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Long Trip for Psychedelic Drugs
By Kristen Philipkoski
02:00 AM Sep. 27, 2004 PT
Psychedelic drugs are inching their way slowly but surely toward prescription status in the United States, thanks to a group of persistent scientists who believe drugs like ecstasy and psilocybin can help people with terminal cancer, obsessive-compulsive disorder and post-traumatic stress disorder, to name just a few.
The Heffter Research Institute, the Multidisciplinary Association for Psychedelic Studies and others have managed to persuade the Food and Drug Administration to approve a handful of clinical trials using psychedelics. The movement seems to be gaining ground in recent years. Since 2001, the FDA and the Drug Enforcement Administration have given the go-ahead to three clinical trials testing psychedelics on symptomatic patients, and several more are on deck.
Doctors who saw their patients benefit from psychedelic drugs back when they were legal are dedicated to jumping through bureaucratic hoops and diminishing the drugs' party stigma to get psychedelics in patients' hands, and brains.
"I'm interested in the treatment being available to people who need it, and doing it aboveboard and publishing good results," said George Greer, founder of the Heffter Research Institute, a scientific organization that organizes and funds trials involving psychedelics.
At first blush, it seems like an uphill battle more challenging than the one medical-marijuana advocates have been facing. MDMA has been vilified by the National Institute on Drug Abuse and in news stories, making it seem unlikely that federal agencies will ever allow the legal use of psychedelics.
But it might actually be easier to get psychedelics through the approval process than marijuana, according to Rick Doblin, founder and president of MAPS. The roadblock with marijuana has centered on supply. A government-controlled crop in Mississippi is the only marijuana the government will allow in clinical trials. But the supply of psychedelics is decentralized, and the researchers have control of much of it.
Doblin's persistence and know-how -- he has a doctorate in public policy from Harvard's John F. Kennedy School of Government -- led to the launch of the first FDA-approved clinical trial testing MDMA as a therapy (in this case for post-traumatic stress disorder) since the drug became illegal.
And now it looks like Doblin's alma mater may be close to launching the first psychedelic research that Harvard has allowed on its campus in almost 40 years. Two weeks ago, Dr. John Halpern, an associate director of the substance-abuse research program at Harvard's McLean Hospital, presented his proposal for testing MDMA as a treatment for anxiety in terminal cancer patients to an institutional review board -- a body of scientists, ethicists and community members -- which approves and keeps tabs on studies.
"It feels like we're getting close to opening the door to psychedelic research at Harvard, which has been shut since 1965, so these are exciting times," Doblin said.
Halpern is also working with Bob Wold, a 51-year-old construction firm owner who suffered from debilitating cluster headaches, which are rare but brutal, until four years ago when he tried psilocybin to treat them. Wold had never used psychedelic drugs recreationally, and he was concerned and skeptical about using an illegal substance. But he was in the midst of choosing between three surgeries for his cluster headaches, each of which would have cost about $35,000. One involved a gamma knife to cut into his brain; the other two required holes drilled in his skull. Given those options, psilocybin didn't seem so radical.
"(The psilocybin) broke my cycle" of headaches, Wold said. "There is nothing on the market now, and there never has been, that will actually break a cycle."
Achieving relief from his nightmarish pain spurred Wold to start a movement. He now runs clusterbusters.com, where he communicates with about 200 other cluster-headache victims who have tried psilocybin to relieve their pain. Wold has collected reams of data in the form of questionnaires, which Halpern can present to Harvard's institutional review board.
Studies starting as early as the '30s that showed positive results treating cluster and migraine headaches with psilocybin and LSD helped Wold decide to try a psychedelic. The studies also showed success with other disorders including depression, alcoholism and addiction to other drugs like heroin.
The Heffter institute's Greer saw firsthand the effects of MDMA on his patients in the early '80s. He synthesized his own MDMA (it was first synthesized by Merck in 1912) along with Alexander Shulgin, who became a cult figure for psychedelic enthusiasts. In 1986, Greer and his wife, Requa Tolbert, a clinical nurse, published the first and what is still the largest body of data on the therapeutic effects of ecstasy.
Greer hoped eventually to discover the mechanism of MDMA, which stands for 3,4-methylenedioxy-N-methylamphetamine, and get it approved as a prescription drug for certain ailments. But starting in 1985, the tone of psychedelic research changed. Ecstasy had become a popular street drug, and the DEA declared MDMA a schedule 1 drug, the highest level of illegal drug in the United States. Anyone caught using or distributing ecstasy, including doctors, would face fines and jail time, and Greer stopped prescribing it for his patients.
