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Global Health Emergency or Corporate Payday?

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The World Health Organisation (WHO) has declared Monkeypox a global public health emergency, triggering emergency powers to drive vaccine sales that benefit big pharmaceutical companies with ties to the organisation. This decision serves corporate interests rather than public health. Regulatory agencies that are meant to protect the public fall under undue influence from the industries they regulate. The WHO is a corrupt organisation that is designed to funnel taxpayer money to its billionaire donors. Australian taxpayers gave $30 million to the WHO last year, likely as a show of loyalty.

Transparency is lacking. Major donors include Gavi, a vaccine alliance funded by corporations tied to predatory giants like BlackRock and Vanguard, who also own large shares in pharmaceutical companies. The WHO’s Monkeypox emergency, declared solely by its director-general, Tedros Ghebreyesus, highlights the unchecked power of the position. This decision created a market for four already-approved vaccines linked to companies backed by BlackRock and Vanguard, ensuring massive profits for their shareholders. A new Monkeypox vaccine is expected soon, likely fast-tracked by compromised regulators like Australia’s Therapeutic Goods Administration (TGA).

The WHO previously tried to raise alarm over Monkeypox but found little public concern, so they rebranded it as “Mpox” to push vaccine sales. This benefits the predatory billionaires who control vaccine companies, funnel money to Gavi and the WHO, and fund political parties, including Australia’s Liberal and Labor parties. Recent revelations show Anthony Fauci concealed plans to engineer a more deadly and highly transmissible Mpox virus. This “gain-of-function” research has pandemic potential and should be stopped immediately. It’s troubling that Australia’s CSIRO was involved in gain-of-function research for COVID-19, yet faces no consequences.

The WHO and the TGA have failed in their regulatory duties, serving political agendas rather than public interest. During COVID, the TGA prioritised government control over public health, and there are concerns the same will happen again with Mpox. Every Monkeypox case should be verified through public lab tests, especially as redacted data was used to justify COVID measures that harmed public health.

The time of blind trust in the WHO’s narrative is over; it’s now the age of ‘prove it’.

Transcript

The UN’s World Health Organization, the WHO, has declared monkeypox a public health emergency of international concern. This triggers WHO emergency powers to drive vaccine sales to financially benefit big pharmaceutical companies that donate to the WHO through their other commercial and ownership interests. The first thing a house of review like our Senate should do is ask, ‘Is this a legitimate decision?’ The answer is: it is not, no. The UN WHO has succumbed to regulatory capture—a troubling development in governance. That may plunge Western society into serfdom under large corporations. 

Regulatory capture occurs where a regulatory agency mandated to oversee and enforce rules to protect the public interest ends up under undue influence from companies with vested interests such as the entities it’s meant to regulate or special interest groups. This can result in the agency making decisions that prioritise the interests of these parties over the broader public interest. The New South Wales government lists six areas for regulatory capture: adherence to public interest principles; organisational culture; structure; processes; transparency; and staff experience. The WHO fails all six. 

I’ve often spoken about the corruption, cronyism and illegal behaviour of the World Health Organization; some of my WHO speeches are on my website. The WHO fails to hold staff accountable for misbehaviour, including rape and sexual assault. Its own investigators conclude the WHO is ‘rotten with rapists’—their words. It is a failure of organisational culture and of staffing quality. The WHO is a corrupt organisation whose decisions benefit its billionaire sponsors with substantial health interests. The scam is simple: take a disease that’s around for generations—firstly the flu, and more recently bird flu and now monkeypox; plant scary stories in a media desperate for clickbait articles; use the media driven fear to declare a pandemic; and then—payday!—mandate vaccines financially benefiting the billionaires that funded the media scare. This betrays the public interest. 

The WHO is a con, a fraud and a criminal enterprise designed to transfer wealth from taxpayers into the pockets of their billionaire donors and owners. It is an organisation to which Australian taxpayers gave $30 million last year despite them having $8 billion in financial assets; that donation was likely more about fealty than financing. Identifying the WHO’s donors is difficult since its annual accounts show 32 per cent of donations as ‘other’—another failure of transparency. One of the WHO’s major donors is Gavi, the globalist vaccine alliance of international academics, bureaucrats and pharmaceutical companies funded through corporate donations from companies whose share registers feature investment funds like BlackRock and Vanguard. They feature on big pharma share registries; they own big pharma. If Australia had racketeering laws this arrangement would be illegal. This is a failure in structure. 

