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.

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.

HPV Mandates failing

Merck developed a clever scheme for marketing HPV vaccine:  it would lobby for laws that would add the vaccine to state Medicaid entitlements, require it be covered by private insurers and mandate the vaccine to attend school.  I know of two different approaches at the state level.

In 2007 in Texas, Governor Perry simply issued an executive order that all Texas schoolgirls entering sixth grade must receive the vaccine.  This was the first state mandate for this vaccine.  Merck had provided Perry financial support.  The Texas Medical Association was against the mandate.  After several months, the Texas legislature overturned Perry's order.


Merck provided money to the organization "Women in Government", a national association of female state legislators.  Women in Government, in conjunction with Merck, developed a massive campaign to encourage use of the vaccine and support state vaccine mandates.  At first glance, it looked like a "win win" strategy for legislators:  using state funds to prevent cervical cancer, in children.

At least a dozen state legislatures considered instituting HPV mandates.  But in the end, only Virginia and Washington D.C. passed HPV mandates for middle school girls.

However, vaccinations have not been popular.  "Opt out" provisions have been used by the majority of families.  Only 17% of Virginia's eligible sixth graders had begun the 3 shot series, and only 23% of eligible sixth graders in the District had done likewise, at the start of this school year.

On January 21, the Virginia House of Delegates passed a bill to eliminate the HPV requirement.  It may not pass the Senate, and may not be enacted.  Still, the bill gives notice that legislators are rethinking their hubris:  citizens do not want decisons about their children's sexual health to be made by the state.  Especially given the conflicts of interest.

Finland's Chief Medical Officer: Had I known of potential consequences, I would not have vaccinated 5-20 year olds for swine flu/ YLE

From YLE:

The Chief Medical Officer of Finland's National Public Health Institute has conceded that children and young people should possibly not have been vaccinated against swine flu. Dr Terhi Kilpi told the Väli-Suomi newspaper group's Sunday newspaper supplement that the vaccine perhaps should not have been given to 5-20 year-olds.

Kilpi said that she would no longer recommend the vaccination for this age group. She added that if she had known of the potential consequences, she would have not inoculated 5-20 year-olds.

"A year ago, the current understanding was that the swine flu was a danger specifically for the young. At that time there was not yet any reason to suspect serious side effects to the vaccine," said Kilpi.

The vaccine is now suspected to be linked to an increase in the number of cases of narcolepsy affecting children and young people in Finland, Sweden and Iceland. In Finland, 54 children have been diagnosed with narcolepsy...

Finland's National Public Health Institute is to publish an interim report on the links between narcolepsy, the swine flu, and the vaccine this coming Tuesday.

David Kelly: 5 items found on his body had no fingerprints! / Daily Mail

It might not be murder, but there was definite hanky panky at the scene of David Kelly's death.  Not only did the knife, the water bottle and the pill package on Dr. Kelly's person lack any fingerprints.  Turns out his cell phone and a watch had also been wiped clean.  Since there were no gloves at the scene, Kelly could not have cut his own wrist, causing an arterial hemorrhage allegedly sufficient to cause death, and left no fingerprints.  Did Kelly try to call for help, and have his cell  phone grabbed by his attacker...who perhaps touched the watch as he sliced at Kelly's wrist?  From the Daily Mail:

Further questions have been raised over the death of Dr David Kelly after police admitted that two personal items found with his body – his mobile phone and a watch – did not have any fingerprints on them.

The news brings the number of objects without fingerprints at the site where the weapons inspector’s body was discovered to five – the other three being the knife he allegedly used to slash his wrist, the packs of pills he is said to have overdosed on, and a water bottle...

Breast Implants Are Linked to Rare but Treatable Cancer, F.D.A. Finds/ NY Times

Autoimmune disorders encompass a large variety of illnesses, the fourth-largest general category of disease, it is said.  A rare lymphoma, or neoplastic disease of the immune system, has been associated with breast implants.  This article does not say the disease is autoimmune, and the mechanism by which the implant may lead to the disease is unspecified. 

But the likeliest causes imho are a) physical, i.e., the normal tissue was disrupted and this led to neoplasia; b) toxic (a result of the plastic material--silicone--intimately exposed 24/7 to human tissues) and c) autoimmune.  These causes may be linked, or more than one may be involved in disease causality.  Other autoimmune conditions have been identified with breast implants, but the nature of the beast is such that this has never been proven nor disproved.

