Dr. Barton Cobert, who resides in Governors Club in Chatham County, is a consultant in drug safety and pharmacovigilance with 30 years in the pharmaceutical industry. He’s written six textbooks on …
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Dr. Barton Cobert, who resides in Governors Club in Chatham County, is a consultant in drug safety and pharmacovigilance with 30 years in the pharmaceutical industry. He’s written six textbooks on drug safety. As a gastroenterologist and fellow of the American College of Physicians, the American College of Gastroenterology, Dr. Cobert has specialized in the side effects of medications. He is licensed in three states and is on the staff at the NYU School of Medicine and Rutgers. He was head of global drug safety at Schering Plough from 1993 until his retirement in 2004. He also headed the global drug safety group at Novartis Consumer Health and has a decade of experience in clinical research and the side effects of drugs. He now teaches and consults to governments, companies and the public on the benefits and risks of drugs.
You’ve authored five textbooks about drug safety and work now as a consultant on the benefits and risks of drugs. What specifically has drawn your interest to the subject of the use of medical marijuana?
First, what are marijuana, cannabis and hemp. Cannabis or marijuana is a preparation from the cannabis sativa plant that contains leaves, flowers, stems or seeds or extracts from them. Cannabis actually contains up to 400 chemicals in varying amounts including up to 100 “cannabinoids.” This is a chemical class of compounds which act on the brain to produce many different effects. Simplifying, there are two basic compounds everyone is talking about. The first is tetrahydrocannabinol (THC) which gives a “high” and has some medical actions and cannabidiol (CBD) which does not give a high but does have some medical actions.
The situation with Marijuana and Cannabis is quite tricky and in many ways unique. Possession and use of marijuana and cannabis are illegal in the US at the federal level. The Drug Enforcement Administration (DEA) considers marijuana a Schedule I drug which is a drug with no currently accepted medical use and a high potential for abuse. Schedule 1 drugs are the most dangerous ones known with potentially severe psychological or physical dependence and include marijuana, LSD, peyote, methaqualone, ecstacy and others. The Food and Drug Administration does not regulate Schedule 1 drugs because they have no accepted medical use.
Clearly, not everyone agrees with this scheduling and more than 30 states have approved medical marijuana/cannabis and about 10 have approved recreational use also. North Carolina has not approved either medical or recreational use. This poses a real paradox for the country as the federal government can arrest and jail people for possession, selling, manufacturing etc. But the states have issued licenses to many companies to produce and sell marijuana and other cannabis products. This is a complex issue with the states opposing the federals. Washington has responded with the Department of Justice saying, more or less, that we reserve the right to arrest and prosecute but will use discretion in arrests and prosecutions. The Justice Department and DEA are working on new laws and regulations to allow more federally approved growers for research on cannabis.
Another complication is that The Agriculture Improvement Act of December 2018 changed the definition of marijuana to exclude “hemp”— a plant material that contains 0.3 percent or less THC on a dry weight basis. Accordingly, hemp, including hemp plants and cannabidiol (CBD) preparations at or below the 0.3 percent THC threshold, is not a controlled substance, and DEA approval is not required to grow, market or research it.
So what we are seeing now are many stores selling foods, drugs, “supplements”, “nutritionals” etc. with CBD. This is now largely unregulated! CBD products, except for one prescription drug approved earlier this year, are not tested or approved for medical or recreational use by the FDA or DEA.
Cannabis acts on the brain receptors and other parts of the body. The actions, benefits and risks are largely unknown. There has not been much research done on marijuana even though it’s been used for thousands of years! Why? No one made money doing research; patents and trademarks were not issued; it was illegal to do research in the US, Canada, Europe and elsewhere. Big companies such as pharmaceutical and tobacco companies could not legally get involved. Medical centers and universities could not study it. This has started to change and many studies are now underway in the US, Canada, Europe, Israel and elsewhere. The problem though is that almost all the data we have now is based on anecdotes, stories, testimonials and social media. This is not the acceptable way to develop and sell new drugs. Drug research is formal, regulated by FDA, tightly controlled, incredibly expensive and takes years.
Yet, what we now have is the incredible and probably unique situation where a product that has been illegal in the US for decades and where possession can be a criminal offense, has suddenly become legal and recommended by medical, governmental and other “authorities” for the general public including pregnant women, cancer patients, children and pets! Use is extensive and many states are now bringing in enormous amounts of money in license fees and taxes on CBD and medical marijuana.
So one can say that the culture war over marijuana and cannabis is over. The people want it readily available and it is rapidly becoming easy to buy and use in many different forms (smoke, cream, food, pills, liquids etc.).
This is a long and long-winded introduction to answer the question you ask on what drew my interest to medical marijuana. The answer is that no matter how one defines or regulates it, cannabis/marijuana is a drug. I am not aware of any drug or products that went from being a felony if possessed, to being a widely used medical treatment that one can obtain without a doctor’s prescription or recommendation. The closest is the ending of Prohibition when alcohol went from being illegal to easily available. The unhappy consequences of alcohol use have been well documented.
