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Replace Health Pharmacrats With People-First Health Care

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One thing that has come out of the COVID response is how it’s exposed the pharmaceutical industry to more scrutiny from the public than ever before. More questions have been raised about the Therapeutic Goods Authority (TGA) and our Health Pharmacrats than ever before. Yet, what is the alternative?

In this parliamentary speech, I put it on record that we must look at the influence of pharmaceutical companies on the education system for medical professionals, and the relationships between pharma giants and former health department executives. The toxic, inhuman killer ‘pharmaceutical only’ model is failing Australian taxpayers. People are dying needlessly.

As an example, Albicidin is a natural antibiotic with clear potential to become our leading antimicrobial. It’s proven to not create resistance. Albicidin could be, and most likely is the answer to antimicrobial resistance. There are many others, but they don’t get patented. They don’t receive sponsorship and therefore they don’t get approved.

It’s time for an entirely new medical paradigm. One that puts humans first, not big pharma.

Antimicrobial resistance is the new climate change, allowing for control over agriculture, medicine and household and industrial cleaning, in the name of reducing use of antimicrobials. That’s why an alternative solution, using an antimicrobial that doesn’t cause antimicrobial resistance, is being ignored and quietly buried. It’s to protect globalist profits and to control people – and to hell with human and animal health and safety!

Globalists WANT control. Globalists NEED control to complete their agenda.

Australia needs a customer consumer advocate, or natural product advocate, to advance natural products that can’t be patented, yet are safe and effective treatments — products to be listed under Schedule 4 and offered under the PBS as frontline medicines. Not watered down products sold in supermarkets as complementary medicines so that their efficacy can plausibly be dismissed.

Instead of advancing people-first health care, our Pharmacrats are actively promoting mRNA vaccines and medications to the commercial benefit of big pharma. This is caused by “the patent cliff”, which refers to the expiration of patents on popular drugs, leading pharmaceutical companies to face intense competition from generic drug makers, dramatically reducing their profits. The new mRNA technology allows big pharma to replace off-patent drugs with newly patented mRNA drugs at prices that guarantee their profits for the next 30 years. Our health authorities are actively promoting this solution to the patent cliff, despite the myriad of adverse health outcomes from the mRNA vaccines.

Why? These are important matters that can only be answered by a Royal Commission.

What should not wait for a Royal Commission is a system to incorporate affordable, natural remedies into our health approval process. This could be implemented immediately if the Pharmacrats were interested in providing people-first health care.

Transcript

Where’s the scrutiny on our health authorities? During COVID, drugs were rushed through that would never have been approved on safety and efficacy grounds, such as molnupiravir and remdesivir. Last year, these two inhuman pharmaceuticals cost taxpayers $1 billion. Alternatively, tried and tested drugs that are out of patent could have been used for a fraction of the price. Remember that our authorities and the mouthpiece media called ivermectin ‘horse paste’. The statist Left rushed to demonise anyone who defended ivermectin, because the control side of politics—the so-called Left—loves to follow orders. Ivermectin is a Nobel-Prize-winning antiviral for humans. Over 40 years, it has saved millions of lives. Around the world, it’s now been proven safe and effective as an early-stage treatment for COVID, as it always was.

Our health authorities demonised ivermectin to prevent early-stage treatment of COVID in order to build demand for an untested novel mRNA vaccine. How many died because of the long-term strategy that our health authorities followed and pushed—a strategy to use COVID as a cover to introduce a class of mRNA drugs that the public would have rightly baulked at and rejected? How many died from the side effects of mRNA technology—technology that was not tested in Australia and was not tested off the production line, for which the method of production was changed after overseas testing and approval and the fake trials were at best shambolic and at worst criminally negligent?

Why would our health authorities tolerate this? Simply because of a thing called the patent cliff. Pharmaceutical companies are profitable because they develop a new drug and then get a patent, exclusive sale of the drug for 25 years. Drug companies can afford to put that drug through the approval process because once it’s approved they add the approval cost to the selling price—kerching, kerching!

The system of drug patents has created a $2 trillion industry whose tentacles of influence extend to political parties, who happily accept donations, and to health authorities. Their tentacles extend to the USFDA and Anthony Fauci’s National Institutes of Health, who hold patents on drug processes they license to big pharma in return for hundreds of millions of dollars in personal royalties. Their tentacles extend to the World Health Organization, the United Nations and the World Economic Forum, whose young global leaders sit in this parliament.

This is influence that our healthy authorities cultivate while coveting lucrative careers in the pharmaceutical industry. For example, just eight months after approving Pfizer’s untested COVID injections, Professor John Skerritt, former head of the Therapeutic Goods Administration, the TGA, is now on the board of the pharmaceutical industry lobby group Medicines Australia. This isn’t the normal operation of a free-enterprise system that One Nation would support; this is a cabal of greedy, unprincipled, evil individuals treating everyday citizens as cash cows. They want everything you have for themselves, including your health.

The patent cliff is upon us. There’s increasing urgency—desperation—in the measures being rammed through government. Two-thirds of the revenue is from drugs being sold to you that are out of patent now or will go out of patent over the next five years. That threatens big pharma’s harvesting of humans for profit. Modern drugs, once out of patent, can be made for cents per tablet. India specialises in that. Australia used to, and we can do it again. The patent cliff threatens the entire pharmaceutical industry and stops the ability of chemical pharmaceuticals to do better than they do now, in terms of profit.

From where are the new patents going to come? I’m glad you asked, Mr Acting Deputy President: from mRNA of course. There are 400 new mRNA vaccines and drugs currently under development. Such is the expected volume of these things that two manufacturing plants are being prepared here in Australia. Our health authorities decided to press ahead with mRNA technology to save the pharmaceutical status quo—the pharmaceutical gouging of people to extract exorbitant profits. Patient harm apparently no longer matters.

Last week, a study of 99 million COVID-jab users, including in New South Wales and Victoria, found the product was not safe. The study was published by Elsevier, for more than 140 years the world’s leading scientific publisher and data analytics company. The study showed the following conditions were occurring above baseline levels: brain and spinal cord swelling, up 380 per cent; blood clots, up 320 per cent; Guillain-Barre syndrome, up 250 per cent; and myocarditis, up 278 per cent for Moderna and up 350 per cent for Pfizer. After a second injection, myocarditis was up a damning 610 per cent and pericarditis was up 690 per cent. I told you so four years ago. Many good people warned that COVID products were not tested, that they were experimental, and that forcing them on the general population was an insane, inhuman abuse of government power. Now look at those figures. It’s another area for a royal commission to investigate.

It’s time for an entirely new medical paradigm in this country and throughout the West. Pharmaceutical companies are embracing mRNA as their saviour because it can be patented. They can charge whatever they want for it, and compliant health bureaucrats like our TGA, acting out of self-interest, protect pharmaceutical companies from financial harm. The expert medical advice the TGA relies on comes either directly from drug companies or from advisers who have worked for big pharma, who have accepted research grants or sponsorship from big pharma, or who covet doing so in the future. After all, $29-million Sydney harbourside mansions don’t just buy themselves.

These are things that make for a royal commission. One thing that should not wait for a royal commission is a system for getting cheap, natural remedies into our health approval system. Australia needs an office of the consumer advocate to oversee complaints and the harm bureaucrats cause—bureaucrats who appear incapable of acknowledging odious and obvious adverse events. We need a customer consumer advocate or a natural product advocate to advance natural products that can’t be patented but are safe and effective treatments—products to be listed under schedule 4 and offered under the PBS as frontline medicines, not watered down and sold in supermarkets as complementary medicines so their efficacy can be dismissed. Albicidin, for example, is a natural antibiotic with clear potential to become our leading antimicrobial. It’s proven to not create resistance. Albicidin could be the answer, and highly likely is the answer to antimicrobial resistance.

Antimicrobial resistance is the new climate change, allowing for control over agricultural, medicine, and household and industrial cleaning in the name of reducing use of antimicrobials. That’s why an alternative solution, using an antimicrobial that doesn’t cause antimicrobial resistance, is being ignored and quietly buried: to protect globalist profits and to control people—and to hell with human and animal health and safety! Globalists want control. Globalists need control to complete their agenda.

