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© Copyright 1995, 1996 Centrum voor Drugsonderzoek, Universiteit van Amsterdam. All rights reserved.
9 The medicalization of marijuana
Lana D. Harrison, Michael Backenheimer and James A. Inciardi
By 1992, some 35 states (or parts thereof) had enacted legislation that would, in one form or another, legitimatize the use of marijuana for very specific medical purposes. Three other states have introduced legislation related to the medicalization of marijuana (NewsBriefs, 1995). California proposes that patients be allowed to possess and cultivate marijuana providing they have a doctor's recommendation. In addition, pro-marijuana groups in California hope to have a ballot initiative in November 1996 on the medicalization of marijuana. Legislation has been introduced in Missouri which would allow patients to use marijuana under the supervision of a physician. A bill has been introduced in Oregon permitting the therapeutic use of marijuana. Several pro-marijuana groups have supported and continue to support the medicalization of marijuana. Among such groups are the Drug Policy Foundation, the National Organization for the Reform of Marijuana Laws (NORML) and the Alliance for Cannabis Therapeutics (ACT). In addition and from time-to-time, individuals, many of them respectable, and groups, many with familiar and recognizable names as members, set forth the proposition that marijuana has legitimate medical value and should thus be rescheduled under the Controlled Substances Act from Schedule I to Schedule II. Such a transfer would move marijuana from a schedule in which a drug has no accepted medical utility to a schedule which would allow any licensed medical practitioner to prescribe it.
Two respectable proponents of marijuana who strongly advocate its medicalization and move to Schedule II are Drs. Lester Grinspoon and James B. Balakar. In their book, Marijuana, the Forbidden Medicine, they argue strongly for marijuana's use in several medical conditions (Grinspoon and Balakar, 1993). They also (probably unfortunately) state their belief and their case that it is safe to drive under the influence of marijuana. Equally respectable reviewers of the volume take a dramatically opposite view saying it is unfortunate that the book will be used as 'medical evidence' to further the argument that marijuana should be legalized. They conclude the volume has 'no medical use and a high potential for abuse' (Voth and Brookoff, 1994, p. 348).
The thesis that marijuana has legitimate medical value has been repeatedly denied at the Federal Government Level, specifically by the Drug Enforcement Administration (DEA). On March 18, 1992, the Administrator of DEA, Robert C. Bonner, (as had his predecessor) denied the petition of the Drug Policy Foundation and NORML (with the support of the Alliance for Cannabis Therapeutics (ACT) to reschedule marijuana to Schedule II (Federal Register, 1992). The current decision not to reschedule marijuana is based on its failure to meet a five-part criterion for ascertaining whether or not a given substance qualifies as being in 'currently accepted medical use.' These criterion (taken from the United States Court of Appeals, argued October 1, 1993 and decided February 18, 1994) are:
- The drug's chemistry must be known and reproducible;
- There must be adequate safety studies;
- There must be adequate and well-controlled studies proving efficacy;
- The drug must be accepted by qualified experts; and
- The scientific evidence must be widely available.
Marijuana has been claimed to have medical benefits in the treatment of multiple sclerosis, cancer, AIDS (and HIV), and glaucoma, but many leading medical experts are quick to point out that dronabinol (Marinol, Roxane Laboratories, Inc.), a synthetic form of delta-9-THC, is available by prescription in those cases where THC might be of benefit. It has been approved by the Food and Drug Administration (FDA) for the treatment of nausea and vomiting associated with cancer therapies in patients who have failed to respond to other anti-nausea drugs. Further, at the beginning of 1993, dronabinol was approved under a Supplemental New Drug Application for anorexia found to be associated with weight loss and loss of appetite in AIDS patients ((Drug Topics, 1993). Thus many experts argue that marijuana cigarettes are not necessary to the medical arsenal. Other medical experts in the field of the cited conditions and illnesses are unanimous in their opinion that smoked marijuana offers no medical benefit to their patients and may cause harm. It is noteworthy that 'marijuana has been rejected as medicine by the American Medical Association, the National Multiple Sclerosis Society, the American Glaucoma Society, the American Academy of Ophthalmology and the American Cancer Society. Not one American health association accepts marijuana as medicine' (Federal Register, 1992). This last statement seems totally at odds with the earlier statement that some 35 states have at least taken the medicalization of marijuana as a serious possibility.
Further, the National Institutes of Health (NIH), perhaps the premier Federally supported research facility in the world, reported no scientific basis supporting claims that smoked marijuana has value in treating glaucoma or multiple sclerosis. NIH reports new drugs available that exceed THC's therapeutic value in 'calming cancer patients' chemotherapy-induced nausea.' For patients suffering the HIV wasting syndrome, NIH reports the availability of dronabinol and notes the potential risk of immunocompromised patients 'smoking a carcinogen-containing substance' (Journal of the American Medical Association, 1994, p. 1647). These scientists, after an examination of both preclinical and human data, are of the position that no evidence exists to support the claim that smoked marijuana is superior to currently available medications 'for glaucoma, weight loss associated with AIDS, nausea and vomiting associated with cancer chemotherapy, muscle spasticity associated with multiple sclerosis or intractable pain' (Lee, 1994).
