Dear Colleagues,
It is our pleasure to invite you to participate in The 3rd International Annual Congress on Controversies on Cannabis-Based Medicines (Med-Cannabis2022) which will take place 02-03 November 2022 in Copenhagen, Denmark.
Med-Cannabis2022 will address the many controversies surrounding cannabis-based medicines. Strong public and patient demand has led to the decision to allow cannabis products for medical use in most European countries. There is a lot of basic-science and clinical research on the potential use of cannabis products for chronic pain and cancer management as well as controversies on the potential harms.
Dr. Silviu Brill |
Congress Agenda
University of Galway, Ireland
McGill University, Canada
Tel Aviv Medical Center, Israel
Syqe, Israel
University of Turin Medical School and Plateau Rosà Hypoxia Medicine, Italy/Switzerland
Placebo effects represent one of the most important confounding variables in the design and interpretation of clinical trials, thus their understanding is today a priority in biomedical research. In this talk, I will present some examples of how recent research and insights into the neurobiological mechanisms of placebo effects provide some interesting information that may help better design and interpret clinical trials. This is particularly important for trials on cannabis, which is quite an unexplored field of clinical research. First, patients’ expectations have been found to be the main mediators of placebo effects, thus their assessment should be the rule in any clinical trial. Second, previous exposure to active treatments may lead to substantial placebo responses, thus the history of pre-trial pharmacological and non-pharmacological treatments should be assessed very carefully. Third, communication across the participants of a trial has been found to affect several outcome measures, thus communication across participants should be avoided. Fourth, today we can identify and create placebo responders and non-responders in the lab by using both learning procedures and genetics, which indicates that placebo effects can be manipulated. These four examples suggest that this new scientific knowledge may have profound implications for clinical trials, including cannabis trials, thus moving trial design from speculative to evidence-based.
University of Bern, Switzerland
Jürg Gertsch
Institute of Biochemistry and Molecular Medicine, University of Bern, Switzerland
The botanical drug cannabis flos has a unique popular status as being a potent recreational drug and bona fide universal remedy (panacea). Generally, cannabinoids exert therapeutic effects in a broad range of pathophysiologies related to inflammation, pain, neuropsychiatric, metabolic and stress-related conditions in preclinical animal models. However, the translation of such data to humans still lacks an evidence-based foundation. While undoubtedly cannabis products have a pharmaceutical potential in very diverse therapeutic settings, it remains unclear how different patients react to the complex cannabimimetic pharmacology and how this affects the outcome. Motivated by the booming cannabis manufacturing industry and the increasing worldwide self-therapy by patients, there are cumulative accounts about broad therapeutic effects of cannabis and legal cannabinoids like cannabidiol (CBD) beyond statistical evidence. The numerous affirming anecdotal reports by patients pose a challenge to physicians and legal authorities. Given the recent insight that the endocannabinoid system is mediating, at least in part, a placebo effect, psychoactive cannabis and cannabinoids could exert complex neuropharmacological actions. As will be outlined, placebo effects may play a role in the broad palliative and therapeutic effects of medical cannabis unprecedented by other phytopharmaceuticals. The urgent need for human biomarkers to improve clinical trials will be discussed.
Department of Health, Australia
Implementation of a Regulatory Framework for Medicinal Cannabis – Evidence Reviews, Clinical Guidance and Patient Access – the Australian Experience
Adjunct Professor John Skerritt, Deputy Secretary, Australian Department of Health
Australian Government policy treats medicinal cannabis products as prescription medicines, and several steps have been taken to improve patient access. These included introduction of a regulatory scheme for cultivation and manufacture as well as patient access schemes. Under an “Authorised prescriber” route prescribers are approved for a particular product for set of conditions while “Special Access” Schemes (SAS) enable individual patient access. Typically online SAS applications require review (in under 48 hours) by departmental health care professionals since these products have not been assessed for safety, quality and efficacy. Australian state and territory laws also require assessment of the doctor and patient for diversion or dependency risks for THC-containing medicines.
