An April 27 article about a study of direct-to-consumer advertising of prescription drugs referred to a 2001 Food and Drug Administration warning letter sent to Merck & Co. regarding misleading promotion of its arthritis drug Vioxx. The letter concerned promotional audio conferences given on behalf of Merck, a company news release and comments by sales representatives, but not to direct-to-consumer advertising.
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Doctors Influenced By Mention Of Drug Ads
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Concerns have recently grown about the safety of antidepressants after disclosures that the pharmaceutical industry withheld studies that found the drugs were no better than sugar pills. The FDA recently concluded that the drugs increase suicidal thinking and behavior among children and required them to carry black-box warnings -- which have greatly reduced direct-to-consumer advertising of such drugs.
Advertising could be useful for drugs with large benefits and few risks, said researcher Ronald M. Epstein, but the industry's bias against negative studies raises questions about which drugs ought to be marketed in this fashion. Epstein is a professor of family medicine at the University of Rochester.
Nancy Leone, a spokeswoman for GlaxoSmithKline PLC, the maker of Paxil, said physicians are not unduly influenced by ads, and denied that such "education campaigns" lead to inappropriate prescribing. It was "difficult to draw conclusions" about the new study, she said, because Paxil was not being heavily advertised during the study period.
In his editorial, Hollon said 80 percent of physicians believe such ads prompt patients to seek medications they do not need, and less than 10 percent believe the ads are a good thing.
Johnson & Johnson's chief executive, William C. Weldon, now chairman of the PhRMA board, said last month that the industry ought to revise its approach to drug ads because they "may inadvertently minimize the importance and power of medicines and their risks."
Direct-to-consumer (DTC) advertising soared after the FDA allowed drug promotions on television for the first time in 1997. Efforts to limit such advertising have run afoul of Supreme Court rulings protecting commercial speech.
The ads are regulated by the FDA's Division of Drug Marketing, Advertising and Communications. The office, which has barely three dozen employees, must review 30,000 to 40,000 ads a year. Acting commissioner Lester M. Crawford said recently that "our patience is sometimes worn thin" by the advertising claims.
Dan Troy, chief counsel for the FDA in President Bush's first term and now with a Washington law firm, said laws on drug advertising written by Congress in the 1960s have made it difficult to change policy. He added that most FDA professionals were "quite pro-DTC."
PhRMA's Tauzin said companies are working on a new code of conduct that would be preferable to federal regulation.
The FDA has moved against scores of ads that it found to be inaccurate or misleading. In 2001, it warned Merck and Co. that its ads for the arthritis drug Vioxx were misleading and did not adequately warn viewers of cardiovascular risks. After Merck took Vioxx off the market last September, Pfizer Inc. aggressively increased advertising for its competing painkiller, Celebrex, but also got a warning from the FDA.
