4
O ne of the most intensely debated drug policy issues in recent years has con- cerned the question of medical marijuana (the legalized availability of marijuana when limited to the treatment of specific medical conditions). As a psychologist whose interests lie in the study of drug abuse and drug policy, I am frequently asked to voice my opinion. Unfortunately, answers to the question of medical mari- juana do not come easily. The principal reason is that it is an issue that must be debated on more than simply a medical level. There are also significant economic, social and political considerations. First of all, the question of medical marijuana must be examined in terms of the complex picture of present-day drug use and abuse in the United States. It is widely acknowledged that drug-related problems in our society arise from an enormous range of psychoactive sub- stances, with vastly different biological, psychological, sociopolitical and histori- cal profiles. Psychoactive effects can be obtained from legally available sources such as alcohol and tobacco, as well as illicit sources such as heroin, cocaine, amphetamines and marijuana. Some abusable psychoactive drugs, such as lighter fluid or cleaning solvents, are read- ily accessible to the general public in the form of common household products. Drug problems can also arise from the misuse of FDA-approved medications (Oxycontin ® and Ritalin ® are examples) that have been developed to treat legiti- mate physical disorders. While there are advocates of drug legalization as a whole, the immense diversity in the character of drug use in our society makes their argu- ment a very hard sell. Even when debates on drug policy concentrate on one partic- ular drug and a specific circumstance of legality (such as with the medicalization of marijuana), considerations need to be made in the context of the larger picture of drug use in the United States. We also need to recognize that, even if it is desirable to make a change in drug policy or one aspect of it, the change itself will be successful only if it is feasible to implement it. Indeed, it can be argued that a particular drug policy should be based as much upon its practicality as its desirabil- ity. Would it be feasible, for example, to provide medical marijuana to patients at an affordable price without changing the presently illegal status of marijuana itself? How would commercial sources of med- ical marijuana be differentiated from sources presently existing for illicit mari- juana? What would be the economic impact on the pharmaceutical industry? Ultimately, we cannot ignore the symbolic implications of any change in national drug policy, including the medical- ization of marijuana. The kind of drug pol- icy we have in America, in the eyes of many people, is a political statement of what kind of country we wish to live in. The sociopo- litical implications cannot be ignored. As sociologist Erich Goode has expressed in his book Between Politics and Reason: The Drug Legalization Debate (1997), “Regardless of whether it reduces crime or not, does endorsing methadone maintenance clinics for all addicts who wish to enroll tell you the society is too “soft” on drugs? . . . Does the term “legalization” sound like an endorsement of drug use to you? The balancing act between ide- ology and fact will continue to dog us throughout any exploration of the issue of drug policy.” A brief history of medical marijuana As with many psychoactive sub- stances, the medicinal benefits of marijua- na have been noted for thousands of years. The first direct reference to cannabis (the name for the hemp plant, the leaves of which constitute marijuana) dates back to 2737 B.C.E. in the writings of the mythical Chinese emperor Shen Nung, which focused upon its powers as a medication for rheumatism, gout, malaria, and strangely enough, absent- mindedness. Mention was made of its intoxicating properties, but the medicinal possibilities were evidently considered more important. In 1964, a major step toward understanding the effects on the brain of marijuana and other cannabis products on the brain was the isolation and identification of THC (delta-9- tetrahydrocannabinol) as the chief active ingredient that produces cannabis- induced psychoactive effects. Not surprisingly, the psychoactive potencies of various forms of cannabis are directly tied to THC concentration, from marijuana (usually the crushed leaves and stems of the cannabis plant) having a THC concentration of one to seven per- cent to hashish (the sticky resin of the cannabis plant) having a THC concentra- tion of eight to 14 percent. However, THC is only one of more than 80 separate chemical compounds (called cannabi- noids) in the cannabis plant. Therefore, an important question is whether medical benefits are gained from ingesting THC or other cannabinoid alone without smoking marijuana itself or whether we require the smoking of marijuana in its natural state, thus ingesting not only THC but all the other cannabinoids as well. Since 1985, two FDA-approved prescription drugs containing THC alone or a variation of it have been available in capsule form. Dronabinol (brand name: Marinol ® ) is essentially THC in a sesame oil suspen- sion; nabilone (brand name: Cesamet ® ) is Debating the Question of Medical Marijuana Charles F. Levinthal Professor Department of Psychology 8 Charles F. Levinthal’s Point/Counterpoint published in by Allyn & Bacon.

