17/01/2018
http://www.theaustralian.com.au/news/inquirer/medicinal-cannabis-cant-come-quickly-enough-for-some/news-story/e95f19f662297c32765ec60d6cd67b69
Nicole Cowles has been dosing her daughter with cannabis for years. Before she began, Alice, now nearly 12, often had dozens of seizures a day. The so-called “hippie drug” has made all the difference for one little girl.
“She’s really healthy and well now,” Nicole says. “She still has seizures if she has a temperature, but they are nothing in comparison to those she used to have.”
From Kingston in Tasmania, Cowles, 45, blames some of Alice’s ongoing disability on the “horse doses” of anti-convulsants she was fed as a child by panicking doctors. Alice has a rare genetic condition, CDKL5, and cannabis, or ma*****na, is the only medication that seems to work for her.
But it’s illegal.
Although Australia legalised medicinal cannabis in 2016, it is still strictly monitored by the government and considered a schedule 8 “controlled drug”. A schedule 8 pharmaceutical, according to the federal Department of Health, “has an established therapeutic value but its use, at established therapeutic dosage levels, is recognised to produce dependency and has a high propensity for misuse, abuse or illicit use”.
To date only about 360 Australians have been prescribed legal cannabis by their doctors, either via the Therapeutic Goods Administration’s Special Access Scheme or from authorised prescribers. At the same time, experts estimate that as many as 100,000 Australians are self-medicating with illegal cannabis, using it to treat a vast range of ailments, from epilepsy to psoriasis to cancer pain.
Earlier this month, federal Health Minister Greg Hunt announced that the current export restrictions on medicinal cannabis products manufactured in Australia would be eliminated, fuelling a rush on Australian cannabis shares (colloquially known as “pot stocks”), some of which shot up in value by as much as 50 per cent overnight. At the time, Hunt said the move was an important step for domestic patients, because it would boost domestic production and improve domestic supply.
But while shareholders were gleeful and the companies optimistic about growth and innovation, many unwell Australians were furious. They believe the government has put profits before people, boosting the companies, but failing to ease the restrictions that have curbed legitimate prescriptions.
A spokeswoman for the Health Department concedes “the requirement for practitioners to also apply to states and territory health departments does add to the complexity” for doctors, adding there is ongoing work with the states and territories to simplify the procedures for doctors, and noting that the federal department itself is dealing with all the different state and territory types of legislation and regulation.
Hunt, the spokeswoman says, is keen to simplify the process, to make it as easy as possible for the appropriate patients to get medicinal cannabis, and in the coming months the TGA will work with the states and territories on smoothing the way.
Nicole Cowles, for one, is disappointed with the progress on medicinal cannabis. As a long-term activist, she hoped for rapid action.
“It’s a huge move forward for Australian health, but the fact that it’s so disjointed from state to state makes it complicated,” she says.
“One of the biggest issues is that patients can’t access it. There are very few people in Tasmania, or even in NSW and Victoria, who are actually accessing legal cannabis through the government scheme.”
Cowles relies on illegal supplies of cannabis to keep Alice well. “If I’d known what I know now, I would have used cannabis as the first-line drug,” she says. “It has so many neural protective benefits and regenerative benefits. We don’t see it as just something to stop Alice’s seizures, we see it as something to heal her brain.”
A fellow Tasmanian, John Reeves, from Dover, says the government’s priorities seem confused. The 55-year-old uses medical cannabis to treat fibro-myalgia, a chronic condition characterised by widespread pain in the bones and muscles.
“It’s completely ridiculous to us,” he says. “We honestly couldn’t give a flying hoot if they export it overseas. We need it here.”
Ross Walker, a cardiologist and a board member of the industry’s Medical Cannabis Council, says Australia is an infant in the world of medicinal cannabis.
Certain companies now have permission to cultivate the cannabis plant, he says, but it took them a long time and they had to fulfil many bureaucratic requirements to get the permits and licences.
“People have been granted cultivation licences, but there are Âabsolutely no pharmaceutical products (manufactured in Australia) that are ready to go, or ready for local use, let alone for export,” Walker adds.
At the same time, patients with Parkinson’s, or Crohn’s disease (a chronic inflammatory bowel condition), or cancer pain, struggle to get prescriptions for medicinal cannabis.
“To get medical cannabis in Australia you have to jump through so many hoops,” says Walker, who is on the board of one of the ASX-listed cannabis companies, MGC Pharmaceuticals.
“I think there are around 200 authorised prescribers. If you’re not an authorised prescriber but you think someone needs medical cannabis, you have to fill in pages of forms. Even if the TGA will grant you a licence for this particular patient, it costs them (the patients) $1500 a month.
“It’s prohibitive. You name a person with a chronic illness, they’re not going to be able to afford $1500 a month indefinitely to control their condition.”
Many doctors have been reluctant to prescribe medicinal cannabis, partly because they don’t want to wade through the paperwork, and partly because they often don’t know much about the drug’s properties: how it works, how much works, where it works.
The Health Department issued clinical guidance protocols last month to help doctors, but the guidance is cautious, often citing “insufficient evidence” for effective treatment.
Some medical cannabis users find the caution difficult to understand, since the drug has been in use therapeutically in Israel, Canada and certain states in the US for many years.
However, Australia’s Health Department notes that “Canada and Israel have medicinal cannabis regulatory regimes separate to their medicine regulation”. Some experts say this essentially means that Canada and Israel, and potentially certain states in the US, are happier to give some overall credit to the efficacy of cannabis, and allow the consumers to choose.
Walker says our Health Department is cautious because the gold standard for medicine is the huge, randomised controlled clinical trial: a lengthy process that can cost many tens of millions of dollars. Very few trials of this size have tested the benefits of medicinal cannabis.
