PM Partying Instead of Running the Country

I called out the Prime Minister’s jet set lifestyle during parliament. Australians can see how out of touch and ineffective Anthony Albanese is as a leader.

The Prime Minister has spent too much time rubbing shoulders with pop stars, sucking up to billionaires and flying around the world in long overseas trips and too little time talking with everyday Australians.

Meanwhile Climate Change Minister Chris Bowen and his Ministry of Misery is making life harder for everyday Australians with every new net zero measure.

This is a PM who clearly cares more about globalists and celebrities than he does for the people of the country he was born into.

If ever the comparison to ‘Nero Fiddling While Rome Burned’ was appropriate for a political leader, it is Anthony Albanese.

Transcript

In a speech earlier this year, I made the point that one can judge a man by the company he keeps. I observed that one of Prime Minister, Anthony Albanese’s first orders of business was a private meeting with globalist billionaire and manipulator extraordinaire Bill Gates. And I spoke to a more recent meeting the Prime Minister had with Larry Fink, chairman of BlackRock, the merchant bank that now owns Australia and tries to control Australia.

In the break, the Prime Minister once again used taxpayers money and a taxpayers plane to hobnob at concerts, exhibition openings and attend a billionaire’s birthday soiree. In so doing, the Prime Minister has demonstrated he will show fealty to anyone he needs to, in order to keep swanning around as though the weight of responsibility of running this beautiful country of ours was somehow not on his shoulders.

It’s not the job of the Prime Minister to party at a time when everyday Australians are struggling to pay their rent, pay their mortgages, find a roof to put over their heads and pay their electricity bills. Especially because of his government’s policies. Can someone on the Government benches remind Prime Minister Anthony Albanese the word party in Labor Party doesn’t mean what he seems to think it means.

All the while, Chris Bowen MP, Minister for Climate Change and Energy, and now known as the Ministry of Misery, has been out there destroying our productive capacity, making people’s lives harder. His latest policy is a tax on commercial vehicles, including utes that tradies need to be a tradie. How can a so-called party of working Australians introduce a ute tax that will make it harder for tradies to own what is an essential tool of their trade?

Have you considered what that tax will do to housing construction? It will cut house production and raise house costs. If ever the analogy of fiddling while Rome burns is appropriate to a modern leader, it’s now: Prime Minister, Anthony Albanese. What a bloody disgrace!

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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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Anti-depressants Highlight Failure of our Health Policy

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Australia has the third highest rate of anti-depressant use in the western world. My question on the rate of anti-depressant use was clearly not one the Minister or the Department were expecting. To our health authorities, a positive outcome is getting a pharmaceutical product into someone’s body and calling the job done. Yet non-medical interventions for depression are available—exercise, social interactions and human touch (social dancing being a well-recognised therapy). These therapies are being ignored and high drug use celebrated. I believe this shows a pharmaceutical bias in the Health Department’s approach to depression. It feels like the Department of Health has become the Department of Pharmaceuticals.

Cannabis is used to treat depression overseas, yet this is not available in Australia in a practical way because no pharmaceutical company will sponsor a natural cannabis product. Why? Because the absence of a patent means they can’t get their money back on the cost of the application.

Transcript

Senator ROBERTS: Let’s move to antidepressants. Australia has an antidepressant use of 89 persons per 1,000. That’s the third-highest in the world, not far behind the highest, which is America at 110. The UK has less than we do: 71. Korea is the best at only 13. In other words, we have one of the highest rates of antidepressant use in the world. Isn’t this a failure of public health policy? We’re not treating these issues with a ‘Life. Be in it.’ campaign, knowing that exercise, dancing and group socialising all help with depression. We just write a script and call it done. Minister, what happened to preventive medicine—or is it now just about money for pharmaceutical companies?

Senator McCarthy: Again, your question is loaded with all sorts of accusations which I reject outright. We do our best to inform Australians of all things. In particular throughout COVID, we worked considerably hard to engage with communities remote and regional as well as across cities, so I reject the premise of your question.

Senator ROBERTS: This is not about COVID; this is about our remarkably high antidepressant use—close to the highest in the world.

Mr Comley: Professor Singer, would you like to make any comment on that as the Chief Medical Officer?

Prof. Singer: Clearly, there are different strategies used by different practitioners in relation to depression. A lot of the access to drugs depends on the access this is available as well as cultural factors. For example, you’ve commented that South Korea has a relatively low rate. I would expect that some of that would, in fact, relate to their cultural attitudes to the use of medication to treat depression as well as to attitudes around depression itself. I think one of the things that the use in Australia probably does indicate that people are prepared to be much more open about having depression and needing help. Clearly, prescriptions in some ways do reflect that issue.

