‘Veterans court’ faces a backlog that continues to grow/WaPo

Half of combat veterans from Afghanistan and Iraq have filed for benefits since 2001.  From the Washington Post:

The caseload at the U.S. Court of Appeals for Veterans Claims has doubled in recent years, with the court deciding more than 600 cases per judge each year — far more than other federal appellate courts.... By the time Bruce E. Kasold became chief judge in August, hundreds of cases were awaiting decisions. Retired judges had been helping with motions and simpler cases, but Kasold decided to turn more complex cases over to the retirees, who work with the help of staff attorneys.

... Congress created the court in 1988, after lobbying by Vietnam veterans. Before that, veterans who were denied benefits had no judicial recourse.

... New claims at the VA have nearly doubled since 2005, and of the 1.3 million living combat veterans discharged since 2001, nearly half have filed for benefits.

Flu Warning: Beware the Drug Companies!/ NY Review of Books

This long piece meanders from the H1N1 pandemic and the billions spent to save us from a flu much less malign than usual, to the marketing of Tamiflu (a dangerous drug for influenza whose efficacy may be zero) to the problems with industry control of research on all drugs in our pharmacopeiea.  The points may be familiar to readers of this blog.  But the issues are crucial to resolve if we are to regain trust in our medications and our medical litreature.  By Helen Epstein:

... On June 11, 2009, Margaret Chan, the director-general of the WHO, announced that a “pandemic emergency”—or worldwide epidemic—of H1N1 influenza was officially underway. Governments around the world placed immediate orders for anti-flu drugs and vaccines worth hundreds of millions of dollars, as a new stock index, *RXFLU, tracked company profits. According to J.P. Morgan, up to $10 billion was spent globally on “influenza preparedness” in 2009, including over $4 billion by the US alone.⁶

The predicted dire emergency did not occur. In the 2009–2010 “influenza season” about 18,000 people died from the disease worldwide, fewer than in previous years, and the vast majority of victims had serious underlying conditions such as cancer, lung disease, AIDS, or severe obesity, which can impair breathing.⁷ Since one influenza strain usually dominates all others during a typical flu season, H1N1 may actually have saved lives by displacing more aggressive viruses. The WHO maintains that its decisions were based on the best available evidence, but last year European governments, stuck with hundreds of millions of euros’ worth of unused medicines and vaccines, began asking questions.
In March 2010, a Council of Europe report⁸ concluded that the H1N1 virus was known to be mild well before the WHO issued the pandemic “declaration” and expressed concern about the influence of powerful pharmaceutical companies over decision-making at the agency. A draft of the WHO’s response was released in March 2011.⁹ It calls for more “transparency” but concludes that “no critic of WHO has produced any direct evidence of commercial influence on decision-making.” Unfortunately, the response does not account for the billions of dollars lost in the panic or for the lives that may have been put at risk by the agency’s hasty medical recommendations...

GlaxoSmithKline’s diabetes drug Avandia was linked to thousands of heart attacks, and earlier in the decade, the company’s antidepressant Paxil was discovered to exacerbate the risk of suicide in young people. Merck’s painkiller Vioxx was also linked to thousands of heart disease deaths. In each case, the scientific literature gave little hint of these dangers. The companies have agreed to pay settlements in class action lawsuits amounting to far less than the profits the drugs earned on the market.⁵⁴ These precedents could be creating incentives for reduced vigilance concerning the side effects of prescription drugs in general....
Forcing drug companies to make all their original data available to all independent researchers would achieve much the same thing, and cost absolutely nothing. Legislators and the public should demand both of these reforms without delay.

Was FBI too quick to judge anthrax suspect killer?/ McClatchy

Greg Gordon may not be as well-known as some investigative journalists, but he is one of the best in the business.  Greg has penned an incredible series on Goldman Sachs, detailing how the company bet against investment vehicles they had designed (to fail), for which he was a finalist for a Pulitzer last year.  [See the sidebar for links to his many 2009 stories on the financial crash.]  He has continued to cover this area, as well as many others, turning out a major story a week.

Today Greg Gordon focused on the evidence against Bruce Ivins, pointing up a major failure in the FBI's case.  This failure is the FBI's inability to link a contaminant found in the first set of letters to Ivins.  It is not clear how hard the FBI tried to find the contaminant in anyone else's laboratory.

The contaminant is Bacillus subtilis, a usually benign bacterial strain that is closely related to the bacteria that cause anthrax.  Whoever made the anthrax for the first set of letters included some Bacillus subtilis in the mix, and therefore had it in their possession (and lab).  The FBI's failure to find this contaminant in hundreds of samples from Ivins' home, car, office and laboratory virtually assures us that Ivins did not grow the anthrax for the first set of letters... at least not in the only lab equipment to which he had access.

UPDATE:  Video of Greg Gordon discussing this subject is here.

...  But the FBI's decision not to fully test for the distinct bacterial contaminant, pieced together by McClatchy Newspapers in interviews with scientists, federal law enforcement officials and in a review of recently declassified bureau records, could reignite the debate over whether its agents found the real killer.

The Justice Department closed the eight-year investigation, said to cost as much as $100 million. However, none of the circumstantial evidence it found showed that Ivins prepared the deadly powder, scrawled "Death to America" in a seeming mimic of al-Qaida, or twice sneaked away on 61/2-hour roundtrip drives to drop them in a Princeton, N.J., mailbox.

If the FBI got the right man, then there is no consequence to its decision to stop hunting for bacillus subtilis, a harmless bacterial contaminant that resembles anthrax. But if Ivins was innocent, then the killer is at large, and the bureau may have missed a big opportunity...

One person close to the investigation, who requested anonymity to avoid harming relationships, suggested that FBI officials felt "trapped" by Ivins' suicide.  "If they ever had any doubts, once he committed suicide, they had to unite," this person said. "Otherwise, you've driven an innocent man to suicide. And that's a terrible thing..."

Read more: http://www.miamiherald.com/2011/04/20/2177735/was-fbi-too-quick-to-judge-anthrax.html#ixzz1K7VyFsLk

EU agency flags narcolepsy risk on GSK flu shot/ Reuters

From Reuters today:

European regulators have recommended changes to the product label for GlaxoSmithKline's (GSK.L) pandemic flu vaccine Pandemrix to highlight the potential risk of narcolepsy in children or adolescents.  The decision is based on preliminary results of studies from Finland, Sweden and France suggesting a possible link between the vaccine and the rare sleeping disorder. The move does not apply to adults...

UPDATE:  Press Release from the European Medicines Agency.

Why vaccines for emergencies should not be mandated/ Nass testimony

UPDATE:  Both LD 941 and LD 694 made it out of committee and will be voted on by the entire legislature.--Meryl

Meryl Nass, MD
Mount Desert Island Hospital
Bar Harbor, Maine 04609

April 9, 2011

Dear HHS Committee Member (Maine Legislature):

I am writing with regard to LD 941 and the subject of mandatory vaccinations. I am an internist

who has practiced in Maine since 1997.  I am knowledgeable about medical emergencies

designated by the governor, or by the Secretary of DHHS, and about vaccine safety.  I have

testified to the US Congress on bioterrorism and emergency vaccinations 7 times (3 oral, 4

written). I treat vaccine-injured patients. I have also submitted testimony for LD 694.

Governor Baldacci declared an emergency during the 2009 swine flu pandemic. We now

know that swine flu caused fewer deaths than ordinary seasonal flu epidemics.[1] The swine flu

pandemic caused little disruption in Maine, but an emergency declaration was made nonetheless.

It could have, but did not, lead to mandatory vaccinations in Maine. We now know swine flu

vaccinations were unnecessary for all but high-risk patients.

Vaccines are an important component of public health. But they should not be seen as a panacea

in times of emergencies and disasters.

