The Therapeutics Good Administration (TGA) has been established as an independent body to approve or reject applications for drugs, vaccines and medical devices. For many years, the TGA stood strong against pressure from the USA and pharmaceutical companies to shred our long-established approval processes that protected Australians from drug harm.
Recently that pressure won out and the TGA has adopted the language of pharmaceutical companies, especially as used by their lobby group, Medicines Australia. The result has been the fast tracking of drugs and vaccine-like products that would not have been approved under the old system.
I ask about the rate of approval -vs- rejection of drug applications. In the last 3 years, 140 drugs were approved. The Department dodged the question as to how many were rejected. Most likely this was because drug companies are allowed to withdraw their application rather than face rejection, so they can bring the application again. My information is less than a dozen applications have been “withdrawn”, suggesting the TGA is approving at a much higher rate than they have in the past.
The actions of the TGA may have led to the spike in unexplained deaths and increases in serious harm to Australians. Only a Royal Commission will get to the bottom of their recent shift in process and the harm this may have caused to our health.
Transcript
Senator ROBERTS: I’m stunned that you wouldn’t study the long-term effects of COVID-19 spike proteins, given that the COVID injections cause the body to become a factory for the spike proteins. Let’s move on, though. The TGA website has a page entitled ‘Australian prescription medicine decision summaries’, which displays new drug approvals.
CHAIR: Before you go on, Senator Roberts, you just made an assertion—
Senator ROBERTS: I said I was stunned—
CHAIR: They may not wish to, but I want to check if anyone from the department or the TGA wants to respond to the preamble before your question.
Prof. Lawler : No, I don’t. Thank you, Chair.
CHAIR: You’re okay? Alright. Senator Roberts.
Senator ROBERTS: In terms of new drug approvals for calendar 2022, 2023 and 2024, three years—we’re in the third year—140 drugs were listed as approved. Is there a separate list of rejected applications?
Mr Henderson : We do publish the medicines that are under evaluation as well as the medicines that are approved. Medicines are either rejected or—a lot of times medicines are withdrawn by the sponsor.
Senator ROBERTS: Do you publish them?
Mr Henderson : No, we just publish the number of medicines that have been approved as well as the medicines that are under evaluation.
Senator ROBERTS: How many were rejected?
Mr Henderson : I’ll need to take that on notice for those periods.
Senator ROBERTS: Do you have a rough idea?
Mr Henderson : I don’t know—
CHAIR: If he’s taken it on notice, he’s taken it on notice.
Mr Henderson : I’ll take it on notice.
Senator ROBERTS: Thank you. Professor Skerritt was in charge of the TGA for most of that period. They approved 140 new drugs, and you don’t know how many have been rejected. Let’s go to plasmidgate. There were questions from several senators, including myself, at the last estimates relating to the scandal known as plasmidgate, which was the contamination of COVID injections with foreign DNA originating from E. coli bacteria used in the production process for making the COVID injections. Your answers on notice to all senators’ questions are essentially the same, which is ‘There’s no contamination,’ and you cast shade on the papers and persons who claim there is. Is this still your position?
CHAIR: That seemed to be quite a personal reflection in that question. Who particularly were you talking about?
Senator ROBERTS: There’s no personal reflection. It’s the TGA.
CHAIR: The TGA?
Senator ROBERTS: At last Senate estimates—and since, in answers to questions on notice.
Prof. Lawler : Again, I apologise for having lost track of the question. There were a number of elements there. Could you repeat the question for me, and I can get the best person here to answer it.
Senator ROBERTS: Sure—
Mr Comley : Sorry, the essence of the question is, ‘Do you stand by the answers you’ve given to questions on notice related to contamination?’ and the answer is yes, we do.
Senator ROBERTS: Okay. Have you tested a sample of these products in your own laboratory and have you personally assured yourself that there is no contamination in the COVID vaccines?
Prof. Lawler : Thank you for the question. All vaccines that have been released have been tested by the TGA and have passed.
