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The Maelstrom over Medical Marijuana
By Alice Mead

Edited by Barbara Kate Repa
Category: Substance Abuse



Marijuana, slang for Cannabis sativa, is a pejorative term that originated during the early 1900s, when the public came to associate the plant's recreational use with ethnic and racial minorities that suffered widespread discrimination. Since that time, marijuana has continued to be laden with cultural baggage, and it is now the subject of raging legal battles that show little hope of abating.

Supporters of natural cannabis medicines believe that the elements of the plant work in synergy to mitigate its negative side effects and to enhance the plant's therapeutic effectiveness. The federal government contends that suffering patients already have legal access to a cannabinoid-containing medicine, a pharmaceutical product containing pure synthetic tetrahydrocannibinol (THC)-Marinol-but many patients claim not to tolerate it well. A third alternative-a whole-plant, nonsmoked prescription medicine-is likely to be on the market soon in Europe and perhaps also in Canada, but that choice may not be available to U.S. patients in the near future. Faced with limited choices, the legal debate here is extremely narrow and polarized.

Scheduling Cannabis
A complex patchwork of state and federal laws determines whether and when a psychoactive substance with abuse potential can be available for general medical use. The federal Controlled Substances Act (CSA) and the Food, Drug, and Cosmetic Act (FDCA) are the two primary statutes that govern. (21 U.S.C. §§ 801-971; 21 U.S.C. §§ 301-97.) The CSA has five schedules into which psychoactive substances are placed, depending on acknowledged medical usefulness, on the one hand, and dependence-producing potential on the other. Cannabis, and its primary psychoactive component, THC, are both on Schedule I, the most restrictive schedule.

A Schedule I substance is defined as having a high potential for abuse, no currently accepted medical use, and a lack of accepted safety for use under medical supervision. The CSA's Schedule I products are not available for general prescriptive use; they can be used only within a federally approved research study.

Escaping Schedule I
In an attempt to reschedule cannabis, advocacy groups have several times initiated special petitions urging that it be transferred to another schedule or removed from the schedules altogether. (21 U.S.C. § 811.) However, the Drug Enforcement Administration, the Department of Health and Human Services, and the courts have ultimately rejected those petitions. (See, 57 Fed. Reg. 10,499 (Mar. 26, 1992); Alliance for Cannabis Therapeutics v. Drug Enforcemt Admin., 15 F.3d 1131 (D.C. Cir. 1994); 66 Fed Reg. 20,038 (April 18, 2001); Gettman v. Drug Enforcemt Admin., 290 F.3d 430 (D.C. Cir. 2002).) A new petition, filed in 2002, is currently pending.

Cannabis dispensaries currently offer medicinal cannabis in various forms, including tinctures and candies-and a number of patients are able to obtain their medicine through home cultivation of the plant. But this informal system lives uneasily beside the federal regulatory structure.

Chinks in the Federal Fortress
In 1998 the government filed a number of federal civil actions against cannabis dispensaries in Northern California. It contended that the dispensaries were conducted in violation of federal law, which prohibits selling, manufacturing, or distributing cannabis. The federal district court agreed and refused to modify its injunction to allow distributing cannabis to patients showing medical necessity-that is, those who tried standard medications without success and for whom medicinal cannabis was the only treatment alleviating their symptoms. (United States v. Cannibis Cultivators Club, 5 F. Supp. 2d 1086 (N.D. Cal 1998).) The U.S. Court of Appeals for the Ninth Circuit reversed, however, ruling that there could be a medical-necessity defense to an action under the act. (United States v. Oakland Cannabis Buyers' Cooperative, 190 F.3d 1109 (9th Cir. 1999).)

The U.S. Supreme Court, however, subsequently determined that there is no medical-necessity exception to the CSA's statutory prohibitions against manufacturing and distributing cannabis. (United States v. Oakland Cannabis Buyers' Coop. (OCBC), 532 U.S. 483 (2001).) The Court concluded that placement in Schedule I establishes that cannabis has no medical benefits and cannot be used outside the confines of a federally approved research project.

Cannabis and the Constitution
Since OCBC, a number of additional cases have reached the Ninth Circuit-and they all raise two primary constitutional issues. First, the proponents of medicinal cannabis contend that the federal government lacks power under the commerce clause to regulate wholly intrastate, noncommercial cultivation of medicinal cannabis. Interestingly, the FDCA regulates only misbranded or adulterated food and drugs that move in interstate commerce, whereas the CSA purports to regulate the use and distribution of controlled substances in both intrastate and interstate commerce. (Compare, 21 U.S.C. § 331(a)-(d) with 21 U.S.C. § 801.)

