LEDA at Harvard Law School



State Medical Marijuana Initiatives:

A Justification and Analysis

Submitted in Conjunction with Food & Drug Law, Winter 1998

and in Fulfillment of the Written Work Requirement for Harvard Law School

Paper Supervisor: Peter Barton Hutt

Dean Leckie

May 4, 1998

I. Introduction

H. Relevant Federal Legislation

A. The Food Drug and Cosmetics Act (FDCAi

B. The Controlled Substances Act (CSA)

C. Physician Liability Under the CSA and FDCA

m. History of Efforts at the Federal Level to gain Access to Marijuana for Patients Who May Benefit

A. NORML v. DEA

B. The Compassionate IND Procram

~ Roadblocks to Clinical Testing

IV. Analysis of What Drafts of Future Medical Marijuana Initiatives Can Learn from the Arizona and California Initiatives.

A . ___

1.

2.

3.

£~ AiizQna

1.

Goals

~ I ~ Ana~t State Medical Mar~"'~"~ Ttth,~

Argument That Marijuana Is Not FDA Approved

Argument that legalizing marijuana for medical uses sends the wrong message to children Patients do not even need a doctors prescription to use marijuana

Summary

b .

Subsequent Developments

General Provisions Provisions Relating to Marijuana

2.

D California

1. Summary

2. Subsequent Developments

a. Federal Response

State Response

c. Positive develoDments

E. Lessons learned form the California and Arizona Initiatives .

1. Political issues

a. Political Issues Resultine From Necessary Provision in the Initiative

b. Avoidable Political Issues

c . ________________

__ Judeement calls

illnesses that qualify for treatment with marijuana

ii. Legalizing other schedule I drugs as weil

2. Problems That Have Arisen in the Wake of Propositions 200 and 215

a. No distribution mechanism

k. The Initiative Does Not Define Usable Mariiuana or Personal Use.

The Initiative Restricts Coverage to California Residents

Initiative Drafters Should Avoid Givin2 Le2islatures Control over the lmplementin2 the

Initiative

IJULIUL L41I~~ I ~AI.U~I — I~~I~fl~II

3. Potential Problems that have not yet Become Problematic

a. Reauirements That the Patients Health Benefit. Severability

V. Analysis of State Initiatives Currently Being Advanced by Sponsors

A 1 AIni~

1. Colorado

2. Alaska

3. Oregon

4. Washington D.C.

5. Maine

6. Evaluation of AMR Initiatives

B. Non-AMR Initiatives

1. Alaska

2. Colorado

3. Florida

4. Maine

5. Washington

6. Washington D.C.

VI. Conclusion

I. IntroductioD

In 1996, California and Arizona passed medical marijuana initiatives with 55.6%' and 65.4%2 of the votes respectively. The elections stunned federal, state and local leaders, who convened in an emergency session of the Senate Judiciary Committee to determine what had happened. These leaders maintained that the Arizona and California voters had been duped by pro drug legalization advocates masquerading as compassionate groups seeking to comfort the sick and dying. Government leaders maintained that systems were in place to deal with medicines and that misguided voters should not subvert these safeguards.

The government leaders failed to recognized that in the case of Schedule I drugs, these systems had failed. The current political, legal, and administrative syste~n in the United States does not provide a method to determine whether Schedule I substances are medically beneficial. Modern science does not accept anecdotal evidence; it requires rigorous and exhaustive testing before a drug is deemed safe and effective. Yet the federal government has thwarted any attempt to perform this necessary scientific testing. Therefore, according to the scientific standards in the United States, nobody knows whether marijuana possesses medically beneficial properties that outweigh its risks.3 On the other hand, for the same reasons, nobody knows whether marijuana is not medically beneficial. For the past twenty five years, the federal government has refused to allow this question to be answered.

'California Secretary of State web site, 1996 Election Results,

<http://Vote96.ss.ca.gov/Vote96/html/vote/prop/page.96 1218083528 .html> (January 14, 1998).

2 Arizona Secretary of State web site, Unofficial Election Results, <http://sosaz.corn/results/l996general/FEN5600.htm>, (January 14, 1998).

3 Marinol, a drug approved by the FDA is a synthetic form of THC, the primary active substance in marijuana. Logic dictates that if Marinol has medical benefits, marijuana would have medical benefits. The debate then centers on whether the risks associated with raw marijuana outweigh the benefits.

2

In this paper, I take the position that according to contemporary scientific standards in the United States, marijuana has not been shown to be medically beneficial. I also takes the position that even if marijuana has medically beneficial properties, the current syctem in the United States offers no method for proving such a fact in a scientifically acceptable manner. Therefore, patients, physicians, and other advocates who believe that marijuana is medically effective, have no alternative but to pursue alternative methods, such as state voter initiatives, to achieve their goal. This strategy has proven effective in pressuring the federal government to relent and allow scientific testing of marijuana to finally answer the question of whether marijuana has medical benefits. The ultimate goal, for the purposes of this paper, is to answer the medical marijuana question in a definitive manner. If marijuana is shown to be beneficial, it should be absorbed into the proper systems regulated by the Food and Drug Administration.

This paper briefly chronicles the efforts of marijuana activists at the federal level. Then it analyzes the text, implementation and subsequent developments of the California and Arizona initiatives passed by the voters in 1996, with the goal of helping future initiative drafters learn from the failures and successes of these initiatives. Finally, this paper critically analyzes medical marijuana initiatives currently being pursued throughout the country.

H. Relevant Federal Legislation

In order to understand marijuana's recent history, as well as the nuances of the state initiatives, it is necessary to have at least a cursory understanding of the Food Drug and Cosmetics Act (FDCA) and the Controlled Substances Act (CSA), and how the two interact when a drug classified as a controlled substance is involved. Understanding how the two acts fit together is not an easy task. "The interrelationship between the two Acts is far from clear."4

4 National Organization For the Reform of Marijuana Laws (NORML) v. DEA, 559 F.2d 735.

750 note 65, 118 U.S. App. D.C. 114 (D.C. Cir. 1977).

3

A. The Food Drug and Cosmetics Act (FDCA )

The Food Drug and Cosmetics Act (FDCA) is a sweeping legislation that regulates just about any substance that goes on or into the bodies of humans and animals.5 As it relates to drugs, the FDCA is directed mainly at keeping unsafe drugs out of interstate commerce. Because it is more like a consumer protection statute than a criminal statute, the FDCA focuses primarily on issues of distribution as opposed to possession. It does not prohibit the possession of unapproved drugs.

The FDCA s regulation of drugs begins with its definition of a drug. A drug is (a) any article recognized by an official compendium6 such as the United States Pharmacopoeia; (b) any article intended to diagnose, cure, mitigate, treat, or prevent disease in humans or animals; (c) any article (other than food) that is intended to affect the structure or function of the body; and (d) components of any article in the first three categories.7 No new drug may be introduced or delivered into interstate commerce without the approval of the Food and Drug Administration

(FDA).8

5 This discussion is intended to give a brief sketch of the drug approval process and give the reader a feel for how the FDA gets its authority to regulate drugs. For a more in-depth discussion of the FDA approval process, see Veronica Henry, Problems with Pharmaceutical regulation in the United States , 14 Journal of Legal Medicine 617 (1993).

621 U.S.C.A. §33216).

~2l U.S.C.A. §321(g).

~2l U.S.C.A. §§331(d), 355(a).

4

While nobody would question the fact that marijuana is a drug according to this definition,9 one may wonder why marijuana would fall into the new drug category considering it has been used as medicine for centuries.'0 The term "new drug" is defined as any drug that does not meet one of the following two exemptions. First, drugs that are generally recognized by experts as safe and effective for the use described in the labeling are exempted." Second, drugs subject to the Food and Drug Act of June 30, 1962 are not considered new drugs if their labels have not changed with respect to uses of the drug.'2 Some experts argue that marijuana is safe and effective,13 but Congress has determined that it lacks an accepted medical use or level of safety by virtue of its designation as a Schedule I substance.'4

In order to receive approval by the FDA of a new drug, one must first perform rigorous clinical trials of the drug. The process begins with the submission of an Investigational New Drug Application (IND) to the FDA, which must occur before clinical testing can begin.'5 Because the FDCA prohibits the introduction into interstate commerce of unapproved new drugs, and one cannot realistically perform clinical trials on a drug without violating the prohibition, the FDCA creates an exemption for new drugs intended for investigational use.'6

9 At least for medical uses, marijuana is intended to be used as a drug.

"'Robert C. Clarke & David W. Pate, Medical Marijuana , in Hemp Today 303, 306 (Ed Rosenthal ed., 1994).

"21 U.S.C.A. §321(p).

1221 U.S.C.A. §321(p)(l).

3~ Ed Rosenthal, Introduction , in Hemp Today, and Robert C. Clarke & David W. Pate, Medical Marijuana in Hemp Today 299-309 (Ed Rosenthal ed., 1994).

'~2l C.F.R. §3 12.20.

621 U.S.C.A. §355(i).

5

The new drug sponsor must then perform three stages of human clinical evaluations for safety and efficacy.'7 These three phases last approximately six years.'8 After the clinical trials, the sponsor submits a New Drug Application (NDA), which must contain reports of all investigations and all other information pertinent to the drug, to the FDA.'9 When the FDA approves a NDA, it classifies it as either a prescription drug or a non prescription drug.20

Once a drug's NDA is approved, the FDCA no longer prohibits its distribution. However, the FDCA still regulates all drugs (both approved new drugs and exempted old drugs), as well as food and cosmetics, through restrictions on misbranded and adulterated substances.2 ' While the terms misbranded and adulterated seem narrow, these two words provide the basis for an entire regulatory structure. For example, a prescription drug dispensed without a valid prescription is deemed to be misbranded. In fact, a manufacturer, who markets its drug for a use other than that for which the FDA approved it, misbrands the drug.22 Furthermore, any distribution of material distributed by the manufacturer that describes the use of a drug is deemed labeling by the FDCA.23 Therefore, falsehoods in such materials would constitute misbranding.24

'7 See Veronica Henry, Problems with Pharmaceutical Regulation in the United States , 14 Journal of Legal Medicine 617, 621 (1993).

"'Veronica Henry, Problems with Pharmaceutical Regulation in the United States , 14 Journal

of Legal Medicine 617, 621 (1993).

'~21 C.F.R. §3 14.50.

2021 U.S.C.A. §353(b)(1)(B); $~ National Nutritional Foods Association v. Weinberger, 512 F.2d 688, 699 (2nd Cir. 1975) (ruling that the FDA has the power to determine which products are prescription drugs).