Take another example: blushwood is an Australian native berry. It was shown, in a 2014 test, to kill skin cancer in just 10 days. Did our health authorities rush to understand this plant and bring a potentially lifesaving medication to market? No; they did not. Another one: conolidine is a natural treatment for severe pain. Ignored! Natural remedies include cannabis. Senator Pauline Hanson has led way, advocating for medicinal cannabis since 1996. I joined her, and now there are others.

A recent paper pointed out that natural products work differently to chemical products, yet our system for understanding and testing substance efficacy is geared to chemical drugs. The paper and system offer a new way of measuring efficacy that confirms plants like cannabis and conolidine do work, and explains how they work. The truth is this: currently only when a product is patented and presented as the TGA on a plate, ready for the TGA’s rubberstamp, does it enter our pharmaceutical system. I urge the Minister for Health and Aged Care to introduce a consumer natural products advocate to provide much needed supervision and accountability over our health authorities. Failing that, I ask the Greens to consider if the agency they’re establishing with the Legalising Cannabis Bill would be better suited to handle natural medications in general—those that the TGA refuse to handle in addition to cannabis.

I’m not offering medical advice on the examples I’ve used in this speech; I’m asking why the health department and medical schools first response is to the scalpel and the prescription pad instead of natural medications that cost a fraction of the price. We must have an independent office in the TGA with the budget to sponsor natural alternatives through the safety, testing and efficacy stages, and to have these promoted to doctors who most likely have never even heard of them.

We must look at the influence of pharmaceutical companies in the education system for medical people, in their relationship with former health department executives and their influence through advertising and sponsorship. The toxic inhuman killer ‘pharmaceutical only’ model is failing Australian taxpayers. People are dying needlessly. Stop so-called health authorities committing homicide, child homicide, infanticide. As a servant to the people of Queensland and Australia, I say call a royal commission now and make an immediate start on the obvious reforms to our health administration that we need.

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TGA and Pharmaceutical Interests Are Too Close

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I questioned the Minister and the Senior Health Department Bureaucrats about the behaviour of former TGA head, Professor Skerritt, who spent 11 years in charge of the TGA before resigning last year and soon after accepted a position on the board of Medicines Australia. This is the peak body representing and lobbying for pharmaceutical companies. The deputy chair for instance is the Head of Pfizer in Australia.

The answers I received in this session highlight that former senior bureaucrats like Professor Skerritt only have one rule to follow—they can’t lobby the Government for 12 months. That’s the only rule applying to former senior health officials. That’s not good enough.

Professor Skerritt and the TGA spent the COVID years dismantling and re-assembling Australia’s drug assessment process to provide drug companies with streamlined approvals, free from the need to provide testing of brand new drugs. Approval has gone from active inquiry to a desktop review of provided literature, before rubber-stamping. This appointment does not pass the pub test.

A Royal Commission must look into the TGA’s behaviour during COVID and the changes made to our drug approval process, without public debate.

Transcript

Senator ROBERTS: Thank you for being here again today. Professor Skerritt’s career includes a period as deputy head of the Department of Health and Aged Care and as head of the Therapeutic Goods Administration. Eight months after leaving the TGA, Professor Skerritt has been appointed to the board of a lobby group, Medicines Australia—in fact, the leading pharmaceutical industry lobby group. The deputy chair of that organisation is the Managing Director of Pfizer. There are other members on the board who are heads of other companies. As head of the TGA, Professor Skerritt introduced the mRNA into Australia and provided authorisation—without testing, as he admitted to me—creating a whole new industry that he is now working in. Does this sound like an appropriate arrangement to you? It sounds like a massive conflict of interest to me. It’s just brazen, like the rules don’t apply to him—or are there no rules?

Mr Comley: I don’t know whether Professor Lawler or Ms Balmanno want to comment. There are rules in terms of former public servants and what they can do, but those rules are largely limited to lobbying activities related to their previous departments. There’s not a broader prohibition on their activity in related areas that they’ve worked in the Public Service.

Senator ROBERTS: He has joined the most significant, powerful lobby group for the pharmaceutical sector, which he was previously regulating.

Mr Comley: As long as he’s not undertaking lobbying activity to us—I think it’s in a 12-month period—that is appropriate.

Ms Balmanno: His obligations in relation to confidentiality of any information gained while in the Public Service continue to apply.

Senator ROBERTS: Let’s unpack that a bit further. This is what Medicines Australia’s latest annual report said about Professor Skerritt: After 11 years leadership of the TGA, Prof John Skerrit retired in April Professor Skerritt has been a cornerstone of our health system for many years. … Medicines Australia and member companies worked closely with his Department during the Medicines and Medical Devices Review, and the rapid registration of COVID-19 vaccines and treatments. On behalf of our industry, members and Board, we thank him for his service and dedication to Australia. Medicines Australia hired him as a thankyou for tearing up years of prudent drug approval and testing while authorising a whole new mRNA drug industry with no testing. How could you read this any other way?

Mr Comley: I’ll allow Professor Lawler to comment first and then I may come back. I do note the point Ms Balmanno made that the obligations for confidentiality and use of information are still retained even when someone has left the service.

Prof. Lawler: Thanks for the question. I recognise that there are a number of underlying elements to your comments around testing and evaluation that I don’t think are necessarily the main thrust of your question. I would highlight that our interaction with Medicines Australia is predominantly through our very well publicised stakeholder engagement processes. We don’t interact directly with the board. We don’t receive lobbying approaches from board members of organisations. We haven’t received any lobbying approaches from Professor Skerritt. The decision—

Senator ROBERTS: With respect, I’m not talking about the board interacting. I’m talking about a former senior member of TGA—the senior member; the head of the TGA—now being on the Medicines Australia board.

Prof. Lawler: Working on the board. As Ms Balmanno and the secretary have highlighted, there are code of conduct provisions that relate to the lobbying activities of former senior employees. We’re not lobbied by Professor Skerritt. We interact with Medicines Australia as we do—

Senator ROBERTS: I’m not talking about that. I’m talking about—

CHAIR: Senator Roberts, you do need to allow Professor Lawler to finish his sentences. Professor Lawler, please continue.

Senator ROBERTS: Sorry.

Prof. Lawler: I may be incorrect in this, but I’m taking that there is undue influence being applied to the decisions of the TGA by a former senior leader of that organisation?

Senator ROBERTS: No, that’s not what I’m—

Prof. Lawler: Sorry. I would ask for clarification then.

Senator ROBERTS: My question is: is his appointment a reward for work he has done in the past?

Prof. Lawler: Thank you for the question. The decisions that are taken by Medicines Australia on who does or does not sit on their board are questions for them.

Senator ROBERTS: It certainly doesn’t look good. It looks like he’s being rewarded for things he’s done for them in the past when he was head of the TGA. The Chief Executive Officer of Medicines Australia is Ms Elizabeth de Somer. Is this the same person who was a member of your Health Technology Assessment Policy and Methods Review reference committee, which is a paid position responsible for: … ensuring that our assessment processes keep pace with rapid advances in health technology and barriers to access are minimised. That’s from your website. Barriers to the entry of her products. Are we paying the pharmaceutical industry to promote pharmaceutical industry agendas to neuter our approval process? This is not looking good.

Mr Comley: I will ask Ms Shakespeare to comment.

CHAIR: Senator Roberts, I do ask that you direct things to the officials as questions. It’s reasonable to ask questions of them.

Senator ROBERTS: I did. I said, ‘Barriers to entry of her products’—

CHAIR: My hearing of it was that it was a statement, given how you finished.

Senator ROBERTS: My last words were a statement, but my question was: are we paying the pharmaceutical industry to promote pharmaceutical industry agendas to neuter our approval process?

CHAIR: Followed by a statement. Please continue; I just remind you to please direct things as questions.

