Australia Needs Independent Drug Scrutiny — the TGA is Compromised

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

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

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

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

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

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

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

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

Transcript

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Senator ROBERTS: Why is the first question that one?

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

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

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

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

Mr Henderson: Senator, could you repeat the question?

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Dr Langham: Correct.

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

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

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

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

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

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

Senator ROBERTS: Do you support them or not?

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

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

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

Senator ROBERTS: Did you do anything to stop it?

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

Senator ROBERTS: Yes.

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

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

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

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

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

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

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

Transcript

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

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

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

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

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

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

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

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

Dr Langham: You would expect so, absolutely.

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

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

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

Senator ROBERTS: Yes, it is a question.

CHAIR: What was the question?

Senator ROBERTS: Isn’t that the case?

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

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

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

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

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

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

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

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

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

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

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

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

Senator ROBERTS: Do you want me to repeat it?

Dr Gilmour-Walsh: Yes.

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

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

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

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

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

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

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

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

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

Senator McCarthy: I’ll take that on notice.

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

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

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

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

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

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

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

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

Senator McCarthy: I’ll take that on notice.

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

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

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

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

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

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

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

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

Dr Langham: Certainly not.

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TGA’s Process Patently Not Effective

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.

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Pursuing Accountability Among the Agencies

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The Australian National Audit Office (ANAO) is thorough and does some fine work. Its audit of the National Emergency Management Agency (NEMA) and the National Recovery and Resilience Agency (NRRA) found performance accountability missing.

At Senate Estimates the ANAO audit of Disaster Recovery Funding uncovered several reporting deficits with NEMA and NRRA that need to be addressed, vindicating my previous call for a Senate Inquiry into the administration of Disaster Relief Funding Arrangements to expose the misuse funds.

I called for an ANAO audit of Coal LSL (Long Service Leave) after Chartered Accountants KPMG’s concerning report of Coal LSL revealed many governance problems and the non-paying of entitlements to Hunter Valley coal miners.

I’ve been raising these issues for the past four years and will keep raising them on behalf of Australians until these identified problems and governance issues are resolved.

ANAO has agreed to examine this so watch this space.

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The COVID Censorship Chain of Command

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During the May/June Senate Estimates hearings, I asked the Department of Health and Aged Care to clarify their role with the Department of Home Affairs in censoring social media posts.

Home Affairs had indicated that it relied upon the Department of Health to identify social media posts that ‘contravened Facebook/Meta’s guidelines’. This of course is just more dodging of responsibility as the agency trampling the fundamental rights of speech. Although it’s government doing the censoring, they give the social media corporations the button to push.

It turns out that when Home Affairs wanted to censor or provide information to social media platforms where posts breached the platform’s own guidelines during the COVID response, they relied upon the Department of Health to identify whether or not there was a breach. The Department of Health rarely identified posts and merely provided the information that the government decreed to be ‘correct’.

Transcript

Senator Roberts: Yes. Professor Murphy, could you please clarify your department’s relationship with the Department of Home Affairs, because Home Affairs seem to think that they relied upon the Department of Health for identifying social media posts that contravened Meta’s guidelines.

Prof. Murphy: Ms Balmanno can go over that again.

Ms Balmanno: As evidence became available in terms of the nature of the virus and the nature of treatments, vaccines and all of those sorts of things and how it was being transmitted, obviously there was a growing evidence base there, and it was our job to collate that and to point to the source information, whether that be the Australian Health Protection Principal Committee, whether that be the World Health Organization or whatever it might be. We would collate that information for the Department of Home Affairs. That would be what they were able to the then assess posts against. But ultimately the assessment is against the social media platform’s own policies about what is appropriate and not appropriate to be put onto their platforms. They each have a published policy, so they would use our evidence base to inform that decision and assess against those policies. Where they felt there was a breach and a post or an account was putting forward information that was not consistent with those policies, they would refer that to the social media company to look at.

Senator Roberts: Let me clarify, then, to make sure I’ve got the understanding. Home Affairs wanted to censor or provide information to social media platforms where a post breached a social media platform’s own guidelines, and they relied upon you to identify whether there was a breach.

Ms Balmanno: We were part of informing that, in that—

Senator Roberts: Who else was part?

Ms Balmanno: My point is the elements that we were able to contribute to were whether if, for example, they were making a referral specifically because they thought the information was false and was disinformation being deliberately promulgated to cause harm, they would use the evidence sources that we had collated for them to make that assessment and say, ‘According to all of this published research or according to the views of the Australian Health Protection Principal Committee and the position in Australia, here is the evidence we are pointing to to suggest that this post is incorrect.’ So we would help provide that evidence. That was our role.

