11

LEGAL ISSUES

Although the focus of this book—and of the IOM report on which it is based—is on science, such knowledge does not exist in a vacuum. The scientific evidence of marijuana's potential risks and benefits as a source of medicine needs to be considered in a social context. That is true whether the decision at hand concerns the care of a single patient or the law of the land.

Much has been written about the impact of marijuana laws on society, a topic that often overshadows science in debates concerning marijuana 's worth as a medicine. We will not attempt to address this complex subject, nor do we provide anything remotely resembling legal advice, which should be sought from a professional. The aim here is simpler: to give an overview of marijuana's legal status as both a medicine and a source of new pharmaceuticals. The previous chapter described how economic issues affect marijuana-based drug development; this chapter explores the influence of the law on medical use of marijuana.

Because marijuana legislation has changed markedly over the past 70 years and will probably continue to do so, our survey is at best a snapshot of a moving target. This is particularly true at the state level, where laws vary widely; local enforcement is even more variable. The picture is considerably clearer at the national level, and it applies to every resident of the United States (except



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MARIJUANA AS MEDICINE?: The Science Beyond the Controversy 11 LEGAL ISSUES Although the focus of this book—and of the IOM report on which it is based—is on science, such knowledge does not exist in a vacuum. The scientific evidence of marijuana's potential risks and benefits as a source of medicine needs to be considered in a social context. That is true whether the decision at hand concerns the care of a single patient or the law of the land. Much has been written about the impact of marijuana laws on society, a topic that often overshadows science in debates concerning marijuana 's worth as a medicine. We will not attempt to address this complex subject, nor do we provide anything remotely resembling legal advice, which should be sought from a professional. The aim here is simpler: to give an overview of marijuana's legal status as both a medicine and a source of new pharmaceuticals. The previous chapter described how economic issues affect marijuana-based drug development; this chapter explores the influence of the law on medical use of marijuana. Because marijuana legislation has changed markedly over the past 70 years and will probably continue to do so, our survey is at best a snapshot of a moving target. This is particularly true at the state level, where laws vary widely; local enforcement is even more variable. The picture is considerably clearer at the national level, and it applies to every resident of the United States (except

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MARIJUANA AS MEDICINE?: The Science Beyond the Controversy for a handful of isolated cases, which we will subsequently describe): to use marijuana, even if solely to relieve medical symptoms, is to violate federal law. This fact should be kept in mind in reading this chapter. Readers should also note that, while much of this chapter concerns the medicinal use of smoked marijuana, it is not intended as an endorsement of this practice. Rather, it is a reflection of the primitive stage of development of marijuana-based therapeutics—that is, compared with modern expectations that drugs should be proven effective before they are prescribed. Since cannabinoid medications other than Marinol or a smoke-free vaporizer are probably years away, the issue of marijuana 's legal status is bound to concern today's patients at least as much as its promise as a source of new medicines. FROM MEDICINE TO ILLICIT DRUG Long before marijuana acquired its reputation as a substance of abuse, it was regarded as a folk medicine in several cultures. In the United States, patent remedies contained extracts of the marijuana plant well into the 1930s; by that time, though, doctors were far more likely to prescribe opiates or synthetic drugs such as barbiturates for conditions once treated with marijuana. Then, for three decades after passage of the federal Marijuana Tax Act in 1937, the drug essentially disappeared from medical use in this country.1 Several states had already outlawed marijuana for nonmedical purposes by 1920. These laws were passed mainly in reaction to reports of marijuana use among Mexican immigrants, who introduced the drug to the United States. Congress later drafted the Marijuana Tax Act in an attempt to quash the spread of marijuana use without interfering with the rights of individual states to regulate drug sales. Although the tax act allowed medical use of marijuana, it created a formidable bureaucracy with which few doctors or pharmaceutical firms were willing to contend. Manufacturers and medical users of the drug were required to comply with burdensome registration procedures and pay a tax of $1 per ounce. By contrast, marijuana for nonmedical use—the act's intended tar-

