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Pubdate: Tue, 06 Nov 2001 Source: Wall Street Journal (US) Copyright: 2001 Dow Jones & Company, Inc. Contact: http://www.wsj.com/ Details: http://www.mapinc.org/media/487 Author: Rachel Zimmerman, Staff Reporter Of The Wall Street Journal Cited: Multidisciplinary Association for Psychedelic Studies http://www.maps.org Rick Doblin http://www.mapinc.org/people/Rick+Doblin National Institute on Drug Abuse http://www.nida.nih.gov/ Alan Leshner http://www.mapinc.org/people/Alan+Leshner Bookmark: http://www.mapinc.org/mdma.htm (Ecstasy) FDA PERMITS FIRST TEST OF ECSTASY AS TREATMENT FOR STRESS DISORDER Sixteen years after the so-called love drug Ecstasy was criminalized, the U.S. Food and Drug Administration has approved the first study of the substance as a treatment for people with posttraumatic stress disorder. The nonprofit group conducting the small pilot study with an eye toward developing Ecstasy, or MDMA, as a prescription drug says the recent wave of terrorism makes finding effective treatments for the condition more important than ever. "There's something ennobling about taking MDMA to work through things and really grapple with deep, painful emotions at that level of honesty and openness," says study sponsor Rick Doblin, founder and director of the Multidisciplinary Association for Psychedelic Studies, an organization that advocates using Ecstasy and other psychedelic drugs for therapy. The FDA declines to comment on MAPS's Investigational New Drug Application, which is an early step in the clinical trial process. The MAPS test still requires approval by an Institutional Review Board at the Medical University of South Carolina in Charleston, where the trial would take place. If all goes as planned, the study will include 20 subjects; 12 will undergo MDMA-assisted therapy twice, each time taking a single, 125-milligram capsule, and eight will get a placebo. Each person will also undergo 16 hours of therapy without drugs, over three months. All sessions will be under the direct supervision of a husband-and-wife team of therapists, Michael Mithoefer, a psychiatrist and Annie Mithoefer, a psychiatric nurse in Charleston. MAPS says it will use a supply of MDMA stored at Purdue University in Indiana that was manufactured for earlier studies. The test is already drawing strong criticism. Alan Leshner, director of the government's National Institute on Drug Abuse says, "I know of no evidence in the scientific literature that demonstrates the efficacy of Ecstasy for any clinical indication." While Mr. Leshner hasn't reviewed the MAPS protocol, he says, "we don't give drugs of abuse to naive subjects except under extraordinary circumstance." Known as an "empathogen," MDMA was accidentally discovered by a Merck & Co. scientist in 1912. The drug is structurally related to amphetamines and has some stimulant qualities but doesn't really have the same effect as "speed." It is also related to mescaline but isn't generally a hallucinogenic. Indeed, the name Ecstasy is a product of marketers more than medical science, Dr. Mithoefer says. The hypothesis of the study is that Ecstasy works to reduce fear and anxiety and allows sufferers to revisit a disabling trauma without being overwhelmed. While many agree that more diagnoses of posttraumatic stress disorder are an inevitable by-product of Sept. 11, the anthrax scare and war in Afghanistan, some clinicians are skeptical about the claims made by MDMA backers that the drug is a magical catalyst that will facilitate recovery. "It's a quaint idea, says Thomas Gualtieri, medical director at the North Carolina Neuropsychiatry Clinic in Chapel Hill. "I'm not sure I'd want to give psychedelics to some of our PTSD patients." Dr. Gualtieri says that the most common treatment for PTSD is drugs, including a range of antidepressants. For about 70% of PTSD sufferers, he says, medication helps control symptoms and allows patients to function. But for the remaining 30%, PTSD can be one of the most "debilitating of psychological conditions," and one that doesn't improve at all with drug therapy, he says. These are precisely the patients Mr. Doblin of MAPS says he is trying to reach. The Ecstasy study marks a critical step in his five-year, $5 million campaign to introduce the drug as a prescription medicine to treat PTSD, and ultimately, other anxiety disorders. He wants to transform MAPS into a "nonprofit, member-based psychedelic-pharmaceutical company," whose products will compete head on against blockbusters like Pfizer Inc.'s antidepressant Zoloft, the only drug currently indicated specifically for PTSD. Last year Zoloft's global sales, to treat depression, PTSD and other psychiatric illnesses, topped $2.1 billion. A Pfizer spokesman declined to comment on the MAPS study. Mr. Doblin, who is 47 years old and has a doctorate in public policy from Harvard University, says he has used Ecstasy therapeutically and characterizes his family as one "that values psychedelics." In 1984, he and a small group of therapists and advocates of psychedelics organized opposition to the Drug Enforcement Agency's criminalization of MDMA. They lost, and MDMA is now a "Schedule 1" drug, along with heroin and marijuana, which means it has a high potential for abuse and is prohibited except in government-approved research. Without question, the intense popularity of Ecstasy in the underground dance scene at "raves" has led to abuses. Unmonitored, and in conjunction with arduous physical exercise, the drug can lead to hyperthermia, a dangerous increase in body temperature. It also triggers an excessive release of serotonin that can lead to confusion, difficulty walking, diarrhea, muscle jerks, poor control of heart rate and blood pressure and shivering. Cardiac complications and liver abnormalities have been reported in some cases, but supporters of the research say this is due to impurities in the illicit drug. Emergency-room data indicate that MDMA use is increasing. Emergency-room visits related to MDMA rose to 796 in 1999 from eight in 1990. Ecstasy tablets seized by the DEA increased to 949,257 in 2000, up from 13,342 in 1996. There were 13 MDMA-related deaths in 1999, according to the National Institute of Drug Abuse. But for Marcela Ot'alora G, a native of Medellin, Colombia, who was badly beaten and raped at 17, MDMA-assisted therapy seven years after the attack allowed her to talk about the crime for the first time. Her first session was 12 hours. The follow-up session was eight hours. Soon after that, Ms. Ot'alora G says she began to understand what happened to her and move on. "It speeds up the process tremendously," she says. "In talk therapy you get to a point and stay in the same place for years. MDMA doesn't get rid of the fear but it allows you to look at the fear, instead of it being a block." Ms. Ot'alora G is now a therapist and "interventionist" who works with at-risk children in Boulder, Colo. She worked as a therapist in a MAPS-sponsored MDMA trial in Spain specifically for female victims of sexual assault suffering from posttraumatic stress disorder. A future study, in Israel, plans to use the drug for PTSD sufferers who have endured war and terrorism. - --- MAP posted-by: Richard Lake