Thursday, May 7, 2009

CDC's anthrax vaccine safety studies defunded/ Science online

from Science: Michael McNeil's portfolio of flawed anthrax vaccine safety studies at CDC is going away. Drum roll, please.

This is a good thing, since the studies were basically a boondoggle lacking a scientific foundation. Even Army vaccine scientists, as well as this blog's owner, published criticisms of the laughable methodologies used by the CDC group in its first published study. That study purported to show no increase in cases of optic neuropathy following anthrax vaccine, by using idiosyncratic study methods that enhanced bias.

The Institute of Medicine was asked to review this study portfolio back in 2001. Here are some comments (verbatim) from their interim report in January 2002:
  • CDC's plan appears to include useful components that have not to date been integrated into a whole or comprehensive plan.
  • No matter how meritorious the parts, however, the apparent lack of overall planning and coordination of the whole is a deficit that should be remedied.
  • The CDC either has not developed, or has not communicated, a comprehensive plan for the CDC's role in anthrax vaccine safety and efficacy research.
The final report of the IOM was ignored by CDC, which continued on with projects that IOM had found to lack merit and recommended ending.

This group also worked on the CDC anthrax vaccine trial, a 42 month study designed to look at long-term adverse vaccine reactions. What did they do instead? After the study had been completed, they published a paper discussing data from only the first 7 months of the study. This allowed CDC to hide long-term adverse reactions, and get the vaccine approved for civilians last October, potentially leading to large profits for the vaccine maker: Bioport aka Emergent Biosolutions. Qui Bono? Not the first responders who were slated for vaccination, since they were barred from seeking compensation if they got sick from either the manufacturer or government officials. Coincidentally, what barred them was an Emergency Declaration from HHS' Secretary Leavitt...conveniently issued the same month CDC published its paper and approved the vaccine for civilian first responders.

If CDC is serious about getting back on track with transparency, accurate information and quality research that will enhance public health, the anthrax vaccine safety group needed to go. Bravo to those at CDC who chose this program to cut.

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