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Prominent cardiologist criticizes drug ads
- Los Angeles Times
Wednesday, December 29, 2004


Washington -- The government should reassess its policy of allowing
prescription drugs to be advertised directly to consumers, a prominent
cardiologist urged Tuesday in the Journal of the American Medical
Association.

The heart-attack risks of arthritis painkillers Vioxx, Bextra and
Celebrex have exposed a regulatory "house of cards" at the Food and
Drug Administration, wrote Dr. Eric J. Topol, chairman of
cardiovascular medicine at the Cleveland Clinic.

"Unbridled promotion exacerbated the public health problem," Topol
concluded. "The combination of mass promotion of a medicine with an
unknown and suspect safety profile cannot be tolerated in the future."

FDA officials have not publicly addressed the issue of whether high-
powered advertising campaigns for newly approved drugs are in the best
interest of public health. Other leading academic researchers have
suggested that new drugs should be subject to a trial period before
they can be touted directly to patients.

Topol's sharply worded opinion, to be formally published next month,
was posted online by the medical journal as part of the growing
debate. Critics have accused the FDA of being too cozy with the drug
industry and unwilling to pursue evidence of problems with medications
that it has already approved.

Manufacturer Merck & Co. withdrew Vioxx from the market this fall
after a company-sponsored study confirmed research by Topol and others
that it increased chances of heart attacks and strokes.

New warnings have been added to the Bextra label, and concerns have
been raised about possible problems with Celebrex, both produced by
Pfizer Inc. The company recently agreed to suspend Celebrex
advertising while experts sort out preliminary findings that indicated
a heart risk for patients taking a high dose over many months.

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