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Medical Marijuana 2010: It's Time to Fix the Regulatory Vacuum

Published online by Cambridge University Press:  01 January 2021

Peter J. Cohen
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Washington, D.C.’s City Council has recently taken the first step towards legalizing the use of “medical marijuana” in accordance with the provisions of the Legalization of Marijuana for Medical Treatment Initiative of 1998 (Initiative 59). This action was not overruled by the United States Congress within the 30-day deadline imposed by the District of Columbia’s Home Rule Statute. The Council is now crafting regulations that will govern the therapeutic and palliative use of this drug with the goal of avoiding some of the problems faced by the other states that have legalized medical marijuana; however, the proposed rules do not establish criteria for legitimate medical practice when medical marijuana is recommended (discussed infra). If the enabling regulations are passed by the D.C. Council and not rejected by the Congress, the District of Columbia will join over onequarter of the states in legalizing medical marijuana (Table I). On the other hand, if the D.C. Council fails to act favorably on the final regulations (or if Congress nullifies the Council’s approval), then the effective legalization of medical marijuana will die and not be reconsidered until next year.

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Independent
Information
Journal of Law, Medicine & Ethics , Volume 38 , Issue 3 , Fall 2010 , pp. 654 - 666
Copyright
Copyright © American Society of Law, Medicine and Ethics 2010

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References

The terms “medical marijuana” and “medicinal marijuana” refer to any form of Cannabis sativa used (usually by smoking) to treat a wide variety of pathologic states and diseases.Google Scholar
Until recently, the Legalization of Marijuana for Medical Treatment Initiative of 1998 (Initiative 59 adopted under the District's Home Rule Charter) has been repealed by the Congress every year. Congress did not take such action in 2010. Provided that implementing legislation is also passed, the Initiative will provide (non-inclusive):Google ScholarGoogle Scholar
“Editorial: Medical Marijuana,” Washington Post, April 19, 2010, at A14:Google ScholarGoogle Scholar
Under the Controlled Substances Act (21 U.S.C. § 812(c)), a schedule I controlled substance has a high potential for abuse, has no currently accepted medical use in the United States, and lacks safety even when used under medical supervision. For the usual role played by scientific data in scheduling drugs under the Controlled Substances Act (21 U.S.C. § § 801–971) when the drug is found to have potential addiction liability, see King, J. H., “Federal Regulations for the Prescription of Controlled Substances,” in Nahas, G. G. et al., eds., Marihuana and Medicine (New York: Humana, 1999): At 745, 747:Google Scholar
This “two tier” system of scheduling was specifically addressed in United States v. Oakland Cannabis Buyers' Cooperative, U.S. 483, 492; 121 S. Ct. 1711, 1718 (2001):Google ScholarGoogle Scholar
Cannabis cannot be patented and, from a practical point of view, is readily available “on the street.” Thus, it is unlikely for a pharmaceutical company to see any significant benefit in studying this substance with the aim of future marketing. As a result, in addition to its Congressionally-imposed schedule I status, the absence of an industrial sponsor that could petition for the drug's rescheduling has delayed evaluation of smoked marijuana as a bona, fide pharmaceutical agent.Google Scholar
Grinspoon, L., Bakalar, J. B., and Doblin, R., “Marijuana, the AIDS Wasting Syndrome, and the U.S. Government,” New England Journal of Medicine 333 (1995): 670–671. Although not specifically stated by Grinspoon, it appears likely that political rather than scientific or financial considerations were largely responsible for the decision of the National Institute on Drug Abuse (NIDA) and the DEA to deny Abrams the necessary support of this research:Google Scholar
