FDA
Okays
Second
Ecstasy
Study
--
Effect
on
Terminal
Cancer
Patients
to
be
Tested
1/7/05
The Food and Drug Administration has approved a pilot study to examine whether MDMA, better known as the popular club drug Ecstasy, can help terminal cancer patients come to grips with end-of-life anxiety and depression. Pending final approval by the Drug Enforcement Administration, the study, led by Harvard Medical School researcher Dr. John Halpern, is set to begin this spring with 12 cancer patients at the Lahey Clinic and McLean Hospital in the Boston area. After a virtual ban on psychedelic research dating back to the fallout over the research projects of another Harvard researcher, Timothy Leary, the Harvard study marks the second time in a few months that the FDA has approved research into the use of Ecstasy for therapeutic purposes. Last year, the agency gave final approval to a South Carolina study of Ecstasy's efficacy in treating patients with post-traumatic stress disorder (https://stopthedrugwar.org/chronicle-old/304/maps.shtml). Other studies testing the efficacy of psilocybin, the active ingredient in psychedelic mushrooms, for people with anxiety and obsessive-compulsive disorders are also underway. According to Dr. Halpern, Ecstasy is an "empathogen," a substance that can reduce stress and increase empathy. Unlike LSD, said Halpern, Ecstasy is "ego friendly," and unlike many pain medications, it does not make people groggy or over-sedated. Instead, according to anecdotal reports, people with terminal illnesses who have taken the drug found it easier to talk to friends and families about death and other uncomfortable subjects. "End of life issues are very important and are getting more and more attention, and yet there are very few options for patients who are facing death," he said in a statement Monday.
"The approval of this study by McLean Hospital, the Lahey Clinic, and the FDA represents a triumph of hope over fear, hope for the too-long obstructed promise of MDMA-assisted psychotherapy versus fear of the risks of MDMA exaggerated by anti-drug crusaders and scientists for their own ends," said Doblin. "At a time when the US government has placed all its eggs in the basket of fear -- war, terrorism, 'drugs,' failing Social Security, the 'menace' of gay marriage -- the remarkably widespread media coverage of the FDA's approval of psychedelic research again at Harvard after 40 years shows that people are eager for balance and hopeful news," he told DRCNet. "It is now clear that the American public would welcome whatever help can be provided in facing directly life's great challenge, to die gracefully and in peace, even if such help comes from a previously demonized and criminalized substance also used by young people seeking pleasure." The discoverer of the big daddy of psychedelics, LSD, Dr. Albert Hoffman, who turns 99 this month, referred to the substance as "my problem child" because its widespread recreational use by 'hippies' removed it from the realm of medicine and science and embroiled it in the culture wars. But Hoffman remains convinced that psychedelics like LSD can have positive therapeutic effects. And while psychedelics have indeed been demonized since they were popularized for recreational use by the likes of Leary, recent research into their therapeutic effects is already providing evidence Hoffman's optimism is not misplaced. Dr. Charles Grob, a psychiatrist at the Harbor-UCLA Medical Center in Los Angeles who is leading an FDA-approved study of the efficacy of psilocybin in helping terminal cancer patients deal with end-of-life emotional and spiritual issues, told the Washington Post that while psychedelics may be dangerous if used improperly, if used in a therapeutic setting, they can yield impressive results. "When taken under adverse circumstances by ill-prepared individuals, there are substantial risks," said Grob. "But when taken in the context of carefully structured and approved research protocols, adverse effects can be contained to a minimum." Grob's patients, who take "modest" doses of synthetic psilocybin and then spend the next few hours in a comfortable setting with a psychiatrist, are doing well, he said. "So far they have had impressive results in terms of amelioration of anxiety, improvement of mood, increased rapport with family and friends and, interestingly, significant and lasting reductions in pain. These are extraordinary compounds that seem to have an uncanny ability to reliably induce spiritual or religious experiences when taken in the right conditions." Dr. Michael Mithoefer, the South Carolina psychiatrist running the study of Ecstasy in the treatment of post-traumatic stress disorder, has reported no problems in the early stages of his study, the Post noted. Dr. Halpern, who will lead the Boston study, told the Post psychedelics may not be for everyone, but "may be helpful" for many facing death. In that interview, he took pains to distance himself from Leary, whose free-wheeling experimentation on students with LSD led to his dismissal from Harvard and a decades-long virtual moratorium on psychedelic research nationwide. "This is not about hippy dippy Halpern trying to turn on the world," he said. "I'm not looking for a magic bullet, but for a lot of people, the anxiety about death is so tremendous there is no way to get their arms around the problems that were ongoing in their families. This could be a substantial contribution to the range of palliative care strategies we're trying to develop for people facing death."
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