AMA to scrutinize usefulness of DTC drug ads

Chicago -- Should a prescription medication be on the market for a period of time before its manufacturer advertises it directly to patients? Should a direct-to-consumer ad always include data comparing its drug to similar ones? Should print ads be allowed and broadcast ones be banned? Or should DTC drug ads be banned outright? And what about strengthening federal regulation?

These are all questions delegates wrestled with at last month's Annual Meeting of the American Medical Association. Banning DTC advertising has been debated many times before, but the focus this time appeared to be different -- one that considers how this medium could be harnessed to be more informative and less deleterious to patient care.

"The horse is out of the barn, but I think we can do something to affect how this is done," said Kathleen A. Weaver, MD, an internist and delegate from Lake Oswego, Ore. "The promise of direct-to-consumer prescription drug advertising lies in its potential to educate consumers about medical conditions and the possibility of treatment, but this promise can only be fulfilled if consumers are given clear and accurate information."

Some physicians do see benefits. They say that DTC drug advertising helps to reduce the stigma associated with certain medical conditions and alerts consumers to treatments. These positives may be enough to counterbalance some of the less palatable effects.

"Nothing has ever brought in as many patients to my addiction clinic to stop smoking as the brief period of time in which [GlaxoSmithKline] advertised bupropion for that purpose," said Stuart Gitlow, MD, MPH, an addiction psychiatrist from Providence, R.I and a delegate of the American Society of Addiction Medicine. "Did it mean I always prescribed the drug? Of course not. I have the ability to tell whether a medication is necessary. That's my job."

Nonetheless, there are still many physicians who wish the AMA would advocate for an all-out ban. However, existing AMA policy calls for all DTC ads to be disease-specific, enhance consumer education and convey a clear health education message. Ads must also direct patients to their physicians. And, confirming this issue's complexity, no additional policy on the topic was adopted last month. Instead, delegates directed the Association to study the issue, a task that will likely be referred to the Council on Science and Public Health, formerly the Council on Scientific Affairs. A report is expected at next year's Annual Meeting.

"I don't think the Association is backing away from the ban," said AMA Trustee Rebecca J. Patchin, MD. "What we're wanting to do is to have more information and a more comprehensive evaluation of what occurs."

Others in on the act

Meanwhile, it is not only physicians who are stepping up scrutiny of DTC drug ads. Certain pharmaceutical companies also are working on it.

Bristol-Myers Squibb announced June 13 that it would wait a minimum of a year after a new drug is launched to advertise it directly to consumers. During that time, the company would emphasize educating and getting input from physicians. The company also will submit all advertising to the Food and Drug Administration for advisory comments.

The ads will run in media vehicles that target audiences deemed appropriate, and disease-awareness advertising for conditions treated by new drugs will also be developed.

This approach was praised by delegates who said that the AMA may ultimately endorse a similar route.

"I would hope that AMA support for such an initiative might encourage other pharmaceutical companies to act accordingly," said David Fassler, MD, a delegate from the American Academy of Child and Adolescent Psychiatry.

The Pharmaceutical Research and Manufacturers of America also announced during the AMA meeting that they were working on revising their own code.

"It's unlikely that a ban would stand up," said PhRMA's Chief Medical Officer Paul Antony, MD, MPH. "The better question to ask is, 'How can we make direct-to-consumer advertising better?' "

Some physicians insist, though, that eradicating DTC prescription drug advertising is the only way to go. They complain that too many patients are asking for specific drugs, and they are having to spend too much time explaining why they may or may not be appropriate. Many doctors also maintain that the resources that support such advertising could be better spent.

"Patients are asking for things they don't need, and a lot of money is being spent, money that could go for lowering the cost of drugs overall or back into research and development," said Bryan Pechous, MD, an ophthalmologist and delegate from Dubuque, Iowa, who proposed one of the resolutions calling for a ban.

In addition to studying recommendations for future regulations of DTC pharmaceutical advertising, the Association will also scrutinize the impact of this on health care cost, prescribing patterns, treatment compliance, patient safety and the quality of health care.