A two-year investigation reveals a broken approval system where ineffective—and sometimes deadly—drugs are fast-tracked to market without solid evidence.
Great journalisn Maryanne. Thank you once again. Truly scary and saddening. Trust is melting down everywhere. I may not agree with all RFK propses, but at lesst he seems ready to challenge the staus quo keepers.
this morning I was reminding myself which was the oldest profession
.. the debate will continue for eons
but surely Snake Oil Salesman is right up there .. now rebranded: Big Pharma
their leading Salesman of The Year .. decades running .. as this story again confirms
- the FDA -
when Folk appreciate the FDA is now a front for Big Pharma to (improperly) legitimize their products and thereafter ensure their sales .. then, perhaps, the worm will turn
.. but for now, a little list .. so many choices .. feel free to add a new one:
Federal Drug Advocates
For Drug Approvals
Friends of Drugmakers Association
Funded by Drugmakers Administration
Front for Drug Authorization
Fast-track Drug Approvers
Federal Dispensers of Approvals
Fabricated Data Acceptors
.. just another day in the USA .. old wine in new bottles .. and the shock of it all replayed all over again
this FDA, Folks, is who Australia's dear TGA looks to ..
.. it's a racket of regulators regulating nothing - but the Truth .. a truth about failed products paraded as miracles — poisons in disguise, propped up by ghostwritten science and protected by a mutual alibi society
I seem to have triggered myself feeling another list coming on .. so will wrap it up here
Makary and RFK Jr. understand this—it will take legislative reform to break the agency’s dependence on user fees. And that’s no small task, given, as you’ve rightly noted in the past, Congress is awash with drug industry money.
So ‘regulators’ such as the FDA, TGA and MHRA are worse than useless…
What is the point of them - just facilitators for the snake oil manufacturers and salesmen?
It seems the FDA, TGA and MHRA are a danger to the public, particularly when products approved by them are imposed upon the public by governments, e.g. mandatory vaccination under threat of penalty for refusal to comply.
Would we not be better off without these so-called ‘regulators’, and instead rely upon ‘buyer beware’?
Your work for us Dr Maryanne Demasi, is historic, thank you deeply, you're incredibly appreciated by all of us blessed ones who're informed by you're careful veracity. ❤️
I wonder sort of informed consent is going on with these drugs…
E.g. are young women being warned about this…
QUOTE
Anyone who gets pregnant while using the drugs should also stop taking the medicine, it added, because “there is not enough safety data to know whether taking the medicine could cause harm to the baby”.
And
“We don’t know how harmful GLP-1 drugs are during pregnancy; however, we know that other forms of weight loss like weight-loss surgery can increase chances of a miscarriage. So, women are advised to do all they can to prevent pregnancy while taking GLP-1 drugs.”
Also Maryanne, FYI, I also left the comment above as a response on The Australian article…and it was censored…
Think about that…
I quoted from the article directly, in reference to the obligation for informed consent, and the moderators at The Australian censored my comment.
This has been going on for years, the corporate media shutting out the public from openly discussing health policy, as we found most egregiously during ‘Covid’ times.
We are in dire straits in our supposedly ‘free countries’…
I asked AI if people need to stay on Mountjaro to maintain weight loss…received this response…
QUOTE
Yes, Mounjaro is generally considered to be a long-term treatment for weight loss, and individuals likely need to continue taking it to maintain weight loss and prevent weight regain. Studies have shown that weight loss achieved with Mounjaro is not sustainable long-term if the medication is discontinued.
END OF QUOTE
Think about that in relation to young women planning to have children… 😳
Oh dear. I can imagine there are plenty of women taking GLP-1 agonists in the hope that losing weight will boost their chances of getting pregnant. Ugh.
The doctors… The doctors who are the frontline sales/police force for pHarma…
The doctors who hand out drugs like sweets, authentic ‘informed consent’ is a sham.
And just think how often medical interventions are imposed when people most likely would have recovered with time from many ailments, or could have taken appropriate action themselves, e.g. eat less and move around more for weight loss.
