Intractable Pain Advisory Panel Office of Medical Cannabis Minnesota Department of Health Thursday, September 3, 2015, 4:00 to 8:00 p.m. 14600 Minnetonka Boulevard, Minnetonka MN Present: Orlando Charry, Nancy Jaworski, Erin Krebs, Mary Pat Noonan, Daniel Truax, Neal Walker, Arthur Wineman MDH Staff present: Tom Arneson, Alix Noonan, Alison Bjork, Susan Anderson, Deepa McGriff, Michelle Larson, Scott Smith and Deputy Commissioner Dan Pollock Introductions Charlie Peterson from Management Analytics & Development (MAD – part of the state agency MN Management and Budget) welcomed everyone to the panel meeting and public comment session and lead introductions. Presentations Medical Cannabis for Non-Cancer Chronic Pain: Systematic Review Mary Butler, PhD, MBA; Co-Director, Minnesota Evidence-based Practice Center Dr. Butler provided a process update on the review of scientific literature on cannabis as therapy for noncancer chronic pain that is being conducted by the Minnesota EPC. Their report from this work will be completed at the end of September. Cannabis: A Medicine to Treat Pain? Kalpna Gupta, PhD Vascular Biology Centre, Division of Hematology, Oncology and Transplantation, Department of Medicine, U of MN Medical School Dr. Gupta presented an overview of what is known about mechanisms for how cannabinoids reduce pain, comparison of effects of cannabinoids and opioids, and background and methodology for her clinical trial of vaporized cannabis for treating pain in patients with sickle cell disease. Q&A Discussion • There are currently few options for children with sickle cell disease and fewer for those who age into adult care. Thank you for doing this work. o All you can do is empathize and your heart goes out to them. I heard a 10-year-old kid speak of his pain, and I asked doctors and pain scientists about how they were managing his pain. There clearly is need for better pain management strategies for these patients. • Though it is a double blind experiment, patients will tell researchers whether they think they are currently on the treatment or the placebo. The advisory panel mentioned the value of specifically asking that question to patients. Researchers are currently struggling with patient recruitment due to patient reluctance to be part of the placebo group for any period of time. • The study does not recruit people during crises—the treatment is for stable, chronic pain. Researchers control and monitor the amount of treatment received by using a vaporizer to administer treatment consistently. • Animal studies show synergism between medical cannabis and opioids, and the effect of one is escalated when other is used. Researchers also found that while using medical cannabis to treat Page 1|8 • • animals, they could reduce the amount of opioids and see superior results. There has been no toxicity observed, and there were no serious adverse effects found in a 2011 study on humans. Currently, there are not studies of cannabis therapy for sickle cell disease in other countries. The limitations are the same in others countries as in the US, and even studies in countries with more liberal cannabis laws struggle to find funding. There is a sect of people in India that have used cannabis almost their entire lives. They vary in age from very young to nearly 100 years old. Dr. Gupta has spoken to them and learned their opinion of proper and improper ways of using cannabis. When Dr. Gupta asked them why they use cannabis, they say it makes them feel comfortable or normal and provides relief from the complexities of the world. They also did not report adverse effects. Intractable Pain Written Public Comment (to date) Lisa Anderson, Management Analytics & Development MAD provided an update and preliminary themes that emerge from the written public comments now present on the Office of Medical Cannabis web site. Written synthesis of comments will be provided to the advisory panel after public comment has closed. Public Testimony on Inclusion of Intractable Pain as a Qualifying Condition Deputy Commissioner Dan Pollock thanked everyone for coming and expressed appreciation for comments. He asked for feedback on the process for collecting information to inform the decision on intractable pain and recognized that there are other conditions that people would like approved for medical cannabis treatment. Q. What will the timeline be for considering other conditions? A. The Office of Medical Cannabis is currently focused intensely both on intractable pain and developing a process for considering future conditions. Additional conditions will likely not be considered until the intractable pain process is complete. Q. Will there be a full advisory panel for every condition? A. That is what the Office of Medical Cannabis is currently considering, but they are open to other ideas. The Commissioner of Health ultimately makes the determination, but this process has been very open and given people the opportunity for providing input. Please contact the Minnesota Department of Health with other suggestions. Following these comments from the