Such challenges have been difficult to mount in the past. However, recent U.S. Supreme Court decisions appear to have narrowed the commerce clause's reach. (United States v. Lopez, 514 U.S. 549 (1995); United States v. Morrison, 529 U.S. 598 (2000).) And the Ninth Circuit has recently followed the Court's lead in this area. (United States v. McCoy, 323 F.3d 1114 (9th Cir. 2003); But see, United States v. Adams, 343 F.3d 1024 (9th Cir. 2003).)
On December 16, 2003, the United States Court of Appeals for the Ninth Circuit ruled in one of these cases that the federal Controlled Substances Act is likely unconstitutional as applied to the intrastate, noncommercial cultivation, possession and use of medicinal cannabis, where that medical use has been recommended by a physician. Under the court's analysis, Congress has no jurisdiction to regulate such activity under the Commerce Clause of the federal constitution. The Court remanded the case to the district court for entry of a preliminary injunction against the federal government. The federal government is seeking rehearing and rehearing en banc. However, currently, the cultivation and use of medicinal cannabis under such circumstances would seem to be lawful under both state and federal law. (Raich v. Ashcroft, 2003 WL 22962231.)

Second, the medicinal cannabis cases contend that individual patients have a fundamental right to rely on their physicians' recommendations to use medicinal cannabis when it is the only medicine demonstrated to alleviate their suffering. This is the medical-necessity argument raised to a constitutional level. Past cases have generally held there is no fundamental right to choose an unapproved medicine. (See, Carnohan v. United States, 616 F.2d 1120 (9th Cir. 1980) (per curiam).) However, patients who cultivate their own medicinal cannabis or obtain it from intrastate sources avowedly beyond the jurisdiction of the Food and Drug Administration may be able to distinguish their situations from those in prior holdings.

In addition, the fundamental-rights argument may have been bolstered by a recent U.S. Supreme Court decision that may portend a broadening of the doctrine. In Lawrence v. Texas (123 S. Ct. 2472 (2003)), the Court found a Texas statute criminalizing sexual relations between people of the same gender to be an unconstitutional restriction on liberty under the due process clause of the Fourteenth Amendment.

Proposition 215's Role
Enacted by 56 percent of the electorate in November 1996, Proposition 215, or the Compassionate Use Act (Cal. Health & Safety Code § 11362.5), stands in stark contrast to the narrow constraints of federal law. Prop. 215 authorizes a seriously ill patient or the patient's primary caregiver to cultivate and possess cannabis for medical purposes as long as he or she has a physician's oral or written approval or recommendation. A recent California attorney general opinion states that the term marijuana in the initiative includes concentrated cannabis or hashish. (Cal. Op. Atty. Gen. No. 03-411 (Oct. 21, 2003).)

Prop. 215 abrogates California's own criminal laws prohibiting cultivation and possession of cannabis. Although the state is free to abolish its own laws without running afoul of the supremacy clause, patients, primary caregivers, cannabis dispensaries, and even physicians who act in accordance with Prop. 215's text and purpose may be at risk of federal prosecution or other sanctions.

How Strong Is the Initiative?
Soon after Prop. 215 was enacted, many commentators, as well as state and local law enforcement personnel, concluded that the initiative provided only an affirmative defense that the patient-defendant would have to raise at trial. Accordingly, in many counties, patients who clearly possessed physicians' recommendations were arrested and forced to stand trial; they argued that they were entitled to complete immunity from arrest and prosecution.

That uncertainty was finally resolved in People v. Mower (28 Cal. 4th 457 (2002)), in which the California Supreme Court ruled that the status of a patient or primary caregiver may be raised either as a basis for moving to set aside an indictment or information before trial, or as an affirmative defense at trial. The court further ruled that although the patient-defendant has the burden of proof regarding status, he or she need only raise a reasonable doubt as to guilt rather than prove status by a preponderance of the evidence.

Who Qualifies?
Prop. 215 specifies a number of serious diseases and conditions that are presumed to constitute "serious illness" for which treatment with medicinal cannabis is appropriate: cancer, anorexia, AIDS, chronic pain, spasticity, glaucoma, arthritis, and migraine. However, the law is not limited to these conditions. It also applies to "any other illness for which marijuana provides relief" as long as a physician has determined that the person's health would benefit from such a therapeutic option. The act therefore has a broad scope, enabling patients with a variety of conditions to qualify for its protections.

Where Do They Get the Stuff?
Unfortunately, many patients are too ill to cultivate their own cannabis. Furthermore, a patient's primary caregiver, defined as the individual designated by a patient "who has consistently assumed responsibility for the housing, health, or safety of that person," may not be skilled enough or have the space to manage a successful garden. However, Prop. 215 did not establish any other distribution mechanism, potentially forcing patients to obtain their medicine illegally.

