Australian Senators vs TGA

IN CONflict$
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Here are my chosen clips from the Senate Hearing vs. TGA held on Aug 3rd, 2023.

Held on the 3rd of August, 2023, here are the clips I thought people most needed to know (that don’t sit through hours of political chess like I do), but you can watch the Full Session in it’s original format on ParlView:

Therapeutic Goods Administration (TGA) Representatives

  • Professor Anthony Lawler, Deputy Secretary, Health Products Regulation Group
    • (fmr?) President of the Australasian College for Emergency Medicine, Professor of Health Services at the University of Tasmania. member of the Australian Medical Council’s Specialist Education Accreditation Committee, and member of the Council of Presidents of Medical Colleges. Director of the International Federation for Emergency Medicine, and of the Postgraduate Medical Education Council of Tasmania. Fmr member of the Federal Council and Federal Executive of the Australian Medical Association, and fmr President of the Tasmanian Branch of the Australian Medical Association. At Healthdirect Australia, Anthony is Chair of the Clinical Governance Advisory Group (CGAG). (03)
    • Current Board member: Australian Commission on Safety and Quality in Health Care, Royal Australasian College of Medical Administrators, National Health and Medical Research Council (NHMRC), past 12 years as Professor of Health Science at University of Tasmania (2011-2023). Joined TGA last month (June 2023) (04)
  • Mr Nick Henderson, First Assistant Secretary (A/g), Medicines Regulation Division
  • Dr Andrew Pengilly, Medical Officer 5, Medicines Regulation Division
    • former Acting ACT Chief Health Officer
Senators v new TGA crew

  1. 2min—Senator Antic calls out TGA for being pharma-owned
  2. 2min—Senator Canavan asks TGA for evidence that vaccines stop the spread
  3. 1min—Senator Sheldon asks TGA what role pharma plays in policy
  4. 8min—Senator Rennick grills TGA on WA adverse event data
  5. 7min—Senator Roberts vs TGA — Why is TGA deleting deaths?

Senator Antic calls out TGA for being pharma-owned

Of the six leading regulators in Australia, Canada, Europe, Japan, the UK, and the US, the TGA has the highest proportion of budget from industry fees, 96%. And from 2020 to 2021, the TGA approved nine out of every ten drug company applications. Does the TGA consider that it is horribly conflicted by virtue of that industry-funded model? (05) (06) (07)

TGA: uh, No.

And what percentage of current members of the TGA executive of the Health Products Group, the advisory panel, or any of the other advisory bodies under the executive arm of TGA are prior employees of big pharmaceutical companies?

TGA: Yeah, I don’t have an answer to that question. Senator Antic, I’ll take that on notice. And of course, we do have a detailed process around managing conflicts of interest within the TGA and also within our committees, so I’m happy to provide those.

Is it not a problem, though, that something like 170 million dollars worth of pharmaceutical money comes to the TGA and represents 96% of your funding?

“Here’s why that is a good thing… – TGA-funded head-honcho”

TGA: It means that the quality of applications that are coming to us are very high.

This is ultimately a big, cosy club, though, is it not?

TGA: No.

It’s not?

TGA: No, it is not unusual in the regulatory world for the activities of the regulated to be undertaken on a cost-recovery basis. And it is undertaken on a cost-recovery basis. And I would also indicate that we establish the fees and charges to undertake the work and we communicate that to industry, and the work that we undertake all the way from the assessment of applications for authorisation and entry onto the Australian Register of Therapeutic Goods all the way through to the inspection that we undertake for manufacturing and product quality is all undertaken in a way that is absolutely in line with effective codes of practice…

The TGA is not going to bite the hand that feeds it. (08)

Senator Canavan asks TGA for evidence that vaccines stop the spread

Did Pfizer, Moderna, or even AstraZeneca, did any of those companies share with you or provide you any evidence about the effectiveness of their vaccine in reducing or stopping transmission?

I think you’d look at transmission broadly two ways. You can look at the effectiveness of the vaccine in preventing somebody getting COVID because obviously if you do that, then you prevented transmission to that person. And there are both in the clinical studies have been submitted for registration but also moreover in the literature now and abundance of evidence that vaccination has the ability to prevent people from acquiring infection with COVID. However, that is defined whether you define it with symptomatic infection, serious infection or just.

