September 19th, 2008

Physicians Discuss Concerns About Device DTC Advertising with US Lawmakers

By Michael O'Riordan
theheart.org

Lawmakers in Washington, DC, gathered this week to discuss recommendations for increased regulations on direct-to-consumer (DTC) advertisements for medical devices. On hand were several witnesses, including two cardiologists and an orthopedic surgeon, to discuss growing concerns about device companies, such as those who manufacture stents for PCI, advertising their products directly to the public.

“Unlike the direct-to-consumer advertising of drugs, direct-to-consumer advertising of medical devices has not yet been highly scrutinized,” said Sen Herb Kohl (D-WI), chair of the Senate Aging Committee. “The medical-device industry is just beginning to get into the game. Over the past four or five years, their use of DTC ads is growing in print and on the internet.”

The device industry spends just a fraction on DTC advertising compared with the pharmaceutical industry. One study cited $160 million spent on advertising to consumers in 2005 compared with the $4 billion spent by the pharmaceutical companies. The concern, however, is that spending is increasing, but more important, the products advertised require invasive surgical procedures to implant.

Consumers unable to assess complex medical choices

Speaking before the senate committee, Dr William Boden (Buffalo General Hospital, NY) asked permission to first play one of the device ads, a 60-second commercial for the Cypher stent by Johnson & Johnson that debuted on Thanksgiving weekend 2007 during an NFL football game between the Dallas Cowboys and the New York Jets. The Cypher TV ad starts with a man slumped in a chair and asks, “How big is the world? Ask the tough guy cornered by chest pains.” It then shows several other people enjoying various different physical activities and says: “When your arteries narrow, so does your life,” and, “It’s time to open it up.”

Boden has been critical of the ads in the past and, along with Dr George Diamond (Cedars Sinai Medical Center, Los Angeles, CA), who also attended the senate committee hearing, previously wrote an editorial questioning their value to the public and physicians [1]. Both told the senate committee they have concerns about the Cypher stent ad because the decision to use a stent or to use that particular stent requires sophisticated medical understanding beyond the domain of the public.

“We believe that this initial medical advertisement has crossed the line in promoting a particular coronary device to millions of individuals who are unable to discern many of the subtle and complex therapeutic issues that even we cardiac specialists continue to debate,” Boden told the committee. He previously said that the idea of consumers requesting not only a stent but a specific brand and model of stent is frightening, if not utterly absurd.

“The goal of medicine . . . is to improve longevity or quality of life,” Diamond told the committee. “The direct-to-consumer ad serves this higher goal no better than the average political ad serves the ideals of the democratic process. It simply introduces another myopic link in the chain, consumer opinion.”

Boden offered some suggestions to the committee, the first being that the Food and Drug Administration place drug and device advertising on the same regulatory footing, and then that all DTC advertisements highlight only evidence-based clinical data that reflect the proven benefit. Boden said there is a need for a multidisciplinary committee to vet and discuss all advertising before it heads to the air, and there should be a ban on DTC advertising of drugs/devices for two years after FDA approval to make sure the drug/device fulfills postmarketing safety surveillance.

Orthopedic surgeon Dr Kevin Bozick (University of California, San Francisco), speaking on behalf of the American Association of Hip and Knee Surgeons and American Association of Orthopedic Surgeons, noted that proponents of DTC advertising say the commercials empower patients, encourage dialogue with physicians about treatment options, and eliminate the stigma of certain conditions.

“Conversely, opponents claim that DTC advertising does not educate consumers, because the information contained in DTC ads is biased and misleading and benefits of the drug or device are exaggerated and risks are at best downplayed,” said Bozick. “Additionally, opponents argue that DTC advertising significantly strains the doctor-patient relationship by increasing the length of office visits and diminishing the role of the physician in clinical decision making.”

Bozick cited his study that found 74% of surgeons thought the ads “negatively impacted their relationships with patients” and 84% thought patients had “unrealistic expectations regarding the benefits” of the devices after seeing the ads.

Role of the FDA

The senate committee also heard from Dr Daniel Schultz, director of the Center for Devices and Radiological Health at the FDA. He told lawmakers that pharmaceutical companies are required by current regulations to obtain prior authorization from the FDA for DTC ads, and these ads must meet criteria for accuracy and balance, but no requirements are in place for device companies. The FDA can act against misleading DTC advertising for devices after it appears, however.

When asked about regulation of device DTC advertising, Schultz told the committee he is in favor of stricter regulations but added that the FDA needs to “do something that is effective, not just do something for the sake of doing something.” Boden told Kohl he would prefer to see a ban on DTC advertising for devices in place but realizes such a ban is difficult. Boden, along with Diamond, urged stricter regulation.

Also present at the senate hearing was Stephen Ubl of the industry group AdvaMed. He told the committee that the FDA and the Federal Trade Commission already have legal authority to regulate false or misleading advertising for medical devices. He said the group supports the enforcement of advertising standards, shares concerns about celebrity ads, and supports a ban on advertising for newly launched devices so there is sufficient time for doctors to be trained in their use. Ubl said ads should highlight risk, and the organization is willing to work with FDA to tailor appropriate language to communicate the risk/safety trade-offs. 

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