Healthy Skepticism Library item: 869

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Publication type: news

Drug Study Registries Raise Competitive Concerns (for Big Pharma)
Reuters 2004 Sep 20

Full text:

Drug makers are worried that calls for greater disclosure of early-stage clinical trials might lead to the release of scientific information that could help competitors, an industry lobbyist said on Monday.

The industry likely will oppose efforts by medical journals to force companies to reveal the existence of the earliest studies, known as phase I trials, said Alan Goldhammer, associate vice president for regulatory affairs at the Pharmaceutical Research and Manufacturers of America (PhRMA).

Publishing details on the design of such trials “would really tip off to your competitor your development program,” Goldhammer said at a discussion held by the American Enterprise Institute (AEI), a conservative think tank.

Editors of major medical journals have agreed not to publish any studies that were not listed in a national registry when they began, a move to keep companies from hiding unflattering or unclear results later.

PhRMA still is reviewing the plan, but “the decision will probably come down against a mandatory registry of phase I trials,” Goldhammer said.

The industry lobbying group has developed its own database for companies to voluntarily publish results of certain late-stage clinical trials. Some companies also have put trial results on their Websites.

Movement toward better disclosure gained momentum in recent months amid controversy over the safety of antidepressants for children and teens.
Manufacturers did not publicize findings from several studies that failed to prove most of the drugs worked for pediatric patients.

Attorney Bert Rein, also speaking at AEI, said the availability of negative or unclear findings might make drug makers more frequent targets of liability lawsuits. Physicians also might be sued if they prescribed a drug without being aware of information in a registry, Rein said.

“You’ve got to think about it. You can’t just throw [the information] out there with all the liability issues that will arise,” said Rein, who represents drug companies and is founding partner of law firm Wiley, Rein & Fielding.