots in health workers
Robert Roos News Editor
http://www.cidrap.umn.edu/cidrap/content/influenza/general/news/oct1008apic.html

Oct 10, 2008 (CIDRAP News) – In the face of chronic low influenza vaccination rates among healthcare workers, the leading US society of infection control professionals says it's time to require medically eligible workers to either get the immunization or sign a form saying they understand the risks to patients if they skip it.

"As part of a comprehensive strategy, we recommend that influenza vaccine be required annually for all healthcare personnel with direct patient care," the Association for Professionals in Infection Control and Epidemiology (APIC) said in a policy statement released yesterday.

"Organizations should adopt a system in which an informed declination is obtained from employees that decline for other than medical reasons," the statement continues. "This information should be utilized by the facility to develop improvement strategies for the following vaccine season."

APIC urges vaccination for all medical and nonmedical personnel in contact with patients or patient samples, including physicians, nurses, physical therapists, dieticians, religious workers, and cleaning, kitchen, and laboratory personnel.

Voluntary programs haven't worked
Recent national survey data show that only 42% of healthcare workers receive an annual flu shot, and the rate has not risen significantly in the past decade, the APIC statement notes. Long-standing recommendations from APIC, the Centers for Disease Control and Prevention, and other national organizations have made little difference.

"Voluntary efforts are clearly not effective—it's time for hospitals and other healthcare facilities to require influenza immunization," said Linda R. Greene, RN, MPS, CIC, lead author of APIC's position statement, in a press release.

The policy statement notes that health workers can transmit the flu virus to others before they have any symptoms. Further, it says multiple studies show that 70% of health workers continue to work even when sick with the flu.

A multifaceted approach
APIC has strongly advocated flu shots for healthcare workers for years, along with a variety of strategies to promote them, but this is the first time the organization has used the word "require," Greene told CIDRAP News in an interview.

She said the declination form is the major new element in APIC's recommendation, but emphasized that it should be just part of a broad strategy for encouraging immunization.

"This isn't just a declination that says, 'I don't want to get it and here's the reason.' It's an informed declination, where the employee really understands that by refusing to get the vaccine for other than medical reasons, they're not only putting their patients at risk, but also themselves and their family and the community as a whole," said Greene, who is director of infection prevention for Rochester General Health Systems in Rochester, N.Y.

"This is the idea of active declination—it's not just a form that's floating around and you're supposed to sign it sometime; you actually have a conversation about why this is important for you," she added.

But other measures must be linked with informed declination, she said.

There is only limited evidence on how well declination forms work, she said. "But what we see is that declination alone, if you're not going to employ the other measures, has not necessarily been particularly effective," yielding only modest increases in immunization rates.

For example, her institution used a declination approach last year, but it was not coupled with "a tremendously proactive statement about putting patients at risk." The result was that the immunization rate increased about 10%, she said.

Getting administrators' buy-in
Greene hopes for much better results with a more comprehensive approach this year. "This year our approach is very robust. The administration is encouraging it, the CEO sent a letter to employees, we're going to post our [immunization] rates weekly. Managers must ensure that employees who didn’t get the vaccine are told of the risks to patients.

"Our goal is at least 75% and hopefully higher; but what we're seeing already is tremendous interest."

Greene said a key part of promoting flu immunization is enlisting the support of a facility's administration and other departments, so "it's not just sitting in occupational health." Administrators can promote the effort by using the flu immunization rate as an important indicator of safety and quality for the facility, she said.

In New York state, informed declination has been used successfully with hepatitis B vaccine for healthcare workers, Greene said. "We've found that we have a very, very high acceptance rate for the hepatitis vaccine." The vaccine is offered to direct-care workers when they are hired, and they see it as a benefit for protecting themselves, she added.

Some institutions now require workers to get a flu shot as a condition for being hired, but APIC decided not go that far in its recommendation, Greene said.

Taking a stronger stance
As for the timing of the new policy, Greene said a combination of factors was at work. They included many new studies about flu and flu immunization in recent years. Also, some other professional societies had taken much stronger positions on the issue than APIC had.

"Some of my colleagues here said it would really help us if APIC had a much stronger statement," she said. At the same time, the Joint Commission on Accreditation of Healthcare Organizations has challenged facilities to exceed the 42% immunization rate.

"I think we're going to see some results," Greene said. "I think we'll be surprised and pleased to see that vaccine rates will increase and continue to increase."

See also:

Oct 9 APIC news release

APIC position paper on flu immunization for healthcare personnel

Attorney general turns up heat in seeking promotion for Guard officer

2008-10-03T09:13:00.000-05:00

By Thomas D. Williams
Special to the Journal Inquirer

Published: Friday, October 3, 2008 9:15 AM EDT

Attorney General Richard Blumenthal last week sent another letter to Gov. Jodi Rell asking her to posthumously promote former Air Force Nation al Guard officer Russell Dingle of East Hartford .

Blumenthal sent the letter Sept. 26, two days after a story in the Journal Inquirer cited evidence that Dingle was forced to resign from the Nation al Guard in 1999 after he disputed the military’s policy concerning mandatory anthrax vaccinations.

Christopher Cooper, Rell’s spokesman, said the governor is out of town until Monday, so there is no immediate comment on the letter.

Dingle’s resignation followed a Guard investigation he led into the military’s mandatory anthrax vaccinations. The investigation concluded that the anthrax vaccine the military was requiring was improperly licensed and potentially unsafe. Dingle and seven others refused to take the vaccine ordered by the Guard, citing the inquiry’s conclusions that it could cause serious adverse reactions.

Dingle had earned the rank of major before he left the Nation al Guard. Later, after joining to the Air Force Reserves, he earned the rank of lieutenant colonel there.

Blumenthal’s request is that Dingle, who died of cancer in September 2005, be made a full colonel in the Nation al Guard.

“Lieutenant Colonel Dingle performed this mission in an extraordinarily thorough and exemplary manner,” Blumenthal said. “The research he did in carrying out his orders concluded that the vaccine was investigatory and the mandatory order (to use it) illegal. His work contributed significantly to the ‘good order and discipline’” of the Nation al Guard.

Blumenthal had written a similar letter to Rell last May calling for Dingle’s after-death promotion to full colonel. But, a month later, Maj. Gen. Thaddeus J. Martin, the state’s adjutant general, rejected the request.

Martin said Dingle “voluntarily transferred” from the Guard to the Air Force Reserve, so he wasn’t qualified for Guard promotion. After his resignation became known, Dingle wrote a complaining letter to the Guard that Martin had berated him as a result of his anthrax inquiry. Martin would not comment on the letter.

The Sept. 24 Journal Inquirer story reported that contrary to Martin’s rationale, there was documentary evidence that Dingle, as he had insisted consistently afterward, had been forced to resign.

The story cited a transcript and a video of former Air Force Nation al Guard Cmdr. Col. Walter Burns suggesting to Guard troops in 1998 that they would be considered traitors if they didn’t take the vaccine. It additionally noted a Connecticut freedom-of-information ruling concluding that Dingle and Maj. Thomas Rempfer, whom Burns assigned to investigate the vaccine, were forced to resign after that inquiry when they said they intended not to be vaccinated.

Blumenthal’s most recent letter tells the governor that Martin’s position largely is based on the understanding that Dingle voluntarily transferred. “In fact, Lieutenant Colonel Dingle was told he could follow the illegal order and take the vaccine, refuse to take it and be court-martialed, or resign,” he wrote.

The attorney general said Martin also apparently misunderstood his first request as asking for Dingle’s promotion within the Reserves, when he actually had called for it within the Guard, an action totally within the jurisdiction of the Guard and the governor. Blumenthal cited precedence and other promotions within the Guard in arguing that it was likely, had Dingle not been forced out, that he would have become a full colonel.

That would not have changed his ranking as a lieutenant colonel within the Reserves, a federal, not a state entity, like the Guard, Blumenthal said.

Blumenthal long has supported efforts to stop use of the anthrax vaccine, because he considered it unsafe and improperly licensed.

Before his death at age 49, Dingle fought an unprecedented eight-year battle to compel government recognition of improper licensing of the controversial vaccine. Eventually, his protests to government agencies, the courts, and two presidential administrations helped result in a 2003 U.S. District Court ruling temporarily blocking required military inoculations.

After the Food and Drug Administration made adjustments to the vaccine’s license, as ordered under the ruling, the Pentagon continued mandatory vaccinations. The inoculations caused thousands of adverse reactions and hundreds of disciplinary actions, including service removals for those in the military who refused to be vaccinated.

Dingle flew more than 2,000 hours in the A-10 Thunderbolt II on active duty. He served as an instructor pilot and a flight commander for the Connecticut Air Nation al Guard. Culminating more than 21 years of military service, Dingle retired as a recruiter for the U.S. Air Force Academy in 2003. His double career included more than 16 years of service as a pilot and captain for American Airlines in the Boeing 767, 737, and the McDonnell-Douglas S-80.

Feds Declare 'Anthrax Emergency'

2008-10-01T12:11:00.000-05:00

[Federal Register: October 6, 2008 (Volume 73, Number 194)] [Notices] [Page 58239-58242] From the Federal Register Online via GPO Access [wais.access. gpo.gov] [DOCID:fr06oc08- 76]

------------ ----

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary
Declaration Under the Public Readiness and Emergency Preparedness Act

October 1, 2008. AGENCY: Office of the Secretary (OS), Department of Health and Human Services (HHS).

ACTION: Notice.

------------ --------- --------- --------- --------- ------- ------------ ----

SUMMARY: Declaration pursuant to section 319F-3 of the Public Health Service Act (42 U.S.C. 247d-6d) to provide targeted liability protections for anthrax countermeasures based on a credible risk that the threat of exposure to Bacillus anthracis and the resulting disease constitutes a public health emergency.

DATES: This notice and the attached declaration are effective as of the date of signature of the declaration.

FOR FURTHER INFORMATION CONTACT: RADM W.C. Vanderwagen, Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, 200 Independence Avenue, SW., Washington, DC 20201, Telephone (202) 205-2882 (this is not a toll-free number).

HHS Secretary's Declaration for Utilization of Public Readiness and Emergency Preparedness Act for Anthrax Countermeasures

Whereas significant changes in the nature, regularity and degree of threats to health posed by the use of infectious agents as weapons of biological warfare have generated increased concern for the safety of the general American population particularly following the deliberate exposure of citizens in the

[[Page 58240]]

United States to Bacillus anthracis (B. anthracis) spores in 2001 that demonstrated the ease of dissemination, infectivity, and mortality; Whereas the Secretary of Homeland Security has determined that B. anthracis and multi-drug-resistan t B. anthracis present a material threat against the United States population, sufficient to affect national security; Whereas there are covered countermeasures to treat, identify, or prevent adverse health consequences or death from exposure to B. anthracis; Whereas such countermeasures, including vaccines, antimicrobials/ antibiotics, and antitoxins for pre-exposure and post- exposure prevention and treatment, diagnostics to identify such exposure, and additional countermeasures for treatment of adverse events arising from use of these countermeasures exist or may be the subject of research and/or development; Whereas such countermeasures may be used and administered in accordance with Federal contracts, cooperative
agreements, grants, interagency agreements, and memoranda of understanding, and may also be used and administered at the Regional, State, and local level in accordance with the public health and medical response of the Authority Having Jurisdiction; Whereas, the possibility of governmental program planners obtaining stockpiles from private sector entities except through voluntary means such as commercial sale, donation, or deployment would undermine national preparedness efforts and should be discouraged as provided for in section 319F-3(b)(2) (E) of the Public Health Service Act (42 U.S.C. 247d-6d(b)) (``the Act''); Whereas, immunity under section 319F-3(a) of the Act should be available to governmental program planners for distributions of Covered Countermeasures obtained voluntarily, such as by (1) Donation; (2) commercial sale; (3) deployment of Covered Countermeasures from Federal stockpiles; or (4) deployment of donated, purchased, or otherwise
voluntarily obtained Covered Countermeasures from State, local, or private stockpiles; Whereas, the extent of immunity under section 319F- 3(a) of the Act afforded to a governmental program planner that obtains covered countermeasures except through voluntary means is not intended to affect the extent of immunity afforded other covered persons with respect to such covered countermeasures. Whereas, in accordance with section 319F-3(b)(6) of the Act, I have considered the desirability of encouraging the design, development, clinical testing or investigation, manufacturing, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, and use of such countermeasures with respect to the category of disease and population described in sections II and IV below, and have found it desirable to encourage such activities for the covered countermeasures; and Whereas, to encourage
the design, development, clinical testing or investigation, manufacturing and product formulation, labeling, distribution, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, and use of medical countermeasures with respect to the category of disease and population described in sections II and IV below, it is advisable, in accordance with section 319F-3(a) and (b) of the Act, to provide immunity from liability for covered persons, as that term is defined at section 319F-3(i)(2) of the Act, and to include as such covered persons such other qualified persons as I have identified in section VI of this declaration; Therefore, pursuant to section 319F-3(b) of the Act, I have determined there is a credible risk that the threat of exposure of B. anthracis and the resulting disease constitutes a public health emergency.

I. Covered Countermeasures (As Required by Section 319F-3(b)(1) of the Act)

Covered Countermeasures are defined at section 319F-3(i) of the Act. At this time, and in accordance with the provisions contained herein, I am recommending the manufacture, testing, development, distribution, dispensing; and, with respect to the category of disease and population described in sections II and IV below, the administration and usage of anthrax countermeasures as defined in section IX below. The immunity specified in section 319F-3(a) of the Act shall only be in effect with respect to: (1) Present (see Appendix I) or future Federal contracts, cooperative agreements, grants, interagency agreements, or memoranda of understanding involving countermeasures that are used and administered in accordance with this declaration, and (2) activities authorized in accordance with the public health and medical response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute or dispense the Covered Countermeasure following a
declaration of an emergency, as defined in section IX below. In accordance with section 319F- 3(b)(2)(E) of the Act, for governmental program planners, the immunity specified in section 319F-3(a) of the Act shall be in effect to extent they obtain Covered Countermeasures through voluntary means of distribution, such as (1) Donation; (2) commercial sale; (3) deployment of Covered Countermeasures from Federal stockpiles; or (4) deployment of donated, purchased, or otherwise voluntarily obtained Covered Countermeasures from State, local, or private stockpiles. For all other covered persons, including other program planners, the immunity specified in section 319F-3(a) of the Act shall, in accordance with section 319F- 3(b)(2)(E) of the Act, be in effect pursuant to any means of distribution. This declaration shall subsequently refer to the countermeasures identified above as ``Covered Countermeasures. '' This declaration shall apply to all Covered
Countermeasures administered or used during the effective time period of the declaration. This declaration also shall apply to all Covered Countermeasures (see Appendix I) administered or used by or on behalf of the Department of Defense.

II. Category of Disease (As Required by Section 319F- 3(b)(2)(A) of the Act)

The category of disease, health condition, or threat to health for which I am recommending the administration or use of the Covered Countermeasures is anthrax, which may result from exposure to B. anthracis.

III. Effective Time Period (As Required by Section 319F-3(b)(2) (B) of the Act)

With respect to Covered Countermeasures administered and used in accordance with present or future Federal contracts, cooperative agreements, grants, interagency agreements, or memoranda of understanding, the effective period of time of this Declaration commences on signature of the declaration and extends through December 31, 2015. With respect to Covered Countermeasures administered and used in accordance with the public health and medical response of the Authority Having Jurisdiction, the effective period of time of this Declaration commences on the date of a declaration of an emergency and lasts through and includes the final day that the emergency declaration is in effect including any extensions thereof.

[[Page 58241]]

IV. Population (As Required by Section 319F-3(b)(2) (C) of the Act)

Section 319F-3(a)(4) (A) of the Act confers immunity to manufacturers and distributors of the Covered Countermeasure, regardless of the defined population. Section 319F-3(a)(3) (C)(i) of the Act confers immunity to covered persons who may be a program planner or qualified persons with respect to the Covered Countermeasure only if a member of the population specified in the declaration as persons who use the Covered Countermeasure or to whom such a Covered Countermeasure is administered, is in or connected to the geographic location specified in this declaration, or the program planner or qualified person reasonably could have believed that these conditions are met. The populations specified in this declaration are all persons who use a Covered Countermeasure or to whom a Covered Countermeasure is administered in accordance with this declaration, including, but not limited to: Department of Defense military personnel and supporting civilian-employee and
contractor personnel; any person conducting research and development of Covered Countermeasures directly by the Federal government or pursuant to a contract, grant, or cooperative agreement with the Federal government; any person who receives a Covered Countermeasure from persons authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute, or dispense the Covered Countermeasure, and their officials, agents, employees, contractors, and volunteers following a declaration of an emergency; any person who receives a Covered Countermeasure from a person authorized to prescribe, administer or dispense the countermeasure or who is otherwise authorized under an Emergency Use Authorization; any person who receives a Covered Countermeasure as an investigational new drug in human clinical trials being conducted directly by the Federal government or pursuant to a
contract, grant, or cooperative agreement with the Federal government.

V. Geographic Area (As Required by Section 319F- 3(b)(2)(D) of the Act)

Section 319F-3(a) of the Act applies to the administration and use of a Covered Countermeasure without geographic limitation.

VI. Qualified Persons (As Required by Section 319F- 3(i)(8)(B) of the Act)

With regard to the administration or use of a Covered Countermeasure, Section 319F-3(i)(8) (A) of the Act defines the term ``qualified person'' as a licensed individual who is authorized to prescribe, administer, or dispense the Covered Countermeasure under the law of the State in which such Covered Countermeasure was prescribed, administered or dispensed. Additional persons who are qualified persons pursuant to section 319F-3(i)(8) (B) are the following: (1) Any person who is authorized to prescribe, administer, deliver, distribute or dispense Covered Countermeasures to Department of Defense military personnel and supporting civilian-employee and contractor personnel, (2) Any person authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute or dispense Covered Countermeasures, and their officials, agents, employees, contractors and volunteers, following
a declaration of an emergency, and (3) Any person authorized to prescribe, administer, or dispense Covered Countermeasures or who is otherwise authorized under an Emergency Use Authorization, including, but not limited to Department of Defense military personnel and supporting civilian employee and contractor personnel.

VII. Additional Time Periods of Coverage After Expiration of Declaration (As Required by Section 319F-3(b)(3) (B) of the Act)

I have determined that, upon expiration of the time period specified in Section III above, an additional twelve (12) months is a reasonable period to allow for manufacturers and other covered persons to take such other actions as are appropriate to limit the administration or use of the Covered Countermeasure, and the liability protection of section 319F-3(a) of the Act shall extend for that period. Further, as to doses shipped by the CDC to the DoD pursuant to the DoD/CDC Interagency Agreement (IAA) dated March 10, 2008, an additional period of time of liability protection shall extend for as long as the SNS or its successor exists and the IAA remains in effect, plus, if the additional twelve (12) months following the time period in Section III above has expired, an additional twelve (12) months upon expiration of the IAA.

VIII. Amendments

This declaration has not previously been amended. Any future amendment to this declaration will be published in the Federal Register, pursuant to section 319F-3(b)(4) of the Act.

IX. Definitions

For the purpose of this declaration, including any claim for loss brought in accordance with section 319F-3 of the PHS Act against any covered persons defined in the Act or this declaration, the following definitions will be used: Administration of a Covered Countermeasure: As used in Section 319F-3(a)(2) (B) of the Act includes, but is not limited to, public and private delivery, distribution, and dispensing activities relating to physical administration of the Covered Countermeasures to patients/ recipients, management and operation of delivery systems, and management and operation of distribution and dispensing locations. Anthrax Countermeasure: Any vaccine; antimicrobial/ antibiotic, other drug or antitoxin; or diagnostic or device to identify, prevent or treat anthrax or adverse events from such countermeasures (1) Licensed under section 351 of the Public Health Service Act; (2) approved under section 505 or section 515 of the Federal Food, Drug, and
Cosmetic Act (FDCA); (3) cleared under section 510(k) of the FDCA; (4) authorized for emergency use under section 564 of the FDCA ; (5) used under section 505(i) of the FDCA or section 351(a)(3) of the PHS Act, and 21 CFR Part 312; or (6) used under section 520(g) of the FDCA and 21 CFR part 812. Authority Having Jurisdiction: The public agency or its delegate that has legal responsibility and authority for responding to an incident, based on political or geographical (e.g., city, county, tribal, State, or Federal boundary lines) or functional (e.g., law enforcement, public health) range or sphere of authority. Covered persons: As defined at section 319F-3(i)(2) of the Act include the United States, manufacturers, distributors, program planners, and qualified persons. The terms ``manufacturer, '' ``distributor, '' ``program planner,'' and ``qualified person'' are further defined at sections 319F-3(i)(3) , (4), (6), and (8) of the Act. Declaration of an
emergency: A declaration by any authorized local, regional, State, or federal official of an emergency specific to events that indicate an immediate need to administer and use anthrax countermeasures, with the exception of

[[Page 58242]]

a federal declaration in support of an emergency use authorization under section 564 of the FDCA unless such declaration specifies otherwise.

This first day of October, 2008. Michael O. Leavitt, Secretary of Health and Human Services.

Appendix I--List of U.S. Government Contracts ------------ --------- --------- --------- --------- ------- ------------ --------- --------- --------- --------- ------- -- Contract Manufacturer Covered countermeasure PL 85- 804 coverage* ------------ --------- --------- --------- --------- ------- ------------ --------- --------- --------- --------- ------- -- HHSO100200500007C. ......... ......... Cangene..... ......... .. Anthrax immune globulin-- No.

AI G. HHSO100200500006C. ......... ......... HGS......... ......... .. Anthrax monoclonal antibody- No.

ABThrax. HHSO100200600019C. ......... ......... Emergent Biodefense BioThrax (Anthrax Vaccine Yes.

