Medical marijuana: The conflict between scientific evidence and political ideology. part two of two

Journal of Pain and Palliative Care Pharmacotherapy

Volumn 23, Issue 2, 2009, Pages 120-140

  Cohen, Peter J ^a  

^a GEORGETOWN UNIVERSITY LAW CENTER   (United States)

Author keywords

Cannabis; Law; Marijuana; Medical; Nausea; Pain; Policy

Indexed keywords

ANTINEOPLASTIC AGENT; CANNABIS; DIAMORPHINE; DRONABINOL; LYSERGIDE; MESCALINE; OPIATE; PLACEBO; TETRAHYDROCANNABINOL;

ANALGESIC ACTIVITY; CHRONIC PAIN; CLINICAL TRIAL; CONVULSION; DELIRIUM TREMENS; DRUG APPROVAL; DRUG COST; DRUG EFFICACY; DRUG MEGADOSE; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; GASTROINTESTINAL DISEASE; GOUT; HEALTH CARE POLICY; HEPATITIS C; HISTORY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; IDEOLOGY; INSOMNIA; LAW; LOW DRUG DOSE; MEDICAL ETHICS; MEDICAL PRACTICE; MENTAL DISEASE; MESOTHELIOMA; NAUSEA; NAUSEA AND VOMITING; NEURALGIA; NEUROPATHIC PAIN; OPTIMAL DRUG DOSE; ORGANIZATION; PAIN; PALLIATIVE THERAPY; PEER REVIEW; POLITICS; PRESCRIPTION; REVIEW; RHEUMATIC DISEASE; SCIENTIFIC LITERATURE; SENSORY NEUROPATHY; SMOKING; SPASTICITY; TREATMENT INDICATION; UNITED STATES; WASTING SYNDROME; CANNABIS SMOKING; DRUG LEGISLATION; EVIDENCE BASED MEDICINE; LEGAL ASPECT; PHYTOTHERAPY; POLICY;

CANNABIS; EVIDENCE-BASED MEDICINE; HUMANS; LEGISLATION, DRUG; MARIJUANA SMOKING; PHYTOTHERAPY; POLITICS; PUBLIC POLICY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 68549122927     PISSN: 15360288     EISSN: 15360539     Source Type: Journal    
DOI: 10.1080/15360280902900620     Document Type: Review

References (107)

1. U. S. Pharmacopoeia, see http://www.usp.org/ about USP (Last accessed August 29, 2008). The United States Pharmacopeia (USP) is an official public standards-setting authority for all prescription and over-the-counter medicines and other health care products manufactured or sold in the United States. USP also sets widely recognized standards for food ingredients and dietary supplements. USP sets standards for the quality, purity, strength, and consistency of these products-critical to the public health. USP's standards are recognized and used in more than 130 countries around the globe. These standards have helped to ensure public health throughout the world for close to 200 years. USP is a nongovernmental, not-for-profit public health organization whose independent, volunteer experts work under strict conflict-of-interest rules to set its scientific standards. USP's contributions to public health are enriched by the participation and oversight of volunteers representing pharmacy, medicine, and other health care professions as well as academia, government, the pharmaceutical and food industries, health plans, and consumer organizations.
2. See U.S. Pharmacopoeia (3rd edition, 1851): Extractum Cannabis. Extract of hemp. An alcoholic extract of the dried tops of Cannabis sativa-variety Indica.
3. IanWilliam Goddard, Cannabis: Medical Reality versus Authoritarian Brutality. See reference 5: United States Dispensatory, 310-311 (9th ed. 1851). (Last accessed on July 22, 2008 at: http://www.drogeninfo.de/ files/hemp-med.htm.)
4. Maud Grieve, C. F. Leyel, Manya Marshall. A Modern Herbal (Courier Dover Publications, 1982). (Last accessed August 31, 2008, at http://books.google. com/books?id=tLWve-VvBLoC&pg=PA397&lpg= PA397&dq= The+principal+use+of+Hemp+in+medicine+ is+for+easing+pain+and+inducing+sleep,+ and+for+soothing+influences+in+nervous+disorders& source=web&ots= Rj2fZ4ctbV&sig=94grsl8i-YUJhyiZe5ttyzrjX7Kc&hl=en&sa=X&oi=book result& resnum=1&ct=result.)
5. Such anecdotal reports are not confined to marijuana, but have anteceded scientific documentation of the efficacy of many of today's commonly used therapeutic agents. See, e.g., Thomas Sydenham (1624- 1689). "Among the remedies which it has pleased Almighty God to give to man to relieve his sufferings, none is so universal and so efficacious as opium." (written in 1680).
6. George J. Annas. Reefer Madness-the Federal response to California's Medical-Marijuana Law. New Engl J Med. 1997:337:435, quoting Stephen Jay Gould.
7. Supra note 21 in the first Section of the paper.
8. DI Abrams, CA Jay, SB Shade, H Vizoso, H Reda, S Press,MEKelly,MC Rowbotham, KL Petersen. Cannabis in painful HIV-associated sensory neuropathy: a randomized placebo-controlled trial. Neurology. 2007;68:515.
9. From which the cannabinoids had been extracted.
10. Abrams, supra note 8.
11. Mark Wallace, Gery Schulteis, J Hampton Atkinson, Tanya Wolfson, Deborah Lazzaretto, Heather Bentley, Ben Gouaux, Ian Abramson. Dose-dependent effects of smoked cannabis on capsaicin-induced pain and hyperalgesia in healthy volunteers. Anesthesiology. 2007;107:785.
