By Rick Doblin

Master of Public Policy Candidate at the John F. Kennedy School of Government, Cambridge, Massachusetts

In September 1388, after two years of hearings, DEA Chief Administrative Law Judge Francis L. Young, Jr. recommended to DEA Administrator John Lawn that marijuana be reclassified into Schedule 2 of the Controlled Substances Act (CSA), to permit its use by physicians in the treatment of life- and sense-threatening diseases (1). Currently, patients who need marijuana must choose between inadequate treatment and buying black market drugs. Synthetic THC - Marinol. the major active molecule in marijuana, is in Schedule 2, as are cocaine, morphine and methadone. Marijuana in its natural form remains, with heroin, in Schedule 1.

The primary legal issue is whether the medical use of marijuana is "currently accepted" under the provisions of the Controlled Substances Act of 1970. The primary social issue is the concern that sanctioning the medical use of marijuana will have a deleterious effect on drug abuse prevention. The primary political issue concerns the possibility that rescheduling will be perceived as a retreat in the 'war on drugs'. Policy questions concern the proper relationship between governmental controls and the practice of medicine. The decision reached in this case will reflect on how the US government balances the legitimate medical needs of patients suffering from grave physical disorders against policies designed to control drug abuse.

Mr. Lawn's ruling on the rescheduling of marijuana is pending. After analyzing the issues, this review recommends that the DEA accepts Judge Young's recommendation.

Legal proceedings concerning the rescheduling of marijuana to permit its medical use began in 1972 (2). Over the years, first the Bureau of Narcotics and Dangerous Drugs (BNDD) and then the DEA have repeatedly denied rescheduling on substantive or procedural grounds. On three successive occasions, U.S. Courts of Appeals decisions have rejected BNDD and DEA arguments. remanded the matter for further administrative hearings attempting to spur the agencies to action by requiring them to report to the courts in writing on a quarterly basis (3). After two years of hearings in the latest round, Administrative Law Judge Young concluded marijuana has an "accepted medical use" under the language of the CSA of 1970, repeatedly stating that a contrary finding would be "unreasonable, arbitrary, and capricious." Though Judge Young recommended that marijuana be rescheduled, DEA attorneys continue to argue that even if marijuana has a history of medical use, it has "no currently accepted medical use" according to standards they have articulated (4). Two U.S. Courts of Appeals decisions have emphatically rejected the DEA attorneys' definition of "accepted medical use" as "disingenuous." (5) .

In several criminal cases, U.S. courts have ruled marijuana is a drug of medical necessity In the treatment of glaucoma (6) and of spasticity (relative to neurologlcal disorders) (7) and have ordered the release of marijuana to a cancer patient undergoing chemotherapy (8). The Washington, D.C., law firm of Steptoe and Johnson has committed itself to pursue the rescheduling case pro bono, on behalf of a patients' group (the Alliance for Cannabis therapeutics), to whatever level of appeal necessary to secure legal access to needed medicines. The Drug Policy Foundation has agreed to do the same on behalf of the original petitioner, the National Organisation for the Reform of Marijuana Laws (NORML).

Over the last decade, thirty-four states beginning with New Mexico in 1978 have legislatively determined that marijuana has legitimate medical uses for the treatment of sense- and life-threatening illness. In 1983, the National Association of Attorneys General (NAAG) passed a resolution (9) that called on Congress, the Department Of Justice and other administrative agencies to reschedule marijuana to Schedule 2 (10). Pennsylvania Attorney General Leroy Zimmerman, Chairman of NMG's Criminal Law and Law Enforcement Committee, explained that the resolution "would allow the controlled use of marijuana for treatment of glaucoma and relief of the debilitating side effects of anti-cancer treatments."(11). He further commented that making marijuana available for medical purposes "will in no way affect or impede existing efforts by law enforcement authorities to crack down on illegal drug trafficking in this country."(12). In resolution calling for an end to federal prohibitions which deny patient access to marijuana, as did the National Association of Criminal Defence Lawyers in 1988.(13).

