JULY 27, 2018
IT WAS THE mid-1970s, and medicine’s so-called golden age was beginning to lose its luster. The pharmaceutical industry was booming, a sure sign to some that the medical profession had sold its soul — if it ever had one to begin with — to big business. Indeed, that was what Ivan Illich, a Catholic priest and philosopher, charged in a damning, if arcane, attack on what he called the “iatrogenic” culture of medicine: its healers’ tendency to bring forth harm.
Illich did not believe physicians were intentionally trying to hurt their patients. Rather, he blamed the system in which they practiced, one that was oriented toward a dispassionate embrace of science at the expense of humility and humanity. As a spiritual thinker, Illich held a deeper concern that doctors had become cogs in an institutional machine that robbed them of the ability to adequately address human suffering. In 1975, Illich’s takedown of the profession, Medical Nemesis, became a nonfiction best seller.
Illich had an unlikely ally in Hollywood, where a young, Harvard-trained MD named Michael Crichton was broadcasting calls for medical reform through fiction. Crichton had already achieved commercial success with the novel The Andromeda Strain (made into a film by Robert Wise), and, in 1973, he wrote and directed a movie that used his insider knowledge of the medical present to project a dire posthuman future. The movie was called Westworld. In an interview in Playboy, Crichton explained that medicine’s obsession with the scientific cutting edge had cast the “the physician as technician and the patient as a biological machine that was broken.”
In 2018, the priest and the pulp fiction writer both seem like prophets. One of the most talked about shows of this year has been HBO’s Westworld, a reboot of Crichton’s 1973 film. This has also been the year when Silicon Valley’s heroic self-narrative began to crumble under the weighty evidence of its dystopic potential, allowing Westworld to emerge as shorthand for anxieties about human’s relationships to their machines. The Bleeding Edge is a timely and harrowing new documentary for Netflix that exposes, much like a Crichton tale, medical innovation gone out of control. The film’s aesthetic self-consciously echoes Westworld’s intro, featuring seductive imagery of medical technology against a spooky soundtrack. And the analogy works. While medical devices are less sexy than scantily clad androids, they both become possible in a world where innovation is its own justification and regulation more often protects those who make technology than those whose bodies it alters. And like Westworld, The Bleeding Edge is a contemporary portrait of how a misguided quest for innovation is eroding the forms of connection that make us human.
Under the regulatory apparatus of the Food and Drug Administration (FDA), the category of medical device includes everything from tongue depressors and heating pads to imaging technologies and implantable technologies ranging from stents to pacemakers. It is this last category, devices that become an enduring part of the patients in whom they are implanted, that claim the spotlight in The Bleeding Edge. Are such medical devices a “means to an end of unleashing innovation to improve and save lives,” as one industry lobbyist featured in the film insists to a room full of business people and politicians? Or are they the latest instruments of the iatrogenic culture of medicine? By 2050, the techno-optimists of this room are told, their organs will be custom-regenerated and their doctors will be computers. It’s a futurist fantasy that’s at least a century old but has yet to become obsolete. A reporter covering the medical industry goes so far as to suggest that the production and use of medical devices are not only “a way of life for post-industrial society — they are a reason for the existence of post-industrial society.”
The Bleeding Edge, by veteran filmmaking team Kirby Dick and Amy Ziering, shows the violent side of this industrial Wild West, one that has wrought tremendous suffering for those whose bodies have become crucibles of innovation. The medical device industry, which is both more powerful and far less regulated than its pharmaceutical companion, is also perhaps more deeply cannibalistic, turning patients into expendable consumers without any incentive or regulatory burden to account for its costs. The emotional and evidentiary core of the film is a disparate group of Americans who might best be described as survivors of medical innovation. In several cases, the medical devices in question are connected to elective procedures that lead to a cascade of new medical problems — ones that shrewd device manufacturers will likely seize as emerging markets.
When the body becomes a site of industry, it also becomes a window into some of the most intimate consequences of governance in our late industrial age. Though the FDA was created in 1907, it wasn’t until 1976 that laws were put in place to regulate medical devices. With the exception of a few relatively minor amendments (the most significant being the 1990 Safe Medical Device Act, which authorizes FDA to recall devices after they are on the market) those are the laws we still have. And those laws do not even require that devices be safe or effective in order to be approved. David Kessler, a former FDA commissioner, is blunt in his diagnosis: “The system doesn’t work.” It never did, and as devices have become more complex and more intimate — over the past 10 years, nearly 70 million Americans have been implanted with devices — the regulatory system that many imagine protects them is an agent of injury.
The relationship between profit and protection is an essential tension facing regulators in the United States, who see the flourishing of industry as necessary for maintenance of capitalism. Yet, the FDA is a system that one interviewee describes as a “revolving door,” in which agency leadership is populated by people who work in industry (and often after leaving, such figures go on to help provide guidance to medical device companies in navigating the system). This insight collapses the distinction between public and private interests — one that has been used to imagine a form of knowledge-making that is purified of the market.
If I had not myself studied the history of medical device regulation, I might have a hard time accepting the veracity of this state of affairs. And while I cannot vouch for the individual cases featured in The Bleeding Edge — which range from poisonous hip replacements to slinky-like implants to prevent pregnancy — the filmmakers have unquestionably homed in on a scandal that predates Trump and will likely post-date him, if we can survive the present, let alone bask in the future of 2050 that has so captivated device manufacturers.
Not that Trump is off the hook. Kirby and Ziering show the “revolving door” in action as Scott Gottlieb, a major industry insider, is installed as FDA commissioner — a turn of events that is celebrated by the lobbyists interviewed. By this point in the film, it becomes easier to imagine a future of robotic doctors than an overhaul of the regulatory system in an administration that seems set against social goods.
