OOPS! - "KILLER ECSTASY" STUDY RETRACTED

NIDA Credibility on the Line, RAVE Act Still Law

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 UCLA Bayview 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.