Fortune | FORTUNE 07月17日
RFK Jr. wants to approve psychedelics like LSD and ecstasy for people with depression and other conditions within 12 months
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近期,美国总统政府释放出对迷幻剂疗法的积极信号,卫生部长罗伯特·肯尼迪表示,目标在12个月内将此类疗法引入临床。此举在支持者中引发了兴奋,但也伴随着担忧,尤其是在前总统特朗普政府官员里克·佩里等人士的支持下,迷幻剂正逐渐渗透到保守派州。尽管FDA曾因数据问题拒绝MDMA用于治疗创伤后应激障碍,但新任FDA官员已将评估MDMA和其他迷幻剂列为优先事项,并计划通过缩短审批时间、放宽部分研究要求等方式加速其上市进程。然而,有专家担心过快推进可能损害迷幻剂的声誉,并呼吁在科学严谨的前提下进行。

🇺🇸 美国总统政府正在积极推动迷幻剂疗法,卫生部长罗伯特·肯尼迪的目标是在未来12个月内实现其在临床上的应用。这一表态标志着政府在迷幻剂研究和应用方面态度的转变,并得到了包括德克萨斯州等保守派州前官员的支持。

⚖️ FDA在拜登政府时期曾因数据和研究问题拒绝MDMA用于治疗创伤后应激障碍,但新任FDA官员已将评估MDMA和其他迷幻剂视为“首要任务”,并推出加速审批计划,可能缩短审批时间甚至放宽部分研究要求,例如允许在患者几乎能分辨出药物与安慰剂的情况下进行研究。

🔬 尽管政府释放出积极信号,但部分专家对过快推进迷幻剂疗法表示担忧。耶鲁大学的菲利普·科莱特博士认为,绕过严格的临床试验可能会损害该领域的发展并危及患者安全,强调在科学严谨的基础上推进的重要性。

🗺️ 在联邦政府审议迷幻剂未来之际,一些州已开始自行推进相关项目。俄勒冈州和科罗拉多州已将迷幻剂疗法合法化。德克萨斯州更是批准了5000万美元用于研究一种名为伊博碱(ibogaine)的迷幻剂,作为治疗阿片类药物成瘾和创伤后应激障碍等疾病的潜力疗法,这是政府层面对此类研究的最大一笔资助。

💡 伊博碱作为一种强效迷幻剂,在缓解成瘾和创伤方面展现出潜力,但同时也存在导致严重心律失常的风险。尽管联邦科学家曾因其“心血管毒性”而中止相关研究,但美国国家药物滥用研究所(NIDA)表示仍对迷幻剂感兴趣,并正在资助一家美国药企开发其更安全的合成版本。

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 pursued 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.’”

FDA may reconsider MDMA

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 studies, in which patients can almost always correctly guess whether they’ve received the drug or a dummy pill.

The U.S. Department of Health and Human Services and FDA also recently hired several new staffers with ties to the psychedelic movement.

“These are all very promising signs that the administration is aware of the potential of psychedelics and is trying to make overtures that they’re ready to approve them,” said Greg Ferenstein, a fellow at the libertarian Reason Foundation, who also consults for psychedelic companies. “We didn’t hear anything about that in the Biden administration”

A spokesperson for HHS did not respond to a request for comment.

As a presidential candidate, Kennedy discussed how his son and several close friends benefited from using psychedelics to deal with grief and other issues.

A number of veterans lobbying for psychedelic access have already met with Trump’s Secretary of Veterans Affairs, Doug Collins.

“What we’re seeing so far is positive,” Collins told House lawmakers in May.

But some experts worry the hope and hype surrounding psychedelics has gotten ahead of the science.

Philip Corlett, a psychiatric researcher at Yale University, says bypassing rigorous clinical trials could set back the field and jeopardize patients.

“If RFK and the new administration are serious about this work, there are things they could do to shepherd it into reality by meeting the benchmarks of medical science,” Corlett said. “I just don’t think that’s going to happen.”

Texas goes all-in on ibogaine research

As officials in Washington weigh the future of psychedelics, some states are moving ahead with their own projects in hopes of nudging the federal government. Oregon and Colorado have legalized psychedelic therapy.

And last month, Texas approved $50 million to study ibogaine, a potent psychedelic made from a shrub that’s native to West Africa, as a treatment for opioid addiction, PTSD and other conditions. The research grant — the largest of its kind by any government — passed with support from the state’s former GOP governor, Perry, and combat veterans, some who have traveled to clinics in Mexico that offer ibogaine.

Ibogaine is on the U.S. government’s ultra-restrictive list of illegal, Schedule 1 drugs, which also includes heroin. So advocates in Texas are hoping to build a national movement to ease restrictions on researching its use.

“Governmental systems move slowly and inefficiently,” said Bryan Hubbard of Americans for Ibogaine, a group formed with Perry. “Sometimes you find yourself constrained in terms of the progress you can make from within.”

Ibogaine is unique among psychedelics in both its purported benefits and risks. Small studies and anecdotal reports suggest the drug may be able to dramatically ease addiction and trauma. It was sold for medical use in France for several decades starting in the 1930s, but the drug can also cause dangerous irregular heart rhythms, which can be fatal if left untreated.

Some veterans who have taken the drug say the risks can be managed and ibogaine’s healing properties go far beyond antidepressants, mood stabilizers, counseling and other standard treatments.

Marcus Capone struggled with anger, insomnia and mood swings after 13 years as a Navy Seal. In 2017, at the urging of his wife Amber, he agreed to try ibogaine as a last resort. He described his first ibogaine session as “a complete purge of everything.”

“But afterward I felt the weight just completely off my shoulders,” he said. “No more anxiety, no more depression, life made sense all of a sudden.”

A nonprofit founded by the Capones, Veterans Exploring Treatment Solutions, or VETS, has helped over 1,000 veterans travel abroad to receive ibogaine and other psychedelics.

But federal scientists have looked at the drug before — three decades ago, when the National Institute on Drug Abuse funded preliminary studies on using it as an addiction treatment. The research was discontinued after it identified “cardiovascular toxicity.”

“It would be dead in the water,” in terms of winning FDA approval, longtime NIDA director Nora Volkow said.

But Volkow said her agency remains interested in psychedelics, including ibogaine, and is funding an American drugmaker that’s working to develop a safer, synthetic version of the drug.

“I am very intrigued by their pharmacological properties and how they are influencing the brain,” Volkow said. “But you also have to be very mindful not to fall into the hype and to be objective and rigorous in evaluating them.”

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迷幻剂疗法 FDA审批 MDMA 伊博碱 精神健康
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