Operations. Adsorbed, AVA). HHSO100200700037C. ......... ......... Emergent Biodefense BioThrax (Anthrax Vaccine No.

Operations. Adsorbed, AVA). W9113M-04-D- 0002..... ......... ...... BioPort (Emergent BioThrax (Anthrax Vaccine Yes.

Biosolutions) . Adsorbed, AVA). DAMD 17-97-D-00003. ......... ........ BioPort (Emergent BioThrax (Anthrax Vaccine Yes.

Biosolutions) . Adsorbed, AVA) Shipping. HHSN 272200700035C. ......... ........ Elusys...... ......... .. Anthrax monoclonal No.

antibody--ETI- 204. HHSN 272200700033C. ......... ........ Pharmathene. ......... .. Anthrax monoclonal No.

antibody--Valortim. HHSN 272200700034C. ......... ........ Emergent BioSolutions. . Anthrax immune globulin-- No.

AIG. NO1-A1-30052. ......... ......... ..... Avecia (Pharmathene) ... Recombinant protective No.

antigen (rPA) anthrax

vaccine. V797P-5777x. ......... ......... ...... Shering Corp........ ... Cipro 250mg/5ml; 100ml No.

suspension. V797P-5977x. ......... ......... ...... Cobalt Pharmaceuticals. Cipro 500mg tablets..... ... No. V797P-5941x. ......... ......... ...... Blu Pharmaceuticals. ... Doxycycline 100mg tablets.. No. V797P-5883x. ......... ......... ...... Pfizer, Inc......... ... Doxycycline 25mg/5ml No.

suspension 60ml. V797P-5669x. ......... ......... ...... Abraxis Bioscience, Inc Doxycycline 100mg vial IV.. No. V797-DSNS-8002. ......... ......... ... Sandoz, Inc......... ... Amoxicillin 500mg capsules. No. V797-DSNS-8002. ......... ......... ... Sandoz, Inc......... ... Amoxicillin 400mg/5ml; No.

100ml suspension. V797BPA0015. ......... ......... ...... Bedford Labs........ ... Rifampin 600mg vial IV..... No. V797P-5396x. ......... ......... ...... Hospira..... ......... .. Clindamycin 150mg/ml 6ml No.

vial IV. V797P-5669x. ......... ......... ...... Abraxis Bioscience, Inc Vancomycin 1 g vial IV..... No. V797P-1020x. ......... ......... ...... McKesson.... ......... .. Penicillin GK 20 million No.

unit vial IV. V797P-5387x. ......... ......... ...... Johnson and Johnson Levofloxacin 5mg/ml 150ml No.

Healthcare. bag IV.

------------ --------- --------- --------- --------- ------- ------------ --------- --------- --------- --------- ------- -- * Status of indemnification coverage under P.L. 85-804 (An Act to authorize the making, amendment and modification of contracts to facilitate the national defense.)

[FR Doc. E8-23547 Filed 10-1-08; 4:15 pm]

BILLING CODE 4150-37-P

[Federal Register: October 6, 2008 (Volume 73, Number 194)] [Notices] [Page 58242-58243] From the Federal Register Online via GPO Access [wais.access. gpo.gov] [DOCID:fr06oc08- 77]

------------ --------- --------- --------- --------- ------- ------------ ----

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

Determination and Declaration Regarding Emergency Use of Doxycycline Hyclate Tablets Accompanied by Emergency Use Information

AGENCY: Office of the Secretary (OS), HHS.

ACTION: Notice.

------------ --------- --------- --------- --------- ------- ------------ ----

SUMMARY: The Secretary of the Department of Health and Human Services (HHS) is issuing this notice pursuant to section 564(b)(4) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 360bbb-3(b)( 4), to justify the emergency use of doxycycline hyclate tablets accompanied by emergency use information, contained in emergency kits for eligible United States Postal Service (USPS) Cities Readiness Initiative (CRI) participants and their household members in advance of a potential attack involving Bacillus anthracis. Bacillus anthracis is a biological agent known to cause anthrax. The Secretary, HHS, provides notice of the determination of the Secretary of Homeland Security on September 23, 2008 that there is a significant potential for a domestic emergency involving a heightened risk of attack with a specified biological, chemical, radiological, or nuclear agent or agents--in this case, Bacillus anthracis, although there is no current domestic
emergency involving anthrax, no current heightened risk of an anthrax attack, and no credible information indicating an imminent threat of an attack involving Bacillus anthracis. The Secretary also provides notice that, on the basis of such determination, he has declared an emergency justifying the authorization of emergency use of doxycycline hyclate tablets accompanied by emergency use information subject to the terms of any authorization issued by the Food and Drug Commissioner under 21 U.S.C. 360bbb-3(a).

DATES: This Notice and referenced HHS declaration are effective as of October 1, 2008.

FOR FURTHER INFORMATION CONTACT: RADM W.C. Vanderwagen, M.D., Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, 200 Independence Avenue, SW., Washington, DC 20201, Telephone (202) 205-2882 (this is not a toll free number).

SUPPLEMENTARY INFORMATION:

I. Background

The CRI, begun in 2004, is a federally supported effort to prepare 72 major U.S. metropolitan areas to effectively respond to a large- scale bioterrorist event by dispensing antibiotics to their entire identified population within 48 hours of the decision to do so. Over the past several years, HHS and the USPS have developed and tested in three U.S. cities--Seattle, Philadelphia and Boston-- the ability of letter carriers to quickly deliver door-to-door a few days' worth of antibiotics to residential addresses. This quick-strike capability is intended to buy time for State and local public health authorities to set up points of dispensing for further provision of antibiotics across the community, as needed. Under Section 564 of the FFDCA, the Secretary of Homeland Security may determine that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a specified biological chemical,
radiological or nuclear agent or agents.

[[Page 58243]]

Based on such a determination, the Secretary of Health and Human Services may declare an emergency that justifies the authorization of a product that is not otherwise approved, licensed or cleared for commercial use (``unapproved product'') or is not approved, licensed, or cleared for a particular use (``unapproved use of an approved product.''). Following that declaration, the Commissioner of the Food and Drug Administration (FDA) may issue an Emergency Use Authorization (EUA). The Biomedical Advanced Research and Development Authority (BARDA) of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) has requested that FDA issue an EUA for doxycycline hyclate tablets accompanied by emergency use information for use by eligible USPS participants in the CRI and their household members. Doxycyline hyclate tablets are approved by the FDA for the post- exposure prophylaxis of anthrax. However, the doxycycline hyclate tablets for which
BARDA seeks an EUA would be accompanied by emergency use information that is not included in any of the approved applications for doxyclycline hyclate tablets. For this reason, an EUA is necessary. The September 23, 2008 determination by the Secretary of Homeland Security that there is a significant potential for a domestic emergency, involving a heightened risk of attack with a specified biological, chemical, radiological, or nuclear agent or agents--in this case, Bacillus anthracis, and the October 1, 2008 declaration by the Secretary of Health and Human Services based on that determination that there is an emergency justifying the authorization of emergency use of doxycycline hyclate tablets accompanied by emergency use information, enables the FDA Commissioner to issue an EUA for doxycyline hyclate tablet emergency kits under section 564(a) of the FFDCA, 21 U.S.C. 360bbb-3(a). With issuance of the EUA, eligible letter carriers participating in the
CRI may receive the doxycycline hyclate tablet emergency kits, if not medically contraindicated, for future use by them and other members of their households during an anthrax emergency, subject to the terms of the authorization. The antibiotics and accompanying information may help protect these letter carriers and household members against contracting anthrax if, following an outdoor anthrax attack, the USPS is called upon to deliver the same or similar antibiotics to homes across their community where people may have been exposed to Bacillus anthracis. In an anthrax attack, time is of the essence in preventing illness and death by getting antibiotics to people who may have been exposed. By providing advance protection to letter carriers who willingly put themselves at risk by delivering antibiotics in an affected community, the unique capabilities of the USPS may be used to get antibiotics to those who need them quickly. The USPS initiative and EUA
are one part of the Federal Government's strategy to encourage preparedness at all levels of government to enable the nation to respond effectively in the event of an anthrax emergency.

II. Determination of the Secretary of Homeland Security

On September 23, 2008, pursuant to section 564(b)(1)(A) of the FFDCA, 21 U.S.C. 360bbb-3(b)( 1)(A), the Secretary of Homeland Security determined that there is a significant potential for a domestic emergency, involving a heightened risk of attack with a specified biological, chemical, radiological, or nuclear agent or agents--in this case, Bacillus anthracis. The Secretary of Homeland Security made this determination in a September 23, 2008 memorandum addressed to the Secretary of Health and Human Services. In that memorandum, the Secretary of Homeland Security stated that there is not currently a domestic emergency involving anthrax, there is not currently a heightened risk of an anthrax attack, and his Department has no credible information indicating an imminent threat of an attack involving Bacillus anthracis. The Secretary of Homeland Security determined that there is a significant potential for a domestic emergency, involving a heightened risk of
attack with Bacillus anthracis, on two bases: (1) The Department of Homeland Security has already found that an anthrax attack poses a material threat to the United States population sufficient to affect national security, which allows the Secretary to conclude that there is a non-negligible possibility that a heightened risk of attack will arise. The finding that an anthrax attack poses a material threat to the United States population sufficient to affect national security was made on January 20, 2004 regarding anthrax, and on September 22, 2006 regarding multi-drug resistant Bacillus anthracis, pursuant to section 319F-2(c)(2) of the Public Health Service (PHS) Act, 42 U.S.C. 247d-6b(c)(2) . (2) Were the government to determine in the future that there is a heightened risk of an anthrax attack--if, for example, there were credible information about an imminent threat of such an attack--that would almost certainly result in a domestic emergency. That
is so, among other important reasons, because those exposed to Bacillus anthracis need to take appropriate antimicrobials rapidly after exposure to avoid contracting anthrax and because of the significant challenges to rapidly delivering such antimicrobials to those at risk in an anthrax emergency. Given his determination that there is a significant potential for a domestic emergency, the Secretary of Homeland Security also urged the Secretary of Health and Human Services to employ all relevant emergency powers under section 564 of the FFDCA to ensure distribution of pre- need countermeasures that may be effective in preventing the contracting of anthrax by people in the delivery chain, such as USPS workers; first responders, including law enforcement; to essential government and non-government workers; and to the general public.

III. Declaration of the Secretary of Health and Human Services

On September 23, 2008, the Secretary of the Department of Homeland Security determined that there is a significant potential for a domestic emergency, involving a heightened risk of attack with a specified biological, chemical, radiological, or nuclear agent or agents--in this case, Bacillus anthracis. Pursuant to section 564(b) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. 360bbb-3(b), and on the basis of such determination, on October 1, 2008, I declared an emergency justifying the authorization of the emergency use of doxycycline hyclate tablets accompanied by emergency use information subject to the terms of any authorization issued under 21 U.S.C. 360bbb-3(a).

Dated: October 1, 2008. Michael O. Leavitt, Secretary. [FR Doc. E8-23544 Filed 10-1-08; 4:15 pm]

HHS Announces New Steps in Anthrax Preparedness

2008-10-01T09:07:00.001-05:00

http://www.hhs.gov/news/press/2008pres/10/20081001a.html

FOR IMMEDIATE RELEASE
Wednesday, October 1, 2008 Contact: HHS Press Office
(202) 690-6343

HHS Secretary Mike Leavitt today announced two new actions in the department’s ongoing activities to bolster the nation’s preparedness for a potential outdoor anthrax attack. In development since March of this year, the steps being implemented today build upon more than a decade of preparedness efforts across HHS and other agencies of the federal government.

The first of today’s actions focuses on United States Postal Service letter carriers who volunteer to deliver medicines directly to residences in their communities during an emergency.

Homeland Security Secretary Michael Chertoff and HHS Secretary Leavitt have invoked their authority under section 564 of the Federal Food, Drug, and Cosmetic Act to make the determination and declaration of emergency required by law in order for HHS’ Food and Drug Administration (FDA) to consider issuing an Emergency Use Authorization (EUA) allowing eligible letter carriers to receive kits containing small quantities of antibiotics for future use by them and other members of their households during an anthrax emergency. The Biomedical Advanced Research and Development Authority within HHS requested that FDA issue a EUA for this purpose.

These antibiotics would help protect volunteers against contracting anthrax if, following an outdoor anthrax attack, the Postal Service was called upon to deliver the same life-saving antibiotics directly to homes across their community where people may have been exposed to the bacterium that causes anthrax. Although no imminent threat currently exists, these legal actions would enable FDA to issue a EUA.

“In an anthrax attack, time is of the essence in preventing illness and death by getting antibiotics to those who may have been exposed,” Secretary Leavitt said. “By providing advance protection to letter carriers who volunteer to deliver antibiotics in an affected community, we can gain the benefits of the unique capabilities of the Postal Service to get much needed medicines to those who need it quickly. This is one part of our strategy to encourage preparedness at all levels of government to enable our nation to respond effectively in the event of an anthrax emergency.”

Over the past several years, under the Cities Readiness Initiative (CRI), HHS and the Postal Service have successfully developed and tested in three U.S. cities -- Seattle, Philadelphia and Boston --the ability of letter carriers to quickly deliver door-to-door quantities of antibiotics from the Strategic National Stockpile to residential addresses. This quick-strike capability is intended to buy time for local and State public health authorities to set up points of dispensing for further provision of antibiotics across the community.

“The letter carrier has long been a reliable presence in America's neighborhoods. This important and potentially life saving undertaking is a natural extension of what the carriers see as a service to their community,” Postmaster General John E. Potter said.

Begun in 2004, CRI is a federally funded effort to prepare 72 major U.S. cities and metropolitan areas to effectively respond to a large scale bioterrorist event by dispensing antibiotics to their entire identified population within 48 hours of the decision to do so. With today’s actions, CRI cities will now have another distribution tool at their disposal when crafting their plans to protect their populations. Such innovations have been encouraged by the National Academy of Sciences’ Institute of Medicine, which earlier this year conducted an evaluation of medical countermeasure distribution capabilities.

In a related action, Secretary Leavitt today issued a declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) that provides liability protection for activities related to developing, manufacturing, distributing, prescribing, dispensing, administering and using anthrax countermeasures in preparation for, and in response to, a potential anthrax attack. This includes entities, such as large “big-box” retail stores, retail pharmacies, and other private sector businesses, that help to deliver and distribute medicines. Providing liability protection to all involved in such efforts will help ensure their full participation and bolster response efforts.

“Preparedness is a shared responsibility that must involve all sectors of society, including the private sector, community groups, families and individuals,” Secretary Leavitt said. “We are using the authorities available to us to do all we can to support preparedness at all levels.”

The DHS Determination of an Emergency (under Section 564(b) of the Federal Food, Drug and Cosmetic Act) is available at http://www.dhs.gov/xlibrary/assets/ofsec_signed_determination092308.pdf; the HHS Declaration of an Emergency (under Section 564(b) of the Federal Food, Drug and Cosmetic Act) is available at http://www.hhs.gov/disasters/emergency/manmadedisasters/bioterorism/564anthrax-declaration.html; and the HHS PREP Act Declaration available at http://www.hhs.gov/disasters/emergency/manmadedisasters/bioterorism/prepact-081001.html.

For further information on HHS’ emergency preparedness efforts related to anthrax as well as other emergencies in general, please visit http://www.hhs.gov/emergency.

Efforts continue to posthumously promote EHartford man who opposed military vaccinations

2008-09-24T13:11:00.000-05:00

Efforts continue to posthumously promote EHartford man who opposed military vaccinations
By Thomas D. Williams
Special to the Journal Inquirer
Published: Wednesday, September 24, 2008 10:34 AM EDT

Attorney General Richard Blumenthal is continuing months of efforts to press the state’s National Guard and Gov. M. Jodi Rell to posthumously promote Russell Dingle of East Hartford — one of the nationwide leaders of a successful effort to promote drug safety and licensing requirements for the military’s mandatory anthrax vaccine inoculations.

“Lieutenant Colonel Dingle, at great personal and professional sacrifice, not only persevered in challenging the legality of the vaccine, but also succeeded in forcing the (U.S. Food and Drug Administration) to correct the warning label on the vaccine — thereby avoiding birth defects and other serious health problems for many people,” Blumenthal said in a May letter to Rell.

“Therefore, I strongly urge you to consider this posthumous promotion as a fitting tribute to a Connecticut Air National Guard member, someone who did so much for his fellow soldiers, his state, and his country,” he wrote.

The attorney general long has supported efforts by Dingle and others to stop the use of the vaccine because he considered it unsafe and improperly licensed.

Dingle, who died of cancer at 49 in September 2005, waged an unprecedented eight-year battle to compel government recognition of improper licensing of the controversial vaccine.

Eventually, his protests to government agencies, the courts, and two presidential administrations helped result in a December 2003 ruling from U.S. District Court Judge Emmet G. Sullivan in Washington, D.C., temporarily blocking required military inoculations eventually aimed at all 2.4 million service members.

After the Food and Drug Administration made adjustments to the vaccine’s license, ordered by Sullivan’s ruling, the Pentagon continued mandatory vaccinations. The inoculations caused thousands of adverse reactions and hundreds of disciplinary actions, including service removals of military men and women who refused to be vaccinated.

“What began as a task to investigate the anthrax vaccine (Tiger Team Alpha) has resulted in nonspecific personal threats, verbal abuse, ostracism, and, most recently, defamation of character and slander,” Dingle wrote in a February 1999 letter to his commander, Col. Walter Burns, weeks after he and seven other veteran combat pilots announced they were being forced out of the Air National Guard. He and others involved in opposing the vaccine, Dingle said, were being compared to “Nazi sympathizers.”

In August of this year, the FBI identified its second prime suspect in the September 2001 attacks that involved anthrax spore mailed to media outlets, two Democratic U.S. senators, and others: military lab vaccine scientist Bruce Ivans. The FBI insisted the national threat to cut off use of the anthrax vaccine motivated Ivans to spread terror with the spores to promote the vaccine he had a financial interest in.

Federal government discussions, including some involving former Defense Secretary Donald Rumsfeld, aimed at possibly halting the mandatory inoculations resulted in part from the earlier legal battle and other governmental pressures brought by Dingle and several Air Force colleagues. Initially, soon after the attacks, high-level officials, including President Bush, suggested foreign agents spread the anthrax spores and, as a result, the threat to discontinue the vaccine ended.

But, in fact, Dingle and Air Force Reserve Maj. Thomas Rempfer — a close friend, fellow military pilot, and vaccine-fighting colleague — argued that the threat of a foreign anthrax spore attack is remote. It had been used only once, and unsuccessfully, in 1995 by terrorist group Aum Shinrikyo in a Tokyo subway station, they said. And what’s more, Dingle and Rempfer added, the spore is difficult, dangerous, and expensive to produce.

A month after Blumenthal’s request to promote Dingle, Maj. Gen. Thaddeus J. Martin, the state’s adjutant general, rejected it. Martin said Dingle “voluntarily transferred” from the Guard to the U.S. Air Force Reserve, so he wasn’t qualified for Guard promotion.

But Dingle repeatedly had insisted he was forced out of the Guard in early 1999 because Guard officials didn’t want to accept his investigative findings that the vaccine was a dangerous health threat and was improperly licensed.

Most recently this month, Blumenthal — after reviewing evidence supporting Dingle’s claim supplied by a reporter — sent another request to authorities because he became convinced that Dingle was illegally forced out of the National Guard.

Dingle’s inspiration to oppose the vaccine arose in 1998 after Burns, his former Air Force National Guard commander, assigned him and Rempfer, then both majors and pilots, to research all aspects of the controversial drug.

After their “Tiger Team Alpha” found the vaccine to be too likely to cause adverse reactions, to have failed manufacturing inspections, and to have been improperly licensed, Burns rejected their conclusions.

A video shows that Burns later told Guard members they would be “traitors” if they failed to take the vaccine.

A deposition of Burns quotes him as saying: “If you do not get the shot during this time period … all you’re doing is kicking the can … if some of these issues are burning inside you. … Can’t have that because words like traitor start coming up in my mind, and I don’t have a lot of time for those kind of people. … If you’re not going to be ready to go to war whenever we’re called, you are sponging America as far as I’m concerned.”

The videotape, sworn testimony, and other data were e-mailed by a reporter to Martin, the state’s adjutant general. Martin, who in the February 1999 letter from Dingle to the Guard was accused of berating Dingle, continued to insist Dingle voluntarily resigned.

Ultimately, his press spokesman, Lt. Col. John Whitford, insisted that all queries be directed to Air Force headquarters in Washington, D.C. Air Force spokesman Michael Andrews said any such questions should be addressed instead to the National Guard Bureau in Washington, D.C. And there, spokeswoman Kristine M. Munn ultimately told a reporter that such subjects were in the purview of the Connecticut National Guard.

Blumenthal is asking the Guard and Rell to promote Dingle to the rank of full colonel from his Guard rank as major. After leaving the Guard in early 1999, Dingle moved into the Air Force Reserves and eventually was promoted to lieutenant colonel.

Rempfer supports the attorney general’s efforts. He said Dingle “should be posthumously promoted to full colonel, though he likely would have risen farther had he been allowed to remain. Russ was a leader with unparalleled integrity, and the state of Connecticut should honor his service accordingly.”

A Rell spokesman, Christopher Cooper, declined comment until the governor reviews a letter Blumenthal is preparing for unidentified authorities.

In May 2001 Dingle wrote to three congressmen seeking their intervention in the court-martial of then-Air Force Capt. John Buck, a medical doctor, who refused to take the vaccine.

He said: “`When the U.S. military no longer allows for professional dissent within its ranks; when the U.S. military mandates that any and all orders be obeyed regardless of their moral or legal basis; when the U.S. military allows its members to defend themselves with ‘I was just following orders’; then the U.S. military will cease to attract men and women of principle and honor. … It will end up resembling the military organizations that we have fought for the last 60 years.”