I’m late to this discussion and what I have to say is a bit off topic but I feel compelled to add that the FDA is not the only regulator that has been captured and is causing great harm. This is true also of the EPA. Years ago based on lobbying by the climate alarmist scammers the EPA declared carbon dioxide—plant food!—to be a pollutant. This has led to the strangulation by regulators of oil and gas production and the promotion of unreliable and harmful so-called sustainable energy generators, ie wind and solar. The harms are hiding in plain sight. The recent blackouts in Europe are a harbinger of things to come. Meanwhile wildlife, bats, birds, and now whales are being killed en mass and children are being thrown into serious depression having been told that the world will be uninhabitable by the time they grow up due to forces beyond their control, all rubbish from those who want to control and destroy our lives for fun and profit.
If one looks at Covid policies and environmental policies the similarities are striking and the regulators are in the thick of it!
The plot thickens. The health system is a place where sharks do dwell and we are on offer as sacrifices to the greed, wickedness and laziness of big Pharma, bureaucrats and doctors who should know better.
There is an unwritten acknowledgment in US medicine - one needs to wait 10 years after FDA approval to ascertain if a drug is actually safe. When we forget this basic tenet - doctors and patients both get burned. I put drugs into categories now - the good, the bad and the ugly.
Ok let’s look at Pfizer PF-07321332 later named Paxlovid
March 2021 mention moving into phase 1 trials as antiviral protease inhibitor which combined novel drug nirmatrelvir and HIV antiviral ritonavir. Ritonavir was known to have large range of adverse effects.
On 7 April 2021 at American chemical society meeting in Washington, PF-07321332 was launched announcing phase 1 trials.
9 April 2021 under 20 year cabinet confidentially of NAT Cabinet decision - PM Morrison and Secret 2nd Health Minister announced double mRNA VAXES to 40mill & delivery brought forward - ATAGI and Health Minister (which one?) worked overnight to get deal with Pfizer (also 7/8 April). Pfizer is a friend to Australia says Morrison. Papers to Nat cabinet safety locked up for 20 yrs. Did Pfizer not mention the progress on the big second objective of Pandemic- a Covid treatment !?
There was just one little problem for Pfizer to get that EUA fast track that this article is all about - they needed to sign a declaration IND to allow them to progress to COMBINED phase2/3 which said…
NO ALTERNATIVE
Europe approval of VIRALEZE™ in Nov 2020 had packaging with SARS-CoV-2 99% inactivation claim and sales were going gangbusters in UK
Pharmacy sales were going gangbusters in UK by April 2021. With Brexit regs changing from EU to UK MRHA - strategic compliant got review of packaging claim and withdrawal of VIRALEZE™ for consideration by UK MHRA. Australia was Country of origin but TGA hadn’t registered it in ARTG MDs so Pfizer needed to sign that there was no alternative - what easier than TGA funded 96% by big pharma and a corrupt PM - VIRALEZE™ could be stopped. Also publicity in Channel 7 News (still on FB) said VIRALEZE™ Wolf be used by Aussie swim team at Tokyo Olympics to protect from COVID. What better comparison with other teams not using it.
Ph1 PF-07321332 Paxlovid would be complete in June.
VIRALEZE™ was banned on 2 July 2021
Paxlovid ph2/3 EPIC-HR (high risk unvaxed) first date in WHO clinical trial database 8 July 2021
Olympics mid July
Phew they made it
EPIC-HR rolling results allowed FDA EUA by Nov 2021 89% efficacy
Scripts starred in US
By December 21 first rolling results of EPIC/SR (part vaxed) were showing fail in efficacy - June 22 Pfizer stop recruiting on SR when the results finally are published in April 2024 time to negative Paxlovid 11 days placebo 12 days p=06
Interestingly TGA also fast tracked Paxlovid in January 2022 when rotating doors Skerritt exempted drug and registration from normal process (also under Morrison/Murphy) and although Australian elderly were highly vaccinated they took no notice of the December 2021 EPIC SR rolling results.
