Oops!
--
"Killer
Ecstasy"
Study
Retracted,
NIDA
Credibility
on
the
Line,
RAVE
Act
Still
Law
9/12/03
Last September, a team of Johns Hopkins University researchers led by Dr. George Ricaurte announced dramatic, frightening findings about the effects of the popular dance culture drug ecstasy (MDMA) on the human brain: "One Night's Ecstasy Use Can Cause Brain Damage," read a typical newspaper headline based on his study. The research results, which suggested that a single recreational dose of ecstasy could lead to brain damage and Parkinson's disease, were widely trumpeted by the National Institutes on Drug Abuse (NIDA) and helped create the panicked atmosphere in which the repressive RAVE Act became law. Now, a year later and with much less fanfare, the team has quietly asked the journal Science, in which the research was published, to retract the findings. It turns out, the researchers reported, that the drug they were using was not MDMA at all, but methamphetamine mistakenly labeled as ecstasy. The error was discovered, Ricaurte said in a letter to Science, when his team sought to replicate the results of the "ecstasy" injections with oral doses and got wildly different results. Ricaurte and team are blaming the drugs' supplier, North Carolina's Research Triangle Institute, for the error, but Research Triangle has yet to confirm or deny that it mislabeled the drugs. The research results were hotly questioned at the time by other researchers in the field, but those questions were largely ignored in media reports warning of a new danger from ecstasy use. The results should have been more sharply scrutinized. While Ricaurte wrote that his experiments showed that modest doses of ecstasy could cause damage to neurons that use dopamine, it should have been evident that something was wrong. Of 10 monkeys and baboons dosed with the drug, two died quickly and two became so ill they could not take a third dose. Such high mortality and morbidity rates, which have never been associated with recreational ecstasy use, should have been a warning signal that something was seriously flawed with the research project. Instead, Ricaurte and associates used the findings to suggest that ecstasy users were playing Russian Roulette with their brains. It is possible that Ricaurte's flawed findings were the result of honest error, but Ricaurte's record as a leading propagandist for the dangers of ecstasy -- he is also responsible for the now discredited "plain brain/ecstasy brain" NIDA campaign -- leaves his critics unwilling to give him the benefit of the doubt. "This is not just a lab or labeling error," said Rick Doblin, president of the Multidisciplinary Association for Psychedelic Studies (MAPS), a Sarasota, Florida-based group that funds studies of the therapeutic uses of psychedelic drugs and is seeking government permission to do human MDMA tests. "The lab hasn't accepted responsibility for making a mistake. But the real error is in how Ricaurte presented his data," Doblin told DRCNet. "In order to make his study reach the conclusions he wanted, he had to ignore three previous published studies that showed that MDMA had no effect on dopamine in humans. He should never have said that MDMA users were at risk of Parkinson's. He should never have made such bold claims. And clearly, what Ricaurte was giving those animals was not a common recreational dose, because those animals were dropping dead." Dr. Charles Grob of the Harbor-UCLA Medical Center, another leading researcher on ecstasy, was equally critical. "I was shocked but not surprised" at the retraction revelation, he told DRCNet. "In 2000, I published a long review article in the Journal of Addiction Research where I reviewed many of the serious flaws in Ricaurte's research program going back to the 1980s. There is a pattern there of serious methodological flaws, questionable data analysis, misleading and hyped conclusions, and presenting sensationalized results to the media in particular," Grob said. That's not how Johns Hopkins University, where Ricaurte is a professor of neurology, sees it. In a press release announcing the retraction, Johns Hopkins argued that the blunder "in no way undermines the results of numerous previous studies performed in multiple laboratories worldwide demonstrating the serotonin neurotoxic potential of recreational doses of MDMA in various animal species, including several primate species." Furthermore, the university asserted, "The study results replicate what was previously published regarding the neurotoxic effects of methamphetamine use, and the researchers' efforts to investigate conflicting data in the laboratory are an excellent example of how science is self-correcting." All well and true, if a bit self-congratulatory given the circumstances, but it is worth noting that Ricaurte trumpeted the danger of ecstasy -- not methamphetamine -- to humans, not "various animal species." As for Ricaurte's professional standing, Johns Hopkins had no reservations. When asked by DRCNet what consequences Ricaurte and his team faced, John Hopkins spokesman Trent Stockton replied, "None from Johns Hopkins. He remains a faculty member in good standing." A NIDA spokeswoman told DRCNet the anti-drug agency was just beginning to look into the matter. "We're not sure how much money in NIDA grants Ricaurte has received," said NIDA's Beverly Jackson, "but many people are asking. He's been a grantee for many, many years. We're trying to put that together right now." As for consequences for Ricaurte and team, Jackson said NIDA was at this point unsure where errors occurred. "There is a normal scientific investigation going on," she said. "Everyone is looking into this." Ricaurte did not return a DRCNet call for comment by press time. For Doblin and Grob, many questions remain. "There