Mr Comley: I will throw to Ms Shakespeare, but I’ll make a general comment that, where we, or other departments within government, are supporting reviews of policy matters that affect a range of stakeholders, it’s not uncommon for those stakeholders to be part of that review process. It’s also not uncommon for those stakeholders to be very clear when people declare what conflicts of interest they have and that people be aware of that. But there is a real balance here in having appropriate expertise in the room, including of what will happen on the ground, with making that policy process. Most of those reviews—almost all that I can think of—are never the final decision-maker. They make an input to government decision-making which is informed by their experience on the ground. Ms Shakespeare may have some further information.

Ms Shakespeare: Ms de Somer, who’s the Chief Executive Officer of Medicines Australia, is a member of the health technology assessment review panel. The membership of the review panel was established under an agreement between the government and Medicines Australia, called a strategic agreement. She’s not paid for the work on that; it’s not a paid position. It’s a review led by an independent chair and it has other experts on it, including the Chair of the Pharmaceutical Benefits Advisory Committee. It has two consumer representatives, a government representative and also experts in health technology assessment.

Senator ROBERTS: So the government has a—I’m sorry, continue.

Ms Shakespeare: As Mr Comley said, the review is currently underway. It’s going to prepare recommendations to the government, but the government will decide whether or not it implements those recommendations.

Senator ROBERTS: So the government has an agreement with Medicines Australia?

Ms Shakespeare: We have a strategic agreement with Medicines Australia. We’ve got strategic agreements with a range of different groups.

Senator ROBERTS: Where is the talk about ensuring safety across long-term use, which used to keep Australia safe for generations? Now it’s all about, it seems, not costing pharmaceutical companies money and approving killer drugs, like remdesivir and molnupiravir, that would never have been approved on a cost-benefit safety analysis before Professor Skerritt rewrote the rulebook. Are you aware of this?

Prof. Lawler: Sorry, I’m struggling. There were two questions there, and I’m not quite clear on what it is that you’re asking. Are we aware of—

Senator ROBERTS: Are you aware of Professor Skerritt’s involvement in approving antivirals molnupiravir and remdesivir, which are killer drugs, it seems—they’ve got very bad records overseas. What I’m saying is: rather than putting safety paramount, are the TGA and the department of health removing barriers to pharmaceutical company approvals?

Prof. Lawler: I see. Thank you for the question, Senator. No.

Senator ROBERTS: The patent cliff is a real problem—I’ll explain what that is in a minute—facing the pharmaceutical industry. Billions of dollars of sales are at risk as patents expire around the same time, producing a loss of revenue totalling $200 billion this decade for the pharmaceutical companies. MRNA technology, which has not been tested, will be the saviour of the drug industry, allowing drugs that are now off patent to be replaced with new mRNA drugs. I understand that in America they’re favouring two companies, one of which is Pfizer. That means the new drugs will be subject to patent, meaning profits all around—wonderful!—except for taxpayers.

Minister, has your government—and the previous government—made a deliberate decision to allow patents on these novel mRNA products to save the profitability of the pharmaceutical industry over considerations of safety and financial cost to taxpayers?

Senator McCarthy: I might start with acknowledging that Professor Skerritt did a commendable job in his previous role, and we certainly wish him all the best in what he’s doing going forward I think your questions place a slur on people’s character, and you might want to have a good look at that. People who move on, whether it’s in political life or in other forms of organisations, deserve the opportunity to move on.

Senator ROBERTS: And I want to protect the taxpayer by making sure there are no conflicts of interest. You didn’t answer my question, Minister.

Senator McCarthy: I’ll take your question on notice.

Senator ROBERTS: I will repeat it. Has your government—

CHAIR: Senator Roberts, you don’t need to repeat it. The minister’s taken it on notice.

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Pharma Exclusivity in TGA Processes a Barrier to Natural Products

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Before a drug or natural therapy can be approved by the “regulator” — the TGA — it must have a sponsor whose job is to pay the license fee, fill out the paperwork, and prepare safety and efficacy reports. These can be overseas because we no longer require local trials for new drugs. Drug companies are happy to develop new drugs and sponsor the applications because they have 25 years to get their money back from the patent which gives them exclusive rights to the product’s profits. After that, a product can be ‘generic’ or off-patent and any pharma company can make it.

Natural products such as cannabis and Aboriginal medicine from native plants cannot be patented which means nobody can afford to act as a sponsor. The result is the only thing doctors can prescribe are patented or ‘generic’ pharmaceutical drugs.

I asked why there is not an office of the consumer advocate who can sponsor natural therapies like Cannabis and Albicidin (a natural antibiotic). Instead, the TGA chose to speak about their program to re-purpose pharmaceutical drugs that have already been approved for different uses. This answer really shows the pharmaceutical mindset our health administrators have. The legislation needs to be changed to give natural products a path to market.

Transcript

Senator ROBERTS: Thank you. That leads to another point. It opens it up from this one. We have a system that says that, unless a product has a sponsor, it will never be approved. This isn’t the TGA system. They don’t write policy. This is a department and minister problem. There are multiple studies on the efficacy of medicinal cannabis for some conditions, and yet they’re not listed in schedule 4. There are 150 substances in Aboriginal medicine, yet only two have been commercialised, because natural products, even with postprocessing, can’t be approved by your system, because, without a patent, nobody will sponsor the product. Minister, why is there not a public advocate within the department that can bring natural remedies to the people under poison schedules 2, 3, 4 under the PBS where appropriate? 

Senator McCarthy: I will refer to the department. 

Prof. Lawler : As you highlighted and as we’ve discussed previously, the act does require a sponsor to bring medicines for evaluation. There are a number of reasons for this, and not least among them is the fact that, once a medicine is listed on the Register of Therapeutic Goods, there is a need for postmarket surveillance, pharmacovigilance, and safety and quality assurance, so it’s obviously very important that there be a point of accountability for these medicines. We are undertaking some work in terms of a repurposing initiative, and I will ask Mr Henderson to speak to that. It is about ways in which some of the medicines that are currently on the market can be used in other ways and how that might extend beyond the current sponsorship arrangements. 

Mr Henderson : As part of the last budget, the government approved funding of roughly $10 million over four years for the TGA to initiate a repurposing program for medicines. The context or the objective of that program is to incentivise sponsors—and non-pharmaceutical sponsors as part of that as well—to come forward with submissions to the TGA for medicines that are predominantly used off label. They are registered on the ARTG, the Australian Register of Therapeutic Goods, but for indications for which it may not have been feasible for low-population groups or niche population groups to have had a sponsor come forward in the past, so we’re looking to implement a program where we incentivise through waiving fees associated with the regulatory fees and charges as well as through working closely with our colleagues in the reimbursement space in relation to processes through the PBAC, pharmaceutical benefits and fee waivers. 

Senator ROBERTS: Thank you. So there may be some hope. 

CHAIR: We will return to this after the break. 

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The TGA are Administrators not Regulators

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Until a few years ago, new vaccines and drugs were required to have local safety testing and went through a process that took years. This ensured a high degree of safety. During the COVID period, the Therapeutics Goods Administration (TGA) waved approvals through for new technologies (e.g. mRNA injections) and new drugs in a matter of months. Included in this new streamlined approval process were Molnupiravir and Remdesivir.

Remdesivir was refused approval for 20 years owing to serious side effects in trials, including death. Molnupiravir also has a long history of failure. There are multiple studies out recently that show it is simply not effective against COVID, and yet this is the #1 drug on the Pharmaceutical Benefits Scheme. Australia spends $650m a year on Molnupiravir.

I asked why we approved a drug with so much evidence showing negative efficacy and fatal outcomes, including cancer, to replace the Ivermectin + Zinc combo, which costs a fraction of the price and has been proven safe and effective across many years.

I also raised the question of who supervises the supervisor — the TGA. “Nobody” was the response. That answer highlighted the overly cosy relationship between the international pharmaceutical movement and Australian pharmaceutical companies. The TGA requires further inquiry.

A Royal Commission is the only institution in Australia with the powers of inquiry to understand how the TGA has gone from regulator to administrator, seemingly with none of the customary vigilance.

