Pubdate: Wed, 07 Nov 2001
Source: Los Angeles Times (CA)
Copyright: 2001 Los Angeles Times
Contact:  http://www.latimes.com/
Details: http://www.mapinc.org/media/248
Author: Christopher Newton, Associated Press Writer
Bookmark: http://www.mapinc.org/mdma.htm (Ecstasy)

FDA APPROVES ECSTASY CLINICAL TEST

WASHINGTON -- 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."
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