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.
2.
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for Medical Treatment Initiative of 1998 (Initiative 59 adopted under the District's Home Rule Charter) has been repealed by the Congress every year.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):
3.
Sec. 1. All seriously ill individuals have the right to obtain and use marijuana for medical purposes when a licensed physician has found the use of marijuana to be medically necessary and has recommended the use of marijuana for the treatment (or to mitigate the side effects of other treatments such as chemotherapy, including the use of AZT, protease inhibitors, etc., radiotherapy, etc.) or diseases and conditions associated with HIV and AIDS, glaucoma, muscle spasm, cancer and other serious or chronic illnesses for which the recommending physician reasonably believes that marijuana has demonstrated utility.
4.
Sec. 2. Medical patients who use, and their primary caregivers who obtain for such patients, marijuana for medical purposes upon the recommendation of a licensed physician do not violate the District of Columbia Uniform Controlled Substances Act of 1981, effective August 5, 1981 (DC Law 4–29; DC Code 33–501 et seq.) (“Controlled Substances Act”), as amended and in so far as they comply with this act, are not subject to criminal prosecution or sanction.
5.
See also, CraigT., “Swift Action Sought on Medical Marijuana: D.C. Council Chairman Ready to Begin Crafting Policy with Lifting of Ban,”Washington Post, at B2 (December 15, 2009).
6.
“Editorial: Medical Marijuana,”Washington Post, April 19, 2010, at A14:
7.
A bill (B18–622) that will come before the D.C. Council on [April 20, 2010]… would set up a strict regulatory structure that aims to guard against the problem experienced by some of the 14 other jurisdictions that allow marijuana use… Key to that effort are strict registration requirements for patients, caregivers, dispensaries and cultivation centers.
8.
B18–622 was approved (first reading) on April 20, 2010 and passed its second reading on May 4, 2010 (see SouthallA., “Washington Approves Medical Use of Marijuana,”New York Times, May 5, 2010, at A17). All that now remains is for Mayor Fenty to sign it (he has indicated he will) and for Congress to take no action against the final signed legislation. Of course, if the D.C. Council fails to act favorably on this second vote (or if Congress nullifies the Council's approval of the regulations within the statutory 30-day period after the Mayor signs it), the effective legalization of medical marijuana will die and not be reconsidered until next year. See also, TurnerW., “Medical Marijuana in D.C.: The Council Gets it Right,”Washington Post, February 21, 2010 at C5:.
9.
D.C. Council Chairman Vincent C. Gray (D), along with council members David A. Catania (I-At Large) and Phil Mendelson (D-At Large), has introduced legislation to implement Initiative 59. It's a sound proposal that tracks the design and intent of the original initiative by creating a tightly regulated system whereby patients with serious, chronic or debilitating medical conditions can have safe and affordable access to medical marijuana.
10.
That's good, because in recent years we've seen what a vague law and lack of regulation can do.
11.
Appropriately, the council members seek to head off the abuses that have emerged in some of the 14 states with medical marijuana laws. California's law, for example, is so broadly worded that almost any use of marijuana could qualify as medical.
12.
The council's bill would limit the number and location of dispensaries and require tight monitoring of marijuana distribution. In this way, the proposal builds on the framework in the initiative's original legislative text, which called for dispensaries operated as nonprofits subject to government licensing and regulation.
13.
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 KingJ. H., “Federal Regulations for the Prescription of Controlled Substances,” in NahasG. G., eds., Marihuana and Medicine (New York: Humana, 1999): At 745, 747:
14.
The scheduling process usually begins with a scientific review performed by two divisions of the Department of Health and Human Services—the FDA and the National Institute on Drug Abuse (NIDA), the latter of which is an institute of the National Institutes of Health (NIH). The Controlled Substances Act also provides that the Congress may take any action it wishes regarding scheduling on its own without regard to available scientific evidence, [Emphasis added].
15.
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):
16.
The Cooperative points out, however, that the Attorney General did not place marijuana into schedule I [after appropriate scientific review]. Congress put it there, and Congress was not required to find, that a drug lacks an accepted medical use before including the drug in schedule I. [Emphasis added].
17.
Marijuana is not unique in having been declared a schedule I controlled substance by Congress (21 U.S.C. § 812(c)(l0)); this body took similar action with regard to heroin (21 U.S.C. § 812(b)(l0)), although heroin is an accepted and legal therapeutic agent in many western developed democracies. See, e.g., GiovannelliM.BedforthN.AitkenheadA., “Survey of Intrathecal Opioid Usage in the UK,”European Journal of Anesthesiology25 (2008): 118–122, at 118 (2008) (finding that opioids such as diamorphine were used in 78.2%) of anesthesia departments); SawynokJ., “The Therapeutic Use of Heroin: A Review of the Pharmacological Literature,”Canadian Journal of Physiology and Pharmacology64 (1986): 1–6, at 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 [a controlled substance that is legal in the U.S.]).
18.
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.
19.
GrinspoonL.BakalarJ. B.DoblinR., “Marijuana, the AIDS Wasting Syndrome, and the U.S. Government,”New England Journal of Medicine333 (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:
20.
