Responding to the TGA in regards to Accessing Medicinal Cannabis Products

Lateline Story Medical cannabis ‘red tape’ pushing doctors and patients back to illegal products on 16 August 2017. 

• Patients say legal medicinal cannabis remains difficult to access
• “Onerous, complex” regulation part of the problem, lawyer says
• Government insists turnaround times “often as little as two days”
• Interviews with:
  • Sydney GP Brad McKay
  • Brisbane father Steve Peek
  • Dr Teresa Nicoletti a partner at the law firm Mills Oakley
  • Sydney pharmacognosist Justin Sinclair

The TGA made the following statement Responding to Lateline – accessing medicinal cannabis products on 17 August 2017. 

This scheme has operated for many years and the TGA provides over 20 000 approvals per year for doctors to prescribe a range of unregistered medicines. Clearly, it can and does work efficiently to meet the needs of patients.

Why are prescription levels for medicinal cannabis products relatively low? The Lateline story itself provided the answer. One of the interviewees, Justin Sinclair, stated, ‘There is a great paucity of evidence in the literature, at least when it comes to human trials’.

Response from Dr Teresa Nicolletti Partner at the law firm Mills Oakley

Please read the full response here. 

…What the regulators are refusing to acknowledge, in this regard, is that it is not the evidence at large which is relevant in assessing any application by Suli for individual patient access to medicinal cannabis; it is the evidence in her that is relevant…

…Queensland Health recently introduced a “policy” directing that medicinal cannabis products containing THC not be administered to patients under 25 years of age. This appears to be the basis upon which Suli’s treating doctors are prima facie refusing to prescribe a THC-containing product to Suli, the very type of product she needs.

To those who may argue that Suli is being denied treatment based on the proposition that medicinal cannabis may cause harm to developing brains, I have this to say: the potential harm, including the significant brain damage, caused by the multiple seizures that Suli has suffered without medicinal cannabis, combined with the severe and debilitating side effects she has suffered from the use of conventional treatments, far outweighs any theoretical risk that medicinal cannabis may cause to her developing brain…

Response from Sydney pharmacognosist Justin Sinclair

Please read the full response here.

Australia operates an evidence-based system of medicine, but what is confusing is that denying patients legal access due to lack of the highest levels of scientific evidence means many are left with the only option of tackling complex health problems alone and without appropriate clinical oversight by a licensed medical practitioner…

Of particular relevance to this discussion is the N of 1 clinical trial, which fits within the hierarchy of evidence framework. This level of evidence considers an individual patient as the sole unit of observation…

Results of such studies can be collected and collated to ascertain proof of concept and establish a scientific rationale for treatment of a particular condition, which can then lead to more rigorous forms of evidence such as randomised, double blind, placebo controlled clinical trials being implemented.

Response from Executive Director of UIC Lucy Haslam

Please read the full response here.

This is not about medical Cannabis. It is about Political Cannabis!

TGA, you are not meeting the needs of these patients….if you were they would be under the legal cannabis system that you have claimed ‘does work efficiently to meet their needs’. This is clear denial on your part.

You take your advice from the peak bodies like the pain specialists who have vested interests in continuing to push opioids on the general public…. whether safe or not, you have failed to support and encourage those doctors, especially GPs who do wish to prescribe cannabis for their patients. You have failed to co-ordinate State and Territory health departments so we now have a mish mash of catch-22 and inconsistent regulations that add layers of bureaucracy and that operate in a vacuum, further adding additional hoops for sick folk to jump through.

Why do you not encourage N=1 trials? Why can doctors (including GPs) not put their needy patients onto personalised medicine trials where the patient can be monitored and supported, where the evidence can be built over time, where the safety of the patient is recognised in a practical way…