In a notice published on June 23, 2015, in the Federal Register, the Department of Health and Human Services announced that researchers who want to conduct non-federally funded research involving marijuana will no longer have to submit study proposals for Public Health Service review. The PHS review was seen as largely duplicative of another level of review performed by the Food and Drug Administration.
The reaction from researchers and advocates has been positive, but somewhat tempered by the realization that the road ahead is still long and difficult. There is also growing evidence that some of the therapeutic benefits of cannabis come from use of the whole plant and not just isolatable components.
The FDA approval process is simply not designed to deal with this aspect of marijuana medicine and seems increasingly irrelevant to the body of knowledge and practice being developed by doctors and dispensaries on the front lines of cannabis medicine.
The elimination of the PHS review was an idea first floated as part of the CARERS Act, introduced on March 10 by Sens. Cory Booker, D-N.J., Kirsten Gillibrand, D-N.Y., and Rand Paul, R-Ky. “The good news,” according to Amanda Reiman, Manager, Marijuana Law and Policy at the Drug Policy Alliance, “is that we’re finally seeing some movement at the federal level after decades of nothing.
As more and more states legalize and the barriers to research fall in Canada, patients and others, like the parents of desperately sick children, are simply not satisfied with the excuse that too little is known about the drug. Why is there not more research?”
Mike Liszewski, Director of Government Affairs at Americans for Safe Access, added, “The PHA review process was one of the major barriers to research. It took years and years and discouraged many researchers from ever bothering to go through the existing channels. It just prevented a lot of research.”
The experience of Dr. Sue Sisley, a practicing physician and clinical psychologist, whose study into the potential for marijuana as a treatment of PTSD is the only marijuana research to have passed the PHS review, serves as a cautionary tale for many researchers. It cost her a position at the University of Arizona and has been delayed for years.
“That [PHS} review was designed specifically to impede marijuana research in this country,” Sisley said, according to U.S. News and World Report. “[It] served as a shameful tactic used by opponents of marijuana research who never wanted the American citizenry to see objective data about the efficacy of marijuana.”
FDA research approval still requires that researchers:
- Submit the study proposal to the FDA for a thorough review of its scientific validity and ethical soundness;
- Get a marijuana permit from the Drug Enforcement Administration; and
- Obtain a quantity of medical marijuana via the Drug Supply Program run by the National Institute on Drug Abuse.
The last step remains a serious stumbling block. For nearly 50 years NIDA has been the only source of marijuana for researchers who seek federal drug approval. A consensus is emerging that the next important step is to end that monopoly.
NIDA routinely denies requests for studies designed to investigate potential benefits. “NIDA primarily funds only harm research because that’s its mission. No agency is tasked with looking at the drug’s potential benefits,” Reiman said.
The marijuana grown at NIDA’s University of Mississippi facility is also of poor research quality. Largely the product of contraband seized in the 1960s from Mexico, it bears little resemblance to the strains available at legal dispensaries today. Sisley’s study, now greenlighted, is still on hold while NIDA grows the strain she requires.
Finally, much international research is also funded by U.S government agencies, which further constricts the potential for research into therapeutic uses. Scientists rarely have the option of decamping to another country to conduct and publish research that cannot be done in the United States.
It need not be this way. According to Liszewski, “The U.S. has interpreted international treaties to say that only one government agency can grow marijuana for research purposes. Some of our allies do this differently. The United Kingdom, for example, allows multiple parties to get these licenses, and that’s how GW Pharmaceuticals was able to develop Sativex and Epidiolex.” The variety of licensees in Holland and Israel produce a greater variety of research plants.
FDA Approval May Not Be the Whole Story
New Frontier’s Quarterly Marijuana Industry Overview for the first quarter of 2015 identifies key market factors expected to shape the legal marijuana industry. Among these are the graying of the U.S. population, the expected rise in chronic conditions associated with age and increasing interest in non-opioid treatments.
Although many of benefits of marijuana-based medicine can be linked to specific cannabinoids, as is the case with Sativex and Epidiolex, other benefits seem to depend on the use of whole plant extracts. As Liszewski noted,
“One of the problems when it comes to evaluating marijuana medicine under the standards and protocols that we’ve been using since World War II is that is it a multi-compound botanical with 60-something chemical components. The way the current FDA approval process is built makes it very difficult to evaluate something like marijuana in its whole plant form.”
But policy and research interact on more than one level when it comes to cannabis medicine. Liszewski further noted that, “the development of treatments like Charlotte’s Web would not have happened but for Colorado having a comprehensive medical marijuana law that allowed for its production.”
Reiman weighed in with the suggestion that there was no need for medicine to choose between whole plant therapies and those produced through established FDA protocols. It may make sense, she suggested, to look at the future of medical marijuana as proceeding simultaneously along two tracks, as both a pharmaceutical product and a botanical one, much like Echinacea or St. John’s Wort. The essential task is to devise appropriate consumer protection regulations for each.