Transcript

Senator ROBERTS: My questions are to the TGA, and these questions go to the approval for molnupiravir. This is a drug developed in 2014 to treat encephalitis. It was then repurposed for influenza but was discontinued after concerns it was mutagenic. Merck then bought the company and used their influence with regulators—such as the TGA, apparently—to have the product approved as a treatment for COVID. This was on the back of a single trial where the preliminary results supported the application but the final results showed that, if anything, it had negative efficacy. Given the weight of evidence, in study after study, that molnupiravir has zero to negative efficacy, why is it still approved?

Prof. Lawler: While one of our medical officers, Dr Kaye Robertson, comes to the table to respond, I would just highlight a couple of things. I take the comment that you made that the drug company used its influence on the TGA. There is a process that we follow, obviously, in the evaluation of all medications. Sponsors bring them for evaluation of safety, quality and efficacy, and that’s the process that is undertaken, rather than one of influence. I think it’s important to note that. In terms of the question you raised around why the medication is still approved for the indication that it has, I’ll ask Dr Kaye Robertson to respond to that.

Dr Robertson: The TGA considered the evidence to support the approval of molnupiravir from the dossier that was submitted by the sponsor, in accordance with our standard processes, and drew the conclusion that, at the time, the benefits outweighed the risks. In terms of the specifics of any subsequent information that has been provided to the TGA, I am actually not in a position to comment with certainty. This is not the area I work in particularly, and I think we would be best advised, if the senator pleases, to take this question on notice and provide you with further detail.

Senator ROBERTS: I appreciate your giving that offer and I will accept your offer for the question to be answered on notice. It does surprise me that approval was given on a single trial where the preliminary results supported the application but the final results showed that, if anything, it had negative efficacy. The weight of evidence, in study after study, shows zero to negative efficacy, so I’m amazed that it’s still approved. The approval required Merck to continue to provide ongoing safety data and testing around mutagenicity and interaction with the mRNA vaccines. Have they done that, and does the data justify retaining approval?

Dr Robertson: I have before me the AusPAR that was published in relation to the studies that assessed the risk of mutagenicity. We can provide that to you in our response. I am reading from that, and it says: ‘Molnupiravir and NHC were mutagenic in the bacterial assay (with and without metabolic activation). Molnupiravir and NHC were not genotoxic in in vitro and in vivo micronuclei tests, and in vivo mutation assay at the cII locus (in Big Blue Transgenic F344 Rats). Equivocal results were obtained in an in vivo Pig-a mutagenicity assay … Carcinogenicity studies are not generally required for drugs for short term clinical use. However, the sponsor has initiated a short-term carcinogenicity in … mice.’ This was put to the clinicians on the ACM and other invited experts regarding this matter. It was considered at the time that, on balance, the drug remained to have a positive benefit-risk balance.

Prof. Lawler: I thank Dr Robertson for that response. I’d also just add, Senator, that, because you’re asking for some quite specific currency and comprehensiveness of ongoing postmarket reporting, we’ll take that on notice and bring that information back to you.

Senator ROBERTS: Thank you. In 2023 molnupiravir was top of the pops, Australia’s No. 1 drug, costing taxpayers $654 million last year, at $1,125 a prescription. Molnupiravir is 26 times more expensive than the out-of-patent ivermectin-plus-zinc combo, which is about $40 per prescription. And that’s what molnupiravir replaced—proven, safe and effective. Why are you spending $654 million—on something that is highly questionable as to its efficacy and its safety—when $25 million would have done?

Prof. Lawler: I can’t speak to the specifics of the amount spent on molnupiravir, but I can certainly indicate that the second amount that you said—I didn’t catch the amount—

Senator ROBERTS: The ivermectin-plus-zinc combo is $40 per prescription, and the total for the year would have been $25 million.

Prof. Lawler: I think that the comparison is flawed, in that there is no credible, supportable evidence that ivermectin and zinc is an effective treatment. So I’m not convinced that you are—

Senator ROBERTS: There is no credible evidence? There are 100 papers.

Prof. Lawler: I’m not convinced that the comparison is sound.

Senator ROBERTS: You based the decision on molnupiravir on one paper, and you’re ignoring 100 papers proving ivermectin’s success. Does anyone question the process—

CHAIR: Sorry, Senator Roberts; I’m going to give Professor Lawler an opportunity to respond to that.

Prof. Lawler: I didn’t hear a question.

Senator ROBERTS: The question is this: does anyone question the TGA’s processes—

Prof. Lawler: Yes.

Senator ROBERTS: for approving drugs? How often do you evaluate them?

Prof. Lawler: Drugs are—

Senator ROBERTS: Who audits them? Is there an independent auditor?

Prof. Lawler: I’m not sure which question you would like me to answer.

Senator ROBERTS: All of them.

CHAIR: Professor Lawler, are you clear on the question placed? There is a mixture of questions and assertions moving around here, so let’s just step back and, Senator Roberts, please place a question.

Senator ROBERTS: The question is: how often do you scrutinise your process, and is there an external auditor who does that who is qualified to do it and to assess the process?

Prof. Lawler: The processes that we follow are continually informed by our international collaboration and also by significant interaction with stakeholders, particularly the advisory committees that we have in respect of the assessments and evaluations that we undertake for products. We also undertake, obviously, the premarket review and evaluation of medicines and other therapeutic goods, and we undertake significant postmarket surveillance of the goods as well. We have outlined in significant detail on previous occasions the postmarket surveillance that we undertake. I might ask Mr Henderson to add to that.

Mr Henderson: Senator, I think you asked about the number of submissions or medicines that we evaluate. Just for context, at the moment there are about 150 applications that the TGA is evaluating for both new medicines and changes to indications to current medicines.

Senator ROBERTS: What is the point of telling me that?

Mr Henderson: Sorry; I thought you asked that as part of your question.

Senator ROBERTS: No, I didn’t ask for the number. Who are your stakeholders? Do they include the sponsors?

Prof. Lawler: As a contemporary regulator, we have a broad stable of stakeholders. They do include industry. As with any regulator, we work to refine our processes to balance the appropriate observance of safety, quality and efficacy with appropriate access and streamlining processes to bring products to market with a minimum of inappropriate regulatory burden. We undertake annual stakeholder engagement surveys to understand the views of the TGA, and the three key stakeholder groups that we survey on an annual basis are industry; health professionals—and obviously it’s important we work with health professionals for a number of ways, in that they both inform us and are informed by our decisions—and the community. It is notable that the responses we get reflect that the TGA, among all groups, comes across as a recognised, understood and valued regulator in the Australian healthcare system.

We have other stakeholders with whom we interact. We obviously interact very closely with the state health jurisdictions, and this is for a number of reasons. Our decisions on a number of elements, such as scheduling, for example, which we’ve already discussed today, have a significant impact on the state and territory poisons legislation and how they’re implemented for the delivery of medicines. We also interact quite closely with expertise across the regulatory sector. We have a number of advisory committees, the membership of which incorporates consumer views and expertise and also those from the academic and research sectors.

It’s also important to note that we obviously have close relationships with our international collaborative regulators. We are part of the International Coalition of Medicines Regulatory Authorities and the International Medical Device Regulators Forum, and we also work closely with individual regulators such as the MHRA and the UK, European Medicines Agency and the FDA.

CHAIR: Senator Roberts, I will shortly rotate the call to Senator Rennick and then can come back to you. Is this a sensible place to pause?

Senator ROBERTS: I’ll make it a short one, and then you’ll come back to me. Spike proteins can enter the body in two ways in the context of COVID: from the virus itself and from the vaccines. What work has the TGA done on the health outcomes of the long-term retention of spike proteins by the body after the mRNA vaccines that you recommended? It’s been four years now, so some good old-fashioned science by the TGA must be available. Is there any assessment?

Prof. Lawler: As has been indicated previously, as with all regulators around the world, we undertake a significant program of post-market surveillance and pharmacovigilance. This includes having a clear and well-communicated preference for adverse events post the vaccine to be reported. Those are reported and entered into our database of adverse event notifications, and, along with examination of that and also in collaboration with partner international regulators, we are very much aware and alive to emerging safety signals and act accordingly.

Senator ROBERTS: But you haven’t done any studies on the retention specifically of the spike proteins? The COVID injections dramatically increased the spike protein. You haven’t done any studies of that?