12. Barth Wilsey, Thomas Marcotte, Alexander Tsodikov, Jeanna Millman, Heather Bentley, Ben Gouaux, Scott Fishman. A randomized, placebocontrolled, crossover trial of cannabis cigarettes in neuropathic pain. J Pain. 2008;9:506.
13. The ability of some drugs to affect memory is certainly not confined to marijuana. Dealing with undesirable mental effects of approved medications is an essential component of pain management.Moreover, memory loss is not always an undesirable pharmacologic effect; legal antianxiety and amnesia-inducing drugs (falling within the ambit of the CSA) may be prescribed specifically for their ability to modify memory. See, e.g., David V. Heisterkamp, Peter J. Cohen. The effect of intravenous premedication with lorazepam (Ativan), Pentobarbitone or diazepam on recall. Br. J. Anaesth. 1975;47:79, 81. ("Lorazepam 3 and 5 mg was found to affect anterograde recall significantly . . . Patient acceptance of lorazepam was very good [and two patients] requested the drug for a second operation.")
14. Supra n. 133.
15. RJ Ellis, W Toperoff, F Vaida, G Van den Brande, J Gonzales, B Gouaux, H Bentley, JH Atkinson. Smoked medicinal cannabis for neuropathic pain in HIV: a randomized, crossover clinical trial. Neuropsychopharmacology. 2009;34:672.
16. Id.
17. Diana L. Sylvestre, Barry J. Clements, Yyvonne Malibu. Cannabis use improves retention and virological outcomes in patients treated for hepatitis C. Eur J Gastroenterol Hepatol. 2006;18:1057.
18. Benedikt Fischer, Jens Reimer, Michelle Firestone, Kate Kalousek, Juergen Rehm, Jenny Heathcote. Treatment for hepatitis C virus and cannabis use in illicit drug user patients: implications and questions. Eur J Gastroenterol Hepatol. 2006;18:1039.
19. -21 U.S.C. §812(c).
20. ARS Report for Congress, supra note 12 in the first Section of the paper.
21. See, e.g., "The laws of nature, physical phenomena, and abstract ideas have been held not patentable." Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980).
22. See also Christopher Mitchell and Mehdi Ganjeizadeh, Claiming Pitfalls in Bioinformatics Patent Applications, 4 The Scitech Lawyer 4 (2008): For a patent claim to contain eligible subject matter, it must recite a "new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof." 35 U.S.C. §101;
23. Jessie A. Leak, Herbal Medicines: What do we Need to Know, ASA Newsletter (American Society of Anesthesiologists, February 2000). ("Plants and parts of plants are not patent-eligible.") (Last accessed July 22, 2008 at http://www.asahq.org/ Newsletters/2000/02 00/herbal0200.html.)
24. Dronabinol (synthetic THC, MarinolTM) is an FDA-approved schedule III medication. SativexTM (an oromucosal spray containing equal amounts of-9-tetrahydrocannabinol and cannabidiol) is under investigation in the United States and Europe and has been approved in Canada.
25. The National Institutes of Health. A Resource Guide, April 2005, page 38. (Last accessed July 22, 2008, at http://www.aamc.org/research/adhocgp/pdfs/ nida.pdf.)
26. The following four paragraphs are excerpted from Drugs, Addiction, and the Law, Chapter 15.
27. Drugs, Addiction, and the Law, Chapter 15.
28. Lisa M. Krieger, Study Targets Stalemate Over Medicinal Use of Marijuana, San Jose Mercury News, July 19, 1998 at 1A: Five years ago, Abrams first tried to win permission to scientifically study the drug. He found a supplier of pot in the Netherlands, but the Drug Enforcement Administration (DEA) refused to let it be imported. Nor would the DEA donate pot confiscated in arrests.
29. National Advisory Council on Drug Abuse, Provision of Marijuana and Other Compounds for Scientific Research. Recommendations of The National Institute on Drug Abuse National Advisory Council, January, 1998. (Last accessed August 4, 2008, at http://www. nida.nih.gov/about/organization/nacda/marijuanastatement. html): According to international treaties, only an agency of the Federal government can produce and supply cannabis. Although NIDA has been the responsible Federal agency since 1974, any other Federal agency could assume both the costs and responsibilities of maintaining the farm and supplying cannabis. NIDA's legal authority allows for the provision of cannabis only for drug abuse research purposes . . . In addition to providing cannabis for research activities, NIDA also provides cannabis to the seven patients still covered by the single patient INDs.
30. Report to NIDA's Expert Panel on Medical Marijuana Research submitted February 25, 1997 following the February 19-20, 1997 NIHWorkshop on the Medical Utility of Marijuana held at the NIH Campus in Bethesda,MD. Notes 1 and 2. (Last accessedAugust 23, 2008, at http://www.maps.org/mmj/5recsmmj.shtml): NIDA currently has a monopoly on the supply of marijuana available to researchers who have obtained FDAapproval for their proposed protocols. The cost to NIDA of its marijuana has been cited as a main justification for the need for extensive NIH peer-review of all new medical marijuana protocols. Just how expensive is NIDA marijuana? Dr. ElSohly, director of NIDA's marijuana farm at the University of Mississippi, estimates that the production cost is $1,120 per kilogram. This is a relatively minor cost compared to NIDA's estimated $487 million budget.
