Is the Information We Have About Pharmaceutical Drugs Really Reliable?

A report in the current issue of the British Medical Journal questions the reliability of what we know about the latest drugs, such as antidepressants or statins.

The Food and Drug Administration Amendments Act (FDAAA) of 2007 stipulated that the results of clinical trials conducted for a new drug are published in a public database, say journalists Jeanne Lenzer and Shannon Brownlee. Despite this Act, lack of access to reliable data remains an ongoing problem. Not all trials have to be registered, while trade secrecy laws protect other products from providing access to full data.

Data can be demanded under the Freedom of Information Act, but trade secrecy laws allow information about a drug that is not approved for a new indication to be withheld, even though the drug is already being marketed for other indications. The stated purpose of these trade secrets is to prevent a company being placed at a "competitive disadvantage" to other companies.

For example, in 2001 Valdecoxib, a COX 2 inhibitor failed to obtain FDA approval as a treatment for acute pain. Some of the trial information was removed from the FDA website, with the public and medical researchers unaware of possible side effects—a situation that should be remedied at once, say the authors.

One possible solution would be to make the FDA database available to researchers, a move resisted by the FDA which claims that putting all its data online would be too burdensome. But doing this future Freedom of Information requests would be reduced, say the critics. Failing to make trial participant data available to the public has to be accomplished, if the public interest is to be served, say the authors.

Source: British Medical Journal, Volume 336, pp 532-534

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