AMA's plan for trial registry puts wrinkle in pharma PR

CHICAGO: The American Medical Association's proposal for a public registry of clinical studies - whether positive, negative, or inconclusive - would appear to bring PR headaches to drug and medical-device companies.

CHICAGO: The American Medical Association's proposal for a public registry of clinical studies - whether positive, negative, or inconclusive - would appear to bring PR headaches to drug and medical-device companies.

But experts say this might not be the case. And, in any event, the studies are often so complex that PR professionals would have a role in making them palatable to the general public through the press.

The proposal responds to criticisms that medical journals tend to favor positive studies, and that unpublished negative studies are lost to the public.

The AMA, which passed the proposal Tuesday at its annual meeting, cannot enforce the registry, but can put pressure on those who would.

These organizations include institutional review boards, medical journals, and regulatory agencies.

Support for a registry came to a head when New York Attorney General Eliot Spitzer sued GlaxoSmithKline for not releasing all data on how its antidepressant Paxil affects children and teenagers.

The drug company, which has insisted that it has released all unpublished results through the appropriate regulatory channels, now has that data available on its website.

Positive or negative, studies in medical journals are just one part of a PR campaign, said Harry Sweeney, CEO of Dorland Global Health Communications.

"The medical journals have very small, segmented audiences," Sweeney said. "That's the raw material from which healthcare PR campaigns are constructed. The gold standard of healthcare PR is to have the authors [featured in] the consumer publications."

Even with a clinical registry, there still will be filters for negative studies, said Deborah Kaplan, editor of Patient Care, a medical trade publication.

Studies in a registry usually include intricate statistical analyses and, where consumers are concerned, complicated jargon. Studies often contradict each other because different research methods are used, adding to the confusion.

"This stuff is really difficult to understand," Kaplan said. "That might be an opportunity for the consumer press to help people make decisions."

A former editor of a medical journal who asked not to be named noted that it is often researchers, not journal editors, who are reluctant to publish results that reflect poorly on the company funding their work.

Kaplan said that she'd encourage reporters to use the registry. But even the medical press relies on its editorial board to point out research with "significance, power, or credibility," she added.

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