Dissent journalist Rebekah Barnett, has pointed out in her Dystopian Down Under substack, that Australia's drug regulator, the Therapeutic Goods Administration (TGA), does not how many of the adverse events reported to its database are actually caused by the Covid vaxxes. Although they claim to assess every claim for causality, information is limited. Hence, all reports are assigned a category of “possible.” As detailed below, it seems that that is about all the information the TGA is willing to give out. Clearly, the organisation needs Spring cleaning. In particular, as Barnett shows below, the TGA having a business funding level of 96 percent, according to one estimate, is a definite problem.
https://news.rebekahbarnett.com.au/p/australias-drug-regulator-admits
“Australia's drug regulator, the Therapeutic Goods Administration (TGA), has no idea how many of the adverse events reported to its database are actually caused by the Covid vaccines.
Despite refusing to answer straightforward questions about how many reports it has assessed for causality, the TGA has confirmed that it does not have the information required to properly assess all adverse events (AEs) reported to its safety surveillance database, the DAEN (Database of Adverse Event Notifications).
Yet, there is a widespread perception that the TGA assesses all reports, particularly of serious AEs, for causality.
This is the stated belief of Country Medical Director of Pfizer Australia & New Zealand, Dr Krishan Thiru, who told a Senate Committee Hearing on 3 August 2023, "The TGA carefully analyses all of the reports that it receives and makes a determination if there is a link to the therapeutic product or not."
But by the TGA’s own admission, this is not the case.
Following Dr Thiru’s statement to the Senate, I asked the TGA to specify how many Covid vaccine adverse event reports they have assessed, and how many they have determined as causally linked to the vaccines.
The TGA expertly deflected, responding (emphasis mine):
“The TGA has received over 139,000 adverse event reports for COVID-19 vaccines. It is common for the reports to have limited information on which to conduct a causality assessment. For this reason, almost all reports received by the TGA are assigned a causality of ‘possible’, even where the reporter provides limited information, or information that suggests the adverse event was not related to vaccination. This enables the TGA to include a broad dataset in our statistical analyses which are used to identify signals. The TGA’s COVID-19 vaccine safety monitoring system has delivered clear results for the Australian public, including first in the world action on several emerging safety concerns.”
This wordy response confirms that, contrary to Dr Thiru’s claim, the TGA does not assess all reports to determine if there is (or is not) a link to the therapeutic product because it does not have the information required to do so.
Rather, the TGA assigns “almost all reports” a causality status of ‘possible,’ neither confirming nor denying causality. This allows enough uncertainty for the TGA to maintain that high AE reporting rates cannot be construed to indicate causality, while also avoiding the burden of proving that the reported AEs are not causally linked to the Covid vaccine products.
As the TGA failed to answer my specific questions, I went back a second time, asking, how many AEs have you assessed and how many did you determine to be causally linked to the Covid vaccines?
This time, the response was even wordier, while managing to say nothing at all:
“The Therapeutic Goods Administration (TGA), which is part of the Department of Health and Aged Care, has robust processes for monitoring the safety of medicines and vaccines. Many of these processes have been enhanced dramatically for COVID-19 vaccines, making this the most intense safety monitoring of therapeutic goods ever conducted in Australia.
“Enormous amounts of real-world data, based on more than 13 billion doses of COVID-19 vaccines administered globally, continue to show that the benefits of vaccination strongly outweigh the potential risks, including rare serious adverse events. This is supported by the recent statement by the International Coalition of Medicines Regulatory Authorities (ICMRA), which is available at: www.tga.gov.au/news/media-releases/icmra-statement-safety-covid-19-vaccines.
“The Department has made extensive information available to the public about the COVID-19 vaccines, which is available at: www.health.gov.au/our-work/covid-19-vaccines. The TGA also publishes comprehensive regulatory information on its website at: www.tga.gov.au/products/covid-19. Since March 2021, the TGA has published a regular COVID-19 vaccine safety report, which is available at: www.tga.gov.au/news/covid-19-vaccine-safety-reports.
“In addition, the Department has provided detailed technical responses through appearances before the Senate Estimates Community Affairs Legislation Committee (transcripts and written answers to Questions on Notice are available at www.aph.gov.au/Parliamentary_Business/Senate_estimates/ca).”
I asked the TGA my questions a third time, this time with clear directions, in red. Additionally, I requested that if the TGA was refusing to answer my questions, that it provide an explanation as to why.
After following up a further three times, I received the following reply from a Department of Health spokesperson:
“We worked with our colleagues at the TGA to provide these two responses and we won’t be providing anything further for this query.”
The TGA outright refuses to tell the Australian public how many of the AEs reported to its safety surveillance database have been assessed for causality, and how many have been determined to be linked (or not) to the Covid vaccine products.
A ‘horribly conflicted’ business model
The unwillingness of the TGA to even explain why it won’t answer my straightforward questions and the lengths they went to in obfuscating to protect Dr Thiru, who appears to have misled the Senate (whether deliberately or not) raises a new question:
Who does the TGA work for? The Australian public? Or the drug sponsors?
A much-cited investigation into drug regulator funding conducted by Maryanne Demasi for the British Medical Journal found that the TGA receives more industry funding than any other regulator in the world, at 96 per cent. More than nine out of every ten applications for new drugs are approved by the regulator.
In the above-mentioned Senate Hearing after Pfizer’s Dr Thiru asserted (falsely) that the TGA assesses every reported AE to determine causality, Liberal Senator Alex Antic asked the panel representing the TGA, “does the TGA accept that it is horribly conflicted by virtue of that industry-funded model?”
The TGA panel disputed Senator Antic’s assertion, with Professor Tony Lawler, who replaced outgoing Professor John Skerritt as TGA head in June this year, countering that the portion of the TGA’s funding coming from industry is “somewhat lower” than 96 per cent.”