UP IN SMOKE

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 the University of
Massachusets at 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 Dec. 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 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."