Ecstasy research at center of debate
Charleston (SC) Post and Courier
August 4, 2004
by Jonathan Maze
Post and Courier Staff
Some warn dangers don’t offset benefits
It’s in the same legal category as heroin, but Dr. Michael Mithoefer has been giving his patients Ecstasy for months. And while it’s perfectly legal, it’s also highly controversial.
The Mount Pleasant psychiatrist is engaged in the first U.S. human trials of Ecstasy’s therapeutic value. But with the risks unclear and the potential for permanent brain damage so great, Mithoefer’s work has put him at the center of a debate over the drug’s potential as a legitimate medical treatment.
Mithoefer received the government’s go-ahead earlier this year to see whether Ecstasy could help people with post-traumatic stress disorder. He is hoping to find evidence that the drug, also known as MDMA, can help treat a number of psychological problems.
Many say it’s a flawed approach, and that any benefits won’t outweigh the drug’s dangers. They also worry that Mithoefer’s research could send the wrong message to teenagers and young adults that Ecstasy is somehow safe.
“I take that concern seriously,” Mithoefer said. “It’s important that people realize that it isn’t safe in any setting. It certainly can be dangerous.”
But, he added, “I don’t think it makes sense to not do research into potential treatments with the idea that it could send the wrong message. We use many medications in medicine that can be harmful or fatal, and they can be abused and they are abused.”
Mithoefer’s study is backed by the Multidisciplinary Association for Psychedelic Studies, a nonprofit organization that supports research into psychedelic drugs.
His study will provide an early look into whether Ecstasy can help people in therapy for post-traumatic stress disorder. PTSD most often occurs after people find themselves in a life-threatening situation, including military combat, natural disasters, accidents or violent assaults like rape. People who suffer from the disorder often relive the experience through nightmares and flashbacks, according to the National Center for PTSD.
Mithoefer’s study involves 20 people with crime-related PTSD for whom therapy and medications haven’t worked. In his study, Ecstasy is being administered to 12 of the patients. None of the drug is being sent home with the patients, and each time it is given, an emergency room doctor and nurse are nearby. The other eight patients are getting placebos.
“We’re testing a hypothesis,” Mithoefer said. “We don’t know what the results will be. Our agenda is to do careful research and find out the facts. If it does look promising, then it’s likely we’ll do further research. Right now, it’s too early to draw any conclusions.”
Rick Doblin, director of MAPS, said he believes the drug will not get rid of patients’ problems but will help them work through problems during therapy.
Mithoefer spent more than four years forming the parameters of his study and getting the government’s blessing. He and MAPS went through several different medical Institutional Review Boards, or committees that oversee studies to protect human subjects, before they found one that would OK their Ecstasy research. A review board must approve a study before the government will allow it to go forward.
Mithoefer, who wouldn’t comment about the details in getting his study off the ground, ultimately received a Drug Enforcement Agency license to obtain the drug in February, thus allowing him to begin his research.
MDMA, or methylenedioxy-methamphetamine, was developed in Germany in 1912. The drug gained a small following in the 1970s among psychiatrists in the United States who began using it as a therapeutic tool without approval from the Food and Drug Administration, according to the National Institute of Drug Abuse.
It gained a following as a recreational drug, and in 1985 the DEA placed MDMA on the list of outlawed drugs with no therapeutic value. Known as “X,” “E” or the “hug drug,” Ecstasy is both a stimulant and a hallucinogen that gives its users a general sense of well-being and empathy toward others.
The drug became popular in the 1990s as a “club drug” in clubs and all-night dance parties called “raves.” By 2002, according to the government, 10 million people 12 or older had used it at least once.
Now, there are signs the drug is losing its popularity. Use of Ecstasy among eighth-, 10th- and 12th-graders decreased 50 percent in the past two years, according to NIDA.
The drug is not addictive. Its biggest danger is in the potential for brain damage. According to NIDA, several animal studies have shown MDMA can damage the brain’s neurons that release serotonin, an important neurotransmitter involved in sleep, depression and memory. Some studies have shown these effects are long-lasting.
Confusing matters was a study done last year by a Johns Hopkins University neurologist, which said even a small dose of MDMA could cause Parkinson’s. The study was retracted after it was found researchers accidentally used meth-amphetamine instead of MDMA.
Nevertheless, many scientists still believe Ecstasy is highly dangerous. And given those dangers and the drug’s widespread use, many believe that a study could send the wrong message to users that the drug is somehow safe.
“I have concerns that it sends an oblique message to adolescents that it is OK,” said Alexander Morton, a pharmacist at the Medical University of South Carolina who specializes in psychiatric drugs. “The risk of getting brain damage is low. But it is there. Overall, its benefit to society is negative. Yes, it helps some individuals, but overall I think it would be a negative thing.”
Mithoefer’s study may not be the last. John Halpern, a Harvard psychiatrist, wants to do a MAPS-backed study on the drug to see whether it can help in the treatment of anxiety faced by dying cancer patients. While both Halpern and Mithoefer say it’s too early to say whether the drug will work or not, Doblin believes it will.
He’s confident the early research will yield results showing MDMA can help post-traumatic stress disorder victims, leading to more studies and, eventually, FDA approval to use the drug in a clinical setting.
Doblin, who has a doctorate from Harvard’s Kennedy School of Government, where he studied drug laws, has spent much of his life working for more studies on the benefits of psychedelic drugs. He came across Ecstasy in the early 1980s after hearing from therapists convinced of its therapeutic value and decided to try it himself.
Doblin has since taken the drug more than 100 times. “I was shocked at how it performed, and how subtle a shift it was,” he said. “It was easier to remember what happened. It allowed me to bring something into my non-drug life. It has enhanced my life.”
Read the letter to the editor written by Michael Mithoefer MD in response to this article.
The Charleston, South Carolina Post and Courier published an article about the MDMA/PTSD study. While the article overemphasizes the supposed dangers of MDMA, it does at least give the impression that MDMA may indeed have therapeutic potential. Dr. Mithoefer has written a letter to the editor clarifying some misleading statements made in the Post and Courier article. The Post and Courier also published another article on the history of psychedelic research.
On August 8, the Post and Courier printed the following correction: “A story on Page 1A of Wednesday’s editions of The Post and Courier incorrectly stated that Dr. Michael C. Mithoefer was administering Ecstasy to “patients.” The story should have made it clear that the drug was being given to research subjects. The federally approved research program is unrelated to Mithoefer’s private practice and patients. Dr. Mithoefer also notes that the story would have more appropriately drawn a distinction between dangerous recreational use of Ecstasy and
controlled clinical studies if it had noted other studies, including three US studies approved by the FDA, that found “no serious adverse events” and “no evidence of neurotoxicity” in tests administered under medical supervision.”