Prof. Lawler: I’m happy to have any additional response, but what I would highlight is that our role as a regulator is to assess evidence that is brought to us, and we undertake that assessment in the evaluation.

Senator ROBERTS: So you don’t go looking for it?

Prof. Lawler: We utilise that evidence in the assessment and evaluation of products, and we utilise the pharmacovigilance and post-market surveillance exercises that I’ve highlighted.

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TGA is Rubber Stamping Approvals

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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. 

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Pharma Exclusivity in TGA Processes a Barrier to Natural Products

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Before a drug or natural therapy can be approved by the “regulator” — the TGA — it must have a sponsor whose job is to pay the license fee, fill out the paperwork, and prepare safety and efficacy reports. These can be overseas because we no longer require local trials for new drugs. Drug companies are happy to develop new drugs and sponsor the applications because they have 25 years to get their money back from the patent which gives them exclusive rights to the product’s profits. After that, a product can be ‘generic’ or off-patent and any pharma company can make it.

Natural products such as cannabis and Aboriginal medicine from native plants cannot be patented which means nobody can afford to act as a sponsor. The result is the only thing doctors can prescribe are patented or ‘generic’ pharmaceutical drugs. I asked why there is not an office of the consumer advocate who can sponsor natural therapies like Cannabis and Albicidin (a natural antibiotic). Instead, the TGA chose to speak about their program to re-purpose pharmaceutical drugs that have already been approved for different uses. This answer really shows the pharmaceutical mindset our health administrators have.

The legislation needs to be changed to give natural products a path to market.

Transcript

Senator ROBERTS: Thank you. That leads to another point. It opens it up from this one. We have a system that says that, unless a product has a sponsor, it will never be approved. This isn’t the TGA system. They don’t write policy. This is a department and minister problem. There are multiple studies on the efficacy of medicinal cannabis for some conditions, and yet they’re not listed in schedule 4. There are 150 substances in Aboriginal medicine, yet only two have been commercialised, because natural products, even with postprocessing, can’t be approved by your system, because, without a patent, nobody will sponsor the product. Minister, why is there not a public advocate within the department that can bring natural remedies to the people under poison schedules 2, 3, 4 under the PBS where appropriate? 

Senator McCarthy: I will refer to the department. 

Prof. Lawler : As you highlighted and as we’ve discussed previously, the act does require a sponsor to bring medicines for evaluation. There are a number of reasons for this, and not least among them is the fact that, once a medicine is listed on the Register of Therapeutic Goods, there is a need for postmarket surveillance, pharmacovigilance, and safety and quality assurance, so it’s obviously very important that there be a point of accountability for these medicines. We are undertaking some work in terms of a repurposing initiative, and I will ask Mr Henderson to speak to that. It is about ways in which some of the medicines that are currently on the market can be used in other ways and how that might extend beyond the current sponsorship arrangements. 

Mr Henderson : As part of the last budget, the government approved funding of roughly $10 million over four years for the TGA to initiate a repurposing program for medicines. The context or the objective of that program is to incentivise sponsors—and non-pharmaceutical sponsors as part of that as well—to come forward with submissions to the TGA for medicines that are predominantly used off label. They are registered on the ARTG, the Australian Register of Therapeutic Goods, but for indications for which it may not have been feasible for low-population groups or niche population groups to have had a sponsor come forward in the past, so we’re looking to implement a program where we incentivise through waiving fees associated with the regulatory fees and charges as well as through working closely with our colleagues in the reimbursement space in relation to processes through the PBAC, pharmaceutical benefits and fee waivers. 

Senator ROBERTS: Thank you. So there may be some hope. 

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Good Manufacturing Practice and the COVID “Vaccines”

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I have been asking the Health Department across multiple estimates a simple question. Every drug approved in Australia must be made using Good Manufacturing Practice (GMP), which is a detailed standard to ensure quality and consistency in manufacturing of pharmaceutical products.

If the “speed of science” prevented using GMP then say so. Instead, the TGA and Health Department has bobbed and weaved to prevent giving me a straight answer, and today is no different.

The last response I got was to send me a list of GMP certificates issued to Pfizer. There was no ability to check the certificates back to the injection batch numbers. This looks to me like there is a coverup to hide that the vaccines were not produced using GMP until late in the rollout. This was a decision that was not open to the TGA to make. Accepting products made in a rush may have been why the original doses were accompanied by such a high and unpredictable rate of harm. I will continue to pursue this matter.

Transcript

Senator ROBERTS: Let’s move to good manufacturing practice. I have just two questions left. At the last estimates, I tried to get to the bottom of whether every batch of Pfizer COVID injections was made using good manufacturing processes. If they were not, that may explain the huge variance in adverse events between batches. If they were made with good manufacturing processes, there is another cause we really need to understand for the huge number of excess deaths. In your answer on notice, you did not answer the question, but you gave me a list of entries in your manufacturing information database. This is a little confusing, because your answer does not allow me to check good manufacturing process certificates off against batch numbers. What your data tells me is that all of these good manufacturing process certificates were issued as a result of a desktop audit rather than an in-person inspection, which means you took the manufacturers’ word for it based on whatever it was they sent you. Is that correct?

Prof. Lawler : Thank you for the question. I would just highlight that we’ve received these questions regarding the batch testing of vaccines and the associated release a number of times before, and we’ve answered these questions—most recently, I think, SQ23-002145. Those answers are clearly on the record.

Senator ROBERTS: That’s not the one I have. Secondly, there are 44 good manufacturing process certificates for all COVID vaccines, yet there are 410 batches listed in your COVID vaccine batch release assessment. Some of those are duplications and some, admittedly, are for AstraZeneca, but the number seems off. Can you please give me on notice a full list of Pfizer batch numbers and the corresponding good manufacturing process—or is it true that good manufacturing process was only used from the bivalent vaccines onwards?

Prof. Lawler : Thank you for the question. I’m happy to either take that on notice or to return to that under outcome 1.8 when my—

Senator ROBERTS: Perhaps you could take it on notice.

Prof. Lawler : Absolutely.

Senator ROBERTS: Thank you.

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Does Australia have a Vaccine Queen Calling the Shots?

Australia’s premier vaccine sales advocate, the National Centre for Immunisation Research and Surveillance (NCIRS) is in charge of recommending if the federal government should add more vaccines to the schedule. Yet it’s the same organisation monitoring for adverse events from the vaccines it promotes. I asked the Minister if that sounds like a suitable arrangement to her. I also asked why the Chair of NCIRS is also the chair of the government’s advisory committee on vaccines. Should the person who promotes new vaccines be a different person to the one looking for harms caused by the vaccine?

I understand that grant funding received by the Chair of the NCIRS is substantial and raises conflict of interest issues.

There is an obvious reluctance to confront the possibility of conflicts of interest by the government and its drug regulatory authority. We only need to look at the situation with Dr Fauci, with his vast research grants and his position as both the advisor, the safety officer and the marketeer of the products to understand the potential for conflicts of interest leading to harm.

Transcript

CHAIR: Senator Roberts, we are coming towards the end of your block.

Senator ROBERTS: This is a scoping question to find out why the federal government funded National Centre for Immunisation Research and Surveillance is not present at estimates. They bill themselves as Australia’s leading immunisation organisation that provides expert evidence on vaccine preventable diseases and all aspects of immunisation to inform policy and planning in Australia and our region. Why aren’t they here at estimates?

Prof. Kelly: Senator, they are not an agency of the Commonwealth. They are a research institute, in fact. They do some work for us in relation to surveillance and research into immunisation, as their name suggests. We do have the chair of ATAGI online. He does not work at NCIRS. NCIRS is a very strong supporter of the ATAGI work. If there is a question specifically in relation to that—

Senator ROBERTS: Well, I understand the chair of NCIRS is also the chair of your advisory committee on vaccines, which recommends vaccines to the government. Is that correct?

Prof. Kelly: That’s a matter for the TGA. She is on that committee.

Prof. Lawler: I understand that’s correct.

