Dr. Marty Makary: What His Leadership Could Mean for the Future of Psychedelics
Exploring the Potential Impact of FDA's Newest Nominee on Psychedelic Medicine
Disclaimer: I used Deep Research tool from AI to learn about him, his writings, reviews, and comments he has made. The questions and prompts were my own and focused on mental health and Psychedelics specifically.
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Recently, I wrote about how we can change policy at the state and local level and how should the psychedelic community either support or oppose legislation
Dr. Marty Makary, a renowned surgeon and public health person at Johns Hopkins University, is no stranger to questioning the conventional wisdom in medicine. Known for his outspoken critiques of overmedication and the influence of pharmaceutical companies, Makary's approach to health policy centers on evidence-based medicine and the relentless pursuit of better outcomes for patients. A consistent theme in Makary’s work is concern that well-intentioned doctors often embrace interventions without solid evidence, while sometimes dismissing promising alternatives
Per the New York Times - as the potential incoming commissioner of the U.S. Food and Drug Administration (FDA), Makary’s views on health interventions—whether physical or mental—are likely to have a profound impact on how we think about health care in America. But what can we expect from him when it comes to the intersection of physical and mental health treatments, particularly when it comes to psychedelics and other innovative therapies?
As an advocate, Mind Lumen focuses on safe and ethical access to anyone that wants it without gatekeeping
A Stringent Standard for Physical Health Interventions
Dr. Makary has been a vocal critic of the overuse of medical treatments in the physical health sphere. In his writings, including his book Blind Spots (2024), Makary underscores the perils of overprescribing drugs, unnecessary surgeries, and the general over-medicalization of society. He points to the United States as the most overmedicated population in history, with treatments often prescribed without adequate evidence to support their effectiveness. His primary concern is that modern medicine has a tendency to embrace interventions without robust data, all while disregarding alternatives that may be safer or more effective.
A good example of his position is his criticism of the over-prescribing of antibiotics and opioid painkillers—two of the most commonly overused treatments in the U.S. Makary has gone so far as to claim that over-prescription in these areas has led to more harm than good, including drug resistance and long-term health complications. For him, the solution lies not in prescribing more pills but in taking a deeper look at factors like nutrition, lifestyle, and environmental influences.
What about his approach to Mental Health?
While Dr. Makary has been relentless in scrutinizing physical health interventions, his stance on mental health is similarly rigorous but is it open-minded?.
He recognizes that this is an area “where these issues are salient”, meaning there are many blind spots and unanswered questions. “Is psychedelic medicine a new hope for sustained treatment without the risks of ongoing medications?”. The field of mental health, especially in America, has been marked by an over-reliance on medications like antidepressants, many of which come with long-term side effects and limited efficacy. Makary has criticized the lack of evidence behind many commonly prescribed psychiatric drugs and has urged for more transparency and research into alternative treatments.
In Blind Spots, Makary addresses the mounting dissatisfaction with traditional psychiatric care and raises important questions about whether there are better ways to treat mental illness. For example, he considers the potential of psychedelic-assisted therapies, which have shown promise in clinical trials for conditions like depression, PTSD, and anxiety. Unlike conventional psychiatric drugs that require long-term use, psychedelic therapies have demonstrated the possibility of creating lasting changes with only a few sessions, sparking Makary’s interest in these groundbreaking treatments. “With regard to many of the topics he takes on, contradictory findings get reported in the lay press so often that it is like watching a ping pong match. It is no wonder that both practicing clinicians and the public are confused, and that there are thriving communities of alternative practitioners.”
