Everyone involved in the medical device industry should watch The Bleeding Edge documentary on Netflix. As a human being, it is hard to sit through and there were moments, I had tears in my eyes. But for an active participant in the industry, it is imperative to watch the documentary to truly comprehend the great harm medical devices can wreak on the very people whose lives they are meant to enhance.
For those who haven’t viewed it yet, it tells the tale of defective medical devices that have hurt both women and men, but mainly women. Hurt is an understatement. For one particular patient, her continued health hassles that began with the implantation of the FDA-approved Essure permanent birth control device sold by Bayer ultimately led to her losing her job, her home, and being forced to leave her kids with foster parents from church.
The director of the documentary — Kirby Dick— draws a straight line between devastated patients, defective products and a complicit industry where a deeply broken regulatory regime leads to poorly-researched products landing on the market. Given the subject matter of The Bleeding Edge, it made sense to ask for comment from Scott Whitaker, CEO of AdvaMed during the routine press conference held last week at the Washington-based trade association’s annual MedTech Conference in Philadelphia.
Whitaker takes up the very first frames of the documentary and is portrayed as someone touting the innovative qualities of the products the industry makes while glossing over any risks. So at the press conference last week, journalists including myself asked Whitaker about the documentary and how the public perceives the industry.
Here’s his response (lightly edited)
I think the public perception of the industry is still very high based on everything we’ve seen. Unfortunately, The Bleeding Edge to me became more of an entertainment documentary than it did a fact-based documentary.
That is not to suggest in any way that the patients who have had some harm associated with products that have used should be in any way discounted. Each of those issues is serious.
But what the film didn’t do is talk about all the patients whose lives have been changed for the better and that’s millions and millions and millions of patients.
If you are going to tell one side of the story, you need to tell the other side of the story too. But that narrative doesn’t play as well when you are trying to, like Netflix, draw viewers to watch this.
Did I watch the husband recount how his penis got cut by a shard of his wife’s pelvic floor mesh product during intercourse and think, “Wow, now that’s entertaining?”
Uh no. How can Whitaker say he doesn’t discount the trauma endured by those patients and in the same breath breath dismiss the overall documentary as just entertainment? So I pushed back for clarification saying I didn’t see the movie as entertainment. To which he responded:
I guess it depends on how you view entertainment. Netflix is an entertainment thing and if a documentary is done to better educate the customer, the consumer or the population more broadly, they should tell a complete story. When you are not telling the complete story, you are driving to a specific outcome.
It leads one to believe that you are drawing people to view it as opposed to try to draw people to solve the problem. And I didn’t see that film as a way to solve any of the issues they believed existed. It only came across as a way to savage the industry in my opinion, which has done amazing things for the global population.
If there are ways to improve the FDA process I am happy to have that conversation. If we can make it better, we should.
First, I think journalists have the responsibility of presenting both sides of an issue and not necessarily documentary directors who are presenting a certain point of view. They are kind of like columnists.
Second, Whitaker charges that The Bleeding Edge is not fact-based because it doesn’t present stories of people whose lives have been saved or sustained because of amazing medical devices. He is correct but missing the point – the documentary presents facts about those people who have been hurt by bad products; it is factual in saying that most devices are approved by the less stringent 510(k) route and it truthfully presents the revolving doors between industry and regulators.
What it presents is an inconvenient truth about an industry that has long resisted accountability. That’s what makes the documentary compelling. That’s why it’s on Netflix. But by attacking the platform on which it released, Whitaker seems to be attempting to reduce the power of the documentary.
Now let’s get back to regulatory pathways that the movie depicts as deeply flawed — especially the 510(k) — and the reason why bad products end up on the market. That not just the documentary director’s opinion. Remember the Institute of Medicine’s report on 510(k) from years ago?
In 2011 – when Whitaker was well-ensconced at BIO International Convention, the biotech lobby group having left the Department of Health and Human Services several years earlier – the IOM released a scathing report on the 510(k). It basically recommended FDA eliminate the process altogether. The report declared that the 510(k) approval process “cannot be transformed into a premarket evaluation of safety and effectiveness as long as the standard for clearance is substantial equivalence to any previously cleared device.”
AdvaMed’s then CEO, Stephen Ubl, was swift in denouncing the report. Eliminating the 510(k) would upend the industry and FDA’s Jeffrey Shuren, who heads up the Center for Devices and Radiological Health, similarly argued that the agency should not jettison the 510(k).
So the 510(k) has survived but still taking some hits. But after a documentary like The Bleeding Edge, the natural question arose can it be improved?
I don’t have any solutions to offer but I did ask a startup CEO who I ran into at AdvaMed about how to improve the 510(k). Being a thoughtful guy, he talked about how it’s imperative to balance the innovation and reimbursement issues of the device industry while taking into account patient safety. Instead of getting a 510(k) on a product and allowing it on the market to anyone, perhaps there is a middle ground. Perhaps restrict use of a new device, cleared through a 510(k) or even a premarket approval to a few thousand people as the product gathers evidence about effectiveness while also ensuring the manufacturer gets paid. And as that evidence is collected and shows efficacy, increased the number of people it may reach next and improve the reimbursement rate too. This would perhaps catch bad products before it gets released to the unsuspecting masses, reducing risk to them while also allowing the vendor – especially those that developing premarket approval products – to garner revenue.
This sounds reasonable but somehow I don’t think the industry will bend to slowing down timelines to gather deep clinical evidence for new products with a predicate device. Value-based care, the tech industry, and consumerization of healthcare is giving the medical device industry a run for its money but historically the industry has reaped riches by tweaking products and slapping on a premium. And calling it innovation you must buy. In that context, the message that The Bleeding Edge aims to deliver — that new isn’t always better — is likely to fall on deaf ears.