Earlier this month, the U.S. House of Representatives passed legislation that was promoted as a way to streamline the FDA’s process for approving medical devices in order to deliver new treatments to patients sooner.
But some voices have been raised in opposition to the measure because they believe it feeds the worst of commercial instincts while compromising patient safety. Writing in the New York Times, Drs. Rita F. Redberg and Sanket S. Dhruva, both cardiologists, are among those hoping the U.S. Senate takes a more critical view of the 21st Century Cures Act, commonly referred to as Cures.
Although the FDA has regulated approval of medical devices since 1976, the writers noted that the agency has not kept up with technology. “Many high-risk medical devices today are approved on the basis of just one clinical trial (as opposed to new medications, which usually require two trials),” they pointed out. “And only a small minority of clinical studies of medical devices are randomized, controlled and blinded — the gold standard for reliable evidence (and the benchmark to which studies of drugs are held).”
That accounts, they said, for the disturbing frequency of the FDA issuing warnings and recalls after products entered the consumer market and were found to be dangerous. We often write about such events.
Redberg and Dhruva alluded to the 2009 recall of Sprint Fidelis defibrillators, which had been implanted in hundreds of thousands of heart patients and had malfunctioned frequently, causing not only harm but numerous deaths. They wondered, in light of the FDA’s weak record, how many other products of lurking danger remain undetected.
Cures, the authors contended, invites medical device manufacturers to submit evidence of safety and efficacy based on sources other than clinical trials, such as case histories. Those aren’t science, but anecdotes that relate the experiences of individual patients.
Is that really how we should be stamping approval on medical treatments? By relying on the experience of people who might not reflect reality, much less majority?
Cures also would promote faster approval for what it refers to as “breakthrough technologies” “that are believed,” the authors wrote, “but not necessarily proved to offer significant advantages over existing alternatives. This would allow a device to be approved based on even lower standards of evidence than are currently used, on the theory that the need outweighs the risk.”
Earlier this year, we wrote about an FDA proposal to grant gravely ill people faster access to experimental drugs, but that’s different from the Cures definition of “breakthrough.” Those people have no other options and limited time for any treatment. In contrast, Redberg and Dhruva believe that this legislative interpretation creates “a perverse incentive for manufacturers to use this term both to take advantage of the faster approval process and as a marketing gimmick.”
No one familiar with Big Pharma’s and device manufacturers’ habits of hiding bad trial results and working to shape reports to their benefit would doubt that claim.
Basically, the op-ed writers said, Cures would shift the burden of evidence to clinical studies that are conducted only after the new devices have been put on the market. That means delays of months and maybe years, because the lag time of such studies is that long. Many are never completed, the writers commented, and when they are, the results often are not made public.
Cures mentions “timely postmarket data collection,” but in the medical realm, where precision should rule, that’s too vague. You can’t enforce something that’s vague, as history informs. “[A]ccording to a 2014 journal article co-written by one of us,” the writers recalled, “the FDA has never issued a warning letter or penalty for a postmarket study delay.”
Let’s say a postmarket clinical study does conclude that a medical device is dangerous; it’s still difficult to yank it off the consumer shelves. “In 2005, … an intracranial stent called the Wingspan was approved on an expedited basis to prevent recurrent strokes. When a high-quality clinical trial was finally completed, in 2011, it found that patients who had the device implanted were more likely to have another stroke and to die than those just receiving medical management. Despite this evidence,” Redberg and Dhruva wrote, “the FDA did not withdraw the device (though it did narrow its recommended uses). The Wingspan continues to be marketed and implanted today, putting patients at unnecessary risk.”
After a medical device is approved by the FDA, its manufacturer still can alter it. For example, it might change to a different gauge wire, or a new material. The FDA is supposed to monitor and approve such changes to ensure the device remains safe and effective. Cures, the writers pointed out, essentially gives this oversight the heave-ho.
“[A]larmingly,” they wrote, “[Cures] would establish a third-party program of nongovernment authorities to assess whether a company is permitted to make such changes. The act would enable the device manufacturer itself to select — and pay [our emphasis] — the third party from an approved list. This flagrant conflict of interest would make it impossible for physicians or patients to have trust in the safety or effectiveness of updated medical devices.”
It’s one thing, an appropriate and righteous thing, for the government to acknowledge and address the need to expedite medical treatments people need to heal, or to retard their decline. But’s it’s another to take action that appears to do so while actually inviting greater harm and ethical sleaze. Cures, according to Redberg, Dhruva and a whole lot of thinking people who are paying attention, “would subject millions of Americans to unsafe or untested medical devices.”
We and they hope that when the Senate considers the bill that it eliminates the dangerous provisions. “Unlike medical drugs,” they pointed out, “which can readily be discontinued if problems are found, many medical devices are permanently implanted and cannot easily be removed if found to be defective. Stricter evidence standards and increased federal funding of the FDA are needed to ensure that innovative medical devices lead to better health.”