I have been asking the Health Department across multiple estimates a simple question. Every drug approved in Australia must be made using Good Manufacturing Practice (GMP), which is a detailed standard to ensure quality and consistency in manufacturing of pharmaceutical products.
If the “speed of science” prevented using GMP then say so. Instead, the TGA and Health Department has bobbed and weaved to prevent giving me a straight answer, and today is no different.
The last response I got was to send me a list of GMP certificates issued to Pfizer. There was no ability to check the certificates back to the injection batch numbers. This looks to me like there is a coverup to hide that the vaccines were not produced using GMP until late in the rollout. This was a decision that was not open to the TGA to make. Accepting products made in a rush may have been why the original doses were accompanied by such a high and unpredictable rate of harm. I will continue to pursue this matter.
Transcript
Senator ROBERTS: Let’s move to good manufacturing practice. I have just two questions left. At the last estimates, I tried to get to the bottom of whether every batch of Pfizer COVID injections was made using good manufacturing processes. If they were not, that may explain the huge variance in adverse events between batches. If they were made with good manufacturing processes, there is another cause we really need to understand for the huge number of excess deaths. In your answer on notice, you did not answer the question, but you gave me a list of entries in your manufacturing information database. This is a little confusing, because your answer does not allow me to check good manufacturing process certificates off against batch numbers. What your data tells me is that all of these good manufacturing process certificates were issued as a result of a desktop audit rather than an in-person inspection, which means you took the manufacturers’ word for it based on whatever it was they sent you. Is that correct?
Prof. Lawler : Thank you for the question. I would just highlight that we’ve received these questions regarding the batch testing of vaccines and the associated release a number of times before, and we’ve answered these questions—most recently, I think, SQ23-002145. Those answers are clearly on the record.
Senator ROBERTS: That’s not the one I have. Secondly, there are 44 good manufacturing process certificates for all COVID vaccines, yet there are 410 batches listed in your COVID vaccine batch release assessment. Some of those are duplications and some, admittedly, are for AstraZeneca, but the number seems off. Can you please give me on notice a full list of Pfizer batch numbers and the corresponding good manufacturing process—or is it true that good manufacturing process was only used from the bivalent vaccines onwards?
Prof. Lawler : Thank you for the question. I’m happy to either take that on notice or to return to that under outcome 1.8 when my—
Senator ROBERTS: Perhaps you could take it on notice.
https://img.youtube.com/vi/qfO7pK-GOxQ/maxresdefault.jpg7201280Senator Malcolm Robertshttps://www.malcolmrobertsqld.com.au/wp-content/uploads/2020/04/One-Nation-Logo1-300x150.pngSenator Malcolm Roberts2024-02-23 10:31:502024-02-23 10:31:55Good Manufacturing Practice and the COVID “Vaccines”
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.
https://i0.wp.com/www.malcolmrobertsqld.com.au/wp-content/uploads/2024/02/OpenDAEN.jpg?fit=1206%2C872&ssl=18721206Senator Malcolm Robertshttps://www.malcolmrobertsqld.com.au/wp-content/uploads/2020/04/One-Nation-Logo1-300x150.pngSenator Malcolm Roberts2024-02-01 14:10:192024-02-01 14:10:24Australia’s Best Research Tool for Adverse Events
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.
Transcript
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.
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?
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.
https://img.youtube.com/vi/792LxTu1Tgs/maxresdefault.jpg7201280Senator Malcolm Robertshttps://www.malcolmrobertsqld.com.au/wp-content/uploads/2020/04/One-Nation-Logo1-300x150.pngSenator Malcolm Roberts2023-10-09 10:19:212023-10-09 10:21:57TGA is Risking Your Health to Act as a Sales Agent for Big Pharma
At the June Senate Estimates I asked several questions of the Therapeutic Goods Association (TGA).
I asked what the TGA was doing to help Australians access a potential new antibacterial to overcome antimicrobial resistance, medicinal cannabis, and off-label Ivermectin. What this trio of medicines has in common is that they are not profitable for pharma because, in the case of the first two, they cannot be patented and patents are how pharma makes its $billions.
Ivermectin is an award-winning drug with a huge body of evidence supporting both its anti-parasitic and anti-viral activity. Because it’s been around for over 70 years, is off-patent and inexpensive, there is little interest from pharma in sponsoring the drug. See how it works? These medications should not be left behind because of pharmaceutical company profit margins.
From the answers provided by the TGA, it’s clear that health products that don’t add to the wealth of pharmaceutical companies have no chance of approval under this Government. The TGA should be acting in the best interests of the Australian people, not the profit margins of big pharma.
Transcript
Senator Roberts: Given the backflip, Mr Fletcher, by the TGA that now allows the prescribing of ivermectin, which can be used off label as treatment for COVID—the TGA makes it clear that it does not endorse it as a treatment but now allows it as a treatment for COVID—what is the attitude of Ahpra towards those doctors now who were cast aside because they supported ivermectin?
Mr Fletcher: Any regulatory action we have taken or would take in relation to a health practitioner would always take account of the public health advice at the time that the alleged concern occurred.
Senator Roberts: The public advice was wrong.
