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Cannabinoid Therapeutics

by FRED GARDNER

The directors of the University of California’s Center for Medical Cannabis Research–Igor Grant, MD, and Drew Mattison, PhD–organized a “workshop” in Paestum, Italy last month that seemed to violate their basic mandate.

The event, entitled “Future Directions in Cannabinoid Therapeutics II: From the Bench to the Clinic,” was held on Sunday, June 27, following the International Cannabinoid Research Society’s annual meeting. Participants included many prestigious scientists -Raphael Mechoulam, Roger Pertwee, Raj Razdan, Alexandros Makriyannis, Daniele Piomelli, Cecilia Hillard, Vincenzo di Marzo, Ester Fride, Natsuo Ueda, Jun Fu, George Kunos, Geoffrey Guy, and others. The guests had no idea, presumably, that the session was unauthorized by the people of California.

The CMCR conference was not publicized in advance and as of this writing is not reported on their website. I first heard about it as the ICRS meeting got underway from Sumner Burstein, a UMass medical school researcher who has developed a synthetic drug, ajulemic acid (named after his granddaughters) that activates the cannabinoid receptors. Burstein said that a Massachusetts drug company, Indevus, was testing AJA as a treatment for pain, and that their promising early results would be reported at “the meeting on Sunday.” He said he hoped I could attend. (The ICRS program ran through Saturday.)

Next evening two California doctors, Jeff Hergenrather of Sebastopol and R. Stephen Ellis of San Francisco, were seated at dinner with Drew Mattison, who revealed that the CMCR was holding a meeting on Sunday for companies developing drugs they hoped to test and market in the U.S. Mattison said it was “by invitation only,” and he did not extend an invite to the California docs (who, being gentlemen, did not protest).

The following afternoon I encountered Mattison outside the lecture hall and told him that Burstein had invited me to the CMCR session. He said, in obvious displeasure, that “since there had been so many complaints,” he’d been forced to “open it up” on a first-come, first-served basis to 20 more participants. I could get in if I showed up early enough.

I asked Mattison if the CMCR -which has headquarters at UC San Diego and an office at UC San Francisco- might find a way to provide analytical-lab services so that California patients, doctors and growers could identify the composition of the plants they were using and begin to duplicate, however crudely, the G.W. approach to research. He gave me a horrified look and, instead of responding, said “Gerard might be starting his talk” and scurried into the hall where Gerard Le Fur of Sanofi was about to describe the effectiveness of a cannabinoid-antagonist drug in treating obesity.

The CMCR Sunday conference was held in a room at the Ariston Hotel, same as the ICRS meeting. About 40 distinguished scientists sat around tables with nameplates, microphones, water, gift notepads, etc. (There was a noticeably higher percentage of men than at the ICRS meeting.) Breakfast and lunch were provided. The abstract book acknowledged grants from the U.S. National Institute on Drug Abuse, Health Canada, Solvay (makers of Marinol), Lilly, Merck, Esteve, Valeant, Indevus, Kadmus, and G.W. Pharmaceuticals. At least five people from UC San Diego were involved -Mattison and Grant, staffer Heather Bentley, a grad student and a distraught technician who kept scurrying along the floor trying to get the mikes to work and/or stop screeching.

The program was organized into four sections: “Cannabinoid Agonists,” “Cannabinoid Antagonists,” “New Trends in Cannabinoid Therapeutics,” and “Cannabinoid Drug Development.” Except for the promotion of antagonist drugs -which work by blocking the body’s cannabinoid receptors and pose dangers about which the designers remain in deep denial- most of the research being described had positive therapeutic implications. The talks involved very arcane chemistry, with the exception of Geoffrey Guy’s report that tolerance did not build up in more than 1,000 patients who had taken Sativex for more than a year (for various conditions).

Our concern is not that the CMCR honchos spent taxpayers’ money on making themselves “players” in the cannabisiness world (the legislation creating the CMCR allows them to spend five percent of their time raising money from outside sources), but that the program itself violated their reason for being, which was and is to study “marijuana,” not ajulemic acid, or Marinol, or “cannbinoid therapeutics.”

The CMCR was created by “The Marijuana Research Act of 1999” -SB-487- which was introduced by State Sen. John Vasconcellos explicitly in response to the passage of Prop 215. SB-487 authorized the UC regents to create a “Marijuana Research Program… (to) develop and conduct studies intended to ascertain the general medical safety and efficacy of marijuana and, if found valuable (sic), shall develop medical guidelines for the appropriate administration and use of marijuana.”

