Heat of the Spotlight

It’s probably safe to say that after a hectic workweek, most busy professionals have a weekend routine that they eagerly anticipate to help them wind down. On Sunday morning, mine usually involves a few cups of coffee, The Washington Post and my regular news shows such as “Meet the Press,” “This Week” and “CBS Sunday Morning.” On a recent Sunday morning, as I read the newspaper and sipped my coffee with the TV on in the background, I overheard a voice reminding me not to miss the story coming up next: When medical implants fail. OK, they had my attention. Healthcare stories and topics are commonplace on such shows, but medical devices specifically, not as much.

You certainly can’t help but notice the mainstream attention that the medtech industry has garnered lately. The medical device tax has made it into the public debate in an election year, while the healthcare reform law it is part of is debated by the U.S. Supreme Court. And the U.S. Food and Drug Administration (FDA) has been beaten from pillar to post by a host of different stakeholders on a variety of issues—high-profile recalls; reports from the Government Accountability Office (GAO) calling its review processes into question; and Capitol Hill hearings debating agency funding and patient safety. Industry says the FDA moves unpredictably and much too slowly. Consumer groups claim the agency is overly friendly with industry and that reviews are quick, not based on good science and put the American public in danger.

It’s a lot to sort out—even if you’re part of the industry. As is the case with most things in and of Washington, D.C., the topic of medical device approvals, the role of FDA, government and the public is highly nuanced. There’s a sea of gray. It probably should be black and white, but it isn’t.

That is, unless you’re affected by a device that goes wrong and you’re searching for answers. That was the story that was told a few weekends ago in the piece aired by “CBS Sunday Morning.” The
reporting began with a positive bit of information: Statistically, fewer than one percent of all medical devices fail their patients—far fewer, in fact. Of course, there’s little consolation in the “less than one percent,” for families impacted by a faulty device. It may as well be 50-50 odds.

Joshua Oukrop was 21 when he died seven years ago of a heart attack. Due to a heart condition inherited from his father, Joshua required an implantable cardioverter defibrillator (ICD). The device failed while the younger Oukrop was on a hiking trip with his girlfriend. Instead of shocking the heart back into rhythm, the ICD shorted out. Joshua’s doctor, Robert Hauser, researched the issue and discovered based on FDA data that Guidant, the device’s manufacturer (which since has been purchased by Boston Scientific) knew about possible faults since 2002. In a meeting to urge the company to inform patients and physicians of the problem, Hauser told CBS that company officials declined to do so, saying that they were afraid physicians would overreact and remove the devices unnecessarily. The company said despite what happened to Josh, the likelihood of failure was very low.

“The FDA should have been on top of this because Guidant had filed a report with the FDA in August of 2004 laying out the details of the problem with the device,” Hauser told CBS reporter Jim
Axelrod. Hauser eventually told his story to The New York Times. The device was recalled shortly thereafter.

Marcia Crosse, healthcare director at the GAO, the federal government’s watchdog agency, told CBS that she knows the FDA had the reports but can’t say if anyone read them. “The data we have from our review of recalls showed that FDA had approximately 26 reports of serious adverse events related to this type of device over a three-year period before the device was recalled,” Crosse said. She believes the negative press of Joshua’s death is what triggered the response. “It shouldn’t be what it takes,” Crosse told Axelrod. “That’s the concern that we have about their [FDA’s] use of information that they receive.”

Though the agency declined to be interviewed on camera (as did Boston Scientific), it did release a statement. “Medical device safety is critical to protecting the public health, but there is a potential risk with any drug or medical device, from aspirin to heart valves,” the FDA noted, adding that it weighs the benefits and risks of every medical device. “While mitigating risk helps protect public health, we must balance risk with the careful evaluation of patient benefit—this helps promote public health,” the statement continued, reiterating that FDA has “a strong track record of safety and effectiveness. Evidence suggests that the vast majority of these devices perform well and improve patient health.”

Indeed it does have a strong record of success. And these are highly complex issues that often can be much too easily digested and spit back out by mainstream media. But, as an former editor of mine used to say: “It’s a story with ‘teeth.’” And this kind of news takes a chunk out of everyone involved. The takeaway message is that the assignment of blame isn’t as important as what we do with this knowledge. How do we make a good process even better? If we can elevate the dialogue above Washington’s typical sound bite rhetoric and vitriolic mudslinging, there’s an opportunity to take the heat of the spotlight and turn it into benefits for the patient and industry.