Oct 24, 2018 · 8 minutes

Early in my career, I covered venture capital investments in biotech and medical devices for BusinessWeek.

We were a few years past the fervor enthusiasm of decoding the human genome, and it was starting to dawn on folks that the industry may never see the creation of another massive powerhouse like Amgen or Genentech again.

Why? Bringing a drug all the way to market was just so damn expensive, time consuming and risky with all that Federal regulation, yunno, making sure new drugs didn’t kill people. Instead, drug discovery companies were finding something novel, proving it in the early phases, and then licensing it to big pharma to test and bring to market. Silicon Valley’s biotech industry was basically becoming an outsourced R&D lab.

Around this time, I started to speak with more and more investors who were talking up investing in medical devices instead. Sure, medical device companies also weren’t turning into publicly traded companies by-and-large either. And it was long seen as the less potentially lucrative category of the healthcare investing world. But it was a solid way of getting “doubles” and “triples” in portfolio management speak, with one massive advantage: Way less of a “regulatory headache.”

This was also a time when investing in healthcare and tech was increasingly becoming de-coupled in Silicon Valley. In the aftermath of the dot com bubble, the view was that healthcare VCs simply were playing a different game than investors who could fund a company like Netscape and take it public in 18 months. Firms were breaking in two, with each sets of partners going their own way. Still, healthcare investors couldn’t help but have some tech-return envy.

It didn’t jar me at the time, hearing investors become positive giddy imagining a world where the government took a more “disruptive” “wait and see” attitude when it came to human lives, to the efficacy and safety of things millions of people would be advised by doctors to put inside their bodies. From an investor point of view, I got the logic.

It’s only now— after seeing so much of the dark side of “disruption”— that I see that, much like feminists, regulators aren’t there to be buzz kills or to ruin a VC’s day. They are there to keep people alive.

People like me— in a small, tiny way— have collaborated in enabling an terrifying crisis when it comes to medical devices in America, according to a blistering new documentary by Amy Ziering and Kirby Dick, “The Bleeding Edge.” I just saw the film last night at a screening sponsored by Netflix, and it has-- once again-- forever changed how I think about yet another corner of the Silicon Valley industrial complex. It’s also changed how I think about medical care for myself or my loved ones.

The film details — complete with interviews from past senior FDA executives and scientists— the many ways the regulatory process for medical devices simply fails Americans. How devices require far thinner and shorter clinical trials, if they require them at all. A loophole has allowed the vast majority of devices to get approved without trials, simply by proving it’s similar to an existing approved device. It doesn’t matter if that existing approved device has since been pulled from the market or has since been proven to be unsafe.

The film also details how trade-offs get made between science and marketing within large companies. (Spoiler: Marketing always wins.).

In one of the most chilling segments, the film even shows how women in a clinical trial for Essure had their answers on their survey forms secretly changed after the fact. Women who reported experiencing intense pain were later shocked to discover their responses had been crossed out and replaced with the lie that they were, in fact, very satisfied with their treatment.

But the most chilling parts of the film were the dozens of stories — of faces— of people whose lives had been ruined by getting talked into either unnecessary, elective procedures, or “improved” versions of procedures that had worked just fine since the 1970s. It’s horrific to watch a loved one suffer under the treatment of a disease like cancer. But you can’t make sense of someone’s life and family being ruined because she opted for a new way to, say, essentially have her tubes tied or have a hysterectomy or get a new kind of hip replacement. A way that was ultimately untested or known to have risks. But it was so novel, the industry could charge way more for it.

Ziering and Dick have won or been nominated for multiple awards because they are so good at telling almost-unwatchable stories of unnecessary suffering without giving the viewer anywhere to go to delude themselves that, well, maybe, things aren’t so bad. They don’t overreach. They start their film by laying out how many medical devices are great life saving technologies. They include interviews by FDA scientists who were just as concerned about some of these issues— and were later retaliated against. They say that most people investing in this stuff, building it, and even selling it got into this business to save lives. They don’t paint them as monsters so much as people following a set of incentives in a system that is set up for disaster.

To underline the importance of their work, Ziering told a story in the Q&A after the film about a senior doctor for a major hospital chain who was an early screening for it in LA. He ran into her later on in line at Whole Foods and told her that he’d seen her film and it had changed how he practices medicine. She asked how. He told her he’d been sent a new device that the rep told him could be used in everyone from infants to adults. He wrote back and asked for the trials. They sent him trials that studied the devices in twelve-year-olds to adults. He wrote back and asked for the research on babies. They said they didn’t have any. He told Ziering that before seeing her film, he wouldn’t have pressed them on it. He would have taken their word for it. Thinking of the helplessness of a tiny infant and the confusion that a new mother may feel when it comes to helping her child, that anecdote has haunted me for a good 12 hours now.

You cannot deny the stories of the victims in this film. How unnecessary procedures destroyed their lives and families in some cases. Although, several people in the film actually try. No woman can watch this film and not feel pangs of familiarity at a scene where a male gynecologist is telling one of the victims of Essure that she and the tens of thousands of women in her group simply didn’t experience the things they are saying they experienced. They’re just wrong. They didn’t feel all that pain, experience all that bleeding, go through all of those subsequent surgeries. It reminded me of Uber’s Travis Kalanick telling Gawker early on that alleged sexual assaults simply didn’t occur in his cars.

That’s the thing that the filmmakers didn’t intend, according to Ziering: This film also became a devastating commentary on the state of women’s health. Untested medical devices certainly hurt men and women. But because women’s pain is taken less seriously in American medicine, they wind up suffering more.

It’s not a gloom and doom piece of filmmaking that gives you nowhere to go, nowhere to hope. I left with illusions shattered about the role the FDA plays in protecting us, and just how much doctors even know about what’s being marketing to them. For the first time I saw how similar the culture behind “move fast and break things” tech investing and healthcare investing are. Before this film, I thought the reason that so many venture firms had split their healthcare and tech investing into two practices was because they were so different in the way they approached investing, risk, and reward. I guess that was naive. It’s amazing that after 20 years, I still find ways I’ve given Silicon Valley too much of the benefit of the doubt.

And lest you think this is just a jaded journalist being a jaded journalist, note how many Silicon Valley execs are increasingly calling for more regulation of their own industry. Tim Cook being the latest to add his name to the list. 

I also left this screening with a sense of agency. I know how to make better medical decisions now. This film may save the life of a loved one of mine, or of yours.

This is a film that has already had tremendous impact. After it was screened, Essure’s manufacturers finally announced plans to withdraw it from the US market. It has already been removed from the European market, where regulations are stricter. In order to make a bigger difference, more people need to watch this film.

Put “The Bleeding Edge” on your Netflix Queue right now and tell everyone you know to do the same. Show it to elderly loved ones who may be weighing different hip and joint replacements. Show it to young women in your family. Show it to everyone you love. Please help send a signal to Netflix that investing in content like this is every bit as important as the “Queer Eye” reboot.

Because in America right now, we can’t rely on the FDA to keep us safe or companies to self-report when things go wrong. The take away for Ziering after the brutal two year journey of making this film: It’s buyer beware.