MISUSE OF DRUGS (MEDICINAL CANNABIS) AMENDMENT BILL

Transcription

1 MISUSE OF DRUGS (MEDICINAL CANNABIS) AMENDMENT BILL CannabisCare NZ Ltd, March 2018 COMPASSION Let s start with compassion If your Pain Specialist said there was no treatment for your chronic pain, would you consider medicinal cannabis? If the Oncologist said there was no cure for your partner s cancer, would you consider medicinal cannabis? If none of the anticonvulsants controlled your child s seizures and the sideeffects were intolerable, would you consider medicinal cannabis? Science and the experience of patients confirm the benefits of medicinal cannabis for many, but not all patients. Medicinal cannabis offers hope when all hope has gone. We all deserve that chance. SUMMARY CannabisCare supports the amendment and congratulates the Government for this long over-due initiative, but has further recommendations to improve access to medicinal cannabis. I am a registered medical practitioner working for CannabisCare NZ Ltd. CannabisCare was formed in 2017 and opened the first medicinal cannabis clinic in Aotearoa NZ. As of 16 March 2018 I have prescribed CBD oil to 56 patients and Sativex (with specialist sign-off) to 8 patients. Exception and statutory defence for terminally ill people this exception must include other conditions such as chronic pain, neurological and inflammatory conditions. Preparations made from cannabis should be excepted, eg oils, tinctures and balms. Please note that most people using medicinal cannabis do not want the high or any mental blurring. They simply want relief from suffering and have a clear head to relate to themselves and whanau. Regulation-making power as the main medicinal cannabis prescriber in NZ I would like to comment to the Committee at oral submission time. Ideally consumers and doctors will be consulted about the establishment of a regulation-making power. CBD products no longer classed as controlled drugs I support this amendment but would un-control all cannabinoids because potential benefits are immense for those suffering and the abuse potential is so low. Declassifying CBD may help to bring down the compliances and price and will incentivise indigenous industry. I wish to meet the Health Select Committee to make an oral submission because I am the most experienced medicinal cannabis prescriber in NZ. I would like to update you on the stories, concerns and outcomes for my patients since this written Page 1 of 8

2 submission. I believe I can give you a real picture of the desperate need for medicinal cannabis and what is required to improve access guided by the principles of fairness, quality and safety, and compassion. CANNABIS CARE CLINIC Owned and operated by Dr Graham Gulbransen MB ChB, Dip Obs, PG Dip MedSc (Addiction), FRNZCGP, FAChAM. He is a GP, Addiction Specialist & Cannabis Consultant. Dr Gulbransen has prescribed Sativex with Specialist endorsement since February He has prescribed Tilray CBD oil to be used as drops taken orally, since December There are no other medicinal cannabis products available on prescription in NZ. Patients were seen with chronic pain (65%), cancers (13%). Others were for neurological conditions eg Parkinsons, muscle spasms and seizures, or for anxiety and/or insomnia. There is scientific evidence of benefit for these conditions and others involving the nervous or immune systems being the main sites of action of medicinal cannabis. The Cannabis Care Clinic is at the West Care Specialist Centre, 131 Lincoln Rd, Henderson alongside other medical Specialists. Case History 1 Lynda Williams, patient advocate, asked me to use her real name. Lynda died from pancreatic cancer in She was just 67. She reluctantly tried smoking cannabis for the nausea, low appetite and weight loss from chemotherapy. However she hated smoking and using illegal cannabis. Her Oncologist and I completed the 6 page Application for APPROVAL TO PRESCRIBE SATIVEX FOR AN UAPPROVED USE under Regulation 22 of the Misuse of Drugs Regulations We waited 8 days for Ministry of Health approval. She then paid $950 for Sativex oral spray, working out at $3.50 per spray. Two sprays daily eased pain and nausea, had a calming effect, allowed her to gain weight and improved the quality of the final months of her life. WHAT PATIENTS AND THEIR DOCTORS NEED Sativex: all Registered Medical Practitioners should be able to prescribe without needing Ministry of Health approval. The spray will always be expensive and has a low abuse potential. For those who can afford it there are significant medical benefits. Please streamline the process for those already suffering Page 2 of 8

