Pubdate: Tue, 06 Nov 2001
Source: Associated Press (Wire)
Copyright: 2001 Associated Press
Author: Christopher Newton, Associated Press Writer

FDA OKS CLINICAL TESTING OF ECSTASY

WASHINGTON (AP) - Researchers have gained government approval to test the 
drug "Ecstasy" as a treatment of post-traumatic stress disorder for the 
first time since the drug was criminalized in 1985.

The decision was made this week by 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 yet 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 the fact that Ecstasy is a hot commodity among some 
teen-agers should not impede research.

"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 will also undergo 16 hours of therapy 
without drugs.

Post-traumatic stress disorder, a mental problem for millions of Americans, 
is caused by a fixation with an emotionally charged event. Victims often 
experience bad dreams and have trouble with relationships - essentially 
becoming 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 funded by the Multidisciplinary Association for 
Psychedelic Studies, a group that advocates the use of psychedelic drugs 
for therapy.

Rick Doblin, the founder and director of the group, 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."
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