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 living and working in Westchester, 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 (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.”