Some orthopedists not buying FDA’s direct-to-consumer advertising policy

In its policy statement, the AAOS expresses concern about patients being misled or lacking information.

Issue: February 2006

Orthopedic surgeons have mixed feelings about direct-to-consumer advertising. This type of advertising was the focus of a recent FDA meeting set up to collect public comment about its policy.

DTC advertising may lead to better informed patients, joint patient/physician decision making, better physician/patient communication, more patient compliance and less stigma associated with diseases, according to the American Academy of Orthopaedic Surgeons’ (AAOS) official position statement.

“However, DTC advertising also has the potential for negative consequences,” the AAOS statement said. “For example, advertising may confuse patients by implying that minor differences among competing products represent major therapeutic advances. ... (AAOS) believes direct-to-consumer advertising that is presented in a responsible and ethical manner may be of some value to patients. Such information should be scientifically substantiated, accurately presented and free of false of misleading claims. Direct-to-consumer advertising and marketing of pharmaceuticals, devices or surgical procedures may create patient safety concerns if it leads patients to seek health care solutions without consulting with a physician.”

The FDA relaxed restrictions on DTC advertising back in 1997. At present, no laws or regulations prohibit DTC ads in various media, and the FDA may regulate only prescription drug advertising it finds false or misleading. Other restrictions require all risks included on product labeling to also appear in print ads, while broadcast ads must cite only the most severe risks. The FDA may not require review of prescription drug ads before their use. Companies submitted 586 DTC broadcast ads for FDA review in 2004, up from 293 in 1999.

The FDA will continue accepting comment on DTC advertising until Feb. 28, and is not expected to make a decision before spring.

AAOS’ extended position

The AAOS also notes that DTC advertising might not inform patients about orthopedic product design differences, materials and device strength. Also, patients might not have access to post-marketing data on device performance and safety. Consumers also might be unaware of implant wear issues, though surgeons considering those issues when tailoring devices to specific patient needs, the AAOS said.

“Because of the highly individual nature of surgery and other musculoskeletal treatments, the AAOS believes that great care should be taken in advertising orthopedic devices, drugs and procedures directly to consumers,” the statement said. “Advertising should be truthful, useful to patients and not misleading and ambiguous. Advertising that an individual surgeon has received training to perform a procedure does not imply the same standards as certification by the American Board of Orthopaedic Surgery (ABOS). The AAOS supports continued research efforts on the effects of direct-to-consumer advertising on public health.”

The AAOS statement cited some additional problems concerning pharmaceutical ads, including the following:

patients seeking medication from pharmacies on the Internet, outside the United States without a physician's prescription or without a physician monitoring medications;
patients' lack of awareness of more effective or less expensive alternatives to advertised drugs;
side effects often not being communicated in detail in advertising or marketing materials; and
patients often being unaware of drug-drug, drug-herb, drug-supplement and drug-food interactions.

Douglas W. Jackson, MD, ORTHOPEDICS TODAY’S chief medical editor and former AAOS president, characterized DTC ads as sometimes “offensive” and for contributing to higher health care costs.

“I see more cons than pros,” Jackson said. “It is good that patients are educated and participate in their care. The problem with DTC is it is to promote drugs and devices with the most profit margins for the company or to increase their market share. Patients then want that product or device if it will help them. Often the product or device is more expensive than the alternatives not marketed.”

On the positive side, DTC advertisement may spur more patients to see their physicians because "the ads suggest better and more natural healing and help patients to overcome some of their hesitancies to seek out a medication or surgery," Jackson said.

But some companies’ Web sites refer patients to physicians who use a particular product, he noted, a practice many physicians frown on because it can color efforts to reach objective treatment choices.

Warnings can be obscured

And advertising “hype” often obscures warnings about side effects too, Jackson said. “There is a lot of initial ‘hype’ after the ads run and then the number of patients talking about it diminishes,” he said. “The impressions the patients bring to the office seem to minimize the potential side effects or possible alternatives. The side effects are usually mentioned fairly quickly at the end of the ad, and the patient is told to see if the advertised product is right for them by asking their doctor.” Jackson called for less government regulation and more self-regulation.

“Seeking more government regulation is a dilemma in a ‘free market place’ environment,” he said. “Too much government regulation has its problems. Industry has adopted a code of ethics for marketing to doctors and I hope they will do a similar thing on DTC advertising. Usually the threat of more government regulation moves them to develop more acceptable guidelines for themselves.”

For more information:
American Academy of Orthopaedic Surgeons, Web site: www.aaos.org.
For FDA advisory committee news and information, visit: www.FDAAdvisoryCommittee.com.