I was invited to by Dannemiller (a company whose mission is to provide health care professionals with premier educational and informational resources and to foster an environment where they can strengthen their skills in order to provide better care for their patients)to contribute to a point/counterpoint discussion on the reclassification of Medical Marijuana.
Following up on the question of medical marijuana, Sunil Aggarwal, PhD, MD Candidate from the University of Washington has graciously offered his opinion. The problem is not really should the FDA approve medical marijuana, it’s that the federal government (DEA) should reschedule marijuana to enable the medical researchers the opportunity to further investigate methods to safely utilize this drug to determine its full medicinal purposes and benefits and possible detrimental ramifications using vetted scientific methodology.
Should the federal government reclassify or reschedule marijuana to make it available for use by prescription for pain management?
Yes! The Government Should Reclassify Marijuana
Sunil Kumar Aggarwal, MD, PhD
Medical Scientist Training Program
University of Washington
For the last 72 years, the federal government has held that marijuana is extremely dangerous and should be subjected to the highest degree of control on pain of lengthy imprisonment.
According to the 1937 Congressional Record, official deliberations that led to the first federal law on marijuana (spelled at the time as ‘marihuana’, as it is still to this day in federal law) are rife with lurid tales of homicidal mania, racial slurs, and fears of miscegenation, all targeted at marijuana users of the time. The American Medical Association (AMA) stood virtually alone in opposing the first federal law against marijuana on the grounds that, by any measure of rational analysis, the drug was not inherently dangerous, had already been part of the United States Pharmacopoeia for nearly a century, and had already-accepted and future-promising medical utilities that would be irreparably stifled by the law.
Their position was both ignored and actually falsified on the floor of Congress before a voice vote was taken in favor of the law’s passage. The federal government’s expert marijuana witness was Dr. James C. Munch, a pharmacologist from Temple University. He testified before Congress in favor of a federal ban on marijuana. In later years, Munch continued to serve in his official capacity in marijuana-related court trials as an expert witness where defendants claimed that merely being in the presence of marijuana caused them to be overcome by murderous rage. This “official expert” testified at one such trial that, in the course of his research, he himself had tried marijuana and it had caused him to turn into a bat and fly wildly through the air, eventually landing head-down in a vat of ink on his desk. Notwithstanding the absurdities, in 1969, when the US Supreme Court struck down the federal marijuana law, finding it unconstitutional, the Executive Branch seized the opportunity to lobby Congress to adopt a new system of control that would comprehensively classify all drugs that they felt could pose a significant danger to society if federal regulation did not intervene.
It was at this point, in 1970, during this era of Presidential disdain of antiwar protestors as documented in the Nixon Tapes, that marijuana was classified in Schedule I, the most dangerous risk category. By law, this Schedule is reserved for substances that “have a high potential for abuse,” “no currently accepted medical use in treatment in the United States,” and “no accepted standard of safety for use under medical supervision.” Initially, according to the Congressional Record, marijuana was only to be placed in Schedule I as a ‘placeholder’ pending the policy recommendations of the Presidential Commission that was then studying marijuana in American society. In 1972, the commission recommended a laxer system of federal control of marijuana that would have eliminated criminal penalties for its general use and non-commercial transfer and in many ways resembled a “Schedule V” drug control scheme. President Nixon summarily ignored their recommendations and marijuana has remained in Schedule I to this day. In response to federal obstinacy for this classification of marijuana, 14 states have adopted laws that acknowledge and respect a physician’s recommendation to use marijuana in treatment, and approximately 7,000 doctors have participated in such programs.
The AMA, the largest and oldest physician’s group in the United States representing approximately 250,000 doctors, has recently adopted an evidence-based policy urging the federal government to review the Schedule I classification of marijuana so that clinical research and development of cannabinoid-based medicines can be furthered and expanded. The AMA report from its respected Council on Science and Public Health which recommended the organization’s policy, covers a wide range of historical and scientific data. Supporting research includes the results of three randomized, double-blind, placebo-controlled clinical trials of marijuana for chronic neuropathic pain published in the last two years which involved a total of 127 patients, all three of which independently found statistically and clinically significant reductions in pain intensity in patients receiving the treatment. The report predicts: “The future of cannabinoid-based medicine lies in the rapidly evolving field of botanical drug substance development, as well as the design of molecules that target various aspects of the endocannabinoid system. To the extent that rescheduling marijuana out of Schedule I will benefit this effort, such a move can be supported.”
In adopting their stance on marijuana’s classification, the AMA joined the American College of Physicians (ACP), the largest medical specialty society in the United States and second largest physicians group in the country representing approximately 124,000 internists. The ACP adopted a similarly worded policy last year after conducting a review of the evidence that calls on the federal government to undertake their own evidence-based review of marijuana’s status as a Schedule I controlled substance to determine whether it should be reclassified to a different Schedule. The ACP noted in their position paper, “A clear discord exists between the scientific community and federal legal and regulatory agencies over the medicinal value of marijuana, which impedes the expansion of research.” They also expressed their belief that, “an evidence-based review by federal regulatory authorities on the safety and efficacy of marijuana and cannabinoids for therapeutic purposes will likely provide evidence to support both appropriate reclassification and adjustment of federal drug enforcement laws, reduce conflict between federal and state law, and strengthen public confidence in the federal regulatory structure.”
When the two largest medical organizations in the US independently arrive at the evidence-based conclusion that marijuana’s status as a Schedule I drug should be seriously reconsidered, federal drug regulators should take note. In expected lawyerly restraint, neither the AMA or the ACP wants to step on the toes of federal drug regulators and tell them exactly what they must do, as they feel government officials in the Executive Branch are the ones who need to call the shots when it comes to rescheduling marijuana, as they are empowered to do so by Congress. Nevertheless, both organizations are clearly pointing their fingers downward from Schedule I for marijuana and are urging the federal authorities to take notice and act accordingly in the interests of science and medicine. President Obama, Attorney General Holder, and HHS Secretary Sebelius should rise above the politically and morally charged rhetoric and use their legally granted authority to reclassify marijuana to a more appropriate, science-based Schedule.
Hypothetically, as a Schedule II drug, marijuana, properly referred to by its scientific name Cannabis, would be still be an FDA-unapproved botanical drug substance, but it could actually be prescribed to pain patients in locally implemented, empiric treatment trials, given that a pharmacy stocking system would be in place to carry and compound this hypothetical Schedule II drug. Physicians could conduct clinical research in this fashion with the drug. They could feel confident in the safety profile of marijuana, essentially a cannabinoid botanical drug with no risk of lethal overdose. They could feel knowledgeable in applying Cannabis’s well-described mechanism of analgesia, centered on its agonism of cannabinoid receptors, the most abundant G-protein coupled receptors in the brain, also expressed on peripheral nociceptors, spinal interneurons, immune cells, and other tissues. Moreover, pharmaceutical companies interested in bringing cannabis-based medicines to market would have a much better shot at developing these ‘green medicines’ and conducting the large clinical trials needed to win approval from the FDA, which already has a protocol in place for approving botanical drugs. It would be a win-win-win situation for doctors, patients, and therapeutics development.
To have a copy for your own Library, please read and download the paper here: