The Feds and Medical Cannabis: Signs Of Change or Business as Usual?


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The Feds and Medical Cannabis: Signs Of Change or Business as Usual?

  1. 1. The Feds and Medical Cannabis : Signs Of Change? Or Business as Usual? Paul Armentano Deputy Director NORML, NORML Foundation April 23, 2011 40 th Annual National NORML Conference Denver, CO
  2. 2. Sign of Change? NCI For The First Time Acknowledges Cancer-Fighting Properties of Cannabis <ul><li>March 21, 2011: Website of the National Cancer Institute updates its website </li></ul><ul><li> (Laboratory/Animal/Preclinical Studies) </li></ul><ul><ul><li>“ Cannabinoids may cause antitumor effects by various mechanisms, including induction of cell death, inhibition of cell growth, and inhibition of tumor angiogenesis and metastasis. Cannabinoids appear to kill tumor cells but do not affect their nontransformed counterparts and may even protect them from cell death. ” </li></ul></ul><ul><li> (General Information) </li></ul><ul><ul><li>“ The potential benefits of medicinal cannabis for people living with cancer include antiemetic effects, appetite stimulation, pain relief, and improved sleep. In the practice of integrative oncology, the health care provider may recommend medicinal cannabis not only for symptom management but also for its possible direct antitumor effect .” </li></ul></ul>
  3. 3. Or Business As Usual? NCI Amends Website To Downplay The Role of Cannabis In Cancer Treatment <ul><li>March 21, 2011: Website of the National Cancer Institute is amended after several media outlets, including MSNBC, report that their summary “could have an impact on the classification of marijuana as a schedule I drug.” </li></ul><ul><li> (General Information) </li></ul><ul><ul><li>“ Though no relevant surveys of practice patterns exist, it appears that physicians caring for cancer patients who prescribe medicinal Cannabis predominantly do so for symptom management .” </li></ul></ul><ul><ul><li>“ The U.S. Food and Drug Administration (FDA) has not approved the use of Cannabis as a treatment for any medical condition.” </li></ul></ul><ul><li>NCI prepared statement, published March 23, 2011: “In light of the attention garnered by the PDQ summary statement on 'Cannabis and Cannabinoids,' reviewers ... reexamined the recently posted statement and decided to change the wording, in order to clarify the meaning that the Board originally intended to convey and to correct several possible misinterpretations .” </li></ul>
  4. 4. Sign of Change? DEA Considers Rescheduling Marijuana Plant-Derived Formulated Medicines <ul><li>November 1, 2010: United States Drug Enforcement Administration publishes a notice of proposed rulemaking in the Federal Register </li></ul><ul><li> </li></ul><ul><ul><li>“ This proposed action expands the schedule III listing to include formulations having naturally-derived dronabinol and products encapsulated in hard gelatin capsules.” </li></ul></ul><ul><ul><li>“ The DEA has received four petitions from companies that have products that are currently the subject of ANDAs (abbreviated new drug application) under review by the FDA. … [T]hese firms have requested that 21 CFR 1308.13(g)(1) be expanded to include naturally derived or synthetically produced dronabinol.” </li></ul></ul><ul><ul><li>“ The submissions to DHHS also requested that they consider (1) whether dronabinol extracted from Cannabis sativa (i.e. naturally-derived), is identical to synthetically-produced dronabinol found in Marinol® ; and (2) whether a formulation encapsulated in hard gelatin capsules, instead of soft gelatin capsules, changes a product’s abuse potential.” </li></ul></ul><ul><li>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. This drug product contains naturally-derived dronabinol dissolved in sesame seed oil and encapsulated in a gelatin capsule.” </li></ul><ul><ul><li>Other companies with naturally-derived cannabis pharmaceuticals in development include: Mallincrodkt Baker (now Avantor), Bionorica Worlwide, GW Pharmaceuticals </li></ul></ul>
  5. 5. Or Business As Usual? DEA Affirms That Plant-Derived Cannabinoids Will Nevertheless Remain Schedule I <ul><li>February 11, 2011: DEA representative affirms to The Daily Caller that the action will have no effect on the overall scheduling or legality of plant-derived cannabinoids </li></ul><ul><ul><li>“ Please note that DEA is not ‘rescheduling … organic THC.” </li></ul></ul><ul><ul><li>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 of the drug, regardless of whether the THC used in the generic version was synthesized by man or derived from the cannabis plant. THC, natural or synthetic, [will] remain a schedule I controlled substance .&quot; </li></ul></ul><ul><li>DEA 2010 Agency White Paper: “DEA Position on Marijuana” </li></ul><ul><ul><li>“ [M]arijuana has no scientifically proven medical value.” </li></ul></ul>
  6. 6. Sign of Change? Drug Czar Claims “Hundreds” Of Clinical Trials Are Taking Place Assessing Medical Cannabis <ul><li>November 11, 2009: American Medical Association “urges that marijuana's status as a federal Schedule I controlled substance be reviewed with the goal of facilitating the conduct of clinical research and development of cannabinoid-based medicines.” </li></ul><ul><li>March 9, 2009: White House issues ‘Scientific Integrity Memorandum” </li></ul><ul><ul><li> (Memorandum for the Heads of Executive Departments and Agencies) </li></ul></ul><ul><ul><ul><li>&quot;Science and the scientific process must inform and guide decisions of my Administration.” </li></ul></ul></ul><ul><li>February 11, 2011: Drug Czar interview with The Daily Caller </li></ul><ul><ul><li>“ And you know there are over 100 groups doing marijuana research, and they’re getting their marijuana from the University of Mississippi. There are several things in clinical trials right now. So we’ll just have to wait for those.” </li></ul></ul>
  7. 7. Or Business As Usual? Lists Virtually No Ongoing Clinical Trials Assessing Cannabis <ul><li>An online search of ongoing FDA-approved clinical trials using the keyword &quot;cannabinoids&quot; (the active components in marijuana) yielded me 65 worldwide hits, only six involved subjects use of actual cannabis. </li></ul><ul><ul><li>Of the six, two of the studies have already been completed </li></ul></ul><ul><ul><li>The four remaining studies are still in the &quot;recruitment&quot; phase. Of these, only two pertain to the potential medical use of cannabis. </li></ul></ul><ul><li>NIDA to the New York Times : “As the National Institute on Drug Abuse, our focus is primarily on the negative consequences of marijuana use. We generally do not fund research focused on the potential beneficial medical effects of marijuana.” </li></ul><ul><li>DEA 2010 Agency White Paper: “DEA Position on Marijuana” </li></ul><ul><ul><li>“ Eighteen … researchers are approved to conduct research with smoked marijuana on human subjects .” </li></ul></ul>
  8. 8. The Lesson To Be Learned? <ul><li>In Washington, DC, the more things change, the more they stay the same (at least when it comes to marijuana) </li></ul>
  9. 9. About Me <ul><li>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 field of marijuana policy, health, and pharmacology. He has served as a consultant for Health Canada, Safety First: A Reality-Based Approach to Teens and Drugs, and the Canadian Public Health Association. He frequently serves as a legal consultant and expert witness for the defense in cannabis-associated criminal cases. Mr. Armentano is the author of over 500 published papers and magazine articles, and was a 2008 recipient of the 'Project Censored Real News Award for Outstanding Investigative Journalism.’ He is the co-author of the book 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 northern California with his wife and son. </li></ul><ul><li>Contact me at : </li></ul>