31. Lisa M. Krieger, Study Targets Stalemate Over Medicinal Use of Marijuana, San Jose Mercury News, July 19, 1998 at 1A. The National Institutes of Drug Abuse would give him government-grown pot only if the National Institutes of Health approved the study. But his proposal was turned down by NIH, which . . . expressed concerns about the risks of smoking. See also MSNBC, November 1997, Waiting to Inhale: Hemp for Health, (Erowid. Last accessed on August 31, 2008, at http://www.erowid.org/plants/cannabis/ cannabis medical media6.shtml. San Francisco AIDS specialist Dr. Donald Abrams has been trying to unravel marijuana's mysteries since 1992, when he proposed a pilot trial to determine if marijuana helps to increase appetite in HIV-positive patients-give them the "munchies," as it were-thereby warding off the debilitating weight loss associated with the AIDS wasting syndrome. "But our proposal was turned down time and again," he says. See also Drugs, Addiction, and the Law, Chapter 15.
32. Whether these events were actually a direct cause of or were simply associated in time with California's action, on November 5, 1996, California voters passed the Compassionate Use Act (Proposition 215) by a wide margin (56% to 44%). This law permitted "seriously ill" patients and their primary caregivers to cultivate and possess marijuana for the patients' personal medical use if they had the "written or oral recommendation or approval of a physician." Several diagnoses for which marijuana may have palliative benefit were listed in Proposition 215, but its use was not limited to these diagnoses, and there was no age limitation on those who used it. See infra note 183.
33. For Abrams' personal response to NIDA's intransigence, see Donald I. Abrams, Carroll C. Child, Thomas F. Mitchell. 333 New Engl J Med. 1995;670:333 (excerpted): Inhaled marijuana is being used increasingly by people with HIV infection, especially for its purported benefit as an anti-emetic agent and an appetite stimulant in those with the AIDS wasting syndrome. Up to 2000 people infected with HIV are reported to be obtaining marijuana at a cannabis buyer's club in our area . . . In an effort to determine whether inhaled marijuana is truly of any potential benefit and, more important, to evaluate its safety in people with AIDS, [we] designed a pilot study . . . of the overall feasibility of investigating inhaled marijuana use by such patients, before embarking on a full-scale trial of its efficacy. The pilot-drug-evaluation staff at the FDA provided valuable comments on the design of the protocol . . . The FDA and the institutional review board supported the study. Unfortunately, the DEA and the NIDA opposed it. Most disturbing was the absence of a response from either agency for an unacceptably long period, followed by the NIDA's outright rejection of the proposal without any opportunity for dialogue or compromise. Such behavior is offensive not only to the investigators but to the patients for whom we seek to find safe and effective treatments.
34. Supra note 129. The availability of marijuana for scientific investigations also removed barriers to the studies that were detailed in Part IV (supra).
35. -68 FR 43755 (July 24, 2003): Pursuant to Section 1301.33(a) of Title 21 of the Code of Federal Regulations (CFR), this is notice that on June 25, 2001, the University of Massachusetts, Lyle E. Craker, Professor, Department of Plant and Soil Science, Stockbridge Hall, Box 37245, Amherst, Massachusetts 01003, made application to the Drug Enforcement Administration (DEA) for registration as a bulk manufacturer of Marijuana (7360) and Tetrahydrocannabinols (7370), basic classes of Schedule I controlled substances. The University of Massachusetts-Amherst plans to bulk manufacture (cultivate) Marijuana and Tetrahydrocannabinols for distribution to approved researchers.
36. This is not the first time that an Administrative Law Judge's ruling was overturned by the DEA. In 1998, Administrative Law Judge Francis L. Young granted a petition by the National Organization for the Reform of Marijuana Laws to have the DEA downgrade marijuana from a schedule I to a schedule II controlled substance. The administration rejected the decision.
37. Amy Lynn Sorrel, DEA Judge's Ruling Could Help Medical Marijuana Research. American Medical News, March 19, 2007.
38. National Institutes of Health, Workshop on the Medical Utility of Marijuana, February 19-20, 1997, Executive Summary. I did not participate in this Workshop. The entire document is available at http://www. nih.gov/news/medmarijuana/MedicalMarijuana.htm. (Last accessed on August 23, 2008.)
39. Id.
40. This conference took place only a few months after California voters had passed Proposition 215.
41. Supra note 36.
42. Id.
43. Supra notes 15 and 41 in the first Section of the paper.
44. Supra note 36.
45. Id. (Emphasis added).
46. Marijuana And Medicine: Assessing The Science Base (Janet E. Joy, Stanley J. Watson, Jr., and John A. Benson, Jr., eds., National Academies Press, 1999). (Last accessed August 4, 2008 at http://www.iom. edu/CMS/3775/5608.aspx.)
47. U.S. Food and Drug Administration Press Release: Inter-Agency Advisory Regarding Claims That Smoked Marijuana Is Medicine. April 20, 2006. (Last accessed on July 22, 2008, at www.fda.gov/ bbs/topics/NEWS/2006/NEW01362.html.)
48. Gardiner Harris, F.D.A. Dismisses Medical Benefit from Marijuana, New York Times, April 21, 2006, at A1.
49. Id.
50. Id.
51. Supporting Research Into The Therapeutic Role Of Marijuana, A Position Paper Of The American College Of Physicians (2008). This paper,written by Tia Taylor, MPH, was developed for the Health and Public Policy Committee of the American College of Physicians: J. Fred Ralston, MD, FACP, Chair; Molly Cooke, MD, FACP, Vice Chair; AndrewA. Chang, MA, Charles Cutler, MD, FACP, MA; David A. Fleming, MD, FACP; Brian P. Freeman, MD, FACP; Robert Gluckman, MD, FACP; Mark Liebow, MD, FACP; Kenneth Musana, MB, ChB; Robert McLean, MD, FACP; Mark Purtle, MD, FACP; P. Preston Reynolds; and KathleenWeaver, MD, FACP. It was approved by the Board of Regents in January 2008. (Last accessed on July 22, 2008, at http://www.acponline.org/advocacy/where we stand/ other issues/medmarijuana.pdf; http://www.acponline. org/acp news/medmarinews.htm.)
