Marijuana Cannabis Seven Legal Marijuana Patients NIDA

Marijuana/Cannabis

Seven Legal Marijuana Patients • NIDA supplies marijuana to seven patients under FDA Compassionate Use Program. • Russo E, et al. Chronic Cannabis Use in the Compassionate Investigational New Drug Program: An Examination of Benefits and Adverse Effects of Legal Clinical Cannabis. Journal of Cannabis Therapeutics Vol. 2 (1) (2002): 3 -57. (MAPS supported-in part by grandson of W. Erastus Upjohn)

Efficacy Conclusions • Cannabis smoking, even of a crude, lowgrade product, provides effective symptomatic relief of pain, muscle spasms, and intraocular pressure elevations in selected patients failing other modes of treatment. • Patients reduce use of other prescription medicines and improve quality of life.

Safety Conclusions • Side effect profile of NIDA cannabis in chronic usage suggests mild pulmonary risk. • No malignant deterioration observed, nor consistent or attributable neuropsychological or neurological deterioration. • No endocrine, hematological or immunological sequelae observed.

Medical Marijuana Research • At present, there is no research outside of the US in which smoked marijuana is being administered to patients in a clinical research study. • Research is proceeding with marijuana extracts such as sublingual lozenges and THC capsules (Marinol).

Dr. Abrams Marijuana/AIDS Research • Recently completed, this is the first FDAapproved study of the use of marijuana in any patient population in 15 years! • Study took 7 years to obtain approval, MAPS worked closely with Dr. Abrams and funded two of his NIH grant applications. • Funded by NIDA- $1 million.

Study Design • 21 -day in-patient study, HIV+ patients taking protease inhibitors • Twenty-one subjects were randomized for smoked marijuana, 25 for oral dronabinol, and 21 for the oral placebo. • Viral loads (HIV RNA levels), immune system, caloric intake, weight gain.

Dr. Abrams’ conclusions • Patients with HIV infection taking protease inhibitors do not experience short-term adverse virologic or immunological effects from using smoked marijuana or oral THC as compared to placebo. • Caloric intake and weight gain highest in marijuana group >oral THC > placebo. • Paper under review

Medical Marijuana Research • There is only one study in the US in which smoked marijuana is being administered to patients, in this case to AIDS patients. • Dr. Dennis Israelski, chief of infectious diseases and AIDS medicine at San Mateo County Hospital and Clinics. • Funded by San Mateo County.

Center for Medical Cannabis Research • • Funded by the State of California Approvals required by CMCR CA Research Advisory Panel IRB FDA DEA NIDA/Public Health Service

Upcoming CMCR Studies • The Effect of Marijuana on Neuropathic Pain in HIV-related Peripheral Neuropathy, Donald Abrams, M. D. (UCSF) • Placebo-controlled, Double Blind Trial of Medicinal Cannabis in Painful HIV Neuropathy, Ron Ellis, M. D. , Ph. D. (UCSD) • Short-Term Effects of Cannabis Therapy on Spasticity in MS, Jody. Corey-Bloom, M. D. , Ph. D. (UCSD)

UPCOMING CMCR Studies • Marijuana in Combination with Opioids for Cancer Pain, Donald Abrams, M. D. ( U • Cannabis for Spasticity/Tremor in MS: Placebo controlled study, Mark Agius, M. D. (UC Davis) • Analgesic Efficacy of Smoked Cannabis, Mark Wallace, M. D. (UCSD)

UPCOMING CMCR Studies • Effects of Medicinal Cannabis on CD 4 Immunity in AIDS, Rachel Schrier, Ph. D. (UCSD) • Mechanisms of Cannabinoid Analgesia, Ian Meng, Ph. D. (UCSF) • Effects of Cannabis Therapy on Endogenous Cannabinoids, Daniele Piomelli. Ph. D. (UC Irvine)

San Mateo County Study • Pilot study into AIDS-related nausea, pain. • "I know after I take a few hits that within 10 minutes I'm going to be hungry and my nausea is going to go away, " said [subject] Alden, who suffers from chronic persistent wasting syndrome. Nicole Achs Freeling, Half Moon Bay Review, October 13, 2001