Senator ROBERTS: How did you test the vaccines? Professor Skerritt told me he relied on the FDA, and the FDA said, before Professor Skerritt said that, that they relied upon Pfizer’s testing? What test did you do?
Prof. Lawler : Could I just clarify that you’re talking about batch-release testing.
Senator ROBERTS: I’m talking about COVID injections approval.
Prof. Lawler : I’m trying to clarify whether you’re talking about the release of vaccines for use.
Senator ROBERTS: I’m talking about the approval of the original COVID injections. Professor Skerritt told me that they were not tested here because you relied upon the FDA. The FDA had previously already stated that they did not do any testing; they relied on Pfizer’s testing, which was broken up.
Dr Kerr : Thank you for the question. We do do our own testing.
Senator ROBERTS: Did you test for contamination in the batches?
Dr Kerr : Yes, we do test for contamination in the batches, including for residual DNA.
Senator ROBERTS: And E. coli?
Dr Kerr : The E. coli can be determined through a test called endotoxin testing. We do test for endotoxins, and all of the batches that have been released into the Australia market passed the endotoxin test.
Senator ROBERTS: Attempts to examine batch-lot testing through freedom of information have resulted in documents that are 100 per cent redacted. I can flick the pages. You have the ability to put plasmid-gate to bed right now by publishing the results of your own testing without redaction. Will you provide to the committee that unredacted proof that there is no contamination?
Dr Kerr : We publish the summary of our test results on the TGA website. One of those tests is contamination, and I can confirm that the batches are not contaminated with residual DNA or endotoxin.
Senator ROBERTS: Thank you. Can we have a look at them? They’re on the website?
Dr Kerr : Yes.
Senator ROBERTS: I turn to blood clots. There’s an aspect of these injections that just doesn’t go away; in fact, it is becoming more common. Embalmers are reporting that bodies that they are embalming are affected by large blood clots. There are multiple videos and photos online. Dr John Campbell, a British doctor, did an excellent show recently on this. Have you looked at this issue? We know that it’s a problem with some of the injections.
Prof. Lawler : Taking on board the fact that it’s difficult for us to corroborate or validate some of the comments that you made, I’ll ask Ms Kay to comment.
Senator ROBERTS: I just want to know if you’ve looked at it.
Ms Kay : We have not confirmed an association between mRNA COVID-19 vaccines and thrombosis, or blood clots. We have released an extensive list of the safety investigations that we’ve undertaken in response to a question on notice. I can provide that to you again so that you can see which safety signals we have investigated. I can’t tell you off the top of my head right now whether blood clots is one of those.
Senator ROBERTS: Could you also tell me how you’ve done that evaluation?
Ms Kay : Right, okay.
Senator ROBERTS: You can take it on notice.
Ms Kay : I can tell you now, if you like, how we detect safety signals and investigate them. We have a number of different approaches to detecting safety signals. A key mechanism for detecting safety signals is the statistical analysis of the adverse event reports that we hold in our database, where we look for unusual patterns of reporting that might indicate a new safety signal. We then undertake a medical assessment of those safety signals, and that medical assessment will determine the need for further investigation. That further investigation then takes into account a broad range of different sorts of evidence. We’ll look, in detail, at the adverse event reports within our database, as well as looking at published literature and information released by other regulators. Those investigations assess the strength of the evidence for an association between an adverse event and a vaccine. Where we find a likely association, we’ll take regulatory action, such as updating the product information to make that information available to health professionals.
Senator ROBERTS: Can you tell me about the medical assessment?
Ms Kay : The medical assessment of those statistical signals? Certainly. It’s an accepted approach in pharmacovigilance to undertake what’s called a disproportionality analysis, where we look for signals of disproportionate reporting of a particular adverse event with a particular exposure—a medicine or a vaccine. It’s also accepted in pharmacovigilance that those statistical signals need to be put through a medical assessment to understand whether they might have arisen through bias or whether there may be a signal there that needs to be further investigated. There are quite a number of different aspects that are considered in that assessment, and I’d be happy to provide you with that information on notice.
Senator ROBERTS: Thank you very much.
