Doctors say release of Paxil data helps

Though it contained information that had previously been released, GlaxoSmithKline’s posting last week of studies about the antidepressant Paxil in children was a “positive step,” said a psychiatrist who has pushed for a public registry of all clinical trials.

“I think that we will see other pharmaceutical companies increasingly willing to share this kind of data,” said David Fassler, a Vermont child and adolescent psychiatrist.

Many doctors complain that drug companies, who fund a high proportion of clinical trials, do not make all the information about their products available. The Food and Drug Administration gets trial results when a company seeks approval for a drug, but the data is considered proprietary and is not released, in detail, to the public. Medical journals can publish only a small percentage of the studies submitted and tend to select those with the strongest results.

The issue has drawn attention from multiple quarters this month:

New York Attorney General Eliot Spitzer filed a civil lawsuit accusing Glaxo of consumer fraud in its promotion of Paxil. The suit alleges that Glaxo, which has a U.S. headquarters in Philadelphia, failed to disclose negative information from tests of the drug in children and misinformed its sales staff about Paxil‘s effectiveness.

Last week, the American Medical Association called on the federal government to create a registry of all clinical trials and their results. It also suggested that hospitals should not approve clinical trials unless they are registered.

A group of prestigious medical journals said that it is considering publishing data only from registered trials.

Merck, another pharmaceutical giant, said it supports expanding a government Web site that lists trials involving life-threatening illnesses. Glaxo announced it would post summaries of its clinical trials on its Web site.

“Clearly, we are seeing a convergence of interests and efforts on this issue,” Fassler said.

He said summaries of the Glaxo data, which runs to hundreds of pages, have been presented at medical meetings and FDA hearings. “I don’t expect this will change any particular practice patterns,” he said.

Glaxo posted results of nine studies on the drug’s safety and/or effectiveness in treating children and adolescents for depression and obsessive-compulsive and anxiety disorders.

The information, Fassler said, will be most useful to researchers “who will be reviewing this in detail for a long time to come.”

Paxil is not FDA-approved for treatment of depression in children, but doctors can prescribe it “off-label.”

Spitzer’s lawsuit cites the studies that Glaxo posted. It accuses the Brentford, England-based company of promoting one relatively positive study while it “concealed and suppressed” information in others that had found the drug was no better than placebo.

Though no participants in the nine studies committed suicide, four studies found higher levels of emotional instability - suicidal thinking and acts, mood swings and crying - among children taking Paxil than among those taking placebo. The rate of emotional instability ranged from 3.6 to 7.7 percent of children on Paxil and from 1.1 to 3.2 percent in the placebo group.

A spokeswoman for Spitzer last week said employees there had not had time to ascertain whether the Glaxo posting contained information they had not previously seen.

Brian Strom, an expert on adverse drug reactions at the University of Pennsylvania Health System, said Glaxo’s posting contained only completed studies.

Fassler agreed that’s a problem. Sometimes trials are stopped because the drugs have nasty side effects or obviously don’t work. Doctors want to know about those trials, too.

And, he said, the disclosures don’t fix a bigger problem for doctors who treat children with depression; they still don’t have enough information to know what to prescribe.

“Clearly,” Fassler said, “we need more studies of both the safety and efficacy of these medications in children and adolescents.”

Provided by ArmMed Media
Revision date: July 9, 2011
Last revised: by Jorge P. Ribeiro, MD