Tuesday, June 8, 2010

Swine Flu pandemic response due to conflicts of interest? Journal Nature rebuts this claim

Nature's Declan Butler examines and rebuts the claim that WHO experts' paid consultancies affected the advice they gave WHO on the swine flu pandemic.  Butler correctly notes that many governments ordered some swine flu vaccine before WHO declared a Level 6 Pandemic.  He further reports that scientists said, "severity is impossible to pin down until many months after [a pandemic] starts."  Another issue he discusses is whether WHO and its experts had declared their conflicts of interest correctly.

Yes, some swine flu vaccine was purchased prior to WHO's June 11, 2009 Pandemic Level 6 declaration.  But what has not been adequately discussed anywhere, to my knowledge, are pre-existing contracts that were forcibly triggered by the declaration of a Level 6 Pandemic.  Such contracts had been entered into by governments and vaccine manufacturers as a result of earlier fears [circa 2000-2004] over a potential avian flu pandemic disaster.  The contracts allegedly committed governments to large purchases of "pandemic" vaccines, no matter what pandemic eventuated.  WHO knew of these contracts, and both its officers and expert consultants understood that billions of dollars in vaccine purchases hung on the decision to declare a Level 6 Pandemic.  These contracts were not made known to the public at the time.

I would posit that by June 11, 2009 the epidemic looked a lot tamer than it had in April 2009. WHO's Margaret Chan discussed severity when she declared a Level 6 Pandemic, acknowledging, "On present evidence, the overwhelming majority of patients experience mild symptoms and make a rapid and full recovery, often in the absence of any form of medical treatment.

 I would further posit that although discussions about the definition of pandemic had been ongoing, the decision to omit severity from the definition is, at a minimum, medically unsound.  The current WHO definition allows for every widespread new common cold virus to be termed a Level 6 pandemic.  Thus the altered definition lacks specificity and therefore lacks usefulness.

Given the knowledge of disease severity in June 2009, compared to April 2009, there was no clear public health need to raise the pandemic level and activate the preexisting vaccine contracts.  Recall that those contracts had been written when a bird flu pandemic, associated with a 50% plus case fatality rate, had been envisioned.   Probably many of the same people were involved in the swine flu response as were involved with bird flu planning and response.  Certainly Doctors Margaret Chan (China) and Keiji Fukuda (USA) (respectively WHO Director-General and Deputy Director-General, both from countries where vaccine makers were located) were central to the response to both pandemics.

One would have expected these experts to distinguish the enormous difference in severity between the bird and swine flu pandemics, and respond accordingly.  Scuttlebut at the time of WHO's June 11 declaration was that different countries had been jockeying to influence the decision, suggesting that politics influenced the declaration.  WHO Director-General Chan says that, "At no time, not for one second, did commercial interests enter my decision-making," Okay.  But then, what did lead Dr. Chan to raise the pandemic level last June?  And what has led her to retain that designation today, when there is no serious swine flu pandemic anywhere?  Given that the current (absent) state of swine flu disease is still being called a maximum Level 6 Pandemic by WHO, I'd advise countries with pandemic vaccine contracts that will be activated by future WHO pandemic designations to scuttle those contracts, asap. 

I beg to differ with Butler's experts, who claimed that months were needed to assess swine flu severity.  When you are dealing with a potentially calamitous situation, and directing huge amounts of resources to understanding and controlling it, you can get a very good handle on mechanisms and ease of spread, as well as disease severity, in a very few weeks (and sometimes days), as long as the incubation period is short, as this one was.

As to the issue of experts' conflicts of interest:  these are pervasive throughout governments and international organizations.  It has been very hard to find any expert advisors on FDA, CDC and WHO advisory panels (WHO has kept its pandemic flu emergency committee members a secret) who have not regularly consulted for industry.  This is a recent cultural phenomenon, and it appears to be changing at FDA, following Congressional investigation.  No one knows how to measure or manage the inherent conflicts, so they are mostly ignored.  To what extent they influence decision-making remains to be seen.  Personally, I feel such conflicts have been instrumental in dismantling safety standards and weakening government oversight (for example, by insufficient safety testing of swine flu vaccines before distribution, and not properly overseeing oil well construction).

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