Call to Order and Roll Call
The2nd meeting of the Interim Joint Committee on Licensing and Occupations was held on Friday, July 8, 2016, at 10:00 AM, in Room 129 of the Capitol Annex. Senator John Schickel, Chair, called the meeting to order, and the secretary called the roll.
Members:Senator John Schickel, Co-Chair; Senators Joe Bowen, Tom Buford, Denise Harper Angel, Jimmy Higdon, Paul Hornback, Christian McDaniel, and Dan "Malano" Seum; Representatives Tom Burch, Denver Butler, Larry Clark, Daniel Elliott, Dennis Horlander, Joni L. Jenkins, Adam Koenig, Jerry T. Miller, Brad Montell, David Osborne, Darryl T. Owens, Ruth Ann Palumbo, Sal Santoro, Arnold Simpson, Diane St. Onge, and Susan Westrom.
Guests: Gregory Barnes, M.D., Ph.D. University of Louisville; Senator Perry Clark, Senator Morgan McGarvey; Jamie Montalvo, Kentuckians for Medical Marijuana; Dr. Danesh Masloomdoost, University of Kentucky, Cory Meadows, Kentucky Medical Association; Van Ingram, Office of Drug Control Policy; Micky Hatmaker, President, Tommy Loving, Executive Director, Kentucky Narcotics’ Officers Association.
Senator Schickel asked for a moment of silence to remember Senator Paul Hornback’s father, Stephen Robert “Bob” Hornback, who passed away Friday, July 1, 2016.
Representative Arnold Simpson asked for a moment of silence in memory of five police officers killed in Dallas, Texas the night before the meeting.
Approval of minutes of the June 10, 2016 meeting.
A motion to approve the minutes of the June 10, 2016 meeting was made by Senator Bowen, seconded by Senator Higdon. The motion was adopted by voice vote.
Ongoing research at University of Louisville.
Gregory Barnes, M.D., Ph.D., at the University of Louisville, said that cannabis salvia has been used for centuries. In China in 8,000 B.C., is was cultivated for use in garments, rope, paper and medicine. Other eastern countries also recognized the medicinal properties of cannabis. There are two types of chemicals in Cannabis called Endocannabinoids that mimic chemicals in the brain, and are released in response to nerve cell activity. Delta 9 Tetrahydrocannabinol (THC) binds to receptor proteins in the brain and is the cannabinoid that is psycho-active. In contrast, the Cannabinoid, called Cannabidiol (CBD), is not psycho-active because it does not work on the typical THC receptors in the brain. CBD has been characterized as an anti-seizure medication effective against both clinical seizures as well as measured epileptiform activity. It has also shown in clinical trials to reduce mortality.
Going back as far as the 1850s in the United States, Cannabis’ efficacy has shown to benefit a large number of medical ailments, including neuralgia, depression, hemorrhage, pain, and muscle spasm. This anti-seizure activity is independent of the THC receptor in the brain. In the 1980s, CBD control trials in epilepsy showed some seizure freedom. Data that was produced by a Colorado epilepsy researcher shows cannabidiol enriched oil derived from marijuana, such as Charlotte’s Web and others with high CBD content, showed reduction in seizure frequency. In surveying parents, it was noted that there was improved alertness, mood, and sleep. This is important in representing a compound that improved behaviors and thinking skills.
In 2013, a partnership was formed with GW Pharmaceuticals in Great Britain and the pediatric epilepsy community in the United States. There are over 20 centers participating in clinical trials involving devastating epilepsy in children; these trials include Dravet Syndrome, which is a genetic defect in the sodium channels in the brain, and Lennox Gastaut. Two double blind, placebo controlled trials, which are FDA criteria, have proved positive using Epidiolex (which is 98 percent CBD) and have shown efficacy in reducing seizures over a sugar pill. CW Pharmaceuticals will submit an application to the FDA by the end of 2016. If approved, this medication could be available in pharmacies by mid-2017.
