I'm currently enjoying the benefits of two products that are on TGA's banned list, not because they are unsafe or ineffective. They're actually extraordinarily safe and effective to the extent that they threaten the profit streams of many multiple pharma products. The TGA is obviously fulfilling its primary, though not stated, function of protecting the financial interests of the piper whose tune they persistently play.
And we all know what they did to Pan Pharmaceuticals in 2003 - bankrupted by being forced to withdraw all its products primarily on the basis of a spurious claim that "someone" had suffered an adverse effect from just one of its products. A total witch hunt if ever there was one. The company's founder, Jim Selim, was awarded damages when it was found the TGA acted excessively, but his company had been destroyed.
All aided and abetted by the old bogey - mainstream media, piping away in chorus.
The story of VIRALEZE™ (blackbanned despite clinical trial as COVID treatment in UK) safe barrier antiviral nasal spray is TGA copiloting Pfizer Paxlovid and Australian govt starting with secret health minister Scott Morrison spending $2.7 Billion on Pfizer Paxlovid $1114 and Merck Lagevrio $1108 per 5 day course… sent to TRUMPs America by our PBS which Trump criticises for cheap medicines
This is credentials of Astodrimer sodium nasal spray that is approved by 35 regulators including Europe EMA since 2020 as medical device and TGA refuses to approve for 4 yrs whilst Pfizer gets 2 day approval on paxlovid and is now heading for blockbuster profits with another Covid novel drug PF-07817883 Ibuzatrelvir to replace failed EPIC SR Paxlovid
Viraleze credentials
Viraleze antiviral nasal sprays by Starpharma 2022 Award by Australian Government dept of health and dept of industry
Starpharma awarded $1 million in matched funding by the Australian Government’s Medical Research Future Fund (MRFF) Biomedical Translation Bridge (BTB) Program to expedite development and commercialisation of VIRALEZE
Winner “Most significant commercial outcome”. DOHAC winner 13 months after TGA (also in DOHAC) irrationally banned & fined product info in Australia despite 35 regulators internationally including European EMA in 2020 approving as Medical Device
Sept 2024 - Astodrimer Sodium Nasal Spray versus Placebo in Non-Hospitalised Patients with COVID-19: A Randomised, Double-Blinded, Placebo-Controlled Trial
Dec 2022 DART conference Astodrimer sodium v other nasal sprays Scripp presentation. In-viva (mouse model) euthanised to study viral load nasal cavity trachea and lung at 4 and 7 days. Comparators nitric oxide, HPMC, heparin, iota-carrageenan, Astodrimer sodium (Viraleze) v saline (PBS)
Victorian State Government report by KPMG January 2021
The research presented in this paper was commissioned by Victoria’s Lead Scientist, Dr Amanda Caples, and the Victorian Department of Jobs, Precincts and Regions (DJPR
Starpharma, an ASX300 company located in Melbourne, has developed a novel antiviral nasal spray, VIRALEZE™, which inactivates more than 99.99 percent of SARS-CoV-2, the virus that causes COVID-19. VIRALEZE™ is a broad spectrum antiviral nasal spray and is virucidal against SARS-CoV-2 and works by blocking the spike proteins on the SARS-CoV-2 and preventing them from binding to host cells thus preventing infection. Starpharma is finalising regulatory documents and manufacturing product in preparation for launch which is planned for the first quarter of 2021. Apart from VIRALEZE™ being a Victorian discovery, critical antiviral testing of the spray was conducted at 360Biolabs at the height of the pandemic in March 2020. Had this testing not been available locally the rapid development of the product would have been significantly compromised. Starpharma was awarded
$1 million in MRFF funding to expedite development and commercialisation of VIRALEZE™
European medical device regulations February 2025:
Earlier this month, Starpharma received certification for Viraleze™ under the new
European Union (EU) Medical Device
Regulations (MDR). Under the new EU MDR classifications, medical device manufacturers must demonstrate
compliance with certain essential
requirements and undergo a new conformity assessment process with a Europea pd Notified Body. Achieving EU MDR certification demonstrates that Viraleze™ and the research supporting the product meet the necessary safety and performance
Re: “How can Australia’s drug regulator claim to be truly independent when nearly all its funding comes from the very industry it is meant to oversee?”
