Correction:

There are 2 errors in what I posted below about the forensic analysis discussed in Professor Jacques Ravel's slides. The first correction is that the over 1,100 samples submitted to the FBI were screened for genotypic differences, and may not have been screened for morphologic differences.

The second error is that the slides say wild-type Ames (isolated from a heifer that died in Texas in 1981) did not vary from an anthrax sample isolated from Bob Stevens' cerebrospinal fluid (over 5 million base pairs identical), rather than from the anthrax letters directly.

What I termed slide 16 has a list of 5 different isolates (morphotypes) from the Leahy letter and 3 from the NY Post letter. One of each is termed "wild-type" so you might say there are 4 (Leahy: A, B, C and E/Opaque) and 2 (NY Post: A and B) morphotypes distinct from the majority colony type listed on the slide.

Later the slides indicate that 3 genotypes were identified within the A morphotype. The slides do not indicate how many genotypes were found in the other morphotypes. Nor how these were determined. There are 2 slides on each page. So what I identified as slide 16 is actually page 16, slide 31.

Slide 45 indicates that 4 PCR assays were developed to distinguish genotypes. I don't know from which samples these distinctive genotypes were found, and used.

The over 1100 submitted samples were screened for PCR genotype differences. Some had 1 or 2 variants but only the sample from Ivins' flask had 4. (It is implied that 4 were found in the anthrax letters.)

BOTTOM LINE:

I erred in mixing up morphotypes and PCR assays in my earlier statement. There is nothing in the slides that indicated the 1100 samples were screened for morphologic colony differences.

There is missing information so I cannot say what kinds of samples were used to discern the genotypic differences. But my guess is these were genetic differences within morphotypically distinct colonies.

However, the slides appear to indicate that the morphologic variants differed between the two letters.

If genotypic differences of rare morphotypes are what was used to nail Ivins' flask, the science may be questionable. If the morphotypes varied between the two letters, is it forensically valid to focus on qualitative genotypic differences in a subset of morphotypes? But I am guessing this is what was done. The FBI needs to tell us precisely what methods were used.

New details from the genomic forensic analysis

Dr. Jacques Ravel of U Maryland, formerly of the Institute for Genomic Research (TIGR), spoke at the MIT faculty club on December 16, 2008 to discuss the scientific evaluation of the anthrax letters' spores.

I requested but did not receive an invitation to the event (despite my Bachelor's degree in Biology from MIT and some expertise in the subject). The slides were shared with me later, but each is labeled "do not distribute."

So I will not share them. They should be posted soon on an MIT website associated with the program that brought Ravel to MIT.

Of interest, the morphologic variations in spore colonies were not entirely identical between the NY Post and Leahy letters. Slide 16 indicates that 5 variations were found in Leahy's anthrax, and (only) 3 of those 5 variations were found in the Post anthrax. No other samples had these 3 variations but some (of greater than 1,100 samples screened) had 1 or 2.

There were no genetic polymorphisms between the 2 samples or a wild-type Ames.

Also of interest, Professor Ravel pays a lot of attention to the criminal-legal aspects of the case and the rules of evidence for trial.

An early article on the genomic studies in the Times is worth a read for comparison.

Military: Repeat of anthrax attacks harder today/AP

From the Annapolis Capital, Maryland

"Lennox said military safety reviews in recent months endorsed many of the security changes already made, from improved cameras and lights to satellite surveillance. But other changes were deemed not workable or too expensive, including limits on scientists' hours or a system that would prohibit workers from being alone with a toxin... As for transporting toxins, there are now requirements that two workers be present at all times during transit and that there be satellite coverage of the shipment."

Terrific. Satellite coverage every time the courier or FedEx carrier goes inside a building or gets on an airplane. How is that going to prevent unauthorized transfers of microorganisms and toxins? Do two workers share a bathroom stall?

The army's PR people will have to do better than this to convince the public the next bioattack won't be originating from a government lab.

Confirmation: Letter spores grown in medium to which silicon added

Although this conclusion is nothing new to many of us, it is gratifying to get confirmation from the National Academy of Engineering of the National Academy of Sciences, and to hear a Sandia National Labs scientist, Paul Kotula, acknowledge that 200 tries to reverse engineer the spores did not create an identical match. Which simply says it is likely the FBI does not know exactly how the spores were made, which makes it more difficult to pin their manufacture on any one individual.

Who is Responsible for Zimbabwe's Current Anthrax and Cholera Epidemics?

Zimbabwe media are reporting that Zimbabwe government officials are blaming British operatives during the liberation struggle--and today--for cholera and anthrax epidemics currently affecting the country:

http://www.newsnet.co.zw/index.php?nID=14583
"Dr Ndlovu quoted a research by Tom Mangold, a researcher in Warfare and Jeff Goldberg, an investigative journalist based in Washington DC, who made the stunning revelations that the British operatives during the liberation struggle planted some anthrax and cholera bacterium to wipe away black Zimbabweans and their herds of cattle.

The minister also said the rains are activating the bacterium and there are some operatives currently in the country who are working on planting the epidemics.

Mangold and Goldberg's 1999 book Plague Wars (you can read the entire book if you click on it) recounted my research on Zimbabwe's anthrax epidemic in chapter 22, and discussed the use of other chem/bio agents during the liberation struggle.

I'd like to make clear that the current cholera outbreak is the result of Zimbabwe's failure to provide safe water to its citizens, and is not a form of biological warfare perpetrated from outside. Adding small amounts of bleach to water would prevent this epidemic--that is, if there were adequate water available. Cholera bacteria spread from infected stools. The bacteria produce a toxin that forces huge amounts of water out of the body in the stool. It is the dehydration which kills. If you could provide sufficient fluid to patients using oral rehydration fluids or intravenous fluids, no one would die.

In the 1990 cholera epidemic in Latin America, the death rate was 1% or less as a result of this treatment, which ought to be cheap and available. (The antibiotics used to kill the bacteria are also inexpensive.)