52. See, e.g., the ACP's recommendation that cannabis not be used to treat glaucoma: High intraocular pressure (IOP) is a known risk factor for glaucoma. Cannabinoids have been shown to have neuroprotective properties and to reduce IOP, pupil restriction, and conjunctival hyperemia. Smoked or eaten marijuana and oral THC can reduce IOP by approximately 25% in people with normal IOP who have visual field changes, with similar results exhibited in healthy adults and glaucoma patients. However, the effects of cannabinoids on IOP are shortlived, and high doses are required to produce any effects at all. There is concern that longterm use of marijuana could reduce blood flow to the optic nerve because of its systemic hypotensive effects and its potential for interaction with other antiglaucoma drugs. In addition, the cardiovascular and psychoactive effects of smoked marijuana contraindicate its use in glaucoma patients, many of whom are elderly and have comorbidities. This led to the development and testing of a topical THC, but its effect on IOP was insignificant. As a result, the IOM and American Academy of Ophthalmology concluded that no scientific evidence has demonstrated increased benefits or diminished risks of marijuana use to treat glaucoma compared with the wide variety of pharmaceutical agents currently available.
53. Supra note 49. Executive Summary, Position 4.
54. Id. Positions 1, 2, 4, and 5.
55. -21 U.S.C. §812(b)(1). ("The drug . . . has a high potential for abuse [and] has no currently accepted medical use in treatment in the United States.")
56. The marijuana-related conflict between political ideology and scientific evidence is not a recent phenomenon, but was seen over 70 years ago during Congressional hearings to discuss the Marijuana Tax Act. See, e.g., David F. Musto, The American Disease: Origins of Narcotic Control, pp. 225, 228 (Oxford University Press, 3rd edition, New York, Oxford, 1999): The Treasury Department collected and considered scientific and medical opinion prior to the Tax Act hearings, but the desire to present a solid front when the department appeared before the committees of Congress caused the officials to ignore anything that qualified or minimized the evils of marijuana.
57. The political pressure to put "something on the books" . . . [made] the marijuana hearings a classic example of bureaucratic overkill. Everyone from the Treasury Department who appeared for the Tax Act gave it full support while those who might have had more moderate views remained in the background. [Even] the most "liberal" spokesmen were among the most eager to protect the public by prohibiting cannabis. Congressional action based on politics rather than scientific evidence has not been confined to marijuana. A far more recent example is the fate of an effective public health measure based on an inaccurate, but politically expedient belief, that needle exchange (supplying clean needles to drug users) would increase illegal drug use. Until 2008, Congress had repeatedly legislated against this proven means of preventing transmission of HIV and hepatitis. As a result, "The District of Columbia [was] the only city in the nation barred by federal law from investing its own locally raised tax dollars to support needle exchange programs." See, e.g., Prevention Works: Needle Exchange in the Nation's Capital (1998). (Last accessed August 23, 2008, at http://www.preventionworksdc.org/about.html.)
58. -21 U.S.C. §812(c).
59. Heroin, designated as a Schedule I controlled substance under 21 U.S.C. §812(a), is an accepted and legal therapeutic agent in many countries and there is no scientific justification for designating it as schedule I. Indeed, once heroin is administered to humans, it is converted to morphine (Schedule II) by the liver and, therefore, has properties not dissimilar to those of morphine. Its designation as schedule I exemplifies that the interaction of politics and science is not confined to medical marijuana. See, e.g., M Giovannelli, N Bedforth,. Aitkenhead. Survey of intrathecal opioid usage in the UK. Eur J Anaesthesiol. 2008;25:118. (Opioids such as diamorphine were used in 136 (78.2%) of departments.)
60. See also A Hallett, F O'Higgins, V Francis, TMCook. Patient-controlled intranasal diamorphine for postoperative pain: an acceptability study. Anaesthesia 2000;55:532. ("We found patient-controlled [heroin] analgesia an effective technique, which was well tolerated by patients and . . . was without unpleasant side-effects.")
61. M Hewitt, A Goldman, GS Collins, M Childs, R Hain. Opioid use in palliative care of children and young people with cancer. J Pediatr. 2008;152:39. (The use of heroin was documented in 58% of pediatric patients undergoing palliative care for terminal cancer.)
62. JasonM.Kendall, Barnaby C. Reeves,Victoria S. Latter. Multicentre randomised controlled trial of nasal diamorphine for analgesia in children and teenagers with clinical fractures. BMJ. 2001;322:261. ("Nasal diamorphine [heroin] spray should be the preferred method of pain relief in children and teenagers presenting to emergency departments in acute pain with clinical fractures. The diamorphine spray should be used in place of intramuscular morphine.")
63. J. Sawynok. The therapeutic use of heroin: a reviewof the pharmacological literature. Can J Physiol Pharmacol. 1986;64:1. ("Administered orally, heroin is approximately 1.5 times more potent than morphine in controlling chronic pain in terminal cancer patients. . . . Given parenterally for acute pain, heroin is 2-4 times more potent than morphine and faster in onset of action. When the potency difference is accounted for, the pharmacological effects of heroin do not differ appreciably from those of morphine.")
64. United States v. Oakland Cannabis Buyers' Cooperative, 532 U.S. 483, 492-3; 121 S. Ct. 1711, 1718-1719 (2001) (emphasis added, citations omitted).
65. Gonzales v. Raich, 545 U.S. 1, 14, 15 (2005) (emphasis added, citations omitted).
66. Note, however, that if medical marijuana were removed from schedule I and approved for relief of these conditions, it probably could then be used "offlabel" for any purpose a physician deemed reasonable (further discussed in Part VI, infra). See United States v. Evers, 643 F.2d 1043 (5th Cir. 1981).