However, Makary is not one to support new treatments without thoroughly evaluating them. His stance on psychedelics, like his views on physical health interventions, is evidence-driven. He insists that psychedelic-assisted therapies, despite their potential, must undergo rigorous clinical trials before they are rolled out to the public. For him, the potential of psychedelics to transform mental health care is exciting, but it must be backed by science. As the writer Dr. Dinah Miller who reviewed the book says:
Blind Spots makes a strong argument for holding off on medical recommendations and owning up to what we just do not know. [Clinical] Medicine does not like to do this
The thing is we can’t wait for the slow process of the clinical trial evidence on which decisions and policies rest, without taking into account real world use cases. He hasn’t spoken about using historical data and experiential use of psychedelics to inform “safety and efficacy”. Hopefully, now the FDA can look at real world data as part of their evidence to determine safety and efficacy. Enable use while clinical trials continue, and only if there is evidence of harm and significant risk compared to existing substances, the FDA can then use it’s authority to warn or recall.
The Influence of Robert F. Kennedy Jr.
One aspect of Makary’s perspective that deserves attention is his connection with Robert F. Kennedy Jr., a prominent critic of the pharmaceutical industry. Both men share a common distrust of Big Pharma's influence over health policy and are passionate about reforming a system they see as broken. RFK Jr. has been an outspoken advocate for psychedelics and other alternative therapies, and this has likely influenced Makary’s stance on the issue.
Given that RFK Jr. has been supportive of expanding access to psychedelics, it’s reasonable to assume that this will play a role in Makary's approach as FDA commissioner. However, Makary’s approach is likely to remain balanced—he’s open to exploring innovative therapies, but only when they have been thoroughly tested and shown to be effective. If confirmed as FDA commissioner, Makary’s leadership is expected to reflect this cautious but progressive approach, supporting research into psychedelics while ensuring that safety and efficacy come first.
I would have hoped that the previous administration would have been more progressive but they weren’t although they did push for de-scheduling Cannabis.
Isn’t it time to reframe how we think about of safety and efficacy based on real world use and experience? If a substances does not cause harm to anyone and is a way less risky than existing substances already out on the market as shown by many studies, including the Imperial College of London study on harms, then why do we need to have the limited clinical trial of testing as the only method to determine safety and efficacy?
The Future
Dr. Marty Makary's approach to health policy will be something to watch for the psychedelic industry. It seems hopeful. Is he one of careful scrutiny and somewhat open-minded? 🤷🏽♂️. He has established himself as a steadfast advocate for evidence-based medicine and is unafraid to challenge the status quo in both physical and mental health care. While he advocates for alternative therapies like psychedelics, his approval is conditional on robust clinical evidence. As the potential incoming FDA commissioner, Makary’s leadership could usher in a new era of more transparent, scientifically rigorous health care, while also opening the door to innovative therapies that could reshape how we treat both physical and mental health.
What do you think? How will he impact FDA’s stance on Psychedelics?
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Sources:
Makary, M. Blind Spots: When Medicine Gets It Wrong and What It Means for Our Health. Bloomsbury, 2024 – as reviewed by Dr. Dinah Miller in Psychiatric Times.
EconTalk interview with Dr. Marty Makary (Aug. 15, 2024) – summary of Blind Spots and discussion of evidence failures.
JDSupra (Faegre Drinker LLP) briefing on Makary’s FDA nomination – notes Makary’s critiques of overprescription and pharma influence, similar to RFK Jr.’s stance.
The Economic Times (ET Online), “Marty Makary… gained prominence by bashing the medical establishment:” (Mar. 4, 2025) – highlights Makary’s views on overmedication, food supply, and COVID policies.
PsychCentral Inside Mental Health podcast (Feb. 20, 2025) – Makary interview on groupthink in medicine, with quotes on addressing diet and screen-time instead of medicating children.
Life Science Leader (Nov. 27, 2024), “FDA’s Psychedelic Reckoning” – industry perspective noting RFK Jr.’s pro-psychedelic stance and anticipated openness under Makary’s FDA.
Psychedelic Alpha (Nov 14, 2024), “Tripping Over Trump: Will the New Administration Embrace Psychedelic Exceptionalism or ‘Just Say No’?”