Vaccines are drugs, and like drugs, their benefits and risks cannot be wholly understood until

they have been given to large numbers of people. The numbers required, and the duration of

time that must elapse, preclude adequate data coming from clinical trials.[2] In other words, until

millions of people have received a vaccine, we do not know what its risks are.

The recent swine flu pandemic is instructive. New vaccines were hurriedly developed [3] and

given to hundreds of millions of people worldwide. Over a year later, we have learned that

the CSL vaccine used in Australia caused one seizure for every 100-200 children vaccinated,

approximately ten times the expected rate of this adverse reaction. In Finland, the GSK Pandemrix

swine flu vaccine led to 20 times the expected rate of narcolepsy in children. Twelve other

countries are investigating narcolepsy increases.

In the US and worldwide, pandemic vaccine manufacturers (and those involved in planning and

administering vaccinations) were given a waiver of liability for adverse reactions caused by these

vaccines. [4] Injured recipients have no ability to sue for damages, and await (possible) payments from the federal government. [5]

Swine flu vaccinations in 2009 were voluntary. However, since the pandemic appeared, swine

flu and/or seasonal flu vaccinations became required (outside Maine) for many hospital and

clinic employees, by their employers and by NY State. Vaccinations were ordered by NY’s

appointed public health chief. An injunction was then issued against mandatory vaccinations [6]

and NY’s Governor Patterson reversed the vaccine mandate.

Surprisingly, no published data exist to show that vaccinating staff at health care facilities protects patients, either by reducing hospitalizations or by reducing deaths due to flu.

Smallpox vaccine caused so many serious side effects that the 2003 plan to vaccinate millions

of Americans stopped after only 40,000 civilian vaccinations. A National Academy of Science

panel found little evidence to support the program’s benefit. [7] Anthrax vaccinations have caused

serious chronic illnesses in 1-2% of military personnel vaccinated, according to the Government

Accountability Office (GAO). [8] A little-known fact is that FDA can issue (and has issued)

Emergency Use Authorizations, [9] allowing unlicensed drugs and vaccines (that may not have

undergone human testing) to be used.

To sum up:

1. When an emergency strikes, the need to “Do Something” is very strong, and emergency

vaccinations may be a solution chosen by government officials.

2. Emergencies can be declared in Maine with very little basis, yet may result in forced

vaccinations.

3. Vaccines developed for emergencies are more likely than standard vaccines to have

safety problems, due to rapid development, insufficient testing and the liability waiver

given to their manufacturers.

4. Because vaccines for emergencies are given to large numbers of people in a short period

of time, their serious side effects probably won’t be known until after millions have been

vaccinated.

5. Vaccines likely to be mandated will be those with unknown safety problems and

uncertain effectiveness, or those that are already known to be dangerous.

6. Vaccine mandates are increasing. They are controversial and lead to legal actions.

7. Maine citizens should be protected from vaccine mandates issued by those who may

be unaware of their potential ramifications. Maine citizens deserve to choose what is

injected into their bodies. Please support this bill.

Sincerely yours,

Meryl Nass, M.D.

 1.  http://www.europarl.europa.eu/en/pressroom/content/20110308IPR15032/html/Swine-flu-learning-from-past-mistakes

 “H1N1 had caused 2,900 deaths in Europe by April 2010, which compares with 40,000 for seasonal flu in a moderate year.” [European Parliament]

 2.  http://www.who.int/csr/disease/swineflu/notes/h1n1_safety_vaccines_20090805/en/index.html

 “Special safety issues will inevitably arise during a pandemic when vaccine is administered on a massive scale. For example, adverse events too rare to show up even in a large clinical trial may become apparent when very large numbers of people receive a pandemic vaccine.” [WHO]

 3.  http://www.who.int/csr/disease/swineflu/notes/h1n1_safety_vaccines_20090805/en/index.html

 “Specific regulatory procedures have been devised to expedite the approval of pandemic vaccines. In the USA, for example, fewer data are required when the manufacturer already has a licensed influenza vaccine and intends to use the same manufacturing process for its pandemic vaccine.” [WHO]

 4.  http://www.pandemicflu.gov/professional/federal/vaccineliability.html [US Government]

 5.  http://www.pandemicflu.gov/professional/federal/vaccineliability.html [US Government]

 “The U.S. Department of Health and Human Services is establishing a Countermeasures Injury Compensation Program for H1N1 vaccines. Under this program, compensation may be available to eligible individuals who suffer serious physical injuries or death from administration of the vaccine under the declarations. Eligibility, and the types of injuries for which compensation may be available, will be defined by regulations. Compensation can include medical benefits, lost wages and death benefits.”

 6.  http://cityroom.blogs.nytimes.com/2009/10/16/judge-halts-mandatory-flu-vaccines-for-health-care-workers/?partner=rss&emc=rss [NY Times]

 7.  http://www.nap.edu/catalog.php?record_id=11240#toc [National Academy of Sciences]

 8.  http://www.gao.gov/new.items/d07787r.pdf [GAO]

 9.  http://www.fda.gov/RegulatoryInformation/Guidances/ucm125127.htm#categories [FDA]

Why vaccines should be given with a list of their ingredients/ Nass testimony

UPDATE:  Here is a list of vaccine ingredients posted by CDC.  I have annotated the list with yellow highlights for animal-derived materials, and annotated in red MRC-5 DNA and protein.  MRC-5 is a human fetal cell line derived from lung tissue. -- Meryl


Meryl Nass, MD
Mount Desert Island Hospital
Bar Harbor, Maine 04609

April 9, 2011

Dear HHS Committee Member:

Re:  LD 694, bill requiring that a list of vaccine ingredients be provided with all pediatric vaccinations

1.  Listing vaccine ingredients may not be absolutely necessary.  But consider that FDA requires food manufacturers to list all ingredients.  This allows consumers to avoid ingredients to which they may be allergic, and avoid those to which there may be a religious prohibition.

Some vaccines contain eggs, which occasionally cause serious allergic reactions.  Some vaccines contain gelatin (prohibited for kosher Jews); others are made in [aborted] fetal cells or their derivatives, and are avoided for that reason.

2.  Hundreds of new vaccines are in development, and they contain a wide array of new ingredients to stimulate increased immunity.  These ingredients do not have to be tested for their individual toxicity:  their only required testing occurs during a clinical trial of the complete vaccine.  Most human vaccine studies last one month.  If no serious side effect is identified within that period, the tested vaccine may be licensed.

This kind of testing is insufficient to identify whether the vaccine or its components may cause or promote cancers.  It will miss most birth defects and autoimmune illnesses that might be related to vaccination.  Vaccine trials usually avoid pregnant women.  Cancers and autoimmune illnesses may take months or years to appear.

3.  In 2009-10, swine flu vaccines were made with and without novel adjuvants (new additives used to enhance the immune response), using abbreviated testing.  Novel adjuvants had not been used in previously licensed US vaccines.

Recently it was learned that the Pandemrix swine flu vaccine caused or contributed to narcolepsy in children, and that some other swine flu vaccines caused seizures.  Their use in children has been stopped in some countries (Finland [1], Ireland [2] and Australia [3],  for example).

Pandemrix, made by GlaxoSmithKline, used a novel adjuvant that had not been used in children before, nor used in the US.  Subsequently, Glaxo’s Cervarix HPV vaccine was licensed in the US, containing this novel adjuvant.

This offers an example of how an ingredient list would be beneficial:

The Pandemrix adjuvant is not present in Merck’s Gardasil HPV vaccine, but is present in Glaxo's Cervarix HPV vaccine.  Knowing the ingredients, one could make an educated choice about which vaccine to use.

4.  Consider the difference between ingesting food and injecting vaccines.  Food has to pass through the gastrointestinal tract, which acts as a barrier against noxious substances entering the body, protecting us from harm.

