H1N1 update: Australia/Hong Kong/US

While CDC has not committed to a strategy beyond Tamiflu (to which some viral strains in Hong Kong have resistance), Australia faces a major H1N1 outbreak, as the southern hemisphere winter just began. But mathematical modelling suggests the US has already experienced 1 million H1N1 cases.

On May 17, Australia moved to a new national health alert level, called “protect,” to focus on the early treatment of those vulnerable to [severe illness from] the flu, including pregnant women, people with respiratory disease, heart disease, diabetes and obesity. And on July 2, Australia's Health Minister, Nicola Roxon, reassured parents that swine flu does not pose a greater danger to children than seasonal flu.

Separately, Sydney immunisation specialist Robert Booy said swine flu was likely to kill twice as many children over the next 12 months as regular influenza. The professor estimated 10-12 children could die from the virus, compared with five or six from normal flu strains in a typical year.

In the US, normally under 100 children die each year as a result of seasonal influenza infections. To prevent an estimated 100 excess deaths (this is a very rough estimate), up to 50 million children might receive a vaccine containing novel adjuvants, for which testing was limited.

H1N1 vaccines with novel adjuvants being developed for potential mass use

The US government has contracted with at least 5 pharmaceutical manufacturers to develop and produce H1N1 vaccines, using a variety of platforms and manufacturing methods. This is an excellent approach, since at this point no one knows which will succeed and how long it will take to obtain desired quantities of vaccine.

A novel feature of the two H1N1 vaccines being developed by companies Novartis and Glaxo-Smith Kline is the addition of squalene-containing adjuvants to boost immunogenicity and dramatically reduce the amount of viral antigen needed. This translates to much faster production of desired vaccine quantities.

Each company has its own proprietary adjuvant, acquired in each case at high cost and intended for the high-stakes business of rapidly producing vaccines for novel pandemics or biological warfare threats.

Novartis' adjuvant is named MF-59, and Glaxo's is ASO3. We know they work beautifully to strengthen vaccine efficacy. But how safe are they?

That is a very difficult question to answer. Novartis claims MF-59 has been used safely by over 40 million people. However, FDA has not seen fit to approve even a single US vaccine that contains these novel adjuvants.

One European vaccine contains MF-59, and two European vaccines contain ASO4, which is a Glaxo adjuvant related to ASO3. Fluad (with MF-59) is only licensed for use in the over-65 population. This age group responds weakly to standard flu vaccines, and whether standard flu vaccines actually reduce flu cases in this age group is controversial. So a stronger vaccine may be indicated for this group. And as we age, we are much less likely to develop autoimmune disorders, so potential autoimmune side effects should also be less in this age group.

However, in the 13 years since Fluad was approved in Europe for older adults, I am not aware of a single other vaccine containing MF-59 that has been licensed... even though MF-59 has been used in a large number of vaccine trials. Virtually all the scientific literature on this adjuvant has been produced by scientists working for the manufacturer, precluding an unbiased assessment of safety at this time.

Glaxo's ASO4 is used in Fendrix (a Hepatitis B vaccine). Fendrix may only be used for people with kidney disease. Patients on kidney dialysis have a high rate of Hepatitis B infection, and a weak immune system. So they are good candidates for an especially potent vaccine against a disease to which they are highly susceptible, and these recipients are unlikely to develop autoimmune complications.

Cervarix is a vaccine directed against several strains of human papilloma virus (HPV), licensed in both Europe and Australia, which contains ASO4. It is difficult to assess Cervarix' safety at this point in time, as data are limited. It is worth noting that FDA has delayed giving Cervarix a US license at least twice, so far.

The June 19, 2009 Science magazine discusses use of these "next-generation," antigen-sparing adjuvants for an H1N1 pandemic. It quotes Norman Baylor, director of FDA's Office of Vaccine Research and Review, who noted that antigen-sparing strategies benefit populations, not individuals. "You have to think about those trade-offs," Baylor said.

National Academy of Science forms committee to review the science of FBI's anthrax investigation

The National Academies today announced its committee membership to review the FBI's scientific analysis of anthrax. In an unusual move, the NAS has issued a 20 day comment period in which the public may dispute proposed committee members on the basis of bias.

Why was the NAS committee formed? The first mention of such a committee was made by FBI Director Mueller at a House Judiciary Oversight Committee hearing last September. I attended the hearing. Mueller only brought up the subject of a National Academy of Science investigation to sidetrack his Congressional questioners. Here is what I wrote at the time:

... responding to Rep. Nadler's question of whether the FBI would cooperate with an independent investigation, Mueller attempted to confuse the issue of an independent investigation, saying FBI was requesting this from the National Academy of Sciences (NAS). However, the NAS will only be asked to review FBI's "microbial forensic" science. (FBI's M.O. is to keep trotting out the genomics, no matter what question is asked.) And NAS didn't even know they were going to get this gig until today's hearing, suggesting NAS' study might just be a bone thrown to the committee to head off a truly independent investigation of the letters case.

The NAS will determine whether FBI's genomics work used acceptable science. I certainly hope it did, given the national security implications if it didn't, let alone the time and expense to complete the FBI-sponsored research program.

However, the very best the committee and FBI can do with all the scientific data is to determine whether the progenitor anthrax used in some of the anthrax letters came from a flask used by deceased scientist Bruce Ivins. Yet over 100 other people also had access to this flask, and might have been involved.

Therefore, what this committee finds will be entirely tangential to who sent the anthrax letters. To solve that problem requires old-fashioned police work, which includes developing a logical theory of the crime. Means, motive, opportunity and evidence will then assume their rightful places in this case.

Better Info on H1N1: Cidrap at U. Minnesota

Here is a compendium of very useful info on H1N1, both for clinicians and the public. It appears to be regularly updated. Cidrap has gathered its information from WHO, CDC and other sources.

Wake up, CDC! Your pandemic is here!

We are 2 months into the outbreak with H1N1 (swine) influenza, a variant not previously identified in humans. However, data suggest it was circulating unnoticed in pigs for years. It has two characteristics of concern: it spreads from person to person a bit more readily than older flu strains, and it seems to keep on spreading through the warmer months. This is likely due to the large number of susceptible people in the population, since it seems that younger people have little "crossover" immunity from exposure to previous flu strains, while the oldies appear to have partial immunity, based on the pattern of spread. These features might be seen with any strain arising de novo (not derived from recently circulating human strains).

Recent research suggests that, in terms of a repeat of the 1918 flu, we have less to be worried about than has been thought. These studies note that an estimated 95% of deaths from the 1918 pandemic occurred as a result of complicating, secondary illnesses that developed in people weakened by the flu, rather than by the flu itself. Furthermore, this analysis suggests that by preventing and/or treating such secondary illnesses, many lives could be saved.

Brundage et al.'s abstract notes that this "hypothesis suggests opportunities for prevention and treatment during the next pandemic (e.g., with bacterial vaccines and antimicrobial drugs [antibiotics]), particularly if a pandemic strain-specific vaccine is unavailable or inaccessible to isolated, crowded, or medically underserved populations."

CDC posts an H1N1 Flu Situation Update at least weekly. As of June 19, there were 21,449 "confirmed or probable" cases in the US and 87 deaths, or 1 death per 250 cases. It is great that CDC is keeping such close track of things. But what are they doing with this information, in terms of analyzing how many people died from secondary infections, what complications might lead to death, and which patients are most at risk and need special care. Most importantly, what do the data tell me can be done to prevent my patients from dying?

Unfortunately, the expert advice needed is MIA. CDC's "Interim Guidance for Clinicians on Identifying and Caring for Patients" with H1N1 flu was written on May 4, when there were just a few cases in the US. CDC has yet to update it with information from the 20,000 cases diagnosed since then. Instead, the (old) website says, "There is insufficient information to date about clinical complications of this novel influenza A (H1N1)..."

The only treatments and preventives recommended are Tamiflu and Relenza, even though CDC still fails to provide any information on how well or poorly they affect the clinical course of the illness. Meantime, CDC suggests that longstanding guidelines for the treatment of community acquired pneumonias could be followed for secondary infections. The link they provide did not work for me. And anyway, I know the guidelines. What I need to know is whether this advice is the best possible in patients with H1N1 flu.

On May 17, Australia moved to a new national health alert level, called “protect,” to focus on the early treatment of those vulnerable to [severe illness from] the flu, including pregnant women, people with respiratory disease, heart disease, diabetes and obesity. And on July 2, Australia's Health Minister, Nicola Roxon, reassured parents that swine flu does not pose a greater danger to children than seasonal flu.

CDC, wake up!

Do you really want to improve healthcare? You do it as a doctor by not settling for anything but the best outcome

Atul Gawande wrote a 2004 article in the New Yorker that was a stunner. I thought cystic fibrosis patients died around thirty years of age. Turns out they don't have to. At one cystic fibrosis clinic in Minnesota, patients hardly ever die. How was this achieved? It took a doctor who was absolutely compulsive about getting the very best outcomes. He just kept trying things and working harder and pushing everyone else harder too. He didn't just keeps repeating the practices in the textbooks.

Medical culture is one of complacency and uniformity. Malpractice laws require that we practice according to a local standard. You want to try something different? Stepping outside the mainstream makes you more susceptible to losing a malpractice suit. It usually makes your colleagues uncomfortable, too. If the local standard amounts to doing every test and procedure in the book---well, that is what you are expected to do, actually it is what you are legally required to do.

But if we want stellar outcomes, not to mention cost savings, that is absolutely the wrong way to get them. Gawande's articles are game-changers.

What we need is a paradigm shift. We have to make sure everything we do, for every patient we see, uses every arrow in our quiver to aim for that perfect outcome. And we have to use data and science a lot more, to make sure we know what works to achieve those results. We have to train docs to think differently.

The demand that doctors practice at the level of a local standard probably makes sense as a legal doctrine. But it sets the bar for healing way too low. It's basically a race to the bottom.

Gawande shows us exactly the kind of cultural shift that could truly achieve the world's best healthcare system. If you read nothing else on improving healthcare, READ THIS ARTICLE.

Laboratory Says Security Is Tighter, but Earlier Count Missed Dangerous Vials/ Wash Post

Over 9,000 undocumented microbial samples turned up in Fort Detrick's three-month long inventory, completed last month. But that doesn't mean we have a problem with biosecurity at the Army labs, does it? Nor does it suggest a similar problem might exist at the many labs that have sprung up since 9/11 in the US Government-sponsored biosecurity cottage industry, does it? And why should Obama's nomination for the Department of Homeland Security bioterrorism czar worry about biosecurity at these labs?

I should have directed readers to Lew Weinstein's blog on the anthrax letters case and the subject of biosecurity long before. Lots of interesting material there.

Rationing is Not a 4-Letter Word

Finally a mainstream article (in the NY Times, no less) redefines the misunderstood notion of rationing and healthcare reform.

David Leonhardt's timely and important article deconstructs (I love that word; here's one definition of it: textual analysis that can reveal hidden ideological assumptions) rationing. Here is a definition of rationing: the controlled distribution of resources and scarce goods or services.

Most Americans do not feel they get sufficient time and attention from their medical providers. They find the prices of drugs (or even their fractional co-payments) too high. They do not get enough information on wellness and prevention. Hello. Those problems are the result of an unacknowledged system of rationing. And the current rationing system works to prevent doctors conversing together about your medical problems, to prevent doctors reviewing your old medical records, to prevent doctors educating you about wellness. That is because the current system rations those services by failing to pay for them.

Oh, and by the way--don't you dare come down with an illness that cannot be successfully treated with a drug or operation, because other forms of treatment are highly rationed in the current system.

Most Americans put up with long waits for care, too-short visits, too many tests and not enough face time, because they have been led to believe they have the best healthcare system in the world. If best is costliest, with the most varied and numerous medical devices, procedures, and specialists, then we do have the best system. But if best is measured by outcomes, then we aren't doing very well.

What we really need is rational rationing. Not decided by medicare bureaucrats or by default, but by the stakeholders. We have got to get the price of healthcare down, and that will take rationing. Let's do it in ways that enhance health, longevity and safety. (I could name hundreds of ways to save that would yield better results.) Hello.

Anyway, Leonhardt makes these points so much better than I can. Read his short piece. Uwe Reinhardt discusses the misunderstood concept of healthcare rationing in another excellent article.

Barriers to an Improved and more Cost-Effective Medical System

Health care per capita in the United States costs at least double nearly every other country on earth. Yet our longevity, infant mortality, and other health indices lag behind the rest of the industrial world. What's not to change about such a system? Think of it: we do the same tests and radiology studies as other countries, use the same drugs, and I get paid about the same (as a primary care doctor) as if I lived in western Europe, Canada or Australia. But healthcare costs twice as much over here, because we do more or different things than we need to do for patients, our drugs cost more, our equipment costs more, and there is an enormous amount of "fat" everywhere you squeeze the system.

Egregious financial conflicts of interest can be found under every stone you care to turn up in the healthcare garden.

Profit margins have been reliably above 10% per year for most healthcare companies. No wonder members of Congress and the administration have invested in them. However, those investments are anchors, preventing the US from turning around the ship of state when it comes to healthcare. Shouldn't our legislators recuse themselves from a role in healthcare policy reform while hamstrung by personal investments?

We administer more in the US. A lot of the administration is not designed to reduce procedures or cut costs. Instead, it redirects resources. For example, insurer A contracts with Pharmacy Benefits Manager (PBM) B to supply medications to its customers. Drug manufacturers or wholesalers make deals with the PBM to sell only certain drugs, and to shift prescribed drugs to others in the same class. This is done through the mechanism of the Formulary, a fancy name for limiting the selection of available drugs. But every year the formulary (or pricing pattern of available drugs) changes, so patients (and hospitals) have to frequently change the drugs they have available, or pay through the nose. This is one of many wasteful situations in healthcare, in which the beneficiary of the change (the PBM) shifts the costs of the change onto consumers, hospitals and pharmacies. It is a shell game.

Here is another example of crazy healthcare economics. I see a patient on referral. Another doctor thought I had some expertise to offer this patient. I do a complete evaluation, and give the patient and referring doctor my advice. I bill the patient's insurance company, which decides how much it wants to pay me for the service. I never know what I will receive, how long it will take to arrive, and I frequently receive nothing. I can write letters, make phone calls, and sometimes some money will arrive late, but it is entirely unpredictable. Can you name any other industry in which the price that will be paid for a service (if any) is kept a secret by the payer until after the service is rendered, and often bears little relationship to the time spent or complexity of the service?

Since billing rules are constantly changing (another version of the shell game) billing cannot be done cost-effectively in a small office, for you cannot keep up with the changing regulations and software needed.

The unpredictable payment system led many doctors to sell their practices and take a salary, swapping autonomy for income stability. (I gave away my practice in 2002, and was mighty glad to relinquish captivity to an incomprehensible system of reimbursement.)

There has been a revolving door at FDA for employees or consultants to drug and device manufacturers, who become regulators for awhile. Maybe that is why the rules for scrutinizing new medical devices have been so weak. Attorney Daniel Troy was the top attorney and enfant terrible at FDA, appointed by Bush to gut public health protections. He is infamous for creating the legal doctrine of "preemption": if FDA approved it, no state courts can hear challenges to the safety or efficacy of the product. Now he has returned to the pharma industry as senior VP at Glaxo.

Let's talk pricing. Competition controls prices, right? But FDA approval gives manufacturers a license to steal, since no one else can sell your drug while it is on patent, and no one can tell the manufacturer how to price it. Is the drug used for cancer, a heart attack or stroke? Then it is worth thousands of dollars a dose. (You heard me right. Thousands. No wonder the drug companies focus on drugs for the final year of life.) Because most patients are shielded from the full cost by insurers, there is no outcry. Those not shielded may go bankrupt trying to pay.

Need I go on? An army of hardworking, well-intentioned health professionals puts a good face on a heathcare industry replete with dirt. And given the nutty payment system, healthcare institutions are practically forced to steal from Peter (i.e., overcharge) to pay Paul, a very unsatisfactory situation that currently is a requirement for hospitals (and healthcare professionals like me) to stay in business.

Our nation is desperate for an accounting of where the healthcare dollars are going; for accountability for quality outcomes; and to develop a system in which excellent health indices, broad preventive services, and enhanced provider communications occur -- one for which we can all be proud, and healthier!

The Cost Conundrum: What a Texas town can teach us about health care

Atul Gawande is a marvelous writer, as well as a surgeon. In an article in today's New Yorker, Gawande proves himself to be in the first rank of health care pundits, as well. His extraordinary article is a joy to read, but also extremely important. For example, it identifies and explores the reasons a negative correlation between healthcare costs and quality of care exists.

"Two economists working at Dartmouth, Katherine Baicker and Amitabh Chandra, found that the more money Medicare spent per person in a given state the lower that state’s quality ranking tended to be. In fact, the four states with the highest levels of spending—Louisiana, Texas, California, and Florida—were near the bottom of the national rankings on the quality of patient care."

Gawande travelled to McAllen, Texas, to investigate why per capita healthcare costs (paid by medicare) were higher there than almost anywhere else in the country. Many theories that might explain this were examined, but eventually had to be rejected. Finally, it became clear that in McAllen, many of the doctors had learned how to game the system for maximal financial benefit. The medical culture had evolved to one in which "financial considerations drove the decisions doctors made for patients."

McAllen's patients got an overabundance of illness care. However, preventive care was lacking, and people were no healthier than in markets where health care costs were 50% less. "So here, along the banks of the Rio Grande, in the Square Dance Capital of the World, a medical community came to treat patients the way subprime-mortgage lenders treated home buyers: as profit centers."

Things were McAllen's mirror image at the Mayo Clinic in Rochester, Minnesota. "Among the things that stand out from that visit was how much time the doctors spent with patients," Atul noted. Yet costs were among the nation's lowest at Mayo. Mayo doctors were salaried, and primarily focused on improving the quality of care.

“When doctors put their heads together in a room, when they share expertise, you get more thinking and less testing,” Denis Cortese, Mayo's CEO, told Atul.

Colorado had an interesting model. "Grand Junction’s medical community was not following anyone else’s recipe. But, like Mayo, it created what Elliott Fisher, of Dartmouth, calls an accountable-care organization. The leading doctors and the hospital system adopted measures to blunt harmful financial incentives, and they took collective responsibility for improving the sum total of patient care."

"When you look across the spectrum from Grand Junction to McAllen—and the almost threefold difference in the costs of care—you come to realize that we are witnessing a battle for the soul of American medicine."

Gawande questions whether the doctor--any doctor-- "is set up to meet the needs of the patient, first and foremost, or to maximize revenue. There is no insurance system that will make the two aims match perfectly. But having a system that does so much to misalign them has proved disastrous. . . Every incentive in the system is an invitation to go the way McAllen has gone. "

Gawande concludes, "As America struggles to extend health-care coverage while curbing health-care costs, we face a decision that is more important than whether we have a public-insurance option, more important than whether we will have a single-payer system in the long run or a mixture of public and private insurance, as we do now. The decision is whether we are going to reward the leaders who are trying to build a new generation of Mayos and Grand Junctions. If we don’t, McAllen won’t be an outlier. It will be our future."

How am I to treat patients with H1N1 flu? How am I to protect them from the treatment?

The 2009 "Swine flu" A (H1N1) outbreak has been recognized for the past six weeks. It has been studied intensively, we are told, and a number of Americans have died from the disorder, although less than 1% of those diagnosed with this specific virus. It apparently is a bit more contagious than the usual flu, but may cause the same or fewer deaths than usual flu. However, since we have no good data on the number of Americans who die from flu every year, it is very hard to say how this swine flu compares to others in virulence.

CDC has told medical practitioners from the beginning to use Tamiflu or Relenza (the generic names of these drugs are oseltamvir and zanamivir) for treatment, or for prophylaxis of exposed persons. An Emergency Use Authorization has been issued for these drugs, which allowed them to be released from the Strategic National Stockpile for distribution to states and localities, to be used outside the labeled indications, and to somehow avoid GMP (Good Manufacturing Practices) standards if necessary.

However, although CDC has repeatedly told doctors to use the antivirals above, what it has failed to tell us, even once, even on its frequently updated website, is how effective we can expect these drugs to be. Nor has CDC gone into much detail about safety, particularly when the drug is being used on very young children, off-label.

Since safety and efficacy are the only two facts one needs to know about any drug (apart from the fidelity of the manufacturing and distribution processes) these are two very big omissions.

Furthermore, I want to know what clinical syndromes patients are developing that occur in those who become critically ill, so that I can treat those aspects of the illness in the best possible manner. Are seriously ill patients developing a secondary, bacterial pneumonia, sepsis or Adult Respiratory Distress Syndrome (ARDS)? Do they benefit from mechanical ventilation, steroids or antibiotics? This could be life-saving information, yet it is not being disseminated and I could not find anything related to it on the CDC website.

If that is not bad enough, you may be interested to learn that the government has invoked the Public Readiness and Emergency Preparedness Act (PREP Act), which makes it almost impossible to sue the manufacturer (as well as the government) for injuries you sustain from use of Tamiflu and Relenza. How is that, you may ask: there has been no media coverage of this. But you can confirm it on CDC's website and in the Federal Register of October 10, 2008. Here is how it works.

Guess what? Tamiflu and Relenza were given the benefit of the PREP Act in 2008, by Secretary Leavitt, before there was any swine flu pandemic. The Center for Infectious Disease Research & Policy at the University of Minnesota had this to say last December:

... A recent declaration by HHS Secretary Mike Leavitt provides that state and local governments will be immune to liability related to the use of oseltamivir and zanamivir only to the extent the drugs are obtained by voluntary means, not confiscation. The Public Readiness and Emergency Preparedness (PREP Act) gives the HHS secretary the authority to do that, the document states.

For a good primer on PREPA, the Congressional Research Service has written a valuable report.
If use you Tamiflu or Relenza and develop a serious adverse reaction, you will be on your own. The manufacturer, distributors and the government program planners involved in the decision to invoke the PREP Act, were all given near-total immunity for liability by the Act. The Declaration (and immunity shield) will remain in effect through the end of 2015.

The Anthrax Vaccine: A Dilemma for Homeland Security/LtCol Tom Rempfer

This article, from the journal Homeland Security Affairs, recaps the history of the anthrax vaccine program and explores how the anthrax letters attack might be related to it.

Past problems with the Department of Defense anthrax vaccine currently impact
national emergency response plans approved by the Department of Homeland
Security and Department of Health and Human Services. Following the 2001 anthrax letter attacks, those departments diverged from long established protocols advocating limited use of the old anthrax vaccine, also known as BioThrax®. The Executive departments procured mass quantities of the product for the Strategic National Stockpile as a prophylaxis for citizens under emergency contingencies.
The departments share oversight responsibilities for the emergency stockpile’s
composition of vaccines and drugs based on Presidential Directives. (1) Yet a
review of past oversight efforts reveals regulatory problems, ethical controversies and dubious threat assessments underlying use of the vaccine. Based on the historic controversy, and studies suggesting the majority of U.S. service members continue to object to the vaccine’s use, (2) the government should resurvey the vaccine’s suitability for American citizens. A thorough review may find that widespread use of a known antiquated product of disputed safety and efficacy in treating a non- communicable threat provides an imprudent illusion of protection for our citizens.

This article explores the Department of Defense’s experience with the anthrax vaccine, and the troubling possibility that the 2001 anthrax letter attacks were a deliberate and successful effort to sustain a program that federal investigators determined was on the verge of failing. . .

.

U.S. funded anthrax vaccine trials on IDF soldiers/ Haaretz

According to an article by Yossi Melman, the US spent $200 million dollars for Israel to develop and produce an anthrax vaccine, and test it on Israeli soldiers during the 1990s.

When the US military was testing plenty of other experimental vaccines on American soldiers during the 1990s (I know of at least half a dozen) what might have led them to test this one offshore? What did the military know about the anthrax vaccine? And when did they know it?

It seems they knew it before the mass mandatory inoculation program began in 1998, but went ahead anyway. That program was initially slated to vaccinate every soldier, but after many vaccine refusals and production problems, vaccinations were limited to those soldiers deploying to Asia.

This story is getting a lot more interesting...

CDC's anthrax vaccine safety studies defunded/ Science online

from Science: Michael McNeil's portfolio of flawed anthrax vaccine safety studies at CDC is going away. Drum roll, please.

This is a good thing, since the studies were basically a boondoggle lacking a scientific foundation. Even Army vaccine scientists, as well as this blog's owner, published criticisms of the laughable methodologies used by the CDC group in its first published study. That study purported to show no increase in cases of optic neuropathy following anthrax vaccine, by using idiosyncratic study methods that enhanced bias.

The Institute of Medicine was asked to review this study portfolio back in 2001. Here are some comments (verbatim) from their interim report in January 2002:

• CDC's plan appears to include useful components that have not to date been integrated into a whole or comprehensive plan.
• No matter how meritorious the parts, however, the apparent lack of overall planning and coordination of the whole is a deficit that should be remedied.
• The CDC either has not developed, or has not communicated, a comprehensive plan for the CDC's role in anthrax vaccine safety and efficacy research.

The final report of the IOM was ignored by CDC, which continued on with projects that IOM had found to lack merit and recommended ending.

This group also worked on the CDC anthrax vaccine trial, a 42 month study designed to look at long-term adverse vaccine reactions. What did they do instead? After the study had been completed, they published a paper discussing data from only the first 7 months of the study. This allowed CDC to hide long-term adverse reactions, and get the vaccine approved for civilians last October, potentially leading to large profits for the vaccine maker: Bioport aka Emergent Biosolutions. Qui Bono? Not the first responders who were slated for vaccination, since they were barred from seeking compensation if they got sick from either the manufacturer or government officials. Coincidentally, what barred them was an Emergency Declaration from HHS' Secretary Leavitt...conveniently issued the same month CDC published its paper and approved the vaccine for civilian first responders.

If CDC is serious about getting back on track with transparency, accurate information and quality research that will enhance public health, the anthrax vaccine safety group needed to go. Bravo to those at CDC who chose this program to cut.

FBI Anthrax Investigation Under Scientific Review/ Science online

Brief article by Yudhijit Bhattacharjee:

A long-awaited review of the scientific evidence relating to the investigation
of the 2001 anthrax letter attacks is finally getting off the ground. The study,
to be conducted by the National Academies, will check the validity of the
scientific techniques used by the Federal Bureau of Investigation in solving the
case. What the study will not do, as spelled out in the academies’ official
description of the study, is issue a verdict on whether U.S. Army researcher
Bruce Ivins was indeed guilty of the crime, as concluded by FBI officials. . .

Research Advisory Committee on GW Illness Chairman explains how Institute of Medicine was Made to Perform Studies Whose Conclusions Were Predetermined

Jim Binns, chairman of VA's Research Advisory Committee on GW Veterans' Illnesses since its inception, authored a detailed memo, with supporting documents, to show how Congress' statutory charge to the IOM was changed to exclude animal studies and raise the bar for granting presumptive disabilities to ill Gulf War veterans.

Jim deserves enormous thanks for his tireless pursuit of fairness for ill veterans, and his methodical discussion of how a series of mostly useless IOM reports came to be produced.

Army Nearly Done With Probe of Fort Detrick Lab/ Wash Post

No Signs of Criminal Misconduct Found Yet in Disappearance of Virus, Official Says

This rather inconsequential article (lacking context) says Fort Detrick is still working on its inventory...going on 3 months now? Not surprisingly, the Army hasn't found anything to be concerned about, according to Fort Detrick's PR person. The article implies that much of the base's research remains on hold.

Despite fines and sanctions at other research institutes for safety lapses, I have never heard of a single research center that basically shut down for weeks or months pending a review. That back story--what it took to shut the place down, and whether it relates to the anthrax letters--could be extremely interesting.

The 2008 Naval Environmental Health Center Study by Dr. Margaret Ryan et al. on anthrax vaccination during pregnancy: a critique and historical review

Comments on: Ryan, MAK, et al. Birth Defects among Infants Born to Women Who Received Anthrax Vaccine in Pregnancy. American Journal of Epidemiology; July 2008.

Meryl Nass, MD

April 20, 2009

Dr. Margaret AK Ryan reports that of the 95,595 military women who delivered babies between 1998 and 2004, anthrax vaccine (one dose or more) was given to 3,465 military women during their first trimester of pregnancy. Dr. Ryan, a physician epidemiologist and Navy Commander, has studied these women for the past eight years, and published results in 2008.

The Original Study Led to Major Policy Changes

Dr. Ryan presented results of a subset of this group (those vaccinated 1998 through mid 2001) in late 2001 and early 2002. Shortly after her presentation to FDA, in January 2002 FDA changed the pregnancy warning on the anthrax vaccine label to category D from C, indicating that data showed the vaccine was associated with birth defects, and should not be given to women during pregnancy. The Assistant Secretary of Defense for Health Affairs, Dr. William Winkenwerder, also responded to Dr. Ryan's findings. He sent memos to all the military services, directing that special efforts should be made to avoid giving the vaccine during pregnancy, including the use of pregnancy tests if appropriate.

[He was reacting to the increased rate of birth defects, but also to the relatively high rate of first trimester vaccinations. Before 2002, military medical professionals tended to vaccinate women who thought they might be pregnant but had no proof. Fortunately, that changed after Dr. Ryan's 2001 preliminary report. A much smaller number of women with first trimester pregnancies have been vaccinated since.]

Her 1998-2001 study data were shared with the Institute of Medicine Committee to Assess the Safety and Efficacy of Anthrax Vaccine and with the Armed Forces Epidemiology Board, as well as FDA. When initially presented, the study compared first trimester-vaccinated women to women who had been vaccinated at any other time. The data showed a reportedly small increase in birth defects in offspring of first trimester-vaccinated women, yet the increase was statistically significant. For some reason, these data were never published, despite the effect they had on both vaccination policy for military women, and changing the pregnancy warning on the vaccine label.

Expanding the Dataset but Reducing Statistical Significance

Subsequently, Dr. Ryan et al. added to the original data collection, extending the period of births through 2004. In 2008, Dr. Ryan published these data, discussing the original comparison between first trimester-vaccinated mothers and mothers vaccinated at another time, but the published paper also compared these births to births in mothers never vaccinated against anthrax.

This expanded dataset yielded a smaller difference in birth defect rates in offspring between first trimester-vaccinated women and those vaccinated at any other time, which was only statistically significant when offspring of first trimester-vaccinated women were compared with offspring of those never vaccinated.

In February 2002 it was reported (in the CDC’s Morbidity and Mortality Weekly Report: MMWR 127 vol 51 No. 6: Notice to Readers: Status of US Department of Defense preliminary evaluation of the association of anthrax vaccination and congenital anomalies) that investigators were conducting a systematic evaluation of original (paper) medical records of women who received anthrax vaccine to determine how well the electronic medical data agreed with the (paper) medical records.

In 2008, Dr. Ryan described significant problems with the electronic data that she used. Her published paper states that only “a subset of women whose data were archived after they left military service” had their hard-copy data compared with the electronic database. Hardcopy records were reviewed for 11,271 of the 95,595 women who gave birth during the study period, and “were more likely from women who gave birth earlier in the observation period and left military service soon after” and “did not represent a random sample.”

Of the 11,271 women whose paper records were reviewed, 1,318 had anthrax vaccinations recorded on paper. Of these 1,318, only 1,158 had anthrax vaccination recorded electronically. “When compared with those of [paper] medical records, the specificity of electronic data was 97.5%, and the sensitivity was 61.5% for correctly identifying [anthrax] vaccine recipients.” This means very few women whose paper records showed they did not get the vaccine were identified electronically as having received it, but that many who did receive it, according to their paper medical records, failed to have the vaccinations recorded electronically.

Could it be that the poorer sensitivity (ability to correctly identify those who received the vaccine) of the electronic database contributed to the drop in birth defect rates in offspring of those vaccinated women added to the database later? Given the demonstrated low sensitivity of the electronic record for identifying vaccinations, it is very likely that some of the women who had infants with birth defects failed to have their vaccinations accurately recorded in the electronic database. Since electronic records supplied more of the study data for women vaccinated later compared to earlier, relatively more late-vaccinated women would be expected to be incorrectly placed in the unvaccinated group. This could dilute the measured adverse vaccine effect in infants born later, compared with the data used in Ryan’s earlier assessment.

In other words, the greater use of the more accurate paper records, for those vaccinated earlier, would be expected to result in more accurate vaccination ascertainment for mothers of infants with birth defects who were born earlier.

Merging data from both paper and electronic records, despite low sensitivity for identifying anthrax vaccinations in the electronic records, is a major problem with this study. It may have led to loss of statistical significance for some comparisons despite a larger number of subjects in the later study.

Biologic Plausibility of Vaccine-Induced Birth Defects

Dr. Ryan stated that, “there is little information available to support biologic plausibility of anthrax vaccine as being teratogenic.” The CDC’s Morbidity and Mortality Weekly report, cited earlier, reported that, “although the Food and Drug Administration-licensed vaccine has not been suspected to be a hazard to reproductive health, no studies of animals or pregnant women have been conducted.” Shouldn’t studies in pregnant animals have been required prior to mandatory use of the vaccine in the young female military population? Then again, if no animal studies had been conducted, it was easy to say there was no information linking the vaccine to birth defects.

The anthrax vaccine contains formaldehyde, aluminum, benzethonium, 3 anthrax toxins that are known to exert profound biologic effects, and an array of uncharacterized substances derived from anthrax fermentation. Why is it implausible to think that injecting this mix might contribute to birth defects?

Dose-Response Relationship

Is there a dose-response effect from anthrax vaccine on the rate of birth defects, as might be expected if the vaccine were truly causing such problems? Ryan et al. state that “infants exposed to two or more maternal anthrax vaccine doses in the first trimester did not have a significantly increased risk of birth defects,” implying that there was no dose-response relationship.

But a positive dose-response relationship did exist. Infants exposed to two or more vaccine doses in the first trimester had an adjusted rate of birth defects 1.19 times higher than infants of mothers vaccinated at another time. But a smaller number of infants received 2 or more vaccinations prior to detecting a pregnancy, rather than just one, so this increased rate did not achieve statistical significance. More infants of multiply-vaccinated first trimester mothers would have been needed to achieve statistical significance.

Birth Defect Rates

In the US overall, 3.0% of infants are born with a significant birth defect. However, in military women vaccinated outside the first trimester, 4.2% of offspring had at least one major birth defect. In never-vaccinated women, 4.03% of offspring had a birth defect. In those vaccinated during the first trimester, 4.7% had at least one major birth defect.

When 4.7% is compared to 4.2%, the increase in the birth defect rate is only 12%. But consider the vaccine's makeup. Anthrax vaccine uses the aluminum adjuvant Alhydrogel to create a depot effect, slowly releasing vaccine antigen over some months following an injection. So women vaccinated prior to the first trimester could still be exposing their fetus to the vaccine. That is why they should not have been included in the control group: at least, those vaccinated in the year prior to conception should not have been used as controls.

Ryan’s data support the hypothesis of pre-pregnancy vaccination contributing to birth defects. In women vaccinated during the first trimester, the birth defect rate in offspring was 4.68%. In offspring of women vaccinated prior to pregnancy, the birth defect rate in offspring was 4.56%: nearly as high. In those vaccinated after pregnancy, the birth defect rate in offspring was only 3.85%.

By including pre-pregnancy vaccinations in the original control group, the effect of the vaccine on birth defect rates was diluted.

Now compare birth defect rates of infants born to women given anthrax vaccine during their first trimester with all infants born in the United States. When you compare 4.7% to 3.0% (the rate of major birth defects diagnosed in the first year for all infants) the unadjusted increase in the birth defect rate is 57%. This suggests that the increase in birth defects attributable to anthrax vaccine could be quite considerable. (However, these numbers have not been adjusted to take account of other possible differences between the two populations. On the other hand, military populations are considered healthier, on average, than their civilian counterparts, so the comparison is probably fair.)

Conclusions

In the 2008 paper’s conclusions, Dr. Ryan et al. note that additional research should be done, and make the excellent suggestion to perform active follow-up, such as that being performed by the Smallpox Vaccine in Pregnancy Registry. Ryan et al. also point out that potential adverse effects of vaccinations given pre-conception should be assessed.

But the sentence immediately following this recommendation states incorrectly that, “these analyses found no evidence that prepregnancy maternal anthrax vaccination is associated with an increased risk for birth defects.” Maybe the relationship was not significant, but the rate was considerably higher than for offspring of military women never vaccinated, of military women vaccinated postpregnancy, and for offspring of American women overall.

Ryan’s final sentence makes this reasonable point: “… women with no known exposure to inhalation anthrax should continue to avoid anthrax vaccination during pregnancy.”Overall, the data presented by Ryan et al. give cause for concern, and should provide the impetus to further study the issue of anthrax vaccine and birth defects. Most importantly, these data tell us that the military’s electronic database has serious flaws, and requires enhanced data entry and ongoing testing to assess the validity of the information it contains.

For future study of the effects of anthrax vaccine in pregnancy, paper records should be used. Furthermore, women receiving pre-pregnancy vaccinations, who were shown to have high rates of infants with birth defects, cannot be used as the control group in a scientifically valid study. Finally, an understanding of how and why birth defects rates in the offspring of military women exceed civilian rates must be sought.

Redesigning Healthcare: Don't Miss This Reinhardt Gem!

Uwe Reinhardt, Princeton's healthcare economist who has previously been featured in this blog, has posted a very interesting article to his NY Times blog. In it, he dissects the various roles of the healthcare system, using the German model to explain how some roles can be performed by government and others by private health insurance companies. In the German system, everyone (90%) is covered, all workers and their employers contribute, and social goals are attained, at a cost less than half that in the US. Germans can choose from 200 different health insurance funds to get their health needs met.

Reinhardt has also started talking about one of the (cultural) elephants in the healthcare room. Must it take someone who hails from outside the US to explain to us our cultural biases? One recalls the success of DeToqueville in a similar arena.

Reinhardt spits it out: prevailing views of what our rights should be, vis a vis health care costs and entitlements, is inherently contradictory:

They [health plans in Germany, Netherlands, Switzerland] all rely on purely private, nonprofit or for-profit insurers that are goaded by tight regulation to work toward socially desired ends. And they do so at average per-capita health-care costs far below those of the United States — costs in Germany and the Netherlands are less than half of those here. . .

In Europe, as in Canada, that social ethic [guiding the payment for and provision of healthcare] is based on the principle of social solidarity. It means that health care should be financed by individuals on the basis of their ability to pay, but should be available to all who need it on roughly equal terms. The regulations imposed on health care in these countries are rooted in this overarching principle.

First, these countries all mandate the individual to be insured for a basic package of health care benefits.

Many Americans oppose such a mandate as an infringement of their personal rights, all the while believing that they have a perfect right to highly expensive, critically needed health care, even when they cannot pay for it. This immature, asocial mentality is rare in the rest of the world.

Read the full article, browse his other posts, and be grateful that a few pundits like Reinhardt are pointing to sensible solutions to the health care morass choking our nation.

One step could dramatically improve hospital care and patient safety

Information has many ways of falling through the cracks in hospitals and medical practices.

The wrong test may be mistakenly ordered by the doctor. The ward secretary may order the wrong test. The lab may perform the wrong test, or rarely perform it on the wrong person. The result may not be available until after the patient leaves the hospital, and then gets lost in cyberspace; or it reaches the chart after the doctor has dictated the discharge summary and is never seen.

Usually more than one doctor takes care of each patient, but each may not be aware of everything the other has done, or which tests were ordered and are still pending.

A simple fix would be to require that all electronic medical records systems must be linked to the laboratory and radiology departments, and must be able to generate a list of all tests ordered; their results; and those tests whose results are still pending. At the end of a hospitalization, each doctor would have to sign off on the list, to ensure all tests had been considered.

We currently have a hodge-podge of hundreds of proprietary EMR systems that do not communicate with each other throughout the US, and the system I use does not have this capability.

Electronic medical records are a wonderful idea in theory. In practice, they are fraught with difficulties and potentially may be accessed or "hacked" by unauthorized individuals, making a mockery of patient confidentiality. The problem of confidentiality is central to getting a working EMR system in place throughout the nation, through which doctors and patients can communicate; yet it requires cybersecurity resources beyond the financial resources of hospitals and medical practices in the private sector. This is why the development and maintenance of such a system must be federalized.

MK Shai calls for anthrax vaccine experiment probe

from YNet:

Kadima Knesset Member and former Israeli Defense Force spokesman Nachman Shai on Friday said either a state commission of inquiry or a parliamentary commission of inquiry should be set up to look into the anthrax vaccine experiments conducted on IDF soldiers. MK Shai said, "The fact that the experiment was hidden from the public and the examinees is a moral issue of the highest degree".

More on the Israeli anthrax vaccine experiment on soldiers

From the Jerusalem Post

From the AP

Excerpts from today's Ha'aretz:

Dr. Reuven Porat, who chaired the medical committee, told Haaretz the panel had not been presented with any official documentation that shows the decision to develop, test and produce the vaccine had been authorized by the government. Similarly, there was no authorization presented from the defense minister, who is charged with responsibility for the Institute for Biological Research, and not from the IDF, and there was no proof the chief of staff was consulted about or agreed to the project...

In its report the panel is highly critical of the "secrecy" imposed by the managers of the experiment and ask "whether the secrecy was necessary because the experiment was to be hidden from the Israeli public."

The medical panel noted: "Selecting soldiers as the population for the experiment prevented achieving the declared aim of the experiment, which was to examine its safety and effectiveness in broad use among the general civilian public, the elderly, women, children and sick patients," the committee wrote.

From YNet come these excerpts:

Israel has admitted to developing a vaccine against anthrax, fearing it might be used as a bio-weapon by enemy nations against civilians, and tested it on IDF soldiers. "Once we face a substantial threat, we would be able to vaccinate all citizens, ranging from babies to the elderly, and protect them against the virus," a senior defense source told Ynet. (But the report indicates Israel already had a large enough stock of vaccine for its population prior to beginning this trial--Nass) From PressTV: Some of the soldiers, who say that the experiment has had life-threatening side effects for them are now filing a lawsuit against the Israeli Army, Haaretz reported... Israeli Physicians for Human Rights have also filed a lawsuit against the army over the experiments.

Medical panel: Anthrax experiments on IDF soldiers were unjustified

Another fascinating article on the Israeli anthrax vaccine experiments by Yossi Melman in Haaretz. Excerpts follow. It seems no one in Israel would take any responsibility for the experiment, which is being laid at the feet of (assassinated) former Prime Minister Itzhak Rabin -- but no documentary evidence was given to the Israeli Medical Association committee invesetigating the experiment to support the putative association with Rabin.

In the US, I have been unable to learn who has been behind approval of the anthrax vaccine for mass use, when there exists no experimental evidence for human efficacy, the safety profile is awful, and the need has never been demonstrated.

Following a three-month legal battle in Israel's High Court of Justice, the report was finally approved for publication Wednesday...

The experiments were carried out in light of what was then defined as the "strategic threat of a surprise biological attack facing Israel. However, the report said that it was not clear who the decision makers were who determined the vaccine's necessity...

The Chairman of the medical committee, Dr. Reuven Porat, told Haaretz that the panel was not presented with any official evidence indicating that either the government, the defense minister of the IDF chief of staff had authorized the development, testing, or production of the vaccine...

The report insinuates that it was improper motivation that prompted the launch of the experiments, but it does not specify what these motivations were, saying that the panel "could not make out the true inspiration behind them..."

The report reveals that even while the experiment was taking place Israel already had a stock of vaccines, a fact which further raised the concern that the experiment wasn't necessary; that it was carried out as a result of external pressure. "An accelerated effort to produce large quantities of the vaccine was underway a year prior to the experiment, and by the time the experiments were launched, Israel had enough vaccines to cover the civilian concerns," the report said...

Israel and the IDF accepted the principles of the Helsinki Accords, declaring many times that they meet their standards. In reality, however, the report states that "the military Helsinki committee failed to fulfill its duties in 'Omer 2' in every one of the points examined by the report."

"No scientific justification was found for the experiment, scientific background was lacking, the experiment's design and execution did not suit its goals, and no result would have justified those goals. Also, conventional guidelines were not followed, risks and possible side effects were not thoroughly investigated, and a follow-up mechanism to keep track of participating soldiers was not set up....."

Preventing Bioterrorism (Op/Ed by Rep. Rush Holt)

Preventing bioterrorism:

Thursday, March 12, 2009
BY RUSH HOLT
Last year, the Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism -- itself an outgrowth of the 9/11 Commission and its recommendations -- issued its report. It used alarming language to prod our government to act. It affirmed something that was demonstrated with the deadly anthrax attacks: Terrorists will likely use WMD attacks on America that feature biological weapons. The question now is: Have we implemented "lessons learned" from these attacks that took place in the fall of 2001, which caused such havoc here in New Jersey and across the nation?

I agree with the commission's assertion that "only by elevating the priority of preventing bioterrorism will it be possible to substantially improve U.S. and global biosecurity." To that end, the commission made a number of recommendations for improving biosecurity here at home, including the more thorough and persistent monitoring of personnel working at high-containment laboratories (i.e., those who work with dangerous pathogens) and the designation of a single federal agency for tracking the number of such labs in the United States.

I support those and other measures, but I do not believe Congress and the incoming administration can craft an effective biosecurity program for our country unless and until we take the time to investigate thoroughly the only major (and still unsolved, according to many) bioterror attack on our country to date.
Last week, I reintroduced the Anthrax Attacks Investigation Act, to examine and to report on how the attacks occurred and how we can best prevent similar episodes in the future.

Readers may wonder why the commission did not address the 2001 anthrax attacks in detail in its report. The answer is that examining those attacks was not an explicit mandate of the WMD Commission. This is in contrast to the 9/11 Commission, which was specifically charged with looking at how the Sept. 11, 2001 attacks happened, why the federal government failed to prevent the attacks, and what remedial measures are necessary to prevent a similar catastrophe in the future.

A thorough investigation into the federal government's response to the first modern bioterror attack on our soil is absolutely essential if we are to ensure that we have learned the right lessons from that episode to implement countermeasures and changes in policy that are directly tied to those "lessons learned" -- something that The Times of Trenton repeatedly has pointed out in its frequent coverage of this tragedy.

While many of the WMD Commission's recommendations for improving biosecurity look sound on the surface, none of their specific action proposals are based on a detailed examination of how the 2001 anthrax attacks occurred. More than seven years after the attacks, many critical questions remain unanswered. Chief among them is why the Federal Bureau of Investigation's (FBI) "Amerithrax" investigation focused for so long on the wrong suspect.

The FBI's performance in the wake of the attacks has left me and many other Americans wondering whether the Bureau is truly equipped to handle bioterrorism. Deterring such attacks in the future depends in part on at least the expectation of swift and certain detection and punishment.

Neither happened in the case of the 2001 anthrax attacks. We need to know why the first attack succeeded and why the perpetrator or perpetrators escaped justice.

Just as the 9/11 Commission looked not only at the attacks of that morning, but also at recommended changes in the structure of government agencies, screening methods and even congressional oversight, so should an anthrax commission look at the specific crime, but also at measures for prevention, detection and investigation of any future bioterrorism.

An anthrax attack investigation would help address these kinds of policy questions in a level of detail that the WMD Commission could not.

Rep. Rush Holt, D-Hopewell Township, is chairman of the House Select Intelligence Oversight Panel.

FBI Press Release details the meaning of the ASM presentations in Baltimore last week--with comments

For Immediate Release
March 6, 2009

Washington D.C.
FBI National Press Office
(202) 324-3691

FBI Responds to Science Issues in Anthrax Case

FBI Laboratory Director D. Christian Hassell, PhD issued the following statement:

During a recent American Society for Microbiology Biodefense (ASMBD) meeting in Baltimore , Maryland , questions were raised regarding two scientific analyses conducted during the course of the anthrax investigation. While this information is not new, it is important for the FBI to clarify the science since these findings continue to be misinterpreted by various media outlets.

The first item involves the elemental analysis of the anthrax spores that was conducted by Dr. Joseph Michael, a materials scientist at Sandia National Laboratories. At the conference, Dr. Michael presented analyses of three anthrax letters (Leahy, Daschle, and New York Post). He concluded that the anthrax powder in the three letters shared a chemical fingerprint but did not match the chemical fingerprint of spores in Ivins’ flask. Spores from the letters showed a distinct chemical signature that included silicon, oxygen, iron, tin, and other elements. Spores from Ivins’ RMR-1029 flask did not contain those elements in quantities that matched the letter spores. This is not unusual considering that Ivins’ RMR-1029 preparation had been submerged in water and other chemicals since 1997 and was a mixture of 34 different spore preparations. The letter spores were dried spores, produced from two separate growth preparations as indicated by differences in the New York and Washington, D.C. mailings. Although the chemical fingerprint of the spores is interesting, given the variability involved in the growth process, it was not relevant to the investigation.

It is important to note that the genetic profile of the spores from the letters and the spores from Ivins’ RMR-1029 flask was identical. Ivins’ RMR-1029 spore preparation had the same combination of anthrax mutations found in the letters. Only eight of the anthrax samples collected during the course of the investigation matched the genetic profile in the letter material and all were linked back to RMR-1029. This conclusion was the most significant and relevant scientific finding in the case.

By analogy, if one were to grow a corn stalk from a specific corn seed, the trace chemical fingerprint of the stalk might differ from that of the seed due to different compositions—for example iron—in the respective fertilizers used to grow each; however, the genetic profile of the seed and the stalk would be identical.

The second item involves isotopic analysis of the mailed anthrax. Media reports indicated that FBI scientists had concluded in 2004 that out of many domestic and foreign water samples analyzed only water from near Fort Detrick, Maryland, where Dr. Ivins worked, had the same isotopic signature as the water used to grow the mailed anthrax. This statement is incorrect. While water isotopic analysis was researched, the FBI concluded that there were too many confounding variables to precisely match bacteria that were grown using different materials and recipes. This technique was not relevant to the investigation.

While we have full confidence in our scientific approach, an additional independent review will provide further validation and thus benefit the larger scientific community. Consideration of an outside review began before any public disclosure of the scientific aspects of the investigation. This follows our approach throughout the investigation: to bring in external scientists to review and provide advise on our methodologies.

Nass comments: Even if everything stated above is accurate, the FBI has yet to prove that Ivins himself, not just his flask, provided the parent spores for the anthrax letters.

-- How did the FBI "rule out" as perpetrators over 100 other people who had access to spores from Ivins' flask?

-- How did the FBI ascertain that all of the secondary spore collections, derived from the flask, were 100% secure and could not have been surreptitiously obtained by others?

-- How was the FBI sure that no one else received spores from Fort Detrick, given that Fort Detrick's inventory problems were serious enough for there to have been a temporary "stand-down" of research just last month? Also consider that Ivins' flask was in a separate building from his lab, to which others had access, for over a year.

Since a thorough, complete accounting of its six year long, resource-intensive investigation has yet to be provided by the FBI, the following questions (raised by Representative Rush Holt on October 16, 2008) are additionally relevant:

"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?"

It is now 7 months since FBI announced the case was closed. During that time, FBI has released many pieces of (selected) evidence. The latest release, at a special ASM meeting convened for the purpose, was designed to make the scientific case.

The FBI charade has failed. The most basic questions remain unanswered.

Israeli Ministries take 'full responsibility' for anthrax vaccine trials

Article in THE JERUSALEM POST
Mar. 4, 2009
Yaakov Lappin

The Defense Ministry, Health Ministry and IDF said they took "full responsibility" for all side effects suffered by participants in a test of an anthrax vaccine, in a joint statement issued Wednesday.

The statement will be submitted to the High Court next week as a reply to petitions submitted by two IDF soldiers who took part in the trial and suffered negative aftereffects.

The petitioners raised questions about the way the vaccine trial was conducted, and are claiming the monitoring of volunteers and subsequent care provided to them was inadequate.

