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TO CREATE (Options in Health Care and Education)  
     
     
MDMA Neurotox (Brain Damage)?
(Tiny URL=http://tinyurl.com/mhnk)

Second Ecstasy paper to be retracted:

Additional published research affected by drug mix-up | By Robert Walgate

The European Journal of Pharmacology has received an e-mail from George Ricaurte, principal author of the recently retracted Science paper on the effects of the recreational drug Ecstasy (methylenedioxymethamphetamine, or MDMA), which may indicate that another paper will have to be retracted. Editorial representatives of the journal would not describe the contents of the e-mail, but told The Scientist that a decision on the matters therein will be taken at tomorrow's (September 18) editorial board meeting.

The Baltimore Sun last week reported that according to a spokesperson for the Ricaurte group, Una McCann, "a letter of retraction had been sent to a
medical journal, which she declined to identify until editors there decide how to "handle the matter."

McCann's admission indicated that experiments other than the one reported in Science may also have used the wrong chemical. The letter of retraction to Science indicated that the suspect container for Ecstasy was now empty, suggesting much use must have been made of it. The controversial issue of whether
MDMA is neurotoxic is one of the group's principal fields of work.

McCann told the Sun that the new study to be retracted involved rats and was not designed to look at toxicity to dopamine cells. The European Journal of Pharmacology paper involves rats and looks at the effect of MDMA on the density
of serotonin transporter.

The group published several papers on related issues in several journals in 2002, the year of publication of the retracted Science study. In that study,
mislabeled vials meant that experimental animals were being given not Ecstasy, but methamphetamine ("speed"), which is known to be toxic to the dopamine system. Ecstasy immediately affects the serotonin system, but its long-term effects
are disputed.

Among the journals that published related work by the Ricaurte group, the Journal of Neurochemistry and the Journal of Pharmacology and Experimental
Therapeutics told The Scientist that they have not received any letter. No other journals contacted have yet indicated that they have received a letter from the Ricaurte group, but not all editorial departments had responded by press time.
Neither McCann nor Ricaurte was available for comment.

Links for this article:
R. Walgate, "Retracted ecstasy paper an 'outrageous scandal,'" The Scientist, September 16, 2003.(http://www.biomedcentral.com/news/20030916/04)

J. Bor, "Scientists retract second drug study," The Baltimore Sun, September 12, 2003.(http://www.sunspot.net/news/health/bal-te.ecstasy12sep12,0,5961
581.story?coll=bal-health-headlines)


Researchers Retract Ectasy Study (Associated Press) (http://story.news.yahoo.com/news?tmpl=story&u=/ap/20030906/ap_on_he_me/science_retraction_4)
Researchers who studied the effects of the drug Ecstasy on animals are retracting their report in a major scientific journal after discovering a labeling mix-up caused them to use a different drug.

--------------------------------------------------------------------------------
Scientific Journal Prints Retraction (Associated Press)
(http://story.news.yahoo.com/news?tmpl=story&u=/ap/20030905/ap_on_he_me/science_retraction_1)
A prestigious scientific journal is retracting a study about the effects of the drug Ecstasy on the brain because the animals used in the research were given a different drug.

--------------------------------------------------------------------------------
Scientists Retract Story on Ecstasy Brain Damage (Reuters)
(http://story.news.yahoo.com/news?tmpl=story&u=/nm/20030905/sc_nm/science_retraction_dc_1)
Researchers horrified to find they had used a mislabeled bottle in an experiment retracted their findings on Friday, saying they had failed to show the drug Ecstasy can cause a certain pattern of brain damage.

--------------------------------------------------------------------------------

LINKS TO OTHER REPORTS:
http://www.washingtonpost.com/wp-dyn/articles/A33096-2003Sep5.html

http://www.nytimes.com/2003/09/06/health/06ECST.html

http://www.sunspot.net/news/health/bal-te.md.ecstasy06sep06,0,1049895.story?
coll=bal-home-headlines


http://www.chicagotribune.com/news/nationworld/chi-0309060122sep06,1,2761612
.story

--------------------------------------------------------------------------------

LINKS TO QUOTATIONS AND COVERAGE OF ORIGINAL PUBLICATION, BY NIDA AND NIDA DIRECTOR (AT THAT TIME), ALAN LESHNER, Ph.D.:

"Using Science To Counter the Spread of Ecstasy Abuse"
By NIDA Director Alan I. Leshner, Ph.D.(http://www.drugabuse.gov/NIDA_Notes/NNVol16N5/DirRepVol16N5.html)

(http://165.112.78.61/NIDA_Notes/NNVol14N4/Ecstasy.html)

(http://www.drugabuse.gov/NIDA_Notes/NNVol16N5/DirRepVol16N5.html)

(http://www.drugabuse.gov/NIDA_Notes/NNVol16N5/Conference.html)

(http://165.112.78.61/DrugPages/MDMA.html)

Testimony by Alan Leshner (http://165.112.78.61/Testimony/7-30-01Testimony.html)

Local Copies of Full Text NIDA Statements on MDMA Causing Brain Damage Copied 9/6/2003
By Alan Leshner et al.

--------------------------------------------------------------------------------

POPULAR PRESS REPORTS (full text):

Results Retracted On Ecstasy Study

By Rick Weiss
Washington Post Staff Writer
Saturday, September 6, 2003; Page A03


Scientists at Johns Hopkins University who last year published a frightening and controversial report suggesting that a single evening's use of the illicit drug ecstasy could cause permanent brain damage and Parkinson's disease are retracting their research in its entirety, saying the drug they used in their experiments was not ecstasy after all.

The retraction, to be published in next Friday's issue of the journal Science, has reignited a smoldering and sometimes angry debate over the risks and benefits of the drug, also known as MDMA.

The drug is popular at all-night raves and other venues for its ability to reduce inhibitions and induce expansive feelings of open-heartedness. But some studies have indicated that the drug can at least temporarily damage neurons that use the mood-altering brain chemical serotonin. Some users also have spiked fevers, which rarely have proven fatal.

Last year's research, involving monkeys and baboons, purported to show that three modest doses of ecstasy -- the amount a person might take in a one-night rave -- could cause serious damage to another part of the brain: neurons that use the brain chemical dopamine.

Two of 10 animals died quickly after their second or third dose of the drug, and two others were too sick to take the third dose. Six weeks later, dopamine levels in the surviving animals were still down 65 percent. That led Hopkins team leader George Ricaurte and his colleagues to conclude that users were playing Russian roulette with their brains.

Advocates of ecstasy's therapeutic potential, including a number of scientists and doctors who believe it may be useful in treating post-traumatic stress disorder or other psychiatric conditions, criticized the study. They noted that the drug was given in higher doses than people commonly take and was administered by injection, not by mouth. They wondered why large numbers of users were not dying or growing deathly ill from the drug, as the animals did, and why no previous link had been made between ecstasy and Parkinson's despite decades of use and a large number of studies.

The answer to at least some of those questions became clear with the retraction, which is being released by Science on Sunday evening but was obtained independently by The Washington Post. Because of a mislabeling of vials, the scientists wrote, all but one of the animals were injected not with ecstasy but with methamphetamine, or "speed" -- a drug known to damage the dopamine system.

The researchers said they discovered the mistake when follow-up tests gave conflicting results, and they offered evidence that the tubes were mislabeled by the supplier, identified by sources as Research Triangle Institute of North Carolina. A spokesman for the company said last night that he did not know whether the company had erred.

The error has renewed charges that government-funded scientists, and Ricaurte in particular, have been biased in their assessment of ecstasy's risks and potential benefits.

Rick Doblin, president of Multidisciplinary Association for Psychedelic Studies, a Sarasota, Fla.-based group that funds studies on therapeutic uses of mind-altering drugs and is seeking permission to conduct human tests of MDMA, said the evidence of serotonin system damage is weak.

"The largest and best-controlled study of the effect of MDMA on serotonin showed no long-term effects in former users and minimal to no effects in current users," he said.

Una McCann, one of the Hopkins scientists, said she regretted the role the false results may have played in a debate going on last year in Congress and within the Drug Enforcement Administration over how to deal with ecstasy abuse.

"I feel personally terrible," she said. "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."

But she and Ricaurte emphasized last night that the retraction had not changed their feelings about the danger of taking ecstasy.

"I still wouldn't recommend it to anybody," McCann said.