Injections bypass all skin and mucosal barriers, overriding important protective mechanisms.  Substances injected into us therefore need even more careful vetting than is given to foods. Vaccines should be at least as safe as foods, and their components should be equally transparent.

5. Providing a list of ingredients at the time of inoculation will not add a significant burden to medical providers or manufacturers.

Federal regulations already require that a CDC-designed “Vaccine Information Statement” be given to parents with each child’s inoculation.  This form could be easily amended to include a list of vaccine ingredients. 

An ingredient list is part of the vaccine label/package insert that is included with every bottle of vaccine sent to vaccine providers. This package insert or its list of vaccine ingredients could be given to patients with the Vaccine Information Statement.

Thank you for the opportunity to comment on this piece of legislation.

Sincerely,

Meryl Nass, M.D.

1.   http://www.yle.fi/uutiset/news/2011/01/health_official_swine_flu_vaccinations_for_children_possibly_a_mistake_2326931.html
2.   http://www.independent.ie/health/swine-flu/gps-must-return-flu-vaccine-over-narcolepsy-fears-2607513.html
3.  http://www.theaustralian.com.au/news/health-science/risk-of-fits-prompts-bans-of-four-flu-jabs/story-e6frg8y6-1226020122589

GPs must return flu vaccine over narcolepsy fears/ Independent

In early January, Ireland's Health Service Executive advised doctors to use the Pandemrix (GSK) brand of swine flu vaccine only in the event they ran out of seasonal flu vaccine.  This is the brand linked to narcolepsy cases.

Apparently that warning was not sufficient.  On April 3 Ireland's Health Service informed doctors that they would be coming to the offices of all GPs to remove any remaining Pandemrix vaccine stock:

The Heath Service Executive (HSE) will remove all stocks of the swine flu vaccine Pandemrix from GPs' surgeries, the Sunday Independent has learned.
The vaccine has been linked to the disabling sleep disorder, narcolepsy...

Sweden's Medical Products Agency concluded that those under 20 vaccinated with Pandemrix may be four times as likely to develop narcolepsy than those who did not get the shot. 
The Swedish findings by the Lakemedelsverket agency broadly reflect a recent study in Finland, though that investigation found that the risk of children suffering from narcolepsy was nine times higher among those vaccinated with Pandemrix.
Since August 2010, at least 12 countries have reported cases of narcolepsy, particularly among young people...

GPs are told in the HSE directive that while there has been an increase in narcolepsy in Finland and Sweden, it has not been noted in all countries using Pandemrix.
"No increase has been seen in the United Kingdom, which also used Pandemrix," the briefing document noted.
The European Centre for Disease Control is undertaking a study in nine European countries, with the results expected by July this year.
"The European Medicines Agency has stated that no definitive conclusions can be drawn until further studies are completed and has therefore not recommended any changes to the marketing authorisation for Pandemrix," it said.
Here, the Health Protection Surveillance Centre will now work with the IMB to examine data available on narcolepsy in Ireland.
"In summary, there has been conflicting data emerging in relation to narcolepsy and the situation is as yet unclear," the HSE told Irish doctors.

Rise in sleep illness cases linked to swine-flu jab/ Ireland Independent

Still no news about narcolepsy or any other specific adverse effects from the US and Canada, who used the most  swine flu vaccines in 2009 and 2010.  So much for claims that the US put into effect special monitoring programs for this vaccine!

Ireland is finding increased narcolepsy cases in the vaccinated 4-19 age group as well as Finland and Sweden.

... Last month, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) confirmed that it had reviewed further information from Finland on the suspected link between narcolepsy in children and adolescents and Pandemrix.
"The committee concluded that the new evidence added to the concern arising from case reports in Finland and Sweden, but that the data were still insufficient to establish a causal relationship between Pandemrix and narcolepsy.
"Further analyses and study results are awaited to clarify the observations in Finland."
In addition to the information coming from Finland, research is continuing in Sweden, where there has also been an unexpected number of narcolepsy reports following vaccination with Pandemrix.
In last month's statement, the CHMP said that other non-Nordic countries had not seen similar increased rates of reporting of narcolepsy.
That assessment may change in the light of the eight suspected cases that have been reported in Ireland of people who have received the Pandemrix vaccine and who have subsequently developed narcolepsy...

Anthrax Redux: Did the Feds Nab the Wrong Guy?/ Wired

Noah Schactman has an extremely detailed, useful piece on the anthrax mailings in Wired.  Noah did his homework.  The 72 comments are also interesting.

UPDATE:  Podcast with Noah here.  Extracts of the magazine story follow:

In February 2003, anthrax became part of the rationale for invading Iraq. Colin Powell went to the United Nations Security Council, in part to discuss the potential bioweapon. “Less than a teaspoonful of dry anthrax in an envelope shut down the United States Senate,” he said. “Saddam Hussein could have … enough to fill tens upon tens upon tens of thousands of teaspoons.” Two weeks later, Tom Ridge told Americans to buy duct tape and plastic sheeting to protect themselves from a bioterror attack. Four weeks after that, the invasion of Iraq began.

The National Research Council report also casts doubt on whether the killer spores really were descendants of Ivins’ RMR-1029 flask. The FBI resampled RMR-1029 a total of 30 different times, the report found. They could get all four telltale morphs on only 16 occasions.

Further, the FBI says that only eight samples in its Ames repository were genetic matches to all four morphs of the killer spores—and that the scientists with access to those isolates were thoroughly scrutinized. But the National Research Council found that the FBI’s collection can’t be fully trusted: Too many of the samples were intermingled or descended from other labs’ anthracis to provide a truly representative cross-section of Ames anthrax. This may also be a reason why nearly one in 10 samples in the repository tested positive for at least one mutant.

Paul Keim, who helped assemble the FBI’s Ames collection, still wonders how much to trust an anthrax repository that relied on scientists (and potential murder suspects) submitting their own samples. “We don’t know if people did it correctly, and there’s no real way to control for that,” Keim says...

There are still other problems with the case against Ivins. The killing spores were so volatile that they cross-contaminated piles and piles of mail. Yet spores were never found in Ivins’ house or his car, and only a handful were discovered in his lab. There’s no evidence of any trip to Princeton to mail the letters. And just because the killer spores were descendants of a USAMRIID flask, there’s no guarantee a USAMRIID scientist was actually the mailer. In fact, the FBI was never able to prove where the attack anthrax was cultured. “It would’ve been very easy to take the anthrax out, to steal some,” a former USAMRIID officer says. “Anybody could do that.”

Finally, there’s the matter of motive. The Justice Department asserts in its investigative summary that Ivins mailed the letters to gin up support for an anthrax vaccine, offering a few ambiguous emails and comments to friends and investigators as proof. If there’s any further, credible evidence to support this notion, Wired couldn’t find it in the thousands of pages of case documents released by the government or in the hours of interviews conducted with the investigators. Montooth [who led the FBI's case in the beginning] concedes it’s a placeholder rationale at best...

There’s an irony in the fact that the culprit was likely a top government anthrax expert: Since 2001, the US has built dozens of labs, spent just under $62 billion, and hired an army of researchers to prevent a second bioterror attack. In effect, Washington has devoted the past decade to training and equipping hundreds of people like Ivins.

It’s an unnerving scenario. But there’s something much scarier to contemplate. There’s still the possibility that the government was as wrong about Ivins as it was about Hatfill. If that’s the case, the anthrax mailer is still at large. And that means someone launched the deadliest biological attack in the history of the United States—and got away with it.

David Kelly inquest plea made to David Cameron/ BBC

From the BBC:

A group of doctors campaigning for a full inquest for Dr David Kelly have appealed to Prime Minister David Cameron to intervene on their behalf...

