UP IN SMOKE
A setback for medical marijuana
BY MIKE MILIARD , Boston Phoenix
Two weeks ago, while hearing arguments in the landmark Supreme Court case Ashcroft vs. Raich — which by this spring will decide whether federal agents can arrest medical-marijuana users even in states where such use is legal — Justice Stephen Breyer questioned the logic of having a patchwork of disparate state laws. Instead, he suggested, medical-marijuana proponents would be better off petitioning the Food and Drug Administration (FDA) to reclassify pot as a prescribable drug. “That seems to be the obvious way to get this done,” he said. “Medicine by regulation is better than medicine by referendum.”
Would that it were so easy. As it happens, the Drug Enforcement Agency (DEA) late last week effectively blocked the only proposed project that might lead to FDA-approved marijuana, rejecting a petition by Dr. Lyle Craker, professor of plant and soil sciences at UMass Amherst, to obtain DEA approval to grow pot for FDA-approved research. “In practical terms, this really does mean that the door is shut to pursuing FDA approval of marijuana as a medicine in any reasonable time frame,” says Bruce Mirken, director of communications for the Marijuana Policy Project.
Currently, all marijuana used for research in the United States comes from a Mississippi farm overseen by the National Institute on Drug Abuse. But researchers have complained that the stuff is of poor quality, and that the feds are stingy distributing it. More important, says Mirken, “The NIDA crop is grown for the specific purpose of research. There’s absolutely no indication that it could ever be available for prescription sale, should the FDA ever authorize that. The reason that’s critical is that the FDA, if they’re going to approve something as a prescription drug, needs to know how that drug is going to be manufactured, and needs to review clinical trials on the same product that’s going to be sold.” Craker’s facility would have offered an alternative source for FDA study and, perhaps, a strain that could someday be prescribed.
The DEA’s decision comes grudgingly. Craker first submitted his application in June 2001, and this past July, after more than three years without an answer, Craker and the Belmont-based Multidisciplinary Association for Psychedelic Studies (MAPS), which would have financed the UMass facility, filed suit, charging the agency with stalling unreasonably.
In a December 10 letter to Craker, the DEA’s William J. Walker reasoned that granting approval “would not be consistent with the public interest,” since “current marijuana research has not progressed to Phase II of the clinical trials [exploratory research into safety and efficacy, with human subjects] because current research must use smoked marijuana….”
DEA spokeswoman Rogene Waite declined to comment, pointing instead to the text of Walker’s letter. But MAPS president Rick Doblin, PhD., charges the DEA with essentially prejudging a study that has yet to take place. “They’re making this decision, before the research is done, that the research would show that it can’t work.” Moreover, he says, their claim is simply not true. State-funded Phase II research is indeed taking place right now in California. Also, the feds have stalled approval of MAPS-funded work with vaporizers, an alternative to smoking, for almost a year and a half.
“We knew that they would rather delay, as long as they could, than to explicitly telegraph to everybody that they’re not going to permit the research to be done,” Doblin says. But now that they have, “we get to argue them on the merits.” The next 30 days will find Craker, possibly in conjunction with MAPS, filing for an administrative-law hearing to appeal the decision once and for all — a process that, all told, could take more than a year.
Mirken, for one, isn’t holding his breath. “As long as the DEA appears to have a deep prejudice against the medical use of marijuana, which their letter certainly suggests, the game will always be rigged. They will make you jump through these bureaucratic hoops, but they know what the outcome will be, because they’ve decided in advance what it’s going to be.” Moreover, he says, what this finding means in the near term is that “the only way that [medical marijuana] patients are going to be protected is through changes in state law and changes in federal law. The Supreme Court might help us out some in Ashcroft v. Raich, but nobody’s betting the farm on that. And even that would only provide protection to patients in states that have medical-marijuana laws.”
Still, there may be a silver lining. “Now, what’s going to happen is that this is gonna fuel more effort to pass state laws, even if the Supreme Court says the feds have primacy,” says Doblin. Mirken, too, thinks state lawmakers will be compelled to pay more attention to medical marijuana once they “realize what [the DEA] has done. I think a lot of people have taken the view that Justice Breyer expressed in the Supreme Court two weeks ago when he said, ‘Why don’t you guys just go to the FDA?’ With that door shut, legislators should see — and our job is to make sure they understand — that the actions they can take are the only protections available to patients for the foreseeable future.”
“We’re disappointed, but we’re not surprised,” says Mirken. “This simply illustrates, very clearly, how deep the official prejudice is against considering that marijuana might be a medicine. In the DEA’s letter, they essentially pass judgment on research that hasn’t occurred yet, saying that the deleterious effect would be too great. Isn’t that for the FDA to judge? But I think in some ways it’s probably helpful to the cause to have that naked prejudice out there in black and white. It’s clear that there’s this whole anti-drug bureaucracy that just has no interest in science.”
Issue Date: December 17 – 23, 2004
An excellent article in the Boston Phoenix dissects the DEA’s rejection of the UMass Amherst application.