Carla Spartos

Ecstasy Relieved from Agony

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 Village 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 Village 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 Village 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."

Carla Spartos is a regular contributor to the Village Voice.

Ecstasy Therapy Is Back

He reclined on his bed, talking, while another man, a friend, looked on from a nearby chair. The lights were dim, and the soft music floating in the background had no lyrics to distract. Every so often, the friend responded to his words, or, when the recorder stopped, replaced the cassette taping their conversation. They went on this way, intimately, searchingly, for eight hours.

"After the session, I found immediate relief," says Steven, a 32-year-old director of a Washington, D.C.-based nonprofit, who, in May, suffered from a series of panic attacks triggered by a terrible breakup. Prone to low-level anxiety already, he found himself popping the sedative Ativan several times a day just to cope. Then a friend suggested he try Ecstasy. This would be the first of three times he would take two pills of MDMA purely for therapeutic reasons. "The MDMA allowed me to look at experiences otherwise too painful," says Steven, not his real name. "I was able to more rationally observe my behavior, my relationships, my responsibility in the breakup."

Before Ecstasy became illegal in 1985 and illicit recreational use bloomed, MDMA was mainly a couch tool for a handful of therapists. For years, supporters of medical MDMA have pointed to promising anecdotal evidence from that era, saying the drug could help patients accomplish in a couple of sessions what would otherwise take years. Some therapists have continued relying on Ecstasy as an underground practice, and regular people have been dosing on their own. Now the pro-Ecstasy lobby is getting a shot at turning anecdote into fact.

In November, the Food and Drug Administration approved the first ever U.S. study of Ecstasy as helpful medicine. Previous testing has centered not on the drug's benefits, but on issues like how toxic it might be. These new clinical trials -- which may be held at the Medical University of South Carolina -- will measure the effectiveness of MDMA-assisted psychotherapy for post-traumatic stress disorder. Twelve subjects, all victims of criminal assault, will be given Ecstasy under the supervision of a doctor and then put through a talk session; eight others will receive placebo sugar pills before hitting the couch. Everyone will get 16 hours of drug-free therapy, but supporters think the group taking Ecstasy will see great results.

"Think of [MDMA] as Prozac plus," says Rick Doblin, director of the Multidisciplinary Association for Psychedelic Studies, the organization funding the research. Like Prozac, Ecstasy boosts serotonin, the feel-good neurotransmitter that regulates mood and other critical brain functions. Proponents believe Ecstasy can also relieve pain, anxiety, and depression, and researchers hope to study potential benefits of the drug for people dealing with terminal illness. But while society approves of the myriad mood enhancers regularly prescribed to millions of Americans each year, Ecstasy is considered a scourge. "It's so hard to do research on, but so easy to buy in clubs," says Dr. Julie Holland, a psychiatrist at Bellevue Hospital and editor of Ecstasy: The Complete Guide.

Would-be MDMA researchers argue that the drug's ability to "open people up" will make it a good candidate for PTSD sufferers, who often have trouble discussing the traumatic events that haunt them. "It's kind of like anesthesia during surgery," says Holland. "It allows you to remove this malignant thing." Taking one or two pills of pure MDMA over the course of a lifetime may be safe for some people, but it's not so attractive to pharmaceutical companies. After all, drugs like Prozac turn a profit -- and lots of it, since patients need to take them every day. Unlike struggling researchers, the wealthy manufacturers can afford an army of Capitol Hill lobbyists to turn politicians' heads the other way.

Still, the FDA's decision to approve the study of an illegal substance is no fluke. On November 27, Dr. Francisco Moreno of the University of Arizona at Tucson began dosing subjects who suffer from obsessive-compulsive disorder with psilocybin, the active ingredient in mushrooms. The government-approved research is funded by MAPS and another psychedelic think tank, the Heffter Research Institute. "For a quarter century, [psychedelic] researchers have been locked out of the laboratory, but we're starting to get back in now," Doblin says. "Not in massive ways, but in important, small steps."

Scientists overseas are seeing progress, too. The Israeli Ministry of Health has considered a protocol for treating victims of terrorist attacks with Ecstasy -- an idea with obvious implications for post- September 11 America.