And, addressing the prime minister directly, they caution: "If an inquest is denied, despite all the evidence carefully provided to the attorney general, there is a real and grave risk that your government will be seen as continuing, and being complicit in, an enormous conspiracy to pervert the course of justice.  "Further, any 'no' decision will be vigorously contested in the courts via judicial review by the doctors' lawyers..."

Pushing the envelope: Psychobabble "solves" FBI's case/ NYT

A group of psychiatrists [UPDATE:  See Dr. Jeffrey Kaye's analysis of the panel composition] offered their forensic expertise in solving the anthrax criminal investigation, by using their insight into the criminal mind.  Somehow DC Judge Royce E. Lamberth blessed them, and FBI paid the $38,000  bill.  The group only had one suspect, whose confidential medical records were supplied by the FBI.  The Executive Summary makes clear that the panels' conclusions were built into its charge:

...the Panel was asked to offer, based on the available materials, a better understanding of Dr. Ivins’ mental state before and after the anthrax mailings, his possible motives — and the connections, if any, between his mental state and the commission of the crimes.

If the group's trove of documents resembled that of the National Academy of Sciences panel, then it was carefully cherry-picked, designed to elicit a single conclusion.  The NY Times' Scott Shane notes their conclusion:

“Dr. Ivins was psychologically disposed to undertake the mailings; his behavioral history demonstrated his potential for carrying them out; and he had the motivation and the means,” the panel wrote in its 285-page report, released at a news conference on Wednesday...  It also found that Dr. Ivins, who was 62 when he died, was “homicidal” in the last weeks of his life. Only his involuntary commitment for psychiatric treatment, the panel wrote, “prevented a mass shooting and fulfillment of his promise to go out in a ‘blaze of glory,’ “ the report said.

How much of their evidence is derived from Ivins' alcohol abuse counselor, who was under house arrest at the time and working with the FBI in the final months of Ivins' life?  Was her profound conflict of interest clear to these experts?

How could these experts possibly know Ivins had the motivation and means, when the FBI failed to produce a logical motive or provide evidence of means?

From the report's executive summary:

The key themes were revenge, a desperate need for personal validation, career reservation and professional redemption, and loss. These themes guided him not only in making the attacks, but in choosing his targets and shaping his methods...

The [mail]box thus appears to have represented to him the two key reservoirs of his obsession and rage. Dr. Ivins’ statements to therapists and the FBI suggest that KKG represented authority and all the successful, talented, attractive people who had rejected him and inspired his rage. Princeton represented his father and perhaps his unmet college aspirations and the humiliation and rage wrapped up in these concepts for him. For him, dropping anthrax in this [mail]box appears to have represented both a conquest and a desecration — in short, payback.

Is psychobabble too strong a word to describe this outpouring of gibberish?

UPDATE:  Scientia Press has an analysis of Ivins' criminal propensity/ lack of any history of aggression here.

This report was completed last August, but was pulled out of the deep freeze yesterday in a last-ditch attempt to trump the NAS report. The website that offers this report for sale, provides the Executive Summary and  bios of the authors ends with the following, in a clear attempt to link this psychiatric report to the NAS report, and presumably give it equal weight in future discussions of the case. 

National Academy of Sciences (NAS) Panel

Investigators in this case relied on new microbial forensic techniques developed by government, academic, and private-sector scientists to address these specific attacks. Because these techniques were new, the FBI requested the formation of a separate commission through the National Academy of Sciences to evaluate “the reliability of the principles and methods used by the FBI, and whether the principles and methods were applied appropriately to the facts.” At the time of this report’s submission to Chief Judge Lamberth in August 2010, that report had not yet been released.  The report was released on February 15, 2011.

2/3 of Whooping Cough Patients in California Fully Vaccinated/ KPBS and CDC

From San Diego's station KPBS:

SAN DIEGO — A KPBS investigation has found that nearly two out of three people diagnosed with whooping cough in San Diego County this year were fully immunized. California is in the midst of the worst whooping cough epidemic in 50 years.
The numbers raise questions about how well the vaccine works.
Whooping cough, or pertussis is a contagious upper respiratory illness that in adults can mimic a bad cold. But in babies it can be deadly. Eight babies have died in California from whooping cough since January...

 

UTD = up-to-date with age appropriate pertussis vaccinations by immunization record review or parent report

NUTD = not up-to-date with age appropriate pertussis vaccinations

PBE = personal belief exemption reported by parent and/or physician

UNK = unknown

TDAP DUE = any child 11-18 years old who had only 5 pertussis containing immunizations with no Tdap noted
(source: San Diego County Health & Human Services Agency)

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

“I think we have to be honest and try to find out what’s happening.” Dr. Fritz Mooi says, of the Netherlands Center for Infectious Diseases Control.
Mooi believes researchers need to develop new vaccines. But he says the idea that the disease may be mutating and out-smarting current vaccines has been ignored by many public health officials
“That’s not good science and that’s not good public health.”
When KPBS asked the CDC why it believed so many vaccinated people in San Diego county contracted whooping cough - nearly two out of three people - the agency provided a written statement. The CDC says statistically, higher vaccination rates increases the probability a sick person will have been immunized.

CDC Statement On Why Vaccinated People In Calif. Are Contracting Pertussis

Vaccines for pertussis are very effective, but no vaccine protects forever in 100 percent of those vaccinated. Protection wanes over time, which is the reason for intermittent “booster doses.” High vaccination coverage in communities and in families also protects others, including those who are too young to be vaccinated or whose immunity from vaccination has waned.
CA is experiencing a significant increase in pertussis circulating in the community. That disease pressure is causing more fully vaccinated and recently vaccinated people to become infected than in a typical year. It does not mean the vaccine is not working. Rather, the higher the vaccine coverage, the higher the proportion of cases who have been vaccinated. This is commonly misinterpreted to mean that a vaccine is not working, when in fact it means that coverage is high.

Draft Report: Independent investigation of WHO's handling of swine flu pandemic

The "Review Committee on the Functioning of the International Health Regulations (2005) and on Pandemic Influenza A (H1N1) 2009"  was charged with assessing the usefulness of existing International Health Regulations in light of the H1N1 swine flu pandemic, improving preparedness, and evaluating WHO's response to the swine flu pandemic.  Thus much of its draft report speaks to increasing the capacity to manufacture vaccines, expediting the process of sharing vaccines, and obtaining money to fund vaccines in future.  Liability issues were one impediment to sharing (countries needed to indemnify manufacturers from liability before they could receive vaccines).  And the report stated that no evidence of WHO malfeasance (acting on behalf of manufacturers rather than governments and populations) had been seen.

But the report's criticisms of WHO's process got to the heart of what was wrong.  Here are excerpts:

• Even if the definition of a pandemic depends exclusively on spread, its degree of severity affects policy choices, personal decisions and the public interest... The degree of severity of
  the pandemic was very uncertain throughout the summer of 2009, well past the time, for example, when countries would have needed to place orders for vaccine.
• Inadequately dispelling confusion about the definition of a pandemic. One online WHO document described pandemics as causing “enormous numbers of deaths and illness”, while the official definition of a pandemic was based only on the degree of spread. 
• A pandemic phase structure that was needlessly complex.
• Continued counting of cases yielded less useful information than would have been provided by rates of hospitalization, complications and death in countries affected early on in the pandemic.
• The decision to keep confidential the identities of Emergency Committee members.
• Lack of a sufficiently robust, systematic and open set of procedures for disclosing, recognizing and managing conflicts of interest among expert advisers.
• At a critical point of decision-making about the pandemic (moving from Phase 4 to 5), conferring with only a subset of the Emergency Committee rather than inviting input from the full Emergency Committee. 
• Discontinuing routine press conferences focused on the evolving pandemic was ill-advised.
• Lack of a cohesive, overarching set of procedures and priorities for publishing consistent and timely technical guidance...