is the question of a cover-up," Doblin pointed out. "Ricaurte attempted to replicate his results with oral administrations, but could not do so. That was last year, but in June of this year he was still defending his paper in the pages of Science. He knew he couldn't replicate those results, but he was still trying to promote the idea that MDMA hurts dopamine in humans. Even as he retracts his findings, he is still trying to throw mud at MDMA." According to Doblin, Ricaurte's knowing lies helped shut down a research project on ecstasy and post-traumatic stress disorder in Spain this summer. "He was in Madrid telling people about dopamine problems and promoting the theory that ecstasy causes Parkinson's when he already knew better," Doblin said. "He contributed to the pressure to shut down the research. His whole career seems to be one where he takes extreme positions about the risk of MDMA and then has to juggle his risk estimates to justify his claims." Ricaurte and his team were also a baleful influence working against MAPS efforts to win FDA approval for human ecstasy studies, Doblin said. "In 2001, we got FDA approval for MDMA studies and subsequent approval from the Internal Review Board, but someone on the board didn't like it and called [Ricaurte researcher] Una McCann, and suddenly our approval was revoked," he said. "We tried again last year, but their study came out last September, and after that the review board said our research was too political. Ricaurte and his team have had a deleterious effect on our ability to do therapeutic research," Doblin continued. "The review boards are scared because of [former NIDA head Alan] Leshner, Ricaurte and McCann fanning the flames and shouting 'danger, danger, danger.'" Both Grob and Doblin would also like to know what happened to the other mislabeled drugs used by Ricaurte's team. In his retraction letter to Science, Ricaurte wrote that the drugs came in a 10-gram vial, but the research in question only used up 1.5 grams of the methamphetamine. "What's the story with the other 8.5 grams of material?" Grob asked. "The Washington Post says at least one other paper needs to be retracted, but who knows what else Ricaurte did? What else needs to be retracted? It's probably more than one paper, and they must have already known this when they announced the retraction." While the need to clarify Ricaurte's other research is clear, his work has had as much impact in the field of public policy as in the field of scientific research. "His work helped lay the groundwork for the RAVE Act," said Doblin. "You had all these senators thinking they had to save a generation of kids, so now we have the RAVE Act and these other borderline unconstitutional, draconian laws because of fears generated about the dangers of MDMA use. Those senators were misled by heartless advocates of the position that MDMA will give them Parkinson's disease, and now even Ricaurte has to admit there was no basis for that." "Ricaurte's work has been pivotal in getting politicians to enact draconian, ineffectual and even counterproductive legislation," Grob concurred. One member of Ricaurte's team, Una McCann, did express regret for misleading scientists, politicians, and the public alike, but Ricaurte has so far declined to do so. "I feel personally terrible," she told the Washington Post. "You spend a lot of time trying to get things right, not only for the congressional record but for other scientists around the country who are basing new hypotheses on your work and are writing grant proposals to study this." What should be done? "The people who have to do something are Ricaurte's funders and employers," said Doblin. "They need to be asking lots of questions, especially about when his attempts to replicate his results orally took place. When did he know his results were bad and how long did he continue to defend his study knowing this?" There needs to be a broader investigation, said Grob. "We need a thorough review of his research, his published articles, and his published comments going back 15 years or so. Many of his studies are seriously problematic. I've spent a lot of time going through his work, and there is a solid case for questioning his credibility," he said. "And the journals that have published his work have some serious remedial work to do." But Grob isn't holding his breath. "NIDA will try to sweep this under the rug, there will be a lot of resistance to going beyond the excuse given, but the flaws and problems with Ricaurte's work are too compelling to be ignored. The cat is out of the bag. He says the lab made a mistake -- yeah, and the dog ate my homework." For Doblin, there is a lesson in the Ricaurte scandal. "There is a tendency for people to say that those of us who have taken MDMA are biased," he said. "Alan Leshner often said we claim MDMA is harmless. We have never claimed that MDMA is harmless and we have a great interest in knowing what the risks are. It is the people who wage the drug war who need to distort and demonize these drugs to justify the infringements on personal freedom. I hope this help makes it clear to people where the real incentive for bias lies." To read Ricaurte's retraction letter to Science, go to http://www.sciencemag.org and search for "Ricaurte" and "retraction." For more information about Ricaurte's retraction of his Science article, see a collection of media articles at http://www.maps.org/media/ online. For correspondence between MAPS, Science and Ricaurte about other misleading statements made in Ricaurte's original Sept. 27 paper and in a June 6, 2003 exchange of letters in Science between MAPS' MDMA/PTSD protocol development team and Ricaurte et al., see http://www.maps.org/research/mdma/studyresponse.html online.
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