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Tuesday, September 23, 2008

FDA and Big Pharma: Where's the Data?

The full report on this study is found at PLoS Medicine. It is certainly worth reading so you can get a better understanding of the serious iisues surrounding the FDA and drugs.

There is more than just an appearance of subverting the facts.

The European press is giving this much more coverage than here in the states.
The United States (US) Food and Drug Administration (FDA) approves new drugs based on sponsor-submitted clinical trials. The publication status of these trials in the medical literature and factors associated with publication have not been evaluated. We sought to determine the proportion of trials submitted to the FDA in support of newly approved drugs that are published in biomedical journals that a typical clinician, consumer, or policy maker living in the US would reasonably search.

CONCLUSIONS: Over half of all supporting trials for FDA-approved drugs remained unpublished 5 y after approval. Pivotal trials and trials with statistically significant results and larger sample sizes are more likely to be published. Selective reporting of trial results exists for commonly marketed drugs. Our data provide a baseline for evaluating publication bias as the new FDA Amendments Act comes into force mandating basic results reporting of clinical trials.

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