Good to Grow (Unabridged Version)

The New York Times, June 8, 2005

By Sally Satel

Relief for medical marijuana patients went up in smoke this week. The Supreme Court ruled that they will be subject to federal prosecution even if their own state’s law permits use of marijuana.

The case just decided in a 6 to 3 vote was Gonzales v. Raich. It was brought before the Court by the Justice Department after Angel Raich, a 40 year old disabled woman from Oakland California successfully sued in the 9th circuit court of appeals to be able to use medical marijuana over the protest of Justice. That 2003 circuit decision spurred the federal government to ask the Supreme Court to overturn the appeal because marijuana is illegal under the Controlled Substances Act.

The fed’s success in having done so means that — short of Congress legalizing medical marijuana — the only way such patients can be protected from stiff financial penalties or incarceration is if marijuana is turned into an FDA-approved prescription medicine. Justice Stephen Breyer said as much during oral arguments last November: “medicine by regulation is better than medical by referendum.”

Fair enough. The problem is that the very agencies integral to facilitating the research and development have actually been impeding progress.

The first obstacle is ideological. The Drug Enforcement Administration maintains that marijuana has no medicinal value. But scientific consensus says otherwise. Drug czar John Walters insists that research has “not yet determined [it to be] safe and effective.” Unfortunately, pro-pot activists have given these opponents ammunition by using medical marijuana as a wedge to liberalize pot laws.

Nonetheless, science shows benefit. As summarized in a federally-commissioned 1999 Institute of Medicine report, cannabinoids in smoked marijuana can relieve chemotherapy-induced nausea, can stimulate appetite and suppress pain in patients who have failed conventional treatments or get insufficient relief from them.

To learn more about the medicinal value, in fact, doctors and regulators will be looking northward. Last April Canadian regulators approved a marijuana extract called Sativex which is self-administered by the patient as an oral spray. It is specifically approved for relief of symptoms of nerve pain associated with multiple sclerosis. Sativex will be in Canadian pharmacies soon, surely weakening the DEA’s claim that marijuana compounds have no medicinal function.

A more imposing obstacle to developing medicine, is that there is only one legal source of research marijuana in the country: The National Institute on Drug Abuse (NIDA), part of the National Institutes of Health. As gatekeeper of the supply, which is grown on a government farm in Mississippi, NIDA must review and approve all proposed marijuana research projects, an onerous process for researchers who already have private funding.

And redundant. Researchers already must undergo at least three other oversight evaluations before they can enroll their first subject. The FDA must approve all research on Schedule 1 drugs – a category that includes marijuana and other drugs that have no allowed medical uses – for safety and scientific merit, irrespective of who is willing to fund the work. The Drug Enforcement Agency must license the researcher to handle the drug and the human subjects protection committee of the institution or academic hospital in which the research is to take place must give approval.

Right now a privately funded scientific team working with Chemic Labs in Canton, Mass. is eager to begin analytical research on the constituents of the vapors of marijuana, but is stymied by NIDA’s hold on the plant.

Chemic’s plan is to develop a non-smoking delivery device that heats marijuana, but doesn’t burn it, to create a vapor, or steam, that patients inhale. Unlike smoking there are no toxic combustion byproducts that irritate the lungs. A vaporizer would provide more immediate relief than the spray with more complete absorption. And it would be cheaper than a spray.

For almost two years Chemic has been trying to get a mere 10 grams of marijuana from NIDA. The research protocol is mired in review at the Department of Health and Human Services even though it does not involve human subjects.

Nor will NIDA fund research on the potential medical benefits of smoked marijuana. Though the institute has provided marijuana to the state-funded Center for Medicinal Cannabis Research in San Diego, the center is now out of money.

Any expanded studies with the marijuana plant, either smoked or vaporized, will need to be privately funded as NIDA’s mission does not include the development of marijuana into a commercial, prescription medicine. But, in catch-22 fashion, private resources are unattainable as long as only NIDA marijuana can be used.

After all, for large-scale development to proceed, a pharmaceutical development team must have access to a stable source of raw material at an adequate level of purity. Researchers must be able to control the ratio of active to inert compounds in the plant, something that cannot be done without the freedom to manipulate growing conditions. Unless a pharmaceutical company could be certain that it could produce a drug or device for commercial sale it would not invest millions of dollars in clinical trials.

The solution is obvious. Get NIDA out of the marijuana supply business. Allow researchers to obtain marijuana directly from the government approved Mississippi farm or even overseas, such as the Dutch Office of Medicinal Cannabis. Better yet, permit a privately funded DEA-approved farm.

This is what Lyle Craker, Professor of Plant and Soil Sciences at the University of Massachussetts at Amherst and expert in medicinal plants, wants to do. For over three years he has been trying to obtain a DEA license to establish an alternative source of research grade marijuana to be used in federally approved research. In addition to producing higher-potency, cleaner marijuana — NIDA-grown marijuana is notoriously weak and poorly manicured — the University of Massachusetts operation could offer strains with varying levels of cannabinoids which may contribute to marijuana’s therapeutic effects.

Developing cannabis into an approved prescription medication need not be a pipe dream. But it will take the federal government that is truly open to research it claims to value.