Bad Science Slandered a Generation's Favorite Drug. Now a New Study Aims to
Undo the Damage.

THE ECSTASY FACTOR

Today is different: You're speaking to a psychiatrist--not in a sterile,
fluorescent-lit hospital, but in a residential office on a peaceful,
tree-lined street. You suffer from post-traumatic stress disorder, and
you've talked for hours in this very room, but always skipping the violent
chapter that keeps you up at night, giving you flashbacks and causing you
to feel estranged from your loved ones. Now an emergency room doctor and
nurse are stationed inside the house. You've brought an overnight bag.
Today, you've been given 125 milligrams of Ecstasy, and maybe, just maybe,
you'll finally be able to face your demons.

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 one--with its hidden
agendas, career-obsessed scientists, powerful patrons, and switched
pills--has 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 known--and thus is hotly debated--is 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 injected--not 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 government--more specifically, the FDA--has 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."