Dingle was survived by his wife, Jane; two daughters, Megan and Emma; and his mother, Barbara.

Scientist concedes 'honest mistake' about weaponized anthrax

2008-09-17T07:05:00.000-05:00

http://www.latimes.com/news/nationworld/nation/la-na-anthrax17-2008sep17,0,1753550.story
From the Los Angeles Times

Scientist concedes 'honest mistake' about weaponized anthrax

Peter B. Jahrling, who aided the federal probe of the 2001 mailings, says he erred when he told White House officials that material he examined probably had been altered to make it more deadly. By David Willman
Los Angeles Times Staff Writer

9:53 PM PDT, September 16, 2008

WASHINGTON — An acclaimed government scientist who assisted the federal investigation of the 2001 anthrax mailings said Tuesday that he erred seven years ago when he told top Bush administration officials that material he examined probably had been altered to make it more deadly.

The scientist, Peter B. Jahrling, had observed anthrax spores with the aid of an electron microscope at the government's biological warfare research facility at Ft. Detrick, Md.

On Oct. 24, 2001, Jahrling was summoned to the White House after reporting to his superiors what he believed to be signs that silicon had been added to anthrax recovered from a letter addressed to then-Senate Majority Leader Tom Daschle (D-S.D.).

The presence of silicon was viewed with alarm because the material, if artificially added to the anthrax, would make it more buoyant in air and more capable of penetrating deeply into the lungs.

"I believe I made an honest mistake," Jahrling said in response to questions e-mailed to him for this article, adding that he had been "overly impressed" by what he thought he saw under the microscope.

"I should never have ventured into this area," said Jahrling, who is a virologist, referring to his analysis of the anthrax, which is a bacterium. Jahrling's initial analysis -- and his briefing of officials at the White House -- was first detailed in a 2002 book by bestselling author Richard Preston.

Although Jahrling was careful in 2001 not to implicate Iraq or any other regime in the mailings, others used his analysis to allege that the silicon perhaps linked the letters to Iraqi President Saddam Hussein.

Inhaled anthrax can kill at a rate of 80% to 90% unless patients are treated quickly with an antibiotic.

Jahrling's comments Tuesday came soon after a congressional hearing at which FBI Director Robert S. Mueller III announced that he was arranging for an outside review of scientific findings that helped the bureau conclude that another scientist at Ft. Detrick, Bruce E. Ivins, perpetrated the deadly mailings. The review is to be overseen by the National Academy of Sciences, Mueller said.

FBI scientists and outside experts hired by the bureau to analyze the anthrax recovered from the mailings announced Aug. 18 that although they had found silicon, it occurred within the spores naturally and was not added.

In challenging those experts, one journalist reminded them that Jahrling, among other scientists, had concluded otherwise.

Some critics of the FBI investigation have asserted that Ivins lacked the skills to have "weaponized" the anthrax with any additive that enhanced its virulence.

At Tuesday's hearing, a member of the House Judiciary Committee, Rep. Jerrold Nadler (D-N.Y.), pressed Mueller anew about how the silicon got into the spores.

After being informed of the events at the hearing, Jahrling renounced his earlier analysis.

"In retrospect," Jahrling said, "I believe I was mistaken and defer to the experts."

Ivins, 62, a civilian bacteriologist for the Army, died July 29 after ingesting a massive dose of prescription Tylenol 3.

Attorneys Ivins had hired to defend him against criminal charges being prepared by the Justice Department have said that they would have won his acquittal if the case had gone to trial.

In 2001, Jahrling briefed a roomful of officials at the White House, including Atty. Gen. John Ashcroft, Mueller and Tom Ridge, President Bush's secretary of Homeland Security.

The next day, the Washington Post published a front-page article headlined "Additive Made Spores Deadlier" that reported:

"The presence of the high-grade additive was confirmed for the first time yesterday by a government source familiar with the ongoing studies, which are being conducted by scientists" at Ft. Detrick.

The article said that the United States, the former Soviet Union and Iraq were "the only three nations known to have developed the kind of additives that enable anthrax spores to remain suspended in the air, making them more easily inhaled" and more deadly.

At the time, Jahrling was employed as the senior civilian scientist at the U.S. Army Medical Research Institute of Infectious Diseases, within Ft. Detrick.

Jahrling is a past winner of the Secretary of Defense Meritorious Civilian Service Award.

Michael P. Kortan, a spokesman for Mueller, said after the congressional hearing that the FBI was seeking the outside review while maintaining "full confidence in our scientific approach."

"Consideration of an outside review began before any public disclosure of the scientific aspects of the investigation," Kortan said.

david.willman@latimes.com

Times researcher Janet Lundblad in Los Angeles contributed to this report.

United States citizens are increasingly enslaved, manipulated and murdered by corporations, and very few of them seem to realize it

2008-09-16T14:07:00.000-05:00

http://www.pr-inside.com/united-states-citizens-are-increasingly-enslaved-r808665.htm

United States citizens are increasingly enslaved, manipulated and murdered by corporations, and very few of them seem to realize it!

2008-09-16 13:37:30 - US Attorney Jeff Taylor was sweating on August 6, as he laid out his case against the late Dr. Bruce Ivins at a news conferenceand with good reason. Anyone familiar with the case is well aware that Dr. Ivins was railroaded, and that the news conference was a flimsy web of lies.

Washington DC-based journalist Sheila Casey and attorney/peace activist Barry Kissin write:

Ivins had nothing to do with the 2001 anthrax attacks. The attacks were almost certainly carried out by the only group that had the means to produce the highly weaponized anthrax in the letters: the CIA, its contractor Battelle Memorial Institute of West Jefferson, Ohio, and the Army at Dugway in Utah.

The DOJ-FBI frame-up of Ivins rests heavily upon the claim of new advances in genetic testing which supposedly prove that the killer anthrax could have come only from Ivins' flask. Jeff Taylor stated: "The FBI sought out the best experts in the scientific community and, over time, four highly sensitive and specific tests were developed that were capable of detecting the unique qualities of the anthrax used in the 2001 attacks."

This is a distraction. No special tests were required to assess the genetic heritage of the Ames strain in the envelopes. The Washington Post reported on December 16, 2001 that "only five laboratories, so far, have been found to have spores with perfect genetic matches to those in the Senate letters."

The distinguishing feature of the anthrax that killed five people in 2001 is not related to its genes. What made that anthrax unique was that it was highly weaponized. Anthrax is a common pathogen found in the soil in many places. It doesn't become a potential weapon unless produced in such a way that it behaves like a gas, floating easily in the air and deep into a victim's lungs. The anthrax used in the attacks was beyond cutting edge.

Donald A. Henderson, former assistant secretary for the Office of Public Health Preparedness at the Department of Health and Human Services, told Science magazine: "It just didn't have to be that good" to be lethal.

Why the killer anthrax was so deadly?

Precisely-sized particles1.5 to 5 microns. Anything smaller is exhaled, anything larger tends to get caught either in the nose or in the cilia in the trachea.
Coated with silica. The silica acted as a buffer, preventing spores from adhering to one another. The silica on the attack anthrax rested on a thin layer of polymerized glass, which is a highly advanced technique for coating anthrax spores. To do this required a "spray dryer," the cheapest of which sells for $50,000. The lyophilizer in Ivins' lab is used to dry anthrax, but can NOT be used to coat the spores with silica. Ivins did not have a spray dryer.

Highly concentrated. The letter to Senator Daschle's office contained two grams of anthrax, about the weight of a dime. Each gram contained a trillion pure spores of anthrax, or enough to kill 200 million people.

Electrically charged. The same charge on each particle (of spores) caused the particles to repel each other and thus to spread out into the room after the envelope was opened.

No electrostatic charge. The particles were specially treated to eliminate electrostatic charges so they float in the air. It is these attributes of the anthraxnot its genetic heritagewhich made it so unique and so lethal.

The source of the anthrax was clear in 2001

US Attorney Jeff Taylor characterized a flask in Dr. Ivin's possession as "the murder weapon." But a December 12, 2001 article in the Baltimore Sun stated: For nearly a decade, US Army scientists at Dugway Proving Ground in Utah have made small quantities of weapons-grade anthrax that is virtually identical to the powdery spores used in the mail attacks that have killed five people.

The article refers to Dugway as "the only site in the United States where weapons-grade anthrax has been made in recent years," and also includes this: Dugway's production of weapons-grade anthrax, which has never before been publicly revealed, is apparently the first by the U.S. government since President Richard M. Nixon ordered the US offensive bio-warfare program closed in 1969.

The following day, The Washington Post echoed the Sun article: An Army biological and chemical warfare facility in Utah has been quietly developing a virulent, weapons-grade formulation of anthrax spores since at least 1992.

On December 16, 2001, The Washington Post corroborated the Sun report by stating that "Dugway is the only facility known in recent years to have processed anthrax spores into the powdery form that is most easily inhaled," also stating, "Army officials in Washington said yesterday that Fort Detrick does not have the equipment for making dried anthrax spores."

On September 4, 2001, The New York Times exposed: Over the past several years, the United States has embarked on a program of secret research on biological weapons . . . even the [Clinton] White House was unaware of their full scope. The projects, which have not been previously disclosed . . . have been embraced by the Bush administration, which intends to expand them.

These projects involve the CIA, Battelle Memorial Laboratories in West Jefferson, Ohio, and the Army at Dugway in Utah.

The need to keep such projects secret was a significant reason behind President Bush's recent rejection of a draft agreement to strengthen the germ-weapons treaty, (the 1972 Biological Weapons Convention) which has been signed by 143 nations. Had the treaty been strengthened, the Dugway and West Jefferson sites would have been subject to international inspections. It is important to note that Battelle not only operates its labs in West Jefferson, but also is contracted by the Army to operate the labs at Dugway.

The DOJ-FBI news conference on August 6, 2008, was a deliberate attempt to divert attention from the secret anthrax weaponization projects by pinning the crimes on a dead man. So far the DOJ-FBI have succeeded in covering up the real perpetrators of the crime, concealing the illegal weapons program, and persuading many that it is time to close the investigation.

Dr. Ivins was an immunologist; he had neither the knowledge nor the equipment to produce the silica-coated, electro-statically charged, 1.5 to 5 micron sized, one trillion spore per gram anthrax that was mailed to Senators Leahy and Daschle. The DOJ has made much of the fact that Ivins worked 45 extra hours in September and October of 2001. Yet when the FBI attempted to reverse engineer the weaponized anthrax from the attacks, they admitted after a year of trying that they were unable to come up with a product as potent as that in the letters.

Scientists doubt FBI's story

As far back as October 28, 2002, The Washington Post reported that bio-weapons experts were skeptical about the view that the anthrax in the letters could have come from a lone nut: 'In my opinion, there are maybe four or five people in the whole country who might be able to make this stuff, and I'm one of them,' said Richard O. Spertzel, former deputy commander of USAMRIID (the Army bio-defense facility at Detrick). 'And even with a good lab and staff to help run it, it might take me a year to come up with a product as good.'

Writing in The New York Times on August 9, 2008, Gerry Andrews, an assistant professor of microbiology at the University of Wyoming, described the envelopes' contents as "a startlingly refined weapons-grade anthrax spore preparation, the likes of which had never been seen before by personnel at Fort Detrick." He continued: "It is extremely improbable that this type of preparation could ever have been produced at Fort Detrick, certainly not of the grade and quality found in that envelope."

Abundant evidence that Ivins is innocent

Ivins passed two polygraph tests and no link was made between his handwriting and that on the anthrax letters. Investigators were so frustrated at Ivins passing the polygraph tests that they searched his house for books or articles on how to fool a polygraph, but found none. US Attorney Jeff Taylor stated that the investigators zeroed in on Ivins when they "conducted additional investigative steps," and thus were "able to narrow the focus even further, exclude individuals, and that left us looking at Dr. Ivins." Those "additional investigative steps" were polygraph tests. Where passing a polygraph test was enough to exclude certain people, it did not exclude Ivins.

Ivins' car, work locker, safe deposit box and house were thoroughly swabbed for anthrax spores multiple times over the space of years; not a single spore was found, although the killer anthrax was so highly weaponized that it behaved like a gas and was very difficult to contain.

None of the materials in the mailings were found at his house: not the tape, the envelopes, nor the pen used to write the letters. There isn't one piece of evidence placing him in New Jersey at the time the letters were mailed: not a credit card receipt, restaurant receipt, nor a witness.

On August 3, 2008, Glen Greenwald wrote in Salon: "It is so vital to emphasize that not a shred of evidence has yet been presented that the now-deceased Bruce Ivins played any role in the anthrax attacks, let alone that he was the sole or even primary culprit. Nonetheless, just as they did with Steven Hatfill, the media (with some notable and important exceptions) are reporting this case as though the matter is resolved."

Bruce Ivins: juggler, Red Cross volunteer, pianist

Jeff Taylor's case against Ivins rests heavily on claims that Ivins was mentally ill. If Ivins was truly so unhinged, why was he allowed to work with toxic substances? His security clearance was never revoked. Certainly a brilliant homicidal serial killer who is determined to avoid detection would immediately get rid of the Ames strain with the incriminating genotype in his flask, if he had used it to make weaponized powder and kill five people. Yet years later, the same genotype was still in Ivins' lab! The DOJ and FBI ask us to believe that Ivins launched the attacks because his vaccine research was not going well and he feared he might lose his job. It's just not a plausible motivation.

In 2003, Ivins received the Decoration for Exceptional Civilian Servicethe highest award given to the Defense Department's civilian employees. He had been a respected scientist at USAMRIID for 35 years and had a very secure job.

Ivins had been married for 33 years. He played keyboard at his local church, he was a member of the American Red Cross, an avid juggler and founder of the Frederick Jugglers. He also played keyboards in a Celtic band and would often compose and play songs for coworkers who were moving to new jobs. The FBI focused on him as a probable fall guy in 2006, and for two years was all over him, repeatedly questioning him, searching his home, car and office, and confronting him and his family in public with accusations that he had "killed people." His daughter was shown pictures of dead anthrax victims and told "your father did this." His son was promised $2.5 million and a sports car of his choice if he would implicate his father in the anthrax attacks. Who among us would not resort to drink, or drugs, or fantasies of revenge under those circumstances?

Who had the expertise to weaponize anthrax?

William C. Patrick III, and Ken Alibek. William Patrick was the originator of the first anthrax weaponization process. He has five patents on anthrax weaponization and wrote a paper in 1999 setting out exactly what an anthrax attack by mail would look like. Patrick's scenario is very similar to what actually happened in 2001. For example, he suggests no more than 2.5 grams of anthrax per envelope; the envelopes contained two grams. One footnote in his paper reveals "we now have the ability to purify to one trillion spores per gram." William Patrick was a consultant to the CIA, Battelle, the Army, the DIA and the FBI on bio-weapons.

Ken Alibek headed up the Soviet bio-weapon programs until defecting to the USA in 1992. He brought with him the technology that was key in the anthrax attacks: using polymerized glass to coat anthrax spores. He worked for Battelle Memorial Institute in the late 90s.

These men had to have been instrumental in developing the technology used in the 2001 anthrax attacks.

Who can control the FBI, DOJ and the media?

The significance of the railroading of the deceased Ivins cannot be overstated. This railroading is not a matter of incompetence. In detail after detail, the joint FBI-DOJ prosecution deliberately lies, evades and obfuscates in a desperate attempt to pin blame somewhere and close the case. (A transcript of the entire August 6 news conference is available on npr.org, titled "DOJ News Conference On Bruce Ivins)

US Attorney Jeff Taylor states at the news conference that the envelopes used in the attacks were "very likely sold at a post office in the Frederick, Md. area," and that Ivins had a post office box there. This is another outright lie. Taylor's own application for a search warrant stated: -envelopes with printing defects, identical to printing defects identified on the envelopes utilized in the anthrax attacks during the fall of 2001, were collected from the Fairfax Main post office in Fairfax, Virginia, and the Cumberland and Elkton post offices in Maryland.

Taylor and his supervisors at DOJ must be hoping that no one will notice or care that they are blatantly lying about their evidence against Ivins.

Reading the transcript, it is striking how often Jeff Taylor and Joseph Persichini refuse to answer questions. They either refer reporters to the Department of Defense (which is not holding a news conference) or to the documents they have been given. When asked when their all new, ground-breaking DNA research would be published, Taylor replies "I'm not going to comment on (that When asked a direct question about how many others were investigated other than Ivins, Taylor replies "I'm not going to get into the details."

Not only does he not get into the details, he doesn't even give us the broad strokes. When asked how he can be so sure that there wasn't another person involved, Taylor replies: The evidence I described in my statement, and that I've described throughout this question-and-answer period, as I said, led us to conclude that Dr. Ivins is the person who committed this crime. We are confident, based on the evidence we have, that we could prove this case beyond a reasonable doubt.

In other words, he doesn't answer.

Honest citizens must ask themselves: who are the FBI and DOJ protecting?

Who has the ability to control and corrupt an investigation of this importance?

And why, after sitting through a news conference that is obviously a hastily constructed web of lies, have so many journalists dutifully reported the story just as instructed by Jeff Taylor?

We no longer have a working government in the United States ... what we have are functionaries in various departmentsCongress, FBI, DOJ, CIAwho take their orders from the corporations who make vast sums of money waging war and selling vaccines. Their influence extends to the major media outlets who control the flow of information to the American people. We are increasingly enslaved, manipulated and murdered by these corporations, and very few of us seem to realize it.

Sheila Casey is a DC based journalist. Her work has appeared in The Denver Post, Buzz Flash, Common Dreams and Dissident Voice. She blogs at www.sheilacasey.com/

Barry Kissin is an attorney/peace activist based in Frederick, MD, home of Fort Detrick, and can be contacted at barrykissin@hotmail.com

Is FDA Interested in the Safety of Anthrax Vaccine?

2008-09-10T08:10:00.000-05:00

Wednesday, August 27, 2008

Is FDA Interested in the Safety of Anthrax Vaccine?

FDA answered a Freedom of Information Act request for me today. I asked how many adverse event reports had been filed for anthrax vaccine (5,931 reports through July 22, 2008) and how many FDA had designated as SERIOUS (618 reports). Serious reports are those indicating an event requiring hospitalization, a life-threatening event, permanent disability, or loss of life.

I further asked whether FDA has performed any studies to assess causality (i.e., were adverse outcomes a result of the vaccination?) or if FDA has required the manufacturer to do so. The answer was 'No' to both questions.

FDA referred me to CDC. CDC began a clinical trial of anthrax vaccine in 1,564 people in 2002. Subjects were enrolled for 43 months, which theoretically should yield excellent long-term data. But no report from the study has been made public, despite early promises that a preliminary report would be released in 2004, and a final report in 2007.

The CDC's Advisory Committee on Immunization Practices met February 27-28, 2008 and discussed anthrax vaccine and this trial. Slides from every talk except the anthrax vaccine talks were posted by the CDC here. But the slides from each of the 4 talks on anthrax vaccine are listed as "coming soon."

However, I did manage to find this tidbit (see page 155 of the report): in CDC's clinical trial of 1,564 subjects, there were 229 reports of serious adverse events! That means, if you entered the anthrax vaccine trial, you had a greater than 1 in 7 chance of suffering a serious adverse event within the next 43 months. Yet despite failing to cite quantitative data, CDC thought the vast majority of serious events were not related to the vaccine. (But something bad was happening to this cohort of subjects, about 85% of whom received anthrax vaccine.)

Over 2 million people have received more than 7.5 million doses of the Bioport (now Emergent BioSolutions/ EBS) anthrax vaccine since 1998, and all deploying soldiers and most contractors must be vaccinated as a condition of employment. Yet no federal public health agency is anxious to release definitive safety/injury data. Wonder why?

Meryl Nass, MD
Mount Desert Island Hospital
Bar Harbor, Maine 04609
W 207 288-5081 ext. 1220
C 207 522-5229
H 207 244-9165
pager 207 818-0708
http://anthraxvaccine.blogspot.com
http://www.anthraxvaccine.org

Lawmakers Seek Anthrax Details

2008-09-07T08:26:00.000-05:00

http://www.nytimes.com/2008/09/07/washington/07anthrax.html?_r=1&hp=&pagewanted=all

September 7, 2008
Lawmakers Seek Anthrax Details
By SCOTT SHANE and ERIC LICHTBLAU

WASHINGTON — A month after the F.B.I. declared that an Army scientist was the anthrax killer, leading members of Congress are demanding more information about the seven-year investigation, saying they do not think the bureau has proved its case.

In a letter sent Friday to Robert S. Mueller III, the director of the Federal Bureau of Investigation, Democratic leaders of the House Judiciary Committee said that “important and lingering questions remain that are crucial for you to address, especially since there will never be a trial to examine the facts of the case.”

The scientist, Bruce E. Ivins, committed suicide in July, and Mr. Mueller is likely to face demands for additional answers about the anthrax case when he appears before the House and Senate Judiciary Committees on Sept. 16 and 17.

“My conclusion at this point is that it’s very much an open matter,” Senator Arlen Specter of Pennsylvania, the top Republican on the Senate committee, said of the strength of the case against Dr. Ivins, a microbiologist at the Army’s biodefense laboratory who worked on anthrax vaccines. “There are some very serious questions that have yet to be answered and need to be made public.”

Bureau officials say they are certain they have solved the nation’s first major bioterrorism attack, in which anthrax-laced letters killed five people, after a long and troubled investigation that by several measures was the most complex in the bureau’s history.

But in interviews last week, two dozen bioterrorism experts, veteran investigators and members of Congress expressed doubts about the bureau’s conclusions. Some called for an independent review of the case to reassure the public and assess policies on the handling of dangerous pathogens like anthrax.

Meanwhile, new details of the investigation, revealed in recent interviews, raised questions about when the bureau focused on Dr. Ivins as the likely perpetrator and how solid its evidence was.

