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Major medical marijuana trial underway

Author
Simon Plumb, NZ Herald,
Publish Date
Sun, 13 Nov 2016, 7:31AM
Dr Peter Bergin (NZ Herald)
Dr Peter Bergin (NZ Herald)

Major medical marijuana trial underway

Author
Simon Plumb, NZ Herald,
Publish Date
Sun, 13 Nov 2016, 7:31AM

A major medical marijuana trial is underway in New Zealand - testing the effects of a new cannabis gel on epilepsy patients.

The Ministry of Health has given the green light for Kiwis to be part of the ground-breaking clinical trial, investigating the effects of the newly-developed cannabidiol gel ZYN002 in stopping or reducing epileptic seizures.

Across Auckland, Wellington, Hamilton and Christchurch, 12-week trials have been going on with the last wave of New Zealanders being recruited before the trial ends in late November. Also running across 10 centres in Australia, a total of 210 adult patients will be involved.

Every 12 hours, patients rub the gel into their upper arms and shoulders. However, the randomised test means neither the recruits, or their doctors, will know which of three possible gels they are receiving - high dose, low dose or a placebo - until the trial is over.

By being absorbed into the skin, it's understood the gel's cannabis-derived contents will hit the brain more quickly and powerfully than oral forms of medicines which must first pass through the gut and liver.

Auckland City Hospital neurologist and epilepsy specialist Dr Peter Bergin is one of the medical experts overseeing the Kiwi trial. He says provisional research on animals indicates there could be significant results for the 40,000 New Zealanders whose lives are effected by epilepsy.

"I tend to be a bit sceptical about treatments which are unproven, but there is good reason to believe that there are compounds from the marijuana plant which will be effective in preventing seizures," Bergin said.

"We are keen to get new treatments available and this is exactly the way we need to investigate cannabidiol or indeed any other substance to do a randomised, blind, controlled trial."

Bergin - the vice president of Epilepsy New Zealand - said the gel's cannabis extract is not expected to produce any form of psychoactive effect due to it not including the tetrahydrocannabinol (THC) compound found in marijuana.

One Kiwi recruit, who requested she be identified only as Sandra, was diagnosed with epilepsy in 2012. She has noticed her body build tolerance to traditional drugs and is desperate for an increased quality of life.

"A lot of people stand to benefit from this research, not only myself, but obviously a lot of other people out there," Sandra said.

"It might enable me to take less drugs and get my life back."

According to the Ministry of Health, epilepsy affects 1-2 people in every 100. The Ministry of Health defines epilepsy as a condition affecting 1-2 people in 100. Some are born with the conditions while it can also be developing in children or adults, including after sustaining a head injury or suffering a stroke.

Hearing, speech and memory can all be affected as well as a range of other symptoms including hallucinations, depression, screaming and convulsions.

Bergin said New Zealand was invited to take part in the clinical trial by Zynerba Pharmaceuticals, the Unites States developer of the cannabidiol gel.

A Ministry of Health spokesperson said provideing the appropriate licences and approvals are issued, cannabis-based products can be prescribed legally in New Zealand and used in clinical trials.

"As long as the appropriate licences and approvals are obtained, clinical trials of cannabis-based products can occur in the same way as a trial of any other controlled drug," the spokesperson said.

"The Assciate Minister of Health [Peter Dunne] has made it clear that he is in favour of clinical trials of cannabis-based products to obtain good evidence as to whether these products have the medicinal benefits that many people claim."

In addition, Dunne has approved applications to prescribe and import non-pharmaceutical grade products for the treatment of three patients.

Before her death three weeks ago, former president of the New Zealand Council of Trade Unions, Helen Kelly, called for a referendum on legalising medicinal marijuana saying it was "absolutely ludicrous" she and others have to break the law to ease medical conditions.

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