FDA’s dubious oversight of heart devices: hidden complaints and shaky tests

FDA-logo-300x129Cardiac patients may wish to take to heart how news reports have undercut federal regulators’ claims that they provide the most rigorous oversight to medical devices that treat complex conditions in ways that pose the greatest risk. With certain heart pumps and defibrillator units, both implanted in patients, the Federal Food and Drug Administration deserves criticism for putting the interests of device makers ahead of patients, excellent stories by the Kaiser Health News Service and Axios show.

KHN reporter Christina Jewett followed up her investigation into how FDA bureaucrats let device makers  file 1.1 million reports of injuries or malfunctions with their products to a little-known internal agency database, discovering how this practice contributed to what one cardiologist described as “the worst cardiac device problem” he has seen in a quarter-century of practice.

The incidents involved the Sprint Fidelis, a small device surgically installed in hundreds of thousands of patients to monitor and supposedly to administer small shocks to deal with their irregular heartbeat. Instead, the device — especially due to problems with its corroding and cracking electrical leads — gave patients random jolts, failed to perform in genuine emergencies, and led to a torrent of complaints and deaths. Doctors, medical researchers, and patients forced into wide public view the substantial defects of the defibrillator, including in congressional hearings.

Jewett since has found that early on “the FDA and [the defibrillator’s maker] Medtronic made a deal to keep reports about the widely used device’s malfunction incidents — now totaling 50,000 — shielded from public scrutiny.”

Even as patient safety advocates grew alarmed and sought to sleuth out how serious the defibrillator defects might be, its maker quietly was reporting problems to the FDA — not in the publicly visible MAUDE system, but collected, thousands of reports at a time, in a private system. Records went from the maker to the agency on computer disks. The agency twice exempted Medtronic from public reporting of mounting problems with its device, Jewett reported:

Under that second … exemption, Medtronic reported a total of 36,914 cases with 50,205 complications. They include more than 22,000 instances of lead fracture and nearly 2,900 incidents of inappropriate shocks.

Once major problems became known, the maker says it put in place an extensive monitoring and public reporting system. But, since the device’s 2007 recall, Jewett noted, “more than 2,300 reports of deaths in which the device was suspected to have played a role were filed with the FDA …”

Patients also have wrestled with the difficult and complex challenge of deciding what to do about their defective defibrillators because the surgery to fix or remove the device poses its own significant risk.

In a pointed but understated comment on the FDA’s dubious practice of allowing device makers to hide their legally required reports of product problems, Dr. Frederic Resnic, cardiovascular medicine division chairman at Lahey Hospital & Medical Center in Burlington, Mass., and a Tufts University medical school professor, told Jewett that the “lack of communication and transparency” over the Sprint Fidelis exemption “challenges the FDA’s unique role as the primary, trusted, information source regarding medical device safety.”

Concerns about a heart pump

The agency’s more recent oversight of the Impella PR heart pump from Abiomed has raised more and other concerns about FDA regulation of medical devices, the news site Axios says, reporting that developments “around this heart device also shows how a lack of rigorous testing causes confusion about whether devices are beneficial and working as intended.”

The FDA granted Abiomed premarket humanitarian approval to market its heart pump for short-term support for patients who “develop acute right heart failure or decompensation following left ventricular assist device implantation, MI [myocardial infarction], heart transplant, or open-heart surgery.” The agency acted based on results from a small group of patients, so it imposed guidelines on the device’s use and ordered follow-up studies.

The studies’ results “aren’t good,” Axios reported: “The survival rate has dropped precipitously — just 4 of 23 patients (17%) who got the Impella RP were alive within a month. Since 2015, there have been 21 adverse events linked to the Impella RP, including three deaths, according to federal data analyzed by Madris Tomes, a former FDA regulator who founded the software firm Device Events. Her analysis, shared with Axios, indicated 10 of those adverse events occurred in 2018.

The FDA has updated its warnings about the heart pump and its use, particularly with failing patients. But the agency still is dealing with problematic data and studies about a device for use in dire situations,  Robert Yeh, an interventional cardiologist in Boston who has used the Impella and who has received money from heart device makers, told Axios: “We don’t have great randomized trials … for many of the devices like Impella. As a result, we are left to a data-free zone.”

That’s not good. In my practice, I see not only the harms that patients suffer while seeking medical services, but also the damage that can be inflicted on them by defective and dangerous products, especially medical devices.

They have become a booming industry, valued at more than $150 billion annually, and with powerful political allies and well-placed friends within the FDA. The agency’s new commissioner has not been as forward as his predecessor, Scott Gottlieb, who pushed the Trump Administration view that the FDA should speed up its review and clearance processes to speed innovative products to market. Gottlieb made faint stabs at reforming those processes before departing last fall. Patient safety advocates, however, have denounced what they describe as the “Wild, wild west” atmosphere surrounding medical devices, many of which receive light and little review before hundreds of thousands of patients may be exposed to them and their considerable risks.

If devices can benefit patients, let’s of course get them with due haste to them. But this can’t be rushed if patients’ safety and even their lives gets put at unnecessary risk. How to decide? We need rigorous research and evidence — and that includes full, deep, and public disclosure of harms and deaths associated with products. This seems simple, direct, and inarguable. Why the FDA can’t grasp this is unacceptable and hard to fathom. If the bureaucrats can’t provide the needed oversight, then the White House and Congress must do their jobs and provide tougher oversight of the agency. It’s something to keep in mind as we race toward the 2020 elections.

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