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MARIJUANA AS MEDICINE?: The Science Beyond the Controversy get—was taxed at the prohibitive rate of $100 per ounce. In 1942 marijuana lost its legitimacy as a prescription medication when it was removed from the United States Pharmacopoeia (USP). Few Americans were familiar with marijuana in the late 1930s and even fewer had tried the drug. Its use was limited almost entirely to Mexican immigrants, except in a handful of cities where artists, students, and musicians experimented with it. As a result, there was little dissent when the federal government sought to tax marijuana out of existence. The only exception was the American Medical Association (AMA), whose objections to the Marijuana Tax Act were twofold: that scientific data on marijuana's harmful effects were lacking and that the act would impede investigation of potential medical uses of the drug.2 As Congress considered passage of the law, the AMA's legislative activities committee wrote in protest: Cannabis at the present time is slightly used for medicinal purposes, but it would seem worthwhile to maintain its status as a medical agent. . . . There is [also] the possibility that a restudy of the drug by modern means may show other advantages to be derived from its medicinal use.3 The Marijuana Tax Act successfully curtailed marijuana's spread until the 1960s, when recreational use of the drug surged far beyond previous levels. In response to this development and also out of an effort to consolidate and reform federal narcotics laws, Congress passed the Comprehensive Drug Abuse Prevention and Control Act in October 1970. The portion of this law that concerns drug classification and control, known as the Controlled Substances Act (CSA), has remained largely unchanged since its inception. According to the CSA, drugs with potential for abuse are placed into one of five categories called schedules. The assignment of a drug to a particular schedule is supposed to take into account the likelihood that it will cause physical and psychological dependence, as well as its medical utility (see Box 10.1). The lower the schedule number of a given drug, the higher an abuse risk it presents, and the greater the restrictions on access to it. For example, LSD and heroin appear in Schedule I, along with marijuana; Schedule V lists pain relievers that contain codeine. Efforts to reschedule marijuana commenced with passage of the CSA. In 1972 NORML filed a petition with the federal govern-

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MARIJUANA AS MEDICINE?: The Science Beyond the Controversy ment, which was denied two years later. NORML continued to press for public hearings on the issue, which were finally held between 1986 and 1988. Once again, however, the DEA rejected NORML's position and that of several additional supporting groups, despite recommendations to the contrary by the administrative law judge in charge of the case.4 The rescheduling advocates then petitioned for a review of the case by the U.S. Court of Appeals, which eventually denied the request in February 1994.5 In contrast to these unsuccessful attempts to reschedule marijuana, its principal psychoactive ingredient, THC—in the form of the prescription drug dronabinol (Marinol)—has twice been rescheduled and is now listed in Schedule III. After receiving FDA approval in 1985, the drug was moved from Schedule I to Schedule II, enabling physicians to prescribe it. In July 1999 dronabinol was once again rescheduled following a petition from Unimed Pharmaceuticals, the company that manufactures Marinol. The drug is now listed in a category reserved for substances, such as anabolic steroids, that can produce low-to-moderate physical dependence or high psychological dependence. A MEDICAL NECESSITY? With the rise in marijuana use in the 1960s, a few Americans discovered its medicinal properties either through contact with cultures where it was used as a folk remedy or simply by noting that their symptoms improved after smoking marijuana. Among them was Robert Randall, a glaucoma patient whose troubles led to two important legal developments concerning medical marijuana use: the creation of a government-sponsored marijuana treatment program and the birth of the “medical necessity ” defense against the charge of marijuana possession. In 1975 Randall was arrested for cultivating marijuana on his porch in Washington, D.C. He admitted that the plants were his but claimed that he grew them to treat the symptoms of glaucoma and thereby preserve his eyesight. At the time of his arrest, Randall's vision was already greatly impaired; conventional drugs, which initially controlled the damaging pressure in his eyes, had ceased to help him. He won the ensuing case, Randall v. United States, on the grounds that marijuana use kept him from

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MARIJUANA AS MEDICINE?: The Science Beyond the Controversy becoming blind. The federal government then looked for a way to provide other such patients with marijuana. A solution to this dilemma, the Compassionate Use Program, was launched in 1976. It was administered as part of an existing program to provide seriously ill patients with promising medicines prior to their approval by the FDA. Thirteen patients were accepted into this program between 1976 and 1991. They received government-grown marijuana to treat a variety of symptoms and were later joined by hundreds of patients in state-run experimental treatment programs. To obtain this legal marijuana, a patient's physician—or the physician in charge of the state program —submitted a lengthy application to the FDA, after which the DEA conducted inspections to assure that the drug would not be diverted from its intended use. Then, as now, the National Institute on Drug Abuse (NIDA)—an arm of the National Institutes of Health—oversaw the cultivation and distribution of all marijuana provided by the U.S. government.6 In 1991 the Public Health Service closed the Compassionate Use program for smoked marijuana after a National Institutes of Health review concluded that marijuana was not the best treatment for any of the patients who were receiving it. Increasing numbers of AIDS patients were applying to the program, and its administrators worried that smoking marijuana would be harmful to people with compromised immune systems. At the time the program closed, 28 people had been approved for treatment, but only the 13 who were already receiving marijuana continued to have it provided to them. Since then five of those original patients have died of AIDS. Most state-sponsored clinical research programs folded in the 1980s due to lack of patient interest and after 1986 due to their inability to obtain research-grade marijuana from the federal government. Upon reconsidering the Compassionate Use suspension in 1994, the Clinton administration decided to keep the program closed. However, with the recent release of the IOM report to the White House's Office of National Drug Control Policy, the subject of government-sponsored marijuana use has again come under federal scrutiny. Rather than argue for the resurrection of the suspended program, the IOM team advocated support for research that could

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MARIJUANA AS MEDICINE?: The Science Beyond the Controversy further the development of a smoke-free cannabinoid delivery system. The team also wrote: “We acknowledge that [at the present time] there is no clear alternative for people suffering from conditions that might be relieved by smoking marijuana.” Such patients could be treated as the subjects of individual clinical trials that would be overseen by a medical review board. Patients would receive marijuana to smoke under close medical supervision and only after being informed of their status as experimental subjects using a harmful drug delivery system. The results of these studies would increase scientific understanding of the risks and benefits of marijuana use, the IOM researchers contended. The IOM researchers recommended pursuing two types of short-term (less than six months) clinical trials of smoked marijuana: for conditions that appear likely to be improved with such treatment and for patients with debilitating, otherwise incurable symptoms such as chronic pain or AIDS wasting. They did not recommend such trials to promote the smoking of marijuana but rather because such trials could help accelerate the development of a smoke-free cannabinoid delivery system. While the Compassionate Use program for marijuana smokers now exists solely as a historical artifact, the medical necessity defense remains viable for some patients who treat their symptoms with marijuana. This defense originates from the common law principle that illegal actions are excusable or justified if they are taken to avoid even greater harms. Courts considering such cases must balance the interest of the individual patient against the government's interest in upholding the law. The specific requirements to mount a defense of medical necessity for marijuana use vary from state to state. In most cases, patients must show that they used marijuana in order to avoid serious medical harm. To do so, the defense typically calls the treating physician or another medical expert to testify that marijuana relieves the patient's symptoms. The defense must also convince the judge or jury that the harm of breaking the law in question is less severe than the harm the patient would suffer if deprived of marijuana. Many courts also require patients to prove that no legal alternative treatment exists; this is often a major point of contention between the prosecution and defense in medical marijuana cases.7