Senator ROBERTS: Thank you. A program within the NCIRS is AusVaxSafety, which monitors safety signals, meaning adverse events from vaccinations through the body. There is the Adverse Events Following
Immunisation Clinical Assessment Network, or AEFI-CAN. How do you come up with all these acronyms? Here we have an organisation which, according to their About Us website page, is Australia’s premier vaccine sales advocate. The NCIRS is in charge of recommending if the federal government should add more vaccines to the schedule. That same organisation also monitors for adverse events from the vaccines it promotes. Minister, does that sound like a suitable arrangement to you?

Senator Gallagher: Sorry, Senator Roberts, you will have to repeat that.

Senator ROBERTS: We have an organisation—

Senator Gallagher: Is this ATAGI?

Senator ROBERTS: No, NCIRS. It is in charge of recommending if the federal government should add more vaccines to the schedule. That same organisation also monitors for adverse events from the vaccines it promotes. So it advocates for vaccines and it supposedly monitors for the events.

Senator Gallagher: That is not part of the regulatory framework of government.

Prof. Kelly: The TGA is the main provider of information about adverse events from vaccination. The NCIRS does run something. It’s actually on behalf of NSW Health, as I understand it, but we can place that on notice.

Senator Gallagher: The TGA provides reports regularly online.

Prof. Lawler: So in addition to what both the minister and Professor Kelly have said, the TGA undertakes both approval and post-approval monitoring of adverse events associated with approved goods. We do produce
and publish the database of adverse event notifications. I don’t know whether Elspeth Kay, our assistant secretary from the pharmacovigilance branch, would have anything to add.

Senator ROBERTS: Let’s move on. My interest here is possible conflicts of interest. Minister, you had the same person, Professor McCartney, as chair of all these bodies—the ones I went through before that question.
Should the person who promotes new vaccines be a different person to the one looking for harms caused by the vaccine? You seem to set up Professor McCartney as some sort of vaccine queen. Is it correct that Professor McCartney has received $65 million in research grants over the last five or so years? If so, what were those research grants for? What body of work did those grants produce, if anything? Could I have that on notice?

Senator Gallagher: I think Professor Kelly might be able to answer some of that.

Prof. Kelly: I can answer that.

Senator Gallagher: Can I just say as a general rule that I do think it’s unfortunate that individuals are named in this way with no right of reply in the context that you are raising this. I will put that on the record.

Prof. Kelly: Professor McCartney is the head of the NCIRS. She is a world-recognised expert in immunology and infectious diseases. She is a paediatrician who works at Westmead Hospital. She has multiple hats. She is part of an advisory group for the minister.

Senator ROBERTS: Excuse me, Professor Kelly. I’m not interested in her qualifications. I want to know her research grants.

Senator Gallagher: I think it’s deeply relevant to the aspersions that you seem to having about her.

Senator ROBERTS: I want to know her research grants—

Senator Gallagher: And her role.

Senator ROBERTS: I want to know her research grants and how much money she has received.

Prof. Kelly: I will finish, Senator. She is, as you’ve said, the chair of an advisory committee to the TGA. It does not make decisions. She is a member of ATAGI, which is an advisory group for the minister and does not
make decisions. In terms of research grants, we have the NHMRC, but they might need to take that on notice. She probably has other sources of funds. I can’t talk to the $65 million.

Senator ROBERTS: Can I get the answers on notice, please?

Prof. Kelly: We can take that on notice, yes.

Senator ROBERTS: I want a list of the $65 million in research grants over the last five years.

Senator Gallagher: I think that information would be publicly available. You seem to be able to do a fair bit of research on her. I’m sure you can do the same. If there are NHMRC grants, they will all be available publicly.

Prof. Lawler: I will add to Professor Kelly’s comments. I’m taking the imputation that the funding somehow does lead to a conflict. The two elements that you wrote—

Senator ROBERTS: No. It’s not only the funding.

CHAIR: Senator Roberts, you do need to let the witnesses finish their sentences.

Prof. Lawler: You raise two elements. One is that Professor McCartney decides which vaccines are added. As Professor Kelly has indicated, her role is as the chair of an advisory committee with the NHMRC that advises the delegate to make those determinations. Her role is to identify the harms that derive from these vaccines. That is the role of the pharmacovigilance function within the TGA.

/5 Comments/by

Government’s Health Authorities Baffled by Excess Deaths

I tabled a graph based on data from the Australian Bureau of Statistics which shows a significant spike in excess deaths. This significant increase in 2021 and a further spike in 2022 are unexplained. The graph excludes respiratory diseases and COVID, which takes out the ‘COVID confusion’ and allows us to look at other factors, such as heart disease, strokes and organ failure. The Chief Medical Officer has a primary responsibility to keep Australians healthy (and alive). He must be called on to explain why 10,000 Australians more than average have died from causes that were not COVID related.

The spike in deaths correlates to the rollout of the COVID jabs. CMO Kelly testified the jabs were not the cause, but offered no explanation of what the alternative cause could be.

They don’t have any answers for us and that is simply not acceptable. I promised to hound down those responsible for our COVID catastrophe and I will keep that promise.

The principle of Occam’s Razor, whereby the most obvious explanation is the most likely, is being deliberately ignored by agencies and advisors to the government who are reliant on the flow of funding from the companies that made these jabs. Is it any wonder there is a flat out refusal to confront the truth of what is becoming a scandal of the century?

It’s time Dr Baffled was referred to a Royal Commission.

Graph-of-vaccine-signalDownload

Transcript

Senator ROBERTS: I need to get through all my TGA questions.

CHAIR: I will endeavour to move to five-minute blocks to assist the committee progress. We will go as quickly as we can.

Senator ROBERTS: Thank you for being here. My questions are to the TGA. I would like to table these graphs.

CHAIR: We’ll consider them, Senator Roberts. We’ll distribute them. I am happy for this to be circulated to officials, but the decision on tabling will have to wait, Senator Roberts, until we have a source for the document. I don’t want to—

Senator ROBERTS: The Australian Bureau of Statistics.

CHAIR: I just need a link so we can verify the information. We’ve had issues today already with the content tabled. It can be circulated for officials to consider as part of your conversation, but it won’t go on the website until we’ve had time to consider it.

Senator ROBERTS: Sure. This is a graph of all causes of mortality in Australia over the last 10 years, with respiratory and COVID removed to focus on all other causes of death graphed as a percentage of the population. The source is the recently released ABS, or Australian Bureau of Statistics, Causes of death report, which added 2022 data. You’ll also note that the COVID measures themselves in 2020 did not have a noticeable impact on deaths, meaning there was something else in play here. You can see that the deaths bounced around the FRP, which is typical, of natural variation around 0.59 per cent deaths each year. In 2022, it shot up. That is clearly significant. What is more, the provisional deaths are still not included in the 2022 deaths. According to the Bureau of Statistics in Senate estimates last time, I think, they said that those deaths are 15 per cent below where they will end up once the coroner’s investigations are completed. That peak that you see there is clearly significant. It is going to be higher. That’s 10,000 deaths per annum unexplained and another 5,000 to 10,000 once the provisional deaths are changed with the autopsy included. This is about half to two-thirds of all casualties in World War II. If this is not cause—

Senator URQUHART: We traversed this morning. I think Senator Rennick asked similar questions this morning when you weren’t in here. I’m not sure whether they are the same and we’re going over the same ground.

Senator ROBERTS: No. I also have papers here that are available online by statistician Wilson Sy. There is a statistical evaluation of COVID-19 injections for safety and effectiveness in the New South Wales epidemic.
There is also an evaluation entitled ‘Australian COVID-19 pandemic: A Bradford Hill analysis of iatrogenic excess mortality’. He provides many graphs that clearly show correlation up and down with the injections. If this excess death in 2022 is not caused by the COVID injections, what the hell is the cause?

CHAIR: Senator Roberts, please try to keep your language parliamentary.

Senator ROBERTS: At the moment, it is 10,000. It will be 15,000 to 20,000 once the coroner’s report has come in. I will not leave this estimates session without an answer as to why so many people are dying all of a
sudden.