Recognizing this need, even before Prop. 215 was passed, a number of dispensaries, then called "cannabis clubs," opened their doors. In some cases, the operators of the clubs were designated by hundreds of patients as the patients' primary caregivers. However, a California court determined that an operator did not meet the statutory criteria and therefore was not covered by the act. (Lungren v. Peron, 59 Cal. App. 4th 1383 (1997) and People v. Galambos, 104 Cal. App. 4th 1147 (2002).) Many cannabis dispensaries may now be operating in violation of both state and federal law.

Clarification, Not Modification
After Prop. 215 was passed, it became increasingly apparent that interpretations and applications of it were not fulfilling the initiative's purpose-and in some ways were undermining it. In 1999 state Attorney General Bill Lockyer convened a medical marijuana task force to draft guidelines to attempt to address these problems. The effort resulted in a bill, finally signed into law in October 2003 (S.B. 420 adds Article 2.5, commencing with § 11362.7, to the Cal. Health & Safety Code.)

Under California law, an initiative cannot be amended by statute, unless its language permits (Cal. Const., Art. II, Sec. 10(c)), and Prop. 215 does not allow for such amendment. So S.B. 420 was intended not to amend but to clarify the scope of the initiative: to identify qualified patients and their designated primary caregivers, to avoid unnecessary arrest and prosecution of these individuals, and to "provide needed guidance" to law enforcement officers.

To those ends, the new law requires the California Department of Health Services to establish a fee-based, voluntary identification-card system. A mandatory ID-card system would have constituted an invalid amendment to Prop. 215. (Office of the Legislative Counsel of California, "Medical Marijuana: Identification Program (S.B. 420)," #16771 (Aug. 20, 2003).)

S.B. 420 sets forth a transparent process by which qualified patients and their primary caregivers may obtain ID cards. It defines serious medical condition as one that "substantially limits the ability of the person to conduct one or more major life activities as defined in the Americans With Disabilities Act" or that "may cause serious harm to the patient's safety or physical or mental health." (Cal. Health & Safety Code § 11362.7(h)(12).) It also clarifies that a copy of the patient's medical records shall constitute the requisite documentation to substantiate a physician's diagnosis of a serious medical condition and that the use of medicinal cannabis is "appropriate." (Cal. Health & Safety Code § 11362.7(i).) The law also attempts to address, in a limited way, the "supply problem," by recognizing the existence and legitimacy of collective or cooperative medicinal cannabis cultivation projects, although they are not specifically defined. (Cal. Health & Safety Code § 11362.775.) It also facilitates cultivation by primary caregivers. Finally, by setting a specific amount of dried herb (eight ounces) and numbers of plants (six mature or twelve immature) allowable, the law attempts to protect patients against improper arrest and prosecution. (Cal. Health & Safety Code § 11362.77.)

What's Up with the Doctors?
A patient can claim Prop. 215's protection only if a physician has approved or recommended use of medicinal cannabis. Recognizing this importance in the statutory scheme, the electorate sought to encourage physicians' involvement by affording them explicit protection: "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." (Cal. Health & Safety Code § 11362.5(c).)

But even this forceful language has not been sufficient to attract significant numbers of physicians. Many of them do not like the idea of "smoking a medicine" and are further discomforted by the unstandardized nature of crude herbal cannabis products; some are not informed enough to discuss-much less recommend-medicinal cannabis; still others are fearful of being punished by the federal government.

Such fears, at least until very recently, have been well-founded. Immediately upon Prop. 215's passage, the federal government announced a policy under which physicians who recommended medicinal cannabis would be stripped of their licenses to prescribe all controlled substances-a death knell for most physicians' practices, barred from MediCal and Medicare, and potentially subject to criminal prosecution. The chill from that threat has hung heavy, deterring most physicians from even discussing the subject with their patients.

The First Amendment
In 1997, shortly after the "federal threat" had been broadcast across the country, a group of physicians and patients sought an injunction against the federal government, asserting that physicians had a First Amendment right to advise their patients concerning medicinal cannabis. The Court of Appeals for the Ninth Circuit agreed. (Conant v. Walters, 309 F.3d 629 (9th Cir. 2002).) The court stressed that the government cannot punish or even initiate an investigation against a physician solely for giving such an opinion unless it in good faith believes that it has substantial evidence that the physician acted unlawfully. The U.S. Supreme Court recently denied certiorari, rendering the Ninth Circuit's decision final. (2003 U.S. LEXIS 7446 (2003).)

However, physicians' freedom of speech is still not without boundaries. Conant emphasizes that those who step out of the role of medical adviser and act for the sole purpose of assisting a patient in obtaining cannabis could be guilty of aiding and abetting, or conspiring in, a violation of federal law.

Alice Mead (apm@gwpharm.com) is a legal consultant with clients in the fields of health care and pharmaceutical development.

Article updated: January 2004

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