--------------------------------------------------------------------------------

NY TIMES
September 6, 2003
Report of Ecstasy Drug's Great Risks Is Retracted
By DONALD G. McNEIL Jr.
leading scientific journal yesterday retracted a paper it published last year saying that one night's typical dose of the drug Ecstasy might cause permanent brain damage.

The monkeys and baboons in the study were not injected with Ecstasy but with a powerful amphetamine, said the journal, Science magazine.

The retraction was submitted by the team at Johns Hopkins University School of Medicine that did the study.

A medical school spokesman called the mistake "unfortunate" but said that Dr. George A. Ricaurte, the researcher who made it, was "still a faculty member in good standing whose research is solid and respected."

The study, released last Sept. 27, concluded that a dose of Ecstasy a partygoer would take in a single night could lead to symptoms resembling Parkinson's disease.

The study was ridiculed at the time by other scientists working with the drug, who said the primates must have been injected with huge overdoses.

Two of the 10 primates died of heat stroke, they pointed out, and another two were in such distress that they were not given all the doses.

If a typical Ecstasy dose killed 20 percent of those who took it, the critics said, no one would use it recreationally.

In an interview yesterday, Dr. Ricaurte said he realized his mistake when he could not reproduce his own results by giving the drug to monkeys orally. He then realized that two vials his laboratory bought the same day must have been mislabeled: one contained Ecstasy, the other d-methamphetamine.

Dr. Ricaurte's laboratory has received millions of dollars from the National Institute on Drug Abuse, and has produced several studies concluding that Ecstasy is dangerous. Other scientists accuse him of ignoring their studies showing that typical doses do no permanent damage.

At the time Dr. Ricaurte's study was published, it was strongly defended against those critics by Dr. Alan I. Leshner, the former head of the drug abuse institute, who had just become the chief executive officer of the American Academy for the Advancement of Science, which publishes Science.

Dr. Leshner had testified before Congress that Ecstasy was dangerous, and Dr. Ricaurte's critics accused him of rushing his results into print because a bill known as the Anti-Rave Act was before Congress. The act would punish club owners who knew that drugs like Ecstasy were being used at their dance gatherings.

Dr. Ricaurte yesterday called that accusation "ludicrous."

His laboratory made "a simple human error," he said. "We're scientists, not politicians."

Asked why the vials were not checked first, he answered: "We're not chemists. We get hundreds of chemicals here. It's not customary to check them." (?!!!***)

--------------------------------------------------------------------------------

BALTIMORE SUN:
Researchers retract study tying Ecstasy to Parkinson's
Hopkins doctors used mislabeled drugs in tests

By Frank D. Roylance and Dennis O'Brien
Sun Staff
Originally published September 6, 2003

Researchers at the Johns Hopkins Bayview Medical Center have been forced to retract a highly publicized paper linking the drug Ecstasy to serious brain damage after discovering that they had actually administered a different drug to most of the animals in their study.

In a retraction scheduled for publication next week in the prestigious journal Science - which ran the original results a year ago - the team led by Hopkins neurologist George A. Ricaurte says that a vial labeled as MDMA, the active chemical in Ecstasy, actually contained methamphetamine, a similar but chemically distinct drug known as "speed." Researchers said the vials were apparently mislabeled by a supplier.

The retraction states that the mislabeled drug was used on all but one of the 15 primates in the two-year study. Although the methamphetamine would be expected to have effects similar to Ecstasy's, the researchers said, the results of the study were invalidated by the labeling error.

Influential and widely publicized at the time, the Hopkins study was seized on by health officials who argue that the drug causes serious, long-term brain damage, a conclusion that is not universal in the scientific community. The study was funded by the National Institute on Drug Abuse (NIDA).

Minor corrections are common in Science, but Ginger Pinholster, director of public programs for the journal, said she could recall "maybe a handful" of retractions in the past four years.

The professional journal, with 140,000 subscribers, is published by the American Association for the Advancement of Science and is one of the most influential publications of its kind the world. Pinholster credited the scientists with "doing the right thing."

"These researchers should be applauded for coming forward the way they did," she said.

Dr. Una D. McCann, one of the study's co-authors, said she worries that the false results may mislead other researchers and erode public confidence in drug research. "We're very regretful about what it might have done, not only to our scientific colleagues, but to the public at large," she said.

