HARVARD SEEKS TO TEST ECSTASY DRUG ON THE DYING

BELMONT -- Harvard researchers are preparing for the first time in three
decades to conduct human experiments using a psychedelic drug, a study that
would seek to harness the mind-altering effects of the drug ecstasy to help
ease the crushing psychic burdens faced by dying cancer patients. In the
experiment, 12 terminal cancer patients would be given MDMA, the active
ingredient in ecstasy, to determine whether the drug helps alleviate their
anxiety. If the results are positive, the Harvard scientists said, they
will push forward with large-scale tests that could make end-of-life
ecstasy treatments generally available to terminally-ill patients. The
experiment seeks to establish a medical use for a drug whose abuse has been
on the rise among some young people, who use it recreationally for its
euphoric effects.

A small but growing group of scientists contends the drug, administered in
a controlled medical setting, can improve mental and emotional health. But
critics, including some in the Bush administration, said the experiment may
destigmatize a dangerous substance.

Complicating matters, the experiment will be bankrolled by the
Multidisciplinary Association for Psychedelic Studies, a nonprofit that
advocates legalizing psychedelic drugs.

The group, run by a longtime drug-legalization activist from Belmont named
Rick Doblin, has ambitions to one day establish a nationwide chain of
psychedelic therapy clinics that would dispense LSD, marijuana, and ecstasy
to people with emotional problems.

Doblin acknowledges that getting the experiment accepted by Harvard
scientists is an invaluable public relations coup for his mission.

Despite the potential for controversy, the Harvard scientists remain
committed to the experiment.

"There's enough evidence for possible therapeutic benefits that it
outweighed the risk," said Dr. Bruce Cohen, president of Harvard-affiliated
McLean Hospital in Belmont, where the experiment will be conducted. "If the
evidence suggests this has value, then a more elaborate study will be
done." Cohen acknowledged that others might have been reluctant to pursue
the study: "Some institutions wouldn't want to even take this risk." Ethics
boards at McLean and the Lahey Clinic, which will provide the patients,
have already approved the experiment, as has the US Food and Drug
Administration. The Drug Enforcement Agency still must approve the
experiment, and Harvard officials said they expected to hear from the
agency within weeks. The trial would use a controversial drug to treat a
group of patients believed ill-served by the medical system.

To qualify for the experiment, a cancer patient must have a prognosis of
less than one year to live. These patients, said the Lahey Clinic's Dr.
Todd Shuster, often suffer from deep anxieties that currently can be eased
only by taking daily doses of sedative drugs that render them disconnected
from reality.

"We're trying to avoid sedating people, to allow them to maintain a good
quality of life so they can enjoy the time they have with family and
friends," said Shuster, who will select patients from Lahey for the
experiment. Typically, dying patients are given drugs such as valium, which
can cloud their minds, or antipsychotics that leave them edgy. In any of
these states, said cancer specialists, it becomes difficult to resolve
family issues, arrange financial matters, or approach death with a sense of
peace and understanding. "Any kind of new tools that we could have would
probably be worth looking at," said Dr. John Peteet, clinical director of
the psycho-social oncology program at the Dana-Farber Cancer Institute who
is not involved in the experiment but called it "novel."

David Murray, a policy analyst with the White House Office of National Drug
Control Policy, said he was worried the Harvard experiment could
destigmatize ecstasy while failing to find any clear-cut medical use for
the drug. "It is my impression that we are unlikely to learn anything of
medical value," he said, citing the trial's small size. "I'm surprised, to
tell you the truth, that this has passed muster."

Murray listed a number of studies indicating that ecstasy abusers suffer
neurological problems and said, "The record on the risks of this drug is
unambiguous."

But McLean's Dr. John Halpern, who will run the trial, said the Harvard
experiment will be safe: "The studies didn't raise any concerns about
giving MDMA a few times in a medical setting."

MDMA, short for 3,4-methylenedioxymethamphetamine, works by releasing large
amounts of the brain chemical serotonin, which helps regulate mood, sleep,
and appetite. Numerous human and animal studies have shown that heavy MDMA
use can cause neurological and behavioral problems, though the exact nature
and persistence of the damage is difficult to gauge.

Meanwhile, ecstasy use has exploded in some subcultures, particularly in
so-called rave circles, where young people high on the drug dance
euphorically for hours. "People describe feeling empathy, decreased stress,
increased confidence," said Halpern.

In the experiment, eight patients will get a dose of MDMA that the
researchers believe will elevate their mood, while four patients will
receive a lower dose. The dosing, under the supervision of five doctors,
will occur immediately prior to an intense 8-hour therapy session that
Halpern will run. The drug alone, he said, would provide only a temporary
respite, but when combined with therapy could help permanently resolve
underlying psychological problems, said Halpern. Halpern said these
underlying problems often involve uncertainty about loved ones' futures,
unresolved family conflicts, finances, and fear of death. "The ecstasy is
not in the drug, it's in the person," he said in explaining his approach.
"People need to embrace themselves and talk about what's important to them."

Each patient will have two intensive therapy sessions, preceded by MDMA,
two weeks apart.

The patients will also get six shorter sessions that will not involve the
drug. Halpern's team will use standardized anxiety tests to see whether the
MDMA therapy helps, and they will compare the lower- and higher-dose
patients to help gauge the most effective MDMA dose. If MDMA proves
successful, the researchers plan to propose a series of more rigorous
large-scale experiments designed to win federal government approval for
using MDMA on terminal patients. "There is good evidence that it could
become a therapist's tool," said Halpern. But Murray, of the White House
drug office, said the publicity around the experiment could increase "the
rationalization of young people who can say, 'This can't be dangerous
because Harvard doctors give it out.' " "Perceptions of risk are a powerful
determiner of young people using illegal drugs," he added.

Changing public perceptions of psychedelic drugs is a stated goal of the
group funding the experiment -- and they consider Harvard a high-profile
venue for doing so. Doblin, whose group, MAPS, plans to spend $250,000 on
the study, said the experiment could erase the damage wrought by Dr.
Timothy Leary. A Harvard professor in the 1960s, Leary infamously
experimented with psychedelic drugs at Harvard until he was ousted in 1963,
the last time a Harvard researcher there worked with psychedelic drugs.

Leary conducted medical experiments using students, though his aim was to
determine whether psychedelic drugs could enhance human cognition rather
than alleviate suffering.

He eventually became a pop culture icon, encouraging casual psychedelic
drug experimentation in books and lectures.

He also served time in prison for drug possession and lived briefly as a
fugitive after he escaped from prison.

Doblin said Leary's antics led many Americans to view psychedelic drugs as
dangerous and escapist, while the drugs' more beneficial aspects were
ignored. "To restart it at Harvard means that we have healed the wounds
from that time. With this study we have finally buried the ghost of Timothy
Leary," said Doblin. The idea for the Harvard experiment came about during
a conversation between Doblin and Shuster, who attend the same synagogue.

Doblin's enthusiasm and encyclopedic knowledge of psychedelic drug issues
helped persuade Shuster to undertake the experiment. But in the end, said
Shuster, it was memories of dying patients filled with distress and sadness
that persuaded him to take part in the MDMA experiment.

"I think it is a drug that has a real potential for therapeutic benefits.
Unfortunately, the abuse of the drug has prevented the use of it in
therapeutic trials," he said, then adding a note of caution: "But I'm not
sure what we'll find."