More Heart Device Regulations Could Kill.

September 18, 2005  ·  Michael Fumento  ·  Scripps Howard News Service  ·  Fda

Implantable defibrillators keeping getting smaller, more sophisticated, and cheaper.

More government regulation is always better. Just ask any regulator. Actually, most of us probably feel the same way when it comes to lifesaving medical devices. But what if the added rules actually put people at greater risk?

The issue arose recently with a medical conference presentation by Dr. William Maisel of Boston’s Beth Israel Deaconess Medical Center and his colleagues detailing trends in the removal of pacemakers and implantable defibrillators. (Pacemakers regulate heart rhythm, while defibrillators shock the heart into restarting.) That coincided with a media-heralded Maisel article in the Journal of the American Medical Association (JAMA) calling for slapping the device makers with greatly-expanded reporting requirements.

From 1990 to 2002, American doctors implanted 2.25 million pacemakers and 416,000 defibrillators, reported Maisel’s group. Of these, almost 9,000 pacemakers and about 8,500 defibrillators were removed due to confirmed device malfunctions. Pacemaker "explants" decreased significantly during the entire time period. But for defibrillators, there was a marked increase in removals in the later 1990s.

Terrible news? Not necessarily. Maisel himself noted those 416,000 defibrillators saved about 30,000 lives, or 1,000 lives for each death that would have occurred anyway if no defibrillator had been implanted.

Further, the apparent increase in defects might be attributable to glitches from advances in technology that keep giving the devices more functions in smaller units and at far lower prices, says FDA Deputy Commissioner for Scientific and Medical Affairs Dr. Scott Gottlieb. More defects might be the tradeoff for saving more lives.

But another possibility is that the increase in reporting serious defects is just that, a reporting increase. Maisel didn’t differentiate between serious and non-serious malfunctions and defibrillator makers issued a number of safety advisories in the late 1990s, according to the Advanced Medical Technology Association (AdvaMed). The trade group says these advisories may have prompted clinicians to be more aggressive in returning explanted defibrillators to manufacturers for analysis.

As evidence, they note that from 2001 to 2002 the number of defibrillator removals PLUMETTED almost by half. One year does not a trend make, but AdvaMed says preliminary newer data "may show a continuation of this positive trend."

Still, regardless of whether there’s an increasing problem, wouldn’t directly notifying patients of safety issues – instead of only the FDA and doctors – be an improvement, as Maisel suggested in JAMA?


Sometimes less is more.

Unlike doctors who write prescriptions and often never see the patient again, those who implant heart devices establish a permanent relationship with patients. And unlike parents with defective child car seats (to use Maisel’s rather bizarre comparison), such a patient can’t exactly take remedial action himself. Patient notification would only threaten to weaken the critical patient-doctor relationship.

And what of Maisel’s suggestion in JAMA to expand manufacturer notification beyond significant defects to ALL defects?

The very idea practically gives Larry Pilot a heart attack. Now an attorney with McKenna Long & Aldridge in Washington, D.C., Pilot spent a decade at the FDA including launching what’s now called the Center for Devices and Radiological Health. "The agency already has more than enough authority in this area," he says. "And it doesn’t need more information; it needs to better analyze what it already has."

Says Pilot, "The FDA can’t even handle what it’s currently receiving."

Further, the vast majority of "malfunctions" he notes, really aren’t. They could be as simple as a labeling change. Expanded reporting would simply give the FDA a bigger haystack in which to search for needles. And that can be deadly.

Invoking Vioxx, the pain reliever linked to increased risk of heart attack and strokes, Pilot says, "Merck [the maker] was supplying information to the FDA but what did FDA do?" Not much, actually. Merck issued a voluntary withdrawal, while the FDA admitted it hadn’t "had an opportunity to review the data."

Moreover, Pilot notes, medical devices are already more closely monitored than drugs. Manufacturers and facilities such as hospitals and nursing homes are required to report possible malfunctions. Doctors and patients can readily file reports under the FDA’s Medwatch program.

Truth is, people want distilled information that tells them what REALLY matters. Just look at the gazillions of Dummies Guides sold. Why should it be different for lumbering bureaucracies? As with swimsuits, sometimes less is more.