In April 2007, after the mailed anthrax was genetically linked to Dr. Ivins’s laboratory and after he was questioned about late-night work in the laboratory before the letters were mailed, prosecutors sent Dr. Ivins a formal letter saying he was “not a target” of the investigation. And only a week before Dr. Ivins died did agents first take a mouth swab to collect a DNA sample, officials said.

Justice Department officials, who said in early August that the investigation was likely to be closed formally within days or weeks, now say it is likely to remain open for three to six more months. In the meantime, agents are continuing to conduct interviews with acquaintances of Dr. Ivins and are examining computers he used, seeking information that could strengthen the case.

But bureau and Justice Department officials insist that the delay, which they say is necessary to tie up loose ends in a complex investigation, reflects no doubts about their ultimate verdict. “People feel just as strongly as they did a month ago that this was the guy,” said a department official who spoke on the condition of anonymity.

Even the strongest skeptics acknowledged that the bureau had raised troubling questions about Dr. Ivins’s mental health and had made a strong scientific case linking the mailed anthrax to a supply in his laboratory.

But they said the bureau’s piecemeal release of information, in search warrant affidavits and in briefings for reporters and Congress, had left significant gaps in the trail that led to Dr. Ivins and had failed to explain how investigators ruled out at least 100 other people who the bureau acknowledged had access to the same flasks of anthrax.

In interviews, F.B.I. officials said they knew their findings would face intense scrutiny after the bureau admitted that for years it had pursued the wrong man, Steven J. Hatfill, whom the government paid $4.6 million in June to settle a lawsuit that accused the government of leaking information about him to the news media.

Officials also acknowledged that they did not have a single, definitive piece of evidence indisputably proving that Dr. Ivins mailed the letters — no confession, no trace of his DNA on the letters, no security camera recording the mailings in Princeton, N.J.

But they said the case consisted of a powerfully persuasive accumulation of incriminating details. Dr. Vahid Majidi, head of the F.B.I.’s weapons of mass destruction directorate, said the accumulation of evidence against Dr. Ivins was overwhelming: his oversight of the anthrax supply, his night hours, his mental problems and his habit of driving to far-off locations at night to mail anonymous packages.

“Who had the means, motive and opportunity?” said John Miller, assistant F.B.I. director for public affairs. “Some potential suspects may have had one, some had two, but on the cumulative scale, Dr. Ivins had many more of these elements than any other potential suspect.”

Mr. Miller said the bureau ultimately planned to release much more information from its investigative files, including notes of F.B.I. interviews with Dr. Ivins and other suspects and witnesses and surveillance logs detailing his movements and actions. But those disclosures, requiring a detailed review to remove private and classified information, are likely to be months away.

Mr. Mueller, the F.B.I. director, is likely to face tough questions at next week’s scheduled oversight hearings, not just about the case against Dr. Ivins but about the prolonged pursuit of Dr. Hatfill. Senator Charles E. Grassley, an Iowa Republican and frequent critic of the bureau, said he was frustrated by the delay in closing the case and answering questions.

“If the case is solved, why isn’t it solved?” Mr. Grassley asked. “It’s all very suspicious, and you wonder whether or not the F.B.I. doesn’t have something to cover up and that they don’t want to come clean.”

Investigators have not reviewed three boxes of papers left by Dr. Ivins marked for the attention of his lawyer, Paul F. Kemp, because the records must first be reviewed to see whether they should be kept confidential under attorney-client privilege, Mr. Kemp said. A government lawyer not involved in the investigation will soon review the papers with Mr. Kemp, who said some might be given to investigators or made public.

What is clear is that the disclosures have not closed the matter.

“They took their shot,” said Representative Rush D. Holt, a Democrat who holds a doctorate in physics and has followed the case closely because the letters were mailed in his New Jersey district. “They hoped and maybe believed that the case they laid out would persuade everyone. I think they’re probably surprised by the level of skepticism.”

Many scientists who have tracked the case, too, have found the evidence less than decisive.

“For a lot of the scientific community, the word would be agnostic,” said Dr. Thomas V. Inglesby, an expert on bioterrorism at the Center for Biosecurity of the University of Pittsburgh Medical Center. “They still don’t feel they have enough information to judge whether the case has been solved.”

Mr. Holt and Dr. Inglesby were among a number of outsiders who said that only an independent review of the investigation and the evidence against Dr. Ivins — either by Congress or a commission like the one that investigated the Sept. 11 attacks — could give the public confidence that the case was over.

Dr. Ralph R. Frerichs, an epidemiologist at the University of California, Los Angeles who has created a Web site detailing the anthrax case, said that such a review was critical to establishing how the lethal powder was made.

“There’s no clarity on the simplest aspect: is this hard to do or easy to do?” Dr. Frerichs said. If the powder could be made with basic laboratory equipment and no sophisticated additives, as the bureau maintains, laboratory security and background checks for workers may have to be tightened, he said.

Skepticism toward the bureau’s case remains especially pronounced among Dr. Ivins’s former colleagues at the Army laboratory at Fort Detrick, Md.

“Despite the F.B.I.’s scientific and circumstantial evidence, I and many of Dr. Ivins’s former colleagues don’t believe he did it and don’t believe the spore preparations were made at Detrick,” said Dr. Gerry Andrews, a microbiologist who worked at the Army laboratory for nine years and was Dr. Ivins’s boss for part of that time.

Laboratory records obtained by The New York Times show that the anthrax supply labeled RMR-1029, which the F.B.I. linked to the attacks, was stored in 1997 not in Dr. Ivins’s laboratory, in Building 1425, but in the adjacent Building 1412. Former colleagues said that its storage in both buildings at different times from 1997 to 2001 might mean that the bureau’s estimate of 100 people with physical access to it was two or three times too low.

Some microbiologists question the time records documenting Dr. Ivins’s night hours, pointing out that one F.B.I. affidavit said he was in the secure part of the laboratory for exactly 2 hours and 15 minutes three nights in a row — an unlikely coincidence that they said raised questions about the accuracy of the records.

Confusion remains about silicon found in the mailed powder. Some F.B.I. critics say it shows that there was a sophisticated additive that might point away from Fort Detrick as a source, but the bureau concluded that it was merely an accident of the way the anthrax was grown.

Dr. Majidi said that many technical details would be cleared up by the papers published by bureau scientists and consultants over the next year or more. “It’s the collective body of evidence that’s really strong,” Dr. Majidi said.

Without witnesses or forensic experts linking the killings directly to Dr. Ivins, the Justice Department’s public case against him relies largely on “opportunity evidence,” said Robert J. Cleary, the lead prosecutor a decade ago in the Unabomber attacks.

“What prosecutors have to do to persuade the public that this was the guy is to show the uniqueness of the strain of anthrax and to eliminate everyone else who had opportunity and access to it.” That, Mr. Cleary said, “is a challenge.”

Kristof Still Doesn't Get the Anthrax Story: The Justice Department, Bush Science & Our Sorry Media

2008-09-06T09:10:00.000-05:00

http://www.opednews.com/articles/1/Kristof-Still-Doesn-t-Get-by-Elizabeth-Ferrari-080829-143.html
by Elizabeth Ferrari
www.opednews.com

In his unapologetic apology to Steve Hatfill yesterday, The Media's Balancing Act, Nicholas Kristof warned that the press should err on the side of sharing what it knows over the consequences to an individual should that report be printed. His premise seems to be that the problem in the anthrax reporting has been caused by the press printing "what it knows." Kristof appealed to the need for journalistic balance in order to serve the public good.

I don't know how an employee of the New York Times can still cling to such an idea, let alone, forward it in public. Judith Miller was not a public servant -- can we agree on that? I still have the email former Public Editor Okrent sent to hundreds of us when we asked why the Times would not cover election theft in Ohio 2004. He assured us the Times would cover the story if one developed. Of course, he said that while the Times sat on the Bush Administration's illegal wiretapping and to my knowledge, the Times has not covered the layers of corruption since peeled off of that election and the paper has not apologized in any way for either our stolen election or for shrugging off readers who asked for the paper to do its job.

The problem in our press is not that it prints what it knows. In the case of Dr. Ivins, the trial in the press has been replete with the press sharing what it does not know. The L.A. Times printed that Ivins stood to gain monetarily from the vaccine he was fixing and that he broadcast anthrax to save his job. That turns out to be a massive distortion coupled to an outright falsehood. Ivins' job was secure and he didn't stand to gain much if we used that vaccine or the one he had in development. The AP printed that Dr. Ivins suspiciously did not report a spill in his lab. Untrue, he reported it to his Ethics officer. The Washington Post printed that he had taken time off on 9/17/01 to mail the deadly envelopes. That turned out to be physically impossible: he was in Frederick at the time. Where is the balance in this reporting?

So, it's not a matter of "humanizing" the so called suspect or of adopting his viewpoint, as Kristof says, but of doing basic due diligence before running with these very serious allegations. Dr. Ivins has been prosecuted in the press with more impunity than Steve Hatfill was, although the FBI's case against him is even more flimsy. The larger question here isn't what the press knows but if the press can learn to distinguish a fact from a smear, no matter where that smear originates. In my reading about this case in our press, I've been struck with the repetition of talking points the FBI has put out. Here's one example of the career of the meme "compelling":

NPR August, 6, 2008: Jeff Taylor, US Attorney, Gonzalez appointee and host for the FBI briefing: "So, again, circumstantial evidence? Sure, some of it is. But it's compelling evidence and our view is we are confident it would have helped us prove this case against Dr. Ivins beyond a reasonable doubt."

AP August 18, 2008: Daschle said the most compelling evidence to him is the odd, extended hours that the Army scientist kept shortly after the Sept. 11 terror attacks.

New York Times August 16, 2008: In its case against Dr. Ivins, the F.B.I. developed a compelling profile of an erratic, mentally troubled man who could be threatening and obsessive, as in his odd fascination with a sorority from his college days. But investigators were never able to place him at the New Jersey mailboxes where the anthrax letters were dropped, and the case against him relied at its heart on the scientific evidence linking the anthrax in Dr. Ivins' laboratory to the spores used in the attacks.

Star Ledger: "I am persuaded, unless I'm missing something, there is a compelling case they at least got the one right guy," Smith said. "They claim there's no evidence whatsoever that there was an accomplice, but our hope is that they still keep looking to make sure there wasn't." click here

AP August 8, 2008: Mark Cunningham, a New York Post op-ed editor, one of three staffers there who were sickened by an anthrax-tainted letter, said he also was convinced about the government's case against Ivins. . . "The case is circumstantial but compelling," Cunningham wrote. "I'm glad they're keeping the case open, to tie up loose ends, make absolutely certain he acted alone, and all the rest. But I have my closure."

"The scientific evidence is compelling," says Rita R. Colwell, former director of the National Science Foundation, which funded some of the research behind the investigation. It is impressive how all the different scientific aspects came together, she says. http://pubs.acs.org/cen/n ews/86/i34/8634notw1.html

Nature Magazine August 21, 2008: "Haigwood said FBI agents were "very ethical and above board." And reading their case files convinced her they have the right suspect. "The evidence was compelling," she said."

Did our press know this "evidence" was compelling? Even if the phrase is a direct quote, the fact that it went unchallenged so often argues a kind of innocence no reporter should aspire to. No one included the caveat, for example, "Nancy Haigwood has not seen Dr. Ivins in twenty-five years and her outfit depends on millions of dollars in annual federal grants." The FBI's phrase was just churned out, over and over, as if the language was somehow losing syllables.

In other words, Nick, please share your fears and facts with your public. But clearly label your fears so they don't get spammed all across the country in factual drag as the report that Bruce Ivins was a homicidal sociopath was spammed when the source was a low level mental health worker/recovering addict/FBI witness. It was never interrogated by anyone in the press before being broadcast and it still hasn't been questioned in any substantive manner. Only Bruce Ivins' life as he led it contradicts the hundreds of repetitions of "what the press knew".

There's something else here, too, that is so huge we can't see it. I've yet to see a single caveat in the press regarding the FBI's scientific "findings" in the Ivins case that no scientist outside the government will validate and in the context of the documented manipulation of science itself by the Bush Administration. This administration's suppression, falsifying and censoring of science has been read into the Congressional Record. Surely the press has access to that body of facts. Surely as a mere civilian I'm not the only one that has read or heard or witnessed the iron control the Bush Administration has exerted over government scientists in the last eight years? Anyone with access to a search engine can search "Bush censors scientists" and come up with hundreds of hits such as this one:

SCIENCE-US: Top Scientists Want Research Free From Politics
By Adrianne Appel

BOSTON, Feb 14 (IPS) - Leading U.S. scientists called on Congress Thursday to make sure the next president does not do what they say the George W. Bush Administration has done: censor, suppress and falsify important environmental and health research.

"The next president and Congress must cultivate an environment where reliable scientific advice flows freely," said Susan Wood, a former director of women's research at the U.S. Food and Drug Administration (FDA). Wood resigned her post in 2005 in protest over the FDA's delay in getting emergency, over-the-counter birth control onto the market.

"Serious consequences can result when drug safety decisions are not based on the best available scientific advice from staff scientists and experts," she said.

Wood joined a panel of prominent scientists in Boston -- convened by the Union of Concerned Scientists, an activist group -- to announce a joint statement asking Congress to protect scientific integrity. Among the more than 15,000 government scientists signing onto the statement are Harold Varmus, president of Memorial Sloan-Kettering Cancer Centre and former director of the National Institutes of Health (NIH); and Anthony Robbins, professor of medicine at Tufts University and former director of the National Institute for Occupational Safety and Health.

http://www.ipsnews.net/news.asp?idnews=41205

So, if the FBI's case against Bruce Ivins depends upon "new" science developed by government scientists, a reasonable person has to ask, how reliable is that science? It hasn't been published or peer reviewed. There is no expert outside the government willing (so far) to validate it. Perhaps, in that instance, we are being asked to trust the Bush Justice Department to vet the FBI product.

Unfortunately, even though the press that Kristof defends has not raised the issue, the Bush Justice Department that has sponsored and presented this "new" science to convict Bruce Ivins, has been under investigation for corruption. The Bush Justice Department is under investigation for gutting the Voter Rights Act office, for political discrimination in its hiring practices, for politically motivated prosecutions of Governor Don Siegelman and Paul Minor and others, not to mention, for lying to Congress and for trying to present torture as patriotism to the American public.

Although I respect Kristof as one of his longtime readers, I have to call bullshit on his "apology" to Steve Hatfill because that apology is founded on the premise that our press is diligent enough to be presented with the problem of what to distribute to the public. Would that it were so. What a wonderful dilemma that would be were it true.

Our press shouldn't be criticized for sharing what it knows with the American public. But it should be hung out to dry for sharing what it cannot verify – as Kristof did with respect to Hatfill and as the New York Times, the Washington Post, the L.A. Times and worst offender, the AP have in the last four weeks with respect to Dr. Ivins. They should be hung out to dry again for never raising the obvious problems with the last iteration of the FBI's case: the Bush Justice Department is asking the American public to believe it so respects both science and justice for once that the unpublished case against Bruce Ivins is in any way believable.

I don't fault you, Mr. Kristof, for sharing what you know or for making the best, difficult decision you can make as a journalist. I fault you for not being all over the Ivins chapter of this story. Because you, of all people, should recognize what is being done to Ivins in the press right now and unlike Steve Hatfill, Bruce Ivins is not here to contend with the Bush Justice Department. Covering this story with some kind of insight and integrity is the apology that the American public deserves from you or from anyone who claims to serve the public good in print.

Emergent BioSolutions wins $24.3M to fight anthrax

2008-09-03T08:13:00.000-05:00

Wednesday, September 3, 2008 - 5:03 PM EDT
Emergent BioSolutions wins $24.3M to fight anthrax
Washington Business Journal - by Mara Lee Staff Reporter

http://www.bizjournals.com/washington/stories/2008/09/01/daily28.html

Emergent BioSolutions Inc. has won a contract worth $24.3 million from the Department of Health and Human Services to research an experimental drug to fight anthrax.

Rockville-based Emergent BioSolutions (NYSE:EBS), already has Federal Drug Administration-approved vaccine that prevents anthrax infection called BioThrax.

The bulk of the money, $20 million, would be used to complete the first phase of human testing for the antibody-based drug, which is designed to treat people who have already been exposed to anthrax.

It has been tested in mice, rats and rabbits, and now must be tested in humans, first to see if it is safe, and then to see if it works. The grant will only underwrite the first phase of that testing, though it will also cover costs from making more of the drug for the trials.

“We believe this funding from HHS underscores the U.S. government’s commitment to a multi-prong approach in responding to the threat of bioterrorism in our country,” the company said in a statement.

Emergent did not invent this particular antibody approach — it bought the rights to the experimental drug from Avanir Pharmaceuticals in March 2008.

KU Med researchers share anthrax discovery

2008-08-15T07:47:00.001-05:00

http://www2.ljworld.com/news/2008/aug/15/ku_med_researchers_share_anthrax_discovery/?city_local

Kansas University Medical Center researchers, along with researchers from Harvard Medical School, the University of Missouri-Kansas City and William Jewell College, have made a discovery that could be used to eventually prevent anthrax infections from harming humans.
Although it is known that anthrax is comprised of three proteins, the discovery specifically looks at the structure of the protective antigen pore protein, which is responsible for the delivery of toxins in human cells, according to a press release.

Researchers used an electron microscope to study the structure of the protein. Hiroo Katayma, a biochemistry and molecular biology graduate student, was the one to discover the protein essentially formed a syringe-like appendage which injected the toxins into human cells.

This discovery could eventually lead to prevent anthrax infections from even taking place, rather than requiring a vaccine.

Mark Fisher, KUMC professor of biochemistry and molecular biology who led the research, said that finding drugs that could prevent the structure from forming would be a “first line of defense.”

U.S. Could Owe Millions for Anthrax Mailings

2008-08-13T08:51:00.001-05:00

http://www.nti.org/d_newswire/issues/2008_8_12.html#D335F79B

The United States could face tens of millions of dollars in liability payments over the 2001 anthrax mailings if it is ruled to have overlooked security risks posed by the scientist alleged to be the sole suspect for the attacks that killed five people, USA Today reported yesterday (see GSN, Aug. 11).

The central question is whether the U.S. Army Research Institute of Infectious Diseases was or should have been aware of indicators that microbiologist Bruce Ivins was mentally unstable, according to Jonathan Turley, a law professor at George Washington University.

The U.S. Justice Department last year identified Ivins as the perpetrator of the mailings and was reportedly preparing charges against him when he committed suicide in late July. Ivins’s legal team maintains he had no role in the mailings.

Whether or not the laboratory was aware of Ivins’s mental instability, "the question is whether they should have known," Turley said. "It's like saying that you didn't know that a physician was a perfect lunatic at a hospital. The expectation is that a hospital would have sufficient monitoring to detect lunacy."

One $50 million lawsuit contends that American Media Inc. photo editor Bob Stevens died after exposure to one contaminated envelope because the Fort Detrick biological defense facility failed to properly store and secure an anthrax supply allegedly used in the attacks (see GSN, May 6).

"One of the people that worked at the laboratory told me they had better security at a 7-Eleven than they did at the … laboratory where they had the most dangerous substances known to mankind," said Richard Schuler, a lawyer for Stevens’s family (Ken Dilanian, USA Today, Aug. 11).

The years-long federal investigation of the mailings shattered the careers and personal lives of some people it targeted, the New York Times reported yesterday.

Before setting its sights on Ivins, the probe grilled academics, non-U.S. nationals and biological warfare experts, including other USAMRIID staffers.

“It was not pleasant,” said Jeffrey Adamovicz, a former USAMRIID official who remembered employees viewing each other with suspicion. “There was a general sense of paranoia that they were going to get somebody no matter what.”

When Ohio microbiologist Perry Mikesell came under the scrutiny of investigators, he turned to alcohol abuse and died soon after, according to relatives. A New York doctor lost his marriage and was damaged professionally when he became a suspect, his lawyer said. Two Pakistani brothers were forced to find work outside the United States after falling under suspicion for a short time.

“You do the best you can, and it’s not always pretty,” said former FBI domestic terrorism chief Robert Blitzer. “Here you have a bunch of people dead and several diminished, and you’re charged with solving the crime. You try not to step on people’s toes, but sometimes it happens” (Broad/Shane, New York Times, Aug. 11).

What the FBI Knows: For Bruce Ivins and for us

2008-08-13T08:45:00.001-05:00

Quote: "As a consumer of the BioPort vaccine himself, Bruce was as motivated as anyone to get a better vaccine in place."

What the FBI Knows: For Bruce Ivins and for us

http://www.opednews.com/articles/What-the-FBI-Knows-For-Br-by-Elizabeth-Ferrari-080812-743.html

"I don't think the FBI knows what the FBI knows" – Richard Clark testifying before the 9/11 Commission

In the summer of 2001, two hijackers were renting lodgings from an FBI asset in San Diego, California. But the FBI couldn't be bothered to know in the same way that they ran off John O'Neill when he was "on fire" about Bin Laden and they couldn't be bothered to listen to him. The next thing you know, thousands of people are dead, John O'Neill is dead and there's a scar in the heart of Manhattan. In 2005, the FBI is sure, knows with cold institutional certainty that Steve Hatfill is the anthrax mailer and before you can turn around, they're paying out 5 million dollars for ruining the life of an innocent man and publicly, too, by pillorying him in the press. You'd think they'd have learned by now. You'd think they'd have a picture of Richard Jewell up in every single FBI office and a special promise to say silently every morning before sitting down to the day's work.