Senator ROBERTS: Thank you.

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FSANZ Handling of Lab Grown Meat is a Concern

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I asked questions about the progress of an application by Vow Food for lab-grown quail meat. This is a serious matter that will provide approval for an entirely new industry — an industry that is promoted as being environmentally friendly, while offering a high standard of food, when the truth is the complete opposite.

My questions were based on the timetable for approval published on Food Standards Australia New Zealand’s (FSANZ) own website for this application. A timetable that appears to be out of date. It’s not acceptable that FSANZ would not keep the index page for this most important of applications up to date. I trust the answers provided, which extend the timetable 8 months, are truthful.

While FSANZ are apparently calling for submissions, there has been no attempt to promote the ability of the public and interested groups to do so. This suggests the submission will be curated to provide support for the application. Lab grown meat is a massive threat to public health and safety.

The product is grown in a bioreactor and develops a nutrition profile which is directly related to the fertilizer solution added to the growing medium. Fatal bacteria such as e-coli and salmonella must be controlled. The name of the game here is profit, taking food production away from family farms that produce a healthy natural product and moving it to city-based intensive production facilities owned by foreign corporations operating for profit. I have no confidence under this model that the main input — the nutrition slurry, and the anti-bacterial protections — will not be dialled down so as to dial profits up. I will return to this topic in May.

Transcript

CHAIR: Senator Roberts, you have the call.

Senator ROBERTS: Thank you for appearing today. I’ve got a document that I’m going to try to table later. My questions are about the progress of the Vow company’s lab-grown quail meat. It appears your organisation has recommended that your board approve the lab-grown meat at its next meeting later this month. Is that correct?

Dr Cuthbert: No, that’s not correct. That process goes through two calls for submissions, so we’ve got two processes where we seek comments from any interested stakeholder.

Senator ROBERTS: Any Australian?

Dr Cuthbert: Any stakeholder. It just finished its first call for submissions on, I believe, 5 February. We received approximately 40 submissions on that first round. We’ll then be considering all of the submissions that we’ve received and go out for a second round of consultation once we’ve considered all of those submissions. There will be that second opportunity for people to comment. Only after that will we be putting it forward to the board for consideration.

CHAIR: I’m just going to provide advice on this document. I’m still seeking the source to table, but I’m happy for it to be distributed to witnesses to assist in answering questions. Then we’ll provide advice on tabling.

Senator ROBERTS: Why are there calls for comment?

Dr Cuthbert: Under the FSANZ Act there are models under which we can assess a product. The framework we utilise depends on the product’s complexity and other variables. For this one, because it’s a normal food and because of the complexity that was assessed, we determined that the process that it’s under will include two rounds of public consultation.

Senator ROBERTS: If the board approves a product, which—is that likely?

Dr Cuthbert: We’re still in the process of—

Senator ROBERTS: So it’s too early to say if it’s likely or not. When will you finish your process of consultation and listening, and make a recommendation to the board? When will the board sign off—if it signs off? I’m after rough timing.

Dr Cuthbert: I might seek input from Ms Jenny Hazelton, who’s managing the branch responsible for this piece of work.

Ms Hazelton: The normal process for applications—there are some statutory time frames for completion of that work. At this stage we’re anticipating it will be later this year when we will be putting this to the board. As Dr Cuthbert’s already indicated, we do have another round of public comment, and what comes forward in that second round of public comment will likely then determine when it will actually go to the board.

Senator ROBERTS: So it could go to the board sometime after July or maybe towards the end of the year?

Ms Hazelton: Closer to the end of the year, more likely.

Senator ROBERTS: How long will it take to be gazetted if the board approves it?

Ms Hazelton: The process from there would be that we would notify the Food Ministers Meeting of the outcome.

Senator ROBERTS: That’s federal and state?

Dr Cuthbert: Yes. That’s the representation on the Food Ministers Meeting. They have 60 days to consider that and either ask for us to review that decision or accept, and it would then go on to a gazettal after that time.

Senator ROBERTS: So they’re part of the process of approving or rejecting?

Ms Hazelton: Correct.

Senator ROBERTS: How does that process work? Is it a unanimous vote, or is it just that each state signs up or doesn’t sign up?

Ms Hazelton: It operates through a consensus. Sorry—each state and territory and New Zealand has an opportunity to vote for whether they will accept the approval or whether they will ask for a review.

