Paxil memo raises questions
Wednesday, February 18, 2004
Original story at nj.com.
The maker of a popular antidepressant, which British authorities banned last year for use in children, knew the drug wasn't effective but didn't publish studies because sales could be hurt, according to an internal memo.
The 1998 GlaxoSmithkline document noted two clinical trials showed Paxil was no better than a dummy pill in treating depression. But it would be "commercially unacceptable" to disclose the findings, according to the memo which was circulated by a consumer group.
A synopsis was later circulated by Glaxo at a medical meeting, but complete results were not given to British regulators until last year. The United Kingdom banned Paxil after trial data revealed that more youngsters on the drug considered suicide than those who took a dummy pill.
The disclosure comes two weeks after a meeting of a Food and Drug Administration advisory committee, which was held to examine charges that Paxil and other antidepressants may cause children under 18 to consider suicide. A recommendation is expected by summer.
A Glaxo spokeswoman, Mary Anne Rhyne, said yesterday the memo drew "inappropriate conclusions" and said "not everything may have been published promptly. But we did share the info. Look at what we did, not what the memo says."
She claimed data was distributed at a 1998 medical meeting and, in 2001, published in the Journal of the American Academy of Child & Adolescent Psychiatry. But that article said Paxil is "generally well tolerated and effective for major depression in adolescents."
The publicity surrounding the FDA meeting prompted a congressional lawmaker -- U.S. Rep. James Greenwood (R-Pa.), who chairs the subcommittee on oversight and investigations -- to ask several drug makers to disclose their unpublished clinical trials.
Drug makers own clinical-trial data and are not required to release findings that are not published in medical journals. But industry critics say the lack of disclosure allows negative results to remain suppressed. As a result, they say, patients may be harmed.
"This memo shows why harmful drugs are being prescribed by doctors who lack the necessary knowledge about what can happen to patients," said Vera Sharav of the Alliance for Human Research Protection, a consumer group that wants antidepressants banned.
In commentary published this week in the Canadian Medical Association Journal, Jane Garland, a psychiatry professor at the University of British Columbia in Vancouver, wrote that "publication of all clinical trial results" must become a "research standard."
Ed Silverman can be reached at (973)392-1542 or firstname.lastname@example.org