Ivermectin ban lifted, Australia

The ban on off-label prescribing of the anti-viral drug has been in place for over 18 months

Doctors will be free to prescribe ivermectin ‘off-label’ from 01 June 2023, the Therapeutic Goods Administration (TGA) announced today.

A regulatory U-turn

This is a reversal of a national ban on off-label prescribing of ivermectin, which the TGA enacted on 10 September 2021, in an attempt to prevent doctors from prescribing the drug to treat Covid.

At the time, the TGA stated that the restriction was necessary because:

• People would be at risk if they took ivermectin instead of getting vaccinated

• People who took ivermectin may choose not to get tested or to seek medical care if they had symptoms

• Social media posts were promoting higher doses of ivermectin than what is normally recommended for approved uses

• There had been a 3-4 fold uptake in ivermectin and the TGA was worried about a shortage disadvantaging vulnerable people who really needed the drug

So, instead of launching a nationwide education campaign and recommending that the Australian Government throw a few million dollars at bolstering the national stockpile of ivermectin, the TGA effectively banned the drug for all but a narrow set of uses.

The TGA has now relaxed the ban because, “there is sufficient evidence that the safety risks to individuals and public health is low when prescribed by a general practitioner in the current health climate.”

It would seem, though, that there was sufficient evidence of ivermectin’s safety all along. In July 2021, Rebecca Weisser wrote in Ivermectin. It’s as Aussie as Vegemite, for Spectator Australia:

As for safety, 3.7 billion doses of ivermectin have been used since 1987 and in 30 years, only 20 deaths following its use have been reported to the UN’s Vigi-Access database. Compare that to remdesivir, which has been given emergency use authorisation to treat Covid in Australian hospitals. In 12 months, there have been 551 deaths reported. Indeed, a study published in the prestigious Journal of the American Medical Association this week found remdesivir did not increase survival, just time spent in hospital.

The TGA’s stated concerns over ivermectin’s safety back in September 2021 seem incoherent when taken alongside its authorisation of remdesivir.

A doctor’s perspective

An Australian doctor, who prefers to remain anonymous, was suspended by industry regulator AHPRA for prescribing ivermectin off-label during the pandemic. He says,

“I think the restriction on prescribing ivermectin off-label was disingenuous from the start. It was always about coaching people toward the option of vaccination by removing a legitimate off-label therapeutic option. The decision effectively punished Australians for being self-educated and aware of the scientific evidence supporting ivermectin.

The reversal of the ban is a good step and it appears that doctors may be restored their full rights to off-label prescribing.

But, there remains the question of whether lives have in fact been lost due to the limitation of ivermectin through this policy.”

Did restrictions on off-label prescription of ivermectin cost lives?

This is the question posed by Kara Thomas, Secretary of the Australian Medical Professionals’ Society, and Andrew McIntyre, Gastroenterologist and Coordinator of the Doctors Against Mandates legal action, in an op-ed from March this year, also for Spectator Australia. The article raises more questions than answers, but serves to highlight the disparity between the safety profiles of ivermectin (better) and Covid vaccines (worse), as well as a summary of the scientific evidence for ivermectin’s effectiveness.

The effectiveness of ivermectin in treating Covid is hotly argued in all corners of the internet, but it is worth noting that internationally renowned ICU doctor Paul Marik wept when his hospital enforced a policy preventing him from using it in combination with other therapeutics. There are numerous other frontline doctors who similarly expressed dismay at being prevented from administering the drug, after seeing lives saved under their care.

Lifting of ban is not an endorsement

Though prescribing restrictions on ivermectin are to be lifted, the TGA does not endorse off-label prescribing of ivermectin for the treatment or prevention of Covid.

”A large number of clinical studies have demonstrated ivermectin does not improve outcomes in patients with COVID-19. The National Covid Evidence Taskforce (NCET) and many similar bodies around the world, including the World Health Organization, strongly advises against the use of ivermectin for the prevention or treatment of COVID-19.”

It will now be at the discretion of Australian doctors to make their best clinical judgement on a case by case basis.

Research in progress

Monash University, Melbourne, is running a blinded and randomised clinical trial to test ivermectin’s efficacy for Covid prevention. The trial is led by Dr Kylie Wagstaff, whose preliminary in vitro study in collaboration with the Doherty Institute (April 2020) found that ivermectin stopped the replication of the SARS-CoV-2 virus in cell culture within 48 hours.