For Dr. Abrams' response to the politicization of bona, fide investigations of medical marijuana, see his open letter to Dr. Alan Leshner who was then the Director the National Institute on Drug abuse, the granting agency that had repeatedly turned down Dr. Abrams' requests for the marijuana necessary for his otherwise-funded study, available at <http://www.maps.org/mmj/abrams.html> (last visited August 2, 2010): (last visited August 2, 2010): I am writing in response to your letter of April 19 regarding my request that NIDA consider supplying marijuana for the Community Consortium's proposed study in patients with HIV-related wasting syndrome… The National Institute on Drug Abuse has not been the first body to review our proposed pilot study. It has been reviewed and approved by the Committee on Human Research of the University of California, San Francisco, as well as by our own Scientific Advisory Committee and Community Advisory Forum. In addition, the study has been approved (pending location of the source of inhaled marijuana) by the California Research Advisory Panel. The US Food and Drug Administration has also been involved since the onset in developing the trial and has strongly influenced the study's design. The General Clinical Research Center at San Francisco General Hospital has agreed to collaborate in the study by providing dietary counseling and monitoring of patients, as well as performing the state-of-the-art composition measurements we intend to perform. Collaborating investigators at Chiron Corporation were also eager to participate in this study by donating their newly developed technology to assess HIV viral burden in patients randomized to receive marijuana. Hence, your concerns about the scientific merit of the study have not been shared by a number of competent reviewers and investigators.' href=https://scholar.google.com/scholar?q=For+Dr.+Abrams'+response+to+the+politicization+of+bona,+fide+investigations+of+medical+marijuana,+see+his+open+letter+to+Dr.+Alan+Leshner+who+was+then+the+Director+the+National+Institute+on+Drug+abuse,+the+granting+agency+that+had+repeatedly+turned+down+Dr.+Abrams'+requests+for+the+marijuana+necessary+for+his+otherwise-funded+study,+available+at++(last+visited+August+2,+2010):+I+am+writing+in+response+to+your+letter+of+April+19+regarding+my+request+that+NIDA+consider+supplying+marijuana+for+the+Community+Consortium's+proposed+study+in+patients+with+HIV-related+wasting+syndrome…+The+National+Institute+on+Drug+Abuse+has+not+been+the+first+body+to+review+our+proposed+pilot+study.+It+has+been+reviewed+and+approved+by+the+Committee+on+Human+Research+of+the+University+of+California,+San+Francisco,+as+well+as+by+our+own+Scientific+Advisory+Committee+and+Community+Advisory+Forum.+In+addition,+the+study+has+been+approved+(pending+location+of+the+source+of+inhaled+marijuana)+by+the+California+Research+Advisory+Panel.+The+US+Food+and+Drug+Administration+has+also+been+involved+since+the+onset+in+developing+the+trial+and+has+strongly+influenced+the+study's+design.+The+General+Clinical+Research+Center+at+San+Francisco+General+Hospital+has+agreed+to+collaborate+in+the+study+by+providing+dietary+counseling+and+monitoring+of+patients,+as+well+as+performing+the+state-of-the-art+composition+measurements+we+intend+to+perform.+Collaborating+investigators+at+Chiron+Corporation+were+also+eager+to+participate+in+this+study+by+donating+their+newly+developed+technology+to+assess+HIV+viral+burden+in+patients+randomized+to+receive+marijuana.+Hence,+your+concerns+about+the+scientific+merit+of+the+study+have+not+been+shared+by+a+number+of+competent+reviewers+and+investigators.>Google Scholar
Sorrel, A. L., “Judge's Ruling Could Help Medical Marijuana Research,” American Medical News 50 (March 19, 2007), available at <http://www.ama-assn.org/amednews/2007/03/l9/gvsb0319-htm> (last visited August 2, 2010).Google Scholar
The National Institutes of Health, National Institute on Drug Abuse: A Resource Guide (April 2005), at 38, available at <http://www.aamc.org/research/adhocgp/pdfs/nida.pdf> (last visited August 2, 2010).+(last+visited+August+2,+2010).>Google Scholar
National Institutes of Health, Workshop on the Medical Use of Marijuana (1997), available at <http://www.nih.gov/news/medmarijuana/MedicalMarijuana.htm> (last visited August 2, 2010).+(last+visited+August+2,+2010).>Google Scholar