67. See, e.g., Gonzales v. Raich, 545 U.S. 1, n.23 (2005): After some fleeting success in 1988 when an Administrative Law Judge (ALJ) declared that the DEA would be acting in an "unreasonable, arbitrary, and capricious" manner if it continued to deny marijuana access to seriously ill patients, and concluded that it should be reclassified as a Schedule III substance, Grinspoon v. DEA, 828 F. 2d 881, 883-884 (CA1 1987), the campaign has proved unsuccessful.
68. The DEA Administrator did not endorse the ALJ's findings, 54 Fed. Reg. 53767 (1989), and since that time has routinely denied petitions to reschedule the drug, most recently in 2001. 66 Fed. Reg. 20038 (2001).
69. See also, George J. Annas. Reefer Madness-the Federal response to California's Medical-Marijuana Law. New Engl J Med. 1997;337:435: In 1988, after two years of hearings, DEA administrative-law judge Francis Young recommended shifting marijuana to Schedule II on the grounds that it was safe and had a "currently accepted medical use in treatment." Specifically, Judge Young found that "marijuana, in its natural form, is one of the safest therapeutically active substances known to man . . . At present, it is estimated that marijuana's LD50 (median lethal dose) is around 1:20,000 or 1:40,000. In layman's terms. . . a smoker would theoretically have to consume 20,000 to 40,000 times as much marijuana as is contained in one marijuana cigarette. . . nearly 1500 pounds of marijuana within about fifteen minutes to induce a lethal response." As for medical use, the judge concluded, among other things, that marijuana "has a currently accepted medical use in treatment in the United States for nausea and vomiting resulting from chemotherapy treatment." The administrator of the DEA rejected Young's recommendation, on the basis that there was no scientific evidence showing that marijuana was better than other approved drugs [this is not required by the FDA statute-all that must be demonstrated is safety and efficacy]. Further attempts to get the courts to reclassify marijuana have been unsuccessful.
70. Supra note 21 in the first Section of the paper.
71. The Compassionate Use Act of 1996- SECTION 1. Section 11362.5 is added to the Health and Safety Code, to read: 11362.5. (a) This section shall be known and may be cited as the Compassionate Use Act of 1996. (b) (1) The people of the State of California hereby find and declare that the purposes of The Compassionate Use Act of 1996 are as follows: (A) To ensure that seriously ill Californians have the right to obtain and use marijuana formedical purposes where thatmedical use is deemed appropriate and has been recommended by a physician who has determined that the person's health would benefit from the use of marijuana in the treatment of cancer, anorexia,AIDS, chronic pain, spasticity, glaucoma, arthritis, migraine, or any other illness for which marijuana provides relief. (B) To ensure that patients and their primary caregivers who obtain and use marijuana for medical purposes upon the recommendation of a physician are not subject to criminal prosecution or sanction. (C) To encourage the federal and state governments to implement a plan to provide for the safe and affordable distribution ofmarijuana to all patients in medical need of marijuana. (b) (2) Nothing in this section shall be construed to supersede legislation prohibiting persons from engaging in conduct that endangers others, nor to condone the diversion of marijuana for nonmedical purposes. (c) Notwithstanding any other provision of law, no physician in this state shall be punished, or denied any right or privilege, for having recommended marijuana to a patient for medical purposes. (d) Section 11357, relating to the possession of marijuana, and Section 11358, relating to the cultivation of marijuana, shall not apply to a patient, or to a patient's primary caregiver, who possesses or cultivates marijuana for the personal medical purposes of the patient upon the written or oral recommendation or approval of a physician. (e) For the purposes of this section, "primary caregiver" means the individual designated by the person exempted under this section who has consistently assumed responsibility for the housing, health, or safety of that person. SECTION 2. If any provision of this measure or the application thereof to any person or circumstance is held invalid, that invalidity shall not affect other provisions or applications of the measure that can be given effect without the invalid provision or application, and to this end the provisions of this measure are severable.
72. Raich v. Gonzales, 500 F.3d 850, 855 (9th Cir. 2007): Appellant Angel McClary Raich is a Californian who uses marijuana for medical treatment. Raich has been diagnosed with more than ten serious medical conditions, including an inoperable brain tumor, a seizure disorder, life-threatening weight loss, nausea, and several chronic pain disorders. Raich's doctor . . . testified that he had explored virtually every legal treatment alternative, and that all were either ineffective or resulted in intolerable side effects [and] provided a list of thirty-five medications that were unworkable because of their side effects.
73. Raich v. Gonzales, 500 F.3d 850, 863 (9th Cir. 2007).
74. See, e.g., Jesse McKinley, Dying Woman Loses Appeal On Marijuana As Medication, New York Times, March 15, 2007 at A18: Angel McClary Raich says she uses marijuana [eating or smoking it every couple of hours] on doctors' recommendation to treat an inoperable brain tumor and a battery of other serious ailments [including scoliosis and chronic nausea]. Ms. Raich, 41, asserts that the drug effectively keeps her alive, by stimulating appetite and relieving pain, in a way that prescription drugs do not.
75. Bob Egelko, Jim Herron Zamora, Medical Pot User Loses Again in Federal Court, San Francisco Chronicle, March 15, 2007 at A11: "I don't want that coffin, but from this point on I am walking dead," she said. "I will continue to use cannabis. I will continue to smoke cannabis . . . This is real medicine and the federal government cannot tell us any differently."