Debating the Question of Medical Marijuana€¦ · two FDA-approved prescription drugs containing THC alone or a variation of it have been available in capsule form. Dronabinol (brand

  • Upload
    others

  • View
    1

  • Download
    0

Embed Size (px)

Citation preview

Page 1: Debating the Question of Medical Marijuana€¦ · two FDA-approved prescription drugs containing THC alone or a variation of it have been available in capsule form. Dronabinol (brand

One of the most intensely debated drugpolicy issues in recent years has con-

cerned the question of medical marijuana(the legalized availability of marijuanawhen limited to the treatment of specificmedical conditions). As a psychologistwhose interests lie in the study of drugabuse and drug policy, I am frequentlyasked to voice my opinion. Unfortunately,answers to the question of medical mari-juana do not come easily. The principalreason is that it is an issue that must bedebated on more than simply a medicallevel. There are also significant economic,social and political considerations.

First of all, the question of medicalmarijuana must be examined in terms ofthe complex picture of present-day druguse and abuse in the United States. It iswidely acknowledged that drug-relatedproblems in our society arise from anenormous range of psychoactive sub-stances, with vastly different biological,psychological, sociopolitical and histori-cal profiles. Psychoactive effects can beobtained from legally available sourcessuch as alcohol and tobacco, as well as

illicit sources such as heroin, cocaine,amphetamines and marijuana. Someabusable psychoactive drugs, such aslighter fluid or cleaning solvents, are read-ily accessible to the general public in theform of common household products.Drug problems can also arise from themisuse of FDA-approved medications(Oxycontin® and Ritalin® are examples)that have been developed to treat legiti-mate physical disorders. While there areadvocates of drug legalization as a whole,the immense diversity in the character ofdrug use in our society makes their argu-ment a very hard sell. Even when debateson drug policy concentrate on one partic-ular drug and a specific circumstance oflegality (such as with the medicalizationof marijuana), considerations need to bemade in the context of the larger pictureof drug use in the United States.

We also need to recognize that, even ifit is desirable to make a change in drugpolicy or one aspect of it, the change itselfwill be successful only if it is feasible toimplement it. Indeed, it can be argued thata particular drug policy should be based asmuch upon its practicality as its desirabil-ity. Would it be feasible, for example, toprovide medical marijuana to patients atan affordable price without changing thepresently illegal status of marijuana itself?How would commercial sources of med-ical marijuana be differentiated fromsources presently existing for illicit mari-juana? What would be the economicimpact on the pharmaceutical industry?

Ultimately, we cannot ignore thesymbolic implications of any change innational drug policy, including the medical-ization of marijuana. The kind of drug pol-icy we have in America, in the eyes of manypeople, is a political statement of what kindof country we wish to live in. The sociopo-litical implications cannot be ignored. Associologist Erich Goode has expressed inhis book Between Politics and Reason: TheDrug Legalization Debate (1997),

“Regardless of whether it reducescrime or not, does endorsingmethadone maintenance clinics forall addicts who wish to enroll tell youthe society is too “soft” on drugs? . . .Does the term “legalization” soundlike an endorsement of drug use to

you? The balancing act between ide-ology and fact will continue to dog usthroughout any exploration of theissue of drug policy.”

A brief history of medical marijuana

As with many psychoactive sub-stances, the medicinal benefits of marijua-na have been noted for thousands ofyears. The first direct reference tocannabis (the name for the hemp plant,the leaves of which constitute marijuana)dates back to 2737 B.C.E. in the writingsof the mythical Chinese emperor ShenNung, which focused upon its powers asa medication for rheumatism, gout,malaria, and strangely enough, absent-mindedness. Mention was made of itsintoxicating properties, but the medicinalpossibilities were evidently consideredmore important. In 1964, a major steptoward understanding the effects on thebrain of marijuana and other cannabisproducts on the brain was the isolationand identification of THC (delta-9-tetrahydrocannabinol) as the chief activeingredient that produces cannabis-induced psychoactive effects.