The worldwide market for breast implants is roughly $820 million a year and growing at 8 percent a year, according to industry figures.

But in the NY Times' current case, statistically, breast implants are strongly linked to a rare lymphoma:

Breast implants may cause a small but significant increase in the risk of an extremely rare but treatable type of cancer, the Food and Drug Administration said on Wednesday.
The risk applies to both saline- and silicone-filled implants, and to all women who have them, whether for reconstruction after cancer surgery or for cosmetic enlargement of the breasts.
The cancer, anaplastic large-cell lymphoma, involves the immune system. It is not breast cancer. It is usually a systemic disease, but in the cases linked to implants, the lymphoma grew in the breast, usually in the capsule of scar tissue that formed around the implant...

Scientists fear MMR link to autism/ MailOnline

UPDATE:  This is a 2006 article.  Sorry.

Too bad we have to get our science from the Mail, but in the era of Conflicts of Interest, maybe it isn't so strange that we read about the flip side of pharmaceuticals from media outlets that don't rely on pharmaceutical company advertising to survive.

New American research shows that there could be a link between the controversial MMR triple vaccine and autism and bowel disease in children.

The study appears to confirm the findings of British doctor Andrew Wakefield, who caused a storm in 1998 by suggesting a possible link.

Now a team from the Wake Forest University School of Medicine in North Carolina are examining 275 children with regressive autism and bowel disease - and of the 82 tested so far, 70 prove positive for the measles virus.

Last night the team's leader, Dr Stephen Walker, said: 'Of the handful of results we have in so far, all are vaccine strain and none are wild measles...

Read more: http://www.dailymail.co.uk/news/article-388051/Scientists-fear-MMR-link-autism.html#ixzz1C0kh5xq1

1300 cases of vaccine-related brain damage compensated in US courts/ CBS News

From CBS News in September:

... occasionally, vaccines cause injury or death. Very rarely, patients are left with what's known as "encephalopathy", the medical term for brain damage.  In fact, CBS News has found nearly 1,300 cases in which vaccine-related brain damage has been compensated in court over the past 20 years.

The debate over any links between vaccines and autism - a behavior problem triggered by brain damage - couldn't be more contentious. The great majority of medical opinion holds that vaccines don't cause autism. However, many of the same experts don't dispute that vaccines can, in rare instances, cause brain damage.

Our examination of federal vaccine court decisions over the years reflects this. Children who end up with autistic symptoms or autism have won vaccine injury claims over the years-as long as they highlighted general, widely-accepted brain damage; not autism specifically. But when autism or autistic symptoms are alleged as the primary brain damage, the cases are lost...

From today's CBS News:

... government officials have said they have no plans to study ... cases that victims are winning against the government in the little-known federal vaccine court...

... The former head of the National Institutes of Health, Dr. Bernardine Healy, has said such study [identifying children who are more susceptible to brain injury from vaccinations ahead of time] would actually protect the integrity of the vaccine program, rather than threaten it (as she says many government officials fear). So far, though, no takers... 

What made these children get sick? Why couldn't they tolerate their vaccines when most kids can? Unanswered questions.

25 Tons of Bombs Wipe Afghan Town Off Map/ Wired

Shades of Vietnam:  we had to destroy this village to save it.  And the  US plans to spend $1,000,000 to rebuild it.  Of course no civilians, only Taliban, were killed.  And we managed to save the pomegranite trees:  good aim, guys!  Read the WIRED story. 

An American-led military unit pulverized an Afghan village in Kandahar’s Arghandab River Valley in October, after it became overrun with Taliban insurgents. It’s hard to understand how turning an entire village into dust fits into America’s counterinsurgency strategy — which supposedly prizes the local people’s loyalty above all else...

Petraeus has waged a far more violent, intense fight than many expected.

Air strikes, curtailed under Gen. Stanley McChrystal, are at their highest levels since the invasion. Tanks have moved into Helmand Province, rockets batter Taliban positions in Kandahar, and throughout the east and the south Special Operations Forces conduct intense raiding operations. Petraeus rebuked Karzai when the Afghan leader urged an end to the raids....

