Federal Health Agencies Admit That Classification
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Posted On: 07/07/2022 5:26:38 PM
Federal Health Agencies Admit That Classification of Psychedelics Is Impeding Research
Several psychedelics are outlawed by federal law, with the United States classifying drugs such as psilocybin, LSD, MDMA, mescaline and peyote as Schedule I controlled substances with no accepted medical use. Even though a few states have loosened some of their psychedelic policies, federal law prohibits the production, sale and use of psychedelic drugs.
According to two federal health agencies, federal prohibition has forced researchers to jump through numerous regulatory hoops and held back efforts to study the potential benefits and risks of psychedelic drugs. In a four-page letter sent as a response to Sen. Cory Booker’s and Sen. Brian Schatz’s request for an update on psychedelic drug research, the directors of the National Institute of Mental Health (NIMH) and the National Institute on Drug Abuse (NIDA) said that early research showed that psychedelic drugs had medical potential.
In May, the aforementioned senators sent a letter to the heads of the FDA and NIH arguing that federal prohibition was hindering psychedelics research and asking them to provide an update. The federal agencies admitted that although these psychedelic drugs do seem to have medical potential, the fact that they are controlled substances means any research involving psychedelics has to abide by requirements set forth by the Drug Enforcement (DEA).
The four-page reply letter noted that further research could help scientists uncover underlying disease mechanisms and develop new treatments with fewer side effects and reduced misuse potential.
NIDA Director Nora Volkow and NIMH Director Joshua Gordon stated in the letter that federally funded psychedelic research programs could find better ways to treat chronic pain or help smokers quit. They said that in the last fiscal year, NIH spent around $34 million on programs dedicated to studying the potential health benefits of psychedelics and psychedelic-derived drugs.
However, the letter stated that psychedelics offer unique methodological challenges when it comes to research because of their effects. For starters, running placebo-controlled clinical trials is a major challenge because the effects of psychedelic drugs on consciousness and perception mean that it is quite easy to distinguish them from a placebo.
Responding to a question from the two senators about research into psychedelics such as LSD from the 1950s and 1960s, the agencies said that these studies also showed that they have potential against mood disorders and addiction. However, they noted that a majority of these studies were carried out before modern human subject protections and ethical standards were developed.
The federal classification notwithstanding, a number of companies such as Silo Pharma Inc. (OTCQB: SILO) have run the psychedelic research gauntlet and are now focused on developing therapeutic formulations from these substances whose medical value is becoming more apparent with each passing year.
NOTE TO INVESTORS: The latest news and updates relating to Silo Pharma Inc. (OTCQB: SILO) are available in the company’s newsroom at https://ibn.fm/SILO
Please see full terms of use and disclaimers on the PsychedelicNewsWire website applicable to all content provided by PNW, wherever published or re-published: https://www.PsychedelicNewsWire.com/Disclaimer
Several psychedelics are outlawed by federal law, with the United States classifying drugs such as psilocybin, LSD, MDMA, mescaline and peyote as Schedule I controlled substances with no accepted medical use. Even though a few states have loosened some of their psychedelic policies, federal law prohibits the production, sale and use of psychedelic drugs.
According to two federal health agencies, federal prohibition has forced researchers to jump through numerous regulatory hoops and held back efforts to study the potential benefits and risks of psychedelic drugs. In a four-page letter sent as a response to Sen. Cory Booker’s and Sen. Brian Schatz’s request for an update on psychedelic drug research, the directors of the National Institute of Mental Health (NIMH) and the National Institute on Drug Abuse (NIDA) said that early research showed that psychedelic drugs had medical potential.
In May, the aforementioned senators sent a letter to the heads of the FDA and NIH arguing that federal prohibition was hindering psychedelics research and asking them to provide an update. The federal agencies admitted that although these psychedelic drugs do seem to have medical potential, the fact that they are controlled substances means any research involving psychedelics has to abide by requirements set forth by the Drug Enforcement (DEA).
The four-page reply letter noted that further research could help scientists uncover underlying disease mechanisms and develop new treatments with fewer side effects and reduced misuse potential.
NIDA Director Nora Volkow and NIMH Director Joshua Gordon stated in the letter that federally funded psychedelic research programs could find better ways to treat chronic pain or help smokers quit. They said that in the last fiscal year, NIH spent around $34 million on programs dedicated to studying the potential health benefits of psychedelics and psychedelic-derived drugs.
However, the letter stated that psychedelics offer unique methodological challenges when it comes to research because of their effects. For starters, running placebo-controlled clinical trials is a major challenge because the effects of psychedelic drugs on consciousness and perception mean that it is quite easy to distinguish them from a placebo.
Responding to a question from the two senators about research into psychedelics such as LSD from the 1950s and 1960s, the agencies said that these studies also showed that they have potential against mood disorders and addiction. However, they noted that a majority of these studies were carried out before modern human subject protections and ethical standards were developed.
The federal classification notwithstanding, a number of companies such as Silo Pharma Inc. (OTCQB: SILO) have run the psychedelic research gauntlet and are now focused on developing therapeutic formulations from these substances whose medical value is becoming more apparent with each passing year.
NOTE TO INVESTORS: The latest news and updates relating to Silo Pharma Inc. (OTCQB: SILO) are available in the company’s newsroom at https://ibn.fm/SILO
Please see full terms of use and disclaimers on the PsychedelicNewsWire website applicable to all content provided by PNW, wherever published or re-published: https://www.PsychedelicNewsWire.com/Disclaimer
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