For Isabel, a 27-year-old journalist, this is a good thing. "It's like a truth serum," she explains. Isabel, not her real name, took her first E two and half years ago and says she has done it about 15 times since then, "sometimes at a club, sometimes just chilling at home." She remembers sitting on a park bench, rolling on four pills, with a friend. "He had liked me for a long time, but wouldn't come out and say it," she recalls. That night, they talked about how they felt. "It was freeing," she says.

Other drugs people routinely take -- the aspirin, the cold medicine -- come with explicit instructions. For Ecstasy, it's not even possible to know exactly what you're taking, and there's no doctor to warn against using too much. Once, coming down off seven and a half pills, Isabel fell into a two-day crying jag. "I felt depressed. Just sad."

The FDA's timing couldn't seem stranger. In July, Florida senator Bob Graham introduced the Ecstasy Prevention Act of 2001, which would allocate more than $22 million to heightened law enforcement, a "Just Say No"-type media campaign, and the creation of a new Ecstasy drug test. The bill coincided with a two-day conference at the National Institutes of Health that summarily blasted MDMA.

"People who take a single, oral dose [of Ecstasy] run the risk of partial brain serotonin injury," Dr. George Ricaurte, a leading MDMA researcher at Johns Hopkins Medical Institutions, told the audience.

Federal law-enforcement officials have been busy, too. In October, the Drug Enforcement Agency seized 48,000 Ecstasy pills during Operation Triple X. Displaying no compassion for compassionate use, the DEA raided the Los Angeles Cannabis Resource Center a week later, confiscating the medical-marijuana outfit's computers, patient records, and pot plants. It was California's third such crackdown in a month. A serious blow had been dealt to medical-marijuana supporters. Or so it seemed.

A day after psilocybin was being doled out to patients in Arizona, the DEA gave final approval for two medical-marijuana studies, the first of several planned by the University of California's Center for Medicinal Cannabis Research. The center just got a DEA-issued certificate allowing it to obtain legal, government-grade pot from the National Institute on Drug Abuse (NIDA). And if the results look promising? "We may see some [reclassifying of marijuana] if there is reason to believe there are legitimate medical reasons," says Donald Thornhill, a DEA spokesman in San Diego.

The real source of these changing attitudes is the FDA. According to Dr. David E. Nichols, president of the Heffter Institute and a professor of pharmacology at Purdue University, the groundwork for much of the current research was laid in the mid '90s, when the FDA approved psychiatry professor Dr. Rick Strassman's studies with DMT, a potent hallucinogen, at the University of New Mexico. "There was a lot of dialogue in the FDA that there should be no different requirements with these drugs, which is the way the FDA should have always been operating," explains Nichols.

In a government bent on eradicating illegal drugs, the FDA may be the agency most immune to political pressures. It's made up of scientists whose mission is to help develop medicine, and they're open to the idea that any given compound is not entirely good or bad. Just listen to the words of Katherine Bonson, a pharmacologist who addressed an Ecstasy conference organized by the Lindesmith Center in February. Since her post at the FDA prevented her from discussing any particular drug, Bonson spoke of a "Drug X," in remarks now catalogued online < a href="http://www.drugpolicy.org/ecstasy_conf" target="_alternet">(www.drugpolicy.org/ecstasy_conf). "It's unclear whether this alleged Drug X could actually be approved, because we don't have any data," said Bonson, who stressed that she was speaking as an independent scientist rather than as an FDA official. "That's the take-home message. We really need to see something. So if you give us data that makes it look like a good drug, we'll approve that drug."

If the FDA has been viewed by many as an agency guided by reason and not politics, its next of kin -- NIDA -- has been held in less esteem. "I think of NIDA as science in the service of repression," says Doblin. "They want to know what's wrong with these drugs and how they can use the data to justify the drug war."

