For the first time since 1941, the federal government’s illegal monopoly on research-grade marijuana is in real danger of being vanquished. If so, the window of opportunity would finally be open for putting marijuana through Food and Drug Administration (FDA)-approved clinical trials seeking to develop the marijuana plant, smoked and/or vaporized, into a legal prescription medicine.
Professor Lyle Craker, Ph.D., Director, Medicinal Plant Program, Department of Plant, Soil and Insect Sciences, at the University of Massachusetts-Amherst (UMASS-Amherst), has been attempting for six years to obtain a Drug Enforcement Administration (DEA) Schedule I license to manufacture marijuana exclusively for privately-funded, federally-approved research, under contract to the Multidisciplinary Association for Psychedelic Studies (MAPS). Prof. Craker’s case is the focal point of the struggle to bring medical marijuana before FDA, to actually determine once and for all whether it meets FDA’s standards for safety and efficacy.
On February 12, 2007, following a comprehensive review of the available evidence gathered during the 2005 DEA Administrative Law Judge (ALJ) hearings, DEA ALJ Mary Ellen Bittner issued a decisive—but non-binding-Opinion and Recommended Ruling that Prof. Craker’s application be approved. ALJ Bittner’s thorough 87-page ruling rebukes each of DEA’s arguments and concluded that it was in the public interest for DEA to issue Prof. Craker his license. It is now up to DEA to decide whether to accept or reject ALJ Bittner’s recommendation.
Prof. Craker’s applications for regulatory approval, legal struggles, and proposed facility are sponsored by MAPS, a non-profit research and educational organization that plans to design, fund, obtain government approval for and conduct the clinical research necessary to develop marijuana into an FDA-approved prescription medicine. If successful, MAPS would bring smoked and/or vaporized marijuana to market under a non-profit pharmaceutical model similar to Planned Parenthood and the Population Council’s development and distribution of RU-486. DEA licensing is the final regulatory hurdle in MAPS’ quest to create a privately-funded federally-approved medical marijuana production facility, which would pave the way for a drug development effort aimed at developing marijuana into an FDA-approved prescription medicine.
NIDA’s Monopoly: Game Over?
Since 1968, the federal government’s National Institute on Drug Abuse (NIDA) has maintained a monopoly over the supply of marijuana-but no other Schedule I drug-and uses that monopoly to obstruct privately funded research. NIDA’s monopoly makes very little sense given that DEA has licensed privately-funded manufacturers of methamphetamine, LSD, MDMA (Ecstasy), heroin, and cocaine, and virtually all other controlled substances. According to federal law, which clearly requires “adequate competition in the production of Schedule I drugs,” NIDA’s monopoly is illegal [21 U.S.C. § 823(a)(1); 21 C.F.R. § 1301.33(b)].
But that’s just the beginning. Human studies on any Schedule I drug must gain approval from the Food and Drug Administration (FDA), yet for studies with marijuana, researchers must submit their protocols for an additional review process by NIDA and the Department of Health and Human Services (HHS) that exists for no other drug. This extra review process has been imposed on medical marijuana research as a result of NIDA’s monopoly power, The HHS/NIDA review board is composed entirely of government employees, with no outside experts. It has no deadlines-in contrast to FDA’s 30-day deadline—and no formal appeals process. Thus, NIDA’s monopoly results in lengthy delays or refusals in providing research material.
For instance, NIDA has refused to supply marijuana to two FDA-approved protocols sponsored by MAPS, preventing these studies from taking place (Dr. Abrams, University of California -San Francisco, marijuana for AIDS wasting syndrome-IND #43-542; Dr. Russo, U. Montana, marijuana for migraines—IND #58, 177). In addition, for the last three and a half years, NIDA has refused to sell 10 grams of marijuana to a MAPS/California NORML-sponsored laboratory study evaluating the effectiveness of a marijuana vaporizer, a non-smoking drug delivery device that eliminates the products of combustion that patients inhale after burning marijuana. NIDA has also prevented this study from taking place, despite the fact that the development of non-smoking drug delivery devices was recommended by the Institute of Medicine in its 1999 report on medical marijuana.