2121 U.S.C.A. §331(a)-(c).

22 5ee Richard A. Merrill, The Architecture of Government Regulation of Medical Products ,

82 Virginia Law Review 1753, 1853-4 (1996).

2321 U.S.C.A. § 321(m)-(n); Kordel v. Untied States 335 U.S. 345, 349-50 (1948) (ruIini.~ tku pamphlets and other materials describing a drug constitute labeling regardless of whether iK> ire

6

The FDA has used this misbranding restriction to institute a comprehensive set of guidelines on manufacturer advertising.25

When an individual distributes an unapproved new drug, or a drug deemed misbranded or adulterated, federal courts have the authority to enjoin such distribution.26 Furthermore, the person who distributes the drug is subject to imprisonment for up to one year and fines up to $1,000 for a first offense and three years and $10,000 for a subsequent offense.27

B. The Controlled Substances Act (CSA )

The Comprehensive Drug Abuse Prevention and Control Act of 1970, better known as the Controlled Substances Act (CSA) categorizes substances that pose a danger of abuse and dependence into five schedules, according to the level of danger for abuse and dependence the substance poses.28 A substance placed in any of the schedules is considered to be a controlled substance. Marijuana is a Schedule I drug, which means that it has a high potential for abuse, "no currently accepted medical use in treatment in the United States," and is not accepted as safe, even under medical supervision.29 Examples of other Schedule I drugs include peyote, PCP, heroin, and LSD.30 A Schedule II drug has a high potential for abuse, has a currently accepted medical use in the United States with severe restrictions, and poses a danger of severe

physically attached to the product).

2421 U.S.C.A. § 33 1(a).

2521 C.F.R. § 202.1.

2621 U.S.C.A. §332(a).

2721 U.S.C.A. §333(a).

2821 U.S.C.A. §812(b)(1).

2921 U.S.C.A. §812(b)(1); 21 C.F.R. §1308.11 Schedule I (d)(19)

~~21 C.F.R. §1308.11 Schedule I.

7

psychological or physical dependence.3 ' Examples of Schedule H drugs include cocaine and opium?2 A Schedule 111 drug has a lower potential for abuse compared to Schedule I and H drugs, a currently accepted medical use in the United States, and a moderate to low risk of physical dependence or a high risk of psychological dependence.33 Examples of Schedule HI drugs include anabolic steroids and certain diluted mixtures of codeine.34 A Schedule IV drug has a relatively low potential for abuse compared to Schedule HI drugs, a currently accepted medical use in the United States, and a potential for limited physical or psychological dependence compared to Schedule III drugs.35 Examples of Schedule IV drugs include both components of the diet drug Phen fen (phentermine and fenfluramine).36 A Schedule V drug has a low potential for abuse and physical or psychological dependence relative to Schedule IV drugs, and an accepted medical use in the United States.37 Examples of Schedule V drugs include further diluted mixtures of codeine.38

The Controlled Substances Act authorizes the Attorney General to either reschedule a drug or remove it from scheduling after taking into account its potential for abuse, its potential for dependency, and scientific knowledge of the drug.39 The Attorney General has delegated all

~'21 U.S.C.A. § 812(b)(2).

3221 C.F.R. §1308.12 Schedule II.

~~21 C.F.R. §1308.13 Schedule III.

3621 C.F.R. § 1308.14 Schedule IV.

3821 C.F.R. §1308.15 Schedule V.

~~2l U.S.C.A. §811(c).

8

authority derived from the CSA to the Administrator of the Drug Enforcement Administration (DEA),40 who may delegate its authority to subordinates in the DEA.4 ' Therefore, the DEA has the legal authority to reschedule or deschedule a drug. While the DEA has the formal legal authority to schedule a drug, the FDA retains significant power over the drug scheduling process. The Attorney General, Secretary of Health and Human Services, or an interested party may file a petition to reschedule a controlled substance.42 Once a petition is filed, the DEA must request scientific and medical evaluations from the Secretary of Health and Human Services (Secretary), along with the Secretary's recommendation as to how the drug should be scheduled and hold a public hearing on the matter.43 The Secretary has delegated this responsibility to the FDA~ These scientific and medical evaluations are binding on the DEA.45 Because a Schedule I drug by definition does not have an acceptable medical use in the United States, if the FDA recognizes an acceptable medical use, the DEA may no longer keep a drug in Schedule I. Furthermore, the DEA may not control a drug at all if the FDA recommends that the drug not be controlled. In effect, unless the FDA does not make a recommendation, the DEA merely has authority to determine in which schedule to place a drug, consistent with the FDA's scientific and medical evaluations.

4028 C.F.R. 0.100.

~'28 C.F.R. 0.104.

4221 U.S.C.A. 811(a).

~~2l U.S.C.A. 811(b).

45 1d.

9

This preceding explanation is a bit simplistic and possibly misleading because if an international treaty or obligation, to which the United States has adhered, requires control of a certain drug, 21 U.S.C.A. §811(d) states that the Attorney General (who's authority is delegated to the DEA) shall schedule the drug as she deems fit, without regard to the recommendations of the FDA. Since most substances covered by the CSA are controlled by treaties, a literal reading would effectively void the power Congress gave to the Secretary. In National Organization For the Reform of Marijuana Laws (NORML) v. DEA46 the court found that Congress never intended to bestow such discretion on the DEA. Instead, the court found, the DEA may overrule the FDA only to the extent necessary to satisf~,' the treaty obligations of the United States.47 Although the Secretary of Health and Human Services and the FDA maintain significant power.

The question then becomes, how does one access a Schedule I drug, not yet approved by the FDA, to perform the clinical testing necessary for FDA approval of a New Drug Application? To distribute a Schedule I or II controlled substance, one must obtain DEA registration.48 The DEA has broad discretion in terms of whose registration application it approves.49 For clinical research, one must first receive approval of an Investigational New Drug Application (IIND) by the FDA.50 Then the researcher must submit the approved ND to the DEA along with a statement of security provisions the researcher intends to implement.5 ' The CSA requires the DEA to forward the application and protocol to the Secretary of Health and Human Services,

46559 F.2d 735, 746, 182 U.S. App. D.C. 114 (D.C. Cir. 1977).

47 1d.

4821 C.F.R. 1301.11.

~~21 U.S.C.A. 823(b)

5021 C.F.R. 1301.18(b); 21 C.F.R. 312.20 (requirements foraniND).

~'21 C.F.R. 1301.18(b).

10

who has ultimate authority to approve or reject the protocol. This requirement is moot because the Secretary has delegated this authority to the FDA, which has already approved the protocol.52 The FDA should, however, defer to the DEA for issues of adequate safeguards to prevent diversion of the drug.53 Once the FDA has approved the ND and the DEA has approved the research protocol application, thus registering the applicant as an approved Schedule I or II distributor under 21 U.S.C.A. 823, the researcher may proceed as with any other new drug clinical trial. With a Schedule I drug, however, the researcher still has a problem of access to the drug. Unless the researchers wish to manufacture (or grow) the drug themselves (an endeavor that also requires DEA approval54 ), finding a domestic source of the drug may prove difficult.55 Another alternative is to import the drug, which requires DEA approval.56 Although not impossible to perform, experiments involving Schedule I drugs pose greater obstacles to researchers than experiments involving drugs in other schedules." In the case of approving imports, the DEA retains sole authority to approve or reject the application.

C. Physician Liability Under the CSA and FDCA

The two biggest issues for medical marijuana and the two Acts are how the law applies to a patient using marijuana and how the law applies to a physician who prescribes it. The FDCA is primarily aimed at commerce involving misbranded, adulterated, and unapproved new drugs. A

5221 C.F.R. 5lO(a)(8-l0).

~~21 C.F.R. § 1301.32(a).

~~21 C.F.R. §1301.1 8(a)(2)(vii).

"For example, the only legal source for marijuana in the United States is the National Institute on Drug Abuse. Chemist is USA's Guardian of Grass USA Today, February 10, 1997, 3A.

5621 C.F.R. 1312.11, 1312.12, 1312.13.

"See Grinspoon v. DEA, 828 F. 2d 881, 896 (1st Cir. 1987).

11

drug marketed intrastate could theoretically be sold without FDA approval.58 It is not an attempt to restrict possession of a substance, or regulate physicians or the practice of medicine.59 In other words, it regulates the availability of drugs that a physician may prescribe, as opposed to regulating a physician's ability to prescribe drugs. Attempts have occasionally been made to prosecute physicians for prescribing drugs absent a legitimate patient-doctor relationship; however, most of these prosecutions involve a physician personally distributing a drug, as opposed to merely prescribing it.60

Case law and FDA policy, however, both indicate that the FDCA may not regulate physicians prescribing habits within a legitimate doctor-patient relationship. For a number of years, the FDA has facilitated a personal use importation exemption that allows patients to import limited amounts of unapproved drugs, if done so under the supervision of a physician.6 ' Implicit in this program is the act of a physician prescribing, or at least supervising the use of, an unapproved new drug. Additionally, the FDA allows, and possibly does not have the authority to prevent, physicians writing off-label prescriptions.62 An off-I abel prescription is one where a physician prescribes a drug for an ailment, or in a manner, that the FDA has not approved. Such

5t See Grinspoon v. DEA at 887.

59 U.S. v. Evers, 643 F.2d 1043, 1048 (5th Cir. 1981).

60 Most prosecutions were for distribution of drugs by a physician, as opposed to drug prescription. These cases became moot after the passage of the Controlled Substances Act of 1970. See DeFreese v. United States, 270 F.2d 730 (5th Cir. 1959); Brown v United States, 250 F.2d 745 (5th Cir. 1958). Physicians, however, have been prosecuted for prescribing drugs outside of a doctor-patient relationship. Doe v. Untied States, 801 F.2d 1164 (9th Cir. 1986).

61 ~g. Eric Lindemann, Importing Aids Drugs: Food and Drug Administration Policy and its Limitations . 28 Geo. Wash. J. of Int'l. L. & Econ. 133 140-142 and fn 8, 1994.

6237 Fed. Reg. 16,503 (1972). See also , Lars Noah, Constraints on the Off-Label Uses of Prescription Drug Products , 16 J. Prods. & Toxics Liab. 139 (1994).

12

activity is "not only common, but frequently represent[s] acceptable, sometimes even essential, clinical practice.63 The FDA draws a clear distinction between prescribing, and promoting or distributing drugs.64 It recognizes that it is powerless to sanction a physician for prescription practices, and is limited in its statutory mandate to controlling the actual drug through restricting its movement in interstate commerce.65

Conversely, a physician who prescribes a Schedule I drug without permission from the DEA is subject to prosecution. First time offenders are subject to one year in prison and a $25,000 fine.66 Furthermore, the physicians may lose their registrations permitting them to prescribe any controlled substances.67

While most people understand that the CSA prohibits the possession and distribution of certain kinds of drugs, it is important to understand how the statute affects drugs in the medical realm and where the DEA derives its authority to impose sanctions on physicians for their prescribing practices. The CSA generally restricts possession of a controlled substance without a prescription.68 It does not, however, authorize prescriptions for Schedule I drugs.69 For a real life example--in the context of marijuana, a patient who wishes to lawfully use marijuana for medical

"Richard A. Merrill, The Architecture of Government Regulation of Medical Products , 82 Va. L. Rev. 1753, 1854.

