In 1978, the federal government of the United States launched the Compassionate Investigational New Drug (IND) Program, an initiative intended to provide medical cannabis grown by the government to those with serious diseases and health issues — for life. The program, however, wasn’t launched as a result of a curiosity regarding the medicinal efficacy of cannabis on the part of the nation’s leaders. Rather, it was the culmination of two lawsuits by Robert Randall, a pioneering patient from Sarasota, Florida.
In 1976, Randall sued the government and won in a federal court the right to use medical cannabis to treat his glaucoma. A Federal District Court ruled that Randall’s use of marijuana was a necessity for his health. In fact, it was this case that established the precedent of medical necessity as a plausible legal defense for prosecuted patients. However, according to the New York Times:
“Two years later, the government cut off his access to the drug, but he sued for reinstatement and won.”
Randall’s second legal battle and victory resulted in the creation of the Compassionate IND Program, which — although it serves a very small number of patients — is still in effect today. Roughly 1,200 low-quality cannabis joints (cigarettes) are distributed to patients around the United States each month.
Although Randall died in June 2001, several other patients continue to each month receive large tins containing 300 low-grade pre-rolled joints from the federal government. The cannabis is grown on a farm at the University of Mississippi that has been managed by the National Institute on Drug Abuse (NIDA) since 1968. Unfortunately, the Bush administration closed enrollment to the IND Program in 1992. Existing participants, however, remain within the program until death and continue to receive their canisters of low-THC cannabis joints.
Many are shocked to learn of this 37-year-old program and its participants. Upon first gaining knowledge of the program, it is easy to dismiss the story as an urban legend or internet clickbait. What is most problematic, however, is the hypocrisy illustrated by this effort. While government officials can arguably defend themselves by noting that it was a court decision that forced them to begin producing and delivering cannabis medicine to a small group of patients, the fact that cannabis continues to be categorized as Schedule I by the federal government is a blatant example of illogical and hypocritical public policy.
The FDA doesn’t reveal the number of patients participating in the IND Program, but some believe that between two and four remain. Two of these patients reside in Florida, including Irvin Rosenfeld, a 61-year-old stockbroker who has a tumor disorder, and Elvy Musikka, a 72-year-old glaucoma sufferer and cannabis legalization activist.
Rosenfeld began receiving cannabis under the program in 1982 and has written a book about his experience entitled My Medicine, the cover of which features him holding a large tin of low-grade government joints from the Compassionate IND program (grown on the NIDA-managed farm). He is probably the most publicized and interviewed of the participants. Echoing the perception that the government’s actions are hypocritical, Rosenfeld said:
“The United States federal government has been supplying me 10 marijuana cigarettes per day for almost 33 years, and in the same vein arresting people for possessing marijuana they give me for medical use.”
Rosenfeld uses cannabis to treat a rare bone tumor disease and has calculated his consumption of legal government cannabis over more than three decades, estimating that he has smoked more than 120,000 joints provided by the government’s pot farm at the University of Mississippi. Mussika, who has been highly critical of the IND Program and prohibition overall, notes that many federal lawmakers are completely unaware of this program.
“They’re very surprised — [most] didn’t know the government ever supplied anybody,”
Irvin Rosenfeld smoking one of the cannabis joints provided to him by the U.S. Government.
Until the government allows robust clinical research and human trials into the therapeutic benefits of medical cannabis, access to the drug for patients in states that have yet to legalize adult use will lag. It is currently the Schedule I status of cannabis that officially categorizes it as a highly addictive and dangerous drug with zero medical value (along with bath salts and heroin). Schedule II, a Controlled Substances Act category intended for less dangerous drugs, features methamphetamine and cocaine, both of which can be prescribed by a physician.
Because of its Schedule I status, doctors — even those in states with medical or adult use laws — cannot prescribe cannabis. Instead, they are limited to writing a recommendation. Many medical cannabis advocates are insisting on a Schedule III categorization, or lower, to ensure that ample research can be conducted that involves human trials and high-quality cannabis, such as that which can be purchased in states like Washington, Oregon, and Colorado.
Eventually, attrition will dwindle the patient population of the Compassionate IND Program to nothing and it will cease to exist. Although this will reduce the government’s hypocrisy, it will do little to provide safe access to cannabis medicine for millions of sick patients like Rosenfeld and Mussika.
“If I didn’t have my medical marijuana, most likely I’d be dead. If I was still alive, I’d be on disability and homebound. Instead, I’m a stockbroker here in Fort Lauderdale.”
Photo credit: wptv.com; philly.com
In late December 2015, lost amongst the hustle and bustle of holiday shopping, office parties, and spiked egg nog, a group of eight U.S. senators, all Democrats, sent a letter to three high-level bureaucrats in Washington, D.C., one each at the Department of Health and Human Services (HHS), the Office of National Drug Control Policy (ONDCP), and the Drug Enforcement Administration (DEA).
Senators Barbara Boxer (California), Elizabeth Warren and Edward Markey (Massachusetts), Cory Booker (New Jersey), Kirsten Gillibrand (New York), Jeff Merkley and Ron Wyden (Oregon), and Barbara Mikulski (Maryland) sent a nearly four-page letter to the acting officers of these government agencies. Conspicuously absent from the author list was Republican senator and libertarian torch bearer Rand Paul (Kentucky), possibly due to his presidential campaign.