The vaccine trial, code-named Omer 2, took place between 1998 and 2006, and sought volunteers from elite IDF units. Following the test, a number of participants complained of breathing problems and skin conditions.

A quarter of participants were given an American version of the vaccine, while 75 percent were injected with the Israeli vaccine, which had not been previously tested. Members of both groups suffered side effects.

According to the statement, which was released by the Defense Ministry, 716 soldiers took part in the trial, and 11 later required medical treatment.

"Volunteers were given a detailed explanation about the vaccination, the study, and potential side effects. They were given a sheet to study and sign," the statement said.

"All of the soldiers who requested medical care received it," it added.

The Defense Ministry went on to describe Omer 2 as a project with "strategic importance for the State of Israel," adding, "Thanks to Omer 2, Israel has a medical response for the general public against a most severe threat. We thank the volunteers and appreciate their willingness to take part in this important trial, and their contribution to the general security of residents of Israel."

The vaccine is as safe as the anti-anthrax vaccine developed by the US, the Defense Ministry said.

Academic experts and oversight committees within the IDF closely monitored the vaccine trial, the statement added.

Remembering the anthrax attack

Glenn Greenwald's March 4, 2009 Salon article on Representative Rush Holt's bill and the ramifications of the anthrax attack is a must-read. Great links. Here is an excerpt:

The ultimate establishment organ, The Washington Post Editorial Page, issued numerous editorials expressing serious doubts about the FBI's case against Ivins and called for an independent investigation. The New York Times Editorial Page echoed those views. Even The Wall St. Journal Editorial Page, citing the FBI's "so long and so many missteps," argued that "independent parties need to review all the evidence, especially the scientific forensics" and concluded that "this is an opportunity for Congress to conduct legitimate oversight."
In the wake of the FBI's accusations against Ivins, the science journal Nature flatly declared in its editorial headline -- "Case Not Closed" -- and demanded an independent investigation into the FBI's case. After the FBI publicly disclosed some of its evidence against Ivins, The New York Times reported "growing doubts from scientists about the strength of the government's case." The Baltimore Sun detailed that "scientists and legal experts criticized the strength of the case and cast doubt on whether it could have succeeded." Dr. Alan Pearson, Director of the Biological and Chemical Weapons Control Program at the Center for Arms Control and Non-Proliferation -- representative of numerous experts in the field -- expressed many of those scientific doubts and demanded a full investigation.
There may be legitimate grounds for doubting whether an independent, 9/11-type Commission of the type Holt proposes is the ideal tribunal to conduct a real investigation, but it is clearly the best of all the realistic options. The only other plausible alternative -- an investigation by Congress itself -- is far inferior, as anyone who has observed any so-called "Congressional investigation" over the last decade should immediately recognize (here, as but one example, is the account I wrote about a House hearing last September attempting -- with cringe-inducing ineptitude and total futility -- to "grill" FBI Director Robert Mueller about the FBI's case against Ivins). How effective an independent investigative Commission like this will be will depend on the details of its structure -- its subpoena powers, punishments for defiance, and the independence of its members. That Rush Holt will play a key role, if not the key role, in overseeing its creation is a reassuring feature that the bill he introduced can be actually productive.

HOLT INTRODUCES ANTHRAX COMMISSION LEGISLATION

For Immediate Release Contact: Zach Goldberg March 3, 2009
202-225-5801

HOLT INTRODUCES ANTHRAX COMMISSION LEGISLATION

Bill Would Create 9/11 Commission-Style Panel to Investigate Anthrax Attacks and Government Response

(Washington, D.C.) – Rep. Rush Holt (NJ-12) today introduced the Anthrax Attacks Investigation Act of 2009 (HR 1248), legislation that would establish a Congressional commission to investigate the 2001 anthrax attacks and the federal government’s response to and investigation of the attacks. The bipartisan commission would make recommendations to the President and Congress on how the country can best prevent and respond to any future bioterrorism attack. The attacks evidently originated from a postal box in Holt’s Central New Jersey congressional district, disrupting the lives and livelihoods of many of his constituents. Holt has consistently raised questions about the federal investigation into the attacks.

“All of us – but especially the families of the victims of the anthrax attacks – deserve credible answers about how the attacks happened and whether the case really is closed,” Holt said. “The Commission, like the 9/11 Commission, would do that, and it would help American families know that the government is better prepared to protect them and their children from future bioterrorism attacks.”

Under Holt’s legislation, the commission would be comprised of no more than six members from the same political party. The commission would hold public hearings, except in situations where classified information would be discussed. The commission would have to consult the National Academies of Sciences for recommendations on scientific staff to serve on the Commission. The Commission’s final report would be due 18 months after the Commission begins operations.

“Myriad questions remain about the anthrax attacks and the government’s bungled response to the attacks,” Holt said. “One of the most effective oversight mechanisms we can employ to get answers to those questions is a 9/11 style Commission.”

Examining Other Healthcare Models

Healthcare is highly valued by our society, yet it seems that many of our pundits and politicians are willing to create a new healthcare system from whole cloth. In other words, let's consider this or that experiment, and the winner will be the compromise melange that gets passed by Congress. (Definition of melange: a collection containing a variety of miscellaneous things.)

Well, we already experimented with the theory that government was the problem, tossing strict regulation (of banks, mortgage providers, stockbrokers, the food and drug industries, and military procurement, to name a few) in the wastebin, and where did it get us? Do we really want our healthcare system to be crafted by a bunch of horse-traders, and laden with pork?

I, for one, don't think we have the time or money for another major social experiment. I think it is time to put the available information to work to craft a system that we know will meet our needs, before we put it into place.

So far, there has been deafening silence on the subject of healthcare systems in the rest of the world, and what is wrong and right with them. Yet these models can tell us so much about how different programs are likely to work. We should be examining the other systems under a microscope right now, as the administration and Congress begin taking positions.

Thankfully, blogger Tim Foley at Change.org has begun this conversation, describing how a low-cost, high tech, high drug use system has led to enviable life expectancy and infant mortality rates in Japan. Enjoy his enlightening piece.

NY Times "Postscript" to Scott Shane's article on Ivins of Jan 4, 2009

A two-paragraph article in today's NY Times, sans byline, appears to end discussion of the so-called "chemical signature" said to identify the source of water used to grow the anthrax letter spores:

On Tuesday at an American Society for Microbiology conference in Baltimore, an F.B.I. scientist, Jason D. Bannan, said the water research ultimately was inconclusive about where the anthrax was grown. An F.B.I. spokeswoman, Ann Todd, said on Wednesday that the bureau “stands by the statements” of Dr. Bannan.

It is a postscript to Scott Shane's major article on Bruce Ivins dated January 4, 2009, which reported that a "chemical signature" of the water in which spores were grown pointed to Fort Detrick, Md.

Revealed: Scientific evidence for the 2001 anthrax attacks

from an article by Debora MacKenzie, who has been knowledgeably reporting on anthrax and bioterrorism at the New Scientist for more than a decade:

. . . Next the team developed highly sensitive tests to screen all 1072 samples for four of the mutations. Eight samples had all four. One came from a flask labelled RMR-1029 that Ivins was responsible for at USAMRIID. The other seven came from cultures taken from that flask, only one of which was not located at USAMRIID. So while these findings show the attack spores came from one of these cultures, the FBI has gone further in concluding the attack came directly from the RMR-1029 flask.

Another question is how the attacker turned the water-based slurry of spores in the flask to the fine, dry powder in the letters. . .

How to Heal the Ailing FDA

Six spot-on suggestions from Steve Nissen, MD to the Obama administration.

Anthrax investigation still yielding findings: Chemical composition of spores doesn't match suspect flask.

Nature article by Roberta Kwok discusses the American Society for Microbiology's Biodefense and Emerging Diseases Research Meeting in Baltimore, Maryland on February 24, 2009. Excerpt:

Joseph Michael, a materials scientist at Sandia National Laboratories in Albuquerque, New Mexico, presented analyses of three letters sent to the New York Post and to the offices of Senators Tom Daschle and Patrick Leahy. Spores from two of those show a distinct chemical signature that includes silicon, oxygen, iron, and tin; the third letter had silicon, oxygen, iron and possibly also tin, says Michael. Bacteria from Ivins' RMR-1029 flask did not contain any of those four elements. . .

NICE on Mars

Merrill Goozner discusses a BMJ article by Nigel Hawke about Britain's National Institute for Health and Clinical Excellence, and how it might help those of us in the less-regulated medical world to get useful information on pharmaceuticals. Excerpts:

The global pharmaceutical industry considers Great Britain's National Institute for Health and Clinical Excellence (NICE) about as welcome as salmonella-tainted peanut butter at a Super Bowl party.

NICE has used independent researchers to compare the effectiveness of new drugs (especially cancer drugs) to what's already available. It then proceeds to establish their value by measuring how much they extend life and wellbeing (the dreaded cost-effectiveness analysis, also independently derived). Finally, the agency provides the information to England's National Health Service, which uses it to determine what services it can provide through its limited budget.

Great Britain also has longer life expectancy, lower infant mortality and health care costs about 60 percent of what we pay in the U.S.

NICE may export its model for profit to -- oh, double the horror -- the U.S. "It's clear that what we do and how we do it is of interest to healthcare systems around the world, regardless of how they are funded," NICE chief executive Andrew Dillon told BMJ.

Good for Business, Bad for Patients?

Excerpts from Dr. Jon Abramson's ABC News Op-Ed:

It's perfect. Pfizer buys Wyeth's pipeline, the behemoth marketing power of Pfizer gets leveraged, the work force gets consolidated and the $22 billion borrowed is read as a sign that banks are willing to lend again...

The core problem with American medicine isn't really access or cost. It's that medical knowledge itself has been turned into a commodity, produced and disseminated with the primary goal of optimizing profits rather than health...

What we've got is a good old-fashioned case of market failure. But understanding the magnitude and consequences of the failure of the market to oversee the relevance and integrity of commercially generated medical knowledge is virtually impossible to see unless you're a corporate insider or have a subpoena to gain access to the unspun scientific evidence (closely held as proprietary information by the drug companies) and other corporate documents...

More pictures +/- the complete exosporium

Here (or here, if you are having trouble viewing the first set of images) is a side by side comparison of the Sandia pictures (from Anonymous) with pictures of 2 different batches of anthrax spores from another paper. One picture shows anthrax spores WITH an intact exosporium, the other WITHOUT an intact exosporium. Clearly the Sandia picture most resembles the one WITHOUT an exosporium. This contradicts Sandia's claim that their picture of the mailed spores has an intact exosporium.

More on health financing (NYT Blog): How Do Hospitals Get Paid? A Primer

Wonderful article by economist Uwe Reinhardt clarifying bizarre hospital charges and third-party reimbursements, and how much of the healthcare dollar they waste. Excerpt:

Americans can be forgiven their ignorance on this issue because, as I put it in a recent paper on the subject, the pricing of hospital services is best described as “Chaos Behind a Veil of Secrecy.”

Army releases some e-mails from anthrax suspect/Frederick News-Post

Article by Justin Palk

The U.S. Army released 33 pages of Bruce Ivins' e-mails Thursday from his account at Fort Detrick.

The e-mails, obtained by The Frederick News-Post under the Federal Freedom of Information Act, span the period from September 1998 through January 2002.

The documents contain 16 threads of communication, some including multiple e-mails between Ivins and his correspondents.

The e-mails all address one of three issues: the work of Ivins and other individuals to plan an international meeting of anthrax researchers in Annapolis for the summer of 2001; discussions of lab research; and in two cases, copies of The New York Times articles about the investigation into the 2001 anthrax mailings that Ivins e-mailed to himself.

The news articles both concern the difficulty investigators had early on in tracking the history and origins of the Ames strain of anthrax used in the mailings.

The Army continues to review additional e-mail messages from Ivins.

In August, the Department of Justice announced it considered Ivins, a U.S. Army Medical Research Institute of Infectious Diseases microbiologist, its sole suspect in the 2001 anthrax mailings that killed five and hospitalized 17 others.

Ivins died on July 27 after intentionally overdosing on acetaminophen.

His attorney has maintained Ivins was innocent.

Defense attempting to block report about anthrax trial/Haaretz

Excerpts from the article:

... IDF soldiers were given seven doses of an anti-anthrax vaccine developed by the Nes Tziona biological institute. But there was no extended medical supervision of the vaccinated soldiers.

A year and a half ago, a group of soldiers vaccinated in the experiment asked the IDF and Defense Ministry for all the details of the experiment, saying they suffered from debilitating side effects. The army and Defense Ministry ignored the request and would not recognize the soldiers as disabled veterans - eligible for benefits from the IDF.

Fixing the financial incentives in medicine

Medco (this is the pharmacy benefits company that settled for $155 million over charges of defrauding the federal government and paying kickbacks in 2006) manager Dave Snow has jumped into the healthcare debate. His idea is to force doctors to prescribe pre-selected treatments: if you diagnose A, you treat with B.

Obviously, Mr. Snow doesn't understand why medicine is an art. You have to take into account preexisting illnesses, risk factors, other medications, drugs allergies, drug intolerances, likelihood of compliance, and patient psychological, social and too often, financial factors to come up with a treatment. And then you should negotiate it with the patient to increase compliance and understanding. That is why B is often not the best choice. (Medco may not even offer B on its formulary, which is an additional reason to choose C.)

Granted, there are numerous problems with our medical system, and there are many possible solutions. In contrast to Mr. Snow, let's look a little deeper at why we have so many problems:

1. The financial incentives are all wrong.

a) You don't get paid more for getting things right: you get paid more for ordering more tests, increasing the number of visits, and spending the shortest possible time with the patient. Four fifteen minute visits pay almost twice as much as one hour-long visit. Spend an hour performing a detailed evaluation of a complex patient, get the diagnosis right and bingo! you have just forfeited reimbursements for additional visits, as well as earning considerably less for the hour you just spent than if you had seen patients with 4 sore throats.

b) You don't get paid for keeping people well, in general.

c) Outcome measures are rudimentary. Doctors are currently graded on whether a sufficient proportion of patients have regular mammograms, PAP tests and vaccinations, and whether their patients with chest pain receive appropriate emergency medications. But these measures indicate nothing about the proportion of correct diagnoses, or patient satisfaction. And they may incentivize bad behaviors. For example, the reasonable requirement to give all patients with pneumonia an antibiotic within 4 hours of ER arrival led to excessive antibiotic prescribing in every patient who "might" have had pneumonia.

d) Primary care docs are paid very little relative to docs who perform procedures. Procedures rule medicine. High profit procedures like cardiac catheterizations, neurosurgery, orthopedic surgery, and endoscopy subsidize ordinary patient care in hospitals and clinics. Hospitals pay hospitalists considerably more than they can bring in (in reimbursements from third party payers), in part because hospitals cannot function without them, but also because these primary care doctors order more lucrative tests and procedures on their patients.

e) Due to concerns about malpractice and meeting patient expectations (most patients expect that everything that can be done for them, will be done) doctors order more tests and procedures than are justified by existing guidelines.

f) The medical literature is contradictory on an enormous number of medical issues, so doctors are hard-pressed to trust the literature to give them the best or most accurate answers...leading to increased testing and procedures, since our culture punishes sins of omission much harder than sins of comission, or "doing too much."

g) The negative results of "doing too much" fail to be acknowledged or quantified. How many cancers are caused by unnecessary CT scans? I have no idea. How many patients die after undergoing cardiac catheterizations, when a medication adjustment might have been as effective? Studies of such questions fail to be published in major journals and do not appear to have affected clinical practice.

h) Professionalism currently demands from doctors that they meet the "standard of care" provided by other local practitioners. In part because the medical system is so complex, and there are so many medical tests, procedures and specialties, our expectation of ourselves as practitioners is more about ordering the right test and referring to the right specialist, rather than correctly diagnosing the patient. We expect that the test or the specialist will provide the answers if we do not have them. Cognitive skills have been devalued.

There is little financial or professional incentive to keep studying and struggling to find answers for the most challenging patients. And no financial or other reward if you succeed.

More later...

Coated and uncoated spores may look alike

Pictures of coated and uncoated spores are here, courtesy of Anonymous.

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

Global Security Newswire article
National Journal Group

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

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.

Critique of the "chemical signature" assertion and other points by Barry Kissin

Barry Kissin, an attorney in Frederick, Maryland, analyzes several assertions in Scott Shane's January 4 article, by reviewing media and other reports published since 2001. These include the unsupported claim that the "chemical signature" of the water used to grow the letter anthrax could only come from Frederick, Maryland, and that other US government and quasi-governmental biodefense laboratories have been ruled out as sources.

Frederick Police Report out

The Frederick Post has made available a pdf of the Frederick Police Department report regarding its investigation of Ivins' last days.

I have several questions after reading this material. First, I would assume that Ivins made two trips to the Giant Eagle pharmacy an hour apart in order to drop off prescriptions then pick up the medications. The police report claims he purchased one bottle of 70 tylenol pills. Scott Shane said he purchased two bottles of tylenol PM, which includes benadryl, one during each visit to the pharmacy. Prior reports (and one mention in this police report) indicated he ingested tylenol with codeine, which would have required a prescription, and does not appear to have been purchased on July 24.

Thus it still remains unclear what he purchased, what he had available at home, and how much tylenol (and other substances?) he may have ingested. There should have been investigations of the contents of the orange soda and red liquid found in Ivins' bathroom and bedroom, respectively, but the police report fails to indicate whether these materials were collected and studied.