Senator ROBERTS: Thank you. I referenced your document 273-23 ‘Consumer insights tracker’, which is one of these. There it is; 273-23. Are you familiar with that?

Dr Cuthbert: Our consumer insights tracker?

Senator ROBERTS: Yes. This is a supporting document to consumer literature review application A1269.

Dr Cuthbert: Apologies. Yes; thank you very much.

Senator ROBERTS: It’s available on your website, which concludes, the best name to give this novel food is ‘cell cultured,’ which makes it sound better than ‘lab grown’ or ‘Frankenfood’. I note that your language on subsequent documents uses ‘cell cultured’ or ‘cultured’. Why are you using language that promotes adoption of this product?

Ms Hazelton: We did do a literature review in terms of looking at consumers understanding of what that type of language would be. We are only at the first stage of this process—we’ve just received submissions—so that’s what we have proposed to date. That may not necessarily be what is ultimately in the final approval.

Senator ROBERTS: Your document, which was in that pile there, A1269 hazard and risk assessment, that document references the food safety aspects of cell-based food from the United Nations and the World Health Organization—both organisations I have very little regard for, but nonetheless even they list 53 potential hazards from lab grown meat. That report concludes on page 118: ‘Risk assessment was only the first part of the process of approving lab grown meat for human consumption. What needs to follow are our regulatory authorities cooperating with each other to share information around these potential health risks, which can be pretty severe.’ Rather than doing that and asking for in-depth studies, is FSANZ intending on waving these products through?

Dr Cuthbert: We will continue to do our assessment, and that assessment is quite broad, to determine the safety that needs to be considered through the process.

Senator ROBERTS: Has Vow addressed all your concerns?

Ms Leemhuis: We have received a raft of information from the applicant, Vow, but in addition to that we do look globally at what other evidence is available to inform our assessment.

Senator ROBERTS: Okay. Could you take on notice—I won’t take up the committee’s time now because we’re behind schedule—the approval processes or the steps that you take to consider an application, please? Did you ask Vow for genotoxicity studies in rats, commonly used to ascertain the safety of the product on reproduction and on the growth of cancers or organ damage.

Ms Leemhuis: We regularly ask for toxicity studies for almost all applications that we receive. I’d have to take on notice the specific studies we received for this one, although they will be referenced in the A1269 report online.

Senator ROBERTS: Including genotoxicity?

Ms Leemhuis: Including genotoxicity, yes.

Senator ROBERTS: The approval process seems to be, ‘Well, we can’t find literature that says’—this is casting the net broadly about the approval process, not necessarily yours—’this novel food is dangerous, so we won’t do the work to fill that gap and make sure this product is safe.’ That sounds like malfeasance. Have you done much work with other agencies, including your own, on whether the process is rigorous?

Ms Leemhuis: We work internationally with all of our regulatory partners in this area. We are not alone in looking at these new products coming to market, so, yes, we have regular conversations with a number of agencies globally around this, and the evidence required to assess the safety of these products.

Senator ROBERTS: Could you take it on notice to list those agencies for me, please?

Ms Leemhuis: Yes.

Senator ROBERTS: And would you characterise the exercise in some agencies overseas as just tick and flick, ‘Just approve it’, ‘Might as well do it’?

Ms Leemhuis: I’m not sure we could comment on other agencies processes, just our own.

Senator ROBERTS: Okay. How would you describe your process of assessment and approval? Rigorous?

Ms Leemhuis: Yes.

Dr Cuthbert: Yes.

Senator ROBERTS: These products, these fake meats, are grown in a bioreactor that needs to force cell growth as fast as possible to make money in what is a chemical and energy intensive process. One outcome that many authors have warned about is how the forcing of cell division leads to cancerous cells growing and that people could, in fact, be eating a product that is cancer. I don’t even see that dealt with in your risk assessment. Why not?

Ms Leemhuis: We look at the toxicity of these products and all the evidence provided for that. So, not only do we look at the end product, but we also look at all the inputs into how that product is made. Our view is informed by that.

Senator ROBERTS: Okay. These products have all the nutrition in them that is introduced into the bioreactor. You talk about nutritional value, but it appears no ongoing monitoring will be imposed on Vow to ensure they keep shovelling these nutrients in there at the same rate as the samples they send you. Is that correct? Is there any ongoing monitoring?

Ms Leemhuis: Again, I’d note we’re not finalised with our process yet. In terms of management, that will be in the next call for submission.

