- 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 a just a few.
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- 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.
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- 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.
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- 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.
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- 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.
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- 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.
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- 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 65 years. Two weeks ago, Dr. John Halpern, an associate
director
of the substance-abuse research program at Harvard's McClean 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.
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- "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.
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- 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.
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- "(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."
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- 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.
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- 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.
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- 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.
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- 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.
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- "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."
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- 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.
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- 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.
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- 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.
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- "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."
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- 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.
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- 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.
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- "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."
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