Second, Ivins' disclosure to the Red Cross of his medical history provides support for the hypothesis that Ivins suffered from chronic medical problems that are commonly found in patients who become ill following receipt of anthrax vaccinations. He reported chronic pain issues ("back/joint/bone problems" for which he took neurontin, lidocaine patches, aleve and diazepam); psychiatric issues ("anxiety/PTSD/Bipolar Disorder" and "depression"); and sleep apnea.

All 3 are among the most common symptoms that occur as sequellae of anthrax vaccine, as noted by me but also by the Vaccine Healthcare Centers Network, which screens many patients for sleep apnea. This diagnosis is relatively rare in thin males, but has occurred in 80% of those disabled males I have evaluated in the past 3 years for the sequellae of anthrax vaccine. All those patients had chronic widespread pain disorders and psychiatric sequellae as well.

Third, Ivins had rhabdomyolysis and (probably secondary) renal failure when he arrived at the ER, in addition to the subacute sequellae of liver failure (presumably from a tylenol ingestion). It is not clear what led to his developing this, which seems to have significantly added to the severity of his final illness. Release of more medical information would help clarify whether the known facts fully explain the medical consequences Ivins experienced.

NYT: Portrait Emerges of Anthrax Suspect’s Troubled Life

Scott Shane's newest, detailed exploration of Bruce Ivins can be summarized in Shane's statement, "unless new evidence were to surface, the enormous public investment in the case would appear to have yielded nothing more persuasive than a strong hunch, based on a pattern of damning circumstances, that Dr. Ivins was the perpetrator."

Let me make a few comments on this very detailed story.

...anthrax specialists who have not spoken out previously said that, contrary to some skeptics’ claims, Dr. Ivins had the equipment and expertise to make the powder in his laboratory.

He may well have--but this begs the bigger question of how long it would have taken and whether he could have done so without being detected.


And most importantly:

The science alone could not close the case. “We could get to a lab, to a refrigerator, to a flask,” said Dwight E. Adams, the F.B.I. laboratory director until 2006. “But that didn’t put the letters in anyone’s hand.”

As the bureau’s undercover informant, Dr. Haigwood struck up a breezy e-mail correspondence about scientific grants, pets and travel. Dr. Ivins complained about psychological screening and other “rather obnoxious and invasive measures” imposed at Fort Detrick since the anthrax attacks.

Dr. Nancy Haigwood believed Ivins was the culprit and had additionally, "damaged my property, he impersonated me and he stalked me.” She was afraid he would send her an anthrax letter. Her goal in renewing their friendship was to get him to incriminate himself. So any evidence resulting from their correspondence would need to be viewed from this perspective and in its entirety.

Dr. Ivins still carried resentment from four decades earlier at Lebanon High School in Ohio, where he had been a nerdy, awkward teenager devoted to photography and, even then, to the study of bacteria.

What percent of Ph.D. scientists did not feel nerdy, awkward and excluded as teens, I wonder? (I do not mean to target scientists. The teen years are awkward for most people.)

Though a public debate had raged for years over whether the mailed anthrax had been “weaponized” with sophisticated chemical additives, the F.B.I. had concluded early on that it was not.

The jury is still out on this issue, but many believe otherwise.

By 2004, secret scientific testing established that the mailed anthrax had been grown somewhere near Fort Detrick.

Presumably this comment refers to properties of the water used to grow anthrax; whether such analysis can reliably pinpoint the Frederick, Maryland area remains open to question.

Rockefeller vows fight on Gulf War syndrome

Excerpted from an article in the December 29 Charleston, W.V. Daily Mail:

.... The senator said it was shameful that neither the Department of Defense nor the Department of Veterans Affairs acknowledge Gulf War syndrome as a real illness.

"We were stonewalled by the DOD in hearing after hearing after hearing," Rockefeller said of several meetings on the issue since the early 1990s. "They thought we were wrong, crazy, and came up with some kind of cockamamie theory. No matter what we produced, they'd send it back and call it nonsense..."

"My attitude is that we should never stop fighting until they get the money and benefits they need," Rockefeller said. ... he'd continue to push for those veterans as a member of the Senate Veterans Committee. He also is set to begin his tenure as chairman of the Senate Commerce Committee."

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.

Emergent Biosolutions wins $364M anthrax vaccine award

This week DHHS contracted to buy 14.5 million more doses of EBS' anthrax vaccine. It has already purchased about 25 million doses for a civilian stockpile. This supply may be where the vaccine for first responders will come from. GAO reported in 2007 on the large losses DHHS will incur when the anthrax vaccine outdates; vaccinating first responders may be a way of rotating vaccine stocks.

NAS Study May Fail to Settle Anthrax Case: Science Magazine

The October 3 article by Yudhijit Bhattacharjee (below) discusses the FBI's request to NAS. How can the National Academy of Sciences answer whether the scientific work would meet evidentiary standards in a court of law? They are scientists, not lawyers.

The Federal Bureau of Investigation (FBI) has provided the U.S. National Academy of Sciences (NAS) with a list of 15 questions that it wants the academy to consider in its review of the scientific evidence in the FBI's case against Bruce Ivins, the Army microbiologist implicated in the anthrax letter attacks of 2001. Besides asking whether the genomic analysis carried out to trace the source of the anthrax was valid, the questions address aspects such as the source of silicon found in the spores and whether the attacker needed specialized equipment to grind the spores into an easily dispersible powder.

But even before the academy frames the scope of the study and seeks approval from its governing board, members of Congress and bioterrorism experts are voicing concerns that a purely scientific review won't counter skepticism that Ivins, working solo, was the perpetrator of the attacks. One expert calls the FBI's request "a nice little jujitsu move" to deflect attention from nonscientific questions about the investigation, such as how the FBI ruled out all the other individuals who had access to RMR-1029, the flask of anthrax under Ivins's control. Last week, those concerns prompted Representative Rush Holt (D-NJ) to introduce legislation proposing a commission--similar to the one that investigated the 11 September 2001 terrorist strikes--that would review all the evidence in the case.

Since Ivins committed suicide on 29 July, FBI officials have unsealed court documents that detail part of the scientific evidence linking the anthrax in the letters to the flask under Ivins's control at the U.S. Army Medical Research Institute of Infectious Diseases at Fort Detrick, Maryland. By requesting the NAS study, the FBI is essentially subjecting that evidence to peer review in lieu of a jury trial. The last question on the FBI's 15 September list is whether "testimony regarding the methods used to link the mailed anthrax to RMR 1029" would meet evidentiary standards in a court of law.

Gregory Koblentz, a biodefense researcher at George Mason University in Fairfax, Virginia, says even for a scientific review, the questions posed by the FBI don't go far enough. He and Alan Pearson of the Center for Arms Control and Non-Proliferation in Washington, D.C., want the academy to ask more probing questions about the science as well as undertake a broader investigation; they are submitting their suggestions to NAS. For example, says Pearson, referring to a question on the FBI's list, it isn't pertinent to ask whether "Bacillus anthracis samples dried with a rudimentary methodology can pose an inhalation hazard resulting in pulmonary anthrax. Of course they can. The question is whether [this method] can produce anthrax like that found in the letter."

"Our aim here is to lay out the facts gathered in this investigation and be as transparent as we can," says FBI spokesperson Paul Bresson. "That is all we can do and all we can control. As we have stated previously, we would have preferred to have brought this case to trial."

JAMA: CDC Spins the results of its multicenter trial of EBS's licensed anthrax vaccine

1. Omitting one dose, and injecting the vaccine deeper into muscle was widely reported to reduce adverse effects. But only brief local reactions at the skin are reduced, as one might expect with a deeper shot. The occurrence of the more consequential systemic adverse events was "not significantly influence[d]" by route of administration.

2. Women continued to have signficantly higher local and systemic event rates (approximately double the systemic adverse event rate of men) as has been reported in 4 previous studies since 2001.

3. Immunogenicity was assessed by using a measure relatively unique to anthrax vaccine: the geometric mean concentration and geometric mean titre of anti-PA antibody, as well as a fourfold rise in titre. In several animal models, antibody titres have not corresponded with survival rates following anthrax exposure. There is still no direct measure of efficacy in humans for this vaccine, in any published literature or manufacturer submission, although required by FDA regulations. (The FDA's Animal Rule, which includes ways to use substitute animal data for this requirement, has not been used to license this vaccine.)

4. There were 229 serious adverse events reports (including 7 deaths) filed with VAERS during the study, and a number of people were withdrawn from the study at the direction of the principal investigator due to adverse events. Yet the Data Safety Monitoring Board rated only seven subjects' adverse events as possibly related to the vaccine. The problem with this is that there is still no standard to tell us the kinds of reaction caused by anthrax vaccine; the package insert fails to provide this information, and one goal of this study originally was to learn about the reactions by comparing the vaccinated and placebo groups. That has not been done.

5. Despite the fact that this report provides no meaningful data to suggest EBS' anthrax vaccine is either safe or effective, the study is being used by CDC to ask its Advisory Committee on Immunization Practices to make a new recommendation for anthrax vaccine use in civilian first responders at its next meeting on October 22, 2008.

FBI won't release details on anthrax suspect

Thanks to Marisa Taylor at McClatchy Newspapers for this well-researched report on where the release of the records stands, and how the FBI justifies withholding these records.

Nature: Silicon highlights remaining questions over anthrax investigation

Nature discusses weaponization and silicon, but not much new yet.

Another anthrax accident was reported at Fort Detrick in 2002

A letter published in the Journal of Environmental and Occupational Medicine, April 2004 described two lab workers using standard procedures to grow and handle anthrax at USAMRIID. Despite this, medium leaked from a flask and spores were recovered from the nares of one of the workers. The potential for inhalation anthrax was considered serious, and the worker received an extra vaccine booster dose and both took cipro for a month.

There was also a case of cutaneous anthrax reported in a lab worker in Texas in 2002 (MMWR 2002;51:482). It appears Ivins' accident was by no means a unique event.

Congressman Rush Holt files HR 7049

Following two dissatisfying Congressional hearings on the anthrax letters, and in the 110th Congress' final week, Congressman Rush Holt filed HR 7049 as a shot across the bow: he is serious about getting to the bottom of the anthrax letter attacks. The 111th Congress will have to pick up this ball and run with it, following a change in Administration.

HR 7049: To establish the National Commission on the Anthrax Attacks Upon the United States, to examine and report on the facts and causes relating to the anthrax letter attacks of September and October 2001, and investigate and report to the President and Congress on its findings, conclusions, and recommendations for corrective measures that can be taken to prevent and respond to acts of bioterrorism.

Biotechs Get Rival Deals To Build Anthrax Vaccine

The Washington Post reports on $113.6 million in government contracts to develop new anthrax vaccines. Two rival biotechs -- Emergent BioSolutions of Rockville and PharmAthene of Annapolis -- announced yesterday that they received separate federal development contracts. This is further evidence that, despite a $448 million contract landed by Emergent to supply 18.75 million doses of anthrax vaccine, the Emergent/Bioport vaccine is unsatisfactory and must be replaced--primarily due to its weak efficacy, required yearly boosters and frequent serious (and permanent) side effects.

FBI Proposal to NAS

Here is the FBI letter to NAS with a list of questions for NAS to address. Perhaps of interest, it is dated September 15, the day before the first Congressional hearing, but fails to commit to the study financially until October. NAS was not aware of the FBI's interest in moving forward until Director Mueller announced it at the September 16 hearing.

NYT: Anthrax-Case Affidavits Add to Bizarre Portrait

A judge unsealed a new batch of court documents in the anthrax case on Wednesday, at http://www.usdoj.gov/amerithrax/

FBI investigation did not analyze anthrax from biodefense lab

USA Today: The FBI never examined anthrax samples from the 2001 contamination event at (Ivins') biodefense lab, which he allegedly covered up after the anthrax mailings. Yet these samples should have been the first to examine once Ivins was deemed a suspect.

Additional comments by Dr. Popov on producing anthrax

1. I agree with all scientific conclusions [of the Analytical Chemistry article] except for the one that the silicon in the spore coat excludes its artificial origin. Sandia people think about the exosporium as an absolute barrier for small molecules but it is a diffuse, loosely-bound, and permeable layer. We can think about the spores as impregnated with the silicon compound. It may be true that the silicon did not help make the spores more dispersable, but it was added on purpose. See the following:

PERMEABILITY OF BACTERIAL SPORES II. Molecular Variables Affecting Solute Permeation. Philipp Gerhardt and S. H. Black, Department of Bacteriology, The University of Michigan Medical School, Ann Arbor, Michigan. J Bacteriol. 1961 November; 82(5): 750-760.

2. In order to test my scenario of the inconspicuous preparation of anthrax powders in the lab by somebody like Bruce Ivins, I estimated the amount of spores required for one letter. The information on internet says that the letters contained about seven to ten grams of material, of which roughly two to three grams were weaponized spores . Federal investigators say the Leahy anthrax powder had not been lost in the letter's opening. The amount, typical of the tainted letters, was 0.871 g .

So, let’s assume it was 0.9 g. According to Dugway and my estimates of the spore weight (based on the spore size of 1 micron^3) one gram of dry spores contains from (0.7 to 1)x10^12 spores. It is (0.6 to 0.9)x10^12 spores/letter. If the Bruce anthrax was 3x10^9/ml, it would take him at least 200 ml of the spore suspension per letter from the flask he possessed. For all five letters, he must have used up the whole one-liter flask. The solid medium process in the lab gives us 5x10^9 spores from a regular Petri dish. It would require at least 100 plates/letter. This number of plates is impossible to handle inconspicuously. In any case, if the amount of powder in the letter is correct, and the spores constitute the majority of it, there is more than a 10-fold discrepancy between the required amount of spores and the amount the perpetrator could have covertly taken from the flask or prepared on the agar plates. This bolsters a hypothesis of the fermentor-cultivated spores at the microbiological facility.

Interestingly, the powder from the first letters sent on Sep 18th to NY contained a lot of unsporulated bacteria. It is impossible to imagine that the powder of this quality could have been prepared for the military experiments by knowledgeable personnel. They would certainly discard the prep. Was the perp in rush to prepare the spores as quick as possible to make a connection with 9/11and therefore, by mistake, stopped the fermentation before the culture sporulated completely? It was only a week between the bombing and the mailings – very tight but possible schedule for this kind of job, if all the equipment was readily available. The next preps were more successful, but took longer. Has the equipment been previously used to cultivate B. subtilis for training purposes? This would be consistent with a contamination. Again, it indicates availability of a facility, and I’m afraid to say – a team effort, which is something fundamentally different from a lonely Bruce using Petri dishes and alyophilyzer.

3. The perpetrator did not have to use plates, but it is the simplest way. However, I disagree with the investigators’ time estimate. 3 to 7 days for several grams of spores? Have they tried to do it themselves? Running a fermentor and drying spores is not a 3-day job. It is not enough time even for a growth and sporulation on plates (we harvest spores on the 5th day). As I said earlier, a week is a very tight schedule. For a fermentor, there are additional steps of growing the seeding cultures (one or more days, depending on the volume). And fermentation cannot be accomplished during the evening hours only. By the way, did Bruce have access to the fermentor?

The theory of fermentor can only stand if other people were aware of the perpetrator’s experiments. If we accept this, we ought to conclude it was a collective effort at the well-equipped facility: it wasn’t just Bruce alone.

Tracing KIller Spores: The science behind the anthrax investigation.

News article from the journal Analytical Chemistry

NYT: Critics of Anthrax Inquiry Seek an Independent Review

Article by Scott Shane

September 23, 2008

WASHINGTON — Congressional critics of the F.B.I.’s anthrax investigation are seeking an independent review of the seven-year inquiry to assess the bureau’s performance and its conclusion that an Army scientist, Bruce E. Ivins, carried out the 2001 attacks alone.

Rush D. Holt, Democrat of New Jersey, would create a national commission on the anthrax attacks, a scaled-down version of the commission that studied the Sept. 11, 2001, terrorist attacks. Two Republican senators, Arlen Specter of Pennsylvania and Charles E. Grassley of Iowa, said they would not rule out a commission but thought a Congressional investigation or a series of hearings might work.

“Ultimately I may join Congressman Holt on this,” said Mr. Specter, the top Republican on the Judiciary Committee, who served in 1964 as assistant counsel to the Warren Commission on the assassination of President John F. Kennedy. “But first we need to decide whether the Judiciary Committee can do the job.”

Beth Levine, a spokeswoman for Mr. Grassley, said he supported Mr. Holt’s goal but feared a national commission might prove too expensive and time-consuming.

The proposals came a week after the Federal Bureau of Investigation’s director, Robert S. Mueller III, said he had asked the National Academy of Sciences to review the scientific aspects of the investigation. Mr. Holt and the two senators said they thought a review by the academy would be too narrow to resolve the case.

“They’ll give us a scientific analysis of the anthrax,” Mr. Specter said. “I don’t know that they can cover the broad spectrum of the adequacy of the investigation.”

Mr. Holt said that in addition to assessing the bureau’s detective work and management of the investigation, a commission could gauge the bioterrorist threat and consider how attacks might be prevented and how they should be investigated.

Mr. Holt’s draft bill calls for an 11-member commission appointed by the president and Congressional leaders. The commission would have subpoena power, would hold public hearings and would complete its report in no more than 18 months.

