ECSTASY RESEARCH AT CENTER OF DEBATE

Some warn dangers don't offset benefits

Of The Post and Courier Staff It's in the same legal category as heroin, but
Dr. Michael Mithoefer has been giving his patients Ecstasy for months. And
while it's perfectly legal, it's also highly controversial.

The Mount Pleasant psychiatrist is engaged in the first U.S. human trials of
Ecstasy's therapeutic value. But with the risks unclear and the potential
for permanent brain damage so great, Mithoefer's work has put him at the
center of a debate over the drug's potential as a legitimate medical
treatment.

Mithoefer received the government's go-ahead earlier this year to see
whether Ecstasy could help people with post-traumatic stress disorder. He is
hoping to find evidence that the drug, also known as MDMA, can help treat a
number of psychological problems.

Many say it's a flawed approach, and that any benefits won't outweigh the
drug's dangers. They also worry that Mithoefer's research could send the
wrong message to teenagers and young adults that Ecstasy is somehow safe.

"I take that concern seriously," Mithoefer said. "It's important that people
realize that it isn't safe in any setting. It certainly can be dangerous."

But, he added, "I don't think it makes sense to not do research into
potential treatments with the idea that it could send the wrong message. We
use many medications in medicine that can be harmful or fatal, and they can
be abused and they are abused."

Mithoefer's study is backed by the Multidisciplinary Association for
Psychedelic Studies, a nonprofit organization that supports research into
psychedelic drugs.

His study will provide an early look into whether Ecstasy can help people in
therapy for post-traumatic stress disorder. PTSD most often occurs after
people find themselves in a life-threatening situation, including military
combat, natural disasters, accidents or violent assaults like rape. People
who suffer from the disorder often relive the experience through nightmares
and flashbacks, according to the National Center for PTSD.

Mithoefer's study involves 20 people with crime-related PTSD for whom
therapy and medications haven't worked. In his study, Ecstasy is being
administered to 12 of the patients. None of the drug is being sent home with
the patients, and each time it is given, an emergency room doctor and nurse
are nearby. The other eight patients are getting placebos.

"We're testing a hypothesis," Mithoefer said. "We don't know what the
results will be. Our agenda is to do careful research and find out the
facts. If it does look promising, then it's likely we'll do further
research. Right now, it's too early to draw any conclusions."

Rick Doblin, director of MAPS, said he believes the drug will not get rid of
patients' problems but will help them work through problems during therapy.

Mithoefer spent more than four years forming the parameters of his study and
getting the government's blessing. He and MAPS went through several
different medical Institutional Review Boards, or committees that oversee
studies to protect human subjects, before they found one that would OK their
Ecstasy research. A review board must approve a study before the government
will allow it to go forward.

Mithoefer, who wouldn't comment about the details in getting his study off
the ground, ultimately received a Drug Enforcement Agency license to obtain
the drug in February, thus allowing him to begin his research.

MDMA, or methylenedioxy-methamphetamine, was developed in Germany in 1912.
The drug gained a small following in the 1970s among psychiatrists in the
United States who began using it as a therapeutic tool without approval from
the Food and Drug Administration, according to the National Institute of
Drug Abuse.

It gained a following as a recreational drug, and in 1985 the DEA placed
MDMA on the list of outlawed drugs with no therapeutic value. Known as "X,"
"E" or the "hug drug," Ecstasy is both a stimulant and a hallucinogen that
gives its users a general sense of well-being and empathy toward others.

The drug became popular in the 1990s as a "club drug" in clubs and all-night
dance parties called "raves." By 2002, according to the government, 10
million people 12 or older had used it at least once.

Now, there are signs the drug is losing its popularity. Use of Ecstasy among
eighth-, 10th- and 12th-graders decreased 50 percent in the past two years,
according to NIDA.

The drug is not addictive. Its biggest danger is in the potential for brain
damage. According to NIDA, several animal studies have shown MDMA can damage
the brain's neurons that release serotonin, an important neurotransmitter
involved in sleep, depression and memory. Some studies have shown these
effects are long-lasting.

Confusing matters was a study done last year by a Johns Hopkins University
neurologist, which said even a small dose of MDMA could cause Parkinson's.
The study was retracted after it was found researchers accidentally used
meth-amphetamine instead of MDMA.

Nevertheless, many scientists still believe Ecstasy is highly dangerous. And
given those dangers and the drug's widespread use, many believe that a study
could send the wrong message to users that the drug is somehow safe.

"I have concerns that it sends an oblique message to adolescents that it is
OK," said Alexander Morton, a pharmacist at the Medical University of South
Carolina who specializes in psychiatric drugs. "The risk of getting brain
damage is low. But it is there. Overall, its benefit to society is negative.
Yes, it helps some individuals, but overall I think it would be a negative
thing."

Mithoefer's study may not be the last. John Halpern, a Harvard psychiatrist,
wants to do a MAPS-backed study on the drug to see whether it can help in
the treatment of anxiety faced by dying cancer patients. While both Halpern
and Mithoefer say it's too early to say whether the drug will work or not,
Doblin believes it will.

He's confident the early research will yield results showing MDMA can help
post-traumatic stress disorder victims, leading to more studies and,
eventually, FDA approval to use the drug in a clinical setting.

Doblin, who has a doctorate from Harvard's Kennedy School of Government,
where he studied drug laws, has spent much of his life working for more
studies on the benefits of psychedelic drugs. He came across Ecstasy in the
early 1980s after hearing from therapists convinced of its therapeutic value
and decided to try it himself.

Doblin has since taken the drug more than 100 times. "I was shocked at how
it performed, and how subtle a shift it was," he said. "It was easier to
remember what happened. It allowed me to bring something into my non-drug
life. It has enhanced my life."