Psychedelic therapy is a rapidly growing field with the potential to revolutionize the treatment of mental health disorders. In today’s interview, we have the privilege of speaking with two leading figures in the world of psychedelic therapy: James Linden, the Founder and Chairperson of Alvarius Pharma, and Graeme McFarlane, CEO. They provide valuable insights into the future of psychedelics in healthcare, discussing everything from clinical trials and regulatory challenges to funding and societal perceptions.

Moe Alsumidaie: James, your work in plant medicine and clinical research is well-known. Could you elaborate on how you see psychedelics playing a role in mainstream medicine in the coming years?

James Linden: The future of psychedelics in mainstream medicine is complex. On one hand, we’ve seen promising clinical trials showcasing their efficacy in treating mental health disorders like depression, anxiety, and PTSD. On the other hand, there are substantial roadblocks in terms of regulation and public perception. For instance, we at Alvarius must work closely with the FDA to navigate the complex approval processes, which often require multi-phase, multi-year clinical trials.

Dr. James Linden, Co-Founder of Alvarius Pharma
Dr James Linden Co Founder of Alvarius Pharma

Moe Alsumidaie: Can you elaborate on the challenges of conducting psychedelic therapy clinical trials?

James Linden: Clinical trials for psychedelics face unique regulatory and logistical challenges. For instance, the double-blind placebo-controlled model, a cornerstone of clinical trials, is challenging to implement because the effects of psychedelics are so distinct that participants can often guess whether they’ve received the treatment or the placebo. This can introduce bias into the results. Additionally, the Schedule I status of many psychedelics complicates the approval process and imposes stringent security measures, driving up costs and timelines.

Graeme McFarlane: Overcoming these challenges will require innovative trial designs and perhaps even changes to how regulatory bodies evaluate the efficacy of psychedelic substances. Multi-disciplinary collaborations between researchers, ethicists, and regulators will be crucial. Also, as the body of evidence grows, I hope the regulatory landscape will evolve to facilitate easier approvals for well-designed trials.

James Linden: Cost is also a significant factor for startup biopharmaceutical companies. In our case, producing pharmaceutical-grade psychedelics at Alvarius involves rigorous quality controls, which aren’t cheap. This could potentially make the end product quite expensive, limiting accessibility. However, economies of scale could decrease costs as the market grows and technologies improve.

Moe Alsumidaie: With the growing body of evidence supporting the efficacy of psychedelics, do you think we’re close to seeing major policy shifts?

James Linden: Policy change is a slow and laborious process. While the scientific evidence is mounting, it has to be corroborated by long-term studies to influence policy effectively. At Alvarius, we compete with deeply ingrained legal frameworks that categorize many psychedelics as Schedule I substances, implying high abuse potential and no medical value. Changing that classification would be a significant first step, but it would require a massive advocacy effort backed by undeniable scientific evidence.

Graeme McFarlane: Ethical considerations are also paramount, especially when discussing substances that profoundly affect mental states. Informed consent and patient autonomy are crucial. Patients need to be made fully aware of the potential risks and benefits. Moreover, we must consider many of these substances’ cultural and traditional origins. The medical community needs to be conscious of ethical sourcing and respect for indigenous knowledge.

Graeme Mcfarlane CEO of Alvarius Pharma

Moe Alsumidaie: Do you think psychedelic therapy applications could go beyond mental health?

Graeme McFarlane: Absolutely. While mental health is the most researched application, emerging studies suggest potential in other fields. For example, psychedelics like psilocybin are being looked into for their anti-inflammatory properties, which could have applications in diseases like Crohn’s or even arthritis. But as with any new medical frontier, this involves a thorough scientific process, which includes clinical trials, peer-reviewed studies, ethical considerations, and long-term impact assessments.

Moe Alsumidaie: What hurdles do you foresee in incorporating psychedelics into healthcare frameworks?

James Linden: The challenges are multi-faceted. Regulatory compliance is a significant hurdle, as I mentioned earlier. Then there’s the issue of educating medical professionals. Many healthcare providers are not well-versed in the pharmacology of psychedelics or their potential interactions with other medications, which is a critical aspect of safe integration.

Graeme McFarlane: To add to James’s point, societal perception is challenged. Psychedelics have been stigmatized for decades, and changing that perception is no small feat. The stigma associated with psychedelics is largely a result of misinformation. Educational initiatives aimed at both the public and healthcare providers can go a long way in correcting misconceptions. The more people understand the science and its potential benefits; the easier it will be to navigate the regulatory and ethical complexities we’ve discussed.

Moe Alsumidaie: Where do you see the field of psychedelic medicine five or ten years from now?

James Linden: I’m cautiously optimistic. With the current pace of research, I expect we’ll see a handful of psychedelic substances approved for medical use within the next decade, particularly in mental health. However, the scalability of psychedelic therapy models also needs to be addressed. It’s not just about the substance but the therapeutic context in which it’s administered.

Graeme McFarlane: I share James’s optimism. I also expect that as the stigma diminishes and the body of research grows, we’ll see psychedelics entering medical school curricula and becoming a standard part of psychiatric care. However, this is contingent on the collective efforts of all stakeholders involved.

Moe Alsumidaie: Shifting gears a bit, let’s talk about research and funding. James, can you shed some light on how research in this field is funded?

James Linden: Most funding today comes from private foundations and philanthropists interested in mental health. There’s also some public funding, but it’s limited due to the legal status of these substances. The challenge with limited funding is that it restricts the scope and scale of clinical trials, affecting how quickly these therapies can be widely available.

Moe Alsumidaie: Do you think the funding landscape will change as public perception shifts?

Graeme McFarlane: I believe so. As the medical benefits of psychedelics become more widely accepted, I anticipate an uptick in private and public funding. More funding means more comprehensive research, which could accelerate the pace at which these treatments become available to the general public. While I can’t speak to personal use, the testimonials from patients undergoing psychedelic therapy are compelling. Hearing firsthand accounts of people who have found relief from chronic conditions motivates me to continue advocating for research in this area.

Moe Alsumidaie: Corporate social responsibility is an essential initiative in biotech. Could you elaborate on some of the initiatives you’ve undertaken?

James Linden: At Alvarius, we prioritize social responsibility alongside our core operations. Contrary to the suggestion that a mere 1% of profit to charity is generous, we’ve funded life-saving defibrillators in the Dublin and Wicklow mountains and initiated a social enterprise, “Nature Worx,” that champions outdoor activities as mental health alternatives, with an investment of around €60k. We’ve also sponsored a pilot study on therapeutic mountain biking, collaborating with local parks and Trinity College Dublin. Alvarius has committed a significant portion of our equity (over 10%) to benefit tribes and charities where many medicinal secrets originated. Such endeavors, including those by figures like Christian Angermeyer, who funded an Ayahuasca trial, underscore the broader societal potential of psychedelics.

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Moe Alsumidaie Chief Editor
Moe Alsumidaie is Chief Editor of The Clinical Trial Vanguard. Moe holds decades of experience in the clinical trials industry. Moe also serves as Head of Research at CliniBiz and Chief Data Scientist at Annex Clinical Corporation.