Senator ROBERTS: Forget about Vow for a minute. If you authorise or approve this fake meat from some company, then do you monitor the consequences of that in succeeding years?

Ms Leemhuis: FSANZ has an ongoing role in monitoring the food supplies, so, yes. But as part of our assessment process we can also impose conditions that do look to monitor these products if they are of concern or concerns are raised through the assessment that we want to continue to look at into the future.

Senator ROBERTS: I guess there’s a difference between monitoring something in closed conditions and letting it go through a manufacturing process that may or may not be sloppy—who knows what will happen in there? Listeria has been identified as a medium- to high-risk foodborne pathogen that can enter during the final stage of cell growth, meaning it gets into the bioreactor. You have identified potential risks from salmonella and E. coli. Vow have made the claim that lab meats help antimicrobial resistance by using fewer antimicrobial products in production, cleaning and sanitising their factory than natural meat. How accurate is that statement?

Ms Leemhuis: Sorry; I’m not quite sure what statement you’re referring to.

Senator ROBERTS: Vow has made the claim that lab meats help antimicrobial resistance by using fewer antimicrobial products in production, cleaning and sanitising than is the case in natural meat. Is that correct?

Dr Cuthbert: I don’t know that it’s necessary for us to comment on the accuracy of a claim that a company is making. Our job is to ensure that we’re evaluating the safety of the product that’s before us to determine if it’s suitable and safe to be circulated for consumption. Whether it’s more or less than another process is not part of the process.

Senator ROBERTS: So I guess you’ll do that assessment as part of your approval process?

Mr Comley: What’s an absolute assessment?

Senator ROBERTS: Sorry, Mr Comley?

Mr Comley: Sorry; I should leave it to the food authority. I was just saying I think what Dr Cuthbert was saying is it’s an absolute assessment rather than relative assessment against other products that are on the market at the moment.

Dr Cuthbert: Exactly.

Senator ROBERTS: Okay. Thank you for clarifying that. Your documentation, some could say, dresses up this decision as some kind of saviour for the environment. I have circulated an Oxford University article and a peer reviewed paper that finds that very energy intensive bioreactors could have worse long-term environmental consequences than livestock farming in terms of carbon dioxide equivalent emissions—CO2e. Now I don’t think the carbon dioxide production is at all a threat to humanity but, for those who do, recent calculations show that if we wanted to meet the additional demand for meat by 2030 exclusively with cultured meat we would have to build 150,000 bioreactors, which would produce 352 million tonnes of carbon dioxide equivalent as against 150 million tonnes of carbon dioxide equivalent for natural livestock farming. Why shouldn’t people conclude that approving this lab meat is a terrible mistake?

Ms Leemhuis: Just in terms of our roles and responsibilities, it really is about the safety of this product. That’s the act. It says that our role is to assess the safety of the product for human consumption, which is the role we have taken in looking at this application—

Senator ROBERTS: And not just in the lab, but in practical terms.

Ms Leemhuis: rather than the carbon emissions. That’s not within our scope to consider; it’s the safety of the product.

Senator ROBERTS: Okay. Thank you very much.

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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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Slow Start on Classification System Inquiry

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I have been asking questions about books like ‘The Boys’ and ‘Welcome to Sex’ that expose young children to adult sexual concepts and behaviours. Even worse these books do so in a way that encourages and normalises child sexual behaviour. The rating system for printed works, like these graphic novels, has failed to keep pace with the appearance of the graphic novels more than 20 years ago.

A review of the classification system for written works was promised last year by the Mininster during a meeting with me and I am still waiting for that review to start. At the moment this adult cartoon content is legal to sell to a child of any age because of a loophole in the current system.

After these questions, I hope the Minister with call the review immediately. Sexual material of this nature must be at least rated MA14+, making it illegal to sell to children under 14.

Transcript

Senator ROBERTS: Thank you for appearing, Mr Sharp.  

Mr Sharp: Pleasure, Senator. 

Senator ROBERTS: In response to a question at October Senate estimates relating to the inquiry into the adequacy of the rating system, Senator Brown made this statement. I will quote: “Informal consultation with government stakeholders has commenced. Public consultation will occur early in 2024”. I subsequently received a response to my question on notice which provided the same information. It’s early in 2024 and the Classification Board website does not mention an inquiry. Has public consultation started? If not, when will it? 