Deputy Commissioner, public testimony proceeded. It is documented below. Next Steps The next advisory panel meeting date is yet to be determined. The Office of Medical Cannabis will be hosting listening sessions around the state in the coming weeks. ---------------------------------------------------------------------------------------------------------------------------- Page 2|8 Public testimony on inclusion of intractable pain The September 3, 2015 meeting of the Intractable Pain Advisory Panel allowed time for public testimony regarding whether intractable pain should be added to the list of qualifying conditions for the Minnesota Medical Cannabis Program. While not a verbatim transcription of oral testimony, the comments below represent the input—in their words when captured--of those that spoke. Public testimony was offered by 12 persons. Documentation of the testimony is housed on the Office of Medical Cannabis’s web site section on Intractable Pain public comments, as well as included here. • • [Already submitted written comment] I am here requesting that Minnesota add intractable pain to the list of conditions for doctors to prescribe for medical cannabis. I have been a registered nurse for 23 years. Every day my job involves assessing patients’ pain and talking to patients about what works and what doesn’t work to manage their pain. Pain management is difficult. Pain is subjective and invisible. We have to find the balance of helping patients maximize their ability to function while preventing side effects, dependence and addiction. It takes multiple interventions to manage pain. While I have a professional interest in including cannabis as a therapy for pain patients, I am also here to speak to you as person living with pain. I was born with a genetic condition called Ehlers Danlos Syndrome. My sister, both of my daughters and I are living with it. For simplicity, I will refer to Ehlers Danlos Syndrome as EDS. EDS is a collagen deficiency. My body is simply lacking the “glue” that supports every system of my body. My skin is fragile and stretchy, I bleed and bruise easily, I have hyperextensive joints which dislocate easily. I have had painful gastrointestinal problems including GI bleeds, gastroparesis, IBS, fistulas between organs, I have lost my sigmoid colon to diverticulitis, and I have had 3 feet of small intestine removed due to tissue pathology consistent with EDS. My most persistent symptom is joint pain, which I feel mainly in my knees, hips, hands and neck. Please know that I am not just advocating that cannabis be available for those only with EDS, I would like to offer to you that I am here thoughtfully pointing out that current pain meds available are not enough. Narcotic pain meds exacerbate GI problems including constipation and nausea, NSAIDS don’t’ work for some of us because of bleeding complications; muscle relaxants and pain meds can be too sedating and prevent us from functioning. I don’t tolerate opioids. I use low dose naltrexone which was very hard for me to get. I understand the concerns that people have legalizing the use of cannabis. I am looking for relief and the continued ability to function. I would welcome the opportunity to try cannabis under the supervision of a physician and pharmacist. Those of us living with pain need cannabis as an option. Thank you for considering adding intractable pain as a condition for the use of medical cannabis in the state of Minnesota. I would first like to thank all of you for this opportunity to share our experiences and for the consideration of including intractable pain. In 2009, I was rear ended in a motor vehicle accident. At the time there were no apparent injuries but a couple months later I began to experience pain and discomfort. I had no clue that the accident would change my life forever. I am currently 26 years old. I have had three back surgeries, 10 fusions, over a half-million dollars in medical expenses, and I have had a narcotic pump implanted that delivers an opioid to my back. The pain I experienced is indescribable. The best words to describe the pain are excruciating, torture, absolute misery, and hell. Due to the pain there was no other option than to become dependent on opioid medication. A year ago I was taking 60 mg of morphine twice a day and 30 mg of oxycodone four times a day. We have become a pharmaceutical nation. Because of this we are forced to deal with doctors that treat patients like drug addicts. I spent a year with one of the top neurologists in the state who only saw me as a drug addict because he didn’t take the time to take an MRI of my upper back, so I suffered for a year without any pain medication. Fortunately, I have been off of oral narcotic pain medication for six months thanks to the pump implant, my recent Page 3|8 • back surgery and cannabis. Eight months ago, I was trapped and stuck in my apartment with no escape from the pain. At that point I had been suffering for a few years and I was fed up. I lost all hope long before this point and I was full of anger, self-loathing, and I feared that this was what