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Pharmaceutical Study Fraud: Group Weighs Plan for Full Drug-Trial Disclosure

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Group Weighs Plan for Full Drug-Trial Disclosure
Published: June 15, 2004
Source: New York Times

An organization of top medical journals is considering a proposal that would require drug makers to register clinical trials at their start in a public database in order for results, whether successful or not, to be later considered for publication, according to three people working with the group.

Pharmaceutical companies are not generally required now to disclose results of a trial or even whether one was conducted. Some academic researchers have long argued that fuller registries of drug trials are needed because companies, as well as medical journals and scientists, tend to spotlight only trials that show positive results.

The plan, if adopted by the organization, the International Committee of Medical Journal Editors, is likely to put pressure on pharmaceutical makers to disclose more about the trials they run. The group includes 12 major medical journals like The Journal of the American Medical Association, The New England Journal of Medicine, The Lancet and The Annals of Internal Medicine.

The recent discussion among the journal editors about a trial registry comes amid public controversy about clinical trial data after the disclosures that the results of antidepressant tests in children were not adequately publicized.

Because the medical journals in the group are prestigious, and publication of the results of a clinical trial in them carries much weight, companies frequently use articles from them as marketing tools to persuade doctors to prescribe a drug. If the International Committee of Medical Journal Editors adopts the proposal for a registry, drug companies not wanting to participate could still seek to have their research published in other less-prominent medical journals, but the research might not get as much attention from physicians.

A spokesman for the Pharmaceutical Research and Manufacturers Association of America, a group representing drug makers, said it was not aware of the proposal being considered by medical journal editors to require registration of trials, so it could not comment on it. In the past, the group has not supported a registry, although a few companies have adopted a registry.

Many drug companies without registries have noted that they voluntarily disclose the results of all clinical trials they conduct, either at scientific conferences or through publications.

But critics say that there is no central registry where clinical trials and their results are available, making it difficult for researchers to track all studies that have been done on a single drug.

Ideally, advocates of clinical trial registries say, such databases would show when a trial was started, list its objectives and then update that information with the trial's results or the reason it was terminated.

A proposal to mandate trial registration as a prerequisite for publication was discussed last week at a meeting of the journal editors' group, said the three people working with the organization who insisted on anonymity because, they said, the proposal was still under discussion and because the group was not planning to announce any change unless it was adopted.

A decision could come in the summer, one person said.

In a related development, policy makers at the American Medical Association, which represents many of the nation's doctors, are expected to vote as early as today on a proposal that would urge the government to create a public registry of clinical trials and their results, a spokesman for the A.M.A. said.

Yesterday, GlaxoSmithKline, the manufacturer of the antidepressant Paxil, released on its company Web site the reports of clinical tests of that drug in children and adolescents suffering from psychological conditions including depression.

The action follows a civil lawsuit filed this month by the New York State attorney general, Eliot Spitzer, that accused the company of misleading doctors by publicizing a favorable study of Paxil for pediatric depression while playing down other trials that showed the drug did not work better than a placebo.

GlaxoSmithKline officials have denied that they selectively disclosed trial findings.

Regulators in this country and elsewhere are now scrambling to review unpublished test data on Paxil and several other popular antidepressants to see if the drugs pose dangers.

In a statement issued yesterday, Mr. Spitzer said that the company's actions had not resolved his lawsuit but called it a positive move. "This is a positive first step toward changing a dangerous industry practice," he said.

A decision by the International Committee of Medical Journal Editors to consider for publication only clinical trials that have been registered from the start would be the organization's latest effort to push for greater disclosure of data.

Two years ago, the group published a joint editorial calling on companies to provide university researchers with a greater role in designing trials and access to the analysis of results. That same editorial also pointed to the fact that the results of some trials were never published.

"The results of the unfinished trial may be buried rather than published if they are unfavorable to the sponsor's product," the editorial stated. "Such issues are not theoretical. There have been a number of recent public examples of such problems, and we suspect that many more go unreported."

But some academic researchers have also argued that medical journals are themselves part of the problem, even if unwittingly so. A growing number of studies have found that clinical trials published in leading medical journals tend to show positive results about the drug or medical devices being tested, a phenomenon referred to as publication bias.

As a result, those researchers say, physicians who rely on medical journals for information about drugs and medical devices may get an incomplete view of their effectiveness or safety because they may be unaware of other less favorable or inconclusive studies.

In an interview this month, Dr. Alan Goldhammer, associate vice president for regulatory affairs for the Pharmaceutical Research and Manufacturers Association of America, said that to date the organization had not supported the idea of a public registry for clinical trials. He said the association might reconsider its stance in light of the antidepressant controversy.

Another trade group, the Association of the British Pharmaceutical Industry, recommended to its members last year that they voluntarily create trial registries. A spokesman for the group said recently that 8 of its 80 members had created such databases.

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Pharmaceutical manufacturers cannot promote the use of drugs for other uses than those approved for the label, however it has become normal practice to dishonestly slant the reporting of scientific studies to suggest such unapproved use of drugs or to ... Read More

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