The leader of the Greens has slammed Australia’s medicines watchdog for its approach to regulating cannabis products as “nothing short of a disgrace”, vowing to continue the fight for a new national system of regulation.
Senator Richard Di Natale said “the government model” of using the Therapeutic Goods Administration (TGA) to control patient access to medicinal cannabis had been a “failure”.
His comments come after an investigation by The New Daily found prominent underground medicinal cannabis suppliers were selling contaminated products to seriously ill patients.
The New Daily arranged for independent testing of a number of medicinal cannabis products obtained on the black market by desperate customers frustrated by the Australian system.
Fourteen samples of cannabis extract – sold to chronically and terminally ill Australians for hundreds to thousands of dollars – were tested by a top Australian research facility (which did not want to be named).
Contrary to some suppliers’ claims, seven of the cannabis products contained no cannabidiol (CBD) which according to the TGA is “the main non-psychoactive substance extracted from cannabis due its therapeutic benefit”.
Although patients “shouldn’t have to rely on getting products externally tested”, Senator Di Natale said this would become an inevitable necessity “in the absence of regulations that deliver a product of known quality and purity”.
He said the “best solution” would be to launch an independent regulatory system for medicinal cannabis.
“Patients who need it would go and see their doctor, and their doctor would prescribe it from a manufacturer and supplier that has met the standards that the independent regulator has set,” he said.
Senator Di Natale said the current laws around medicinal cannabis need immediate reform because “at the moment, doctors have to jump through far too many hoops to be able to prescribe it for patients”.
“Unless the TGA can immediately demonstrate that people are able to access this when they need it, then we should have an independent regulator established as soon as possible,” he said.
The TGA’s medicinal cannabis experts, when approached by The New Daily to assess the lab reports of 14 tested cannabis samples, were unwilling to comment on the data, despite four other experts providing comment.
Senator Di Natale said: “The TGA clearly don’t want to admit that there’s a problem because they are part of the problem.”
A spokeswoman for the federal Department of Health said: “It is not possible to determine whether the product contains what it alleges it contains … [and] draw any definitive conclusions on the safety.”
Upon request, The New Daily supplied information on quantities, dose rates and patient conditions to the TGA but they still declined to comment.
Former federal government senior research scientist Dr Steve Short said “there was a reasonable expectation that the TGA could have provided some educated comment”.
“This is puzzling behaviour from a federal authority which purports to be able to speak authoritatively to all Australians on all therapeutic goods.”
A spokesperson for Shadow Health Minister Catherine King said The New Daily’s discovery “shows the importance of setting up a nationally regulated scheme with reliable supply – something the Turnbull government has been disastrously slow on”.
A spokesperson for Health Minister Greg Hunt said the federal government had already put in place arrangements to allow faster access to cannabis products by qualified doctors.
“We are now making it easier to access medicinal cannabis products more rapidly,” the spokesperson said.
Hurdles to access
There are several issues preventing doctors from gaining approval to prescribe medicinal cannabis, despite the fact it has become legal in Australia.
A doctor seeking authorisation must receive approval from a human research ethics committee (HREC) or a specialist college.
An HREC must include people that don’t engage in medical, scientific, legal or academic work, someone with a pastoral care role in a community, such as an Aboriginal elder, a minister of religion or a lawyer, for example.
Managing director of AusCann, a licensed manufacturer of medicinal cannabis, Elaine Darby said: “These are all great individuals for making an ethics decision, but not really for assessing whether a doctor should prescribe a product.”
And there is no limit on the time they could spend in reaching a decision.
Doctors seeking endorsements from a specialist college to prescribe cannabis face another formidable barrier.
One of the country’s largest specialist medical colleges, The Australian and New Zealand College of Anaesthetists (ANZCA) presently does not endorse any medical specialist who wants to become an authorised prescriber of medicinal cannabis, a spokesperson told The New Daily.
According to their Faculty of Pain Medicine: “Scientific evidence shows that, at best, there is marginal clinical benefit that does not outweigh the risk of harm” of medicinal cannabinoids in patients with chronic non-cancer pain.
If permission to prescribe medicinal cannabis is granted, doctors face another difficulty – finding the right cannabis medicine for their patient.
‘Hang in there’
When Amanda Preece approached her neurologist about accessing cannabis for her severely epileptic child Ella, she was told to “hang in there”.
While “there is a pathway”, accessing the right drug is “very complex”, the neurologist said in an email obtained by The New Daily.
There are “[cannabis] drugs with no recommended dosage regimens, minimal safety studies and lots of uncertainty”, the neurologist wrote. “I hope the government will change policy soon and it will release clinicians like me who are frustrated and willing to prescribe.”
Ms Preece, said she wasted $600 on poor-quality cannabis oils from different underground suppliers because it was “just impossible” to access a legal supply.
A spokeswomen for the TGA – which did accept TND’s invitation to comment on the system more broadly – said the problem was “not that the system is too protracted and difficult”.
“[It’s] because medicinal cannabis has not been treated as a medicine in other parts of the world, all of the product information is either missing, or is very difficult to find, so doctors are unable to access it easily.”
Dr Teresa Towpik, a general practitioner based in Katoomba, NSW, applied for TGA approval to prescribe cannabis to patients with chronic debilitating pain and Lewy body dementia.
Her application was initially rejected by the TGA because she did not have an endorsement from a relevant specialist – a requirement which Dr Towpik found “insulting”.
After receiving the endorsement of a neurologist, Dr Towpik was authorised to prescribe overnight but still required the approval of the state health department.
NSW Health rejected her application and so Dr Towpik hired a lawyer and requested an internal review of her initial submission but was again blocked from prescribing.
“I felt so demoralised, I felt really flat, I felt useless,” Dr Towpik said.
“The process … is just so difficult, so convoluted, (there is) so much paperwork that I’m not even sure if I have a chance,” she said.
“We’ve been conditioned into thinking that cannabis is such a bad drug. I was very ignorant because of a lack of knowledge but my attitudes changed after studying and researching the plant. Now I understand I’m dealing with a therapeutic agent.”
The complex process for patients to access medicinal cannabis