The final report is due out in May.

Adverse events following flu vaccination in Australia/ BMJ

Data suggest that children may have been hospitalized for post-swine flu vaccination seizures at a rate 2-6 times greater than their rate of hospitalization for swine flu disease.  Data are lacking on other post-vaccination side effects that might also occur. 

I suggest you read this short BMJ piece by authors Peter Collignan, Peter Doshi and Tom Jefferson in its entirety online.  Excerpts follow:

In Australia last year, one febrile convulsion occurred for every 100 to 200 young children vaccinated with CSL's influenza vaccine (2,3,4). Now in the US there have been similar concerns. A recent analysis of the American experience reported a rate of 60 seizures per 100,000 influenza vaccinations when given together with conjugated pneumococcal vaccine (5). However this is likely to under-estimate the true rate. One post-marketing vaccine safety study showed reports of febrile seizures admitted to hospital, was 5 times lower with passive surveillance (6)... in Australia's recent experience, 38% of children with febrile convulsions following vaccination (19 of 56) were admitted to hospital (4)...

In Australia in 2009, during winter when young children (0-4 years) were first hit with the new H1N1 strain, the admission rate for influenza was 57 per 100,000 (8). In the US, CDC says that influenza results in hospitalization for approximately 20 per 100,000 children aged 2 to 5 years (9), but vaccine-induced febrile convulsions resulting in hospitalization in US young children, likely occurred at a rate of 114 per 100,000 children vaccinated . According to the FDA, a "serious adverse event" is defined as hospitalization that results from a vaccine adverse event (10). Thus vaccinating young children without risk factors likely caused more serious adverse events than disease from the new "pandemic" itself.

There is poor safety data available for other serious adverse events that might occur in young children in addition to febrile seizures (11)...  In 2005, when a new study demonstrated that influenza vaccines were not saving elderly lives (16), many argued that this underscored the importance of vaccinating more children (17). Yet we have no evidence demonstrating that children are benefiting from this strategy but do have evidence that these vaccines are hospitalizing children...

UK Department of Health Suggests End to Pneumococcal Vaccine Program in Elderly/ UK Dept. Health

Professor David Salisbury, the Director of Immunisation for the UK Department of Health, wrote to colleagues/stakeholders on March 16 suggesting that routine pneumococcal immunisation in the over-65 age group be ended, and asking for their views before making a final decision on the program.  Ending routine vaccinations in the elderly is the recommendation of the Joint Committee on Vaccination and Immunisation, an independent advisory committee of vaccine experts to UK government ministers.

The committee made several important points:

• There had been no decrease in invasive pneumococcal disease since routine vaccinations were begun in 2003 [this refers to pneumonia, meningitis and sepsis--Nass]
• Vaccine effectiveness is poor in the over-65 age group
• Revaccination did not help, and may have led to a poorer response due to "immune hyporesponsiveness"

At the same time, vaccination may be useful for persons at increased risk of pneumococcal disease, and vaccination recommendations for those under 65 are not affected by this guidance.

Being an observer of the rush to add vaccines to the list of approved medications before there is adequate safety and efficacy data, and then institute their widespread use, this recommendation adds a breath of fresh air to the conversation on vaccines' net benefits.

To my knowledge, this is the first time a standard vaccine program will be ended in the UK.  The Hepatitis B vaccine program ended in France in the mid 1990s after half the population was vaccinated.  The Rotavirus vaccine program ended in the US in 1999, but restarted recently with another version of the vaccine.  The 1976 swine flu program ended precipitously.  Each vaccine program ended due to unacceptably high rates of serious adverse reactions.  I am not sure there are data on how effective these programs were at preventing disease, though swine flu never became an epidemic in 1976, never spread beyond Fort Dix, and the vaccine program was entirely unnecessary.

Acknowledgment that revaccination may actually increase the risk of pneumococcal disease is welcome.  Several animal vaccines in widespread use were found to increase the disease they were meant to prevent, and I have wondered whether any human vaccines may have done the same thing.

Evidence from Hong Kong and Canada that being vaccinated for seasonal influenza in 2008 was associated with twice the risk of becoming ill with H1N1 swine influnza in 2009-10 suggests that the same problem may be associated with human vaccines.

Using antibody levels (serology) to predict vaccine efficacy against disease, as is often done today, instead of looking for cases of disease prevented, both overstakes vaccine efficacy and masks any possible effect on disease promotion by a vaccine.  University of Michigan researchers Monto, Petrie et al. have just published a nice piece on how influenza efficacy is overstated by serologic tests.

Let's vaccinate against a nonexistent flu virus: the "preemptive strike" rears its head again/ BBC

UPDATE:  I just learned that in 2008 GSK obtained European regulatory approval to market a so-called "Prepandemic" Vaccine for H5N1 avian flu.  This virus is not circulating in humans.  The theory behind the vaccine is that if a bird flu virus emerged to cause a pandemic, the GSK vaccine is likely to be somewhat similar to it, and might provide partial immunity.  Such immunity could then be theoretically boosted by a more specific vaccine, made to order for the specific disease-causing virus. 

However, it remains more likely than not that a vaccine for a new pandemic would not be available until 4-6 months or more after the pandemic was identified, likely too late to have much effect.  This happened for the 2009 swine flu pandemic.  The swine flu vaccine was probably only needed for small numbers of people who were at particularly high risk of  severe sequelae from the virus.  The European Parliament now suggests that the death rate in Europe from swine flu was only 1/10th as high as from an average seasonal flu.  This is because those over 50 were, in large part, already immune.

From the BBC:

Governments should launch a vaccination programme now to guard against a possible H2N2 flu pandemic, according to an article in the journal Nature.

The US authors say immunity to the H2N2 flu strain is very low in people under the age of 50. But a safe vaccine already exists after an H2N2 outbreak in the 1950s and '60s.  They say that vaccinating now could save billions of dollars if a pandemic does develop.

Dr Gary Nabel and colleagues from the Vaccine Research Centre in the US say H2N2 has the ability to cause a pandemic in the same way that H1N1 did in 2009.

Between 1957 and 1968, the strain is thought to have caused up to 4 million deaths in a global outbreak, during which time a vaccine was developed.

When the pandemic was over the H2N2 vaccination programme was stopped in the late 1960s, although the virus is still present today among birds and swine...

"Another major influenza pandemic is likely to cost far more and create a much greater health burden than a well-planned pre-emptive programme.

"The US Centres for Disease Control and Prevention estimates that a pandemic outbreak costs the United States between $71 billion and $167 billion."  Dr Wendy Barclay, Chair in Influenza Virology at Imperial College, says the H2 flu virus does pose a credible pandemic threat, as do other strains of bird flu.  But she believes there are some big questions about whether a pre-emptive vaccination programme would be welcomed by the public.

"Now we are in the calm after the storm of that swine flu pandemic, it is timely to open up the debate about pre-pandemic vaccines. As Dr Nabel himself points out in his article, we have to ask whether the public will want or accept a vaccine against a disease that does not at the moment exist.

"Work towards making such vaccines available is ongoing in many laboratories around the world.  "Scientifically we are in a position to be able to offer a good solution, the issues to be decided are of cost and of public attitude."

WHO's response to swine flu pandemic flawed/ AP-WaPo

An excellent piece was published by Agence France Presse.  The article below is by MARIA CHENG, The Associated Press-Washington Post, March 10, 2011:

LONDON -- An expert panel commissioned by the World Health Organization to investigate its handling of the swine flu pandemic has slammed mistakes made by the U.N. body and warned tens of millions could die if there is a severe flu outbreak in the future.

The U.N. health agency established the review committee to evaluate its performance after the 2009 global outbreak of swine flu, or H1N1. In a draft report released on Thursday, the committee said WHO performed well in many ways, but made crucial errors.

