By Jared Chausow
By Katie Toth
By Elizabeth Flock
By Albert Samaha
By Anna Merlan
By Jon Campbell
By Jon Campbell
By Albert Samaha
On February 24, the DEA issued Dr. Michael Mithoefer a Schedule I license to legally obtain Ecstasy for a study of its potential therapeutic effects in the treatment of PTSD. Researchers hope that the drug, which melts anxiety, will help PTSD patients talk openly about the experiences that scarred them. It is the first study of Ecstasy-enhanced psychotherapy ever green-lighted in the United States, one that's been in the making for almost two decades. "There's been so much struggle over this approval process," says Rick Doblin, director of MAPS, the Multidisciplinary Association for Psychedelic Studies, the organization sponsoring the research.
Doblin's group stands to create a new landscape for Ecstasy, which has been at the center of the nation's war on drugs. The old onewith its hidden agendas, career-obsessed scientists, powerful patrons, and switched pillshas only recently been scorched. It all began in September, when the journal Science published a retraction from a group of Johns Hopkins scientists who'd discovered that a bottle they thought contained Ecstasy was in fact filled with methamphetamine, commonly known as speed. The mix-up corrupted the results of a study, published in Science in September 2002, which found that a single, recreational dose of Ecstasy was so damaging it could lead to Parkinson's disease. Another study, published in the European Journal of Pharmacology, would also be recalled.
The British journal Nature promptly published an editorial dubbing the incident "one of the more bizarre episodes in the history of drug research." Colin Blakemore, head of the U.K.'s Medical Research Council (the British equivalent of the National Institutes of Health), demanded that an independent inquiry be conducted into the affair. And The New York Times' Donald G. McNeil Jr. wrote a scathing indictment of the study's lead scientist, George Ricaurte, alleging "a pattern of shaky research supporting alarmist press releases."
Ricaurte did not respond to repeated messages left on his voice mail at Johns Hopkins or to an official request through Johns Hopkins representatives, but he has long been dismissive of his work's critics. In 2001, he told the Voice, "Everyone in the field has accepted [MDMA] is a neurotoxin. I think those [dissenting] arguments have to be put in perspective." It is this unyielding conviction that has been the hallmark of Ricaurte's career as the nation's foremost Ecstasy researcher.
But critics say the science has been less than convincing. Ecstasy promotes strong feelings of empathy by flooding the brain with serotonin, a feel-good neurotransmitter manipulated by drugs like Prozac. Once the high wears off, users register markedly depleted serotonin levels for about two weeks. What is not knownand thus is hotly debatedis whether these changes presage permanent brain damage.
That debate seemed settled when Science issued a press release in September 2002 announcing the devastating results of Ricaurte's study: After taking doses of Ecstasy akin to what teens might take at a rave, 60 to 80 percent of dopamine-related neurons in the test monkeys' brains were destroyed. The release was picked up in headlines around the globe. But some of those who got around to reading the actual study say what they found troubled them.
"The press release deliberately misrepresented the data," says Colin Blakemore. "There was no evidence of the 60 to 80 percent cell-death claim." There were other red flags: 20 percent of the monkeys had died; another 20 percent had gotten so sick they had to be withdrawn. Yet there simply aren't thousands of people dying from Ecstasy every weekend. Then there was the problem that the drugs were injectednot administered orally as suggested in the paper's introduction.
"The more I looked at it, the more I felt there was an agenda," says Blakemore, who immediately fired off a letter to Science editor in chief Donald Kennedy, complaining of "flaws so radical, so deep, they would have been picked up by any referee." But Science maintains it did everything right. "This study was peer-reviewed according to the same rigorous system used in all articles published in Science," says Ginger Pinholster, spokesperson for the Association for the Advancement of Science, which publishes the journal. According to Pinholster, the prompt retraction proved that "science is self-correcting."
Public policy, however, is not so mutable. Weeks after the botched study was published, its conclusions were repeatedly invoked by witnesses at a House subcommittee hearing on the Reducing Americans' Vulnerability to Ecstasy Act (RAVE Act). The bill was quietly passed last April as the slightly reworded Illicit Drug Anti-Proliferation Act. Aimed at quelling club drugs like Ecstasy and GHB, the law permits the prosecution of venue owners and club promoters for drug use on their premises. Only a month after it became law, it was used by a federal agent to shut down a benefit for Students for Sensible Drug Policy and the National Organization for the Reform of Marijuana Laws. And last weekend, it was used to shutter the Sound Factory nightclub in Manhattan.