And to think that products approved by the industry-funded TGA can go on to be MANDATED for use…i.e. vaccines…
With TGA-approved and ATAGI-recommended COVID-19 vaccine products being GOVERNMENT MANDATED under threat of people losing their livelihood and participation in society for refusal to comply.
This travesty happened in a supposed ‘free country’…
And speaking of conflicts of interest Maryanne, are you looking into ATAGI?
I heard Dr Malhotra talk about this when he did his talking tour. I was shocked then and even more shocked that it is still going on. Such a blatant conflict of interest going on under our noses.
I am sorry you have received pushback. Most disconcerting. But the ones with guilty consciences don’t like the truth. I am glad that you haven’t given up.
To be clean - TGA needs public funding - it needs independent trial oversight and where International drug distributing is involved a branch of WHO (or cleaned up WHO) that oversees applications. The small numbers of worldwide professionally qualified specialists needs to be recognised as a risk of conflict and strong methods to combat conflict documented.
The pharmaceutical industry is significantly larger than the arms industry, with global revenues estimated at $1.6 trillion in 2023, compared to $632 billion for the top 100 arms producers.
The pandemic gave TGA public servants dangerous opportunities to game this conflicted system
The gaming covered by Morrison Secret health minister flicking many decisions into 20 yr cabinet confidentiality has been particularly disadvantageous to 20 million Australians or 80% of the population having no access to COVID prevention / treatment developed by small Australian pharma that lacks STANDING as it doesn’t pay big fees of big pharma ie Pfizer Merck etc.
International companies obtaining ABNs and Australian addresses obtain lobbying influence in MEDICINES AUSTRALIA also biased to big member fees - the body where John Skerritt hotfooted to a board position just 6 months after leaving TGA (revolving door’s report by Maryanne) and donor to political parties of $244k in 2023
Beyond what MA identifies as organisational control of big pharma - there are the Public servants who control committees, provide delegates, choose committee members and write up decisions. There are decisions to avoid public consultations as seen by John Skerritt exempting Paxlovid and Lagevrio from Poison Standard legally required consultation with a 2 day approval in January 2022 which benefited Pfizer and Merck with $2.7 BILLION payments from PBS
The Parliament’s auditor general has reported on TGA failure to record conflicts of interest after the BMJ report by Maryanne quoted above:
I wonder what has happened with recommendations about DOHAC maintaining register of conflicts of interest in TGA
I'm currently enjoying the benefits of two products that are on TGA's banned list, not because they are unsafe or ineffective. They're actually extraordinarily safe and effective to the extent that they threaten the profit streams of many multiple pharma products. The TGA is obviously fulfilling its primary, though not stated, function of protecting the financial interests of the piper whose tune they persistently play.
And we all know what they did to Pan Pharmaceuticals in 2003 - bankrupted by being forced to withdraw all its products primarily on the basis of a spurious claim that "someone" had suffered an adverse effect from just one of its products. A total witch hunt if ever there was one. The company's founder, Jim Selim, was awarded damages when it was found the TGA acted excessively, but his company had been destroyed.
All aided and abetted by the old bogey - mainstream media, piping away in chorus.
The story of VIRALEZE™ (blackbanned despite clinical trial as COVID treatment in UK) safe barrier antiviral nasal spray is TGA copiloting Pfizer Paxlovid and Australian govt starting with secret health minister Scott Morrison spending $2.7 Billion on Pfizer Paxlovid $1114 and Merck Lagevrio $1108 per 5 day course… sent to TRUMPs America by our PBS which Trump criticises for cheap medicines
This is credentials of Astodrimer sodium nasal spray that is approved by 35 regulators including Europe EMA since 2020 as medical device and TGA refuses to approve for 4 yrs whilst Pfizer gets 2 day approval on paxlovid and is now heading for blockbuster profits with another Covid novel drug PF-07817883 Ibuzatrelvir to replace failed EPIC SR Paxlovid
Viraleze credentials
Viraleze antiviral nasal sprays by Starpharma 2022 Award by Australian Government dept of health and dept of industry
Starpharma awarded $1 million in matched funding by the Australian Government’s Medical Research Future Fund (MRFF) Biomedical Translation Bridge (BTB) Program to expedite development and commercialisation of VIRALEZE
Winner “Most significant commercial outcome”. DOHAC winner 13 months after TGA (also in DOHAC) irrationally banned & fined product info in Australia despite 35 regulators internationally including European EMA in 2020 approving as Medical Device
https://biotechdispatch.com.au/news/starpharma-wins-recognition-for-development-of-covid-19-antivira#:~:text=Starpharma%20was%20selected%20by%20an,development%20and%20commercialisation%20of%20VIRALEZE.