The group described WHO's definition of a pandemic and its phases as "needlessly complex," criticized the agency's decision to keep the members of its advisory committee secret, and said potential conflicts of interest among those experts, some of whom had ties to drug companies, were not well managed.

It warned that under WHO's health oversight, the world is not ready to handle a major health disaster in the future . . .

The European Parliament adopted a resolution regarding the Swine Flu pandemic on 3/8/2011.  Its press release reads:

Swine flu: learning from past mistakes
The EU's response to the outbreak of the H1N1 ("swine flu") virus in 2009-2010 is scrutinised and found wanting in a resolution adopted by Parliament on Tuesday which weighs up the cost of vaccination programmes and the relative risks. Suggestions for the future include group purchases of vaccines and tighter safeguards against conflicts of interest.

H1N1 had caused 2,900 deaths in Europe by April 2010, which compares with 40,000 for seasonal flu in a moderate year..

Vaccination programmes

EU Member States' responses ranged from wholesale vaccination programmes to none at all (in the case of Poland). Billions of euros were spent in total. Pointing to the need to reassess vaccination strategies and prevention plans, Parliament urges better cooperation between Member States, such as group purchases of vaccines.

Assessments of and communication about flu outbreaks must be more independent, says the resolution. Safeguards are needed to prevent conflicts of interest. For example, declarations of interest by experts who advise European health authorities should be published. And under EU legislation, full liability for vaccines must lie with the manufacturer, not with Member States.

WHO and EU

The World Health Organisation is asked to review its definition of a "pandemic", to take into account the severity of the illness, not only the spread of a virus. To buttress the EU's own risk assessment capacity, the European Centre for Disease Prevention and Control should be equipped to assess risks independently as well as perform its other tasks, say MEPs.

Information to citizens

Consistent communication by the Member States to their citizens is also crucial, believes Parliament. Governments and the Commission are asked to devise better vaccination and communication strategies to build confidence in public health measures designed to prevent pandemics.

The resolution was adopted by show of hands.

New Suspected Narcolepsy Cases in Finland/ YLE

UPDATE:  Australia has banned 4 flu vaccines and approved 2 for children under age ten, on March 11, 2011.  The 2011 flu vaccine in Australia has identical antigens as last year.  According to The Australian, up to 1 in 100 children under five vaccinated with the CSL vaccine last year suffered a seizure, more than the ninefold increase previously reported (see below).

Now one in 10,000 Pandemrix (GSK)-vaccinated children in Finland have developed narcolepsy.  How does this relate to the ninefold increase in seizures in vaccinated Australian children (using the CSL vaccine)?  We have heard very little about adverse reactions other countries are finding.  Recall that in both Australia, Finland and Sweden, the rate of both seizures (Australia) and narcolepsy (Finland and Sweden) post-vaccination is at least 9 times greater than expected.  From YLE:

About ten new suspected cases of swine flu vaccine-related narcolepsy have been reported in Finland. The National Institute for Health and Welfare (THL) says that altogether 69 suspected cases of narcolepsy or cataplexy have been reported.

The diagnoses for seven of these patients are still in process.

Cataplexy is a severe muscle weakness that can lead to a complete collapse up to 20-30 times a day.

The THL has received 900 complaints regarding the Pandemrix vaccine by Wednesday. Of these, 182 have been classified as serious. Serious cases are those that demand hospital treatment, are life-threatening or could lead to death. The classification for those cases may yet change, since some patient data is missing.

New review of anthrax case discussed by review committee vice chair, Stanford bioterrorism expert

David Relman, vice chair of the National Academy of Science committee that reported on the FBI's anthrax letters research last week, did some clearer speaking (compared to the committee report and his statements at the NAS press conference on 2/15) about the committee's findings for a press release from Stanford University, where he is a professor.

...However, we also found some problems and gaps in the scientific investigation. Although the scientific evidence was supportive of a link between the letters and that flask, it did not definitively demonstrate such a relationship, for at least two reasons.

First, the FBI was looking to match the anthrax strain in the letters to what existed in labs. But large-scale production of anthrax spores encourages the emergence of just the kind of mutant strains that were found in the anthrax letters. Since labs tend to save original isolates and may not save samples of large-scale production runs, it’s possible that the samples gathered by the FBI missed mutants that arose during such runs. This possibility was not given adequate consideration.

Second, the FBI still might not have found other matches, because there’s no guarantee that the bureau had assembled a comprehensive library of lab strains: The repository of anthrax samples that the FBI created for comparison with the anthrax in the letters may not have been representative of all relevant anthrax stocks around the world. The newly revealed, but inconclusive, information about possible B. anthracis Ames at an al Qaeda overseas location highlights this issue. In addition, the instructions in the subpoena the FBI sent to scientists known to be in possession of the B. anthracis Ames strain lacked specificity, so there’s no certainty that scientists who were subpoenaed submitted samples of all the mutant strains in their possession. In light of these and other problems and gaps in the science performed as part of this investigation, our overarching finding was that it is not possible to reach a definitive conclusion about the origins of the B. anthracis in the mailings based on the available scientific evidence alone.

WHO statement on narcolepsy and Pandemrix vaccine

WHO Statement on Narcolepsy and Vaccination


8 February 2011

Since August 2010, following widespread use of vaccines against influenza (H1N1) 2009, cases of narcolepsy, especially in children and adolescents, have been reported from at least 12 countries. Narcolepsy is a rare sleep disorder that causes a person to fall asleep suddenly and unexpectedly. The rates reported from Sweden, Finland and Iceland have been notably higher than those from other countries. The National Institute for Health and Welfare of Finland issued a preliminary statement on 1 February 2011 following an investigation into the cases in Finland. A systematic retrospective registry-based review was conducted of all new narcolepsy cases diagnosed during 2006-2010 and cases in 2009-2010, born in 1990 or later, were reviewed using newly developed Brighton collaboration criteria for the disease. During 2009-2010 they found a higher risk of narcolepsy among those aged 4-19 years old who had received the vaccination against influenza (H1N1) 2009 compared with those who had not been vaccinated. The only pandemic vaccine used in Finland was Pandemrix, an adjuvanted influenza (H1N1) 2009 monovalent vaccine manufactured by GlaxoSmithKline. Pandemrix vaccine was used in 47 countries worldwide during the 2009-2010 season. Studies are ongoing to determine if the apparent increased risk of narcolepsy reported in Sweden is higher in vaccinated persons.

The National Institute in Finland (on the advice of the Finnish National Narcolepsy Task Force) has concluded that the risk of developing narcolepsy among those vaccinated aged between 4 and 19 years is about nine times greater than those unvaccinated in the same age group, corresponding to a risk of about 1 case of narcolepsy per 12,000 vaccinated in this age group. The increased risk has not been seen in younger or older age groups. Narcolepsy is a condition that has a strong genetic linkage, being almost uniquely seen in persons who have the (HLA) DQB1*0602 genotype. Of the cases of narcolepsy tested so far in Finland (n=22), diagnosed during 2009-2010, all have that genotype. The National Institute considers it probable that the Pandemrix vaccine was a contributing factor to this observed increase, and has called for further investigation of other co-factors that may be associated with the increased risk. . .

UPDATE:  In the US, an average of about 75 children/year die from flu-related causes.  Most of these children have underlying, chronic medical illnesses.  Usually about 15-20 child deaths/year occur in otherwise healthy children in the US.

There are over 50 million children in the US.  If half were vaccinated, and their rate of developing narcolepsy was the same as in Finland (one in 12,000), we might expect 2,000 new cases of narcolepsy in vaccinated children.  They would need a certain HLA type (a specific genetic predisposition).  But most people with that HLA type do not develop narcolepsy; in Finland narcolepsy appears to have been triggered by vaccination and possibly other unidentified exposures.