You'd think by now the FBI would have a long needed moment of ontological panic and ask themselves how they know what they know. In 2003, they mapped out every single minute of Steve Hatfill's life on the days surrounding the two anthrax mailings and they were not loathe to announce that to the New York Times. But in the last few weeks, when they were accusing Bruce Ivins in the press, they didn't seem to know that Ivins couldn't be in Frederick, Maryland at 4:30 and in Princeton, New Jersey at 5:00 p.m. on September 17th, 2001, although they seemed to know each fact separately. It's as if the FBI has had the membrane connecting the two lobes of its institutional brain slashed, isolating one working hemisphere from the other.

The FBI claims that new technology can trace DNA from the weapon to Dr. Ivins when the tech to map a genome was available in 1998 and while withholding the exact nature of that new technology. Do you believe in magic? They claim that Ivins was the sole custodian of that flask of anthrax but do not mention the origins of that anthrax at the Dugway Proving Ground and they also elide the fact that ten other researchers had access to that same anthrax at Fort Detrick alone. And that's without considering all the researchers and labs that obtained samples from Dr. Ivins over the years, or the fact that Ivins helped evaluate the letter sent to Tom Daschle. The FBI is dealing with a crime scene faceted over space and time as if it was a simple plane, or a projection, a Power Point presentation they can point to unambiguously. The FBI does not know what it knows. Richard Clarke was right.

I'd like to ask them if Bruce Ivins was so careful that he could drive weaponized anthrax two hundred miles and mail it without leaving any trace at all on his person, in his car or around his residence or, if he was so careless that he mailed anthrax to Pat Leahy and Tom Daschle and didn't know that postal machines would pound the deadly powder out into the public sphere long before the envelopes were delivered. Which is it?

The FBI has said Bruce Ivins was afraid his vaccine program would be canceled and that motivated him to mail the anthrax. How is that possible? Ivins had a new vaccine in the works. No matter what happened to the BioPort vaccine he had been hired to fix, Dr. Ivins would get work. Make no mistake about it. Even if BioPort's product went down in flames, Dr. Ivins had another vaccine in development and his expertise would be in demand. There is always work for skilled people like Bruce Ivins. As a consumer of the BioPort vaccine himself, Bruce was as motivated as anyone to get a better vaccine in place.

In 2001, the FBI knew the anthrax mailer was a loner

Source: Los Angeles Times, November 10, 2001.

By ERIC LICHTBLAU and MEGAN GARVEY, TIMES STAFF WRITERS

WASHINGTON -- The FBI is increasingly convinced that the person behind the recent anthrax attacks is a lone wolf within the United States who has no links to terrorist groups but is an opportunist using the Sept. 11 hijackings to vent his rage, investigators said Friday.

http://www.ph.ucla.edu/EPI/bioter/lonerlikelyanthrax.ht...

The FBI is still pushing the idea that Ivins fits the "loner" description. But he doesn't. He was a married man with two adopted children, with mentees and colleagues and neighbors.

Fairfield resident recalls time at Fort Detrick; worked with suspected anthrax terrorist

While civilians like Battersby work at Fort Detrick, the site has military management, she said. And some people, such as those who want to advance their careers, have stayed quiet about their experience there, according to Battersby. (Emphasis added.)

But the few people not worried about talking about their experience with the government should talk, she said. "It's painful to me on a whole bunch of levels," Battersby said. "I feel like I should tell my story because I know I can." (Emphasis added.)

http://www.eveningsun.com/news/ci_10157273

Are people who knew Bruce Ivins afraid to speak out for fear of losing their jobs if they disagree with what the FBI "knows"? Battersby seems to say exactly that.

The reality is that this case hinges not on what the FBI knows but what the American public can be made to fear. Again. When asked last week why the FBI didn't take Ivins into custody, a Defense Department spokesperson (spokes spinner?) said the FBI didn't want to compromise the investigation – when the whole neighborhood saw how Bruce could barely get around FBI vehicles to get into his own driveway. It's one of the few acts of solidarity seen lately between DoD and Justice. They haven't co-operated so well since the Justice Department came up with the rationale for torture and the Defense Department found the means to implement that policy. (And here there is a subtext of corruption so profound that you wonder how long, if ever, it will take to clean up the Justice Department and how long it will be before we can again believe the Defense Department deserves the respect our uniformed young people pay it by their service.)

To grease the hinge of this case, last week the FBI fronted Jean Duley, a low level mental health worker, in a much challenged recovery herself to be generous or just plain "wet" in the vernacular of alcohol rehab. She lit up the media like a Christmas tree. Instead of quietly seeking a restraining order in private, she chose to go to a public hearing and to do a very bad impression of the clinician she is not. She accused Ivins of being a revenge killer, of hating women, of being a homicidal sociopath as if that was a diagnosis in the DSM IV, which it is not.

It's worth mentioning that while Ms. Duley was making these serious accusations, Ivins had no criminal record at all but, she did.

The media lit up like Macy's on Christmas Eve when the Salvation Army bell is ringing loudest over the heads of hassled shoppers. In particular, there was a pair at the Associated Press that could not recycle these outlandish claims often enough and without a shred of skepticism. From that venerable fount, these claims were spammed all over the American press and the cable channels. The fact that Ms. Duley was only recently out of house detention for her own problems or that she had no degree in psychology or that she had only seen Ivins a handful of times over the period of six months or that she was firmly in the hands of the FBI while making these claims, never seemed to make it into even the fifth paragraph of any of these cloned stories.

Predictably, the resulting spam from the AP hit pieces wind up reducing Bruce Ivins into a stereotype at Wikipedia, where as late as last night he is described as a "conservative Catholic". Bruce Ivins was not a conservative. His letters to the Frederick News-Press are the letters of a curious, left-leaning, inclusive writer. A person with a quiet and persistent sense of humor that is often turned on himself. A thoughtful person who believes women should be included in the priesthood, that people are indeed born gay, that all people deserve the respect of their fellows. Someone who cared deeply about his community. These are not the letters of a hidebound ideologue or an abortion clinic bomber. But, like those iconographic portraits of Renaissance monarchs, Bruce Ivins the person is becoming indistinguishable from the FBI Bruce Ivins caricature at Wikipedia, illustrated but not represented.

Contrast this public misrepresentation with the issue of coerced silence brought up by Battersby who remembers the actual man. The best example of that silence may be the hundreds of people attending Ivins' two memorials last week in Frederick, ironically one private and one public, their very attendance a rejection of the official story in favor of honoring the man they knew who juggled with their children and wrote songs to celebrate their promotions.

In the middle of the Ivins tragedy and in the middle of the FBI claiming to know more than they know and more than they will tell the public, the Department of Health and Human Services took new bids for the national stockpile of anthrax vaccines from contractors in Maryland. The news item stuck in my mind because July 31st is my son's birthday.

I need to get this clear for my son, in the way that mothers always need to get danger real clear. The anthrax attacks were terrorism, not discrete attacks on individuals. Whoever mailed that anthrax meant to terrorize, not to attack specific targets. Those envelopes were all mailed to executives and anyone sophisticated enough to mail that substance was sophisticated enough to know that executives don't open their own mail. So, when the FBI makes claims about Ivins' motives regarding the addressees, it just makes them look impotently disconnected from their own purpose. Ivins had no motive to send those envelopes to those people. No one did. That mail was sent to frighten a people, not to attack anyone in particular.

And as for Dr. Ivins in particular, there is nothing in his mountain of writings that demonstrates he ever imagined hurting other people in particular or in general. When his relapse was pounding him, he drank, he wrote to his friends and he went to his doctor. He made up silly jingles about his symptoms in the way that optimists deploy humor against danger. But there is not one sentence anywhere that indicates he even considered harming another as a solution to his distress. The FBI cannot place him at the scene of the crime – not physically and not in imagination. If there is more, we haven't seen it.

This has been the the biggest investigation the FBI has taken on in its entire history second only to 9/11. What a spectacular failure. And how identically twinned that failure has been by our media's failure to interrogate, at every point and over and over, the shoddy media circus that has passed for crime solving.

Rush Holt and Pat Leahy are rumbling about Congressional hearings but as well intentioned as they are, there is no reason to have confidence that our Congress will resolve this crime against the American people, against Ivins, his family, or the Fort Detrick community just there is no reason to have confidence that appointing an independent investigative panel will mend our broken justice system. How sad is it that we cannot rely on our institutions to take care of us in this most basic way.

We have slipped so far down the rabbit hole of unaccountability, I only hope that the next time someone decides to send vectors into the public sphere, the deaths will not be too terrible and the fear will be more mercifully short. At some point, though, you have to wonder who our media believes will consume its product if we are rightfully unwilling to handle our own mail.

The anthrax attacks were deadly and we can never forget those terrible losses. It's equally true that the Bush Justice Department and its shameful media gaggle have been more destructive than the person who deliberately put that deadly substance into our mail. Between them, they misled us into bombing an innocent people – enabling hundreds of thousands of deaths, the displacing of millions and the irresolution of this case which speaks to the foundation of any government: the safety of its citizenry. There is no reason to have confidence in either the remains of the Justice Department or in the remains of our news media.

And in the meanwhile, Bruce Ivins was driven to suicide. How can anyone feel all right with that when there is not only a "reasonable doubt" of his guilt, but a doubt so big that the Grand Canyon could safely use it for a pit stop?

Who can feel safer today knowing Dr. Ivins is dead and will not get a day in court? Without that process, who can trust that this case has been closed against future harm to the American people? Some wise guy said, "Trust but verify". When did verifying the most basic elements of our system of justice become so impossible in our country? I don't trust the FBI to know what it knows. I don't see our media checking behind them. To quote Mr. Poe of Texas, "And that's just how it is".

"Gerard P. Andrews, another of Dr. Ivins' former colleagues, said he knew that Dr. Ivins was frustrated, but that he doubted that Dr. Ivins would consider such a step."

I'm with you, Mr. Andrews. A lot of us are frustrated. I don't know if Bruce Ivins did the crime that he has been convicted of in the press. I sincerely doubt it. That we allowed him to be so convicted is more destructive than the original crime.

If the civil, peaceful and private expression of frustration is now a terrorist activity by implication, rumor or assertion, and without resort to a court of law, then the attacks on us, on the American people are ongoing, no matter what the FBI believes it knows or refuses to know, and no matter how cheerfully this doubtful "knowledge" is broadcast by a contaminated press.

HHS evaluates proposals for new anthrax vaccine

2008-08-13T08:18:00.000-05:00

Lisa Schnirring Staff Writer
http://www.cidrap.umn.edu/cidrap/content/bt/anthrax/news/aug1208vaccine-jw.html

Aug 12, 2008 (CIDRAP News) – Two Maryland pharmaceutical companies recently announced that they have submitted proposals to produce and deliver at least 25 million doses of a next-generation anthrax vaccine to the nation's Strategic National Stockpile.

Both companies—Emergent BioSolutions, based in Rockville, and PharmAthene, based in Annapolis—announced in Jul 31 statements that they submitted responses to a request for proposal (RFP) from the US Department of Health and Human Services (HHS). The RFP was issued in February and seeks 25 million doses of recombinant protective antigen (rPA) anthrax vaccine, based on a key anthrax protein, with a shelf life of at least 2 years.

Federal officials didn't say if any other companies submitted proposals to produce an rPA anthrax vaccine for HHS. Robin Robinson, director of the HHS Biomedical Advanced Research and Development Authority (BARDA), said the agency received multiple offers and that they appear promising, according to a report yesterday in the Baltimore Sun.

Robinson told the Sun that BARDA expects to allocate $1.5 billion toward adding anthrax vaccines to the national stockpile. The government has said it wants to boost the national anthrax vaccine stockpile from 18.2 million doses to enough to protect 300 million, the report said.

Feds spell out vaccine request
The contract would require companies to secure Food and Drug Administration approval for the rPA anthrax vaccine. Initially, the vaccine would be used for pre-exposure prophylaxis in adults, with a future label extension to allow postexposure prophylaxis alongside antibiotics.

Federal officials said they expect to award the contract to one or more companies, based on available funding, by late September.

Federal officials have been seeking a new vaccine formulation that can provide immunity in three doses, rather than the six doses required for the licensed vaccine, and that will cause fewer side effects.

The anthrax vaccine currently in the national stockpile, Anthrax Vaccine Adsorbed (AVA), was developed in the 1950s and is produced by Emergent BioSolutions under the brand name BioThrax. The product, required for US military personnel serving in high-risk areas such as the Middle East, is given in six doses over 18 months, followed by an annual booster.

A number of service members have reported serious side effects from the vaccine, and some sued to shelve the program. However, in late February a US district court judge dismissed the suit.

The latest federal call for a new version of the anthrax vaccine came 4 months after the Government Accountability Office (GAO), the investigative arm of Congress, criticized previous attempts to secure a second-generation anthrax vaccine as premature, unrealistic, and vague regarding its intended use.

In 2007, HHS withdrew an $877.5 million contract to VaxGen, a South San Francisco, Calif., biotechnology company, after it missed some of its development milestones. The contract required VaxGen to produce 75 million doses of the rPA anthrax vaccine, enough to immunize 25 million people.

In May, VaxGen sold its experimental anthrax vaccine to its competitor, Emergent BioSolutions, according to previous reports. One month earlier, PharmAthene acquired an rPA anthrax vaccine candidate that was developed by Avecia, a biotechnology company based in the United Kingdom. The National Institute for Allergy and Infectious Diseases (NIAID) has supported both candidates with research grants.

Phase 2 studies complete

Emergent BioSolutions said its vaccine candidate is a reformulated and more stable version of the rPA 102 vaccine that was originally developed at the US Army Medical Research Institute of Infectious Diseases. In its statement, the company said phase 2 studies of rPA have been completed.

James Jackson, senior vice president and chief executive officer (CEO) of Emergent BioSolutions, said in the statement its analytical and nonclinical data support the vaccine's stability improvements: "We believe that the current formulation will meet the US government's stability requirements for an rPA vaccine," he said.

The company said it would produce the vaccine at its new manufacturing facility in Lansing, Mich.

PharmAthene said its new anthrax vaccine consists of rPA adsorbed into alhydrogel and packaged as a filled syringe for intramuscular injection. In its statement, the company said preclinical studies suggest that two or three doses administered several weeks produce an immune response that requires annual boosters.

It said phase 1 and 2 studies involving 700 human subjects suggest that its rPA anthrax vaccine is safe and well tolerated and produces a protective immune response.

David P. Wright, PharmAthene's president and CEO, said the competition for the HHS contract is stiff, according to the Sun report. "This will not be a cakewalk for us. We have very strong competitors, but I believe, with the caliber of staff we have, that we will be successful at the end of the day in producing for this country the vaccine we need," he told the Sun.

See also:

Jul 31 Emergent BioSolutions press release

Jul 31 PharmAthene press release

HHS request for proposal listing

Oct 31, 2007, CIDRAP News story "GAO critiques anthrax vaccine procurement, management"

Jul 29 CIDRAP News story "Anthrax vaccine maker wins NIAID grants"

What If the FBI Is Right

2008-08-13T08:12:00.001-05:00

http://online.wsj.com/article/SB121850430521931913.html?mod=googlenews_wsj

By RANDALL J. LARSEN
August 12, 2008; Page A19

If the FBI theory on the man responsible for the anthrax attacks of 2001 is correct, then the threat of bioterrorism is far more troubling than we have imagined.

I am not a scientist, and will leave the debate on the scientific evidence against Bruce Ivins to the sort of thorough, independent examination recommended by Sen. Charles Grassley (R., Iowa). But such an examination is crucial. It could have profound national security implications, which have been missed in most public discussions of the case. Here's why:

In the years since 1999, while I've provided an executive-level course on the threat of bioterrorism to more than 3,000 senior military officers, plus scores of other presentations, lectures and seminars, one of the most frequent questions asked is, "If the Unabomber had been a biologist instead of a mathematician, could he have produced a sophisticated bioweapon?"

The answer has always been "No: That would require a team of individuals." However, if the FBI is right about Ivins, such a lone individual can produce such a weapon.

This would be a watershed. The arsenals of the U.S. and the USSR once included bioweapons, but producing them required a massive scientific and industrial effort. In 1969, President Richard Nixon unilaterally removed bioweapons from our arsenal, and the U.S. led an international effort to ban biological weapons. The Soviets signed the Biological Weapons Convention, but continued their massive program into the early 1990s. That program, too, was a giant effort: At one time, more than 30,000 scientists and technicians worked in their illegal bioweapons program.

Since then, the intelligence community has been aware that revolutionary advances in biotechnology now provide nonstate actors with the potential to build and deliver highly sophisticated bioweapons. This was stated in an unclassified Defense Science Board report in June 2001, and repeated by virtually every subsequent government and think-tank assessment.

However, in all of these assessments, most believed that it would still take a team of scientists, or perhaps a team of highly skilled technicians led by a scientist, to produce a sophisticated bioweapon. Now that received wisdom may be obsolete.

If the FBI theory on Dr. Ivins is correct, we could be living now in a world where a single individual -- with no prior training in weaponization of pathogens -- can convert anthrax spores into a dry-powdered weaponized form that was of a quality equal to (some would say better) than that produced in the not-too-distant past in billion-dollar, superpower arsenals.

It is important to keep in mind here that Bruce Ivins had no training or experience in the weaponization process. His government work was limited to vaccine development.

We also need to keep in mind that the type of anthrax spores that the FBI alleges Ivins weaponized are available in laboratories around the world. For that matter, they are also contained in soil from Amarillo, Texas, to Azerbaijan. Furthermore, if the FBI theory is correct, the equipment used for the weaponization process is now available in thousands of academic and industrial biology labs, or you could just buy it on LabX.com or eBay.

A thorough, independent scientific analysis of all evidence the FBI has amassed should be an immediate, top priority of the Bush administration and the U.S. Congress. Yes, it is something that the Ivins family deserves. But more important, our national security rests on determining whether the threat of bioweapons has reached a new, more dangerous plateau. If the FBI is right, the threat is greater than most have assessed.

Col. Larsen (U.S. Air Force, Ret.) is a former chairman of the Department of Military Strategy and Operations at the National War College, and the author of "Our Own Worst Enemy: Asking the Right Questions About Security for You, Your Family, and America" (Grand Central, 2007).

Our own worst bioenemy

2008-08-13T07:11:00.001-05:00

http://www.latimes.com/news/opinion/la-oe-orent13-2008aug13,0,1045104.story

The U.S. bioweapons program has grown so large that it has become a threat to Americans.
By Wendy Orent
August 13, 2008

'Whatever you can say about the Soviet bioweapons scientists," a Bush administration official once told me, "they never killed anyone."

We can't say the same about our bioweapons scientists. Someone, most likely Bruce Ivins, at the U.S. Army Medical Research Institute of Infectious Diseases at Ft. Detrick, Md., turned powdered anthrax spores into a deadly weapon. It's ironic that the Soviet scientists were making offensive weapons. Our people, since 1969, have worked strictly to defend us.

One of those defenders killed five people, sickened 17 others and plunged the nation into hysteria for weeks in the fall of 2001. After a seven-year investigation by the FBI, the source of the deadly anthrax strain has been identified -- our own biodefense program at Ft. Detrick. That is the real legacy of the FBI investigation.

Since the anthrax-laced letters were mailed in September and October of 2001, U.S. biodefense has blown up out of all proportion to any rational assessment of the bioweapons threat. Earlier this year, an article in the journal Biosecurity and Bioterrorism, analyzing government biodefense spending from 2001 to 2008, stated that $49.66 billion has been allocated for civilian biodefense. According to microbiologist and longtime biodefense critic Richard Ebright of Rutgers University, actual spending is even higher, amounting to $57 billion.

In 2005, he and 757 other microbiologists sent a stinging open letter to Elias Zerhouni, director of the National Institutes of Health, protesting the government's preoccupation with "priority pathogens" -- germs such as anthrax that could be used in a bioweapons attack. But Zerhouni and Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, would have none of it. In a letter published in the journal Science, they disagreed: "The United States has experienced an anthrax attack, and security experts repeatedly express concern that future attacks with biological weapons are likely, if not inevitable."

But we didn't actually experience an anthrax attack. The whole incident amounted to a snake eating its own tail. No ingenious biowarrior from Al Qaeda sent the lethal envelopes through the U.S. postal system. An American scientist did. The FBI and its genetic analyses leave no doubt: Though 16 laboratories had access to the "Ames strain" of anthrax used in the letters, only the samples that came from Ivins' laboratory at Ft. Detrick matched the genetic fingerprint of the attack strain.

In the sorry aftermath of the anthrax investigation, it's clear that the National Institutes of Health and the Centers for Disease Control and Prevention have to rethink the priority-pathogens list, which includes anthrax, smallpox, plague, tularemia, Ebola and other germs that rarely, if ever, threaten American lives. It's the "non-defense-related" germs that are killing us. Randall Wolcott of the Southwest Regional Wound Care Center points out that 500,000 Americans a year die of biofilm infections -- such as diabetic ulcers -- that are almost impossible to treat by conventional means. That's almost twice as many as die of cancer.

According to the CDC, infections caused by methicillin-sensitive Staphylococcus aureus, or MRSA, kill 19,000 people a year. Still, staph itself isn't considered a priority pathogen, despite the emergence of highly resistant and increasingly virulent strains. Only one of 40 staph toxins is on the priority list.

There's another problem created by the priority-pathogens list. The ballooning of the biodefense program, according to Ebright, means that about 14,000 individuals are now considered qualified to work with priority pathogens.

It hasn't always been easy to find qualified people for this research. In the days when the FBI was pursuing former "person of interest" -- and now exonerated -- Steven J. Hatfill, one senior government scientist said of Hatfill's background, "You take what you can get -- not many people with his abilities show up very often." So where do 14,000 suddenly qualified biodefense experts come from? And how can they be vetted? As biodefense expert Leonard Cole, author of "The Anthrax Letters," told me: "There are 15,000 to 16,000 people now working in labs on select agents -- that's many more possibilities of another bizarre individual doing illicit work."

