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Officials at two agencies within the National Institutes of Health (NIH) have acknowledged in a letter to two U.S. senators that federal prohibition makes it harder to study the benefits of psychedelics, requiring researchers to jump through additional regulatory hoops.<\/p>\n
The four-page letter, which was shared with Marijuana Moment, is a response to Sens. Brian Schatz (D-HI) and Cory Booker (D-NJ), who last month wrote to the heads of the NIH and the Food and Drug Administration (FDA)<\/a> asking for an update on psychedelics research. The lawmakers argued that federal prohibition has stymied research into the efficacy and safety of the drugs despite growing evidence of their potential benefits.<\/p>\n \u201cBecause psychedelic drugs are controlled substances,\u201d the June 15 letter from the directors of the National Institute on Drug Abuse (NIDA) and the National Institute of Mental Health (NIMH) says, \u201cone additional regulatory consideration for basic and applied research using psychedelic drugs is that these studies must also follow Drug Enforcement (DEA) requirements, including registration, inspection, and certification of the drugs. These requirements apply to all psychedelic drugs, including natural or botanical products.\u201d<\/p>\n The officials said early research shows that psychedelics do have medical potential, but they signaled in the letter that they\u2019re interested in enabling the development of new drugs that can give patients the medical benefits of substances like psilocybin but without what they called \u201cnegative side effects.\u201d<\/p>\n \u201cResearch on psychedelic drugs holds promise for uncovering mechanisms of illness and possible interventions,\u201d they wrote, \u201cultimately leading to novel treatments with fewer side effects and lower potential for misuse.\u201d<\/p>\n The reply letter, signed by NIMH Director Joshua Gordon and NIDA Director Nora Volkow, acknowledges the therapeutic promise of psychedelics and other controlled substances\u2014noting federal funding, for example, supporting research into whether psilocybin might improve smoking cessation or help treat chronic pain. All told, the NIH officials said, the institute\u2019s component agencies spent about $34 million in the most recent fiscal year on 57 projects studying psychedelic and psychedelic-derived drugs with potential health benefits.<\/p>\n At the same time, the letter emphasizes what officials described as \u201cunique methodological challenges\u201d of studying psychedelics, such as the difficulty of conducting placebo-controlled clinical trials because the substances\u2019 \u201ceffects on perception and consciousness make them easy to distinguish from a placebo.\u201d<\/p>\n \u201cThese types of confounds make it especially challenging to design clinical trials for psychedelic drugs,\u201d the agency says, \u201cand to accurately interpret results.\u201d<\/p>\n In response to a question from the senators about earlier research into LSD and other psychedelic drugs in the 1950s and \u201960s, the federal officials said the studies \u201crevealed promising effects in mood disorders and addiction, but were conducted prior to the development of modern ethical standards and human subjects protections.\u201d<\/p>\n Regarding the modern protections for participants, they added that \u201cNIH does not view these regulatory considerations as barriers, but rather as necessary and essential safeguards.\u201d<\/p>\n Going forward, the NIDA and NIMH officials said the government supports an \u201cexperimental therapeutics approach\u2026in which the studies not only evaluate the clinical effect of an intervention, but also generate information about the mechanisms underlying a disorder or an intervention response.\u201d<\/p>\n \u201cUnderstanding the mechanisms of psychedelic drugs is important for identifying new therapeutic targets that could preserve therapeutic effects while minimizing negative side effects,\u201d the letter says. \u201cA key objective of these research efforts is to \u2018de-risk\u2019 novel drugs.\u201d<\/p>\n Other federal agencies, such as the U.S. Department of Defense\u2019s Defense Advanced Research Projects Agency (DARPA), have expressed similar interests in discovering how psychedelics work in order to <\/span>develop new drugs that exhibit similar therapeutic benefits<\/a> but without the accompanying psychedelic experience.<\/span><\/p>\n Schatz sent a similar letter questioning NIH and FDA<\/a> in 2019. At the time, the agencies sent an update recognizing possible medical uses but stressing that additional research is needed to understand the \u201cefficacy and long-term safety of psychedelic drugs,\u201d among other issues.