Proponents of medical MDMA accused NIDA of shutting them out of the July conference. "They didn't want anyone talking there that would diverge from the party line," says Dr. Charles Grob, director of child and adolescent psychiatry at Harbor-UCLA Medical Center, who headed up the first FDA-approved research with MDMA. That 1994 study was to have considered benefits for cancer patients. Preliminary research showed the drug was safe enough for more testing, Grob says, but FDA resistance effectively shelved the project.

Nearly a decade later, the party line still seemed to be that Ecstasy was unequivocally harmful. "Maybe this drug will be called 'despair' in the future," said chairman Jerry Frankenheim during the government conference's closing remarks.

So how did the scientists behind the new trials get past the gloomy prognostics? For starters, they were able to gather statistics showing MDMA was safe at the proposed doses and wouldn't cause the harm to memory feared by the government. A leading researcher in the field of Ecstasy and memory wrote a letter of support. And, perhaps most important, the protocol mimicked drug giant Pfizer's trials for the antidepressant Zoloft. All of that seem to sway the FDA, opening the door for research.

In the end, other agencies will have to follow the FDA's lead. "If the [MDMA study] has been approved through the proper channels, we really don't have a say in it," says the DEA's Agent Thornhill. Even NIDA, which Doblin says refused to provide psilocybin for the University of Arizona study, is not impenetrable -- at least on paper. "It's easy to say that the government isn't approving studies because they're politically incorrect," says Dr. Alan Leshner, former NIDA director. "The government may say yes."

Scientists hoping to study taboo drugs like MDMA must continue to jump through bureaucratic hoops. The success of the movement has relied heavily on trading tie-dyes for ties, and paranoia for faith in paperwork -- Investigational New Drug applications, Schedule I permits, and outlines for good manufacturing procedures, to name a few. A model for psychedelic scientists has been the Center for Medicinal Cannabis Research, created in 2000 by California's state legislature to make studying medical marijuana easier. "The reason we needed a center established is no one scientist can easily navigate the regulatory process," explains the director, Dr. Igor Grant.

Still, for medical-MDMA researchers, who have no state initiative and no mass base of support, the barriers are higher. Researchers like the Heffter Institute's Nichols seem antsy about impending controversy. Initial media attention has upset officials at the University of South Carolina, and Nichols worries "congressmen and angry drug warriors" may have the last word. Rick Doblin, however, remains undeterred in his $5 million, five-year plan to develop MDMA as a prescription medicine. He's got patience, he's raising money, and he may surprise a lot of his detractors. He's done it before. "I think we can demonstrate that our society can handle this type of research," says Doblin. "We have to craft messages based on truth."

Carla Spartos writes for the Village Voice, where this article first appeared.

Injecting Big Brother

The war on drugs may soon be over, but not because of legalization, stiffer penalties, or a truce between cartels and prohibitionists. This uneasy peace would come at the hands of pharmaceutical companies and biotech labs, which are about to unleash the ultimate weapon: the antidrug vaccine.

One anti-cocaine vaccine, already shown to be safe for humans, prevents people who snort coke from getting high. Researchers are also testing vaccines for nicotine. And results look promising for the eradication of PCP abuse and methamphetamine addiction. The National Institute on Drug Abuse has funded much of the development cost -- approximately $4.5 million since 1996. "Just as medications have been developed for other chronic diseases, such as hypertension, diabetes, and cancer," writes NIDA in its five-year strategic plan, "drug addiction is a disease that also merits medication for its treatment."

Looking at social ills through a medical lens is not a new phenomenon. By studying disorders from alcoholism and compulsive gambling to attention deficit disorder and depression, scientists have discovered not only genetic factors responsible for so-called abnormal behavior, but also the way such behavior affects the brain's neural map. According to Dr. Frank Vocci, director of NIDA's Treatment Research and Development division, the antidrug vaccines can provide a powerful weapon against substance addiction, especially when combined with therapy and psychiatric medicine. And vaccines, which unleash an onslaught of drug-busting antibodies, can do what traditional treatment can't. "If a patient is in an emergency room with high methamphetamine levels and experiencing a cardiovascular crisis," says Vocci, "antibodies would bind the drug up and cause the individual to excrete it." In other words, an injection of antibodies could reduce the specter of death by overdose to a bad '70s flashback.

