Aug 12, 2022
This podcast is about big ideas on how technology is making life better for people with vision loss.
Innovations in implant technology are advancing at lightning speed, profoundly impacting the lives of people who are blind or visually impaired. In On Tech And Vision, we’ve profiled some amazing new implant technologies that have the potential to restore people’s sight. But in this episode, we pump the breaks — because we need to address a critical part of the innovation process: the ethical frameworks that protect participants in early clinical trials, and the need for an updated framework that ensures patient protections without stifling innovation and development.
Discussions between doctors and participants in clinical trials almost always focus on the new technology and very rarely on the manufacturer who sponsors the clinical trial — and almost never on the long-term commitment and financial viability of the company sponsoring the technology. And while clinical trial informed consent includes whose responsibility it is to remove the implants should they fail during the trial, that responsibility usually ends once the trial is over. At that stage, who will maintain or remove the implants that are still housed in patients’ bodies?
In this episode, we talk about innovative implants such as the Argus II, which we featured in the first season of On Tech And Vision. The Argus II is a microchip implanted under the retina that, in combination with a special headset, provided some vision to people who otherwise had none. And while the technology was exciting, the company discontinued the retinal implant three years ago, and the Argus II was eventually sold to another pharmaceutical company.
Dr. Joseph Fins, Professor of Medical Ethics and Professor of Medicine at Weill Cornell Medical Center in New York, joins us to share his thoughts on today’s big idea: How do we balance the life-changing potential of electroceutical implant technology with the ethics of caring for early participants — particularly after clinical trials are over?
The Big Takeaways:
- Examples of electroceutical implants. Cochlear implants, retinal implants, and deep brain stimulators are examples of scientific advances that rely on in-dwelling devices.
- Regulatory framework today. The relationships between researchers and clinical trial participants are regulated by institutional review boards, which came out of the National Research Act of 1974. However, while this framework works well for drug trials, new issues specific to implants need to be addressed by new regulations. For example, who is responsible for people left with in-dwelling devices once trials are over? If the sponsoring company no longer supports their devices, are they victims of abandonment? Are the timelines for drug trial success too short to be relevant for implant device trials, since it may take the body longer to adopt a new technology than to respond to a new drug?
- Ancillary care obligations. Henry Richardson, in his book Moral Entanglements: The Ancillary Care Obligations of Medical Researchers writes that historically, researchers — to avoid conflicts of interest — did not assume a clinical care role. However, that is changing, as researchers realize they have an obligation to share actionable results with patients. The result is that there is even less of a “bright line distinction,” as Dr. Fins says, “between research and therapy.”
- Collective responsibility. Who is responsible for the long-term well-being of participants in electroceutical trials? Dr. Fins suggests that the sponsoring company, the medical school where the research is taking place, and the government should share responsibility. It’s a collective problem, he says.
- Some solutions. Requiring researchers, sponsoring companies, and researching universities to include in the costs of development insurance to cover long-term care for participants is one potential solution that Dr. Fins imagines. He also offers that researchers and sponsoring companies that develop successful and adopted medical products could subsidize the field. Or, he suggests, a tax on gaming devices (adjacent to electroceutical implants) to sustain people who are given indwelling devices in clinical trials.
- The law. The law needs to evolve to address the specific vulnerabilities of participants in electroceutical implant trials. Dr. Fins suggests that there are provisions within the Americans with Disabilities Act that account for assistive technologies that were relevant when the act was written in the nineties. According to Dr. Fins, these provisions in that could be read with a more contemporary lens, to include the assistive technologies of today (which would encompass electroceutical implants). There is room for lawyers and legal scholars to impact the legal frameworks in place now, to expand coverage from the ADA to protect participants in clinical trials for electroceutical implants.
- “Victims of Our Own Success.” Electroceutical implants are a miracle, says Dr. Fins. They are human ingenuity at its best. The science is harder to solve than the bureaucracy, but the bureaucracy to sustain medical advancements like these must catch up, or, ultimately, the vulnerability of trial participants threatens to impede scientific progress.
- Danger to the field. Clinical trials rely on willing participants, and when participants are not supported after trials end, it erodes participants’ trust across the field. Without a clear set of protections in place for participants in clinical trials, scientific and medical advancement in the area of electroceutical implants may be impeded.
Tweetables:
- “I think this is a perfect rationale for insurance.”— Dr. Joseph Fins, Weill Cornell Medical Center
- “This is a huge problem. … We’re victims of our own success.”— Dr. Joseph Fins, Weill Cornell Medical Center
- “It's human ingenuity at its very best. And the fact that we can’t figure out the bureaucracy to sustain this? … The science is harder than the politics and the bureaucracy, but we’re being overmatched by the politics and the bureaucracy.” — Dr. Joseph Fins, Weill Cornell Medical Center
- “When stories like this come out it makes recruitment very hard.” — Dr. Joseph Fins, Weill Cornell Medical Center
- “These retinal implants, these deep brain stimulators, … they're gonna be looked upon as primitive halfway technologies 50 and 100 years from now. But we're only gonna get there if we're able to do this research.” — Dr. Joseph Fins, Weill Cornell Medical Center
- “Once you understand these facts, the ethics are pristine. They’re clear.” — Dr. Joseph Fins, Weill Cornell Medical Center
Contact Us:
- Contact us at podcasts@lighthouseguild.org with your innovative new technology ideas for people with vision loss.
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