Can I just stop you there given the time? I’m more interested I think in the second definition you’re going to raise. The reason just to bring it back and I know this committee has been wide ranged which is fine but we are here to discuss a bill about ending vaccine mandates. And it’s really that other form of transmission .. can I being vaccinated, do I stop spreading it? That’s what I want to know because we were told, we were often told that we should get the vaccine to protect our grandma and not necessarily ourselves. And so I’m more interested to get any evidence that by getting the vaccine I would reduce my propensity to spread it.

Yeah, fair point. I would just say that obviously one way you can prevent spreading it is don’t get the disease. However, and I don’t believe it was in the original regulatory dossiers because I think most companies have said the initial purpose was to prevent disease in individuals. However, there are a number of studies and that we’ll be happy to provide these. Which have subsequently done those studies.

About stopping the spread?

Yes, looking at the reduction in the spread, among vaccinated people into households, in prison communities, in healthcare facilities, these are secondary transmissions. They’re not as frequent because they’re harder studies to do but they certainly have been done.

I’ll be interested in them. I mean, we just, I was just was wholly unconvinced, especially Pfizer tonight wouldn’t stand behind their own statements as a company. And when you check their official statements, haven’t made any statement, and basically since mid-2021 about the effectives of transmission. (09)

Senator Sheldon asks TGA what role pharma plays in policy

What role, if any, has the pharmaceutical companies had in policy formulation by the TGA?

The TGA is a regulator that sets its own regulatory settings. It interacts with industry in that industry sponsors bring medications and other devices to the TGA, for registration on the approval. We have a role, obviously, in terms of, as I say, as a contemporary regulator in collaboration and engagement, but it’s very clear in that relationship that we undertake the regulatory role.

And that’s independent of the pharmaceutical companies, it’s decisions made by the TGA, is that what you’re saying?

And delegates within the TGA, that’s right.

Very clear for the Hansard. Thank you. (10)

Senator Rennick grills TGA on WA adverse event data

“Rate of adverse events per 100,000 doses is 264.1 per COVID-19 vaccine, versus non-COVID vaccines of 11.1., per dose… and I note that in order to be up to speed with the COVID vaccine, you needed two or three doses. So that’s at least 52-75 times higher rate of event to be, you know, assuming you need three doses a year, than non-COVID vaccines. Given the higher rate of injury, do you think that the COVID vaccine has a much higher risk of adverse events than normal vaccines based on this real-world data from the Western Australian government?” and “Can you explain why the vaccine damages heart cells?” (11)

Hansard:

Senator RENNICK: Thank you very much, Chair. Guys, could I refer you to the Western Australian vaccine safety surveillance—annual report 2021, page 28. I’d like to think you’re up to speed with this already, but that’s why I provided the documents. There’s a table there, 8.1 on page 28, that says the rate of adverse events per 100,000 doses is 264.1 for COVID-19 vaccines versus 11.1 for non-COVID-19 vaccines. That’s per dose, so that effectively means that the rate of adverse events for COVID vaccines is 24 times higher than for non-COVID vaccines. This is the Western Australian safety data from 2021, and that’s per dose. I note that in order to be up to speed with the COVID vaccine you needed either two or three doses. Assuming you need three doses a year, that’s at least a 60 to 75 times higher rate of an event than for non-COVID vaccines. Given the higher rate of injury, do you think that the COVID vaccine has a much higher risk of adverse events than normal vaccines, based on this real-world data from the Western Australian government?

Prof. Lawler : There are a couple of features that I had intended to explain in my previous answer around adverse event reporting, and I think that they’re relevant to this answer. There are issues of causality. Obviously, one is that we do frequently see adverse events after vaccination of any kind, and that does not necessarily mean that there is a causal link. It can be a temporal link.

Senator RENNICK: I’m well aware of that.

Prof. Lawler : Secondly, I think it’s important to note that many of the adverse events that were reported in the Western Australian vaccine safety surveillance report—which, again, as I mentioned previously, is one of a number of different surveillance mechanisms that we use to identify signals—were quite mild and expected—

Senator RENNICK: Okay. Could I ask you to refer to the table on page 11, now that you’ve seen that figure—go to the bottom set of figures, please—because I dispute that. If you actually look at the figures in 2021 down the bottom right-hand side, you will see that 48 per cent of people who reported an adverse event to the COVID vaccine went to the emergency department, and nine per cent were admitted to hospital. That’s 57 per cent of people who reported an adverse event who actually went to hospital. That’s twice as high, if not higher, than in prior years for non-COVID vaccines, so I think it’s not fair to say that these are mild events.

