Glaxo to release data on antidepressant trials

Stung by criticism of its handling of clinical-trial studies, GlaxoSmithKline yesterday said it will soon release summaries of safety and effectiveness data of its antidepressant pill in children under the age of 18.

The move comes one week after New York Attorney General Eliot Spitzer filed a civil lawsuit accusing the British drug maker of fraud for allegedly withholding negative information about its Paxil drug. Glaxo was accused of failing to tell doctors that some studies showed Paxil did not work in teenagers and may lead to suicidal thoughts.

In a novel attempt to regulate the pharmaceutical industry, the lawsuit highlighted a growing controversy over the availability of clinical-trial data. Currently, there is no requirement that a drug maker publish or disseminate all of its data. But industry critics say the lack of disclosure allows negative information to be suppressed.

The issue is an outgrowth of the ongoing debate over antidepressants and whether the drugs are linked to suicide. The Food and Drug Administration commissioned researchers to review studies and side effect reports, and asked drug makers to issue stronger warnings on product labels. Last year, U.K. regulators urged doctors to write fewer prescriptions.

Other companies that make these pills include Wyeth, Pfizer and Lilly. But Glaxo, in particular, has generated criticism over an internal 1998 memo, which indicates the drug maker intended to manage the release of clinical-trial data in order to "minimize any potential negative commercial impact."

In a statement yesterday, Glaxo maintained that clinical-trial data on Paxil has already been provided to U.S. and U.K. regulators. The company also reiterated earlier comments that data has been made available previously to doctors through publication in medical journals or poster presentations at scientific meetings. Glaxo called this approach "standard practice."

But in order to "clarify the nature of these data," Glaxo will make summaries of Paxil safety and effectiveness data available "shortly" on its Web site, which is www.gsk.com.

In an interview earlier this week with the Daily Telegraph, the British newspaper, Jean-Pierre Garnier, Glaxo's chief executive, denied acting on the instructions in the memo.

"Of course we didn't follow this advice," he said. "We didn't selectively publicize the data. This is not a smoking gun.

"It's a stupid memo, and there are lots of stupid memos in every company's file and it is really unfair to look at the company's actions through the small hole of one memo written among thousands and thousands in 1998. I do regret that those memos exist, but I'm not going to lose sleep over the fact."