EACH time he slips on his cream lab coat, gloves and mask, Antony Condina is — legally — going where no South Australian has gone before.
When his 25ml vials of cannabis oil become available to be prescribed next month, Mr Condina will be the provider of an Australian-made product patients are desperate for, but have for so long struggled to access.
In his suburban Adelaide manufacturing centre, the GD Pharma chief executive is at the cutting edge of the newly legal, yet still confusing world of medicinal cannabis.
Despite being legalised as a medicine by the Federal Government 10 months ago, no SA doctors can prescribe the drug and just eight SA patients have received approval to use it legally, according to the latest Therapeutic Goods Administration figures.
That delay can be pinned on the State Government not finalising its own patient access pathway until April.
But as he glances at his 25ml bottles of imported cannabis oil, Mr Condina doesn’t care who is to blame. He just wants the logjam resolved.
“I don’t get into the politics, I’m just here at the coalface, but that (patient access) is where we’re stuck,” Mr Condina said.
“We’ve got doctors who are interested in prescribing it, we’ve got a pharmacy who can dispense it and talk to patients on how to use it, we’ve got a facility where we can actually make it — where we get stuck is the approval process.”
GD Pharma chief executive Antony Condina. Picture: Tait Schmaal.
The 39-year-old started his pharmacy career in 2002, and has been working as a compounding pharmacist since 2010.
He has worked at GD Pharma since it was established in 2010, but it wasn’t until 2016 that he owned the company in his own right.
He then accelerated his plans to provide alternative medicines to patients whose needs had not been met by what was available on the commercial market.
GD Pharma produces six main products including pain medicines, treatments for addiction, eye drops, and its newest medicinal cannabis line.
The company regularly manufactures medicines out of drugs like ketamine, but under the TGA’s licencing scheme, required a special import licence to bring in cannabidiol (CBD) and tetrahydrocannibanol (THC) — two types of cannabinoids found in the resin of the cannabis plant.
During the Sunday Mail’s visit, Mr Condina repeatedly pointed out the unregulated drugs he manufactures that are stronger and potentially more dangerous than medicinal cannabis.
“With all of our other products — some that are not registered — they are able to be supplied in a much easier fashion, but due to the stigma around medicinal cannabis it’s made it much more difficult,” he said.
“If someone treated this as a medicine, which it is, and called it a different name, such as cannabinoid medicine, or a different class of product, then it wouldn’t produce such a hype or the scare around it.”
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Mr Condina imports about 1kg of the pure, powdered form of each drug from the Netherlands at a time — each becoming 400 little 25ml bottles.
Each bottle is eye-wateringly expensive.
The THC oil contains 10 milligrams per ml of liquid — with a 25ml bottle retailing for $250.
Mr Condina says the psychoactive product will be predominantly used legally by cancer patients to lessen the nausea and pain brought on by chemotherapy.
He says a regular dosage is between 0.5ml and 1ml, meaning the bottle could last patients almost a month before they were paying for a new prescription.
But the dosage rapidly increases with the CBD product helpful for epilepsy sufferers. He says the amount of oil ingested depending on the patient could be up to 8ml a day.
South Australia's first manufacturer of legal medicinal cannabis products. Picture: Tait Schmaal.
It means a patient could be exhausting a 25ml, $500 bottle in just three or four days.
“For epilepsy it’s very expensive when you’re looking at $500 for four days’ supply — but really where most people are using medicinal cannabis is in the pain space,” Mr Condina said.
“With those patients they’re using more the psychoactive THC (tetrahydrocannabinol) component and those doses can range between half a ml and a ml.
Mr Condina won’t reveal the cost of importing the drugs from the Netherlands but confirms it is very expensive.
“We make no money on it. It’s because it’s a new industry. The cost of materials is extremely high through being imported so we’re trying to keep the price of product realistic,” he said.
“As the industry evolves and the doctors will be the ones prescribing it, I think that volume can increase and our profit and margin can increase too.
“Whenever you’re first to market you’re kind of ironing out the bugs and working out where thew market is ... we’re lucky we haven’t got investors because they wouldn’t be getting a return on investment.” WAITING FOR THE GREEN LIGHT
THE first South Australian business to be granted an import licence by the Office of Drug Control, GD Pharma has also applied to manufacture a medicinal cannabis product directly from the plant.
Eight licences to grow medicinal cannabis have been handed out around Australian states, but a SA company is yet to receive the green light.
But waiting to establish a deal with a local grower would take time that Mr Condina said he simply did not have if he wanted to be a pioneer in the industry.
“By the time we get it licensed and then partner with a cultivator, by the time a cultivator is able to get a licence as well to grow, harvest, package and then send to us, that could be at least a year to two years away,” he said.
