Vinay Prasad: A wake-up call for the medical profession

Vinay Prasad reviews Jeanne Lenzer’s book on the medical device industry

There is growing awareness of the weaknesses in medical device regulation, driven by news coverage of high-profile scandals (e.g. metal on metal hip implants) as well as award winning documentaries, such as Netflix’s The Bleeding Edge. The fundamental failure is that devices, often made of metals, plastics, computer chips, and polymers, are often implanted in human beings for decades with limited or no trial data showing that the benefits outweigh the risks. One notorious pathway for US marketing authorization is called 510(k). This pathway permits invasive, harmful devices like the IVC filter to be sold on the US market, become a blockbuster device, and remain on the market for 30+ years, without a single randomized trial showing efficacy on patient centered outcomes. The 510(k) pathway allows devices to come to market solely because they are equivalent to a device already on the market, though this definition has been stretched and expanded to the point of meaninglessness. For this reason, the Institute of Medicine has recommended that the 510k pathway be discarded.

In her book The Danger Within Us, investigative journalist Jeanne Lenzer dissects the device industry. She weaves the story of one patient—Dennis Fegan—a patient with epilepsy, who underwent placement of a vagal nerve stimulator—alongside empirical evidence regarding the laxities of the medical device industry to create a riveting and concerning narrative. The book reads like a mystery, not a work of medical non-fiction: it turns out to be both. Two key strands form the core of the narrative.

Firstly, the man. Lenzer describes in detail the story of Dennis Fegan. As a child, Fegan was expelled from a moving vehicle, and later developed epilepsy. In 1997, the FDA cleared Cyberonics vagus nerve stimulator for epilepsy, though the device had an unclear mechanism of action, and controversial data. At the age of 42, Fegan had the device implanted. Afterwards, he was taken to the hospital with EKG suggestive of heart block, which seemed to occur at precisely the 3-minute interval at which the vagus nerve stimulator was active. Other patients have been reported to have had poor outcomes thought related to the vagus nerve stimulator. Lenzer uses the story of Fegan to highlight the pitfalls of the devices that come to market, lacking robust evidence. Some may even be harmful, she says.

Next, the regulators. Lenzer builds the case that the regulatory agency that is supposed to hold companies responsible for their products engages in relationships that are simply too cozy.  A few years ago, Bien and I reported in The BMJ that the majority of medical reviewers who left the FDA went to work for or consult for biopharma, what some call a “revolving door.” Piller confirmed this in Science magazine. Lenzer describes other potentially concerning instances. For example, in 2005, Lester Crawford resigned two months after being confirmed as commissioner. Lenzer notes this “may have been tied to a Justice Department finding that he illegally withheld information about his financial ties…” (p134). She also notes that top FDA official Jeffrey Shuren and the device lobbying arm “’met regularly during the legislative process and the agency and the device lobbying arm had jointly written the legislative text…’” (p135) of the 21st Century Cures bill, a bill that many experts believe lowers the regulatory standard for approval.

These are just two of the narratives woven in the Danger Within Us, but they are not all. We learn more about the life and times of the cardiology legend Eugene Braunwald. Some of what we learn is unflattering, and shows how eager medicine is to engage in hero worship, while many leaders exist in shades of gray. Lenzer also discusses the corporatization of medicine, the pernicious effect of financial conflict of interest, and the massive incentives for device sales people.   

Together, these issues bother Lenzer deeply, and her concern shows. By the time you finish the book, the issues will concern you too. The solutions to our predicament are simple, though not politically appealing. Conflict of interest among experts must be curbed. Drug regulators must be impartial experts who always and only work in the public interest. We cannot allow them to be “captured”—to see their client as the industry and not the public. They are simply too important for that. Evidence based medicine is the antidote to uncontrolled prospective studies, or case series. Randomization alone can show that an intervention (with modest to marginal effect size) works under some circumstances, a vital bar for new technologies. And, the most honest, impartial, and dutiful physicians are the ones who do not succumb to hype, and who are critical thinkers above all else. Lenzer’s book joins an impressive body of medical books that should serve as a wake-up call for the profession. Reform is not only possible, it is inescapable.

The Danger Within Us: America’s Untested, Unregulated Medical Device Industry, By Jeanne Lenzer

Vinay Prasad is an assistant professor of medicine in the Division of Hematology Oncology in the Knight Cancer Institute, Department of Public Health and Preventive Medicine, Oregon Health and Sciences University, Portland, Oregon. He is also a senior scholar in the University’s Center for Health Care Ethics.

Competing interests: Vinay Prasad wrote Ending Medical Reversal in 2015 and receives royalties from that. One of his research projects is funded by the Laura and John Arnold Foundation. VP reports receiving royalties from his book Ending Medical Reversal, that his work is funded by the Laura and John Arnold Foundation, that he has received honoraria for Grand Rounds/lectures from several universities, medical centers, nonprofit groups, and professional societies, and is a writer for Medscape. He makes the podcast Plenary Session, which has Patreon backers.