Our department has worked with universities, clinical and patient groups on reviews of the efficacy evidence for medicinal cannabis components and products in epilepsies, multiple sclerosis, chemotherapy-induced nausea and vomiting, pain types and palliative care. Annotated bibliographies of relevant publications as well as prescriber and patient guidance documents that provide information about the current state of clinical evidence were first published in December 2017 and are currently being updated, along with information on clinical trials of medicinal cannabis products. They are provided on the TGA website along with other educational and information resources.
The ultimate goal is to have a wider range of medicinal cannabis products available as market authorised medicines following review of their quality, safety and efficacy for the proposed indication/s.
University Göttingen, Germany
Aarhus University, Denmark
Tel Aviv Medical Center, Israel
National Drug and Alcohol Research Centre, Australia
University of Lethbridge, Canada
Tel Aviv Medical Center, Israel
Neuropathic pain is a chronic pain condition caused by a lesion or disease of the somatosensory nervous system. Examples include trigeminal neuralgia, painful polyneuropathy, postherpetic neuralgia and central poststroke pain. Several randomized placebo-controlled trials (RCTs) of 3 to 15 weeks-duration have examined the effect of sativex, an oromucosally delivered spray prepared from cannabis sativa extract containing mainly tetrahydrocannabinol (THC) and cannabidiol (CBD), and synthetic THC for the treatment of neuropathic pain. These trials show lack of clinical relevant effects. Because of the negative results, potential misuse, and possible long-term health risks, the Special Interest Group of Neuropathic Pain (NeuPSIG) provided a weak recommendation against the use of cannabis-based medicinal products for neuropathic pain. Inhaled cannabis has shown some effect for chronic neuropathic pain in short-duration RCTs (hours or days) and is associated with psychological and cognitive side effects. Few drugs that potentiate the action of endocannabinoids have been tested and studies have so far not provided consistent evidence of effect for neuropathic pain. Currently, there is no evidence for a long-term clinical relevant effect or safe use of cannabis-based medicinal products or medicinal cannabis for the treatment of chronic neuropathic pain.
Tel Aviv Medical Center, Israel
King's College London, UK
University Göttingen, Germany
McGill University, Canada
Imperial College Healthcare NHS Trust, UK
The Government announced in mid-2018 from 01 November 2018 that 80,000 doctors in the UK would be able to prescribe medicinal cannabis. This was preceded by a communication from the Chief Medical Officer that cannabis is no longer a Schedule A drug. Understandably there was a lot of interest from the patients who had benefit from using cannabis and were keen on getting the prescription on the NHS. The various Royal Colleges and other stake holders representing various medical specialities issued position statements indicating the paucity of evidence for medicinal cannabis based on robust clinical trials and called for better quality clinical trials to gather evidence for the use of medicinal cannabis. In November 2019, NICE brought out their recommendations on chemotherapy-induced nausea & vomiting, treatment resistant epilepsy, spasticity in multiple sclerosis and chronic pain. The general feeling was that there were not enough clinical trials on the safety and efficacy for cannabis-based medicinal products that met the rigorous criteria NICE stipulates for their guidance. There are research recommendations for medicinal cannabis and hence clinical trials are underway in the UK. The British Pain Society in its updated position statement recognises that there could be a role for cannabis-based medicinal products in the management of chronic pain, but recommends that this should be part of a clinical trial and that data should be collected to evaluate the safety and efficacy profile.
Aarhus University, Denmark
Spanish Pain Society, Spain
Federal Institute for Drugs and Medical Devices, Germany
Medical doctors who prescribe cannabis medicines at the expense of the German statutory health insurance were obliged to take part in a non-interventional survey, which was conducted from April 2017 until 31 March 2022.
The survey served the collection and evaluation of anonymized treatment data.
