The Feds and Medical CannabisThe Feds and Medical Cannabis::Signs Of Change?Signs Of Change?

Or Business as Usual?Or Business as Usual?

Paul ArmentanoPaul ArmentanoDeputy DirectorDeputy Director

NORML, NORML FoundationNORML, NORML Foundation

April 23, 2011April 23, 2011

4040thth Annual National NORML Conference Annual National NORML Conference

Denver, CODenver, CO

Sign of Change?Sign of Change?NCI For The First Time Acknowledges Cancer-Fighting NCI For The First Time Acknowledges Cancer-Fighting

Properties of CannabisProperties of Cannabis

March 21, 2011: Website of the National Cancer Institute updates its March 21, 2011: Website of the National Cancer Institute updates its cancer.gov websitecancer.gov website

http://www.cancer.gov/cancertopics/pdq/cam/cannabis/http://www.cancer.gov/cancertopics/pdq/cam/cannabis/healthprofessional/page4 (Laboratory/Animal/Preclinical Studies)healthprofessional/page4 (Laboratory/Animal/Preclinical Studies)

““Cannabinoids may cause antitumor effects by various mechanisms, including induction of cell Cannabinoids may cause antitumor effects by various mechanisms, including induction of cell death, inhibition of cell growth, and inhibition of tumor angiogenesis and metastasis. death, inhibition of cell growth, and inhibition of tumor angiogenesis and metastasis. Cannabinoids appear to kill tumor cells but do not affect their nontransformed Cannabinoids appear to kill tumor cells but do not affect their nontransformed counterparts and may even protect them from cell death.counterparts and may even protect them from cell death.””

http://www.cancer.gov/cancertopics/pdq/cam/cannabis/http://www.cancer.gov/cancertopics/pdq/cam/cannabis/healthprofessional/page2 (General Information)healthprofessional/page2 (General Information)

““The potential benefits of medicinal cannabis for people living with cancer include antiemetic The potential benefits of medicinal cannabis for people living with cancer include antiemetic effects, appetite stimulation, pain relief, and improved sleep. effects, appetite stimulation, pain relief, and improved sleep. In the practice of integrative In the practice of integrative oncology, the health care provider may recommend medicinal cannabis not only for oncology, the health care provider may recommend medicinal cannabis not only for symptom management but also for its possible direct antitumor effectsymptom management but also for its possible direct antitumor effect.”.”

Or Business As Usual?Or Business As Usual?NCI Amends Website To Downplay The Role of Cannabis NCI Amends Website To Downplay The Role of Cannabis

In Cancer TreatmentIn Cancer Treatment March 21, 2011: Website of the National Cancer Institute is amended after March 21, 2011: Website of the National Cancer Institute is amended after

several media outlets, including MSNBC, report that their summary “could have several media outlets, including MSNBC, report that their summary “could have an impact on the classification of marijuana as a schedule I drug.”an impact on the classification of marijuana as a schedule I drug.”

http://www.cancer.gov/cancertopics/pdq/cam/cannabis/http://www.cancer.gov/cancertopics/pdq/cam/cannabis/healthprofessional/page2 (General Information)healthprofessional/page2 (General Information) ““Though no relevant surveys of practice patterns exist, it appears that physicians Though no relevant surveys of practice patterns exist, it appears that physicians

caring for cancer patients who prescribe medicinal Cannabis caring for cancer patients who prescribe medicinal Cannabis predominantly do so predominantly do so for symptom managementfor symptom management.”.”

““The U.S. Food and Drug Administration (FDA) has not approved the use of The U.S. Food and Drug Administration (FDA) has not approved the use of Cannabis as a treatment for any medical condition.”Cannabis as a treatment for any medical condition.”

NCI prepared statement, published March 23, 2011: “In light of the attention NCI prepared statement, published March 23, 2011: “In light of the attention garnered by the PDQ summary statement on 'Cannabis and Cannabinoids,' garnered by the PDQ summary statement on 'Cannabis and Cannabinoids,' reviewers ... reexamined the recently posted statement and decided to reviewers ... reexamined the recently posted statement and decided to change the wording, in order to clarify the meaning that the Board change the wording, in order to clarify the meaning that the Board originally intended to convey and to correct several possible originally intended to convey and to correct several possible misinterpretationsmisinterpretations.”.”

