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Editors of influential journals, like Dr. Jeffrey M. Drazen of the New England Journal of Medicine and Dr. Catherine D. DeAngelis of the Journal of the American Medical Association, said they were worried about becoming a marketing arm for drug makers.

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Drugs (Pharmaceuticals)

Medicine and Health

American Journal of Psychiatry

Forest Laboratories Incorporated

A Medical Journal Quandary: How to Report on Drug Trials


Published: June 21, 2004

The issue of The American Journal of Psychiatry that hit the desks of its 37,000 readers this month reported test results for the antidepressant drug Celexa, indicating it could help children and teenagers.

Before publication, the article received the kind of scrutiny common among medical journals. The study's authors had been asked to divulge their financial ties, if any, to the drug's marketer, Forest Laboratories Inc., which sponsored the clinical trial. And the report was sent to reviewers who examined the trial methodology and checked to make sure that the article reflected other relevant research about the use of antidepressants in youngsters.

But neither the article nor the 27 scholarly footnotes that accompanied it mentioned another major drug-industry-sponsored trial completed in 2002, which found that Celexa did not help depressed adolescents any more than a placebo. Nor would the article's reviewers have been likely to find any clues of that trial's existence. The results of that trial were first noted last year on a single line of a chart that appeared on Page 96 of a textbook - one written in Danish.

Like most medical journals, The American Journal of Psychiatry does not require company sponsors of drug trials to divulge information about all relevant trials of a medication. But that may soon change, as some leading journal editors try to address what they see as shortcomings in the way clinical tests are designed and analyzed by the drug industry, and how test results are disclosed.

"There is so much sophistication, that if the journals are not careful they could end up being part of the drug industry's marketing arm," said Dr. Richard Smith, the editor of The British Medical Journal.

In written responses to inquiries from The New York Times, Forest stated that the negative Celexa test, sponsored by a related company, was not mentioned in the recent article because "there was no citable public reference for the authors to examine."

But drug makers often announce trials with positive results without waiting for the results to be published. Forest, for example, issued a news release three years ago that highlighted the outcome of the positive Celexa trial. That was shortly after the test's completion, when the findings were first presented at a medical conference, but before the study was even submitted to The American Journal of Psychiatry for consideration. Three of the authors of the Celexa drug article in this month's issue are Forest employees.

Dr. Smith and other editors say the challenges they face are not limited to the tendency by companies and academic researchers to showcase positive tests results while playing down trials with negative or inconclusive findings. Editors say they must also be vigilant against companies' cherry-picking favorable but limited data from a trial that had originally set out to test other aspects of a drug's performance.

Some companies, several editors said, have also apparently milked tests for maximum publicity by submitting different parts of them under different authors' names to different medical journals.

A group of 12 medical journals worldwide including The Journal of the American Medical Association, The New England Journal of Medicine, The Lancet and The Annals of Internal Medicine are weighing a proposal that would require a drug trial to be listed at its start in a public database or registry as a prerequisite to its results being considered for publication. The British Medical Journal is not part of that group, which is known as the International Committee of Medical Journal Editors, but Dr. Smith said he also supported the initiative.

Editors say that a database could offer several benefits. Assigning a test a unique number could allow it to be tracked from start to finish. The results, be they positive or negative, could then be put into context with other relevant trials of the same drug. Moreover, journal editors say that if a trial's objectives were listed at the outset, they would know how to better assess an article that presented its results.

"It would be useful for us from an editorial perspective if trials were registered, so we could see what was on the mind of investigators when they started," said Dr. Jeffrey M. Drazen, the editor of The New England Journal of Medicine.

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. Merck Backs U.S. Database to Track Drug Trials (June 18, 2004) 
. A.M.A. Urges Disclosure on Drug Trials (June 16, 2004) 
. Now at Your Drugstore: A Cheap and Dangerous High (June 15, 2004) 
. Medical Journals Weigh Plan for Full Drug-Trial Disclosure (June 15, 2004) 
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