NCPA - National Center for Policy Analysis


August 18, 2004

The results of clinical trials of many drugs are going unreported or unnoticed -- especially results of clinical trials where drugs don't perform as hoped or expected. This flies in the face of science and may even harm patients, say critics.

Two cases have brought the issue to light recently:

  • First, New York Attorney General Eliot Spitzer filed a civil suit against giant GlaxoSmithKline for failing to adequately publicize studies indicating that the antidepressant Paxil may lead to severe emotional problems and possibly suicide when given to children.
  • Then the New York Times and other publications exposed a clinical trial that was never published, showing that a similar drug, called Celexa, worked no better than a placebo for relieving depression in adolescents, while a much-publicized trial reached the opposite conclusion.

These are not isolated cases, said Kay Dickerson, a professor at Brown University's Center for Clinical Trials and Evidence-Based Healthcare. Over the years, she has collected data that she says illustrate a systematic bias in the medical literature. Studies showing that drugs work are three times as likely to be published as those showing they don't work or do more harm than good, she says.

That doesn't mean there's no safety net out there to protect society from bad drugs. The Food and Drug Administration still won't approve a new prescription drug until the manufacturers demonstrate its safety and efficacy in specified applications in a regimented series of experimental trials. But in recent years, the rules have been relaxed and the number of required trials decreased in an attempt to speed drug approvals.

In many cases, it's not that the journals refuse to publish negative results, Dickerson says, but that researchers never write them up or send them to the journals.

Source: Faye Flam, "Clinical Trials: Industry Biases Prevent Full Disclosure, Some Say," Philadelphia Inquirer, August 15, 2004.


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