Sign of Change?Sign of Change?DEA Considers Rescheduling Marijuana Plant-Derived DEA Considers Rescheduling Marijuana Plant-Derived

Formulated MedicinesFormulated Medicines

November 1, 2010: United States Drug Enforcement Administration publishes a notice of November 1, 2010: United States Drug Enforcement Administration publishes a notice of proposed rulemaking in the Federal Registerproposed rulemaking in the Federal Register

http://edocket.access.gpo.gov/2010/pdf/2010-27502.pdfhttp://edocket.access.gpo.gov/2010/pdf/2010-27502.pdf ““This proposed action expands the schedule III listing to include formulations having This proposed action expands the schedule III listing to include formulations having naturally-naturally-

derived derived dronabinol and products encapsulated in hard gelatin capsules.”dronabinol and products encapsulated in hard gelatin capsules.” ““The DEA has received The DEA has received four petitions from companies four petitions from companies that have products that are currently the that have products that are currently the

subject of ANDAs (abbreviated new drug application) under review by the FDA. … [T]hese firms subject of ANDAs (abbreviated new drug application) under review by the FDA. … [T]hese firms have requested that 21 CFR 1308.13(g)(1) have requested that 21 CFR 1308.13(g)(1) be expanded to include naturally derived be expanded to include naturally derived or or synthetically produced dronabinol.”synthetically produced dronabinol.”

““The submissions to DHHS also requested that they consider (1) The submissions to DHHS also requested that they consider (1) whether dronabinol extracted whether dronabinol extracted from Cannabis sativa (i.e. naturally-derived), is identical to synthetically-produced from Cannabis sativa (i.e. naturally-derived), is identical to synthetically-produced dronabinol found in Marinol®dronabinol found in Marinol®; and (2) whether a formulation encapsulated in hard gelatin ; and (2) whether a formulation encapsulated in hard gelatin capsules, instead of soft gelatin capsules, changes a product’s abuse potential.”capsules, instead of soft gelatin capsules, changes a product’s abuse potential.”

June 1, 2010 letter from HHS to DEA: “Cobalt is developing a generic drug product that June 1, 2010 letter from HHS to DEA: “Cobalt is developing a generic drug product that references Marinol [and is] requesting that the product be placed into schedule III. references Marinol [and is] requesting that the product be placed into schedule III. This This drug product contains naturally-derived dronabinol drug product contains naturally-derived dronabinol dissolved in sesame seed oil and dissolved in sesame seed oil and encapsulated in a gelatin capsule.”encapsulated in a gelatin capsule.”

Other companies with naturally-derived cannabis pharmaceuticals in development include: Other companies with naturally-derived cannabis pharmaceuticals in development include: Mallincrodkt Baker (now Avantor), Bionorica Worlwide, GW PharmaceuticalsMallincrodkt Baker (now Avantor), Bionorica Worlwide, GW Pharmaceuticals

Or Business As Usual?Or Business As Usual?DEA Affirms That Plant-Derived Cannabinoids Will DEA Affirms That Plant-Derived Cannabinoids Will

Nevertheless Remain Schedule INevertheless Remain Schedule I

February 11, 2011: DEA representative affirms to February 11, 2011: DEA representative affirms to The Daily CallerThe Daily Caller that that the action will have no effect on the overall scheduling or legality of plant-the action will have no effect on the overall scheduling or legality of plant-derived cannabinoidsderived cannabinoids

““Please note that DEA is not ‘rescheduling … organic THC.”Please note that DEA is not ‘rescheduling … organic THC.” Under the proposed rule, in those instances in the future where FDA might approve a generic Under the proposed rule, in those instances in the future where FDA might approve a generic

version of Marinol, that version of the drug will be in the same schedule as the brand name version version of Marinol, that version of the drug will be in the same schedule as the brand name version of the drug, regardless of whether the THC used in the generic version was synthesized by man or of the drug, regardless of whether the THC used in the generic version was synthesized by man or derived from the cannabis plant. derived from the cannabis plant. THC, natural or synthetic, [will] remain a schedule I controlled THC, natural or synthetic, [will] remain a schedule I controlled substancesubstance."."

DEA 2010 Agency White Paper: “DEA Position on Marijuana”DEA 2010 Agency White Paper: “DEA Position on Marijuana” ““[M]arijuana has no scientifically proven medical value.”[M]arijuana has no scientifically proven medical value.”

Sign of Change?Sign of Change?Drug Czar Claims “Hundreds” Of Clinical Trials Are Drug Czar Claims “Hundreds” Of Clinical Trials Are

Taking Place Assessing Medical CannabisTaking Place Assessing Medical Cannabis

November 11, 2009: American Medical Association “urges that November 11, 2009: American Medical Association “urges that marijuana's status as a federal Schedule I controlled substance be marijuana's status as a federal Schedule I controlled substance be reviewed with the goal of facilitating the conduct of clinical research reviewed with the goal of facilitating the conduct of clinical research and development of cannabinoid-based medicines.”and development of cannabinoid-based medicines.”