the rest of my life was going to be like. It’s hard to comprehend but for me, my condition became my life. I endured endless appointments with weeks where I would have an appointment every single day along with excruciating pain while trying to live my life. Years of this would take its toll on any individual. I knew something had to change and I was willing to try or do anything for relief so I decided to try cannabis. Cannabis saved my life and my sanity. When I use cannabis the pain and discomfort melt away. Due to the trauma and the surgeries the muscles throughout my back, down my sides and in my legs become extremely tight and cause severe spasms. Cannabis allows my muscles to relax along with my entire body. It is not only good for pain but for the mind and the soul as well. It gave me enough of a distraction from the pain that I was able to focus on everything that was happening around me instead of only on myself and my condition. I was able to find myself again, and soon the weight on my shoulders began to disappear. It gave me a different perspective and a better outlook on life. Currently I am a student at the University of Minnesota. This summer I changed my major to plant science to grow medical marijuana because I have decided to devote my life to this miraculous plant. I am going to help as many people as I can to inform everyone about the benefits of this God given plant. [later in the conversation] Marijuana—I would choose it over an opioid any day. I’ve been through it and I was super depressed and it helped me find myself. o Follow-up question: Are you still on the pain pump as well? Yes. [Already submitted written comment] I’m the Medical Director at the Health East Pain Clinic in St. Paul and just moved here a few months ago from Vermont. At the pain clinic in Vermont I followed a number of patients using medical cannabis over 4 to 5 years, maybe 60-80 patients. As a physician I would certify a patient for chronic pain. We had dispensaries in town that would dispense it in forms that were smokeable among other options, high CBD to help with sleep and pain and low THC, so they don’t sit around high. I helped an ex-cop get off methadone for peripheral neuropathy, Crohn’s disease, and lumbar pain. People did well. I would be in contact with families and providers to see how people were doing. People function well and have a higher quality of life. I did have some patients that died of opioids. I get the idea there’s not a lot of providers in Minnesota that understand this, so I thought I would come here and share my experience and I’d be happy to share more. o Do you have criteria for establishing who might or might not be a good candidate? I didn’t have any restrictions. By the time they have come to see me they have been through a number of things already, such as opioids and neuropathics. So I look to cannabinoids. And often they bring it up too because they’ve done their research. o Did you use cannabinoids on children? I didn’t see a lot of pediatric patients—some with seizures, fibromyalgia, and headaches. They were generally in their 30’s or older. There’s some concern doctors don’t want those kinds of patients in their offices. Most of my patients were like middle aged social studies teachers with debilitating pain. They often didn’t want to smoke it because they had kids at home. o Many of the studies included in prior reviews and one currently in process have been of FDA cannabis derivatives. These reviews often loop that in with whole plant extract. I never see dronabinol or nabilone prescribed for pain. Did you try those first? Those are really hard to get through insurance, rarely Marinol, so it’s unaffordable. I tried to get Sativex from Canada, which is CBD and not THC, but even then I’d see people come to the dispensaries and who knows exactly what the component is of that? It’s really hard to sort out what’s going on; there’s a lot of interest in getting Page 4|8 • • • marijuana rated as class 2. It’s very confusing and anecdotal. This is very different than any other medication. I’d rather continue to have this option to work with than trying to get one more opioid. o Did you observe any adverse effects from the use of medical cannabis? Rarely did I see an adverse effect—maybe a little headache or nausea, but they would work with people in the dispensary to try different things. So I rely on them [dispensaries] but I talk to them pretty often. Did not see major side effects, and by being able to cut down on other medications there would be a lot less. o It’s helpful to hear people who have found medical cannabis helpful. You’re the first physician I’ve talked to who’s actually used it. Can we contact you with further questions? Absolutely. I’ve registered a few people with other conditions and I’d be happy to answer questions. I consider it part of my role to do that. I am a pain warrior. I have really bad neuropathic pain. It’s in my hands and my feet and testicles and legs. Putting on my socks is torture; so is showering. There is no medication to take care of this. I take gabapentin at the maximum dosage that I can take—I think that a human can take— and it provides nearly no relief. Cannabis works. It helps me live my life and put on socks—you need to put socks on to live your life, right?