Joy, J. E. et al., eds., Institute of Medicine, Marijuana and Medicine: Assessing the Science Base (1999), available at <http://www.nap.edu/openbook.php?record_id=6376> (last visited August 2, 2010). The IOM's recommendations are not only of scientific importance but address the significant ethical impact of denying society a potentially useful medication. See, e.g., Clark, P. A., “The Ethics of Medical Marijuana: Government Restrictions vs. Medical Necessity,” Journal of Public Health Policy 21 (2000): 40–60:Google Scholar
U.S. Food and Drug Administration, Inter-Agency Advisory Regarding Claims that Smoked Marijuana Is a Medicine, Press Release, April 20, 2006, available at <http://www.fda.gov/NewsEvents/Newsroom/PressAn-nouncements/2006/ucml08643.htm> (last visited August 3, 2010). However, at least one human study (infra, Table II, n. I) had been published at the time the press release declared that no “human data supported the safety or efficacy of marijuana for general medical use.” Moreover, it is most ironic that the federal government having imposed barriers to clinical investigations should now complain about the lack of information that such studies would have developed.+(last+visited+August+3,+2010).+However,+at+least+one+human+study+(infra,+Table+II,+n.+I)+had+been+published+at+the+time+the+press+release+declared+that+no+“human+data+supported+the+safety+or+efficacy+of+marijuana+for+general+medical+use.”+Moreover,+it+is+most+ironic+that+the+federal+government+having+imposed+barriers+to+clinical+investigations+should+now+complain+about+the+lack+of+information+that+such+studies+would+have+developed.>Google Scholar
Harris, G., “F.D.A. Dismisses Medical Benefit from Marijuana,” New York Times, April 21, 2006, at Al.Google Scholar
Id.Google Scholar
Report 6 of the Council on Scientific Affairs (A-01, Medical Marijuana) of the American Medical Association, available at <http://www.ama-assn.org/ama/no-index/about-ama/l3625.shtml> (last visited August 3, 2010).+(last+visited+August+3,+2010).>Google Scholar
O'Reilly, K. B., “AMA Meeting Delegates Support Review of Marijuana's Schedule I Status,” http://AmedNews.com (November 23, 2009), available at <http://www.ama-assn.org/amed-news/2009/ll/23/prsell23.htm> (last visited August 3, 2010). (last visited August 3, 2010).' href=https://scholar.google.com/scholar?q=O'Reilly,+K.+B.,+“AMA+Meeting+Delegates+Support+Review+of+Marijuana's+Schedule+I+Status,”+http://AmedNews.com+(November+23,+2009),+available+at++(last+visited+August+3,+2010).>Google Scholar
Taylor, T., American College of Physicians Supporting Research into the Therapeutic Role of Marijuana: A Position Paper (2008), available at <http://www.acponline.org/advocacy/where_we_stand/other_issues/medmarijuana.pdf> (last visited August 3, 2010).+(last+visited+August+3,+2010).>Google Scholar
Temple, R and Ellenberg, S. S., “Placebo-Controlled Trials and Active-Control Trials in the Evaluation of New Treatments,” Annals of Internal Medicine 133 (2000): 455–463 (“[U]nder law, a drug need not be superior to or even as good as [another drug] to be approved.”); Hutt, P. B., Merrill, R. A., Food and Drug Law: Cases and Materials, 2nd ed. (New York: Foundation Press, 1991). See supra note 4, at 527 (“The history of the 1962 Amendments clearly reveals Congress' intention that FDA not refuse to approve a drug on the ground of ‘relative efficacy,’ i.e., that a more effective drug is available.”).CrossRefGoogle Scholar
21 U.S.C.A. § 355(d): The Food, Drug, and Cosmetic Act requires only that the sponsor of the drug provide “substantial evidence that the drug will have the effect it purports…”Google Scholar
Annas, G. J., “Reefer Madness—the Federal Response to California's Medical-Marijuana Law,” New England Journal of Medicine 337 (1997): 435–439.CrossRefGoogle Scholar
Lynskey, M. T. et al., “Escalation of Drug Use in Early-Onset Cannabis Users vs Co-twin Controls,” JAMA 289 (2003): 427–433.CrossRefGoogle Scholar
Kandel, D. B., “Does Marijuana Use Cause the Use of Other Drugs?” JAMA 289 (2003): 482–483. (“There are, unfortunately, no empirical data to guide policy. However, inferences can be made from appropriate medical use of morphine, which does not lead to addiction.”).CrossRefGoogle Scholar
Cohen, P. J., “Medical Marijuana – The Conflict Between Scientific Evidence and Political Ideology,” Utah Law Review (2009): 35–104, at 67–69.Google Scholar