Mr Fletcher: It would be on the basis of the advice that was in place at the time.
Senator Roberts: Isn’t it strange that ivermectin started off as a highly regarded, very safe drug, given in four billion doses around the world, and then we were told that it was a dangerous drug, and now it’s remarkably safe again with a worldwide profile of being a safe treatment for COVID-19?
Prof. Murphy: Senator, I do have to intervene. There is no change. There is no recommendation that ivermectin be used for COVID. The regulatory changes—
Senator Roberts: I didn’t say that. I said to the contrary. I said the TGA does not endorse them.
Prof. Murphy: No, it’s not—
Senator Roberts: I did not say that there was an endorsement.
Prof. Murphy: No, there isn’t an endorsement. But the change in the regulation has nothing to do with any change in its efficacy or otherwise for COVID simply to reflect the changing circumstances and there’s no need to keep what’s a very unusual restriction on a drug. The TGA as decided it’s no longer proportionate, but there’s still no evidence of any value.
Senator Roberts: So what changed with the TGA?
Prof. Murphy: What changed with the TGA? We’ll get the TGA to address that.
Senator Gallagher: They’re due this evening.
Senator Roberts: Okay. Ahpra never did its own research on the COVID injections and relied on what it was told by the TGA. You said that a little while ago. The TGA never did its own research. In answering a question that I put to them at the last estimates it relied instead on what it was told by the FDA. It has never assessed the patient-level data.
Prof. Murphy: This is not a question for Ahpra.
Senator Roberts: I’m getting to that.
Chair: Senator Roberts, could you put it as a question?
Senator Roberts: Are you aware that the TGA, which you rely on, has never assessed the patient-level data.
Mr Fletcher: As I said earlier, the sources of public health advice to us are the TGA, ATAGI and the public health officials in each state and territory and the Commonwealth health department.
Senator Roberts: Are you aware that the TGA relied on the FDA and that the FDA itself, in America, never did its own research and relied simply on what Pfizer told it? According to its own records, Pfizer only ever did limited research and knew the vaccines injections were of limited value and had a significant risk profile. Pfizer lied when it said the vaccines were safe and effective, and Ahpra peddled this lie. You enforced that lie.
Chair: Senator Roberts, this is not a question. It’s very hard for me to maintain order if you don’t put questions.
Senator Roberts: Are you aware of the facts that I’ve just said about Pfizer? Are you aware of those facts?
Prof. Murphy: These are questions for the TGA. It’s not a question for Ahpra.
Senator Roberts: I want to know is he aware of what the TGA based their decision on?
Chair: Senator, if officials at the table indicate that this is not the appropriate place within the program to ask a question, we do need to respect that. My understanding of what Professor Murphy has said is that there is a time for these questions, and that is when we return to the TGA.
Senator Roberts: Thank you, Chair. I notice your silence. Why isn’t Ahpra aware of the false, fraudulent science underpinning the use of the vaccine?
Senator Gallagher: We don’t agree with that.
Senator Roberts: Thank you for answering, Minister. Why does Ahpra still support the use of the injections now that there is a body of respected, peer-reviewed science condemning the use of the so-called vaccines? Is it because the TGA—
Senator Gallagher: It’s not a matter for Ahpra.
Senator Roberts: How can so many deaths and serious injuries attributed to the vaccines continue to be ignored by Ahpra?
Prof. Murphy: Again, that is not a matter for Ahpra.
Senator Roberts: Ahpra are silent, okay.
Senator Gallagher: It’s not ‘silent’. It’s not a matter they have responsibility for. Witnesses come here to answer questions on areas they have responsibility for.
Senator Roberts: You’ve just taken responsibility for their response. That’s fine. Given that Ahpra—
Chair: Senator Roberts, we have dealt with this issue over the last few days. It is appropriate for the minister to respond to our questions put to the witnesses if that question is not put in the correct place or is not within that purview. It’s appropriate for Senator Gallagher to respond. Do you have another question, Senator Roberts?
Senator Roberts: Given that Ahpra is a board, I would suggest that board members are jointly responsible for the outcomes of their directions to health practitioners which now include the countless death and serious injuries that have befallen many otherwise healthy people who took the injections believing they were safe and effective, when they were not. Are you aware that board members will be culpable?
Senator Gallagher: They will not. It’s not their—
Senator Roberts: Can you give me the qualifications of every board member—their medical qualifications?
Senator Gallagher: I reject your assertions. I just want to be very clear. I’m not going to speak for everyone, but my position here is that we do not agree with the assertions you are continuously putting in this hearing.
Senator Roberts: That’s fine, Minister. I hear you. The board members—can you give me their qualifications, Mr Fletcher?
Prof. Murphy: The Ahpra board is a board that regulates the operations of the agency. The decisions around registration standards are made by the national boards, like the Medical Board, which is comprised of community and qualified practitioners. The board of Ahpra is simply a governance board of the bureaucratic operations of Ahpra. The decisions—
Senator Roberts: A governance board?
Prof. Murphy: It does not govern the regulatory decisions. Those decisions are made by the relevant professional national boards, as Mr Fletcher has pointed out on many occasions.
Senator Roberts: State bodies?
