HAMPERING RESEARCH - DEA WON'T ALLOW MEDICAL MARIJUANA TRIALS

During U.S. Supreme Court oral arguments in Ashcroft v. Raich, the
latest medical marijuana case, Justice Stephen Breyer commented last
month that instead of passing a patchwork of state laws, medical
marijuana advocates would be better off petitioning the Food and Drug
Administration to have marijuana, or cannabis, reclassified as a
prescription drug. "Medicine by regulation is better than medicine by
referendum," he opined.

In fact, both regulation and referendum are poor ways to do medicine.
Whatever happened to research and dispassionate scientific
investigation, unhampered by bureaucratic constraints or popular
passions, as a model?

Still, Breyer's suggestion sounded reasonable on its face.

A few weeks later, part of the answer emerged as to why the FDA model
is unlikely to work as long as marijuana is subject to strict federal
prohibition and the Drug Enforcement Administration, with a vested
interest in preventing research that might undermine the notion that
marijuana is a drug with no redeeming characteristics, has veto power
over who can do research.

On Dec. 10, after a delay of almost four years, the DEA rejected a
2001 proposal from Dr. Lyle Craker, professor of plant and soil
sciences at the University of Massachusetts at Amherst, to grow
marijuana for FDA-approved research. The decision came only after Dr.
Craker filed a suit in July demanding a response.

Currently, the only marijuana available for research is grown at a
Mississippi farm overseen by the National Institute on Drug Abuse. But
researchers claim that the product is of poor and inconsistent quality.

Furthermore, if the FDA were ever to consider approving something as a
prescription drug, it would have to review clinical trials on the
product that was going to be sold. The federal farm at Mississippi has
no intention of getting into commercial growing. But the University of
Massachusetts proposal had in mind developing strains of
clinical-grade cannabis that could eventually - if FDA approval were
ever forthcoming - be used commercially.

The DEA's letter also included a fascinating prejudgment. "Current
marijuana research has not progressed to Phase 2 of the clinical
trials because current research must use smoked marijuana, which
ultimately cannot be the permitted delivery system for any potential
marijuana medication."

Not only does this ignore the fact that tests are beginning in
California using vaporization, a technique by which cannabis can be
ingested without being smoked, but it decides in advance a question
that should be subject to the very research that opponents of medical
marijuana say needs to be done before it can be approved.

By denying the application, the DEA effectively is prohibiting any
research that might eventually lead to FDA approval of cannabis as a
federally authorized prescription drug. The decision said, in effect,
that the feds don't approve of the medicinal use of marijuana and they
will block any research that might challenge that predetermined opinion.

Perhaps the DEA has done medical marijuana advocates a favor. It has
made it clear that research that might lead to FDA approval is simply
impossible so long as current federal laws and federal bureaucracies
are in place. Thus the only avenue open is political - persuading the
75 to 80 percent of Americans who in national polls say they favor the
medicinal use of marijuana to convince legislators to move against
strict prohibition.

Medicine by referendum is indeed less than ideal. But it beats
bureaucratically enforced ignorance.