The transmission of the data for the survey took place via an online portal operated by the BfArM (Federal Institute for Drugs and Medical Devices). The first data transmission took place after a treatment period of one year or, if the treatment discontinued before the end of one year, directly after discontinuation of therapy. Demographic data and information on the treated disease or symptoms, previous treatment, co-treatment, adverse reactions, treatment success and change of quality of life were evaluated in five categories (cannabis flowers, cannabis extract, dronabinol, Sativex® (Nabiximols) off-label, Canemes®(Nabilon) off-label).
Key results of the final report (analysis of 16,809 cases) will be presented.
Reference:
University of Newcastle, Australia
The New South Wales (NSW) Cannabis Medicines Advisory Service (CMAS) was an Australian State government-funded medical advisory service that operated between 2018 and mid-2022. The NSW CMAS model led by a Clinical Pharmacologist and Pharmacist provided comprehensive clinical advice and guidance to medical practitioners and allied health professionals.
A preliminary analysis of survey results and enquiry trends will be presented, along with prescribing guidance developed to support clinicians.
NSW CMAS played a key role in the rapid translation of cannabis medicine research into clinical practice in NSW, Australia during a period of rapid regulatory change. The NSW CMAS research projects provide an innovative and much-needed insight into how prescribed cannabis medicines are being used in real-world settings and what information health professionals are seeking to inform their clinical decision-making.
National Institute of Health, Italy
Copenhagen Research Center for Mental Health - CORE and University of Copenhagen, Denmark
In January 2018, a pilot program was launched in Denmark with medicinal cannabis. We will present results from the ongoing evaluation of this program.
The pilot program is being evaluated with a triangulation of methods. Patients who have redeemed a prescription of medicinal cannabis have been identified from the nationwide Danish registers. A random selection of nine patients have been included for qualitative interviews. A larger selection have been randomly selected for quantitative interviews and surveys. These have been matched using propensity score matching to controls who have not used medicinal cannabis, but who have received other types of medication for the same disorders. Finally, all patients redeeming at least one prescription for medicinal cannabis, and matched controls, have been tracked in the nationwide Danish registers.
Results will be ready in April 2020, as per demand from the Ministry of Health which funded the evaluation.
The triangulation of methods we apply allow for the best possible evaluation of the Danish pilot program. The register-based assessment is free from selection bias, but is limited regarding the depth of information; the quantitative interview-and-survey assessment comes with a potential selection bias, but has a thorough level of information; finally, the qualitative assessment is not necessarily generalizable, but provides in-depth information which could not be obtained in a structured or even semi-structured manner.
Monash University, Australia
Whether or not cannabinoids represent an effective strategy to reduce opioid use and opioid-related harm, either at the individual or population level, has been the topic of much debate in recent years. This presentation will summarise the results of two reviews that synthesise what is known about the potential for cannabinoids to reduce opioid-related harm. The first systematic review and meta-analyses examined evidence from 28 pre-clinical and clinical studies to determine whether cannabinoids may have an opioid-sparing effect. Preclinical studies consistently demonstrated synergistic effects of concurrent cannabinoid and opioid administration. Yet, the findings from clinical studies were inconsistent. A second comprehensive review examined the epidemiological and ecological evidence from 25 studies to consider whether cannabis use and availability was associated with reduced opioid-related harms. Some epidemiological and ecological studies suggest that cannabis may reduce opioid use and related harms, although important methodological weaknesses were identified, and recent research has produced conflicting results. Taken together, this work may help identify where further clinical research could be conducted to inform the debate as to whether cannabinoids may have an important role in reducing opioid use and harm from either a clinical or population health perspective.
Tel Aviv Medical Center, Israel
Horsted Institute, Denmark
University Göttingen, Germany
Monash University, Australia
Tel Aviv Medical Center, Israel
Horsted Institute, Denmark
European Perspective – Frank Petzke, Germany
Australian Perspective – Suzanne Nielsen, Australia
Israeli Perspective – Silviu Brill, Israel
Danish Perspective – Tina Horsted, Denmark
EXPLORE COPENHAGEN
MEET OUR SPONSORS
Contact Us
We look forward to hearing from you.