" See id . at fn 318.

65 J~ 37 Fed. Reg. 16503 (1972), the FDA proposed regulation that would have allowed the FDA to change a drug's labeling, restrict its distribution, or revoke approval if off-label prescribing became a problem. The FDA recognized that it could not regulate the physicians and had to effect change through regulating the products.

6621 U.S.C.A. §842(c)(2).

6721 U.S.C.A. §824(a)(2).

6821 U.S.C.A. §844(a).

6921 U.S.C.A. §829.

13

purposes needs a prescription; however, physicians are not permitted to issue prescriptions for marijuana. Therefore, notwithstanding state laws to the contrary, a patient who possesses marijuana, regardless of purpose, is in violation of federal law. The only exception to this prohibition would be possession in connection with DEA approved clinical research.70

Furthermore, under the Act, a physician may not dispense or prescribe7 ' a controlled substance unless registered by the Attorney General to do so.72 Physicians who prescribe marijuana to their patients are subject to prosecution and loss of registration to prescribe controlled substances. The DEA has also taken the position that it may revoke the registration of physicians who recommend Schedule I drugs to their patients." Although recommending would not violate a law, the DEA claims that 21 U.S.C.A. §824(a)(4) allows it to reject registrations for acts that violate the public interest.74 Rescinding a physician's registration, however, for acts that do not constitute a crime and involve communication with a patient may violate the physician's First Amendment right to speech. The line between acts against public interest and free speech is unclear. A recent district court decision indicates that recommending may be covered by the First Amendment.75

7021 C.F.R. §1301.18.

71 The Act considers prescribing a drug to be the equivalent of dispensing. 21 U.S.C.A.

802(10).

7221 U.S.C.A. §§823(f~, 844(a).

73 Conant v. McCaffrey, 172 F.R.D. 681, 699 (N.D. CA 1997).

74 1d.

75 1d.

14

If the Attorney General revokes a physician's license to prescribe controlled substances, the Attorney General has effectively revoked a physician's ability to prescribe drugs, because a large number of commonly prescribed drugs are controlled substances.76 This power the DEA wields significantly impacts any state laws aimed at making marijuana available for medical purposes because these laws cannot utilize the prescription process to make marijuana available to patients while restricting it from recreational users.

III. History of Efforts at the Federal Level to gain Access to Marijuana for Patients Who May Benefit

Soon after the CSA passed, marijuana advocates began a campaign to gain access to marijuana for patients. Due to marijuana's unique situation, this group could not follow the traditional avenue taken by pharmaceutical companies seeking FDA approval for their drugs. Efforts to obtain FDA approval for a new drug take years and cost millions of dollars. To compensate these companies for their time and expense, the government grants them the exclusive right to sell their drugs for a certain number of years. In order to recoup these costs, pharmaceutical companies sell their drugs at inflated prices. Without the exclusive right to sell the drug, competitors unburdened by these millions of dollars in sunk costs could sell the drugs at lower prices, becoming free riders on the original company's research.

Just as with any other drug, efforts to gain FDA approval for marijuana would take a number of years and cost millions of dollars. Because marijuana is a plant that can grow just about anywhere, if the FDA were to approve it as a drug, patients would have little incentive to purchase it at inflated prices from pharmacies when they could grow their own. Consequently, pharmaceutical companies have little incentive to incur the costs of securing FDA approval for marijuana, especially when its approval may take market share away from drugs that they

76~~ Cal. Att'y. Gen. Office, Proposition 215: An Analysis, (December 20, 1996), 5.

15

currently market. Medical marijuana advocates recognized this problem and focused their original efforts at rescheduling marijuana to a Schedule that allowed doctors to prescribe it to their patients on an individual basis. They also attempted to allow patients access to marijuana while it remained a Schedule I drug on a case by case basis. When they realized that marijuana would not be rescheduled, they began to seek FDA approval. By 1996, they had failed on all three fronts.

A. NORML v. DEA

In 1972, the National Organization for the Reform of Marijuana Laws (NORMiL) petitioned the DEA's predecessor, the Bureau of Narcotics and Dangerous Drugs (BNDD) to reschedule marijuana and found itself locked in litigation with an intransigent DEA for twenty-two years. NORMIL originally requested the government to either remove marijuana from scheduling or alternatively reschedule it to Schedule V. Under 21 U.S.C.A. 811, the BNDD was required to refer the petition to the Secretary of Health, Education and Welfare (HEW), the predecessor to the Department of Health and Human Services (HHS), for scientific evaluation. The BNDD refused to accept the petition or refer it to HEW, claiming that it had sole authority for scheduling drugs covered by international treaties to which the United States was a party.77

NORMIL sought appellate review of BNDD's refusal to even accept their petition for rescheduling and the court of appeals ruled that the treaty obligations did not prevent the BNDD (now the DEA) from reviewing the petition, even ifjust to determine what the United States treaty obligations really were.78 The court remanded the case, requiring the DEA to determine

7737 Fed. Reg. 18097 (1972). See also NORMI v. Ingersol, 497 F.2d 654, 656 (D.C. Cir. 1974).

78 NORMIL v. Ingersol at 661.

16

whether international treaties allowed the DEA to place marijuana in any other Schedules. It also ordered the DEA to seek evaluations and recommendations from HEW.79

The DEA held a hearing before Administrative Law Judge Parker to determine the extent of the treaty obligations. He ruled that the DEA had the authority to reschedule cannabis (flowers and tops) and cannabis resin to Schedule II, cannabis leaves to Schedule V, and it could deschedule synthetic THC. He also ruled that the DEA should follow normal procedures relating to rescheduling, including abiding by HEW's recommendations.80

The DEA Administrator rejected Judge Parker's conclusions, ruled that marijuana would remain in Schedule I, and refused to refer the petition to HEW for recommendations.8 ' He maintained that 21 U.S.C.A. 20 1(d) gave him sole discretion to schedule controlled substances and he did not have to seek recommendations from HEW.82 He argued that even if he did have to refer the petition for rescheduling to HEW, a letter the DEA had received from the Acting Assistant Secretary of Health that stated "there is currently no accepted medical use of marijuana in the United States," met that requirement.83

NORMIL appealed for the second time and the court of appeals ruled that the DEA was bound to follow HEW's recommendations up to the point at which they would cause a violation of an international treaty and ordered it to refer NORML's rescheduling petition to I-IEW.84 By this time, five years had passed since NORMIL filed its petition and the DEA had yet to take

~NORML v. Ingersol at 661.

80 NOv~L v. DEA, 559 F.2d 735, 742 (D.C. Cir. 1977).

8l4Q Fed. Reg. 44164, 44168 (1975).

82 4O~J~4j~ v. DEA, 559 F.2d 735, 743 (D.C. Cir. 1977).

83 NORML v. DEA, 559 F.2d 735, 742 (D.C. Cir. 1977).

84 NORMIL v. DEA, 559 F.2d 735, 746-7 (D.C. Cir. 1977).

17

action on its merits or refer it to HEW. The court ordered the DEA to obtain separate recommendations from HEW for cannabis and cannabis resin, leaves, seeds capable of germination, and synthetic THC.85 It chastised the DEA for relying on the letter, and, noting a HEW report on potential therapeutic aspects of marijuana, ordered the DEA to hold a formal hearing on the question of marijuana's medical potential.86 Contrary to the court's order, however, HEW did not make separate evaluations and merely recommended that marijuana remain in Schedule 1.87

NORML appealed for the third time, and for the third time the DEA Administrator was reversed. The court chastised the DEA and HEW for not following its order to evaluate the four separate classifications of marijuana and implied that the DEA had attempted to skirt the spirit of its previous decision.88 The Court again ordered the DEA to refer the petition to HEW's successor HHS for scientific and medical findings for each of the four classifications.89

The FDA, under its authority from I{HS, reviewed NOR.ML's petition and concluded that all portions of marijuana should remain in Schedule 17' After the FDA's recommendation, notwithstanding the CSA's requirement for a public hearing, the DEA did not hold a hearing on

85 NORMIL v. DEA, 559 F.2d 735, 749 (D.C. Cir. 1977).

86 NORML v. DEA, 559 F.2d 735, 757 (D.C. Cir. 1977).

87 In the Matter of Marijuana Rescheduling Petition, Opinion and Recommended Ruling, Findings of Fact, Conclusions of Law and Decision of Administrative Law Judge Francis L. Young, September 6, 1988, No. 86-22, accessed at

<http ://mojo.calyx.notl—olsen/MEDICAL/YOUNG/young 1 .html> (January 10, 1998).

88 NORML v. DEA No. 79.1660, unpublished D.C. Circuit order filed October 16, 1980. cited in In the Matter of Marijuana Rescheduling Petition at 3.

89 NORML v. DEA No. 79.1660, unpublished D.C. Circuit order filed October 16, 1980. cited in In the Matter of Marijuana Rescheduling Petition at 3.

~47 Fed. Reg. 28141 (1982).

18

the petition for six years. By this time, NORMI. had modified its petition, seeking only that marijuana be moved to schedule II. The Administrative Law Judge presiding over the hearing, Francis L. Young, found that a "respectable minority" of doctors accepted marijuana as having a medical use in treating cancer patients, multiple sclerosis, and hyperparathyroidism.9 ' He cited copious examples of marijuana's usefulness in treatment and concluded that any decision claiming that marijuana had no acceptable medical use in the United States would be "unreasonable, arbitrary, and capricious."92 He concluded that marijuana was medically beneficial and recommended that the DEA reschedule marijuana to Schedule H.93

The DEA administrator, for the second time, rejected the findings of an administrative law judge, in this case claiming that the anecdotal evidence Judge Young relied on did not meet the requirements of scientific evidence.94 He applied an eight part test previously developed by

9 'In the Matter of Mariluana Rescheduling Petition at 29, 34, 54-5.

" In the Matter of Marijuana Rescheduling Petition at 34.

93 In the Matter of Marijuana Rescheduling Petition at 67.

9454 Fed. Reg. 53767 (1989)

19

the DEA to determine whether marijuana had an accepted medical use in the United States,95 and on the basis of that test denied NORML's petition.

