12
Nov2010

by Wendy Tate, PSM, CIP, PRIM&R Blog Squad member

PRIM&R is pleased to bring you more blog posts from the PRIM&R Blog Squad. The Blog Squad is composed of four PRIM&R members who are devoted to blogging prior to, live from and after the 2010 Advancing Ethical Research Conference.
So, medical marijuana is on the ballot in Arizona…again. For my non-Arizona resident friends out there, this is the fourth time in the last 14 years that the issue has been sent to the voters. To date, a statewide proposition has passed twice but was never enacted, failed once, and now, is pending a final decision. Ten days post-election, Proposition 203, the 2010 measure, is still too close to call. According to this article from the Arizona Daily Star, out of 1.6 million ballots, the measure is failing by 3,500 votes with 89,000 ballots yet to be counted.Any use of marijuana is prohibited under federal law. In 1996, California was the first state to pass a law allowing the use of marijuana for medicinal purposes. Since then, medical marijuana use has been approved in a total of 14 states plus the District of Columbia, either through ballot measures or legislative bills. Marijuana is not a stranger to the Food and Drug Administration (FDA) regulations. Cannabis, the marijuana plant, is listed in the FDA poisonous plant database. It is also classified as an opiate under the Controlled Substance Act (21 CFR 13). However, marijuana is not exempt from being an FDA approved drug. Classification as a controlled substance does not imply the presence or absence of medical benefit. In fact, 21 CFR 13.801(1) states, “Many of the drugs included within this subchapter have a useful and legitimate medical purpose and are necessary to maintain the health and general welfare of the American people.” Permits and licenses can be obtained to conduct research with controlled substances. To apply for approval of a controlled substance to be prescribed as a drug, there are several investigational new drug (IND) and institutional review board (IRB) requirements that apply. This discussion naturally leads to the question, “Why hasn’t marijuana gone through the FDA drug approval process?” One reason may be that marijuana is not a profitable drug. As a plant, marijuana cannot be patented. Since the research and development process to get a drug through the approval process can cost millions of dollars, marijuana may be too much of a risk for a company to undertake. There has, however, been some research done on the clinical effects of marijuana. In a brief PubMed search, more than 100 articles on randomized controlled trials came up regarding the use of cannabis for pain (some support the claim that marijuana helps control pain, some do not; however, my evaluation of the efficacy is not the point of this article). To recap, we have the regulatory structure to approve a controlled substance as a drug, clinical research papers on the effects of medical marijuana, and public interest in the legalization of marijuana for medicinal use. But what is the FDA’s stance on the matter? In a memorandum dated April 20, 2006, the FDA issued an official opinion regarding the use of marijuana for medicinal purposes. In it, the FDA states:

“A past evaluation by several Department of Health and Human Services (HHS)
agencies, including the Food and Drug Administration (FDA), Substance Abuse and
Mental Health Services Administration (SAMHSA) and National Institute for Drug
Abuse (NIDA), concluded that no sound scientific studies supported medical use
of marijuana for treatment in the United States, and no animal or human data
supported the safety or efficacy of marijuana for general medical use. There are
alternative FDA-approved medications in existence for treatment of many of the
proposed uses of smoked marijuana.”

The issue of medical marijuana is a politically charged platform that hits a personal note with many people. Nobody wants to see another human being, especially a loved one, suffer. The area of pain management is progressing, but the number of diseases that cause chronic pain seems to be overshadowing any accomplishments. While many voters are highly educated, knowledgeable about current events, and potentially involved in the fields of medicine and/or science, politics should not supersede the FDA review process. Instead of using the polls to undermine the safety review process that past atrocities have helped define, voters can use the political process to better support funding research studies in areas of public interest, and giving the necessary infrastructure to the FDA to review data in an expeditious manner.

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