As a participant in Australia’s medicinal cannabis “phenomenon” I have been very impressed with the rigorous, evidence-based approach the government and the industry have taken to regulating the product. I’ve also been astonished by the wild exaggerated claims and uninformed opinions that have appeared in the media and online about the use of cannabis. One of those claims was that the World Health Organisation (WHO) has declared cannabis to be ‘safe’. The lay person reading that headline might well assume that cannabis is safe to use by anyone and at any dose. Sadly, this is far from the truth.
How safe is cannabis?
There is overwhelming evidence to support the therapeutic effect of cannabis for some medical uses. Some of that evidence was generated from double blind clinical human trials, a very sound scientific method.
However, the Australian drug regulator, the Therapeutic Goods Administration (TGA) has listed medicinal cannabis as a Schedule 4 drug i.e. one that only be obtained on prescription from a doctor. They announced this in a consultation email released in late December 2017. This means that the TGA has assessed that the use of medicinal cannabis is risky enough that it must be supervised by a medical professional and distributed by the regulated pharmacy industry.
One example of the potential problems associated with cannabis use is whether it can cause a psychotic illness in susceptible people. There has been considerable debate (and lots of publications) regarding the relationship between chronic cannabis abuse and psychiatric disorders. Clinicians agree that cannabis use can cause acute adverse mental effects that mimic psychiatric disorders. This includes schizophrenia and bipolar disorder. Although there is good evidence to support this, the connections are complex and not fully understood. However, it is understood that if you already have a predisposition, chronic cannabis use can trigger such an illness.
I am therefore startled when headlines such as “Medical Cannabis is safe, says WHO” (World Health Organisation)” appear in the media. I recall the old pharmaceutical maxim, “The dose makes the poison” or in Latin “Sola dosis facit venenum” (originally attributed to Paracelsus). It means that a substance can produce toxic effects within a susceptible biological system in the body when it reaches high enough concentration. Even water can kill if consumed in high enough volumes.
In effect, all drugs are poisons. They are regulated in many countries as poisons, i.e. the “drug schedule” is a “poisons schedule”. I fully support the considered and consultative approach the TGA has always taken when regulating drugs, including medicinal cannabis.
The screaming heading proclaiming cannabis’ safety also infers that the WHO states that medicinal cannabis will cure certain cancers. I’ve included the WHO statement below. I’ll let you decide on what you think the WHO’s position is on the use of cannabis!
WHO Report – Cannabidiol (CBD)
There is increased interest from Member States in the use of cannabis for medical indications including for palliative care. Responding to that interest and increase in use, WHO has in recent years gathered more robust scientific evidence on therapeutic use and side effects of cannabis and cannabis components.
To that end, the Expert Committee on Drug Dependence did an initial review of a cannabis compound called cannabidiol (CBD). Recent evidence from animal and human studies shows that its use could have some therapeutic value for seizures due to epilepsy and related conditions. Current evidence also shows that cannabidiol is not likely to be abused or create dependence as for other cannabinoids (such as Tetra Hydro Cannabinol (THC), for instance). The ECDD therefore concluded that current information does not justify scheduling of cannabidiol and postponed a fuller review of cannabidiol preparations to May 2018, when the committee will undertake a comprehensive review of cannabis and cannabis related substances.
WHO’s concern about drug misuse
In other parts of the report, the WHO raises concerns about the misuse of other drugs. This is well founded, given that 1808 people died in Australia in 2016 due to drug use. Of those, an estimated 70% died from prescription drug use. Deaths from prescription drugs is mentioned in the WHO report, but rarely makes the media headlines, unless it’s someone famous such as Heath Ledger or Prince.
I was delighted to see an Australian initiative, the NATIONAL WASTEWATER DRUG MONITORING PROGRAM release it’s 2016 report. This program uses wastewater analysis to quantify drug abuse in Australia. This method has become the standard for measuring population-scale use of a range of different drug compounds. The underlying concepts involved in wastewater analysis are well established in Australia and have been applied to a wide range of licit and illicit drugs. Estimates of drug usage in a population can be back-calculated from measured concentrations of drug metabolites (excreted into the sewer system after consumption) in wastewater samples. One of the scary examples of the drugs they identified in the program is Carfentanil.
Carfentanil – designed for animals, abused by humans
Carfentanil was designed as a veterinary drug. It is used to sedate large animals, such as elephants, in emergency situations, such as a zoo escape.
Carfentanil was never intended for human use but is produced illicitly and is often taken with heroin or by users who believe they are taking heroin or other illicit opioids. Carfentanil is similar to the well-known opioid Fentanyl, recently associated with a surge in overdose deaths. Unfortunately, Carfentanil is about 100 times more potent than Fentanyl. It can produce lethal effects at extremely small doses – equivalent to a few granules of salt. This makes it particularly dangerous when it’s manufactured and used illegally.
North America is currently in the midst of an opiate crisis and Carfentanil is one of the problems. According to the most recent data from the Centers for Disease Control (CDC), overdoses killed roughly 64 000 people in the United States in 2016, a 22% rise on the previous year. Most of those deaths were due to synthetic opioids — primarily fentanyl and its analogues.
The WHO’s Expert Committee on Drug Dependence has also recommended five other fentanyl analogues (acryloylfentanyl, fluoroisobutyrfentanyl, furanyl fentanyl, ocfentanil, and tetrahydrofuranyl fentanyl) be controlled by Schedule I of the 1961 UN Single Convention on Narcotic Drugs.
I do worry that we have created a society where we convince our children that any pain or illness can be solved with a pill or a puff. This extends to treating normal teenage anxiety, or social awkwardness with a prescription.
What we do
PharmOut is dedicated to helping our clients make cost effective, safe and effective (legal) drugs that have significant therapeutic benefit. We do this by designing quality into the manufacturing plant from the outset, ensuring compliance with regulations. Cannabis is just one of these drugs.
If you are looking for help in understanding the Australian Medical Cannabis Legislation, Regulation, Scheduling, obtaining a Cultivation License or an API Manufacturing License or a Final Dosage Form License we can help.