DEA Denies Petition To Reschedule Marijuana For Medical Use, To The Detriment Of Patients

http://www.forbes.com/sites/davidkroll/2016/08/11/dea-denies-petition-to-reschedule-marijuana-for-medical-use-prolongs-human-suffering/#7c2528c51a3b

The U.S. Drug Enforcement Agency has denied petitions by two former state governors and a New Mexico psychiatric nurse practitioner to remove marijuana from the most restrictive classification of controlled substances.

In a 180-page document to be published Friday, August 12 in the Federal Register, the DEA has deemed that marijuana has no legitimate medical use and while also possessing substantial risk for abuse and physical dependence. The determination is based largely on an evaluation by the U.S. Food and Drug Administration.

The ruling flies in the face of the 25 states who’ve passed medical marijuana provisions. And, to some marijuana proponents, the decision fuels speculation that the FDA and DEA are favoring the pharmaceutical development of prescription products containing specific, isolated or synthetic marijuana components.

In one sense, denial of the medical value of marijuana is disingenuous, particularly in cancer pain or the nausea, vomiting and anorexia of cancer and cancer chemotherapy. In these cases, the FDA has already approved for medical use pharmaceutical products derived from marijuana.

One is dronabinol (Marinol; AbbVie), the generic name for synthetic delta9-THC, the primary neurochemically active component of plants from the genus Cannabis. It was approved way back in 1985 to stimulate appetite in patients suffering from the anorexia of HIV/AIDS and for chemotherapy-induced nausea and vomiting (CINV).

The second is nabilone (Cesamet; Meda Pharmaceuticals), also approved in 1985 for chemotherapy-induced nausea and vomiting as well. Nabilone is a chemically-synthesized THC relative that doesn’t occur naturally.

The FDA is also currently fielding clinical trials of a mouth spray containing cannabidiol (Epidiolex; GWPharma) for debilitating childhood seizure disorders. GWPharma has a related oromucosal spray product containing nabiximols called Sativex that’s available in 15 countries for the treatment of spasticity associated with multiple sclerosis and cancer and neuropathic pain, and is approved in another 12 countries. The GWPharma products differ from the others in that the products that use super-cold liquid carbon dioxide extractions of Cannabis plants that the company has developed to produce reproducible amounts of THC, cannabidiol, or both, along with many of the plants’ other cannabinoid chemicals.

Pro-pharma conspiracy against marijuana?

The DEA report estimates that 18.9 million U.S. citizens already use marijuana, recreationally or medically. On one hand, a product that you can grow at home or purchase legally in certain states shouldn’t be restricted by the federal government. I’ve been a homebrewer of my own craft beer throughout my life, producing intoxicating ethyl alcohol, or ethanol, with yeast feeding on sugars dissolved by heating germinated barley. States regulate and tax the sale of products containing this alcohol and the federal government maintains a regulatory authority called the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF).

The difference between homebrewed alcohol and marijuana is that the plant was placed on the U.S. Controlled Substances list of “scheduled” drugs when Congress passed legislation in 1970. Signed by President Richard Nixon, the Controlled Substances Act consolidated more than 200 laws regulating different drugs since the 1906 Food and Drugs Act. The Drug Enforcement Agency was then established in 1973 to, well, enforce the provisions of the Act.

The highest restriction, Schedule I, is for agents with no known medical use. These include chemicals like heroin, LSD and mescaline, as well as the peyote cactus from which mesacline is derived. Classification on Schedule I effectively criminalizes the possession and sale of such agents. Highly addictive opioid pain relievers like morphine and oxycodone represent the most restrictive class of medically useful drugs and are listed in Schedule II. Medically useful compounds with progressively lower potential for abuse or physical dependence are in Schedules III, IV and V. Drugs with no known abuse potential are exempt from the Controlled Substances Act.

