In a safe bolted to the floor and protected by an alarm system, Michael Mithoefer keeps his supply of Ecstasy. He is not a dealer or a user; he is simply following Drug Enforcement Administration rules to keep the drug in a secret place.
“You could probably go down to the local college campus and buy a lot more with less trouble than breaking into the safe,” the psychiatrist jokes.
Mithoefer is one of a handful of people in the US allowed to do human research with Ecstasy, which the US and UK governments put in the same legal category as heroin.
He is studying whether Ecstasy can help trauma victims to heal their emotional wounds. The research has put him at the centre of an intense debate over the drug?s potential as a legitimate medical treatment.
A small group of determined supporters – among them researchers and doctors at Harvard University and the University of California, Los Angeles – have spent more than a decade fighting with the government and institutions for permission to do research. A few months ago, after years of wrangling, the DEA agreed and Mithoefer?s study is the first US trial of Ecstasy?s therapeutic value.
Advocates say it could help treat a range of psychological problems. “I?d like to see it used in psychiatry,” says Harvard psychiatrist John Halpern, a leading proponent. “It is potentially a very valuable tool.”
But some scientists and officials question the research, saying the drug has been proved to cause permanent harm to the brain. “Let?s not kid ourselves,” argues David Murray, policy analyst at the White House Office of National Drug Control Policy. “The bulk of the evidence is on the side of risk. The only question is how permanent and how extensive the damage is.”
The controversy echoes the long-running dispute between advocates and the government over the use of marijuana for a range of ailments, including glaucoma and nausea.
Although it has been illegal in the US since 1985, Ecstasy is widely used as a recreational drug. More than three million Americans take it at least once a year, according to a 2002 government survey. Unlike heroin and cocaine, it is not physically addictive. It has stimulant and hallucinogenic properties, and generally gives users a sense of euphoria and contentment without impairing cognitive or motor abilities, as alcohol does.
Ecstasy pills are produced in illegal laboratories. Mithoefer?s source of the drug, officially called MDMA, is a government-licensed lab. He, Halpern and others think it could be particularly helpful for people with post-traumatic stress disorder (PTSD). Many patients can?t bring themselves to talk about the painful events that triggered their problems. Ecstasy, the theory goes, could help them to confront these traumas.
“MDMA makes people comfortable with themselves,” says Rick Doblin, a director of the Multidisciplinary Association for Psychedelic Studies, a non-profit group funding Mithoefer?s research. “It brings them into the moment. With PTSD, people are trapped in the past.??
Although Doblin, 50, is not a doctor or a researcher, he has extensive experience with the drug, having taken it more than 100 times. “It?s ontributed enormously to my life,” he says. Over the past 20 years, he has devoted himself to spreading the idea that Ecstasy and other hallucinogens have important medical benefits.
The $250,000 Mithoefer trial in Charleston, South Carolina, represents a milestone in his quest. If it goes well, Doblin hopes to fund larger national studies. His ultimate goal is persuading the Food and Drug Administration to approve MDMA as a prescription drug.
Mithoefer?s study involves 20 subjects: 12 will take the drug, and eight will receive a placebo. Patients will take it twice during a 12-week course of psycho-therapy. Early results, based on “problem” talks with patients, are promising, claims Mithoefer, but the study won?t be complete until next summer.
MDMA therapy is not new. Before the drug was criminalised, a few hundred psychiatrists and therapists were using it. Though no controlled studies were done, many who tried the method say it worked.
Between 1980 and 1985, George Greer used the technique with about 200 patients. The psychiatrist in Santa Fe, New Mexico, says almost all thought the therapy helped them. He finds it “incredibly frustrating” that he can?t use the drug in his practice. “I see patients every day who could benefit,” he says.
Proponents of the therapy take pains to distinguish its medical use from its recreational use, which they see as potentially dangerous.
Street users aren?t in a controlled setting, they say, and often unknowingly take pills tainted with methamphetamine and other drugs.
During the MDMA sessions in Mithoefer?s trial, an emergency-room doctor and a nurse are in the next room. The drug often raises body temperature, and in rare cases causes fatal hyperthermia. But what concerns some researchers more than overheating is the possibility that even a few doses of MDMA could cause permanent brain damage.
Over the past decade, the question of Ecstasy?s “neurotoxicity?? has engendered enormous controversy. Some animal research has found that even small amounts of the drug harmed brain neurons that release serotonin, a key neurotransmitter involved in memory. In some studies, memory deficiencies persisted long after the drug was taken.
And some human research on Ecstasy users has also found memory problems.
“There is a consensus that MDMA has the ability to damage brain serotonin cells,” says Johns Hopkins University neurologist George Ricaurte, a leading MDMA researcher. And proponents of the research agree that those who take the drug many times may risk brain damage. But they say that therapeutic doses – one or two over a few weeks – are far below potentially harmful levels.
“The neurotoxicity issue has been hyped,” says Charles Grob, a UCLA psychiatry professor. “The notion that one or two doses will induce irrevocable harm is wrong.??
Grob and Halpern, the Harvard researcher, have studied the drug?s safety and found that low doses caused no permanent changes to brain structure or memory function in humans.
Advocates argue that even if higher amounts do cause damage, there is no reason to ban all use of MDMA. “Most drugs we use in medicine can be dangerous or even lethal if you take too much,” Mithoefer argues.
Ricaurte agrees, and says Ecstasy may well end up being seen as both a dangerous drug of abuse and a helpful treatment. “Look at morphine,” he says. “It has potential for abuse, but it?s also a great painkiller. MDMA is no different.??
There is another major study looking at Ecstasy?s potential benefits with regard to PTSD in Spain, but although research into the drug in the UK is permitted under licence from the Home Office, there are no major ongoing human studies.
However, the BBC?s Horizon programme highlighted the case of a Parkinson?s sufferer who found that recreational use of the drug considerably alleviated symptoms of his disease.
Parkinson?s patients suffer from loss of a neurotransmitter, called dopamine, which has a knock-on effect on other neurotransmitters, such as serotonin. The levels of serotonin are abnormal in people with Parkinson?s, and Ecstasy modulates the brain?s serotonin.
BY DAVID KOHN AND HILARY MARSHALL
Source: http://news.scotsman.com/index.cfm?id=870742004