MARIJUANA, "CANNABINOID THERAPEUTICS"

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.