There is the potential to use this medication for treatment of anxiety, schizophrenia, addiction, autism, and cerebral palsy in infants due to lack of oxygen. Kentucky has over 200,000 patients with special needs, the highest in the country. Clinical trials are ongoing to identify the developmental neurotoxicity in the brain. There have been no signs that the Epidiolex has an adverse effect. There are 102 clinical trials for conditions other than pediatric epilepsy, including inflammatory conditions such as ulcerative colitis, Type 2 Diabetes, Huntington Disease, and Multiple Sclerosis.
A major barrier for the clinical trials is that the CBD is a schedule 1 drug, requiring a schedule 1 DEA license, as well as initial and repeat DEA inspections. GW Pharmaceuticals is the only approved laboratory to provide for clinical trials. Data suggests that CBD can have anti-seizure properties and the benefit to risk ratio is favorable.
In response to a question from Senator Schickel, Dr. Barnes said federal law is very clear. CBD is a schedule 1 drug, and most physician’s licenses only permit them to write prescriptions for schedule 2. His research license is a schedule 1, therefore he can use the CBD for clinical trials. The dichotomy between federal and state law also is an issue.
In response to a question from Senator McDaniel, Dr. Barnes said the compounds are vastly different between CBD oil and medical marijuana. CBD oil in not psychoactive. THC causes psychoactivity, including psychosis involving emergency rooms visits for children. The real question is how the DEA and FDA can reclassify the CBD drug and still maintain control over the medical marijuana.
In response to a question from Representative Jerry Miller, Dr. Barnes said the questions on his slide are hypothetical. He does not have answers from parents that he could supply.
In response to a question from Senator Bowen, Dr. Barnes said the miraculous effects parents have seen with CBD use have driven a populist movement.
In response to a question from Senator Hornback, Dr. Barnes said CBD is usually 98 percent pure.
In response to a question from Representative Koenig, Dr. Barnes said he advocates’ good science and understanding of the benefits of using these compounds. Understanding good manufacturing processes and high grade product are also important.
In response to a question from Representative Owens, Dr. Barnes said it takes approximately one year for a drug to be tested by the FDA, and GW Pharmaceuticals should have their product through the trials by mid to end of 2017. If it is reclassified as a schedule 2 drug, it will be widely available.
Recent Legislation on Medical Marijuana.
Senator Perry Clark said that this issue is not going away. Opinions are changing. 2016 SB 263 set a framework for quality cannabis and a good distribution system. The Salk Institute found that THC and other compounds found in marijuana can promote the cellular removal of amyloid beta, a toxic protein associated with Alzheimer’s. In 1999, a U.S. patent was filed to use Cannabinoids as antioxidants and neuroprotectants. The Centers for Disease Control released a study finding 17 legal over-the-counter drugs cause 11,000 deaths per year. There are findings that provide strong evidence that marijuana use by teenagers does not increase after a state legalized medical marijuana. Twenty-five other states have now legalized the use of medical marijuana. The National Bureau of Economic Research, a “think tank” with 25 Noble Prizes for economic thinking, has said that there is zero credibility that legalizing marijuana leads to more use by teenagers. Politicians, not doctors, made marijuana illegal. Fifteen additional states are considering making marijuana legal. If marijuana becomes legal for medical use, doctors can practice and the patients will not be criminalized.
Senator Morgan McGarvey said that the issue is important and is going to have to be dealt with. 2016 SB 304 was an initial step that describes medically necessary marijuana administered to treat or alleviate life threatening illness. This bill focused on an end-of-life conditions in people who have cancer or an incurable disease. This is done through a doctor in a responsible way. The state will grow and regulate the product. Doctors already prescribe morphine and fentanyl to these same patients. These drugs are killing people in Kentucky every day. This is not a hospice bill however. Hospice deals with only 40% of the terminally ill people in Kentucky. The definition of terminally ill is six month or less to live. The word palliative care is to cover people who do live longer than six months after diagnosis but still need something to relieve their suffering. The bill does recognize that there are some therapeutic benefits to medical cannabis and it does provide comfort and relief for patients that need it most.
