Editorial: Lack of disclosure

Monday, Nov. 5, 2007 | 7:17 a.m.

New federal legislation requiring pharmaceutical companies to disclose clinical trial results for all approved drugs and medical devices falls short of requiring the same disclosure for products that have been tested on people but never marketed.

In debate over the measure, which Congress approved in September, drug and medical device manufacturers said releasing data for failed products would confuse patients and give competitors information about products under development, The New York Times reports.

But patient advocates say it is unfair to withhold clinical trial results from participants who, in some cases, end up walking around with experimental medical devices implanted in their bodies.

Medical products fail to make it to the market for a variety of reasons, such as poor performance in clinical trials or rejection by regulators. It is unknown how many people participate in clinical trials for these products because no such information is readily available, the Times adds.

Researchers are required to notify clinical trial participants of dangers as they emerge with a drug or device being tested. And, to gain approval for starting a clinical trial, manufacturers often must promise to keep track of study participants' health. But, as experts and patient advocates told the Times, such requirements - minimal ones, in our view - are not always met.

As an example, the Food and Drug Administration last summer admonished Boston Scientific, a medical-device manufacturer, because it failed to tell patients why it stopped work on a tiny tube that was supposed to prevent the rupture of an aneurysm, or weakening, of an abdominal artery.

Researchers had discovered that the device frequently cracked and shifted position, rendering it useless in treating the serious condition. But researchers never revealed this information to clinical trial participants in whom these devices had been implanted.

Manufacturers' concern about competition is a poor reason for hiding this important data. Clinical trial participants often are sick people who take chances on unproven products to advance treatments for themselves and others. They should be informed of all outcomes - failure or success.

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