Note that the act refers to “marijuana” as it was and is being used by Californians under Prop 215 -in other words, the plant. The crude plant that grows in the crude soil and that we voted to legalize for medical use. SB-487 made no reference to synthetic formulations, let alone antagonist drugs. It authorized UC to sponsor studies involving “marijuana.” For example: “Proposals shall contain procedures for outreach to patients with various medical conditions who may be suitable participants in research on marijuana…” And “Proposals shall contain protocols suitable for research on marijuana…” And “Studies conducted pursuant to this section shall include the greatest amount of new scientific research possible on the medical uses of, and medical hazards associated with, marijuana…” And “The marijuana studies shall employ state-of-the-art research methodologies.” And so forth.

How did it come to pass that research into the safety and efficacy of marijuana got transmuted into studies involving synthetics? A key step was the selection of UC San Diego -where the influence of the medical marijuana movement was almost nil- to be the headquarters and Mattison and Grant -a major recipient of NIDA funding throughout his career- to be the directors.

Whereas SB-847 had called for “Marijuana Research” the UC center changed its name to Cannabis (Latin is so much classier than Mexican). The launch was accompanied by a self-congratulatory mission statement that eradicated marijuana, introduced the ambiguous term “cannabis products,” and added a gratuitous goal that ignores the people of California while blowing a kiss to fellow bureaucrats:

“The Center for Medicinal Cannabis Research will conduct high quality scientific studies intended to ascertain the general medical safety and efficacy of cannabis and cannabis products and examine alternative forms of cannabis administration. The center will be seen as a model resource for health policy planning by virtue of its close collaboration with federal, state, and academic entities.”

Had the CMCR been based at UC San Francisco its operation might have been monitored by doctors and cannabis-using patients who want and need studies relevant to their own situation. Who is better positioned than the CMCR to collect data on the conditions that Californians have been treating with cannabis. And to collect and analyze the results? Who is better positioned to analyze and provide data on the strains being used in the here and now? A director whose ambitions were on the clinical rather than the research side of medicine would have promoted such studies.

Instead we have Igor Grant and Drew Mattison “bringing together the major stakeholders in the development of cannabinoid therapeutics,” as their abstract book puts it, “to survey the laboratory compounds that are most promising for testing in human trials, confront potential stumbling blocks to testing and development of these compounds, and identify opportunities for progressing (sic, sic, sic) new compounds to clinical readiness.”

The CMCR leaders showed disrespect for the people they’re supposed to be serving when they didn’t invite Hergenrather and Ellis -who between them have monitored cannabis use by more than 5,000 patients!- to their confab.

A member of the CMCR scientific advisory board (which has not met in two years) told your correspondent that he had not been apprised of the “workshop” in Paestum. He sought to defend the CMCR by saying that SB-847 requires that their studies be conducted with marijuana provided by NIDA. But the wording of the law suggests that studies could be conducted with California-grown herb! “The program shall ensure that all marijuana used in the studies is of the appropriate medical quality and shall be obtained from the National Institute on Drug Abuse or any other federal agency designated to supply marijuana for authorized research. ITAL If these federal agencies fail to provide a supply of adequate quality END ITAL and quantity within six months of the effective date of this section, the Attorney General shall provide an adequate supply pursuant to Section 11478.”

The federal agencies have indeed failed to provide marijuana of adequate quality -which is why several CMCR studies couldn’t entice enough test subjects and have been “on hold” for years. (Most egregious example: a San Mateo study designed for 58 subjects that recruited just one!) Why don’t the scientists involved ask the AG to start supplying medicine comparable to what Californians are growing in their own gardens? Why don’t they just get real? While they’re at it they can discard any “placebo” protocols that are keeping prospective patients out of their studies. What seriously ill person would risk getting a placebo when they desperately need effective medicine?

We have to remind ourselves that the CMCR was created in response to Prop 215, which was a rejection of a prohibition upheld not just by the government but by the biomedical establishment. Research inspired by Prop 215 should be realistic, practical, and designed to answer questions raised by Californians who use cannabis as medicine in the now.

FRED GARDNER writes the weekly Politics of Marijuana column for CounterPunch and the Anderson Valley Advertiser.

 

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Fred Gardner is the managing editor of O’Shaughnessy’s. He can be reached at fred@plebesite.com

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