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.

FBI ducks and dodges NAS anthrax conclusions/ WaPo

From today's Washington Post:

FBI continues to claim Ivins misled them with his original anthrax sample, although NAS pointed out that the instructions for sample collection were ambiguous, and FBI failed to collect needed information about the specific procedures used by those submitting samples.

FBI claims it had to meet a stiffer standard than The National Academy of Science committee, which had the luxury to be "theoretical."

"It's somewhat disingenuous that they can use the word 'theoretical,' " said one investigator involved in the case, who spoke on the condition of anonymity to be candid about the report's findings. "They're talking about hypotheticals. We didn't have that luxury. We were trying to solve a crime, and we didn't know if the mailer would strike again."

Every story I've read, in which FBI spokespeople are questioned, has given the FBI personnel anonymity.  This is the most expensive and likely the most complex case the FBI has ever handled, and it was botched from start to finish.  The lives of at least 3 scientists have been ruined (Hatfill) or lost (Ivins and Mikesell) as a result of the investigation.  Yet FBI continues the pernicious practice of twisting the truth, claiming it solved the case definitively when it has essentially NO hard evidence, and covering its butt via lack of attribution of any of these claims.

[The NAS Report] offered another possible explanation for the apparent link between the letters and the Ivins flask: that some of the mutations identified in the letters could have arisen independently, through a process known as "parallel evolution."
The report said this possibility "was not rigorously explored" by the FBI.

So FBI retorts that "rarely does science alone solve an investigation.''  (No, it doesn't if the science is done poorly.)  Yet back in 2008, when FBI announced it had solved the case, the critical evidence was supposed to have come from the microbial forensics science.

And now?  FBI has created the lie (anonymously, of course) that

... the government was satisfied that its science would have met the standard of proof in federal court, which is to a reasonable degree of scientific certainty. "The standard is not beyond all doubt," the official said.

Luckily for the FBI, with Ivins' death, they dodged federal court.

UPDATE:  And don't forget Ivins passed 2 polygraph tests.  FBI later claimed he used classic countermeasures to defeat them, but the evidence for this is slim to none.  The WaPo comments on this here.

Rush Holt reintroduced legislation today to establish an anthrax investigative commission

From the LA Times:

... Rep. Rush D. Holt, a Democrat from New Jersey, the site of the postal box where the letters were mailed, reintroduced legislation Tuesday to establish an 11-member commission to study the anthrax attacks.
"There are still questions to be answered and still lessons to be learned," Holt said. "It would take a credulous person to believe the circumstantial evidence that the FBI used to draw its conclusions with such certainty. The FBI has not proven to me that this is an open-and-shut case."
Sen. Charles E. Grassley of Iowa, the senior Republican on the Senate Judiciary Committee, also called for further investigation of the anthrax scare, saying the new report "shows that the science is not necessarily a slam dunk."

UPDATE:  See Representative Holt's press release.

NAS Report and press conference pull rug out from under FBI's "case closed"

There is no getting away from the NAS report conclusions, as reported worldwide:  the science does not support FBI's claims that Ivins was the anthrax perpetrator.

See articles from the AFP, NPR, AP, Science, and a later WP article.

The FBI responded that their case was based on a totality of the evidence, not just the science.  But when the rest of the FBI's evidence is examined, one finds only smoke.  There has been no physical evidence tying Ivins to the case.  The totality of the FBI case against Ivins rests on colorful and sometimes exaggerated personal quirks and odd habits.  The FBI has presented no convincing evidence that Ivins had the means, a motive, or the oppportunity to commit the letters crime.  (See my Nov. 29, 2010 talk on this subject here.)

Anthrax report casts doubt on scientific evidence in FBI case against Bruce Ivins/ WP

From Jerry Markon at the Washington Post:

A panel of prominent scientists is casting new doubt on scientific evidence that was a key part of the FBI's case against Bruce E. Ivins, the deceased Army scientist accused of carrying out the deadly 2001 anthrax attacks.

The National Research Council, in a report issued Tuesday, questioned the link between a flask of anthrax bacteria in Ivins's lab at Fort Detrick, Md., and the anthrax-infested letters that killed five people and sickened 17 others.