An F.B.I. spokesman, Bill Carter, declined to comment on the commission proposal but noted that Mr. Mueller said at a hearing last week that he was “absolutely open to third-party review” on the case.

Days after the July 29 suicide of Dr. Ivins, a microbiologist who worked on anthrax vaccines at the Army’s biodefense laboratory at Fort Detrick, Md., F.B.I. and Justice Department officials said he alone had mailed the anthrax letters, which killed five people.

Since then, colleagues and friends of Dr. Ivins, bioterrorism experts and members of Congress have said they do not believe the evidence the bureau has released proves he did it.

Congressional probe more than warranted

Editorial from the The New York Post, reprinted in the Troy, NY Record:

The often-partisan Democratic-run Congress has found a worthy target for the legislative branch's constitutional oversight responsibilities: The FBI anthrax investigations.

The House Judiciary Committee notified FBI Director Robert Mueller that oversight hearings will focus on the bureau's investigation of Dr. Bruce Ivins - and the conclusion that he was solely responsible for the 2001 anthrax attacks, which killed five people and injured 17 others.

Ivins committed suicide this summer when his name surfaced.

After his death, the bureau held a press conference to discuss the evidence pointing to Ivins' guilt. Yet the press conference raised nearly as many questions as it answered - including the FBI's admission that the sample of a unique strain of anthrax that it got from Ivins back in 2002 was discarded because he hadn't followed proper protocol. It took the bureau another four years to obtain a duplicate sample.

Meanwhile, reports surfaced recently that, in April 2007, just as the FBI linked the mailed anthrax to samples in Ivins' labs, he was notified by prosecutors that he was "not a target" of the investigation.

Hovering over all this, of course, is the recent FBI history of misidentifying individuals in high-profile cases. Indeed, another scientist in the same laboratory - Stephen Hatfill - was previously identified by the FBI and remained under a cloud for nearly five years. The government finally paid Hatfill $5.8 million this year as compensation for smearing his name.

That, in turn, was reminiscent of what occurred to Richard Jewell (wrongly identified as the Atlanta Olympic Park bomber in 1996) and scientist Wen Ho Lee (falsely accused of selling technology secrets to the Chinese).

Had Hatfill snapped from the pressure of FBI suspicion and taken his life, would the FBI have been crowing over how "sure" they were that that he was the guy thus eliminating the need for further investigation? Hard to say.

But a congressional probe is more than warranted. After years of sloppiness, the FBI has lost any benefit of the doubt.

The American people deserve to have Congress take an independent look a the entire anthrax investigations - if only to render an objective assurance that the real culprit actually was identified.

Overcoming Anthrax Doubts (Las Vegas Sun)

SUN EDITORIAL:

Overcoming Anthrax Doubts: Panel that will review government investigation of attacks must be independent (September 20, 2008)

The FBI, the U.S. attorney for Washington, D.C., and postal inspectors did not convince everyone last month when they laid out their case against the late Army microbiologist Dr. Bruce Ivins.

Ivins, they said with surety, committed the anthrax attacks that took place in September and October 2001. The attacks killed five people, injured 17 and spread fear that terrorists responsible for 9/11 were branching out into biological warfare.

But not everyone was sold on the federal officials’ presentation, which followed Ivins’ apparent suicide ["apparent" as there was no autopsy--Nass] July 29 as federal agents were finalizing their largely circumstantial case against him.

Skeptics include members of Congress, who are still expressing concern that the case, which for years focused on another Army microbiologist, has not been fully solved.

Sen. Patrick Leahy, D-Vt., chairman of the Senate Judiciary Committee, told FBI Director Robert Mueller at a hearing Wednesday that he believes the anthrax attacks involved more than one person.

One of the anthrax letters was addressed to Leahy. That letter, which never reached the senator, was the likely source of an anthrax infection contracted by a government mail worker.

Sen. Arlen Specter of Pennsylvania, a former chairman of the Judiciary Committee who today is its ranking Republican, also expressed doubts. He was rebuffed when he demanded that some of the scientists who will do an independent review of the Ivins investigation be selected by the Judiciary Committee.

Mueller had announced Tuesday that, partly owing to pressure from members of Congress, he will ask the National Academy of Sciences to conduct the review.

Responding to Specter, Mueller said he would consider his request, but the academy and the Justice Department would likely have to agree to it.

Specter responded: “What’s there to consider, Director Mueller? We’d like ... to name some people there to be sure of its objectivity. We’re not interlopers. This is an oversight matter.”

Specter is right. To help prevent doubt from lingering forever, the public — and Congress — must be assured the review panel is indeed independent.

Seven Years Later: Electrons Unlocked Post-9/11 Anthrax Mail Mystery

Scientific American today posted an article on the Sandia anthrax investigation performed by materials scientists. I'm not sure how much it adds to the weaponization discussion, and it includes some minor errors, but does expand on the role and timeline of Sandia's work for the anthrax investigation.

Comments by Professor Sergei Popov on anthrax and on Dr. B.H. Rosenberg's paper

Dr. Popov worked in the former Soviet Union's Biopreparat Program and is a professor at George Mason University. Having met with him several years ago, I can attest to his impressive knowledge of anthrax. Here he demonstrates a deep understanding of the principles of weaponization.

Some of his other comments include the following:

1. The Sandia pictures completely agree with my expectation of partially collapsed exosporium. It may be still there but hard to detect in the dry spores. Treatment of the B. subtilis spores with urea helped reveal the exosporium-like layer (A picture from Nature 263, 53 - 54 is on the second of the attached slides). Please notice the similarities with Sandia spores. This technique could be useful to determine the amount of exosporium in Sandia samples. Your calculations present a strong argument that the silicon content is unnaturally high. However, I’m in doubt that the highly variable amount of Si in the samples can be used as a reliable forensic marker on par with genetic ones. The anthrax attack was a deliberate action, and there is nothing surprising to learn that the spores were treated deliberately. Can this conclusion help identify a particular perpetrator?

2. The nature of debris clearly visible in the spore prep is intriguing. It looks quite similar to dry agar from a Petri dish

3. I think you may overestimate the technical difficulty of the siliconization. It may be just a drop of an old-style school glue (liquid glass). A well-developed technology is supposed to give consistent results, but we see a high variability of the Si content, which indicates experimentation with different treatments. In your opinion the perpetrator is primitive and this effectively exculpates Detrick. In my opinion, even at Detrick there could be people with a creative mind who know chemistry beyond written protocols.

4. I don’t know what the FBI has tried for reverse engineering. Did they even consider soluble silicates, not siloxanes? I guess we have to admit that the perp was/is a clever guy. Why should he leave a trace ordering a reagent if it was available from Wal Mart? The person obviously realized the possibility to be traced back and therefore took advantage of his unique knowledge of how to accomplish his task in the most inconspicuous way possible?

5. As I wrote, a familiar example is the drug Simethicone, which is the active ingredient in drugs such as Gas-X. Simethicone is generally available over the counter under many trade names in varying dosage sizes, including: Flatulex, Baby's Own Infant Drops, Gas Relief, Gas-X, Genasyme, Maalox Anti-Gas, Maalox Max, etc. The use of antifoaming agent such as Simethicone will result in detectable Si without other inorganic component. I’m not talking about a paper glue, which is a pure sodium silicate.

Anthrax Suspicions (Washington Post Editorial)

Anthrax Suspicions: Why an independent look at the FBI probe is essential

Friday, September 19, 2008; Page A18

THERE'S NO better proof of the need for an independent review of the FBI's anthrax investigation than the words of Sen. Patrick J. Leahy (D-Vt.). Mr. Leahy was one of the intended recipients of anthrax-filled letters sent in 2001. Chairing a Senate Judiciary Committee hearing Wednesday at which FBI Director Robert S. Mueller III testified, Mr. Leahy rejected the agency's assertion that government scientist Bruce E. Ivins acted alone in creating and dispensing the deadly spores that killed five people and sickened 17 others.

"I believe there are others involved, either as accessories before or accessories after the fact," Mr. Leahy said. "I believe there are others who can be charged with murder." Mr. Leahy's skepticism was echoed by GOP Sens. Arlen Specter (Pa.) and Charles E. Grassley (Iowa).

Mr. Mueller said this week that the FBI would turn to the National Academy of Sciences to review the novel genetic fingerprinting test the bureau developed to identify the unique spores used in the attacks. The bureau says that test enabled it to trace the spores to a vial in Mr. Ivins's lab at Fort Detrick in Maryland. Agreeing to a review of its lab work is a good if belated first step, but it does not go far enough: Even if the FBI got the science right, it still must explain how and why it eliminated from suspicion some 100 other people who had access to the vial.

Because Mr. Ivins committed suicide in July, as the government was close to indicting him, the evidence will not be tested in a court of law. Serious missteps throughout the investigation -- including the original identification of a different Fort Detrick scientist as the FBI's top suspect -- demand that all of the bureau's work be examined by an independent commission or the Justice Department's inspector general.

The FBI does not do itself or the public any favors by rolling out its evidence in the anthrax matter in a piecemeal fashion. If anything, its attempts to share pieces of information and justify its conclusion have raised more questions than they have answered. The FBI may very well be right that Bruce Ivins was the anthrax killer and that he acted alone. But the only way to ensure confidence is to subject its work to a comprehensive outside review. That is the right approach for victims, survivors and would-be victims such as Mr. Leahy; for Mr. Ivins's family; and for the public.

More on the Senate hearing

Webcast of the hearing can be viewed here

Remember Senator Grassley's 18 questions about the case, posed to the FBI on August 7? They have still not been answered. Senator Grassley was very impressive during the hearing: logical, refusing to be sidetracked, steady like a bulldozer. He also submitted a Statement for the Record, from which the following is taken:

Dozens and dozens of serious questions remain unanswered...there needs to be a substantive, in-depth, and independent inquiry of the sort that only Congress can conduct at this point. I challenge Director Mueller to embrace this sort of scrutiny and open the FBI's files on this matter for inspection by representatives of the American people. I challenge the leadership of the Senate and this Committee to put the time, resources and energy necessary into conducting a thorough review in which the public can have confidence.

I have a question for FBI Director Mueller. During both hearings he noted how much he "abhors leaks." Then why did FBI try to convince us of Ivins' guilt using a crescendo of leaks? Many were unsubstantiated, while some of the leaked events had been orchestrated by FBI. Then, following criticisms of the 'leak method' in the media, FBI official John Miller apologized.

If Mueller so abhors leaks, why has no one been punished for them, and why have they been so carefully aligned with the FBI's game plan for this case? The Bureau looks more like a public relations agency than a law enforcement agency these days. How much farther can its credibility fall?

Jahrling: Honest Mistake

An LA Times article by David Willman discusses an email response by virologist Peter Jahrling, one of the first people to examine the Daschle anthrax, and to remark repeatedly on its properties that indicated deliberate weaponization:

After being informed of the events at the (9/16/2008 House Judiciary Committee) hearing, Jahrling renounced his earlier analysis. "In retrospect," Jahrling said, "I believe I was mistaken and defer to the experts."

In "The Demon in the Freezer," a 2002 book by Richard Preston, Jahrling:

...said that USAMRIID had found that the anthrax powder in the letter mailed to Senator Daschle was "professionally done" and "energetic". By "energetic" he meant that the particles had a tendency to fly up into the air if they were disturbed.

Please see Comments 3 and 4 for an informed and referenced discussion on this.

Mueller was also interviewed by Preston. He attended Jahrling's White House briefing, and:

Mueller thanked the Army for bringing the nature of the anthrax to the FBI's attention. He said that the FBI had received conflicting data on the anthrax. The FBI had been trying to sort this issue through, but Mueller now acknowledged that the Army had been right: the Daschle anthrax was a weapon.

Well, Jahrling may be correct now. Or he may have been correct then. Same goes for Mueller.

Senate Judiciary Hearing 9/17/2008

Webcast of the hearing can be accessed here.

Eight senators attended some of today's hearing, and had a lot more to say about the anthrax letters. The Washington Post, AP, Reuters, USA Today and Salon (Glenn Greenwald) have all posted reports of the hearing, in which the FBI was lambasted over the letters case. Most notably, Senator Leahy told Director Mueller he was convinced that if Ivins was a culprit, that he had not acted alone, and Leahy was convinced there are more persons who can be charged with murder.

Senator Spector wanted to know why there was no attempt to obtain DNA from Ivins until the week he died. (Since it takes a while to die from tylenol, it is possible the DNA wasn't obtained until after Ivins overdosed.) He asked why Ivins received an April 2007 letter indicating he was not a target of the investigation; whether the anthrax was weaponized or not; how did FBI come to its conclusion when the investigation is still ongoing; and he noted that so many questions have yet to be answered.

Leahy asked whether any US facilities besides Dugway and Battelle were capable of making this kind of anthrax. Mueller tried to muddy the water by responding about how many facilities had Ames, but the Senators weren't buying it. Leahy told him to make a call and get some answers during the break.

Senator Spector asked if the committee could designate members of the NAS committee performing the review, and Mueller refused to commit to this.

Senator Grassley noted that the NAS would not be reviewing the FBI investigation, only the science--not the detective work, and said both need to be reviewed. He also wondered when the FBI learned about Ivins' late nights in the lab: 2002, and why it took 5 years to focus on Ivins. He also asked why it took so long (until after the death of Ivins) to exonerate Hatfill. Mueller also "abhorred" the Hatfill leaks.

After the break, Mueller requested a closed session to discuss the matter of labs making anthrax powder, since the subject was classified. Leahy agreed to arrange this.

Senator Cardin wondered why Ivins maintained his security clearance until July 10, 2008. Mueller replied that Ivins' access to some facilities at USAMRIID had been limited earlier.

Grassley wanted to know if Ivins' flask contained silicon, but Mueller was "out of his expertise" on that question. (Why were the four officials sitting behind him keeping quiet for these questions, I wondered?)

It was gratifying to see that the Senators grasped the essentials of the Ivins case, and were asking the right questions. But it was disheartening to hear them say how badly the FBI and Attorney General had responded to their questions and concerns in the past, and how they were unable to perform their oversight function due to stonewalling on the part of the executive branch agencies. Senator Whitehouse even used the word "Toadies" to describe appointed agency officials who were required to "bow down" to the White House, ignoring agency needs and failing to provide the administration with appropriate feedback.

So whether anything will come of this exercise in legislative branch oversight is anyone's guess.

FBI Director Mueller Not Forthcoming

The House Judiciary Committee hearing can be viewed here.

Eleven or twelve members attended the House Judiciary Committee's FBI oversight hearing today. Repeatedly, they expressed disappointment with the FBI's continuing failure to answer their questions, and to respond to written questions. Director Mueller only produced a written response to the Committee's September 5, 2008 letter last night, and copies were not made available to the audience. His verbal testimony had nothing to do with their questions: instead it was an exercise in cheerleading for the FBI team and proposed new guidelines, which would expand FBI authority. Oh, and by the way: Mueller abhors leaks.

Mueller spoke in generalities, failing to answer specific questions. Rep. Delahunt suggested that the FBI's lack of transparency skirted our system of checks and balances and placed our democracy at risk. Mueller could only reply, repeatedly, that he was happy to sit down "informally" with members, but essentially refused to answer their questions on the record.

Only Rep. Nadler asked about anthrax (details from Glenn Greenwald), and to his credit inquired pointedly about the Silicon signature and weaponization. Mueller had no answers.

Instead, responding to Nadler's question of whether the FBI would cooperate with an independent investigation, Mueller attempted to confuse the issue of an independent investigation, saying FBI was requesting this from the National Academy of Sciences (NAS). However, the NAS will only be asked to review FBI's "microbial forensic" science. (FBI's M.O. is to keep trotting out the genomics, no matter what question is asked.) And NAS didn't even know they were going to get this gig until today's hearing, suggesting NAS' study might just be a bone thrown to the committee to head off a truly independent investigation of the letters case.

FBI's science takes us to a flask, and stops there. I have no bone to pick with FBI's science, although many details have yet to be revealed.

It's FBI's investigation that is unsatisfactory in every way, requiring an independent appraisal. Don't be fooled by an expensive and time-consuming NAS smokescreen.

The Anthrax Case: Congress Must Demand an Independent Inquiry

David Harris of the University of Pittsburgh School of Law says that in light of questions about the FBI's public identification of the late Dr. Bruce Ivins as “the only person responsible” for the 2001 anthrax attacks, Congress should demand an independent investigation to test the government’s evidence of its accusatory claim.

The Black Art of Weaponization

With respect to whether and how the spores were weaponized, I have both feet in the weaponization camp, having reviewed numerous anthrax epidemics and seen nothing like the Senate letters' effect elsewhere, except Sverdlovsk. Yeltsin later admitted the 1979 Sverdlovsk epidemic resulted from a leak of anthrax from a biowarfare program.

However, the problem remains that nearly all research on weaponization is unavailable in the open literature. Although we can make educated guesses about how the letter spores may have been prepared, the only way to be certain is to experimentally demonstrate that a particular method produces an identical product. While the FBI waffles about how Ivins could have dried the spores this way or that way, and they don't really care how, FBI has failed to demonstrate that any of the methods they don't care about would yield the correct product. FBI has further failed to demonstrate that Ivins could dry and prepare the volume of spores used, within the window of time available between September 11 and the mailings.

The new field of forensics has led us to a flask available to hundreds. The old field of weaponization could narrow down that number of suspects considerably, but has remained unexplored.