Prof. Murphy: National boards. There’s a national Medical Board, a national nursing board—
Senator Roberts: So why do we need Ahpra? They’re not accountable.
Prof. Murphy: Ahpra is the organisation that brings the work of those boards and sets up a national regulation system to enable practitioners to be regulated across the country. It is a means of bringing them together. This is professional registration, so each of those boards—
Senator Roberts: And deregistration. I’d like the qualifications, Mr Fletcher, on notice, of your board members, their qualifications in medicine, specifically what qualifications they have, and I’d like to know who appointed them. Can you take that on notice?
Prof. Murphy: It’s on the website.
Senator Gallagher: It is on the website, look it up. In relation to profession-specific, as Professor Murphy said, there is the Medical Board, which has representatives; there’s nursing; there’s a whole range of them. They used to be the state and territory boards; they came together to be national boards. They would have different representatives.
Senator Roberts: Can you tell me who appointed each of the members?
Mr Fletcher: The national board members are appointed by state, territory and Commonwealth health ministers.
Senator Roberts: And Ahpra?
Mr Fletcher: The Ahpra board is also appointed by state and territory health ministers and the Commonwealth health minister.
Chair: Thank you very much, Ahpra. We appreciate your favourable response to our request to join us at Senate estimates.
I joined Topher Field of The Aussie Wire to discuss my disappointment in the “toothless” COVID inquiry Anthony Albanese announced recently.
Transcript
Topher Field: Cast your mind back to before the last federal election. If you can remember that long ago, and you may recall that promises were made. Specifically, Anthony Albanese promised that if he were to win election, he would hold a Royal Commission into COVID, looking into all the various aspects of the COVID response. That was quite some time ago, and the Royal Commission has not been forthcoming, but good news, we’ve just had the announcement of an inquiry. Surely that means that Anthony Albanese is making good on his word, and we will have a full and thorough inquiry into all aspects of the COVID response so that lessons can be learned and we can get it right next time. My next guest isn’t quite convinced and has released a press release to that effect. It is Senator Malcolm Roberts from the Pauline Hanson’s One Nation Party. You’re a senator for Queensland, and I’m very, very grateful for you coming on The Aussie Wire.
Malcolm Roberts: Thank you very much for the invitation, Topher. It’s always a pleasure to have a chat with you.
Topher Field: Now your press release caught my eye, but honestly, there has been quite a lot of commentary on this already. This is something that a lot of people are very quick to point out. The terms of reference are a concern, are they not? Can you take us through your concerns and why you felt the need to release that press release?
Malcolm Roberts: Certainly, I do share huge concerns. I’ll make a quote from Dan Andrews. He says, “Any inquiry into COVID-19 should be forward-focused and not centre on the actions of government during the pandemic.” The premiers have rolled the Prime Minister because the premiers have done the dirty work for Scott Morrison, and the media release, as I pointed out, this is toothless. There’s no power to compel witnesses. It’s compromised because there’s a limited scope. It’s federal only. It’s a whitewash to protect labour premises, as I’ve said. For example, they raised the topic of international border closures in the terms of reference but not state. So it’s strictly federal.
He’s running from a Royal Commission, yet the same man, Albanese Anthony Albanese, had a Robodebt Royal Commission, which was far smaller. Robodebt was far smaller in cost impact. So he has broken his promise regarding a Royal Commission on the COVID tragedy, mismanagement, deceit. This COVID, what would you call it? COVID mismanagement was the most invasive and expensive responses in Australia’s history. We’re still suffering from it. We’ve got a high inflation. We’ve got excess of 40,000 excess deaths due to the COVID injections. We’ve got lingering injuries. This morning I am at a small business conference back in your old town of Melbourne,-
Topher Field: My hometown, yes.
Malcolm Roberts: … and I went to print out my speech just for practising it, and a lovely lady printed it out for me at the help desk, and I saw that she was walking very awkwardly. Sure enough, and this is months and months after her third injection, but there’s no doubt. I’ve got people, friends at home, who’ve been paralysed. They literally woke up in the morning, and they’re paralysed from the neck down. The three people they’ve appointed to be their reviewers for this panel, it’s not an investigation, it’s not an inquiry, it’s a review, the three insiders appear to be compromised. They appear to be former public servants, and one or two of them look as though they’ve had lots of grants in the past, and this will be a ticket for lots more grants in the future. So what I’m going to do, Topher, is, before the end of the year, as I said in my media release, I’m going to ask the Senate for an inquiry to recommend the Royal Commission in terms of reference because we’re going to have one.
Topher Field: Look, we need to. With the powers that were seized by governments, state and federal, and the sorts of things that they did, it’s quite extraordinary to think that we’re going to have an inquiry. But that inquiry in the terms of reference, correct me if I’ve misunderstood, explicitly excludes unilateral actions taken by a state, and yet during the pandemic we had now admittedly a different political party. The liberal party Prime Minister at the time, Scott Morrison, was sitting there saying, “Oh, the federal government can’t do so many different things. It’s up to the states.” And now that we’re having an inquiry, we’re excluding the decisions made by the states. Isn’t that where the response was, according to the federal government of the time?
