They’ve Got Rhythm, But Not Regulation

They’ve Got Rhythm, But Not Regulation

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ProPublica, the online investigative website, carried a revealing set of stories Thursday documenting the financial ties between the Heart Rhythm Society, which represents the nation’s 5,100 invasive cardiologists, and the medical device industry, which manufactures the stents, pacemakers and other widgets designed to protect people with serious heart disease from fatal heart attacks.

The society’s four-day annual meeting, which was held in San Francisco this week, pulled in $5 million in advertising, education sponsorship and promotion booths from companies like Medtronic, Boston Scientific and St. Jude Medical, which account for a large share of the $6.7 billion heart rhythm device market. Device makers contributed fully half of the society’s $16 million annual budget last year, and 12 of its 18 board members have financial ties to device firms in the form of consultant contracts, speaking fees or stock ownership, the report said.

Conflicts of interest in medicine are an old story. A decade ago, one medical journal editor, in trying to explain how the journal failed to disclose the conflicts of a published study’s author, lamented that “conflicts of interest in medicine are ubiquitous.”

Maybe so, but they matter a lot, and need to be reined in, especially if the nation is going to get serious about controlling health care costs. The Journal of the American Medical Association (JAMA) carried a study earlier this year that claimed one in five implanted cardiac defibrillators were unnecessary. Given the $30,000-plus price tag on such devices, the financial implications of such overuse for insurers like Medicare are huge.

It’s also a major safety issue for patients who do not really need the devices, since there are considerable risks associated with getting them implanted, and not just from the operation. There is a high likelihood that at some point, a device will either misfire or will be triggered by a minor heart flutter that poses no medical threat. The result is a shock that has been likened to being kicked in the chest by a mule.

The ProPublica reporters, Charles Orenstein and Tracy Weber, went to the Heart Rhythm Society website to see if these risks were adequately described. They were not. In fact, they were ignored. The website does claim that the devices were “99 percent effective in detecting and stopping deadly heart rhythm disorders.”

It wouldn’t take much for the society to inform patients about the risks. This study, which appeared in JAMA in 2006 and I found in two minutes by searching the government database of medical research, showed that more than 2 percent of the 415,780 defibrillators implanted over a 12-year period malfunctioned and had to be replaced.

Why hasn’t the Food and Drug Administration stepped in and insisted that the Heart Rhythm Society provide accurate information on their website? After all, drug advertising is required to carry long laundry lists of side effects and risks, as any viewer of the evening news can attest.

Alas, the nation’s medical device regulations do not have the same requirements as the drug regulations. “It’s a little murky,” said Karen Riley, a spokeswoman for the agency. “They can’t be misleading, but guidance on risks was never developed.”

The FDA in 2009 did publish a draft guidance for the medical device industry in how it should present risk information. “FDA believes it is critically important to disclose risk information in prescription drug and medical device promotion appropriately and effectively to healthcare professionals and consumers,” it said.

Alas, the guidance languishes, while the beat goes on at the Heart Rhythm Society.

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spent 25 years as a foreign correspondent, economics writer and investigative business reporter for the Chicago Tribune and other publications. He is the author of the 2004 book, The $800 Million Pill: The Truth Behind the Cost of New Drugs.