Representative Clark said that medical marijuana is a populist movement and that Dr. Barnes had done an excellent job. He encouraged Senators Clark and McGarvey to have the medical society engaged so that, when a bill is passed, it is for medical use and not recreational use.
Senator Seum said he has followed the oil issue, and it is not available until there is a change at the federal level. Senator McGarvey said that there are 25 states that have already done this. He is looking at how these states have passed their legislation.
In response to a question from Representative Owens, Senator Clark said in the other states there is a framework that sets up management of quality, production, and distribution of medical marijuana. Senator McGarvey added that in SB 304 there is a definition of what “medically necessary marijuana” means.
Representative St. Onge said that there seemed to be a need for clarification regarding the difference between the two categories for medical marijuana.
Senator Bowen asked whether, if the medical marijuana legislation were passed, the issue then go away. Senator Clark said there will always be an outcry. Looking at other states that have passed medical marijuana legislation, there are still problems and a need to make changes.
Jamie Montalvo, Kentuckians for Medical Marijuana, said there are thousands of Kentuckians who would like safe access to medical cannabis. In 2007, he was diagnosed with multiple sclerosis. He takes dozens of prescription drugs, all of which have side effects. One drug caused his blood pressure to drop, and he passed out frequently. Cannabis has proved to improve the quality of life in patients who suffer from neuropathy, spinal cord injury, or diseases of the nervous system. FDA data shows that one person dies every 19 minutes from side effects from legal drugs. No one, according to the FDA, has died from responsible use of medical cannabis. Many patients choose to inhale; however, some patients choose to use concentrates, edibles or other forms of delivery. Laws in other states allow for the production and sale of the flower. The patient then requests the dispensary to make the product in the form that best relieves their condition.
Until 1942, physicians prescribed and used cannabis as a form of medication for their patients. In 1944, the LaGuardia Committee reported that a study by the New York Academy of Medicine found that marijuana was not physically addictive, or a gateway drug. In 1970, the Controlled Substance Act was created and marijuana was set as a Schedule 1 drug. In 2009, the American Medical Association recommended the DEA review the status of marijuana’s Schedule 1 status. Twenty-five states have taken the step to use their state rights to regulate medical cannabis. Over 1 million patients have registered as medical cannabis patients although some states do not require their patients to register. Laws vary from state to state. Some allow for cultivation by the patient, some have compassion centers, and 14 states tax the cannabis products. Allowing medical marijuana to become legal will create jobs and a way to regulate the product. By creating a Cannabis Enforcement Department, Kentucky could set an application fee, have packaging and labeling, and provide a secure facility. There could be 15 compassion centers and 15 cultivation facilities; one per Area Development Distrust. The patient then knows what he or she is purchasing. Patients are requesting that all participants be registered and qualify under the departments regulations.
In response to a question from Representative St. Onge, Mr. Montalvo said each way cannabis is ingested affects the body differently. Different modalities such as salves or tincture can be applied to specific areas, whereas inhalation is a different method for quicker relief if needed. The patient figures which works best for them. None of these forms are toxic.
In response to a question from Representative Montell, Mr. Montalvo said according to the federal government, pharmacies follow federal guidelines and are not allowed to dispense a Schedule 1 drug. Hospitals are not allowed to dispense Schedule 1 drugs either.