This example shows failure to apply proper procedures in both regulators FDA and TGA
I understand that Pfizer is now pushing fast track FDA for novel drug replacement of Paxlovid PF-07817883 Ibuzatrelvir - watch this space as more illicit profiteering rolls out
There was just one little problem for Pfizer to get that EUA fast track that this article is all about - they needed to sign a declaration IND to allow them to progress to COMBINED phase2/3 which said…
Your interest in informed consent is important in Covid av drugs too - the public understanding is Paxlovid is treatment. But do doctors refer to vax status and EPIC-HR efficacy was about keeping out of hospital and death not fast cure of COVID
Metalic taste, coughs and rebound are big issues
Do doctors say that and of course the antiviral nasal spray VIRALEZE™ which had post market study provided independently and peer reviewed paper UK NHS Hosp found statistically significant 7 day treatment v placebo in cohorts over 45 (p=0.016) and over 65 (p=0.005) - less loss of taste and smell. But doctors in Australia can’t suggest nasal spray VIRALEZE™ because for 4 years TGA has refused to allow a MD Class 1 normally an easy non audit approval particularly where EU EMA and conformity already given.
Out of interest the words of the delegates decision are worth reading where there is NO APPROVED TREATMENT FOR 45 to 70 yr olds with normal health.. this only position standards schedule 2 not REGISTERED IN ARTG as medical device or medicine. With 4 written threats of refusal that I saw in ARTG application FOI info in October 2024 just before change of regulations - Starpharma withdrew their ARTG application …
The FOI shows .TGA was given the UK NHS results in January 2024 and was covering them up to March ie they had randomised placebo statistical evidence of effectiveness in vaxed persons more than anything Paxlovid or Lagevrio could provide
It is a blatant lie that there is no clinical trial - it was a regulator trial not even a manufacturer trial - something RFK is supposed to be supporting now in US
Reasons for the final decision (including findings on material questions of fact)
I have made a final decision to confirm my interim decision to amend the current Poisons Standard with respect to astodrimer sodium. My reasons for making the final decision are those set out in the interim decision. In making my final decision, I have taken into account the material in the interim decision and the 11 public submissions which were received in response to the interim decision consultation. Of these submissions 10 were supportive of the interim decision and one was partially supportive.
In considering the main points raised by public submissions in partial support of my interim decision,
### I disagree that there is negligible risk of the substance being advertised or promoted for use as a treatment for serious respiratory conditions, such as COVID-19. #####
I am of the view that there remains potential for misleading or suggestive marketing of anti-viral products. Furthermore, as noted by the Committee, there is presently no clinical data to support the use of astodrimer sodium in the treatment of COVID-19, though clinical trials are ongoing in the UK where astodrimer sodium nasal spray is being assessed for its safety and performance in patients with COVID-19.
I agree with the public submissions that the risk of patients delaying seeking medical attention or deterring mask wearing and vaccination is relatively low. However, no new evidence was provided by public submission regarding how the proposed amendments in the Application would negate the risk of consumers delaying seeking medical advice for more serious respiratory conditions. Access to health professional advice at point of sale for a nasal spray product containing astodrimer sodium remains an important risk mitigation strategy in misdiagnosis or inappropriate use. As such the risk of delaying seeking medical attention is consistent with SPF factors of Schedule 2 and would be mitigated through pharmacy-only sale and availability of health professional intervention if required.
I remain of the opinion that inclusion of astodrimer sodium in nasal sprays in Schedule 2 of the Poisons Standard is consistent with similar nasal spray products. I agree with the public submissions that, unlike similar Schedule 2 substances, the mechanism of astodrimer sodium is non-pharmacological and the substance is not systemically absorbed. Other nasal sprays which are used to manage symptoms of colds, other than nasal saline sprays, are included in Schedule 2 of the Poisons Standard.
As I understand it fast track allows EUA to be granted with Rolling Results EPIC-HR was about 3000 participants - by Nov 2021 they had about 900 (the Pfizer media statements show) The EPIC-SR started in Sept I think- 2 months after EPIC-HR. First rolling results on SR came Dec 21 and Pfizer reported disappointing - about 500 participants. Pfizer conducted all its own trials - no independant until Feb 2025 as far as I can find and that was RWE from Canada.