Malcolm Roberts: I happen to think that the key response was in Scott Morrison, but the implementation was in the premier. So the premiers hold the can. They did it. They did it. So I agree with you entirely. We’ve had media criticising, we’ve had opposition, which you’d expect to criticise. We’ve had doctors criticise, I think, the front page headlines on the Australian newspaper today this evening, words to the effect that the medical practitioners have come out against it. So we’ve got, as you said, the terms of reference include the following areas, are not in scope for the inquiry.
Topher Field: Yeah.
Malcolm Roberts:Actions taken unilaterally by state and territory governments and international programmes and activities assisting foreign countries are not in it. That’s pretty much everything they did.
Topher Field: Yeah.
Malcolm Roberts: Then you get infectious disease expert Peter Collignon today, and I’m reading from these notes I made for you. He told the Australian, “A Royal Commission should examine measures taken to curb COVID infections, including those taken by states as their utility will not be probed during an inquiry.” He said, “Were lockdowns beneficial? Were border closures beneficial? This is an infectious diseases doctor stopping people going outside for more than an hour. That is what affected people personally the most.” He said, and the people that’ve got on this review, they’re not the sort of people who understand what everyday people suffered. They won’t understand what you suffered at the hands of that tyrant, Dan Andrews. This is ridiculous. It’s just a whitewash to protect Dan Andrews, Annastacia, Palaszczuk and the other labour premiers. McGowan was the other one, wasn’t he?
Topher Field: Yeah. Some people could be forgiven for asking the question. Senator Malcolm Robertson, yourself, and if I can mention a few names, we’ve had some wonderful work from senators Alex Antic, Gerard Rennick, Matt Canavan. Ralph Babet is a recent edition, but he’s really making a name for himself and getting stuck in. We’ve got a handful of really fantastic people who are getting stuck in on this issue. There are other great politicians who are getting stuck in on other issues as well, but just singling it down to this issue. We’re seeing a handful standing up, but we’re not seeing a lot of results.
Some people get very disillusioned. They say, “You’re a politician. Fix this. Why can’t you fix this for us?” We’re in a situation now where yourself and a handful of others are saying, “We need a Royal Commission.” The government is saying, “You’re not going to get one. All you’re going to get is this incredibly prejudiced whitewash inquiry.” What’s to be done from this point forward? You’re saying you’re going to be calling for a Royal Commission. You’re going to hold a Senate inquiry. What are the mechanisms at your disposal? How do we move forward from here towards what we all want to see?
Malcolm Roberts: I’ll be asking for the Senate to prove an inquiry to develop the terms of reference. The Senate will give me permission or not give us permission for that inquiry, just as the Senate does in every other request. So that’s one thing I’ll be doing some work. We’re lining that up at the moment, but doing an inquiry of our own, much the same as we did in March and August of 2021, I think, I can’t remember, 2022, where we had a multi-party, cross-party inquiry. But this one we’ll probably do in-house because it’s going to take a lot of getting top experts from around the world, particularly from Australia, and a whole variety of people, not just experts but also vaccine injection-injured people.
So we’re working on those kinds of things. But you might notice that every week in the Senate, I give an update. Two of my staff team are just wonderful on this issue, and we give an update every week in the Senate. We didn’t do it last week because we were flat out, but we give an update on the latest things unearthed around the world, and it is startling what’s coming out. It is absolutely beyond my most wonderful expectations. So we’re really getting there, and we’ll put a lot of pressure on these people to come clean, Topher, so we’ll just keep the pressure up. We will continue this forever until we get the Royal Commission, until we get the truth out, and until the guilty are punished.
Topher Field: The future is written by those who show up, and Senator Malcolm Roberts, I’m grateful that you just keep showing up every day, every week in that Senate, despite overwhelming odds against you at times. Like I said, there are some other wonderful people in there, but you continue to show up, you continue to persevere, and you continue to chip away. I tend to share your optimism. I look at what’s happening around the world. I do think we are making progress. Sometimes it doesn’t look that way, but I do think we are. The narrative has shifted, and the sins of the past are coming home to roost on those who committed them, and it can’t come soon enough as far as I’m concerned. Senator Malcolm Roberts, thank you for your press release today. Thank you for continuing to try and hold the federal government accountable, and he’s hoping we will see that Royal Commission someday. Thank you for coming on The Aussie Wire.
Malcolm Roberts: You’re welcome, Topher. Keep going with what you’re doing. Aussie Wire needs success. For Australia’s sake, we need success of the independent new media. Thank you very much for doing what you’re doing.
I’ve been asking for a Royal Commission into COVID for more than 2 years. I am told it’s too early.
It’s now been 4 years since COVID was first found in Wuhan and in Italy and sent the world insane. Lock-downs, business closures and job losses, civil rights violations, coerced vaccination contrary to the Nuremberg Code. Simply inhuman!
Now we have a “scary” new variant, Pirola. Medical evidence provided to me by qualified medical practitioners state that it’s extremely mild and isn’t cause for keeping the COVID scare alive.
I also share the latest research which shows the reason why the “vaccinated” are getting more sick, more often than the unvaccinated, and that this may continue to be an issue for quite some time to come.
