An accidental editorial change to the National Cancer Institute?s (NCI) website earlier this month has caused a major stir in medical marijuana and public policy circles, noting that the federal agency has uncharacteristically crossed a line in recognizing the medical efficacy of marijuana. NCI as part of the National Institutes of Health (NIH) has listed for the first time cannabis (medical marijuana) as a Complementary Alternative Medicine (CAM) in apparent contrast to information disseminated by the U.S. Department of Health and Human Services (HHS), which calls marijuana a dangerous drug with no medical value.
The NCI website states that, ?The potential benefits of medicinal Cannabis for people living with cancer include antiemetic effects, appetite stimulation, pain relief, and improved sleep. In the practice of integrative oncology, the health care provider may recommend medicinal Cannabis not only for symptom management but also for its possible direct antitumor effect.? The NCI website further states that, ?Cannabis has been used for medicinal purposes for thousands of years prior to its current status as an illegal substance.?
NCI?s recognition of marijuana?s medical efficacy comes as a pending federal petition to reschedule cannabis is approaching its 10-year anniversary with no response whatsoever from the federal government. Since the Coalition for Rescheduling Cannabis (CRC) filed its petition in 2002, several additional studies have recognized the therapeutic effects of cannabis, eight more states have passed medical marijuana laws, and the country?s two largest physician groups ? American Medical Association and American College of Physicians ? have both called for a review of marijuana?s status as a Schedule I substance.
The rescheduling coalition, which includes groups like Americans for Safe Access (ASA), is seeking recognition of marijuana?s medical benefits while underscoring its relatively benign side-effects. However, even previous rescheduling petitions have been rejected despite strong recommendations to the contrary. In 1988, the Drug Enforcement Administration (DEA) ignored its own judicial recommendations from Judge Francis L. Young, denying the pending petition despite his conclusion that, ?The evidence in this record clearly shows that marijuana has been accepted as capable of relieving the distress of great numbers of very ill people, and doing so with safety under medical supervision.? Although final rescheduling determinations are made by DEA, the review process relies heavily on recommendations from the Department of Health and Human Services, the federal department that oversees NIH and NCI.
As prescription Dronabinol (Marinol?, Par Pharmaceutical) is a schedule III controlled substance that contains delta-9-tetrahydrocannabinol (THC), goes off-patent this year, companies are asking the government to allow them to grow marijuana in order to extract the natural form of THC, the primary active chemical in the plant used in the prescription drug. Dronabinol is made with synthetic THC, but it is cheaper to extract the chemical from the plant. ?It is not acceptable to hold millions of sick Americans hostage to a political double standard,? said Steph Sherer, Executive Director of ASA, the country?s leading medical marijuana advocacy group. ?It?s time for the Obama Administration to recognize the science, act with integrity, and reschedule marijuana.?
The accidental editorial change on the website of the National Cancer Institute is of particular interest to Coalition for Rescheduling Cannabis because the reviewability of the Data Quality Act was not addressed by the Ninth Circuit in Americans for Safe Access v. Department of Health and Human Services. The court claimed that the thrust of the petition was being addressed in another forum?the rescheduling petition described which has seen no movement for a nearly a decade. In Prime Time the DC Circuit found the DQA to be binding on agencies. The NCI announcement provides a basis for a reconsideration of the Ninth Circuit decision because it emphasizes that the ASA venue is the only practicable forum for the introduction of the new information.
Coalition for Rescheduling Cannabis has a Data Quality Act menthol petition pending at the FDA. The coalition is hopeful that the FDA will emulate the actions of the NCI and not await judicial action to address a violation of the DQA. However, regardless the statement of NCI and the legal and political and policy implication this created, a 2010 study showed that regarding the medical use of cannabis, a rigorous benefit-risk analysis and an exact psychiatric assessment should be conducted before and during prescribed treatment. The study confirms that the use of cannabinoids is limited mainly by their undesirable effects. On the other hand, systematic review of 18 randomized trials published earlier this month demonstrated a significant analgesic effect of cannabinoid as compared to placebo with significant improvements in sleep and limited serious adverse effects.
For more information:
National Cancer Institute: PDQ? Cannabis and Cannabinoids. Bethesda, MD: National Cancer Institute. Last accessed 03/29/2011.
American College of Physicians Statement on Medical Marijuana
The Center for Regulatory Effectiveness
Cannabis: pharmacology and toxicology in animals and humans. Adams IB, Martin BR. Addiction. 1996 Nov;91(11):1585-614
Kaufmann RM, Kraft B, Frey R, Winkler D, Weiszenbichler S, et al. Acute psychotropic effects of oral cannabis extract with a defined content of Delta9-tetrahydrocannabinol (THC) in healthy volunteers. Pharmacopsychiatry. 2010 Jan;43(1):24-32. Epub 2009 Dec 10.
Lynch ME, Campbell F. Cannabinoids for Treatment of Chronic Non-Cancer Pain; a Systematic Review of Randomized Trials. Br J Clin Pharmacol. 2011 Mar 23. doi: 10.1111/j.1365-2125.2011.03970.x. [Epub ahead of print]