Public consultation on proposed amendments to the Poisons Standard - ACMS/ACCS/Joint ACMS-ACCS, NOVEMBER 2022




ACMS

Ivermectin
There is a bit of a backstory to my first submission to the ACMS lodged recently, which I think is important, because it goes to explain my motivation for submitting.
Like a lot of Australians, even though we were in our 70s, back in February 2022, my wife and I were excluded from those permitted to receive the new antivirals sotrovimab, nirmaltrevir/ritonavir or molnupiravir. So the authorities had consigned us, along with all those in our cohort, to the dustbin of history. We were to be sacrificial fodder to a blinkered policy. We were not to be treated with anything likely to attack the virus until the disease had progressed far enough to land us in hospital. No policy of “health in the home”packs, as issued in some countries overseas. Ivermectin prescribed by a doctor wasn’t going to kill us, and it had the potential to be better than doing nothing. The alternative was possible death or long term health issues, after a potentially very unpleasant hospital stay, seriously stretching health staff support.
In late August 2022, I wrote to a doctor, saying in February I had applied to the TGA to be allowed to be prescribed ivermectin. Access to an early treatment antiviral could have meant the difference between life and death for us. The TGA said it wasn’t their decision. I then wrote to the Health Department secretary. After phone calls in which I was told key officers wouldn’t take my calls, eventually I got a reply (see it and my comment below at *1), saying the matter rested with the Secretary’s delegate, apparently a senior medical officer, that the Secretary had no power to vary it for my wife and I, and that any decision to vary the September 2021 decision on ivermectin would not be considered until November 2022. This was with covid deaths running at about 12 times the road toll, worse than the previous two years, and afflicting a greater proportion of the elderly. They still are running at about ten times.
I was sent from pillar to post, totally disappointed in the Ombudsman’s attitude, and six months and about 8500 covid deaths later, I was yet to find out who the delegate to the Secretary for Health was. I still don’t. I cited legal authority back then to the Ombudsman for the fact that a delegator does not lose their decision making power even if they appoint a delegate. (Huth vs. Clark). The Ombudsman had said they lacked medical expertise, even though I had raised a matter of administrative procedure, not medicine per se.
The AAT when contacted pointed out that Parliament had severely circumscribed, in the enabling Act, their power to oversight the TGA, limiting appeals to certain aspects, largely offering drug and device companies appeal routes but not ordinary members of the public.
Small wonder then that I became actively interested in another way of trying to save our lives with early treatment, if needed, and that is the use, based on several reported trials eg. Koshak, Ashraf, of Nigella sativa, the seed found on Turkish bread.
The rules around antivirals changed again later in 2022, and my wife and are now eligible, but many still aren’t. Having said that, in inquiries at our local level, there was inadequate current knowledge at the GP pharmacies about the new antivirals from about February 2022 to July 2022, even with an RACGP online seminar occurring in April 2022.

Parallel approaches to early stage treatment
I should also note the marked lack of medico-scientific drive in Australia since 2020 to carry out any trials of potential early effect-ameliorating treatments, even at the simple level of iodine or other throat gargles, and nasal sprays. Redacted text, an OTC drug in Japan, noted in 2020 by the NSW treatment guidelines authority, was not trialled, even though it showed promise in combination with ritonavir in in vitro trials in China by HH Fan, in in vitro trials by Ohashi, and it was reviewed by Rogoznitsky. I even offered to buy some for Monash University to try against covid in vitro.
Pointing out to a number of people in the public arena about the potential benefits of promising treatment (even a ten percent reduction in hospital admissions due to early stage treatment of ambulant patients would reduce the stresses on the health system and its staff) fell on deaf ears.
It is worth remembering too that Ramos, a cardiopulmonary specialist in Peru wrote up success with ivermectin in May 2020, and Aguirre Chang, Chesler and Tavares in three separate countries also noted beneficial effects around that time. Chetty in Kwazulu also noted in October 2020 the benefits of of early treatment of incipient hypoxia with antihistamine and steroid.

*1
“RE: Request for exemption from your decision of 10.9.21 [SEC=OFFICIAL]

I have no authority or delegation to provide the approval you request for two reasons.

Firstly, I was not the decision-maker regarding the changes to ivermectin access. Secondly, the decision is implemented in law by your state government not the commonwealth.

If you are seeking an ivermectin prescription I suggest you make an appointment with a relevant specialist who can prescribe if they see it medically appropriate.

Note however the approved oral antivirals are now available in every state and territory.

Adjunct Prof John Skerritt FTSE FIPAA (Vic)
Deputy Secretary for Health Products Regulation
Australian Government Department of Health
PO Box 100 Woden ACT 2606 AUSTRALIA”

Comment: Yet the states and territories take their lead from the Commonwealth, and secondly there was a very low chance of getting a script early enough in the course of the disease, given the pressure on GPs and the time it would take to get an appointment with a designated type of specialist with a referral in the midst of the pandemic pressure.