Australia’s best research tool for interpreting adverse events from the COVID vaccines, plus FOI information and more. All in the one spot and it’s free.
A lot of work has gone into this resource. ‘OpenDAEN’ is an easy-to-use database of TGA-reported COVID-19 Vaccines Adverse Events (de-identified) on a non-commercial, non-profit website.
The Labor government has done everything it can to avoid the scrutiny of a Royal Commission into COVID despite promising a Royal Commission on several occasions. Instead, PM Albanese has announced an inquiry that is guaranteed to be a whitewash to try an appease the Australian public who have been waiting for the Royal Commission.
I asked the minister why the government is afraid of a Royal Commission. Her answer was instead directed at the inhouse inquiry which is essentially three insiders investigating their mates. This is a travesty after the suffering, disruption and death that the COVID years brought to Australia.
This inquiry is a cover-up. Australians deserve a Royal Commission to bring the truth to light and prevent the same mistakes from happening again.
Senator ROBERTS: Thank you. Minister, why do you fear a COVID royal commission, and is your support for the Chief Medical Officer and the TGA unequivocal?
Senator Gallagher: In relation to the second part, yes, absolutely. In relation to the first part, there is nothing to fear about the COVID inquiry.
Senator ROBERTS: There certainly isn’t.
Senator Gallagher: Hopefully genuine learnings will come out of it and we’ll all be better prepared for the next time we have a pandemic like that.
Senator ROBERTS: Thank you, Minister.
Many doctors have been targeted or notified by the Australian Health Practitioner Regulation Authority (AHPRA) simply for questioning the COVID injections.
These injections have since been found to be unsafe, not effective, and testing was inadequate. Doctors were targeted by AHPRA simply for fulfilling their professional duty by proactively warning of risks and providing information in reaction to questions from their patients. In providing patients with the advice and information required to give informed consent, health practitioners were providing a standard of care that is universally accepted as competent. Is political interference acceptable?
When questioning AHPRA recently, the Chief Medical Officer (CMO) jumped in and said they do not accept any of my three statements. The government still maintains, in the face of overwhelming international evidence, that the vaccines are safe, effective and that they work. During Senate Estimate in February, I asked Professor Skerritt for details about the Therapeutic Goods Administration’s (TGA) testing of the COVID injections in Australia. He responded that they did no testing here. He said the TGA relied on the US Food and Drug Administration (FDA). In turn, the FDA have stated they did no testing. Why? Because they relied on Pfizer’s in-house tests, yet Pfizer’s trials were shut down because of the poor results.
There have been strong criticisms of their methods and falsified results. The post marketing release of papers exposes both the flaws and the risks of these mRNA injections. If health practitioners are choosing to practice their duty of care as professionals in providing the advice that allows their patients to make an informed choice around the medicines they take, then this should be celebrated. Any health authority or regulatory body that vilifies or punishes this standard of care is acting only on behalf of pharmaceutical interests and not in the best interests of patients or the healthcare profession.
Senator ROBERTS: Thank you for being here. Ahpra has made many unjustifiable decisions against doctors and other allied health professionals. Many doctors have told us this. What proportion of Ahpra members are practising doctors? Why is there such a lack of medical input into Ahpra’s investigations of doctors?
Mr Fletcher: Thank you, Senator. There are about 130,000 registered medical practitioners in Australia. I can give you the exact number on notice. It is roughly that figure. The regulation of medical practitioners in Australia is overseen by the Medical Board of Australia. That board has two-thirds medical practitioner members and one-third community members and is chaired by a medical practitioner.
Senator ROBERTS: Many doctors in Australia were suspended for commenting on COVID vaccinations. Many of the concerns expressed have now been shown to be evidence-based. Can you please explain Ahpra’s actions which deprived Australia of valuable medical manpower at a key juncture when doctors were sorely needed?
Mr Fletcher: I think we have previously advised the committee that there were, in fact, 31 practitioners suspended associated with concerns in relation to COVID-19 and the pandemic. There has been no further use of our IA, or immediate action, powers or suspensions since we last met with the committee. There are 15 practitioners who are currently suspended. In nine of those cases, there is an investigation ongoing. In six of those cases, a referral has been made to the tribunal. We make a referral to the tribunal—it is the independent tribunal in each state and territory—where there is a concern about possible professional misconduct. Those tribunal matters are either at a hearing stage or awaiting an outcome. That’s the current status of practitioners who have been suspended. Of the ones who are no longer suspended, there have been two where we’ve completed tribunal proceedings and the tribunal has taken action. In other words, it has upheld the view that there was a finding that required action on the part of the tribunal. Six of those practitioners have either surrendered their registration or moved to a form of non-practising registration. We’ve closed those matters on the basis that there wasn’t a public interest in continuing to pursue those matters. One has surrendered, awaiting a tribunal outcome. Five have had their suspension lifted. Another restriction was imposed by a board. That might be a condition on their registration or an undertaking that they’ve agreed to accept in relation to certain requirements on their registration around additional education, training or supervision.
