February 27, 2004
Dr. Michael Mithoefer finally obtained a Schedule I license from the Drug Enforcement Administration (DEA) this week to conduct the first U.S. government approved study of MDMA-assisted psychotherapy in more than eighteen years. MDMA, commonly known as ecstasy, was outlawed in 1985 but had been used in therapeutic settings for several years. Dr. Mithoefer's research will look into the assertions of many psychiatrists and psychotherapists who gave ecstasy to their patients to treat PTSD and some forms of anxiety. He will conduct psychotherapy sessions with twenty victims of violence who suffer from post-traumatic stress disorder (PTSD) and who have not been helped by other treatment strategies.
Though the Food and Drug Administration (FDA) sanctioned Dr. Mithoefer's research in 2001, final approval was hampered by numerous government-regulated Institutional Review Boards that feared approving research with a controversial drug such as MDMA, and by a series of DEA hurdles. Throughout the past 20 years, government approved MDMA research has primarily been limited to harm assessment. The most famous of these studies were conducted by Johns Hopkins University researcher Dr. George A. Ricaurte who erroneously claimed that his research showed how ecstasy could cause permanent brain damage and lead to Parkinson's Disease. Ricaurte received $10 million from the government’s National Institute on Drug Abuse to conduct the research which was sensationalized in press across the globe and was later found to be fundamentally flawed. Meanwhile, the DEA held up approving Dr. Mithoefer's research until finally giving him his Schedule I license this week, almost two years after his application was filed.
"The last 20 years of MDMA research have belonged to George Ricaurte and have been focused primarily on neurotoxicity and possible functional consequences, to the exclusion of other research agendas." said Rick Doblin, founder and president of the Multidisciplinary Association for Psychedelic Studies (MAPS), which is sponsoring Dr. Mithoefer's work. "I believe that the next 20 years will belong to all of us, to a balanced investigation of the risks and the benefits of MDMA in a variety of contexts."
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