Questions about accuracy of Prozac research

The Guardian reports: "Yesterday the journal PLoS Medicine published a study which combined the results of 47 trials on some anti-depressant drugs, including Prozac, and found only minimal benefits over placebo, except for the most depressed patients. It has been misreported as a definitive nail in the coffin: this is not true. It was a restricted analysis but, more important, on the question of antidepressants, it added very little. We already knew SSRIs give only a modest benefit in mild and moderate depression and, indeed, the Nice guidelines themselves have actively advised against using them in milder cases.

But the real story goes way beyond the question of Prozac. This new study - published, paradoxically, in an open-access journal - tells a fascinating story of buried data and of our collective failure, as a society, over half a century, to adequately regulate the colossal global $550bn pharmaceutical industry.

The key issue is simple. In any situation, to make any kind of sensible decision about which treatment is best, a doctor must be able to take into account all of the available information. But drug companies have repeatedly been shown to bury unflattering data.
Sometimes they bury data that shows drugs to be actively harmful. This happened in the case of Vioxx and heart attacks, and SSRIs and suicidal thoughts. Such stories feel, intuitively, like cover-ups. But there are also more subtle issues at stake in the burying of results showing minimal efficacy, and these have only been revealed through the investigative work of medical academics.

The new study, published this week, has analysed all the data from the FDA, using the Freedom of Information Act to obtain the results for some of the trials. That medical academics should need to use that kind of legislation to obtain information about trials on pills that are prescribed to millions of people is absurd. More than that, it breaks a key moral contract between patient and researcher.

When a patient agrees to participate in a clinical trial, they give their consent on the understanding that their information will be used to increase the sum of our knowledge about treatments, to ensure that other people, in the future, will be treated more effectively. Burying unwelcome results is an unambiguous betrayal of their trust and generosity."

A quick fix would stop drug firms bending the truth (The Guardian, 27 February 2008)