Mr Sharp: Senator, I refer you to the department on that. We have been participating in the stage 1 reforms that have been passed. That legislation has been passed. The board has been consulted as part of that. Effectively, the preparation for the implementation of that is occurring. As for the stage 2, the board has no further information on when that will occur. I refer you to the department for further information. 

Senator ROBERTS: When is the review into the classification scheme going to start? Senator Brown said that it would be starting in early 2024. 

Mr Sharp: I don’t have that information, Senator. We are a key stakeholder, but that’s a decision for the minister and the department. 

Senator ROBERTS: So I have to ask the department? 

Mr Sharp: Yes, Senator. 

Senator ROBERTS: Senator Brown, you said it would start in early 2024. 

Senator Carol Brown: And it’s very early 2024. Are we talking about the second stage of the reform? 

Senator ROBERTS: The review into the classification system. 

Senator Carol Brown: The second stage of the reform will clarify the scheme’s purpose and scope and establish fit-for-purpose regulatory and governance arrangements and improve the responsiveness of the scheme to evolving community standards and expectations. I will have to take on notice any particular date. The departmental representative can answer. 

Mr Windeyer: I caught your question. Just to assist, yes, the intention is still that public consultation will kick off early this year. A precise date I don’t have, but that remains the intention. 

Senator ROBERTS: Are we talking a month or so? 

Mr Windeyer: I don’t want to put a time on it. Yes, the intention is still early this year to commence public consultation on the stage 2 reforms. 

Senator ROBERTS: In response to my question regarding the graphic novel Welcome to sex, which I described as targeted to 10-year-olds and up—the author in fact says it’s suitable for eight-year-olds and up—Ms Jolly, who I guess is your predecessor— 

Mr Sharp: Correct, Senator. 

Senator ROBERTS: responded, and I quote: Our understanding is that the book clearly states that it is targeted to teenagers from 13 up. Here is the book, which on the flyleaf identifies the reader as an ‘apprehensive 11-year-old’. Amazon still has the listing at 10 plus. I do note that Hardie Grant, the publishers, have removed reference to an age entirely, so we’re heading in the right direction. It is unhelpful, though, to potential purchasers and where other booksellers have it listed at 14 plus. Can you clarify, on notice please, Mr Sharp, what age is the Classification Board happy with— 10 plus or 14 plus—and why? 

Mr Sharp: Senator, it’s actually not the place of the board to predict what age something should be available other than through the classification process. We’ve had no applications for that book at this time and the board has not reviewed it. 

Senator ROBERTS: It’s now self-classification, I take it, since the legislation was passed. Is that correct? 

Mr Sharp: No, Senator. That’s not correct. The stage 1 reforms did not address anything to do with publications. Publications can either be submitted for classification by the publisher or they can be called in by the director if there’s a belief that it could possibly be a submittable publication. 

Senator ROBERTS: In other words, self-publication is one of the choices or submitted to the board? 

Mr Sharp: Well, it’s not self-classification, Senator. It is the publisher choosing to have the board classify it by making an application for that. Self-classification generally is referred to as them making a choice about what that classification is and publishing it in that way. Senator ROBERTS: I thought the publisher could classify it or ask the board to classify it. I thought that’s what you said. 

Mr Sharp: No. The publisher can put it forward as an application to be classified by the board, or the board can call it in separately. 

Senator ROBERTS: Thank you for clarifying. There seems to be some backside covering going on with the publishers because they’ve started to shift the age upwards slightly. In the last estimates, in response to my question about the options available to the Classification Board for graphic novels, Ms Jolly, your predecessor said, and I quote: “I think the board’s submission to the Stevens review back in 2020 was that we felt there would be benefit in having some greater graduations in classifications”. The Stevens report did not make that recommendation at all. In fact, quoting from page 66 of his report, Mr Stevens said: “On balance, I do not consider that a compelling case has been made for an additional classification category in isolation of a more fundamental look at all the categories”. Mr Sharp and Senator Brown, will you assure the committee that your work in this imminent review will provide that in-depth look at available options that supports a legally binding intermediate classification such as MA14+ or MA15+? 

Mr Sharp: Well, Senator, it’s a good question. The board does not have any input into the scope of that review. However, I can say that on the public record the board in 2020 for the Stevens review made a submission and made recommendations around publications with the idea of harmonising and aligning all the guidelines—the film, computer game and the publication—so that they are more clear in their administering and for the public to understand. Within that, the board did note that it would make sense to abolish the existing unrestricted category 1 and category 2, which really is unclear to the public, and institute possibly an M, an R18+ or an X18+, which would align to those three categories and are well understood by the public within the film classification and computer games classification. That was part of the board’s submission in 2020. The board still has a position. 