This worries me immensely. Hundreds or thousands or unregulated or minimally regulated drugs (and they are drugs, whether in brownies, joints or pills) are being used without any real control. The “labels” on the packages have been shown to be frequently incorrect and inaccurate. The potency/strength of the marijuana available now is much higher than was the product available (illegally) twenty or so years ago and not all users are aware of this.
So my view is that we are going to see a slow motion train wreck as people now start paying more attention to side effects, counterfeits, tainted products (e.g. fentanyl or other things added to cannabis). My fear is that a similar scenario will take place that mimics the history of FDA’s drug regulation in the US. The FDA was not seriously empowered to regulate drugs until 1937 when disaster struck with an unregulated drug: 71 adults and 34 kids died after using Elixir Sulfanilamide to treat a variety of ailments, from gonorrhea to sore throat. See a brief summary of this if you more detail at: https://www.the-scientist.com/foundations/the-elixir-tragedy-1937-39231. The public and Congress demanded action and the modern FDA was created with very tight regulation and controls.
I greatly fear we are going to see a similar situation with some bad batches of cannabis. People will die or get terribly ill from toxic cannabis products and action by Congress and FDA will begin. So I have gotten involved in trying to warn people that you should be very careful about what drugs, nutritionals, supplements etc. you put in your body.
Your work and research, of course, is focused on the scientific aspects and data. You typically don’t address recreational marijuana use, but here’s a related question: more and more states are legalizing marijuana use. As a physician, and as a researcher from a medicinal standpoint, is marijuana a “gateway drug” that leads users to harder, more potent controlled substances?
This is a very important question for which we have no clear answer yet. The data is weak and controversial. There is a figure thrown around of about 10 percent of users becoming “dependent” which is not necessarily the same thing as actually being addicted. Many marijuana users also use multiple other drugs so it is not clear whether the heroin or ecstasy, for example, came before the use of marijuana or not. Other people talk of the “liability to addiction” concept. This states that some people are at risk for addiction for other reasons and just happen to use marijuana before using alcohol or some other product. There is also some suggestion that teenagers and adolescents are at greater risk of addiction than older individuals. The National Institutes of Health have stated that epidemiologic and animal data support the idea that marijuana is a gateway drug as other drugs like alcohol and nicotine can also be categorized as gateway drugs. There is a big controversy brewing now over whether vaping is also a gateway drug. We also know people are vaping cannabis and have almost no data on what this implies. So my personal view is that we should consider cannabis to possibly be a gateway drug and that caution should be exercised. Kids, teenagers, adolescents, heavy drinkers worry me far more that older or elderly people using marijuana for cancer pain or chemotherapy support etc.
When it comes to medical use, some of us may envision users rolling their own and smoking to relieve pain. But what other forms are patients using? What types are drugs and medications are in the marketplace now that are derived from marijuana, and how do they differ from the rapidly growing use of CBD?
Well, keep in mind that CBD, by definition, has minimal amounts of THC (the compound producing “highs”). Many people, rightly or wrongly, say that CBD is marijuana without the “high”. The idea here is that to avoid the high (which may or may not be harmful) use CBD. Some say they both work medically but CBD is safer. Maybe, maybe not.
So if we reach the stage where we have good data on which one to use, in what formulation (smoke, pill etc.) and how much we may see a parallel to diabetes patients who draw up their own insulin to treat themselves after checking their blood sugar. This would be excellent if we can get there. In the meanwhile, since the removal of CBD from the dangerous drug category we are now seeing enormous numbers of products.
I just googled “CBD products” and got 178 million hits. Here are just a few of them: citron hemp oil hair and body wash, hemp olive oil, raw honey and hemp extract, kosher vegan hemp olive oil, hydration emulsion cream hemp seed oil, hemp beauty chocolates, radiance hemp face oil for aging skin, hemp pain relief roll on (looks like a deodorant bottle), hemp extract for pain, anxiety and stress relief, also heals with sleep, skin and hair, hemp infused water, hemp chamomile chews for to relax dogs, hemp gummies, hemp chocolate truffles, hemp cigarettes with or without tobacco, turmeric hemp oil and more. There are dozens of cookbooks including, not surprisingly Cannabis for Dummies™. One finds hemp and cannabis products at major stores, supermarkets, on-line etc. For state regulated medical cannabis many preparations are available. Most require some sort or registration by both the prescriber (physician etc.) and “patient”. Purchases are made in shops. Searching on one randomly chosen California pot shop shows 538 products available including flower, vape, extract, edible, tincture, topical, roll-on and seeds to grow your own.
In terms of drug and medication types, one sees almost all possible formulations. Unless marijuana leaves or plant parts are smoked, most if not all other products require that the plants be treated to obtain active ingredients in liquid form (e.g. emulsions) which can then be mixed with creams, oils, foods etc. This requires complex chemistry and this manufacturing process is, to a certain degree, regulated in many of the states where medical and recreational cannabis is permitted. One can choose products by potency of THC and CBD.
