“When the policy gets ahead of the science, it's challenging”: 5 Questions for bioethicist Amy McGuire

McGuire discusses the challenges ahead in regulating psychedelics and creating data-informed psychedelic policy.

As a college student in 1995, Amy McGuire visited the Shuar Nation for the first time on a trip with the non-profit Dream Change. The Indigenous community lives in the Ecuadorian Amazon, and the Shuar people use ayahuasca in traditional healing ceremonies. McGuire learned about their belief systems around plant medicines, and for years after, she led Dream Change trips to visit the Shuar community. 

McGuire went on to get a law degree from the University of Houston, then a Ph.D. in medical humanities from the University of Texas. Her research centers on emerging technology and therapeutics. She studied the law, policy, and ethics around genomics just as the Human Genome Project wrapped up in the mid-2000s, and has recently started integrating her long-time interest in psychedelics into her academic work. 

McGuire is now a professor of biomedical ethics at the Baylor College of Medicine in Houston, Texas, and the director of the college’s Center for Medical Ethics and Health Policy, which just launched a new program to explore the Ethical Legal Implications of Psychedelics in Society, or ELIPSIS. McGuire, along with three other legal and medical ethics experts, just published a new paper in Science calling for regulatory changes in psychedelic medicine.The Microdose spoke with McGuire about the challenges ahead in regulating psychedelics and creating data-informed psychedelic policy.   

Many speculate that MDMA and psilocybin could be approved by the FDA for medical use in the not too distant future. But currently, the way those drugs are being studied for their potential use in a medical context usually involves some form of facilitation or therapy and not just the substance. But, as you know, the FDA doesn’t regulate therapy. If these drugs are approved, how might the therapy part be regulated? 

The FDA regulates drugs and drug products exchanged in interstate commerce; they don't typically regulate the practice of medicine, how drugs are administered, or the conditions under which they are used. That’s why we have off-label prescribing of drugs. 

People in the psychedelic space recognize that set and setting — participant mindset and the physical setting you’re in — are really important to psychedelic therapy. Yet there haven't been a tremendous number of rigorous studies that have shown why it's important or what effect it has beyond the drug itself. Clinical trials are implementing set and setting but not studying the contributory impact of those on safety and efficacy of the drug. There are lots of schools of thought about this. Some believe the psychedelic substance is what's doing the work and you don't need to have a psychedelic experience for healing. Some people believe you can isolate the compound that’s causing neuroplasticity, and that can have just as an effective impact on mental health. Others think psychedelics are a tool to enhance the therapeutic process,  opening you up to be more vulnerable and suggestible so that the therapeutic process works more quickly and effectively. But it's early days, so we don’t have the data or evidence to help tease those theories apart.

So what can the FDA do? Sometimes when they have a drug product with significant safety concerns, they can issue what’s called a risk evaluation and mitigation strategy, or REMS. The REMS will say that the prescriber has to do something specific, like checking on patients for two hours after administration to make sure they don't have disassociation. Or that prescribers have to reinforce safety concerns to participants during the consent process. But REMS are only allowed to address serious safety concerns, so if we think there are serious safety concerns with set and setting, REMS may be appropriate. Most people don't think there are serious safety concerns with set and setting. More often, people just think it contributes to the overall efficacy or impact of the drug. So in that case, it’s unclear whether the FDA would have jurisdiction to issue REMS.

Another possibility is that states could get involved.  States regulate where certain drugs can be administered — like in a hospital setting versus an outpatient setting. And states set laws and regulations around licensure, and who is able to administer the approved drugs. At a more local level, professional societies could put out guidance documents about how particular approved drugs ought to be used to ensure safety, but that isn’t binding. In our paper in Science, we argue that it’s going to require an unprecedented amount of cooperation and coordination between different agencies to develop a more holistic approach to regulating psychedelics.

In that paper, you and your co-authors warn against using a state-by-state model for psychedelics, but between Oregon, Colorado, and other states’ new psychedelics bills, that’s essentially what’s happening. What are your concerns about that approach?

Our major concern is that if you start decriminalizing these substances prior to developing a strong evidence base for their efficacy, it undermines efforts to do research. We’ve seen that with cannabis: state decriminalization and widespread availability and access to cannabis has made it difficult to do rigorous clinical trials. You need to show drugs’ efficacy for different conditions as a medication; that data is needed for insurance reimbursement. If these drugs are going to be used as a medication, we need to understand what conditions they work for, and at what doses, and for what people in what circumstances. 

How do you feel about these new state run programs and businesses launching while we’re still studying these things? Do you feel things are moving too quickly?

I have complicated feelings about this. I don't think psychedelics should be highly regulated and that we should limit access, and I feel very strongly that we need to preserve access for traditional use. Because of how I got interested in psychedelics, that’s a top priority for me.

When the policy gets ahead of the science it's challenging. We have policies that are being enacted based on enthusiasm or even hype — or maybe not, but we just don't know yet — as well as policy based on unjustified fears. Neither of those are a good place to be. You want to have policy that’s informed by data.

I do think there are ways to generate the data alongside the policy. There are mitigation strategies we should be thinking about. For instance, for states that are decriminalizing, I would very strongly recommend that there be systems in place for tracking adverse events, or collecting data on how new programs are being implemented and what their impact is.

What you’re suggesting sounds similar to what’s being proposed in Oregon’s Senate Bill 303, which would require psilocybin service centers to collect and then report some aggregated data about who uses their services. Advocates of the bill argue that data collection is necessary for showing efficacy and tracking safety; people who oppose it are concerned about privacy. What are the potential impacts of this type of data collection?

Privacy is always an issue around “illicit drug use” and mental health. There are a lot of concerns about stigma and discrimination generally, and there's a conflict between decriminalization in-state while it’s still federally illegal under the Controlled Substances Act. You  never know if the federal government is going to exercise its enforcement. That puts an extra layer on the privacy conversation. We need to share data but to do so in a way that protects individuals. Otherwise, that’s going to impede our ability to do important data sharing. 

There’s a whole underground world, which is starting to be unearthed, but we don't have any real sense of what's going on in those communities, who’s administering drugs under what conditions, and what requirements there are for participants. One question we’re asking right now in retreat settings or individualized guided sessions: Are people asked to do washout periods when they go off of other medications they might be on before taking psychedelics? And is that being done under supervision of their physicians or not? And are there safety concerns with that? The more you drive things underground, the more fear and the less data you're going to have to make informed decisions.

What other big ethical questions do you think the psychedelics field should be considering right now?

There are so many issues we’re interested in at ELIPSIS: research ethics, how all of that research is being funded, and commercialization. This is big business — there’s potential for psychedelics to be a giant market in healthcare and lots of people want to get in on that market, but certain business decisions may be in conflict with other values people in the psychedelics field want to preserve. 

There are also a whole host of other issues that will come up once psychedelics do get approved for medical use. How will they be integrated into the medical system? What’s the appropriate role of therapeutic touch and boundary issues — how do we ensure safety?

I’m also interested in issues related to Indigenous communities: respect for and giving back to Indigenous communities, intellectual property, issues of appropriation, and environmental issues around exploiting natural resources like peyote, as opposed to developing synthetic molecules. We’re trying to attract the next generation of scholars in the academic world who are really interested in thinking about psychedelics from a perspective of humility rather than from an authoritarian Western perspective.

This interview has been edited and condensed for clarity and length.