The monkeypox declaration came from the WHO director-general, Tedros Ghebreyesus, acting alone. The process for making such an important decision is not meaningfully regulated and gives Ghebreyesus too much power to direct a worldwide health response. This is a failure of process, and it’s deliberate. The proclamation is designed to create an international market for new monkeypox vaccines. The WHO already have four approved vaccines for monkeypox: cidofovir, distributed through Pfizer; brincidofovir, manufactured and distributed through Chimerix, whose controlling shareholders include Vanguard and predatory wealth fund cronies; TPOXX, from Siga Pharmaceuticals, with shareholders BlackRock and Vanguard; and ACAM2000 from Emergent Biosolutions, whose largest shareholders are—wait for it—BlackRock and Vanguard. With these drugs the world’s predatory billionaires have decided it’s time for another fundraiser. All four drugs are off-label use—so, any day now, expect a killer new vaccine for monkeypox to be given the hosanna palm frond parade through our disgraced regulators like Canberra’s Therapeutic Goods Administration, the TGA. 

The WHO tested this scam a few years ago with a minor media fear campaign that discovered the public didn’t take something called monkeypox seriously. So they rebranded it as mpox. Amusingly, they claimed the name monkeypox was insulting to monkeys; monkeys have feelings too, you know! So mpox is monkeypox rebranded to sell more vaccines from vaccine companies who funnel the profits to the world’s predatory billionaires—those same billionaires who own the corporations that donate to Gavi and the WHO as well as fill the coffers of political parties around the world, including massive donations to both cheeks of the Liberal-Labor uniparty in this country. 

Last Tuesday, American congressional investigators revealed that, for nearly nine years, Anthony Fauci concealed plans to engineer a pandemic-capable mpox virus with high transmissibility and a case fatality rate of up to 15 per cent. That’s homicide. The gain-of-function project proposed through NIAID in America from virologist Bernard Moss was to splice genes conferring high pathogenicity from the clade I virus into the more transmissible clade II virus. The new chimeric virus or combined virus could have retained up to a 15 per cent fatality rate and a 2.4 reproductive rate—a measure of transmissibility—meaning, on average, every sick person could infect up to 2.4 other people, giving it pandemic potential. It’s marvellous, what it’s designed to do! 

We know gain-of-function research produced the COVID-19 virus. Is this monkeypox outbreak also man-made? 

Gain-of-function research serves no useful purpose and should be terminated immediately. It’s deeply troubling that Australia’s CSIRO admitted and bragged about its involvement in gain-of-function research that produced COVID-19. And now an online meme simply says: ‘They’re doing it again because you didn’t punish them last time.’ That’s truth indeed. 

The WHO fails all six elements of regulatory capture and so does Australia’s Therapeutic Goods Administration, the TGA. The TGA is not acting in public interest, which former New South Wales deputy ombudsman Chris Wheeler considers fundamental to representative democratic government. The TGA may claim that, during COVID, it was caught between the parliament, its direct employer, and the wider public. It chose to serve the government’s need for air cover for controls decided on political, not medical, grounds. The TGA should have read the findings of the 1990 WA Inc royal commission, which found: 

The institutions of government and the officials and agencies of government exist for the public, to serve the interests of the public. 

That’s clear. Yet, during COVID, the TGA chose a different path: to support their own agency, to the detriment of the public. What will the TGA do this time, with monkeypox? 

Monkeypox is transmitted through direct contact from sexual activity or intravenous drug use. A Philpot scientific study found 98.7 per cent of infections resulted from gay male sexual transmission. Transmission can occur through direct personal contact of the infected site. Infected animals can spread the disease. Asymptomatic spread, though, is, like COVID, an assertion with no evidence. The clade Ia variant of monkeypox can affect children. The clades currently circulating, though, clade Ib and II, have not been proven to infect children. 

