By Bruce Japsen
Chicago Tribune staff reporter

The American Medical Association on Wednesday urged the government to force pharmaceutical companies to delay advertising new prescription drugs directly to consumers until physicians have time to review and study their safety and effectiveness.

The largest U.S. doctor group wants the Food and Drug Administration to impose rules that would require an unspecified amount of time between a drug’s approval and the start of a consumer ad campaign, particularly commercials on television.

“A temporary moratorium on direct-to-consumer advertising of prescribed drugs and medical devices will benefit both the patient and physician,” said AMA president-elect Dr. Ronald Davis, a preventive medicine specialist from Michigan. “It’s possible that companies could do it voluntarily with some coordination or oversight of their trade association, but failing that, the government could step in to put that policy in effect.”

The FDA does not require a moratorium, but there has been interest by some Republican and Democratic federal lawmakers in such a measure. No bills have been moving through Congress of late.

The decision to back a moratorium, made by the AMA’s policymaking House of Delegates on the last day of its five-day annual meeting at the Hilton Chicago Hotel, puts the organization’s political clout behind federal regulations that could rekindle congressional action.

For its part, the FDA said it does not have the authority to enforce a moratorium.

“FDA does not believe that such a moratorium would survive a constitutional challenge,” said spokeswoman Susan Bro.

But, she said, the agency closely monitors direct-to-consumer promotional material.

Such increased scrutiny of drug ads comes in the wake of product safety issues involving heavily promoted drugs including Vioxx, a painkiller that was pulled from the market nearly two years ago after studies showed it increased risks of heart attacks and strokes.

Doctors also say the ads get in the way of the doctor-patient relationship while contributing to rising health-care costs because the drugs advertised are usually the latest, most-expensive brand-name products.

Drug ad spending has quadrupled to more than $4 billion since 1998, the first full year after the FDA eased drug ad restrictions.

AMA delegates testified throughout their meeting that they become frustrated when patients visit their offices and ask about drugs the doctors know nothing about or have not had time to evaluate through medical journals or scientific studies. Doctors also take issue with other messages they say mislead patients, such as the use of actors playing doctors in ads.

“We object to the use of physician likenesses,” said Dr. Bobby Mukkamala, an AMA delegate and ear, nose and throat specialist from Flint, Mich. “To use actors is misleading.”

In particular, AMA delegates complained about Merck & Co.’s ad for the cholesterol drug Zetia, saying its use of actors playing physicians made the drug appear to be as effective a stand-alone treatment as other cholesterol drugs, though studies show otherwise. Merck spokeswoman Amy Rose said the ad “clearly identifies the participants as actors so as not to mislead anyone.”

The drug industry’s trade group and lobbying organization, Pharmaceutical Research and Manufacturers of America, says pharmaceutical companies have improved their ads in the wake of criticism but have offered voluntary solutions.

Under current federal regulations, companies submit their consumer ads to the FDA “at the time of first use,” said trade group senior vice president Ken Johnson. He said the industry’s voluntary guidelines encourage companies to submit new consumer ads to the FDA “a reasonable time in advance of release.”

The drug industry trade group does not support a government moratorium.
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