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Campaign for Medical Device Bypasses Doctors


Taking a page from the drug industry, two medical device makers are going head to head with national campaigns that advertise hip-replacement implants to consumers.

The dueling campaigns, which began this fall, are the first time manufacturers of complex medical devices requiring patients to undergo major surgery have advertised so prominently.

One company, the Stryker Corporation, hired the golfer Jack Nicklaus to appear in a television commercial that ran during "60 Minutes" on CBS. In the ads, Mr. Nicklaus, who had hip-replacement surgery in 1999, urges patients with painful osteoarthritis in their hips to ask their doctors whether the company's new device, made from ceramics and titanium, is right for them. "If I could tell you one thing it would be, 'Don't wait,' " Mr. Nicklaus tells viewers, while the ad shows him playing ball with his grandchildren.

The other company, Zimmer Holdings, placed ads in Time and Newsweek featuring an older woman on a swing - ads that spell out the advantages of having a minimally invasive hip-replacement surgery that Zimmer developed. The surgery requires use of Zimmer's device and instruments.

"The best part is, I might be out of the hospital in 24 hours," the woman says. "Rehab is shorter, too. I don't know why I waited so long to do this."

Both ads refer viewers to a Web site and phone number directing them to local surgeons trained to implant the company's devices.

Until now, manufacturers of medical devices that require surgery or other complex procedures have largely focused promotional efforts on doctors. But in the last year or so, a growing number have turned their attention to consumers, but in limited ways. Medtronic, for example, placed ads for its implantable device to relieve incontinence in the women's restrooms in dozens of restaurants in Minneapolis and St. Paul. And DePuy, a Johnson & Johnson subsidiary, recently ran television ads for its knee-replacement devices in Phoenix and West Palm Beach, Fla.

The trend worries some patient advocates, who say it is impossible for consumers to get enough information from one-page magazine ads or 60-second television spots to understand whether such risky and complicated devices may be right for them.

"This is not how people should be making important decisions on procedures that can help them, but also come at great risk as well," said Arthur A. Levin, director of the Center for Medical Consumers in Manhattan.

Mr. Levin said that hip-replacement surgeries could prove almost miraculous when performed properly on the right patient. But they can also lead to life-threatening complications, especially in the elderly, he said, and can require repeated operations on young patients. Over time, the devices wear out and can cause extreme pain.

But analysts say the ads may be only the beginning.

"The device manufacturers have seen the success of the pharmaceutical industry," said Charlie Whelan, an analyst with Frost & Sullivan, an international consulting firm. He said that both medical device companies and drug makers were responding to patients who were no longer content to sit back and follow doctors' advice and who wanted a larger role in their care.

But while pharmaceutical companies must follow strict advertising rules set by the Food and Drug Administration, few rules apply to device makers. Only ads for the riskiest devices - like artificial hearts and pacemakers - must follow F.D.A. rules, which require companies to disclose detailed information on risks. Advertising for other medical devices is regulated by the Federal Trade Commission, which simply requires that companies not make false or deceptive claims, said Richard Cleland, assistant director for the F.T.C.'s division of advertising practices.

Stryker's television ads include a brief statement that "surgery involves potential risks and recovery time," while Zimmer's ads include no information on risks other than making it clear that a hip replacement involves surgery and rehab.

"This type of advertising is inevitable," Mr. Cleland said. "There is a sense out there that marketing works."

Zimmer, of Warsaw, Ind., and Stryker, of Kalamazoo, Mich., are now the leading manufacturers in the hip-replacement market, which was worth an estimated $2.6 billion worldwide last year, said David J. Lothson, an analyst at UBS Securities, which has no investment banking relationship with the companies and holds none of the companies' stock. Both companies' hip-replacement sales in the United States grew at an annual rate of 23 percent in the third quarter, he said. About 300,000 hip-replacement procedures are performed in this country each year.

In a 2001 report for investors, Mr. Lothson explained how device makers have traditionally marketed hip and knee replacements. Because the implants are similar and patients are almost never consulted on what device will be used, he said, the companies have focused marketing on surgeons. The companies work with leading surgeons, many of whom are affiliated with medical schools, to develop new implants, he said. These surgeons then train other doctors in how to implant a company's device.

As a result, he said, sales representatives "begin bonding with young surgeons during their residency programs, hoping to make them lifelong users of their companies' implant lines."

In an interview, Mr. Lothson said the consumer ads might help to increase sales by persuading people who have hesitated to go ahead with the procedures because of new technologies aimed at making surgery less invasive and the devices last longer.

Ray Elliot, Zimmer's chairman, said the company began studying who its potential customers were in 1998, when it was developing its technique for minimally invasive hip-implant surgery. The company learned, he said, that many elderly patients today are better informed than earlier generations, with many adept at using the Internet.

"People who are 70 today are not like my grandmother," Mr. Elliot said. "They are not going to have a piece of metal put in without doing the research."

The goal of Zimmer's new ads, he said, is to persuade patients that the company's method, which requires smaller incisions, can require shorter hospital stays and less rehabilitation.

"It is frightening surgery if you do it the traditional way," Mr. Elliot said. "We're trying to let people know you don't have to give up your life."

The company has also paid for advertising in U.S. News & World Report, Better Homes & Gardens, Arthritis Today, Modern Maturity and several newspapers. He said that the company was considering whether to begin television ads next year.

Ned Lipes, group president of Stryker's orthopedic implant business, said the company polled potential patients and learned that many spent much of the day in pain but had delayed having surgery.

"There are many patients suffering with joint pain who are intimidated or just don't know enough about it," Mr. Lipes said. He said that while the television ads featuring Mr. Nicklaus might lead to more sales by all hip-replacement manufacturers, the company hopes patients will ask doctors "about the implant that Jack Nicklaus has."

Stryker's new ceramic and titanium device sells for $4,000 to $5,000 - a premium compared with implants made from traditional materials of plastic and metal, Mr. Lipes said. He says that the company thinks the new device is better for younger patients because ceramics have been shown to last longer than plastic, which can break down into particles that contribute to bone loss.

Mr. Whelan, the consultant, said it was not yet clear that the campaigns would prove to be a good investment. Because such a small fraction of Americans need hip replacements, the companies could be paying too much for national ads that reach millions of people who may never need such devices.

"For something as complicated as hip surgery," he said, "I don't know how successful this will be."

Posted on aef.com: November 3, 2003

 

Melody Petersen, The New York Times. October 30, 2003

Copyright © 2003 The New York Times Company. All rights reserved.