Australia has two monkeypox vaccines approved for over-18s. Both are off-label repurposed drugs approved for smallpox. JYNNEOS from Bavarian Nordic uses cidofovir, which I mentioned earlier, as the active ingredient. Bavarian Nordic have an application in to America’s Food and Drug Administration to give this vaccine to children aged 12 to 18 and are in early testing to support their application to extend use to children aged two and above—two and above! Why does a child need a vaccine against a disease that’s predominately only transmitted through sexual contact or intravenous drug use? The case for a monkeypox vaccination program must be a very high bar for any person who does not engage in risky sexual activity. 

TGA’s website data from the 2022 monkeypox round of vaccinations in Australia shows 3,163 adverse events per 100,000 vaccinations—a staggeringly high three per cent. I note a study published in the journal Frontiers in Medicine, with authors from the University of New South Wales, entitled ‘Autoimmune blistering skin diseases triggered by COVID-19 vaccinations: an Australian case series’. This report found that COVID-19 vaccination either caused the recipient to develop autoimmune blistering disease or made the recipient’s existing condition worse. The cases are extremely rare, and, for once, I can agree with the TGA. I alert Australia to the chance that these outbreaks of a related disease could be mistaken for monkeypox. I note that autoimmune diseases and shingles—that is, herpes zoster—can intersect, and both are side effects of the COVID vaccines. If the Senate is going to be called on to support a monkeypox response, then it’s essential every case is verified through publicly disclosed laboratory testing. 

Page after page of redacted data was used to support COVID measures and the damage to public health is undeniable. It’s homicide. ‘Safe and effective’ was not one lie; it was two. People are not believing the UN World Health Organization mpox narrative. The time for blind trust is over. We’re now in the age of ‘prove it’. 

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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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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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Medicinal Cannabis Overdue for Down Regulation

Proven over thousands of years and once America’s most prescribed medicine – until Pharma realised the profits it could make from patented products – medicinal cannabis has much to offer in terms of health and well-being. With 820 varieties growing in the Australian cultivar database, there’s a cannabis strain for many individual health conditions.

The Therapeutic Goods Authority (TGA) however, insists on tight control of the industry. This inevitably has enabled criminal gangs to provide much of the domestic medicinal supply, leaving the public vulnerable to potentially narcotics-laced products in the black market.

One Nation has advanced legislation to down-regulate medicinal cannabis so that any doctor can prescribe medicinal cannabis for any patient with a medical need and have that prescription filled by a chemist on the PBS. The goal here is to remove the industry’s criminal elements while providing the widest range of quality, whole-plant and natural cannabis for individual patient needs.

The TGA has authorised a range of cannabis products for prescription under its restrictive pathways program, yet there’s no reason not to offer these products in schedule 4, for any doctor to prescribe — truly safe and effective products that have already been prescribed successfully for many years.

By restricting these products using an approval system that has buried the TGA in paperwork they never check, the TGA is just looking out for the pharmaceutical industry and ignoring the needs of everyday Australians.

Transcript

As a servant to the many different people in our one Queensland community, I was pleased to accept an invitation from Isaac Balbin, founder of cannabis.org.au, to attend last Thursday’s national cannabis industry roundtable. What a pleasure it was meeting Isaac, Rhys and their team in Melbourne and speaking with other members of parliament who, like One Nation, believe medicinal cannabis is long overdue for sensible downregulation. Medicinal cannabis is marvellous. Proven over thousands of years, in the 1920s it was America’s most prescribed medicine before Big Pharma realised it could not make as much money from a natural plant. There are now 820 varieties—and growing—in the Australian cannabis cultivar database, many developed to suit specific health conditions or needs. 

Victorian MP David Limbrick made sensible comments about where the line between government regulation for the good of society and personal freedom should be—and it’s nowhere near where it is now. Legalise Cannabis Party MLC from Western Australia Sophia Moermond spoke to the need for some level of personal growth. While we may not agree on personal growing, there was so much commonality in views being expressed. I’m excited for the potential of the cannabis industry uniting behind a sensible cannabis downregulation. 

United Kingdom member of parliament Crispin Blunt updated us on how this is progressing better in the UK than here and provided a framework for evidence-based drug policy. Now, that’s an idea I can get behind: evidence based policy on medicine. 

