While there are pockets of physicians and health organizations outspoken in their opposition to the $5 billion direct-to-consumer drug-ad market, the industry's key players -- such as the American Medical Association, American College of Cardiology and New England Journal of Medicine -- have been surprisingly mute.
Despite increasing scrutiny of prescription-drug advertising, none of those groups have set policies regarding DTC drug ads.
Two years ago, at its annual meeting, the AMA voted for a temporary moratorium on DTC advertising of newly approved prescription drugs. But that's as far as the organization went -- despite some state federations' calls for more. Robert Mills, spokesman for the AMA, said he did not know if DTC would be on the meeting agenda this June.
"Frankly, the AMA knows the reality that this is a First Amendment issue and you can't ask for a blanket ban on DTC," Mr. Mills said. "The evidence suggests there might be some use in having a moratorium on new drugs."
Dr. Nancy Nielsen, president-elect of the AMA, did not return a phone call seeking comment.
The government has begun a more in-depth look at the industry in the past month after Merck & Co. and Schering-Plough Corp. delayed for 21 months the results of a study that showed cholesterol medication Vytorin did not reduce plaque buildup in arteries, as claimed. Congress is also interested in Pfizer's use of artificial-heart inventor Dr. Robert Jarvik in ads for Lipitor, saying his appearance in the ads might be misinterpreted because he is not a practicing physician. The Energy and Commerce Committee recently sent letters to 10 companies involved in producing the spots, including Cline Davis & Mann and Kaplan Thaler Group, requesting documents related to the commercials, which are said to have used a stunt double to show Dr. Jarvik rowing.
Also recently came news the Senate Finance Committee was examining the marketing practices of Amgen after two former sales representatives claimed they were fired or forced out for refusing to engage in what they called unethical and illegal marketing aimed at boosting sales of psoriasis drug Enbrel. The Securities and Exchange Commission and the attorneys general for New York, New Jersey, Connecticut and Florida also are investigating.
The New England Journal of Medicine, arguably the medical community's most important editorial voice, has done several articles on DTC, including a nine-page examination of the practice in 2007. The article noted that DTC spending more than quadrupled between 1996 and 2005, that FDA warning letters fell to 21 in 2006 from 142 in 1995, and that DTC ad campaigns generally began within a year after FDA approval of the drug. But the only conclusion drawn by the article was that "calls for a moratorium on such advertising for new drugs would represent a dramatic departure from current practices."
Attempts to reach Dr. Jeffrey Drazen, editor in chief of the journal, were unsuccessful. Messages for Dr. Gregory Curfman, executive editor, were not returned. A spokeswoman said the closing paragraph of a 2002 editorial by Dr. Drazen -- "Although advertising does inform patients, it should not be confused with medical advice given in the best interest of the patient by a learned intermediary" -- was "as close as you'll come to his opinion on the matter."
The American College of Cardiology, the umbrella group for heart doctors, also said it did not have a stance on DTC ads. "We stay away from that," spokeswoman Amy Murphy said. "We obviously think the doctor is the best person to determine a patient's treatment, but we don't have a policy on [DTC advertising]."
Traditional media have weighed in, including the Richmond (Va.) Times, which called for a ban on all TV drug ads in a recent editorial. "The House committee should be persuaded to go much further than looking at deceptive marketing and instead renew the ban on marketing to consumers," the editorial concluded.