Kentucky Medical Association/Research at the University of Kentucky
Cory Meadows, Director of Advocacy and Legal Affairs for the Kentucky Medical Association, said KMA policy supports further clinical research, as approved by the FDA, to determine whether cannabis can be effective in the treatment of medical conditions. Marijuana’s status as a Schedule 1 controlled drug should be reviewed and possibly changed for the limited purpose of research and the development of cannabis-based medications. When done the right way, there can be very promising results for particular conditions. If scientific evidence confirms cannabis-derived substances possess medical benefits, alternate delivery methods should be explored in order to avoid the inherent dangers of smoke inhalation and the uncontrolled variables affecting potency and dosage. Until such goals are achieved and marijuana is approved for use by the FDA, the KMA cannot support legislation intended to involve physicians in the area of medicinal marijuana outside of scientific clinical trials. Attitudes are changing and the KMA will commit to holding forums and panel discussions such as this and other educational programs for physicians, policy makers and other interested stake holders.
Danesh Masloomdoost, MD, University of Kentucky, said his training was in anesthesiology and pain management. As a scientist and physician he advocates restraint in using medical marijuana. In raw form it is impossible to obtain consistent levels of active ingredients because they compete for the same receptors, which lowers the efficacy of needed drugs. Even in best case scenarios, cannabis oils like Charlotte’s web cannot concentrate CBD (the helpful ingredient) over delta9THC (the psychoactive ingredient) enough to avoid the psychoactive properties. CBD is not equal to medical marijuana. While the different ingredients in marijuana have similarities, small variations in bioactive molecules can make a huge difference. Furthermore, there is little enforcement or oversite of additives, microbes, pesticides, fertilizers and other chemicals which may change the effect. There are pharmaceutically derived marijuana products such as dronabinol (delta9THC) and phase III and phase IV drug trails for CBD which Dr. Barnes mentioned. When he was a fellow at M.D. Anderson, Dr. Masloomdoost used dronabinol with a patient in hope of relieving her severe pain. Unfortunately, it did not help any more than using conventional treatments that had been used.
Sensationalizing the failures of conventional medicine is being used as the rationale for legalization. However, following legalization in California, the average medical marijuana recipient was a 32 year old white male with a history of other drug use. In Arizona, vague diagnoses like chronic pain were cited as the rationale for use. The argument that legalization will reduce the burden on the justice system has not proven accurate. In Colorado and Washington, there were increases in DUI arrests related to marijuana, motor-vehicle accidents related to marijuana use, and higher accident fatalities when higher doses of marijuana were found. After legalization in the Netherlands, cartels flourished to circumvent taxation or dose restrictions.
The biggest impact in legitimizing marijuana will be in the adolescent populations. Teenagers reason that marijuana must be safe if it is used medicinally. Dr. Barnes stated that CBD does not appear to affect the developing brain; however, there are components of raw marijuana which clearly do. Early and regular use of marijuana shows signs of developmental changes in areas of the brain that help with motivation and coping. Therefore, adolescents who used marijuana are biologically less capable of self-soothing and more prone to a lifetime of seeking chemical coping mechanisms. Marijuana irreversibly drops an IQ by at least 8 points. Marijuana users and children of marijuana users show lower life motivational and achievement rates. While it may give the illusion of calming effects to bipolar and PTSD patients, there is rebound volatility when the drug effects fade. Marijuana addiction rates exceed those for alcoholism. In the professional workforce, marijuana use is associated with higher absenteeism, work injuries, and disability. Kentucky is already in the top five in disability. The arguments of economic gains through taxation and jobs are easily offset by the intangible impact on productivity, accidents, and disability, not accounting for the health costs.
Marijuana is in the same DEA risk category as heroin. Cannabinoids deserve more study, which will require federal downgrading of its DEA scheduling from 1 to 2. In its native form, marijuana shows insufficient therapeutic benefit over existing therapies that can justify its known harms.
Senator McDaniel discussed Dr. Masloomdoost’s credentials.
Representative Owens requested a copy of Dr. Masloomdoost comments.
