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."