Senator ROBERTS: Are we able to get the details of those cases on notice?
Mr Fletcher: I can certainly provide that data to you, yes. We need to be careful not to identify individuals. We can certainly give you some of the general themes in relation to the actions we’ve taken.
Senator ROBERTS: Yes, please. I know a number of doctors who have said, ‘To hell with it’, and they’ve left medicine. They are very good doctors. That is because of the way Ahpra has chased them. Ahpra has been reported as having targeted 20 of the 60 addiction medicine physicians in Victoria. It also targeted a leading addiction medicine physician in Queensland. The Queensland doctor’s and the Victorian doctor’s stories were covered in the press. In both cases, they were reinstated. Why was that? Please explain this vendetta against addiction physicians across the country. How can Ahpra suddenly forget their case against community minded doctors who are supported by the media?
Mr Fletcher: Senator, I can’t agree with the opening statement in your question. We don’t target medical practitioners. We don’t target any registered health practitioner. We respond to—
Senator ROBERTS: Excuse me. A lot of doctors think you do. A lot of doctors.
Mr Fletcher: Well, they are wrong to think that. We don’t target practitioners. What we do is respond to concerns that are raised with us, often by members of the public, sometimes by employers and sometimes by other practitioners. We assess each of those in the context of the concern that has been raised and the context of that person’s practice. If there is a concern that we have about a potential future risk for patient safety, that’s when a board would take regulatory action. So we don’t target practitioners. We certainly don’t have a campaign against particular areas of medical or clinical practice.
Senator ROBERTS: So how is it that some doctors have been targeted by Ahpra or notified by Ahpra simply for questioning the COVID injections, which have since been found to be unsafe and not effective and were never tested? Why is it that those doctors have been questioned by Ahpra simply for giving informed information and asking patients to give informed consent?
Prof. Kelly: Before Mr Fletcher answers, we don’t accept—
Senator Gallagher: We don’t accept that proposition.
Prof. Kelly: any of those or all of those three statements. The vaccines are safe.
Senator ROBERTS: Well, let’s have a look at the one they tested.
Prof. Kelly: They are effective—
CHAIR: Senator Roberts, you need to let the officials answer.
Prof. Kelly: and they do work.
Senator ROBERTS: Let’s have a look at the one they’re testing. I asked Professor Skerritt, and he said, ‘No, they did no testing here.’ That was in February Senate estimates. He said they relied on the FDA. The FDA said they did no testing. They relied on Pfizer. Pfizer shut down its trials because of the poor results. They’ve been heavily criticised. Where is your testing of the COVID injections?
Prof. Kelly: There was a full regulatory assessment, Senator. Our colleagues from the TGA, when you get to ask them, will assure us of that. They were safe, they were tested and they were effective.
Senator ROBERTS: We’ll come back to that.
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.
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.
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.
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.
We know COVID injections contain spike proteins that instruct human cells to make spike proteins for extended periods of time.
I asked these questions in the Senate:
Moderna has told us that spike proteins are the same whether derived from COVID or the injections. Spike proteins fuse cells together.
Big pharma tried and failed for 20 years to use spike proteins as an antigen so they’re nothing new. COVID was just an excuse to finally use them without the usual safety net of robust regulations and trial data, and make obscene profits.
The spike protein has an unknown impact on the body’s complex mechanisms involving laminin. These large cross-shaped proteins are often called the ‘god molecule’ for their shape. They are part of the body’s healing processes.
Another problem with the spike protein in these injections is that the virus mutates rapidly, making the injection lose any effectiveness very quickly. This is why the so-called ‘vaccine’ was not an immunisation and did not stop infection or transmission.
The COVID injections did not offer protection against new strains. There was no valid independent science to support that statement. That was a lie. The TGA would normally prosecute any pharma company making such claims, and yet it was the TGA itself making that statement!
Spike proteins are also able to trigger cell fusion in brain tissue, possibly causing brain dysfunction and damage leading to ‘long COVID’. As Moderna has revealed, there is no difference between spike proteins from COVID or the COVID injection.
The West has spent the past three years injecting people with the very thing that causes long COVID. Spike proteins.
How this has happened is the scandal that must be investigated immediately.