Confused vaccine messages in the UK/ Telegraph

The UK's Telegraph is on a tear about flu vaccine.  Two weeks ago, the Telegraph complained that the UK government had dropped its flu vaccine advertising campaign.  Last year the UK spent 15 million pounds for swine flu vaccine ads.  But people are being vaccinated nonetheless:

After earlier complaints that the failure to advertise flu jabs had led to low take-up rates this winter, the UK chief medical officer, Professor Sally Davies, said that vaccination rates were now at normal levels for the time of year.

This week the Telegraph berated the government because jabs for children were stopped in north-west England, despite a 3 year old dying.  The Telegraph says this "has left parents feeling fearful and anxious."  Two experts, vaccine proponents, were quoted about feeling "uneasy" over the government's "stumbling" decision-making; the other was "very disappointed" about not vaccinating children as is routinely done in the US.  [It is not routinely done elsewhere in Europe.] 

An earlier Telegraph piece had more facts.  Government policy is to offer flu vaccine only to children at high risk due to an underlying condition.  This makes good sense, in terms of balancing risk and benefit.  Eighty per cent of the 70 children who died from flu complications last year had underlying health problems:  for such children, the potential benefit of vaccination is much greater than for otherwise healthy children.  Only 20% of UK child deaths from flu last year (14 children) were otherwise healthy.  Healthy children, being at much lower risk of death or serious injury would have a reduced benefit from vaccination relative to chronically ill children, but equal potential risk from vaccination.

According to the UK's Chief Medical Officer Sally Davies, "The data from the pandemic last year showed - and this year's data is very similar - that if you are in an at-risk group you are 18 times more likely to die of flu if you catch it than a healthy person, so we need to focus on getting those at risk to come forward and have vaccinations."

Should healthy children be vaccinated nonetheless?  The Cochrane Collaboration has found no evidence of benefit for flu vaccine in young children, based on metaanalysis of all published research, which Cochrane submits to a careful methodologic review.  If it is a very bad flu season with many child deaths, it might make sense to vaccinate regardless.  The Daily Mail reports 15 deaths in the 14 and under age group from flu in the UK this season.

But during Australia's 2010 autumn, flu vaccinations for under-5's were stopped due to seizures in one child per 110 vaccinated, and several child deaths after vaccination.  In other words, in very rare cases you may die from flu or from vaccine.  The vaccine works, at best, 70% of the time, and some seasons it is entirely ineffective.  It is also less effective in some groups compared to others.

We don't know what the side effect profile of a flu vaccine will be until after millions have been vaccinated, since the vaccine is newly designed each year with selected viral antigens,  Thus performing a reasonable risk-benefit calculation is difficult if not impossible.  Improving early data collection of benefits and harms would help this situation, and is greatly needed.

"Complete Revamp" of country's drugs regulatory system promised by French Health Minister/ BBC

BBC News reports that "France pledges reform after diabetes drug scandal":

 

Mr Bertrand said it was his duty to rebuild the system to protect the public

French Health Minister Xavier Bertrand has promised a complete revamp of the country's medical regulatory system.He was speaking after an official report said a diabetes drug which caused up to 2,000 deaths should have been banned 10 years earlier.

The drug - known as Mediator - should have been banned as early as 1999, when it began to emerge that it could cause heart disease, the report said.  Several other European countries and the US then withdrew it.

'Political connections'

But Mediator remained on sale in France for another 10 years.  Between 500 and 2,000 people in France are believed to have died because of its side effects.  It was developed to treat diabetics but millions of people took it simply to lose weight.

The report by a government agency, the Social Affairs Inspectorate, said it was incomprehensible that the authorities had failed to act sooner.  Mr Bertrand said it was now his duty to rebuild the regulatory system to protect the public.  His statement is being seen as an admission that one of the biggest medical scandals in France in recent years may not be an isolated case.

The affair has become politicised as the pharmaceutical company which manufactured the drug, Servier, reportedly had high-level political connections.

The health minister himself has been implicated by French media reports alleging that two of his advisors had previously worked for the company.

Wakefield Witch Hunt: What's Up?