There are strong rules that EUA can only be given if no alternative. Medical devices can be alternatives - although placebo trials have smaller no of participants than medicines but their safety is much more established
I don’t get into ivermectin hydroxychloroquine argument as I understand some early studies were retracted from journals. The ivermectin story is potential effectiveness in Dr My Le Trinh suspended case to point. Ivermectin is made by Merck but was unlikely to be sponsored by Merck as out of patent and Oz pbs cost $48 whereas Merck got ARTG (parallel with Paxlovid) for novel drug Lagevrio which sells at $1108 to PBS cf Paxlovid at $1114. Perfect competitors and both on 20 yr patents. So Merck was not going into battle for Ivermectin. We were all told it was horse dewormer but human use is scabbies, rosacea. Interestingly in aboriginal communities it is a communal drug for endemic scabbies - wonder if any research re covid in those communities?
As for the other av hydroxychloroquine- known for Clive Palmer import - until Sept 2021 from Sept 2020 there was a large consignment on national stockpile / some govt purchase - the issue for Palmer was he wanted his co logo on his purchase. Then in September 2021 all was destroyed.
I reckon this is all a very big story.
Australia spent $2.7 billion up to z April 2025 on Pfizer and Merck antivirals whilst procrastinating on antiviral nasal sprays
It may be a truism, but if you want to stay healthy, steer clear of the medical profession.
Great journalisn Maryanne. Thank you once again. Truly scary and saddening. Trust is melting down everywhere. I may not agree with all RFK propses, but at lesst he seems ready to challenge the staus quo keepers.
Thanks Jim 🙏
thank you Dr Demasi,
this morning I was reminding myself which was the oldest profession
.. the debate will continue for eons
but surely Snake Oil Salesman is right up there .. now rebranded: Big Pharma
their leading Salesman of The Year .. decades running .. as this story again confirms
- the FDA -
when Folk appreciate the FDA is now a front for Big Pharma to (improperly) legitimize their products and thereafter ensure their sales .. then, perhaps, the worm will turn
.. but for now, a little list .. so many choices .. feel free to add a new one:
Federal Drug Advocates
For Drug Approvals
Friends of Drugmakers Association
Funded by Drugmakers Administration
Front for Drug Authorization
Fast-track Drug Approvers
Federal Dispensers of Approvals
Fabricated Data Acceptors
.. just another day in the USA .. old wine in new bottles .. and the shock of it all replayed all over again
this FDA, Folks, is who Australia's dear TGA looks to ..
.. it's a racket of regulators regulating nothing - but the Truth .. a truth about failed products paraded as miracles — poisons in disguise, propped up by ghostwritten science and protected by a mutual alibi society
I seem to have triggered myself feeling another list coming on .. so will wrap it up here
Indeed.
Makary and RFK Jr. understand this—it will take legislative reform to break the agency’s dependence on user fees. And that’s no small task, given, as you’ve rightly noted in the past, Congress is awash with drug industry money.
So ‘regulators’ such as the FDA, TGA and MHRA are worse than useless…
What is the point of them - just facilitators for the snake oil manufacturers and salesmen?
It seems the FDA, TGA and MHRA are a danger to the public, particularly when products approved by them are imposed upon the public by governments, e.g. mandatory vaccination under threat of penalty for refusal to comply.
Would we not be better off without these so-called ‘regulators’, and instead rely upon ‘buyer beware’?
Your work for us Dr Maryanne Demasi, is historic, thank you deeply, you're incredibly appreciated by all of us blessed ones who're informed by you're careful veracity. ❤️
Thank you Robin 🙌
Thanks, Maryanne, for giving their report. This indeed is so sad. Sadly, the Covid Debacle has brought so much to light!
Just Shocking! 😲
Maryanne,
You’ re a courageous bright ´´ shining light ‘’ for us in this period of darkness
Too kind. Thank you 🙏
Crikey!!!
Have you seen this article in The Australian today Maryanne?
