Responding to Critics

Neurotech therapies using implanted stimulation devices have transformed the lives of countless patients and drawn praise from a number of sources. Occasionally, the neurotech device industry receives harsh criticism from watchdogs, journalists, nonprofit organizations, and disgruntled patients. How the industry responds to such criticism could have a significant impact on growth and new product development.

Recently, two such journalists have taken aim at two specific devices: LivaNova’s implanted VNS system for treating epilepsy, and Abbott’s DBS system used in the BROADEN trial of DBS for treatment-resistant depression. In her book The Danger Within Us (Little, Brown and Company, 2017), medical journalist Jeanne Lenzer tells the story of a Texas firefighter implanted with a VNS system who experienced a life-threatening cardiac emergency in 2006. She uses the story as a basis to attack “America’s untested, unregulated medical device industry.”

In a recent interview on NPR’s FreshAir program, Lenzer claimed that neither Cyberonics nor the FDA adequately tracked the number of deaths that occur in VNS device recipients. She also claimed that FDA regulators are biased in favor of manufacturers and trial sponsors.

In another recent article on the website Mad in America, journalist Danielle Egan tells the stories of three participants in the BROADEN trial who had negative experiences with the DBS therapy. She also claimed that investigators and regulators had conflicts of interest and did not accurately report trial results.

This editor has posted a response to the Egan article on a social media website (medium.com/@neurotechwriter). But it would be in the industry’s interest for device vendors, investigators, and patients to offer their views. Some of the claims made by these two journalists are clearly off base and need to be refuted. Anyone who claims, for example, that the FDA is a rubber stamp for neurotech device vendors should have a chat with Frank Fischer of NeuroPace. Did all of the regulatory delays that kept the RNS system off the market for several years more make patients any safer?

Still, other issues raised by Lenzer and Egan may have merit and the industry would be wise to address them. For example, we applaud the NIH’s new rule that says their investigators must publish results even if a clinical trial fails to meet its endpoints [see article, p1]. Trial sponsors also need to do more to insure that the needs of clinical trial participants are being met, both during the trial and after its completion. And it does not seem unreasonable for the FDA to ask device vendors to keep track of the number of deaths in post-market surveillance. Neurotech critics may seem like an unneeded distraction to vendors in the short term, but they could help build a stronger industry in the end.

James Cavuoto
Editor and Publisher