The lesson of the anthrax letters isn't that we're in danger of a bioweapons attack from terrorists. It's that U.S. biodefense itself has become a threat: We have met the enemy -- and it is us.

The next administration should pull the plug on the biodefense excesses of the Bush administration and put most of the thousands of microbiologists to work on the germs we really need to worry about.

Wendy Orent is the author of "Plague: The Mysterious Past and Terrifying Future of the World's Most Dangerous Disease."

Ivins would benefit how?

2008-08-10T13:07:00.000-05:00

Older, but worth the repeat....

In Search Of The Anthrax Attacker - Following Valuable Clues

By Meryl Nass, MD
February 3, 2002

"Senior Bush administration officials have privately said that little
progress is being made in the anthrax investigation, which has
involved hundreds of investigators, [who] are no closer to finding the
culprit, they say." So reported Todd J Gillman and Michelle
Mittelstadt of the Dallas Morning News on January 31.

It has been four months since the first case of inhalation anthrax was
diagnosed. Last week, the FBI announced that it would be sending
flyers to 500,000 residents of the Trenton, New Jersey region, asking
for leads. This week, the FBI arranged with the American Society for
Microbiology to e-mail its US membership, in another attempt to reach
out to scientists that might have insight into the attacks.

Dr. Barbara Hatch Rosenberg, an arms control expert at the State
University of New York, Purchase, and chair of a bioweapons panel at
the Federation of American Scientists authored an analysis of the
attacks that may have prodded the FBI into investigating the US
bioterrorism establishment. She thinks the scientific details could be
too complicated for investigators to grasp.

But if the FBI has no anthrax expertise, there are plenty of
scientists who do, and who would be happy to assist in the
investigation.

Last October, both Ken Alibek (the defector who was #2 in the Soviet
biowarfare establishment, and who also developed the most virulent
Soviet anthrax) and William Patrick (the man who was #1 in the US
biowarfare establishment, and developed a powder used for weaponizing
anthrax, allegedly the same material used in the attacks) were quoted
as saying that no one had sought their help in the investigation. That
made me extremely curious, since they were two public figures most
knowledgeable about weaponized anthrax, and would know how to analyze
the anthrax and identify its origin.

Why had the anthrax been sent in letters, rather than released in
ventilation systems, tunnels or subways? The (estimated) two trillion
spores per letter could have caused a lot more mischief in another
setting.

Something else was odd. The attacker had actually warned the
recipients that the letters contained anthrax, and suggested they take
penicillin. Then a lightbulb went off: someone was sending these
letters to create an effect, not to cause damage. The letters were
sealed with tape, presumably to further prevent the escape of spores.
The point was to frighten, not to kill. And the targets were chosen
with an eye to getting publicity and making an impact on Congress.

The attacker also had familiarity with forensic investigations. He
avoided using saliva on the letters, used a form of printing that is
most difficult to analyze, and otherwise left a paucity of evidence.
Did he have professional help?

(I am referring here to the anthrax attacker in the singular and using
the male gender, although I suspect that, for logistical reasons, it
is unlikely that one person acted alone, or was even a loner, as the
FBI profile has suggested.)

I subsequently learned of William Patrickís 1999 analysis of anthrax
sent by mail, written for a defense contractor. Iíve not seen the
report, but have been told he did not consider that envelopes
contained pores, and was not aware that postal machines squeeze and
compress the mail, forcing anthrax spores out of intact envelopes.

The attacker may well have read Patrickís report, or even used it as a
model. Who had access to this report?

To commit a crime one must have a motive. Because of the
unpredictability of who might become ill, or die after exposure to the
letters, I doubt that the attacker had specific victims in mind. A
grudge against Tom Brokaw or Senator Daschle has been postulated. Did
the attacker really think they opened their own mail?

More likely, the attacker wanted to frighten Congress, which controls
spending for bioterrorism. If new appropriations for bioterrorism
defense are a measure of the attackerís success, he has certainly
triumphed.

Who are the beneficiaries of a bioterrorism scare?

The biowarfare establishment has benefited so far: CDC got $450
million extra for bioterrorism, and the states will get $1.1 billion
dollars. More money has been spent on stockpiling antibiotics, and the
government has contracted for 209 million doses of smallpox vaccine,
at a cost of $850 million. Other biowarfare vaccines in development
have probably had new life breathed into them.

The US Army Medical Research Institute of Infectious Diseases (where
the Armyís center for biodefense, Fort Detrick, is located) will
receive increased funding and stature. Bioport, the anthrax vaccine
manufacturer that tried in vain for the past 2 years to get FDA
approval, after as major overhaul of its facility, just got it -
though Congressman Ben Gilman has asked the GAO to investigate this,
and the Defense Department has declined to say whether anthrax
inoculations for the military will resume.

Who had the means?

After the attacks it was revealed that the powdered, weaponized
anthrax is identical to that made by our own biowarfare establishment;
that is, by the same people who are benefiting from the attacks.

One area of wasted investigative effort was the search for the origin
of the "Ames" anthrax strain used. It was reported initially that
hundreds of labs held Ames anthrax samples. Then it turned out that
few actually did.

On October 11, after receiving FBI approval to do so, Iowa State
University destroyed their anthrax collection. Did this result in the
loss of crucial evidence?

But how would tracing back the Ames strain solve the case? Even if
only 20 labs had samples, not all of them had high levels of security.
After all, some are university labs. Scientists share strains with
hardly a thought. Ames anthrax could have been stolen, shared, or even
dug up from Texas soil. Or removed from one of the labs by a scientist
with access.

Dr. Paul Keim of Northern Arizona University maintains an extensive
anthrax database; he examined the Ames anthrax used in the attacks
with a series of genetic probes, and said it was identical to the
strain held at several government labs. But to be certain, the entire
genome of the attack anthrax and the government anthrax are being
deciphered, so that individual differences can be counted and
examined, and estimates made as to precisely how close (or how many
generations apart) the two strains really are. (Of course, this
assumes that the actual government strain, and the actual letter
strain were provided to the Institute for Genomic Research in
Rockville, Md.)

Reading William Broadís article, "Geographic Gaffe Misguides Anthrax
Inquiry," in the January 29 New York Times, one finds confusion over
the meaning of the strainís origin. Broad also takes Dr. Rosenberg to
task over her earlier statement that the anthrax "may be a remnant of
the US biological weapons program."

Broad discovered that the Ames strain came from a cow that died in
Texas in 1981, not from a cow that died in Iowa in the 1930ís. He then
inferred that the strain did not come from the US biowarfare
stockpile, which was officially destroyed by 1975, when the Biological
Weapons Convention went into effect.

But a CIA memo signed by Thomas Karamessines, and provided to the
Senate, informs us that the CIA (at least) kept 100 grams of anthrax,
illegally, after the Convention went into effect. So some of the old
stockpile could still be around.

The fact that the Ames strain was isolated from a cow in 1981, and
from a goat several hundred miles away in 1997, indicates that there
is a lot of Ames in Texas, and it most likely was there well before
1981, and ever since. So it could have comprised part of the old US
stockpile. William Patrick and others would know, and there should be
records to show what was actually produced.

The more germane issue, however, is whether the isolation of Ames in
1981 exonerates the Defense Department, CIA, or US government
contractors from possible involvement in the anthrax attacks. It does
not.

No matter whether the government first got its supply of Ames before
or after 1970, when it officially ended its offensive biowarfare
program, Ames was eventually used to create a government supply of
dry, weaponized anthrax, which at this time appears to be identical to
that used in the attacks.

Of more importance to the investigation, however, is the origin of:

a) the material added to the anthrax spores that causes them to
separate from each other, greatly enhancing virulence, and

b) the method that assured the spores were relatively uniform in size,
and were sized for optimal lethality.

Although Ames was shared, this method of production, as well as the
additive, would have been closely-guarded secrets. They are what made
Ames extremely lethal, and the same could be done with other strains.

Furthermore, the Biological and Toxin Weapons Convention, which the US
initiated and signed in 1972, prohibits the possession of biological
agents that are not used for defensive purposes. No defensive use for
this form of anthrax has ever been publicly disclosed.

In contrast, the Ames anthrax that is used in (defensive) vaccine
experiments is dispersed by an aerosolizer from a liquid slurry. No
dry anthrax is used. (In liquid form, anthrax is a poor weapon.)

To test our defenses against dry anthrax, you can use a benign
Bacillus spore, a cousin of anthrax. The mere possession of dry,
weaponized anthrax could be deemed illegal under the terms of the
Convention. So the United States kept its existence secret, and would
have had little reason to share it. We wouldnít want the material or
recipe for making highly dispersible spores to reach potential enemies.

The real question is: who had access to this material, or knew the
method for its production? A clue: you will find the attacker among
the very small clique of bioweaponeers with this specialized knowledge
or access to the weaponized end product.

Now to the question of whether the anthrax was homemade, or snatched
from a government inventory. It is much more likely to have been
snatched, but either is possible.

Anthrax cannot be produced without leaving evidenceótelltale spores
that have escaped into the environment. Companies that use spore-
forming organisms to manufacture vaccines (for tetanus and botulinum
toxoid, for instance) can never use the facility for making other
products, due to persistent contamination with invisible spores. The
Hart Senate Office Building clean-up took 3 months and cost $14
million, and may not have rid the building of every anthrax spore.

Therefore, production in a basement lab could lead to spore detection
(and proof of guilt) for the foreseeable future, if environmental
samples were obtained and cultured. Furthermore, the equipment and
materials the attacker purchased to produce the anthrax could be traced.

In addition to increasing the attackerís chances of being detected,
spore production is dangerous. Remember, this is someone who knows all
about anthrax. He knows what these spores can do, and would not have
wanted to expose himself to them.

Anthrax experts know that physical protection (particularly the use of
a self-contained breathing apparatus) is your primary protection from
inhaled anthrax. It has long been established that large spore counts
can overwhelm vaccine-induced immunity and antibiotic protection. In
fact, for a long time the Ames strain was called "vaccine resistant"
at Fort Detrick. So anyone in-the-know would have worked with the
spores in a safe setting. They might well have been vaccinated and
used antibiotics, but would not have relied on them exclusively for
protection.

Therefore, anthrax was almost certainly manufactured, mixed with the
anti-cling powder, and placed into envelopes in a protected environment.

Placing the spores - two trillion at a time - into envelopes would
have been particularly dangerous. These spores floated off the glass
slides when scientists first tried to look at them. You canít fill an
envelope without losing millions or billions of spores in the process.

It is only logical that the filling occurred within an official
anthrax "hot suite"- a Biosafety Level 3 or 4 facility, by someone in
a "moon suit" using a protected air supply. There are a small number
of these facilities. They must have substantial security, possibly
video cameras, and there must be logs that indicate who used them.

If the attacker used government-made (or defense contractor-made)
anthrax, and filled the envelopes in hot suites already contaminated
with Ames anthrax, he will have left no evidence. He could walk out of
the hot suite with his filled envelopes in a plastic bag or other
secure container, and no one would be the wiser.

Furthermore, the first known letters were postmarked September 18, and
contained a fake Islamic message.

Yet another clue: although anthrax degrades extremely slowly, and
could have been obtained or produced at any time, the choice of
September and an Islamic message suggests the first envelopes, at
least, were filled between September 11 and 18. Who used the hot
suites then?

This past week a new, important wrinkle was reported. An Egyptian-born
scientist, Dr. Ayaad Assaad, had been fingered as a possible
bioterrorist in an anonymous letter sent to Quantico Marine Corps
Base, before any anthrax letters had even been discovered. It is
unclear whether the letter was sent to the military or to the FBI,
which maintains a substantial presence on the base.

Assaad had worked at Fort Detrick for years, but was laid off in 1997,
and had an age discrimination lawsuit pending against his former
employer. Furthermore, while at Detrick he had been the butt of a
salacious and demeaning poem circulated by a group of coworkers- all
Army scientists- who called themselves the "Camel Club." Unauthorized
nighttime research and missing anthrax slides at the lab where the
club members worked embellish the story.

Although one might manage to grow anthrax from a spore found on a
stolen pathology slide, itís unlikely. Slides are generally heated,
and the material may have been treated with formaldehyde, which kills
anthrax. There must be easier ways to obtain anthrax, especially if
you work at Fort Detrick. Although itís a juicy story, there is a huge
divide between anthrax on a pathology slide and the production of
weaponized anthrax. They do not equate.

At first glance, the letter about Assaad seemed to have been written
by a former Camel Club member, who decided to revive an old
antagonism. But it is much more likely that the real attacker knew of
the club, and meant to lay guilt on former club members. (The club
members were not anthrax scientists, but instead worked on pathogenic
viruses.)

Letís look more closely. The first letters to arrive with anthrax took
a long time to cause illness. Until then, they were dismissed as
hoaxes. The letters to the New York Post and NBC were postmarked
September 18; the letter to The Sun, a Florida-based tabloid, has
never been found. The first anthrax case was diagnosed in Florida on
October 3, probably 15 days after the letter was sent.

It seems logical, therefore, that the Quantico letter (that insinuated
Assaad was a bioterrorist) was meant to arrive after the public had
become aware of an anthrax attack. Had that happened, the letter would
have been perceived as a response to the attacks. But since it arrived
first, indicating foreknowledge of the attacks, it could only come
from the attacker himself.

Therefore, where the letter came from, when it was sent, and the
personal details of Assaadís life that it contained are vitally
important. Only a small number of people could be sufficiently
familiar with Assaad and the Camel Club shenanigans to have written it.

A very important clue: one of these people is the perpetrator. He may
also have some connection to Quantico.

Where does this leave us?

Most likely, the suspect still works in the biodefense field, but
might be a former employee. He may have read William Patrickís report
on mailed anthrax. Places where the perpetrator likely worked may
include Fort Detrick, Dugway Proving Ground (where a large Biosafety
level 3 facility for testing biowarfare aerosols exists), Battelle
Memorial Institute, CDC, and Bioport, but there are others. All these
entities potentially stand to benefit from the new interest in
bioterrorism. The person probably worked at Fort Detrick years ago,
and knew Assaad and the Camel Club members. Either recently, or in the
past, the attacker had access to weaponized anthrax. He used a high
containment, Biosafety 3 or 4 facility to prepare his anthrax-laden
envelopes between September 11 and 18.

Where do we go from here?

People who fit this profile should be investigated, to include
interviews possibly using lie detectors. If warranted, their homes and
businesses should be carefully cultured for stray spores. Retired Fort
Detrick workers, who are familiar with what was stockpiled, and how
anthrax products were made, should be interviewed. Several are on
record as saying they have not been approached. All appropriate
Biosafety facilities, here and in other nations, should have their
logs reviewed. It should be easy to construct lists of those who
worked at Detrick and knew Assaad, those who had access to weaponized
anthrax or knew the recipe, and those with access to the hot suites.
However, if there do exist several attackers, the overlap might be
hard to find. This person, or his program, if such is the case, is
likely to benefit nicely from the anthrax scare.

The anthrax attacks were a heinous crime in a number of ways. First,
they caused the deaths of five innocent civilians, who in military
jargon might be considered "collateral damage." Second, they directly
attacked the center of our government, and our free press. Third, they
appear to have been motivated by the calculation that the country
needed to be scared to death, in order to act in a way the attacker
wanted. And so we have, allocating billions of taxpayer dollars for
responding to and preparing for bioterrorism. That is not how
decisions should be made in a democracy. Finally, biological attacks
are a clandestine, cowardly method of attack, in which the perpetrator
is usually difficult to identify.

If the attacker remains free, the attractiveness of future biological
attack only increases.

Clashing portraits emerge of anthrax suspect

2008-08-10T10:09:00.000-05:00

http://www.latimes.com/news/nationworld/nation/la-na-ivins10-2008aug10,0,2832068,full.story

Bruce E. Ivins was a well-respected biowarfare expert and obsessive oddball whose eccentricities seemingly blossomed into madness at one of the U.S. government's most secure facilities.

By Stephen Braun,, David Zucchino and Nicole Gaouette, Los Angeles Times Staff Writers

August 10, 2008

FREDERICK, MD. -- Inside Ft. Detrick's cloistered high-security laboratories, Bruce E. Ivins was regarded as a seasoned researcher and an affable, if slightly odd, colleague. He showed up for work in thrift-store clothes, gobbled down powdered milk and foul-smelling lunches of fish and other foodstuffs layered in jars. Sometimes he abruptly dropped to the floor to juggle balls while lying on his back.

That was "just Bruce," colleagues would say, shaking their heads. It was his endearing qualities that were recalled Saturday at a memorial service for the once-unknown scientist.

But there was another Bruce, one who sometimes lashed out in disjointed hostility. Starting in 1982 and continuing through last year, Ivins obsessively contacted a fellow University of North Carolina graduate student he'd known in the 1970s. The woman was a member of the Kappa Kappa Gamma sorority, which FBI officials said may have been "linked to location of anthrax mailings" in Princeton, N.J.

The object of Ivins' fixation was Dr. Nancy L. Haigwood, who now directs the Oregon National Primate Research Center in Portland. Haigwood confronted Ivins in 1982 after she found her sorority's initials scrawled in red paint on her fiance's car and the sidewalk and gate of the condominium where she lived.

Ivins denied involvement. But for 25 years after that episode, Haigwood said, he regularly bombarded her with "creepy" letters and then e-mails, asking about her life and referencing details about her family that she had never discussed with him.

Shortly after the anthrax letters were mailed in late 2001, Haigwood said, Ivins included her in a group e-mail bragging about his work with the toxic spores. He sent along photographs of himself working in his Ft. Detrick lab.

"This is someone who thinks he can do anything to anybody at any time," Haigwood said.

The clashing portrayals that emerge of an accomplished biowarfare expert and obsessive oddball chart the downward trajectory of a veteran scientist whose eccentricities seemingly blossomed into madness inside one of the U.S. government's most secure installations.

After his apparent suicide late last month, he was accused of murdering five people with the anthrax bacterium he had spent his life trying to protect people from by developing better vaccines.

On Saturday, several hundred people filled St. John the Evangelist Catholic Church in Frederick for a memorial service celebrating Ivins' life. Friends, colleagues and family remembered the scientist as a generous and talented man with a keen sense of humor. They spoke about his love of music and Gary Larson's "The Far Side" cartoons, about his enthusiasm for helping others and about his mischievous jokes -- including the remote-control device he kept in his office that made flatulence sounds.

The circumstances of Ivins' death went unmentioned inside St. John.

But outside the spare white and gray house of worship, a cordon of police officers and a phalanx of television cameras acted as silent reminders of the accusations the Justice Department has leveled against Ivins.

The closest acknowledgment of the controversy came from Ivins' younger brother Charles, who ended his remarks by addressing his dead brother directly.

"I'll miss you, buddy," he said. "I'm glad your torment is over."

Ivins' wife and two children did not speak during the memorial. His wife, Diane, her hair cropped short since her husband's death, was composed throughout the ceremony and afterward greeted friends with hugs.

Ivins' son, Andy, 24, was subdued in a dark suit and shook hands with friends at the end of the service. Andy's twin sister, Amanda, wiped away tears and hugged friends, her right wrist in a cast.

The priest leading the music-filled service asked God to forgive "Bruce's sins and failings" and led the congregation in two Bible readings that he said were chosen by Diane Ivins.

One, from St. Paul's letters to the Corinthians, emphasized that only God can judge man. The other was from the story of Job.

Chronicling his decline

Ivins himself provided a ghoulish commentary on his disintegrating inner self. Prescribed a mix of psychotropic medications from 2000 to 2006 for unspecified mental illness, according to FBI documents, Ivins e-mailed an eerie poem to a friend in December 2001: "Hickory dickory Doc! Bruce and this other guy, sitting by some trees, exchanging personalities. It's like having two in one. Actually it's rather fun!"

Last week, one anthrax expert suggested that Ivins' deteriorating mental state after 2000 might have been affected by the annual vaccinations he would have received over his 28-year career to protect against infection by the potent anthrax spores he cultivated. Ironically, much of Ivins' research was aimed at developing a new vaccine.

Meryl Nass, a Maine physician and expert on the anthrax vaccine, said Ivins complained to her in 1998 that he was suffering from a blood disorder he worried might be a side effect of anthrax vaccinations.

Nass suggested last week that Ivins may have had psychological side effects as well, especially if the vaccines interacted with the antipsychotic drugs he took over the last decade.

The old vaccine has been linked to psychological effects in a report by the National Academies of Science Institute of Medicine. Examining active-duty military personnel who received shots from 1998 to 2000, the study found that the diagnosis rate for psychoses and other personality disorders more than tripled after the vaccinations.

Friends of Bruce Ivins say he was a frail man who simply unraveled under the extreme stress of the government's pressure-cooker investigation. "Their science is suspect, but even if they had done a better job, it's still the wrong guy," said Dr. W. Russell Byrne, who was Ivins' supervisor from 1998 through 2000.

At home and around Frederick, Ivins seemed the model citizen. Living in a cramped white frame house across the street from the walled-off military installation, Ivins played keyboards during Sunday folk Mass concerts at St. John. He taught lifesaving courses. He juggled for delighted children at the county fair.

At his lab table, Ivins was regarded as a top-notch researcher who excelled in "spore prep," the cultivation of virulent strains of anthrax for use in efforts to find a cure that could be used by American soldiers in the event of a mass biowarfare attack.

Ivins was deemed promising when he joined Ft. Detrick's research staff in 1980. Microbiologist John W. Ezzell, who was on the hiring committee that brought Ivins into the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), laughed at his 1970s-era bell-bottom pants but was impressed by his "teamwork. That's what we were looking for."

Troubled childhood

Ivins came from Lebanon, Ohio, where he had impressed his small-town high school teachers with his acuity in biology and chemistry. His chemistry teacher, Dean Deerhake, said Ivins was "very intelligent but pretty much a loner."

