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Ecstasy to be tested on cancer patients

  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 dis-ease.

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 Ecstasy in patients diagnosed with severe anxiety related to advanced cancer. The study will look at whether the drug can help terminally ill patients lessen their fears, quell thoughts of suicide and make it easier for them to deal with loved ones.

"End-of-life issues are very important and are getting more and more attention, and yet there are very few options for patients who are facing death," Dr. John Halpern, the Harvard research psychiatrist in charge of the study, said yesterday.

The small, four-month study is expected to begin early next spring. It will test the drug's effects on 12 cancer patients from the Lahey Clinic Medical Center in the Boston area.

Psychiatrists refer to Ecstasy — also known as 3,4-methylenedioxymethamphetamine, or MDMA — 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 drug is a chemical cousin of methamphetamine and typically induces feelings of euphoria, increased energy and sexual arousal. But it also suppresses appetite, thirst and the need to sleep, and in high doses can sharply increase body temperature, leading to kidney and heart failure, and death.

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, Fla.-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.

"When taken under adverse circumstances by ill-prepared individuals, there are substantial psychological risks," said Dr. Charles Grob, a psychiatrist at Harbor-UCLA Medical Center in Los Angeles.

"But when taken in the context of carefully structured and approved research protocols and facilitated by individuals with expertise, adverse effects can be contained to a minimum," he said.

Grob is leading an FDA-approved study in which terminally ill cancer patients are being given psilocybin to see whether it can help them sort through emotional and spiritual issues. He said the patients take a "modest" dose of synthetic psilocybin, equivalent to two or three illicit mushrooms. They spend the next six hours or so in a comfortable setting with a psychiatrist — talking, thinking and sometimes listening to music with headphones.

"So far they have had very impressive results in terms of amelioration of anxiety, improvement of mood, improved rapport with close family and friends and, interestingly, significant and lasting reductions in pain," Grob said of the first few patients to enroll.

Promising results have also been reported at the University of Arizona from a 10-person study of psilocybin for obsessive-compulsive disorder, which locks people into repetitive thoughts and actions.