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AMA Wants Halt on Drug Ads Aimed at Consumers

Group says doctors need to learn more about pros and cons of prescription medicines

THURSDAY, June 15, 2006 (HealthDay News) -- In an effort to make prescription-drug ads aimed at consumers more understandable and informative, the American Medical Association is calling for a temporary halt on advertising for newly approved drugs.

The AMA is also calling for guidelines for future ads, which would be subject to approval by the U.S. Food and Drug Administration before they appeared.

At its just-concluded annual House of Delegates meeting in Chicago, the AMA endorsed a policy asking for a temporary moratorium on so-called direct-to-consumer (DTC) advertising of new prescription drugs and implantable medical devices.

"A temporary moratorium on DTC advertising of prescribed drugs and medical devices will benefit both the patient and physician," AMA President-elect Dr. Ronald M. Davis said in a prepared statement. "Physicians will have the opportunity to become better educated on the pros and cons of prescription drug uses before prescribing them, and will be better able to determine when they are best suited for their patients' medical needs."

Medical devices were added to the proposal because many doctors who spoke at the AMA meeting said direct-to-consumer ads for medical devices were already appearing, Davis told HealthDay. "This is happening in such fields as orthopedics," he said.

The association plans to ask the FDA to enact the policy, so the length of any moratorium would be determined by the drug agency. "If you have a drug which is critical to the treatment of a particular disease for which alternate treatments are not available, that would push to limiting the length of the moratorium," Davis said.

The AMA also endorsed new guidelines for advertising prescription drugs to consumers. The guidelines call for providing objective information about the benefits and risks of a drug as determined in clinical trials. They also urge more research into the effects of direct-to-consumer advertising on "the patient-physician relationship, overall health outcomes and health-care costs."

The doctors' group also wants the FDA to approve all direct-to-consumer ads before they appear. "We crafted our proposal to provide for very tight FDA authority over DTC ads," Davis said.

In addition, ads should allow enough time or space for consumers to understand all the warnings, precautions and potential side effects, without being distracted by other content in the advertisement, the doctors' group said.

The ads should also refer patients to their doctors for a full explanation of a drug and its use, and be targeted to age-appropriate audiences, the guidelines state.

The Pharmaceutical Research and Manufacturers of America said it generally supports the AMA's position. But the drug industry group believes its own voluntary monitoring program is sufficient to deal with the content of direct-to-consumer ads.

"PhRMA appreciates and supports the American Medical Association's continuing efforts to improve patient education and to provide quality information on health conditions and the treatment options available to conquer disease," Dr. Paul Antony, chief medical officer for the group, said in a prepared statement. "Informed patients are better patients and DTC advertising provides doctors and patients with accurate, educational information about disease and treatment options."

"PhRMA and its member companies announced last year its voluntary Guiding Principles on Direct-to-Consumer Advertisements About Prescription Medicines in an effort to further enhance the educational value of prescription drug advertising," Antony added. "While there are subtle differences between the Guiding Principles and the AMA's report, both emphasize the critical need to educate physicians and other health-care providers about a new medicine before it is advertised to the public."

Dr. Peter Lurie, deputy director of consumer advocacy group Public Citizen's Health Research Group, thinks the AMA proposal doesn't go far enough to guarantee complete information on prescription drugs to the public.

"The AMA suggestion is fine but it is nonspecific," said Lurie, adding there's no mention of how many years the moratorium would be in effect. "All that is up in the air, and there is no reason why that can't be made more specific," he said.

The most important part of the proposal calls for the FDA to prescreening ads, Lurie said. "If prescreening really happened that would be a big help," he said.

"The real solution to the problem of lack of patient information is not to leave it to the market, where self-interested people advertise only those products on which they can make a buck," Lurie said. "The real solution is to provide patients with government-sanctioned information on each and every drug."

Another consumer advocate doesn't think the AMA proposal would do anything to protect the public.

"Direct-to-consumer drug ads are dangerous and should be illegal," said Gary Ruskin, executive director of the consumer watchdog group Commercial Alert. "The AMA's policy is so weak that it will do little, if anything, to protect public health. It won't make much of a difference at all."

The AMA's Davis said his group considered a ban on direct-to-consumer ads but opted for FDA oversight instead. "There are some potential benefits from DTC advertising," he said. "In particular, educating the public about the availably of new medications and prompting discussions between patients and physicians about new medications."

But there are some risks, Davis added. "Such as building up false expectations among patients about what these drugs may or may not do, or whether they are appropriate for the disease or condition that a patient has," he said. "Laying out the advantages and disadvantages of DTC ads and the benefits and harms, we came down on the side of tight FDA oversight over DTC ads as opposed to a total ban," he said.

More information

To learn more about direct-to-consumer ads, visit the U.S. Federal Trade Commission.

SOURCES: Ronald M. Davis, M.D., president-elect, American Medical Association, Chicago; Peter Lurie, M.D., M.P.H., deputy director, Public Citizen's Health Research Group, Washington, D.C; Pharmaceutical Research and Manufacturers of America, Washington, D.C.; Gary Ruskin, executive director, Commercial Alert, Portland, Ore; June 14, 2006, American Medical Association's annual House of Delegates Meeting, Chicago
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