Women on Mounjaro ‘cannot rely on contraceptive pill’, say UK health officials https://www.theaustralian.com.au/health/medical/uk-health-officials-warn-women-on-mounjaro-cannot-rely-on-the-pill/news-story/9573d20f996864180ab1b27d9263973f?giftid=4swQyubEa5
I wonder sort of informed consent is going on with these drugs…
E.g. are young women being warned about this…
QUOTE
Anyone who gets pregnant while using the drugs should also stop taking the medicine, it added, because “there is not enough safety data to know whether taking the medicine could cause harm to the baby”.
And
“We don’t know how harmful GLP-1 drugs are during pregnancy; however, we know that other forms of weight loss like weight-loss surgery can increase chances of a miscarriage. So, women are advised to do all they can to prevent pregnancy while taking GLP-1 drugs.”
END OF QUOTES
I don’t believe fully informed consent exists for most prescription medications.
Also Maryanne, FYI, I also left the comment above as a response on The Australian article…and it was censored…
Think about that…
I quoted from the article directly, in reference to the obligation for informed consent, and the moderators at The Australian censored my comment.
This has been going on for years, the corporate media shutting out the public from openly discussing health policy, as we found most egregiously during ‘Covid’ times.
We are in dire straits in our supposedly ‘free countries’…
I asked AI if people need to stay on Mountjaro to maintain weight loss…received this response…
QUOTE
Yes, Mounjaro is generally considered to be a long-term treatment for weight loss, and individuals likely need to continue taking it to maintain weight loss and prevent weight regain. Studies have shown that weight loss achieved with Mounjaro is not sustainable long-term if the medication is discontinued.
END OF QUOTE
Think about that in relation to young women planning to have children… 😳
Oh dear. I can imagine there are plenty of women taking GLP-1 agonists in the hope that losing weight will boost their chances of getting pregnant. Ugh.
It is a dire situation…
And you know who is in the thick of it?
The doctors… The doctors who are the frontline sales/police force for pHarma…
The doctors who hand out drugs like sweets, authentic ‘informed consent’ is a sham.
And just think how often medical interventions are imposed when people most likely would have recovered with time from many ailments, or could have taken appropriate action themselves, e.g. eat less and move around more for weight loss.
I’m late to this discussion and what I have to say is a bit off topic but I feel compelled to add that the FDA is not the only regulator that has been captured and is causing great harm. This is true also of the EPA. Years ago based on lobbying by the climate alarmist scammers the EPA declared carbon dioxide—plant food!—to be a pollutant. This has led to the strangulation by regulators of oil and gas production and the promotion of unreliable and harmful so-called sustainable energy generators, ie wind and solar. The harms are hiding in plain sight. The recent blackouts in Europe are a harbinger of things to come. Meanwhile wildlife, bats, birds, and now whales are being killed en mass and children are being thrown into serious depression having been told that the world will be uninhabitable by the time they grow up due to forces beyond their control, all rubbish from those who want to control and destroy our lives for fun and profit.
If one looks at Covid policies and environmental policies the similarities are striking and the regulators are in the thick of it!
The plot thickens. The health system is a place where sharks do dwell and we are on offer as sacrifices to the greed, wickedness and laziness of big Pharma, bureaucrats and doctors who should know better.
Thank you so much for your hard work, Maryam.
There is an unwritten acknowledgment in US medicine - one needs to wait 10 years after FDA approval to ascertain if a drug is actually safe. When we forget this basic tenet - doctors and patients both get burned. I put drugs into categories now - the good, the bad and the ugly.
Ok let’s look at Pfizer PF-07321332 later named Paxlovid
March 2021 mention moving into phase 1 trials as antiviral protease inhibitor which combined novel drug nirmatrelvir and HIV antiviral ritonavir. Ritonavir was known to have large range of adverse effects.
On 7 April 2021 at American chemical society meeting in Washington, PF-07321332 was launched announcing phase 1 trials.
