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Kevin J. Bozic, MD, MBA, addresses a Senate panel on direct-to-consumer advertising.

AAOS Now

Published 11/1/2008
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Carolyn Rogers

Are medical device ads playing doctor?

Fellow testifies at Senate hearing on DTC device ads

“Until you know how this medicine will affect you, you shouldn’t drive or operate machinery.”

“Side effects may include next-day drowsiness, dizziness, headache, or irritability.”

The onslaught of direct-to-consumer (DTC) drug ads hitting the airwaves over the past 10 years has made statements like these a part of the popular vernacular. Comedy shows regularly lampoon those seemingly endless lists of embarrassing side effects.

Drug companies may not relish the prospect of becoming late-night punch lines, but the U.S. Food and Drug Administration (FDA) requires the to disclose all of the major risks associated with a drug, meet accuracy criteria, and include a balanced representation of the product’s risks and benefits.

Consumer-directed ads for medical devices, such as artificial knees and hips, however, are subject to surprisingly little monitoring.

As more medical device companies pitch their products directly to consumers, some lawmakers, medical groups, and others are calling for increased scrutiny of the ads, claiming they mislead con­sumers and may pose even greater risks to patients than ads for drugs.

Device makers ramp up ad campaigns
The $5 billion spent by pharmaceutical firms last year still dwarfs DTC spending by medical device makers, but industry spending is growing fast—to $193 million in 2007, nearly double the amount spent in 2005.

During the past 3 years, several device makers have implemented high-profile DTC ad campaigns. Some have borrowed from the consumer-product model by hiring celebrities to tout their devices.

Dr. Bozic testifies at Senate hearing
Recognizing that the medical device industry is “beginning to get into the [DTC advertising] game,” Sen. Herb Kohl (D-Wis.), chair of the U.S. Senate Special Committee on Aging, convened a hearing on Sept. 17, 2008, to examine issues related to DTC advertising for medical devices such as replacement hips, heart stents, and other implants.

Academy fellow Kevin J. Bozic, MD, MBA, addressed the panel, speaking on behalf of the AAOS and the American Association of Hip and Knee Surgeons (AAHKS).

Because device ads are not required to give equal balance to the risks and benefits of their products, Dr. Bozic said, the ads “have the potential to cause tremendous harm to the doctor-patient relationship, create unrealistic expectations among patients, and lead to overutilization of inappropriate, costly, and unproven medical technologies, which could have dire and expensive public health consequences.”

Harming the patient-physician relationship
Citing his 2007 award-winning study of orthopaedic surgeons and their patients—“The Impact of Direct-to-Consumer Advertising in Orthopaedics”—Dr. Bozic told lawmakers that 74 percent of surgeon respondents thought the DTC medical device ads “negatively impacted their relationships with patients,” and 78 percent believed their patients were “confused or misinformed about the appropriate treatment for their condition based on an advertisement.”

A full 84 percent of surveyed surgeons thought that patients who had seen the ads had “unrealistic expectations regarding the benefits” of the devices.

Sixty percent of patients surveyed reported that they had “formed an opinion about the type of treatment or device that was appropriate for them before consulting with a doctor.” More than half of patient respondents said they were “more likely to request a specific type of surgery or brand of implant from their surgeon after seeing an advertisement.”

Another survey, taken in 2006 at an orthopaedic meeting, revealed that orthopaedic surgeons felt tremendous pressure to accede to the treatment demands of their patients. Of surgeons in attendance, 88 percent believed that patients might seek out someone else if the surgeon was unwilling to provide a specific brand of device.

Device ads pose “greater risks”
Medical device ads are more deserving of restrictions than pharmaceutical ads, said several experts at the hearing, because implants often involve greater risks to patients.

Although all drugs have side effects, taking a pill for insomnia or impotence is not nearly as risky as having a medical device surgically implanted, stated William E. Boden, MD, a cardiovascular surgeon.

When it comes to medical implants, “the results are irreversible,” Dr. Bozic added.

“AAOS and AAHKS believe that DTC advertising of restricted medical products has the potential to create a distorted market,” he told the committee. He urged the panel to support greater restraint from the medical device industry and greater oversight from the FDA.

The other side
Stephen J. Ubl, president and CEO of the industry group AdvaMed, said DTC advertising informs patients about options they might be unaware of, adding that “the FDA and the FTC [Federal Trade Com­mission] already have ample legal authority to regulate false or mis­leading advertising for medical devices.”

Mr. Ubl also stressed that the medical technology industry is different from other life sciences, and that advertising regulations should acknowledge those 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,” he said.

Possible moratorium on ads
In his closing statement, Sen. Kohl threw down the gauntlet for device makers and the FDA.

“There are real risks and serious complications involved,” he said, adding that “we are prepared to call for future moratoriums” on DTC ads. Such moratoriums would allow doctors to familiarize themselves with the devices before they are advertised broadly to the public.

He closed the session by calling for increased collaboration between the medical device industry and the FDA to ensure that consumers receive accurate and balanced information about the benefits and the risks of the advertised medical devices.

After the hearing, Sen. 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.

Carolyn Rogers is a staff writer for AAOS Now. She can be reached at rogers@aaos.org