Two Prerequisites for FDA Drug Development Research of Marijuana

Unlike NIDA, MAPS and CaNORML believe that the medical use of marijuana is an issue that needs to be resolved scientifically rather than politically. MAPS has identified two essential prerequisites before we can justify starting a serious ($10 million) drug development effort conducting studies under FDA’s Investigational New Drug (IND) program. The first prerequisite was that a vaporizer device needed to be accepted by FDA for use in clinical research. This objective has been met, since our initial vaporization research was used by Dr. Donald Abrams to obtain a $137,000 grant in 2004 from California’s Center for Medicinal Cannabis Research (CMCR) for a Phase I vaporizer research protocol. The study compared subjective effects, cannabinoid blood levels and carbon monoxide levels in exhaled breath and used the Volcano vaporizer. The study concluded that vaporization produced similar cannabinoid blood levels and subjective effects as smoking but with reduced carbon monoxide.

MAPS second prerequisite is obtaining DEA permission for our own independent supply of marijuana, thereby breaking the NIDA monopoly so we can work directly with FDA without the obstruction, delays and outright refusal of NIDA to provide the necessary marijuana. We’ve been working since 2001 with Prof. Lyle Craker, UMass Amherst, seeking a DEA license for a MAPS-sponsored medical marijuana production facility. On February 12, 2007, Prof. Craker won a DEA Administrative Law Judge (ALJ) hearing when DEA ALJ Mary Ellen Bittner found that it would be in the public interest for DEA to issue a license to Prof. Craker and recommended that DEA issue Prof. Craker a license, thereby ending the federal monopoly on supply. DEA has not yet issued its required final ruling, following its highly successful strategy of delay which has prevented marijuana from becoming an FDA-approved prescription medicine for almost 40 years, since 1970 when the use of marijuana to control nausea associated with cancer chemotherapy was reported. MAPS is working with the Americans for Safe Access and other drug policy reform organizations seeking to persuade the Obama Administration to issue Prof. Craker his license.

MAPS Planned Vaporizer Research

In a prolonged triumph of drug-war politics over science, our vaporizer research has been blocked since June 2003 by the National Institute on Drug Abuse (NIDA), which has a monopoly on the supply of marijuana that can be used in research. Since 2003, NIDA has rejected and/or ignored our repeated requests (including one lawsuit for “unreasonable delay”) seeking to purchase 10 grams of marijuana to continue our studies. NIDA uses its monopoly to obstruct studies into both the beneficial medical uses of marijuana as well as into drug delivery devices that might increase the chances of FDA approval of marijuana as a prescription medicine, and might decrease the harms associated with the non-medical uses of marijuana.

In our initial studies, when NIDA wasn’t so politicized about medical marijuana, we learned early on that water-pipes don’t help filter out undesirable particulate matter, although water-pipes may help reduce certain water-soluble gases. In contrast, vaporizers do eliminate combustion products and address the Institute of Medicine’s 1999 recommendation for the development of non-smoking delivery systems for the medicinal use of marijuana. Vaporizers are the only non-smoking delivery system that use the marijuana plant itself, rather than patented and for-profit, pharmaceutical-company-marketed marijuana extracts in spray, lozenge, drops, or pill form. In contrast, vaporizers could conceivably be used in conjunction with material that patients grow themselves or obtain in other ways, at substantially reduced cost as compared to patented products, and, as our preliminary research suggests, at virtually no increased health risk or reduced efficacy.

While the use of vaporizers in medical marijuana research is the most politically desirable route, since they don’t involve smoking, we plan to include groups that smoke as well as vaporize marijuana in future clinical studies. We would be surprised if there are significant differences in safety and efficacy for most patients, due to the lack of evidence linking marijuana smoking and cancer and the increasing body of evidence about the anti-tumor properties of marijuana.

Results from MAPS Studies of Vaporizers and Water-Pipes

Results from a MAPS-supported study in 2003 found that inhaling vaporized marijuana can drastically reduce toxins found in marijuana smoke

Results from a MAPS- and California NORML-supported study in 1996 found that water pipes are ineffective at removing harmful tars from marijuana smoke

Links to Vaporizer Distributors