One of Australia’s leading cannabis doctors, Dr Nic Guimmarra, Vice President of the Society of Cannabis Clinicians, raised his concerns that the current licensing schedule has led to a situation where some disreputable cannabis clinics are pushing patients through so quickly that the resulting prescription and instructions for use are counterproductive for the patient. It’s One Nation’s belief that the heavily regulated and restricted pathway system is burying the Therapeutic Goods Administration in paperwork that it’s not checking, causing suboptimal care and, likely, patient harm as conditions worsen instead of being treated. 

This is why One Nation advanced legislation to downregulate medicinal cannabis so that any doctor can prescribe medicinal cannabis for any patient with a medical need and have that prescription filled by a chemist on the PBS. Our legislation harmonises the THC level below which a planet is hemp, not cannabis, to one per cent. This aligns with changes made in all states. The bill further adds a level of THC and CBD below which a pharmacist could sell the product to an adult without prescription. 

I was pleased to hear Michael Balderstone, President of the Legalise Cannabis Party and a legend of the Australian cannabis industry, warn that new hybrid cannabis strains with THC of up to 35 per cent were a concern needing some regulation. Thirty-five per cent THC is insane. It would suit the treatment of chronic pain and palliative care and very little else. Michael called for some commercial growth activity as otherwise development of new strains will be compromised. This is the problem with free growing without a commercial option. The plant works best when the profile of THC, CBD, terpenes and flavonoids are set to the needs of a person with a specific health condition. Unlike pharmaceuticals, with natural plant cannabis, one size is not expected to fit all. For this development to continue, it needs a commercial market presence. Consensus in the industry may ultimately fall on some level of licensed free growing. One Nation will cross that bridge, in consultation with our members, when we get there. 

Last Thursday I heard an analogy for free growing. It was the belief that, just because people can brew their own beer, it doesn’t mean people will. In fact, almost nobody does, because people can readily buy what’s needed commercially. The challenge is to take out the industry’s criminal elements while providing the widest range of quality Australian whole-plant and natural medicinal cannabis at an affordable price. 

It’s a scandal that regulatory authorities insist on tight volume controls that enable criminal gangs to provide much of the domestic medicinal supply. These are gangs that lace cannabis with narcotics and then deliberately target kids at events like Schoolies. The TGA is driving practices hurtful and dangerous to children. It’s a scandal that the minister could downschedule cannabis today yet has not done so; scheduling is regulatory, not legislative. It’s a scandal that some in the cannabis industry, including pioneers, have developed their business under the current regulatory regime environment and see downscheduling as a threat to their nice little money-earners. 

There’s no reason the entire cannabis product offering that the TGA has authorised for prescription under their restrictive pathways program could not be offered in schedule 4, for any doctor to prescribe—products that have already been prescribed successfully and safely for many years. The minister could use a regulatory instrument to make it happen today, yet he will not, because predatory billionaire owners of pharmaceutical companies pull the strings in Canberra. Australians with a medical need for cannabis don’t get a look-in. This government is saying to everyday Australians, ‘Your needs don’t matter.’  

The TGA monitors impacts of cannabis and has found that medicinal cannabis has a lower adverse event rate than prescribed pharmaceuticals. Sensible downregulation will save lives. It will provide hundreds of tailored strains of medicinal cannabis designed to ease suffering and improve the health of our society, while taking the profit and control away from crime gangs. I look forward to working with cannabis.org.au to make this happen. 

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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.

/4 Comments/by

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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TGA is Risking Your Health to Act as a Sales Agent for Big Pharma

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A cheap, safe, award-winning, generic medicine, one that has been around for decades and was readily available, was shown to save people’s lives during an outbreak of a virus. Do you think it was a good decision for Australia’s Therapeutic Drug Administration (TGA) to arbitrarily ban its availability and off-label prescription in order to save it for skin conditions? Why not just buy more of it?

Despite substantial bodies of evidence from around the world, Australia did not recognise the available proof supporting Ivermectin’s use because no ‘sponsor’ (read pharmaceutical company) brought it to the TGA. What they did do was convene a Commonwealth-funded Clinical Evidence ‘Kangaroo Court’ which declared Ivermectin had no value in the treatment or prevention of COVID19.