The BMJ, a medical journal that is more open to controversial subjects than most, just published an investigative piece and editorial claiming that Andrew Wakefield et al's research on children with developmental and gastrointestinal disorders and the MMR vaccine was "fraud." Wakefield's original research paper was retracted last year by the Lancet, following a decision by the General Medical Council (GMC) to pull Wakefield's license to practice medicine in the UK on the basis of his work on autism, 12 years after initial publication.  I commented here.  The paper had been, in its day, the exemplar of research on vaccine safety problems.

As such, it drew heavy fire from its initial publication until retraction in February 2010.  Lancet pulled the paper on the basis that the child subjects were not "consecutively referred," and that the research had not been approved by a local ethics committee. A large proportion of academic papers in top tier journals are tainted by gross forms of research misconduct, such as not having been written by their purported authors (an estimated 10% plus according to JAMA editors).  Yet very few papers get retracted.

The author of the BMJ piece is Brian Deer, a journalist who has been writing attack articles about Wakefield's work since 2004.  Deer's interest appears to be uncovering scandals.  He has pursued a variety of targets, but has especially focused on "uncovering" the truth about DPT/ pertussis and MMR vaccine injuries.  Deer has challenged some parents and doctors of alleged vaccine-injured kids as liars.

His piece in the BMJ claims that several of Wakefield's case series patients did not really have autism, or developed symptoms prior to receiving the MMR vaccine.  Yet some of the parents he interviewed have challenged his statements.  Brian Deer apparently interviewed parents using a false name and grossly false pretenses (promising to try and get them funds to help care for their children).  See video by Alan Golding here.  How did he even learn the patient names, which were confidential?  For Deer to call Wakefield a fraud is an example of the pot calling the kettle black. 

Fraud is very serious, and should absolutely be uncovered and punished when it occurs.  But I am not convinced that Brian Deer is a trustworthy source of such charges.  And there is no other independent source to utilize at this point to sort out the truth of the matter.

Another issue regarding Deer is massive conflict of interest.  Deer was the  complainant with the UK General Medical Council that led to the GMC spending millions of pounds to conduct its case against Wakefield.  So Deer was essential to creating the story and keeping the pot boiling... then covering the story as if he was an uninvolved journalist:  another example of acting under false pretenses.  Martin Walker has written extensively on this subject.

The BMJ article was immediately re-reported by media worldwide, presumably to discredit the vaccine-autism link.  I found 720 articles on Google News this week that include the terms "Andrew Wakefield" and "fraud".  It would be surprising if this outpouring of "news" occurred by chance.

After  BMJ editor Fiona Godlee slammed Wakefield for fraud, she said the following in an interview:

I’m in no doubt at all that there’s a lot of bad science. There are people who feel it’s got so bad that one can’t really trust anything that’s in medical journals. I’m not really at that level. I think there’s some good science around, too. Telling the difference is what’s hard. There’s also the difference between bad science and fraud. I think there’s a great deal more bad science out there than there is fraud...

I think fraud is always going to be extremely hard to detect. In other cases, frauds have been detected sooner, so I think this is unusual in having survived in the glare of full publicity for so long without being detected.

For me, Wakefield and Deer aside, the bottom line is whether receiving the MMR (or measles vaccine alone) may lead to neurological disease in susceptible children.  

I have spoken with many parents of autistic children (sometimes my own patients) over many years.  I have heard the parents report chronic diarrhea and other bowel problems more often than not in affected children.  A number of parents have told me how their child regressed into autism, after being neurologically normal, around 12-18 months of age: after receiving the MMR vaccine.  Some of the parents had never considered a vaccine link when they told me their story.

One month after Wakefield's original Lancet paper, a study of vaccine injury claims by US government scientists in the journal Pediatrics found that 48 claimants developed encephalopathy within 15 days after receiving an attenuated measles vaccine, resulting in severe neurological sequelae or death.  This happened in "a nonrandom, statistically significant distribution of cases on days 8 and 9."  The authors concluded:

This clustering suggests that a causal relationship between measles vaccine and encephalopathy may exist as a rare complication of measles immunization.

Here is the abstract and here is the full text. 

You cannot deny that the lives of some children and their parents have been destroyed after a measles vaccination.  Their number keeps growing.  It behooves us to find out why, and to find preventive measures for infectious diseases that will be safer for all children.