Clinical trials to use cannabis in the treatment of debilitating illness proving successful for licensed UK company.
Whilst the release of their flagship medicine, Sativex and its success in 24 countries around the world has been taking place, GW Pharmaceuticals have been developing more treatment options for illnesses that can benefit from cannabis’ medical components.
In recent months news and information about GW Pharmaceuticals new designated “orphan drug” Epidiolex designed to treat children with severe seizure disorders such as epilepsy and dravets syndrome has been the peak of interest. The cannabis extract used for this treatment is high in Cannabidiol (CBD) and a variation of this, Cannabidivarin (CBDV) that is also being trialed as it is also showing to be responsible for many healing but non psychoactive effects of cannabis. It appears to not have any THC in it from the information its creators have released.
It is also now confirmed that Phase 1 trials for CBDV (GWP42006) have now been completed. 66 patients took place and the intention of the trial was to see how safe it was looking out for signs of toxicity of which none were reported. GW’s press release confirms “CBDV was well tolerated even at the highest tested dose and no significant side effects were observed.”
The fact that these patients are given as much cannabis as they could handle and there were no negatives to report from this is a testament to the safety of this medication – and goes a lot to support the parents that have currently been self-medicating their children with cannabis because nothing else the doctors prescribe is working. This issue has been of concern to some politicians in the US and of health care professionals, including those involved in the trials for GW.
Despite epilepsy treatment being at the center of medical cannabis at the moment, taking the lime light from the fact that cannabis can shrink, reduce and reverse cancers; there seems to still be a distinct lack of recognition of this in the UK where the medicine is actually produced. Approximately 15 children suffer with orphan seizure disorders in the UK.
GW Pharmaceuticals have also announced that they have been granted a patent by the Intellectual Property office in the UK patent number “GB2479153B”says that they have the rights to use CBDV (GWP42006) in the treatment of epilepsy on its own or with another drug with protection until 2030. This means another company cannot develop treatments for epilepsy or seizure disorders with the use of CBDV at least until 2030.
CBDV needs to be genetically available to the specific plant and natural sunlight is known to increase these potential levels, rather than artificial lighting.
Cannabis vs Insulin
Type 2 Diabetes is another huge area of concern in medicine. Currently diabetics are maintained on insulin as they cannot produce their own. What if cannabis could help change that though? There is much anecdotal evidence that cannabis is a good alternative to having to inject insulin every day for some patients, multiple times a day.
GW42004, a Tetrahydrocannabivarin (THCV) preparation from GW Pharmaceuticals is starting phase 2b trials to see if this is indeed this could be the case. In the earlier stages of the trial 2a in 2012 reports showed that out of the 62 patients involved a range of “desirable anti-diabetic” effects were accounted for. These included reduced fasting plasma glucose levels, an increase in fasting insulin, improved pancreatic beta-cell function, increased serum adiponectin, reduced systolic blood pressure, and reduced serum IL-6 levels.
Their press release states that, “Several of these findings are consistent with pre-clinical data suggesting that GWP42004 protects the insulin-producing cells of the pancreatic islets, a highly desirable feature of a new anti-diabetic medicine, increases insulin sensitivity, and reduces fasting plasma glucose levels.”
Cannabis’ effects may also be preventative against diabetes in those with metabolic disorders. Dr David Potter, Director of Botanical Research and Cultivation at GW Pharmaceuticals, says in an interview with The UK Plant Sciences Federation: “Metabolic syndrome is a disruption of the way the body metabolises food to produce energy or to store as fat. It is most common in obese people and can lead to major health problems such as Type II diabetes.”
One of the problems with Insulin is that people can be, or become resistant to it so other options are needed. Another concern that patients of this incurable disorder have to worry about is dosage, too much can have adverse effects and can cause tachycardia and even a coma. Cannabis does not have the same toxicity but diabetic patients that do use cannabis argue that some strains do work better whilst some can have undesirable effects on just how much it can drop blood glucose levels, having access to tested and labelled strains does reduce the harm though and allows patients to consistently receive the right medication option for them.
Dr Mark Downs, Chief Executive of the Society of Biology, says:
“Metabolic syndrome, and the health problems it leads to, is a huge strain on the NHS, and can massively reduce the quality of life of those affected. It is always exciting to see new avenues being explored to tackle the issue.”
Cannabis and Schizophrenia
One of the biggest scare tactics that is used against cannabis is that of its effects on mental health. We are at a point where we are going to have to admit that yes, cannabis does have an effect on mental health. GW Pharmaceuticals are paving the way on this with their research and testing on schizophrenia. Their Phase 2a trials on GW42003 have just started, again looking at the potential within the CBD molecule produced by the cannabis plant. Even though it does not induce a high, its psychoactive effects can normalise patient’s state of mind that suffer with psychotic states.
The question if those with mental health problems are using cannabis to self medicate or whether it is responsible for the metal health problems, certainly having access to cannabis that said what it was and its effects were could help resolve that issue but these trials should help to prove if some kinds of cannabis are in fact useful to patients suffering with mental health problems.
Once this trial is completed we will have to wait until Phase 3 trials take place to see just how effect it is as a treatment at the worked out dosage which is what this current stage of the trial is designed for.
Another study published in Harvard in 2014 also backs up the previous Keele University largest peer reviewed study on cannabis and mental health which showed no causal links between cannabis use and the development of schizophrenia and psychosis.
Mental health practitioners have claimed that we are living in a mental health time bomb at the moment with more mental health issues than we have seen before amongst the population including PTSD and depression. Could cannabis be another treatment option for doctors and patients to the currently prescribed pharmaceutical and “convention” treatments? Imagine the help that soldiers returning from war zones could get from CBD medication?
With the stringent way the UK medicines approval process is, we are looking at 20 years before we know if things work out pharmaceutically. For epilepsy we may be slightly closer but diabetes, schizophrenia and other disorders they are investigating such as Ulcerative Colitis, cancer pain and as a non invasive treatment to recurrent glioblastoma multiforme (brain cancer) patients are going to have to wait a long time. Meanwhile hundreds of thousands if not millions of these same patients that have found some hope in cannabis are left to try and find out for themselves by self-titrating and experimenting with different strains, all available on the internet in all of its unregulated and untrustworthiness.
We can see that cannabis is not causing the harm that has been previously anecdotally reported by the press and we can see with the scientific proof from these carefully planned out trials that there is no harm even at the highest of doses when used in a clinical environment. For those that need it most urgently we must fill the gap and close the space of time they have to get hold of this vitally important treatment.
If it is showing no harm, what is the real harm?