Sept 2024 - Astodrimer Sodium Nasal Spray versus Placebo in Non-Hospitalised Patients with COVID-19: A Randomised, Double-Blinded, Placebo-Controlled Trial
https://www.mdpi.com/1999-4923/16/9/1173
PEER VIEWED PUBLICATION
January 2024 Covid19 viral load post market study placebo based ASX announcement Jan 2024
https://cdn-api.markitdigital.com/apiman-gateway/ASX/asx-research/1.0/file/2924-02766071-3A635280&v=fc9bdb61fe50ea61f8225e24ce041a0e155a9400
June 2022 Astodrimer sodium human v placebo safety trials reported https://www.researchgate.net/publication/361382162_Astodrimer_sodium_antiviral_nasal_spray_for_reducing_respiratory_infections_is_safe_and_well_tolerated_in_a_randomized_controlled_trial
2021 Scripp Research Institute in-vito and in-vivo humanised mouse genome Astodrimer sodium studies
https://www.scripps.edu/gallay/sars-cov-2.html
Sept 2024 Astodrimer sodium nasal spray forms a barrier to SARS-CoV-2 in vitro and preserves normal mucociliary function in human nasal epithelium
https://www.nature.com/articles/s41598-024-72262-w
Dec 2022 DART conference Astodrimer sodium v other nasal sprays Scripp presentation. In-viva (mouse model) euthanised to study viral load nasal cavity trachea and lung at 4 and 7 days. Comparators nitric oxide, HPMC, heparin, iota-carrageenan, Astodrimer sodium (Viraleze) v saline (PBS)
https://starpharma.com/assets/221201-respidart-poster.pdf
Other publications
Nasal delivery as a strategy for the prevention and treatment of COVID-19
See 3.2. Astodrimer sodium
https://www.tandfonline.com/doi/full/10.1080/17425247.2023.2263363#d1e823
Victorian State Government report by KPMG January 2021
The research presented in this paper was commissioned by Victoria’s Lead Scientist, Dr Amanda Caples, and the Victorian Department of Jobs, Precincts and Regions (DJPR
https://djsir.vic.gov.au/__data/assets/pdf_file/0009/1988532/Creating-a-Healthy-Future-Report.pdf
P5; 33
Starpharma, an ASX300 company located in Melbourne, has developed a novel antiviral nasal spray, VIRALEZE™, which inactivates more than 99.99 percent of SARS-CoV-2, the virus that causes COVID-19. VIRALEZE™ is a broad spectrum antiviral nasal spray and is virucidal against SARS-CoV-2 and works by blocking the spike proteins on the SARS-CoV-2 and preventing them from binding to host cells thus preventing infection. Starpharma is finalising regulatory documents and manufacturing product in preparation for launch which is planned for the first quarter of 2021. Apart from VIRALEZE™ being a Victorian discovery, critical antiviral testing of the spray was conducted at 360Biolabs at the height of the pandemic in March 2020. Had this testing not been available locally the rapid development of the product would have been significantly compromised. Starpharma was awarded
$1 million in MRFF funding to expedite development and commercialisation of VIRALEZE™
European medical device regulations February 2025:
Earlier this month, Starpharma received certification for Viraleze™ under the new
European Union (EU) Medical Device
Regulations (MDR). Under the new EU MDR classifications, medical device manufacturers must demonstrate
compliance with certain essential
requirements and undergo a new conformity assessment process with a Europea pd Notified Body. Achieving EU MDR certification demonstrates that Viraleze™ and the research supporting the product meet the necessary safety and performance
Re: “How can Australia’s drug regulator claim to be truly independent when nearly all its funding comes from the very industry it is meant to oversee?”
