Monday, July 27, 2009

Underlying assumptions about a swine flu immunization program should be explicit and shared with the public

The 1978 National Academy of Sciences (NAS) report on the 1976 Swine Flu Vaccination Program points out that a large number of assumptions going into the program were never acknowledged or critically examined. For example, the report lists the following assumptions that were made when the program was conceived:
high-yield eggs, one dose per person, high efficacy, unparalleled acceptance, favorable publicity, sustained congressional support, wide private involvement, adequate state operations, three months to complete vaccinations, no useful stockpiling, no liability legislation, few (if any) opportunity costs, etcetera.
And the report's authors emphasize:
In short, we advocate a comprehensive definition and review of assumptions everyone can see and weigh before decision and remember after. The review thus should be public.
Today, it is unclear what assumptions policymakers have made about the Swine Flu program. In 1976, President Ford was told an epidemic resembling the 1918 Pandemic was lurking, and he was pressed into acquiescing to the program with limited information, on the basis of "expert" advice.

In the context of the 1976 Swine Flu Program, the 1978 NAS report calls attention to a major problem with expert advisory panels:
Panels tend toward “group think” and over-selling, tendencies nurtured by long-standing interchanges and intimacy, as in the influenza fraternity. Other competent scientists, who do not share their group identity or vested interests, should be able to appraise the scientific logic applied to available evidence. In medicine, as in law, there are rules of evidence by which argument can be tested.
Expert medical and scientific opinion, obtained from outside the beltway and devoid of personal agendas, is of critical importance. Policymakers are unpracticed at dealing with the breadth of issues to be considered in large vaccination programs, and with attendant risk/benefit analysis. Can they, and we, learn the lessons of 1976?


AR said...

Dr. Nass,

In case you haven't yet read this Bloomberg article of July 29, 2009:

Swine Flu Shot May Rely on Emergency Use of Additives

"July 29 (Bloomberg) -- Swine flu vaccine makers may rely on a U.S. emergency declaration to use experimental additives made by GlaxoSmithKline Plc and Novartis AG to boost a limited supply of shots that will be available to fight the pandemic.

"The ingredients, known as adjuvants, may be added for the first time to flu shots in the U.S. Health officials today are meeting to discuss the additives at the U.S. Centers for Disease Control and Prevention in Atlanta..."

So, I guess the FDA has changed its mind, since you wrote "FDA appears unwilling, currently, to take the bigger risk of approving novel adjuvants, which have not been tested in at-risk populations, without data." on July 24th.
Has squalene been tested?

Meryl Nass, M.D. said...

The facts are confusing. FDA has not issued a LICENSE for squalene-containing vaccines. Laws require that safety standards be met for licensure. On the other hand, FDA can in future issue an Emergency Use Authorization, which will enable mass use of UNLICENSED squalene-containing vaccines. No standards would need to be met in this instance.

According to the Canadian Press,

"In the U.S., the Food and Drug Administration will use a mechanism called an emergency use authorization or EUA if the U.S. administration decides adjuvants must be used there.

That decision, FDA officials signalled at a vaccine advisory committee meeting last week, will be a political one, not one that rests with the regulatory agency."