The UN Single Convention on Narcotic Substances (1961) recognizes that marijuana may have important medical applications. The Convention permits any signatory country to recognize these applications and establish government-controlled systems of production and distribution to meet legitimate human needs. (14)

Testimony before Judge Young established that marijuana could help alleviate the suffering of hundreds of thousands of cancer, glaucoma and spasticity patients. Each year about 1.3 million Americans are diagnosed as having cancer. At least 250,000 of those people would benefit from the introduction of marijuana as an anti-nausea medicine (Unimed Pharmaceuticals, 1988a). THC, the major active ingredient in marijuana, was prescribed for about 80,000 cancer patients last year (Unimed Pharmaceuticals, 1988b). Unfortunately, several studies indicate that THC is both more psychoactive than smoked marijuana and less effective in treating nausea.(15) (Chang et al, 1979)

Glaucoma, the leading cause of blindness in the United States, afflicts two million Americans. Conventional medical and surgical therapies succeed in controlling symptoms in only 80 to 90 per cent of glaucoma patients, as many as 200,000 to 400,000 patients cannot be adequately treated with conventional therapies. Glaucoma patients are likely to gain additional relief from elevated intraoccular blood pressure through the use of marijuana. (16)

Today, about one million Americans are afflicted with neurological disorders such as multiple sclerosis which result in spasticity. Marijuana is a highly effective anti-spasmodic agent (17). The few medicines currently available to treat spasticity have serious adverse effects. In the absence of a safe, effective mode of treatment, physicians prescribe tranquillizers, sedatives, narcotics and other addictive drugs to MS patients and to para- and quadriplegics. Marijuana as an anti-spasmodic drug may be the most widely used, but least well known, of its three major medical uses.

No scientific studies have ever suggested a causal relationship between regulatory acceptance of the medical use of a drug and increased adolescent or adult abuse of that drug. Nevertheless, various parent and anti-drug groups and the International Association of Chiefs of Police have expressed concern about the "signal value" of sanctioning marijuana's medical use. They fear medical use of marijuana might lead to increased experimentation by adolescents resulting in deleterious consequences. The demonstrated medical benefits of marijuana must be weighed against the hypothetical link between regulatory acceptance of marijuana's medical use and adolescent and adult abuse.

One of the most recent and authoritative studies of adolescent drug use, conducted by RAND in 1984, is completely silent about the impact of the medical status of drugs on abuse. The study found that "there is a wealth of evidence that mere knowledge of the facts does not affect behavior directly, particularly if social influences contradict the facts. In addition, many previous education efforts were marred by exaggerations or 'scare tactics' which today's sophisticated youth easily detect and discount." The study goes on to say that because adolescents are present oriented, there is likely to be little or no deterrent effect from warnings that drug use will result in future health problems. (Polich et al, 1984).

Placing marijuana in Schedule 2, which already contains synthetic THC, cocaine, morphine and methadone, does not communicate approval of illicit marijuana use. The fact that cocaine and morphine are used medically in no way justifies their recreational use. It can easily be pointed out that medical use of marijuana in no way speaks to the question of recreational use, as marijuana's medical value is not related to its psychological effects, but rather is due to its physiological properties.

For good or ill, signals that marijuana has a medical use have already been sent through the media. Information about the medical use of marijuana would not come as a shock to American adolescents, nor will denying rescheduling remove the issue from public deliberation and attention. Publicity surrounding the medical use of marijuana and DEA attempts to deny such use will increase if the case goes to the U.S. Court of Appeals . Medical necessity cases will also increase if marijuana is not made available for medical use, and will receive widespread publicity likely to be detrimental to the government.

Last year, at least two patients (one glaucoma and one cancer) raised medical necessity defenses after being arrested for marijuana possession and cultivation. In State vs Mussika, (6) the Florida court sustained the defense of the glaucoma patient, who is now receiving legal marijuana from NIDA. The DEA chief spokesman for South Florida appeared on a radio talk show with the defendant, Mussika, and after hearing her case admitted on the air that if confronted with the same circumstances, he would not hesitate to break the law to obtain the marijuana he medically needed. In State v Morris (18) (Paintsville, Kentucky), a cancer patient was charged with possession. The jury convicted him of possession but refused to impose a penalty. The judge later expunged the record. The Alliance for Cannabis Therapeutics and The Drug Policy Foundation provided assistance to the defendants in both these cases.

One could reasonably wonder whether denying the medical use of marijuana in eminently reasonable medical cases will have a deleterious effect on the credibility of the government's drug abuse education campaigns. The government's voice may be more persuasive if it has not squandered its credibility by defending an increasingly

untenable position that marijuana has no medical uses.