Prof. Kelly: I might start, Senator. Thank you for your question. I would point out that we have provided multiple answers to these similar questions over the last few months in questions on notice. It was actually, in
fact, very closely related to questions that came from Senator Rennick this morning. Your question really goes to excess deaths and the reason we are having excess deaths in Australia in the past couple of years. I will pass to my colleague Dr Phillip Gould for an explanation briefly.

Dr Gould: Senator Roberts, the statistic that you refer to around a 15 per cent underreporting of deaths in the ABS statistics is incorrect. The ABS has advised that since 2022 they’ve actually updated the way they report on deaths. That 15 per cent that was quoted to you—I understand it was quoted to you—was based on deaths which the coroner would not have included in the ABS statistics. In the data you are referring to, that has been amended.

Senator ROBERTS: Thank you for that. I didn’t know about that. I was going on what the ABS told me. That’s still a huge spike. It’s clearly significant.

Dr Gould: On that point of fact, that 15 per cent is not correct.

Senator ROBERTS: That is a huge spike. No-one has told us what is causing it.

Prof. Kelly: We did talk about it this morning. The perception you’re trying to put forward is that because there was vaccination at that time and there is excess death, that is not—

Senator ROBERTS: I’m not putting forward a perception. All I’m saying is that is statistically significant. It is a huge increase in deaths. I’d like to know the cause.

Prof. Kelly: And we don’t dispute that, Senator. I take the point that you are trying to make that there is some relationship between that graph you’ve got there and the temporal association with vaccines. We do not accept that as a premise. What we did talk about earlier today is a peer reviewed paper that has now been published that I mentioned at the last estimates. It clearly demonstrates there’s no link between the vaccines and all-cause mortality and that there is an extremely strong link between protection from COVID related mortality from vaccination. That is going back to the issue earlier of it being effective. It clearly is effective. It is not associated with this increase in mortality. There has been an increase in mortality; we don’t dispute that. You’ve removed respiratory mortality from this. It is an even more spectacular rise when you include that. In 2022 in particular, there was an increase in excess mortality respiratory related.

Senator ROBERTS: Respiratory diseases have been removed because of COVID. We know that all of the respiratory diseases have been removed. This is something other than COVID.

Prof. Kelly: Well, it may actually still be related to COVID, but it is not a respiratory disease. If we take into account that it goes to 2022. In this year, the testing for COVID has decreased, so there will be undiagnosed
COVID out there in the community, which may be associated with longer term issues, in which case—

Senator ROBERTS: Which tells me that you don’t see it as a threat. Otherwise you would still be testing.

Prof. Kelly: It’s still a serious disease. We know that there are some long-term effects. Many other countries in the world have seen cardiovascular death, for example, related to COVID. We haven’t seen that as much here in Australia. There are many of those other causes that Dr Gould went into earlier that have been potentially associated with long-term effects of COVID.

Senator ROBERTS: I will move on. Wilson Sy’s paper, by the way, shows clear up and down close correlation. I’m happy to give you the references to them later, if you want.

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Australia Needs Independent Drug Scrutiny — the TGA is Compromised

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In Senate Estimates, Professor Brendan Murphy, former Chief Medical Officer for the Australian Government and now Health Secretary, rejected the suggestion that the TGA ever took a position on vaccine mandates.

You can listen to him saying here that the government only supported mandates in limited circumstances earlier in the COVID injection roll-out. He says they were only needed in health, disability and aged care settings due to their high vulnerability.

National Cabinet had no strong position on community-wide mandates. Professor Murphy claims that everyone, including other departments and jurisdictions, took their own position. The TGA did not promote the COVID injections or mandates. Incredible!

The TGA authorised Moderna’s injection for young children with co-existing health conditions despite the fact the study is only being conducted in healthy children. That study is also not yet completed. ATAGI’s guidance is that the ‘vaccine’ is recommended ONLY for high-risk children with a comorbidity. Under questioning, the TGA admits it does not require patient level data and relies on a dossier from the sponsor (the pharma company). The ATAGI advice was that this shot be reserved for use in ‘at-risk’ children, i.e those with immuno-compromising pre-existing conditions.

I asked the TGA about reporting performances in the DAEN database of adverse events including fatalities. I wanted to know whether adverse event notifications were higher in those parts of the country where reporting is required compared to those without mandatory reporting. I’m advised that reporting rates are not higher in the jurisdictions where it is obligatory to report. The TGA has advised that consumer reporting of adverse events directly to the TGA increased by 28-fold in 2021 compared to 2020. Similarly, health professionals submitted nearly three times as many adverse event reports to the TGA in 2021 compared to 2020.

Strict independence of scrutiny for these products is clearly needed and is now being called for by a highly regarded epidemiologist.

Mortality figures for cancer are higher since the injections were introduced. The COVID products were not tested for carcinogenic properties simply because those responsible have taken the position that the substances involved don’t warrant such studies. The TGA did review Pfizer product on paper only for genotoxic and carcinogenic potential. In its dossier, Pfizer justified the absence of studies into cancer risk based on the exposure threshold concept. However, there is an absence of repeat dose toxicity data and the assessment of the stimulation of cytokine release.

Pfizer’s dossier, as sponsor of the product, adequately justified the authorisation of its use in Australia by the TGA, and so we joined what former Minister for Health, Greg Hunt, called the largest human trial and the largest vaccination trial that the world has ever engaged in.

Transcript

Senator ROBERTS: Let’s talk about approval of paediatric COVID vaccines. The TGA approved the Moderna COVID paediatric vaccine on 19 July last year for children aged six months to five years. According to
your website, this was based on the results of the KidCOVE clinical trial run by Moderna in the USA and Canada. The approval was for all children, but ATAGI’s guidance is that the vaccine is recommended only for high-risk kids having one of a list of serious comorbidities. Is that correct?

Dr Langham: I believe so. I would have to check the current ATAGI guidance, though. I can take that one on notice.

Senator ROBERTS: Thank you. The KidCOVE clinical trial is listed on clinicaltrials.gov as ‘a study to evaluate the effectiveness of Moderna’s vaccine in healthy children’—healthy children—’aged six months to 12
years’. On what basis did TGA authorise the use of a vaccine, tested on healthy kids, for use in Australia on high-risk kids with serious comorbidities?

Dr Langham: What we’ve learned throughout the pandemic is that the disease of COVID is most damaging to those with other comorbidities, and particularly people who have immune systems that don’t work well. Our recommendation, or the recommendation of ATAGI and the recommendation of the TGA, would have been to be able to support young children with precisely those conditions by demonstrating that the virus was safe and efficacious in a healthy population.

Senator ROBERTS: The study was to evaluate effectiveness of Moderna’s vaccine in healthy children, yet you’ve approved it for children with comorbidities—no basis.

Dr Langham: Again, it is the sort of thing that can be extrapolated. It was very important to be able to provide a protective therapy for young Australians who were at risk of serious illness from COVID-19.

Senator ROBERTS: You just extended the study into a completely different field without testing?

Prof. Murphy: You can’t do the clinical trials—those trials have to be done in healthy children. You wouldn’t be able to do that first in-population trial in people with severe underlying diseases. You’d have to get healthy volunteers. The ATAGI advice considers all of the other risks of COVID as well. The safety can be shown in healthy people but the ATAGI advice is relevant to the risk of severe COVID. There’s no disconnect there.

Senator ROBERTS: Your approval was in July 2021. That clinical trial finishes in November 2023, so it is not even finished yet. The TGA must have worked from interim documents. Did the TGA evaluate the patient-level data, or did you just take Moderna’s word for it, like you took Pfizer’s word for it?

Mr Henderson: The Moderna vaccine was approved through the provisional pathway, which is a wellestablished pathway. It was an established pathway before the pandemic. That allows for approval based on
interim clinical data, and data will be supplied on a rolling basis over a period of time.

Senator ROBERTS: Did you evaluate the patient-level data before you approved it?

Mr Henderson: We have answered questions in relation to patient-level data. At the TGA, we do not require patient-level data. We do require clinical data that is sufficient evidence from the sponsor of the vaccines.

Senator ROBERTS: So you relied on sponsors of the vaccines?

Mr Henderson: We relied on the dossier provided by the sponsor, with clinical data provided.

Senator ROBERTS: Would this be misfeasance on the part of the TGA?

