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By Mariann Garner-Wizard
The United States Food and Drug Administration (FDA) issued an unexpected statement on April 19, 2006 saying that the Agency does not recognize any legitimate medicinal value for smoked marijuana (Cannabis sativa, C. indica ).1 The statement unleashed a strong response from many experts who consider the FDA’s release to be evidence of the “politicization” of agency policy in defiance of a growing body of empirical and scientific evidence and opinion.
The FDA’s statement included the following:
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 ... (e.g., marijuana has a high potential for abuse, has no currently accepted medical use ... 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 [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…”1
The agency incredibly adds the erroneous statement, “and no animal or human data supported the safety or efficacy of marijuana for general medical use.” 1
The FDA emphasizes that it is
the sole Federal agency that approves drug products as safe and effective for intended indications…. 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... Efforts that seek to bypass the FDA drug approval process would not serve the interests of public health ... FDA has not approved smoked marijuana for any condition or disease indication. 1
FDA’s release acknowledged that
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 standards of the [Food Drug and Cosmetic Act]. Accordingly, FDA, as the federal agency responsible for reviewing the safety and efficacy of drugs, DEA as the federal agency charged with enforcing the [Controlled Substances Act], and the Office of National Drug Policy, as the federal coordinator of drug control policy, do not support the use of smoked marijuana for medical purposes.” 1
Medical and Science Experts Criticize FDA’s Policy
Response from many sectors of the scientific and medical community was swift and primarily negative. ScientificAmerican.com’s editors promptly started a blog on the topic, with a scathing introductory posting by John Rennie which recaps recent SA articles on cannabinoid research and says the FDA’s position is “completely wrong... it continues to impede not just the medical use of marijuana but also medical research on marijuana, which could lead to superior therapies that don’t involve smoking or getting high at all.” 2
John Benson, MD, co-chairman of the Institute of Medicine committee that wrote a 1999 review of marijuana’s therapeutic potential and risks, is quoted in Gardiner Harris’ article in the New York Times’ that the federal government “loves to ignore our report.” 3 The IOM review found that smoked marijuana has therapeutic potential for pain and spasticity, for chemotherapy-induced nausea and vomiting, and for AIDS wasting syndrome, and called for more research. 4 But in the 7 years since it was issued, most efforts to conduct research on marijuana in the US have been thwarted by the DEA, which must provide all marijuana used in research, as well as approve the design, objectives, and protocols of all clinical research on the herb.
Donald Abrams, MD, professor of clinical medicine at the University of California at San Francisco, reportedly tried for years to get approval for marijuana research but was repeatedly denied. Finally, Gardiner writes, with funding from the State of California, Abrams conducted a placebo-controlled trial of marijuana smoking in HIV patients with nerve pain, with good results. However, he has had trouble getting the results of this trial published.3
Lyle Craker, PhD, a professor in the Department of Plant and Soil Sciences at the University of Massachusetts at Amherst and member of the American Botanical Council Advisory Board, applied to grow marijuana for researchers because he and other experts have determined that the DEA’s marijuana, grown at a high-security government farm at the University of Mississippi at Oxford, is of unacceptably poor quality. Craker’s application was denied after a 4-year battle, leading The Republican of Massachusetts to comment, “The FDA says there are no sound studies to support the medical use of marijuana, but it is also taking advice from the very agency that is blocking the studies.... The DEA has enlisted the FDA in its fight against the legalization of marijuana, and once again a federal agency that most Americans had trusted to be above politics is in the thick of it.”5
Sydney Spiesel, MD, a Woodbridge, CT pediatrician and Associate Clinical Professor of Pediatrics at Yale University’s School of Medicine, said that, due to the paucity of studies since the IOM report, the FDA’s claim to have “definitively established” marijuana’s lack of medical value is a case of politics trumping science at the agency, and that it is “certainly not the first time”. She cites the FDA’s initial decision to block over-the-counter sale of emergency contraceptives, although “overwhelming evidence” found them both safe and effective, and their availability was supported by the FDA’s own advisory committee. (The decision was later reversed.) “Marijuana as medicine - whatever its risk and benefits are eventually determined to be - may turn out to be much less important than the question of whether we can count on agencies like the FDA to be honest....”6
The FDA’s pronouncement was reportedly issued in response to a request by Rep. Mark Souder (R-IN), a critic of medical marijuana legislation passed in 11 states. Rep. Ron Paul (D-TX) and Rep. Maurice Hinchey (D-NY) joined Americans for Safe Access in demanding that the FDA either produce evidence of new research or explain why the statement was issued. 7 The FDA’s release acknowledges that “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.”1
Allen St. Pierre, Executive Director of the National Organization for the Reform of Marijuana Laws (NORML), called the FDA’s statement a “lame public relations stunt” and “attempt to sully 4/20 [April 20], a worldwide celebration day in favor of marijuana, and the opening day of NORML’s annual conference. Thankfully,” St. Pierre told the American Botanical Council, “newspaper columnists and editorial boards around the country are panning the FDA’s uber-political denial that medical marijuana is an effective, non-toxic and safe medicine for qualified medical patients.”[St. Pierre A. Personal communication email) to Wizard MG, April 26, 2006.]
