Monday, March 28, 2011

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

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

Ireland is finding increased narcolepsy cases in the vaccinated 4-19 age group as well as Finland and Sweden.
... Last month, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) confirmed that it had reviewed further information from Finland on the suspected link between narcolepsy in children and adolescents and Pandemrix.
"The committee concluded that the new evidence added to the concern arising from case reports in Finland and Sweden, but that the data were still insufficient to establish a causal relationship between Pandemrix and narcolepsy.
"Further analyses and study results are awaited to clarify the observations in Finland."
In addition to the information coming from Finland, research is continuing in Sweden, where there has also been an unexpected number of narcolepsy reports following vaccination with Pandemrix.
In last month's statement, the CHMP said that other non-Nordic countries had not seen similar increased rates of reporting of narcolepsy.
That assessment may change in the light of the eight suspected cases that have been reported in Ireland of people who have received the Pandemrix vaccine and who have subsequently developed narcolepsy...

Saturday, March 26, 2011

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

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

UPDATE:  Podcast with Noah here.  Extracts of the magazine story follow:
In February 2003, anthrax became part of the rationale for invading Iraq. Colin Powell went to the United Nations Security Council, in part to discuss the potential bioweapon. “Less than a teaspoonful of dry anthrax in an envelope shut down the United States Senate,” he said. “Saddam Hussein could have … enough to fill tens upon tens upon tens of thousands of teaspoons.” Two weeks later, Tom Ridge told Americans to buy duct tape and plastic sheeting to protect themselves from a bioterror attack. Four weeks after that, the invasion of Iraq began.
The National Research Council report also casts doubt on whether the killer spores really were descendants of Ivins’ RMR-1029 flask. The FBI resampled RMR-1029 a total of 30 different times, the report found. They could get all four telltale morphs on only 16 occasions.
Further, the FBI says that only eight samples in its Ames repository were genetic matches to all four morphs of the killer spores—and that the scientists with access to those isolates were thoroughly scrutinized. But the National Research Council found that the FBI’s collection can’t be fully trusted: Too many of the samples were intermingled or descended from other labs’ anthracis to provide a truly representative cross-section of Ames anthrax. This may also be a reason why nearly one in 10 samples in the repository tested positive for at least one mutant.
Paul Keim, who helped assemble the FBI’s Ames collection, still wonders how much to trust an anthrax repository that relied on scientists (and potential murder suspects) submitting their own samples. “We don’t know if people did it correctly, and there’s no real way to control for that,” Keim says...
There are still other problems with the case against Ivins. The killing spores were so volatile that they cross-contaminated piles and piles of mail. Yet spores were never found in Ivins’ house or his car, and only a handful were discovered in his lab. There’s no evidence of any trip to Princeton to mail the letters. And just because the killer spores were descendants of a USAMRIID flask, there’s no guarantee a USAMRIID scientist was actually the mailer. In fact, the FBI was never able to prove where the attack anthrax was cultured. “It would’ve been very easy to take the anthrax out, to steal some,” a former USAMRIID officer says. “Anybody could do that.”
Finally, there’s the matter of motive. The Justice Department asserts in its investigative summary that Ivins mailed the letters to gin up support for an anthrax vaccine, offering a few ambiguous emails and comments to friends and investigators as proof. If there’s any further, credible evidence to support this notion, Wired couldn’t find it in the thousands of pages of case documents released by the government or in the hours of interviews conducted with the investigators. Montooth [who led the FBI's case in the beginning] concedes it’s a placeholder rationale at best...
There’s an irony in the fact that the culprit was likely a top government anthrax expert: Since 2001, the US has built dozens of labs, spent just under $62 billion, and hired an army of researchers to prevent a second bioterror attack. In effect, Washington has devoted the past decade to training and equipping hundreds of people like Ivins.
It’s an unnerving scenario. But there’s something much scarier to contemplate. There’s still the possibility that the government was as wrong about Ivins as it was about Hatfill. If that’s the case, the anthrax mailer is still at large. And that means someone launched the deadliest biological attack in the history of the United States—and got away with it.

David Kelly inquest plea made to David Cameron/ BBC

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

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

Thursday, March 24, 2011

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

A group of psychiatrists [UPDATE:  See Dr. Jeffrey Kaye's analysis of the panel composition] offered their forensic expertise in solving the anthrax criminal investigation, by using their insight into the criminal mind.  Somehow DC Judge Royce E. Lamberth blessed them, and FBI paid the $38,000  bill.  The group only had one suspect, whose confidential medical records were supplied by the FBI.  The Executive Summary makes clear that the panels' conclusions were built into its charge:
...the Panel was asked to offer, based on the available materials, a better understanding of Dr. Ivins’ mental state before and after the anthrax mailings, his possible motives — and the connections, if any, between his mental state and the commission of the crimes.
If the group's trove of documents resembled that of the National Academy of Sciences panel, then it was carefully cherry-picked, designed to elicit a single conclusion.  The NY Times' Scott Shane notes their conclusion:
“Dr. Ivins was psychologically disposed to undertake the mailings; his behavioral history demonstrated his potential for carrying them out; and he had the motivation and the means,” the panel wrote in its 285-page report, released at a news conference on Wednesday...  It also found that Dr. Ivins, who was 62 when he died, was “homicidal” in the last weeks of his life. Only his involuntary commitment for psychiatric treatment, the panel wrote, “prevented a mass shooting and fulfillment of his promise to go out in a ‘blaze of glory,’ “ the report said.
How much of their evidence is derived from Ivins' alcohol abuse counselor, who was under house arrest at the time and working with the FBI in the final months of Ivins' life?  Was her profound conflict of interest clear to these experts?

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

From the report's executive summary:
The key themes were revenge, a desperate need for personal validation, career reservation and professional redemption, and loss. These themes guided him not only in making the attacks, but in choosing his targets and shaping his methods...
The [mail]box thus appears to have represented to him the two key reservoirs of his obsession and rage. Dr. Ivins’ statements to therapists and the FBI suggest that KKG represented authority and all the successful, talented, attractive people who had rejected him and inspired his rage. Princeton represented his father and perhaps his unmet college aspirations and the humiliation and rage wrapped up in these concepts for him. For him, dropping anthrax in this [mail]box appears to have represented both a conquest and a desecration — in short, payback.
Is psychobabble too strong a word to describe this outpouring of gibberish?

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

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

National Academy of Sciences (NAS) Panel

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

Monday, March 21, 2011

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

From San Diego's station KPBS:
— A KPBS investigation has found that nearly two out of three people diagnosed with whooping cough in San Diego County this year were fully immunized. California is in the midst of the worst whooping cough epidemic in 50 years.
The numbers raise questions about how well the vaccine works.
Whooping cough, or pertussis is a contagious upper respiratory illness that in adults can mimic a bad cold. But in babies it can be deadly. Eight babies have died in California from whooping cough since January...
UTD = up-to-date with age appropriate pertussis vaccinations by immunization record review or parent report

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

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

UNK = unknown

TDAP DUE = any child 11-18 years old who had only 5 pertussis containing immunizations with no Tdap noted

(source: San Diego County Health & Human Services Agency)
UTD = up-to-date with age appropriate pertussis vaccinations by immunization record review or parent report

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

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

UNK = unknown

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

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

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

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

Sunday, March 20, 2011

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.

Thursday, March 10, 2011

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.