Id. at 79. (In October 1996, four years after he had first initiated requests to obtain marijuana legally, Abrams was again informed that the NIH would not supply it. Whether this federal intransigence was actually a direct cause of or was 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.).Google Scholar
Mikos, R. A., “On the Limits of Supremacy: Medical Marijuana and the States' Overlooked Power to Legalize Federal Crime,” Vanderbilt Law Review 62 (2009): 1421–1482, at 1453.Google Scholar
Cal. Health & Safety Code Ann. §11362.5 (The Compassionate Use Act of 1996). See also “14 Legal Medical Marijuana States and DC,” http://ProCon.org website, available at <http://medicalm-arijuana.procon.org/view.resource.php?resourceID=000881> (last visited August 3, 2010). The statute:+(last+visited+August+3,+2010).+The+statute:+removes+state-level+criminal+penalties+on+the+use,+possession+and+cultivation+of+marijuana+by+patients+who+possess+a+“written+or+oral+recommendation”+from+their+physician+that+he+or+she+“would+benefit+from+medical+marijuana.”+Patients+diagnosed+with+any+debilitating+illness+where+the+medical+use+of+marijuana+has+been+“deemed+appropriate+and+has+been+recommended+by+a+physician”+are+afforded+legal+protection+under+this+act…+[and]+grants+implied+legal+protection+to+the+state's+medicinal+marijuana+dispensaries,+stating,+“Qualified+patients,+persons+with+valid+identification+cards,+and+the+designated+primary+caregivers+of+qualified+patients…+who+associate+within+the+state+of+California+in+order+collectively+or+cooperatively+to+cultivate+marijuana+for+medical+purposes,+shall+not+solely+on+the+basis+of+that+fact+be+subject+to+state+criminal+sanctions.>Google Scholar
McKinley, J., “Marijuana Hotbed Retreats on Medicinal Use,” New York Times, June 9, 2008, at A-1.Google Scholar
Colo. Const. Art. XVIII §4, available at<http://www.cdphe.state.co.us/hs/medicalmarijuana/mjamendment.html> (last visited August 3, 2010). See also “Medical Marijuana: ProCon. Org. Supra, n. 27. Colorado's legislation:+(last+visited+August+3,+2010).+See+also+“Medical+Marijuana:+ProCon.+Org.+Supra,+n.+27.+Colorado's+legislation:+removes+state-level+criminal+penalties+on+the+use,+possession+and+cultivation+of+marijuana+by+patients+who+possess+written+documentation+from+their+physician+affirming+that+he+or+she+suffers+from+a+debilitating+condition+and+advising+that+they+“might+benefit+from+the+medical+use+of+marijuana.”+(Patients+must+possess+this+documentation+prior+to+an+arrest.).>Google Scholar
Since marijuana is a schedule I controlled substance rather than an FDA-approved medication, it may not be “prescribed.” Instead, its use may only be “recommended” by a physician or other authorized health care provider.Google Scholar
Ingold, J., “Pot Competition Branches Out,” Denver Post, December 20, 2009, at B-l.Google Scholar
Fish, S., “Lawmakers Grapple with Booming Medical Marijuana Business,” Politics Daily website, available at <http://www.politicsdaily.eom/2010/04/08/lawmakers-grapple-with-booming-medical-marijuana-business/> (last visited August 3, 2010). (Sen. Chris Romer, a Denver Democrat championing regulations, at one point likened the situation to a “Wild West explosion.”) See also, “Denver Reportedly Has More Pot Dispensaries Than Starbucks Shops,” Fox News website, January 5, 2010, available at <http://www.foxnews.com/story/0,2933,582013,OO.html> (last visited August 3, 2010): “There are more dispensaries in Denver than there are Starbucks coffee shops in the whole state of Colorado.” Gath-Right, A., “Denver Pot Dispensaries: 390; Colo. Starbucks: 208,” 7 News, January 4, 2010: “Los Angeles… [has] an estimated 1,000 medical marijuana dispensaries.”Google Scholar
Hurwitz v. Virginia Bd, Of Med., 46 VA. Cir. 119, Case No. 96–676 (1998). Following an appeal under the Virginia Administrative Process Act (§ § 9–6.14:1 through 9–6.14:25), the court held:Google Scholar
“Excerpts from DEA Warning Letter,” available at <http://www.papausa.com/gazette/v3Il/Papa%20Gazette%20030105_files/page0007.htm> (last visited August 3, 2010).+(last+visited+August+3,+2010).+A+patient+completing+a+questionnaire+that+is+then+reviewed+by+a+physician…+does+not+establish+a+doctor/patient+relationship.+A+consumer+can+more+easily+provide+false+information+in+a+questionnaire+than+in+a+face-to-+face+meeting+with+the+physician.+It+is+illegal+to+receive+a+prescription+for+a+controlled+substance+without+the+establishment+of+a+legitimate+doctor/patient+relationship.>Google Scholar
