Senate probe shows why we need to bust up regulators’ cozy ties with medical device makers

A U.S. Senate Committee has ripped a medical device maker, hospitals, and federal regulators for their shameful roles in allowing scores of patients to be sickened and some to die due to defects in a flexible, state-of-art scope used in gastrointestinal procedures. The committee’s findings and some other recent reports ought, in particular, to raise lawmakers’ hackles about the cozy relationships between regulators and industry and how these work to the public’s detriment.

I wrote recently about this scandal, uncovered by the Los Angeles Times. The paper’s investigation found three infection outbreaks linked to Olympus scopes and blamed 21 deaths on dirty scopes.

Senate investigators found the situation was far more widespread — with 25 outbreaks — and the conduct of the various parties even more problematic. We already knew that Olympus dissembled throughout the growing crisis. It blamed others for faulty cleaning. It told European customers there might be problems with the devices but failed to warn users in the bigger, more profitable American market. Olympus, though it knew of spreading concerns, sought to persuade affected hospitals that they were alone in their problems. The company moved as slowly as it could in filing incident reports with federal regulators.

The Times filled in some blanks about the actions of the Food and Drug Administration, the federal watchdogs of medical devices on the public’s behalf. Senate investigators assailed the FDA for its bungling and delay. The agency spent 17 months in back and forth chatter with Olympus, examining issues of hygiene and proper cleaning of the devices without grasping the larger and deadly woes, the Senate report says. The FDA also ran — and still runs — a haplessly passive system to collect critical information that could provide warnings about device dangers. Regulators, for example, ask manufacturers and hospitals to file incident reports when harms or deaths occur; in this case, the maker and hospital either failed to file the reports or did so in such slow and delayed fashion that the information was unhelpful. The agency also grants anonymity to hospitals, in particular, when they do file reports, making it harder to see patterns and outbreaks.

Sen. Patty Murray (D-Wash.), a ranking member of the Health, Education, Labor, and Pensions committee that investigated the dirty scopes’ outbreaks, including one at a Seattle hospital, observed:  “Patients should be able to trust that the devices they need for treatment are safe and effective. Unfortunately this investigation makes clear that current policies for monitoring medical device safety put patients at risk, and in this case, allowed tragedies to occur that could have, and should have, been prevented …” Murray also has posted a news release saying that, under her committee’s prodding of the FDA, Olympus has recalled all its scopes and will replace and repair them with a new design that experts say will avert the spread of infections.

What’s next?

OK, Congress, now that the media had to provide the digging and spotlight to disclose bad conduct with this medical device, how about fixing the glaring problems with the regulatory agency?

It’s also under fire in another medical device situation. As the folks at the Health News Review point out, NBC, to its credit, has stayed atop a running story about Bard, a big medical device manufacturer based in New Jersey. Bard, NBC reports, has made a “blood-clot filter associated with 27 deaths and hundreds of problems.…[The firm] replaced the device with a modified version that it knew had similar and potentially fatal flaws soon after it was put on the market.” A U.S. senator has written the FDA to ask what it’s doing about this case.

Meantime, a healthcare industry trade publication, deserves credit for tracking the unseemly, tight ties between the FDA and medical device manufacturers. I’ve written about Congress’ big, end-of-the-year budget crunch and how it boosted federal support for healthcare. I said then that taxpayers needed to keep a close watch on all the sizable legislative actions connected with healthcare funding.

Too cozy for comfort

Indeed, InsideHealthPolicy has reported that, in the hectic wind-down of 2015: “FDA and the largest medical device lobbying group worked together to develop proposed legislative language for most of the medical device provisions included in the House-passed 21st Century Cures bill, one of the largest FDA reform bills to pass the House in recent years, and are developing a synchronized regulatory strategy for the Senate version.” The trade publication found this in internal emails and documents obtained under the Freedom of Information Act.

The Health News Review folks add more context and other information on the cozy dealings, as reported by other media, including the outrage by consumer advocates at being shut out in the drafting of the FDA “reform” legislation.

Americans, I hope, are now permanently wary of any actions by Big Tobacco. Recent, soaring drug prices have sharpened our doubts and guard about Big Pharma (even as we give thanks and credit for therapies that work, are affordable, and available). Big Med Device Makers look hell-bent on not just creating and selling potentially life-changing things but also in gaining the notoriety and ill will that took some other corporate bad actors time to earn. We’ll all need to pursue multiple fronts — personal, electoral, legislative, through the civil justice system, and others — to keep in check the avarice and down-right villainy of the malevolent among these interests.

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