NORMiL appealed for the fourth time and the court for the fourth time reversed the DEA, calling its eight part test "arbitrary and capricious."96 It noted that at least three of the eight factors in the DEA's test could not possibly be met by a Schedule I drug, creating a catch 22 where no Schedule I substance could ever be rescheduled because it would fail the test by virtue of its classification as a schedule I drug.97 The DEA Administrator issued a new five part test that omitted the three impossible factors, and ruled that because marijuana did not meet this test either, it would remain in Schedule 1.98 He also noted that in the future, anecdotal evidence of

95 The eight part test required a drug to meet the following requirements to be considered to

have an accepted medical use in treatment in the United States:

1. Scientifically determined and accepted knowledge of its chemistry;

2. The toxicology and pharmacology of the substance in animals;

3. Establishment of its effectiveness in humans through scientifically designed clinical trials;

4. General availability of the substance and information regarding the substance and its use;

5. Recognition of its clinical use in generally accepted pharmacopeia, medical references, joumals or textbooks;

6. specific indications for the treatment of recognized disorders;

7. Recognition of the use of the substance by organizations or associations of physicians;

8. Recognition and use of the substance by a substantial segment of the medical practitioners in the United States. 54 Fed. Reg. 53767, 53783 (1989).

96 Alliance for Cannabis Therapeutics et al. v. DEA, 930 F.2d 936, 940 (1991).

97 Numbers 4, 5 and 8 were deemed impossible for a Schedule I drug to meet. Alliance for Cannabis Therapeutics et al. v. DEA, 930 F.2d 936, 940 (1991).

98 The five part test includes the following factors:

1. The drug's chemistry must be known and reproducible;

2. There must be adequate Safety Studies;

3. There must be adequate and well-controlled studies proving efficacy;

4. The drug must be accepted by qualified experts

5. The scientific evidence must be widely available.

20

effectiveness and opinions of practitioners would not be considered by the DEA in evaluating rescheduling petitions 7' NORML appealed for the fifth time and lost.'~

NORMIL spent twenty-two years attempting to reschedule marijuana. The DEA spent sixteen years avoiding the petition before it ever held a hearing on its merits; then it rejected the administrative law judge's recommendations. Four times, the DEA was overturned by appellate courts, sometimes with criticism for acting in bad faith. This experience led marijuana advocates to conclude that at the federal level politics and medicine were inseparable and the politics would prevail.

B. The Compassionate ND Program

During these years, marijuana advocates also pursued other avenues to allow patients and physicians to obtain marijuana on a case by case basis for treatment. In the late 1970's, they succeeded in persuading the FDA to create a single patient ND program also known as the compassionate ND program, which allowed approved physicians to receive and dispense marijuana to their patients."" The FDA administered the program and evaluated the applications, and the National Institute on Drug Abuse (NIDA) provided the marijuana.'02 To comply with the

57 Fed. Reg. 10499, 10506 (1992).

~S7 Fed. Reg. 10499, 10506 (1992).

'00 Alliance for Cannabis Therapeutics et al. v. DEA, 15 F.3d 1131 (1994).

""Lester Grinspoon, M.D. & James B. Bakalar, ID, Marihuana as Medicine: A Plea for Reconsideration JAMA, June 1995 ~~ised at the Schaffer Library of Drug Policy web site <http ://www.druglibrary.org/schafferlhemp/medical/grinjama.htm> (January 10, 1998).

'02 Declaration of Daniel A. Spyker, Ph.D., M.D., Huffman v. FDA, No. 93-0237 NHJ (June 13, 1993), accessed at <http://mojo.calyxnetkolsen/M1EDlCAL/spyker.html> (January 10.

21

Controlled Substances Act, the physicians also had to obtain DEA registration before they could obtain the marijuana from NIDA.'03

As the AIDS epidemic increased, more patients began applying to the program. In response, the federal government discontinued the program, citing its opposition to illegal drugs and the lack of persuasive research to indicate the program's value.'04 NIDA would continue to supply patients already receiving marijuana, but patients who had been approved by the FDA but not yet by the DEA were excluded.'05 Due to attrition, the program currently provides marijuana to eight patients. 06

By 1992, the compassionate ND program had been discontinued and the futility of NORMIL's petition to reschedule marijuana was becoming apparent. Marijuana would remain forbidden unless its advocates could obtain FDA approval. On the other hand, the AIDS epidemic coupled with evidence that marijuana could help alleviate the nausea and weight loss associated with AIDS had increased the support for access to marijuana. These factors led to renewed attempts at clinical testing.

'03 Id.

'04 Lester Grinspoon, M.D. & James B. Bakalar, ID, Marihuana as Medicine: A Plea for Reconsideration JAMA, June 1995 ~~at the Schaffer Library of Drug Policy web site <http://www.druglibrary.org/schaffer/hemp/medicallgrinjania.htm> (January 10, 1998); Peter Gwynne, Trials of Marijuana's Medical Potential Languish as Government Just Says No , The Scientist Vol:9, No.23, November 27, 1995, 3, accessed at The Scientist web site <http://www.the-scientist.library.upenn.edulyrl 995/nov/smoke_95112 .html> (April 29, 1998).

'05 Declaration of Daniel A. Spyker, Ph.D., M.D., Huffman v. FDA, No. 93-0237 NHJ (June 13, 1993), accessed at <http://mojo.calyxnet/—olsen/MEDICAL/spyker.html> (January 10, 1998).

'06 Lester Grinspoon, M.D. & James B. Bakalar, ID, Marihuana as Medicine: A Plea for Reconsideration JAMA, June 1995 accessed at the Schaffer Library of Drug Policy web site <http://www.druglibrary.org/schaffer/hemp/medical/grinjama.htm> (January 10, 1998).

22

~.. Roadblocks to Clinical Testing

Dr. Donald Abrams, an AIDS researcher, worked with the FDA to develop a suitable protocol for a study of marijuana's effects on AIDS wasting syndrome. The FDA approved ND No. 43,542 allowing Abrams to proceed. Abrams encountered difficulty, however, in obtaining the marijuana to perform the study. The only legal access to Schedule I drugs is by importing it with the approval of the DEA or obtaining it from a DEA registered domestic producer.'07 The DEA refused to allow Dr. Abrams to import marijuana and the only registered domestic producer in the United States, NIDA, refused to provide a supply.'08 Researchers in the United States were left with a Catch 22. The DEA refused to reschedule marijuana until legitimate scientific research showed that it had medical benefits; however, the federal government was preventing researchers from performing FDA approved research.

In 1996, marijuana advocates' assertions that politics, not science, was driving the government's resistance to marijuana and that the DEA had intentionally thwarted Dr. Abrams study were substantiated. After the DEA refused a Freedom of Information Act request, Public Citizen sued the DEA and obtained a letter written by the DEA to the FDA accusing it of approving an illegitimate study and informing it that the DEA would not cooperate.'09 In the letter, the DEA expressed its intention to prevent Dr. Abrams from importing marijuana and to reject his request for registration to dispense a Schedule I drug unless the FDA changed the study

t0721 C.F.R. 1301.18(a).

'08 Lester Grinspoon, M.C. & James Bakalar, Marijuana. The AIDS Wastin2 Syndrome. and the U.S. Government , New EDgiand Journal of Medicine, September 7, 1995, accessed at MAPS web site <http://www.maps.org/mmj/nejm.htm.> (January 10, 1998).

'09 Letter from Gene R. Haislip, Deputy Assistant Administrator, Drug Enforcement

Administration to David A. Kessler, M.D., Commissioner, Food and Drug Administration (June

8, 1994) accessed at The Marijuana Policy Project web site <http://www.mpp.org/deal.html>

(April 14, 1998).

23

to fit the DEA's criteria."0 The most distressing aspect of the letter is that it indicated an effort by a law enforcement agency to force the agency responsible for scientific evaluation of medicines in the United States to alter its scientific procedures.

In the early 1990's, marijuana advocates were faced with a problem. In 1992, the government discontinued the compassionate ND program. Then in 1994, NORML lost its final appeal to reschedule marijuana to Schedule II. Finally, in 1995, NIDA and the DEA refused to allow an FDA approved study on marijuana's efficacy to proceed. The advocates were left with conundrums and Catch 22's, but without options.

Shortly thereafter, the movement tumed its attention away from the federal avenues that had proven futile after twenty three years of effort, and directed its efforts towards the states. This movement to the states was a reasonable and natural progression of their efforts. Advocates felt that while federal politics opposed medical marijuana, the people did not. They were right. In 1996 voters in California and Arizona passed initiatives that would legalize marijuana, at the state level, for medical purposes.

IV. Analysis of What Drafts of Future Medical Marijuana Initiatives Can Learn from the Arizona and California Initiatives.

Now that medical marijuana activists have moved away from the traditional routs of

change, they need to define their ultimate goals. Marijuana advocates have diverse ultimate goals; some see medical marijuana as the first step in legalizing either marijuana or all drugs, others care only about the issue of medical access to marijuana, and others joined the movement because they disagree with government influence in personal choices generally, and they see medical marijuana prohibition as such interference. Activists who see medical marijuana legalization as a step in a broader ultimate plan may prefer a different approach than those

"0 1d.

24

focused strictly on obtaining medicine for the sick. For example, if marijuana is approved by the FDA and rescheduled, it still may not be distributed without a prescription, and physicians and pharmacists must comply with strict record keeping requirements."' Activists with strong libertarian leanings want the government completely uninvolved with medical marijuana and see the issue as one of personal privacy. These activists may disapprove of such stringent controls of marijuana, especially if they seek to legalize marijuana completely as the next step. They might prefer a system that hindered law enforcement officers by making it difficult for them to quickly distinguish medical marijuana from black market recreational marijuana.

This paper does not attempt to divine medical marijuana activist's motivations and assumes that the ultimate goal is to achieve FDA approval of marijuana and treatment by federal and state governments equivalent to any other medical drug, unaffected by politics.

A . ~

Notwithstanding the varied ultimate goals of medical marijuana initiative drafters, pursuing state medical marijuana initiatives involves three more basic goals or strategies that drafters must keep in mind: drafting an initiative that the voters will pass, exerting pressure on the federal government to change its policy, and creating a statute that works after the federal government does change its policy. First, drafters must create an initiative that is politically palatable to more than half of the voters so it will pass. An initiative that allows anybody to get marijuana for any condition anytime without restriction would certainly fail. Activists often feel

"'21 C.F.R. 1306.05.

25

that any concessions to placate their opponents constitutes capitulation or selling out and they need to remain true to the cause regardless of the cost. The failure of medical marijuana initiatives throughout the country, however, would damage the movement and give opponents more credibility. In this case, it is not better to have tried and failed than to never have tried at all. Therefore, drafters must consider how the public will perceive the text and more importantly, in what ways the text lends itself to negative spins by opponents.