In their original paper, the researchers said that when MDMA was given to squirrel monkeys and baboons, it produced the same sort of brain damage seen in people who suffer from Parkinson's disease.

They said the doses they used were similar to those taken by young people during all-night "rave" parties - three doses at three-hour intervals.

In their retraction, the scientists said the labeling error does not invalidate past studies concluding that Ecstasy can have serious effects on brain function in rats. McCann said the error does mean that it remains to be established whether Ecstasy has similar effects on primates.

According to their retraction statement, the scientists began to suspect something was amiss after the original study was published when they couldn't reproduce the results using orally-administered doses of the drug instead of injections.

Realizing that they were using a new batch of MDMA, they had it tested and found it authentic. So they returned to the original study and found records showing that both drugs - MDMA and methamphetamine - had been ordered on the same date and arrived at the lab from the supplier in the same package. The two bottles had different labels and batch numbers. They were stored in a locked laboratory safe.

Suspecting that the labels had been switched, the scientists had the contents of the original methamphetamine vial tested. It proved to contain MDMA. But the original vial of MDMA had been used up and discarded, so the researchers tested frozen brains from two of the animals that had originally received the supposed MDMA. They contained no trace of MDMA but did contain traces of methamphetamine.

The two drugs were supplied to the Hopkins lab by Research Triangle Institute International (RTI) of North Carolina and paid for under a contract with NIDA.

"We know all the supplies come from RTI. We don't know where the errors occurred," said Beverly Jackson, a NIDA spokesman. "Everybody needs to take a close look at what happened."

Representatives from RTI could not be reached for comment last night.

Research into Ecstasy has been controversial, with some physicians arguing that funding targeted at finding problems with the drug is politically motivated and that neurological damage has been exaggerated.

Dr. Charles Grob, a Hopkins-trained psychiatrist on the faculty at the UCLA School of Medicine and longtime critic of Ecstasy research, said that many studies of the drug at Hopkins have been flawed, targeting the drug's ill effects and discouraging research into its possible therapeutic value.

Grob said MDMA may have applications for patients suffering from severe anxiety or trauma. "It's been a seriously hyped issue," he said. "We have a drug war going on, and it's hard to shift gears and examine a drug in an entirely different context, where it could be useful for psychiatric treatment," he said.

The other investigators in the Hopkins study were Doctors Jie Yuan and George Hatzidimitriou of the Hopkins Department of Neurology and Branden J. Cord of the Department of Neurosciences.
The Baltimore Sun

--------------------------------------------------------------------------------

CHICAGO TRIBUNE

http://www.chicagotribune.com/news/nationworld/chi-0309060122sep06,1,2761612.STORY

ACROSS THE NATION

Scientific journal retracts drug study

September 6, 2003

WASHINGTON, D.C. -- The journal Science, a prestigious scientific publication, retracted Friday a study about the effects of the drug Ecstasy on the brain because of a mix-up.

Researchers said the test animals were given methamphetamine because of a labeling mistake.

Scientists at Johns Hopkins University reported last September that key neurons in the brains of squirrel monkeys and baboons were damaged by doses of Ecstasy that mimicked those often taken by users of the drug.

Previous studies noted the hazards of Ecstasy, and the researchers said the problems with their study did not call into question the earlier ones.
Chicago Tribune

--------------------------------------------------------------------------------
"***" Denotes a personal (definitely unofficial and basically meaningless) editorial comment by Dr. Trachtenberg.

Kleiman Blog: (http://www.markarkleiman.com/archives/drug_policy_/2003/12/mdma_neurotoxicity_an_ouchie_for_george.php)

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NIDA Statements on MDMA Causing Brain Damage
By Alan Leshner et al (Full Text copied 9/6/2003)

Even More from THE SCIENTIST: (http://www.biomedcentral.com/news/20030916/04)

More Under Construction: (http://www.biomedcentral.com/news/20030916/04)

More Under Construction: (http://www.biomedcentral.com/news/20030916/04)

More Under Construction: (http://www.biomedcentral.com/news/20030916/04)

More Under Construction: (http://www.biomedcentral.com/news/20030916/04)

More Under Construction: (http://www.biomedcentral.com/news/20030916/04)

More Under Construction: (http://www.biomedcentral.com/news/20030916/04)

More Under Construction: (http://www.biomedcentral.com/news/20030916/04)