13 May 2023
Has anyone else noticed a pattern around the Covid-related restrictions of the past three years?
Each infringement felt like a wave crashing on the shore of Australian freedoms, which, after a while, would quietly recede into the background with little fanfare, media, or attention. So it was with the introduction of lockdowns, masks, and mandates.
No wonder we’ve all felt ‘at sea’.
On May 3, 2023, the TGA quietly announced it was removing the prescribing restrictions on ivermectin. These restrictions were imposed on September 10, 2021 in an effort to stop doctors prescribing the drug to treat Covid.
These original restrictions were described as an ‘extraordinary intervention’.
Ivermectin is an (actual) ‘safe and effective’ medication with decades of safety data and known side effects. Heck, it’s even on the World Health Organisation’s list of essential medications. At the time, ivermectin was being used by several countries around the world to treat Covid and several studies were in process of being conducted.
But why would the TGA restrict ivermectin? Good question. The reasons given for the amendment to the Poisons Standard include:
- A rise in the number of off-label prescriptions of ivermectin.
- A significant increase in personal importation of ivermectin into Australia.
- Concern that people who had been prescribed ivermectin might believe themselves to be protected and therefore not get vaccinated.
- Concern that ivermectin would come into short supply in Australia.
- Ivermectin also has the potential to cause severe adverse events, particularly when taken in high doses; though oral ivermectin is generally well-tolerated at recommended doses.
Nowhere, back in September 2021, did the TGA say there had been a rise in serious adverse events associated with ivermectin. The closest the regulator came was stating a ‘potential’ to cause severe adverse events.
Hmm… So, if a therapeutic agent is restricted for ‘potentially’ causing serious adverse events, what happens when a therapeutic agent actually causes serious adverse events?
Let’s move on.
The concern that ivermectin would come into short supply is perplexing. As an ‘off-patent’ drug, ivermectin is incredibly cheap to make (around 55 US cents per course of treatment) and widely available. As one commentator ponders, ‘If the TGA foresaw a potential shortage, why did no one in the Australian government think to phone an order through to Indiamart?’ Another good question.
In light of the above, the rise in number of off-label prescriptions of ivermectin and increase in personal importation is no reason to restrict a medication. These signals should be taken as an indication to investigate (why is it being used and what is the ‘front-line’ experience) and educate (regarding potential side effects). According to Dr Peter McCullough, ‘About two dozen countries have ivermectin as a first-line treatment for Covid in their government guidelines.’ They can’t all be wrong.
Furthermore, the increased prescription and importation heralds another consideration, something prohibition taught our friends across the Pacific: when you prohibit something the people want, you just drive it underground.
The reason that incited me most back in September 2021 was the ‘concern that people who had been prescribed ivermectin might … not get vaccinated’.
So, as the government funneled the Australian people down the ‘vaccine or bust’ pathway with mass coercion, an essentially safe and potentially significant therapeutic option was removed. This was done not because it was causing harm, but because it might stop people from getting the ‘experimental’ injection.
I find this outrageous.
Why? Because in a time of ‘unknowns’, the TGA put its weight behind an injection with minimal safety data over a medication with a known safety and therapeutic profile.
So, in what seems like a miracle, ivermectin is now deemed ‘safe’ again.
‘How can ivermectin go from being a toxic horse de-wormer in 2021 and then be declared to have a low safety risk in 2023?’ asks Pharmacologist and Drug Regulatory Affairs consultant Dr Philip Altman. Yet another good question.
In my opinion, the only reason a therapeutic agent like ivermectin, with a proven track record, should be restricted is a demonstrated safety signal that truly indicates the health of Australians is at risk. To do otherwise makes no sense to me.
Dr Philip Altman takes it further, ‘If the Australian TGA cannot tell the difference between a toxic horse deworming medicine and a potentially life-saving, widely used, essential safe medicine – they should not exist.’
Dr Julie Sladden believes ivermectin is very useful for treating scabies, river blindness, and intestinal strongyloidiasis. If you’d like to support her caffeine-inspired writing, you can shout her a coffee here.