Join me for the 4th COVID science update this year.
Transcript
As a servant to the many different people who make up our one Queensland community, tonight, on the fourth anniversary of COVID-19, I ask the Senate to consider the latest scientific discoveries. I’ll then make a request.
The latest variant of COVID-19, called pirola, is now dominating the news cycle and leading to calls for a return of masks, lockdowns and injections, despite there being only 12 cases in five countries. Dr Byram Bridle, a viral immunologist who specialises in vaccines, has published work relevant to pirola, which I will now summarise here.
If pirola were a dangerous virus, it would be easily detected because the increase in suffering and death would prompt testing. With only 12 cases, pirola is not serious. Pirola contains more than 30 mutations on the spike protein, which is what helps the virus enter cells and cause an infection. An accumulation of mutations in the spike protein is exactly the expected result from the poor design of these COVID injections that we’ve been inflicted with; specifically, the targeting of a single spike protein. The approach of targeting a single spike protein encourages the virus to mutate until it finds a variant the shot does not protect against. In this case, vaccination causes mutation. Natural immunity, though, targets multiple components of COVID-19. A person with natural immunity will have both antibodies and T cells that can kill COVID-19 by virtue of recognising things other than the spike protein, so it will be more difficult for new variants to completely evade natural immunity. He continues that Australians with only vaccine induced immunity will be more susceptible to getting infected. That means no immunity. And he says—listen to this quote—they ‘will be prone to more severe illness than people with natural immunity’.
In our haste to force vaccination on every Australian we have weakened the immune systems of our nation and delivered weakened bodies into the hands of the medical establishment responsible for this crime in the first place. In the months ahead, as the medical establishment and their media mouthpieces scare the Australian public into more injections, masks and other manifestations of Soviet control, remember this: pirola is likely less dangerous than any other strain, especially for those with natural immunity. So far it looks like pirola might cause a typical wave of the common cold. It might spread to a lot of people, like most cold-causing viruses do, and for most it will cause mild, if any, disease. Of course, follow medical advice if you’re immunocompromised or unwell. Thank you, Dr Byram Bridle.
Next, David Dowdy, a professor of epidemiology at the John Hopkins Bloomberg School of Public Health, commented:
We don’t want to be sounding alarm bells over a variant that is just as likely to die out as it is to become the next big thing. If we did that for every single variant we’d be sounding alarm bells every single day.
The professor seems to be missing the point that fear is the point, and from fear comes control. If you want to slow the emergence of new variants, like pirola, stop the shots—stop the COVID-19 injections.
While we’re at it, stop manufacturing viruses like COVID-19 in laboratories. Seriously, what else in these labs may escape one day? Surely a royal commission would have to ask that question. It’s now been four years since COVID-19 was discovered in the wild, when three junior researchers at the Wuhan Institute of Virology presented to a hospital in Wuhan with flu-like symptoms. It’s been four years since 14 September 2019, the date Italian medical staff detected what became known as COVID-19. In the years since, the world has gone insane, with lockdowns; business closures and job losses; civil rights violations; coerced vaccination, contrary to the Geneva convention and inhuman; and military on the streets acting on instructions from the Medical Countermeasures Consortium, a military-health joint venture that oversaw the development of COVID-19 as a medical countermeasure, along with the antidote—sorry, the vaccine—produced in case the virus ever occurred in the wild. That’s what medical countermeasures are. Was this unholy military-health alliance responsible for suppressing inquiry into the source of COVID-19 lest it call into the question the wisdom of gain-of-function research? That’s an important question.
The same research was conducted with funding from the US government and supported across USA vassal states, including ours, Australia. I’ve previously spoken about our CSIRO’s involvement in gain-of-function research. Injectables were produced with the claim they could do something a real vaccine can’t do: stop the spread. In the decade before COVID, mRNA vaccines were tested and rejected, repeatedly, for product failure and adverse health outcomes. Then along came a lab engineered virus and those failures were swept aside in what almost felt like a Palm Sunday Hosanna reception. The injections were said to be our salvation, rescuing us from restrictions that governments imposed in order to sell the damn injections—a masterful media manipulation worthy of a royal commission inquiry into the approval and response process that has proven deadly.
Meanwhile, the medical establishment has ignored the obvious signs of injection-induced injury and death. Our medical establishment has responded to each alarming new study and damning data with a routine the internet has dubbed ‘Dr Baffled’. The World Health Organization is currently investigating an unusual rise in severe myocarditis cases amongst newborns and infants in the United Kingdom, one of which resulted in the death of the infant. ‘Dr Baffled’ doesn’t know what’s behind the rise in paediatric myocarditis. He’s baffled! Yet, somehow, he does know for sure that it isn’t the injections, despite myocarditis being a known COVID injection side effect.
In a peer reviewed study published in the Cureus Journal of Medical Science on 20 July, researchers found a correlation between neonatal vaccine doses and infant mortality rates in developed countries. According to data collected from 2019 to 2021, there’s a positive correlation between mortality rates and the number of vaccinations administered to neonates aged from birth to five years. In short: higher vaccine rates were linked with higher infant mortality rates. ‘Dr Baffled’ refuses to even look at this and so many other similar findings. As a result, ‘ Dr Baffled’ remains baffled as to why these children are not thriving on a diet of injected chemicals and genetic material.
