Op-Ed New York Times
Good to Grow
By SALLY SATEL
Published: June 8, 2005
RELIEF for medical marijuana patients was snatched away this week. In Gonzales v. Raich, the Supreme Court ruled that such patients will be subject to federal prosecution even if their own state’s laws permit use of marijuana. Now, short of Congress legalizing medical marijuana, the only way that its users can avoid stiff financial penalties or jail is if it is turned into a prescription medicine approved by the Food and Drug Administration. Justice Stephen G. Breyer said as much during oral arguments last November with his comment that “medicine by regulation is better than medicine by referendum.”
Fair enough. The problem is that the very agencies integral to facilitating the research and development of medical marijuana have actually been impeding progress.
The first obstacle is ideological. The Drug Enforcement Administration has fought marijuana’s use as a medicine, maintaining that it has no therapeutic value. (It hasn’t helped that activists have tried to use medical marijuana as a wedge to liberalize drug laws.)
But scientific consensus says otherwise. Surveying a range of findings, a federally commissioned Institute of Medicine report issued in 1999 noted the active ingredients in marijuana, cannabinoids, can relieve chemotherapy-induced nausea, stimulate appetite and suppress pain in patients who have failed to get relief from conventional treatments. Other countries have embraced such findings. Last April, for example, regulators in Canada approved a marijuana extract delivered in an oral spray for relief of symptoms of nerve pain associated with multiple sclerosis.
A more imposing obstacle to developing medicine in the United States is that there is only one legal source of research marijuana: a farm in Mississippi run by the National Institute on Drug Abuse, part of the National Institutes of Health. As gatekeeper of the supply, the drug abuse institute must review and approve all proposed marijuana research projects, a hurdle for researchers that is both onerous and redundant: they already must undergo at least three other oversight evaluations (from the Food and Drug Administration, the D.E.A. and their own institutions) before they can enroll their first subject.
One scientific team has been trying for two years to get a mere 10 grams of marijuana from the drug abuse institute for its effort to develop a device that heats marijuana but doesn’t burn it, thereby providing nontoxic and immediate relief to patients.
Since the drug abuse institute’s mission does not include the development of marijuana into a commercial prescription medicine, any expanded studies with the marijuana plant must be privately financed. But, in a Catch-22, private resources are out of reach as long as only federal marijuana – which is notoriously weak and poorly manicured – can be used.
After all, a pharmaceutical development team must have a stable source of raw material with adequate purity. Researchers need to be able to control the ratio of active to inert compounds in the plant by manipulating growing conditions. Unless a pharmaceutical company could be sure of producing a drug or device for commercial sale, it won’t invest millions of dollars in clinical trials.
One solution is to get the National Institute on Drug Abuse out of the marijuana supply business. Let researchers get marijuana directly from the government-approved Mississippi farm or from overseas sources like the Dutch Office of Medicinal Cannabis. Better yet, permit a privately financed D.E.A.-approved farm, like the kind that Lyle Craker, a medicinal plants expert at the University of Massachusetts, has been hoping to create for the last three years. In addition to producing higher-potency, cleaner marijuana, such a farm could offer strains with varying levels of cannabinoids that may contribute to marijuana’s therapeutic effects.
Developing cannabis into an approved and effective prescription medication can be a goal within reach. But it will take a federal government that is truly open to the research that it claims to value. Sally Satel, a psychiatrist and resident scholar at the American Enterprise Institute, is the co-author of “One Nation Under Therapy: How the Helping Culture Is Eroding Self-Reliance.”
Sally Satel pens an Op-Ed in the New York Times today about medical marijuana, focusing on Lyle Craker, UMass Amherst and Federal obstruction of medical marijuana research.