Three hundred and fifty years ago, while pioneering the use of microscopes, the British scientist Robert Hooke foresaw that science would eventually create artificial organs and implantable devices to enhance sight, hearing and memory. He wrote “By the addition of such artificial Instruments and methods, there may be, in some manner, a reparation made for the mischiefs, and imperfection, mankind has drawn upon itself.”
In fact, the dream of improving on the fallible human body through technology was central to the scientific Enlightenment vision. Many 18th century philosophes, from Diderot and Condorcet to Ben Franklin and Joseph Priestley, looked forward to drugs and devices providing greater health, life and ability.
In the same period there were romantics, like the author of Frankenstein, Mary Shelley, with serious reservations about the direction that biotechnologies might lead. Bioconservative resistance to biotechnology’s hubris stems in part from a revulsion at anything that blurs the line between human beings and machines. Such violations of the natural order will, they are certain, lead to dire unintended consequences. Technologies are also seen as tools for the nefarious schemes of the powerful and wealthy – scientists, the military, corporations, elites.
The argument between these two streams of thought – Enlightenment enthusiasm for and romantic hostility to the technologically enhanced body – have been woven through the history of biotechnology, and shapes the way we regulate medical devices. At the Institute for Ethics and Emerging Technologies (IEET) we call this the biopolitical debate, and we see it played out every day in the media and public policy.
So far the public has been less anxious about medical devices than they have been about reproductive technologies, genetics and psychopharmacology. This is quickly changing however, as the radical potential of implantable devices, artificial organs, prosthetics, brain-computer interfaces and nanomedicine inspires some and dismays others.
We see biopolitics in the glee of opponents of medical RFID implants - some of whom see RFIDs as literally the mark of the Beast - at the discovery of studies supposedly linking RFIDs to cancer. We see biopolitics in the treatment of prosthetics in popular culture from the enthusiastic cyborg heroes of the Six Million Man and Bionic Woman to the ambivalence of Robocop and the bioconservatism of the Darth Vader and the Terminator. We see biopolitics when medical innovations are the McGuffins of horror stories, as when Michael Chrichton’s Terminal Man is driven murderously insane by a device very similar to NeuroPace’s brain pacemaker. We see biopolitics when some in the deaf community oppose cochlear implants as a plot against the deaf, and in the mind-control anxieties expressed by some opponents of vagus nerve stimulators for the treatment of depression.
Enthusiasts for biotechnologies are prone to our own biases of course, such as gullibility for innovators’ hype, overestimation of the pace of progress, underestimation of risks, and inattention to regulatory, legal and access challenges. Pursuing the Enlightenment project of better living through technology requires as much attention to risks and harms as to benefits and future potentials.
Recently at the IEET we’ve started a project we call “Cyborg Life” to track and discuss the ethical and biopolitical issues around medical devices. We’ve been collaborating in the project with Peter Houghton, the longest living recipient of an LVAD heart assist device and the founder of a charity in Britain to support research on and access to heart assist devices. Peter has conducted interviews with the recipients of a variety of devices, documenting their gratitude at the gift of “extra life” as well as the challenges posed by their medical conditions. We want to argue through the project that while the future prospects for implanted medical devices are bright we need new policies to speed up the innovation pipeline while improving safety, access and quality of life.
A recent profile of Peter Houghton in the Washington Post illustrated how difficult it is for the burdens and benefits of medical devices to be judged without the distortions of biopolitical biases. Instead of describing the difficulty of carrying around a large battery plugged into one’s skull that powers one’s heart pump, the article focused on whether heart assist devices might reduce a person’s capacity to feel emotion since it turns your heart into a cold machine. That is about as useful as questioning splenectomies on the grounds that they would prevent people from “venting their spleen” or vertebral fusion since it might interfere with the flow of kundalini through the chakras.
The disabled and chronically ill need less hand-wringing that medical devices are somehow dehumanizing, disempowering or unnatural, and more rapid innovation and safety testing of smaller, cheaper, more powerful devices. The expanded funding and authority for the FDA in last week’s Congressional legislation is a welcome step in the right direction. Mandatory aggregation of clinical trial data and post-approval adverse events reporting, done right, can speed up the innovation and diffusion of safe devices, while helping to increase consumer confidence.
As biotechnology innovation accelerates, however, the 20th century clinical trial regime has become a serious bottleneck, even with the new funding and openness. We need a 21st century model which liberalizes access, speeds innovation and safety testing, and provides high quality health maintenance. Patients could be enrolled for experimental use of drugs and devices as an alternative to Phase 3 trials, with the quid pro quo that their care and health be intensively managed through home medical monitoring, electronic patient records, and direct telemetry from implanted devices. Sufficiently large and diverse populations of subjects using drugs and devices in a myriad of real-world ways can provide as good or better safety and efficacy information as clinical trials.
The FDA’s Humanitarian Device Exemption for therapies with a market of fewer than 4000 already provides a kind of precedent such a liberal experimental regime. Although the Supreme Court has rejected in August the argument that patients should be able to circumvent the FDA altogether, patient lobbying for access experimental drugs will only grow louder. A model that liberalizes access to experimental drugs and devices while providing high quality safety and efficacy data could satisfy both sides.
Such a model may seem wildly unlikely as the pendulum now swings in a regulatory direction. But as the growth of medical tourism suggests, patients will seek out potentially beneficial therapies without the guarantees of safety and efficacy. Allowing easier access to experimental therapies, with the quid pro quo of intensive monitoring of one’s health, would be very appealing to the aging, demanding Baby Boomers.
New drugs and devices will also increasingly push those biopolitical buttons in the popular culture, of hyped anticipation and apocalyptic dread. Efforts to speed up the Enlightenment project through regulatory and finance reforms may be slowed by strong crosswinds of anxiety about where humanity may be headed. By getting the largest possible proportions of the population engaged as active participants in drug and device innovation, as empowered technocitizens choosing and managing the emerging biotechnologies in their lives, we can hopefully have a regulatory process less influenced by both Frankenstein and the Six Million Dollar Man.
IEET Blog