76. Raich v. Gonzales, 500 F.3d 850, 866 (9th Cir. 2007): We agree with Raich that medical and conventional wisdom that recognizes the use of marijuana for medical purposes is gaining traction in the law as well. But that legal recognition has not yet reached the point where a conclusion can be drawn that the right to use medical marijuana is "fundamental" and "implicit in the concept of ordered liberty." For the time being, this issue remains in the arena of public debate and legislative action. (Emphasis added.)
77. This problem has not escaped the notice of California's Attorney General. See e.g., California Issues New Medical-Marijuana Guidelines, Join Together (September 2, 2008). (Last accessed on September 8, 2008, at http://www.jointogether.org/news/ headlines/inthenews/2008/california-issues- new.html): New guidelines from the California Attorney General's office aim to clear up some of the confusion that has long plagued the state's 1996 medical-marijuana law . . . The guidelines, issued by AG Jerry Brown this week, give legal sanction under state law to storefront medical-marijuana collectives, but also clarify the circumstances under which law enforcement can go after drug dealers using the law as a front for illicit marijuana sales. "It clarifies the rules and makes it easier for law enforcement to do their jobs. . . and the users and advocates are happy because it restated what is permitted by the initiative and the statute," Brown said. "It did what law is supposed to do-it set the ground rules for action both by individuals and by the government." Dispensaries cannot be operated for profit, the guidelines say, and must maintain detailed records, including documents proving that customers are legitimate medical users. "The collective should not purchase marijuana from, or sell to, nonmembers; instead, it should only provide a means for facilitating or coordinating transactions between members," the new guidelines state. "The cycle should be a closed circuit of marijuana cultivation and consumption with no purchases or sales to or from nonmembers. To help prevent diversion of medical marijuana to nonmedical markets, collectives and cooperatives should document each member's contribution of labor, resources, or money to the enterprise. They also should track and record the source of theirmedical-marijuana dispensaries thought to be violating state and/or federal laws.
78. Jesse McKinley, Marijuana Hotbed Retreats on Medicinal Use, New York Times, June 9, 2008 at A1.
79. See, e.g., http://www.mainevocals.net/printablemedform. htm: Medical Marijuana Provider Form (Maine)- 1. My name is: (insert full name) My mailing address is: (insert full address) 2. I suffer from: ONE OF THE DESIGNATED MEDICAL PROBLEMS OUTLINED IN THE MEDICAL MARIJUANA LAW OF THE STATE OF MAINE 22 M.R.S.A. 2383-B and use marijuana to ease, control, and relieve the symptoms of my medical disease/condition. 3.
80. In order to procure my marijuana, I need to either grow it or buy it from someone which is a problem and a danger to me. I am concerned that I won't be able to grow enough or find enough marijuana to buy for my needs, and I need someone to help me to do this. 4. I hereby nominate, appoint, and constitute as my medical marijuana provider for the sole purpose of assisting me with the growing of marijuana, and/or growing marijuana for my use, and/or supplying me with commercial marijuana which I require to treat my medical condition/disease. Dated: Signature: Personally appeared the above-named. Before me on the date above-written and acknowledged his/her signature and the above stated facts as true to the best of his/her knowledge. Notary Public/Attorney at Law My commission expires: Must Be an Original Copy with Notary Stamp on Each Provider/Care Giver Form. No Photo Copies of The Originals are Accepted as "Authenticated Copies" See also http://www.medicalmarijuana.org (Welcome to SIMM [the Netherlands]: "Our purpose-to produce and supply patients with high quality medical cannabis, at the lowest possible price."). See also http://www.maryjanesgarden.com (Mary Jane's Garden: "Amsterdam Marijuana Seeds has on [sic] for sale where you can get 10 free when you buy indoor or outdoor pot seeds for a limited time only.").
81. See also http://www.headshopsupply.com/medical.php (Head Shop Supply: "[G]rowing medical marijuana is nowlegal in many states in theUnited States such asCalifornia, Nevada, Alaska and Oregon . . . If you are wondering how to become licensed for medical marijuana as a grower or a user you can seek out and ask questions at your local compassion club. If you are licensed to grow a certain number of plants for personal medical marijuana use and you need medical marijuana seedswe have many available at a discount price for medical marijuana growing.") (Last accessed September 8, 2008.)
82. Percent of Online Pharmacies Don't Require Prescription, CASA Study Finds (July 10, 2008). (Last accessed on July 22, 2008, at http://www.jointogether. org/news/research/summaries/2008/85-percentof-online.html.)
83. Id.
84. William E. Hurwitz v. Virginia Board of Medicine, Case No. (Chancery) 96-676, Circuit Court of Arlington County, Virginia, 46 Va. Cir. 119; 1998 Va. Cir. LEXIS 198: The board [of medicine] exercised its summary suspension power, concluding that the doctor's unprofessional conduct, coupled with an apparent unquestioning compliance with patients' requests for prescriptions and refills, all justified board intervention to prevent danger to his patients. . . . It was not just a "clerical error" for the doctor to fail to record the justification for refilling prescriptions, but it was an absence of certifying the medical necessity for the excess dosage in the patients' medical records as required by Va. Code Ann. §54.1-2971.01.
85. Jerry Markon, Va. Pain Doctor's Prison Term Is Cut to 57 Months: Originally Sentenced to 25 Years, Specialist Did More Good than Harm, Judge Says, Washington Post, July 14, 2007 at B1. (After Dr. William Hurwitz was convicted of illegal drug trafficking his 25-year prison term was voided (United States v. Hurwitz 459 F.3d 463 (4th Cir. 2006)). However, a second trial again convicted him of 16 counts of drug trafficking and he was sentenced to 57 months in jail.)
