FDA PERMITS FIRST TEST OF ECSTASY AS TREATMENT FOR STRESS DISORDER

Sixteen years after the so-called love drug Ecstasy was criminalized,
the U.S. Food and Drug Administration has approved the first study of
the substance as a treatment for people with posttraumatic stress disorder.

The nonprofit group conducting the small pilot study with an eye
toward developing Ecstasy, or MDMA, as a prescription drug says the
recent wave of terrorism makes finding effective treatments for the
condition more important than ever. "There's something ennobling about
taking MDMA to work through things and really grapple with deep,
painful emotions at that level of honesty and openness," says study
sponsor Rick Doblin, founder and director of the Multidisciplinary
Association for Psychedelic Studies, an organization that advocates
using Ecstasy and other psychedelic drugs for therapy.

The FDA declines to comment on MAPS's Investigational New Drug
Application, which is an early step in the clinical trial process. The
MAPS test still requires approval by an Institutional Review Board at
the Medical University of South Carolina in Charleston, where the
trial would take place.

If all goes as planned, the study will include 20 subjects; 12 will
undergo MDMA-assisted therapy twice, each time taking a single,
125-milligram capsule, and eight will get a placebo. Each person will
also undergo 16 hours of therapy without drugs, over three months. All
sessions will be under the direct supervision of a husband-and-wife
team of therapists, Michael Mithoefer, a psychiatrist and Annie
Mithoefer, a psychiatric nurse in Charleston. MAPS says it will use a
supply of MDMA stored at Purdue University in Indiana that was
manufactured for earlier studies.

The test is already drawing strong criticism. Alan Leshner, director
of the government's National Institute on Drug Abuse says, "I know of
no evidence in the scientific literature that demonstrates the
efficacy of Ecstasy for any clinical indication." While Mr. Leshner
hasn't reviewed the MAPS protocol, he says, "we don't give drugs of
abuse to naive subjects except under extraordinary
circumstance."

Known as an "empathogen," MDMA was accidentally discovered by a Merck
& Co. scientist in 1912. The drug is structurally related to
amphetamines and has some stimulant qualities but doesn't really have
the same effect as "speed." It is also related to mescaline but isn't
generally a hallucinogenic. Indeed, the name Ecstasy is a product of
marketers more than medical science, Dr. Mithoefer says.

The hypothesis of the study is that Ecstasy works to reduce fear and
anxiety and allows sufferers to revisit a disabling trauma without
being overwhelmed. While many agree that more diagnoses of
posttraumatic stress disorder are an inevitable by-product of Sept.
11, the anthrax scare and war in Afghanistan, some clinicians are
skeptical about the claims made by MDMA backers that the drug is a
magical catalyst that will facilitate recovery. "It's a quaint idea,
says Thomas Gualtieri, medical director at the North Carolina
Neuropsychiatry Clinic in Chapel Hill. "I'm not sure I'd want to give
psychedelics to some of our PTSD patients."

Dr. Gualtieri says that the most common treatment for PTSD is drugs,
including a range of antidepressants. For about 70% of PTSD sufferers,
he says, medication helps control symptoms and allows patients to
function. But for the remaining 30%, PTSD can be one of the most
"debilitating of psychological conditions," and one that doesn't
improve at all with drug therapy, he says.

These are precisely the patients Mr. Doblin of MAPS says he is trying
to reach. The Ecstasy study marks a critical step in his five-year, $5
million campaign to introduce the drug as a prescription medicine to
treat PTSD, and ultimately, other anxiety disorders. He wants to
transform MAPS into a "nonprofit, member-based psychedelic-pharmaceutical
company," whose products will compete head on against blockbusters
like Pfizer Inc.'s antidepressant Zoloft, the only drug currently
indicated specifically for PTSD. Last year Zoloft's global sales, to
treat depression, PTSD and other psychiatric illnesses, topped $2.1
billion.

A Pfizer spokesman declined to comment on the MAPS study.

Mr. Doblin, who is 47 years old and has a doctorate in public policy
from Harvard University, says he has used Ecstasy therapeutically and
characterizes his family as one "that values psychedelics." In 1984,
he and a small group of therapists and advocates of psychedelics
organized opposition to the Drug Enforcement Agency's criminalization
of MDMA. They lost, and MDMA is now a "Schedule 1" drug, along with
heroin and marijuana, which means it has a high potential for abuse
and is prohibited except in government-approved research.

Without question, the intense popularity of Ecstasy in the underground
dance scene at "raves" has led to abuses. Unmonitored, and in
conjunction with arduous physical exercise, the drug can lead to
hyperthermia, a dangerous increase in body temperature. It also
triggers an excessive release of serotonin that can lead to confusion,
difficulty walking, diarrhea, muscle jerks, poor control of heart rate
and blood pressure and shivering. Cardiac complications and liver
abnormalities have been reported in some cases, but supporters of the
research say this is due to impurities in the illicit drug.

Emergency-room data indicate that MDMA use is increasing.
Emergency-room visits related to MDMA rose to 796 in 1999 from eight
in 1990. Ecstasy tablets seized by the DEA increased to 949,257 in
2000, up from 13,342 in 1996.

There were 13 MDMA-related deaths in 1999, according to the National
Institute of Drug Abuse.

But for Marcela Ot'alora G, a native of Medellin, Colombia, who was
badly beaten and raped at 17, MDMA-assisted therapy seven years after
the attack allowed her to talk about the crime for the first time. Her
first session was 12 hours. The follow-up session was eight hours.
Soon after that, Ms. Ot'alora G says she began to understand what
happened to her and move on. "It speeds up the process tremendously,"
she says. "In talk therapy you get to a point and stay in the same
place for years. MDMA doesn't get rid of the fear but it allows you to
look at the fear, instead of it being a block."

Ms. Ot'alora G is now a therapist and "interventionist" who works with
at-risk children in Boulder, Colo. She worked as a therapist in a
MAPS-sponsored MDMA trial in Spain specifically for female victims of
sexual assault suffering from posttraumatic stress disorder. A future
study, in Israel, plans to use the drug for PTSD sufferers who have
endured war and terrorism.