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A Plan to End Secret Studies

Medical journal editors craft a new policy to stop drug makers from suppressing clinical trials that don't support their products.

September 09, 2004|Alan Zarembo | Times Staff Writer

Editors of some of the most influential medical journals have announced a new policy aimed at preventing pharmaceutical companies from selectively concealing clinical trials.

Over the last several months, drug makers have faced increasing criticism for suppressing studies that fail to support their products.

"Honest reporting begins with revealing the existence of all clinical studies, even those that reflect unfavorably on a research sponsor's product," the editors wrote in an editorial published today in 11 periodicals, including the New England Journal of Medicine, the Journal of the American Medical Assn. and the Lancet.

The group, which calls itself the International Committee of Medical Journal Editors, argued that current publishing practices stifled medical advancement by skewing the "body of evidence" that guides patients, doctors and researchers.

Starting in July, the journals will only consider for publication studies that were registered in publicly accessible databases before research subjects were enrolled.

The database must be run by a nonprofit organization and include basic information such as the hypothesis of the study, a timeline, the eligibility criteria for research subjects and the funding source.

The industry contends that such a requirement could compromise trade secrets, particularly in the early stages of drug testing, when companies do not want their competitors to know what drugs are in the pipeline.

"This could put at risk the competitive edge of a company, and ultimately that could impact the innovation of these companies," said Caroline J. Loew, vice president for scientific and regulatory affairs at the Pharmaceutical Research and Manufacturers of America, an industry trade association.

The group announced this week that it would create its own database, where companies could voluntarily post results -- good or bad -- of late-stage trials of all drugs on the market.

Industry representatives say that part of the reason unfavorable drug studies are often not published is because journals are not apt to accept papers that show negative or ambiguous results.

Companies rely on articles in top-notch journals to educate doctors about their drugs. But study results do not have to be published for a new drug to win approval from the Food and Drug Administration.

Conceivably, pharmaceutical companies could submit their studies to the government and skip publishing. Or they could use lesser-known journals.

The issue of selective publishing gained importance earlier this year after it was disclosed that drug companies did not release studies showing that certain antidepressants could increase the risk of suicidal thinking in children.

Eliot Spitzer, New York state attorney general, sued Glaxo- SmithKline, accusing the company of "repeated and persistent fraud" for allegedly hiding unfavorable data from pediatric trials of its blockbuster antidepressant drug Paxil. The company denied the charges but settled last month for $2.5 million and a promise to publish summaries of its drug trials in an online registry.

Merck & Co. and Eli Lilly & Co. said they would do the same.

For some federal legislators, however, voluntary reporting of clinical trial results does not go far enough. Reps. Henry A. Waxman (D-Los Angeles) and Edward J. Markey (D-Mass.) plan to introduce a bill as early as this month that would make the push by the journal editors redundant.

The legislation would require listing of all clinical trials in a federal registry before they start and publication of their results.

"Congress must require public disclosure of the results of clinical trials," Waxman said in a prepared statement. "The lesson from antidepressants is that the drug industry will suppress negative data whenever they can. That helps their bottom line, but it jeopardizes public health."

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