Medical devices race onto the market with little or no effective testing or regulatory safeguards, and a proposed “reform” of the oversight system of products that are implanted in tens of millions of Americans is a sham, safety advocates say.
That’s because there are gaping flaws in the proposal to alter the so-called 510(k) procedure under which the federal Food and Drug Administration clears medical devices for sale, say medical journalist Jeanne Lenzer (right) and health care activist Shannon Brownlee (left).
Their Op-Ed in the Washington Post is the latest salvo against FDA Commissioner Scott Gottlieb’s claims of “transformative” changes in medical device regulation by his agency. News organizations around the world in recent weeks have published investigations of how poorly such products are tested, reviewed, and then released on markets, killing and injuring patients as a result.
Lenzer and Brownlee trace the FDA’s problems with medical device regulation to the 1970s, when lawmakers first gave the agency the responsibility for protecting the public from flaws in such products. Rather than create huge turmoil, the FDA “grandfathered” in existing devices. And the agency declined to order that medical devices, like prescription medications, undergo rigorous testing, including human clinical trials.
Instead, the authors write, the agency then created a giant loophole for device makers. The FDA let them skip tougher safety standards, if their products could be “shown to have ‘substantial equivalence’ to a previously cleared ‘predicate’ device.’ Four out of five devices are cleared for sale this way. Of those, at least 95 percent were cleared without clinical studies, according to research by Diana Zuckerman and her colleagues at the National Center for Health Research.”
One of Gottlieb’s big but faux changes would be to push the time horizon, so makers could go back just 10 years in citing existing products. But the authors point out that those products themselves might never have been human tested and had relied on older, unsafe precedent devices.
It’s as if 21st century car makers could point to the Edsel, then the Corvair as reasons why they didn’t need seat belts, shatter-proof windshields, steering columns that don’t turn into bayonets, and cabins that don’t crush like egg shells.
But there are further problems with Gottlieb’s plans, say Lenzer, the author of a recent book on the nightmares of medical devices, and Brownlee, who is a senior vice president of the Lown Institute, which describes itself as a “think tank advocating a radically better and uniquely American health system that overturns high-cost, low-value care.”
They point out that makers of highest-risk devices — artificial hips, deep brain stimulators and spine implants — also can waltz past rigorous oversight by the FDA just by informing the agency that a product contains just “minor changes” before it gets to market. This supplement pathway, the authors note, lets makers circumvent clinical trials, and Harvard researchers “found that 99 percent (5,829 of 5,906) of implanted cardiac devices, such as pacemakers and defibrillators, were approved through the supplement pathway from 1979 to 2012.”
The results have been problematic, they reported:
The supplement pathway has led to a number of disasters, such as one involving Medtronic’s Sprint Fidelis defibrillators, which are implanted in the chest to shock the heart if it goes into a deadly rhythm known as ventricular fibrillation. The company told the FDA in 2003 that it had updated the device to use thinner electrical leads into the heart. But the new wires were prone to fracture, hitting some patients repeatedly with shocks when their hearts were fine, and not delivering shocks to others who needed them. … By the time Medtronic recalled the defibrillator in 2007, about a quarter-million were in circulation worldwide. Individuals implanted with it live under a sword of Damocles: They risk electrocution and possible death if they leave the Sprint Fidelis alone — and they risk death if their heart stops and the product fails. If they choose to have it removed, they face a 12 to 16 percent rate of serious complications or death from the surgery, according to a study published in 2010 in the journal Circulation.
In my practice, I see not only the harms that patients suffer while seeking medical services, but also the injuries that can be wreaked on them by dangerous drugs and defective and dangerous products, notably by medical devices. Patients are staggered by the costs of medical devices, and they deserve greater protection from their harms.
Lawmakers need to stop heeding the “poor me” or hurry-hurry innovation claims of medical device makers and to push the FDA to safeguard the public, not advance industry interests. As Lenzer and Brownlee write, however, the agency may already have become the “captive” of the very enterprises it is supposed to oversee. That’s because pro-business and partisan lawmakers not only have shoved the FDA into lighter, speedier reviews of medical devices, they also created a system in which much of the money for the process comes from the companies in the form of fees.
This is unacceptable, and we have a major mess to clean up in the days ahead. Lenzer and Brownlee have ideas on how and they’re worth reading, because, as they write of the FDA:
The agency’s laissez faire attitude has resulted in artificial hips that cause cobalt poisoning (which can damage the heart and brain); surgical mesh that cuts through flesh and organs, causing infections and hemorrhage; and defibrillators that repeatedly shock patients beyond human endurance. Safety problems have led to recalls of devices implanted in hundreds of thousands of people. And the devices can be difficult or impossible to remove if they go bad.