Medtech DTC Advertising under Fire in Senate Panel

September 1, 2008

10 Min Read
Medtech DTC Advertising under Fire in Senate Panel

In yet another indication of the increasing governmental scrutiny of the medtech industry, the U.S. Senate earlier this month set its sights on direct-to-consumer (DTC) advertising of medical devices. The hearings, dubbed “Marketing or Medicine: Are Direct-to-Consumer Medical Device Ads Playing Doctor?,” were part of an ongoing 15-month investigational series conducted by the Senate Special Committee on Aging.

In his opening remarks, Senator Herb Kohl (D–WI), committee chairman said, “ Unlike direct-to-consumer advertising of drugs, DTC advertising of medical devices has not yet been highly scrutinized . . . as the medical device industry is just beginning to get into the game.” Kohl noted that device industry spending on DTC ads is still only a fraction of pharmaceutical industry outlays, but that “the medical device industry's stake in this marketing practice is growing.”

Notable medtech participants in DTC advertising include Biomet Inc. (Warsaw, IN), Medtronic Inc. (Minneapolis), Johnson & Johnson Inc. (New Brunswick, NJ), Stryker Corp. (Kalamazoo, MI), and Zimmer Holdings Inc. (Warsaw, IN). Borrowing from the consumer-product model, several medtech firms have used celebrity endorsements to tout the benefits of their devices. Biomet ads featured Olympic gymnast Mary Lou Retton; Stryker employed championship golfer Arnold Palmer; and J&J's DePuy Orthopedics featured Duke University basketball coach Mike Krzyzewski.

Medtronic's television and online ads for its implantable cardioverter-defibrillators (ICDs), drew concern from cardiologists upon their introduction in January 2007. According to the company, the ads, themed “What's Inside,” showed “the link between medical device technology and the benefits people can experience by living with ICD therapy” to prevent sudden cardiac arrest. The ads no longer run and, according to Medtronic, the campaign has been retired.

Perhaps the most controversial medtech DTC ad was developed by J&J's Cordis division for its Cypher drug-eluting stent and introduced to the market in October 2007. The “Life Wide Open” campaign featured older patients—primarily ‘active' males—and the tagline, “When your arteries narrow, so does your life. The Cypher stent can widen your arteries, increase the flow of blood to your heart and give you back your active life.” In addition to the television commercial, ads were run in the New York Times, the Wall Street Journal, and USA Today.

Boden: Crossing the line.

Cordis's “Life Wide Open” DTC advertising drew largely negative reaction from cardiologists, hospitals, policy makers, and healthcare consumer groups. The campaign, which was reviewed by FDA prior to its release, was cited and aired during this month's Senate hearings as an example of medtech DTC advertising that “crossed the line” according to William E. Boden, MD, clinical chief of the division of cardiovascular medicine at the University at Buffalo (Buffalo, NY).

Boden said the “Life Wide Open” television broadcast campaign “implicitly promises a better life without adequately informing the public, as print ads are required to do, about the totality of possible complications and adverse clinical events that may occur.” Boden called on FDA to put medtech DTC advertising on the same footing as pharmaceuticals, and recommended that the agency consider enacting a ban on all DTC advertising of drugs or devices during the first two years after they have received FDA approval. Such a waiting period would ensure that postmarket surveillance and adequate clinical data have established an appropriate safety record and profile before the new products are advertised broadly to the public.

In the committee hearing, Kevin J. Bozic, MD, MBA , chair of the healthcare systems committee for the American Association of Orthopaedic Surgeons (AAOS; Rosemont, IL), reported the results of an AAOS study which found that 98% of surgeon respondents had experience with patients who had been exposed to DTC advertising for medtech devices. Among those respondents, 74% believed that such advertising had negatively affected their relationships with patients.

Bozic: Patient pressure.

The AAOS study presented a significant contrast between orthopedic surgeons and their patients. Although 78% of the responding physicians believed that DTC ads confused patients, only 18% of the patients responding to the survey felt that way. Similarly, while 84% of the responding surgeons believed the ads could be misleading, only 37% of patients held that belief. Bozic said that the study findings revealed that orthopedic surgeons felt tremendous pressure to accede to the treatment demands of their patients. Among the responding surgeons, 88% expressed the opinion that their patient might seek out another practitioner if the physician did not prescribe the particular brand of device the patient was seeking.

Bozic, who is an associate professor of orthopedic surgery at the University of California, San Francisco, acknowledged that today's consumers are taking a more active role in their healthcare. “We applaud efforts by our patients to educate themselves regarding their health conditions and their potential treatment options. However, as our research has shown, biased information contained in direct-to-consumer advertisements promoting specific products which are not supported by scientific evidence has the potential to cause tremendous harm to the doctor-patient relationship, to create unrealistic expectations among patients, and lead to overutilization of inappropriate and costly unproven medical technologies which could have dire and expensive public health consequences.”