Though scientists have long used vaccines to trick the immune system into thwarting lethal diseases, the antidrug vaccines are a new breed, designed to attack pleasure-inducing chemicals that the brain craves. Some of these new vaccines use antibodies that bind to the illegal drug, render it inactive, and then leave the bloodstream. Others remain potent for years. This is the type of vaccine that purged the Western world of polio and smallpox -- and may put a choke hold on civil liberties.

The human affinity for altering perception reaches far back in the evolutionary chain. If antidrug vaccines become widely available, parents will be able to decide whether their kids will be able to get high -- even as adults, even recreationally. And governments could target certain communities for vaccination. "Who is going to get it?" asks Dr. Peter Cohen, an adjunct professor at the Georgetown University Law Center, who has written on the legal implications of the vaccines. "Those who have a history of cocaine abuse? Those who may be statistically likely to become addicts? Or do you vaccinate everybody?"

Cohen argues everyone should get the shots, but so far the only human tests have been done on addicts. In one experiment by Yale University this spring, researchers vaccinated 34 former cocaine abusers living in a residential treatment facility. That vaccine, called TA-CD, generates antibodies that grab onto the upper as soon as it enters the bloodstream, preventing the drug from bumrushing the brain.

The new vaccines have limitations. Namely, addicts could still get high if they did enough lines. Enter Dr. Donald Landry, associate professor of medicine at Columbia University's College of Physicians and Surgeons, who's researching so-called catalytic antibodies. With a load of them in your bloodstream, you'd have to snort a lot of coke to feel any effect. So much so thatfinancial limitations (you'd have to spend a ton of money) and physical needs (you'd have to stop and breathe) would kick in. "Everyone attempting to quit cocaine can use the catalytic antibody," Landry says.

But if you can't get high from cocaine, you can get drunk on alcohol or stoned on pot. Substance-abuse counselors say a vaccine alone won't solve the problem of drug abuse, and shouldn't end up replacing more expensive -- and extensive -- treatments that deal with the factors that lead to addiction. "We're not going to run out of new and inventive things that are going to make people high, but that doesn't mean a vaccine won't help for some people," says Peter Kerr, a spokesman for the New York branch of Phoenix House, who compares the use of antidrug vaccines to relying on the synthetic opiate methadone to treat heroin addicts. "The primary emphasis is relieving symptoms. Counseling is an ancillary factor."

Unlike methadone, which is used to fight debilitating withdrawal symptoms, or Anabuse, which causes an alcoholic to become violently ill upon drinking, some vaccines can last a lifetime. There's no turning back. And if the choice of a child is in the hands of a parent, or that of a prisoner in the hands of the government, then involuntary vaccinations become the result. "It's hard to justify vaccinating a million children when only a small percentage are at risk, even in an area where cocaine use is endemic," says Landry.

The vaccines also raise questions of privacy. "Once you're vaccinated, you have antibodies in your blood that would show up in a drug test," saysCohen. "The least controversial solution is universal vaccination: You wouldn't be stigmatizing any one group."

Yet mass vaccinations have always been controversial. "That's treating people like cattle," says Joe Lehman, a spokesman for the Cato Institute, a libertarian think tank. Lehman believes that there would be pressure to get an antidrug vaccine, especially when it comes to insurance companies (who might offer special premiums to the vaccinated) or employers (who in the age of mandatory drug testing have obvious motives). Though mass, forced vaccinations may be unlikely, a scenario in which individuals feel pressured to get the vaccine is no less chilling in its implications.

Civil libertarians, on both the left and right ends of the political spectrum, aren't the only ones concerned over universal vaccination. Critics of childhood vaccinations -- alternative medicine advocates, concerned parents -- are growing in number. The National Vaccine Information Center promotes parental awareness about vaccination risks and the right to refuse shots. Barbara Loe Fisher, president of the center, is outraged by the idea of antidrug vaccines. "To add a vaccine to the mix that doesn't fit into early-childhood diseases seems amazing," she says. "That we can get a vaccine to solve every social problem is short-term thinking."

This article originally appeared in The Village Voice.

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