At home in Lebanon, there were indications of a troubled existence. Thomas Ivins, the scientist's estranged older brother, said that Bruce was alternately "coddled" and punished by a mother who kept him "attached to her apron strings."

Bruce Ivins talked little about his family life with co-workers. He partnered with his wife for the folk Masses at St. John -- while he played the keyboards, she sang.

Their daughter, Amanda, lives in Hagerstown, Md., 25 miles northwest of Frederick. Reached last week, she indicated that she would like to talk about her father eventually but said: "When I do, I will do it with my lawyer. . . . I haven't been charged with anything, but I want my lawyer at my side when I talk about my dad."

Her father seemed most at home inside Building 1425, where he worked long hours in his office and in the high-security labs where anthrax spores were cultivated.

When the anthrax letters surfaced in September and October of 2001, killing five people from New York to Florida, Ivins was one of 80 scientists assigned to investigate the source of the highly weaponized spores. They worked around the clock, analyzing more than 33,000 samples.

"He had a reputation for being trusted with these materials," said Ezzell, whose diagnostics division led the search.

But in April 2002, near the end of the testing frenzy, USAMRIID revealed that anthrax contamination had been found in an office and changing room outside a secure area, sparking a partial evacuation of the building. The leak was traced to Ivins, who admitted that there also had been a December 2001 leak inside his office -- a serious violation of protocol -- which he had tried to contain by spreading bleach on the affected area.

As the FBI and USAMRIID's scientists narrowed their search for the anthrax culprit, they turned to Ft. Detrick itself as the source. Many researchers were forced to take polygraph tests, though it remains unclear whether Ivins was one of those scrutinized.

By summer of last year, Ivins was the prime target. FBI agents parked their cars outside his home, so close to his driveway that Ivins had trouble pulling up in his faded red Dodge van, recalled neighbor Robert Duggan.

At work, he wept at his desk. Voice quavering, he told one colleague: "These guys aren't letting up. Sometimes they're following me home. They won't let me breathe."

In November, after he was medically committed to a Maryland mental health center, Ivins' security clearance was canceled, a crushing blow.

In May, Ivins sent an e-mail to the co-worker, saying he intended to retire in September. "We're not well-paid, and we do what we do because it's interesting," Ivins wrote. "If you take away that, there's no reason to stay in science."

steve.braun@latimes.com

david.zucchino@latimes.com

nicole.gaouette@latimes.com

Times staff writers David Willman in Washington and Charles Piller in San Francisco and researcher Janet Lundblad in Los Angeles contributed to this report.

Bombshell: Was FBI complicit in Ivins' death?

2008-08-09T13:47:00.000-05:00

http://anthraxvaccine.blogspot.com (for links)

Saturday, August 9, 2008
Bombshell: Was FBI complicit in Ivins' death?

In his news conference on Wednesday, August 6, US Attorney Jeffrey Taylor mentioned (evidence point 4) that while Ivins had been under 24/7 surveillance, he discarded some materials on DNA coding.

If the FBI was about to charge Ivins, you would expect he was still under 24/7 surveillance, right?

Well, a tylenol overdose is entirely treatable--curable- -during many hours after consumption. The patient receives N-acetyl cysteine or glutathione, which allows the body to detoxify the tylenol. If you make it to hospital within 16--24 hours you will live.

SO...why was the FBI twiddling its thumbs during and after Ivins ingested his Tylenol #3 (acetaminophen with codeine)? Attorney Taylor began his remarks saying, "We regret that we will not have the opportunity to present the evidence to a jury to determine whether the evidence establishes Dr. Ivins' guilt beyond a reasonable doubt."

Really? I'd like to see the medical records, and see Congress investigate the "traffic" between the agents performing surveillance and FBI headquarters while Ivins was ingesting his poison and starting to die at home.

Meryl Nass, MD

NAS report shows psychiatric illness increases 7 fold after AVA

2008-08-09T13:42:00.000-05:00

http://anthraxvaccine.blogspot.com (See the blog for links to the
report)

National Academy of Science report shows psychiatric illness increases several-fold after anthrax vaccination

Many have asked me if Ivins' anthrax vaccinations or meds might have contributed to his mental state. Bruce admitted a family history of emotional problems, his brother Tom appears psychiatrically impaired, and I don't mean to make light of this history.

However, the answer to whether anthrax vaccine leads to mental disorders is a resounding YES. The National Academy of Science studied anthrax vaccine for Congress, publishing its report in 2002. Table G-3 of the report summarizes data supplied to the Academy by the military from the Defense Medical Surveillance System database on hospitalization rates in 300,000 soldiers, before and after receiving
anthrax immunizations.

In those who received 1-3 doses of vaccine, hospitalizations for affective psychosis were 4.95 times greater after vaccination than before receiving any anthrax vaccine. For other nonorganic psychoses, the rate was 4.82 times higher. Hospitalizations for neurotic disorders were 2.63 times higher. Hospitalizations for personality disorders were 4.66 times higher. Hospitalizations for drug dependence were 5.64 times higher. Hospitalizations for adjustment reaction were 2.96 times higher. For depressive disorder, not otherwise classified, the rate was 2.76 times higher.

Amazing statistics.

Meryl Nass, MD

Doubts Persist Among Anthrax Suspect’s Colleagues

2008-08-09T13:30:00.002-05:00

http://www.nytimes.com/
The New York Times
By ERIC LIPTON

WASHINGTON — Military personnel, under the threat of court-martial, were refusing inoculations of an anthrax vaccine. The vaccine’s sole manufacturing plant was ordered to shut down. Researchers were turning up evidence possibly linking the vaccine to illnesses of soldiers during the Persian Gulf war of 1991.

It was hardly the thank you that Dr. Bruce E. Ivins expected for his years of labor to produce a vaccine that would protect military personnel from an anthrax attack by the Iraqi leader Saddam Hussein or some other adversary.

The criticism, which reached its peak in 2000 and early 2001, was clearly starting to get on Dr. Ivins’s nerves. “I think the **** is about to hit the fan ... big time,” he wrote in a July 2000 e-mail message about the inoculation program, according to a government affidavit. “It’s just a fine mess.”

This turmoil has now been cited by federal investigators as a key part of the reason they believe that Dr. Ivins sent out anthrax-laced letters in the fall of 2001 — as such an attack would, in a single stroke, have eliminated the skepticism and second guessing about the need for an anthrax vaccine.

The investigators suggest that Dr. Ivins had been struggling with psychological problems, and was on medication and undergoing counseling after being overcome by what he described as paranoid, delusional thoughts. The trouble with the vaccine, they argue, may have been enough to set him off.

But Dr. Ivins’s former colleagues reject that two-part theory, saying it is just one of many flaws in the evidence presented by the government in an unconvincing case.

There was a real threat, the former colleagues acknowledged, that the anthrax vaccine Dr. Ivins had worked on during that period, known as Anthrax Vaccine Absorbed or AVA, might be pulled from the market.

Most troubling were problems at the Michigan manufacturing plant, which had been shut down in 1998 after the Food and Drug Administration uncovered serious flaws.

Dr. Ivins and other researchers, however, had been working on a more advanced alternative vaccine — considered safer and more effective — so there was no reason for such a rash act, his former colleagues say.

“There was a lot of consternation, a lot of pressure to rescue this thing,” said Jeffrey Adamovicz, one of Dr. Ivins’s fellow researchers at the time. “But if AVA failed, he had his next vaccine candidate. It was well on its way to what looked to be a very bright future.”

The vaccine controversy erupted in the late 1990s, after the Defense Department ordered the inoculation of all 2.4 million active duty and reserve troops, starting with those most likely to confront biological attacks in war zones, partly because Iraq had confirmed that it once had a large stockpile of anthrax that was destroyed after the first Persian Gulf war.

By 2000, more than 570,000 military personnel had complied with the order, and hundreds had filed an “adverse event report” after receiving the shots, citing reactions that included fatigue, dizziness and muscle pain, and more serious conditions like thyroid disorders and rhabdomyolysis, a muscle ailment.

Congressional hearings were held, and dozens of House members signed a letter to the Pentagon calling the mandatory vaccination program “a flawed policy that should be immediately stopped.”

Protests were also organized.

“What the government is doing is wrong, and it is time to wake up America from its comfortable stupor and say ‘no more,’ ” said a Pennsylvania woman, Gloria Graham, at a 2000 protest over the vaccine, which Ms. Graham said had sickened her son.

The Army Medical Research Institute of Infectious Diseases, at Fort Detrick, Md., where Dr. Ivins worked, had been assigned by the Defense Department to help BioPort, the company that owned the Michigan manufacturing plant, to fix any problems so production could resume.

“Unfortunately, since the BioPort people aren’t scientists, the task of solving their problem has fallen on us,” Dr. Ivins wrote in a June 2000 e-mail message.

The situation became dire as the vaccine supply dwindled, leading Dr. Ivins to speculate openly that the program might be halted. “That would be bad for everyone concerned, including us,” he wrote. “I’m sure that blame will be spread around.”

The pressure was intense for the team at Fort Detrick that had been working on the effort, a group of about half a dozen scientists and technicians, said Dr. Adamovicz, Dr. Ivins’s former colleague.

“It was a big concern for us,” Dr. Adamovicz said in an interview this week. “We wanted obviously to see this vaccine succeed.”

The stakes were particularly high for Dr. Ivins, who, for nearly a decade, had been leading experiments in which laboratory animals — rabbits, monkeys and mice — were injected with vaccines that each had slightly different additives in an effort to increase their effectiveness.

Critics of the program were accusing the Defense Department of using one of the experimental formulas, which featured an oil-based additive called squalene, in vaccines given to military personnel in the gulf war, a decision, they contended, that may have caused autoimmune diseases among returning soldiers.

“It is well documented that the U.S. military has a history of administering experimental vaccines to the troops,” said Gary Matsumoto, who was doing research on a book on the anthrax program and who had submitted Freedom of Information requests to the Army requesting access to Dr. Ivins’s laboratory notebooks.

The Defense Department denied conducting such experiments on troops and defended the vaccine, saying it was both safe and effective, and necessary to protect the military from a possible attack. Dr. Ivins’s notebooks, which were released to the public, suggested, however, that he had found that the vaccine might be making some of the test animals sick.

“Although all vaccinated monkeys survived, they appeared to be sick over the course of two weeks,” Dr. Ivins’s laboratory report said.

In his e-mail messages, Dr. Ivins expressed particular contempt for Mr. Matsumoto and his requests for copies of internal Army test results.

“We’ve got better things to do than shine his shoes and pee on command,” Dr. Ivins wrote, in August 2001, about Mr. Matsumoto. “He’s gotten everything from me he will get.”

What the Justice Department has not produced is evidence documenting that Dr. Ivins’s frustrations motivated him to retaliate with the anthrax letters.

Gerard P. Andrews, another of Dr. Ivins’s former colleagues, said he knew that Dr. Ivins was frustrated, but that he doubted that Dr. Ivins would consider such a step.

“Nothing is unimaginable,” Dr. Andrews said. “But I would definitely say it is doubtful.”

White House memo exposes Rove knew of problems with anthrax vaccine.

2008-08-07T13:27:00.000-05:00

White House memo exposes Rove knew of problems with anthrax vaccine.
Rove memo dated 25 April 2001.

http://rawstory. com/news/ 2008/Memo_ shows_White_ House_knew_ of_0807.html

White House memo exposes Rove knew of problems with anthrax vaccine
08/07/2008 @ 10:51 am
Filed by Allen McDuffee

Rove said Gulf War Syndrome, vaccine political stumbling block

The Department of Defense continued its controversial mandatory anthrax vaccinations program despite high ranking Bush administration officials acknowledging there were problems with the vaccine within months of the Bush administration taking office—well before the 9/11 attacks and the October 2001 anthrax letters.

A 2001 memorandum from former White House Deputy Chief of Staff Karl Rove to then-Deputy Secretary of Defense Paul Wolfowitz indicates that the White House knew of problems relating to the Gulf War Syndrome and the military's controversial anthrax vaccine.

Obtained by RAW STORY earlier this year from a senior military official and referenced in today's New York Daily News, Rove wrote, "I do think we need to examine the issues of both Gulf War Syndrome and the Anthrax vaccine and how they can be dealt with. They are political problems for us."

RAW STORY had held off printing the memorandum (which appears below) in an effort to validate its authenticity. Along with the memo, Rove noted that he had attached "material on the Anthrax vaccine problem," which had been forwarded to him by H. Ross Perot. He titled it "GULF WAR SYNDROME AND ANTHRAX."

"It didn't bother me that Rove referred to it as a political problem at the time because it meant that it would be properly dealt with, finally," the military official who leaked the memo said, speaking on the condition of anonymity. "The political problem became a problem to me when they dropped the ball and allowed the program to continue. It was politics that motivated them to investigate and it was
politics that motivated them to allow the program to continue. Now the political nature bothers me."

The Apr. 25, 2001 memo indicates how long and how far up in the administration the anthrax vaccine—and Gulf War Syndrome—have been considered problematic.

The Pentagon's anthrax vaccine is manufactured by a single contractor, Emergent BioSolutions. It has been plagued with complaints from soldiers and soldiers' advocates, who assert that the vaccine causes myriad debilitating ailments.

The Defense Department was forced to halt mandatory injections in 2004 after a judge ruled that the FDA had not approved the vaccine for its intended use. In 2006, the military resumed mandatory vaccinations after FDA approval, citing letters laced with anthrax in late 2001 as a reason.

Questions about the mailings containing anthrax have re-emerged in the wake of a suicide by a biodefense researcher. At the time of his death, Bruce Ivins, 62, was under federal investigation for the 2001 anthrax attacks that left five people dead and more than a dozen sickened. In a Wednesday joint FBI and Department of Justice press conference, while not officially closing the case, Assistant Director
in Charge Joseph Persichini of the FBI Washington Field Office said, "Bruce Ivins was responsible for the death, sickness, and fear brought to our country by the 2001 anthrax mailings."

The leaked memo also comes on the heels of an announcement by the Department of Homeland Security, which has proposed giving the city where Emergent BioSolutions is located $946,520 to protect the company's facilities. The grant, according to an article in the Lansing State Journal, would "purchase, install and deploy the
eligible Homeland Security equipment and manage related law enforcement protective actions."

A New York Times article following Ivins' death highlighted a number of tensions between public safety and biodefense research, centering around the question: "Has the unprecedented boom in biodefense research made the country less secure?"

Pentagon maintains vaccine is safe, requires injections

Despite repeatedly maintaining it is safe, documents obtained by Raw Story last year showed that the Pentagon and medical military personnel have known since at least 1998 that there are genetic triggers between illnesses and some required immunizations. They also revealed the military knew and did not implement routine pre-screening which could help reduce vaccine-related illnesses.

A flyer posted by the Vaccine Healthcare Center in 2007 showed that Walter Reed solicited servicemembers who have suffered as a result of the vaccine, asserting that "adverse effects may include redness or swelling where the shot was given (larger than the bottom of a soda can) and/or more than 24 hours of headaches, muscle/joint pains, and/or fatigue (tiredness) that interfered with your daily
activities."

Texas billionaire and onetime presidential candidate H. Ross Perot testified to a Congressional committee in 2002 regarding issues with the vaccine and its manufacturer.

"BioPort is a mess," Perot said, referring to the Pentagon contractor, which has since changed its name to Emergent BioSolutions. "BioPort should not be able to keep that contract. For years they never met any goals or objectives.. .For years they got bonuses that equaled or exceeded their salaries and didn't accomplish
their goals."

"The damage that was done to our Tigers in the Armed Forces is incredible," he added. "Hundreds of pilots have left the Air Force rather than take the shot. $6 million to train one pilot. That's a high price to pay, right?"

Ivins had worked on producing an anthrax vaccine. Documents presented by federal prosecutors paint a portrait of a paranoid man who suffered delusions. Their evidence against him, however, has been questioned. Sources who spoke to the press said that the Justice Department was close to charging Ivins when he took his own life, but that they still had more investigating to do. The Department asserts
that Ivins acted alone.

Iowa Republican Sen. Charles Grassley (R-IA), has called for a "full-blown accounting" of the probe, which cost taxpayers $15 million and took seven years, according to the Washington Post. Democratic Rep. Rush D. Holt (D-NJ), who represents the region the deadly letters were mailed from from, says hearings should be held as to "why investigators are so certain that Ivins acted alone."

ROVE MEMO: http://rawstory.com/images/other/rovememoanthrax.pdf

DOJ Spin: Ivins only Anthrax Killer

2008-08-06T13:23:00.000-05:00

http://www.breitbart.com/article.php?id=D92D05T80&show_article=1

Documents, US officials: Ivins only anthrax killer

By LARA JAKES JORDAN and MATT APUZZO
Associated Press Writers

WASHINGTON (AP) - Army scientist Bruce Ivins "was the only person responsible" for anthrax attacks in 2001 that killed five and rattled the nation, the Justice Department said Wednesday, backing up the claim with dozens of documents all pointing to his guilt.

Ivins committed suicide last week as investigators closed in, and U.S. Attorney Jeffrey Taylor said, "We regret that we will not have the opportunity to present evidence to the jury."

The prosecutor's news conference capped a fast-paced series of events in which the government partially lifted its veil of secrecy in the case that followed closely after the airliner terror attacks of Sept. 11, 2001.

Documents made public alleged that Ivins had sole custody of highly purified anthrax spores with "certain genetic mutations identical" to the poison used in the attacks, and that investigators had traced back to Ivins' lab the type of envelopes used to send the deadly spores through the mails.

THIS IS A BREAKING NEWS UPDATE. Check back soon for further information. AP's earlier story is below.

WASHINGTON (AP)—Army scientist Bruce Ivins had sole custody of highly purified anthrax spores with "certain genetic mutations identical" to the poison that killed five people and rattled the nation in 2001, according to documents unsealed Wednesday in the government's investigation.

Investigators also reported tracing back to Ivins' lab the type of envelopes used to send the deadly spores through the mails.

The scientist, depicted in the newly released papers as deeply troubled, committed suicide last week as investigators were preparing to charge him with murder in the attacks.

The documents were released as the FBI held a private briefing for families of the victims of the episode, and officials said the agency was preparing to close the case.

More than 200 pages of documents were made public by the FBI, virtually all of them describing the government's attempts to link Ivins to crimes that his lawyer has said he did not commit.

Senate Sergeant at Arms Terrance Gainer, who attended a briefing for congressional staff, said FBI agents had told the group there was no evidence that anyone else was involved.

According to one affidavit made public, Ivins submitted false anthrax samples to the FBI, was unable to give investigators "an adequate explanation for his late laboratory work hours around the time of" the attacks and sought to frame unnamed co-workers.

He was also said to have received immunizations against anthrax and yellow fever in early September 2001, several weeks before the first anthrax-laced envelope was received in the mail.

The government material describes at length painstaking scientific efforts to trace the source of the anthrax that was used in the attacks.

It says that in his lab, Ivins had custody of a flask of anthrax termed "the genetic parent" to the powder involved—a source that investigators say was used to grow spores for the attacks on "at least two separate occasions."

Anthrax culled from the letters was quickly discovered to be the so-called Ames strain of bacteria, but with genetic mutations that made it distinct. Scientists developed more sophisticated tests for four of those mutations, and concluded that all the samples that matched came from a single batch, code-named RMR-1029, stored at Fort Detrick.

Ivins "has been the sole custodian of RMR-1029 since it was first grown in 1997," said one affidavit.

Powder from anthrax-laden letters sent to the New York Post and Tom Brokaw of NBC contained a bacterial contaminant not found in the anthrax-containing envelopes mailed to Sens. Patrick Leahy or Tom Daschle, the affidavit said.

Investigators concluded that "the contaminant must have been introduced during the production of the Post and Brokaw spores," the affidavit said.

The events in Washington unfolded as a memorial service was held for Ivins at Fort Detrick, the secret government installation in Frederick, Md., where he worked. Reporters were barred.

The documents disclosed that authorities searched Ivins' home on Nov. 2, 2007, taking 22 swabs of vacuum filters and radiators and seizing dozens of items. Among them were video cassettes, family photos, information about guns and a copy of "The Plague" by Albert Camus.

Investigators also reported seizing three cardboard boxes labeled "Paul Kemp ... attorney client privilege."

Ivins' cars and his safe deposit box also were searched as investigators closed in on the respected government scientist who had been troubled by mental health problems for years.

According to an affidavit filed by Charles B. Wickersham, a postal inspector, the scientist told an unnamed co-worker "that he had `incredible paranoid, delusional thoughts at times' and 'feared that he might not be able to control his behavior.'"

A mental health worker who was involved in treating Ivins disclosed last week that she was so concerned about his behavior that she recently sought a court order to keep him away from her.

Allegations that Ivins sought to mislead investigators ran through the material made public.

One FBI document said Ivins "repeatedly named other researchers as possible mailers and claimed that the anthrax used in the attacks resembled that of another researcher" at the same facility.

The name of the other researcher was not disclosed.

Stephen A. Hatfill's career as a bioscientist was ruined after then-Attorney General John Ashcroft named him a "person of interest" in the probe. The government recently paid $6 million to settle a lawsuit by Hatfill, who worked in the same lab.

The documents made public painted a picture of Ivins seeking to mislead investigators beginning in 2002, when he allegedly submitted the wrong samples to FBI investigators.

It wasn't until more than two yeras later, in March 2005, that he was confronted with the alleged switch, according to U.S. Postal Inspector Thomas Dellafera, who added that Ivins insisted he had not sought to deceive.

The documents, which were expected to shed light on many of the mysteries surrounding the case, were released following an order from U.S. District Judge Royce Lamberth. Among them were more than a dozen search warrants issued as the government closed in on Ivins in an investigation into the terrifying mail poisonings a few weeks after the Sept. 11, 2001, terror attacks.

Lamberth ordered the release after consultation with Amy Jeffress, a national security prosecutor at the Department of Justice.

