WASHINGTON — For decades, proponents of psychedelic drugs have come to Washington with a provocative message: Illegal, mind-altering substances like LSD and ecstasy should be approved for Americans grappling with depression, trauma and other hard-to-treat conditions.
A presidential administration finally seems to agree.
“This line of therapeutics has tremendous advantage if given in a clinical setting and we are working very hard to make sure that happens within 12 months,” Health Secretary Robert F. Kennedy Jr. recently told members of Congress.
His suggested timeline for green-lighting psychedelic therapy surprised even the most bullish supporters of the drugs. And it comes as psychedelics are making inroads in deep red states like Texas, where former Trump cabinet secretary and ex-governor Rick Perry has thrown his full support behind the effort.
The administration’s embrace of psychedelics has sparked both excitement as well as concern from those in the field, who worry the drugs might be discredited if they appear to be rushed onto the market or are too closely linked with Kennedy, who is known for controversial views on vaccines, antidepressants and fluoride.
“I’m quite optimistic,” says Rick Doblin, whose organization has pursed the medical use of MDMA (or ecstasy) since the 1980s. “But I’m also worried that the message the public might get is ‘Well, RFK likes psychedelics and now it’s approved.’”
Under President Joe Biden, the FDA rejected MDMA as a treatment for post-traumatic stress disorder, citing flawed data and questionable research. Regulators called for a new study, likely taking several years. It was a major setback for Doblin and other advocates hoping to see the first U.S. approval of a psychedelic for medical use.
But the agency appears ready to reconsider. FDA chief Marty Makary, who reports to Kennedy, has called the evaluation of MDMA and other psychedelics “a top priority,” announcing a slate of initiatives that could be used to accelerate their approval.
One new program promises to expedite drugs that serve “the health interests of Americans,” by slashing their review time from six months or more to as little as one month. Makary has also suggested greater flexibility on requirements for certain drugs, potentially waiving rigorous controlled studies that compare patients to a placebo group.
That approach, considered essential for high-quality research, has long been a stumbling point for psychedelic…
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