Mr Henderson: Sorry, Senator, I’m not sure—

Senator ROBERTS: Let’s move on. Quality of reports in the DAEN: the DAEN reports can come from medical practitioners and also the general public. How many of the reports of deaths from COVID vaccines
recorded by DAEN came from members of the public and how many from medical practitioners?

Mr Henderson: I don’t have those exact numbers with me. I will take it on notice.

Senator ROBERTS: Why is the first question you ask, when a person makes a report: ‘Are you a medical practitioner or a member of the public?’

Mr Henderson: It is to allow us to have as rich a dataset as we can.

Senator ROBERTS: Why is the first question that one?

Ms Duffy: It allows the triaging of the subsequent questions as you go through the form.

Senator ROBERTS: Checking these reports—my staff have checked the reports—suggests there is a waiting room at the DAEN database holding reports that have been made but not yet checked and registered, which seems logical. How many reports of COVID vaccine harm are waiting to be checked? How many of those are reports of death or serious injury?

Mr Henderson: Again, I don’t have those numbers with me. I will take that on notice.

Senator ROBERTS: Thank you. Were more reports to DAEN made by states with mandatory adverse vaccine effect notifications—which I think is New South Wales, Queensland and Western Australia, which is
only 62 per cent—as against states without mandatory reporting of vaccine harm?

Mr Henderson: Senator, could you repeat the question?

Senator ROBERTS: Was there a higher proportion of reports of adverse events from states with mandatory adverse vaccine effect reporting notifications?

Mr Henderson: I would have to take that detailed question on notice.

Senator ROBERTS: There is now a call for a vaccine safety office from an epidemiologist. He is pretty highly regarded, from my understanding. He is calling for independence in the scrutiny. When we have a
provisionally approved medication, surely, it’s even more important to have a very strict reporting of adverse events?

Mr Henderson: We have a very comprehensive and rigorous safety monitoring system at the TGA. We use a number of mechanisms to look for safety signals, as well as talking to our international regulator colleagues and sharing information in relation to safety issues with the vaccines.

Senator ROBERTS: Have you done any testing on what percentage of doctors and the public are reporting adverse events?

Mr Henderson: No, we haven’t done that study. I will take that on notice.

Senator ROBERTS: Let’s go to carcinogenicity of the vaccine. The European Medicines Agency, EMA, had a 140-page assessment report for the Pfizer vaccine. On page 55, it says: No genotoxicity nor carcinogenicity studies have been provided. It then says: The components of the vaccine are lipids, an mRNA, which are not expected to have genotoxic potential. The carcinogenicity part of that statement was skated straight over. I want to ask you about that. Did you receive any genotoxicity or carcinogenicity studies in support of the Pfizer application?

Mr Henderson: I do not believe that we did, Senator.

Senator ROBERTS: The words ‘carcinogenicity’ and ‘cancer’ do not appear in your 42-page assessment report. Did you review the Pfizer product from the perspective of cancer?

Mr Henderson: I believe there was no need for that. I will take it on notice.

Senator ROBERTS: According to the data from the Australian Bureau of Statistics, in their latest release of the provisional mortality statistics, we know that it under-represent deaths—this was from the head of the ABS the other night—by 15 per cent because it does not include autopsy reported deaths, only doctor reported. The figures for provisional mortality from cancer were as follows: based on average for January-February over the last four years, 3,637; January- February cancer deaths in 2023, 3,803—plus 15 per cent; and for 2021 it was 3,816. Both years are above trend. It should be remembered that trend includes autopsy deaths and the provisional mortality figures do not. Yet the provisional mortality figures for cancer are above the past figures. The problem is worse than these figures suggest. Let’s review: we have injections that were approved without carcinogenicity testing. We now have a spike in cancer. Can you please show me where you have investigated this spike and ruled out it being from the COVID injections? Have you even considered that?

Prof. Murphy: There is no evidence that increase in cancer risk is vaccine-associated. As Professor Langham said, there have been many billions of doses of these vaccines administered. If there was a significant association with cancer, I think the international data would have shown it. There is no evidence that there is an association.

Senator ROBERTS: The reference to lipid nanoparticles in earlier conversations around COVID vaccines suggested that the nanoparticles stayed near the injection site, then passed out of the body. Am I remembering that correctly?

Dr Langham: Senator, that’s correct. We’ve dealt with this on a number of occasions, in answer to other questions on notice as well.

Senator ROBERTS: Documents released in the Pfizer-gate court-ordered document dump showed that Pfizer knew at the time of seeking approval for their product that the lipid nanoparticles not only collected at the
injection site but significant concentrations were also recorded in the adrenal glands. A table in the Pfizer test data showed they accumulated in the ovaries, the liver, the kidneys, the brain and the adrenal glands; they go all over the body. Did you know at the time of the Pfizer application that lipid nanoparticles collected across the body?

Dr Langham: Senator Roberts, what you are describing is a particular aspect of the pre-clinical studies by which an element of the lipid nanoparticles was labelled with a fluorescent label. What is seen in those studies is the fluorescent label and not necessarily the lipid nanoparticles.

Senator ROBERTS: Is it still your position that this build-up does not have an adverse health effect?

Dr Langham: Correct.

Senator ROBERTS: Why did former minister Greg Hunt say, ‘The world is engaged in the largest clinical vaccination trial’? Why did he say that as health minister?

Dr Langham: I can’t speak for Minister Hunt’s comment; I am sorry.

Senator ROBERTS: We have dealt with other agencies and employers who relied on you, as the TGA. They cite your advice as the basis of their policies and decisions: CASA, the Civil Aviation Safety Authority, Fair
Work Commission, Fair Work Ombudsman, Department of Employment and Workplace Relations, judiciary, the Department of Home Affairs, the Department of Agriculture, Fisheries and Forestry, the NSW Council for Civil Liberties, state and federal health ministers, the chief medical officer and the chief health officer all drove vaccine mandates. The national cabinet cited you guys. Millions of people have been gutted, based on these horrendous facts and injuries, all pointing their finger at you. Do the members of the board of the TGA understand the concept of misfeasance in public office?

Prof. Murphy: There is no board of the TGA. The TGA is part of the department of health.

Senator ROBERTS: Do the heads of the TGA understand the concept of misfeasance?

Prof. Murphy: We very much understand the concept of misfeasance, and we totally reject any suggestion that has taken place. I should point out that the TGA has never taken a position on vaccine mandates. The TGA’s remit is to assess the safety and efficacy.

Senator ROBERTS: Do you support them or not?

Prof. Murphy: The Commonwealth department has supported them in limited circumstances, particularly early on, when transmission reduction was much more beneficial. We certainly supported them for aged-care
workers and disability workers. The Commonwealth department has not taken a strong position on community-wide mandates. Some of the state and territory governments have taken a much stronger position.

Senator ROBERTS: Who from your senior leadership advised former Prime Minister Scott Morrison to buy the injections, at billions of dollars, to then give them to the states, to indemnify the states, to also then provide the health monitoring data so that vaccine mandates could be introduced? The state premiers then said that they mandated vaccines on the basis of the national cabinet, which the Chief Medical Officer is associated with. Then we saw the former Prime Minister mandate vaccines in Defence, the Australian Electoral Commission and aged care. Then the former Prime Minister said repeatedly, daily, for two weeks, ‘We have no vaccine mandates in this country.’ It was a blatant lie. Did you do anything to stop him lying?

Prof. Murphy: I can’t comment on what the former Prime Minister said. I know he supported vaccine mandates in aged care and disability. That was very much a national cabinet position because of the high
vulnerability of the residents and workforce in those settings. I don’t believe national cabinet took a community-wide mandate approach. Various agencies—state, territory, Commonwealth and private sector agencies—made their own decisions about that. I don’t think it is fair to say that the TGA has been promoting vaccine mandates. It’s not their remit and they have never done it.

Senator ROBERTS: Did you do anything to stop it?

CHAIR: Thank you, Professor Murphy. Senator Roberts, I do need to share the call. Are you able to place the remainder of your questions on notice at this point?

Senator ROBERTS: Yes.

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