86. See, e.g., http://www.justice.gov/dea/ongoing/ marinol.html; http://www.marinol.com/aboutmarinol/ index.html. (Last accessed on July 22, 2008.)
87. In this basis, physicians can legally prescribe dronabinol for treating multiple sclerosis, spasticity, or depression. See, e.g., United States v. Evers, 643 F.2d 1043, 1048 (5th Cir. 1981): Congress did not intend the Food and Drug Administration to interfere with medical practice . . . [or] regulate the practice of medicine as between the physician and the patient. Congress recognized a patient's right to seek civil damages in the courts if there should be evidence of malpractice, and declined to provide any legislative restrictions upon the medical profession.
88. FDA News: FDA Proposes Guidance for Dissemination of Information on Unapproved Uses of Medical Products (February 15, 2008). (Last accessed on September 8, 2008, at http://www.fda.gov/ bbs/topics/NEWS/2008/NEW01798.html): The U.S. Food and Drug Administration (FDA) today issued draft guidance on "Good Reprint Practices" for industry use in the distribution of medical or scientific journal articles and reference publications that involve unapproved uses of FDA-approved drugs and medical devices.
89. Section 401 of the Food and Drug Administration Modernization Act set out guidelines that allowed the dissemination of information on unapproved uses of FDA-approved products. As long as the guidelines were met by the manufacturers, the dissemination of such materials was not viewed by the FDA as evidence of an intent to promote the product for an "off-label" use. However, Section 401 expired on Sept. 30, 2006. The FDA's "Good Reprint Practices" draft guidance recommends principles manufacturers should follow when they distribute scientific or medical journal reprints, articles, or reference publications. Some of the principles include ensuring that the article or reference be published by an organization that has an editorial board. The organization also should fully disclose any conflicts of interest or biases for all authors, contributors or editors associated with the journal article. Articles should be peer-reviewed and published in accordance with specific procedures. In addition, the draft guidance recommends against distribution of special supplements or publications that have been funded by one or more of the manufacturers of the product in the article, and articles that are not supported by credible medical evidence are considered false and misleading and should not be distributed. The FDA retains legal authority to determine whether distribution of an article or publication constitutes promotion of an unapproved "new use," or whether such activities cause a product to be considered misbranded or adulterated under The Federal Food, Drug and Cosmetic Act. (Emphasis added.)
90. See, e.g., Mike Mitka. Critics say FDA's off-label guidance allows marketing disguised as science. JAMA. 2008;299:1759;
91. Aaron S. Kesselheim, Jerry Avorn. Pharmaceutical promotion to physicians and first amendment rights. New Engl J Med. 2008;358:1727, 1731. ("Courts should consider the complex nature of the evaluation of medications when applying the Central Hudson test in the pharmaceutical context and should permit appropriate and necessary constraints on commercial speech in the pharmaceutical industry.");
92. Bruce M. Psaty, Wayne Ray. FDA guidelines on off-label promotion and the state of the literature from sponsors. JAMA 2008;299:1949, 1051. ("Attempting to use peer-reviewed literature for a purpose [i.e., as a substitute for studies mandated and analyzed by the FDA] for which it is so ill suited is likely not only to fail to adequately regulate off-label use but also to degrade the quality of peer-reviewed literature.").
93. http://www.marinol.com/aboutmarinol/howtake. html. (Last accessed July 22, 2008.)
94. Note also that THC is not the only active and useful compound found in Cannabis sativa. For example, cannabidiol is another active constituent of the whole plant. (See infra, discussion of Sativex.)
95. Multiple Sclerosis-Canada Approves Cannabis Derived Pharmaceutical Treatment, Sativex(Reg), Medical News Today, April 22, 2005. (Last accessed August 29, 2008, at http://www.medicalnewstoday. com/articles/23299.php.)
96. W Pharmaceuticals Bulletin dated July 8, 2007. (Last accessed August 29, 2008, at http://production. investis.com/gwp/pressreleases/currentpress/2007-08- 07).
97. See, e.g., MS Society Welcomes Information on Sativex, UK, Medical News Today, December 14, 2007. (Last accessed August 29, 2008, at http://www. medicalnewstoday.com/articles/91814.php). Although currently unlicensed in the United Kingdom, it is legally available to people with multiple sclerosis and around 1,200 people have so far received the drug in the that country.
98. J Nurmikko, MG Serpell, B Hoggart, PJ Toomey, BJ Morlion, D Haines. Sativex successfully treats neuropathic pain characterised by allodynia: a
99. Michael Iskedjian, Basel Bereza, Allan Gordon, Charles Piwko, Thomas R Einarson. Meta-analysis of cannabis based treatments for neuropathic and multiple sclerosis-related pain. Curr Med Res Opin. 2007;23:17. ("[T]he cannabidiol/THC buccal spray [was] effective in treating neuropathic pain in MS.")
100. Derick T Wade, Petra Makela, Philip Robson, Heather House, Cynthia Bateman. Do cannabis-based medicinal extracts have general or specific effects on symptoms in multiple sclerosis? A double-blind, randomized, placebo-controlled study on 160 patients. Mult. Scler. 2004;10:434. ("Spasticity [was] significantly reduced by Sativex in comparison with placebo. There were no significant adverse effects on cognition or mood . . . ")
101. Although the FD&C Act does not require that a new drug be shown to be superior-or even equivalent-to already approved medications (supra note 41), the FDA's approval of SativexTM would very likely be used as a potent political argument in favor of denying approval to medical marijuana even if it were shown to be safe and effective.