For those researchers whose protocols it approves, NIDA provides inferior, low-potency marijuana. NIDA’s marijuana has limited cannabinoid profiles (containing low levels of Tetrahydrocannabinol (THC)—and virtually no Cannabidiol), so researchers are unable to optimize the strain of marijuana they prefer to use for costly drug development efforts. The highest potency marijuana available from NIDA for research is 7%; the marijuana used by patients in states where it is legal has been documented to be between 12–20%.
NIDA’s lone marijuana production facility is directed by Prof. Mahmoud El Sohly, at the University of Mississippi. Another egregious conflict of interest for NIDA is that Prof. El Sohly has personal commercial interests in marijuana-based products. This includes both his THC suppository and his new DEA license permitting him to grow marijuana to extract THC for sale to the pharmaceutical company, Mallinckrodt, to manufacture generic Marinol. Prof. El Sohly would have a major conflict of interest if he were the sole supplier of marijuana to MAPS for prescription use, since marijuana would compete with products in which he has a personal financial interest.
To put the nail in the coffin, NIDA cannot even guarantee that the same research material will be available for prescription use if FDA clinical trials determine that marijuana meets its guidelines for safety and efficacy. This makes any drug development effort using NIDA marijuana a futile exercise. As NIDA well knows, sponsors will not invest millions of dollars into research studies until there is reliable access to a supply of high quality research material that can be used both in research and-if the research should prove successful-as an FDA-approved prescription medicine.
The Quest for Independent Supply, the “Holy Grail” of Marijuana Research
Considering the problems with NIDA’s monopoly, for the past six years MAPS has prioritized creating an independent supply of legal research-grade marijuana for use in FDA-approved studies. One of DEA’s primary tactics for stifling research is delay, and Prof. Craker’s application has been an especially Orwellian case in point.
In June 2001, with support from MAPS and UMASS-Amherst’s blessing, Prof. Craker applied to DEA for a license to manufacture marijuana exclusively for use in federally-approved research. About six months after the application was submitted, DEA claimed it was lost. Prof. Craker then resubmitted a photocopy of the original application, but when he inquired to DEA several months later about the status of his application, DEA informed him that his application had been rejected since it did not contain an original signature. Shortly after that, Prof. Craker received an envelope with a DEA return address, but no cover letter or any indication of whom at DEA had sent it. Inside was the original application, with a DEA date stamp showing that it had been received when Prof. Craker first submitted it, meaning that it had not been lost after all. Prof. Craker then resubmitted the application, with original signature. After DEA failed to respond for more than two years, Prof. Craker sued DEA in federal court claiming unreasonable delay under the Administrative Procedures Act. This prompted DEA to finally reject Prof. Craker’s application in December 2004, three and a half years after the original application was submitted. In turn, MAPS and Prof. Craker immediately requested an Administrative Law Judge hearing, which was held over the course of eleven months in 2005.
Prior to the February 2007 ruling, organizations that had already written to DEA in favor of Prof. Craker’s application included the Multiple Sclerosis Foundation, the Lymphoma Foundation of America, the National Association for Public Health Policy, the United Methodist Church, Americans for Tax Reform, the American Medical Students Association, several state nurses’ associations, the Massachusetts Dept. of Public Health, and the California and Texas State Medical Associations, the two largest US state medical associations. Also, as a result of MAPS’ Congressional lobbying efforts Massachusetts Senators Kerry and Kennedy and 38 members of the US House of Representatives have already previously written to DEA in support of Prof. Craker’s application.
Those of you who have followed the drug policy reform movement since the 1980’s will remember two decisive instances in which DEA rejected the advice of its administrative law judge. First, in 1986, DEA rejected a DEA ALJ ruling that MDMA be placed in Schedule III, rather than Schedule I. Then, in 1989, DEA famously rejected a ruling from the same ALJ, recommending that marijuana be rescheduled, also from Schedule I to Schedule III.
