Antidepressant and Suicide: Paxil, GlaxoSmithKline Must Release All Trial Results
Maker of Paxil to Release All Trial Results
By GARDINER HARRIS
Published: August 26, 2004
Source: New York Times
In a settlement that the New York State attorney general said would transform the drug industry, GlaxoSmithKline agreed today to post on its Web site the results of all clinical trials involving its drugs.
"This settlement is transformational in that it will provide doctors and patients access to the clinical testing data necessary to make informed judgments," the attorney general, Eliot Spitzer, said.
While the case involves only GlaxoSmithKline, the British drug maker, Mr. Spitzer predicted other companies would soon follow its lead by posting the results of their own studies online. Eli Lilly, for example, has said it will create a Web site on which it will list the results of clinical tests of approved drugs, including trials of those drugs for new uses. Several other companies, including Johnson & Johnson and Merck, have said they support the concept of a publicly available database that would list trial results.
If the drug makers do not take action, Mr. Spitzer threatened more lawsuits. "We have ongoing inquiries," he said.
And in comments reminiscent of his battles with the Securities and Exchange Commission and its former chairman, Harvey Pitt, Mr. Spitzer sharply criticized the Food and Drug Administration for failing to require such disclosures years ago.
"Just like with the S.E.C.," Mr. Spitzer said, "we're asking where has the F.D.A. been all these years when clinical data has been hidden from public scrutiny? They have simply failed to confront the problem."
Mr. Spitzer filed suit in June against GlaxoSmithKline, contending that it committed fraud by publicizing the results of only one of five trials studying the effect of its huge-selling antidepressant, Paxil, in children. That single study showed mixed results. The others not only failed to show any benefit for the drug in children but demonstrated that children taking Paxil were more likely to become suicidal than those taking a placebo.
Mr. Spitzer said that GlaxoSmithKline's selective disclosures, which have long been common in the drug industry, constituted a form of consumer fraud. But it is unclear whether posting clinical trial results on a Web site will entirely solve the problem.
In the case of Paxil, for instance, GlaxoSmithKline's original analysis of its trials simply found an increased level of what the company termed "emotional lability" among children given the drug. Only after a reviewer at the F.D.A. asked the company to offer more information about this category did it become clear that the children and teen-agers given Paxil were more suicidal than those given placebos.
Mr. Spitzer acknowledged that postings of clinical trial results online was not a cure-all.
"Nobody should believe that we think this is a panacea and that there will be perfect understanding of testing and clinical variables," Mr. Spitzer said. But he said such postings would allow academics and doctors to ask the right questions about drugs.
Spokeswomen for GlaxoSmithKline and the F.D.A. did not immediately return phone messages.