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MARIJUANA AS MEDICINE?: The Science Beyond the Controversy Legal experts regard the medical necessity defense as an extremely demanding one and note that it fails as often as it succeeds.8 Among the more frequently cited successes is the case of Samuel Diana, a multiple sclerosis patient convicted of marijuana possession in the state of Washington. In appealing Diana's conviction the defense relied on testimony from physicians and other people with MS as well as from Diana himself. The court concluded that marijuana minimized Diana's symptoms, that no other drug would be as effective, and that the benefits of his marijuana use outweighed the harm to society of his criminal action. The court also emphasized that its decision applied only to Diana and his specific circumstances.9 In a similar case tried in Idaho in 1990 (State v. Hastings) the court refused to establish a specific defense of medical necessity in a case of marijuana possession. Nonetheless, it did entitle the defendant, who had rheumatoid arthritis, to employ a more general defense of necessity as stated in common law. Once this defense was allowed, the prosecutor dropped all charges against the defendant. 10 The medical necessity defense also has failed for a variety of reasons. Some defendants have lost because they did not make an effort—futile though it might have been—to obtain marijuana through legal channels such as the federal Compassionate Use or state research programs. Others have aroused the skepticism of the judge or jury by growing or possessing exceptionally large amounts of marijuana. In one case (Commonwealth v. Hutchins), tried in Massachusetts in 1991, the court refused to acknowledge the existence of a medical necessity defense. Dissent from this decision led the state to establish a marijuana research law and the governor to pardon the defendant.11 The advent of new cannabinoid drugs or delivery systems that could replace smoking for some patients may eventually restrict the applicability of the medical necessity defense. On the other hand, the discovery of new medicinal applications for marijuana could result in its expansion. Either way, medical marijuana users should bear in mind that this already unreliable tactic continues to be subject to change. Even more important, patients should understand that the medical necessity defense has not been recognized by courts or

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MARIJUANA AS MEDICINE?: The Science Beyond the Controversy legislatures in most parts of the country. Further, under current federal law there is no legal means to obtain marijuana for medical use. Violators of federal law risk prosecution, imprisonment, fines, and forfeiture of property. State laws concerning medicinal marijuana use and possession, discussed in the next section, vary widely in terms of penalties. MEDICAL MARIJUANA AND THE STATES' LAWS While marijuana is regulated at the federal level as a substance without medicinal value, laws in several states recognize and make allowances for a variety of therapeutic uses. This situation presents a troubling paradox for patients, caregivers, and physicians: if they use, procure, or recommend marijuana for medical purposes in compliance with state law, they are guilty of a federal crime. State laws permitting the medical use of marijuana vary widely and apply to a broader range of situations than individual necessity cases. However, most state laws on medical marijuana belong to one of three general categories. First, several states created therapeutic research programs to study marijuana's effects on seriously or terminally ill patients. Some states have granted permission to physicians to recommend marijuana for such patients. Lastly, some states have established their own controlled substances regulations in which marijuana has been assigned to Schedule II (a largely symbolic measure since the federal CSA prevails).12 Two groups that advocate legalizing medical marijuana, NORML and the Marijuana Policy Project, maintain databases of state marijuana laws on their web sites. Since state marijuana laws can not be implemented without cooperation from the federal government, medical marijuana laws enacted in more than 20 states have had little practical effect. This is particularly true where the state stipulates that marijuana for medical purposes must be obtained through a clinical research program, since these programs no longer exist, except on paper. Several factors contributed to the demise of state-sponsored clinical programs, including the federal government's refusal to provide them with marijuana after 1986. Lack of patient interest also helped doom these programs,