Lone Patient Quits Study • "The pot was stale and it was full of seeds. When marijuana seeds burn, they smell and taste really bad. " • “Apparently, the two joints a day that he was required to smoke through the study had aggravated a throat condition. The doctor issued an edict - no more smoking NIDA marijuana. ”

NIDA’s Product • “We know the level of THC is lower in this federal-provided marijuana [ than what patients purchase through buyer’s clubs] , but unfortunately we don't have any control over that. We have to use whatever we're given by the federal government for this study. " Jonathan Messinger, assistant to program director Dr. Dennis Israelski.

Back to Illicit Supplies • “Once his throat condition clears, Alden says he will go back to treating himself at the cannabis clubs. ” • "It works. I have no doubt about that, " he said.

NIDA’s Monopoly • NIDA has a monoply on the supply of marijuana that can be used in FDAapproved research. This is the only Schedule 1 drug for which NIDA has a monopoly, not MDMA, LSD, psilocybin. • NIDA, whose mission is to research the harms of marijuana, must approve all research into marijuana’s potential benefits.

NIDA Marijuana Label

NIDA Marijuana Cigarettes

NIDA likes “Pall Mall”™ Rolling Papers

Unrolled NIDA Marijuana: Mostly Leaf

Stems and Seeds in 3 NIDASupplied Marijuana Cigarettes

MAPS/UMass Amherst Production Facility • 11/7/00 MAPS offers grant to UMass Amherst to grow 25 lb High-THC marijuana for FDAapproved INDs. • June 2001 Applications filed with DEA and MA Dept. of Public Health • August 1, 2001 MA Inspectors come to visit

MAPS/UMass Amherst Production Facility • December, 2001 - MA Dept. of Public Health says it has no objections in principle. • December, 2001 - DEA says it lost the application. • January, 2002 - Photocopied Application and envelope and faxed them to DEA. • February, 2002 - DEA informed us that it refused to accept application since there was no original signature, just a photocopy.

MAPS/UMass Amherst Production Facility • March 2002 - ACLU begins to work on legal analysis of US International treaty obligations, which DEA informally says do not permit non-governmental production. (GW Pharm. does exactly this in UK) • March 2002 - Marijuana Policy Project begins to gather signatures from Congressional reps on a letter to DEA supporting private production facility. • Application to be submitted in April 2002.

MAPS Marijuana Label

Non-Smoking Delivery System

WWW. VAPORMED. DE

Volatizer Data- Particulates Proof of Concept Study • Combustion THC 8. 9%, CBN. 27%, CBD. 07% Benzene. 3%, Touluene. 07%, Naphthalene 0% • 140 C THC 5. 4%, CBN. 16%, CBD 0 NO Benzene, Touluene, Naphthalene • 180 C THC 6. 9%, CBN. 34%, CBD 0 NO Benzene, Touluene, Naphthalene • 200 C THC 7. 7%, CBN. 35%, CBD 0 NO Benzene, Touluene, Naphthalene

Volatizer - Carbon Monoxide Proof of Principle Study • At 170 C, Carbon Monoxide reduced at least 1/3 compared to combustion. • “Drager System” used to gather carbon monoxide from combustion was saturated. • More carbon monoxide research- $25, 000

Trade-offs: Marijuana v. Extracts in Aerosols, Drops, Sprays (GW Pharm) • Marijuana - High THC with vaporizer • Safety issues, still some particulates • Efficacy likely equal to other delivery systems • Still get high • Cost is low • Health Effect of Wealth • Extracts or other nonsmoking systems • Little or no particulates • Efficacy likely equal, better if higher levels of CBD, CBN are required • Probably get high • Cost is high

Marijuana as Symbolic Politics • Nixon Tapes, May 26, 1971: • "You know, it's a funny thing, every one of the bastards that are out for legalizing marijuana is Jewish. What the Christ is the matter with the Jews, Bob [Haldeman]? What is the matter with them? I suppose it is because most of them are psychiatrists. ” • Now on to the psychiatric use of psychedelics!