Prof. Lawler : I appreciate that. I understand that there has been discussion around the use of the term ‘mild events’ previously, and I absolutely appreciate the fact that those who’ve experienced vaccine injury would find that a diminishing term, and it has certainly not been intended in that way. What I’m saying is that there are a proportion of injuries that are to be expected following COVID or any other vaccination. The other element—

Senator RENNICK: Sorry to interrupt you there, but my point is that the rate of injury is much higher with the COVID vaccines. That’s what these figures prove, because they’re real-world figures of a population of 2½ million people. It’s significantly higher.

Prof. Lawler : Again, I appreciate that. I think it’s also important to note, and it was noted within the report itself, that those undertaking the survey and the collection of data did not specifically ask patients or participants why they accessed medical care in the days following treatment. I think it’s also important to note as well—

Senator RENNICK: Can I say that that’s the fault of the reporting system. We’re rolling out a novel vaccine here. So that’s not my fault; that’s their fault for not tracking—

Prof. Lawler : It’s absolutely not your fault. I do find it, though—and I’m sorry; I don’t mean to interrupt—challenging to rely on one part of the report as representative of a problem with a vaccine and then to dismiss another part of the report as a fault of reporting.

Senator RENNICK: It’s a signal, and a very large sample.

Prof. Lawler : And it’s one of the many signals that we look at. It’s one of the many signals that we incorporate in terms of our determination.

The other thing I would indicate is that there is what we call the Hawthorne effect, which is that there will be a change in the reporting when there is a significant focus on a disease. I think it’s very important to note. And this is in part why we encourage both health professionals and the community to report adverse events, because we want to be picking up those signals. But it actually says on page 28, as you highlighted, that the surveillance of routine vaccines was a small component of the workload.

Senator RENNICK: That’s right.

Prof. Lawler : People expect, to a certain extent, to have vaccine after-effects. Whether we characterise them as adverse events or injuries, they expect to have vaccine after-effects after a routine vaccine.

Senator RENNICK: Okay. Thank you.

Prof. Lawler : There is a more prompt pick-up after—

Senator RENNICK: Thank you. Sorry, but I’ve got to keep moving on. I’ve asked both of the two manufacturers tonight, Pfizer and Moderna, whether they can explain the process by which the vaccine causes myocarditis. I don’t want to talk about benefits and risks; I want to know why the vaccine causes myocarditis. It damages heart cells. Okay?

Prof. Lawler : Yes.

Senator RENNICK: Can you explain why the vaccine damages heart cells?

Prof. Lawler : I’ll ask Dr Pengilley to respond.

Dr Pengilley : This is an issue of some ongoing discussion in the medical literature, and I think it is fair to say that the absolute, definitive mechanism has not been isolated yet.

Senator RENNICK: Thanks for that.

Dr Pengilley : But I’ll caveat those comments by saying that myocarditis is generally an autoimmune phenomenon where antibodies are formed against cells, in this case of the heart. It occurs after COVID at a higher rate than it does after vaccination, and it occurs in relation to a number of other infections, such as coxsackieviruses. It’s something which is observed whenever there is an immune response. It is therefore likely that it is somewhat related to the immune response, and I guess there is a similarity between the immune response to COVID and—

Senator RENNICK: Okay. Thank you. Fantastic answer. I appreciate that.

Dr Pengilley : Well, perhaps I—

Senator RENNICK: So, given that this wasn’t identified before the rollout and, as you said, it’s an ongoing area of concern and investigation, how can you then rule out—and you’ve admitted it’s potentially an autoimmune issue—that other body organs aren’t also being damaged by the vaccine, but they’re subclinical issues because the heart is obviously something that has a higher pain threshold, or sends a greater signal? How can you rule out other issues or side effects from the vaccine? When you’re saying that it’s not necessarily causal, could the vaccine be causing other autoimmune issues in other body organs? Is that a potential risk? Do you accept that that’s a risk?

Dr Pengilley : Senator, as Professor Lawler has pointed out, the TGA maintains an ongoing surveillance of potential risks and potential adverse events as they’re reported to us. The fact of the matter is that with all medical products more information becomes available as they are used. However—

Senator RENNICK: I accept there’s a risk, but my issue is that you never outlined those risks at the start.

Dr Pengilley : Well—

Senator RENNICK: It’s always, ‘The vaccine is safe and effective,’ without any qualification.

Dr Pengilley : I think if you look at the statement regarding provisional registration the basis on which they’re approved is pretty clear. But it’s also the case that there is a risk-benefit. I realise you said you don’t want to discuss it, but if you’re trying to prevent myocarditis then preventing COVID is the best way to do it. So you do look at the—

Senator RENNICK: Well, we had 10 million people, I will dispute, that caught COVID.