Senator Roberts: So you didn’t identify posts; you just provided evidence when Home Affairs asked for the evidence?

Mr Blackwood: Yes, we were proactive in providing it if there were something not covered—

Senator Roberts: So you sometimes did identify posts?

Ms Balmanno: We were proactive in providing evidence as new evidence came to light and adding to the evidence base. If there were an issue they come across that they thought was incorrect—for example, the idea that 5G was causing COVID was one of the early ones that we did a lot of referrals in relation to—and if we didn’t already have that in the evidence base, they would obviously check that with us in terms of an evidence assessment, and that would be added to it.

Senator Roberts: So it was a hybrid role, then. Sometimes you identifies posts—

Ms Balmanno: We very rarely identified posts.

Senator Roberts: But sometimes you did.

Ms Balmanno: We probably have a handful of examples where we identified posts, and I have agreed to take that on notice.

Senator Roberts: Thank you.

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Australia’s Bank Guarantee Scheme – Are You Covered?

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At the May/June Senate Estimates, I asked the Australian Prudential Regulation Authority (APRA) about their accountability and responsibilities for financial services and then probed further into depositor guarantees. I wanted to try and establish whether Australians’ savings are secure in the event of a financial crash. Have a listen.

APRA made the point that Financial Claims Scheme (FCS) is really a last resort. Australian banks and financial institutions are required to have practical plans in place to ensure they can get up and running again in the event of a financial crisis. If that were to fail, however, account holders would be covered for the first $250,000 of their deposited funds per institution.

What this answer failed to mention is that the Financial Guarantee Scheme (FGS) only kicks in once the bank fails. At this point, the bank would have been able to use bail-in provisions to use depositor’s funds to save themselves.

The FCS is also unfunded. The government has not put any money aside to fund the scheme — there is a limit of $20 billion per bank, which is only 10% of what would be needed for just one of the Big-4 banks alone. The Treasurer is not required to trigger the FCS if they don’t want to spend the money.

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Coal LSL Under Question

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At the May/June Senate Estimates I asked questions of the Coal LSL Board to establish that a person working under an Enterprise Agreement contract cannot receive benefits less than the agreed award for the same category.

Under the Black Coal Award there’s no category for casuals because casuals are not allowed to be employed under the Black Coal award.

The Board confirmed that they do not check which category a coal miner works when calculating long service entitlements, merely accepting what the employer tells Coal LSL.

All this contributes to coal miners being exploited in not getting their entitlements.

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Medical Professionals Silenced by AHPRA

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Ten medical professionals have had their registrations suspended by the Australian Health Practitioner Regulation Agency (AHPRA) simply because they spoke out about the COVID injection risks — 4 doctors, 5 nurses and 1 pharmacist.

Even now, AHPRA officials remain in denial about the risks that these injections pose, despite the growing body of evidence that contradicts the marketing slogan of safe and effective.

Australians forced against their will into getting these shots to continue their job, education or see family and loved ones did not have the benefit of ‘honest advice’. Although they should have been able to freely discuss their needs, they were not given this opportunity because the statement AHPRA put out to clarify existing health advice and media coverage around it served to effectively muzzle healthcare providers through fear.

At no time did the agencies involved in providing public health advice reassure medical professionals or their patients that they still had the right to privacy and confidentiality. Patients receiving medical advice before undergoing treatment were entitled to be warned of risk.

Let’s not forget these injections were only provisionally approved due to the experimental nature of the mRNA and vector technology. If our best and brightest medical professionals are feeling silenced by government bodies that will punish any criticism of novel medicines, what have we become?

We now know the jab roll-out is a military/health response which is why it by-passed the usual safety protocols. These were products that were not ready to be injected into the arms of people and yet the only ones protected are the manufacturers.

It’s time for the Health Minister, AHPRA, TGA and ATAGI to loosen the stranglehold they have on our healthcare professionals and let them be free to do their jobs. Australians deserve nothing less.

Transcript

Senator Roberts: Thank you for appearing today, Mr Fletcher. How many health practitioners has AHPRA suspended for being outspoken, contrary to the joint statement of 9 March 2021?

Mr Fletcher: In relation to concerns that we’ve received about any aspect of the conduct of a practitioner related to COVID-19, 31 registered health practitioners have been suspended since the commencement of the pandemic, and 10 of those suspensions were solely with reference to a breach or an alleged breach of the code of conduct related to the vaccination statement. Just to complete that: that’s four medical practitioners, five nurses and one pharmacist.

Senator Roberts: How many health practitioners have had their registration cancelled because of being outspoken contrary to the joint position statement of 9 March 2021?