"The government was funding a lot of research about abuse of psychedelic drugs," Greer said, "but no one was funding research to use them to understand how the brain works or to treat people with psychological or medical problems."
Another reason progress has been slow is because NIDA-funded studies performed by Dr. George Ricaurte and Dr. Una McCann found that MDMA had ill effects on the brain. A 2002 study was particularly worrisome because it showed that ecstasy caused Parkinson's-like brain damage. But a year later, the researchers retracted the study because they discovered they had accidentally used methamphetamine instead of ecstasy.
In the wake of these controversial results, psilocybin, the active ingredient in "magic mushrooms," seemed more acceptable to the FDA and DEA. Dr. Charles Grob, head of adolescent and child psychiatry at the Harbor-UCLA Medical Center, tried for almost a decade to get the go-ahead to perform a study using MDMA to treat anxiety in terminal cancer patients. He got permission in the early '90s to use the drug in a safety study on healthy volunteers, the results of which were published in Behavioral Brain Research in 1996, and the Journal of Magnetic Resonance Imaging in 1999.
But what he really wanted was to work with a patient population. When after several years neither the FDA nor the DEA went for the idea, he changed his proposal.
"By the late '90s felt it felt hopeless to work with MDMA because it had gotten such a negative reputation, so we revamped the study to work with psilocybin," Grob said. "In 2003, it was accepted."
Due to the strict guidelines for the study, however, only two patients out of the 12 necessary to complete the trial have participated in the study, and another is lined up.
Dr. Francisco Moreno at the University of Arizona has administered psilocybin to eight obsessive-compulsive disorder patients. His study, which began in 2001, was the first FDA-approved clinical trial involving a psychedelic in 30 years. He presented positive results at a recent scientific meeting, and is in the process of publishing his data in a medical journal.
"I'm very optimistic for the future," Grob said. "I think these compounds have tremendous untapped potential to be utilized within medicine and psychology. I think they need to be demystified, and safety parameters need to be established and studied. But with good controls, I think they can be used safely and effectively."
:source:
By Kristen Philipkoski
02:00 AM Sep. 27, 2004 PT
Psychedelic drugs are inching their way slowly but surely toward prescription status in the United States, thanks to a group of persistent scientists who believe drugs like ecstasy and psilocybin can help people with terminal cancer, obsessive-compulsive disorder and post-traumatic stress disorder, to name just a few.
The Heffter Research Institute, the Multidisciplinary Association for Psychedelic Studies and others have managed to persuade the Food and Drug Administration to approve a handful of clinical trials using psychedelics. The movement seems to be gaining ground in recent years. Since 2001, the FDA and the Drug Enforcement Administration have given the go-ahead to three clinical trials testing psychedelics on symptomatic patients, and several more are on deck.
Doctors who saw their patients benefit from psychedelic drugs back when they were legal are dedicated to jumping through bureaucratic hoops and diminishing the drugs' party stigma to get psychedelics in patients' hands, and brains.
"I'm interested in the treatment being available to people who need it, and doing it aboveboard and publishing good results," said George Greer, founder of the Heffter Research Institute, a scientific organization that organizes and funds trials involving psychedelics.
At first blush, it seems like an uphill battle more challenging than the one medical-marijuana advocates have been facing. MDMA has been vilified by the National Institute on Drug Abuse and in news stories, making it seem unlikely that federal agencies will ever allow the legal use of psychedelics.
But it might actually be easier to get psychedelics through the approval process than marijuana, according to Rick Doblin, founder and president of MAPS. The roadblock with marijuana has centered on supply. A government-controlled crop in Mississippi is the only marijuana the government will allow in clinical trials. But the supply of psychedelics is decentralized, and the researchers have control of much of it.
Doblin's persistence and know-how -- he has a doctorate in public policy from Harvard's John F. Kennedy School of Government -- led to the launch of the first FDA-approved clinical trial testing MDMA as a therapy (in this case for post-traumatic stress disorder) since the drug became illegal.
And now it looks like Doblin's alma mater may be close to launching the first psychedelic research that Harvard has allowed on its campus in almost 40 years. Two weeks ago, Dr. John Halpern, an associate director of the substance-abuse research program at Harvard's McLean Hospital, presented his proposal for testing MDMA as a treatment for anxiety in terminal cancer patients to an institutional review board -- a body of scientists, ethicists and community members -- which approves and keeps tabs on studies.
