What follows are a few corrections to Donald G. McNeil Jr.'s excellent article (12/2/03, Science Times section of the New York Times) on how Drs. Ricaurte and McCann's NIDA-funded research exaggerated the risks of MDMA.
Most importantly, the article says that a study in Spain using MDMA to treat rape victims is underway. In fact, that MAPS-sponsored study by Jose Carlos Bouso was prematurely shut down as a result of political pressure by the Madrid Anti-Drug Agency, aided in part by an anti-ecstasy climate created by Dr. George Ricaurte in his numerous "scientific" talks in Spain, some at the invitation of the Spanish Anti-Drug Agency. We're trying to restart the study but so far have not been successful. It's painfully clear that the exaggerations of the risks of MDMA have had a devastating impact on research into MDMA's therapeutic potential.
The article mentions that "The Food and Drug Administration recently approved a study in traumatized crime victims who have failed to respond to antidepressants." The FDA first approved the study in November 2001. Due again to the anti-ecstasy climate created in part by Drs. Ricaurte and McCann, we've had a terribly difficult time obtaining Institutional Review Board (IRB) approval for the MDMA research. The Western IRB did approve the protocol in July 2002, but revoked approval in September 2002 after talking to several scientists, among them Dr. Una McCann, right before the original Ricuarte/McCann article in Science came out claiming that MDMA caused Parkinson's. We finally managed to obtain IRB approval again from a different IRB in September 2003. However, the first FDA-approved study of the therapeutic use of MDMA in the 18 1/2 years since it was made illegal in 1985 is still being held up by the Drug Enforcement Administration, which has been delaying issuing Dr. Mithoefer his required Schedule I license since July 2002, when he first submitted his application. We expect DEA to issue Dr. Mithoefer his Schedule I license before the end of 2003, but nothing is certain.
The article mentions that "Since about 1970, when it was called Adam, some psychiatrists had tried giving low doses to trauma victims; in 1985, they stopped, fearing arrest." MDMA wasn't used in therapy under the code name ADAM until the late 1970s, mostly in full (not low) doses. While most psychiatrists did stop using MDMA for fear of arrest, a small number have courageously continued to work with MDMA to treat their patients.
The article claimed that "Dr. Marc Laruelle, a Columbia University PET scan specialist cited a recent German study showing that serotonin decreased only modestly and returned to normal within six weeks." The German study did show that former ecstasy users had normal serotonin transporter levels but the former users had not taken ecstasy for an average of 17 months, not six weeks.
The article claimed that "His 10 squirrel monkeys and baboons had instead been injected with overdoses of methamphetamine, and two of them had died." While Ricaurte's paper claims that the only 10 animals were used in this study, he later admitted that he used 15 animals in this study. He probably used about 15 or more additional primates in his subsequent attempts to replicate his original findings with genuine MDMA, which he was unable to do.
The article stated, "When Dr. Ricaurte's 2002 primate study was published, his critics said he could not possibly have given "typical recreational doses" if 2 of 10 animals died and two others collapsed of heatstroke." The other two were not reported to have collapsed of heatstroke but instead were claimed to have shown some signs of toxicity that prompted the researchers to decide not to administer the third injection. It's doubtful that they actually collapsed of heatstroke but it is possible.
The article claims that "the labels on two vials he bought in 2000, he said, were somehow switched. The problem corrupted four other studies in his lab, forcing him to withdraw four other papers." At present, we're aware of only two studies that were retracted but we have believed that more needed to be retracted. We'll inquire about what other studies have been retracted. Research Triangle Institute, the company that supplied the MDMA and methamphetamine to Ricaurte's lab, denies being responsible for switching the contents of the bottles.
When we consider 1) the increased criminal penalties that have been imposed on Ecstasy users and dealers as a result of exaggerated fears of the dangers of MDMA, 2) the pressure that anti-rave legislation has placed on club owners to eliminate harm reduction measures since these measures could be used as evidence that club owners were aware of possible drug use in their events and thus could be charged in criminal and civil cases, and 3) the difficulties in obtaining permission to conduct MDMA-assisted psychotherapy research as a result of Ricaurte/McCann's claims that even one dose of MDMA could cause serious brain damage, a strong case can be made that the harms caused by the exaggerations of the risks of MDMA exceed the harms of MDMA itself.