Unfortunately, the U.S. government will not allow Dr. Abrams to obtain a legal supply of marijuana. The DEA refused to permit him to import marijuana from Hortapharm, a company licensed by the government of the Netherlands to cultivate cannabis for botanical and pharmaceutical research. The National Institute on Drug Abuse (NIDA), which controls the domestic supply of marijuana for clinical research, rejected Dr. Abrams's request in April 1995. The letter of rejection, from NIDA director Alan I. Leshner, was sent nine months after Dr. Abrams had submitted his request.
21.
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):
22.
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…
23.
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.
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).
JoyJ. E., 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., ClarkP. A., “The Ethics of Medical Marijuana: Government Restrictions vs. Medical Necessity,”Journal of Public Health Policy21 (2000): 40–60:
28.
Marijuana is listed by the Drug Enforcement Agency (DEA) as an illegal Schedule I drug which has no currently accepted medical use. However, on March 17, 1999, 11 independent scientists appointed by the Institute of Medicine reported that medical marijuana was effective in controlling some forms of pain, alleviating nausea and vomiting due to chemotherapy, treating wasting due to AIDS, and combating muscle spasms associated with multiple sclerosis. There was also no evidence that using marijuana would increase illicit drug use or that it was a “gateway” drug. Despite this evidence the DEA refuses to reclassify marijuana as a Schedule II drug, which would allow physicians to prescribe unadulterated and standardized forms of marijuana. After reviewing the pertinent scientific data and applying the principle of double effect, there is a proportionate reason for allowing physicians to prescribe marijuana. Seriously ill patients have the right to effective therapies. To deny patients access to such a therapy is to deny them dignity and respect as persons.
29.
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.
30.
HarrisG., “F.D.A. Dismisses Medical Benefit from Marijuana,”New York Times, April 21, 2006, at Al.
TempleREllenbergS. S., “Placebo-Controlled Trials and Active-Control Trials in the Evaluation of New Treatments,”Annals of Internal Medicine133 (2000): 455–463 (“[U]nder law, a drug need not be superior to or even as good as [another drug] to be approved.”); HuttP. B.MerrillR. 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.”).
36.
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…”
37.
AnnasG. J., “Reefer Madness—the Federal Response to California's Medical-Marijuana Law,”New England Journal of Medicine337 (1997): 435–439.
38.
LynskeyM. T., “Escalation of Drug Use in Early-Onset Cannabis Users vs Co-twin Controls,”JAMA289 (2003): 427–433.
39.
KandelD. B., “Does Marijuana Use Cause the Use of Other Drugs?”JAMA289 (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.”).
40.
CohenP. J., “Medical Marijuana – The Conflict Between Scientific Evidence and Political Ideology,”Utah Law Review (2009): 35–104, at 67–69.
41.
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.).
42.
MikosR. A., “On the Limits of Supremacy: Medical Marijuana and the States' Overlooked Power to Legalize Federal Crime,”Vanderbilt Law Review62 (2009): 1421–1482, at 1453.
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.
45.
McKinleyJ., “Marijuana Hotbed Retreats on Medicinal Use,”New York Times, June 9, 2008, at A-1.
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.).
48.
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.
49.
IngoldJ., “Pot Competition Branches Out,”Denver Post, December 20, 2009, at B-l.
50.
FishS., “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-RightA., “Denver Pot Dispensaries: 390; Colo. Starbucks: 208,”7News, January 4, 2010: “Los Angeles… [has] an estimated 1,000 medical marijuana dispensaries.”
51.
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:
52.
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.
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.
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.
KocieniewskiD., “New Jersey Lawmakers Pass Medical Marijuana Bill,”New York Times, January 12, 2010, at A-1.
63.
“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.
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.
66.
See Utah Law Review, supra, note 24, at 103:
67.
The FDA should be allowed to evaluate medical marijuana with the same methodology, standards, and diligence that the agency would apply to any other investigational drug. While the FDA's role in drug evaluation is not perfect, deficiencies in its regulation and evaluation of pharmaceuticals should not be taken as an excuse to disregard the fundamental utility of the agency and to abandon the philosophy that science rather than politics should be dispositive with regard to acceptance or rejection of medications. If standards of safety and efficacy are met, the drug should be approved and then appropriately scheduled. Conversely, if medical marijuana's analysis as an investigational new drug fails to satisfy these criteria, approval should be denied.
Policy Statement: Marijuana should be subject to the same research, consideration and study as any other potential medicine, under the standards of the U.S. Food and Drug Administration (FDA). Legalizing marijuana for medical use should not be decided by legislative or voter initiative.
70.
See also HoffmannD. E.WeberE., “Medical Marijuana and the Law,”New England Journal of Medicine362 (2010): 1453–1457 (at 1456).
71.
In states debating new legislation, policy makers are grappling with questions that only scientific research can answer: For what conditions does marijuana provide medicinal benefits? Are there equally effectives alternatives? What are the appropriate doses for various conditions? How can states ensure quality and purity?.
72.
Although state laws represent a political response to patients seeking relieffrom debilitating symptoms, they are inadequate to advance effective treatment.
