FDA and NIH Weigh In on Psychedelics

FDA Commissioner, Dr. Scott Gottlieb and NIH Director, Dr. Francis Collins have responded to a letter from Sen. Brian Schatz requesting information about psychedelic drugs

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On June 13th, United States Congress rejected an amendment proposed by Rep. Alexandria Ocasio-Cortez (D-NY) that would strike a provision preventing the expenditure of federal dollars for activities that promote the legalization of Schedule I drugs.  Many psychedelic compounds fall into the US Drug Enforcement Agency’s Schedule I, categorizing them as having no current medical use and a high potential for abuse.  Rep. Ocasio-Cortez’s aim was to make scientific research of psychedelics easier to conduct.

As a part of his research into this political topic, United States Senator Brian Schatz (D-HI) penned a letter to the Director of the and National Institutes of Health, Dr. Francis Collins and to the Commissioner of the United States Food and Drug Administration (FDA), Dr. Scott Gottlieb, requesting “information regarding the latest efforts undertaken” by the two agencies “to research psychoactive drugs to treat mental health illnesses”. You can read the entire letter from Senator Schatz to the FDA and NIH here in PDF form. In his letter, Sen. Schatz requested “a brief and written response to the following inquiries and questions:”

  1. Please provide your research agenda for investigating the use of psychedelic drugs, including LSD, ketamine, MDMA, psilocybin, and ibogaine to treat mental health illnesses.
  2. What gaps exist in our understanding of the medical potential for these psychedelic drugs?
  3. What has the FDA and NIH found in terms of safety and potential for abuse for these drugs?
  4. Is the FDA petitioning to reclassify any psychedelic drugs from schedule I drugs to schedule IV drugs?

On June 13, Drs. Collins and Gottlieb responded to Sen. Schatz with a six-page letter addressing the questions posed in the original request.  The full six-page letter to Sen. Schatz from Drs. Collins and Gottlieb is available here in PDF form.  As much of the letter includes extensive definitions of commonly discussed psychedelic compounds, we’ve pulled out some highlights below (emphasis ours):

Please provide your research agenda for investigating the use of psychedelic drugs, including LSD, ketamine, MDMA, psilocybin, and ibogaine to treat mental health illnesses.

“Over the last 10 years, the number of projects funded by the National Institute of Mental Health (NIMH) investigating the use of psychedelic drugs to treat mental illnesses has increased (with the largest increase occurring from 2009-2013; project numbers have been somewhat stable since then). This appears mainly due to an increase in projects exploring the use of ketamine for patients with acute suicide risk and/or treatment-resistant depression. In addition, research on other psychedelic drugs holds promise for uncovering mechanisms of illness and possible interventions, ultimately leading to novel treatments with fewer side effects and lower abuse potential.”

“NIMH, through both intramural and extramural research programs, is funding ketamine research to determine the correct dosages, potential mechanisms of action, potential related compounds, and which individuals might best respond to ketamine. For example, NIMH scientists and collaborators found that ketamine’s antidepressant effects may be due to a metabolite – a byproduct of ketamine’ s chemical breakdown – and not ketamine itself.”

“NIMH is funding basic research to elucidate the underlying mechanisms of psychoactive drugs, such as lysergic acid diethylamide (LSD). One such study is using high-tech snapshots achieved through x-ray crystallography to examine how drugs bind to and modulate the activity of their receptor sites of action.”

“The National Institute on Drug Abuse (NIDA) has previously funded research on ibogaine (a hallucinogenic West African shrub) and structurally related compounds as a potential therapy for opioid addiction. However, while there were early signs of effectiveness, this research also uncovered safety concerns. Studies found that ibogaine could be toxic to nerve cells in the brain (particularly in the cerebellum), and there are reports of ibogaine-related deaths that suggest it is toxic to the muscles of the heart, causing arrhythmia and, in some cases, cardiac arrest. Given that these potentially fatal complications outweighed the potential benefits, ibogaine was determined not to have therapeutic potential.”

What gaps exist in our understanding of the medical potential for these psychedelic drugs?

“Further research is needed to examine the efficacy and long-term safety of psychedelic drugs, including with repeated exposure and potential interactions with existing treatments.”

What has the FDA and NIH found in terms of safety and potential for abuse for these drugs?

“…psychedelic drugs, such as LSD, MDMA, and psilocybin, are controlled in Schedule I because they have a high potential for abuse and no currently accepted medical use in the United States.”

“Additional research is needed to evaluate the risks associated with psychedelic drugs and their potential use to treat mental illnesses, particularly the effects of long-term use on health and behavior, and their potential for misuse. It is important to note that a dose that is safe and efficacious for therapeutic purposes may be different from a dose used for recreational purposes.”

“…long-term ketamine users may develop conditions that include ulcers in the bladder, kidney problems, and poor memory”

“There is evidence that ketamine has the potential to be addictive … ketamine users can develop signs of tolerance and cravings for the drug.”

“Research suggests that LSD and psilocybin do not cause compulsive and uncontrollable drug­seeking nor does their discontinuation typically cause withdrawal…”

“…over the course of the week following moderate use of MDMA, an individual may experience irritability, impulsiveness, aggression, depression, sleep problems, anxiety, memory and attention problems, decreased appetite, or decreased interest in and pleasure from se.x, High doses of MDMA can affect the body’s ability to regulate temperature. This can lead to a spike in body temperature that can occasionally result in liver, kidney, heart failure, or even death.”

“Research on whether MDMA is addictive is inconclusive.”

“At the current time, there is no evidence that ibogaine is addictive.”

Is the FDA petitioning to reclassify any psychedelic drugs from schedule I drugs to schedule IV drugs?

“FDA is not currently recommending a transfer of any Schedule I psychedelic drugs to any of the schedules applicable for drugs having a currently accepted medical use in the United States.”

“… psychedelic drugs currently controlled in Schedule I could be recommended for placement in Schedule II, II, IV, or V once receiving an FDA approvalfor a therapeutic use.”

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