Grand Rounds at St. Rose

O’Shaughnessy’s • Winter 2018/19 —7— Using Cannabis as Medicine The author, a general practioner in California, has recommended cannabis to some 3,000 patients and monitored its use in treating a wide array of conditions By Jeffrey Hergenrather, MD mation on the internet, also report benefit from THC and This article is based on and includes slides from a ‘grand THC-acid extracts. This is an example of how cannabis rounds’ presentation to doctors at St. Rose Hospital in consultants —and concerned citizens— are far ahead of Hayward, California, February 7, 2018. It has been up- the medical establishment in terms of understanding the dated to reflect the rescheduling of Epidiolex. range of applications and best practices. I would like you to come out of this with an epiphany: The (Changing) Laws “This is wonderful, I would like to incorporate cannabis California law changed in 1996 when voters passed the into my practice!” Compassionate Use Act, enabling Californians to use can- For most of my career —more than 20 years— I was an nabis with the approval of a physician. The first sentence ER doc and had a small general practice. For almost the RVIN OSENFELD AND LVY I R E makes the law applicable to “any... illness for which mari- last 20 years I have been an independent doctor doing MUSIKKA have been supplied juana provides relief.” solely cannabis consultations. with cannabis by the US In 2016 California passed the Adult Use of Marijuana You might have heard through the media about ‘potdocs’ government since the 1980s. Act, which applies to adults over age 21 —more than 29 who are conducting five-minute evaluations and issuing million people. approvals. Less well known are the practioners with real A rare exception to federal marijuana prohibition was the Local jurisdictions can change the rules. There are 114 expertise who are helping seriously ill patients develop investigational new drug program begun in 1978 when a jurisdictions in the Bay Area alone. You won’t know what treatment plans incorporating cannabis. patient named Robert Randall, who was losing his eye- the rules are in a given city unless you go to the internet. Since 2008 I’ve been president of The Society of Can- sight to glaucoma, won the right to cultivate from a Wash- Here in Hayward there are no medical dispensaries and no nabis Clinicians, a group of physicians who meet quarterly ington, DC, judge. A year later the court instructed the recreational stores allowed, but you can grow plants in to talk about our clinical cases and political issues arising federal government to supply Randall with marijuana. For your garden —outdoors. The rules are all over the place. from practicing cannabinoid medicine. The group was the next 20 years he would get a tin of rolled cigarettes California doctors should know about the Ross v. Rag- founded in 2000 by Tod Mikuriya, MD, who died in 2007. containing marijuana grown at the University of Missis- ingwire case. Gary Ross was a contract technician who Our role as doctors is to “recommend” or “approve” the sippi for the National Institute on Drug Abuse (NIDA). tested positive for marijuana at a random drug test. The use of cannabis —not to prescribe it. A prescription is an The program stopped enrolling patients as the AIDS cri- company, RagingWire, fired him. Ross sued to get his job instruction to a pharmacist to provide a drug. The First sis escalated in the early 1990s. Two survivors are still re- back, arguing that he had used a legal medication at home Amendment protects doctors who discuss cannabis with ceiving tins from NIDA. But the government never inves- and was unimpaired at work. The state Supreme Court their patients, but when the patient then obtains cannabis tigated how they have fared. (Irvin Rosenfeld, who has a ruled that the Compassionate Use Act did not protect pa- it’s a violation of federal law. If a doctor advised the pa- severe bone tumor disorder, has not had to use any narcot- tients’ rights to use medical marijuana under California’s tient how to obtain it, he or she would be aiding and abet- ics. Glaucoma patient Elvy Musikka has not experienced Fair Employment and Housing Act. ting a federal crime. So physicians are in a bind, because further loss of vision.) So, in California you can lose your job —or not be patients obviously want to know what brands are trustwor- In 2014 the federal government gave Investigational hired— if you test positive for cannabinoids. California thy and where to get them. New Drug status to Epidiolex, a plant extract that is 99% NORML is promoting a bill in the state legislature that Although the federal government still classifies marijua- CBD and 1% other nonpsychoactive cannabinoids. It is would protect unimpaired employees. [It failed, but will made by a British