In groundbreaking research presented last month, statistician and Luzern University professor Dr Konstantin Beck said:
… miscarriages and stillbirth rates in 2022 corresponded directly to COVID-19 vaccination among pregnant women in Switzerland nine months earlier.
And, he said, vaccine makers and public health officials either knew or could have known this information at the time, if they cared to look.
If they looked, of course, they couldn’t continue to be baffled about the findings. That’s why they’re baffled: they won’t look.
A study of the 500 largest school districts in the USA found that children forced to wear masks in school are on average three times more likely to get sick than those in districts without a mask mandate. Masks amplify diseases found in the wild. A random sample of used children’s masks found pneumonia, meningitis, diphtheria, sepsis and staphylococcus in amplified levels. Schools without masks recorded higher COVID infection rates early in the year, then cases fell away quickly, proving that healthy children only need natural immunity. It’s the best immunity there is. ‘Dr Baffled’ has no comment on the data but assures everyone that masks are safe, contrary to the evidence.
A new paper from the University of Melbourne published in the journal Frontiers in Immunology made the stunning conclusion that the Pfizer vaccine, when given to children, reduces their immune system’s response to other viruses and bacteria, like the bacteria I just mentioned that were found on children’s masks. It reduces children’s health. New information last month shows that Novavax, touted as a protein-only vaccine, free of genetic material, did in fact contain genetic material and a transfectant, saponin, meaning Novavax is a gene-therapy product. Whoops! Another massive scandal the public have not yet been told about. If the media does not speak further on this, I will. The TGA never pulled apart the injectables in their own labs. The TGA relied on what the manufacturers told them was in it so they could maintain plausible deniability of what was in them. A royal commission should short out Professor Baffled and the TGA expert committees on what seems to be a textbook case of malfeasance in office.
Undeterred, the TGA is doubling down. They just announced the removal of pack inserts for all injected products. These inserts used to inform doctors of known side effects and adverse drug interactions. For that reason, printed inserts are a legal requirement, saving the doctor from a web search most would haven’t time to conduct. Typically, when the TGA sees a problem, it hides the problem. Without this information, Dr Baffled will be even more baffled as to why patients keep dying suddenly. On the issue of excess deaths, the latest Australia Bureau of Statistics data shows Australian excess mortality remains at 27 per cent—40,000 Australians are dead this year who should not be dead and nobody in this government gives a damn. No one gives a stuff. One Nation calls on the government to call a royal commission into COVID now and, until that inquiry happens, stop the COVID shots now.
This bill is seeking to provide biosecurity officers with increased powers. With everything we’ve been through over the past few years, I decided to ask for clarification on the bill. I questioned how these new powers could be used and whether there was a risk of discrimination against arrivals into Australia, particularly those who have chosen not to receive medical procedures such as the COVID-19 injections.
I am concerned these amendments would ensure the collection of data from all incoming travellers to support intelligence-gathering and evidence-based predictions of potential biosecurity risks.
Minister Watt offered assurances in the Senate Chamber that there is no intention of using the bill to discriminate against people based on medical status or ethnicity. He also assured me that this bill did not allow for collecting or retaining health information.
Transcript
Senator Roberts: I have two questions. The first is of the minister: could this bill be used to discriminate against arrivals who have chosen not to receive injections related to COVID-19 measures? As part of that, does this bill allow travel documents to include information based on vaccine status?
Senator Watt: I’m just seeking some further advice on that, Senator Roberts, but I’m certainly not aware of any intention to use these powers in that way or even whether the powers could be used that way. I know that there were some concerns raised by a couple of the parliamentary committees about how these powers might be used and the risk of discrimination that might be posed. I think we were certainly able to persuade those committees that there would be no such ability to discriminate. You may have seen, Senator Roberts, that one of the things this bill is doing is providing biosecurity officers with increased powers to seek passports from people, but that’s really about trying to check where they have been and whether they’re repeat offenders when it comes to biosecurity risks rather than checking on people because of their particular racial background, their COVID vaccination background or anything like that. It’s more about, as I said, allowing biosecurity officers to trace when people have been to very high-risk locations or if they’re repeat offenders with biosecurity, in which case I’m sure you’d agree that they’re the people who we really need to focus our biosecurity efforts on.
Senator Roberts: Minister, have you received that advice yet about my specific question?
Senator Watt: The proposed amendments are intended to ensure that the data collected in relation to biosecurity interventions with all incoming travellers can be recorded and analysed consistently to support a more intelligence- and evidence-based approach to predicting and managing the biosecurity risk posed by future traveller cohorts. As such, the requirement to provide a passport or other travel document to a biosecurity officer upon request would apply to all persons regardless of their ethnicity, their national or social origin or their vaccination status. The powers that are being granted here cannot be, or are not intended to be, used to go after particular people based on any characteristic about them. They can be applied to all people, regardless of their vaccination status, their ethnicity or anything like that. I think that you can be confident that your concerns would not be carried out as a result of these powers.