As a servant to the many different people who make up our one Queensland community, I ask a question tonight: what is the biological function of the COVID spike protein? This question asks whether COVID injections are fundamentally safe, because we know that COVID injections contain spike protein that embed into our system a genetic instruction for human cells to make spike proteins for extended periods of time. Could COVID injections be instructing human bodies to make a substance that’s making bodies sicker not healthier? Let’s review the latest data.
First point: spike protein may replace a protein molecule called laminin. Laminin is found in the extracellular matrix, the sheets of protein that form the substrate of all internal organs. Laminin is critical to how our cells hold together. Interfering with laminin can cause our organs to fail. Laminin is shaped like a crucifix and is widely known as the ‘God molecule’. When I met with Moderna in my office a few months ago, they were happy to admit that their spike protein was identical to the spike protein molecule in COVID. So, when studying spike protein, it does not matter what the source is. What matters is that, with the new study on the effects of that spike protein on the body, COVID injections are instructing body cells to produce spike proteins.
What we do know is that the spike protein is fusogenic, meaning its job is to bind cells together—think velcro. It does the same job that laminin does. Big pharma has tried to use spike proteins as an antigen for 20 years, and for 20 years they failed. The COVID injections were not a sudden success. Pharma simply lied and cheated on the clinical trials to use this thing they had spent billions on in an injection arranged to be rushed through approvals, and they made obscene profits in the process.
Now we’re seeing symptoms that can be explained with the discovery that the spike protein replaces laminin in the extracellular matrix. Does the spike protein interfere with laminin? The answer is: we do not know. This is what happens when we do not know yet insist on playing God. The reason using spike proteins as an antigen has failed is because the spike protein mutates in the wild every few weeks. A COVID injection loses any claim to effectiveness very quickly and needs to be updated. This is why the COVID injections are being retired and new ones are being released continually.
Do you remember when we were told that the vaccines offered protection against new strains and to keep taking them? That was a lie—a bloody lie. There was no valid independent science to support that statement. The Australian Therapeutic Goods Administration, the TGA, would normally prosecute a drug maker making misleading comments about their product without proof of the claim. In this case, though, it was the TGA making the misleading claims, so it’s the TGA who should be held to account.
COVID injection effectiveness was knowingly misrepresented, and here’s why. There’s no pathway for an antibody and a serum—blood—to get into the lung. While we can deliver a drug to the lungs and it will get into the serum, it can’t go back the other way, from serum to the lungs. The problem is that, in order to stop infection and transmission, the injections had to get into the lungs and the nose. The COVID injections simply never made it there. People who took the injection had levels of IgG antibody in the nose and lungs that were 1,000 times less than the levels in their blood. This is why the injections did not stop infection or transmission and never could have. The TGA knew, or should have known. This was the science, and they bloody well ignored it to promote injections that failed miserably and killed tens of thousands of people, melting down and exploding the database of adverse events.
Second point: spike proteins cause brain damage, leading to long COVID. Scientists at Macquarie University and the University of Queensland used mini brains infected with the SARS-CoV-2 virus to discover that the spike protein could trigger fusion in cells in both mouse and human brain tissue. The host brain cells are fused, possibly causing brain dysfunction, said Professor Lars Ittner, director of the Dementia Research Centre at Macquarie University. The discovery could explain chronic neurological symptoms such as headaches, brain fog, exhaustion and loss of taste or smell—even long after the initial infection.
Of course, spike protein from the injection was not included in the study, and yet, as Moderna themselves say, there’s no bloody difference. The West has spent three years injecting people with the very thing that’s most likely causing long COVID. Big pharma never researched the effect of their spike protein on the human body yet received approval for their sickening products anyway. How this happened is a scandal that must be referred to a Senate select inquiry immediately.
Thank you Hoody for the great introduction.
If you’re interested in the hearing from all speakers at this AMPS event, including internationally-renowned cardiologist, Dr Aseem Malhotra, watch below.
Senator Roberts: The Greens want to talk about cancelling HECS debt. Well, let’s talk about the HECS debt of students who started their degrees and then were forced to abandon them because of COVID-19 vaccine mandates. Any student who started studying their degree at university before COVID-19 arrived and subsequently was forced to abandon their studies because of an inhumane COVID-19 injection mandate, whether the mandate was at the university or at a placement that they were required to undertake as part of their degree, should have that HECS debt immediately cancelled. When they signed up to their multi-year degrees, there was no requirement for them to take an untested, experimental, gene therapy based injection.
The President: Senator Roberts, if you could resume your seat for a moment. The substance of your response needs to focus on the motion put forward by Senator Faruqi, which is to suspend business to debate the bill the Greens want to put forward, so you do need to respond to why you agree or disagree or make other comments around the urgency of that suspension motion.
