10 Nov An Open Letter to the Incoming Trump Administration About Psychedelics
This this post was originally posted here
Dear Mr. Trump and Mr. Kennedy,
Now, the real work begins.
At the end of August, when you, Mr. Kennedy, dropped out of the presidential race and endorsed Mr. Trump, a coalition of strange bedfellows was formed, many heads exploded, and a new acronym was introduced to the zeitgeist: MAHA.
Make America Healthy Again.
Had you simply made “improving healthcare access” your campaign message, it would have failed.
That is because it is quite clear that something has gone woefully wrong such that the prevalence of chronic diseases has skyrocketed from 7.5% in 1935, when the first epidemiological study on chronic disease was done, to over 60% in 2020 while more than 90% of the $4.5 trillion in annual health care spending is for chronic and mental health conditions.
Patients are underwhelmed and frustrated with their care, and doctors are disheartened by working in a system designed to reward greed at the expense of patient care.
Throughout your campaign, you have repeatedly highlighted the root causes of our healthcare woes—a disease-promoting food system, regulatory and media capture by the pharmaceutical industry, and bad financial incentives—and the American people responded.
Running on a platform of addressing the massive increase in chronic disease burden—including mental illnesses, obesity, type II diabetes, cancer, and others—you have earned the enthusiastic support from many Americans and at least the benefit of the doubt from many others, even if they won’t admit it.
Mr. Kennedy, you have made many promises concerning your goals and ambitions for restructuring the federal health agencies. Recently, you said:
“FDA’s war on public health is about to end. This includes its aggressive suppression of psychedelics, peptides, stem cells, raw milk, hyperbaric therapies, chelating compounds, ivermectin, hydroxychloroquine, vitamins, clean foods, sunshine, exercise, nutraceuticals and anything else that advances human health and can’t be patented by Pharma….”
It is noteworthy that psychedelics is the first item on this list.
I understand that your son benefited greatly from a psychedelic experience after his mother’s passing, and you have discussed the topic at length on podcasts and interviews.
If you are, in fact, serious, and you have the president-elect’s support for rewriting the government’s relationship with psychedelics, please consider the following as logical and appropriately cautious steps that will support a flourishing in psychedelic science and innovation in mental health treatments.
1. Reclassify Psychedelics to Schedule III or IV
The major bureaucratic roadblock that impedes the advancement of psychedelic science is the Controlled Substances Act (CSA) of 1971.
Through this legislation, the federal illicit scheduling system was introduced. As you know, psychedelics and other promising neuroplastic compounds like MDMA are the most restricted classification, Schedule I.
Schedule I compounds are defined as having a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision.
This classification also creates significant barriers to research and limits the number of scientists who can work with these substances.
According to the CSA, the process for moving a compound out of Schedule I is through FDA approval.
However, the Health and Human Services under the Biden-Harris administration has set a new precedent by recommending that cannabis, a Schedule I substance, be reclassified despite the absence of FDA approval.
You have a golden opportunity to rewrite history and this should be a first step.
2. Expand the Federal Research Budget for Psychedelic Research
From the early 1970s through 2021, there was no federal funding for psychedelic treatment research.
In 2021, Johns Hopkins University received a $4 million grant from the National Institutes of Health (NIH) to investigate the potential effects of psilocybin on tobacco addiction. This was described as the “first federal grant for psychedelic treatment research in 50 years.“
The National Defense Authorization Act for Fiscal Year 2024 authorized $10 million for clinical research on psychedelic treatments for military personnel.
Earlier this year, an $8.4 million grant application from the NIH was announced for the use of classical psychedelics in the treatment of chronic pain.
While these amounts represent a significant increase from previous years, they are still relatively small compared to the NIH’s annual budget of about $45 billion in fiscal year 2023.
While the scientific literature on psychedelics is very promising, and the positive experience of literally millions of people supports the use of psychedelics as therapeutics, it is still a very nascent and immature field of research primarily due to inadequate funding.
Believe me, there is an abundance of interest, expertise, and open questions among researchers.
Federal funding for clinical trials of psychedelics is the lowest hanging fruit in advancing safe, rapid-acting, innovative treatment solutions for chronic diseases like depression, anxiety, PTSD, addiction, chronic pain, and even metabolic disease.
3. Expand FDA Remit for “Psychotherapeutic Adjuvants”
After the FDA rejected MDMA Assisted Psychotherapy for the treatment of PTSD, Tom Insel, the former Director of the National Institute for Mental Health, penned an op-ed in STAT News titled Adding psychotherapy to drug therapy works, but the FDA may not be able to handle it.
