FDA Approves Ecstasy Clinical Test
Wednesday, November 7th 2001, 12:00 am
By: News On 6
WASHINGTON (AP) _ For the first time since the drug ecstasy was made illegal, the government will allow researchers to test the drug as a treatment of post-traumatic stress disorder.
Approval came Tuesday from the Food and Drug Administration and marks a shift for the agency, which has virtually banned the drug from researchers for more than a decade.
The trial has not been approved by a review board at the Medical University of South Carolina, the proposed site for the research.
If the university accepts the plan, the test will be supervised by the husband and wife team of Dr. Michael Mithoefer, a psychiatrist, and Annie Mithoefer, a psychiatric nurse in Charleston.
Michael Mithoefer said research should not be impeded because ecstasy is a hot commodity among some teen-agers.
``It's ironic that when these drugs become illegal, the legitimate research goes to zero, and the illegal and recreational use goes way up,'' Mithoefer said. ``It seems foolish to me to have a situation where millions are using the drug in an uncontrolled way and yet physicians who want to do careful research are not allowed.''
The FDA would not comment on the test.
If the study proceeds, 12 people will be given ecstasy, also known as MDMA, as they go through therapy for post-traumatic stress disorder. Eight people will be given a placebo. Each person also will undergo 16 hours of therapy without drugs.
Post-traumatic stress disorder, a mental problem for millions of Americans, is caused by fixation with an emotionally charged event.
Victims often experience bad dreams and have trouble with relationships _ essentially having become stuck in the moment of crisis.
In the 1970s, MDMA was used by many psychiatrists to treat the disorder. Some psychiatrists believe the drug can allow victims to have a cathartic moment, releasing their emotional stress over an incident.
Treatment using MDMA stopped as the federal government began to crack down on the drug for its recreational use.
The study is being financed by the Multidisciplinary Association for Psychedelic Studies, a group that advocates use of psychedelic drugs for therapy.
Rick Doblin, the group's founder and director, said researchers have fought for years to overcome propaganda about the drug.
``The way things work in the drug war is, if a drug is criminalized, it is bad or evil,'' Doblin said. ``There is an effort to produce science to mislead people about the drug. This is a big step away from that for the FDA.''
The plans for the test are producing strong skepticism from those fighting the drug war.
``I know of no evidence in the scientific literature that demonstrates the efficacy of ecstasy for any clinical indication,'' said Alan Leshner, director of the government's National Institute on Drug Abuse, in an interview with The Wall Street Journal. ``We don't give drugs of abuse to naive subjects except under extraordinary circumstance.''