St. Petersburg Times
May 9, 2005
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Party pill gets tryout in therapy
A nonprofit group in Sarasota funds medical research on methylene-dioxymethamphetamine, also known as ecstasy.
By JANET ZINK
If Rick Doblin had his way, ecstasy, an illegal drug popular at all-night dance parties, would be available soon at a physician’s office near you.
Doblin heads a nonprofit corporation in Sarasota that is funding the first U.S. government-approved medical research on the chemical methylenedioxymethamphetamine, also known as ecstasy.
The study takes place in South Carolina in a private doctor’s office where psychiatrist Michael Mithoefer gives the drug, manufactured by a chemist at Purdue University, to posttraumatic stress disorder patients. Already, eight people have been enrolled in a program that will eventually include 20.
Researchers believe that ecstasy, which acts on the same brain chemicals as popular antidepressants, will make psychotherapy more productive for victims of violence whose emotional scars have not healed with other types of treatment.
It’s a theory that has intrigued the likes of Peter Lewis, former CEO of Progressive insurance, who contributed $250,000 to Doblin’s organization for ecstasy studies.
The South Carolina project is part of a new wave of research that focuses on the possible medicinal benefits of illegal drugs – ecstasy, psychedelic mushrooms, LSD and marijuana.
Mithoefer said early results of his ecstasy study, which started last year, have been promising.
Participants – including a drive-by shooting victim from California and a rape victim plagued by nightmares for 25 years – report relief from their stress symptoms. They have fewer nightmares, startle less easily and experience a fuller range of emotion, Mithoefer said.
“These are all people that have failed other treatments,” he said. “They’ve had therapy and medicines and still have PTSD symptoms.”
In Mithoefer’s care, the patients receive two months of psychotherapy. During two eight-hour drug sessions, they take either ecstasy or a placebo.
Patients lie on a futon while wearing eyeshades and listening to instrumental music.
Mithoefer and his co-therapist, wife Ann Mithoefer, encourage the patients to drift between talking about their traumatic past and “paying attention to their inner experience,” Mithoefer said.
After the study, the placebo patients can do it all again – this time with the ecstasy.
To do the study, Mithoefer won approvals from the Food and Drug Administration, the Drug Enforcement Administration, and an Institutional Review Board that includes physicians and scientists who ensure medical research is safe for human subjects.
Funding for Mithoefer’s study comes entirely from Sarasota’s Multidisciplinary Association of Psychedelic Studies, an organization Doblin founded in 1986 when he was a student at New College of Florida, the state’s liberal arts honors college.
Raising money, winning approvals and fighting legal battles for studies has become the life work of 52-year-old Doblin, who guesses he has used ecstasy 100 times over the past 23 years, including recently.
The past 18 months have been big for him.
The ecstasy study began in South Carolina. He helped get FDA approval for a similar study at Harvard University of end-stage cancer patients, and expects a decision from the DEA on the study in the next two weeks.
In the past two months, he has met with government officials and researchers from Switzerland, Israel and Spain who are interested in supporting ecstasy trials. And the U.S. Supreme Court is expected to rule soon on a medical marijuana case in which Doblin filed a legal brief of support.
“Everything is hitting a crescendo right now,” said Doblin, who currently lives outside Cambridge, Mass. “It’s a pivotal time for us.”
The Psychedelic Studies office in Sarasota serves as ground zero for his work.
It’s in a home he built to be a “centering place,” in 1975, three years after dropping out of New College.
He started taking classes again in 1982, graduated in 1987 with a degree in psychology and moved to Massachusetts, where he earned a doctorate in public policy at Harvard.
Doblin returned often to Florida and taught a class on drug policy at New College in 2001.
Three of his former students now live and work in the Sarasota home office. A fourth woman works out of her home in Bradenton.
Whenever news breaks about the organization, employee Valerie Mojeiko said, city officials come knocking to see if Doblin’s people are giving out drugs. They’re not, she said. That’s in South Carolina.
In Sarasota, they push papers for study approvals, schmooze donors and create a journal and e-mail newsletter for 1,600 supporters, who pay $20 or more a year for the privilege. The organization took in more than $1-million in 2003-04. The money came from private donations and grants. About $147,000 goes to modest salaries for Doblin and his staff.
Most backers are medical professionals and hippies, but “there’s this middle group of people you would never suspect, that don’t meet the stereotypes,” Doblin said.
Men’s Wearhouse founder George Zimmer and his family directed $15,000 to Doblin’s organization through the Zimmer Family Foundation.
“Mr. Zimmer’s long-standing interest in this research stems from his experience caring for his mother, who died of cancer without the benefit of alternative therapies,” said Kirk Warren, the foundation’s administrator.
Civil libertarian John Gilmore, who earned his fortune as an early engineer for Sun Microsystems, serves on the Psychedelic Studies association’s board of directors and has donated more than $700,000. He said he supports Doblin’s work because he believes the nation’s drug policy exaggerates the danger of drugs and is based on the Nixon administration’s desire to attack antiwar activists.
