Why worry about gung-ho approvals for medical devices? FDA’s own record

gottliebThe  Food and Drug Administration has closed out the year by issuing a new white paper reaffirming the agency’s three-year-old warning to surgeons and women to avoid in general the use of a surgical device called a morcellator in “key-hole” or laparoscopic gynecological operations.

It wasn’t a surprise that the FDA retained this caution. That’s because the Wall Street Journal, back in 2014, had published a major investigative series linking morcellators to increased cancer incidences, recurrences, and risks in women. Researchers found that the popular surgical tool, by grinding up tissues such as those found in common female fibroid tumors, purportedly to permit their easier, faster removal, spread cancerous tissues throughout the body. The FDA has taken major, deserved criticism for failing for two decades to better protect thousands of women from harms caused by this medical device.

But what else did the agency do in its busy December? Scott Gottlieb, the FDA commissioner, also has reaffirmed that the FDA is motoring ahead with a stepped program to speed up an already loose approval and oversight process for medical devices like the morcellator.

Racing devices to the market will let patients benefit from the latest medical innovations that may improve their health, Gottlieb told the Wall Street Journal, echoing an argument made by the industry itself, President Trump, and Republicans in Washington.

But some doctors are skeptical, especially about heart and other devices installed in patients. Rita F. Redberg, editor of JAMA Internal Medicine and a cardiologist and researcher at the University of California San Francisco, told the newspaper that the FDA regulatory “change would put more patients at risk for having permanently implanted dangerous devices.”

That’s no small issue, considering, for example, the FDA’s running battle with St. Jude Medical, the maker of a defibrillator, for which the company already has issued hundreds of thousands of recall notices.

Patient safety advocates long have fought efforts to speed up the FDA’s approval processes for medical devices. They already aren’t as tough as critics would like, and the agency has a poor record in following up on devices’ performance after they hit the market, as the Wall Street Journal has reported:

Medical devices are already regarded as involving more lenient approvals than drugs, sometimes with bad effects on patients. In recent years, there have been health consequences from devices like metal-on-metal hips that degenerated … and defibrillator wires that fractured, causing deaths. A 2015 article in the medical journal JAMA from researchers at Yale University and elsewhere reported that just 13 percent of post- approval safety and effectiveness studies of high-risk medical devices were completed within three to five years.

The newspaper earlier  reported on how medical device oversight can be laxer and speedier than, say, processes in place to regulate prescription drugs. Medications must be rigorously tested, including in the extensive process of clinical trials. But with congressional approval, the agency can and has approved thousands of medical devices annually if makers show they’re similar to products already OK’d and on the market.

Gottlieb has said that makers sometimes compare new devices with state-of-the-art technology to products four decades old. The agency, instead, wants them to meet “objective safety and performance criteria,” measures that he told the Wall Street Journal also would be in keeping with “international consensus standards.” (That’s a curious mention, considering one of the bigger recent scandals with medical devices involved dirty Japanese medical exam scopes that infected dozens and killed more than 20.)

More key to the agency’s changes: The FDA proposes to let devices into the market with “initial approval,” with planned, later follow-ups on their performance.

In my practice, I see not only the major harms that patients suffer while seeking medical services but also the serious damages that can be inflicted on them by defective and dangerous products, including bad medical devices. Here’s hoping that lawmakers with FDA oversight subject Commissioner Gottlieb’s planned changes on medical device to much more tough thought and questioning. Patients’ safety and well-being are too precious for the FDA to wave on complex and risky devices, pretending that a burdened agency later really will track back on their good or ill for consumers. It’s failing to do this with rigor already, for example, with prescription drugs.

As the FDA should well know, significant numbers of Americans can be harmed before sufficient alarms go off for officials to react. And bad products, like the proverbial bad penny, have the bad habit of hanging around once they somehow get to market. Just look at how consumers still suffer harms from baby strollers and carriers whose poor designs long ago were singled out and supposedly barred. Safety advocates long have warned about the major strangulation dangers posed to kids by window blind cords — but only now are officials cracking down in, fingers crossed, a more meaningful way. Auto products purportedly are subject to rigorous testing and standards these days but a new journalistic investigation has raised big questions, anew, about tire safety and manufacturing.

In a time when building products were expensive and difficult to get, carpenters developed a wisdom that says measure twice, cut once. Human lives are far more valuable than lumber. And the FDA should think hard whether it needs to slow the rush to get medical devices to market.

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
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