Clinical trials are prescription for marijuana

During U.S. Supreme Court oral arguments in Ashcroft v. Raich, the latest medical marijuana case, Justice Stephen Breyer said 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, Justice 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 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 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.