Since the weaponization field of study is classified TOP SECRET, it will require a classified venue to review this material. What is needed is a scientific and investigative review of the evidence, keeping in mind that this "black art" may be encumbered with more than its share of dis/misinformation.

On Weaponization: Some Contributions from Others

From Sandia is a press release discussing their analysis of the spores

From Dr. Henry L. Niman is a discussion of how some letters only caused cutaneous anthrax, while others only caused inhalation anthrax, strong indirect support for weaponization, since in nature there are vastly more cutaneous than inhalation cases, even in areas where spores are regularly inhaled.

Dr. Barbara Rosenberg presents a detailed and well-referenced discussion of several aspects of weaponization. Unfortunately, I have lost the links she provided, but will try to correct this asap.

An Anonymous Scientist made some salient points as comments to my blog that I'd like to highlight also.

If the case is solved, why isn’t it solved?

The Scott Shane/Eric Lichtblau New York Times article, titled "Seeking Details, Lawmakers Cite Anthrax Doubts," is found in today's Sunday paper, although it went online yesterday. It deserves its own post, because it is so important to this developing story.

It is chock full of interesting information and quotes, like this one about how the FBI solves a multiple murder case:

“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.”

and this one by Senator Grassley:

“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.”

New Information on FBI's Case Against Ivins from NY Times and the FBI Briefing of Aug. 18

Today's excellent NY Times piece by Scott Shane and Eric Lichtblau reveals that Ivins as "sole custodian" of the RMR-1029 anthrax flask was a fiction. The flask was not always stored in Ivins' laboratory, but kept in another building at different times between 1997 and 2001, greatly increasing the number of those who had access to 200-300, and weakening the claim that access was controlled by Ivins. Furthermore, the FBI sent Ivins a formal letter in April 2007 stating that he was "not a target" of the investigation. And the FBI only took a mouth swab for DNA a week before Ivins died.

Careful reading of the August 18 FBI briefing transcript suggests that the FBI became suspicious of Ivins as a result of Ivins' first sample not meeting the requirements of their protocol, and his second sample not containing the expected 4 mutations. An unnamed official at the briefing stated, "We had reason to believe that there was something wrong with the April submission. It didn't have these mutations, and so that caused the investigative team to say that it (sic) might be something more to this." In response to a question about when suspicion first turned to Ivins, FBI's Majidi reiterated what the unnamed official had said: "Investigatively, after we saw various mutations outside the RMR-1029, it all pointed back to RMR-1029, so the question became “Why are we seeing these mutations in these samples, and we know where they're coming from and why are we not seeing it in their origin?” '

Yet the FBI admits this behavior, initially deemed "suspicious," is now being called simply "questionable." And that the protocol for sample submission had not even been established at the time Ivins submitted his first sample. But later another official disagreed, saying Ivins had received a subpoena with protocol before he submitted a sample... yet his was the first (of 1,070 total samples) FBI received. Back in 2002, when Ivins' samples were submitted, the methodology to trace the anthrax origin by looking at variable colony morphologies resulting from insertions and deletions did not exist, so Ivins could not have been specifically trying to thwart it.

The FBI said that all 8 of 1070 Ames samples that had the same 4 mutations as Ivins' first sample came from the RMR-1029 flask originally. How many others of the 1070 samples also came from that flask but lacked all 4 mutations? Choosing a different method to use, or seeking a different set of mutations, may have given a different result. It seems obvious that if a pure culture were obtained from the flask (one or even a few spores) it could not contain all four mutations, since each occurred in less than one per cent of colonies derived from samples in the flask. Might other scientists have submitted pure samples though their culture had an RMR-1029 origin as well? Did the FBI do its own collecting at all the labs with Ames anthrax? I don't think so.

Dr. Keim said during the briefing that Ivins' flask contained about a trillion spores (or enough to fill only half a Daschle letter, if he is accurate). But the flask contained a good portion of 35 separate production runs pooled from Dugway and Detrick. This makes it unlikely that sufficient anthrax to fill the letters could have been made in 3 to 7 days (time for only one or two production runs) using Detrick's standard equipment, as claimed by FBI, unless considerable additional equipment was used.

FBI started screening samples for mutations in 2004, but even then the repository of Ames samples was not complete. It would have been much more likely for someone who submitted a sample after the methodology was developed (in 2004) to attempt to hide his tracks, rather than the person who submitted the first sample (which did contain all 4 desired mutations).

During the briefing, Dr. Majidi implied that the method used to dry the spores was of no interest to the FBI investigation. He was asked if the method wasn't an important part of the evidence, and he said no, the important part of the evidence was relating the 4 mutations to RMR-1029! This reflects unwillingness to grapple with a critical part of the case: how the spores were prepared. Then again, Majidi claimed that there was no special preparation of the letter spores.

If the spores were not specially prepared, then the FBI should have had no difficulty re-engineering their precise preparation, and demonstrating the product to us. If FBI could not reproduce it, then the method by which it was produced is an even more essential part of the case to be solved, not dismissed. (BTW, various officials waffled over whether the spores had a charge, or not, during the briefing.)

In summary, when you read the entire FBI transcript, you are left with the impression that almost none of the questions raised by the scientists and journalists in the audience were answered satisfactorily.

Building on 'Outstanding Questions'

The FBI has completed its disclosures, and the media, bloggers and scientists have spent a month discussing the anthrax letters case and putative guilt of Bruce Ivins. Where does the case stand, and what remains to be answered?

Hoax Letters Remain a Mystery
At least one hoax letter was apparently thought by the FBI to have been sent by the anthrax perpetrator (it was sent from England while Steven Hatfill was training there, and was considered, at least by some, to be part of the case against him). Judith Miller at the NY Times received a hoax letter, and Tom Brokaw received both a hoax letter and an anthrax letter around the same time. Anthrax hoax letters were sent from Florida and possibly other places. It is critical that all these letters be publicly revealed, and that information on fingerprints, handwriting analysis, identification of the envelopes, identification of the tape used (if any) and the ink is compared to the true anthrax letters. If any came from the same source, then the anthrax perpetrator(s) must be able to be placed where they were mailed, in the appropriate time frame. Can any of the (now 200 plus--see Sept. 6 NY Times article) persons who had access to the spores from Ivins' flask be placed in New Jersey and the other locations at the right times? If not, the crime involves more than one person.

Sept. 3 note: Thanks to Ed Lake for pointing out that the Malaysia letter was mistakenly thought to contain anthrax, and was not a hoax letter. He also noted that a letter mailed in Florida had its image included in this article in the Saint Petersburg Times.

Allegations Against Dr. Ayaad Assaad May be Important Evidence
Although the letter sent to the FBI at Quantico suggesting former USAMRIID researcher Dr. Ayaad Assaad was a bioterrorist arrived just before the anthrax cases came to light, that is no guarantee it came from an anthrax perpetrator. But it certainly might have, so its provenance is important, as are other details such as the text of the letter (which allegedly contained details about Assaad that few people would know, suggesting a former coworker was the author), where it was posted, and the type of envelope, stationary, ink, possible saliva, fingerprints, etc. Why has the FBI been so secretive about this letter? Unless it is part of an ongoing criminal proceeding, it should be revealed to Congress and the public. On Sept. 7, Assaad told more of his story.

The Princeton Mailbox May Not be the Original Site Where the Letters Were Mailed
Were the letters originally mailed from the designated Princeton mailbox? The mailbox was not investigated for almost a year after the letters were sent, according to Congressman Rush Holt, whose district included the mailbox location. It has been reported that the mailbox that tested positive for anthrax was also used as a box to store bags of mail, in addition to being a box for mailing letters. Thus conceivably the box was cross-contaminated from mail being stored there, and the letters were originally mailed elsewhere. Learning the concentrations of anthrax found at various boxes and post offices might help support whether the Princeton box was the original site at which the letters were mailed.

Was the question of cross contamination, raised by local authorities in 2002, ignored once the Kappa Kappa Gamma storeroom was discovered near this mailbox?

The perpetrator(s) almost certainly lacked awareness that the spores could freely leave the envelopes. (The edges were taped because the perpetrator thought that was where leakage might occur.) So the perp could have been relatively careless about which mailbox was used, on the mistaken assumption it could not be traced. Seeking a suspect for whom this mailbox would be convenient thus makes a lot of sense, but only if the letter was mailed there, and not if the mailbox was only subject to cross-contamination.

Weaponized Spore Preparation of Senate Letters
A vast amount of contradictory information has been provided to the media regarding the "weaponization" of the anthrax spores in the Daschle/Leahy letters. It is critical that the actual weaponization process be identified and compared with what is known of weaponization techniques explored by US and foreign programs. This part of the investigation will need to be discussed in a top secret venue in order for a complete accounting of the facts to be made. Exploration of this topic must include an accurate description of the spore preparation when the Daschle letter was first opened, by those who first evaluated it, discussion of how it could have been produced (and whether FBI or others have successfully re-engineered the exact preparation) and discussion of the materials and equipment required to produce it. Who had knowledge of this process, access to necessary materials and equipment, and a Biosafety 3 or 4 laboratory, to safely produce at least 14 grams of product to fill at least 7 envelopes? (It is accepted that some of the envelopes contained a simpler, unweaponized form of anthrax, but total production was an estimated 14 grams.)

How Many Letters Were There?
Seven envelopes arrived at or were addressed to the following seven locations: the AMI building (The National Enquirer and several other tabloids were located here), FL; the NY Post, NY; ABC News, NY: NBC News, NY; CBS News, NY; Senator Tom Daschle, Washington, DC; Senator Pat Leahy, Washington, DC. Media outlets from which no letters were found had anthrax cases in employees or visitors. There could have been additional letters sent elsewhere that did not cause diagnosed anthrax infections, and were never found.

How Were Letter Recipients Selected?
The most likely explanation for sending letters to the media was to obtain publicity. Isn't it obvious that an anthrax letter would be worth its weight in gold to a tabloid? The National Enquirer produced a multi-page spread about the anthrax letter it received. I was interviewed for the story. I was also queried about what the AMI employees should be doing to prevent illness. How could you get better publicity than by having the story stare at customers from every supermarket checkout counter in the country? The NY Post was probably chosen for a similar reason: the fact it would be unlikely to suppress a story about an attack on itself. The other NYC media outlets were probably chosen because they are the sources of national TV news.

The Letters Weren't Meant to Kill, Though a Few Deaths Enhanced the Effect. What Were They Meant to Do?
Both the choice of recipients, and the letters' warnings, are the reasons I believe the letters were sent to create a major effect--but not to kill. If you wanted to kill, you would not tell the recipient the letter contains anthrax, and to take penicillin. In the absence of those warnings, there would have been a longer delay before recipients received lifesaving antibiotics, and many more deaths.

If you wanted to kill, you would put the anthrax into the ventilation system of a Congressional or other building (in those days there was no BioWatch system) and wait for the deaths to pile up. The anthrax letters were a "best case" scenario for bioterrorism, designed to give the US Congress and public a taste (and only a taste) of a biological Armageddon.

Why? The logical answer is that the second set of letters were designed to scare Congress members to death. This would induce them and the Administration to spend more money on bioterrorism, and pass legislation that appeared to reduce the likelihood of future biological terrorism or its impact. Examples of affected legislation included the Project Bioshield Act and the Patriot Act. DHHS Secretary Tommy Thompson purchased about a billion dollars' worth of Cipro and smallpox vaccine within weeks of the attack, and insisted on getting the moribund anthrax vaccine manufacturer re-approved and producing. Thompson, now a civilian, continues to reap the benefits through commercial interests in a variety of companies providing bioterrorism services to the government. But other government officials have reaped similar benefits; several are on the board of the anthrax vaccine manufacturer now, including a former Secretary of DHHS, a former Assistant Secretary of Defense for Health Affairs, and a former Assistant Secretary at DHHS.

The letters' messages were a crude attempt to direct blame at the Muslim community. The text, along with the general knowledge that Saddam Hussein possessed anthrax, is likely to have bolstered support in the US for war against Iraq, despite a lack of evidence that Iraq was involved with Al Qaeda and the September 11 attacks. (In marketing, perception is everything.)

Spore Virulence and Repulsion
With respect to the actual "weaponized" (or not) spore preparation in the Daschle and Leahy letters, a little more needs to be said. In factories contaminated by dry spores (such as 4 goat hair mills in the Eastern US in the 1940s and 1950s) virtually no one developed inhalation anthrax (prior to a suspicious vaccine trial) although there reliably occurred one cutaneous anthrax case per hundred person-years in factory employees. There were also subclinical infections in employees that led to immunity, as determined serologically. Inhalation anthrax was extremely hard to acquire, despite a study showing that spores were present in the factories' ambient air, and that hundreds were inhaled daily.

Reasons postulated for the lack of inhalation cases include the fact that spores readily adhere to things in the environment. They become subsumed in particles larger than 5 microns, which stick to the walls of the airways and are excreted. A very high spore count, or very impaired immunity, is usually required to overwhelm the lungs' defenses.

Was silicon, found in an elemental analysis of the spores, a natural occurrence or was it added? How much was found? This too is critical in pinning down the nature of the spore preparation.

Description of the first examination of the Daschle anthrax noted its tendency to repel other particles, rather than stick to them. If a charge were added to the spores, the charge would be expected to dissipate over days or weeks; thus the characteristics of the anthrax could have changed when inspected later. Furthermore, Dr. John Ezzell initially evaluated this anthrax in a high containment lab at USAMRIID. It was later processed before sharing with some other labs, to reduce its lethality. This processing likely changed other characteristics as well.

A charge could also lead spores to re-aerosolize after landing on surfaces, increasing virulence considerably. A UN official, Dr. Kay Mereish, reported that the letter anthrax had in fact been prepared with a charge, according to a 2006 lecture at a CBRN meeting by D. Small, who had worked with the anthrax. Marilyn Thompson reported that the US administration had USAMRIID "tone down" its description of the Daschle anthrax as "weaponized."

So there is reason to question the current FBI assertion that no special weaponization process of the spores was performed, beyond washing. How can a Congressional hearing arrive at the truth of this critical piece of information?

Knowing how the spores were weaponized to produce the Daschle product is essential to finding the perpetrator(s) of the crime. Only a small number of people will have knowledge of any spore weaponization processes, and an even smaller number will know how to prepare spores identical to those in Daschle's letter.

Whether the letter anthrax was made using a US or foreign process, such production (and even development of the process) might be considered to contravene the legal limits of the Biological and Toxin Weapons Convention, to which the US and most nations are party. Thus secrecy and/or disinformation might have resulted from the perceived need to protect an illegal US or foreign program.

Getting to the bottom of the letters' weaponization will yield a very small number of suspects, and at least one will be a guilty party.

House Judiciary Wants Answers From FBI Chief on Anthrax

CQ TODAY ONLINE NEWS
Sept. 5, 2008

By Seth Stern, CQ Staff

Members of the House Judiciary Committee made clear Friday they expect more answers from the FBI about its August announcement that a government scientist was responsible for the 2001 anthrax attacks on Capitol Hill and elsewhere.

Committee members submitted a list of questions they want Director Robert S. Mueller III to answer about the anthrax investigation in advance of his first Capitol Hill appearance since the FBI announced Bruce E. Ivins was solely responsible for the attack. Mueller is to appear before the panel Sept. 16.

Ivins, a microbiologist who worked at a U.S. military research institute at Fort Detrick, Md., committed suicide as federal officials prepared to indict him.

“Important and lingering questions remain that are crucial for you to address, especially since there will never be a trail to examine the facts of the case,” wrote Judiciary Chairman John Conyers Jr. , D-Mich., in a letter co-signed by two subcommittee chairmen.

Among the questions they want Mueller to address are whether White House officials initially pressed the FBI to show the attacks were linked to al Qaeda or Iraq and why another government scientist, Steven Hatfill, remained a suspect in the investigation. Judiciary Committee Democrats also want Mueller to explain why Ivins retained his security clearance after becoming the prime suspect in the attacks....

Anthrax: The Demon in the Mailbox

from the Daily Kos, by Califlander

A few months ago, Plutonium Page wrote a diary about the anthrax attacks that made reference to Richard Preston’s 2002 book on the subject, called The Demon in the Freezer.

Because I’d read some of Preston’s earlier work and found it interesting, I picked up a copy of The Demon. It wasn’t entirely what I expected; about a third of the book follows the anthrax attacks and the investigation, and the rest describes the global effort to eradicate smallpox. Still, it was a good book and an easy read.

There was one passage in the book, however, that bothered me. In it, Preston describes a conference call between Dr. Peter B. Jahrling, who was a senior researcher with the U.S. Army Medical Research Institute for Infectious Diseases (USAMRIID) at Fort Detrick (and who was one of Preston’s principal sources when writing The Demon), and scientists at the Centers for Disease Control in Atlanta:

The CDC officials on the call asked Jahrling if he could characterize the particle size. This was an important question, because if the anthrax particles were very small, they could get into people’s lungs, and the powder would be much more deadly.

Peter Jahrling replied that USAMRIID’s data indicated that [the anthrax taken from the letter sent to then-Senate Majority Leader Tom Daschle] was ten times more concentrated and potent than any form of anthrax that had been made by the old American biowarfare program at Fort Detrick in the nineteen sixties.

The passage bothered me because I was a prosecutor for many years, and in that time I became used to people using seemingly-superfluous modifiers to try to avoid telling everything they know without out-and-out lying. In this case, the words that stood out for me were these:

... more concentrated and potent than any form of anthrax that had been made by the old American biowarfare program at Fort Detrick in the nineteen sixties.