Patients who would benefit from marijuana are currently forced to engage in needlessly dangerous criminal activities in order to divert sense- and life-saving drugs from illicit to medical use, an enterprise some patients are currently unwilling or unable to undertake. Sanctioning the medical use of marijuana would remove this function of the illicit market, effectively eliminating that claim to legitimacy

DEA rescheduling of marijuana would not directly lead to its medical use, since FDA and NIDA implementation issues would remain to be resolved. Current federal production of marijuana is licensed by NIDA to the Research Institute of Pharmaceutical Science at the University of Mississippi. NIDA can be relied upon to produce a standardized product that would satisfy the medical market for the foreseeable future.

One possible regulatory context for medical marijuana could involve the FDA's compassionate Investigational New Drug (IND) Program, which has been recently expanded in response to the AIDS crisis. The FDA has agreed to permit the preliminary distribution of certain medicines before the sponsoring pharmaceutical company has completed all the FDA requirements for a New Drug Application (NDA), which had been required before widespread legal marketing. The compassionate IND program is designed to facilitate the availability of drugs which have passed minimum standards for safety to patients with life-threatening illness. Marijuana could easily be placed into this program, although patients with less than life-threatening illnesses such as glaucoma and spasticity might not qualify. On the whole, rescheduling into Schedule 2 is the most appropriate governmental action.

In order to prevent what it sees as inappropriate medical prescription, for example the creation of "stress clinics" prescribing marijuana, FDA could choose to restrict uses of marijuana to treatment of previously identified physical, rather than psychological, illnesses. The medical use of THC is currently controlled in this manner.

In view of the volume of the illicit supply, diversion hardly seems a problem. In any case, illicit diversion seems to have been minimal in regards to THC, and will be controlled by DEA reporting requirements.

In September 1988, Acting Associate Attorney General Francis Keating responded to Judge Young's ruling by remarking, in USA Today, "Marijuana is classified as a mind-altering drug and should remain classified that way." (p.3a). Mr. Keating's remark highlights the main political liability of rescheduling. If rescheduling is seen as in any way weakening the government's position vis-a-vis the illicit use of marijuana, very significant and sustained criticism can be expected. Potential criticism can best be addressed by clear and emphatic statements that Schedule 2 drugs,

such as cocaine, retain their classification as mind-altering drugs, with criminal sanctions for illicit use remaining in full force.

No substantial public opposition to rescheduling has developed so far. Opposition comes primarily from the DEA, who are mainly concerned that a change in the status quo will support efforts to decriminalize marijuana. Public opposition to rescheduling may be significantly less than the DEA estimates. Mr. Keating's indirect response to the substance of Judge Young's recommendation suggests the medical use of marijuana is difficult to oppose directly, either by government officials or their critics. Proponents of decriminalizing marijuana may cite rescheduling as justification for further change, pointing out that the DEA recognizes marijuana is not "bad" under certain circumstances. Such arguments carry little weight and can be easily countered by differentiating medical from recreational use, as is already done with cocaine, morphine, and methadone. Though marijuana is helpful to some seriously ill patients, this implies nothing about its use as a recreational drug. Rescheduling is primarily a health policy decision, with little inherent direct or symbolic relevance to the decriminalization debate.

One fundamental question is raised by the rescheduling of marijuana, will the government find a way to help treat hundreds of thousands of seriously ill patients who are currently suffering both from their illnesses and from a federal drug policy that denies them effective treatment? Or, as Judge Mark Polen said in finding a criminal defendant not guilty of felony cultivation of marijuana based on the defence of medical necessity, "Finally, the Court is deeply disturbed by the broader implications of the testimony presented in this case. Medical necessity is a stringent, demanding legal defense. The practice of medicine, however, cannot be predicated upon the legal requirements of the medical necessity defense if it is to preserve health in a rational, compassionate manner. As this decision, and the earlier decisions cited herein illustrate, marijuana has 'an accepted medical use in treatment'. Indeed, the evidence indicates marijuana is now being employed, albeit illegally, by patients throughout the United States. In the vast majority of such cases, those desperately ill people are being forced underground and away from urgently needed medical supervision to acquire marijuana.