Not surprisingly, the psychoactivepotencies of various forms of cannabis aredirectly tied to THC concentration, frommarijuana (usually the crushed leaves andstems of the cannabis plant) having aTHC concentration of one to seven per-cent to hashish (the sticky resin of thecannabis plant) having a THC concentra-tion of eight to 14 percent. However, THCis only one of more than 80 separatechemical compounds (called cannabi-noids) in the cannabis plant. Therefore,an important question is whether medicalbenefits are gained from ingesting THC orother cannabinoid alone without smokingmarijuana itself or whether we require thesmoking of marijuana in its natural state,thus ingesting not only THC but all theother cannabinoids as well. Since 1985,two FDA-approved prescription drugscontaining THC alone or a variation of ithave been available in capsule form.Dronabinol (brand name: Marinol®) isessentially THC in a sesame oil suspen-sion; nabilone (brand name: Cesamet®) is

Debating the Question of Medical MarijuanaCharles F. LevinthalProfessorDepartment of Psychology

8

Charles F. Levinthal’s Point/Counterpoint published in byAllyn & Bacon.

Page 2: Debating the Question of Medical Marijuana€¦ · two FDA-approved prescription drugs containing THC alone or a variation of it have been available in capsule form. Dronabinol (brand

a synthetic variation of THC. Governmentofficials will argue that the availability ofthese medications meets their obligationon the question of medical marijuana.Others argue that THC alone is not aseffective from a medicinal point of viewthan whole marijuana, and somehow thenaturally-occurring combination ofcannabinoids in the cannabis plant repre-sent the essential therapeutic agent formedicinal purposes.

In the United States, anti-marijuanasentiment since the early 1930s, exempli-fied by the present-day cult classic filmReefer Madness (1936), has made it diffi-cult to conduct objective appraisals of theclinical applications of THC ingestion ormarijuana smoking. In the last 20 years orso, however, this stance has softened,allowing for some medical research.During this period of time, there werethree clinical areas seen as worth exploring:the treatment of glaucoma, the treatmentof asthma, and the treatment of debilitatingnausea. It is now apparent that marijuanadoes not hold a significant advantage overavailable FDA-approved medications forglaucoma or asthma, but the area of nauseatreatment is a different matter, and it isthis specific medical application thatpresently is the focus of efforts to med-icalize marijuana use.

Chemotherapy in the course of can-cer treatment frequently produces anextreme and debilitating nausea (emesis),lack of appetite and loss of body weight;symptoms that are clearly counterproduc-tive in helping the individual contendwith an ongoing fight against cancer.AIDS patients suffer from similar symp-toms, as are those patients diagnosed withthe gastrointestinal condition calledCrohn’s disease. In these circumstances,standard antiemetic (antivomiting) med-ications are often ineffective. Therefore,the possible benefits of smoking marijua-na and consuming it in its entirety overtaking THC as a pill for antiemetic purposes need to be considered.

Despite the fact that Marinol® andCesamet® are presently in use, U.S. feder-al authorities have refused to reclassifymarijuana itself or any other cannabisproduct from a Schedule I category to aless restrictive Schedule II category. To putin this in perspective, the ComprehensiveDrug Abuse Prevention and Control Actof 1970 established five “schedules” of

controlled substances, defining the gov-ernmental judgment on the character ofvarious drugs and restrictions to theiravailability. Schedule I drugs are definedas having the highest potential for abuseand no accepted medical use (examplesinclude heroin and its analogues, LSD,mescaline, as well as marijuana and othercannabis products). Schedule II con-trolled substances (examples are mor-phine, cocaine, codeine, and ampheta-mines) are defined as having high poten-tial for abuse and some accepted medicaluse, though use may lead to severe physi-cal or psychological dependence. At theother end of the spectrum are the leastrestricted Schedule V drugs (examplesinclude prescription cough medicines notcontaining codeine and laxatives). In thelate 1980s, fewer than a dozen medicalpatients were approved to receive mari-juana for symptomatic relief, despite itsSchedule I status, as part of a “compas-sionate-use” federal program. The entireprocedure for reviewing new applicationsto this program was canceled in 1992.