Insel wrote (emphasis added):
“One lesson from the “no” vote on MDMA-assisted psychotherapy for PTSD is that the U.S. regulatory system is not optimized for mental health care.
…I believe the key innovation here was the proposal to combine medication and psychotherapy as a bundled intervention. This combination was not convenient for the FDA or its advisory committee, but wasn’t it really a proposal for a best practice that needs to scale across mental health care? I believe this new drug application could serve as a wake-up call for new regulatory processes that would view psychological treatments as key facilitators rather than as confounders of behavioral change.”
The current FDA drug approval process requires demonstrating efficacy for specific medical conditions.
Consider anesthesia. When the FDA evaluates an anesthetic agent, they don’t ask, “Does it treat pain?” or “Does it cure a condition?” Instead, they ask, “Is it safe and effective at producing and maintaining the necessary state for surgery?”
This precedent is crucial because psychedelics operate in a similar way.
Psychedelics create a temporary but profound shift in consciousness that, when properly supported, can catalyze deep therapeutic work.
I’m suggesting the creation of a new regulatory category: “Psychotherapeutic Adjuvants.”
An adjuvant is a substance added to a drug or therapy to enhance its effectiveness.
Such a framework would recognize these compounds for what they are—not traditional pharmaceuticals but rather sophisticated tools that, in the hands of trained therapists, can help people access extraordinary states of consciousness conducive to healing and personal growth.
This isn’t just semantics—it’s a paradigm shift that could dramatically accelerate research and development while ensuring appropriate safety standards. It would free researchers and clinicians to focus on developing proper protocols, training guidelines, and safety standards for working with these powerful tools.
4. Expand Right-to-Try Access for Terminal and Treatment-Resistant Patients
In 2018, Congress passed the Right-to-Try Act, acknowledging that people facing life-threatening conditions should be granted access to experimental treatment options before the FDA licenses them.
The cruel irony is that right now, someone with terminal cancer experiencing profound existential distress cannot legally access psilocybin therapy despite decades of research showing its potential to ease end-of-life anxiety. The same goes for veterans with treatment-resistant PTSD who’ve tried everything in our current medical toolbox without success.
This needs to change.
Expanding the Right-to-Try to include psychedelic therapies isn’t just compassionate—it’s consistent with the law’s original intent. We’re talking about people who have either exhausted conventional treatments or face terminal diagnoses. They deserve the right to try these promising therapies in controlled, supported settings.
5. Establish a Veterans Affairs Psychedelic Research and Treatment Initiative
Mr. Trump, you’ve often spoken about your commitment to our veterans. Here’s a concrete way to transform that commitment into action.
The VA system presents an extraordinary opportunity. It’s the largest integrated healthcare system in America, with established protocols for mental health treatment and a population that desperately needs better solutions for PTSD, depression, and substance use disorders. We’re talking about men and women who’ve served our country only to find themselves trapped in cycles of trauma that conventional treatments often fail to address.
What I’m proposing isn’t just another research program—it’s a comprehensive initiative that leverages the VA’s unique strengths. Imagine dedicated centers of excellence where VA psychiatrists and therapists receive specialized training in psychedelic-assisted therapy. Picture a systematic approach to screening veterans for these treatments, delivering them in safe, supported settings, and providing crucial integration support afterward.
This isn’t pie-in-the-sky thinking. The Defense Department has already recognized the potential here—that’s why they’ve authorized $10 million for psychedelic research. But we need to think bigger. The VA, with its national reach and established infrastructure, could become the world leader in psychedelic medicine, developing protocols and best practices that could benefit not just veterans but, eventually, the broader population.
The path forward for psychedelic medicine requires bold yet measured steps that balance innovation with safety, scientific rigor, and compassionate access.
These recommendations provide a framework for responsible reform that could fundamentally transform mental healthcare while maintaining appropriate safeguards.
You have a unique opportunity to correct decades of misguided drug policy that has stifled research and denied patients access to promising treatments. By implementing these changes, your administration could usher in a new mental health treatment era that honors scientific evidence and human dignity.
The time has come to move beyond the failed policies of the past and embrace the therapeutic potential of psychedelics.
With proper oversight and careful implementation, these reforms could help address our nation’s mental health crisis while establishing America as a leader in 21st-century medicine.
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