Mr Fletcher: I might ask the general counsel, Dr Jamie Orchard, to join me, because, just to remind you, neither AHPRA nor the Medical Board nor any of the boards have the power to cancel the registration of a health practitioner. A suspension is an interim measure while we investigate the concerns.

Senator Roberts: Who has the power to cancel it?

Mr Fletcher: That’s done by the independent tribunal within each state and territory. If we have a concern that there is professional misconduct, which is the most serious finding we can make, we then have to refer that to the tribunal, and it’s only the tribunal who can make a decision about cancellation. We’ve got five tribunal outcomes to date, but I’ll just ask Dr Orchard to give you the details.

Dr Orchard: So far a number of matters have been referred to tribunal in respect of practitioners relating to COVID related issues. We have five decisions so far from the tribunals. We can’t go into the details of the other matters because they’re still pending before the tribunals. Those matters relate to one dentist whose registration was suspended and a registered nurse who was disqualified. There was another registered nurse who had been the subject of suspension from the board but was not suspended by the tribunal. There was an enrolled nurse whose registration was suspended for 11 months. There is one final matter, where the tribunal has found professional misconduct but hasn’t yet decided on the sanction.

Senator Roberts: All five are associated with COVID?

Dr Orchard: All related to COVID in some way, but not necessarily solely in relation to making antivaccination statements.

Senator Roberts: How many health practitioners have either been suspended or had their registration cancelled because they made statements that supported the use of ivermectin in the context of treatment of COVID-19?

Dr Orchard: We’d have to take that on notice and have a look.

Senator Roberts: In the 9 March 2021 position statement, it threatens regulatory action for criticising the COVID-19 injections and/or the national immunisation campaign. Is that still in effect?

Mr Fletcher: Senator, the statement you refer to, just to remind you of the context, was issued by all of the 15 national boards with AHPRA.

Senator Roberts: It’s a joint statement.

Mr Fletcher: So it’s a joint statement. Essentially, it was issued in response to queries from practitioners about their obligations in relation to COVID-19 and vaccination, and the statement essentially aims to make clear how existing obligations on a registered health practitioner, through codes of conduct and the like, applied in the context of COVID-19 and vaccination. That statement is still in force.

Senator Roberts: When can we expect this statement to be amended or removed in light of the best available medical scientific advice, which now shows the COVID-19 vaccines, the injections, to be unsafe and not effective? The risk-benefit is undoubtedly terrible.

Mr Fletcher: The statement has always been aligned with the public health advice at the time. We look to jurisdictional health departments, the TGA and ATAGI as the primary sources of public health advice. We will certainly be consulting with them in the near future about the current status of that public health advice and whether any amendment to that statement is needed.

Senator Roberts: Health practitioners like the GPs I’m about to mention—they’ve given me permission to use their names—Dr Mark Hobart, 19 months; GP registrar Dr William Bay, nine months; and emergency department registered nurse Beulah Martin, 11 months, continue to have their health practitioner registration suspended for allegedly engaging in conduct not supportive of the COVID-19 injections. Why are they still being punished?

Mr Fletcher: We’re going to need to be a bit careful about what we say publicly about individual matters, but I’ll just ask Dr Orchard to comment about what we can say publicly about at least two of the practitioners you’ve named there.

Senator Roberts: The context is why they are still being punished in regard to what’s now emerging about the injections?

Mr Fletcher: Let me ask Dr Orchard to explain what we can say publicly.

Dr Orchard: Senator, the action in respect of any practitioners—including those that you’ve mentioned—that was taken by the relevant boards at the time to suspend those practitioners was taken pursuant to the provisions of the national law, either for the purpose of preventing serious risk or in the public interest, and that’s the basis on which they were suspended at the time. Those matters are currently still before the courts because there are appeals going on in respect of each of them, so we can’t really go into further detail while the matters are still being considered by the courts.

Senator Roberts: Let’s come back to national law in a minute. Despite lengthy delays in investigation and AHPRA’s commitment to the Senate to achieve timely investigations and keeping in mind that the section 156 suspension powers under so-called national law are meant to be only an emergency and temporary measure for the most serious of threats to the health and safety of the public, how long can we expect AHPRA to keep maintaining the suspension of doctors, nurses and medical professionals around Australia who have expressed concerns regarding these vaccines, these injections, when now, in light of the best available evidence, those concerns are well justified? You have been suppressing medical professionals giving their honest advice and forcing them to go against the Hippocratic oath or to surrender.