We become acquainted with the da Vinci surgical robot (hailed by newscasters as Dr. Robot) and the shocking circumstances of its approval and marketing. This “device” is a big-ticket item that allows surgeons to conduct precision operations by manipulating its mechanical arms like an arcade game. It was developed to overcome certain technical limitations of laparoscopic surgery, which reduced complications associated with traditional “open” surgery. However, da Vinci has not demonstrated similar improvements and often loses money for hospitals. In fact, its greatest value has been as a marketing tool, leading consumers to confuse elaborate technology with better care, driving demand for a machine that may not serve them well. Da Vinci didn’t pass through the most stringent review process, but an FDA regulator intervened to ensure that it could go through the less stringent 510(k) pathway, which allows devices to be approved on no other basis than “substantial similarity” to previously approved devices — even if those devices have since been taken off the market. This “approval by daisy chain” as one expert dubs it, is less a regulatory procedure than, as Kessler explains, “an exception that became the rule.” Or, from the perspective of industry, a loophole.
Throughout the film, we hear politicians, including Trump, argue that innovation is central to job creation. Yet injuries caused by unproven devices are making some unable to work. Many of the survivors profiled have had their work lives negatively affected, and, as will come as no surprise, those who are most socioeconomically precarious before their encounter with a faulty device are least equipped to heal.
Take Ana Fuentes, an administrative assistant who experiences debilitating pain after being implanted with a device intended to induce sterilization. She tells us that her doctors dismissed her accounts of pain, claiming that Latina women are more sensitive. (Recent studies have shown that physicians are significantly more likely to underestimate the pain of people of color, of women, and especially of women of color.) Her husband leaves her because she cannot have sex without severe pain. Indeed, she is in pain even when not having sex and soon loses her job. We last see her having made the wrenching decision to put her four young daughters into foster-care run by her church.
Yet, even an affluent, white, established male physician can find himself cast as an unreliable narrator of his own suffering. We also meet Stephen Tower, an athletic orthopedic surgeon who becomes a patient in need of a hip replacement. Seduced by the promise of a new breed of metal hip, he soon begins having memory problems culminating in a full psychotic break at a medical conference. Blood tests reveal high levels of cobalt in his blood which he has the wherewithal to remember as the innovative component of his bionic joint. When surgeons open him up, they find the device decayed, evidence that poisonous cobalt has leaked into his system. As he makes a full recovery, he is chilled by the realization that his own patients, for whom he had recommended and even implanted this same cobalt hip, are similarly afflicted. Some have even been wrongly diagnosed with Parkinson’s or dementia as a result of their symptoms. Tower’s efforts to undo the harm caused by his cure transform him into a reluctant activist, unable to appreciate why his scientific evidence is unpersuasive to those regulators he believes should be collecting it themselves.
This raises the deeper question of the meaning of scientific objectivity when the evidence is pain — especially, as the filmmakers go out of their way to demonstrate, the pain of women. One of the central arcs of the film follows the grassroots activism of women harmed by a device called Essure, the slinky-like metal coil they had permanently implanted in their fallopian tubes to prevent pregnancy and the same one Fuentes received. They share a symptomology that includes debilitating chronic physical pain, which also results in emotional trauma. Many are unable enjoy sexual intimacy with their male partners. Injury, it becomes clear, is not only physical or relegated to the individual user. It is relational. It is a social problem with profoundly intimate consequences, but it is also an intimate problem with social potential.
In a memorable scene, a delegation of women representing more than 10,000 reported cases of Essure-induced injury meet with a series of female Congresswomen. Louise Slaughter (D-New York), who passed at the age of 88 earlier this year, sympathetically observes, “Women seem to be expendable.” Rosa DeLauro (D-Connecticut), who happens to be my representative, ironically suggests that they are invincible. “Welcome to the NFL. You can’t get tired [if you’re female],” she declares. But what if you’re playing while injured (which we know many NFL players are)?
When the Essure activists do get an audience with FDA Commissioner Gottlieb, it feels like a small miracle of justice. And they do achieve a modicum of success: the FDA will require doctors to state the risks of Essure to future potential users. However, lax regulation in the United States has allowed the device industry to become a major player on the international scene. And there’s another cruel irony at play. The activism of American Essure users leads to the creation of Facebook groups across Europe where women find solace in shoe leather epidemiology, the hard-won knowledge that they are not alone. They are not crazy. After European regulators demand better evidence, Bayer, the company who makes Essure, chooses to pull out of the European market while also issuing a statement undermining the activists efforts to get news media to cover their story, claiming that reporting on the scandal is “inaccurate and biased.” The device remained on the American market until this week, when Bayer announced it will discontinue sales of Essure. But not because the device is dangerous — which the company continues to deny. Rather than accepting the testimony of tens of thousands of women, the company has continued to blame them for the decline of what they continue to insist is a safe and effective device. The idea that someone who has had their reproductive system painfully destroyed is “biased” is tautological at best, a form of medically and legally sanctioned rape.
Yet it’s not a simple choice between innovation or Luddism. It’s not even about doing a better job of maintaining and making do with the technologies we have that work, though that is important too. Until those in power are made to accept ordinary people’s expressions of pain as legitimate forms of knowledge about the world, the logics of innovation will remain but rhetorical designs that sanction injury of those seeking care. In the meantime, it will be other forms of human ingenuity — philosophy, fiction, film — that give inspiration to create less violent futures.