Senator ROBERTS: We think the MA14+ or MA15+ are necessary because it’s not suitable for under 14s and it is suitable for 14s and up and 15s and up. That would fit in with your M. Is that correct? 

Mr Sharp: Well, not exactly, Senator. M is not recommended for persons under 15. MA is a legally restricted classification. 

Senator ROBERTS: What does that mean? 

Mr Sharp: It means that people under 15 years cannot purchase the publication and, similarly with a film, cannot view a film unless they have an adult doing that for them. It’s not that they cannot hold it, but they cannot purchase it or buy a ticket to it themselves. So the board’s previous submission was for an M, which is an equivalent to unrestricted. Currently, you may well be aware that unrestricted can also have an additional consumer advice of not recommended for persons under 15 years. R18 would be the equivalent of a category 1 currently, and there is X18. So the intention of the board in that submission, and our position today still, is to use classification designations that the public understands, recognises and trusts very well within the film classification area and the computer game classification area. 

Senator ROBERTS: So would that mean it would not be possible for a 14-year-old or under 14 to buy this? 

Mr Sharp: It would be strongly recommended that it’s not for that age group. But it would not be legally prohibited to do so. It would be advised that a parent make a decision around that. Parental guidance is part of that process. 

Senator ROBERTS: So you are heading in what would be the right direction for me. 

Mr Sharp: I’m pleased to hear that, Senator. 

Senator ROBERTS: But that’s what it sounds like. I’m just checking. 

Mr Sharp: I believe we’re on the same page. 

Senator ROBERTS: I don’t think under 14s should be able to get this, but let’s see what happens with your review, which is imminent. 

Mr Windeyer: Correct. 

Senator ROBERTS: We’ll ask in May. 

Senator Carol Brown: There will be more to say in due course, Senator Roberts.

Senator ROBERTS: Thank you, Senator Brown. 

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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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Steroid Testing of ADF Athletes

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Some constituents raised some concerns about the steroid testing of Australian Defence Force athletes.

At Senate Estimates I asked Sports Integrity Australia whether they have received any notifications from the ADF in relation to steroid testing.

Transcript

Senator ROBERTS: My questions go to sports integrity, Mr Sharpe. Could you briefly explain the rules around testing for athletes, as in who is eligible and who is required? 

Mr Sharpe : They’re quite broad. Our focus is on international- and national-level athletes from a testing perspective. We can test lower, but our focus and our policy is that where there’s an absence of education at a lower level, in the first instance, we wouldn’t be testing unless there was specific intelligence that would suggest we need to take a facilitator or someone out of sport. 

Senator ROBERTS: Your focus is on international level? 

Mr Sharpe : And on a national level. 

Senator ROBERTS: Can you explain why athletes that are tested are prohibited from private testing? 

Mr Sharpe : They’re not prohibited from private testing. 

Senator ROBERTS: Can they go and test themselves? 

Mr Sharpe : Absolutely. Sports do have illicit policies, where they all conduct testing around that, which is separate to our agencies. But athletes, if they felt they needed to, would not be prevented from doing that. 

Senator ROBERTS: What is the efficacy of hair follicle testing for steroids? 

Mr Sharpe : We don’t do hair follicle testing. 

Senator ROBERTS: Because it’s not efficacious? 

Mr Sharpe : We just don’t do it because we follow the world Anti-Doping Code and it’s not a part of the code. 

Senator ROBERTS: Are you aware of the Defence Force exemption from their testing regimes for competitive athletes in the Australian Defence Force? 

Mr Sharpe : No, I’m not aware. 

Senator ROBERTS: Should Defence be making you aware of any suspicions of doping? 

Mr Sharpe : I think that’s a matter for Defence. We’d certainly be willing to work with Defence if it related to a sporting event that was under an anti-doping policy. 

Senator ROBERTS: I take it they have not made you aware of any of that. 

Mr Sharpe : No, they have not. 

Senator ROBERTS: How would you action it if they did make you aware? 

Mr Sharpe : It would depend on whether the sport is a registered sport in this country and under an anti-doping policy—whether they participate in those sports or not. 

Senator ROBERTS: Thank you. That’s the end of my questions. 

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Labor Abandons Miners

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Labor voted down my amendment that would backpay miners who have been ripped off by dodgy union deals signed off by the government.

This is what I’m doing about it: senroberts.com/48vbjqm

Casual Coal Wage Theft

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