MARIJUANA AS MEDICINE: A Position Paper of Drug-Free Action Alliance and the Alcohol and Drug Abuse Prevention Association

of Ohio

Marijuana should be subject to the same research, consideration and study as any other potential medicine, under the standards of the U.S. Food and Drug Administration (FDA). Legalizing marijuana for medical use should not be decided by legislative or voter initiative.

DRUG-FREE ACTION ALLIANCE POLICY STATEMENT:

Drug-Free Action Alliance 6155 Huntley Road, Suite H Columbus, Ohio 43229 t. 614.540.9985 f. 614.540.9990 www.DrugFreeActionAlliance.org

Drug-Free Action Alliance 6155 Huntley Road, Suite H Columbus, Ohio 43229 t. 614.540.9985 f. 614.540.9990 www.DrugFreeActionAlliance.org

BACKGROUND Efforts to legalize marijuana as medicine in the United States have grown significantly in recent years. Approximately one-fourth of the states have passed legislation or ballot issues allowing marijuana to be prescribed within that state, though few have actually implemented these new policies. Marijuana remains a Schedule I substance under federal law a classification indicating it has no currently accepted medical use in the United States. MEDICAL CLAIMS There is some research that indicates marijuana may help decrease nausea, stimulate appetite, and decrease pain. The research is limited, and the Food and Drug Administration (FDA), along with most national medical associations including the American Medical Association (AMA), American Academy of Pediatrics, National Institutes of Health, Institute of Medicine, American Cancer Society, National Cancer Institute and National Multiple Sclerosis Society do not support smoked marijuana as medicine. However, the AMA has adopted a resolution calling for further clinical research into any therapeutic benefits of cannabinoid-based medicines. The AMA emphasizes that this resolution should not be viewed as endorsing the state marijuana-as-medicine programs. Leading medical organizations note that safer treatment options exist. In addition, the FDA has approved a synthetic version of THC, the psychoactive ingredient in marijuana. Named Marinol, it is taken orally. It is a Schedule II drug and is available by prescription in all 50 states. U.S. FOOD AND DRUG ADMINISTRATION (FDA) Marijuana should be subject to the same research, consideration, and study as any other potential medicine. The U.S. Food and Drug Administration (FDA) is the sole Federal agency that approves drug products as safe and effective for intended indications. The Federal Food, Drug, and Cosmetic (FD&C) Act requires that new drugs be shown to be safe and effective for their intended use before being marketed in this country. FDA's drug approval process requires well-controlled clinical trials that provide the necessary scientific data upon which FDA makes its approval and labeling decisions. If a drug product is to be marketed, then disciplined, systematic, scientifically conducted trials are the best means to obtain data to ensure that drug is safe and effective when used as indicated. Efforts that seek to bypass the FDA drug approval process would not serve the interests of public health because they might expose patients to unsafe and ineffective drug products. FDA has not approved smoked marijuana for any condition or disease indication. Marijuana is listed in Schedule I of the Controlled Substances Act (CSA), the most restrictive schedule. The Drug Enforcement Administration (DEA), which administers the CSA, continues to support that placement, and FDA concurred because marijuana met the three criteria for placement in Schedule I under 21 U.S.C. 812(b)1 (e.g., marijuana has a high potential for abuse, has no currently accepted medical use in treatment in the United States, and has a lack of accepted safety for use under medical supervision). Furthermore, there is currently sound evidence that smoked marijuana is harmful. 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. A growing number of states have passed voter referenda (or legislative actions) making smoked marijuana available for a variety of medical conditions upon a doctor's recommendation. These measures are inconsistent with efforts to ensure that medications undergo the rigorous scientific scrutiny of the FDA approval process and are proven safe and effective under the standards of the FD&C Act. MORE RESEARCH NEEDED There is already a substantial body of research demonstrating the health and safety risks from the use of marijuana. More research on marijuana, including possible medical applications as well as research on associated health and impairment risks from the use of marijuana, is needed. Not only is there a need for more research on any possible medical benefits, but also on identifying the chemicals within marijuana associated with any benefits, appropriate dosage levels, and safe means of administration, should medical benefits exist. VOTER AND LEGISLATIVE INITIATIVES Voter or legislative initiative does not meet the scientific standards for approval of medicine. For example, we would not consider it rational to go to the polls to vote on a potential antibiotic. Voter and legislative passage of marijuana-as-medicine laws may actually inhibit good medicine because they shortcut the necessary step of researching the marijuana plant and the chemicals within that

may have legitimate medical applications. Emotional testimony and personal opinion should not dictate medical treatment. CONCLUSION Consideration of marijuana as medicine should be treated with the same logical, rational approach as any other drug that has demonstrated health and safety risks yet may have some medical benefit. The medical and scientific community establishes policy based on available knowledge while continuing to conduct research on the drug to increase that knowledge base. Anything less puts the safety and health of the general public at risk. Drug-Free Action Alliance and the Alcohol and Drug Abuse Prevention Association of Ohio (ADAPAO) do not support marijuana as medicine nor legislative or ballot initiatives to consider this policy change. Should future research result in the FDA changing position on marijuana as medicine, ADAPAO and Drug-Free Action Alliance would reconsider this position.

REFERENCES U.S. Food and Drug Administration. www.fda.gov. Inter-Agency Advisory Regarding Claims That Smoked Marijuana Is a Medicine. Ibid. Ibid.

DRUG-FREE ACTION ALLIANCE 6155 Huntley Road, Suite H Columbus, Ohio 43229 Telephone 614.540.9985 Fax 614.540.9990 www.DrugFreeActionAlliance.org

ADAPAO
Alcohol and Drug Abuse Prevention Association of Ohio

ADAPAO P.O. Box 2394 Columbus, Ohio 43216 Telephone 614.470.3922 Fax 614.421.5954 www.ADAPAO.org