This completely ignored a generation of evidence that Ivermectin was an effective early stage treatment for coronavirus.

The TGA continued to ignore the new data that showed Ivermectin was an effective and safe early treatment for COVID until the jab rate was over 95%, then they allowed its use. Here’s the kicker — the TGA admits in this video they made this decision because they were worried that people would not seek vaccination if they believed Ivermectin could help them.

Regulatory capture by pharmaceutical industries is a well known concept but I’m reassured that this “doesn’t happen at the TGA”. Yet in the same line of questioning, the TGA admits that if a pharmaceutical company sponsor does not promote a drug with them, and pay the fee of course, they don’t bother to show the initiative themselves.

This is purely a transactional process, as the TGA itself admits in this senate estimates. It’s clear that there is something very wrong with the system.

Transcript

Senator ROBERTS: My questions are to the TGA. In the last Senate estimates, I asked Adjunct Professor Skerritt if the TGA was inquiring into the opportunity presented by albicidin, a natural antibacterial derived from a sugarcane virus that does not cause antimicrobial resistance. Dr Skerritt’s response was: We are very closely monitoring the science. In fact, I’m the keynote speaker next Thursday at the Australian Antimicrobial
Congress…We haven’t had a submission relating to that product because it’s still very early days, but we are monitoring…antimicrobial resistance because…it’s a serious threat.

I was concerned that was a non-answer, so I asked the minister about it, in question on notice 1449. His response was: ‘The department of health is not conducting a review into albicidin.’ Can you clear this up, please? Are you treating albicidin as a prospective revelation in the battle against antimicrobial resistance, thoroughly deserving of active research and development?

Dr Langham: The normal manner in which the TGA evaluates and assesses a product for use is through a process whereby a sponsor brings us a product, with all of the relevant research, clinical trials and a dossier of its safety and quality, and that has not happened at this stage. Until someone comes to us with this, we’re not able to do anything in terms of furthering what could potentially be a really important treatment; we’re not able to further that, in terms of making it available to the public.

Senator ROBERTS: Does the department of health have any role, ability or authority to sponsor?

Prof. Murphy: Generally, no. Occasionally, we have taken the role of sponsoring in very difficult circumstances, when there’s a drug that’s registered and available and the sponsor doesn’t want to sponsor it. But
with an experimental new drug, we would never take that role. Occasionally, there are avenues for us to support drug development through MRFF and NHMRC research. There have certainly been programs that have looked at therapeutic advances in that space. But with a new agent or a new molecule, it would be quite inappropriate for us to take a role as a sponsor.

Senator ROBERTS: The TGA is 96 per cent funded by pharmaceutical companies through fees. Albicidin is a naturally occurring substance. Can it be patented? I would say not.

Prof. Murphy: We’d have to take that on notice. It depends on the use, and patent law is quite complicated. I can’t answer that.

Senator ROBERTS: My point is: would it get a sponsor to make an application? Drug companies rely a lot on patents and making excessive profits.

Dr Langham: You would expect so, absolutely.

Prof. Murphy: If it were proven to be highly effective, I would imagine that a drug company would be very interested in pursuing it, but—

Senator ROBERTS: Drug companies have shown that they’re only interested in profits—the major ones.

CHAIR: Please put that as a question, Senator Roberts.

Senator ROBERTS: Yes, it is a question.

CHAIR: What was the question?

Senator ROBERTS: Isn’t that the case?

Prof. Murphy: No. Private companies all make a profit, but profits can often come by sponsoring highly effective new agents; that’s where they make their biggest profits. This is all highly speculative and I don’t know
that we can progress it much further.

Senator ROBERTS: The CSIRO has produced a guide to controlling antimicrobial resistance that assumes massive government power, including close monitoring and regulation of homes, pets, agriculture, waterways, new vaccines against diseases that used to be controlled by antibiotics and, of course, conferences. Antimicrobial resistance is being set up to be a massive government and pharmaceutical company gravy train. Why are you ignoring a probable solution to antimicrobial resistance? Do you want the power to order more vaccines, to wield more intrusive powers and to make more sales for big pharma, which is the history of the last few years?