3 For 8 Sativex applications (each 6 pages long) the average time to approval was 15 days, the longest being 27 days this is not acceptable for patients suffering chronic pain or cancer All medicinal cannabis products should require a simple standard prescription to improve access, including various ratios of THC:CBD Often GPs are better informed about their patients and about medicinal cannabis than Specialists, so there should not be a requirement for Specialist endorsement for any medicinal cannabis product A range of medicinal cannabis products: the main side effect of CBD is sedation, limiting the dose that some people can tolerate. Products with both THC and CBD are likely to be more efficacious with less sedation. Doctors are well-versed at adjusting doses of combinations of conventional medications and could apply this knowledge and experience to different ratios of medicinal cannabis Affordable: at current prices starting at $285 per month, medicinal cannabis is out of reach to most patients. Those with serious illnesses tend to be on benefits and cannot afford legal medicinal cannabis with the risk of prosecution for possession of illicit cannabis Many patients would prefer NZ produced medicinal cannabis products and would like Government support for local industry, including encouragement to export. THE DIFFERENCE BETWEEN MEDICINAL AND RECREATIONAL CANNABIS 1. Recreational, or adult use cannabis contains abundant THC. 2. Therapeutic cannabis is grown or provided to sick people. It is not standardised and constituents have not been analysed. Many people experience benefits. 3. Medicinal cannabis contains THC and CBD in various ratios. It is researched, free from contamination, of pharmaceutical or medicinal grade and can be prescribed reliably. If you want to get stoned, choose cannabis rich in THC. If you want the medicinal benefits choose plants with lower THC and more CBD, or just CBD Cannabis plants come in a wide variety with different chemical contents This is like the wide range of tomato varieties from the big red beef steak to sweet yellow cherry tomatoes and every other kind of tomato in between, but they are all tomatoes Cannabis comes as thousands of varieties or cultivars from those with abundant tetrahydrocannabinol (THC), those with equal amounts of THC and (cannabidiol) CBD, to those with mainly CBD, and every THC:CBD ratio in between. This is made more complex when considering over 100 known cannabinoids and terpenes that affect the medicinal properties of the plants Page 3 of 8

4 Plants abundant in THC are used by recreational users seeking feelings of pleasure, euphoria, relaxation or excitement, existential well-being etc the high from cannabis The recreational cannabis illicit market or home-grown have selected varieties with abundant THC THC can add to the medicinal benefits of CBD Illicit users sometimes report greater benefits than using prescribed CBD because it contains both CBD and THC Typically recreational or adult users smoke cannabis, although vaping (inhaling heated plant vapor rather than burning it and inhaling smoke) is safer. Medicinal cannabis users consume it by oral spray, lozenges, edibles or drops or rub in balms, though vaping is possible Finally, medicinal cannabis users do not want to get high (mental blurring), they just want relief from their pain, cancer etc. So, more THC to get high, more CBD for the medicinal benefits. However THC can add to the medicinal benefits of CBD. A variety of ratios of THC:CBD allows sophisticated prescribing for different conditions. Abuse or addiction? There is almost no risk with medicinal cannabis compared to risks associated with opioids and benzodiazepines used to treat these condtions. For further information, go to How THC and CBD Work, at the end. Case History 2 73 year old woman with chronic low back and hip pain, worse following surgeries, minimal relief with tramadol, morphine and zopiclone. Prescribed CBD25 oral $285, then the stronger CBD100 oral $660. She reported good pain relief but could not afford to continue the drops. WHY CANNABIS CARE PRESCRIBES MEDICINAL CANNABIS? There are scientific and compassionate grounds for prescribing medicinal cannabis. Even with the 7 September 2017 Amendment to the MoDA patients find the medicinal cannabis product range to be very limited and very expensive. There is a huge emotional component to my consultations: most patients suffer chronic pain most of the time, have cancer or incurable neurological conditions Most have been told that doctors can do nothing more to help them and are left in despair Most have been told by their doctors that medicinal cannabis does not work Most doctors are not aware that they can prescribe CBD or have not been able to figure out the dosing schedules and complexities at the pharmacy. As you know, about 80% of NZers support the use of medicinal cannabis. Page 4 of 8