9 April 2021 under 20 year cabinet confidentially of NAT Cabinet decision - PM Morrison and Secret 2nd Health Minister announced double mRNA VAXES to 40mill & delivery brought forward - ATAGI and Health Minister (which one?) worked overnight to get deal with Pfizer (also 7/8 April). Pfizer is a friend to Australia says Morrison. Papers to Nat cabinet safety locked up for 20 yrs. Did Pfizer not mention the progress on the big second objective of Pandemic- a Covid treatment !?
There was just one little problem for Pfizer to get that EUA fast track that this article is all about - they needed to sign a declaration IND to allow them to progress to COMBINED phase2/3 which said…
NO ALTERNATIVE
Europe approval of VIRALEZE™ in Nov 2020 had packaging with SARS-CoV-2 99% inactivation claim and sales were going gangbusters in UK
Pharmacy sales were going gangbusters in UK by April 2021. With Brexit regs changing from EU to UK MRHA - strategic compliant got review of packaging claim and withdrawal of VIRALEZE™ for consideration by UK MHRA. Australia was Country of origin but TGA hadn’t registered it in ARTG MDs so Pfizer needed to sign that there was no alternative - what easier than TGA funded 96% by big pharma and a corrupt PM - VIRALEZE™ could be stopped. Also publicity in Channel 7 News (still on FB) said VIRALEZE™ Wolf be used by Aussie swim team at Tokyo Olympics to protect from COVID. What better comparison with other teams not using it.
Ph1 PF-07321332 Paxlovid would be complete in June.
VIRALEZE™ was banned on 2 July 2021
Paxlovid ph2/3 EPIC-HR (high risk unvaxed) first date in WHO clinical trial database 8 July 2021
Olympics mid July
Phew they made it
EPIC-HR rolling results allowed FDA EUA by Nov 2021 89% efficacy
Scripts starred in US
By December 21 first rolling results of EPIC/SR (part vaxed) were showing fail in efficacy - June 22 Pfizer stop recruiting on SR when the results finally are published in April 2024 time to negative Paxlovid 11 days placebo 12 days p=06
Interestingly TGA also fast tracked Paxlovid in January 2022 when rotating doors Skerritt exempted drug and registration from normal process (also under Morrison/Murphy) and although Australian elderly were highly vaccinated they took no notice of the December 2021 EPIC SR rolling results.
This example shows failure to apply proper procedures in both regulators FDA and TGA
I understand that Pfizer is now pushing fast track FDA for novel drug replacement of Paxlovid PF-07817883 Ibuzatrelvir - watch this space as more illicit profiteering rolls out
CMaryG, re:
QUOTE
There was just one little problem for Pfizer to get that EUA fast track that this article is all about - they needed to sign a declaration IND to allow them to progress to COMBINED phase2/3 which said…
NO ALTERNATIVE
END OF QUOTE
What does this mean exactly? ‘NO ALTERNATIVE’?
Why was an EUA required? On what basis?
Your interest in informed consent is important in Covid av drugs too - the public understanding is Paxlovid is treatment. But do doctors refer to vax status and EPIC-HR efficacy was about keeping out of hospital and death not fast cure of COVID
Metalic taste, coughs and rebound are big issues
Do doctors say that and of course the antiviral nasal spray VIRALEZE™ which had post market study provided independently and peer reviewed paper UK NHS Hosp found statistically significant 7 day treatment v placebo in cohorts over 45 (p=0.016) and over 65 (p=0.005) - less loss of taste and smell. But doctors in Australia can’t suggest nasal spray VIRALEZE™ because for 4 years TGA has refused to allow a MD Class 1 normally an easy non audit approval particularly where EU EMA and conformity already given.