Prof. Murphy: We reject that assertion. We completely accept the assertion that antimicrobial resistance is a significant problem. One of the ways that we have been, for many years, trying to combat it is to try to encourage prescribers in the use of antibiotics to reduce their use of antibiotics, which is not in the interests necessarily of the pharmaceutical industry. We are very keen to make sure that we limit the use of antibiotics to those situations where they are absolutely essential. There’s a lot of unnecessary prescription of antibiotics, and some of that is a real problem. We certainly have a lot of interest in antimicrobial resistance, and any new agent would be of interest to us. But we are not in a position to sponsor something like that.

Ms Duffy: We are in collaboration with the CSIRO in advancing their work and we have been involved in a number of CSIRO roundtables on this project that they’re going through, so we are working in lockstep with them.

Senator ROBERTS: Let’s turn to medical or medicinal cannabis. My office is getting reports that prescriptions of dried medical cannabis issued under the pathways scheme are being endorsed with the phrase ‘for
vaping’, and that requires patients to also buy and use a vape. A doctor that my office spoke to has advised that this is a TGA instruction; is that correct?

Dr Langham: Medicinal cannabis products, with the exception of two of them, are not regulated as ‘medicinal products’ by the TGA. They are available under a special access scheme, and it’s a condition of the special access scheme that the practitioner who is approved to prescribe adopts all of the undertaking to ‘consent’ patients, to understand the research, to advise on side effects and so forth. The TGA does not regulate any of the medicinal cannabis products in Australia.

Senator ROBERTS: Do you require someone who uses medical cannabis in dried form to purchase a vape— the device?

Dr Langham: It’s not our advice, no, and it would be coming from the medical practitioner, if the medical practitioner felt that there was a substance that was better done as an ointment, a tablet, a spray or a vape. I don’t know whether you’re able to add anything on vaping devices for that.

Ms Duffy: In terms of the method of delivery, it would be up to the treating practitioner to identify the most appropriate method for that patient.

Senator ROBERTS: To list a product under the Australian Register of Therapeutic Goods for prescription under schedule 4, there’s a prescribed process, which is not legislative. The steps, time frames and levels of proof of safety are all in regulation issued by the secretary under delegated powers, and much of the process isn’t even regulatory but administrative. Is that an accurate statement?

Dr Langham: I’d need help on what’s in the act and what’s in the regulations.

Dr Gilmour-Walsh: I didn’t understand all elements of that question.

Senator ROBERTS: Do you want me to repeat it?

Dr Gilmour-Walsh: Yes.

Senator ROBERTS: To list a product under the Australian Register of Therapeutic Goods for prescription under schedule 4, there’s a prescribed process, which is not legislative. The steps, time frames and levels of proof of safety are all in regulation issued by the secretary under delegated powers, and much of the process isn’t even regulatory but administrative. Is that an accurate statement?

Dr Gilmour-Walsh: I don’t know that’s an entirely accurate statement. Some of the process is set out in primary legislation and some of it is set out in delegated legislation. But, yes, there are some administrative
policies that support the administration of the act.

Senator ROBERTS: Does the suspension of these processes by the minister and/or the secretary during COVID prove that the ARTG—the Australian Register of Therapeutic Goods—process is whatever the secretary
or the minister says that it is?

Dr Gilmour-Walsh: That’s simply not the case. The secretary’s powers are bounded by the act and instruments made under the act, including regulations, which are made by the Governor-General.

Senator ROBERTS: COVID vaccines were not manufactured under good manufacturing process, GMP, so even this basic requirement for the approval of a drug is just a preference and not a legislated requirement, is it not?

Mr Henderson: For the provisional approvals of the vaccines, they needed to provide evidence that they were manufactured under good manufacturing practices.

Senator ROBERTS: But they weren’t. Could you get us a copy of that evidence, please?

Mr Henderson: I’ll have to take that on notice.

Senator ROBERTS: Yes, fine. Referencing section 26BF of the Therapeutic Goods Act 1989, this ‘allows the minister to direct the operations of the secretary in respect of the scheduling and listing of products’. Minister, isn’t it true that the minister could down-schedule medicinal cannabis to schedule 4 and move the products approved for prescription under the pathways program onto the Australian Register of Therapeutic Goods right now, if he wanted to? He might not intend doing that, but it is within the minister’s power, isn’t it?