Currently the only legal way to obtain marijuana for medical purposes in the United States is through what is called a Compassionate Investigational New Drug (IND) authority. The more common IND approval is issued (usually to a pharmaceutical company) to evaluate the safety and efficacy of a new drug. In the case of a compassionate IND, authority is given an individual to take an unapproved substance on the grounds of it being humane and compassionate in the sense that usual medications do not appear to work. To date, approximately 40 compassionate INDs have been approved for cannabis but only 13 patients have actually received the substance. (Two have since died of AIDS.) Further, the Federal Government (in 1992 under the Bush Administration) reached a decision not to issue cannabis to anyone in the future. This decision underwent review by the US Public Health Service and was upheld (Grinspoon and Balakar, 1993). Thus, though technically a compassionate IND for cannabis may be sought, the reality is that no new INDs involving cannabis will be approved until and unless an alteration of policy occurs.
One of the major criticisms leveled at marijuana with respect to its efficacy within the medical model is the lack of scientific evidence and clinical trials. The evidence put forth by the advocates has been anecdotal in nature and has not been subjected to the rigors of the scientific method within clinical trials. In fairness, however, the difficulty of doing clinical trials in the United States must be mentioned. A clinical protocol involving a Schedule I substance must be herded through a series of obstacles and pitfalls that often seem more a regulatory nightmare than science. Such is the case with marijuana (Journal of the American Medical Association, 1994, p. 1645-1648). The only marijuana cigarette legally produced in the United States is made by the National Institute on Drug Abuse with marijuana grown under contract in Mississippi and manufactured into cigarettes at the Research Triangle Institute in North Carolina. While clinical protocols involving these cigarettes are not forbidden, they are, in fact, quite rare. The use of foreign cannabis in a clinical trial was proposed by the chair of San Francisco's Community Consortium (to be used in an HIV population) has been stalled because of the Consortium's inability to obtain an import license for the marijuana (Alliance for Cannabis Therapeutics, 1995).
While the issues of anecdotal versus clinical evidence continue to draw spokespeople from both sides of the issue, there is virtual unanimity within the scientific community that the smoking of marijuana causes harm. Even strong proponents of the medicalization of marijuana acknowledge that smoking marijuana may have negative health consequences. The basic view is that human lungs and associated tissue were never intended to inhale smoke - either marijuana or tobacco smoke. The health section of this paper cites evidence for this conclusion - that smoking marijuana (or cigarettes) can be hazardous to one's health.
Proponents of adding marijuana to the medical arsenal of drugs with legitimate medical applications make claims for its efficacy in the treatment of several diseases and conditions including cancer, glaucoma, multiple sclerosis and AIDS. However, in the eyes of the Federal establishment and a highly respectable part of the scientific community, proponents are unable to set forth anything but anecdotal evidence as to the effectiveness of smoked marijuana. Experts within the various cited diseases and conditions are virtually unanimous in their distrust and/or outright rejection of marijuana's medical efficacy. In many cases, other drugs are available which appear to be more efficacious in treatment than marijuana. Given the current state of medical and scientific knowledge and the difficulties in gaining approval for clinical trial protocols, it is highly unlikely that marijuana will emerge as a drug meeting Food and Drug Administration (FDA) standards for medical application and efficacy. At best, the proponents of marijuanax's efficacy might make a case for a rare compassionate Investigational New Drug (IND) application approval involving the use of marijuana; but, given past history (only 13 individuals have actually been given marijuana cigarettes as a result of a compassionate IND), and current policy, this too remains highly unlikely. At the present time marijuana would not seem to have a future within the medical care system of the United States.
ALLIANCE FOR CANNABIS THERAPEUTICS. May 1, 1995. Personal Communication. Washington, D.C.
DRUG TOPICS. 1993. 'Drug Approved for Treating Appetite Loss in AIDS Patients,' Drug Topics 137:3, pp. 28-32.
GRINSPOON, LESTER AND JAMES B. BAKALAR. 1993. Marihuana, the Forbidden Medicine. New Haven: Yale University Press.
FEDERAL REGISTER. March 28, 1992. Vol. 57, No. 59, pp. 10499-10508.
JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION. 1994. 'Medical Marijuana: A Trial of Science and Politics,' Journal of the American Medical Association 271:21 (June 1, 1994), p. 1647.
LEE, PHILIP R., MD; ASSISTANT SECRETARY FOR HEALTH, DEPARTMENT OF HEALTH AND HUMAN SERVICES, July 13, 1994. Letter to Congressman Dan Hamburg.
NEWBRIEFS. 1995. 'Marijuana.' Vol. 6, No. 3, pp. 15-16.
VOTH, ERIC A. AND DANIEL BROOKOFF. 1994. 'Review of Marihuana, the Forbidden Medicine.' , 120(4), p. 348.