One GP wants the dewormer off the Poisons Standard, saying restrictions are ‘negligent and possibly criminal’.
A Victorian GP has applied to have a listing of the controversial drug ivermectin deleted from the Poisons Standard, claiming the failure to have proper access to it for covid treatment is a threat to public safety.
Currently, GPs can only prescribe ivermectin for scabies and certain parasitic infections.
Wangaratta-based Dr Julian Fidge – who is a candidate for the RACGP presidency – says the Appendix D listing of ivermectin in the Poisons Standard has to go.
“The basis for this request is that the Appendix D listing for ivermectin is clearly irrational, irresponsible, reckless, negligent and possibly criminal,” Dr Fidge said in an application to the Department of Health.
“[The listing] poses a serious threat to public safety and may have caused unnecessary deaths of thousands of Australians by preventing GPs from treating the patients with a safe, effective and cheap medication that may prevent 44% of covid infections and may prevent serious illness and death caused by covid infections.”
As a result, patients have to obtain ivermectin on the black market or use veterinarian ivermectin and have to do so without a doctor or pharmacist’s supervision, he said.
“There was never, at any time, a specific health risk that could be mitigated by restricting off-label prescribing of ivermectin to dermatologists and gastroenterologists,” he said, claiming that the TGA had been aware that ivermectin was safe in the doses used for prevention and treatment of covid since 2013, following a rigorous analysis.
The medical goods regulator has not changed its stance since it listed ivermectin on the Poisons Standard 11 September 2021.
“The TGA has observed a significant increase in sales of this product in the last 24 months, with particular increase over the last two months that cannot be attributed to the approved indications alone,” the notice on that listing, written by a DoH official, says. “I am concerned that if action is not taken to address these concerns, it is possible that oral ivermectin will be in shortage in Australia for the treatment of the conditions for which it has been properly evaluated.”
While the state and territory representatives on the medicines scheduling advisory committee were consulted, the decision was otherwise taken behind closed doors.
“My decision was not open to public consultation, given the seriousness of the circumstances, the risks to the community and the immediacy with which action needed to be taken,” the official said.
“Further, it was considered necessary to make the amendment urgently in order to support the Australian Government’s response to the covid-19 public health emergency.”
Dr Fidge told TMR this lack of transparency was one of the problems.
“They’re not explaining their reasoning, so there is a vacuum,” he said, “and that vacuum in reasoning and explanation by the public health authorities is causing a lot of angst in the community and a loss of confidence in those authorities.”
However, Dr Fidge’s view of ivermectin doesn’t align with the findings of research into the drug.
This includes a Cochrane study of randomised controlled trials that investigated ivermectin to prevent or treat covid. The Cochrane team also investigated the trustworthiness of the trials and only included them if they fulfilled clear ethical and scientific criteria.
“For outpatients, there is currently low- to high-certainty evidence that ivermectin has no beneficial effect for people with covid-19,” the study’s authors said.
“Based on the very low-certainty evidence for inpatients, we are still uncertain whether ivermectin prevents death or clinical worsening or increases serious adverse events, while there is low-certainty evidence that it has no beneficial effect regarding clinical improvement, viral clearance and adverse events.
“No evidence is available on ivermectin to prevent SARS-CoV-2 infection.”
Dr Fidge said he didn’t expect much public support from GPs because “you are not allowed to disagree with the government”, he said, citing the recent treatment of WA GP Dr David Berger who was sanctioned for criticising health authorities.
“I worry about my sanity when I look at the evidence, the law, and the covid infection and death rates,” Dr Fidge said. “How can it be that the public health authorities are so lacking they are unable to see there is a significant problem with their therapeutic approach to the covid-19 pandemic?
“Am I really so much more perspicacious, or am I missing some critical evidence?”
Tomorrow, hear a podcast interview TMR recorded with Dr Fidge before he made his application known to us.