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MARIJUANA AS MEDICINE?: The Science Beyond the Controversy most of which focused on relieving chemotherapy-induced nausea. Many of the mostly older participants in such trials dropped out after having adverse reactions to smoked marijuana (see Chapter 6). Other patients and their physicians were discouraged from participating by the burdensome paperwork involved. The fate of several moribund state programs was then sealed with the 1985 approval of dronabinol (Marinol), which led state boards of health to conclude that marijuana was obsolete as a medicine. As a result, by the time the spread of AIDS produced a new group of patients seeking help from marijuana, neither state nor federal Compassionate Use programs were available to them. The demands of these patients, along with a general increase in marijuana 's medicinal properties, led voters in California to pass a state medical marijuana initiative in 1996. Known as Proposition 215, it permits patients and their primary caregivers, with a physician' s recommendation, to possess and cultivate marijuana for the treatment of AIDS, cancer, muscular spasticity, migraines, and several other disorders; it also protects them from punishment if they recommend marijuana to their patients. Since 1996, voters in five other states —Alaska, Arizona, Nevada, Oregon, and Washington as well as the District of Columbia—have approved similar measures, all in direct conflict with federal law. (Although exit polls indicated that voters in the District of Columbia approved the measure by a 69 percent majority, Congress refused to allow the ballots to be counted and nullified the referendum.) Time has shown, however, that medical marijuana initiatives are much easier to pass than they are to implement. As long as marijuana remains in the federal government's Schedule I, the threat of prosecution to anyone involved with its procurement or use has deterred all but a minority of doctors, patients, and providers of medical marijuana from establishing public distribution contemplated by the new state laws.13 For physicians the potential consequences of recommending marijuana to patients include the loss of DEA licenses to prescribe controlled substances as well as cancellation of Medicare and Medicaid contracts. These were among the threats made by federal officials to California doctors following passage of Proposition 215, and they have apparently served to deter many physi-

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MARIJUANA AS MEDICINE?: The Science Beyond the Controversy cians—including those in other states—from recommending marijuana to their patients or even discussing it with them. Physicians remain wary despite a temporary injunction issued by U.S. District Judge Fern Smith in April 1997 preventing the federal government from restricting doctors' right to discuss marijuana with their patients. Such discussions, the judge ruled, are protected as free speech under the First Amendment. Nevertheless, the distinction between recommending marijuana use and “aiding and abetting” patients in obtaining an illicit substance is a fine one, as several state medical associations have noted. For example, in a 1999 bulletin entitled “Medical Use of Marijuana,” the Washington State Medical Association cautions its members as follows: Physicians must not prescribe marijuana. It is prohibited under federal law to knowingly or intentionally distribute, dispense, or possess marijuana. The terms “distribute” and “dispense” have been widely interpreted, and physicians may be found in violation of federal law for writing a prescription for a substance, such as marijuana, for which federal law has no recognized medical use. Violation of federal law can bring significant penalties, including imprisonment and fines. In addition, violating federal law (or aiding and abetting in its violation) may result in other physician sanctions, such as a revocation of a physician 's DEA registration. The bulletin advises doctors who recommend marijuana to provide a signed statement, or a copy of the patient's medical records, indicating “that in the physician's professional opinion, the potential benefits of marijuana outweigh the risks” for the individual. Of course, patients who use marijuana as a medicine also risk criminal conviction. Even where recent voter initiatives exempt such use from state criminal penalties, it is still subject to federal prosecution. As a result, most people who turn to marijuana to relieve their symptoms do so in secrecy and without the full knowledge or consent of a doctor. Most medical users get their marijuana through the same means as recreational users: from friends who give or sell it to them, by growing it themselves, or by buying it “on the street” from professional dealers. A minority of medical users—perhaps 10 percent, according to Chuck Thomas of the Marijuana Policy Project—make use of

