Harvard Seeks to Test Ecstasy Drug on the Dying

Boston Globe
February 23, 2005

Harvard seeks to test ecstasy drug on the dying

By Raja Mishra

[MAPS Note in brackets]

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.

{MAPS’ primary mission is to support research into medical and spiritual uses of MDMA, psychedelic drugs and marijuana, and MAPS members vary on their views of drug policy.]

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. H
e 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.”

You can contact Raja Mishra here. .

Read the MDMA/cancer anxiety study protocol and learn more about the current state of human MDMA research .

The Boston Globe published a lengthy piece on the MDMA/cancer anxiety study that will take place at Harvard University’s McLean Hospital. The piece features quotes from Halpern and from Rick Doblin.