The investigation dates to 2001, when anthrax-laced mail turned up in two Senate offices as well as news media offices and elsewhere. At the time, the events were widely viewed as the work of terrorists, and delivery of mail was crippled when anthrax spores were discovered in mailing equipment that had processed the contaminated envelopes.

The FBI's investigation had dragged on for years, tarnishing the reputation of the agency in the process.

Ivins' lawyer has maintained that the 62-year-old scientist would have been proved innocent had he lived. And some of Ivins' friends and former co-workers at the Fort Detrick biological warfare lab say they doubt he could or would have unleashed the deadly toxin.

DOJ Search Warrant - July 11, 2008

2008-08-03T13:21:00.000-05:00

http://www.justice.gov/amerithrax/08-433%20affidavit.pdf

Overview
The Federal Bureau of Investigation and the U.S. Postal Inspection Service (hereinafter "Task Force") investigation of the anthrax attacks has led to the identification of Dr. Bruce Edward Ivins, an anthrax researcher at the U.S. Army Medical ~esearch'hstitutefo r Infectious Diseases, Fort Detrick, MD (hereinafter "USAMRIID"), as a person necessitating further investigation for several reasons: (1) At the time of the attacks, he was the custodian of a large
flask of highly purified anthrax spores that possess certain genetic mutations identical to the anthrax used in the attacks; (2) Ivins has been unable to give investigators an adequate explanation for his late night laboratory work hours around the time of both anthrax mailings; (3) Ivins has claimed that he was suffering serious mental health issues in the months preceding the attacks, and told a coworker that he had "incredible paranoid, delusional thoughts at times" and
feared that he might not be able to control his behavior; (4) Ivins is believed to have submitted false samples of anthrax from his lab to the FBI for forensic analysis in order to mislead investigators; (5) at the time of the attacks, Ivins was under pressure at work to assist a private company that had lost its FDA approval to produce an anthrax vaccine the Army needed for U.S. troops, and which Ivins elieved was essential for the anthrax program at USAMRIID; and (6)
Ivins sent an email to hfew days before the anthrax attacks warning that "Bin Laden terrorists or sure lave anthrax and sarin gas" and have "just decreed death to ail Jews and all Americans," language similar to the anthrax letters warning "WE HAVE THIS ANTHRAX . . . DEATH TO AMERICA . . . DEATH TO ISRAEL." In his affidavit dated October 3 1,2007, submitted in support of an initial search of the residence and
vehicles of Bruce Edwards Ivins, Supervisory Postal Inspector Thomas F. Delafera described in greater detail information regarding Bruce Edwards Ivins, and his probable connection to the anthrax mailings. I hereby incorporate this affidavit by reference herein.

Suspect in anthrax-letter deaths kills himself

2008-08-01T13:08:00.000-05:00

http://ap.google.com/article/ALeqM5gH1fcT1QrjvwIaAZTO63_lxHs9EQD929OMQG0

NOTE: "For more than a decade, Ivins had worked to develop an anthrax
vaccine that was effective even in cases where different strains of
anthrax were mixed — a situation that made vaccines ineffective —
according to federal documents reviewed by the AP. In 2003, he shared
the Decoration for Exceptional Civilian Service for his work on the
anthrax vaccine. The award is the highest honor given to Defense
Department civilian employees."

By MATT APUZZO and LARA JAKES JORDAN – Aug 1, 2008

WASHINGTON (AP) — Anthrax-laced letters that killed five people and severely rattled the post-9/11 nation may have been part of an Army scientist's warped plan to test his cure for the deadly toxin, officials said Friday. The brilliant but troubled scientist committed suicide this week, knowing prosecutors were closing in.

The sudden naming of scientist Bruce E. Ivins as the top — and perhaps only — suspect in the anthrax attacks marks the latest bizarre twist in a case that has confounded the FBI for nearly seven years. Last month, the Justice Department cleared Ivins' colleague, Steven Hatfill, who had been wrongly suspected in the case, and paid him $5.8 million.

Ivins worked at the Army's biological warfare labs at Fort Detrick, Md., for 18 years until his death on Tuesday. He was one of the government's leading scientists researching vaccines and cures for anthrax exposure. But he also had a long history of homicidal threats, according to papers filed last week in local court by a social worker.

The letters contained anthrax powder were sent on the heels of the terror attacks of Sept. 11, 2001, and turned up at congressional offices, newsrooms and elsewhere, leaving a deadly trail through post offices on the way. The powder killed five and sent numerous victims to hospitals and caused near panic in many locations.

Workers in protective garb that made them look like space men decontaminated U.S. Capitol buildings after anthrax letters were discovered there. Major postal substations were closed for years. Newsrooms were checked all over after anthrax letters were mailed to offices in Florida and New York.

The Justice Department said Friday only that "substantial progress has been made in the investigation." The statement did not identify Ivins.

However, several U.S. officials said prosecutors were focusing on the 62-year-old Ivins and planned to seek a murder indictment and the death penalty. Authorities were investigating whether Ivins, who had complained about the limits of testing anthrax drugs on animals, had released the toxin to test the treatment on humans.

The officials all discussed the continuing investigation on condition of anonymity because they were not authorized to speak to the media.

The Justice Department is expected to decide within days whether to close the "Amerithrax" investigation now that its main target is dead. If the case remains open, that could indicate there still are other suspects.

Ivins' attorney asserted the scientist's innocence and said he had cooperated with investigators for more than a year.

"We are saddened by his death, and disappointed that we will not have the opportunity to defend his good name and reputation in a court of law," said Paul F. Kemp.

Ivins died Tuesday at Frederick Memorial Hospital in Maryland. Relatives told The Associated Press that he killed himself. Kemp said his client's death was the result of the government's "relentless pressure of accusation and innuendo."

For more than a decade, Ivins had worked to develop an anthrax vaccine that was effective even in cases where different strains of anthrax were mixed — a situation that made vaccines ineffective — according to federal documents reviewed by the AP. In 2003, he shared the Decoration for Exceptional Civilian Service for his work on the anthrax vaccine. The award is the highest honor given to Defense Department civilian employees.

Ivins conducted numerous anthrax studies, including one that complained about the limited supply of monkeys available for testing. The study also said animal testing couldn't accurately show how humans would respond to anthrax treatment.

The Fort Detrick laboratory and its specialized scientists for years have been at the center of the FBI's investigation of the anthrax mailings. In late June, the government exonerated Hatfill, whose name has for years had been associated with the attacks. Then-Attorney General John Ashcroft called him a "person of interest" in 2002.

Investigators also had noticed Ivins' unusual behavior at Fort Detrick in the six months following the anthrax mailings. He conducted unauthorized testing for anthrax spores outside containment areas at the infectious disease research unit where he worked, according to an internal report. But the focus stayed on Hatfill.

Ivins' friends, colleagues and court documents paint a picture of a flourishing scientist with an emotionally unstable side. Maryland court documents show he recently received psychiatric treatment and was ordered to stay away from a woman he was accused of stalking and threatening to kill.

Social worker Jean C. Duley filed handwritten court documents last week saying she was preparing to testify before a grand jury. She said Ivins would be charged with five capital murders.

"Client has a history dating to his graduate days of homicidal threats, plans and actions towards therapist," Duley said, adding that his psychiatrist had described him as homicidal and sociopathic.

Authorities have been watching Ivins for some time. His brother, Tom Ivins, said federal agents questioned the scientist about a year and a half ago. Neighbors said FBI agents in cars with tinted windows conducted surveillance on his home. A colleague, Henry S. Heine, said that over the past year, he and others on their team had testified before a federal grand jury in Washington that has been investigating the anthrax mailings.

On July 10, police responded to Fort Detrick to speak with Ivins. He was ultimately removed from his job and taken to a hospital for psychiatric evaluation because of concern he had become a danger to himself or others.

The victims of the attacks had little in common.

Robert Stevens, 63, a photo editor at the Sun, a supermarket tabloid published in Boca Raton, Fla., was the first to die.

Thomas Morris Jr. 55, and Joseph Curseen, 47, worked at a Washington-area postal facility that was a hub for sorting the capital's mail.

Kathy Nguyen, 61, who had emigrated from Vietnam and lived in the Bronx, worked in a stock room at Manhattan Eye Ear & Throat Hospital, a Children's Hearing Institute. Ottilie Lundgren, 94, who lived in Oxford, Conn.

Officials eyed death penalty for anthrax suspect

2008-08-01T13:04:00.000-05:00

*NOTE THE LAST PARAGRAPH:

Honored by Pentagon
In 2003, Ivins and two of his colleagues at the U.S. Army Medical Research Institute of Infectious Diseases at Fort Detrick received the highest honor given to Defense Department civilian employees for helping solve technical problems in the manufacture of anthrax vaccine.

In 1997, U.S. military personnel began receiving the vaccine to protect against a possible biological attack. Within months, a number of vaccine lots failed a potency test required by federal regulators, causing a shortage of vaccine and eventually halting the immunization program. The USAMRIID team's work led to the reapproval of the vaccine for human use.

The Times said Ivins was the son of a Princeton-educated pharmacist who was born and raised in Lebanon, Ohio. He received undergraduate and graduate degrees, including a Ph.D. in microbiology, from the University of Cincinnati.

Officials eyed death penalty for anthrax suspect

http://www.msnbc. msn.com/id/ 25961053/

Death penalty loomed over anthrax suspect

Government researcher apparently killed himself as prosecutors closed in

NBC News and news services

updated 12:46 p.m. ET, Fri., Aug. 1, 2008

WASHINGTON - A top U.S. biodefense researcher apparently committed suicide this week as prosecutors prepared to seek indictment and the death penalty against him for the deadly 2001 anthrax attacks, U.S. officials said Friday.

The scientist, Bruce E. Ivins, was a leading military anthrax researcher who worked for the past 18 years at the government's biodefense labs at Fort Detrick, Md. The laboratory has been at the center of the FBI's investigation of the anthrax mailings.

For more than a decade, Ivins worked to develop an anthrax vaccine that was effective even in cases where different strains of anthrax were mixed, which made vaccines ineffective, according to federal documents reviewed by the AP.

In his research, he complained of the limited supply of monkeys available for testing and said testing on animals is insufficient to demonstrate how humans would respond to treatment.

Federal officials told NBC News that Ivins was asked to help analyze some of the anthrax material recovered from mailings that killed five people in the weeks following the Sept. 11, 2001, attacks. He also helped develop the anthrax vaccine widely given to U.S. troops.

A painstaking scientific examination of the anthrax used in the mailings â€” an analysis that took years â€” showed that it came from anthrax strains held at Ivins' lab, U.S. officials told NBC News on condition of anonymity.

Other U.S. officials, who spoke on condition of anonymity because of the sensitivity of the ongoing grand jury investigation, said prosecutors were closing in on Ivins, 62. They were planning an indictment that would have sought the death penalty for the attacks, which killed five people, crippled the postal system and traumatized a nation still reeling from the Sept. 11 attacks.

Authorities were investigating whether Ivins released the anthrax as a way to test his vaccine, officials said. The Justice Department has not yet decided whether to close the investigation, officials said, meaning it's still not certain whether Ivins acted alone or had help. One official close to the case said that decision was expected within days.

If the case is closed soon, one official said, that will indicate that Ivins was the lone suspect.

White House press secretary Dana Perino declined to comment on the case, except to say that President Bush has maintained an interest in it over the years and was aware there were "about to be developments. " She would not say how much he knew about the Ivins case.

Ivins' attorney said the scientist had cooperated with investigators for more than a year.

"We are saddened by his death, and disappointed that we will not have the opportunity to defend his good name and reputation in a court of law," attorney Paul F. Kemp said. "We assert his innocence in these killings, and would have established that at trial."

Kemp said that Ivins' death was the result of the government's "relentless pressure of accusation and innuendo."

The biodefense institute issued a statement saying its " family mourns the loss of Dr. Bruce Ivins, who served the institute for more than 35 years as a civilian microbiologist. In addition to his long and faithful government service, Bruce contributed to our community as a Red Cross volunteer with the Frederick County chapter. We will miss him very much."

Peer doubts Ivins was guilty
Ivins was "hounded" by aggressive FBI agents who raided his home twice, said Dr. W. Russell Byrne, a colleague who worked in the bacteriology division of the Fort Detrick research facility for 15 years. Byrne said Ivins was forcefully removed from his job by local police recently because of fears that he had become a danger to himself or others. The investigation led to Ivins being hospitalized for depression earlier this month, Byrne said.

He said he does not believe Ivins was behind the anthrax attacks.

Ivins died Tuesday at Frederick Memorial Hospital in Maryland. The Los Angeles Times, which first reported the investigation, said the scientist had taken a massive dose of a prescription Tylenol mixed with codeine. A woman who answered the phone at Bruce Ivins' home in Frederick declined to comment.

Tom Ivins, a brother of the scientist, told The Associated Press that his other brother, Charles, had told him that Bruce committed suicide and Tylenol might have been involved.

Investigated for months
Tom Ivins said Friday that federal officials working on the anthrax case questioned him about his brother a year and a half ago. "They said they were investigating him," he said from Ohio, where he lives, in a CNN interview.

FBI vehicles with tinted windows had watched Ivins' home for a year, neighbor Natalie Duggan, 16, said.

"They said, 'We're on official business,' " she said.

Five people died and 17 were sickened by anthrax powder in letters that were mailed to lawmakers' Capitol Hill offices, TV networks in New York, and tabloid newspaper offices in Florida. Two postal workers in a Washington mail facility, a New York hospital worker, a Florida photo editor and an elderly Connecticut woman were killed.

In late June, the government exonerated a colleague of Ivins, Steven Hatfill. Hatfill's name has for years had been associated with the attacks after investigators named him a "person of interest" in 2002.

The government paid Hatfill $5.82 million to settle a lawsuit contending he was falsely accused and had been made a scapegoat for the crimes.

Due to the privacy lawsuit with Hatfill, the Justice Department and the FBI are being cautious about how much information they reveal about the investigation into Ivins, federal lawyers told NBC News' Pete Williams.

"We are not at this time making any official statements or comments regarding this situation," said Debbie Weierman, a spokeswoman for the FBI's Washington field office, which is investigating the anthrax attacks, said Friday.

Despite his death, Ivins and his estate, which is now controlled by his family, still retain privacy rights, the lawyers said. However, the officials said they are well aware that at some point they will need to make a full accounting.

Unusual behavior by Ivins was noted at Fort Detrick in the six months following the anthrax mailings, when he conducted unauthorized testing for anthrax spores outside containment areas at the infectious disease research unit where he worked, according to an internal report. But the focus long stayed on Hatfill.

After the government's settlement with Hatfill was announced in late June, Ivins started showing signs of strain, the Times said. It quoted a longtime colleague as saying Ivins was being treated for depression and indicated to a therapist that he was considering suicide.

Family members and local police escorted Ivins away from the Army lab, and his access to sensitive areas was curtailed, the colleague told the newspaper. He said Ivins was facing a forced retirement in September.

Maryland court documents show he recently received psychiatric treatment. Last week he was ordered to stay away from a woman he was accused of stalking and threatening to kill.

Ivins played keyboard and helped clean up after masses at St. John the Evangelist Roman Catholic Church in Frederick, where a dozen parishioners gathered after morning Mass to pray for him Friday.

The Rev. Richard Murphy called Ivins â€œa quiet man. He was always very helpful and pleasant.â€

Colleagues react
Henry S. Heine, a scientist who had worked with Ivins on inhalation anthrax research at Fort Detrick, said he and others on their team have testified before a federal grand jury in Washington that has been investigating the anthrax mailings for more than a year.

Heine declined to comment on Ivins' death.

Norman Covert, a retired Fort Detrick spokesman who served with Ivins on an animal-care and protocol committee, said Ivins was "a very intent guy" at their meetings.

Ivins was the co-author of numerous anthrax studies, including one on a treatment for inhalation anthrax published in the July 7 issue of the journal Antimicrobial Agents and Chemotherapy.

The Los Angeles Times said federal investigators moved away from Hatfill and concluded Ivins was the culprit after FBI Director Robert Mueller changed leadership of the investigation in 2006. The new investigators instructed agents to re-examine leads and reconsider potential suspects. In the meantime, investigators made progress in analyzing anthrax powder recovered from letters addressed to two U.S. senators, according to the report.

In January 2002, the FBI doubled the reward for helping solve the case to $2.5 million, and by June officials said the agency was scrutinizing 20 to 30 scientists who might have had the knowledge and opportunity to send the anthrax letters.

Honored by Pentagon
In 2003, Ivins and two of his colleagues at the U.S. Army Medical Research Institute of Infectious Diseases at Fort Detrick received the highest honor given to Defense Department civilian employees for helping solve technical problems in the manufacture of anthrax vaccine.

In 1997, U.S. military personnel began receiving the vaccine to protect against a possible biological attack. Within months, a number of vaccine lots failed a potency test required by federal regulators, causing a shortage of vaccine and eventually halting the immunization program. The USAMRIID team's work led to the reapproval of the vaccine for human use.

The Times said Ivins was the son of a Princeton-educated pharmacist who was born and raised in Lebanon, Ohio. He received undergraduate and graduate degrees, including a Ph.D. in microbiology, from the University of Cincinnati.

NBC News' Pete Williams and The Associated Press contributed to this report.

URL: http://www.msnbc. msn.com/id/ 25961053/

Press Release from Ivin's Attorney

2008-08-01T12:59:00.001-05:00

Paul F. Kemp
t 301.217.5664
f 301.217.5617
pfkemp@venable. com
August 1, 2008

PRESS RELEASE

For more than a year, we have been privileged to represent Dr. Bruce Ivins during the
investigation of the anthrax deaths of September and October of 2001.
For six years, Dr. Ivins fully cooperated with that investigation, assisting the
government in every way that was asked of him. He was a world renowned and highly decorated scientist who served his country for over 33 years with the Department of the Army. We are saddened by his death, and disappointed that we will not have the opportunity to defend his good name and reputation in a court of law. We assert his innocence in these killings, and would have established that at trial. The relentless pressure of accusation and innuendo takes its toll in different ways on different people, as has already been seen in this investigation.
In Dr. Ivins' case, it led to his untimely death. We ask that the media respect the privacy.
of his family, and allow them to grieve.

An Improbable Ending:

2008-08-01T12:55:00.000-05:00

An Improbable Ending:

Scientist Bruce Ivins Tried and Convicted by the Media as Anthrax
Letter perpetrator, after his suicide

by Meryl Nass, MD

For 7 years the Justice Department couldn't seem to get anything right
about the anthrax letters. For years, it harrassed Steven Hatfill, a
self-described bodyguard for South African white supremacist Eugene
Terrblanche and an unlicensed physician, despite a shocking lack of
evidence. He is now $5.8 million richer as a result.

But the White House told press just days after the letters started
appearing that the anthrax came from a government lab. Then that
claim was buried as the justice department "pursued" the case
everywhere else. Only recently were the press informed that
government scientists were being investigated regarding the crime.

Ph.D. scientist Bruce Ivins worked at Fort Detrick, the Army's center
for biodefense, since about 1980. He was one of a small group of
scientists who worked exclusively on anthrax, and most of his career
dealt with the development of anthrax vaccines.

I first met Bruce at a conference on biowarfare in the spring of 1991
at the University of Maryland. We happened to sit next to each other,
in the front row, and enjoyed chatting. Bruce sent me information
relevant to my research on Zimbabwe's anthrax epidemic, and I
commented on his work. We continued to correspond occasionally for
about ten years. Bruce had a chronic blood disorder, which he thought
might have been due to his many anthrax immunizations, and encouraged
me to continue investigating the vaccine's side effects. He shared
papers with me on the effects of the vaccine's aluminum adjuvant in
experimental animals.

Now it turns out that Bruce was one of several scientists the justice
department turned its spotlight on, after Hatfill succeeded in not
only getting them to leave him alone, but also pay him for destroying
his (admittedly tawdry) reputation. Bruce was a gentle guy, the
opposite of Hatfill. While Hatfill stirred up a cauldron of
controversy, held press conferences and initiated many legal efforts
(I was subpoenaed as a witness for his case against the New York
Times), Bruce got depressed. Then killed himself, apparently.

Bruce wasn't the anthrax perpetrator. First off, he had no motive.
He didn't need to direct money toward the bioterrorism effort, or
increase interest in it. He had a very solid job, since he was the
army's top expert on anthrax vaccines. He didn't move on to a better
job in industry, unlike many of his colleagues at Fort Detrick, after
the anthrax letters made bioterrorism a profitable industry.

Second, he had no access to dry, powdered anthrax, according to Fort
Detrick spokespersons, who said that only liquid anthrax was used at
the Fort Detrick facility in animal aerosolization experiments. If he
had been making dry anthrax, it would have been detectable: because
anthrax forms a protective spore, the bacteria contaminate the
facilities where they are produced. A wet swab can then be used to
remove them from surfaces for culture and identification. So if Bruce
had made enough anthrax (at least 10-20 grams) to fill the letters, it
would have been detectable and the strain would have matched that of
the letters. It would not take 7 years to perform the forensics for
this experiment, though it could take 7 months. His colleagues would
have noted something amiss: half an ounce of dried anthrax requires a
lot of fermentation and processing to prepare.

So, we have what appears to be a deliberately botched investigation of
the anthrax letters case, and it is all going to end with the suicide
of an ill and depressed scientist who lacked a motive and probably
lacked access to powdered anthrax.

In my opinion anyway, this case is not closed. I will be reposting an
article I wrote about this investigation in early 2002, to provide
additional perspective, and a statement made by Bruce's attorney.

Meryl Nass, MD
Mount Desert Island Hospital
Bar Harbor, Maine 04609
207 288-5081 ext. 220
http://anthraxvacci ne.blogspot. com
http://www.anthraxv accine.org