5 This includes those end of the line patients who have heard or read about the benefits. Thus, many of my patients have tried illicit cannabis and experienced some benefit. I attended the United in Compassion ( ) 4 day Medicinal Cannabis Symposium in Melbourne in June Speakers included doctors and scientists from Israel (home of cannabis research), USA and Australia led by Prof David Caldicott, Emergency Medicine Specialist, Canberra. I was introduced to thousands of medical and other scientific papers confirming the benefits of medicinal cannabis. Also the minimal risk of harm. On compassionate as well as scientific grounds I believe that every patient who believes that cannabis can reduce or relieve their symptoms should have a chance to use it, because it is so safe. In particular, those who are not being helped with standard medical treatment. This includes chronic pain, cancer, incurable neurological conditions, some mental illnesses, stuck patients where nothing is helping, and finally those who have experienced benefit from illicit cannabis. Case History 3 58 year old man with multiple sclerosis, weakness down his left side, is on disease modifying therapy tecfidera, has muscle spasms despite baclofen. He would like to try Sativex for the spasms, being an approved condition. However his Neurologist will not endorse the prescription and the patient cannot afford $950 for Sativex because he had to stop work and is on a benefit. EVIDENCE OF BENEFIT FROM MEDICINAL CANNABIS 2017 National Academies of Science, Engineering, Medicine, USA reviewed 10,700 clinical studies Few high quality randomised control trials (RCTs) available because: o Prohibition restricts supply and standardisation of cannabis for research purposes o Cannabis plant has hundreds of compounds to study separately and individually, and in different ratios o Plants cannot be patented, reducing funding sources Evidence based medicine (EBM) versus Personalised Medicine: from experience GPs know that RCTs are a guide but not real-world, we personalise prescriptions for patients Neuroscientists have a huge research data-base demonstrating medicinal cannabis benefits Highly recommended is the review of scientific papers in the 747 page Handbook of Cannabis 2014, edited by Roger Pertwee Patients tell me they have benefited from their of illicit cannabis which can be a useful guide to likely dose and response to prescribed CBD Purchasing illicit cannabis or using home-grown is not ideal as a medicine, especially in children, the very sick or elderly Page 5 of 8

6 However illicit cannabis is a more potent medicine for some because it does contain THC. Case History 4 I have known this 20 year old severely autistic man all his life; I was at his birth when I worked as a GP-Obstetrician. He is blind, cannot talk, paces the floor and has seizures. Anticonvulsants were ineffective and tended to over-sedate or agitate him. He was provided with hemp extract drops that gave him unbroken sleep for the first time in his life. He continued to have seizures but recovered far more quickly. When prescribed CBD drops the dose required to reduce seizures had the adverse effect of making him sleep most of the day. His original compassionate-supply drops may have contained THC that helped him stay alert. He would likely benefit from drops with CBD plus THC to improve his quality of life and that of his care-givers and whanau. EXCEPTION AND STATUTORY DEFENCE FOR TERMINALLY ILL PEOPLE This is a start, but I have several concerns. Since 2017 I have been publicly expressing concern that police have been prosecuting sick people who use illicit cannabis for medical reasons and increasing their suffering I believe police have the discretion to not prosecute this amendment would formalise this and make it consistent However, I believe that thousands of people are using illicit cannabis for medicinal purposes They are managing chronic pain, cancer and many other illnesses where they have experienced benefit People making tinctures and balms run the inappropriate risk of possessing Class B drugs. This needs consideration. And from talking to such patients, they don t want to get high. They just want relief from the pain, cancer, neurological symptoms, anxiety, insomnia etc with a clear head! In my work as an addiction specialist I see people who use cannabis daily, but not to get high or for addiction, but for symptomatic relief of pain, anxiety, insomnia etc In addiction, there is evidence that cannabis can be an exit drug helping people to reduce or stop alcohol and benzodiazepines. Opioid users for dependence or chronic pain confirm an opioid-sparing effect whereby opioids work better and dose can be reduced Philosophically, many would prefer to try low-risk medicinal cannabis before going on to strong medical treatments. Because the risk of harm from cannabis is so low and most users of medicinal cannabis are not helped by conventional medicine, I argue that ALL MEDICINAL CANNABIS USERS SHOULD HAVE A STATUTORY DEFENCE pending the Ministry of Page 6 of 8