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MARIJUANA AS MEDICINE?: The Science Beyond the Controversy so-called cannabis buyers' clubs. Most visible in California, buyers' clubs originated with AIDS patients who initially formed the groups to distribute herbal medicines and imported pharmaceuticals not approved for sale in the United States. When club members found that marijuana relieved some of their symptoms, they organized supply networks, which eventually expanded to include people with other disorders. Most buyers' clubs continue to be small and secretive; some are barely distinguishable from the informal relationships that form between many medical marijuana users, growers, and dealers. But in California, as well as such cities as New York, Seattle, Key West, Washington D.C., and Portland, Oregon, several larger buyers' clubs have begun to operate openly in recent years. Ensuing state and federal lawsuits have forced many of these public clubs to close. Those that remain open do so in cooperation with local authorities. Others have been replaced by more “low-key ” distribution networks. There is no such thing as a typical buyers' club. Each has its own culture, determined to a large extent by its policies, patients, and physical location (see Figure 11.1). Some clubs act as marijuana purchasing agents, others as cooperative associations of patients and sometimes growers. Patients can smoke or eat marijuana on the premises at a few clubs, but most tend to operate like pharmacies, dispensing a variety of types and grades of marijuana, often at or below cost. Clubs generally require patients to present some kind of medical documentation, such as a physician 's referral, in order to receive marijuana. At the time of writing, the future of public buyers' clubs appears to be uncertain, largely as a result of a series of lawsuits brought by the federal government against six of the most visible California clubs in 1998. The suits, which remain in litigation, can be viewed as a test of the federal government's ability to enforce the CSA in states that have enacted medical marijuana initiatives. In at least one case, local governments have attempted to protect buyers' clubs from federal interference. When the Oakland Cannabis Buyers' Cooperative was targeted for closure in 1998, the city responded by designating its employees as officers of the city (ironically, by granting them the same privileges as undercover narcotics agents). This tactic failed to save the club, how-

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MARIJUANA AS MEDICINE?: The Science Beyond the Controversy FIGURE 11.1 Contrasting photos of cannabis buyers' clubs in Los Angeles and San Francisco, California. (Top photo by Tyler Hubby, Los Angeles Cannabis Resource Center, identifiable people: Jay Fritz, Mirron Willis, Craig Poore, and Michael Goldberg. Bottom photo by André Grossman, San Francisco Buyer's Club.)

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MARIJUANA AS MEDICINE?: The Science Beyond the Controversy ever. Bowing to federal pressure, the cooperative ceased marijuana and at the time this book was written, operated only as a patient registration center. But in July 2000, a ruling of the Federal District Court restored the right of the Oakland club to distribute marijuana to patients with a serious medical condition who will suffer imminent harm without marijuana, and who have no legal alternative to marijuana for effective treatment for their illness. It is unclear how many of the club's members meet these criteria, but the ruling at least admits the possibility that the Oakland club, as well as others in California, could reopen.14 The federal government also succeeded in closing perhaps the most notorious of all buyers' clubs: the San Francisco Cannabis Cultivators ' Club. In this case, however, local authorities acted to support, rather than thwart, the federal government's efforts. Unlike the Oakland cooperative, which resembled a pharmacy, the San Francisco club not only allowed smoking on the premises but encouraged members to do so by providing them with comfortable lounges and a “cannabis bar.” Registration procedures were reportedly lax, and little effort was made to confirm members' claims of medical need. Several less flamboyant Bay Area buyers' clubs now serve former members of the San Francisco club. At the opposite end of the cannabis club spectrum, the Los Angeles Cannabis Resource Center remains untouched by federal lawsuit. Open since November 1996, the LACRC dispenses marijuana for home consumption only. The club also offers legal assistance, volunteer programs, and support groups for members and their caregivers, who must be at least 18 years old. Nearly 80 percent of the center's more than 650 active members are AIDS patients. To receive marijuana, patients are required to submit a statement signed by a licensed California physician stating that he or she recommends or approves use of the drug. A staff member then calls the physician to verify this information, which is updated annually. To ensure the quality of the marijuana it dispenses, the LACRC obtains 70 percent of its supply from a garden on the premises and from other co-op members who grow marijuana at home. The remainder is acquired from independent growers.