Second, pressuring the federal government flows naturally from the first goal. A primary reason for passing an initiative is to pressure the federal government, either to permit the research necessary to obtain FDA approval, or to back off and acquiesce to the way states wish to regulate medical marijuana use. Such policy changes would occur due to the political message state voters who pass initiatives send to the federal government. They also come from the increased responsibility the federal government must shoulder if certain types of drug violations no longer violate state law. The federal government is simply not equipped to investigate, arrest, and prosecute every dime bag dealer operating in even one large state, let alone several.'12

Third, when the federal government does back off, either through a change of policy or lack or resources, the state needs to have a workable system. When the federal government changes its policy, it will not merely legalize marijuana, nor will it acquiesce to the states forever. It will defer to the states until definitive information on the risks and benefits can be ascertained, whereupon it will adjust its policy accordingly. During this time, the state law will

"2 The DEA rarely prosecutes possession for quantities anywhere near an amount that would constitute personal possession. The average weight of marijuana for DEA conviction cases is over 300 pounds and the U.S. Attorney's threshold policy for prosecution in Los Angeles and Orange County, California is 200 kilograms of marijuana or 200 plants. Hearings on the Arizona and California Medical Drug Use Initiatives Before the Senate Comm. on the Judiciarv , (December 2,1996) (Statements of Tom Constantine, Administrator of the Drug Enforcement Agency and Brad Gates, Sheriff, Orange County, CA), available in LEXIS Legis Library. Fednew File.

26

govern medical marijuana use in the state. If the initiative is unworkable, patients will suffer. In many states, the legislatures cannot alter voter initiatives. The only way to fix the system would be to place a new initiative on the ballot, which is not an attractive option. Therefore, drafters must balance the need to draft a politically feasible initiative with the need to create a workable one.

Writing initiatives while balancing these multiple goals is a complex undertaking. One not only needs to create a workable initiative, but one that voters will approve. Some aspects of an initiative, however, may be desirable in developing a good statute, but are not politically acceptable. Other aspects are not necessary to the effectiveness of the statute, but are politically popular and can help an initiative gain needed votes. Other aspects may be politically damaging, but are essential to a workable statute and must be included regardless of the fodder it provides opponents.

The California, and to a lesser degree, Arizona initiatives provide an opportunity to examine what aspects of an initiative can create political liabilities, which cause unforseen problems, and which are necessary to a properly functioning medical marijuana statute. In this section, I will first describe some of the general criticisms directed at state initiatives. Then I will describe the Arizona and California initiatives and what has occurred since they passed. Finally I will discuss the lessons medical marijuana advocates can glean from the experiences associated with these initiatives.

B. Criticisms Leveled Against State Medical Marijuana Initiatives

Some criticisms opponents level at medical marijuana initiatives apply to all initiatives. They argue that marijuana is not FDA approved, legalizing marijuana as a medicine sends the wrong message to children, and these initiatives are attempts at backdoor legalization, evidenced

27

by the fact that patients do not even need a doctor's prescription to use marijuana. These criticisms are really a product of the situation and drafters cannot avoid them through changes to the texts. Nevertheless, the fundamental flaw in these criticisms suggest the possibility that opponents, many of whom hold government positions, are willing to use disingenuous arguments and untruths to defeat these initiatives.

1. Argument That Marijuana Is Not FDA Approved

Opponents argue that the FDA's purpose is to protect consumers from unsafe drugs, and drugs therefore, should not be available without FDA approval."3 They argue that marijuana should be subject to the same approval process as any other drug. General McCaffrey argued:

"[A] llowing any potential medication to bypass [the FDA] process establishes a loophole that threatens to undermine the imperative for rigorous science as the basis for determining what constitutes good medicine."''4

These opponents fail to note two problems with their argument. First, no market incentive exists for anybody to obtain FDA approval for marijuana."5 Second, as discussed in Section HI, the federal government has thwarted attempts by researchers to do the studies necessary for FDA approval. Given the federal government's history of blocking studies on the potential medical benefits of marijuana, it is disingenuous for its representatives such as Orin

"3 James P. Fox, Michael J. Meyers, M.D., & Sharon Rose, Argument Against Proposition 215 , 1996 California Election Pamphlet, reprinted in Cal. Att'y General's Office, Proposition

215: An Analysis (Dec. 20, 1996) Appendix I.

" 4 Hearings On Medical Marijuana Referenda in America Before the Subcomm. on Crime of the House Comm. on the Judiciary , 105th Cong. (October 1, 1997) (Statement of General Barry R. McCaffrey, Director, Office of National Drug Control Policy), ~ <http://www.whitehousedrugpolicy.gov/news/testimony/medical.html> (April 23, 1998).

"5 See Section HI, discussion on the lack of incentives to seek FDA approval for marijuana

28

Hatch and Barry McCaffrey to argue that marijuana should not be used for medical purposes until the FDA approves it."6

2. Argument that legalizing marijuana for medical uses sends the wrong message to children

The second argument opponents make against medical marijuana initiatives, and the movement in general, is that approving marijuana for medical purposes would send the wrong message to children."7 The opponents, however, fail to note that both cocaine and opium are Schedule II drugs under the Controlled Substances Act. Both cocaine and opium have accepted medical uses in the United States. Cocaine, for example, is used as a local anesthetic."8 Yet the opponents do not seem to fear that cocaine's status as a medicine sends a message to children that it is safe for recreational use. Opponents take a disingenuous position when they argue that treating marijuana equivalent to cocaine and opium sends the wrong message to children. If the marijuana activists had succeeded in creating parity in scheduling between marijuana and cocaine, they probably would not have tumed to the state initiative movement because researchers would have had less restricted access to marijuana to pursue FDA testing and physicians could have prescribed it on an individual basis.

" 6 Hearings on the Arizona and California Medical Drug Use Initiatives Before the Senate Comm. on the Judiciary , (December 2, 1996), available in LEXIS Legis Library, Fednew File.

" 7 Hearings on the Arizona and California Medical Drug Use Initiatives Before the Senate

Comm. on the Judiciary , (December 2, 1996)(statement by Brad Gates, Sheriff, Orange County

California), available in LEXIS Legis Library, Fednew File; Hearings On Medical Marijuana

Referenda in America Before the Subcomm. on Crime of the House Comm. on the Judiciary ,

105th Cong. (October 1, 1997) (Statement of General Barry R. McCaffrey, Director, Office of

National Drug Control Policy), accessed at

<http://www.whitehousedrugpolicy.gov/news/testimony/medical.html> (April 23, 1998).

"8 Stedman's Medical Dictionary 337 (2 1st ed. 1966).

29

3. Patients do not even need a doctors prescription to use marijuana

The third general argument opponents make is that the initiatives are attempts at backdoor legalization evidenced by the fact that patients do not even need a doctor's prescription to use marijuana. "~ As discussed in Section IIC, physicians who prescribe Schedule I drugs risk criminal prosecution and the loss of their licenses to prescribe controlled substances. The initiatives seek to protect physicians by allowing them to merely recommend marijuana to patients. The opponents understand this conundrum,'20 yet disingenuously seize it as an opportunity to accuse the initiative drafters of attempting to surreptitiously legalize marijuana.

C. Arizona

Arizona's Proposition 200 is a broad drug and crime bill that goes beyond the medical marijuana issue and attempts to restructure the way Arizona deals with drugs. It sought to redefine the drug issue as a medical as opposed to punishment minded one. Some of these issues go beyond the scope of this paper. I will highlight them, but only go into detail on the issues surrounding medical marijuana.

'"'James P. Fox, Michael J. Meyers, M.D., & Sharon Rose, Argument Against Proposition

215, 1996 California Election Pamphiet, reprinted in Cal. Att'y General's Office, Proposition

215: An Analysis (Dec. 20, 1996) Appendix I; Leon Worden, Marijuana Initiative is Bad

Medicine , The Signal, (Oct. 2, 1996), reprinted in

<http://www.scvleon.com/signa1/lwl00296.htm> (Feb. 5, 1997).

'20 Cal. Att'y General's Office, Proposition 215: An Analysis (Dec. 20, 1996) at 5.

30

1. Summary

a. General Provisions

Proposition 200 creates a nine member Parents Commission on Drug Education and Prevention appointed by the governor, consisting of parents, law enforcement officials, educators, and drug treatment experts.'2 ' This commission's mandate is to fund programs to increase and enhance parent involvement and education on alcohol and drug problems.'2 The initiative provides for the commission's funding through increased taxes on alcohol and tobacco.'23

Proposition 200 also requires people convicted of violent crimes while under the influence of a controlled substance to serve 100% of their sentences without parole.'4 The initiative also provides that individuals in prison for personal possession of drug charges be immediately eligible for parole.'25 As a condition of their parole, they are required to participate in a drug treatment plan.'26 Furthermore, after the proposition takes effect, new individuals convicted of personal possession charges will be given probation and required to participate in a drug treatment program as a condition of such probation.'27 Individuals convicted of simple

'21 Arizona Proposition 200 §4(1).

'22 1d.

123 pj §§4, 12.

l24~ §5.

125~~ §8.

l26~ §9.

27 J4 §10.

31

possession charges for the third time would then be sentenced to prison under the standard sentencing provisions.128

b. Provisions Relating to Marijuana

Proposition 200 allows seriously and terminally ill patients to possess controlled substances, including those in Schedule I, when prescribed by a physician.'29 When prescribing schedule I drugs, doctors must comply with professional medical standards and document that scientific research exists to support its use.'30 The doctor must also obtain a written second opinion by a second medical doctor stating that the prescription is appropriate.'3 ' Finally, the doctor must obtain written consent from the patient'32 Any failure to meet these requirements will result in discipline by the board of medical examiners. As an additional safeguard, the initiative declares any information given in an effort to unlawfully obtain a Schedule I drug will not be privileged doctor-patient communication.'34

Proposition 200 not only exempts patients from prosecution, but it creates a distribution system by exempting participants in the legitimate drug distribution channel, from the doctor to the pharmacist and common carrier, from drug prohibition laws when acting within guidelines of the statute.'35 Such guidelines include a requirement that doctors and pharmacists act in good

18~ J § 10(7).

l29~ §6(9).

130 pj §7(l)-(2).

l3l~ §7(2).

132k §7(2).

133k §7(3).

134 p~j §6(9)(3).

135 pj §6.

32

faith and in accordance with acceptable medical standards.'36 Allowing for distribution as well as possession avoids the problems associated with the California Proposition 215, which only exempts patients and primary caregivers from prosecution. In that system, patients may possess marijuana, but they cannot obtain the marijuana without causing another person to break the law.'37

2. Subsequent Developments

Proposition 200 does not offer observers a chance to study its implementation. Although it passed with 65.4%l38 of the vote, the Arizona legislature effectively gutted the initiative. In Arizona, the legislature may amend initiatives passed by the voters as if they were any other statute. Taking advantage of this loophole, the Arizona state legislature passed Ariz. H.B. 2518, which does not allow the two sections of the initiative that relate to marijuana (§§ 6, 7) to take

effect until "Congress authorizes the medical use of marijuana or. . . the federal food and drug administration authorizes the medical use of marijuana and the drug enforcement administration reschedules marijuana to a schedule other than schedule I."'~~ Arizonans for Drug Policy Reform, The group that supported Proposition 200, has since renamed itself The People Have Spoken, and is supporting a state initiative to overturn this legislation.'40

'36 H §6(2).

'37 Even patients who grow their own marijuana must obtain the seeds on the black market.

