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  1. Alfa
    'Ecstasy' Use Studied to Ease Fear in Terminally Ill


    For some, the diagnosis comes out of the blue. For others, it arrives after a long battle. Either way, the news that death is just a few months away poses a daunting challenge for both doctor and patient.


    Drugs can ease pain and reduce anxiety, but what about the more profound issues that come with impending death? The wish to resolve lingering conflicts with family members. The longing to know, before it's too late, what it means to love, or what it meant to live. There is no medicine to address such dis-ease.


    Or is there?


    This month, in a little-noted administrative decision, the Food and Drug Administration gave the green light to a Harvard proposal to test the benefits of the illegal street drug known as "ecstasy" in patients diagnosed with severe anxiety related to advanced cancer.


    The drug, also known as 3,4-methylenedioxymethamphetamine, or MDMA, has been referred to by psychiatrists as an "empathogen," a drug especially good at putting people in touch with their emotions. Some believe it could help patients come to terms with the biggest emotional challenge of all: the end of life.


    The FDA's approval puts the study on track to become the first test of a psychedelic substance since 1963 at Harvard, where drug guru Timothy Leary lost his teaching privileges after using students in experiments with LSD and other hallucinogens.


    It also marks a milestone for a small but increasingly effective movement favoring a more open-minded attitude toward the therapeutic potential of psychedelic drugs, virtually all of which have been criminalized and disparaged for decades as medically useless.


    Already, MDMA is being tested for its ability to reduce symptoms of post-traumatic stress disorder. And two U.S. studies are looking at the usefulness of psilocybin -- the active ingredient in "magic mushrooms" -- in terminally ill cancer patients and in people with obsessive-compulsive disorder.


    In the coming year, advocates also hope to submit to the FDA an application to test psilocybin and LSD as treatments for a debilitating syndrome known as cluster headaches.


    That would be a fitting birthday present for Albert Hofmann, the chemist who discovered both compounds while working for the Swiss drug company Sandoz and who turns 99 in January, said Rick Doblin, president of the Multidisciplinary Association for Psychedelic Studies. The Sarasota-based nonprofit has organized and funded much of the new research.


    Hofmann, who has expressed support for clinical studies such as the one being planned at Harvard, has referred to LSD as his "problem child" -- a reference to his belief that despite its widespread abuse, the mind-altering drug has the potential to help some people.


    Although they vary in their chemical structures and specific effects, many psychedelic drugs work on the parts of the brain that regulate serotonin -- the same brain chemical that is the target of many FDA-approved antidepressants. That does not indicate that the drugs are necessarily safe; indeed, they all carry some medical and psychiatric risk.


    Yet even scientists who have been vocal about those risks have expressed at least guarded support for the idea that, in the company of a therapist and with proper medical monitoring, moderate doses might benefit some people. "When taken under adverse circumstances by ill-prepared individuals, there are substantial psychological risks,"


    said Charles Grob, a psychiatrist at Harbor-UCLA Medical Center in Los Angeles. "But when taken in the context of carefully structured and approved research protocols and facilitated by individuals with expertise, adverse effects can be contained to a minimum."


    Grob is leading an FDA-approved study in which terminally ill cancer patients are being given psilocybin to see whether it can help them sort through emotional and spiritual issues. He said the patients take a "modest" dose of synthetic psilocybin, equivalent to two or three illicit mushrooms. They spend the next six hours or so in a comfortable setting with a psychiatrist -- talking, thinking and sometimes listening to music with headphones.


    "So far they have had very impressive results in terms of amelioration of anxiety, improvement of mood, improved rapport with close family and friends and, interestingly, significant and lasting reductions in pain," Grob said of the first few patients to enroll. "These are extraordinary compounds that seem to have an uncanny ability to reliably induce spiritual or religious experiences when taken in the right conditions."


    Promising results have also been reported at the University of Arizona from a 10-person study of psilocybin for obsessive-compulsive disorder, which locks people into repetitive thoughts and actions. And Charleston, S.C., psychiatrist Michael Mithoefer has seen no complications in any of the five patients who have enrolled in his 20-person study of MDMA for victims of violence struggling with post-traumatic stress disorder.


    With the FDA's Dec. 17 approval of the Harvard MDMA protocol -- and permission in hand from ethics review boards at Harvard and the nearby Lahey Clinic, where patients will be recruited -- the only remaining hurdle is getting a special license from the Drug Enforcement Administration. A dozen subjects with less than 12 months to live will get either low or moderate doses of MDMA during two sessions a few weeks apart, along with counseling and a variety of psychological tests before and after treatment.


    The approach has its doubters.


    "Even in antiquity, some groups thought it was especially important to take whatever their local psychedelic was -- including alcohol -- when confronting mortality, whether it's to see into the hereafter, improve spiritual growth or just numb yourself to the reality," said Joanne Lynn, president of the Washington-based Americans for Better Care of the Dying and director of RAND Health, a science and policy research center. But drugs can be disorienting, she said.


    "It's sometimes poetic, sometimes majestic, but often mundane work to wrap up one's life," Lynn said. "I think it's unlikely there's a pill that will make that go away."


    John Halpern, associate director of substance abuse research in the biological psychiatry lab at Harvard's McLean Hospital, who will lead the MDMA study there, agreed that it is not for everyone. But creating a sense of connection with something greater than oneself "may be helpful" for many facing death, he said.


    Halpern emphasized the differences between his study and the freewheeling experiments conducted by Leary in the 1960s.


    "This is not about hippy dippy Halpern trying to turn on the world.


    I'm not looking at this as a magic bullet," he said. "But for a lot of people, the anxiety about death is so tremendous that there is no way to get their arms around the problems that were ongoing in their family. This could be a substantial contribution to the range of palliative care strategies we're trying to develop for people facing their death."


    Laura Huxley, widow of the author and metaphysical pioneer Aldous Huxley, said her husband asked for -- and she provided -- a dose of LSD as he lay dying in 1963. "He wanted to be aware," the 93-year-old supporter of the new research said last week. "It's a very important moment."


    Leary took a wide array of psychedelics in the weeks leading up to his death from cancer in 1996. Some suspect the drugs clouded rather than sharpened his perceptions, but he died with a positive attitude.


    "It's kind of interesting really," he said of dying, talking to a friend in his final days. "You should try it sometime."

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