TV ads oversell drugs, skimp on risks

FOR now at least, Vytorin, the controversial cholesterol-lowering drug under investigation by Congress and state attorneys general, will remain on the market. But its TV ads will not.

In mid-January, Schering-Plough Corp. and Merck & Co., which jointly market the drug, pulled the ads portraying family members dressed like food items to show genetic causes and food sources of high cholesterol. The ads were yanked after members of Congress questioned whether the two companies deliberately delayed releasing clinical trial results for the drug -- results that showed it was no more effective than a generic at reducing the buildup of plaque in the carotid artery. They also questioned whether the ad overstated benefits of the drug, a combination of Zetia and simvastatin (a generic of the statin Zocor).

Those questioning the ads -- John Dingell (D-Mich.), chairman of the powerful House Committee on Energy and Commerce, and Bart Stupak (D-Mich.), chairman of the Subcommittee on Oversight and Investigations -- are also investigating Lipitor advertisements that feature Robert Jarvik, who invented an artificial heart years ago.

Criticism of the Vytorin and Lipitor ads has renewed the debate over the effect of TV drug advertising, even as efforts to rein in the ads have faltered. Last month, an initiative that might have increased FDA oversight over direct-to-consumer television ads for prescription drugs was quashed.

Drug companies are not required to have their TV ads approved before airing, but the companies are subject to warning letters and monetary penalties if the FDA finds that ads are misleading or false, says Areta Kupchyk, a partner at Reed Smith law firm in Washington, D.C., and a former associate chief counsel at the FDA. However, only about 35% of drug ads that make it on air are viewed by FDA staff, says Rita Chapelle, an agency spokeswoman.