21 C.F.R 1306.04(a). U.S. Department of Justice, Drug Enforcement Administration, Office of Diversion Control, available at <http://www.deadiversion.usdoj.gOv/21cfr/cfr/l306/l306_04.htm> (last visited August 3, 2010).+(last+visited+August+3,+2010).>Google Scholar
U.S. Drug Enforcement Administration, “Chapter 1: The Controlled Substances Act,” available at <http://www.justice.gov/dea/pubs/abuse/l-csa.htm> (last visited August 3, 2010).+(last+visited+August+3,+2010).>Google Scholar
U.S. Drug Enforcement Administration, available at <http://www.justice.gov/dea/illegal_internet.html> (last visited August 3, 2010); Federal Register 66, no. 82 (April 27, 2001): 21181–21184.+(last+visited+August+3,+2010);+Federal+Register+66,+no.+82+(April+27,+2001):+21181–21184.>Google Scholar
See U.S. Drug Enforcement Administration, supra, note 36, at “Recordkeeping.” The Controlled Substances Act requires that complete and accurate records be kept of all quantities of controlled substances manufactured, purchased, and sold. Each substance must be inventoried every two years. From these records it is possible to trace the flow of any drug from the time it is first imported or manufactured, through the distribution level, to the pharmacy or hospital that dispensed it, and then to the actual patient who received the drug. The mere existence of this requirement is sufficient to discourage many forms of diversion.Google Scholar
State of New Jersey 113th Legislature, available at <http://www.njleg.state.nj.us/2008/Bills/S0500/ll9_R3.HTM> (last visited August 3, 2010); <http://www.njleg.state.nj.us/2008/bills/al000/804_il.htm> (last visited August 3, 2010).+(last+visited+August+3,+2010);++(last+visited+August+3,+2010).>Google Scholar
Id.Google Scholar
Kocieniewski, D., “New Jersey Assembly Approves Medical Marijuana,” Cannabis News, January 11, 2010, available at <http://cannabisnews.com/news/25/thread25306.shtml> (last visited August 3, 2010).Google Scholar
Kocieniewski, D., “New Jersey Lawmakers Pass Medical Marijuana Bill,” New York Times, January 12, 2010, at A-1.Google Scholar
“Colo. Senate Votes to Tighten Controls on Medical Marijuana,” Join Together Direct, February 4, 2010, available at <http://www.jointogether.org/news/headlines/inthenews/2010/colo-senate-votes-to-tighten.html> (last visited August 3, 2010). See also, “Colo. Senate Panel Votes to Tighten Regulation of Medical Marijuana,” Join Together Direct, February 3, 2010, available at <http://www.jointogether.org/news/headlines/inthenews/2010/colo-senate-panel-votes-to.html> (last visited August 3, 2010). Doctors would be required to conduct physical exams of medical-marijuana patients and provide follow-up treatment. Ned Calogne, of the Colorado Department of Public Health and Environment said that five doctors in the state account for half of all medical-marijuana recommendations, including one doctor who issued 700 recommendations in one month.+(last+visited+August+3,+2010).+See+also,+“Colo.+Senate+Panel+Votes+to+Tighten+Regulation+of+Medical+Marijuana,”+Join+Together+Direct,+February+3,+2010,+available+at++(last+visited+August+3,+2010).+Doctors+would+be+required+to+conduct+physical+exams+of+medical-marijuana+patients+and+provide+follow-up+treatment.+Ned+Calogne,+of+the+Colorado+Department+of+Public+Health+and+Environment+said+that+five+doctors+in+the+state+account+for+half+of+all+medical-marijuana+recommendations,+including+one+doctor+who+issued+700+recommendations+in+one+month.>Google Scholar
Second Regular Session, Sixty-Seventh General Assembly, State of Colorado, available at <http://www.leg.state.co.us/clics/clics2010a/csl.nsf/fsbillcont/AA035E5DDDFB3136872576A8002B8BBD?Open&file=109_01.pdf> (last visited August 3, 2010).+(last+visited+August+3,+2010).>Google Scholar
Id. If marijuana is to be accepted as a legitimate medicine, it is inconsistent for its advocates to oppose the same regulations that apply to FDA-approved controlled substances.Google Scholar
See Utah Law Review, supra, note 24, at 103:Google Scholar+(last+visited+April+16,+2010):.>Google ScholarGoogle Scholar