The NSW Poisons Information Centre in a submission to the Therapeutic Goods Administration (TGA) that dropping restrictions on ivermectin would likely lead to more people using it to treat COVID-19,while the Pharmacy Guild restrictions to remain “as a matter of public safety”.
GPs will once again be allowed to write scripts for Ivermectin for COVID-19.Bloomberg
But the TGA said in that it was “satisfied that the risks to public health … are now otherwise mitigated”.
Ivermectin is an anti-parasitic drug used to treat scabies and river blindness. There is ivermectin,commonly used to de-worm horses,cannot treat or prevent COVID-19. Early in the pandemic,a team of Australian scientists discovered it could stop the growth of COVID-19 – in.
Despite a lack of human evidence,that finding was followed by a surge in the drug’s use in Australia and around the world,leading to Australia’s drug regulator doctors from prescribing it to treat the virus in late-2021.
The TGA’s decision to drop the restrictions overruled its own interim decision in February and advice from its expert committee that the safety of high doses of ivermectin was not established and there was no evidence it could effectively treat the virus.
“There is insufficient evidence for benefit in relation to COVID-19 and significant risk,” an interim decision in February by the Health Department secretary’s TGA delegate reads. “I remain of the opinion there is a significant public health risk”.
But three months later,by the time of the final decision,the anonymous TGA delegate wrote they no longer believed there was a risk to public safety.
The TGA’s delegate explained the change in their decision by saying they had looked at the facts “through a different lens”.
The delegate said doctors should now be well-informed that ivermectin does not work for COVID-19,but evidence suggested that high doses of ivermectin were not toxic,most Australians had been vaccinated and there were no longer shortages of the medicine.
In a statement,the agency noted that the World Health Organisation “strongly advises against the use of ivermectin for the prevention or treatment of COVID-19”.
“Nevertheless,General Practitioners will be permitted to again prescribe ivermectin ‘off-label’ for an unapproved indication if they deem it clinically appropriate because there is sufficient evidence that this poses a low safety risk to individuals and public health in the current health climate.”
Wangaratta GP Dr Julian Fidge,who wrote the application that led to the TGA dropping the restrictions,told this masthead he believed the agency was fearful of being sued over its 2021 decision.
But agency documents suggest it was not legal threats that played a key role but a submission by the Australian Medical Association (AMA) that came after the interim decision. The submission called the justification for the restrictions “weak”,although it did not formally oppose them.
The AMA declined to comment this week.
The TGA ruled the risk of doctors prescribing ivermectin for COVID-19 was “low” because of “the large volume of clinical evidence – which will be widely known among medical professionals – that is now available demonstrating the lack of effectiveness of ivermectin”.
However,the TGA process received several submissions from doctors arguing that there was evidence ivermectin reduced the risk of death from COVID-19.
Experts saidthat the decision – which comes into effect on June 1 – likely did not pose a major risk to public safety.
“There are no shortages any more. And you never hear about COVID-19 any more,” said Associate Professor Nial Wheate,a researcher with the faculty of pharmacy at Sydney University.
“So the number of people asking for it is low. So now we’re just going back to what the status quo was.”
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