AMA offers guidance for direct-to-consumer ads

Delegates seek to discourage casting actors as physicians in these commercials and have the FDA review these advertisements before they reach the public.

By Victoria Stagg Elliott — Posted July 10, 2006

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Peter W. Carmel, MD, is a doctor -- and he plays one on TV, too. The AMA trustee and neurological surgeon from Newark, N.J., appears in the American Medical Association's television commercials.

But when actors play physicians in drug advertising on television, the result can be misleading.

Therefore, the Association wants to discourage this practice, especially in regard to the promotion of prescription products. If actors appear as physicians in product-specific advertisements, a disclaimer should be prominently displayed, according to a new policy adopted by the House of Delegates.

"There are a lot of direct-to-consumer advertisements that have some wonderful kindly doctor who says in the most professional manner, 'This is what you should do.' And, of course, they're not doctors. They're actors," Dr. Carmel said. "They don't really speak from knowledge or experience."

This recommendation is one of many in the beefed-up guidance for direct-to-consumer advertising of prescription products issued in a Board of Trustees report at the AMA Annual Meeting last month.

Many of the recommendations are in line with the principles that were released by the Pharmaceutical Research and Manufacturers of America, the trade group that represents the industry, in August of last year.

"We look forward to working as an industry with the House of Medicine to try to improve [direct-to-consumer advertising]," said PhRMA's Chief Medical Officer Paul Antony, MD, MPH.

Both the AMA and PhRMA agree that these advertisements should educate consumers responsibly about the drug and the disease it is meant to treat, provide objective information that is presented in an understandable way about the medication's benefits and risks, be distinguishable from ads for nonprescription products and foster communication between physicians and patients. The Food and Drug Administration should have a chance to review television ads before they appear, and physicians should be educated about a new product or therapeutic indication before a campaign begins.

"Physicians need time to gain firsthand experience with new medications. In the long run, I believe the AMA's actions will improve safety without limiting access to necessary and appropriate treatment," said David Fassler, MD, who represented the American Academy of Child and Adolescent Psychiatry at the meeting.

More direction

The AMA also offers other recommendations. In addition to wanting to end the practice of actors playing doctors in these types of commercials, the Association is opposing physician and pharmacist incentive programs running concurrently to direct-to-consumer advertising campaigns. In recognition of the fact that the Food and Drug Administration does not have the resources to approve these ads beforehand, the Association is calling for stepped-up agency funding.

The AMA also will urge the FDA, other federal agencies and the pharmaceutical industry to conduct research into the impact of direct-to-consumer advertising. It also calls on the Agency for Healthcare Research and Quality to perform regular evidence reviews. If AHRQ determines that harm is being done by this type of advertising, increased legislation should be considered.

"There's been growing frustration on the part of physicians when consumers are exposed to these ads, and are motivated ... to seek these pharmaceuticals even though they may or may not be candidates for the pharmaceuticals," said AMA President-Elect Ron Davis, MD. "[There's] a lot of concern about whether all this heavy advertising is providing a net positive health outcome for our patients."

The AMA is also broadening its rules to include implantable medical devices. Anecdotal evidence suggests that this kind of advertising is increasing and might be leading to patients requesting the implantation of specific devices.

"Patients are coming in requesting [certain implants and] wondering why we didn't use this device or that device," said David D. Teuscher, MD, an orthopedic surgeon and sports medicine specialist from Beaumont, Texas, who successfully called for this to be added to the report. "It's leading to litigious behavior and interfering with the doctor-patient relationship."

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DTC ad guidelines

According to a Board of Trustees report accepted at the AMA Annual Meeting in Chicago last month, direct-to-consumer advertising of prescription drugs and implantable devices should:

  • Enhance consumer education about both the drug and the disorder it is meant to treat.
  • Provide objective information about the products' benefits and risks.
  • Be distinguishable from advertising for nonprescription products.
  • Not encourage self-diagnosis and treatment.
  • Refer patients to their physicians.
  • Include information about non-drug management possibilities.
  • Not use actors to portray physicians or other health care professionals.
  • Be reviewed and pre-approved by the Food and Drug Administration.
  • Not appear until physicians have been educated about the product.

Source: "Direct-to-Consumer Advertising of Prescription Drugs," Board of Trustees Report, 2006 AMA Annual Meeting

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External links

Reference Committee E, AMA Annual Meeting 2006, Board of Trustees Report 9, "Direct-to-Consumer Advertising of Prescription Drugs" (link)

"Guiding Principles for Direct-to-Consumer Advertisements About Prescription Medicines," Pharmaceutical Research and Manufacturers of America, Aug. 2, 2005, in pdf (link)

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