Dr Pengilley : You do look at what you’re doing in terms of the rate of adverse events. And, since it is also an adverse event of COVID infection, the overall benefit, even for that adverse event, is likely to be positive. Whether there is an unknown adverse event is purely speculative. It goes to proving a negative, and that’s not something that—

Senator RENNICK: You’re playing with people’s lives. You can’t say that’s speculative. You’re risking people’s health here. We’re not speculating in the casino or at a football—

Dr Pengilley : I would say, though, Senator—

CHAIR: Sorry to interrupt, Dr Pengilley. Senator Rennick, I was trying not to interrupt you as you were asking the question, but I will need to go to Senator Canavan. We are over time.

Prof. Lawler : I think the ‘speculative’ comment probably relates more to some of the physiological and virological thoughts around organs and how organ systems are affected. Moving away from the speculative position: as we’ve mentioned a couple of times, we undertake significant adverse event notification and monitoring. In the context of 16 million doses having been developed, the reported rate—and we rely very much on the reported rate—of adverse events of myocarditis and pericarditis has been in the region of two to three per 100,000. As Dr Pengilley has highlighted, we rely on the growing body of real-world evidence in our ongoing assessments—

Senator RENNICK: It’s per thousand, not 100,000.

Prof. Lawler : No, it’s per 100,000 doses.

Senator RENNICK: The reporting injuries, as per your regular reports, are two per thousand.

Prof. Lawler : I’m wanting to make a clear distinction between the specific diagnosis of myocarditis and pericarditis versus—

Senator RENNICK: And I’m talking about the other 998. If it can happen to the heart, it can happen to other body organs; that’s my point. You’re talking about two in 100,000, yet your own weekly report talks about two in a thousand reported injuries. I’ll leave that as a comment. (12)

Senator Roberts vs TGA — Why is TGA deleting deaths?

Note: I would’ve included their full answers like I always do because I like everyone to not just get the “viral clip” but the full-context to be fully-informed, but in this case, they are professionally paid “wafflers” and I deleted long sections of repetitive scripted spiels of bull$shit waffle from the pharma $hills, but put a “black fade in” on any parts where I cut anything out (so you can go and watch the dribble coming out of their mouth for yourself if you want something to put you to sleep if you so desire).

A recent peer-reviewed paper in the Establishment Scientific Journal of Vaccine examines Pfizer’s COVID vaccine randomized Phase 3 clinical trials data. It uses Pfizer’s own data, own trial. It uses the World Health Organization’s framework made for this purpose, the Brighton Collaboration on Adverse Events of Special Interests. Authors included Virology and Pharmacology experts from UCLA, Stanford, University of Baltimore, Queensland’s Bond University. The paper concluded that Pfizer’s vaccine, its injection, was associated with 36% increase in serious adverse events. The most common of coagulation disorders, including thrombosis and acute cardiac injury. In every 10,000 people injected 18, that’s 2 in 1,000 will experience a life-threatening or altering medical complication. Series adverse events from Pfizer’s COVID vaccine are four times higher than any benefit from the vaccine and reduced hospitalization. The paper said the products should never have been approved. These world-leading virologists spent 18 months reviewing the data, Pfizer’s patient level data, and peer-reviewing their paper.

The department reviewed the data in a matter of weeks, and made a finding that is the reverse of this paper’s findings. Who got it wrong? These world-leading virologists or the advisory panel? The politically compromised advisory panel? Who got it wrong?

(Cut out the waffle.. you already know they are going to say… blah blah.. paper is controversial.. blah blah.. safe and effective… blah blah gas-light-gas-light-gas-light zzzz)

Talking about the TGA. Professor Skerritt, as I understand it, admitted in answering a question of mine in the last Senate estimate sessions that the TGA did no testing and relied on the FDA. The FDA in turn, I’m advised, did no testing and relied on Pfizer’s trials, the same trials that that I just discussed. On what scientific basis did you mandate the anticipated injections?

And Professor Skerritt said they didn’t do it because the FDA has $8 billion in annual budget and 15,000 employees. So you relied on the FDA. The FDA relied on Pfizer. So then no one in the TGA as I understand it and reviewed the patient level data.

So I’ll start, Senator, just by saying that I’m not in a position to answer for Professor Skerritt. But there was a question in the middle that I understood to be on what basis did we mandate the vaccinations? Is that correct?

No, I didn’t say that.

Sorry, I missed that then.