Recent developments on medical marijuana

Despite official opposition from fed-eral authorities, advocacy for medicalmarijuana has grown considerably in thelast few years. In 1999, the Institute ofMedicine (IOM), a branch of the NationalAcademy of Sciences, conducted a studyrequested by the White House Office ofNational Drug Control Policy (ONDCP).Its report concluded that, while not rec-ommending marijuana for long-term use,short-term use appeared to be suitable fortreating certain physical conditions, par-ticularly “debilitating symptoms,” whenpatients failed to respond well to tradi-tional medications. By 2000, nine U.S.states (Alaska, Arizona, California,Colorado, Hawaii, Maine, Nevada,Oregon and Washington) had voted bypublic referenda to allow marijuanasmoking for the relief of pain and discom-fort, when prescribed by a physician. In2001, Canada officially approved themedicinal use of marijuana. It is now legalfor Canadian patients to grow and smokemarijuana if their symptoms have beencertified by a physician as warranting thistreatment. It is also permitted, underthese circumstances, to request marijua-

na, free of charge, from government-oper-ated cannabis farms in Manitoba. At thesame time, the U.S. government hasrecently (and somewhat quietly) easedrestrictions on the availability of high-grade marijuana for research studies on itseffectiveness as a medical treatment. Inthe past, only low-grade marijuana hadbeen available, a level of cannabis qualitythat has carried the derogatory designa-tion “ditch weed.”

In November 2002, voters in Nevadawill consider a referendum eliminatingpenalties for possessing up to threeounces of marijuana for any reason anddirecting the state legislature to treat mar-ijuana much like tobacco products andalcohol, through a regulatory system thatwould oversee how marijuana is grown,distributed and sold, with tax revenuegenerated in the process. It should benoted that the Nevada initiative (to beeffective no earlier than 2004, followinganother state vote) goes beyond the med-ical marijuana issue, arguing for a regulat-ed form of marijuana legalization. Theproposal includes prohibitions againstadvertising of any kind, selling marijuanato anyone under 21, or selling it in anypublic place such as schools or parks.Major newspapers in the state haveendorsed the referendum, with oneprominent editorial in July 2002 calling it“a promising first step” toward ending“the needless harassment of individualswho peacefully and privately use marijua-na.” Most state officials, however, haveopposed it or remain neutral. In a pollconducted this July, 44 percent ofNevadan voters favored the initiative, 46percent were opposed and 10 percentwere undecided, with a margin of error offour percentage points.

The federal response to medical marijuana advocacy

The official stance of the U.S. federalgovernment is that marijuana is justifiablya Schedule I controlled substance andestablished federal penalties for its saleand possession for whatever purposemust stand. In 2000, the U.S. SupremeCourt in United States v. Oakland CannabisBuyers’ Cooperative, invoked legal prece-dent with respect to jurisdiction overcommerce and ruled against the legitima-cy of marijuana “buyers clubs” in

9

Page 3: Debating the Question of Medical Marijuana€¦ · two FDA-approved prescription drugs containing THC alone or a variation of it have been available in capsule form. Dronabinol (brand

California, organizations that had beenoperating following the passing of its1996 referendum on medical marijuana.The Supreme Court had previouslyissued decisions establishing thatintrastate commerce could be exemptfrom the federal interference unless thatactivity substantially affected interstatecommerce. In this case, the court basedtheir decision, in part, on the judgmentthat a restriction of medical marijuana tointrastate commerce could not be guaran-teed. Some legal scholars have sinceargued that the court should reconsiderits judgment on this point, but whether itwill do so remains uncertain.

Drug abuse professionals in the fed-eral government have long viewed theacceptance of medical marijuana as a“Trojan horse” for marijuana legalization,pointing out that marijuana legalizationcould cascade to drug legalization in gen-eral. It can only be speculated that the2002 Nevada referendum has done littleto reduce their fears in this regard. On acongressional level, 36 members of theHouse of Representatives introduced inAugust 2002 a bipartisan bill to allow anystate to permit marijuana use for medicalpurposes if they choose to do so, thuseliminating any conflict with federalopposition on this issue (though its illegalstatus for non-medical purposes wouldremain). It is not likely that any furtheraction on this bill will begin until after the

November 2002 elections. Consideringthe ramifications of this change in drugpolicy, the political situation with respectto medical marijuana will remain in fluxfor some time.