Mr Fletcher: I reject the assertion you made that we have in any way been censoring practitioners. What we have said in that statement is that we expect that people dealing with patients use the best available evidence and their clinical judgement. That is an obligation that has been in the code of conduct for health practitioners that predates COVID-19. There is no change in that. Suspension is an interim measure while we investigate, and it has to meet a legal threshold under that national law. Sometimes one of the reasons that suspension is extended or takes a period of time is because a practitioner exercises the right to appeal their suspension, either to a tribunal or a court. Obviously, while those appeals are underway, we put our work on hold. Essentially, the suspension is there, as I say, on the one hand to allow us to ensure there is appropriate public protection meeting a legal threshold under the national law while we investigate each case.

Senator Roberts: Are you aware that some of the country’s best medical people, best specialists, are telling me that they are silent and changing their behaviour because they are suppressed by AHPRA? Are you aware of that?

Mr Fletcher: I have read the commentary on that, yes.

Prof. Murphy: I’ll make a comment. Senator Roberts keeps asserting that there’s new evidence that the vaccines are not safe or effective. We completely refute that suggestion.

Senator Roberts: I knew you would.

Prof. Murphy: There is no credible scientific evidence that the vaccines, other than—

Senator Roberts: That’s a false statement.

Prof. Murphy: No, I’m going on the best available scientific evidence, and I do not think you should be able to make that statement continually.

Senator Roberts: I will keep making the statement based on science.

Senator Gallagher: It cannot be left unchallenged.

Senator Roberts: He can challenge it, but I’m not going to quit.

Chair: Senator Roberts, I was listening carefully. Before you ask your last question, I am going to remind you that it is important that you put these as questions rather than as statements. I believe you did that with your last question, but the question before was a sentence without a question at the end of it. I think it is appropriate in that case for the witnesses at the table to respond, but the best way is to put questions and then we can hear answers.

Senator Roberts: I am happy to show you my questions.

Chair: Senator Roberts, I was listening carefully. I am happy to have a discussion if I have misheard, but in the question before your last question I didn’t hear a question; I heard a statement. You have a supplementary question, and I remind you that it assists the process of the committee if we frame questions for answers, as I’ve said from the start.

Senator Roberts: Many health practitioners have been suspended under the Health Practitioner Regulation National Law. Is it not true that such a singular national law does not exist, and that the national law is not a Commonwealth law at all but a collection of state based health laws such as the Health Practitioner Regulation National Law (Queensland) and the Health Practitioner Regulation National Law (Victoria)?

Mr Fletcher: I defer to my general counsel to talk about the legal construct of the national scheme.

Dr Orchard: You’re correct in saying that it’s not a Commonwealth law; it’s not. It is a cooperative piece of legislation amongst the various states and territories of Australia. The legislation was initially passed, and any amendments that are passed are passed through the Queensland parliament and then the various states and territories have different mechanisms by which they apply both the original law and any amendments to that law in their own jurisdiction.

Senator Roberts: Thank you for confirming. If so, how can AHPRA accurately and lawfully enforce one national law across Australia, when in fact it is not a national law but many state laws, each with its own amendments, across each state and territory of this Commonwealth? We have state laws being enforced by a national body that’s responsible to the states.

Dr Orchard: I will say, when you talk about the differences, there are very limited differences across the various jurisdictions. It does operate largely as a single national law across the country, subject to some exceptions of course. We ensure that, in the course of our regulatory role in applying that law, we do so consistently across the country so that it operates in a sense in a seamless way and practitioners who operate in one jurisdiction are able to move into another jurisdiction and continue their profession without having to worry about the difference in the state laws that might apply to them.

Chair: Senator Roberts, I’m passing the call to the opposition.

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New NAPLAN Scoring Developed By Expert Teachers

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In the May-June Senate Estimates, I asked David de Carvalho, CEO of the Australian Curriculum, Assessment and Reporting Authority (ACARA) why the National Assessment Program — Literacy and Numeracy (NAPLAN) will no longer report progress through the NAPLAN ban system so that parents can see how their child is progressing relative to others?

In light of the latest disappointing NAPLAN results, which shows one in three children failing literacy and numeracy, I thought you’d be interested to hear his response.

Transcript

Senator Roberts: Thank you for appearing again. Why will NAPLAN no longer report progress through the NAPLAN bands so parents know how their child is progressing relative to other children?