Zimbabwe's lack of clean water, the lack of toilet facilities, the lack of available health care produced this cholera epidemic, not foreign operatives.

As for the current anthrax outbreak, that is different. It is the result of anthrax spores spread between 1978 and 1980 by unknown operatives working to prevent majority rule. The spores remain in the soil, causing unpredictable outbreaks in grazing animals for decades or longer, in areas where the soil supports regrowth of spores during special weather conditions.

Cholera was used to contaminate some rivers in the 1970s, but did not spread widely in Zimbabwe because clean water and medical facilities were available then, and it was rapidly diluted.

Are We Safer From Bioterrorism?--ProPublica

A 3-part series of articles by Marcus Stern looks into the financial costs, usefulness and risks of the $48 billion dollars spent on bioterrorism responses since 9/11/01. Additional material with videos can be found at the thought-provoking, new web magazine FLYP (Nov. 25-Dec 12 issue, main story--and the visuals are lovely).

Off Topic: Egalitarian Approach to Improving the Health Care System

This is an introductory talk I gave in 1995 about health care reform. It seems equally relevant today. I will post additional thoughts on improving our health care system as the new administration considers ways to cover all Americans, improve quality and cut costs. I think it is doable!

Hint regarding a future post: we do not know much about what it costs to produce nor to purchase health care items. Virtually all reimbursements for healthcare are negotiated. Charges and prices have very little meaning, since the amounts that are paid for identical items or services vary widely between health care insurers, negotiating entities and individual practitioners.

Until we have transparency about what all these numbers really are, we will understand nothing about the cost of healthcare.

Anthrax poses new threat in cholera-hit Zimbabwe: charity (Agence France Presse)

If you drop anthrax spores in areas where livestock graze or wild animals roam, anthrax's bitter harvest may keep returning. Under the proper weather conditions, spores can regrow and multiply locally. Animals grazing close to the ground may ingest anthrax-infected soil. The animals die suddenly. And hungry humans who butcher, consume or even use the animals' hide or hair are likely to develop anthrax as well.

In nature, luckily, the human disease is less deadly than the animal disease. The vast majority of affected humans develop cutaneous (skin) anthrax. It is slower to develop, and responds nicely to inexpensive antibiotics... if you have the means to get it diagnosed and treated promptly. A wider epidemic can be prevented by vaccinating herds once the disease is recognized.

Zimbabwe's health services have taken an enormous hit lately and are in shambles. People are dying again from the anthrax that was used against them and their cattle 30 years ago, during a long and dirty civil war for majority rule. An FBI informant claimed that Steven Hatfill told friends he had been involved in the original Zimbabwe epidemic. This is one reason he was suspected of having a role in the anthrax letters. Very little is publicly known about who spread Zimbabwe's anthrax, and how it was done.

However, Zimbabwe's experience tells us that even without causing the deadlier (inhalation) form of the disease, anthrax is a terrible problem. Forming a spore that may be viable centuries later, anthrax cannot feasibly be removed from the soil once it lands there.

Zimbabwe teaches that even as we make plans (and spend 50 billion dollars) to mitigate the effects of a biological attack, we should hesitate. We should step back a few paces. Mitigation is a hopeful concept. It may sometimes be effective. But Prevention is guaranteed to work. That is where our focus in the biological arena should be.

WP Editorial: The Next Attorney General (and the anthrax letters)

Editorial from the Washington Post:

...The new attorney general also should ensure that an independent commission or the inspector general review the anthrax investigation. In the summer, the FBI identified Fort Detrick scientist Bruce E. Ivins as the lone suspect in the 2001 anthrax attacks that killed five and sickened many more. Mr. Ivins took his own life before he could be put on trial. An independent examination of the anthrax probe should review the methods used by the FBI in investigating Mr. Ivins and, before him, Steven J. Hatfill, who was the FBI's initial suspect before being exonerated this year. The review must also examine how Mr. Ivins maintained a security clearance despite apparently suffering from serious mental illness.

Self (inflicted) defense can up risk / Balt. Examiner

Op-Ed, 11/23/08

Two clear facts shine from the clouded mystery of anthrax attacks on America and our government’s tenuous claim seven years later of closing the case with the suicide of a suspect.

Fact No. 1: Government warnings about anthrax being a weapon of mass destruction were false. Somebody dispersed the most lethal strain our tax dollars can produce — weapons-grade or near enough — via the U.S. Postal Service, exposing tens of millions of people, yet managed to infect 22. Five died. But from anthrax vaccination, at least 21 died and thousands reported a wide range of illnesses.

Fact No. 2: If FBI accusations against their prime suspect in the 2001 attack are true, it means billions of dollars taxpayers invested on the premise of prevention actually increased the risk.

When senior biodefense researcher Bruce Ivins died from an overdose of Tylenol 3 after being identified as sole suspect, our central
government declared the crime solved.

However, co-workers at the U.S. Army Medical Institute of Infectious Diseases at Fort Detrick in Frederick say the actions attributed to Ivins over the time the government claims are scientifically impossible.

This is going to be another never-healing wound in America’s body of unsolved mysteries.

But mystery should not distract us from the truth. Our government’s response to bioweapons is raising the danger level from them.

Think it through, citizens. The very vaccination program intended to thwart anthrax apparently sickened and killed more people than an actual mass attack.

After the 2001 attack, our government hurled $41 billion at bioterror with no real coordination or study. High-level labs multiplied threefold. A dozen agencies exponentially increased the number of facilities and workers handling pathogens. Now we have more than 15,000 potential Bruce Ivins.

Meanwhile, our leaders provided no adequate increase in oversight, coordination, training, security, surveillance, testing, background checks or psychological screening.

Statistically, something going horribly wrong now approaches sure thing. That is not just a threat to residents of Frederick, Bethesda and other communities. It is, as the spread of anthrax spores proved, a threat to the whole world.

We learned in 2001 the actual danger from anthrax was lower than vaccine.

But these biohazard labs grow a lot more dangerous pathogens than anthrax. The next one to get out could kill millions.