Paul, along with junior senators Booker and Gillibrand, in early 2015 sponsored the CARERS Act, bi-partisan legislation that would further force the federal government to recognize a state’s right to legalize cannabis for any reason, reclassify the herb as Schedule II (it is currently Schedule I), eliminate several barriers to research, and — most important — make it easier for military veterans to obtain recommendations for medical cannabis from Veterans Affairs doctors (most notably for PTSD, depression, and anxiety).
More specifically, the target of the letter was Chuck Rosenberg, the Acting Administrator of the DEA, Michael Botticelli, Director of the ONDCP, and Sylvia Mathews Burwell, the Secretary of HHS. Rosenberg made headlines in late 2015 when he discounted the medicinal properties of cannabis and the efficacy gained by millions of patients nationwide, calling med pot a “joke” and saying that cannabis “never has been shown to be safe or effective as a medicine.”
Call for Collaboration
The letter pointed out the need for a wide range of government agencies and research organizations to somehow combine their efforts to reach the goal of more comprehensive medical cannabis research. Wrote the senators in the opening of their letter:
“…there is a need and unique opportunity for federal agencies to collaborate with each other…”
The letter stressed the “unique opportunity” for states to conduct population-based, clinical, “and other basic research on the risks and benefits of medical marijuana.” The letter went on to note the hurdles and barriers to federally-authorized cannabis research that are supported or maintained by a variety of government agencies. It identified the current regulatory scheme for medical cannabis research as “outdated and in desperate need of serious and immediate review.”
Areas of Focus
The letter focused on five key points, as summarized below:
- Supply Limits. The senators questioned the ability of a single farm at the University of Mississippi to produce an adequate supply of high-quality, “medical grade” cannabis for multiple research studies nationwide. The pot farm at the University of Mississippi holds the only bulk manufacture permit issued by the DEA and has cultivated and produced cannabis that many patients, physicians, and experts have labeled low-quality and as offering relatively little medicinal benefit. Thus, any study conducted in the United States using this low-quality herb would result in lower efficacy rates among participants — in essence, rigging the game for those who oppose medical pot.
- Rescheduling. Cannabis, which currently is part of Schedule I under the Controlled Substances Act, has been argued as a logical candidate for a lower ranking, such as Schedule II or III. The Food and Drug Administration has completed an analysis of the rescheduling of cannabis, and, it appears, HHS has provided “scientific and medical evaluations, as well as a scheduling recommendation” to the DEA. The query from the senators: What was the recommendation, and what is the timetable for review of the recommendation? This section of the letter also calls for the rescheduling of CBD oil.
- Interagency Coordination. Echoing one of the primary themes of the letter, coordination and cooperation, its authors cite a research application approval process that is “long, cumbersome, and difficult to navigate.” The senators request that the recipients explain how they “plan to work together to encourage qualified research applications” and asks them to describe the application process for qualified cannabis researchers.
- Surveillance and Epidemiological Studies. Such studies would gather data regarding how cannabis is actually being used, both medically and recreationally. The letter specifically calls for an investigation of cannabis use in “diverse populations and with multiple modes of administration.” If this actually occurred, government authorities would gather some rare insight into the economic and social aspects of cannabis consumption among a wide variety of demographic groups.
- Coordination with States. The senators would like to see “regular and organized communication” between agencies like HHS and state organizations such as public health departments — especially those in legal medical or recreational states like Michigan, California, Colorado, and Oregon — from which invaluable data can be obtained for further analysis or consideration from a national perspective.
The senators requested responses to their inquiries by January 31, 2016.
Photo credit: MSNBC, CBS News
Cannabinoids, the molecules that have special properties and provide the therapeutic relief of cannabis, were first discovered in 1964. Since then, more than 100 cannabinoids have been isolated and identified. While most are present in only trace amounts and play relatively minor roles in the efficacy of cannabis, major examples like THC, CBG, and CBD are critical to giving the plant its medicinal qualities.
Although relatively little is known about the minor, or supporting, cannabinoids in marijuana, the plant is considerably more complex than originally thought. The recent discovery of seven new cannabinoids by the University of Mississippi brings the total to 111.
The discovery of additional cannabinoids — or more information regarding known cannabis elements — is always welcome news. The entourage effect has shown that cannabinoids work synergistically, serving to enhance or buffer the effects of their sibling molecules. Without a solid knowledge of all cannabinoids, it can easily be argued that the full medical potential of the herb will never be realized.
For example, cannabichromene , or CBC, has been found to enhance the effects of THC. Likewise, another cannabinoid, cannabigerol (CBG), has the opposite effect on THC, serving to buffer its effects and decrease its psychoactive properties. Some cannabinoids also work in tandem with the body’s immune system, helping kill cancer cells or reduce inflammation.
Many experts believe that several diseases and ailments are simply a deficiency in the body’s own internal, or endocannabinoid, system (something called cannabinoid deficiency). This mechanism plays a critical role in the immune system and health of cells throughout the body. It is even believed to help fight aging and a variety of age-related ailments, such as Parkinson’s Disease and Alzheimer’s.
Will these newly discovered cannabinoids play a critical role in future formulations for marijuana extracts or concentrates? What will they reveal about the efficacy of single-cannabinoid extracts such as CBD oils and other products? Would adding one or two minor cannabinoids to the mix create an interactive effect that is greater than the efficacy of the individual cannabinoids alone?
With the parents of epileptic children across the country reporting that many don’t receive the necessary relief from CBD-only oil, will additional knowledge of cannabis and its powerful cannabinoid molecules provide a method by which these medicines might be modified or enhanced to offer help to sufferers of particular diseases?
The discovery of these new cannabinoids solidifies the need for more cannabis research, enabling a better understanding of the healing powers of this fascinating plant.