The Justice Department has said genetic testing conclusively linked the letters to spores in the flask - labeled RMR-1029 - found at the laboratory, where Ivins was a longtime researcher before committing suicide in 2008. The government closed the case last year after concluding that Ivins had single-handedly prepared and mailed the deadly anthrax spores, an incident that terrorized a nation still reeling from the Sept. 11, 2001 terrorist attacks.

"The scientific link between the letter material and flask number RMR-1029 is not as conclusive as stated in the DOJ Investigative Summary,'' said the $1.1 million report by the council, which was commissioned by the FBI. The document added, however, that the "genetic evidence is consistent with and supports an association between the RMR-1029 flask.''

The report, while praising the FBI's energetic pursuit of emerging science in the investigation, offered another possible explanation for the apparent link between the letters and the Ivins flask and said it "was not rigorously explored.''

The 190-page document by the research arm of the National Academy of Sciences also said the FBI's scientific methods in collecting samples of the strain of anthrax used in the attacks were "not optimal,'' and it said the authors could not verify the government's contention that only Ivins and a select group of scientists possessed the required expertise to prepare the spore-laden letters.

"This shows what we've been saying all along: that it was all supposition based on conjecture based on guesswork, without any proof whatsoever,'' said Paul Kemp, a lawyer who represented Ivins in negotiations with federal prosecutors who were preparing to charge him before his death. Kemp called for congressional hearings into the investigation.

The report makes no judgment about Ivins's guilt or innocence, and federal law enforcement officials on Tuesday stood behind their contention that Ivins was the anthrax killer. They pointed to what they said was overwhelming evidence linking him to the attacks, including e-mails and recorded conversations showing an increasingly agitated Ivins seeking to implicate colleagues while misleading investigators about his ability to make the deadly anthrax powder.

Lab records from Fort Detrick revealed that Ivins uncharacteristically logged dozens of hours late at night just before the anthrax envelopes were sent and that he was inexplicably absent during long stretches when investigators think he drove to New Jersey to mail them.

"The FBI has long maintained that while science played a significant role, it was the totality of the investigative process that determined the outcome of the anthrax case,'' the FBI and Justice Department said in a joint statement. "Although there have been great strides in forensic science over the years, rarely does science alone solve an investigation.''

The statement said the FBI had used science that was "innovative and groundbreaking" and that the report "provides valuable guidance" and "better prepares the FBI to respond to attacks of a similar nature in the future. ''

But the long-anticipated report reignited a debate that has been simmering among some scientists and others who have questioned the strength of the FBI's evidence against Ivins.

The extensive eight-year FBI probe, which spanned six continents, has included missteps, including the public naming of Ivins's colleague Stephen Hatfill as a "person of interest" in the investigation. The FBI later apologized to Hatfill.

"This report entirely undercuts the conclusion that RMR-1029 was the source and that Ivins was the perpetrator,'' said Meryl Nass, an anthrax expert and physician at Mount Desert Island Hospital in Maine. "That evidence was totally critical to their case,'' said Nass, who added that hundreds of people had access to the flaks in Ivins's lab. Federal investigators have said they investigated and ruled out all possible other suspects.

The report did endorse a key conclusion reached by FBI scientists: that the anthrax spores used in the mailings had not been altered, either genetically or chemically. That appeared to rule out the possibility that the spores were "weaponized" or manipulated to make them more deadly.

Some scientists have pointed to oddly elevated levels of silicon in the spores as an indication that the deadly powder was enhanced by someone with knowledge of advanced bioweapons techniques. The panel's findings, however, appeared to support the theory that the spores were produced by one or more individuals working alone, and were not the product of a state-run bioweapons program.

The proximity of the anthrax attacks to Sept. 11 had also fueled concern of possible terrorist involvement in the anthrax mailings. And the report reveals that the FBI and intelligence officers collected samples from an overseas site "because of information about efforts by al-Qaeda to develop an anthrax program.''

The report said the tests turned out to be negative but that the evidence was inconsistent, and it called for further review. It said the committee that prepared the report was provided "only fragmentary information" about the tests "very late in our study."

Federal law enforcement officials, speaking on condition of anonymity to discuss sensitive information, said the committee was offered a classified briefing to explain why federal investigators determined there was no evidence of anthrax at the overseas site. The committee declined because it only wanted information that could be made public, the officials said.

Staff reporter Joby Warrick and staff researcher Julie Tate contributed to this story.

I broke my right humerus, so posts will be limited for a few weeks

Associating vaccines and subsequent diseases

WHO noted that narcolepsy has never before been associated with vaccines. 

When there is no prior association, odd diseases occuring in temporal relationship to vaccination are generally felt to be coincidental.  Therefore, they are not generally reported to voluntary reporting systems, like the US' VAERS.  No data get collected, and it remains unknown whether vaccination increases the incidence of most diseases, particularly rare diseases.

Only when large numbers are vaccinated, the disease is severe, and it becomes obvious within a few weeks, is the link between vaccination and the disease made.  Furthermore, the relative risk has had to be high for the link to be identified.

Here are some examples:  swine flu vaccine in 1976 caused about 8 times as many Guillain Barre cases within 6-8 weeks as would have been expected (US).  Rotavirus vaccine in 1999 caused 22 times the expected incidence of intussusception as expected (US).  Swine flu vaccine in 2009-10 caused 9 times as many narcolepsy cases as expected in children (Finland).

We urgently need to establish surveillance systems that analyze diagnoses made at outpatient visits and hospitalizations for at least one year post vaccinations, so that statistically significant links can be identified and assessed for causality.  A good system would have the potential to detect diseases that are less severe than those above; it could detect those associated with smaller relative risks; and could detect those with later onset post-vaccination than currently identified (using limited datasets from voluntary reporting).

Such surveillance systems are possible now using data from large HMOs/ group health plans, which CDC has paid to access.  But simply looking for correlations between vaccinations and the majority of diseases has never been done... or at least, has never been reported.  It would be relatively cheap and easy to generate such correlations.

GlaxoSmithKline not liable to pay Pandemrix damages/ Helsinki Times

UPDATE:  On Feb 8, WHO acknowledged that at least 12 countries were reporting cases of narcolepsy associated with swine flu vaccinations.

From the Helsinki Times, what we already knew and blogged on in 2009 here, here, here, and here finally becomes public knowledge after a vaccine-related, serious illness is identified.  Governments that purchased pandemic swine flu vaccines provided liability waivers to the manufacturers.  Who is now responsible for any deaths and injuries caused by the vaccines?

Finnish medical journal Mediuutiset reported Friday that British drug maker GlaxoSmithKline was not liable to pay compensation for narcolepsy cases potentially caused by the Pandemrix influenza vaccine.

The National Institute for Health and Welfare (THL) confirmed that GlaxoSmithKline had been contractually relieved from liability.

Mediuutiset added that other countries had signed similar agreements with vaccine makers.

Ninefold risk of developing narcolepsy after Pandemrix vaccine for Finnish children/ AP

Finland's National Narcolepsy Task Force released its preliminary report today, and GSK's swine flu vaccine is implicated.  From the Associated Press:

The National Institute for Health and Welfare, which published the findings, said that 60 children and adolescents contracted narcolepsy in Finland in 2009 and 2010. Fifty-two of them — or almost 90 percent — had received the Pandemrix vaccine...

"Based on the preliminary analyses, the risk of falling ill with narcolepsy among those vaccinated in the 4-19 years age group was nine-fold in comparison to those unvaccinated in the same age group," the study said...  the biggest increase was among those aged 5 to 15 years.

The European Medicines Agency (EMEA), which authorized use of the vaccine, began an investigation into the vaccine and narcolepsy last August, which is continuing.  Will it be independent as it investigates possible harm resulting from its own decisions?

Pandemrix is a GlaxoSmithKline (GSK) swine flu vaccine that contains the novel adjuvant ASO3 (of which squalene is one component), as well as thimerosal.  Canada and much of Europe used this GSK vaccine, although the US used non-adjuvanted swine flu vaccines.  So more data should be forthcoming on the subject of swine flu vaccines and narcolepsy. 

Have swine flu vaccines been evaluated for a potential relationship to other neurologic and autoimmune disorders?  Neurological and autoimmune conditions are the types of illnesses that are most likely to occur as a result of vaccinations.

Before the swine flu campaign began, FDA promised that " the agency had set up an exceptionally extensive network for what is known as post-marketing surveillance."  Now is the time to examine those data.