Diana Zuckerman, PhD, President of the National Center for Health Research.
The Bleeding Edge documentary
When I am a guest lecturer on the FDA approval process to audiences of students, doctors, patients, and consumers, they are always shocked to hear that FDA rarely requires clinical trials on medical devices to prove they are safe or effective. The Bleeding Edge provides very compelling examples of how FDA’s unbelievably low standards for devices can have devastating consequences for patients. It will be an important wake-up call for physicians, patients, and hopefully for Congress, as they respond to the concerns of their constituents. The message of this film isn’t about specific products – the message is that none of us can feel confident about our medical care until the FDA requires evidence of safety and effectiveness for all medical devices.
As a scientist, I am very glad that the film is aimed at a broad audience, because everyone should care about the safety of medical products. Of course, a film for a general audience will inevitably simplify some complicated issues. One issue of concern to me is the part of the film where I say that there is a revolving door between the FDA and the industries it regulates. I am very concerned about that, but want to make it clear that I was not talking about previous FDA Commissioners. I was referring to the officials who have headed up the Center for Devices (CDRH), many of whom went to work for industry after leaving the FDA. And, unfortunately, there is also a revolving door for other high level FDA officials as well as some FDA scientists. While several former FDA Commissioners have close ties to industry, many do not.
That revolving door is only one of the reasons why the standards of safety and effectiveness for FDA approval for devices is almost non-existent – and so much lower than the standards for prescription drugs.
Here’s the trailer.
For more information, see The Human Tragedy of Poorly Regulated Medical Devices Gets the Spotlight in a Netflix Film, by Amy Martyn, ConsumerAffairs.com, July 27, 2018. NCHR president speaks out about medical devices, spurring this documentary on Netflix.