Narcolepsy is a serious medical condition, and in Finland, post-vaccination, it has been associated with other neurological problems including personality changes.  Narcolepsy may be deadly when someone with the disorder falls asleep at the wheel of a car.  

A risk benefit analysis might look something like this:  two thousand narcolepsy cases caused by flu vaccination versus 26 child deaths prevented. (This assumes that 50% of children were vaccinated and the vaccine was 70% effective.  These are reasonable assumptions for a year in which the vaccine is a good match to circulating flu strains.)  [75 child deaths x 50% vaccine uptake x 70% vaccine efficacy = 26 child deaths prevented.  I have not thrown in a factor for herd immunity since current vaccine uptake rates are not felt to lead to significant herd immunity for influenza.]

Granted, it is unclear what the risk of narcolepsy is for use of swine flu vaccine in the US; and it is unclear whether the novel Glaxo adjuvant used in Pandemrix swine flu vaccine outside the US may have contributed.  But I just did the math.  And it appears that if Finland has a similar childhood death rate from flu as the US, it could be seeing 80 cases of narcolepsy for every flu death prevented. 

These are serious numbers, and WHO, EMEA, CDC and other public health agencies must be terribly concerned about the findings and implications.

4/5ths of Medical Devices recalled by FDA were not approved using standard procedures/ Archives of Internal Medicine

Steve Nissen et al. hit another homer; the authors examine why bad medical devices (those eventually recalled) were initially approved by FDA, and learn it was due to skirting the standard review process.  Does abbreviated review of products benefit the public in any way?  Shouldn't this abbreviated approval process be eliminated for all but emergency use?

Medical Device Recalls and the FDA Approval Process

Diana M. Zuckerman, PhD; Paul Brown, BS; Steven E. Nissen, MD

Arch Intern Med. Published online February 14, 2011. doi:10.1001/archinternmed.2011.30

ABSTRACT

---

Background  Unlike prescription drugs, medical devices are reviewed by the US Food and Drug Administration (FDA) using 2 alternative regulatory standards: (1) premarket approval (PMA), which requires clinical testing and inspections; or (2) the 510(k) process, which requires that the device be similar to a device already marketed (predicate device). The second standard is intended for devices that the FDA deems to involve low or moderate risk. Methods  We analyzed the FDA's high-risk List of Device Recalls from 2005 through 2009. Using FDA data, we determined whether the recalled devices were approved by the more rigorous (PMA) process, the 510(k) process, or were exempt from FDA review.

Results  There were 113 recalls from 2005 through 2009 that the FDA determined could cause serious health problems or death. Only 21 of the 113 devices had been approved through the PMA process (19%). Eighty were cleared through the 510(k) process (71%), and an additional 8 were exempt from any FDA regulation (7%). Cardiovascular devices comprised the largest recall category, with 35 of the high-risk recalls (31%); two-thirds were cleared by the 510(k) process (66%; n = 23). Fifty-one percent of the high-risk recalls were in 5 other device categories: general hospital, anesthesiology, clinical chemistry, neurology, or ophthalmology.

Conclusions  Most medical devices recalled for life-threatening or very serious hazards were originally cleared for market using the less stringent 510(k) process or were considered so low risk that they were exempt from review (78%). These findings suggest that reform of the regulatory process is needed to ensure the safety of medical devices.

Answers in 2001 anthrax attacks are still elusive/ WaPo editorial

Today the Washington Post called for an independent commission on the anthrax letters:

RESOLUTION OF THE 2001 anthrax attacks continues to prove elusive.
The Justice Department and the FBI identified Maryland scientist Bruce E. Ivins as having single-handedly carried out the attacks that killed five people and seriously sickened 17 others. The department was on the verge of seeking an indictment in 2008 when Mr. Ivins took his own life.
Doubts lingered about Mr. Ivins's guilt, in part because the FBI had had its sights on a different Maryland scientist for several years before admitting he was not the culprit. Now, a report by the National Academy of Sciences (NAS) raises new questions about whether Mr. Ivins was wrongly accused.
The lengthy report cites several instances in which the Justice Department appears to have overstated the strength of the scientific evidence against Mr. Ivins. For example, the department concluded that anthrax spores derived from the RMR-1029 vial in Mr. Ivins's lab were used in the deadly attacks. The report takes exception. "We find the scientific evidence to be consistent with their conclusions but not as definitive as stated," said Lehigh University President Alice Gast, who led the NAS committee. The report insinuates throughout that FBI failure to perform more tests or to be more precise could have erroneously eliminated other suspects or prematurely settled on Mr. Ivins as a suspect.
Yet the report itself is at times misleading. Take, for example, the FBI's assertion that Mr. Ivins deceived investigators by providing a sample purported to be from RMR-1029 but that the FBI concluded could not have come from that particular batch. "The genetic evidence that a disputed sample submitted by the suspect came from a source other than RMR-1029 was weaker" than stated by the Justice Department, the committee said. How much weaker? The NAS panel concluded that there was a 1 percent chance that the sample came from the key vial; that answer could be found only deep in the bowels of the document.
The NAS committee should not be blamed for nitpicking over the test results; that is essentially what it was tasked to do by the FBI, which commissioned its report. But the result is not satisfying - nor is it conclusive.
Congress should convene a nonpartisan commission staffed with individuals experienced in law enforcement to probe all of the evidence in the case, including that which the FBI claims shows Mr. Ivins had the opportunity and the wherewithal to carry out the 2001 attack. The inquiry should explore why and how the Justice Department eliminated other scientists who had access to RMR-1029 as suspects, and it should examine the security protocols at repositories for biological weapons. The exploration also should focus on the country's preparedness to deal with such an attack in the future.

Muddying the waters: contradictory NAS Report interpretations, and how the report itself asks to be read

Professor Paul Keim, an anthrax genetics expert at Northern Arizona University and FBI contractor, is claiming the NAS report supports the FBI's case.  It doesn't.  Please review the report and judge for yourself.

The NAS report has many confusing aspects.  But it basically says:

• The FBI totally screwed up its data collection of anthrax samples, and it should not be considered comprehensive.
• FBI failed to give the committee needed information, although it provided some response (sometimes "tersely") to every request for information.
• FBI found a number of morphologically unusual mutants ("morphotypes") in some letters, then chose some morphotypes to study further, but FBI provided no explanation for why only some morphotypes and not all letters were selected. 
• NAS pointed out that one could not say what expertise and equipment were required, nor how long it would take to produce the amount of spores used, absent that information.  (This conclusion challenged FBI claims that Ivins had the equipment and expertise needed, and also challenged the importance made of Ivins' late nights in the lab.)
• The assertion that Ivins tried to fool the FBI with the samples he submitted is unsupported. 
• FBI was chided for failing to use the newest molecular techniques, which could have speeded up the research and helped to clarify the relationship between the letter spores and Ivins' flask of spores. 

For example, from page 26 of the report:

"No written explanatory materials were provided with these documents that would fully
inform the committee as to why the analyses were done and how these documents contributed to the FBI investigations and conclusions. The material regarding analyses of the FBIR specimens
was coded, often with different numbers for the same sample set. Consequently, the committee
spent a considerable amount of time sorting through and attempting to interpret the available
materials before it could begin to evaluate the science and consider the scientific conclusions. In
addition, much of the information provided to the committee was compartmentalized and
sections of some documents were redacted.
When the committee posed questions to the FBI for clarification, the agency was always
responsive; however, responses to questions were sometimes minimal or terse, or were deflected
as intruding into the criminal investigation and beyond the purview of the committee despite the
committee’s explanation that the questions were of a scientific nature."

And excerpts from page 119:

"The first challenge with the repository was the lack of independence among samples and an incomplete understanding of the provenance of samples due to the known history of sharing...  FBI scientists and investigators sought to determine the history of shipments among institutions and the genealogical relationships among samples in the repository, but they never obtained a complete record.