You’ve pointed out that the legal and regulatory issues surrounding medicinal marijuana are complex, and we get mixed signals from the Food and Drug Administration, the federal Drug Enforcement Administration and from individual states. Can you clarify some of those issues and questions for us?
As noted above, in all states cannabis (except hemp with CBD and THC limits) is illegal. At the state level, pretty much anything goes if that state has approved medical and/or recreational use.
To use medical cannabis, some sort of medical “recommendation” is required. Doctors cannot write a prescription for marijuana or cannabis. Prescriptions are only for FDA-approved (or rarely experimental) drugs. So doctors make “recommendations” sometimes in writing; sometimes on-line. One usually has to find a doctor (or in some states a non-physician prescriber) to make the recommendation. Not all doctors can. One usually goes on-line in these states to find one.
North Carolina, for example, allows the hemp CBD products that were legalized in December 2018 but not recreational or medical marijuana (except for a few patients with epilepsy). The CBD products can be purchased without a recommendation or any medical intervention including in North Carolina. But possession of marijuana is still illegal. Possession is a misdemeanor or felony for depending on the amount possessed. Manufacturing, trafficking, possession with intent to sell, manufacture or deliver are felonies with possible jail time. Crossing state lines, particularly between a legalized marijuana state and a non-legalized state can be very dangerous. Things may change so pay attention.
Your expertise includes looking at the safety of certain drugs. How safe — or unsafe — is medicinal use for adults and children?
As noted, there is not much data to draw from. There is one FDA-approved version of CBD (Epidolex) for a rare form of epilepsy. The common side effects in the official FDA label include: drowsiness, decreased appetite, diarrhea, liver abnormalities, malaise, fatigue, weakness, lethargy rash, insomnia, disordered sleep, infections, (yellow) jaundice, dark urine, stomach area discomfort, itching, suicidal thoughts, depression, anxiety. From this information, one can say that in carefully done clinical studies there were significant side effects with CBD in this population.
There are two FDA-approved synthetic THC drugs (Marinol and Casamet) for the nausea and vomiting of cancer chemotherapy and appetite and weight loss in AIDS. The side effects include: mood change, confusion, delusions, fast heartbeat, feelings of unreality, memory loss, depression, anxiety, memory problems, hallucinations, palpitations, fast heart rate, low blood pressure, muscle pain, vision problems, chills, dizziness, rash, seizures, mouth sores and more.
Marijuana crosses the placenta and gets into the fetus. It is also found in breast milk. There is not a lot of data on use in pregnancy. An Australian study suggested moms who used marijuana were twice as likely to end up with their babies in the neonatal intensive care unit. Another study suggested marijuana moms had d lower birth weight babies compared to tobacco smoker moms. Other data suggests lower cognitive, memory and behavior scores in the babies at 3 and 4 years of age and increased risk of hyperactivity, inattention and impulsivity at 10 years of age.
From a society and public health point of view, there is data from Colorado and other areas suggesting driving safety issues: From 2009-2012 as medical MJ became available, average yearly marijuana-related traffic deaths increased by 48 percent compared with the “early medical marijuana era” between 2006 and 2008. In the first two years after the recreational use of marijuana became legal (2013 to 2014), the average yearly marijuana-related traffic deaths increased by another 41 percent.
Kids’ emergency room visits for marijuana increased in Colorado after legalization even though there was child-resistant packaging. The average age was 2 years old.
Bottom line: No drug anywhere is totally safe. The correct approach to evaluating safety is: do the benefits of the drug outweigh the risks and safety issues. At this point in the cannabis timeline, one cannot say that marijuana has a mild or benign safety profile. We have no idea of the safety profile in “at risk” people such as: babies, children, the elderly, diabetics, cancer patients, psychiatric patients, alcoholics, people with liver or kidney disease, people with weak or abnormal immune systems etc. We do not know the appropriate dose to give or the best means of administration (smoke, pill, cream etc.). So prudence suggests that people should be very very cautious about using cannabis. Pregnant women should not use cannabis and kids should not use cannabis.
As more and more state considering legalizing marijuana, what does the future hold for medicinal marijuana?
Well, as noted, the culture wars are over and cannabis won. It will likely be legal in all of the US for both medicinal and recreational use sooner rather than later if for no other reason than the tax dollars coming in. It will likely become legal at the federal level.
There will be serious, well-run clinical studies out of the U.S., Canada, Europe, Israel and elsewhere that will give us a real idea of the uses and safety profile of the various cannabis preparations. There may be a public health disaster which will force Congress and FDA to put in regulations to cover cannabis.
To me, the simplest course would be to move cannabis under the current drug, food and biologic regulations and laws and handle safety as we handle drug safety. But we will not be able to limit sales to pharmacies as we do with most drugs. CBD/hemp products are widely available in stores, supermarkets etc. Medical marijuana and cannabis may be restricted to cannabis shops only. All this remains to be seen. There is likely to be a blurring amongst CBD, hemp, medical marijuana and recreational marijuana. So the various products will probably be widely available. It is also interesting to see how the illegal organized crime operations currently selling marijuana and cannabis will react to the legalization. Many of us in the field of medicine, public health and drug safety are very scared.