'3t Arizona Secretary of State web site, Unofficial Election Results, <http://www.sosaz.comIresults/l996general/GEN5600.htm> (January 14, 1998).

'39 Ariz. H.B. 2518 (1997). See also Ariz. Stat. §13-3412.01.

'40 National Organization for the Reform of Marijuana Laws (NORML), Press Release. accessed at <http://www.pdxnorml.org/050897.txt> (April 18, 1998).

33

D California

Because the Arizona legislature thwarted Proposition 200, California's Proposition 215 is the first and only medical marijuana initiative passed and implemented. Therefore, it is the only tested guide for future medical marijuana initiative drafters. Future drafters should avoid reinventing the wheel and learn from the issues and problems generated both during the election and implementation process.

Proposition 215 is relatively simple and straightforward. It states the drafters' intentions, and implements them in two sentences. Its simplicity is both a virtue and a hindrance. It is easy to understand and did not confuse the voters with technicalities. On the other hand, its lack of precision opened it to attack both during the election and in its implementation. The California experience has demonstrated the importance of technical precision in the text.

1. Summary

The California initiative entitled the "Compassionate Use Act of 1996," added Section 11362.5 to the California Health and Safety Code. The initiative has two main sections. The first section, 11362.5(b), expresses the intent of the drafters. This expression of intent provides necessary definitions and guidance for interpreting the statute. The second section, 11362.5(c)-(d), provides the affirmative defenses to marijuana laws, or implements the intent expressed in 11362.5(b). The initiative also contains a severability clause protecting the remainder of the initiative if a court declares a portion of it invalid.'4 '

'41 Cal. Proposition 215 §2.

34

The initiative exempts patients and primary caregivers from marijuana cultivation and possession laws when they use marijuana for medical purposes based "upon the written or oral recommendation or approval of a physician."'42 It also protects physicians from punishment or discipline for recommending marijuana for medical purposes to patients."'3 These two exemptions summarize the heart of the law: to protect patients, primary caregivers, and physicians who wish to include marijuana in a patient's treatment. The initiative expressly withholds a defense for conduct endangering others or for diverting marijuana to nonmedical uses.'"

The statute has two express definitions. First, a patient may use marijuana for the following medical conditions: "cancer, anorexia, AIDS, chronic pain, spasticity, glaucoma, arthritis, migraine, or any other illness for which marijuana provides relief."'45 Second, "primary caregiver" means "the individual designated by the [patient] who has consistently assumed responsibility for the housing, health, or safety of that person."'~

2. Subsequent Developments

When proposition 215 passed in November 1996, it initially provoked strong, negative responses from both federal and California government leaders. On the other hand, passage of proposition 215 prompted numerous positive developments from the point of view of the medical

'42 Cal. Proposition 215 §1; Cal. Health & Safety Code § 11362.5(d).

'43 Cal. Proposition 125 §1; Cal. Health & Safety Code §11362.5(c)

'"Cal. Proposition 125 §1; Cal. Health & Safety Code §11362.5(b)(2)

'45 Cal. Proposition 125 §1; Cal. Health & Safety Code §1 1362.5(b)(A)

'"Cal. Proposition 125 §1; Cal. Health & Safety Code §11362.5(e)

35

marijuana movement. Examining these subsequent developments offers drafters an opportunity

to observe how the initiative and its accompanying case law has developed.

a. Federal Response

Both California and Arizona passed initiatives that legalized marijuana for medical uses, so the federal response was generally directed at both initiatives. The initial federal response involved taking a bipartisan tough stance, harshly criticizing the initiatives, and threatening to enforce federal law against physicians and patients involved in medical marijuana.

Senator Orin Hatch convened a meeting of the Senate Judiciary Committee in which, among others, General Barry McCaffrey, the Director of the Office of National Drug Control Policy, and Tom Constantine, the Administrator of the DEA spoke.'47 The committee attempted to determine the ramifications of the initiative and develop a plan for handling the situation. Senator Hatch, General McCaffrey, and Mr. Constantine all used the dearth of scientific studies and the lack of FDA approval to justify their stance opposing the state initiatives.'48 In his remarks, General McCaffrey said that the initiative was a hoax proposition and called it a "Cheech and Chong show."'49 Many speakers voiced fear, pointing out unforeseeable consequences of the initiatives such as marijuana smoking school bus drivers and people using marijuana for corns on their feet, with no possibility for law enforcement agencies to stop such actions. ISO

'~ Hearings on the Arizona and California Medical Drug Use Initiatives Before the Senate Comm. on the Judiciary , (December 2, 1996), available in LEXIS Legis Library, Fednew File.

'48 Id

'49 Id.

'50 1d.

36

Both Mr. Constantine and Senator Hatch expressed concern as to whether state and local law enforcement officials had the authority to make an arrest for violations of federal law in situations where neither the state or federal government had no immediate plans to prosecute.'5 ' Mr. Constantine concluded that the Controlled Substances Act did not provide such authority to local agencies.1 " They also expressed concern that federal agencies were not equipped to handle the load of drug cases that could potentially be shifted from state to federal responsibility.'53 Nevertheless, Mr. Constantine committed to prosecute "significant drug traffickers" including physicians.

Four weeks later, the government was ready to address the issue with the public. On December 30, 1996 General McCaffrey; Donna Shalala, Secretary of Health and Human Services; and Attorney General Janet Reno issued a document and briefed the public on how it intended to handle the situation)54 Attorney General Reno indicated that the government would consider prosecuting or revoking the registration of any physician who rccommended marijuana to patients.'55 She said that the government would "not turn a blind eye toward [its] responsibility to enforce federal law and preserve the integrity of the medical and scientific process to determine if drugs have medical value before allowing them to be used."'56 The written statement, on a stronger note, warned physicians that the DEA would take action to

l5lI~

'"Id.

'54 News Conference With Drug Control Policy Director General Barry McCaffrey, Attorney General Janet Reno, and Donna Shalala, Secretary of Health and Human Services, White House Briefing, December 30, 1996, available in LEXIS Legis Library, Fednew File; 62 F.R. 6164.

'"Id.

37

revoke the registrations of physicians who prescribe or recommend marijuana, and the Department of Health and Human Services (HIHS) would exclude them from participating in Medicare and Medicaid programs.'" HHS and the Department of Justice ("DOJ") backed off of their position a bit and clarified their stance in a joint letter stating that it did not intend to institute a gag rule and a physician could discuss the risks and benefits of marijuana with a patient, but "'physicians may not intentionally provide their patients with oral or written statements in order to enable them to obtain controlled substances in violation of federal law. Physicians who do so risk revocation of their DEA prescription authority, criminal prosecution, and exclusion from participation in the Medicare and Medicaid programs.""58

In response to the Administration's hard line against physicians, a group of California physicians and patients attempted to work out a compromise with the federal government to prevent the abuses that the government feared. They sought an agreement where the federal government would not prosecute a physician "who discusses or recommends medical marijuana in the physician's best medical judgment and in the context of a bona fide physician-patient relationship."'59 McCaffrey and the Justice Department refused to the proposed agreement, again asserting its ability to criminally prosecute physicians who recommend marijuana to a patient. In response, the group filed a class action claiming that the government's threats to discipline physicians who recommend marijuana to their patients caused a chilling of First Amendment

'~~62 F.R. 6164.

'58 Conant v. McCaffrey, 172 F.R.D. 681, 688, 1997 U.S. Dist. LEXIS 8749 (U.S.D.C. Northern Dist. CA 1997).

'59 Eric Brazil, Drug Czar Won't Budge: McCaffrey Rejects Doctors' Settlement on MedicczI Pot, The San Francisco Examiner, February 9, 1997, C-2.

38

speech rights'60 The government countered with the argument that recommending marijuana crossed the line to assisting with a violation of the law.'6 ' On April 30, 1997 the court issued a preliminary injunction against the government from imposing or threatening to impose criminal or civil sanctions on physicians for actions that do not rise to the level of a criminal offense.'62 The court recognized that what constitutes a criminal offense is not exactly clear,'63 but the case nonetheless gave physicians leverage in the dispute and stopped the federal government from threatening physicians and patients.

The Justice Department then turned its attention to the buyers clubs, seeking injunctions against six buyers clubs to force them to close.'64 It is interesting to note that Justice did not target clients of the buyers clubs and chose to file civil suits against the clubs and their operators instead of seeking criminal charges. The Justice Department admitted that political considerations influenced their decision. The action against the buyers clubs indicates that the federal government has moved away from its initial harsh, uncompromising rhetoric.'65

'60 Complaint, Conant v. McCaffrey, January 14, 1997. ~~~diI <http://www.lindesmith.org/mmjsuitIcomplnt.html> (April 15, 1998).

""Hearing Transcript of April 11, 1997 Plaintiffs' Motion for Preliminary Injunction and Defendant's Motion to Dismiss, United States District Court for the Northern District of California, accessed at <http://www.lindesmith.org/mmjsuitItranscrl.html> (April 15, 1998).

'62 Conant v. McCaffrey, 172 F.R.D. 681, 700, 1997 U.S. Dist. LEXIS 8749 (U.S.D.C. Northern Dist. CA 1997).

'63 Id

'64 Kate Rix, Feds Jump into Marijuana Club Prosecutions , The Recorder, January 12, 1998. News 2.

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In addition to Senator Hatch and the Senate Judiciary Committee, both houses of Congress have tackled the issue of the state initiatives. Although many bills and resolutions die in committee, a House vote is scheduled for late April on a Resolution declaring the House of Representatives's opposition to the medical use of marijuana.'66 Other anti-medical marijuana bills have been introduced in Congress, but remain in committee.'67 Judging from the text, they appear to be knee jerk reactions with little chance of passing or being effective. One bill has been introduced in Congress that would reschedule marijuana to Schedule II, allow its use for medical purposes in states that permit such use, and require the National Institute on Drug Abuse to provide marijuana for Investigative New Drug Studies approved by the FDA.'68 This bill has ten co-sponsors and was introduced to the Committee on Commerce on June 4, 1997 and to the Subcommittee on Health and Environment on June 18, 1997. Otherwise it has remained inactive.

Not all responses from the federal government, however, have been negative. The federal government has also responded to the state initiatives in California and Arizona with increased openness toward scientific testing of marijuana. In January of 1997, General McCaffrey and the White House Office of National Drug Control Policy commissioned a study by the Institute of Medicine (IOM) of the National Academy of Science (NAS) to "conduct a comprehensive

'66 H. Res. 372, 2nd Sess. 105th Cong. 1998.

'67 H.R. 1265 (restricting certain benefits for individuals convicted of state offenses when the state does not prohibit marijuana for medical purposes); H.R. 1310 (requiring the Attorney General to revoke physicians' controlled substance registration if they recommend an illegal substance); H.R. 3184 (reiterating federal supremacy of Controlled Substances Act over state law).