There have been none, for instance, to assess the efficacy of medicinal cannabis in treating chronic non-cancer pain, which Walker says is a shame, because the potent prescription narcotics now in use have a number of unfortunate side-effects, including addiction — which has proved particularly disastrous in the US.
“It’s a huge problem in this country with prescription narcotics,” Walker says. “More people are now dying from prescription narcotics than they are from he**in overdoses. We need better alternatives for pain management”.
Debra Lynch slipped on a wet floor in the late 1980s and damaged her spine. The 57-year-old from Cornubia in Queensland had a laminectomy (surgery to expand the spinal canal to relieve pressure) which left her in a great deal of pain, and she says she subsequently developed other medical conditions including systemic sclerosis, which led to significant peripheral artery and nerve damage, digital ulcers and a gangrenous toe. She began using cannabis medically soon after her spinal surgery. Lynch, the president of one of the many medical cannabis users’ groups, says the drug has worked well for her.
“Painkillers didn’t work,” she says. “Anti-inflammatories didn’t work. I had chronic pain. I couldn’t sleep. The pharmaceuticals left me in a drug fog.” Now she is using cannabis oil, one dropperful five times a day. “I have been making my own,” she says.
For this, she faces criminal charges. She says she will plead not guilty, citing justification and excuse defences based on her being refused a prescription.
The scarcity of legal medicinal cannabis for nearly all unwell Australians has pushed many thousands of medical cannabis users underground, where they communicate on secret internet groups, or anonymously via on-line support groups, or by mail (cash only), or in person.
Many users are fearful of pesticides or hormones; others worry their source might suddenly dry up; others have been outright robbed — sending cash for cannabis that never appeared.
Shady internet sites have popped up, such as BudsOasis, which advertised all manner of cannabis types, mostly with lurid names such as Blissful Wizard and Maui Wowie, priced at $US170 for half an ounce (about $210 for 14g), but according to various online forums, apparently failed to send any product. The website has since disappeared into the ether. Other users have tried to buy via the dark web, with mixed results.
Meanwhile, Australians who have provided cannabis products to the desperately ill, often without charge, have been raided and prosecuted. They include Adelaide resident Jenny Hallam, who is being tried on drug charges and has pleaded not guilty, asserting her actions were “morally right”.
Police routinely prosecute thousands of recreational and medicinal users every year, even as successes with medical cannabis are racked up in clinical trials in Australia and around the world.
Walker, for one, believes this hardline stance on recreational cannabis is the right way for Australia to proceed, adding there is a vast difference between carefully controlled clinical cannabis medications and the random recreational use of the “stoner” drug.
“Marijuana should stay illegal because it’s a completely different substance,” he says. “When you smoke ma*****na, it has a high Âpotential to be psychotropic — that’s why people smoke it — but also the potential to cause chronic neuro-psychiatric problems.
“There’s no doubt about that, but unfortunately there are still ill-informed people who have their own barrow to push.”
Medical preparations of cannabis — which come in various forms including drops, oil and paste — can contain little or no THC, the mind-altering ingredient that gives dope smokers their high. The preparations often have only non-psychotropic cannabinoids, although their therapeutic effect is sometimes augmented by THC.
As the word about medicinal cannabis spreads, people are becoming hungrier for the so-called wonder drug. As a remedy for chronic pain, a way to stimulate the appetite of people on chemotherapy, a way to prevent convulsions in children with epilepsy, and a non-toxic medicine for palliative care, its champions say cannabis has a huge range of potential uses.
Michelle Crain, who organises large H**p Expo conferences in Melbourne and Sydney that attract thousands of interested consumers, says she is constantly contacted by desperate people seeking sources of medicinal cannabis.
“A lot of mainstream Australia up to now has been quite unaware about what the cannabis plant can do, other than the recreational side of things that people have always gone on about, but now people are becoming more aware that it does have major health benefits,” she says. “And they want it.”
A number of ASX-listed companies have products waiting in the wings. MGC Pharmaceuticals expects to import its CannEpil oil for epilepsy patients in the coming months, after sorting through the process of becoming an authorised prescriber.
Chief executive Roby Zomer says MGC will set up a team of professionals to provide doctors with all the therapeutic information regarding CannEpil, and help them with the paperwork. The company also manufactures an anti-inflammatory treatment for psoriasis.
“I think we will see a lot of fast movement happening in 2018,” Zomer says.
Medlab Clinical has a medicinal cannabis mouth spray, NanaBis, formulated to alleviate pain in patients with advanced cancer. Now being manufactured at a TGA schedule 8 facility in Melbourne, NanaBis is expected to be available for approved Australian patients by late next month.
Medlab founder Sean Hall remains optimistic about the adoption of medicinal cannabis in Australia. “I think there is momentum there,” Hall says. “I think the government is working hard to try and catch up. I think that momentum will accelerate”.
The chief executive and founder of Creso Pharma, Miri Halperin Wernli, shares Hall’s optimism, adding that Australia’s uptake of medicinal cannabis is not unusually slow compared with, say, Canada. Creso, an ASX-listed comÂpany that grows cannabis in Slovakia and produces medicinal cannabis products in Switzerland, where it is also developing a facility, wants to gain traction here.
“We are trying to get into Australia with all our products,” Halperin Wernli says, listing medicines, therapeutic products, beverages, chocolates and food supplements — expected to be launched in Europe in a month — as well an animal health products.
She acknowledges, though, that the firm will have to overcome a number of obstacles in Australia: “It’s still very difficult to convince the authorities that they should give patients the choice”.
Nicole Cowles has been dosing her daughter with cannabis for years. Before she began, Alice, now nearly 12, often had dozens of seizures a day. The so-called “hippie drug” has made all the difference for one little girl.