Now that the drug policy reform movement has gained unprecedented political muscle and momentum over the past two decades, however, we actually have a fighting chance to pressure DEA to accept this new ruling.
MAPS will be coordinating another Congressional and organizational lobbying campaign after DEA’s lawyers submit their objections on March 26. DEA will begin to process the Judge’s recommendation in May, and has an unlimited amount of time to issue a formal response. In previous DEA ALJ hearings, DEA has taken anywhere between 5–15 months to respond. We will use this intervening period to broadly expand on our Congressional and organizational lobbying efforts, to demonstrate to DEA that there will be a political backlash if they continue to obstruct legitimate and highly demanded scientific research.
Conclusion: The Strategic Benefits of the Federal Research Route
If DEA still decides to reject Judge Bittner’s recommendation, this action will contribute to the passage of state and local marijuana reform efforts. If DEA rejects the ruling, it will be clear that the appropriate administrative channels have been exhausted and that FDA drug development route is fundamentally blocked by NIDA’s monopoly. MAPS and Prof. Craker will appeal in the DC Circuit Court of Appeals, but that would tie the case up in the courts for several more years. A lot of patients and their families can’t wait that long.
Eleven states and numerous municipalities have enacted laws protecting patients who use marijuana when prescribed by a doctor. Several more states, such as New York, Illinois, Minnesota, New Mexico, and Wisconsin are considering similar legislation this year. While recognizing the inspiring success of state and local initiatives over the past decade, it is also important to understand their historical context as it relates to NIDA and DEA’s obstruction of the FDA drug development route, which, for better or worse, is the regulatory channel that all other prescription medicines must successfully pass through in the US.
While enforcement is generally left up to local authorities, there are no guarantees that the Feds will not intervene. In 2005, the US Supreme Court did rule in Gonzales v. Raich that the federal government can arrest medical marijuana patients and enforce federal marijuana laws even in states where it is legal. Justice Breyer stated in oral arguments during the Raich case that medical marijuana patients should go through FDA’s regulatory process to get marijuana approved as a prescription medicine, rather than focusing on courts and referendums. Patients, doctors and scientists are in a catch-22 because the Supreme Court has insisted that they to go to FDA, but DEA, NIDA and the federal government have systematically obstructed their ability to perform FDA-approved research.
As discussed earlier, clinical research with human subjects that meets FDA’s strict guidelines is costly. MAPS estimates that it would cost $5–$7 million to get marijuana approved as a prescription medicine, spent over the course of 5–7 years. Expenditures of this magnitude make sense only after there is an independent source of supply.
When compared to the costs of other forms of medical marijuana policy reform, however, such as statewide ballot initiatives, the costs of research are a bargain. One statewide ballot initiative can cost several million dollars; it would be many, many times more costly for all 50 states to individually pass medical marijuana laws than it would be to go for the whole ball of wax by gaining FDA approval.
Why is the federal government going to such lengths to stop MAPS and Prof. Craker? The federal government knows that if FDA had the opportunity to evaluate medical marijuana based on science, not politics, it would likely approve it for medical use.
For the first time in six and a half decades, since marijuana was removed from the US Pharmacopeia in 1941, there is a window of opportunity for the establishment of a privately-funded source of research-grade marijuana. To take advantage of this unique opportunity, we need all supporters to contact their federal legislators. Ask your Representatives and Senators to add their signature to the Congressional Sign-On letter urging DEA to issue a Schedule I license to Prof. Craker. Tell them that you would like to see the controversy over the medical use of marijuana resolved through FDA-approved scientific research.
Please visit www.MAPS.org for more information.
Editor’s Note: Jag Davies is the Director of Communications for The Multidisciplinary Association for Psychedelic Studies (MAPS). Rick Doblin, Ph.D. is the President of MAPS.