The senses. Brian Schatz (D-HI) and Cory Booker (D-NJ) are pushing top federal officials to provide an update on research into the therapeutic potential of psychedelics, arguing that the ongoing federal ban has hampered studies.
In a letter sent Wednesday to the heads of the National Institutes on Health (NIH) and the Food and Drug Administration (FDA), the senators said the agencies are “essential to ensuring a comprehensive, rigorous and deliberative scientific approach to the study. psychedelics.
This includes the “potential development of drugs and therapies derived from these substances,” they wrote.
The senators said they were encouraged that the NIH hosted a workshop in January to explore regulatory challenges that impede research on psychedelics like psilocybin and MDMA. And they want the agencies to “further expand their role in identifying research gaps, potentially promising therapeutic uses of psychedelics, and regulatory hurdles in the field of psychedelic research.”
“The United States has previously conducted extensive research on psychedelic drugs,” the letter says, citing the litany of early studies supported by government agencies and pharmaceutical companies before many drugs became strictly scheduled.
In the 1960s, the movement’s “embracing of the counterculture of psychedelics and the illicit manufacture and distribution of LSD contributed to its popular cultural rise and increased non-medical use,” Booker and Schatz wrote. “This created a backlash leading to its stigmatization and negative political repercussions in the second half of the 1960s.”
“Pharma and federal funding for psychedelic research has dried up, while [Controlled Substances Act] licensing requirements have made it more difficult to obtain regulatory approval for research,” they said.
Schatz sent a similar letter to the NIH and FDA in 2019, and the agencies provided an update on the state of research on psychedelics, acknowledging that there are possible medical uses, but further research is needed. are needed to understand “long-term efficacy and safety”. psychedelic drugs,” for example.
But Booker’s involvement in this latest letter is notable, as the senator has yet to weigh in on the issue in any meaningful way to date, instead focusing on his drug policy efforts largely to end federal prohibition of marijuana.
“Psychedelics research continues to face significant challenges,” the senators said. “Many large pharmaceutical companies have withdrawn or reduced their funding in this area due to the high rate of failure to find acceptable drugs for FDA approval.”
“Research on psilocybin for severe depression and anxiety-related disorders, as well as MDMA for PTSD, is currently supported primarily by small organizations that lack adequate funding to develop drugs by through expensive safety studies and large-scale phase 3 clinical trials. A key challenge now is to design the optimal clinical trial to demonstrate efficacy, ensure safety and compliance with regulatory authorities, and secure the necessary funding to support large-scale trials.
The letter also references the Biden administration’s position on promoting research on Schedule I drugs. The White House Office of National Drug Control Policy (ONDCP) released a plan at the end of last year which called for the rationalization of these studies.
“It is important that federal research agencies continue to evaluate the effectiveness of potential alternatives to drugs with high potential for abuse,” Schatz and Booker wrote. They added that the NIH has “begun to show greater interest in psychedelic research.”
The letter lists five specific requests they ask the agencies to respond to:
1. Please provide details of current NIH funding for psychedelic research, including a breakdown by institute and a breakdown by basic versus clinical research.
2. Has the NIH conducted a review of scientific studies on psychedelics funded by the NIMH and other federal entities between 1950 and 1965? Has emphasis been placed on the results of these studies and the scientific limitations of these studies, as a means of informing directions for current and future NIH-funded research on psychedelic compounds? If not, would you initiate such a review?
3. What are the gaps in current research on psychedelics, including questions about current clinical trial methods and other key scientific questions that need to be addressed to further our understanding of psychedelics?
4. What is the current status of collaboration between the FDA, NIH, NIH-funded researchers and their academic institutions, and the private sector on psychedelic research, including identifying areas of therapeutic impact and potential drug development?
5. What are the regulatory barriers to research on psychedelics?
a) What, if any, are the additional regulatory barriers or requirements to studying natural or botanical psychedelics, such as psilocybin?
Meanwhile, the psychedelic reform movement has spread rapidly through states and localities across the United States in recent years, following Denver’s decision to become the first city in the nation to decriminalize psilocybin. in 2019.
Separately, a bipartisan group of members of Congress sent a letter in January urging the Drug Enforcement Administration (DEA) to allow terminally ill patients access to psilocybin. The agency, the lawmakers said, “obstructs access to psilocybin for therapeutic purposes in accordance with the letter and intent of the Right to Try (RTT) laws.”
Congress and 41 states have passed right-to-try laws, which allow terminally ill patients to try experimental drugs that have not been approved for general use. Lawmakers said the DEA “failed to comply” with the law.
More than a dozen psychedelic activists were arrested at DEA headquarters on Monday after they protested and used civil disobedience to bring attention to the issue.
The DEA increased production quotas for the production of certain psychedelics like psilocybin in an effort to promote research, but its scheduling decisions continued to present obstacles for scientists.
Read Schatz and Booker’s letter on psychedelic research below:
Photo elements courtesy of carlosemmaskype and Apollo.
Colorado activists collect tens of thousands of signatures to put psychedelic reform on the ballot