—and shower. And because of this I run the risk of a felony. I’m just trying to treat my own pain, and I risk going to jail. So I ask you to take my pain and anyone else’s pain into consideration when you make your recommendations. o Do you experience any side effects? No I do not. None. Thank you for letting me speak. I have had a severe back pain issues that have haunted me for the last 10 years. I had an interesting experience over this last year where I travelled out to the west coast and for the first time in my life was able to get relief that didn’t require the typical process. I usually get Vicodin and Flexeril. The issues I’ve developed over the last ten years have been liberated. When you take Vicodin and hydrocodone you take in acetaminophen that damages the liver. When you take it over the long term it almost certainly will, and that’s irreversible. When I experience what a mild drug—not just the physical effects but the personal effects than hydrocodone and how it carries over into you own life. I’m just hoping that we move forward and include intractable pain for individuals so that no one has to go through the problems I have and the liver damage that I’ve experienced. There are ways to go about treating people with chronic pain. This is going to take a movement forward that we’re all going to have to work together on it. Our society has created a view on medical cannabis that is outdated. Recognizing acetaminophen all by itself and the damaging effects it has on an individual and not limiting this [medical cannabis] and restricting it to such a small portion of the population and allowing it to treat people like myself. [later in the conversation] One of things we’re missing here is that in response to the comments about addiction the opiates are much more addictive, and not only do people experience liver damage but constipation issues, limited ability to drive. Any type of substance that you’re adjusting to, you have to be respectful of that, and that’s where the medical community comes into play. The patient-doctor relationship needs to be tight. No one is discounting that importance. Vicodin was a much more powerful drug and in itself very addictive. So the argument of the slippery slope and with narcotics already being issued for pain seems a little lacking. If you have a milder drug and compare it to harder drug—I can only speak for myself, and I know there are other types of drugs for relief and there really are the strong drugs that are issued and they are issued right off the bat for people. Most people are not in a position to voice their experiences. And I didn’t have the option of the Fentanyl patch at the time. I accepted Vicodin as it is was the options. We just need to encourage viable options for use. This is another tool in the toolkit to treat pain and expansion to treat people with back injuries. Seems like a no brainer. I’m a mother of 6 children ages 7- 17, and up until this last year I’ve been a full time mom and home-schooling them. In 2012, after going to a Mothers of Preschoolers group—I was going Page 5|8 • • • Christmas shopping—I got hit by a drunk driver and I was hit on the driver’s side door. Ever since then I’ve been plagued by chronic pain, mainly on one side and pain under my shoulder. I’ve been trying to treat it with physical therapy and massage therapy and anti-inflammatory diet because I didn’t want to go to the harsh pain medications. And I ended up in the emergency room. And now I got rear ended and I have migraines from pain in the right side of my neck. I have been so desperate and my doctor said I have depression and anxiety after living with this. I have tried other medicines, and they don’t work. I usually end up in urgent care getting shots for migraines. I would do everything for my children. And I finally tried cannabis. My husband was very leery and even locked it up because we have children in the house. But he said I am a better mom. I can talk and engage with them and sweep the floor and play. I think it’s almost inhumane not to use something so effective. [Second public testimony] I’ve been in remission from Crohn’s disease. I’m actually testifying in memory of my father who passed away suddenly one year ago at the age of 46 from a form of arthritis where the vertebrae fuse together. My grandpa has the same condition and Crohn's disease as well. He never went to the doctor for this because he knew that all he could get were opiates. He raised us while my mom worked. The definition of intractable pain in Minnesota is so restrictive that if he wanted to try it he wouldn’t have ever had that opportunity. I know the advisory panel has the option to change that definition and I am asking you to do that and there’s no reason to send people to get opioids when cannabis is a perfectly nonlethal form of treatment. o Which parts of the definition do you find