Monday, September 06, 2004

Pharmaceutical Clinical Trials: Merck

From The New York Times (06 September 2004; free registration required):

Merck Says It Will Post the Results of All Drug Trials
By GARDINER HARRIS

Merck & Company says it will post the results of its clinical trials on drugs on a Web site run by the National Institutes of Health. The move comes ahead of a House subcommittee hearing this week where, it is expected, drug companies will be excoriated for refusing to publish unfavorable clinical trial results.

Merck said Friday that it had already posted on the Web site, ClinicalTrials.gov, the outlines of 46 studies, or every trial for which the company is currently recruiting patients as well as some others. By the end of the month, the company will post 50 more trials that are already under way but where patients are no longer being recruited. And as the studies are published, Merck will post links to their results, the company said.

"Merck has long been committed to publishing the results of all of our trials in a timely manner," said Dr. Peter Honig, a senior vice president, "and now we're strengthening that commitment." One reason for the new postings, Dr. Honig said, is the industry's growing image problem.

"Let's face it, the perceptions of the pharmaceutical industry as a whole are not healthy at the moment," he said.

In recent months, some doctors' groups, researchers, medical journal editors and legislators have criticized drug makers for selective disclosures of clinical trials. Many companies have long declined to make public the results of trials that put their drugs in an unflattering light. At the same time, they actively promote the results of positive trials.

Studies show that this has led to a persistent bias among published clinical trials in drug companies' favor. That bias, some experts say, can distort the practice of medicine and lead doctors to prescribe drugs inappropriately. The New York State attorney general recently sued GlaxoSmithKline for failing to disclose negative study results, saying the company's actions amounted to consumer fraud. Glaxo denied the accusations but agreed to post data on its Web site.

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