Mr de Carvalho: Ministers decided on 10 February this year to move to a much better reporting system, which actually provides more meaningful information for parents. They will now be getting information that indicates where they are in terms of proficiency standards, which were agreed would be introduced as part of the national school reform agreement. The bands, if you go back to 2008, when they were set up, are essentially a statistical construct. We had a scale of around 1,000 points. The mean we set at 500. It was essentially divided into 10 bands. That number was relatively arbitrary. It could have been more. It could have been less. It’s a kind of a goldilocks number, if you like—a nice round number. The cut points in the bands themselves, unlike the new system, which we are introducing, didn’t have inherent educational value other than simply to be kind of marker points on a scale. It’s bit like telling a parent about their child’s height. They’ve moved from the zero to 20-centimetre band into the 21- to 40-centimetre band. Or, with weight, they’ve moved from the zero to 10-kilogram band into the 11- to 20-kilogram band. What parents really want to know is: is my child actually progressing at the normal rate or do they need additional support? These new standards—

Senator Henderson: I would disagree with that, actually.

Mr de Carvalho: The teacher view has been used to say, ‘What questions should children be able to answer to meet a challenging and reasonable expectation?’ We’ve used professional teacher judgement as opposed to a statistical or arithmetical division to identify the standard expected. That’s the one that we road-tested with parents. We asked them, ‘Would you prefer to see an individual student report with the numerical bands or this more meaningful information?’ They were quite unequivocal about it. They preferred the latter. It’s also not correct to say that parents won’t see their progress. Each individual student report has never reported progress. You need to keep the previous reports. Even if you are in year 3 and then year 5 under the new system, you may increase your NAPLAN score, say, from 250 to 300. You may still be reported in year 5 as strong whereas you were also strong in year 3 but the descriptors associated with ‘strong’ will indicate a higher level of capability. Parents will still be able to see that their child has progressed into a higher skill set. There will be more detailed information, more meaningful information, for parents through the new system.

Senator Roberts: Thank you for that. There are things in there that sound attractive, but I don’t understand it well enough. Perhaps you could tell me what is wrong with this description. Instead of providing a reading score in band 3, 4, 5 or 6, giving parents an idea of exactly where their child is in terms of progression, all of those bands will be replaced by the word ‘developing’. ACARA has said parents found the bands confusing. Isn’t that just an indictment on your failure to explain the more accurate band reports? Could you go into more detail? Tell me what is wrong with that.

Mr de Carvalho: I will go back to the point I was trying to make at the start. Those bands were simply arithmetically derived.

Senator Roberts: So a child was placed in there numerically?

Mr de Carvalho: There is a scale of, say, zero to 1,000. You set the mean at 500 and then you have your statistical categories, your differentials, set just by picking 100 or 200 or whatever the scale is to deliver 10 categories. But what we’re doing this time is using teacher professional judgement. We’ve consulted professional expert teachers about where on the scale they expect children to be based on what they’ve learned in previous years. We have asked which questions they should be able to answer to be able to say, ‘Yes, they’re meeting expectations.’ That was not the case under the previous 10-band regime. Parents will be able to see at a glance. What is really important about the new system is that particularly those children who are genuinely struggling will be identified as needing additional support. That is crucial, because under the old system, we had a category called the national minimum standard. It was broadly recognised that the national minimum standard was set too low. There was a relatively small percentage of children below the national minimum standard. It wasn’t really a call to action. Now we will have more students identified in that bottom category and it will be clear through the name of the category or the name of the level that those children need additional support. It will be a prompt to parents to have a discussion with their teachers about what needs to be done. I think that is a  real, important change.

Senator Roberts: So the parent will be able to see the areas in which the child is deficient or strong?

Mr de Carvalho: The descriptors will also be part of the individual student report. It is a paper based report, and you can only put so many words on a paper based report. There will be high-level descriptions for each domain—that is, reading, writing, numeracy, spelling and grammar—and what it means if you are in each of those levels. If you want more fine-grained information, you will be able to go to the ACARA website and get more and more fine-grained information. With that, teachers will be able to have good conversations with parents about what needs to be done.

Senator Roberts: Thank you. It looks like there is more understanding to be gained on my part.

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School Survey Questions Aussie Kids About Parents’ COVID Compliance

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Parents contacted my office with concerns they had about a National Assessment Program (NAP) science quiz survey, which targeted children in Grade 6 (11 and 12 years). One of the survey questions was about families ‘compliance’ with the government’s COVID guidelines/regulations.

In Senate Estimates, I asked how relevant this line of questioning was with the stated NAP science objectives and whether the Australian Curriculum Assessment and Reporting Authority (ACARA) believes this is appropriate questioning for school children, who authorised the questions and who sees the results of the survey.

The COVID response has eroded many people’s faith in the government. Asking children to judge matters of civil compliance does not help build back trust in the wake of the last three years of hell that many families have gone through.

We have yet to receive responses from #ACARA to our questions, but hope to have them before the next Senate Estimates in October.

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