'68 H.R. 1782, 1st Sess. 105th Cong. 1987.

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review of the known health effects and potential medical use of smoked marijuana."'69 Medical marijuana advocates were initially skeptical of such a study, and felt that it was an attempt to give medical marijuana opponents a token study to show that the government was addressing the issue, while avoiding new studies of marijuana.'70 Some activists, however, have changed their position, noting that the IOM group is looking beyond the existing, decades-old research to the anecdotal evidence and is seeking public comment on the issues.'7 '

Additionally, in February 1997, the National Institutes of Health (NIH) held a two day conference where it brought together an ad hoc group of experts to study the medical marijuana issue.172 The group found that the existing studies did not provide definitive answers; however, based on promising preliminary evidence, it recommended new controlled studies.'73 It also recommended that NIDA should supply marijuana to studies that meet U.S. regulatory standards.'74 Subsequently, in September 1997, NIDA not only agreed to provide the marijuana

'69 Statement by General Barry R. McCaffrey, Director, Office of National Drug Control Policy, Submitted for the Record to the House Judiciary, Committee, Subcommittee on Crime, Medical Marijuana Referenda in America, October 1, 1997, accessed at

<http //www whitehousedrugpolicy.gov/news/testimony/medical.html> (April 23, 1998).

170 Telephone interview with Paul Wolf, ACT UP (January 17, 1998).

'~' Telephone interview with Dave Fratello, Spokesperson, Americans For medical Rights (April 2, 1998). ~ Teri Sforza, Pot useful or bad medicine ? The Orange County Register, December 14, 1997, A-i

'"Workshop on the Medical Utility of Marijuana, Report to the Director, National Institutes of Health, by the Ad Hoc Group of Experts (February 1997) accessed at <http://www.nih.gov/news/medmarijuana1MedicalMarijuana.htm> (April 5, 1998).

'73 1d.

'74 Defined as FDA protocol approval and DEA controlled substances registration. Id . This definition is problematic because FDA approval of a protocol does not guarantee the DEA will approve the controlled substance registration. Letter to David A. Kessler, M.D., Commissioner. FDA, from Gene R. Haislip, Deputy Assistant Administrator, DEA, June 8, 1994. (refusing to grant controlled substance registration to researcher with approved ND, citing insufficient FDA assurance of scientific integrity).

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for Dr. Abrams's study on AIDS wasting, but it gave Dr. Abrams a $978,000 grant for the study.'75 "The two-year study will be the first FDA-approved study of the use of smoked marijuana in a patient population in about fifteen years."'76 Ironically, had the federal government taken these steps toward allowing research two years earlier, it may have never had to deal with the problems spawned by the state initiative movements.

b. State Response

On the state level, the response by leaders was critical, albeit a bit unsteady. Attorney General Dan Lungren called Proposition 215's passage a disaster.'" His office expressed concern at the "legal anarchy" the initiative created, but admitted no plans to challenge the new law, noting that it would not have standing.'78 Close to a year after the initiative passed, Lungren softened his stance on the idea of clinical testing. While he maintained that Proposition 215 was a "dumb idea," he expressed support for a state Senate bill that would provide for testing of marijuana's medical value and agreed to provide the marijuana if the federal government refused.'79

'75 Multidisciplinary Association For Psychedelic Studies, Medical Marijuana Research in the 90's : The struggle to begin a medical marijuana research project (updated April 1998), accessed al <http://www.maps.org/mmj/index.htm1> (April 15, 1998). ~ Section IIIC discussing Dr. Abrams's study.

176 Multidisciplinary Association For Psychedelic Studies, Medical Marijuana Research in the

90's : The struggle to begin a medical marijuana research project (updated April 1998), accessed a! <http://www.maps.org/mmj/index.html> (April 15, 1998).

'"Jon Mathews, Voters favor medical marijuana , San Francisco Bee, November 6, 1996, AlS.

'78 Eric Brazil, Medicinal Marijuana Vote Stymies Lungren , The San Francisco Examiner, November 7, 1996, A-8.

'79 Robert B. Gunnison, Lungren Backs Medical Pot Study , The San Francisco Chronicle, August27, 1997, A18.

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Lungren has also actively opposed the buyers clubs. The buyers club concept and their involvement in distributing medical marijuana predates Proposition 215. After Proposition 215, more buyers clubs began forming throughout the state. The state and federal governments, however, did not turn the expected blind eye and are seeking to close them. Because Proposition 215 does not contain a provision for distribution, the buyers clubs turned to the primary caregiver clause for protection. Purporting to fit a buyers club into the primary caregiver definition of an "individual designated by the [patient] who has consistently assumed responsibility for the housing, health, or safety of [the patient]."'80 is a stretch, but it is the only avenue. Denis Peron, the operator of the Cannabis Cultivators Club, the largest and most famous club in California serving over 9,000 clients,'8 ' asserted that he was a primary caregiver to his clients after the California Attorney General's office sued to enjoin his operation.'82 A California appeals court

rejected Peron's argument and ruled that buyer's clubs do not fit the criteria of a primary

183

caregiver.

The court also ruled that Proposition 215 only protects patients and primary care givers from prosecution for marijuana possession and cultivation. It does not provide any defense for people who sell or distribute it outside of a patient-primary caregiver relationship. "Thus.. . one who sells, furnishes, or gives away marijuana to a patient or qualified primary caregiver...

'80 Cal. Health and Safety Code §11362.5(e).

'81 Mary Curtius and Maria L. La Ganga, Judge Orders Closure of Cannabis Club , Los Angeles Times, April 16, 1998, A 3.

'82 The Attorney General's Office brought suit prior to Proposition 215, and Peron asserted the defense after its passage.

'83 Lungren v. Peron, 59 Cal. App. 4th 1383, 1390, 70 Cal. Rptr. 2d 20 (1997).

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violates the law."'84 The court noted that the drafters expressly avoided providing a defense for sale and distribution, even though they could have easily done so.'85 Although it recognized the dilemma of patients who, while immune from prosecution themselves, put those from whom they purchased marijuana at risk, the court refused to interpret the statute in a manner that would contradict the way it was presented to the electorate.'86 On April 16, 1998 a state court issued a permanent injunction against Peron, citing illegal sales as the primary reason for the injunction.'87 The criminal trial is still pending.'88

In a twist of events that shows the strong division among government authorities in California on the medical marijuana issue, the San Francisco County Sheriff refused to close the club as ordered by the judge. Although Lungren announced that he would act to enforce the injunction if the Sheriff refused, he found himself on weak footing because prosecutions for violating the injunction fall under the jurisdiction of the San Francisco District Attorney, who also supports the buyers clubs and appeared unlikely to prosecute.'89 Ultimately, the sheriff closed the buyers club, which reopened the next day under a new name, and Lungren is now in litigation to close the new buyers club.

I84j~~ at 1395. The court did acknowledge that a patient could reimburse a caregiver for expenses related to cultivation, or preclude a caregiver from charging the patient for caregiver services. Id. at 1399-1400.

'85 Lungren v. Peron, 59 Cal. App. 4th at 1394.

'86 1d at 1394-5.

'"Mary Curtius and Maria L. La Ganga, Judge Orders Closure of Cannabis Club , Los Angeles Times, April 16, 1998, A 3.

'88 California Department of Justice, Proposition 215 Update #10, December 8, 1997; People v. Dennis Peron, Beth Moore, et al. (Alameda County).

'89 William Claiborne, San Francisco's Political Potboiler in Fight Over Marijuana as Medicine. Sheriff Backs Growers , Washington Post, April 17, 1998, A3.

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Notwithstanding Lungren's battle with Peron, Lungren appears to have mildly softened his stance on buyers clubs. After his office obtained the injunction against Peron's club, Lungren declined to discuss possible actions against other buyers clubs in the state, possibly indicating that he recognizes that law enforcement against buyers clubs will not resolve the medical marijuana issue. Lungren said, "rather than continuing the debate about cannabis buyers clubs, let's tum our focus to a question that is still undetermined--whether marijuana has any medicinal

1%

Positive developments

Not all government responses to Proposition 215 have been negative, especially at the local level. Many community leaders have voiced their support for the initiative and many communities have made efforts to accommodate patients. In response to a suit by the federal government seeking to shut down the buyers clubs in California, on March 18, 1998 mayors from four cities, including San Francisco Mayor Willie Brown, sent letters to the White House asking the Clinton Administration to let local communities handle the buyers clubs.'9 ' They do not want to see their residents compelled to seek out their marijuana in back alleys and street corners. 92 In a further act of defiance, San Francisco City District Attorney threatened to use city workers to distribute marijuana if the federal government shut down the local buyers clubs.'" Other

'~Mary Curtius and Maria L. La Ganga, Judge Orders Closure of Cannabis Club , Los Angeles Times, April 16, 1998, Part A; Page 3.

'91 Russell Sabin, 4 Mayors Call on Clinton to Stop Pot Club Prosecutions , The San

Francisco Chronicle, March 19, 1998, A 15. The following mayors wrote letters to President

Clinton: San Francisco Mayor Willie Brown, Oakland Mayor Elihu Harris, West Hollywood

Mayor Steve Martin, and Santa Cruz Mayor Celia Scott.

'92 1d.

'"John Lyons, S.F. Set to Defend Medical Pot Clubs , Sacramento Bee, March 22, 1998, A8.

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communities have responded to proposition 215 by instituting guidelines to regulate medical marijuana in their communities. The City Council of San Jose, California unanimously passed an ordinance regulating marijuana dispensaries within the city.'94

Local Law enforcement officials have also shown their willingness to accommodate Proposition 215. In San Francisco, the Sheriff announced that he would accommodate prisoners who needed marijuana for medical purposes.'95 In Arcata, California, the Chief of Police has issued forty watermarked cards with the patient's photograph, the city's seal, and his signature to those for whom physicians have recommended marijuana. 1% His attitude is "The spirit of the law here is you have a defense, let's assert it on the corner instead of in court. It's a 10-second contact where before it would take hours."'97 This registration system has even received guarded praise from John Gordnier, the Deputy Attorney General prosecuting the civil case against Denis Peron's buyers club.'98 Perhaps the most surprising show of cooperation occurred in Mountain View, California where police arrested an AIDS patient for cultivating marijuana. The district attorney's office told the police it would not prosecute anyone who cultivated marijuana solely for medical purposes and that they should give his marijuana and cultivating equipment back, which they did.'~

'94 City of San Jose, California Ordinance No. 25280, March 25, 1997.

'95 Alex Roth, S.F. Sheriff Will Permit Medical use of Marijuana by County-jail Inmates , Los Angeles Daily Journal, April 28, 1997, 3.

'96 Kate Rix, Grass Roots Take Hold of Prop 215 , The Recorder, March 11,1998,1.

"'Id.

'"Id.

"'9 Emelyn Cruzlat, Cops Give Back Aids Patient's Pot Plants , The San Francisco Examiner. March 2, 1997,A I.

