GOVERNMENT & MEDICINE

Lawsuit claims Glaxo hid Paxil findings

Some physicians want access to all clinical trial data. The pharmaceutical industry says its policy doesn't allow study sponsors to suppress findings.

By Tanya Albert, AMNews staff. June 28, 2004.

A lawsuit is drawing increased attention to an issue some physicians have been pushing to improve in recent years: Doctors' access to scientifically sound clinical trial data, especially studies that discover harmful side effects in medications.

New York State Attorney General Eliot Spitzer in June sued GlaxoSmithKline, accusing the pharmaceutical company of concealing information that would have alerted physicians that the antidepressant Paxil could be harmful to children or adolescents.

About 2.1 million prescriptions of paroxetine -- a drug sold under the name Paxil and Paxil CR -- were written for children in the United States in 2002, according to the lawsuit.

Nearly 900,000 of those prescriptions were to treat children's mood disorders. An estimated one-third of such prescriptions were written by non-psychiatrists, including family physicians and pediatricians, the complaint states.

"Doctors should have access to all scientifically sound information so that they can prescribe appropriate medication for their patients," Spitzer said in a statement. "By concealing critically important scientific studies on Paxil, GSK impaired doctors' ability to make the appropriate prescribing decision for their patients and may have jeopardized their health and safety."

The Food and Drug Administration approved Paxil as safe for treating depression in adults. The drug is not FDA-approved for children. As is the case for many prescription medications, pediatricians and other physicians who treat children use their professional discretion in using the drug in children.

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