In response to a question from Representative Montell, Dr. Masloomdoost said that, if one thinks of CBD as a carrot, marijuana is like a soup. The carrot is one ingredient in the soup, and CBD has efficacy. However, when mixed with other chemicals in marijuana, the efficacy drops because there are multiple chemicals competing for the receptors. There are compounds within marijuana that are dangerous and psychoactive. Medical marijuana is not one product. It is 60 products and research is needed to tell the good from the bad.
Law enforcement concerns.
Micky Hatmaker, President of the Kentucky Narcotic Officers’ Association (KNOA), expressed concern regarding the legalization of cannabis for medical purposes. Officials in law enforcement and their partners in prevention and treatment are struggling to keep pace with the drug epidemic in Kentucky. Looking at the Substance Abuse and Mental Health Services Administrations’ 2013-2014 survey on drug use and health, it is clear that in the state where cannabis has been legalized for medical purposes, marijuana use by 12 to 17 year olds is the highest. Children and young adults are using cannabis at an alarming rate. Now they have access to marijuana with THC concentrations exceeding 30 percent, as well as infused edibles, readily available in states that have medicalized cannabis. Officials have no idea what today’s cannabis potency levels are doing to children and young adults.
As a retired State Trooper with over 20 years of drug law enforcement experience, Mr. Hatmaker said he has arrested numerous murderers, rapists, burglars, and drug traffickers. Almost every offender he has arrested was under the influence of drugs at the time of the crime. The majority stated that their initial encounter with drugs was experimenting with marijuana in high school. Colleagues in prevention and treatment will tell you the same thing. Outside of alcohol and tobacco, this is the gateway drug that leads children and young adults to illicit drug use and addiction.
KNOA sympathizes with those who are suffering debilitating diseases and those who are terminally ill. There may be some cannabinoids contained within cannabis that may possess medical value. GW Pharmaceuticals has two products that are direct compounds from the cannabis plants, Sativex and Epidiolex, both of which are in FDA Phase four clinical trials. They are showing promise. KNOA is encouraged by the introduction of the Marijuana Effective Drug Studies (MEDS) Act 2016. This is bipartisan legislation for legitimate medical marijuana research introduced last month that will make it easier for research on the medical effectiveness and safety of marijuana’s components.
Despite the best intentions of the 25 states, raw marijuana either smoked or ingested is not medicine. KNOA believes that medications, including marijuana-based drugs, should go through the scientific process and be accessed through legitimate physicians. KNOA joins the American Medical Association, American Academy of Pediatrics, American Cancer Society, American Society of Addiction Medicine, American Prevention Medical Association, American Pain Society, American Society of Anesthesiologist, and American Academy of Pain Medicine in support of the MEDS Act.
Van Ingram, Executive Director, Office of Drug Control Policy, said this is an important issue that is not going away. Although today’s meeting has been well balanced, there are still others who need to be heard. The substance abuse/treatment community that is on the front line dealing with this issue every day has insight, as do prevention specialists. There are risk and rewards to all medication. As Dr. Barnes testified, there is some medical benefit to marijuana. But, as with all medications, there are risks that have not been explored. While the committee has heard about the positive benefits of medical marijuana, the room can be filled with people who have had negative results using medical marijuana, and those people need to be heard from.
The University of Kentucky’s Center for Drug and Alcohol Research is known nationally for its work on substance abuse disorders. It has performed several studies on marijuana and its effect on the brain.
Mr. Ingram encouraged the committee to hear from other people because there is much to consider. The National Federation of State Medical Boards has issued guidelines for physicians who prescribe marijuana. Strict definition of medical conditions should be written. Physicians should have special training and a special license. There should be an agency familiar with regulatory issues to handle medical marijuana. Background checks for all involved are necessary. Prescription dispensers should report to the prescription monitoring program. If a bill is drafted, it should not allow people to grow their own medicine. This would allow for people to sell what they grow but do not use themselves.
Senator Schickel said that there are statements in the meeting folder from people who submitted their input on the issue.
There being no further business, the meeting was adjourned at 11:57 AM.