An article in The Scientist magazine by Alison McCook discusses struggles with DEA over MAPS’ psychedelic and medical marijuana research protocols.
Originally appearing here.
[MAPS Notes in brackets by Ilsa Jerome]
Less than three years after the retraction of a controversial Science paper1 on methyl-enedioxymethamphetamine (MDMA), the chemical used to make the illegal drug Ecstasy, two researchers in the United States have moved closer to studying the potential benefits of the compound.
They may be going against the grain, however. In recent years, experts have suggested that scientists are encouraged to produce results that support the US government’s war on drugs. For example, when researchers retracted the 2002 Science paper showing that Ecstasy had a destructive effect on the dopaminergic neurons of primate brains, predisposing Ecstasy users to Parkinson disease, experts began to wonder how the paper passed peer review. It turned out that reagents had been mislabeled, resulting in the animals in the experiment receiving methamphetamine, not MDMA. That the paper was published in the first place suggests that the research community feels pressure to demonstrate that drugs are dangerous.
This is still largely true, according to Rick Doblin, president of the Multi-disciplinary Association for Psychedelic Studies (MAPS), now funding studies of whether MDMA helps people cope with posttraumatic stress disorder (PTSD) and fears of dying. He says that the US Food and Drug Administration (FDA) has been “very sympathetic to good science,” but he has hit stumbling blocks while working with the Drug Enforcement Administration (DEA), suggesting, to him, that the agency is reluctant to permit positive research on controlled substances.
For instance, Doblin says the DEA took a long time to issue a license to Michael Mithoefer, a South Carolina researcher investigating MDMA for treatment of PTSD. Mithoefer needed the license to possess and administer MDMA. Finally, a staff person for a US senator called the DEA, and shortly thereafter Mithoefer received his license, Doblin says. In another case, a MAPS-supported researcher is currently suing the DEA because the agency refuses to give him a license to grow marijuana for research. The DEA “wants it simple,” Doblin says: “Illegal drugs are illegal because they’re all bad, and there’s nothing good about them.”
Rogene Waite, a DEA spokesperson, writes in an E-mail that the agency responded to Mithoefer’s request for a license within the 10-day period required, following receipt of all materials. Waite did not speak directly on whether the DEA wants to discourage research on the benefits of illegal drugs.
[Michael Mithoefer received his DEA schedule 1 licence on February 24, 2004, four months after his office was inspected by the DEA.]
In another study, John Halpern of Harvard University is preparing to study whether MDMA helps cancer patients with anxiety disorders to deal with their fears of dying. Many dying patients are hesitant to take sedating drugs or antidepressants, Halpern explains, because they don’t want to take drugs every day. Previous research suggests that MDMA may reduce stress and make people feel less alone, which may ease dying patients’ fears, he says, although some studies were not well-controlled.
The DEA has not yet granted Halpern his license to study MDMA. But Doblin says that Halpern’s and Mithoefer’s research will likely not suffer the same fate as a Spanish study of MDMA for PTSD that was shut down after the media began reporting some positive results. Spain operates under a national healthcare system, Doblin says, and hospitals are therefore more connected to, and influenced by, the government than here in the United States. Doblin says the DEA doesn’t have much of a legal basis for denying Halpern’s request for a license. Also, both the FDA and Harvard’s institutional review board have already okayed the research, and the DEA now knows that MAPS has friends in the US Senate, he notes.
Halpern’s bets are somewhat hedged, in any event: He also studies the risks of MDMA. “We’ve never said it’s perfectly safe,” says Doblin.
References 1. GA Ricaurte et al, “Severe dopaminergic neurotoxicity in primates after a common recreational dose regimen of MDMA (“ecstasy”),” Science 2002, 297: 2260-3