Your Life, Their Hands: Interview with Activist Documentarians Kirby Dick and Amy Ziering on ‘The Bleeding Edge’

The Bleeding Edge is frightening. The documentary looks at the $400 billion medical device industry, exposing the FDA process that sends products to market and into patients’ bodies, without adequate clinical testing or regulation. Director Kirby Dick and producer Amy Ziering make their case with stories of device failures and human resilience, corporate greed and patient activism. Like their previous documentaries, The Invisible War (2012) and The Hunting Ground (2015), The Bleeding Edge offers interviews and research findings, as well as slick examples of how the industry promotes its merchandise to doctors as well as patients.

PopMatters met with Dick and Ziering to discuss activist filmmaking, personal storytelling, and devastating medical devices.

I imagine that when you screen the film, many viewers share their similar experiences with you. I notice at the end of the film, one item on the list of what “we can do” is to be an advocate for patients in hospital.

Amy Ziering: Yes, and we urge everyone to be informed. The system is completely broken, completely devolved into this business that has nothing to do with health.

The film is structured to underline this point, that the system is first and foremost a business, from the open on Scott Whitaker’s Steve-Jobs-like presentation to the medical device ads that serve as a kind of punctuation throughout the film.

Kirby Dick: The film opens as you hear the CEO of AdvaMed, the trade organization for a powerful medical device industry, talking about all the wonderful things about medical devices, how they’ve changed our lives and how they’ll do that even more in the future. He’s smooth and persuasive and you’re sucked in by his appeal.

Three quarters of the way through the film, you come back to that same scene and now you realize he was selling you a bill of goods. You might have bought it at the beginning, but now you’ve seen the film and you realize there’s actually a great deal of danger in medical devices. They’re so poorly regulated: the “innovation” of medical devices is wonderful in theory but they’re not tested, so we don’t know if they’re safe or unsafe. One of the messages of the film is, when you hear the word “innovative”, stop. Everyone’s inclination is “New is better.” No. New may be better but it may be much worse, and you’d better find out which it is before you take another step.

Ziering: And the punctuating, as you said, with the different ads, is to remind you repeatedly, “This is a business,” a marketing gig. Let’s see what the real information is and then let’s see what the sell job is.

Even the archival footage warning, where Dr. Gillespie [Raymond Massey from the 1960s TV series Dr. Kildare] instructing viewers to “investigate before you invest in health services or products.” We’re reminded by this trusted TV doctor from way back when.

Dick: Right. It hasn’t changed.

Part of the sell job has to do with appealing or obfuscating language, from happy acronyms like AdvaMed to company names like “Intuitive Surgical“.

Dick: Intuitive Surgical, which makes the da Vinci robot, has run one of the most aggressive marketing campaigns for medical devices that we’re ever seen, and it’s been very successful for them. It’s a billions-of-dollars company now, they have the only robot like that out there. But because they rushed to get that out into hospitals, they left a wake of people harmed, because doctors weren’t adequately trained. Nobody knows the numbers but tens of thousands of people, probably hundreds of thousands of people, were harmed.

Ziering: Also, in the rush to get the robot out there, parts were malfunctioning, and hospitals weren’t aware that they’d be on the hook to pay not only a huge tab for the product itself, but also replacement products. Hospitals didn’t understand that when they bought the robots, and so they had huge bills, and had to book surgeries to pay those bills, even if the operators were trained. And patients don’t know.

Dick: Intuitive Surgical is an interesting example because the product almost sells itself: you say, “Let’s operate with a robot,” and everyone says, “This sounds fantastic.” The reality is just the opposite, in most cases. It’s following a path like the one where opioids entered the market. The product creates so much profit from people’s pain. Intuitive Surgical have a remarkable machine, but it’s still extremely dangerous, and they were not responsible in the way they put it out there.

Ziering: I like that analogy because the new opioids aren’t necessarily better, they’re more addictive. We didn’t need them. They’re not doing much except causing more damage in the long run, especially in the ways they’re being promoted everywhere, without rigorous testing. The analogy is that this device isn’t necessarily better, but it does cause more harm [than human surgeons]. So, we’re hoping that, since the opioids crisis is getting attention, that the medical devices can also get some attention, and perhaps stave off disaster.