President Bush must immediately halt programs until we can impose coordinated oversight, then assess security and capacity needs.

We must not let self-defense become self-inflicted catastrophe.

Link to GAO reports
http://www.gao.gov/products/GAO-08-108T High-Containment Biosafety Laboratories
http://www.gao.gov/products/GAO-07-333R Issues Associated with Expansion

Blinded by the Science: Research Advisory Committee Report Includes Data from 9 Studies of Anthrax Vaccine and Gulf Illnesses

And every one of the nine studies found a relationship between receiving anthrax vaccine and developing symptoms of Gulf War Syndrome. In eight of the nine studies, the relationship was statistically significant. The study with non-significant results was partly retracted by the authors (from the group associated with Simon Wessely, a UK psychiatrist and controversial Gulf War researcher/grantee) after widespread criticism. Please view these data for yourself; they are included as Appendix A-12a in the RAC's report.

It is incomprehensible how the RAC could have reviewed and published these data, then claimed that anthrax vaccine had been "ruled out" as a cause of Gulf War illnesses.

Perhaps someday the concept of Science as an apolitical, scrupulously honest endeavor will return to our culture. But for now, governmental Science is just another buzzword.

Costly program with a shady past // Sickening results

Deborah Rudacille of the Baltimore Examiner has two more excellent articles exploring the underside of anthrax vaccine; its manufacturer Emergent Biosolutions (formerly named Bioport); and how the anthrax attacks provided life support to both the vaccination program, which was about to be cancelled, and to Emergent, which produced only one product: anthrax vaccine.

Exhaustively researched, both articles are must-reads:

Sickening results

Costly program with a shady past

Md. lawmakers consider anthrax investigation commission

By Sara Michael http://www.baltimoreexaminer.com/local/112108emsANTHRAX.html
Baltimore Examiner 11/21/08

U.S. Rep. Elijah Cummings’ Washington, D.C., office was shuttered in 2001 after anthrax spores were found, so he’s “very sensitive” to the investigation into the crime, he said.

Now, Cummings said he supports a review of the investigation. U.S. Rep. Rush Holt, D-N.J., proposed legislation in September to create a congressional commission to investigate the attacks and the federal government’s response.

“Whatever we have to do to get to the bottom of this anthrax issue, we need to do it,” Cummings said.

Holt’s bipartisan commission would mirror the 9/11 commission and make recommendations on how to prevent such attacks and respond to future bioterrorism threats.

Holt also has questioned the response.

The tainted letters were mailed from his district.

“Myriad questions remain about the anthrax attacks and the government’s bungled response to the attacks,” Holt said in a statement.

The FBI named Bruce Ivins, a microbiologist at Fort Detrick in Frederick, the sole perpetrator of the 2001 attacks.

Ivins died of an apparent overdose in July.

But lawmakers and scientists alike have raised doubts about the FBI’s conclusion.

Cummings said he “didn’t know” if he agreed with FBI’s conclusion.

“I wonder about that. That’s all I can say,” he said.

U.S. Sen. Ben Cardin, D-Md., also has raised concerns about the FBI’s handling of the case and questioned FBI Director Robert S. Mueller III at a hearing in September.

Cardin was still reviewing Holt’s legislation this week and could not comment yet on whether he supports it, said spokeswoman Sue Walitsky.

U.S. Rep. Roscoe Bartlett, R-Md., who represents Frederick, also has expressed skepticism, saying recently that the law enforcement activities resulted in Ivins’ suicide and “damaged morale” among Fort Detrick employees.

“Congressman Bartlett has not been persuaded by the FBI’s evidence presented to date,” said spokeswoman Lisa Wright.

Bartlett also has shown interest in Holt’s measure, but wasn’t sure Holt will reintroduce it in the next session, Wright said.

Holt’s spokesman Zach Goldberg said Holt does plan to reintroduce the measure.

GWS Report: Funny How the Vaccine Message Changed

Reading the entire chapter on vaccines, the RAC report does a fairly good job of reviewing the evidence (with a few notable omissions) and its recommendations are sound:

from page 125 of the report:

Recent studies have indicated that the current anthrax vaccine is associated with high rates of acute adverse reactions, particularly in women. No information is available on rates of persistent symptoms or multisymptom illness following receipt of the anthrax vaccine. Studies have not identified excess hospitalizations or outpatient visits for diagnosed diseases in the weeks and months following receipt of the vaccine. Limitations in the types of information provided by these studies, however, indicate a continued need for long term follow up, to determine whether excess rates of diagnosed or undiagnosed conditions occur in anthrax vaccine recipients.

and from page 127:

Recommendations

Diverse concerns have been raised in relation to vaccines received for the Gulf War, but relatively little reliable information has implicated individual vaccines as prominent risk factors for Gulf War illness. Several issues related to vaccines received by Gulf War veterans have not been adequately addressed by existing research. These include the need for more thorough evaluation of vaccines as risk factors for chronic health problems in epidemiologic studies, a definitive study to conclusively evaluate the previously-­observed association between squalene antibodies and Gulf War illness, and the need for longer­ term evaluation of symptoms and diagnosed diseases following receipt of the anthrax vaccine.

The Committee therefore recommends the following research:

• In previously-­conducted and future epidemiologic studies of Gulf War veterans, analyze associations between Gulf War illness and individual vaccines, combinations of vaccines, and total number of vaccines received using methods that control for potential confounding by other Gulf War­-related exposures.
• Commission a case­-control study to provide clear answers concerning possible associations between Gulf War illness and squalene antibodies. The study should, at minimum, analyze blinded samples from well­ characterized symptomatic and healthy Gulf War veterans for the presence of squalene antibodies using each of the assays developed for this purpose. It should also assess whether there is an identifiable link between levels of squalene antibodies in ill Gulf War veterans and receipt of the anthrax vaccine or vaccines more generally. The project should be organized and overseen by qualified investigators not affiliated with the federal government or civilian scientists whose initial work raised the squalene issue in relation to Gulf War illness.
• Evaluate the association of anthrax vaccine adsorbed (AVA) with chronic symptoms, Gulf War illness, and diagnosed diseases in personnel known to have received the anthrax vaccine during the Gulf War. These health outcomes should also be assessed at least five years after vaccination in deployment and era subgroups of personnel in the Millenium Cohort study as well as other groups vaccinated in association with the military’s anthrax vaccine immunization program and federal anthrax vaccine trials.