It was almost as if Jahrling was trying to avoid saying that he knew of a more recent American biowarfare program, located somewhere other than Fort Detrick.

Of course, Preston didn’t put quotes around anything in that passage, and so it’s possible that the superfluous modifiers came from the author, rather than from Dr. Jahrling himself. But then yesterday, I saw the same modifiers in these passages in the Wall Street Journal op-ed about the Dr. Bruce Ivins case, written by Dr. Richard Spertzel, the former USAMRIID deputy commander:

Let's start with the anthrax in the letters to Sens. Tom Daschle and Patrick Leahy. The spores could not have been produced at the U.S. Army Medical Research Institute of Infectious Diseases, where Ivins worked, without many other people being aware of it. Furthermore, the equipment to make such a product does not exist at the institute.

... the potential lethality of anthrax in this case far exceeds that of any powdered product found in the now extinct U.S. Biological Warfare Program.

Again: it’s almost as if another USAMRIID scientist is tiptoeing around saying that there is a more recent U.S. biological warfare program, located somewhere other than Fort Detrick, that does have the ability to make anthrax like that in the Daschle letter.

I’m not subscribing to any theories about Dr. Ivins’ culpability or lack thereof. I simply find it interesting that these two descriptions of the anthrax used in 2001 contain the same modifiers that suggest an effort to be technically truthful without necessarily revealing the whole truth.

There was another interesting tidbit from Spertzel’s op-ed that caught my eye:

Another FBI leak indicated that each particle was given a weak electric charge, thereby causing the particles to repel each other at the molecular level. This made it easier for the spores to float in the air, and increased their retention in the lungs.

... the product was described by an official at the Department of Homeland Security as "according to the Russian recipes" -- apparently referring to the use of the weak electric charge.

In The Demon, Preston discusses the defection of Dr. Kanatjan Alibekov, who was until his defection to the U.S. in 1992 the first deputy chief of research and production at Biopreparat, the Soviet biowar program. Dr. Alibekov (who now goes by the Westernized name "Ken Alibek") was the director of "the research team that developed the Soviet Union’s most powerful weapons-grade anthrax." Preston's description of the Dr. Alibekov's work sounds like the same product Dr. Spertzel describes:

The Alibekov anthrax, as Alibek described it to me, is an amber-gray powder, finer than bath talc, with smooth, creamy, fluffy particles that tend to fly apart and vanish in the air, becoming invisible and drifting for miles. The particles have a tendency to stick in human lungs like glue.

When Dr. Alibekov defected in 1992, what are the odds that he gave "the Russian recipes" to his CIA debriefers? I would hazard a guess that the odds are very nearly absolute that he did. And if so, what are the odds that someone within the Department of Defense, or some contractor employed by the government, attempted to replicate the Alibekov anthrax – if only to work on countermeasures, as Dr. Ivins supposedly did? I would again suggest that the odds are close to 100 per cent that someone tried – perhaps at the Dugway Proving Grounds, as was suggested in late 2001, or elsewhere. And if they had "Ken Alibek's" help, they probably succeeded.

Where does the demon live now?

Outstanding Questions

See September 6 version above

Frederick News-Post Op-Ed: Elephant in the Room

If Not Ivins by Katherine Heerbrandt


When Norm Covert, a conservative former Fort Detrick public affairs officer, and attorney Barry Kissin, liberal activist opposing Detrick's biolab expansion, agree that Bruce Ivins was not the anthrax killer, either the world's spinning off its axis, or the truth is staring us so hard in the face we'd have to be blind to miss it.

Covert's piece this week in thetentacle.com establishes what many in our community, including scientists and support staff at USAMRIID, past and present, know: Bruce Ivins had nothing to do with preparing or sending the anthrax letters. --

In a recent letter to the FNP editor, Amanda Lane speaks for many who knew him: "I want to shout from the mountain tops that Bruce was the kind of man we look up to ... He was a decorated scientist and the humblest of men who didn't use his title as a status symbol. He picked up a mop or emptied the trash without a moment's hesitation. If he thought you were having a bad day he would offer candy or a catchy tune to cheer you up. If someone had to stay late to accomplish a task, Bruce would work with you so that the task would get completed faster."

Covert echoes what is widely reported by reputable scientists. The anthrax in the mailings, he says, was "highly bred, weapons-grade ... with a silica coating and a slight electrical charge so that each particle repelled the other ... each particle no more than five microns." Ivins had neither the expertise nor the equipment to create such a sophisticated form of anthrax.

But if not Ivins, then who or what?

"It's the elephant in the room nobody's talking about," Kissin says.

Since Nixon terminated the offensive weapons program at Detrick in 1969, there has been only one corporation in our country that operates laboratories where anthrax is weaponized: Battelle Memorial Laboratories, the corporation that does the biolab work for the Central Intelligence Agency, the Defense Intelligence Agency, and the Army at Dugway Proving Ground in Utah.

In December 2001, FBI Director Mueller announced that the Battelle-operated labs in West Jefferson, Ohio and at Dugway had been "searched," and that there were NO suspects in those labs.

The FBI has not mentioned Battelle since.

New York Times science writer William Broad covered the subject in his 2002 book "Germs, Biological Weapons and America's Secret War." According to Broad, Projects Jefferson and Clear Vision, begun in the late '90s were ongoing secret anthrax weaponization projects. Project Clear Vision was managed by the CIA at the Battelle labs in West Jefferson, Ohio. Project Jefferson was managed by the DIA at the Battelle-operated labs at Dugway.

Kissin and writer Sheila Casey thread this information together in a recently published article in the Rock Creek Free Press, http://www.rockcreekfreepress.com/CreekV2No9-Web.pdf, to conclude that the case against Ivins is nothing but a flimsy cover-up of the secret workings of these anthrax weaponization projects.

How do Americans even begin to confront the reality that the only bioattack in our history came from an American military/intelligence lab? An attack we were told made the massive expansion of biolabs at Detrick and across the country necessary.

And guess who's been hired for $750 million to manage and operate the first new biolab facilities at Detrick that are about to open?

Battelle Memorial Laboratories.

FBI's August 18 Briefing: full text

A transcript of the FBI's scientific (afternoon of Aug. 18, 2008) briefing for media can be found here.

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?

Science Magazine/ ANTHRAX INVESTIGATION: FBI Discusses Microbial Forensics--but Key Questions Remain Unanswered

Science 22 August 2008:
Vol. 321. no. 5892, pp. 1026 - 1027

excerpted from the body of the article: (my apologies that a free link is not available)

...The FBI disclosed earlier that only eight samples had all four mutations; on Monday, it said that all but one of these came from USAMRIID. And all eight could be traced to RMR-1029--the flask of spores under Ivins's charge.

That is as far as the science took them, the FBI conceded; conventional detective work--such as checking lab notebooks and shipment records--helped rule out everyone but Ivins who had access to the spores, says Vahid Majidi, head of the agency's Weapons of Mass Destruction Directorate. He declined to give details. "I'm asking you not to second-guess our investigative approach," he said...

But Science was no more able to avoid second-guessing the FBI investigation than the rest of us. The journal came up with additional questions for the FBI:

ANTHRAX INVESTIGATION:
Six Anthrax Science Questions the FBI Has Yet to Answer

Yudhijit Bhattacharjee and Martin Enserink

What were the four mutations the FBI says it used to link the anthrax in the envelopes to Bruce Ivins at USAMRIID?

What are the odds of a false positive--that is, the odds that the spore populations in Ivins's flask RMR-1029 and in the envelopes weren't related but shared the same four mutations by chance?

Eight samples had anthrax with all four mutations; one of those came from a lab other than USAMRIID. On what basis was this lab ruled out as the origin of the letters?

How did the FBI rule out the possibility that others at USAMRIID with access to Ivins's lab prepared the envelopes?

How exactly did Ivins, if he was the perpetrator, produce an easily dispersible powder from his anthrax culture?

What led the FBI to suspect Steven Hatfill in the earlier years of the investigation?

Ivins as Stalker?

Excerpt from original story in The Oregonian indicates extensive contacts and debriefs between Haigwood and the FBI over 6 years. Although agents were close-mouthed with almost everyone else during this investigation, they apparently opened their case files for Dr. Haigwood:

"Haigwood, who researches HIV transmission and vaccines, said she contacted the FBI shortly after the American Society for Microbiology asked its members in 2002 to think of possible suspects in the anthrax case. Agents soon interviewed her and have stayed in touch off and on ever since, she said.

FBI officials told her of their plans to accuse Ivins and of his suicide before the news broke, and they will debrief her more in the coming weeks, she said.

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.

"I have a tremendous sense of relief, I must say," that Ivins is gone, she said. "But also tremendous sadness. Because I always hoped I was wrong."'

A Nature interview with Dr. Haigwood is here.

The Limits of Forensic Microbiology, or "We prosecute people, not beakers"

The FBI and major media have placed a lot of emphasis on the techniques used to identify the specific batch of Ames anthrax used in the Daschle/Leahy letters. Careful consideration of these methods is certainly important, for their accuracy is critical to the FBI's theory of the case.

However, at the end of the day, the forensics are only one piece of evidence. Much as we may desire a tidy resolution to the case, the forensics simply do not have the power to provide it. They can identify a batch, or a pooled sample, and one or more flasks. But they can never tell you who obtained anthrax from the flasks. The strains found in Ivins' flask had been shared; 100 people had access; and who knows how many more had access to the samples maintained by these 100 people?

At the end of the day, it will be the detective work that solves the crime.

As an article in the August 20 NY Times points out:

The scientists say they are confident the F.B.I. has identified the source of the anthrax, a flask in the custody of Bruce E. Ivins, whom the F.B.I. considers to have been the perpetrator of the attacks. But almost a hundred other people were known to have had access to cultures from the flask, and the scientists say they have no opinion as to whether Dr. Ivins, who committed suicide last month, was the culprit.

And the Nature editorial makes the same point:

... The genetic analysis itself seems quite solid. The FBI has collaborated with some of the best outside scientists on anthrax, and on 18 August convened many of them to answer journalists' questions about the science. The researchers on the panel explained that none of the analysis techniques used in this case is new; just the application to anthrax forensics. Several peer-reviewed papers on the forensic work have already been published, and another dozen or so are anticipated.

Although this openness about the techniques is commendable, neither the conclusions drawn from the scientific analysis, nor such crucial legal elements as the veracity of the provenance and handling of samples, have been tested in court. So far only one side of the story has been heard: that of the prosecution...

The FBI should explain why it thinks the scientific evidence implicates Ivins himself, and not just the flask. As Kemp aptly puts it: "In this country, we prosecute people, not beakers."

I much prefer that analogy to the one about the spore on the grassy knoll. Let's get clear about what the scientific evidence does and does not indicate.

How did the FBI get from the beaker to Ivins?

Journal Nature calls for investigation: Case "too important to be brushed under the carpet"

In an editorial published online today, titled "Case Not Closed," Nature noted that "Only full disclosure can lift suspicions that the FBI has again targeted an innocent man:"

... neither the conclusions drawn from the scientific analysis, nor such crucial legal elements as the veracity of the provenance and handling of samples, have been tested in court. So far only one side of the story has been heard: that of the prosecution.

Certainly Ivins's behaviour in the crucial autumn months of 2001 raises questions about his emotional stability, but mental illness does not necessarily a murderer make.

The FBI should explain why it thinks the scientific evidence implicates Ivins himself, and not just the flask. As Kemp aptly puts it: "In this country, we prosecute people, not beakers." The absence of such a full disclosure can only feed suspicions that the FBI has again targeted an innocent man in this case — as it did with former Fort Detrick researcher Steven Hatfill.

This case is too important to be brushed under the carpet. The anthrax attacks killed five people, infected several others, paralysed the United States with fear and shaped the nation's bioterrorism policy. Science and law share a conviction that conclusions require evidence, and that the evidence be debated openly. The FBI says it regrets that Ivins's untimely death has denied it the chance to have its day in court. So presumably the bureau would welcome a full congressional or independent enquiry into this case, as has been called for by Senator Chuck Grassley (Republican, Iowa) and several other lawmakers. It is essential that such an enquiry takes place.

(A pdf of the full article is here.)

Papers of Record Unsatisfied

Washington Post and New York Times editorials today find the FBI's revelations unconvincing, and call for an independent, scientific review of the evidence.

The vial the FBI destroyed, or why there will always be a spore on a grassy knoll

Does this case hinge on the first samples Ivins gave to the FBI, of which one was sent to Dr. Paul Keim in Arizona? Why does that sample matter, if the flask the FBI later confiscated had the same strain and genetic variability?

Furthermore, if Keim's sample is critical to the case, one must ask, "was Keim its sole custodian?" -- i.e., was it definitely the sample Ivins provided? Is there a bulletproof chain of custody?

Why was the FBI's sample destroyed, while an identical sample was considered adequate to be sent to Keim in Arizona? And if the sample was destroyed, as claimed, because it "would never stand up to scientific or legal scrutiny" then why was Keim's (identical) sample used by FBI?

If, as stated, Ivins helped design the protocol for sample submission, it is bizarre that he would have submitted a sample improperly. Might someone have told him to submit it in a special way? Might he have been misdirected regarding sample submission, in an attempt to set him up as a potential suspect?

And why would Ivins send the FBI a first sample that would help to incriminate himself? And then change the sample to further incriminate himself? He had a security clearance, worked in a high-profile, specialized government biodefense lab, and could have lost his job and reputation if he submitted false samples for the investigation.

The story has now changed: CNN reports that, "They (FBI) at first viewed the change as "deceptive" but said they now consider it as simply "questionable." What??!

I am looking for a solution to this case that has a semblance of rationality. The FBI's WMD Directorate's Assistant Director, Majidi, implies in his "grassy knoll" remark that no matter how much evidence the FBI releases, some people will always suspect a cover-up. I found his remark a very smooth put-down of those who are unsatisfied with the FBI's story. But the holes in this case keep multiplying, despite the brilliant PR.

Monday's Briefing

I did not attend either FBI briefing, and the comments below relate to multiple news reports of the briefing.

1. Either one flask or two contained the specific anthrax strain in the letters--it was reported both ways in different newspapers, and apparently there was disagreement at the meeting.
2. Two labs had this strain, but the name of the other lab is still a secret. Why? Was it a lab that manufactures anthrax in powder form, and thus might be easier to link to the crime than the USAMRIID lab, which officially uses liquid anthrax only?
3. Yes, 100 people did have access to the strain--but FBI ruled every one of them out, leaving Ivins as the sole suspect.
4. FBI says it did re-engineer the powder, and it had the same properties as the anthrax found in the Leahy/Daschle letters--but the easily produced, engineered powder did not contain extra silicon, as reported by the Armed Forces Institute of Pathology for the letter anthrax. No explanation was provided, making the FBI claim questionable.
5. No one reported on the mix of B. cereus and B. anthracis that was previously said to provide evidence of where the anthrax came from.

Analysis:

The additional scientific information reported fails to clarify any of the persisting questions in the case. Many other people had access to this strain, and the science is unable to pin it on any one individual.

Maybe the FBI unequivocably ruled out 100 people as the lone suspect, by an inability to place them at the mailing sites, for example. But despite two lame attempts last week to make it appear Ivins could possibly have mailed the letters in Princeton (the first claim putting him at the mailbox too early for the postmark), there has still been no evidence presented establishing he made such a trip.

However, if you concede that the letter attacks are much more likely to have been the work of more than one individual, then the 100 people "ruled out" by FBI (using unreleased criteria) jump back in as suspects. Because perhaps all one of them had to do was to supply a tiny amount of anthrax to someone else who produced the final product. It would be very hard to rule that out.

Furthermore, we know how readily the spores leaked out of envelopes. The person who mailed the Daschle/Leahy letters had to have contaminated themself, simply by the act of placing the letters in a mailbox. This contamination should have extended to their vehicle (unless they showered and changed clothes before driving off), so the lack of contamination is a serious problem in the case against Ivins as sole suspect. Dr. CJ Peters was asked about this issue, and confirmed this point in an August 20 article here.

3 Months Before Anthrax Sent, Daschle Criticized Anthrax Vaccine

Speaking to motive for the Daschle and Leahy letters, there might be multiple motives.

The letters likely influenced their decisions on upcoming legislation like the Patriotic Act, and both had considerable power to promote or suppress legislation. The letters were likely intended to frighten all Congressional Members, whose office buildings were affected, and who, like the rest of us, didn't know what would come next.

Senate Majority Leader Daschle also may have been targeted because of his position regarding the Defense Department's mandatory anthrax vaccine program. In a letter he wrote to Defense Secretary Rumsfeld dated June 21, 2001, Daschle sought to weigh in on an ongoing DoD review of the vaccine program. He criticized the vaccine over its safety and efficacy, as well as persistent problems with its manufacture.

Did someone who read the letter, or was otherwise aware of Daschle's concern about the vaccine, decide that an anthrax letter might shift his thinking on the vaccine -- as well as the Patriot Act and other legislation?

More details revealed

A local Maryland paper provides new information from a colleague who worked at USAMRIID with Ivins through 2007, and published USAMRIID's official response to questions.

Scientific data so far lacking

Eric Lichtblau (NY Times) and Robert Roos (Center for Infectious Disease Research & Policy ) have written two comprehensive articles discussing the scientific and other evidence that has been presented. Lichtblau also discusses a closed-door FBI briefing that took place on August 14. They conclude the case is found seriously wanting.