By Alfa · Mar 10, 2004 ·
  1. Alfa

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

    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

    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

    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

    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

    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

    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."


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