I’m sorry if I said that. Well, what basis did you provisionally approve?

Okay. Thank you and apologies for misunderstanding, Senator. So as you be aware, the therapeutic goods administration does have the responsibility for assessing and approving medications to go onto the Australian registry of therapeutic goods on the basis of safety quality and efficacy. All the COVID-19 vaccines have been approved via our provisional registration pathway, which enables earlier access to promising new medicines while data on longer term efficacy and safety are still being gathered. I think it’s important to –

Sorry, what was it last bit?

While data on longer term efficacy and safety are still being gathered.

(deleted repetitive waffle)

… maintenance of adverse event reporting and also surveillance for the development of signals both in Australia and …

Just on your adverse events reporting. On what basis? Because I’ve asked three times, Professor Skerritt, failed to reply the first two times. It took me months to get it out of him. What is your process for reviewing the adverse events reports, especially doctors reports of death? Doctors have reported around about a thousand deaths. That’s been wiped down to about 14 with no basis, no objective criteria in the assessment process. How can you call that a decent adverse event reporting? Deaths!

So I think that- So if I understand correctly, there are two questions you’re asking this, Senator. One is about the process we undertake for provisional reporting and the other is the issue that we undertake for adverse event notification monitoring. Is that- am I correct.

That’s correct. Changing it from reported deaths to-

Chair: Sorry, Senator, Representative, I want to- I’m only doing four questions there, but after follow-up questions, one more question.

Okay.

So we undertake before the provisional approval of vaccines within Australia, we establish the acceptable safety quality and efficacy of the vaccine based on a comprehensive evaluation of a wide range of information. And that includes leveraging our significant global partnerships with other regulators. It’s important to note that we undertake through a team of clinical and scientific experts at the TGA a careful review of this data and we seek advice as well from the statutory advisory committee on vaccines prior to a senior medical officer making a regulatory decision within the statutes of the of the Therapeutic Goods Act 1989. Vaccine is only provisionally approved by the TGA. This rigorous process is completed and the benefits of the vaccine are considered to be much greater than any potential risks.

Now, on the second question, do you ask Senator around the-

(deleted waffle)

Excuse me, sorry, doctors are charged with the responsibility of writing out a death certificate and signing it. They know the cause. They were close to a thousand of them, but they’ve been wiped by the TGA and in a review without objective criteria, down to 14. How can you justify that?

Well, I don’t think that it’s accurate for you to characterize. Well, sorry, I can’t-

Doctors reported deaths.

I appreciate the determination of the cause of death is a coronial activity. I don’t know, Dr. Pengilly, if you’d like to reflect on-

I won’t reflect on the two-

So how many of these have gone to the coroner?

Chair: So just following this and so off to go to Senator-

How many have gone to the coroner?

So look, I won’t answer the question regarding the thousand reports, but I think the issue Professor Lawler is making is that just because he gets a report and obviously the report of somebody has died, they have died. What we’re actually trying to do is then determine whether that is actually related to the vaccine or to any product. And that is a determination which has to be made by further examination of the circumstances, temporality, whether there are other causes. And that means that a large number of the reports eventually are found not to be associated. And there are a whole range of criteria which you can use for those. I won’t go into them, but we can provide more information on-

Could you put on notice? I want to know the objective criteria you use for changing a doctor’s report who knows the patient-

We’re not changing a doctor’s report.

The doctor reported death attributed…

We’re not- We’re not saying the patient didn’t die.

I didn’t say that. I didn’t say that. You’re misleading.

Well, I’m accurately projecting- We’re not changing a doctor’s report.

We’re happy to take that on-

I want the objective criteria by which you change a doctor’s reported death due to a vaccine. Back to ot associated with the vaccine-

We’re very happy to provide the senator with information on the process that is followed. Following the report of the death, following vaccinations. (13)

These are the two bills relating to this Senate Hearing: (14)

  • “COVID-19 Vaccination Status (Prevention of Discrimination) Bill 2022 (15)
  • Fair Work Amendment (Prohibiting COVID-19 Vaccine Discrimination) Bill 2023″ (16)

The first hearing was held on the 2nd of May 2023. Download the Hansard transcript. (17)

Aug 3 2023 Hansard. Download the Hansard Transcript (18)

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Penny (PennyButler.com)
Penny (PennyButler.com)

Truth-seeker, ever-questioning, ever-learning, ever-researching, ever delving further and deeper, ever trying to 'figure it out'. This site is a legacy of sorts, a place to collect thoughts, notes, book summaries, & random points of interests.