Day: Risk, disadvantaged.

Ruth S. Day , director of the medical cognition laboratory and senior fellow at the center for the study of aging at Duke University (Durham, NC), presented the Senate committee with research about how people understand, remember, and use information in DTC ads. Overall, her findings indicated that risk information is seriously disadvantaged relative to benefits in medical device ads, and that the techniques used to present risk information operate at a lower level of cognitive accessibility. “In device ads,” said Day, “there is often a strong ‘testimonial' aspect, relying heavily on visual images of an individual able to do wonderful things after getting/using a medical device. In one case, these images are so strong that no there is no oral expression of the benefits at all.”

“There is no question that these medical devices can restore high quality of life to many patients who are suffering,” said Ami Gadhia, policy counsel with Consumers Union (Yonkers, NY). “But consumers need to know about the unintended deaths and serious injuries that occur all too often with medical device surgeries. Ads for medical devices should warn consumers about the health risks associated with them, just as the law already requires pharmaceutical companies to warn about drug side effects.”

Schultz: Assisting consumers.

Daniel Schultz, MD, director of FDA's Center for Devices and Radiological Health (CDRH; Rockville, MD) reviewed the agency's role and limitations in regulating DTC advertising of medical devices. Schultz said that FDA can and does take action against medtech firms that engage in misleading advertising. “FDA has regulatory authority over the labeling of all medical devices,” said Schultz. “However, FDA's regulation of medical device advertising is limited to a subset of medical devices. The Federal Trade Commission (FTC) regulates the advertising . . . of most medical devices.”

In his testimony, Schultz went on to say, “FDA believes that, if done properly, medical device advertising can provide consumers with important information about medical devices and new indications for existing medical devices, as well as information about symptoms of treatable illnesses and other conditions. Done properly, medical device advertising can assist consumers in taking a proactive role in improving their health. However, to be of value, these advertisements must not be false or misleading.”

Representing the medtech industry, Stephen Ubl, president and CEO of industry association AdvaMed (Washington, DC), said, “Direct to consumer (DTC) advertising is a powerful educational tool that allows patients to learn of new technologies and treatment options in a timely fashion and can help to initiate important discussions between physicians and patients. Our goal as a health system should be to enhance the exchange of information and empower patients to ask questions about their own health. We believe DTC advertising is an invaluable tool to that end.”

Ubl: Acknowledging differences.

Ubl stressed that the medical technology industry is different from other life sciences, and that advertising regulations should acknowledge those important differences. “The idea that a patient would undergo a complex and invasive procedure based on an advertisement, or that a physician would agree to perform them if inappropriate for the patient, is difficult to imagine,” said Ubl.

As Senator Kohl noted, medtech spending on DTC advertising is just a fraction of what the pharmaceutical industry spends. Several hearing participants cited a report from TNS Media Intelligence (New York City), which pegged 2007 medical device spending for DTC ads on television and the Internet at $193 million. That's double the amount that the industry spent in 2005, but a far cry from the more than $5 billion spent on DTC advertising by the pharmaceutical industry in 2007.

Bolling: From acceptance to action.

Jay Bolling, president of Roska Healthcare Advertising (Montgomeryville, PA), says that about 15–20% of his agency's clients are in the medtech space and many of them are actively considering targeted DTC advertising initiatives. “Broad-based DTC campaigns designed to build brand awareness do not make a great deal of sense here. The key is connecting the right people with the right physicians, and there are an increasing number of vehicles to do that, including patient-specific portals on the Internet, private video channels that reach doctor's offices and pharmacies, as well as focused direct-mail and e-mail campaigns. The key is to customize the point of intercept, where the message reaches the greatest number of people with the greatest need for the product. It's about moving beyond awareness and acceptance to action.” Bolling is also president of the Healthcare Communication and Marketing Association (HCMA; Mt. Royal, NJ).

In wrapping up the current round of hearings by the s pecial committee on aging, Senator Kohl said,

“There are real risks and serious complications involved, and we are prepared to call for future moratoriums on these type of DTC ads for new medical devices. Physicians and consumers must be appropriately educated about these critical devices and their benefits and risks alike. What we do in the near term will be dependent on the proactive actions of FDA and industry.”

On September 26, Kohl sent a letter to Representative Bart Stupak (D–MI), chairman of the House energy and commerce subcommittee on oversight and investigations, regarding the subcommittee's letters to pharmaceutical companies over the implementation of temporary moratoriums on direct-to-consumer (DTC) advertisements featuring newly-approved drugs. In the letter, Kohl suggested that regulatory oversight should be at a commensurate level for both pharmaceutical and medical device DTC advertising, and that the House and Senate should work together toward that goal.

All signals point to oversight and regulation of medtech DTC advertising being likely to increase—perhaps at a pace faster than the category itself. Stay tuned, as this issue will definitely be revisited.

© 2008 Canon Communications LLC

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