March 9, 2009: White House issues ‘Scientific Integrity Memorandum”March 9, 2009: White House issues ‘Scientific Integrity Memorandum” http://www.whitehouse.gov/the_press_office/Memorandum-for-the-Heads-of-http://www.whitehouse.gov/the_press_office/Memorandum-for-the-Heads-of-

Executive-Departments-and-Agencies-3-9-09/ (Memorandum for the Heads of Executive-Departments-and-Agencies-3-9-09/ (Memorandum for the Heads of Executive Departments and Agencies)Executive Departments and Agencies)

"Science and the scientific process must inform and guide decisions of my Administration.”"Science and the scientific process must inform and guide decisions of my Administration.”

February 11, 2011: Drug Czar interview with February 11, 2011: Drug Czar interview with The Daily CallerThe Daily Caller ““And you know And you know there are over 100 groups doing marijuana research, and they’re there are over 100 groups doing marijuana research, and they’re

getting their marijuana from the University of Mississippi.getting their marijuana from the University of Mississippi. There are several There are several things in clinical trials right now. So we’ll just have to wait for those.”things in clinical trials right now. So we’ll just have to wait for those.”

Or Business As Usual?Or Business As Usual?ClinicalTrials.gov Lists Virtually No Ongoing Clinical ClinicalTrials.gov Lists Virtually No Ongoing Clinical

Trials Assessing CannabisTrials Assessing Cannabis

An online search of ongoing FDA-approved clinical trials using the keyword An online search of ongoing FDA-approved clinical trials using the keyword "cannabinoids" (the active components in marijuana) yielded me 65 "cannabinoids" (the active components in marijuana) yielded me 65 worldwide hits, only six involved subjects use of actual cannabis.worldwide hits, only six involved subjects use of actual cannabis.

Of the six, two of the studies have already been completedOf the six, two of the studies have already been completed The four remaining studies are still in the "recruitment" phase. Of these, only two The four remaining studies are still in the "recruitment" phase. Of these, only two

pertain to the potential medical use of cannabis.pertain to the potential medical use of cannabis.

NIDA to the NIDA to the New York TimesNew York Times: “As the National Institute on Drug Abuse, our : “As the National Institute on Drug Abuse, our focus is primarily on the negative consequences of marijuana use. We focus is primarily on the negative consequences of marijuana use. We generally do not fund research focused on the potential beneficial medical generally do not fund research focused on the potential beneficial medical effects of marijuana.”effects of marijuana.”

DEA 2010 Agency White Paper: “DEA Position on Marijuana”DEA 2010 Agency White Paper: “DEA Position on Marijuana” ““Eighteen … researchers are approved to conduct research with smoked Eighteen … researchers are approved to conduct research with smoked

marijuana on human subjectsmarijuana on human subjects.”.”

The Lesson To Be Learned?The Lesson To Be Learned?

In Washington, DC, the more things change, the more In Washington, DC, the more things change, the more they stay the same (at least when it comes to marijuana)they stay the same (at least when it comes to marijuana)

About MeAbout Me

Paul Armentano is the Deputy Director of NORML and the NORML Foundation, Paul Armentano is the Deputy Director of NORML and the NORML Foundation, where he has worked for over twelve years. Mr. Armentano is an expert in the where he has worked for over twelve years. Mr. Armentano is an expert in the field of marijuana policy, health, and pharmacology. He has served as a field of marijuana policy, health, and pharmacology. He has served as a consultant for Health Canada, Safety First: A Reality-Based Approach to Teens consultant for Health Canada, Safety First: A Reality-Based Approach to Teens and Drugs, and the Canadian Public Health Association. He frequently serves as and Drugs, and the Canadian Public Health Association. He frequently serves as a legal consultant and expert witness for the defense in cannabis-associated a legal consultant and expert witness for the defense in cannabis-associated criminal cases.criminal cases. Mr. Armentano is the author of over 500 published papers and Mr. Armentano is the author of over 500 published papers and magazine articles, and was a 2008 recipient of the 'Project Censored Real News magazine articles, and was a 2008 recipient of the 'Project Censored Real News Award for Outstanding Investigative Journalism.’ He is the co-authorAward for Outstanding Investigative Journalism.’ He is the co-author of the book of the book Marijuana is Safer: So Why Are We Driving People to Drink? (2009, Chelsea Marijuana is Safer: So Why Are We Driving People to Drink? (2009, Chelsea Green). He is on the faculty of Oaksterdam University in Oakland. He lives in Green). He is on the faculty of Oaksterdam University in Oakland. He lives in northern California with his wife and son.northern California with his wife and son.

Contact me atContact me at: paul@norml.org: paul@norml.org