Can the marijuana monopoly be broken?
"The question of whether marijuana has any legitimate medical purpose should be determined by sound science and medicine." That is the federal government's official response to the medical marijuana movement, as expressed in November 2001 by Asa Hutchinson, then head of the Drug Enforcement Administration (DEA). Since California and Arizona passed the first medical marijuana initiatives in 1996, both the Clinton and Bush administrations have insisted that the therapeutic value of cannabis should be judged by the Food and Drug Administration (FDA) based on careful research, not by voters or state legislatures based on emotional appeals.
Several years ago, Rick Doblin, president of the Multidisciplinary Association for Psychedelic Studies (MAPS), decided to take the government at its word by promoting the kind of research that could ultimately lead the FDA to approve marijuana as a prescription drug. But along with the usual obstacles posed by the notoriously arduous FDA approval process, MAPS encountered problems unique to marijuana. In particular, it found that the only legal source of marijuana for U.S. research was the National Institute on Drug Abuse (NIDA).
As its name implies, NIDA focuses on marijuana's dangers rather than its potential benefits. Hence getting its permission for research on the drug's medical utility has been tricky. Although a few researchers have managed to obtain marijuana from NIDA, two studies approved by the FDA have been rejected by NIDA, and those examples have discouraged other researchers from bothering to apply. The additional layer of approval, which is not required for any other Schedule I drug, makes an already daunting process even more intimidating. Doblin's audacious but sensible solution is to cut NIDA out of the picture by establishing a private source of cannabis for research (which already has been done in the U.K.).
To accomplish that goal, MAPS needs permission from the DEA, which it has been trying to get since June 2001. The history of this effort, described in detail on the MAPS Web site, demonstrates the disingenuousness of drug warriors who say their opposition to the medical use of marijuana is based on scientific concerns. At the same time that they are complaining about the lack of adequate evidence, they are blocking attempts to obtain it.
MAPS wants to fund a marijuana production facility at the University of Massachusetts in Amherst that would be overseen by Lyle Craker, a professor in the school's Department of Plant and Soil Sciences who has extensive experience with medicinal plants. In addition to eliminating the gratuitous obstacle created by NIDA's marijuana monopoly, such a facility could provide better cannabis that would meet researchers' specifications and eventually be used as a legal medicine.
NIDA's pot, grown under contract at the University of Mississippi for the last three decades, is of relatively low potency and quality. Its THC content ranges from 2 percent to 7 percent. "To improve the safety profile of its product," Doblin writes, "MAPS requires marijuana with a THC content in the 12-15% range, thereby reducing the amount of particulate matter inhaled per unit of THC and improving the risk/benefit ratio of the product." The risks of marijuana use can be further reduced with vaporizers, which heat cannabis to release THC rather than burning it. Doblin says these devices, the subject of MAPS-sponsored research, work especially well with high-potency marijuana.
Dr. Ethan Russo, one of the researchers whose FDA-approved protocols were rejected by NIDA, interviewed patients who receive NIDA's marijuana under the government's "compassionate use" investigational new drug program (closed to new applicants since 1992). "Each of the Compassionate Use IND patients," he reports, "indicated to me that they would prefer to have properly manicured, seedless, unfertilized cannabis of a higher grade so that they might be able to smoke less material to obtain relief of their medical symptoms." He notes that NIDA's marijuana is not comparable to the cannabis typically used by patients in Europe, Canada, or the United States.
In addition to producing higher-potency, cleaner marijuana, the University of Massachusetts operation proposed by MAPS could offer strains with varying levels of cannabinoids other than THC, some of which may contribute to marijuana's therapeutic effects. More important, a new supplier would allow companies trying to get marijuana approved as a medicine to test the same product they planned to market, as required by the FDA. NIDA's mandate is to produce marijuana for research, not for medicinal use. "There is no guarantee that marijuana provided by NIDA for research would be available for commercial use," Doblin notes. "NIDA-supplied marijuana is therefore inadequate for use in a privately funded drug development plan… No rational pharmaceutical company would invest millions of dollars in Phase III clinical trials of a drug that it cannot be certain it could produce for commercial sale should safety and efficacy be demonstrated to the satisfaction of the FDA."
After an 18-month delay, the DEA responded to Lyle Craker's application for a license to produce marijuana with a series of specious objections. First it said licensing the University of Massachusetts facility would violate international drug treaties, an argument demolished in an analysis prepared by Graham Boyd, director of the American Civil Liberties Union's Drug Policy Litigation Project, and two Washington attorneys. Then the DEA said there's no evidence the current marijuana supply is inadequate.
Dismissing Ethan Russo's points out of hand, the DEA insisted on seeing complaints from researchers who are currently using NIDA's marijuana. "While I recognize that the primary researchers now receiving plant material may openly state to you that they are satisfied with the current source," Craker replied, "I am sure you appreciate that in private conversations these same researchers indicate a fear of having the current supply eliminated if they complain about the available source material." The DEA's official record also does not reflect the researchers who would be interested in studying marijuana if a better supply were available and the approval process were less cumbersome.
In short, the odds of breaking NIDA's marijuana monopoly do not look good. But the attempt has at least demonstrated that the drug warriors are not really interested in the thorough scientific investigation they claim to favor. "As long as NIDA is the sole source of supply" for cannabis, Doblin observes, "the FDA process will rightly be perceived by the public as obstructed, further fueling efforts by states to circumvent federal authority over the medical uses of marijuana through ballot initiatives or state legislation." The DEA's intransigence thus will validate state attempts to make marijuana available as a medicine regardless of what the federal government says.