editorial comment since we are in terminal phase.....

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 the drug. Ecstasy use has exploded in some subcultures, particularly in so-called rave circles, where young people high on the drug dance euphorically for hours.

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 non-profit 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," he said.



Ethics boards at McLean and the Lahey Clinic, which will provide the patients, have approved the experiment, as has the Food and Drug Administration. The federal Drug Enforcement Administration 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, the Lahey Clinic's Dr. Todd Shuster said, 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, which 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.

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. "The record on the risks of this drug is unambiguous," he said.

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 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.

"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 before an intense eight-hour therapy session that Halpern will run.

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.

The drug alone, he said, would provide only a temporary respite, but when combined with therapy could help permanently resolve underlying psychological problems, Halpern said. These 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.. "People need to embrace themselves and talk about what's important to them."

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