* But what message did the media get when it interviewed RAC members?

LA Times: " the panel... could find no evidence linking it [GWS] to depleted uranium shells, anthrax vaccine and infectious diseases."

US News and World Report: "There are other factors that, while not likely causes of Gulf War illness, can't be ruled out, Steele said. These include exposure to nerve agents, exposure to smoke from oil well fires, and vaccines given to the troops. The panel ruled out depleted uranium and anthrax vaccine as causes.

The Newshour with Jim Lehrer: "James Binns: Many other exposures that were also happening in the gulf at that time, depleted uranium munitions, anthrax vaccines, special paints and solvents that were used, we do say that the evidence does not show that they were significantly connected."

Either the evidence is adequate and reliable, in which case you can "rule out" that exposure as a cause, or you need more evidence and can say very little about whether that exposure may have caused GWS, and in how many veterans. In the case of anthrax vaccine the RAC's chairman and former scientific director are trying to have it both ways. In so doing, they are mirroring behavior of earlier GW scientists and administrators criticized in their report. The committee's work is critically important to help Gulf War veterans, yet flaws of this kind diminish the report's (and committee's) reliability and value to veterans. This is a pity.

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 yet produced on Gulf War illnesses. 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 about most things.

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 RAC 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 DoD, most of the self-reports are wrong. But other studies indicate that self-reports in GW veterans are highly reliable. Four studies (from 4 different research groups, and 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 relatively more veterans in support locations had 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 they collected. The Defense Medical Surveillance System, according to the Institute of Medicine (IOM) the most important database for studying anthrax vaccine safety, has been kept under wraps since 2001, when it had to be shared with the IOM. 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%. (According to the Veterans Health Administration Office of Public Health and Environmental Hazards, August 2008, of those 347,750 veterans of the Global War on Terror who have sought care in the VA system, 39.7% have demonstrated "Symptoms, signs and ill defined conditions" while 42.5% have mental disorders, 34.9% have diseases of the nervous system/sense organs, 31.8% have digestive disorders and 47.6% have diseases of musculoskeletal system/connective system. This is certainly a red flag that GWS could be affecting a large number of recent veterans, yet the RAC is unaware that many new veterans may suffer similar illnesses as those of the first Gulf War. "Newly released documents reveal that more than 150,000 soldiers who left the military after serving in Iraq and Afghanistan have been at least partly disabled as a result of service–this translates to one in four veterans."

These veterans have been exposed to vaccines and depleted uranium, but much less routinely to pyridostigmine, and not to sarin. If new veterans are, in fact, developing GWS-like illnesses, it would cast doubt on the RAC's conclusions.)

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

"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.

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? ..."

Deborah Rudacille of the Baltimore Examiner provides another in-depth look at the evidence in this case, exploring the time it would take to make the anthrax preparations. She also mentions the presumed contamination by Bacillus subtilis found in some of the letters, whose origin was not investigated by FBI, despite being an important clue. Read the complete article here.

US military chem-bio warfare exposures website unveiled

Justin Palk, Frederick News-Post

http://www.fredericknewspost.com/sections/archives/fnp_display.htm?storyID=88347 From World War II through 1975, thousands of service members and veterans were potentially exposed to chemical or biological weapons as subjects or observers of tests carried out by the Department of Defense. The department unveiled a new website Monday to provide information about what happened during those tests. The data on the site is broadly grouped into three sections: chemical agent tests during World War II; chemical and biological agent tests of Project 112 and its naval component, Shipboard Hazard and Defense or Project SHAD; and Cold War-era chemical and biological weapons testing. The site provides details about specific incidents, such as the release of mustard agent in the Italian port of Bari in 1943 when a U.S. ship carrying the agent to use in response to theoretical German gas attacks was destroyed during a German air raid on the port. Overview sections give broad outlines of what types of testing were performed at what points in history. The biological warfare research at Fort Detrick and the Operation Whitecoat disease immunity experiments are listed under the Cold War section of the site, as are Dugway Proving Ground and Edgewood Arsenal, both sites where chemical weapons research was done. The site does not list the names of service members who might have been exposed to chemical or biological agents. It does, however, include contact information veterans can use to seek help in verifying any potential exposure they may have had, or to provide information they may have about tests the Defense Department conducted. For information, visit fhp.osd.mil/CBexposures/index.jsp

My letter explaining the October PREPA Declaration, new anthrax vaccine purchases, the CDC vote on civilian vaccinations and their impact

October 2008

Dear Representative --------,

I am writing with concerns about a liability shield just issued for anthrax vaccine, a huge new waste of government funds in anthrax vaccine purchases by DHHS, and expansion of anthrax vaccinations to civilian first responders, which is poised to begin after a CDC Advisory Committee on Immunization Practices (ACIP) vote October 22, 2008.

A controversial bill, the Public Readiness and Emergency Preparedness Act (PREPA, Division C of P.L. 109-148) passed in December 2005. A CRS report on this bill reveals that the bill provides almost complete immunity from liability for manufacturers of “covered countermeasures,” preempts state and local laws, and extends blanket immunity to “government program planners.”

On October 1, 2008 DHHS Secretary Leavitt, in consultation with DHS Secretary Chertoff, issued a Declaration of an anthrax emergency, invoking the provisions of PREPA for anthrax countermeasures through 2015 (http://www.kansascity.com/105/story/846427.html) . On October 10, additional Declarations were issued for smallpox, botulinum toxin and radiation sickness emergencies. Secretary Chertoff acknowledged to Secretary Leavitt in a September 23, 2008 memorandum there was no evidence of an anthrax emergency, but that the non-negligible risk of a future anthrax epidemic was sufficient to declare an emergency and trigger PREPA’s liability protections.

