TECH: Thoughts On Product Safety And More From A Medical Device Chairman
May 7th, 2007
by
Jane Hiebert-White
|
In an interview published online at Health Affairs, John Brown, current chairman and past chief executive officer (CEO) of the Stryker Corporation, reviews the development of his device firm and the medical device industry over the past thirty years. He also shares with interviewer Rob Burns (professor at the Wharton School, University of Pennsylvania) his perspective on some of the current policy issues facing the device industry today, including product safety, conflicts of interest, rising product prices, and direct-to-consumer advertising. Here are a few excerpts from the interview:
On Product Safety
Rob Burns: Another issue that has come up deals with product safety: Vioxx, drug-eluting stents, defibrillators. What’s your take on this? Do we have a safety problem, or is it just the fact that we are implanting so many of these things that the issue has finally hit the radar screen? How do you think we’re handling the safety issue?
John Brown: It’s been a media-fanned story. Granted, there are product failures; there always have been. But what the media has missed is the number of lives that are being saved or enhanced by these products, be it stents, defibrillators, pacemakers, hips, or knees. Saying “the product has to be perfect” is not right. It’s not good medicine, and it’s not good social policy. If you’re going to insist that the product has to be perfect, there’s no product that will ever meet that standard. Right or wrong, everything that we do involves probability and some risks.
On Transparency and Conflict of Interest
Burns: Let’s turn to the intersection of your industry with the policy arena. Recently, we have seen a spate of articles published in Journal of the American Medical Association, the New England Journal of Medicine, the Wall Street Journal, and the New York Times about conflict of interest. What’s your take on this issue?
Brown: I think that practitioners want to deliver good health care and do the right thing for their patients. They do get compensated for their ideas and their time. In the device industry, there needs to be ongoing dialogue between physicians and manufacturers to optimize the product, the instruments, and the surgical techniques. Reporters don’t seem to understand this need because it is different than what is required in pharma or other industries, and I believe that their coverage often reflects this lack of understanding.
Burns: What do you think about the steps that Medtronic and its orthopedics division have had to go through as a result of the investigation by the Department of Justice? They have to make sure that whatever payments are given to physicians, those payments were earned and there was a clear expectation of services to be performed for those payments. They have to be sure that they pay fair market value for the new ideas these physicians come up with. They have a corporate integrity agreement at Medtronic to monitor all of the company’s financial deals with physicians. They scrutinize the expense reports of their sales representatives to make sure they’re not doing anything wrong with customers. Is this what’s called for?
Brown: There must be a clear connection between what a consultant is paid and the value of their contribution. They should be compensated for how much they add to a research program or the development of a new product. It is unfortunate when regulators feel that it must take a court order to have this occur. We ought to do it. It’s just good business.
The full interview is available free access online through May 14. Tomorrow, May 8, Health Affairs’ new May/June issue on “The Shifting Risk-Benefit Landscape” will be available online and will expand on these topics, including new proposals on drug safety and patient information.
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