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Medical Cannabis NSW Trials for Epileptic Children… A Source of Hope

Medical Cannabis NSW TRIALS

Recent medical cannabis trials involving children with severe drug-resistant epilepsy in NSW “New South Wales” are now a source of hope.
These trials are a result of a commitment by the NSW government to set aside $3.5 million for the sole purpose of exploring the possibility of providing relief for children with severe cases of drug-resistant epilepsy.
Three hospitals are currently being used as locations for the trials. The Sydney Hospital, the Westmead Children’s Hospital, and the John Hunter Children’s Hospital.
The trials involve compassionate access to a cannabis-based medicine, Epidiolex, which has been developed by GW. (The medicine is orally administered and has been tried internationally as well. It is in fact in phase 3 in international trials. It is administered twice a day.)
Two researchers at the Sydney children’s Hospital, Dr. John Lawson and Dr. Deepak Gill, have been tasked with leading the medical cannabis for epileptic children trials.
Roy Beran, an epilepsy researcher at the university of NSW added that the trials will focus on Dravet Syndrome, a condition where the sick children experience daily seizures that last for minutes.

“No treatment has proven to provide relief for this type of epilepsy and anything that would alleviate the situation would be much welcome,” said Beran.
40 children who could no longer respond to conventional medicine were selected, and this far, about half of them are already under monitored administration of the medicine.
The TGA has authorised specialist paediatric neurologists practising in public hospitals to prescribe the drug, with clinicians monitoring the children.
The number of participants was strictly calculated to ensure that the trial produces accurate results. Some of these children have been experiencing even hundreds of seizures per day.
With ongoing treatment using Epidiolex, some of these patients have shown even 3 – 4 seizure free days when they do get seizures, they are half of what they have been experiencing in a day.
Other children can now communicate, clap their hands and do other things that they could not do before.
12 children are being treated using Epidiolex at the John Hunter Hospital as part of the Compassionate Access Scheme.
Despite these positive results, Dr. Lawson cautions that medical cannabis for epileptic children is not a miracle cure for everyone. In fact, some of the participants have not shown much improvement.
Dr. Lawson expects about half of the participants to benefit from the medicine. This is in line with other trials that have been carried out internationally, specifically in the U.S and Europe.
Dr. Lawson sites the ‘honeymoon’ period, where the medicine may work for a few months and then cease to work. He is cautious to raising unrealistic expectations. However, he adds that the trial is still in its early days, and he is happy to see the significant improvement some of the children have shown.
According to Dr. Lawson, a 30% response means that the drug will be beneficial. If the response is only 10%, then it will be more of a miracle than a response to the drug.
After 3 months, the success of the treatment will be assessed. This far, there is a ray of hope for children who have failed to respond to about 6 types of conventional medicines to treat their epilepsy.
If there is no improvement even after taking the medicine for 3 months, patients will be asked to stop using the medicine.
There is good news for patients who will respond to the drug. There is an agreement to continue supplying the medicine until it is registered in Australia.
Epidiolex is not yet approved by the TGA, being an experiential medication. (The TGA is responsible for regulating the supply, import, export, manufacturing and advertising of therapeutic goods.)

More Trials

Plans are underway to roll out more trials for medical cannabis. The trials are still being developed to ensure that they are carried out safely. They have to be reviewed and approved by the relevant Human Research Ethics Committee. Safety and best practices are crucial. The NSW government has pledged $21 million to fund the trials.
The trials will involve the use of cannabis in helping patients with terminal illnesses have a better quality of life, combating the side effects of chemotherapy where conventional medicine is ineffective, and for children with epilepsy.
Phase one of the trials will be conducted at 2 hospitals – the Calvary Mater Newcastle Hospital and the Sacred Heart Health Service.
When these trials are rolled out, more people will have access to the treatment, which translates to a higher possibility of helping more patients.
For now, the drug should provide hope where hopelessness abounds. Premier Mike Baird hopes that through this research, more cannabis-based medicine can be prescribed, increasing the range of treatment options.
The NSW government has also shown other significant efforts with regards to the study of medical cannabis. A centre for medicinal cannabis research and innovation was established in June 2015. The centre is worth $12 million.
There are also amendments to the SUSMP to include cannabis-based medicines when used in particular ways as part of the less restricted drugs in schedule 8. (SUSMP is ,The Standard for the Uniform Scheduling of Medicines and Poisons.) The federal government has also passed legislation for the cultivation of cannabis for medical and scientific purposes.
In NSW, certain criteria needs to be met for the prescription and supply of unregistered cannabis products.
The criteria include the fact that you must be a specialist in the management of patients whose disease is being managed with a cannabis-based product, hold an authority issued by NSW health, and an approval by the Commonwealth department of health.

Prescription and supply will also be governed by certain criteria. For instance, specifying details like location of dispensing the product, storage, management, rationale for the treatment, scientific evidence to support it, product sustainability to treat the condition, and even product quality. All these conditions are in addition to the usual requirements for schedule 8 prescriptions.

Hope For Epileptic Children

Medical cannabis for epileptic children trials in NSW are indeed a source of hope. Children who have failed to respond to conventional medicine have a better chance to decrease the number of seizures that they experience as a result of epilepsy. Dr. Lawson, however, states that since the trials are still in the early stages, we can only celebrate the wins for those children who are already showing significant improvement.
A 10 to 30% response to treatment with Epidiolex is expected. After 3 months, some children will lead a better quality of life. Unfortunately, the treatment may not work for everybody. Despite the uncertainty, many people are hopeful for better results. With more trials underway, this could be the ultimate solution for severe cases of epilepsy.

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