7 Health and legislators implementation of a system guided by the principles of fairness, quality and safety, and compassion. Start with a low-risk treatment ie medicinal cannabis, rather than leaving it until it is too late for the benefits. Case History 5 44 year old man who saw me in March 2017 because of debilitating neuropathic pain associated with Parkinsons Disease, unresponsive to medication. I wrote a prescription for CBD100 oil to be taken by mouth. Unfortunately he found the evening dose of CBD left him confused the next day. Trial of a lower dose was encouraged. REGULATION-MAKING POWER I understand that a Regulatory Framework is being developed. If further information is available at the time of oral submissions, I would like to appear to comment on this. As NZ s leading medicinal cannabis prescriber, I welcome any invitation to be involved in setting up a Regulatory Framework. It is important to have prescribers and consumers represented from the earliest stages. Case History 6 In February I assessed a 64 year old woman with uncontrolled pain from rheumatoid arthritis, plantar fasciitis, fibromyalgia and irritable bowel syndrome all suggestive of over-active immune and nervous systems. She takes CBD100, but may have a better response to products containing both THC and CBD. Unfortunately such legal products are not available. Like many patients requesting medicinal cannabis, she was in tears because her GP had told her medicinal cannabis was illegal and her Specialist told her that medicinal cannabis would not work. The opportunity to try medicinal cannabis on prescription gave her new hope that she would not have to live with her symptoms forever. CBD PRODUCTS NO LONGER CLASSED AS CONTROLLED DRUGS I support this amendment as I understand that part of the expense of medicinal cannabis products relates to secure transportation and storage as well as the expense of registering the products. Even balanced ratio products like Sativex have low abuse potential, as studies have shown, and should not require lock and key security. Case History 7 This 30 year old man was missing work because of unexplained chronic facial pain for 10 years. He had several surgeries without benefit. For 3 weeks he took 10 drops of hemp extract three times a day. He reported his pain medication worked better and he was able to reduce oxycodone from 70mg to Page 7 of 8

8 40mg daily. He stopped gabapentin 600mg daily and stopped nitrazepam 10mg for sleep. He cried in my waiting room saying, I feel hope for the first time. He did not want to change to prescription CBD because the illicit therapeutic cannabis was working so well and was provided free. HOW THC AND CBD WORK In Israel, when researchers experimented to understand how cannabis causes its effects in animals they discovered the Endo Cannabinoid System (ECS). They found that all animals including humans make their own kinds of cannabis called endocannabinoids. The ones made by our nervous and immune systems are called anandamide and 2-AG. They are widely dispersed in the nervous system where they activate CB1 receptors and in the immune system where they activate CB2 receptors. If you think of nerve cell (neuron) A sending a signal to B sending a signal to C and so on, then our endocannabinoids uniquely send a retrograde signal back from B to A, and C to B to turn down or turn off the original signal. Of course each neuron communicates with about 10,000 other neurons, so signals can get out of hand if there is a lack of endocannabinoids to slow or stop the signals. This stopping of signals getting out of control is homeostasis. Scientific literature will tell you the ECS is involved with a huge range of balancing processes from reproductive cycles, sleeping, eating, pain, organ healing and reducing inflammation. Chronic pain, spasms, seizures, anxiety, insomnia etc could be seen as over-active, out of control nervous system. Inflammatory conditions such as arthritis suggests an over-active immune system. CBD is thought to have a mild action allowing our endocannabinoids to work better. THC is a partial agonist which means it acts in a similar way to our endocannabinoids, but more strongly. Both could help if there was an Endo Cannabinoid deficiency. Over 100 cannabinoids have been identified in cannabis. They each work in different ways and work together with the terpenes (aromatic molecules that give plants their own characteristic aromas) giving different medical benefits. Severe pain, seizure conditions or cancers may respond better to more potent medicinal cannabis containing higher proportions of THC. This is because it acts more strongly and in different cells from CBD. Thank you again for reading this submission. Nga mihi nui. I look forward to the opportunity to meet the Select Committee in person. Help us turn tears of suffering into tears of hope Page 8 of 8