On October 1, DHHS contracted to buy an additional 14.5 million doses of anthrax vaccine at a cost of $364-404 million dollars, although DHHS already has about 25 million doses stored or on order, which cost taxpayers $500 million. Yet a 2007 GAO Report discussing anthrax vaccine noted that, "Officials from the [DOD Vaccine Healthcare Centers] VHC Network and CDC estimate that between 1 and 2 percent of immunized individuals may experience severe adverse events, which could result in disability or death." GAO also noted in October 2007 that $10 million worth of anthrax vaccine was expiring monthly in DHHS’ stockpile.

The CDC recently asked its Advisory Committee on Immunization Practices to change its 2000 and 2002 recommendations, which it did, making anthrax vaccine available to civilian first responders, a group of 3 million people. The vote took place on October 22-23, and coincided with the loss of legal protections for recipients.

Although this is an extraordinarily difficult and busy period for legislators, I hope you will agree that invoking nonexistent emergencies drastically reduces the constitutionally guaranteed right of redress for recipients of “covered countermeasures” such as anthrax vaccine, while at the same time, the recipient pool is about to expand to civilians.

Would you please help overturn this egregious assault on our civil rights? PREPA should be revoked. Emergency declarations should be limited to true emergencies. Liability shields encourage the production and use of untested or sloppily manufactured drugs, and should be used only with great care.

CDC has failed to share detailed safety data from its own 2002-2006 clinical trial of anthrax vaccine recipients with the public; yet there were 229 severe adverse events and 7 deaths during the trial. CDC should follow the precautionary principle with respect to this controversial vaccine, which has demonstrated neither safety nor efficacy in humans. In particular, CDC should not encourage new, expanded use of vaccine in the wake of reduced legal protections for recipients. A myriad of poor outcomes may result from providing anthrax vaccine to up to 3 million first responders.

I would be happy to provide additional information to your staff, and was very glad to have met with you and several of your staff to discuss anthrax vaccine over the past several years.

Sincerely yours,

Meryl Nass, MD

Bioterrorism’s Deadly Math

From Judith Miller, let go from the NY Times for her poorly sourced, Iraq war drumbeat articles, who is now at Manhattan Institute for Policy Research, writing in their City Journal (reprinted by FrontPageMag.com): a long and valuable piece on the biodefense enterprise that has developed since 9/11. It includes the following:

Moreover, while there is no doubt that Ivins had psychological problems that ultimately prompted his suicide, his attorney and family say that being subjected to such intense federal scrutiny was also partly to blame. And those who worked most closely with the eccentric scientist at Fort Detrick have openly challenged the bureau’s claim that Ivins was the perpetrator. Critics have called for more congressional hearings and even an independent commission to examine the entire Amerithrax investigation. In any event, the controversy over the case highlights the continuing difficulty of “attribution”—identifying the source of an attack so that its sponsors can be punished and future strikes deterred—even in an age of sophisticated bioforensics.

NY Post: Scientists Slam FBI 'Thrax Probe In Bid To Clear Buddy 'Dr. Doom'

Susannah Cahalan's NY Post story provides a needed counterpoint to last week's Washington Post puff piece on the Bruce Ivins case. Who would have expected to find higher journalistic standards at the NY Post than at its Washington namesake?

New information in this story includes the fact that the FBI was renting the house next door to Ivins, the better to perform surveillance (and this establishes FBI harrassment, since surveillance is properly performed in secrecy mode).

"One of Ivins' former colleagues was being aggressively pressured to confess to the crimes just two months before Ivins killed himself on July 29, 2008, he told the Post. And he identified at least one other employee who was under the same pressure."

At risk of sounding like a conspiracy theorist, the available facts in this case point to only one conclusion: the Justice Department was desperate to "solve" (read bury) this case any way it could before the Bush administration left office. To accomplish this feat, the FBI illegally harrassed at least 3 Fort Detrick employees. Recall that Perry Mikesell, a former Fort Detrick scientist under FBI surveillance, began drinking heavily and died in 2002.

For Bruce Ivins, a scientist known to have emotional problems, being prevented near the end from doing his research and from socializing or speaking freely with his colleagues, and having spent a small fortune on attorney fees, suicide may have been a predictable result.

[On the other hand, worrisome questions about his death remain. These include the inexplicable failure to perform an autopsy, the alleged choice of poison--tylenol--by a scientist who had access to easier methods of suicide, and the failure by FBI agents (performing 24/7 surveillance in the next house) to identify Ivins' overdose in time to save him (a 16-24 hour window during which an antidote can prevent liver failure) make it hard to dismiss the possibility of negligent homicide or even murder.]

If DoJ actions helped push Ivins over the edge, was this because DoJ was required to provide cover for the letter attacks' real perpetrator? The extreme tactics used in this case suggest that government officials have something major to hide. They do not want this case to remain open, subject to investigation by a Democratic administration that might actually want to know the truth about who sent the anthrax letters, why influential Democratic Senators were targeted, and what the ultimate intent of the letters really was.

Trail of Odd Anthrax Cells Led FBI to Army Scientist: Washington Post

Today's front page Washington Post article by Joby Warrick on the Ivins case appears to present the FBI's side of the story. I will post excerpts from the article and comment (in italics) on its inconsistencies.

Abshire focused her lens on a moldlike clump. Anthrax bacteria were growing here, but some of the cells were odd: strange shapes, strange textures, strange colors. These were mutants, or "morphs," genetic deviants scattered among the ordinary anthrax cells like chocolate chips in a cookie batter...

Ivins, the FBI discovered, had spent more than a year perfecting what agents called his "ultimate creation" -- his signature blend of highly lethal anthrax spores -- and guarded it so carefully that his lab assistants did not know where he kept it...

"It was his ultimate creation," said Jason D. Bannan, an FBI microbiologist assigned to the Amerithrax case. "This was the culmination of a lot of hard work."