The other thing that’s important is there’s a cost to outsourcing your surgeries to a machine that aren’t really thought out. So, all of a sudden, you’ll have people trained on machines who don’t know how to do it manually anymore. There are a million reasons you’d need to know this: the power could fail on the device, something could be shorting on the system itself, a disaster could happen in surgery. And what happens in ten years when these operators are trained on robots and don’t have 300 hours of physical surgical experience? And what if you’re in Doctors Without Borders or in some other triage situation? We’re in a terrorist era now: What happens in emergencies when you don’t have experience in a surgery room and someone’s just lost a limb on the street?

The other analogy has to do with screens and experience: how do screen create distance and emotional states?

Ziering: Right. And what about trust? After making this film, I don’t want the newest device: I want the one that’s been in someone’s body for 30 years and hasn’t had a problem. Newer isn’t necessarily better: there aren’t 4,000 ways to do a hip implant. These new devices are on the market just to sell a product: it’s not about the patient.

As your film points out, the FDA approval system is predicated on the product not being too “new”. Products are approved without testing when they’re similar to previous products.

Dick: When they go to the FDA they say, “This product is almost identical to a previously approved device, so we don’t have to test it.” Then when they market it, they say, “This is a radically new invention, so completely different that it will change your life.” They can’t have it both ways.

Ziering: And if it’s so similar, we don’t really need it. Not only that, but it can be similar to a former product, and be approved even if that former product has recalled. How crazy is that? It’s like Groundhog Day.

Bleeding Edge shows effects of this process on patients and their families. This flies in the face of the calculus made by the companies, where people are percentages: you can lose a certain percentage and still claim success. I was struck by the interview of a doctor conducted by the demonstrators outside the American College of Obstetricians and Gynecologists (ACOG) convention. The doctor says that some patients just fall into a category of “complications”. How can that argument hold up?

Dick: There are a number of factors. One, doctors may be quoting statistics they think are accurate, but a lot of the research is funded by industry and it’s biased. Second, doctors are told the devices go through the FDA process and they think it’s safe. We think doctors are victims of this process too. How devices are regulated is rarely taught in medical school, so even the doctors who are implanting devices don’t know the devices are required to be tested on humans. So, this film is for doctors, too, and they react. Some of them know this is going on, but they’re fearful to speak out.

Ziering: And they’re getting disinformation. The companies themselves do the studies, and they’re not motivated to report bad outcomes. And often, patients that are harmed don’t go back to that same doctor, so they might not know about the bad outcome. Reporting is voluntary, so there is underreporting: [as Rita Redberg, editor of JAMA Internal Medicine], says in our film, it’s estimated that only three-four percent of all adverse events are reported to the FDA.

That’s not unlike the pattern of underreporting of colleges regarding rape, which your film, The Hunting Ground, showed.

Ziering: Right. And apart from the institutional constraints, patients might not know that a problem they have is related to your device. So, when your doctor says it’s perfectly safe, he’s not hearing from all the rheumatologists who are dealing with autoimmune diseases based on the devices that have been implanted in someone’s uterus: it’s not intuitive that your hands are swelling because of an implanted device.

That’s why groups, like the one formed by Angie Firmalino [“Essure Problems” on Facebook] is so heartening: patients share stories and come together to take action. They remind me of the girls [Andrea Pino and Annie Clark] in The Hunting Ground, who decide they need to take control, because no one else is.

Dick: Right, and social media is key. Many of the patients are so ill that they can’t really get together in person, but on social media, they became quite a force, for instance, Angie’s group has more than 36,000 members. They were able to fight the FDA and Bayer in a way I haven’t seen in many years. We wanted to film it because it’s an exciting tory, but we also wanted to film it because it’s a model for patients’ safety movements. There’s a huge constituency out there, and millions of people who’ve been harmed by medical devices. If they get together, and become a movement, they can pressure Congress to change these laws and protect people.

Ziering: This work, coupled with the work of journalists who can amplify their story, can help move the needle. Everyone needs to work together; we all need to be vigilant and protect whistleblowers.

It struck me too that Trump [who appears in the film briefly, promising increased deregulations] is symptomatic and not causative.