The DEA has previously downscheduled a substance previously on Schedule I, THC, in order for the FDA to approve Marinol in 1985. But that was in response to a shepherded process by the FDA for the development of a new drug using the Investigational New Drug Application process. To simplify a complicated and expensive process, the FDA requires that a new medicine meet five requirements:

1. the drug’s chemistry must be known and reproducible
2. there must be adequate safety studies

3. there must be adequate and well-controlled studies proving efficacy
4. the drug must be accepted by qualified experts
5. the scientific evidence must be widely available

The problem with downscheduling marijuana is that it must be shown to have medical uses that meet these five criteria. But researchers object that it’s difficult to obtain marijuana to do this research. Currently, researchers must obtain the products from a regulated farm at the University of Mississippi. The DEA and FDA claim that they are committed to medical research of marijuana safety and effectiveness:

The DEA and the FDA continue to believe that scientifically valid and well-controlled clinical trials conducted under investigational new drug (IND) applications are the most appropriate way to conduct research on the medicinal uses of marijuana. Furthermore, DEA and FDA believe that the drug approval process is the most appropriate way to assess whether a product derived from marijuana or its constituents is safe and effective and has an accepted medical use. This pathway allows the FDA the important ability to determine whether a product meets the FDA criteria for safety and effectiveness for approval.

In support of this contention, the petition denial includes provisions for research marijuana to be made more widely available by growers who apply for licensure with the DEA.

But other practical research hurdles exist in meeting the five-part requirements, not the least of which is a company sponsor willing to make an investment of hundreds of millions to several billion dollars to progress through the drug approval process for a plant that can be grown by anyone.

Lack of capital notwithstanding, the first problem, the drug’s chemistry, is the kind of thing being addressed by GWPharma. Their oral spray is made from a highly defined extract of specific Cannabis cultivars. Homegrown marijuana or that purchased in states where it can be used legally under state laws can vary considerably in its chemical content and may not be reproducible from batch to batch.

Another problem with marijuana under this framework is the adequacy of safety and efficacy studies. The typical means of marijuana administration–smoking–is not considered safe or capable of administering a known amount of bioactive chemicals with reproducible pharmacokinetics. Orally administered marijuana–marijuana edibles–could potentially meet the necessary research framework but the type of matrix in which the marijuana is extracted and packaged can vary considerably. Most high-quality marijuana research these days involves the use of marijuana vaporizing equipment.

The need for acceptance by qualified experts and the wide availability of scientific evidence negates the widespread anecdotal evidence that users, particularly cancer patients, insist shows that marijuana relieves their pain and suffering.

But just as the scientific and medical community downplays herbal medicine enthusiasts about their positive anecdotal experiences with dietary supplements, the community must be consistent with the invalidity of anecdotal reports alone.

And despite my training and decades as a medical researcher, I feel that the anecdotal experience of patients is so overwhelming that federal allowances should have been relaxed to permit medical marijuana use while a structured national research strategy is developed for medical evaluation of marijuana.

Put simply, failure to downschedule marijuana is prolonging human suffering.

While the next best thing would be to fast-track the products under development by GWPharma that best approximate the marijuana plant, the costs of getting a Sativex or Epidiolex prescription and purchasing the drug will be far more financially and practically burdensome on patients with cancer, HIV/AIDS, multiple sclerosis, seizure disorders and others. I can sympathize with people who claim the system favors the pharmaceutical industry when one could either grow one’s own marijuana or purchase it at a federally authorized dispensary.

The discordance of federal and state laws on medical marijuana poses other financial issues on the burgeoning medical and recreational marijuana industries but that’s more peripheral to the story I’m presenting today.

But among other issues I’ve been considering, marijuana has the potential as an alternative or adjunct to opioid pain relievers and should be considered among our options to alleviate the opioid epidemic. To me, it’s an important question that should also be considered while marijuana is federally prohibited by people who are suffering from acute and chronic diseases.

I welcome the input of medical marijuana users, researchers, regulators and any other interested folks here in the comments or by Gmail to my news tips account, tips4davidkroll.

Filed under: General Problems