‘Who guards the guardians?’ asked Juvenal in his sixth Satire, in the second century. He was referring to corruptible lechers who could hardly be expected to ensure the fidelity of a wayward wife but the guardian raising eyebrows in Australia is the Therapeutic Goods Administration (TGA), appointed to ensure the purity of medicines.
On 10 September, the TGA, acting on the advice of the Advisory Committee for Medicines Scheduling (ACMS), removed the right of Australia’s general practitioners to prescribe ivermectin for Covid. This is an extraordinary intervention. Prescribing medications for illnesses other than those for which they were originally approved is extremely common. Around 25 per cent of all medications in Australia are prescribed off-label. Viagra, for example, was approved to treat angina but is widely prescribed to treat erectile dysfunction. Imagine if the TGA suddenly decided that only a specialist could prescribe the ‘little blue pill’. That would have a few politicians seeing red.
It is not the role of the TGA to meddle in the relationship between patient and doctor, it does not regulate healthcare professionals. Its role is to assess the safety and efficacy of new therapeutic goods. Ivermectin is not new. It was approved in 1996.
So, what prompted the TGA to intervene? It certainly wasn’t a rush of reports to the regulator about adverse events. Since 1998 there have only been fourteen, and only one report during the entire pandemic. Even then, the reporter only ‘suspected’ that ivermectin had been taken, in conjunction with albendazole – a drug that has never been linked with Covid treatments.
Rather the TGA is worried that there has been a three to four-fold increased dispensing of ivermectin prescriptions in recent months for the treatment of Covid-19 when it is not approved in other ‘developed countries’. This is insulting not just to the national governments of Slovakia, Czech Republic and Macedonia, which approved ivermectin for Covid, but to all the developing nations who approved it – up to a third of the world’s population – with great effect. You only have to compare cases per million in Indonesia (19) where ivermectin was briefly banned, with Israel (1,080), the US (514) and the UK (499) to see how well the drug works.
The TGA however is uninterested in real world evidence. It says the use of ivermectin for Covid-19 is currently strongly discouraged by Australia’s National Covid Clinical Evidence Taskforce (NCCET). In fact, the NCCET writes that ‘the available research evidence does not yet provide reasonable certainty to recommend for or against the use of ivermectin’.
This echoes the US National Institutes of Health which makes a similar recommendation that there is insufficient evidence ‘to recommend either for or against the use of ivermectin for the treatment of Covid-19’. That has not been used to prevent US doctors from prescribing ivermectin for Covid.
The TGA claims that people taking ivermectin ‘may choose not to get tested or to seek medical care if they experience symptoms’ spreading Covid-19 in the community. If there is a single case of this happening, they haven’t bothered to document it. But it is true that vaccinated healthcare workers have unwittingly spread Covid in hospitals.
The TGA says the doses of ivermectin that are being advocated for use in ‘unreliable social media posts and other sources’ are significantly higher than those approved for scabies or parasite treatment and can be associated with serious adverse effects, including severe nausea, vomiting, dizziness and neurological effects such as seizures and coma. This is an argument in favour of people to get a prescription from their GP, not creating a black market.
Last, it says increased use of ivermectin has led to national and local shortages. There is no one to blame for this, but the TGA which is meant to ensure sufficient supplies. There is no international shortage. There is also no shortage in compounding pharmacies.
On the same day that the TGA made its announcement, a delegate of the federal department of health decided – ‘on their own initiative’ – to wield a poison pen and amend the Poisons Standard Amendment (Ivermectin). In a clown-like act of incompetence, it was withdrawn the following Monday. Yet the intention of the withdrawn legislation will apparently still apply. It seeks to create a federal framework to uniformly restrict the use of ivermectin although each state would have to pass regulations to give the restrictions effect.
In an explanatory note, the delegate said his decision was ‘not open to public consultation because of the seriousness of the circumstances, the risks to the community and the immediacy with which action needed to be taken’. He only deigned to consult the TGA, who, surprise, surprise, supported the amendment. Further, he wrote that, ‘it was considered necessary to make the Amendment Instrument urgently in order to support the Australian government’s response to the Covid-19 public health emergency and to support the continued availability of ivermectin for Australian patients’.
Buried in the note is the real reason for making ivermectin inaccessible – the fear that persons taking it ‘may elect not to be vaccinated as part of the national Covid-19 vaccination program’. This is outrageous. When someone is infected with Covid, it is too late to bother with vaccination. They need early treatment. To deny it to coerce them into accepting a vaccine, one of whose side-effects is death, is immoral.
Already, the Covid-19 Antiviral Advisory group, which advises more than two hundred doctors in the Covid Medical Network on early antiviral treatments, has called on the TGA to reverse its diktat within 48 hours so that people don’t die. The doctors have successfully treated more than 450 patients, keeping them out of hospital as well as protecting hundreds of frontline healthcare workers with prophylaxis.
They have called for Ivermectin Triple Therapy to be provided to the 14,000 Australians in New South Wales currently in quarantine and other states as needed, with a working party of frontline doctors overseeing distribution, management and data collection processes. And they demand complete transparency around the reasoning that informed the TGA decision.
One day we will look back on this pandemic as a period of stark madness, says Dr Wendy Hoy, professor of medicine at the University of Queensland. In restricting ivermectin for Covid the TGA has hopefully reached peak lunacy. Let’s hope so, because this is a poison pill that many Australians will refuse to swallow.
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