“Drug policy has not yet recovered from that political stigma,” Gilmore said.
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Anti drug-abuse groups argue that exploring the medical benefits of drugs such as ecstasy is dangerous and fueled by those with hidden agendas.
Bob DuPont, a Maryland physician and founding director of the National Institute on Drug Abuse, said even discussion of therapeutic uses furthers the cause of those in the drug legalization movement.
“It sends a message that is socially harmful, and that is that this stuff is good for you. That’s a problem,” DuPont said.
The research on ecstasy, he said, can be defended because it’s a carefully synthesized drug and the dosage can be controlled. Still, he doesn’t think it will ever become an approved medication because of its high potential for abuse.
Joyce Nalepka, president of Drug-Free Kids in Silver Spring, Md., has been involved with the antidrug movement for more than 20 years.
People like Doblin just want to weaken drug laws to pave the way for recreational use, she said, noting, “All they want is the freedom to put whatever drug they want in their bodies.”
Doblin acknowledges he supports legalization.
He points out that Oxycontin, a prescription medication, is often abused, and cocaine, while illegal on the street, is used as an anesthetic during nose and throat surgery.
“The government wants to characterize it all as evil and makes no distinction between use and abuse,” he said.
Some scientists distance themselves from Doblin, and even Mithoefer makes a point of separating his work from Doblin’s fundraising methods.
“I leave the fundraising to Rick,” Mithoefer said. “He’s the sponsor. I’m the investigator.”
In October, Doblin’s organization hosted a fundraiser in New York City that drew about 200
Some paid $100 each to hear lectures by the nation’s leading psychedelic researchers, including Mithoefer; Charles Grob of the University of California at Los Angeles, who has treated dying cancer patients with a compound found in psychedelic mushrooms, as part of a study on easing anxiety; and John Halpern, associate director of substance abuse research at Harvard University’s McLean Hospital.
Guests included nearly two dozen New College graduates and Tampa neurologist Juan Sanchez-Ramos, a University of South Florida researcher who thinks psychedelics might offer a physiological fix for brain diseases such as Parkinson’s and Alzheimer’s. Chemicals found in some psychedelic mushrooms stimulate cell growth in the part of the brain damaged by those diseases, he said.
After the lectures, the academics left – Mithoefer and Sanchez-Ramos, among them – and the second prong of Doblin’s fundraiser began in a yoga room turned nightclub. People paid $25 each to attend.
It was a rave, an all-night dance party, and guests offered one another ecstasy.
Some took it; others abstained.
A man wearing only cotton briefs danced with a thin blond woman in black underwear and a tiny silver top. A man with glow-sticks woven into his dreadlocks partnered with a young woman in a crinolin skirt and belly-dancer top.
Doblin had fretted a little about hosting a rave as a fundraiser because the parties have a negative connotation. People risk drinking and dancing themselves to fatal dehydration. He made a point of providing plenty of water and no alcohol.
The way he sees it, psychedelics have been around for thousands of years to enhance spiritual experiences. Dance is often a part of that process. The trancelike state of the dancers at raves is no different, he said.
While the rave went on, he sat on pillows in an adjacent art gallery, watching the people come and go, declaring it all a success.
* * *
With Mithoefer’s study under way, Doblin thinks more research will follow.
It took 17 years to get federal approval to launch the South Carolina study.
It took less than three years to get FDA approval for Harvard’s planned study using ecstasy to treat anxiety in end-stage cancer patients. That study will be conducted by John Halpern, who also wants to study LSD as a treatment for severe headaches.
Halpern – once a defense witness in the trial of Valessa Robinson, a Tampa teenager and LSD-user convicted in 2000 of killing her mother – said dealing with death or trauma often requires a mental transformation that psychedelics might help create.
“If we’re right, we’re going to help people,” he told people at the October fundraiser.
If ecstasy did get approved for therapy, it would only be given in specialized settings, Mithoefer said. “Nobody would be getting it prescribed to take home and not anybody could prescribe it.”
Research on therapeutic uses for psychedelics hasn’t been done in the United States since the early 1970s, when the antidrug movement began.
Studies switched focus to addiction treatment and testing for physiological effects of drugs.
Doblin attributes the renewed interest in psychedelic research in part to the popularity of antidepressants and psychotherapy.
Ecstasy acts on the same brain chemicals – including serotonin – as Prozac, Zoloft and other popular pills.
“It makes it easier for us to explain why it might work,” he said.
The choice of research subjects – terminal cancer patients and trauma victims – is no accident. Even the most conservative can sympathize with them, Doblin said.
“People may be afraid of drugs,” he said.
“But they’re more afraid of dying in pain and dying in fear.”
The St. Petersburg Times ran a front page article, “Party pill gets tryout in therapy” written by Janet Zink, offering reporting on MAPS’ mission of decriminizaling the use of MDMA for therapeutic purposes.