Ethics Newsline®

NEW YORK
Responding to a pending civil suit alleging that it suppresses unflattering research, British pharmaceutical firm GlaxoSmithKline last week posted the data on its antidepressant drug Paxil on its Web site.

In the lawsuit, the state of New York has accused Glaxo of hiding data that proved Paxil to be a possible threat to children who were prescribed the drug, which officially is only vetted for safe use by adults.

Glaxo, which published only one moderately positive study in a prominent medical journal, has said it released all of the troubling data in medical journals or at scientific meetings, reported the Reuters news agency.

Critics of that practice say that it quashes less-than-glowing results by tucking them away in unnoticed corners while giving center stage to positive research, creating a “publication bias,” reported the New York Times.

“We are concerned that this pattern of publication distorts the medical literature, affecting the validity and findings of systematic reviews, the decisions of funding agencies, and ultimately the practice of medicine,” Dr. Joseph Heyman, trustee of the American Medical Association (AMA), said in a statement last week.

Last week, the AMA, which represents one-third of the nation’s doctors, adopted a resolution calling on the government to create a central database that would track all clinical studies from the start, giving researchers one place to turn when studying the pros and cons of prescription drugs.

Merck, one of the world’s top drug companies, last week told the Times it supports such a registry. Late in the week, Glaxo said it plans to publish all of the results from its drug trials on the company’s Web site.

In a tandem move, the International Committee of Medical Journal Editors, representing 12 of the world’s most prestigious medical journals, said it may require companies to register with a similar database in order to have their results appear in their publications.

A decision on that proposal could come this summer, according to the Times.