Reflection on the MEDICAL INNOVATION BILL of Feb 2014

1. Reflection on the MEDICAL INNOVATION BILL of Feb 2014 Prof Willie Pienaar University Stellenbosch

2. Reflection prepared by… • Prof Willie Pienaar • MBChB 1974 • Family doctor in rural area until 1980 • MMed Psychiatry 1984, MD Psych 1992 and Associate Professor University Stellenbosch • Clincal Head of Stikland Psychiatric Hospital 1995-2013 • MPhil – Bioethics 2000 • Special interests • Substance addiction • Bioethics and Human Rights • Being a clinician and teacher • Current post – Contract post as lecturer in psychiatry and bioethics

3. Cannabis - Information • Known and used for 8,000 years • Plant – Cannabis sativa • Male/female plants • Delta 9 tetrahydrocannabinol - cannabinoid receptor identified • Receptors – mainly in basal ganglia, the hippocampus and cerebellum • Used in many forms • Effect (smoked) within minutes, peak 30 min. lasts 2-4 hours • Most widely use illegal drug in the world • Potency increased by improved agricultural techniques • Young people – getting younger - NB: The young brain is very vulnerable ! • Physical – same as tobacco – long term use: cerebral atrophy, seizures, chromosomal damage, birth defects, impaired immunity,

4. Cannabis and HEALTH • Psychiatry • Addictive – dependency does develop • Intoxication • Withdrawal • Psychosis (see later) • Anxiety • Flashbacks • Cognitive impairment – poor scholastic achievement – (Mean IQ lowered in the young) • Amotivational syndrome • Physical • HIV and TB Unique situation in South Africa – resistant to treatment TB • Same as tobacco – long term use (Chronic obstructive lung disease, cancer mouth throat and lungs). Also fungus and bacteria infections (contamination) • Long term use and pregnancy: cerebral atrophy, seizures, chromosomal damage, birth defects, impaired immunity.

5. Cannabis and psychotic disorders… • In the vulnerable causes psychosis • Direct cause for psychosis – lasting hours and days • May trigger schizophrenia – life long course – Incidence can drop 8% if no cannabis use • NB The young brain very vulnerable to cannabis – later develop psychotic illness • NB Negative influence on the developing brain • Cannabis most often the ‘introduction’ to drugging, a gateway drug to become poly-drug abusing culture and psychosis. • Legalization of cannabis (world literature) has not provided world with a clear positive outcome. There are many hidden facts • Do not compare our country with the rest of the world – we have unique specific vulnerability. • Reality: Drug induced psychosis a major burden on available psychiatric beds

6. What are we doing……? • Not talking about legalization of cannabis • Not talking about decriminalization of cannabis • Use for medicinal and beneficial commercial/industrial purposes only! • Medicinal use in what form ? • Smoking dried plant ? • Eaten – cannabis cookies • Pill form – Dronabinol and Nabilone ? • Liquid extracts ? • Oro-mucosal spray - inhalers? • Medicinal use for what conditions ? • Cancer, dementia, pain, diabetes, epilepsy, glaucoma, Tourette, Nausea of chemotherapy, HIV anorexia, multiple scleroses, fibromyalgia, Rheumatoid arthritis, chronic pain disorders, poor appetite, headaches - Please see the slippery slope problem • Prescribed by whom for whom – GPs or specialists – for privileged few or all clients ?

7. Different forms of cannabis have different effects • Tetrahydrocannabinol (THC) first – then cannabinoid receptor – then synthetic cannabinoids • Smoked cannabis will have best effect – (THC) • Absorption – short effect – best psychotropic and physical effect for most named disorders • FDA has approved two synthetic cannabinoids • Dronabinol and Nabilone World literature on treatment outcomes, based on proper researched results on the benefits of treatment, are unclear and poor !

8. Legislation else where…. • Medical use of cannabis or preparations containing THC as active substance legalized Austria, Belgium, Canada, Czech Rep, Finland, Israel, Netherlands, Spain and in many states in the USA (yet still illegal under US federal law) for limited use and with specific indications • Legalization for medical and scientific on the rise world wide. • Proper licensing and control of cultivators, manufactures and distributers, prescribers and specific indications a must !

9. Should we allow the Medical Innovation Bill to become a reality ? • Before we approve this bill, we need to answer the following? • Do we clinicians and our clients need more effective treatment for named disorders and thus allow progress in science and treatment outcomes – YES • Do we truly know exactly what should be researched ? • 1. Effects of smoked cannabis, liquid cannabis, oral spray, inhaled cannabis vapour, or synthetic pills ? • 2. What disorders should be researched ? • 3. What product effectively treat what disorder ? - Need more in depth research • Can our current system regulate and police manufacturers, cultivators and distributors to limit the total cannabis market to ‘for medical and scientific purposes’ only ? - I cannot answer that question, but we need to know ! • Canmedicalization of cannabis produce foreseen and unforeseen negative results – Example: After the bill the public may perceive use as safe, healthy, social acceptability and increased recreational use including in vulnerable populations – World experience not clear on this !

10. Medical Innovation Bill • Questions and clarifications needed: • Do we need a Bill ? Can the MCC, followed by Research Ethics Committees (RECs) not initiate intended research ? • Definitions: ‘cannabinoids’ – a synthetic drug is not a product of the plant • In the envisaged action do we aim at ‘specialist’ level or any medical practitioner • Define commercial and industrial use – if not abuse may become a reality • Who would decide on the level of the ‘pilot health services’ • Are the MCC and RECs be involved in the study ? • 4. e – informed consent can be given by a 12 year old - most vulnerable brain ! • 7. a … no one shall be liable or guilty …. Define what can be produced and by whom • Memorandum: Background: …. legally be prevented from prescribing ‘harmless’ treatments – wrong ! • Memorandum: Background: end of paragraph …death on a mass scale… wrong and rhetorical ! • Memorandum: 3. …reduce the cost of private and public health without imposing additional cost to the state.. Wrong: Will increase cost to the state and psychiatric services

11. Medical Innovation Bill • Bill on ‘Innovation’ should be read in conjunction with Circular H/56/2013 of the Western Cape to the CEO’s of hospitals, Service Directors and Deans of Faculties on unique and novel therapies – Defining ‘innovative therapies’. • An overall yes for the Bill • We cannot be better than our knowledge • We could have progress in science should we secure more treatment options and better illness outcomes • To complete the document – get rid of uncertainties – make it more comprehensive – to be clear about what we would like to achieve. • Economic benefits for the country • Next step: To answer the necessary questions to know what is truly worth doing. Prof Willie Pienaar

12. To be consulted.. • Dr Lize Weich – Consultant and addictionist from Stikland Hospital • Tel 021 – 9404453 • Lizew@sun.ac.za • Dr AK Domingo - Consultant and addictionist from Stikland Hospital • Tel 021 – 9404472 • abduldomingo@gmail.com