Medical and health concerns on medical marijuana

When pressed about the question ofmedical marijuana on strictly medicalgrounds, the ONDCP defers to sections ofthe 1999 Institute of Medicine report,extracting statements that support theirposition and ignoring others that do not.A central issue raised in the report is thefact that marijuana is smoked and conse-quently inhaled into the lungs. One prob-lem is that the customary delivery systemfor marijuana cannot be dissociated fromhealth problems associated with smoking.The second problem is that no presentlyapproved medication has ever beenadministered in this way. Not surprising-ly, the government has placed greatemphasis on the potential health risks ofmarijuana smoking.

In general, there are ample opportu-nities for a selective reading of the conclu-sions of the IOM, because the report itselfis quite complex and fails to make morethan a grudgingly positive stand on themedical marijuana issue. No cost-benefitanalyses are made or even entertained,despite the acknowledgment of the cir-

cumstances of patients who might beprime candidates for marijuana treatment.

Lester Grinspoon, author ofMarihuana Reconsidered (1971) and anexpanded edition of Marihuana: TheForbidden Medicine (1997), has noted thatrecommendations for medical marijuanawere made only with severe limitations:

“The report’s Recommendation Sixwould allow patients with what itcalls “debilitating symptoms (suchas intractable pain or vomiting)” touse smoked marijuana for only sixmonths, and then only after all otherapproved medicines have failed. Thetreatment would have to be moni-tored with “an oversight strategycomparable to an institutionalreview board process” . . . TheInstitute of Medicine would havepatients who find cannabis helpfulwhen taken by inhalation wait foryears until a means of deliveringsmoke-free cannabinoids is devel-oped . . . [They] discuss marijuanaas if it were a drug like thalidomide,with well-established serious toxici-ty (phocomelia) and limited clinicalusefulness (leprosy). This is inap-propriate for a drug with a long history, limited toxicity, unusual versatility, and easy availability.”

Economic concernsin medical marijuana

It should be noted that reclassifica-tion of marijuana to a Schedule II con-trolled substance, in and of itself, wouldbe insufficient to allow its immediateavailability as a prescription drug. By con-gressional mandate, all new Schedule IIdrugs must be first approved by the FDAin clinical trials, showing its safety andeffectiveness for the purposes in which itwould be prescribed. (It has been said thataspirin would have had difficulty passingthe scrutiny of the present-day FDA stan-dards, even if a patent on the drug werepossible.) The current FDA approval pro-cedure takes time and a substantial financialinvestment on the part of pharmaceuticalcompanies, and it is unlikely that thesecompanies would be willing to make thecommitment toward research and devel-opment of a cannabis-based product. Thechallenges in isolating and developing spe-cific cannabinoids or combinations of

10

The legalization of marijuana for medicinal purposes is “an issue that must be debated on more than simply a medical level.There are significant economic, social and political considerations.” Reproduced above is part of a recent advertisement pub-lished in The New York Times by the Coalition for Compassionate Access, an organization advocating the legalization of mar-ijuana for persons suffering from cancer, AIDS and other serious illnesses.

Page 4: Debating the Question of Medical Marijuana€¦ · two FDA-approved prescription drugs containing THC alone or a variation of it have been available in capsule form. Dronabinol (brand

cannabinoids as well as rapid-onset,non-smoked delivery systems (such as anasal spray, nebulizer, skin patch, orsuppository) would be considerable. AsGrinspoon has commented:

“In the end, the commercial suc-cess of any cannabinoid productwill depend on how vigorously theprohibition against marijuana isenforced. It is safe to predict thatnew analogs and extracts will costmuch more than whole smokedmarijuana even at the inflatedprices imposed by the prohibitiontariff [the increased cost of procur-ing marijuana due to its presentillegal status]. I doubt that phar-maceutical companies would beinterested in developing cannabi-noid products if they had to compete with natural marijuanaon a level playing field.”

Medical marijuana in the con-text of marijuana legalization

Significant economic issues make itdifficult to consider the possibility oflegally available medical marijuanaindependently of legal availability ofmarijuana itself. An appropriatemetaphor for present-day options sur-rounding medical marijuana may not bea “Trojan horse” (borrowing the expres-sion of law enforcement officials), butrather a “Catch-22.” The federal govern-ment may be the only reasonable sourceof funds for the development of medicalcannabinoid products and non-smokingdelivery systems for them. Cannabisitself is unpatentable, thus making itunattractive to private pharmaceuticalcompanies. The long-standing hostilityon the part of the government withregard to cannabis in general makes itunlikely that the government would behelpful in underwriting the substantialdevelopment costs of any medicinebased upon it. Besides, it is an openquestion whether any future cannabi-noid product, no matter how sophisti-cated its composition or how safe itsroute of administration, would effective-ly surpass natural marijuana as a medic-inal agent.