most restrictive? The definition now requires two pain specialists to sign off, which is a massive barrier. People can’t even find one doctor to certify them. It also forces you to go through all other standard means of treatment. I would suggest not forcing people to go through opiates first. I grew up here in Minnetonka. I’m 54 in Minneapolis, and at 17 years old I broke my back, my neck, jaw, arms, elbows, knees, and ankles. I’m a professional. I’ve worked in corporate America my whole life and managed professionals on opiates and was stoned out of my mind. I was in California visiting my friend who had cancer, and I said let’s get some for you to smoke to help you gain weight. I told her it was just like we did in high school. My friend has since passed away, but what we learned is that it became another avenue for us with chronic pain, like me. I visited with people that also came from other states. We have the most restrictive program in entire country and Canada. Look at where the movement and where the business has gone. I‘ve moved my businesses to another state. I focus on environmental sustainability in growing cannabis. I think that having a restriction on smoking the cannabis flower is too restrictive because I like the flower. There are differences, and people have different types of reactions. I don’t like the vaporizer, but I use it because I talk to all those people around the nation, and it helps them and their communities. [later in the conversation] I’ve taken all the opiates and all the drugs I have taken trying to get over pain. I told myself—I want you to take note—my doctor and I counted, and we went from 7 pain medications per day down to 1. I lost thirty pounds. I don’t have to take Prilosec anymore because they took—the side effect of that is low iron and magnesium. Everything you see on tv are all the drugs I was one of the first people on. There are drugs that are blockers to put on top of that. People here have asked how I’ve been this past week. I’ll be honest. On my way back my back went out, and I literally was spasming for 4 days. I had to take prescriptions from the drawer—the big drawer—you don’t ever want to open it. I am so much happier I lost weight, and I painted—I was on a ladder 30 feet high. We should at least have a choice. I want to thank you all. I just wanted to say a few words about my mom who suffers from rheumatoid arthritis and fibromyalgia and suffers from depression. It’s frustrating for me that she doesn’t get a lot of relief from the prescriptions she’s on and she views medical cannabis as not a viable solution when I feel like it could work for her. So open it up to intractable pain and provide Page 6|8 • • further education about the benefits. I’m really excited to see relief for our loved ones through less harmful side effects. I’m 33 years old and a disabled citizen of Spring Lake Park, Minnesota. For over 5 years I’ve been using cannabis to treat my life threatening gastrointestinal autoimmune disease; Crohn’s disease; and 3 inflammatory diseases associated with my Crohn’s disease; sacroilitis, cervical spondylits, and pancreatitis. I was also born with a genetic mutation, Ehlers Danlos Syndrome Type 2 and live with chronic intractable pain every day. My life almost ended prematurely because of conventional pharmaceutical drug treatments due to the dangerous side effects with anti-TNF biologics, steroids and anti-cancer medications. I’m also unable to treat my chronic intractable pain with oral opiate based pain medications due to my pancreatitis. The medical option to treat with cannabis is the right of any Minnesota patient suffering from chronic intractable pain of any medical condition. Cannabis protects my universal right to life, liberty and pursuit of happiness by returning a sense of normalcy to my daily life by treating my chronic nausea, chronic intractable pain and deadly inflammation from my complex medical conditions. I was able to get my medical conditions, Crohn’s disease and Ehlers Danlos Syndrome legally covered by Minnesota’s Medical Cannabis Law, under the limited qualifying medical conditions of Crohn’s disease and severe and persistent muscle spasms. The only reason I was able to become certified into Minnesota’s medical cannabis program is because our state’s law discriminates in favor of my medical conditions. Patients don’t get to choose or decide if we want to become ill, disabled, or have our lives prematurely come to an end due to any medical condition. Minnesota’s medical cannabis law discriminates against a patient’s medical conditions. Patients of Minnesota might not share the same exact medical conditions, but the one medical condition we all share and have in common is chronic intractable pain. Chronic intractable pain does not discriminate. Every patient has pain, every patient lives, breathes, eats and battles chronic intractable pain, every moment of our lives. Imagine suffering from the second you wake up, every decision you make is based off pain, to the second you fall asleep, (if you sleep). Your whole life is filled with a