Medical Product Ads Under Scrutiny
Posted on: Thursday, 15 May 2008, 09:00 CDT
By Henry L. Davis, The Buffalo News, N.Y.
May 15--The ad first appeared on television last Thanksgiving during an NFL football game, telling viewers that when your arteries narrow so does your life.
It resembled the prescription drug advertising that now floods TV, print and online promoting everything from restless leg syndrome to anti-impotence drugs.
But critics say the "Life Wide Open" campaign for the Cypher heart stent, which also included spots in newspapers and a Web site for patients, crossed a line by marketing a medical device directly to consumers.
"It's laughable to think that this ad could lead people to make informed decisions about a device when even specialists continue to debate complex treatment issues related to its use," said Dr. William E. Boden, a Buffalo cardiologist who co-wrote a critical article in the upcoming issue of the New England Journal of Medicine.
Publication of the article coincides with hearings in Washington, D. C., in Congress and the Food and Drug Administration on direct-to- consumer advertising of medical products. And it also opens the debate further about increasing concern that current marketing efforts directed at patients encourage overuse of drugs and focus too much on the benefits of treatments while minimizing the risks.
"In a 60-second TV ad, you can't provide the full disclosure about risks that you would expect to find in a print ad," said Boden, medical director of cardiovascular services at Kaleida Health.
Ads are big business
Proponents of advertising to consumers -- which grew from $11.4 billion in 1996 to $29.9 billion in 2005, according to a study published last year in the New England Journal of Medicine -- say it encourages more informed decisions about health care and treatment options.
Critics of this marketing contend it increases the demand for expensive brand-name medications, turns normal human experiences into medical conditions, skims over safety concerns while highlighting benefits and interferes with the doctor-patient relationship.
"Direct-to-consumer advertising has become ubiquitous, and neither regulatory oversight nor research on its impact has kept pace," Dr. Nancy H. Nielsen of Buffalo testified last week before the House subcommittee on oversight and investigations.
Nielsen, senior associate dean of the University at Buffalo School of Medicine and Biomedical Sciences, will take over as president of the American Medical Association in June.
Boden, who was asked by the Journal to co-write the article with another physician, acknowledges that some research shows ads do have some benefit for consumers. In addition, he noted that the Cypher television spot did warn that antiplatelet therapy is also needed to prevent the formation of dangerous clots.
However, he said the ad implied that the stent provided more than just symptom relief and failed to mention serious complications. It's a particularly big issue for Boden because he led a major study released last year that offered the strongest evidence yet that aggressive drug treatment and lifestyle changes in many patients work just as well to prevent heart attacks and death as do procedures to unclog arteries.
"The notion that television viewers, inspired by such an ad, would go to their physicians and request not only a stent but a specific brand and model of stent is frightening, if not utterly absurd," he wrote.
Timing of commercials
In the case of the Cypher stent advertising seen during the NFL games, its manufacturer started the ad campaign to capitalize on a review of studies by researchers showing that drug-coated stents do not pose a higher risk of death in patients than bare-metal stents. The review in the medical journal Lancet countered previous reports suggesting that drug-coated stents, which are inserted into narrowed arteries to keep blood flowing to the heart, may increase the risk of potentially fatal blood clots.
The stent manufacturer was hoping to reassure patients and physicians who might be confused about or fearful of the device's safety, said Carol Goodrich, company spokeswoman.
"We don't really expect patients to ask doctors for the Cypher stent. But we do want doctors to look at the newest data. Our initiative is about facilitating a conversation between physicians and patients about coronary artery disease and the interventions to treat it," said Goodrich.
Cypher worldwide sales were about $400 million in 2007, down 27 percent from the previous year because of new competition, lower prices and fewer procedures, according to a recent Johnson & Johnson conference call with financial analysts.
The script for the television ad was reviewed by the FDA before it was aired, Goodrich said.
The manufacturer has removed the ads from TV except in Baltimore, where the company is measuring its impact on viewers, she said. But the company is continuing to reach out to doctors and maintains a consumer Web site, www.cypherusa.com . The growing debate over direct- to-consumer advertising is likely to ignite a change in regulations.
Nielsen, for instance, called on pharmaceutical and medical device industries to use and comply with the AMA's guidelines to improve the balance in ads between benefits and risks.
Delayed ads
Such groups as Consumers Union have asked Congress to require companies to wait three years after approval of a drug or device to advertise to consumers.
FDA rules require ads to contain "fair balance" of the risks and benefits of a drug or device. But the requirement is not well-defined. In addition, experts say not enough research has been done on direct-to-consumer medical ads.
"We know the ads are effective at getting consumers to ask for particular brands. But we don't know if the ads are really helpful in the care of patients," said Marla B. Royne, a University of Memphis professor who recently reviewed the research on medical advertising for the Journal of Consumer Affairs.
hdavis@buffnews.com
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