ECSTASY TO BE TESTED ON TERMINAL PATIENTS

FDA Ruling Might Lead to Use of Other Psychedelic Drugs

For some, the diagnosis comes out of the blue. For others, it arrives
after a long battle. Either way, the news that death is just a few
months away poses a daunting challenge for both doctor and patient.

Drugs can ease pain and reduce anxiety, but what about the more
profound issues that come with impending death? The wish to resolve
lingering conflicts with family members. The longing to know, before
it's too late, what it means to love, or what it meant to live. There
is no medicine to address such disease.

Or is there?

This month, in a little-noted administrative decision, the Food and
Drug Administration gave the green light to a Harvard proposal to test
the benefits of the illegal street drug known as ecstasy in patients
diagnosed with severe anxiety related to advanced cancer.

The drug, also known as 3-4 methylenedioxymethamphetamine, or MDMA,
has been referred to by psychiatrists as an "empathogen," a drug
especially good at putting people in touch with their emotions. Some
believe it could help patients come to terms with the biggest
emotional challenge of all: the end of life.

The FDA's approval puts the study on track to become the first test of
a psychedelic substance since 1963 at Harvard, where drug guru Timothy
Leary lost his teaching privileges after using students in experiments
with LSD and other hallucinogens.

It also marks a milestone for a small but increasingly effective
movement favoring a more open-minded attitude toward the therapeutic
potential of psychedelic drugs, virtually all of which have been
criminalized and disparaged for decades as medically useless.

Already, MDMA is being tested for its ability to reduce symptoms of
post-traumatic stress disorder. And two U.S. studies are looking at
the usefulness of psilocybin -- the active ingredient in "magic
mushrooms" -- in terminally ill cancer patients and in people with
obsessive-compulsive disorder.

In the coming year, advocates also hope to submit to the FDA an
application to test psilocybin and LSD as treatments for a
debilitating syndrome known as cluster headaches.

That would be a fitting birthday present for Albert Hofmann, the
chemist who discovered both compounds while working for the Swiss drug
company Sandoz and who turns 99 in January, said Rick Doblin,
president of the Multidisciplinary Association for Psychedelic
Studies. The Sarasota-based nonprofit has organized and funded much of
the new research.

Hofmann, who has expressed support for clinical studies such as the
one being planned at Harvard, has referred to LSD as his "problem
child" -- a reference to his belief that despite its widespread abuse,
the mind- altering drug has the potential to help some people.

Although they vary in their chemical structures and specific effects,
many psychedelic drugs work on the parts of the brain that regulate
serotonin -- the same brain chemical that is the target of many FDA-
approved antidepressants. That does not indicate that the drugs are
necessarily safe; indeed, they all carry some medical and psychiatric
risk.

Yet even scientists who have been vocal about those risks have
expressed at least guarded support for the idea that, in the company
of a therapist and with proper medical monitoring, moderate doses
might benefit some people.

With the FDA's Dec. 17 approval of the Harvard MDMA protocol -- and
permission in hand from ethics review boards at Harvard and the nearby
Lahey Clinic, where patients will be recruited -- the only remaining
hurdle is getting a special license from the Drug Enforcement
Administration. A dozen subjects with less than 12 months to live will
get either low or moderate doses of MDMA during two sessions a few
weeks apart, along with counseling and a variety of psychological
tests before and after treatment.