Senator Roberts: You said ‘could’ and then hesitated. So that means these powers cannot be used to discriminate against arrivals who have chosen not to receive injections for COVID-19?
Senator Watt: That’s right. The powers cannot be used to discriminate against anyone for any reason, including their vaccination status.
Senator Roberts: My second question is: should there be time limits on the time which health information about an individual is retained?
Senator Watt: In fact, Senator Roberts, this bill does not provide for the retention of data at all. That being the case, the concern that you have does not even arise. It’s not a matter of—sorry, I’ll just clarify this. There’s nothing in the bill that allows data to be retained for health purposes and so the issue of how long data could be retained for health purposes doesn’t arise, because it can’t be retained for that purpose at all.
https://img.youtube.com/vi/JiJwE9TSfqU/maxresdefault.jpg7201280Sheenagh Langdonhttps://www.malcolmrobertsqld.com.au/wp-content/uploads/2020/04/One-Nation-Logo1-300x150.pngSheenagh Langdon2023-09-05 08:52:032023-09-14 10:46:37Amending the Biosecurity Act — What Does it Mean?
The Australian, American, British & Canadian military forces formed this consortium to dominate COVID response.
Australia joined the consortium in 2012 under the Labor-Gillard government.
A military-pharmaceutical apparatus linking the USA, Australia, Canada and the UK.
Operation Warp Speed: The US Department of Defense signed the first contract between the US government and Pfizer for the purchase of US$11 billion dollars worth of vaccines.
We know our Therapeutic Goods Administration (TGA) did not review stage 2/3 trial data and instead relied on the US FDA, which took Pfizer’s word for how the trials went!
Pfizer committed systemic fraud during its trials, which has come out now through whistle-blowers’ testimony and in the release of Pfizer’s own data.
Pfizer, it seems, gave the US government the vaccine they asked for. It was developed using gain of function research in conjunction with Wuhan in China and, of course, Anthony Fauci. The military-pharmaceutical in action.
These are matters to be dealt with in a Royal Commission. The Royal Commission that was promised by the Albanese government.
Call a Royal Commission into COVID now!
Transcript
As a servant to the many different people who make up our one Queensland community, tonight I speak to an aspect of COVID-19 I haven’t raised before. Information now in the public domain indicates the COVID response was not initiated through commercial interests but, rather, through an organisation called the Medical Countermeasures Consortium that Australia joined in 2012. According to Australia’s defence.gov.au website, the Medical Countermeasures Consortium is a four-nation partnership involving the defence and health departments of Australia, Canada, United Kingdom and the United States. ‘The consortium seeks to develop medical countermeasures to assist with … chemical and radiological threats affecting civilian and military populations and on emerging infectious diseases and pandemics.’ It includes drugs and diagnostics. Who knew we had a military pharmaceutical apparatus linking the United States, Australia, Canada and the UK, in place since the Gillard Labor government—an AUKUS for pandemics?
The consortium maintains a compensation scheme for people injured as a result of taking a countermeasure. Compensation claims were accepted for the 2009 H1N1 vaccine, the anthrax vaccine and flu vaccines. The medical countermeasures unit within the United States Department of Defense has been in the vaccine business for many years and has been injuring people for many years—and getting away with it. So it should come as no surprise that the American Department of Defense signed the first contract between the United States government and Pfizer for the purchase of $11 billion worth of vaccines. President Trump gave the order to the Department of Defense to commence vaccine development and even gave it a cool name: Operation Warp Speed.
President Trump reacted, as we in this place reacted, with the best of intentions and the worst of data. Intelligence was used that our security apparatus knew or should have known was wrong. Videos from China of people dropping dead have proven to be fakes produced with the assistance of Chinese intelligence, and they may not have acted alone. These videos should not have made it to the decision-making process in the West. How that happened—how so much fraudulent information was offered to elected members—is a matter for a royal commission. The United States has already started multiple congressional hearings and court cases that will eventually yield the truth. Australia must play its part in this process—our part, for we are truly all in this together to the very end. There are doors to be kicked down, and this time it will not be the doors of everyday Australians, guilty of no crime, who merely spoke the truth on social media.
The United States response to COVID brought the Medical Countermeasures Consortium into the process at a very, very early stage. Australia’s military were involved early, providing assistance including crowd control, border quarantine, contact tracing and medical personnel—things one would expect the military to help with.
Former Prime Minister and profligate officeholder Scott Morrison shuttered the COAG system because it was open and transparent—COAG being the Council of Australian Governments. COAG was not just a single meeting; COAG was a secretariat with committees, including a health committee, liaising across local councils and state and federal government. Although not a constitutional instrument, this COAG structure was very well positioned to administer our COVID response. Why was it abolished and replaced with a military pharmaceutical apparatus? I hope the royal commission asks that question. In place of COAG, Mr Morrison created a secretive so-called National Cabinet, consisting of only the state premiers and territory chief ministers. What was the secret so important that a well-functioning apparatus like COAG had to be demolished and the truth gagged for 30 years?