We are left with an alternative,though it is a change that would not beeasy to accomplish either on a political

or social level. Congressional actioncould reclassify marijuana as a ScheduleII controlled substance but exempt itfrom FDA-approval requirements. Indoing so, we would avoid the problemsof what Grinspoon has called the “pharmaceuticalization of marijuana.”However, we would still face a numberof practical issues. Where would suffi-cient quantities of medical marijuana begrown and could these areas be suffi-ciently protected from people seekingmarijuana for “non-medical” reasons?Would it be fair for a physician now tobe the gate-keeper on such a controver-sial treatment? How would they makeintelligent judgments about whether itwas appropriate to prescribe smokedmarijuana and in what dosage levels, inthe absence of controlled research stud-ies concerning safety and effectiveness?Would medical insurance cover thecosts to the patient, and, if so, howwould the price of medical marijuana beestablished? How would the positiveurine test results conducted in theworkplace (or schools) of individualswho are smoking marijuana for medici-nal reasons be effectively distinguishedfrom those who are not?

Perhaps, some of these problemscan be resolved. We already have med-ically useful Schedule II controlled sub-stances, such as morphine (used as ananalgesic) and cocaine (used as a localanesthetic) that have retained their illic-it status in the United States when usedoutside a specific medical application.However, the biopsychosocial profile ofmarijuana is clearly different from thatof morphine or cocaine, and the majoradvocates of medical marijuana areseeking far greater access to it than wepresently have to other Schedule IIdrugs. Most significantly, if thereremains major practical obstacles in thesecuring of medical marijuana, in theabsence of marijuana legalization, somepatients may face a difficult dilemma.Having failed to achieve reasonableaccess to a legalized form of medicaltreatment, they might choose to aban-don the legal system in favor of theblack market and retreat back (inGrinspoon’s words) “to their own gar-dens and closets.”

11

Charles Levinthal earned an A.B. summa cum laudein psychology from the University of Cincinnati, andan M.A. and Ph.D. in experimental psychology fromthe University of Michigan. He teaches undergradu-ate courses in introductory psychology, fundamentalperspectives in psychology, statistics, and biopsy-chology, as well as graduate courses in cogni-tion/perception and neural bases of behavior.

Professor Levinthal is the author of eight books, includ-ing three editions of a biopsychology textbookIntroduction to Physiological Psychology (Prentice-Hall,1979, 1983, 1990), a general-audience book onbrain endorphins, Messengers of Paradise: Opiatesand the Brain (Anchor Press/Doubleday, 1988;Spanish and Japanese translations, 1989 and 1991),three editions of a health/physical education/psy-chology textbook, Drugs, Behavior, and ModernSociety (Allyn and Bacon, 1996, 1999, 2002) andPoint/Counterpoint: Opposing Perspectives on Issuesof Drug Policy (Allyn and Bacon, 2003).

His research has ranged from work on Pavlovianconditioning in animals to hemispheric differencesin human cognitive activity. More recently, ProfessorLevinthal has focused on the role of phonologicalprocessing in reading fluency. In 1987, he present-ed the Hofstra University Distinguished FacultyLecture, “Messengers of Paradise: The role of endor-phins in brain evolution.”

Professor Levinthal’s professional accomplishmentshave been featured in Who’s Who in America,Who’s Who in the Biobehavioral Sciences, Who’sWho in the Frontiers of Science and Technology,American Men and Women of Science, amongother professional publications.

Professor Levinthal is a charter member of theHofstra chapter of Phi Beta Kappa and currentlyserves as president of the chapter. He has servedas co-director of the Applied Research andEvaluation in the Psychology Ph.D. Program(1978–1986) and director of UndergraduateStudies in Psychology (1987–1999). He is an asso-ciate editor for the Journal of Drug Education andAwareness and serves as the neuropsychology edi-tor for the Journal of Polymorphous Perversity, ajournal of humor in psychology. -SK