Sean Fenske, Editor-in-Chief09.07.18
Recently, I watched the controversial medical device industry documentary, “The Bleeding Edge,” featured on Netflix. For those who have not had the opportunity to view it, I would certainly encourage you to do so. I would also encourage you to listen to the Mike on Medtech podcasts where we discuss a number of issues brought up in the film. (Find them here: http://bit.ly/mpopodcasts).
Let me start with my disclaimer: My intention is not to come across as uncaring or cold-hearted to the suffering of the many patients featured in the documentary. The medical industry has utterly and obviously failed them and that is truly a catastrophe. For many, no lawsuit will preserve what they’ve lost or make up for the suffering they’ve endured. No patient should lose trust in the healthcare system, their doctors, or the companies developing technologies that are supposed to help them. That clearly happened and, without question, is a tragedy.
This disclaimer, however, is made necessary due to just how much we are shown those patients and hear their stories in the documentary. We are overwhelmingly provided with anecdotal evidence of failed products, whether the Essure device from Bayer, metal-on-metal hip implants from DePuy, or vaginal mesh from J&J, and hear of the suffering these patients endured. Unfortunately, this is done too much for emotional impact and is not sufficiently complemented by hard facts. Sure, some actual data is presented, and in the case of the Essure device, the patient testimonials are overwhelming in number, but the data is sprinkled between the many patient stories.
Another issue I have with the documentary is that it spends so much time sharing the patient stories for a limited number of truly problematic devices, it doesn’t thoroughly explore some of the other issues it mentions almost in passing. It highlights problems with the FDA’s 510(k) process in regard to how predicate devices are used for clearances of new technologies. It states that even if a predicate device is later recalled, it can still be used for the 510(k) process. If this is entirely accurate in how it’s presented, I agree that it’s a problem and should be reviewed.
Also, when you consider the chain of potential technologies that are cleared based on predicate devices, you could conceivably have a very long line of incremental advancements that results in the “first” device not at all resembling the most recent product that’s been cleared. Again, I’m not completely against the idea that this does seem somewhat flawed when one examines the big picture.
Another item presented (almost as a throwaway line at the very beginning of the film) was the statement that for as much power as we believe the pharma industry has, the medical device industry has even more. Later, the documentary describes the medtech industry’s nefarious work behind the scenes, using lobbyists to dupe members of Congress into passing supporting legislation that protects the industry. Frankly, this aspect somewhat confused me. It honestly came across as though the documentary was “crediting” the medtech industry with “inventing” lobbying and this tactic was somehow unique in government to this example. Further, they mention the billions of dollars the medtech industry spends on lobbyists; an industry they cited earlier as bringing in approximately $400 billion in sales each year. Well, if lobbying is the power the medical device industry wields and it has more power than the pharma industry, is the documentary actually stating the pharma industry spends less on lobbying than medical device? When the top 10 or so companies in pharma account for the sales figure of the ENTIRE medtech industry, how is it that medtech is so much more powerful? That question isn’t raised or resolved in “The Bleeding Edge.”
One of the most damning pieces of evidence presented was with regard to a situation involving the FDA monitoring the computers of certain agency reviewers who raised concerns over the safety of certain medical devices. Nine physician inspectors were fired and a congressional committee found this was done in retaliation for whistleblowing. While a case brought against the FDA by several inspectors was ultimately dismissed by the court, the charge of spying was verified and resulted in a change of procedures at HHS. Again, this portion was moved through quickly in the film and not, in my opinion, given the appropriate attention it deserved.
This is just a small portion of what’s covered in the documentary that I found to be worth discussion. There’s much more, which again is why I encourage you listen to the Mike on Medtech podcast mentioned earlier. Then reach out and share your own thoughts with me on my comments or the documentary itself.
Let me start with my disclaimer: My intention is not to come across as uncaring or cold-hearted to the suffering of the many patients featured in the documentary. The medical industry has utterly and obviously failed them and that is truly a catastrophe. For many, no lawsuit will preserve what they’ve lost or make up for the suffering they’ve endured. No patient should lose trust in the healthcare system, their doctors, or the companies developing technologies that are supposed to help them. That clearly happened and, without question, is a tragedy.
This disclaimer, however, is made necessary due to just how much we are shown those patients and hear their stories in the documentary. We are overwhelmingly provided with anecdotal evidence of failed products, whether the Essure device from Bayer, metal-on-metal hip implants from DePuy, or vaginal mesh from J&J, and hear of the suffering these patients endured. Unfortunately, this is done too much for emotional impact and is not sufficiently complemented by hard facts. Sure, some actual data is presented, and in the case of the Essure device, the patient testimonials are overwhelming in number, but the data is sprinkled between the many patient stories.
Another issue I have with the documentary is that it spends so much time sharing the patient stories for a limited number of truly problematic devices, it doesn’t thoroughly explore some of the other issues it mentions almost in passing. It highlights problems with the FDA’s 510(k) process in regard to how predicate devices are used for clearances of new technologies. It states that even if a predicate device is later recalled, it can still be used for the 510(k) process. If this is entirely accurate in how it’s presented, I agree that it’s a problem and should be reviewed.
Also, when you consider the chain of potential technologies that are cleared based on predicate devices, you could conceivably have a very long line of incremental advancements that results in the “first” device not at all resembling the most recent product that’s been cleared. Again, I’m not completely against the idea that this does seem somewhat flawed when one examines the big picture.
Another item presented (almost as a throwaway line at the very beginning of the film) was the statement that for as much power as we believe the pharma industry has, the medical device industry has even more. Later, the documentary describes the medtech industry’s nefarious work behind the scenes, using lobbyists to dupe members of Congress into passing supporting legislation that protects the industry. Frankly, this aspect somewhat confused me. It honestly came across as though the documentary was “crediting” the medtech industry with “inventing” lobbying and this tactic was somehow unique in government to this example. Further, they mention the billions of dollars the medtech industry spends on lobbyists; an industry they cited earlier as bringing in approximately $400 billion in sales each year. Well, if lobbying is the power the medical device industry wields and it has more power than the pharma industry, is the documentary actually stating the pharma industry spends less on lobbying than medical device? When the top 10 or so companies in pharma account for the sales figure of the ENTIRE medtech industry, how is it that medtech is so much more powerful? That question isn’t raised or resolved in “The Bleeding Edge.”
One of the most damning pieces of evidence presented was with regard to a situation involving the FDA monitoring the computers of certain agency reviewers who raised concerns over the safety of certain medical devices. Nine physician inspectors were fired and a congressional committee found this was done in retaliation for whistleblowing. While a case brought against the FDA by several inspectors was ultimately dismissed by the court, the charge of spying was verified and resulted in a change of procedures at HHS. Again, this portion was moved through quickly in the film and not, in my opinion, given the appropriate attention it deserved.
This is just a small portion of what’s covered in the documentary that I found to be worth discussion. There’s much more, which again is why I encourage you listen to the Mike on Medtech podcast mentioned earlier. Then reach out and share your own thoughts with me on my comments or the documentary itself.