<\/p>\n Asked in last month\u2019s letter from Schatz and Booker about what knowledge gaps still remain around psychedelics, the NIH officials replied that one obstacle is the lack of diversity in clinical participants. \u201cThis includes both racial and ethnic diversity, as well as a lack of participants with diverse medical histories,\u201d the letter says, \u201cas most psychedelics trials exclude potential participants with a family or personal history of psychosis or suicidal thoughts or behaviors.\u201d<\/p>\n Researchers at federal health agencies have previously complained about the obstacles created by federal prohibition. In a paper published late last year by the National Cancer Institute, a research team of six\u2014including authors from NIDA, NIH and FDA\u2014wrote that administrative burdens stifle much-needed scientific investigation into the drug\u2019s potential health applications and safety concerns.<\/p>\n Around the same time, Volkow, the NIDA director, said she personally hesitates to study marijuana because of its Schedule I designation<\/a>\u2014a classification that also applies to psilocybin, MDMA and other therapeutically promising drugs.<\/p>\n \u201cAs a researcher, I always hesitate to go into doing research with Schedule I drugs. I do research in human subjects [and] it\u2019s much more cumbersome,\u201d Volkow said at a forum last December. \u201cAnd this is what we hear also from our grantees, that it takes much longer to get the approval in order to initiate the research, and it\u2019s more costly, and that actually delays everyone\u2019s progress.\u201d<\/p>\n Meanwhile, the psychedelics reform movement has spread rapidly in states and localities throughout the U.S. over the past few years, following Denver\u2019s move to become the first city in the country to decriminalize psilocybin in 2019.<\/p>\n Separately, a bipartisan group of members of Congress sent a letter in January that urged the Drug Enforcement Administration (DEA) to let terminally ill patients have access to psilocybin<\/a>. The agency, lawmakers said, is \u201cobstructing access to psilocybin for therapeutic use consistent with the letter and intent Right to Try (RTT) laws.\u201d<\/p>\n Congress and 41 states have adopted right-to-try laws, which allow\u00a0patients with terminal conditions to try investigational medications<\/a>\u00a0that have not been approved for general use. Lawmakers said that DEA \u201chas failed to abide\u201d by the law.<\/p>\n More than a dozen psychedelics activists were arrested at DEA headquarters last month<\/a>\u00a0after protesting and using civil disobedience to draw attention to the issue.<\/p>\n DEA has\u00a0increased production quotas for the production<\/a>\u00a0of certain psychedelics like psilocybin in an effort to promote research, but its scheduling decisions have continued to represent obstacles for scientists.<\/p>\n Read the full psychedelics letter<\/a> from federal health officials below:<\/strong><\/p>\n\n House Committee Leaders Tackle Marijuana Research, Kratom, Impaired Driving And More In New Spending Measures<\/a><\/p>\n<\/blockquote>\n\n Photo courtesy of Wikimedia\/Workman<\/a>.<\/em><\/p>\n The post Federal Health Officials Say Psychedelics\u2019 Illegal Status Makes It Harder For Researchers To Study Them<\/a> appeared first on Marijuana Moment<\/a>.<\/p>\n
Officials at two agencies within the National Institutes of Health (NIH) have acknowledged in a letter to two U.S. senators that federal prohibition makes it harder to study the benefits of psychedelics, requiring researchers to jump through additional regulatory hoops. The four-page letter, which was shared with Marijuana Moment, isContinue Reading<\/a><\/span><\/p>\n","protected":false},"author":24,"featured_media":55569,"comment_status":"false","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[18,81,15462],"tags":[],"_links":{"self":[{"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts\/55568"}],"collection":[{"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/users\/24"}],"replies":[{"embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/comments?post=55568"}],"version-history":[{"count":1,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts\/55568\/revisions"}],"predecessor-version":[{"id":55570,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts\/55568\/revisions\/55570"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/media\/55569"}],"wp:attachment":[{"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/media?parent=55568"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/categories?post=55568"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/tags?post=55568"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}![\"\"](\"https:\/\/cannabiscultivatornews.com\/home\/wp-content\/uploads\/2022\/06\/Screen-Shot-2022-06-24-at-05.50.37-1024x476-1.png\")
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\nRead More: Federal Health Officials Say Psychedelics\u2019 Illegal Status Makes It Harder For Researchers To Study Them<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"