Exceptionally pure concentrations of anthrax spores were Ivins's trademark and placed him in an exclusive class...

It was intended for garden-variety animal experiments, but the collection of anthrax spores known as RMR-1029 was anything but ordinary. Ivins, its creator, had devoted a year to perfecting it, mixing 34 different batches of bacteria-laden broth and distilling them into a single liter of pure lethality...

Ames-strain bacteria was essentially identical wherever it was found, the advisers said...

The art of "spore preparation" is a tedious job often relegated to novices and technicians.

Inconsistency: Ivins made exceptionally pure spore preparations, but his "master" prep was full of mutants.

Exaggerations: FBI agents call his flask of Ames anthrax his "ultimate creation," but all it contained was the combined product of 34 separate small production runs at Fort Detrick and Dugway, only some of which Ivins had made. FBI advisers said that Ames was pretty much the same wherever it was found. So the claim of Ivins' flask having special virulence, compared to other Ames batches, is doubtful.

Ivins spent a year perfecting it? How do you "perfect" 34 separate batches when you didn't make all of them? There has been no prior evidence that the flask contained "special" Ames spores, nor does this article report any such evidence.

Furthermore, as is noted in the article, growing anthrax is usually the work of technicians, and does not require advanced skills. Growing spores is not a method of perfecting them. The recipes are widely available in the open literature. Ivins could have spent a year growing the anthrax in the flask, but he would have been accomplishing plenty of other tasks simultaneously.

Unknowingly, Abshire had discovered a key to solving the anthrax case. But it would take nearly six years to develop the technology to allow FBI investigators to use it...

Some of the technology needed to solve the case had not been invented. And the FBI's top science advisers were warning that the effort would fail...

...the bureau had to invent an entirely new investigative field, microbial forensics...

When the FBI later asked Ivins for anthrax spores from his lab, he deliberately bypassed his prize spore collection, agents said, and gave them a false sample...

Inconsistencies: Ivins gave the FBI a sample from the RMR-1029 flask initially, one tube of which was sent to Paul Keim. When FBI complained about the way the sample was prepared, he gave them a pure specimen, rather than the mixture he initially provided, which contained the 4 mutations FBI later focused on. But why would Ivins have done this to fool the FBI, when he gave them RMR-1029 first, and provided both samples before the methodology to track the mutations had even been invented?

And the WP article acknowledges this:

But Ivins could not have known that RMR-1029 contained genetic mutants, in relatively high numbers. A batch of spores like RMR-1029 might be expected to contain, at most, one mutated variant. But Ivins's flask, because of its unusual pedigree, contained five.

Furthermore, FBI obtained voluntary specimens from most scientists; would a guilty party volunteer the specimen used to prepare the letter spores, as Ivins did initially?

For one thing, no one besides Ivins seems to have known where they were kept. The plain, triangle-shaped storage flask was one of many kept in plastic tubs inside a refrigerated storage room in Ivins's restricted lab. It had only a handwritten label -- RMR-1029, shorthand for "reference material received, No. 1029." When spores were needed for experiments, Ivins alone would retrieve them. "His own people who worked with him on a daily basis didn't know which flask it was," Langham said.

Exaggeration: He kept the vial, properly labeled, in the refrigerated storage room where it belonged. Maybe he didn't share its exact location with others because it contained a huge number of highly lethal spores, equal to millions of lethal doses? Isn't that exactly what he should have been doing from a biosafety perspective?

The list of suspects narrowed, officials said, until only one was left: Ivins. Ivins alone created and controlled the distinctive collection of anthrax cells that provided the seeds for the attacks. And he was the undisputed master at manipulating the bacteria into dense concentrations of deadly spores. While graduate school microbiologists could have performed most of the tasks, Ivins had the experience and the "good set of hands" required to achieve a spore preparation of such quality, a government scientist said.

Exaggeration: you need a master to concentrate spores. No: you need a centrifuge, or a filter, and a college student can do it. Good hands not required.

Exaggeration: "Ivins alone controlled the distinctive concentration of anthrax cells..." But everyone he gave a sample to from that flask also controlled the same distinctive concentration of anthrax cells. That is why FBI received multiple matching samples from other scientists.

"When you go to the true experts and ask them how many people can develop [anthrax spores] into something with this purity and this concentration, they shake their heads," said Montooth, the lead Amerithrax investigator. "Some will say there are perhaps six. Others will say maybe a dozen."

Misleading: the spore purity was a result of the spores having been washed thoroughly after they were grown. When experts say only 6-12 people could have produced similar spore preparations, they are referring to the special features of the dry, weaponized spores, not to the fact the spore preparation was concentrated or lacking in debris. It remains uncertain whether Ivins could have produced such dry spores, and it is doubtful that the spores in the flask, in liquid medium, had the same concentration as the dry letter spores.

But drying the spores turned out to be no obstacle at all, FBI scientists said. It required only one more step, using a common laboratory machine known as a lyophilizer. Ivins had one in his lab.

"Because he grew spores on a daily basis, he was in a position to make [the powder], and no one would be the wiser," Montooth said.

Misleading: The lyophilizer reportedly available to Ivins would have required many runs to dry the volume of spores used in the letters, thus taking a longer time than was available between 9/11 and the letter attacks. It would also be more visible to colleagues, some of whom have said he could not have done it without being detected.

ACIP opens door to anthrax shots for first responders

Robert Roos News Editor

Oct 23, 2008 (CIDRAP News) – The federal Advisory Committee on Immunization Practices (ACIP) has opened the door to voluntary anthrax vaccination for first responders, revising an 8-year-old recommendation against that step.

The committee, meeting yesterday, said the risk of anthrax exposure for emergency responders is low but "may not be zero," and therefore first-responder agencies may want to offer the vaccine on a voluntary basis, according to information supplied by the Centers for Disease Control and Prevention (CDC) today.

The CDC routinely adopts the ACIP's recommendations.