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MARIJUANA AS MEDICINE?: The Science Beyond the Controversy No one is more aware of the precarious legal position held by the LACRC than its director, Scott Imler. But Imler, an architect of Proposition 215, sees buyers' clubs as an interim solution to the medical marijuana problem. Like most of the patients he serves, he would prefer marijuana to be prescribed and dispensed by a pharmacist, as an FDA-approved medication. Unless and until that happens, the relative safety and low-cost products offered by buyers' clubs—whether public or underground—are likely to continue to attract a significant minority of medical marijuana users. RESEARCH AND REGULATION One point on which both sides in the medical marijuana debate can agree is the need for definitive clinical research on marijuana. As a National Institutes of Health committee noted in 1997, “until studies are done using scientifically acceptable clinical trial design and are subjected to appropriate statistical analysis, the questions concerning the therapeutic utility of marijuana will likely remain much as they have to date—largely unanswered.”15 But in order to conduct such research, scientists must thread their way through a complex maze of regulations, beginning with the restrictions imposed by the federal Controlled Substances Act. To use a Schedule I substance such as marijuana in a clinical study, researchers must first be judged qualified and competent by the DHHS, which must also approve the study plan. The applicants may then proceed to the DEA to receive a special registration that allows them to use marijuana for research purposes. In addition, some states have their own controlled-substances laws, adding another regulatory layer. Moreover, studies designed to test marijuana's therapeutic properties must also receive approval from the FDA (see Chapter 10). Beyond obtaining all necessary federal and state approvals as well as funding for their study, scientists proposing to conduct research on marijuana must procure an adequate supply of the drug. Researchers cannot simply grow the marijuana they need but instead must acquire it from the federal government, according to international law. As a party to the United Nations Single Convention on Narcotic Drugs, the United States has agreed to

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MARIJUANA AS MEDICINE?: The Science Beyond the Controversy establish a national agency to cultivate and distribute marijuana for scientific and medical purposes. Currently, that responsibility rests with NIDA; NIDA also screens all research projects for which it provides marijuana. NIDA grows its marijuana on a Mississippi farm. A North Carolina factory processes some of the crop into cigarettes, available in a range of THC concentrations, as well as a placebo. Until recently, NIDA provided this marijuana free of charge, but only for use in studies funded by the National Institutes of Health. Revised procedures issued in May 1999 make it available to researchers supported by other governmental agencies or private organizations.16 But all researchers, except for those funded by NIDA itself, must now reimburse the agency for the cost of raising, processing, and distributing the marijuana they use. While NIDA's revised policies may encourage more studies of marijuana's potential medical benefits, they also impose clear limits on the nature of such research. Guided by the Institute of Medicine's report as well as the findings of the National Institutes of Health's expert panel, NIDA announced that it would give priority to studies on the development of alternative delivery systems for marijuana or its constituent cannabinoids. The agency also stated that it would favor research on patients with serious or life-threatening conditions or those for whom no therapies exist. Much to the dismay of medical marijuana advocates, NIDA did not announce the return of a compassionate use program or even support for ongoing trials of medical marijuana. Instead, NIDA guidelines state that preference will be given to multipatient studies with specific endpoints. Rather than develop whole marijuana as a licensed drug, the stated goal of the NIDA program is to determine whether active compounds in marijuana can be safely delivered as medications that meet the FDA's standards for pharmaceuticals. These policies follow the recommendations stated in the IOM report, which emphasized that even trials of smoked marijuana be directed toward developing smokeless delivery systems for cannabinoids. In August 1999, Health Canada—the equivalent of the DHHS—announced its support for a program of medical research on marijuana with aims similar to those stated in the NIDA guide-