"It feels like we're getting close to opening the door to psychedelic research at Harvard, which has been shut since 1965, so these are exciting times," Doblin said.
Halpern is also working with Bob Wold, a 51-year-old construction firm owner who suffered from debilitating cluster headaches, which are rare but brutal, until four years ago when he tried psilocybin to treat them. Wold had never used psychedelic drugs recreationally, and he was concerned and skeptical about using an illegal substance. But he was in the midst of choosing between three surgeries for his cluster headaches, each of which would have cost about $35,000. One involved a gamma knife to cut into his brain; the other two required holes drilled in his skull. Given those options, psilocybin didn't seem so radical.
"(The psilocybin) broke my cycle" of headaches, Wold said. "There is nothing on the market now, and there never has been, that will actually break a cycle."
Achieving relief from his nightmarish pain spurred Wold to start a movement. He now runs clusterbusters.com, where he communicates with about 200 other cluster-headache victims who have tried psilocybin to relieve their pain. Wold has collected reams of data in the form of questionnaires, which Halpern can present to Harvard's institutional review board.
Studies starting as early as the '30s that showed positive results treating cluster and migraine headaches with psilocybin and LSD helped Wold decide to try a psychedelic. The studies also showed success with other disorders including depression, alcoholism and addiction to other drugs like heroin.
The Heffter institute's Greer saw firsthand the effects of MDMA on his patients in the early '80s. He synthesized his own MDMA (it was first synthesized by Merck in 1912) along with Alexander Shulgin, who became a cult figure for psychedelic enthusiasts. In 1986, Greer and his wife, Requa Tolbert, a clinical nurse, published the first and what is still the largest body of data on the therapeutic effects of ecstasy.
Greer hoped eventually to discover the mechanism of MDMA, which stands for 3,4-methylenedioxy-N-methylamphetamine, and get it approved as a prescription drug for certain ailments. But starting in 1985, the tone of psychedelic research changed. Ecstasy had become a popular street drug, and the DEA declared MDMA a schedule 1 drug, the highest level of illegal drug in the United States. Anyone caught using or distributing ecstasy, including doctors, would face fines and jail time, and Greer stopped prescribing it for his patients.
"The government was funding a lot of research about abuse of psychedelic drugs," Greer said, "but no one was funding research to use them to understand how the brain works or to treat people with psychological or medical problems."
Another reason progress has been slow is because NIDA-funded studies performed by Dr. George Ricaurte and Dr. Una McCann found that MDMA had ill effects on the brain. A 2002 study was particularly worrisome because it showed that ecstasy caused Parkinson's-like brain damage. But a year later, the researchers retracted the study because they discovered they had accidentally used methamphetamine instead of ecstasy.
In the wake of these controversial results, psilocybin, the active ingredient in "magic mushrooms," seemed more acceptable to the FDA and DEA. Dr. Charles Grob, head of adolescent and child psychiatry at the Harbor-UCLA Medical Center, tried for almost a decade to get the go-ahead to perform a study using MDMA to treat anxiety in terminal cancer patients. He got permission in the early '90s to use the drug in a safety study on healthy volunteers, the results of which were published in Behavioral Brain Research in 1996, and the Journal of Magnetic Resonance Imaging in 1999.
But what he really wanted was to work with a patient population. When after several years neither the FDA nor the DEA went for the idea, he changed his proposal.
"By the late '90s felt it felt hopeless to work with MDMA because it had gotten such a negative reputation, so we revamped the study to work with psilocybin," Grob said. "In 2003, it was accepted."
Due to the strict guidelines for the study, however, only two patients out of the 12 necessary to complete the trial have participated in the study, and another is lined up.
Dr. Francisco Moreno at the University of Arizona has administered psilocybin to eight obsessive-compulsive disorder patients. His study, which began in 2001, was the first FDA-approved clinical trial involving a psychedelic in 30 years. He presented positive results at a recent scientific meeting, and is in the process of publishing his data in a medical journal.
"I'm very optimistic for the future," Grob said. "I think these compounds have tremendous untapped potential to be utilized within medicine and psychology. I think they need to be demystified, and safety parameters need to be established and studied. But with good controls, I think they can be used safely and effectively."
:source:
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