never-ending battle with chronic intractable pain. Patients living with pain understand there’s a natural cycle to life. We’re aware everyone dies on our planet, all the stars, and everything in the universe. Death comes for us all and we accept it. The one thing we cannot tolerate, not can we accept, is the unnatural progression of the end. The State of Minnesota can end the premature loss of life, please expand Minnesota’s legal definition of intractable pain and please add chronic intractable pain to Minnesota’s medical cannabis law. Thank you for your time. o How does medical cannabis help you? Relief of pain now. The two manufacturers are not producing strong enough products. [Showed strongest product.] One gram of this is $200, and I would need 10 per month, so I need $2000. I live on $799 per month from Social Security Disability. So I’m not sure where extra $1300 will come from let alone the money for other things. I wouldn’t be here if I didn’t have cannabis. I’d be dead. Minnesota has lots of problems that have to do with costs and potency. I was chemically burned in my mouth due to additives added by MNMed. It’s been reported and led to MNMed changing the additive in its products. There are very powerful emotional stories. Though I’m not flat out opposed to people who have legitimately no other options, I work in the field of public health and prevention. I’m concerned about diversion, abuse of the system, and norms that are shifting and continue to shift as a result of policy. The state set up the current system to avoid issues other states struggle with, but intractable pain is a slippery slope. My family has intractable pain and addiction, but we need to think of what’s best for the patients—for patients that already have complex medical issues. They say medical cannabis is addictive and significantly increases the chance of developing brain disease. Data show that 1 in 10 marijuana users become addicted and that jumps to 1 in 2 for daily users. Dr. Miles Belgrade said to your Page 7|8 • • panel that his patients are as likely (or more) to want to continue to use opioids even when adding medical marijuana. Medical professionals are to “do no harm,” but marijuana use has known risks of harm. “Intractable pain” is subjective, and including this opens up the system to a whole host of complications. Those who are most likely to provide public comment are those with personal experience of use and provide anecdotal evidence—not science—to advocate for inclusion of intractable pain. Addiction, access to youth, increase in mental illness, traffic safety issues, less employee productivity, decreased perception of harm, cost to society from all previous reasons. There are also quotes from “Big Marijuana” organizations such as NORML and MPP stating how medical marijuana is how they will open the door to full legalization. They say that people that use medical cannabis have depression, and NAMI says it’s not helpful and works through anxiety or depression or schizophrenia and patients often don’t follow through on appointments. The comments here and on the website lean one way and will continue to do so. People in my field are afraid to speak up for fear they will lose their job, credibility, and grant funding. I’m playing this by ear. One of the things I, myself, feel I have intractable pain. A while back I hit my head on the roof of the vehicle, and I’m missing 2 parts of my brain and was in a coma for 5 days. I was married to a person from Germany, and I’ve been to Amsterdam a few times and I noticed smoking pot helps a lot. I enjoyed a lot more things. But there’s always a way to change structure. As far as street drugs we’re hoping to not have to buy it on the street because we’re worried about what gets put into it and street gangs. I moved to another state, but my family helps me and they’re here and my friends are here. I went last Thursday night [to the intractable pain listening session] when they were closing. I’m thankful you’re listing to all points of view. I would have liked to be here earlier. I could probably get a lot more focused. I had 5% or less chance of survival. In regard to adding to Minnesota, the most important thing from being the law passed in limited conditions—that’s a great start—including intractable pain can only make things better. My biggest worry is that so many people that I’ve spoken to on medical cannabis are people that said their son or daughter ended up in rehab because they smoked that first joint. They smoked something on the street and didn’t know what they were getting, and it usually came down to the drug dealer sprinkled heroin or something else into it. It wasn’t just cannabis—it always seemed that there was something on top of it. For intractable pain it will be so much safer for those in pain. Our son was actually the first that got it, and he has life threatening seizures and we’re seeing some positive results. It’s a little bit of oil. It’s safe—I would never get something on the street—it’s safe and controlled. Page 8|8
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