"This is an intolerable, untenable legal situation. Unless legislators and regulators heed these urgent human needs and rapidly move to correct the anomaly arising from the absolute prohibition of marijuana which forces law-abiding citizens into the streets - and criminality - to meet their legitimate medical needs, cases of this type will become increasingly common in coming years. There is a pressing need for a more compassionate, humane law which clearly discriminates between the criminal conduct of those who socially abuse chemicals and the legitimate medical needs of seriously ill patients whose prudent therapeutic use of those very same chemical substances".(19)

Rescheduling would leave criminal sanctions against illicit use unchanged. Accepting Judge Young's recommendation is a medically compassionate action entirely consistent with the requirements of the Controlled Substances Act and a tough drug policy. Some political costs will be incurred, but this is equally true if Judge Young's recommendation is rejected. The result of rejection would be a Court of Appeals case most likely to be both embarrassing and widely publicized. There is no evidence, nor is it likely, that illicit marijuana abuse would increase because of rescheduling. Rescheduling would enhance the government's credibility and effectiveness in the area of drug abuse prevention and would not compromise the government's basic message that recreational use of marijuana is unacceptable.

Shortly after his election, President Bush stated in the New York Elmes that The elimination of drugs is going to stem from vigorous change in the society's approach to narcotics. It is going to be successful only ii our education is successful." (1989). Rescheduling can be thought of as an integral part of a tough strategy designed both to respond compassionately to patient needs, and to increase the emphasis of the government on straightforward and honest and therefore, in the long run, more effective drug education.

LEGAL NOTES

1. Recommendations and opinion of DEA Administrative Law Judge Francis Young Jr., re Marijuana Rescheduling Petition (Dept. of Justice, DEA September 6,1988). 2. See 37 Fed . Reg . 18093, September 1,1972.

3. NORML v Ingersoll, 497 F.2i 654 (D.C. Cit. 1974), NORML v. DEA, 559 F.2d at 747-48, NORML v. DEA No. 79-1660.

4. See 53 Fed. Reg. 5156 (1988).

5. Grinspoon v. DEA, 828 F.2d 881 (1st. Cir.1987) and NORML vs. DEA, 59 F.2d 735 (D.C. Cir.1977).

6. U.S.v. Randall, Washington Daily Law Reporter, 2249-2254 (Dec. 20,1976); State v. Mussika, 88-4395 CFA 10 (Circuit Court for Broward County, Dec 29,1988):

7. Washington v. Diana, 24WAP 908,604 P2d 1312 (1981).

8. Orders of Judge Don Work, Superior Court of Imperial County California, January 23,1978.

9. Resolution of the National Association of Attorneys General, Committee on Criminal Law and Enforcement, Therapeutic Use of Marijuana, June 25, 1983.

10. Exhibit A, Affidavit of Robert Stephan, DEA Administrative Hearings, Judge Young Presiding.

11. Exhibit B, Aflidavit of Robert Stephan, DEA Administrative Hearings, Judge Young Presiding.

12. Ibid.

13. Alliance for Cannabis Therapeutics, Miscellaneous Volume 1Tab 1, DEA, Administrative Hearings, Judge Young Presiding

14. 40 fed. Reg. 44167-68, September 25,1975.

15. Alliance for Cannabis Therapeutics, Official State Reports, Volume 2, New Mexico Tab 15, New York Tab 16, Tennessee Tab 17, DEA Administrative Hearings, Judge Young Presiding

16. Aflidavits of Dr. Merritt and Dr. North, DEA Administrative Hearings, Judge Young Presiding.

17. Aflidavit of Valerie Leigh Cover, DEA Administrative Hearings, Judge Young Presiding.

18. State v Morris,1988, Paintsville, Kentucky.

19. Judge Mark Polen's comments in State v Mussika (as above #6)

REFERENCES

Chang, et. al.,1979, Annals of Internal Medicine, 91, 819-824.

Polich, Ellickson, Reuter & Kahan,1984, Strategies for Controlling Adolescent Drug Use, RAND.

Unimed Pharmaceuticals.1988a. Annual Report December,1988.

Unimed Pharmaceuticals,1988b, Ouarterly Report, December,1988.

USA Today, September 7,1988, Page 3A.

New York Times, January 25,1989.