company, GW Pharmaceuticals. Epidio- na as a Schedule I drug —harmful, and with no medical be reintroduced in 2019.] benefit— public attitudes have changed. Some 70 percent lex is nearing FDA approval as an adjunct in the treatment In any case, your patients should know not to go to work of Americans live in states that have reformed their mari- of two very severe forms of epilepsy, Dravet and Lennox- impaired and not to drive impaired. juana laws. Polls show that 60 percent of Americans sup- Gastaut Syndromes. port making marijuana legal for recreational use as we [Epidiolex was approved by the FDA on June 25, 2018. Only the marijuana grown for NIDA can be have done in California. And 90% support allowing the On Oct. 2 the DEA placed it in Schedule V —without mov- medical use of marijuana. ing CBD from Schedule I. See story on page 10.] used in clinical trials that will be approved I have been treating people with seizure disorders with by institutional review boards. high-THC cannabis for decades. We clinicians know that THC is a great anti-convulsant. So if we’re not getting the One aspect of the new law is detrimental to medical users effects we want with CBD-rich strains, we add THC to get who require heavy doses. No dose can exceed 10 milli- better control. Parents of epileptic children, sharing infor- grams, and no product can exceed 100 mgs. But many can- cer patients and others are ingesting 1,000 milligrams per day. A three milliliter syringe of concentrated oil typically Brief Review of Cannabis Laws contains about 2,000 milligrams of cannabinoids. We are told that revised legislation will exempt patients from the Federal: Marijuana cannot be prescribed dosage limits. Controlled Substances Act, Schedule 1: Marijuana The State of the Evidence and its cannabinoid constituents, including CBD The federal government contends that there aren’t (cannabidiol), can’t be prescribed, possessed, cultivated enough studies to justify moving marijuana off Schedule or studied without the permision of the federal 1. That’s a bit disingenuous. There has been a surge of government (FDA, DEA, NIA, NIH, H&HS, ONDCP). publications since 1993, when the elements of the endo- At this point we have six states that allow “adult use” of Cannabis has been available in rare exceptions through cannabinoid system were fully elucidated. cannabis. There are 24 states that allow medical marijua- Compassionate Investigational New Drug programs. A Pubmed and Google Scholar search for “cannabis and na. Fifteen have limited access to CBD-rich strains which The first, established in 1978 with glaucoma patient cannabinoids” turns up 3,530 citation for the years 1980- are minimally psychoactive. Only four states allow no Robert Randall, ended in 1992 with 30 patients. In 1992 1993, and 40,500 citations since then. marijuana use at all. public health officials concluded “there was no scientific If there is a dearth of randomized, placebo-controlled One of the pivotal points came in 2013 when Sanjay value to it.” Three patients remain in the program; two clinical trials it’s because the federal government has ob- Gupta, CNN’s chief medical officer, said to the country, are still receiving tins of joints from NIDA. “We have been terribly and systematically misled for near- • 1986: FDA approves Marinol (synthetic THC) as an stacles to research. Only the marijuana grown for NIDA ly 70 years in the United States and I apologize for my role anti-emetic and appetite stimulant. can be used in clinical trials that will be approved by insti- in that.” • 2014: Compassionate Investigational New Drug tutional review boards. Except for GW Pharmaceuticals, Dr. Gupta focused on a child in Colorado with Dravet programs for Epidiolex (a 99% CBD extract) in treating there is no one with deep pockets trying to get plant-based Syndrome, Charlotte Figi. “Charlotte’s Web” was the can- two severe epilepsies. cannabis medicines approved by the FDA and other regu- nabidiol-rich strain of cannabis that her parents gave her • 2018 FDA approves Epidiolex for Dravet’s and Lennox latory authorities. and she did very well. Gupta’s opinion was changed by Gastaut syndromes. DEA moves Epidiolex, which is The endocannabinoid sys- what he observed —and suddenly the medical benefits of- 99% CBD, to Schedule V. CBD remains on Schedule 1. tem had yet to be discovered marijuana became something people could talk about. when most of us were in med- Some of you, I’m sure, have had questions from patients ical school. The history of State of California: about medical cannabis. Cannabis, the plant, had been Compassionate Use Act (CUA), 1996 thoroughly suppressed. None By passing Proposition 215, voters legalized the medi- of us was taught that a physi- cal use of marijuana.

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