Senator Roberts: Thank you. I’m getting to that point right now. Halfway through their degrees, that rule was changed on them, and they had no say over it. Their debt should be cancelled immediately.
That’s why One Nation will be opposing this motion to suspend standing orders: we want a proper debate. We want a royal commission. We want it dealt with properly so that students who have been kicked out of university, stopped their studies or stopped their placement get a fair say and have their HECS debt cancelled.
As a servant to the many different people who make up our one Queensland community, One Nation has today advanced a matter of public importance calling for a royal commission into Australia’s COVID response. The rush of real science in the last few months makes it clear that COVID-19 has been a tragic and criminal exercise in stakeholder government. The stakeholders have milked COVID for their own personal and corporate benefit, at the expense of everyday Australians, destroying confidence in our health system. For corporations, the objective was profit from the sale of tests, PPE and fake, deadly vaccines that government and private mandates maximised. This profit accrued from fast-tracked TGA approvals that saved pharmaceutical companies billions of dollars and caused a new cost in human suffering, death and injury.
Nothing could illustrate this point more than the heartbreaking testimony last week of Deborah Hamilton at the Senate inquiry into Senator Hanson’s bill to ban COVID injection mandates. Deborah lost her daughter immediately after her COVID injections, which her employer mandated for her to keep her job. Her employer and their parent company had Vanguard investment fund as a leading shareholder and financier. Vanguard is the leading corporate shareholder in Pfizer. Vanguard mandated vaccines they make a profit from. When predatory billionaires and their trillion-dollar investment funds murder a beautiful, vibrant 21-year-old Australian in their unquenchable thirst for profit, it shows corporate ownership and influence have gone too far.
For media the payoff was advertising accepted in return for government’s aggressive propaganda-level promotion of the COVID narrative, messaging broadcasts to citizens who were captives in their own homes. Academics took their research grants and delivered the outcomes they were asked to deliver. So much science in the COVID period was delivered with a high degree of confidence, yet in recent months much of the science underpinning our COVID response has been proven to be dodgy, deceitful and dangerous—inhumanly so. Bureaucrats saw the opportunity to spread their power in a way that was previously never allowed. Bureaucrats who were there to oversee drug companies failed in their duties so badly that malfeasance must be a term of reference for a royal commission.
We know the TGA did not check the Pfizer clinical trial data. The TGA took Pfizer’s word for the trial results, and Pfizer lied repeatedly. When leading international virologists analysed the trial data in a peer reviewed and published paper they found the Pfizer vaccine caused 14 per cent more harm than it saved and should never have been approved. Our politicians—Australians elected to have nothing but the best interests of their constituents at heart—engaged in policy decisions that did more damage to Australians than any foreign enemy has ever achieved.
To emphasise why our COVID response cannot be allowed to go without scrutiny, let me review the COVID developments that have come to light in just the last month. One: ivermectin won the Nobel Prize for medicine in 2015 and was shown over and over again to be a remarkably effective, safe treatment for early-stage COVID. It would have saved thousands of lives. Ivermectin was never horse paste. It was an obstacle to drug company profits, and our authorities sided with drug companies over the best interests of the people.
Two: COVID injections cause eye damage. Stanford University published a study in Nature journal last month using medical data from 4.5 million people showing that retinal vein occlusion, including blindness, significantly increased during the first two weeks after injection and persisted, in the case of Pfizer and Moderna, for two years. Our vaccine approval process was bypassed. It was smashed.
Three: Hamburg and Munich universities’ investigation of long COVID using mouse and human post-mortem tissue found an accumulation of spike protein in the skull marrow and parts of the brain months after infection or injection, leading to a conclusion that spike protein damages the brain and contributes to long COVID, whether the source is the COVID infection or a vaccine. The TGA has now approved the Moderna injection, which uses spike protein, for permanent use. What the hell are they doing!
Four: COVID injections harm menstrual cycles. A study published last month in the British Medical Journal studied three million women in Sweden and concluded the Pfizer vaccine contributed to a 41 per cent increase in menstrual complications. This information was first collated in 2020 and was simply ignored when the fake vaccines were approved.
Finally, the World Health Organization took time out from promoting child grooming to declare COVID no longer a global health emergency. Now is the time to take stock, to end all private and government mandates, suspend all hasty approvals and re-examine every fake vaccine and every drug approved using emergency approval.
Now is the time to call the royal commission Minister Gallagher promised last year.
Now is the time to start the painful-yet-necessary process of taking power from those who misused it and taking liberty from those who manipulated the response for their personal profit.
Jail the bastards. We want justice.
I travelled to Canberra to attend a hearing into Bills that would make discrimination on the basis of vaccination status illegal. This would immediately end any of the mandates that are still in place. Let me know what you thought of the evidence.
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