September 10, 2021, was a black day, the day a group of faceless bureaucrats known as the “Advisory Committee for Medicines Scheduling”, through its effector arm, the Therapeutic Goods Administration (TGA), compromised medical practise and the health of their fellow Australians. The TGA used its regulatory muscle to prevent doctors at the COVID-19 pandemic’s coalface from prescribing ivermectin (IVM), the one therapy available that is safe, cheap and which reduces mortality in the order of 60 per cent. This poorly conceived action threatens the high standards of medical practise we have achieved in Australia, and the credibility of the administrative structure within which medicine operates.
The immediate consequence of the TGA Notice means patients contracting COVID-19 are left to hear, “Sorry, no treatment for COVID-19 is legally available. Just go to hospital when you get very sick.” In the longer term it means that bureaucrats can change the way medicine is practised for whatever reason without review by, or discussion with, the medical community. It is important for Australians to consider two issues that follow the TGA’s decision: first, it adds risk to those exposed to COVID-19, putting additional pressures on health-care facilities; second, it drives a wedge into the fault lines that have appeared in medical practise during the course of the COVID-19 saga.
Looking at the first issue, the decision by the TGA to prevent general practitioners from prescribing IVM to manage COVID-19, the Notice is flawed and misleading, although giving clues to its political motivation. The evidence that IVM is safe and effective in both preventing and treating early (pre-hospital) COVID-19 is overwhelming, as has been laid out in four Quadrant articles published through 2021. Despite this evidence, every artifice has been used to quash IVM’s use and to do so in unprecedented fashion. The causes for the suppression include political agendas, pressures from pharmaceutical companies, ideology and breakdown in medical communication. This latest blow by the TGA follows its previous form in shutting down use of hydroxychloroquine, another safe, effective and cheap COVID-19 therapy. Every experienced doctor prescribes drugs for “off-label” indications. It is anathema and dangerous that the doctor-patient relationship can now be over-ridden by government agendas.
The driving source of “evidence” that IVM has unproven therapeutic value is the Cochrane Review, which concluded from a single meta-analysis that the benefit in treating COVID-19 was “unproven”. This was out of line with a series of supportive meta-analyses by non-conflicted competent epidemiologists. Yet results from Cochrane have singularly been adopted without criticism or discussion, initially by the National COVID Clinical Evidence Taskforce (NCCET), then by diffusion via various professional and regulatory bodies while being fanned by an even less critical mainstream press. Thus IVM is seen by many, including some medical professionals, as the snake-oil of our age. What is not discussed is the validity of the Cochrane Review and the advisory messages from the NCCET. The influence of vested interest parties on Cochrane has been previously raised. The circumstances of generating the review by an unknown German group when experienced epidemiologists were available needs explanation. More immediately, critiques of the Cochrane analysis and the NCCET by unaligned British epidemiologists show defective methodology, cherry-picked data and exclusion of a raft of supportive data.