Cannabis as a Medication: Does it Comport with the Modern Scientific Process?

Alice P. Mead†

Modern medicine increasingly seeks to provide treatment approaches that are “evidence based.” Specifically, the Food, Drug, and Cosmetic Act (FDCA) has been developed over the last 100 years to implement cutting-edge scientific knowledge, with the goal of ensuring that new medications are carefully tested for quality, safety, and efficacy. The Food and Drug Administration (FDA), the agency charged with enforcing the FDCA, closely scrutinizes all aspects of medication development.

This system of medication development also enhances and supports the effectiveness of the physician-patient relationship. Medications that successfully pass through this process are accompanied upon marketing by extensive preclinical and clinical testing which provide a robust body of risk/benefit and pharmacological data. Physicians rely upon these data to inform their prescribing decisions and to facilitate informed consent discussions with their patients. 

Furthermore, the FDA process has additional aspects that further protect patient welfare. Medications are approved for marketing only for use in a particular medical condition and by a specified patient population. The FDA requires that manufacturers’ promotional claims be limited to those supported by clinical trial data. Manufacturing facilities are registered with, and inspected by, the FDA to ensure that the manufacturing process is conducted in accordance with validated quality control tools. Medications must be prescribed and dispensed under the supervision of physicians and pharmacists, labeled with instructions for use, and accompanied by information about side effects. While not without its flaws, the FDA process assures the purity, identity, and potency/standardization of products and it is resoundingly supported by all major medical organizations.  

How does “medical marijuana” comport with this FDA paradigm?

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From Proscription to Prescription: America's Maturing Opinion on Marijuana

Robert J. Corry, Jr. † 

Travis B. Simpson††

Medical marijuana epitomizes the re-maturation of the United States. For the majority of our history, growing and possessing the hemp plant was not only legal, it had been required during notable portions of colonial and wartime history. The Declaration of Independence was printed on hemp paper and a plurality of the Founding Fathers grew hemp on their plantations.

Then, with the onset of the Prohibitionist mentality in the early 20^th Century, it was said that a puff of "marihuana" could turn a mild-mannered, law-abiding American into a raving lunatic. Almost seventy-five years later, thousands of people throughout fourteen states use marijuana as a medicine to effectively treat debilitating medical ailments such as cancer, HIV/AIDS, glaucoma, muscular dystrophy, nausea, muscle spasms, and chronic pain.

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Cannabis: A Commonwealth Medicinal Plant, Long Suppressed, Now at Risk of Monopolization

Sunil Aggarwal†

Introduction

The acknowledgement that cannabis is a medicinal plant has yet to be made by federal drug regulators. However, in July 2010, the Department of Veterans Affairs, a federal agency, adopted a policy that will formally allow patients treated at its hospitals and clinics to use medical marijuana in the states where it is legal.[1] Additionally, in October 2009, another federal agency, the United States Department of Justice (DOJ), announced that, as a matter of priority, it would endeavor not to target or prosecute those who are using and distributing cannabis in "clear and unambiguous compliance" with state medical-marijuana laws. While both of these policies are fraught with loopholes allowing subjective interpretation, and while they create no new legal rights nor grant any medical patient or provider full legal license to produce, provide, or consume cannabis or other botanical cannabinoid-based medicines, they are landmark steps forward for a federal government that for decades has, as a matter of policy, vehemently denied the fact that cannabis has any redeeming qualities whatsoever and treated it as nothing but highly dangerous, deserving of the strictest prohibition both nationally and globally.

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