White House Moves to Scuttle Key FDA Reform

The Bush Administration has notified Senate and House negotiators working on Food and Drug Administration reform legislation that it opposes posting of clinical trial results in a government database, an echo of the position taken by the Pharmaceutical and Research and Manufacturers Association that is reflected in the Senate version of the bill.

According to the industry newsletter Inside FDA (subscription required), the White House's "unofficial" position is that neither the FDA nor the National Institutes of Health will be able to "validate" the results before they are posted. Ignoring the fact that the NIH's Library of Medicine database links to scores of articles on a daily basis that have not been validated by peer review, the administration urged Congress to wait until NIH has completed a study of how to construct a valid database before passing any requirement for disclosing clinical trial results.

The White House also rebelled against giving consumers, patients or physicians demographic data, primary and secondary endpoint data, or the results of clinical trials for drugs that are not yet on the market. The Senate version of the Food and Drug Administration Revitalization Act (FDARA) requires that companies register trials, but not post their results. The House version requires posting of both results data and a summary that can be understood by the lay public.

White House opposition to this aspect of the FDA reform bill is in line with its general approach to open government, which is to say, it opposes it. But disclosure of clinical trial results data is crucial if independent researchers are going to be able to conduct meta-analyses of problematic drugs.

For instance, Steve Nissen of the Cleveland Clinic, who uncovered the heart attack risks associated with the diabetes drug Avandia, used clinical trial results data that had been posted, ironically enough, by the drug's maker, GlaxoSmithKline, on its own website. As Nissen pointed out in his original article outlining the concerns, his analysis suffered because he did not have access to all the data from the Glaxo-funded trials.

Adopting the Senate version of the clinical trials registry will substantially weaken the final bill and make it much less useful to scientists and physicians concerned about patient safety. According to sources on Capitol Hill, this provision -- along with a measure that would limit conflicts of interest on FDA advisory committee to one per meeting -- are the major stumbling blocks as negotiators seek to hammer out the final details of the legislation before September 30.