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UnderregulatedThe Danger Within Us: America’s Untested, Unregulated Medical Device Industry And One Man’s Battle To Survive It By Jeanne Lenzer New York (NY): Little, Brown and Company, 2017 336 pp., $28.00

2018; Project HOPE; Volume: 37; Issue: 6 Linguagem: Inglês

10.1377/hlthaff.2018.0542

2694-233X

Jessica Bylander,

Biomedical Ethics and Regulation

Book Review Health AffairsVol. 37, No. 6: Hospitals, Primary Care & More UnderregulatedJessica Bylander AffiliationsJessica Bylander ([email protected]) is a senior editor at Health Affairs, in Bethesda, Maryland.PUBLISHED:June 2018Free Accesshttps://doi.org/10.1377/hlthaff.2018.0542AboutSectionsView PDFPermissions ShareShare onFacebookTwitterLinked InRedditEmail ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsDownload Exhibits TOPICSMedical devicesPharmaceuticalsAdverse eventsPatient harmFDA approvals processIt took two unprecedented tragedies—a strep throat treatment (Elixir Sulfanilamide) that killed more than a hundred people in 1937 and a not-yet-approved nausea drug (thalidomide) that caused birth defects in babies in the 1960s—to introduce safety and effectiveness standards for drugs regulated by the Food and Drug Administration (FDA). Medical devices didn’t come under the FDA’s regulatory scrutiny until 1976, in the wake of injuries and fatalities linked to the Dalkon Shield, an intrauterine contraceptive device. In the decades since, medical devices in particular have undergone mind-blowing evolutions, with commensurate capabilities and risks. And by many indications, the FDA has struggled to keep pace.Jeanne Lenzer’s The Danger within Us details the birth of the “medical-industrial complex” and with it the rise of a device industry that, as she relates, is not averse to taking shortcuts or even breaking the law to maximize profits. It’s a bleak and somewhat one-sided portrait, but Lenzer’s documentation of bad actors within the device industry and the FDA’s notable failures to keep unsafe or ineffective products off the market is compelling.“The medical device industry is one of the most powerful yet unaccountable sectors of the medical-industrial complex,” Lenzer writes.Lenzer, a medical investigative journalist, makes one particular patient’s story the linchpin of her book: Dennis Fegan, a man with treatment-resistant epilepsy who had a vagus nerve stimulator (VNS) device implanted in his body in 2000 to control his seizures. The FDA had approved the device, which was marketed at the time by a firm called Cyberonics in 1997.Fegan would ultimately discover that shocks from his medical device appeared to be causing his heart to stop at regular intervals, leading him to pass out. But when the shocks began occurring, the symptoms so resembled drop seizures that Fegan and his physicians had been none the wiser. Lenzer refers to this dilemma as “the cure as cause” and says it’s all too common in medicine.The years that followed saw Fegan’s unraveling. It was not simply that the device had caused him harm, but that for years the company did not report his case to the FDA as a device-related adverse event. In addition, any legal recourse on his part was impossible, thanks to the 2008 US Supreme Court ruling in Riegel v. Medtronic, Inc., which barred people from suing a manufacturer for issues related to a device’s safety and effectiveness if the device had received FDA premarket approval (the most stringent regulatory pathway for devices).Lenzer spares nothing in her takedown of the device industry and the FDA. On the industry side, she tackles “kickbacks” paid to key physicians and surgeons to prescribe medical devices, industry funding of medical research, and marketing tactics that encourage physicians to use devices for unapproved (or “off-label”) purposes. On the regulatory side, she points out the inadequacies of the FDA’s adverse event reporting system, the Manufacturer and User Facility Device Experience database (known as MAUDE), which requires manufacturers to report life-threatening events and deaths that could be attributed to a device but leaves it up to those manufacturers to decide whether the device actually caused or contributed to the event. Hospitals, manufacturers, and others can also report adverse events to the database, but this is voluntary.Lenzer concludes her thorough book with an exhaustive list of recommendations. Some are actionable and convincing: make the MAUDE database fully functional and truly comprehensive; return FDA leadership roles to civil servants rather than political appointees; restore the right of patients to sue if they are harmed by an FDA-approved device; and convey to patients when a device has been granted “conditional approval,” which indicates that issues arose in review that require additional scrutiny after the device is in wider use. One could imagine this information being conveyed to patients and physicians as a version of a “black-box warning.”But Lenzer doesn’t stop there. She also calls for single-payer insurance, suggests that two randomized controlled trials should be required for every medical device, recommends campaign finance reform to eliminate industry’s hold over politicians, and argues that the wealth gap must be eliminated. In an attempt to be holistic about the deep roots of the problem, Lenzer comes of as a bit unreasonable in her call to action.Notably, she spends little time on the lifesaving potential of many medical devices and only briefly acknowledges the trade-offs between risk and benefit in every FDA approval decision. She also doesn’t talk about the roles of bench and preclinical testing, important components of the FDA’s premarket review of devices.Nevertheless, The Danger within Us captures the spirit of the issue: The review and surveillance of new medical devices are not adequate. Lenzer reported on these issues for BMJ for years and was frustrated when her reporting didn’t move the needle. It will be worth watching to see whether the FDA’s recently released “Medical Device Safety Action Plan,” which promises to improve safety and detect risks earlier, makes a dent. Unfortunately, it seems that the sorts of medical tragedies that gave rise to the FDA’s review of drugs and devices today spark some bad press and financial woes but have little long-term impact. Loading Comments... Please enable JavaScript to view the comments powered by Disqus. DetailsExhibitsReferencesRelated Article Metrics History Published online 4 June 2018 Information© 2018 Project HOPE—The People-to-People Health Foundation, Inc.PDF download