Anthrax vaccination—which currently involves six doses over 18 months, followed by annual boosters—is required for US military personnel serving in the Middle East and other high-risk areas. Nearly 2 million service members have been vaccinated under the program, according to ACIP reports.

However, a number of military members have complained of negative side effects from the shot, and a lawsuit by several of them interrupted mandatory vaccinations for about 2 years starting in October 2004. Another lawsuit against the program is still in the courts.

Allowing the option
The new recommendation adopted by the ACIP does not actively encourage anthrax shots for first responders. It states:

"Emergency and other responders, including police departments, fire departments, hazardous material units, government responders, the National Guard and others, are not recommended for routine pre-event anthrax vaccination. However, the committee recognized that while the risk of exposure for first responders to anthrax is low it may not be zero. Therefore, first responder units may choose to offer their workers pre-event vaccination on a voluntary basis. The vaccination program should be carried out under the direction of a comprehensive occupational health and safety program."

In 2000 the ACIP recommended against "pre-event" anthrax shots for first responders, and that stance was reaffirmed when the committee revisited the issue after the anthrax attacks of late 2001, according to an online summary of the June 2008 ACIP meeting. The reasons for reconsidering that recommendation included a growing supply of the vaccine and new data suggesting a change in the vaccine's safety profile, plus interest from some first-responder groups, according to comments made at that meeting.

Interest from emergency responders
A change in the recommendation for first responders was proposed at the June meeting by an ACIP subcommittee called the Anthrax Vaccine Workgroup. The panel's work was described by Jennifer G. Wright, DVM, MPH.

"Post-event vaccination in combination with antibiotics is an effective intervention following exposure to B[acillus] anthracis spores, but the workgroup felt that pre-event vaccination could offer additional protection beyond that afforded by antibiotics and post[exposure] vaccination by providing early priming of the immune system," the meeting summary states. "Some respondent 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."

Dr. Richard Besser, director of the CDC's Coordinating Office for Terrorism Preparedness and Emergency Response, commented at the June meeting that a number of emergency response agencies had indicated interest in preemptive anthrax immunization for their workers, but the existing negative recommendation was seen as an impediment.

Also at that meeting, the CDC's Nancy Messonier said that the workgroup's intent in proposing a change was "to open the door, knowing that the vaccine is commercially available and that first responder groups are at liberty to call the manufacture to obtain the vaccine themselves," the meeting summary states.

The FDA-licensed vaccine, called anthrax vaccine adsorbed (AVA) (Biothrax), is made by Emergent BioSolutions Inc. Current annual production capacity is 8 million to 9 million doses, up from about 2 million in 2002, the June meeting report says. A new manufacturing facility that is being tested will eventually boost production to as many as 30 million to 35 million doses, it says.

"The workgroup felt that at the current time, vaccine supply was sufficient to support vaccination for a large group of individuals," the report states. It says the nation may have as many as 3 million first responders, depending on how the term is defined.

The work group concluded that the risk of anthrax exposure for first responders through a bioterrorism event is "undefinable," the summary states. However, the group concluded that the available data suggest that the vaccine is safe and effective.

Fewer adverse events
Through June 2008, 4,705 reports of adverse events associated with anthrax vaccination of military personnel were filed with the government's Vaccine Adverse Event Reporting System, the report says. That represents a rate of 61.1 reports per 100,000 doses, as compared with 117 reports per 100,000 doses of smallpox vaccine. About 10% of the reports described "serious" adverse events.

The report also said that in February the ACIP looked at data showing a decrease in local adverse events when the vaccine was given intramuscularly rather than by the standard subcutaneous route. That was an apparent reference to interim findings in a CDC study, which were reported in the Oct 1 Journal of the American Medical Association (JAMA; see link to news story below).

The JAMA report said people who were vaccinated intramuscularly had fewer injection-site reactions after four doses than those who received subcutaneous shots. It also said those who received three intramuscular shots in the first 6 months had about the same immune response as those who received the standard four subcutaneous shots, suggesting that dose reduction may be possible.

Discussion at the June ACIP meeting pointed out the challenges that would be posed by any effort to vaccinate large numbers of first responders, given the number and timing of doses involved. These include determining who would administer the vaccine, tracking recipients to keep them on schedule, providing liability coverage, monitoring adverse events, and caring for those who experience adverse events.

Postexposure protection
At yesterday's meeting, the CDC reported, the ACIP also made a recommendation on postexposure protection against anthrax: 60 days of antimicrobial treatment in combination with three doses of vaccine. Vaccine should be offered within 10 days of exposure.

"Anthrax vaccine is not licensed for children and has not been studied in children," the CDC update said. "However, postexposure anthrax vaccination in children potentially exposed to anthrax may be considered on an event-by-event basis in conjunction with 60 days of antibiotics."

The recommendation on postexposure prophylaxis includes pregnant women. "Pregnancy is neither a precaution nor a contraindication. Pregnant women should receive vaccine and antibiotics if they are exposed to inhalation anthrax," the CDC said.

See also:

Minutes of June 2008 ACIP meeting, including discussion of anthrax vaccine
http://www.cdc.gov/vaccines/recs/acip/downloads/min-jun08.pdf

Oct 6 CIDRAP News story "Trial offers hope for shortening anthrax-shot series"

Oct 2 CIDRAP News story "To blunt anthrax attack, mail carriers to get antibiotics"

CDC: 1-2% of anthrax vaccinees may die or become disabled...but consider expanding vaccinations

CDC published a report October 1 on its very expensive, 43 month-long trial of anthrax vaccine, but inexplicably discussed only the first 7 months and only 65% of the subjects. No explanation was given for why only partial data were provided in this important paper.

Bloomberg may provide the reason; the selected data discussed in the paper do not explore the 229 serious adverse events that occurred. But the selected data will be used to support new recommendations for expanding vaccinations to civilians that CDC's Advisory Committee will consider on October 22, 2008:

"After seven months, all the groups showed a comparable immune response, leading the researchers to say the three doses of the vaccine are "non-inferior.'' The CDC's Advisory Committee on Immunization Practice may make new recommendations on use of BioThrax that take the study's findings into account, said Curtis Allen, a CDC spokesman."