As easy as it is to paint Ricaurte as a rogue scientist motivated by ambition, the scientific establishment and its patrons also played key roles in the wider scandal, from merely ignoring critical flaws to blatantly promoting problematic studies. Alan Leshner, publisher of Science and former director of the National Institute on Drug Abuse (NIDA), has come under fire for endorsing the botched study at its time of publication. "It isn't clear why an officer of the AAAS should be involved at all in publicly promoting a particular result published in its journal, least of all one whose outcome was questioned at the outset by several experts," wrote Nature. Pinholster says she called upon her boss "to serve as an expert source as a service to reporters," adding, "There was no conspiracy." Leshner declined to be interviewed.
Leshner has long railed against the dangers of Ecstasy. In 2001, when he was director of NIDA, he told the Voice, "We've known since the late '80s that MDMA can damage serotonin neurons, and if you give enough of it, they're blown away."
Rick Doblin, on the eve of his own study, says the payoffs for such shoddy science have been immense. "Leshner was willing to exaggerate findings to pander to politicians for money," he says. Leshner did help NIDA bring home the bacon: NIDA's budget for Ecstasy research has more than quadrupled over the past five years, from $3.4 million to $15.8 million; the agency funds 85 percent of the world's drug-abuse research. In 2001, Leshner testified before a Senate subcommittee on "Ecstasy Abuse and Control"; critics say Leshner manipulated brain scans from a 2000 study by Dr. Linda Chang showing no difference between Ecstasy users and control subjects. But NIDA insists it's independent from political pressures. "We don't set policy; we don't create laws," says Beverly Jackson, the agency's spokesperson.
NIDA wasn't the only benefactor of Ricaurte and wife Una McCann's research. "George and Una are cash cows for Johns Hopkins," says Doblin, who points out that every time a scientist receives a grant, money indirectly goes to the affiliated institution. While both NIDA and The New York Times have clocked Ricaurte's NIDA grant money at around $10 million, Doblin believes that's a low-ball figure. "Just this one study was $1.3 million, and he has done loads and loads of them." Johns Hopkins spokesperson Gary Stevenson declined comment beyond the official statement.
Another consequence of the retracted study and other discredited NIDA-funded findings is that they've helped obstruct legitimate research into the possible medical benefits of Ecstasy. Doblin believes Ricaurte and others are threatened by such research because it doesn't square with their drug-war agenda. In the past, Leshner has balked at those accusations. "It frankly bugs me," he told the Voice in 2001. "It's easy to say that the government isn't approving studies because they're politically incorrect. The government may say yes."
´ Now that the governmentmore specifically, the FDAhas indeed said yes, Doblin's research into the benefits of Ecstasy in treating post-traumatic stress disorder is under way. The $300,000 MAPS project, which is funded by private individuals and family foundations, has had some major setbacks since it initially received FDA approval in November 2001. The study was to have been conducted at the Medical University of South Carolina before that institution backed out; it will now be held in a private doctor's office. While Doblin believes the program would have gotten off the ground without Ricaurte's retraction, he says it's made all the players, including the institutional review board and insurance company, "feel a lot more comfortable."
A study under way in Spain examining the potential therapeutic effects of Ecstasy in rape victims hasn't fared as well. The Madrid Anti-Drug Authority pressured the sponsoring hospital to shut the study down in May 2002. Doblin largely blames Ricaurte for the mounting difficulties the research team has faced since then: Ricaurte, who was born in Ecuador, is fluent in Spanish, and gave four talks in Spain presenting his bungled findings.
As for the Illicit Drug Anti-Proliferation Act, Margaret Aitken, press secretary for Senator Joseph Biden, who sponsored the bill, said, "Senator Biden will not change his position based on this one [retracted] study." A Senate aide also confirmed the legislation would not be revisited, and that there's "no official process to go back and correct the record."
Blakemore, meanwhile, is still calling for a "full and open discussion" from Science, including the disclosure of the paper's referee reports. "If the referees didn't spot what I noticed right away, then what does that say about the quality of [Science's] referees?" asks Blakemore. "And if the referees did make negative comments [that went unheeded], what does that say about Science?" At press time, Blakemore and Leslie Iversen, an Oxford University pharmacologist, were drafting a letter that Don Kennedy has promised to publish in Science. That journal, NIDA, and Johns Hopkins insist there's been no evidence of foul play; no investigations were being conducted at any of these institutions at press time.
In the end, the ones most negatively affected by the studies may be those they purport to help. "I'm very concerned about drug use, but the way to tackle it is not to misrepresent scientific evidence," says Blakemore. "What's going to be the impact of these studies? Young people won't believe anything they read."