Two recent patient-safety initiatives—one designed to curb opioid overprescribing and the other a heart-device recall—reveal the limits of voluntary action when it comes to avoiding harm from drugs and medical devices.
The Centers for Disease Control and Prevention issued voluntary guidelines last week for how physicians and hospitals should prescribe opioids for long-term pain relief. The CDC recommended starting with over-the-counter pills such as ibuprofen before switching to low-dose opioids if the initial treatment is ineffective.
It recommended against the use of extended-release opioids. Those pills can be turned into street drugs, and accounted for a significant number of the nearly 30,000 deaths from opioid overdoses in 2014.
The guidelines have been warmly received by experts who study the growing opioid epidemic. But they have come under steady attack from cancer patient advocates—who are specifically exempted in the guidelines—and doctors who focus on pain management in their practices or the nation's far-flung network of pain clinics.
The American Academy of Pain Management, a 4,000-member credentialing group, immediately took issue with the CDC on the crucial issue of long-term opioid use. The guidelines said such use should be allowed only if patients are showing improvement in their ability to function and have the possibility of weaning themselves from the drugs.
Bad idea, the AAPM said. Continuation of opioid therapy should be tied “to documented progress toward goals of care that were mutually pre-determined by the clinician and the person with pain.”
The rival 2,400-member American Academy of Pain Medicine complained that the guidelines “appear to be focused on society risk mitigation.” That's a strange complaint, since it's the CDC's job to reduce public health risks.
Nobody has to follow the CDC guidelines. Given the reaction from clinicians whose practices would be most affected by adherence to the guidelines, they are unlikely to affect the opioid-abuse epidemic, which has been building for over two decades and, despite all the recent attention from politicians and the press, shows no sign of abating.
Contrast that approach to how the Food and Drug Administration and Abbott Laboratories reacted to early warnings that a recent advance in treating leaky heart valves was causing harm. Abbott's MitraClip and similar devices that may soon come on the market could replace open-heart surgery with a less-invasive catheterization procedure to repair malfunctioning valves. An estimated 350,000 elderly Americans, for whom open-heart surgery is too risky, might benefit.
But FDA reviewers panned the device after it underwent its initial 2013 regulatory scrutiny. A divided advisory committee of outside experts narrowly approved it, but not before voting that the evidence was inadequate to say it was effective. Despite that tepid review, the agency approved the device.
Adoption was slow until the CMS approved national coverage for the procedure last August. But it had a catch—it would pay for the procedure only if the surgeon and the hospital sent the patient's records to a national registry and agreed to track outcomes for at least one year.
These regulatory hurdles focused on outcomes, both at Abbott and among interventional cardiologists using the device. Over the past few months, clinicians reported nine adverse events, including one death, to the FDA and the company. Physicians were erring in how they installed the device—all too typical of the early days with any new medical procedure.
Last month, Abbott sent an “urgent field safety” notice to doctors. Last week, the FDA issued an official recall notice that left the device on the market, but required interventional cardiologists to certify they had been properly trained on installing the device.
Only 3,534 devices were deployed before the problem was identified. But if you apply that adverse-event rate to 350,000 potential patients, it's fair to say quick action, borne of active regulatory monitoring, saved dozens if not hundreds of lives. The lesson? Prudent regulation saves lives. Volunteerism allows problems to fester.