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E. Lessons learned form the California and Arizona Initiatives .

In this section I will discuss what drafters of medical marijuana initiatives can learn from the California and Arizona experiences. In these discussions I will also allude to currently active initiatives, although I will not discuss them in detail until Section V. I will first address how certain aspects of the initiatives created political liabilities, and which of those liabilities can be avoided and which cannot depending on if they are necessary for a properly functioning initiative. Second, I will discuss which aspects of the initiative hindered the goal of creating a workable statute. Some of these problematic aspects are not necessarily attributable to the presence of problematic text or the absence of necessary text, but can also result from judicial decisions and state agency interpretations. A properly functioning statute must withstand or prevent adverse judicial and administrative interpretations. Finally I will discuss the aspects of the initiatives that have not yet proven problematic, but still pose hazards to a properly functioning statute.

1. Political issues

a. Political Issues Resulting From Necessarv Provision in the Initiative

Although not requiring patients to obtain prescriptions from their physicians for marijuana, subjects an initiative to harsh criticism, protecting physicians from prosecution and discipline is imperative to a workable statute. Therefore, no initiative should require patients to obtain a prescription for marijuana. The term recommend is the term of choice; however, Conant v. McCaffrey has not yet resolved the issue of whether a physician recommending marijuana to a patient is protected by the First Amendment. Although the physicians won the preliminary injunction, the issue must still be resolved at trail. The Florida drafters have tried an interesting approach to avoid the uncertainty of the term recommend. By merely requiring physicians to

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certify that marijuana is medically appropriate and the patient may benefit from its use. This

language merely requires the physician to express an opinion, something clearly covered by the First Amendment. Regardless of whether drafters choose recommend, certify, or some other term, they cannot require a prescription, regardless of the political liability such an omission can create.

k 1 Avoidable Political Issues

One of the most politically damaging criticisms of Proposition 215, that it permits unfettered use by minors, was avoidable. The initiative did not address the issue of minors, mostly due to its simplicity. Nevertheless, it provided opponents with a persuasive argument, illustrated by such headlines as "Even Children Could Smoke Pot Legally!"20~ ' The California Attorney General interprets the initiative to allow children to grow and use marijuana, and wams that minors with primary caregivers who are not their parents could conceivably use marijuana legally without parental knowledge or consent. His office has taken a position, however, that doctors would be on weak footing if they recommended marijuana to minors. He notes that

numerous studies indicate marijuana is dangerous to youths and claims that no anecdotal studies

201

He reco

that indicate medical benefits of marijuana in children exist. mmends using child

200 James P. Fox, Michael J. Meyers, M.D., & Sharon Rose, Argument Against Proposition

215 , 1996 California Election Pamphlet, reprinted in Cal. Att'y General's Office, Proposition

215: An Analysis (Dec. 20, 1996) Appendix I.

201 Cal. Att'y General's Office, Proposition 215: An Analysis (Dec. 20, 1996) at 9; Cal. Att'y Gen Peace Officer Guide: Compassionate Use Act of 1996, 3. Although the Attorney generaUs office claims that no anecdotal studies indicating medical benefits of marijuana in children exist, and has made this claim to police departments throughout the state in its Peace Officer Guide, this information is inaccurate. In his decision stemming from the public hearing on NORMIL's rescheduling, Judge Young found several anecdotal claims that marijuana helped children and teenagers with the side-effects of chemotherapy to be persuasive. In the Matter of Marijuana Rescheduling Petition, Opinion and Recommended Ruling, Findings of Fact, Conclusions of Law and Decision of Administrative Law Judge Francis L. Young, September 6, 1988, No. 86-22, pages 20-23, accessed at <http://mojo.calyx.notkolsenJMIEDICAL/yoUNG/yo~g I html>

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welfare laws to intervene and warns of possible police department liability for not intervening. when a minor is involved202

Opponents of the initiative conveniently interpret it in two ways. During the election, they interpreted it broadly in an effort to scare voters with tales of children supplying children. After the election, they construed it narrowly to prevent any access to children. The initiative's silence on the issue was more harmful than any reasonable approach. If initiate drafters do not want to provide access to minors, then they should explicitly exclude them, thereby avoiding harsh criticism for allowing minors. If they do want to provide access to minors, they should include them and provide guidelines to avoid minors using marijuana without their parents' consent. Whether a drafter wishes to include minors or not, the issue is too explosive to ignore and all initiatives should contain a clause addressing the issue.

c. Judgement calls

I. Illnesses that qualify for treatment with marijuana

Some aspects of initiatives that create political liability are avoidable, while others are unavoidable. In other cases, drafters must make a judgment call after weighing the political liability against the desirability of the provision. First, drafters must decide whether they want to allow patients to use marijuana for any illness and trust physicians to recommend it prudently, or restrict the list of eligible conditions to an enumerated list. Proposition 215 has a clause at the end of its list of serious illnesses that says, "or any other illness for which marijuana provides relief." This clause garnered substantial criticism from opponents. They claimed that this clause opened the door to any disease including "stress, headaches, upset stomach, insomnia, a stiff

(January 10, 1998).

202 Cal. Att'y Gen Peace Officer Guide: Compassionate Use Act of 1996, 3

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neck. . . or just about anything."203 General McCaffrey cited a medical adviser to Proposition 215 who listed writer's cramp and corns on toes as conditions for which marijuana may provide relief.204 The statute leaves a lot to the discretion of doctors. While such discretion is common with most other drugs, it poses a political problem in this case.

Some initiative drafters may not want to limit the scope of what marijuana can be used to treat. One cannot contemplate what new diseases may occur, for which marijuana may prove useful. Had the California initiative been drafted in the 1970's, it would not have included AIDS, a relatively new disease. Furthermore, with the increased interest in medical uses of marijuana, new uses may be discovered, requiring a new initiative if the original did not include a savings clause. On the other hand, drafters may feel that marijuana's use should be limited until it can be tested in clinical trials. For these drafters, the state initiatives are primarily focused on pressuring the federal government to change its policy. Consequently, limiting marijuana to those illnesses that marijuana is currently reputed to affect would be acceptable. Regardless of which philosophy drafters subscribe to, they need to balance the political risks associated with an open definition of illness against the benefits of including all individuals who may benefit from marijuana.

ii. Legalizing other Schedule I drugs as well

The second issue requiring drafters to make judgement calls is whether the initiatives should legalize drugs other than marijuana for medical use. Arizona's Proposition 200 legalizes all schedule I drugs for medical purposes. The drafters of the initiative nevertheless view it as a

203 James P. Fox, Michael J. Meyers, M.D., & Sharon Rose, Argument Against Proposition

215 1996 California Election Pamphlet, reprinted in Cal. Att'y General's Office, Proposition

215: An Analysis (Dec. 20, 1996) Appendix I

204 Hearings on the Arizona and California Medical Drug Use Initiatives Before the Senate Comm. on the Judiciary , (December 2, 1996).

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medical marijuana initiative because the initiative requires physicians to document existing scientific research to support a drug's use, and the drafters indicate that they are aware of no other schedule I drug for which scientific research exists to support its use. They contend that they chose to include all Schedule I drugs so that if scientific research established the validity of the use of a substance for medical purposes, they would not have to return to the public with another initiative.205 Although this reasoning makes sense, drafting an initiative that potentially legalizes drugs such as PCP and heroin is politically dangerous. Many attribute the failure of a 1997 Washington State initiative to its inclusion of all Schedule I drugs instead ofjust marijuana. Although including other drugs besides marijuana is a judgement call of the drafters, in most cases, it would be unwise.

2. Problems That Have Arisen in the Wake of Propositions 200 and 215 In addition to the political issues that relate to whether voters will pass an initiative,

drafters of initiatives need to be aware of a number of issues that have proven problematic in terms of deriving a workable system from an initiative.

20S$~ Hearings on the Arizona and California Medical Drug Use Initiatives Before the Senate

Comm. on the Judiciary , (December 2, 1996) (Comments by Marvin Cohen, treasurer of Arizonans for Drug Policy Reform).

While I am not sure which side of the debate would consider the following information more advantageous to their arguments, evidence exists to support claims that MDMA, commonly known as Ecstasy, has medical value in psychotherapeutic treatment. In 1986, an administrative law judge determined that MIDMA had an accepted medical use for treatment in the United States and was safe to use under medical supervision. S.~ Grinspoon, M.D., v. DEA, 828 F.2d 881, 884 (1st Cir. 1987). Furthermore, significant research is being pursued to ascertain the safety and efficacy of MDMA. The Multidisciplinary Association for Psychedelic Studies (MAPS) currently facilitates such research and has opened a Drug Master File for MDMA with the FDA. The opponents of Proposition 215 could point to these facts to show that the initiative would apply to more than marijuana. On the other hand, one could point to the battle marijuana advocates have been forced to wage, and argue that the Proposition 200 drafters are right not to want to have to go through such efforts each time a Schedule I drug shows medical promise.

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a. No distribution mechanism

The California initiative does not address the issue of access to marijuana, except to allow the patient and primary caregiver to grow the marijuana for personal uses.206 The initiative drafters included a clause that encouraged the federal and state governments to "implement a plan to provide for the safe and affordable distribution of marijuana.,'207 They did not, however, provide a mechanism for distribution.

The main reason the drafters did not include a distribution system was to make the initiative more politically attractive.208 They felt that the government would recognize the conundrum and turn a blind eye to buyers clubs.209 They also wanted to avoid conflicts with federal law.210 As the initiative was written, there is no positive conflict with federal law. The government has no ability to attack the initiative on preemption grounds and must attack it collaterally, by closing buyers clubs, sanctioning physicians, or arresting patients under federal law. Regardless of the reasons, the strategy backfired in Califorma.

With both the federal and California state government prosecuting buyers clubs, and the case law determination that distributors are not protected, California patients are put in a precarious situation. They can either grow their own marijuana, which would entail obtaining seeds on the black market; not use marijuana at all, which would defeat the purpose of allowing medical use; or obtain marijuana on the black market, which would place patients at risk as they

206 Cal. Proposition 215 §1; Cal. Health and Safety Code §11362.5(d).

207 Cal. Proposition 215 §1; Cal. Health and Safety Code §1 1362.5(b)(l)(C).

208 Telephone Interview with Ed Rosenthal (April 22, 1998).

209 1d.

'0 E mail from Dave Fratello, Spokesperson, Americans for Medical Rights to Don Christen. Maine Vocals (on file with author).

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associated with a criminal element. Probably the biggest problem with creating an initiative that lacks a distribution system is that even if the federal government changes its policy towards buyers clubs, they will still violate state law. Theoretically, the federal government could either explicitly or implicitly permit buyers clubs to operate, and the California Attorney General could still shut them down and thwart distribution.

To protect patients and create a workable distribution system, drafters have three options:

exempt marijuana 