Senator McCarthy: I’ll take that on notice.

Senator ROBERTS: I understand that the minister could regulate right now to move medicinal cannabis to schedule 4. Thank you, Minister.

CHAIR: I believe that the witness is taking that on notice; is that right?

Dr Gilmour-Walsh: Yes. We can take it on notice, but I’ll just add that I don’t believe that power supports that. The usual process is that there has to be a legislative instrument, made under a power much further down in the act, to amend the Poisons Standard.

Senator ROBERTS: The way that I’ve been advised, I’m pretty confident that it’s just a ministerial regulation.

Dr Gilmour-Walsh: We can consider that further, but that’s not my general understanding.

Senator ROBERTS: Minister, my office checked all the state legislation on prescribing and found much commonality. There is the use of a simple statement such as ‘prescriptions can be issued for anything listed in
schedule 4′. There is no separate state list of drugs. If medicinal cannabis were down-scheduled federally, the states would need to introduce legislation to over-rule that decision and then get that legislation through their own parliament; is that correct?

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

Senator ROBERTS: Thank you. Minister, could the bill introduced by Senator Hanson to down-schedule medicinal cannabis be regulated right now, today, if the minister chose to do so? In other words: the legislation is not needed and the minister could just regulate.

Senator McCarthy: I’ll take that on notice.

Senator ROBERTS: Thank you. Let’s come back to today. Today is a wonderful day to celebrate. Today is 1 June 2023. From 1 June 2023, the prescribing of oral ivermectin for off-label uses will no longer be limited to specialists such as dermatologists et cetera. It’s back and can be used off-label. I must note, to keep the secretary calm, that the TGA says that it does not endorse off-label prescribing of ivermectin for the treatment and prevention of COVID-19. It doesn’t do that, but it can be used for that. Craig Kelly, a former member of parliament, contacted the office of the chief minister in Uttar Pradesh—Uttar Pradesh is a state in India—and
asked for guidance on how Uttar Pradesh had successfully used ivermectin to control the COVID virus in Uttar Pradesh. He received great information on their success. If a member of parliament, at the time, could reach out like that to be better informed, why didn’t the TGA reach out and be better informed on ivermectin?

Prof. Murphy: The TGA relies on the body of scientific evidence. Professor Langham can talk about that. We rely on the published scientific evidence and not the statement of a politician in India. Professor Langham, do you want to comment?

Dr Langham: Thank you. I guess it comes back to my earlier point that a drug, a medicine or a product that is on the ARTG is there for a specific indication. In this case, the specific indication for ivermectin—for which there’s been a dossier provided, evaluated by the TGA as robust, good clinical science—is that it is useful for the treatment of certain parasitic illnesses, be they gastrointestinal or skin based. No evidence has been presented to the TGA by the sponsor to demonstrate in any way, shape or form that ivermectin is useful in treating COVID-19. If the sponsor would like to do so, we’d be happy to consider that, because that’s the only way that the TGA is able to expand that indication.

Senator ROBERTS: Could I table these for discussion, please, Chair.

CHAIR: You can submit them to the committee for consideration. It’s going to take a while to work through them, by the look of it.

Senator ROBERTS: What is being distributed is an affidavit from Dr Pierre Kory in the United States. He has gone through this for many years and he has compiled many references—I think it’s over 96—that praise
ivermectin’s use in treating COVID. It’s been used in many countries and has stopped COVID in its tracks. It has been not only a treatment but also a prophylactic, to prevent the spread of the disease. This is my last question: are you aware of any successful programs overseas that used ivermectin to control the pandemic? Now you’ve got the evidence, Professor Langham.

Dr Langham: Obviously, there’s a very dense article here and a lot of different publications are being referenced. For me to pass judgement on this particular body of evidence, I’d need to take that on notice and get
back to you.

Senator ROBERTS: I’m pleased to hear you say that, because I wouldn’t want it done on the spur of the moment.

Dr Langham: Certainly not.

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