Mr Morrison then appointed a serving military officer, Lieutenant General Frewen, to run Australia’s vaccine rollout, rebranded as—wait for it—Operation COVID Shield. The United Kingdom responded to COVID in March 2020 with a massive military operation called Operation Rescript. This moved 23,000 military personnel into a new unit called the COVID support operation, under British powers known as military aid to civilian authorities, MACA. Command of this large military force remained with the military. And Canada—what of Canada? Canada called in the Canadian Armed Forces with ‘unprecedented measures’—their words, not mine—under operations LASER and VECTOR.
It’s clear the Medical Countermeasures Consortium agreement, which the Gillard Labor government signed in 2012, was designed to make pandemic response a military operation, not a civilian health operation. This should have been clear in July 2021, when General Frewen took to the microphone in full military uniform. Australia saw military checkpoints at borders, military guarding medical facilities, military in their hardware on the streets of Sydney and Melbourne locking people in their homes. All of this created a climate of fear and intimidation that facilitated acceptance of the COVID injection. Was this the plan? Has the pharmaceutical industry now donned fatigues?
Did our civilian health authorities stand up for established medical principles, based on the Hippocratic oath to prescribe only beneficial treatment? No, they did not. We know our Therapeutic Goods Administration, the TGA, did not review the Pfizer stage II and III clinical trial data and instead relied on the American FDA’s paperwork. We know the FDA didn’t review the data and instead took Pfizer’s word for how the trials went. Surely the TGA knew this. If it did, the TGA’s complicit. If it didn’t know, the TGA is hopelessly or wilfully negligent. It’s misfeasance.
Pfizer committed systemic fraud during their clinical trials, with whistleblowers revealing only healthy adult participants were recruited for a stage II/III clinical trial of a vaccine that was intended for the sick and elderly; trial duration was grossly insufficient to capture medium-term and long-term side effects like myocarditis; to drown out the number of adverse events being recorded among real participants, fake participants were created who recorded zero side effects; patients who suffered serious side effects were removed from the study and never existed in the paperwork; and the COVID injection was not tested on pregnant women, and women who fell pregnant were removed from the study before childbirth. The COVID injection was then recommended for pregnant women. How could any human do this? This is inhuman, and it’s monsters that did it. Why did Pfizer think they could get away with the most crooked clinical trial in history? Could an answer to this question be found in testimony of a Pfizer executive to US Congress? They made a comment that Pfizer gave the US government the vaccine the government asked for and so claimed Pfizer is not liable for the adverse events.
The military appears to have been involved in the cover-up of COVID’s origins. It’s now clear that COVID was developed during gain-of-function research in China’s Wuhan Institute for Virology, connected with the Chinese military. Who funded this research in China? The United States National Institutes of Health, under Anthony Fauci. Canada and Australia were involved in this research. In 2020, the CSIRO put out a press release not only admitting their gain-of-function research but defending it. I’ve spoken on that previously. After a series of lab escapes involving pathogens at the headquarters of America’s Centers for Disease Control and Prevention—the CDC—in Georgia, President Obama in 2014 suspended gain-of-function research. Anthony Fauci ignored the president’s order and moved the research offshore to Wuhan, China.
Gain-of-function research is countermeasure research. It’s the same process of finding and manipulating pathogens to produce a new virus—a Frankenstein virus. Once the virus is deadly enough, a vaccine is prepared, and then the whole thing is put on shelf in case an enemy or nature deploys that virus. Once the virus appears in the population, vaccines can be deployed, at a price, of course, because after all this is the corporate United States, racked with parasitic globalist predators.
In the early stages of COVID development and escape, did our medical countermeasure apparatus act independently of government? This is a question for a royal commission. Did anyone in this country accept orders from the United States military to do or not do a thing that may have interfered with this military pharmaceutical plan? That’s another question for a royal commission. Let me be clear: Australia has a long and enviable history of using our military to assist in civilian disasters to the benefit of all. If the need arises again, we should not hesitate to allow our military to help out again. The military should not be used against law-abiding civilians or against healthy civilians for the purposes of forced injections to transfer wealth to big pharma. What we saw was forced injection of people after succumbing to the threat of deprivation of their family’s livelihood and their ability to feed children. Fear, intimidation, blackmail and threats of loss of income and home are elements of force—inhuman force.
I have repeatedly said that COVID-19 was severely mismanaged, because it was never about health. It was about control of people and wealth transfer using deceit—deceit that’s inhuman, monstrously inhuman. We must know whether our TGA, in waving through a vaccine countermeasure that would not have been approved under normal circumstances, bowed to higher powers. Was this a military pharmaceutical operation or a civilian health operation? These are matters ordinarily dealt with in a royal commission. The Albanese Labor government broke its pre-election promise to have a royal commission. If it continues to break its promise, it will be complicit in hiding truth from the people, truth that is slowly yet relentlessly and inevitably coming out. Call the bloody royal commission now.
https://img.youtube.com/vi/Die1Aeax1Tw/maxresdefault.jpg7201280Sheenagh Langdonhttps://www.malcolmrobertsqld.com.au/wp-content/uploads/2020/04/One-Nation-Logo1-300x150.pngSheenagh Langdon2023-08-09 17:02:112023-08-09 17:33:43Did the Medical Countermeasures Consortium run COVID?