Another challenge with the repository was that, since the importance of the mutant genotypes was not fully understood when the subpoena protocol was written, the document was vague (e.g., “use an inoculum taken across multiple colonies”), and was not written in a way that would maximize the chance that variant genotypes in a mixed stock population would be submitted... After the importance of the mutant genotypes became known, there was no request for additional samples using a revised protocol that might have improved the sampling.
 
A final challenge was that the repository collection process was based on the integrity of the individuals asked to provide samples. If the motive for the repository was to identify the source of the letter material, standards of custody of evidence would dictate that agents of the FBI should have obtained the samples. In most instances, holders of the material were asked to provide samples and send them in. The sender could have been the instigator and may not have complied with instructions, as the FBI alleges with respect to Dr. Ivins."

Yet the report was otherwise couched in the most conciliatory language.  FBI was praised whenever possible.

The committee was barred from commenting directly on the guilt or innocence of suspects.  In order to get around this restriction and create a report that complied with its contract, while being as specific as possible about whether the science indicted Ivins, the NAS report included tables that presented FBI and DOJ statements, verbatim.  Then the report commented on whether the committee agreed with the statements.

Using this method, NAS' report was able to say (page 15):

The results of the genetic analyses of the repository samples were consistent with the finding that the spores in the attack letters were derived from RMR-1029, but the analyses did not definitively demonstrate such a relationship. The scientific data alone do not support the strength of the government’s repeated assertions that “RMR-1029 was conclusively identified as the parent material to the anthrax powder used in the mailings” (USDOJ, 2010, p. 20), nor the role suggested for the scientific data in arriving at their conclusions, “the scientific analysis coordinated by the FBI Laboratory determined that RMR-1029, a spore-batch created and maintained at USAMRIID by Dr. Ivins, was the parent material for the anthrax used in the mailings” (USDOJ, 2010, p. 8).

The report created new definitions to specify strength of association.  This goes to the heart of the report's meaning.  Here's what the report says, rather oddly, about how its language conveys the strength of an association (see page 41):

"Quantifying an association, as well as the degree of certainty (or uncertainty) in that
association, involves statistical methods (see Chapter 6). Common language involves qualifiers,
rather than quantifiable measures, of this association and the degree of confidence in it, which
can cause confusion among practitioners from different fields that use the terms. Since the
interpretation of these qualifiers and the ways in which they are used differ across disciplines
(e.g., statistics, science, law, common language), their use by the committee is clarified here. In
the chapters that follow, the committee uses the following four qualifiers of association, listed in
order of increasing certainty (decreasing uncertainty):

consistent with an association
suggest an association
indicate an association
demonstrate an association

The expression “consistent with” is frequently used in this report and conveys the
weakest level of certainty (greatest amount of uncertainty). In general, when the term “consistent
with” is used, it means that an association may or may not be present; the available data can
neither rule out nor confirm an association. The term “suggests” denotes a greater level of
certainty for an association than “consistent with,” but even here the normal use of the word in
science denotes a weaker level of certainty than is implied by the word in everyday parlance.
That is, the potential for an association is stronger, and the evidence for the absence of an
association is weaker, but both are still possible. In contrast, the terms “indicate” and
“demonstrate” denote higher degrees of certainty and these are usually reserved for strong
scientific conclusions (i.e., less uncertainty, or less likelihood of an absence of an association).
All four levels could potentially be quantified with measures of “statistical significance,” but the
committee does not assign such measures in most instances because the data at hand are
generally not appropriate for such precise quantification of the degree of uncertainty.
In summary, the reader is cautioned to consider carefully the terminology in this report in
light of the fact that the qualifiers of certainty used here are those used most commonly in the
scientific literature and that these words can carry different weight in common language and in
the courtroom."

So the term "consistent with an association" in the NAS-FBI context, implies the weakest possible association.  Got that?   Keim and the FBI have taken "consistent with" to mean the NAS Report supports the FBI claims, when the report's own definitions state that "consistent with" implies "the greatest amount of uncertainty" about the association.  UPDATE:   Keim is quoted in the 2/17/11 Global Security Newswire with the following (disingenuous) statement:

Keim disputed news reports suggesting that this week's analysis questions the FBI for naming Ivins as the perpetrator of the attacks.  "The committee isn't saying that. ... All the major conclusions that the FBI came to, the committee said, 'Yeah, the evidence is consistent with that.'"

[Sorry for all the mumbo-jumbo, but this level of detail helps explain how opposing sides may each cite this report to claim victory--Nass]

My earlier posts on this case: highlights

1.  The FBI's anthrax letters investigation:  points to consider

November 30, 2010

 

2.  My summary of unresolved issues in the anthrax letters case

March 7, 2010

 

3.  Jean Duley emerges from undisclosed location after 18 months to bolster FBI's case against Ivins

March 6, 2010

 

4.  The FBI's Anthrax Case/ NYT

February 28, 2010

5.  Bill for more investigation of '01 anthrax case passes House/ Balt Sun

Friday, February 26, 2010

 

6.  Kissin Memo: Piecing Together the Anthrax Letters Story

February 24, 2010

 

7.  Federal Bureau of Invention: CASE CLOSED (and Ivins did it)

February 19, 2010

In depth discussion of anthrax case by Glenn Greenwald/ Salon

Glenn Greenwald (Salon) talks about the origins of this story.  He covers the media response to the FBI's case in 2008, when calls for an independent investigation came from

... the editorial pages of The Washington Post, The New York Times, and The Wall Street Journal).  Mainstream scientific sources were equally skeptical; Nature called for an independent investigation and declared in its editorial headline:  "Case Not Closed," while 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 scientific doubts and also demanded a full independent investigation.  I devoted much time to documenting just some of the serious flaws in the FBI's evidentiary claims, as well as the use of anonymous FBI leaks to unquestioning reporters to convince the public of their validity (see here, here, here, and here).

... Despite all of this, the FBI managed to evade calls for an independent investigation by announcing that it had asked the National Academy of Sciences to convene a panel to review only the FBI's scientific and genetic findings (but not to review its circumstantial case against Ivins or explore the possibility of other culprits).  The FBI believed that its genetic analysis was the strongest aspect of their case against Ivins -- that it definitively linked Ivins' research flask to the spores in the mailed anthrax -- and that once the panel publicly endorsed the FBI's scientific claims, it would vindicate the FBI's case and end calls for a full-scale investigation into the accusations against Ivins.

... It is hard to overstate the political significance of the anthrax attacks.  For reasons I've described at length, that event played at least as much of a role as the 9/11 attacks in elevating the Terrorism fear levels which, through today, sustain endless wars, massive defense and homeland security budgets, and relentless civil liberties erosions.  The pithy version of the vital role played by anthrax was supplied by Atrios here and here; in essence, it was anthrax that convinced large numbers of Americans that Terrorism was something that could show up without warning at their doorstep -- though something as innocuous as their mailbox -- in the form of James-Bond-like attacks featuring invisible, lethal powder.  Moreover, anthrax was exploited in the aftermath of 9/11 to ratchet up the fear levels toward Saddam Hussein, as ABC News' Brian Ross spent a full week screeching to the country -- falsely -- that bentonite had been found in the anthrax and that this agent was the telltale sign of Iraq's chemical weapons program, while George Bush throughout 2002 routinely featured "anthrax" as one of Saddam's scary weapons.

That there's so much lingering doubt about who was responsible for this indescribably consequential attack is astonishing, and it ought to be unacceptable.  Other than a desire to avoid finding out who the culprit was (and/or to avoid having the FBI's case against Ivins subjected to scrutiny), there's no rational reason to oppose an independent, comprehensive investigation into this matter.