It is strange - grubby finger prints
Out of interest the words of the delegates decision are worth reading where there is NO APPROVED TREATMENT FOR 45 to 70 yr olds with normal health.. this only position standards schedule 2 not REGISTERED IN ARTG as medical device or medicine. With 4 written threats of refusal that I saw in ARTG application FOI info in October 2024 just before change of regulations - Starpharma withdrew their ARTG application …
The FOI shows .TGA was given the UK NHS results in January 2024 and was covering them up to March ie they had randomised placebo statistical evidence of effectiveness in vaxed persons more than anything Paxlovid or Lagevrio could provide
It is a blatant lie that there is no clinical trial - it was a regulator trial not even a manufacturer trial - something RFK is supposed to be supporting now in US
————
https://www.tga.gov.au/sites/default/files/2024-05/notice-final-decisions-amend-not-amend-current-poisons-standard-november-2023.docx
Reasons for the final decision (including findings on material questions of fact)
I have made a final decision to confirm my interim decision to amend the current Poisons Standard with respect to astodrimer sodium. My reasons for making the final decision are those set out in the interim decision. In making my final decision, I have taken into account the material in the interim decision and the 11 public submissions which were received in response to the interim decision consultation. Of these submissions 10 were supportive of the interim decision and one was partially supportive.
In considering the main points raised by public submissions in partial support of my interim decision,
### I disagree that there is negligible risk of the substance being advertised or promoted for use as a treatment for serious respiratory conditions, such as COVID-19. #####
I am of the view that there remains potential for misleading or suggestive marketing of anti-viral products. Furthermore, as noted by the Committee, there is presently no clinical data to support the use of astodrimer sodium in the treatment of COVID-19, though clinical trials are ongoing in the UK where astodrimer sodium nasal spray is being assessed for its safety and performance in patients with COVID-19.
I agree with the public submissions that the risk of patients delaying seeking medical attention or deterring mask wearing and vaccination is relatively low. However, no new evidence was provided by public submission regarding how the proposed amendments in the Application would negate the risk of consumers delaying seeking medical advice for more serious respiratory conditions. Access to health professional advice at point of sale for a nasal spray product containing astodrimer sodium remains an important risk mitigation strategy in misdiagnosis or inappropriate use. As such the risk of delaying seeking medical attention is consistent with SPF factors of Schedule 2 and would be mitigated through pharmacy-only sale and availability of health professional intervention if required.
I remain of the opinion that inclusion of astodrimer sodium in nasal sprays in Schedule 2 of the Poisons Standard is consistent with similar nasal spray products. I agree with the public submissions that, unlike similar Schedule 2 substances, the mechanism of astodrimer sodium is non-pharmacological and the substance is not systemically absorbed. Other nasal sprays which are used to manage symptoms of colds, other than nasal saline sprays, are included in Schedule 2 of the Poisons Standard.
Implementation date
1 June 2024
As I understand it fast track allows EUA to be granted with Rolling Results EPIC-HR was about 3000 participants - by Nov 2021 they had about 900 (the Pfizer media statements show) The EPIC-SR started in Sept I think- 2 months after EPIC-HR. First rolling results on SR came Dec 21 and Pfizer reported disappointing - about 500 participants. Pfizer conducted all its own trials - no independant until Feb 2025 as far as I can find and that was RWE from Canada.
There are strong rules that EUA can only be given if no alternative. Medical devices can be alternatives - although placebo trials have smaller no of participants than medicines but their safety is much more established
I don’t get into ivermectin hydroxychloroquine argument as I understand some early studies were retracted from journals. The ivermectin story is potential effectiveness in Dr My Le Trinh suspended case to point. Ivermectin is made by Merck but was unlikely to be sponsored by Merck as out of patent and Oz pbs cost $48 whereas Merck got ARTG (parallel with Paxlovid) for novel drug Lagevrio which sells at $1108 to PBS cf Paxlovid at $1114. Perfect competitors and both on 20 yr patents. So Merck was not going into battle for Ivermectin. We were all told it was horse dewormer but human use is scabbies, rosacea. Interestingly in aboriginal communities it is a communal drug for endemic scabbies - wonder if any research re covid in those communities?
As for the other av hydroxychloroquine- known for Clive Palmer import - until Sept 2021 from Sept 2020 there was a large consignment on national stockpile / some govt purchase - the issue for Palmer was he wanted his co logo on his purchase. Then in September 2021 all was destroyed.
I reckon this is all a very big story.
Australia spent $2.7 billion up to z April 2025 on Pfizer and Merck antivirals whilst procrastinating on antiviral nasal sprays