Regulation of Medical Marijuana - Replies

December 28, 2005

Rajiv Das, MD, MPH and Lawrence O. Gostin, JD, LLD (Hon) , Journal of the American Medical Association

To the Editor: In his Commentary, Dr Gostin1 expresses concern that the current regulation of marijuana is flawed.

He states that the Controlled Substances Act does not adequately address the potential medical benefit that the use of marijuana can provide, citing data from the Institute of Medicine that tetrahydrocannabinol (THC) may be useful in the treatment of pain, nausea, vomiting, and appetite suppression. He states that the present regulation of marijuana inappropriately interferes with the patient-physician relationship by punishing physicians who prescribe marijuana to relieve pain and suffering; this impedes the physician's ability to speak frankly and openly with patients regarding potential treatment options.

An assumption is that the therapeutic benefits from the use of marijuana are derived from THC and not other products of combustion. Perhaps an effective policy would include a distinction for the delivery mechanism for THC. Most medications are supplied in a standardized form with specific concentrations of the active or proactive drug. Dosing regimens are based on the presumption that a standard effect will occur because the amount of active substance is somewhat reliable. Prescribed THC allows such a standard dosing format.

Typical delivery mechanisms of marijuana include inhalation and oral consumption of marijuana, with varied concentrations of THC; inhalation of burnt marijuana may have inherent health risks. A policy could be considered fair if it allowed the prescription and dispensing of THC but disallowed the use of marijuana for therapeutic purposes until more information is available.

Rajiv Das, MD, MPH
Saratoga, Calif

In Reply: Dr Das suggests a reasoned way to think about the use of marijuana for medical purposes. My Commentary also offers a regulatory approach based on scientific evidence. It proposes rigorous research of marijuana's safety and effectiveness, using a dose of fixed purity and strength. Regulatory review and clinical judgment would be based on the research data. For pharmaceuticals (such as morphine) that are proven effective but that still can produce undesirable risks and social consequences, there should be additional regulatory control and oversight. That is the proven standard for approval and use of pharmaceuticals, and marijuana should not be an exception.

That approach leaves several critical issues unresolved. First, federal policy actively discourages high-quality research by making access to marijuana by researchers exceedingly difficult. Even when access to marijuana is finally granted, there is substantial variability in the purity and content of the product. Second, researchers need to test the assumption noted by Das that THC is the active ingredient responsible for the perceived beneficial effects. Although that assumption is reasonable, there remains the possibility that marijuana, not THC in isolation, achieves the desirable effects. Third, researchers should test the most efficient delivery system. There may be some added value in smoking that needs to be evaluated.

If research concludes that THC is the beneficial ingredient and that delivery by tablet is safest and most effective, then there is justification for approval of that method only. A synthetic THC oral medication (dronabinol) is already available for prescription with US Food and Drug Administration-approved indications for anorexia associated with weight loss in patients with AIDS and for nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.

Regulation of the use of marijuana for medical purposes is feasible and socially desirable, but it will require a different way of thinking about the problem. It requires viewing marijuana as a potential medication subject to carefully controlled research, rather than as a drug of strict prohibition.

Lawrence O. Gostin, JD, LLD (Hon)
Georgetown Law Center
Washington, DC

1. Gostin LO. Medical marijuana, American federalism, and the Supreme Court. JAMA. 2005;294:842-844.

 



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