Ivermectin: ACNEM response to new amendments

 

A position statement written by ACNEM President Dr Mark Donohoe, with approval of the ACNEM Board.

Ivermectin is one of the most widely used drugs in the world. It is also one of the safest at doses prescribed by doctors in Australia. Safety can break down when veterinary products are used by humans, and when dosages are excessive. The same is true of all drugs. Safety is maintained in Australia by approval of high quality ivermectin for human use, and doctors’ prescriptions appropriate for the needs of each individual patient.

Original Australian laboratory research as well as a number of clinical trials (63 to date with over 26,000 subjects) have shown that ivermectin may be useful in the treatment of COVID-19, especially when used early in the infection to reduce progression to the more dangerous inflammatory phase. Research shows that hospitalisation and deaths may be decreased significantly by early use of ivermectin. Many trials also combine ivermectin with other medications and/or nutritional supplements.

Vaccination is the primary intervention for prevention of serious illness, hospitalisation and death from COVID-19. There is no suggestion that ivermectin is an alternative to vaccination among medical practitioners. Vaccination has limitations, and does not significantly prevent infection or transmission of the SARS-CoV-2 virus. There is value in having available by prescription a very safe medication with evidence of reduction of morbidity and mortality following SARS-CoV-2 infection in both vaccinated and unvaccinated individuals.

There is no currently approved treatment in Australia for the early viral phase following SARS-CoV-2 infection. On the basis of likely clinical benefit, low cost and very low risk of harm, many doctors have been safely prescribing ivermectin for people suffering early COVID-19 around the world throughout the pandemic.

Evidence-based practice is built on three factors, all of equal importance: clinically relevant research from the basic science of medicine and patient centred clinical research; the judgement and experience of the practitioner; and the preferences and choices of the person seeking treatment.  All three are present in the prescribing of ivermectin in Australia. Until now.

The action of the Deputy Secretary of the TGA in placing restrictions on GPs prescribing of ivermectin represents an unusual and dangerous interference in the medical care of patients. It is a decision more likely to worsen safety, as it removes the GP as a safe prescribing gateway for ivermectin. Tens of thousands of Australians will still find a way to access what they believe to be ivermectin, whether as veterinary products, or other falsely labelled and potentially toxic medications.

In addition, the principle underlying the restriction of a therapeutic agent because of its perceived benefit in managing COVID-19 infection, rather than its innate toxicity, is flawed. If doctors and the public were to “believe” that, say, vitamin C, zinc supplements or vitamin D reduce the risk of progression of COVID-19, would the Deputy Secretary simply reschedule all such therapeutic products as poisons?

Effective prevention and treatment of COVID-19 is not limited to vaccination. Other therapeutic tools are needed for cost-effective and safe prevention and treatment, and many are in trials worldwide, with evidence building progressively. It has always been the obligation of the prescribing doctor to make the decision on the care of each patient based on their evaluation of the data, especially when the agents have low risks associated with appropriate prescribing. The TGA should not be restricting those choices, in our view.

We call on the Federal Minister for Health and Aged Care to reverse this amendment as a matter of urgency, and to restore the right of all registered medical practitioners to prescribe ivermectin as they deem appropriate for patient care without restriction.

We call also for the Minister to determine whether the TGA has exceeded its mandate in restricting access to low risk and potentially life-saving (or significantly beneficial) medications such as ivermectin, and by doing so, interfering with patient care while actually increasing risks to patients who will continue to seek these medications outside the medical system.

Notice of Amendment – Ivermectin 2021

New restrictions on prescribing ivermectin for COVID-19

ACNEM welcomes your thoughts on this critical matter – please reach out to us if you have any feedback.