Ziering: Yes. We’re a corporatocracy.

Is this necessarily a federal legislative problem, or can effects be achieved working state by state?

Dick: Because it’s the FDA, it is federal. State attorneys general can look at individual products and go after the companies, but [change] has to happen at a national level and it has to be directed at the corporations. That’s what Angie’s group did: they went after Bayer again and again and again.

And the timing of Bayer removing Essure from is not coincidental. [Bayer halted sales of Essure on July 20, just before the film’s release, but has also called the film “inaccurate”].

KD: Of course. Bayer did not want to a film showing the issues surrounding Essure and the women fighting Bayer to be out while they’re promoting the product.

Ziering: The activists have been working for years. A couple of days before the film will screen globally on Netflix, after critical acclaim, after news stories, do you think it’s an accident that Bayer does something? They’re saying it’s due to poor sales.

Netflix is an optimum platform for this sort of activism, despite, for instance, Steven Spielberg’s assertion that films released on Netflix don’t “deserve” Oscars.

Ziering: Thank god for Netflix. We’re grateful for corporations that will speak truth to power.

Dick: It’s perfect for this film. People are going to see it and call their relatives. They and other people are going to band together and start a movement. I don’t agree with Steven Spielberg. There isn’t one perfect way to distribute a movie, and there’s a certain reactionary nostalgia in insisting that a film be seen one way.

We’re past the point of going back, and multiple platforms can do so much good.

Dick: Look at the good they’ve already done. It’s not a lesser form.

In its structure, The Bleeding Edge follows a format you’ve used before, making the argument with evidence and personal interviews.

Dick: That’s because of Amy. She’s an amazing interviewer, she develops this connection and empathy with subjects, so they feel they’re able to share in a safe space. They seem to go deeper than interviews in other documentaries. Subjects often say things they’ve never said before, even though they’ve been thinking about these things for years.

Toward the end of the documentary, one patient’s husband turns to her husband, who’s talking about how he felt “insulated” from her horror because he was going to work each day, and she says she’s never heard him say that before. It’s moving for this couple, and also for [fellow pelvic mesh implant survivor] Tammy [Jackson and her husband Byron].

Dick: Yes. The film is structured like The Hunting Ground, as it follows a group of activists. And here we didn’t want to focus on one device or one company. We want people to leave feeling informed, but also empowered to find out more and to act.

Ziering: And I want to give a shout-out to Kirby and Amy Herdy, whose research is unbelievable. Kirby becomes the expert on an issue whenever we undertake it. These are sobering truths and nobody is telling them. I also want to say, what other guy is out there championing women’s rights the way he is? For #MeToo? Okay, maybe Judd Apatow. It’s crazy, right?

I understand you did a lot of research for this film.

Ziering: Right. We don’t base a film on one book. We don’t do biopics or hagiographies, or an event that’s past. It’s breaking news. It’s putting together the arguments, synthesizing information. The Pentagon started using our statistics after The Invisible War came out.

The Hunting Ground became a teaching tool on so many campuses. [Footnote: Jameis Winston is who we thought he was.]

Ziering: And footnote: #MeToo. We were talking about sexual assault before it was trending. No one would give us a penny to do a movie on it. Our talking point on The Hunting Ground in 2015 was, “Believe survivors.” We had to make sure we said that at every interview because it wasn’t a given. Our work, along with the work of many people, supported the explosion of attention to #MeToo.

Yes, in all three films, allies are crucial to the work for change, not only the survivors themselves.

Dick: I want to note especially Dr. Stephen Tower [the orthopedic surgeon who researched his own adverse reaction to a cobalt hip replacement] and continues his work today for patients with hip replacements, showcased in the film.

There has not been enough reporting yet on cobalt on plastic replacements. I’m sure it’s happened but I can’t think of another example where a story of this magnitude has been broken in a documentary, before it’s been covered in the press. This could become one of the major stories of the decade.

Dr. Tower’s work is a testament to a good doctor, who is concerned about his patients. He keeps listening to his patients and puts two and two together. Whereas too often doctors do the implants on hundreds of patients a year, never see those patents again If you don’t have a system where things are tested in advance, once the devices are implanted, they’re not followed closely.