August 4, 2004
Letter to the The Editor
Post and Courier
am writing in reference to yesterdays article entitled Ecstasy research at center of debate. I was opposed to any local media coverage of my research before it is completed because of my concerns about over simplification, sensationalism and inaccuracies that are so often a part of media reporting on complex scientific issues. It was only when your reporter, Mr. Maze, told me the article would appear with or without my interview that I agreed to talk to him. I appreciate the fact that he quoted me accurately several times, but unfortunately this did not prevent the article from being misleading in at least two important ways.
In the first paragraph there is a serious error for which I request a published retraction. He stated Dr. Mithoefer has been giving his patients Ecstasy for months. Mr. Maze apparently fails to appreciate the important distinction between patients and research subjects that is widely recognized and respected in the scientific community. The former are receiving approved treatments. The latter have given informed consent to participate in research into possible treatments. Great care is taken to make the distinction between these groups, and well established, but quite different, controls are in place to protect the rights and safety of each group. It is very misleading and is damaging to my practice to state that I have been giving my patients Ecstasy. This is sensationalism at the expense of accurate and well informed reporting.
Another problem that makes the article misleading is the failure to draw a distinction between the evidence regarding recreational use of Ecstasy and the evidence from controlled clinical studies of MDMA. Your article refers to concerns about toxicity in recreational users of Ecstasy, but does not even mention the evidence supporting the safety of MDMA in clinical research settings. It is true that Ecstasy can be dangerous and even fatal in recreational use, and there is evidence, albeit controversial, that frequent, large doses of Ecstasy in recreational settings may cause damage to systems in the brain. It is, however, important to note that there have been three FDA approved Phase I safety studies in the US and a number in Europe using doses similar to those we are using in our research. These studies have involved approximately 230 subjects who have had testing to monitor for toxicity before and after being administered MDMA under medical supervision. There have been no serious adverse events in any of these studies and no evidence of brain toxicity in neuropsychological tests or in PET scans of the brain.
One of the most unfortunate consequences of misleading reporting about this subject is that it denies readers the accurate information they need to make reasoned judgments about the value of research into possible treatments for people who are suffering, as well as about the real dangers associated with the misuse of MDMA and other drugs.
Michael Mithoefer, MD
Read the article, “Ecstasy Research Center of Debate”