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MARIJUANA AS MEDICINE?: The Science Beyond the Controversy lines. The Canadian agency will provide research-grade marijuana for approved studies and up to $1.5 million a year in funding through 2004. Studies of smoked marijuana will receive support only if they use the drug to treat terminally ill patients or are used in short-term clinical trials as a basis of comparison with other therapies. As in the United States, researchers must submit an IND application to the Canadian equivalent of the FDA before beginning clinical trials. Health Canada's advisory committee declined to specify particular symptoms as acceptable candidates for experimental treatment with marijuana. By contrast, the NIDA guidelines refer applicants to recommendations made by the 1997 National Institutes of Health Workshop on the Medical Utility of Marijuana. That panel identified several promising therapeutic areas for marijuana research, including neuropathic pain, muscular spasticity, glaucoma, and wasting syndromes of AIDS and cancer. The workshop report also notes the heavy regulatory burden on researchers who study controlled substances, particularly Schedule I substances such as marijuana. As a result, the report concludes, many scientists “have been discouraged from pursuing research with these substances. ” A 1995 IOM report on the development of addiction medication reached much the same conclusion, leading its authors to recommend that federal regulations be modified to remove barriers to research on controlled substances.17 NIDA's new guidelines may make marijuana more widely available for clinical studies, but they also leave intact regulations that pose significant hurdles to marijuana research. Whether the promise of marijuana-based medicines will lure scientists to overcome these barriers remains to be seen, but at the moment such a change appears unlikely. At the time of this writing, nearly nine months after NIDA published its revised guidelines, the agency had received only two requests for research-grade marijuana. NOTES 1. Bonnie RJ and Whitebread CH. 1974. The Marihuana Conviction: A History of Marihuana Prohibition in the United States. Charlottesville: University

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MARIJUANA AS MEDICINE?: The Science Beyond the Controversy Press of Virginia; Aldrich M. 1997. “History of therapeutic cannabis,” in Cannabis in Medical Practice, Mathre ML, ed. Jefferson, NC: MacFarland and Co. 2. Report of the Council of Scientific Affairs. 1997. Report to the American Medical Association House of Delegates. Subject: Medical Marijuana. Chicago: AMA. 3. Grinspoon L. 1971. Marihuana Reconsidered. Cambridge, MA: Harvard University Press. 4. Drug Enforcement Agency. Marijuana Rescheduling Petition, Docket No. 86-22, Opinion and Recommended Ruling, Findings of Fact, Conclusions of Law and Decision of Administrative Law Judge Francis L. Young, September 6, 1988. 5. Alliance for Cannabis Therapeutics v. DEA, No. 92-1168, No. 92-1179, 15 F.3d 1131, U.S. Court of Appeals for the District of Columbia Circuit (1994). 6. Zeese K. 1997. “Legal issues related to the use of medical marijuana,” in Cannabis in Medical Practice, Mathre ML, ed. Jefferson, NC: MacFarland and Co.; National Organization for the Reform of Marijuana Laws (NORML). Website visited July 22, 1999. 7. Kent NE. 1997. “People behind the pain,” in Cannabis in Medical Practice, Mathre ML, ed. Jefferson, NC: MacFarland and Co. 8. NORML website. 9. Ibid.; Dogwill N. 1998. “The burning question: How will the United States deal with the medical-marijuana debate?” Detroit College of Law at Michigan State University Law Review, Spring. 10. Kent NE. 1997. 11. Ibid.; Dogwill N. 1998. 12. Kent NE. 1997. 13. Goldstein E. In preparation. “Implementation of Medical Marijuana Referenda: A Study of California, Washington, and Oregon.” Unpublished paper. 14. Ruling in California Favors the Medicinal Use of Marijuana. New York Times. COL 02, P 17. Tuesday July 18 2000 15. National Institutes of Health. 1997. Workshop on the Medical Utility of Marijuana. Report to the Director, National Institutes of Health, by the Ad Hoc Group of Experts. Bethesda, MD: National Institutes of Health. 16. National Institutes of Health. 1999. Announcement of the Department of Health and Human Services' Guidance on Procedure for the Provision of Marijuana for Medical Research. 17. Institute of Medicine. 1995. The Development of Medications for the Treatment of Opiate and Cocaine Addictions: Issues for the Government and Private Sector. Washington, DC: National Academy Press.