And to think that products approved by the industry-funded TGA can go on to be MANDATED for use…i.e. vaccines…
With TGA-approved and ATAGI-recommended COVID-19 vaccine products being GOVERNMENT MANDATED under threat of people losing their livelihood and participation in society for refusal to comply.
This travesty happened in a supposed ‘free country’…
And speaking of conflicts of interest Maryanne, are you looking into ATAGI?
See for example: ATAGI - Disclosures / Conflicts of Interest and historical information - this matter is STILL outstanding, 5 March 2025: https://vaccinationispolitical.net/wp-content/uploads/2025/04/atagi-disclosures-_-conflicts-of-interest-and-historical-information-this-matter-is-still-outstanding-1.pdf
I heard Dr Malhotra talk about this when he did his talking tour. I was shocked then and even more shocked that it is still going on. Such a blatant conflict of interest going on under our noses.
I’ve received quite a bit of pushback on this since publishing my BMJ article—which is exactly why I wrote this piece. ☺️
I am sorry you have received pushback. Most disconcerting. But the ones with guilty consciences don’t like the truth. I am glad that you haven’t given up.
Thanks, Jillian. The institutional corruption is so entrenched that some people fail to see it—even when it’s right in front of them.
He who pays the piper, calls the tune !
Since TGA's role is crucial to drug approval in Australia I can't see why part of the Medicare levy isn't directed to funding the organisation ?
To be clean - TGA needs public funding - it needs independent trial oversight and where International drug distributing is involved a branch of WHO (or cleaned up WHO) that oversees applications. The small numbers of worldwide professionally qualified specialists needs to be recognised as a risk of conflict and strong methods to combat conflict documented.
The pharmaceutical industry is significantly larger than the arms industry, with global revenues estimated at $1.6 trillion in 2023, compared to $632 billion for the top 100 arms producers.
Hmmmmm.
And in some countries linked with Defense industries
The pandemic gave TGA public servants dangerous opportunities to game this conflicted system
The gaming covered by Morrison Secret health minister flicking many decisions into 20 yr cabinet confidentiality has been particularly disadvantageous to 20 million Australians or 80% of the population having no access to COVID prevention / treatment developed by small Australian pharma that lacks STANDING as it doesn’t pay big fees of big pharma ie Pfizer Merck etc.
International companies obtaining ABNs and Australian addresses obtain lobbying influence in MEDICINES AUSTRALIA also biased to big member fees - the body where John Skerritt hotfooted to a board position just 6 months after leaving TGA (revolving door’s report by Maryanne) and donor to political parties of $244k in 2023
Beyond what MA identifies as organisational control of big pharma - there are the Public servants who control committees, provide delegates, choose committee members and write up decisions. There are decisions to avoid public consultations as seen by John Skerritt exempting Paxlovid and Lagevrio from Poison Standard legally required consultation with a 2 day approval in January 2022 which benefited Pfizer and Merck with $2.7 BILLION payments from PBS
The Parliament’s auditor general has reported on TGA failure to record conflicts of interest after the BMJ report by Maryanne quoted above:
I wonder what has happened with recommendations about DOHAC maintaining register of conflicts of interest in TGA
Auditor-General Report No. 3 2023–24
Performance Audit
Management of Non-Compliance with the Therapeutic
Goods Act 1989 for Unapproved Therapeutic Goods
https://www.anao.gov.au/sites/default/files/2023-08/Auditor-General_Report_2023-24_3.pdf?
Children's Health Defence is an excellent resource. A shout out to Maryanne Demasi here at about 28 mins in. https://live.childrenshealthdefense.org/chd-tv/shows/this-week-with-mary--polly/tracking-vaccine-injuries-sids-and-pharma-stocks-fall-show-page/