Yet other CDC officials told GAO in 2007 that 1-2% of vaccinees might have severe adverse events leading to disability or death.

Congressman Holt Asks National Academy of Science to investigate holes in FBI's anthrax letters case

Representative Rush Holt, Chairman of the House Select Intelligence Oversight Panel of the House Committee on Appropriations, and a Representative whose constituents were directly affected by the anthrax attacks, has requested that the National Academy of Science also answer the following questions, should it elect to undertake an independent review of the FBI's scientific methods and conclusions in the Amerithrax case. His October 16, 2008 letter raises a number of important points, including the following:

"Are any of the FBI’s scientific findings inconsistent with the FBI’s conclusions?

Are there any scientific tests that the FBI has not done that might refute their conclusions?

Did the FBI follow all accepted evidence-gathering, chain of possession, and scientific analytical methods? Is it possible that any failure to do so could have affected the FBI’s conclusions?

Is it scientifically possible to exclude multiple actors or accessories?"

Congressional Research Service Legal Report on PREPA

The Public Readiness and Emergency Preparedness Act, also known as Division C of P.L. 109-148 (2005) limits liability with respect to pandemic flu and other public health countermeasures. A Congressional Research Service Report for Congress by Henry Cohen, Legislative Attorney notes the following:

1. The ONLY circumstance in which a shielded person could be held liable for a death or serious injury requires that the action was done "intentionally to achieve wrongful purpose" and "knowingly" --disregarding a high probability of harm.
2. However, the HHS Secretary "shall promulgate regulations...that further restrict the scope of actions or omissions by a covered person that may qualify as 'willful misconduct.'" In other words, HHS is directed to raise the bar even higher on lawsuits than the bill has already done.
3. And no matter how bad the misconduct, federal employees have a special protection: under no circumstances will you be able to bring action "against a federal employee."

There is more: mandatory sanctions for lawyers who bring frivolous claims, for instance. It's antidemocratic provisions are astonishing.

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...

Emergency declarations smooth way for vaccine makers

Fri, Oct. 17, 2008

By ALAN BAVLEY
The Kansas City Star

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 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.”

While terrorists would like to have biological weapons, they don’t have the sophisticated technology yet to make them, said R. Gregory Evans, director of the Institute for Biosecurity at St. Louis University... But someday, terrorists may develop such weapons, Evans said, which makes countermeasures like vaccines and drugs “absolutely necessary.”

“It probably does need some liability protection to get companies to develop vaccines that may never be used,” he said. “The profit margins associated with things like this are very little.” (See post above--Nass)

Health and Human Services is not invoking the law in response to any immediate threat, said William Raub, science adviser to Leavitt.

“We don’t believe there’s anything imminent,” he said. “We’ve tried to be careful to not instill fear in people, (but) if we wait until the day of an event, valuable time is lost … and people could die...”

http://www.kansascity.com/105/story/846427.html

U.S. Limits Anthrax Vaccine Liability--Global Security Newswire

Elaine Grossman
Global Security Newswire Oct. 17, 2008
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 <http://www.nti.org/d_newswire/issues/2005/11/21/e6ab1e9c-4ae3-42ff-b9fa-87b14ca99111.html > , Nov. 21, 2005).

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 <http://www.nti.org/d_newswire/issues/2005/12/16/da976f97-51ae-4b2c-a63f-b6a5fd592234.html > , Dec. 16, 2005).

Leavitt's declaration <http://edocket.access.gpo.gov/2008/E8-23547.htm > was published in the Federal Register and quietly heralded at the end of a two-page news release <http://www.hhs.gov/news/press/2008pres/10/20081001a.html > devoted largely to another anthrax-related initiative (see GSN <http://www.nti.org/d_newswire/issues/2008/10/2/bf39cf1b-7298-474d-86f1-11d56160bd70.html > , Oct. 2).

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 <http://www.emergentbiosolutions.com/NewsReleases.aspx?ReleaseID=1204156 > that Health and Human Services had ordered 14.5 million doses of its BioThrax vaccine, worth as much as $404 million. The company is already under a $448 million contract to produce 18.8 million doses of the vaccine. The vaccine regimen calls for six shots over an 18 month period, plus annual boosters.

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.

(But see previous post for admission by Homeland Security Department's Secretary Chertoff that there is absolutely no evidence of any emergency--Nass)

Chertoff tells Leavitt: No Emergency, No Problem

In a particularly Kafka-esque memorandum, Department of Homeland Security Secretary Chertoff wrote to Department of Health and Human Services Secretary Mike Leavitt on September 23, 2008 and said bluntly that he had no evidence for an anthrax emergency... however, there exists a non-negligible risk there may someday be one, so feel free to invoke the provisions of the PREPA Act.

Read it and weep.

DHHS Likely Repeating its Mistakes with Anthrax Contracts

October 23, 2007:

GAO says HHS has announced that it will issue another rPA anthrax vaccine proposal but has not formally reviewed what went wrong with the VaxGen contract. "They may repeat their mistakes in the absence of a corrective plan," the report says.

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 <http://www.nti.org/d_newswire/issues/2008/10/1/5c85159e-7129-4ca0-b957-2fcc95aa144a.html > , 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 <http://www.nti.org/d_newswire/issues/2007/9/5/c0469347-f23c-4248-a063-c5a57ceafd57.html > , 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 <http://www.nti.org/d_newswire/issues/2008/10/1/0ede5e29-59ab-4680-a2db-b1191e85f631.html > , 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 <http://www.nti.org/d_newswire/issues/2004/10/28/54b0cd56-007b-42fc-b035-d2dcb3329d6e.html > , 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 <http://www.nti.org/d_newswire/issues/2008/3/3/7228bc90-da71-477a-9828-92bfbe0725ed.html > , 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.

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

Excerpts from Wired Blog:

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.

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, 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.

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. DHHS 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.