“This is supplying Australian made product until the domestic market is established.
“Even with the first suppliers in Victoria who are harvesting now, they started planting last year. So it’s a good year before you can make it into a medicine.
“We couldn’t wait two years to do that because patients were suffering, patients were using it illegally.”
In the interim, Mr Condina and his team of nine masked, lab-coated pharmacists remove the bottles of powder from locked safes, weigh and check it and then incorporate it into an oil base known as a medium chain triglyceride.
It’s then mixed and bottled into GD Pharma branded bottles, with two staff members required to check off each stage to ensure the product is exactly what it says on the bottle.
Zuhong Qiu — a production technician — weighing the raw product. Picture: Tait Schmaal
On manufacturing days security is particularly high, and although there’s no searches of staff, Mr Condina says there is a strict emphasis placed on producing a high quality product, as with all other medicines the company produces.
But there is no specific product testing and Mr Condina said the onus on ensuring the safety and efficacy of his product was placed on doctors.
“The products we’ve developed are products that are already registered with the FDA (Food and Drug Administration) in America so we’re confident from a safety and efficacy point of view that these products should meet the same kind of results,” Mr Condina said.
But without clinical trials, doctors — especially the specialists whom the Federal Government’s scheme is set up to allow to become authorised prescribers — feel uneasy about prescribing medicinal cannabis.
And even when there’s research showing a drug might be effective in certain circumstances, there’s a desire for more information about the effect of changing the dosage, or what effect it has on a variety of medical conditions.
Given the wide range of conditions people requesting access to medicinal cannabis can be suffering from, that thirst for knowledge can sometimes seem never-ending, creating an access bottleneck.
Mr Condina said better doctor education and an eventual policy shift to make it easier for GPs to become authorised prescribers is needed to allow patients to receive medicinal cannabis legally, rather than shifting to the black market.
“Doctors would like to know it’s gone through a clinical trial, it’s been tested, ‘X’ amount of dose for these conditions, I know these are the side effects, I know this is how long I have to treat for,” Mr Condina said.
“Because this particular product hasn’t gone through that and only a small amount of products overseas have done that, there’s a degree of caution.”
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It’s that caution that’s led Mr Condina to address medicinal practitioners about the potential benefits of medicinal cannabis.
It’s also what prompted activist Ben Fitzsimons to bring Australian National University medical school researcher Dr David Caldicott to bring his one-day medicinal cannabis crash course to Adelaide in early August.
But for all the optimism, doctors remain guarded, and the Australian Medical Association even more so.
National president Dr Michael Gannon said in March that cannabis would have been used for some time if it was “the panacea for a whole range of medical conditions it was claimed to be by some advocates”.
“The truth is that it potentially does have limited application in a number of areas, including the palliative care setting and including symptom relief for nausea and pain and certainly for spasticity — certain neuromuscular conditions and certain forms of juvenile epilepsy,” Dr Gannon said.
“Show us the scientific evidence and doctors will prescribe it selectively on a patient by patient basis.”
Work is being done to make that prescription process easier at a state level, but the progress is slow.
A spokeswoman for state Manufacturing Minister Kyam Maher — the minister in charge of the state’s medicinal cannabis industry — said the SA Government’s patient access pathway introduced in April meant the decision to prescribe products was in the hands of “our highly trained and respected medical specialists”.
“This means that state approval is no longer required unless Schedule 8 medicinal cannabis is being prescribed for longer than two months or to a patient already using a Schedule 8 drug (which is a controlled drug with high potential for abuse and addiction),” Mr Maher’s spokeswoman said.
“SA Health has also provided information sessions to medical practitioners, pharmacists and other stakeholders, to increase awareness about patient access and use of medicinal cannabis. It is ultimately up to doctors to decide what treatment is appropriate for their patients.”
But it’s that same stumbling block, a reliance on doctors who are cautious to prescribe the drug, that infuriates activists and patients alike, and drives some to turn to the black market.
Kyam Maher
Tammy Franks
SA Greens MP Tammy Franks said federal bureaucracy was largely to blame for the logjam, although she called for the State Government to implement policy that would grant doctors legal indemnity.
“At Dr Caldicott’s session there were people who wanted to grow and manufacture medicinal cannabis and doctors who wanted to prescribe it but everyone was frustrated with the bureaucracy,” she said.
“I’m talking to all sorts of patients who are turning to the black market.
“They (the TGA and the Office of Drug Control) are trying to fit the square peg of medicinal cannabis into a round hole,” she said
Mr Condina likes the European model giving doctors more power, while activists favour the US model that gives patients more control over their drug access.
For now, Mr Condina is focusing on talking to doctors, although he is not allowed to advertise directly.
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