* marijuana/cannabis * seven legal marijuana patients

Marijuana/Cannabis

Seven Legal Marijuana PatientsSeven 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 ConclusionsEfficacy Conclusions

• Cannabis smoking, even of a crude, low-grade 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 ConclusionsSafety 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 ResearchMedical 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

Dr. Abrams Marijuana/AIDS Research

• Recently completed, this is the first FDA-approved 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 DesignStudy 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’ conclusionsDr. 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 ResearchMedical 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

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 StudiesUpcoming 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, JodyCorey-Bloom, M.D., Ph.D. (UCSD)

UPCOMING CMCR StudiesUPCOMING CMCR Studies

• Marijuana in Combination with Opioids for Cancer Pain, Donald Abrams, M.D. (UCSF)

• 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 StudiesUPCOMING CMCR Studies

• Effects of Medicinal Cannabis on CD4 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 StudySan 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 StudyLone 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 ProductNIDA’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 SuppliesBack 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 MonopolyNIDA’s Monopoly

• NIDA has a monoply on the supply of marijuana that can be used in FDA-approved 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 NIDA-Supplied Marijuana Cigarettes

MAPS/UMass Amherst Production Facility

MAPS/UMass Amherst Production Facility

• 11/7/00 MAPS offers grant to UMass Amherst to grow 25 lb High-THC marijuana for FDA-approved 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

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

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 SystemNon-Smoking Delivery SystemNon-Smoking Delivery SystemNon-Smoking Delivery System

WWW.VAPORMED.DEWWW.VAPORMED.DE

Volatizer Data- Particulates Proof of Concept Study

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 MonoxideProof of Principle Study

Volatizer - Carbon MonoxideProof 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)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 non-smoking 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 PoliticsMarijuana 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!