102. Justice Douglas, a jurist with impeccable liberal credentials, called attention to the phenomenon of overreaction, prejudice, and stigmatization: See, e.g., Robinson v. California, 370 U.S. 660, 672 (1962) (Douglas, J., concurring) (quotingN.Y.L.J., June 8, 1960, p. 4, col. 2): To be a confirmed drug addict is to be one of the walking dead. . . . The teeth have rotted out; the appetite is lost and the stomach and intestines don't function properly. The gall bladder becomes inflamed; eyes and skin turn a bilious yellow. In some cases membranes of the nose turn a flaming red; the partition separating the nostrils is eaten away-breathing is difficult. Oxygen in the blood decreases; bronchitis and tuberculosis develop. Good traits of character disappear and bad ones emerge. Sex organs become affected. Veins collapse and livid purplish scars remain. Boils and abscesses plague the skin; gnawing pain racks the body. Nerves snap; vicious twitching develops. Imaginary and fantastic fears blight the mind and sometimes complete insanity results. Often times, too, death comes-much too early in life . . . Such is the torment of being a drug addict; such is the plague of being one of the walking dead.
103. See, e.g., David F. Musto. Opium, cocaine and marijuana in American history. Sci Am 1991:265:40: The practice of smoking cannabis leaves came to theU.S. with Mexican immigrants,who had come North during the 1920s towork in agriculture, and it soon extended to white and black musicians. As the Great Depression of the 1930s settled over America, the immigrants became an unwelcome minority linked with violence and with growing and smoking marijuana.Western states pressured the federal government to control marijuana use. The first official response was to urge adoption of a uniform state Narcotics law. Then a new approach became feasible in 1937, when the Supreme Court upheld the National Firearms Act. This act prohibited the transfer of machine guns between private citizens without purchase of a transfer tax stamp-and the government would not issue the necessary stamp. Prohibition was implemented through the taxing power of the federal government. Within a month of the Supreme Court's decision, the Treasury Department testified before Congress for a bill to establish a marijuana transfer tax. The bill became law, and until the Comprehensive Drug Abuse Act of 1970, marijuana was legally controlled through a transfer tax for which no stamps or licenses were available to private citizens.
104. See, e.g., http://en.wikipedia.org/wiki/Reefer Madness. (Last accessed July 22, 2008): Reefer Madness, a 1936 film was originally produced as a morality tale designed to convince parents of the dire events (including manslaughter, suicide, rape and automobile accidents) that would befall their children if they usedmarijuana. Since its original production, it took on new life as an "unintentional comedy among cannabis smokers," inspired a off-Broadway musical satire in 2001, and has achieved the status of a "cult film."
105. Athough a "favorable" risk-benefit ratio is an ideal concept, the threshold required for a "favorable" cannot be expressed with mathematical precision. Instead, some may consider that the approach taken by regulatory bodies is akin to the standard for evaluating the presence or absence of "hard core pornography" proposed by Justice Stewart in Jacobellis v. Ohio, 378 U.S. 184, 197 (1964): "I know it when I see it." There are several reasons for what I believe to be this inherent lack of precision. First of all, every individual determines his or her own standard for evaluating the balance of risks and benefits for any action, including approval of a new medication. Therefore, it would be difficult, indeed, for society to formulate a universally acceptable approach. Moreover, there are significant philosophical differences between basing the "proper" balance on the concept that nobody should be harmed, as opposed to the utilitarian approach that seeks to maximize the good while conceding that some may be adversely affected. Baruch Fischhoff, Professor of Social and Decision Sciences and of Engineering and Public Policy at Carnegie Mellon University, discussed the risk-benefit equation in terms of technological innovations (Acceptable Risk: A Conceptual Proposal, last accessed on August 24, 2008, at http://www.fplc.edu/risk/ vol5/winter/fischhof.htm (emphasis added): A technology has a societally acceptable level of risk if its benefits outweigh its risks for every member of society . . . There is no reason why these "benefits" should be restricted to economic consequences or even noneconomic ones for which putative economic equivalents exist. People could in principle, be compensated by peace of mind, feelings of satisfaction, or reduction of other risks. . . [In contrast,] one should look at the overall balance of consequences for society, while ignoring the balance actually experienced by individuals. Under this assumption, one would not care if a technology made society as a whole better off, at the price of making some of its members miserable. Nor would one care if a few people received very large net benefits, while many others had small net losses; or, if many people had small net benefits, while imposing large net losses on a few (e.g., those living near a landfill that accepts hazardous wastes from a large area). Nonetheless, the drug approval process requires that decisionmakers within the FDA evaluate the risks and benefits of a proposed medication and determine whether the drug meets societally reasonable criteria for approval. While mathematical precision might be desirable as a basis for this decision, its absence should not be an insurmountable obstacle to the FDA's legal mandate to make an appropriate decision.
106. See, e.g., Cohen and DSHEA at 211-213 (citations omitted): Recent events have illuminated major deficiencies in the FDA's ability to protect the public. Overly hasty and, in the views of some, far too permissive drug approval, real and perceived conflicts of interest and poor morale, lack of post-marketing surveillance, and the intrusive role of politics in the FDA's decision making procedures have severely damaged the agency's reputation. . . . The public's response to at least some of these problems has resulted in significant changes in the way manufacturers report data and journals publish them.
107. President George H.W. Bush, April 23, 1990. Quoted in Statement: Restoring Scientific Integrity in Policymaking, Union of Concerned Scientists, February 18, 2004. (Last accessed on August 13, 2008, at http:// www.ucsusa.org/scientific integrity/interference/scientists-signon-statement. html.): Science, like any field of endeavor, relies on freedom of inquiry; and one of the hallmarks of that freedom is objectivity. Now, more than ever, on issues ranging from climate change to AIDS research to genetic engineering to food additives, government relies on the impartial perspective of science for guidance.