The Honolulu Star-Bulletin took the issue more seriously, opining that the FDA’s statement may indicate a Bush administration “crack down” on medical marijuana use. “The more than 1,000 Hawaii residents registered to grow and use the plant under their doctors’ supervision have reason to feel uneasy.”8
Making the point that FDA approval does not necessarily rest on the best available science, Paul Campos, law professor at the University of Colorado, in his Rocky Mountain News column, quotes Bruce Mirken of the Marijuana Policy Project: “The bottom line is that... science at the FDA has given way to politics. They just pretend research evidence for the medical value of marijuana doesn’t exist... They’re terribly afraid of such research... Continuing to demonize marijuana is the key to the drug war, and the drug war pays the salaries of a lot of people.”9
Dronabinol, a synthetic version of delta-9-tetrahydrocannabinol (THC, one of the primary active cannabinoids in marijuana, made by Roxane Laboratories, Columbus, OH and marketed as Marinol®) and nabilone (another synthetic THC, Cesamet®, Eli Lilly Co) are approved in the U.S. to treat anorexia associated with AIDS and chemotherapy-related nausea and vomiting. 3 GW Pharmaceuticals of London, England, maker of Sativex®, a marijuana extract in a sublingual spray, approved for use as an unlicensed medication in Great Britain and approved as a licensed drug in Canada (where it is distributed by Bayer), has received FDA approval for clinical trails on Sativex in the U.S. 3 The April 24 e-publication of the Journal of Pharmaceutical Science includes a report of the efficacy of cannabis vaporization in delivering beneficial cannabinoids to patients without the toxic by-products of smoking.10
References
1. Food and Drug Administration. Food and Drug Administration Inter-agency advisory regarding claims that smoked marijuana is a medicine [press release]. Apr 20, 2006. Available at: <http://www.fda.gov/bbs/topics/NEWS/2006/NEW01362.html>. Accessed April 25, 2006.
2. Rennie J. Medical marijuana’s Catch-22. ScientificAmerican.com. April 21, 2006. Available at: <http://blog.sciam.com/index.php?title=medical_marijuana_s_catch_22%more>. Accessed April 26, 2006.
3. Harris G. F.D.A. dismissed medical benefit from marijuana. New York Times. April 20, 2006. Available at: <http://www.nytimes.com/2006/04/21/health/21marijuana.html>. Accessed April 25, 2006
4. Joy JE, Watson SJ Jr, Benson JA Jr, eds. Marijuana medicine: Assessing the science base. Washington, D.C.: Division of Neuroscience and Behavioral Health, Institute of Medicine, National Academy of Sciences, National Academy Press; 1999. Available at: <http://newton.nap.edu/html/marimed>. Accessed April 26, 2006.
5. Marijuana research? Don’t hold your breath. The Republican. April 24, 2006. Available at: <http://www.masslive.com/search/indexssf?/base/news-0/1145885848231420.xml?oned> . Accessed April 26, 2006.
6. Spiesel S. All smoke. Slate.com. April 24, 2006. Available at: <http://www.slate.com/id214053 ]>. Accessed April 26, 2006.
7. Americans for Safe Access. <http://www.safeaccessnow.org/article.php?id=3336>. Accessed April 26, 2006.
8. FDA loses credibility with jab at medical pot. Honolulu Star-Bulletin. April 24, 2006. Available at: <http://starbulletin.com/2006/04/24/edidtorial/editorial01.html>. Accessed April 26, 2006.
9. Campos P. Follow the drug war money. Rocky Mountain News. April 25, 2006. Available at: <http://www.rockymountainnews.com/drmn/opinion_columnists/article/0,2777,DRMN_23972_4647471,00.html>. Accessed April 26, 2006.
10. Hazecamp A, Ruhaak R, Zuurman L, van Gerven J, Verpoorte R. Evaluation of a vaporizing device (Volcano®) for the pulmonary administration of tetrahydrocannabinol. J Pharm Sci. April 24, 2006;95(6):1308-1317. E-published ahead of print. Available at: . Accessed April 27, 2006.
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