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Affordable Medicinal Cannabis Needed for Millions of Australians

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On Wednesday of the last sitting week in November, Senator Shoebridge proposed a bill to legalise cannabis. While support for legalising cannabis is growing strongly across Australia and Queensland, it’s essential to approach the topic with care, data, and diligence. It’s important to understand that despite claims by the TGA and the Lib-Lab UniParty that medicinal cannabis is freely available, the reality is quite different. The plant is artificially expensive and restricted in availability.

In an honest and effective way, we need to make medicinal cannabis easy and affordable to access for millions of Australians. One Nation will continue to lead the way in taking this first, humane step.

While we welcome much of Senator Shoebridge’s bill, there are three key sticking points that One Nation cannot accept:

1. One Nation cannot support home grow at this time. The trial of home cultivation in the ACT has shown it’s not widely adopted. A licensed commercial system would benefit more people than home grow at this stage

2. The fines and jail sentences proposed in the bill are excessively high. One Nation believes in ensuring that the punishment fits the crime, and this bill strangely gets that balance wrong.

3. One Nation does not support creating a new government entity to maintain a cultivar database. Instead, we would work with existing entities to achieve this purpose.

That said, the approach of removing cannabis from the control of pharmaceutical company salespeople at the TGA and establishing a new unit led by people who understand the plant, the industry, and can advance medicinal cannabis—is an excellent idea that One Nation fully supports.

A vote for One Nation is a vote for Australian, whole-plant, natural medicinal cannabis for anyone with a medical need. It would be accessible via a prescription from a doctor, nurse practitioner, or cannabis specialist, and filled by a pharmacist or qualified dispensary under the PBS.

This plan will not increase costs to taxpayers. Evidence from countries that have adopted this model shows that cannabis reduces healthcare spending, as it’s cheaper than many expensive pharmaceutical alternatives—if implemented correctly.

Transcript

There’s much in the Legalising Cannabis Bill 2023 which would make the regulatory environment for cannabis in Australia much, much fairer, so I thank Senator Shoebridge for bringing this bill before the Senate. I feel very pleased to speak, excited about some things and disappointed about others. For too long, the government of the day, both Liberal and Labor, have acted to defend the pharmaceutical state from the competition that medical cannabis represents. Indeed, our regulatory body, the Therapeutic Goods Administration, is funded from the pharmaceutical industry that it purports to regulate. The result is regulatory capture. 

In recent years the Therapeutic Goods Administration, the TGA, has taken decisions that defy logic and that breach integrity—decisions that have placed 90 per cent of Australian adults at great risk of harm and death, decisions that have led to excess deaths it refuses to address, because the cause is the TGA and our health authorities. The TGA is a failed experiment; that is abundantly clear. It’s time to shut down the TGA and its apparatus of expert committees and agencies which act in concert to support the pharmaceutical industry to the detriment of the Australian people. It’s time to return control of drug and medical device approvals to the department, where the parliament will be able to exercise oversight and ensure accountability and transparency, which are sadly missing with the TGA. 

The department can be downsized. Health is the state responsibility. Centralised regulation of drugs in the hands of the Commonwealth makes sense, and the states should be charged the cost of doing it or do it themselves, as they used to. Cannabis was removed from medical options in Australia following the Menzies government’s passage of the National Health Act 1953. This legislation placed the British Pharmacopoeia as the primary source of standards for drugs in Australia. Cannabis was a stalwart of pharmacopoeia. In 2024 the only pharmacopoeia that still includes medicinal cannabis is the European version. My point is that cannabis was widely used and accepted as a legitimate medical option across a wide range of profiles for a wide range of conditions. Without a doubt, pharmaceuticals have been a boon for modern society in many ways, although for many people modern pharmaceuticals don’t work, or the side effects can exceed the benefit. There’s a simple reason for this: medical cannabis has thousands of versions, with different combinations of cannabinoids, terpenes, flavonoids, steroids and other elements of the plant. There are thousands of elements. The Australian cannabis cultivar repository has almost 1,000 live cultivars of cannabis and is adding more all the time. 

The significance of this is that it allows a patient, under the right guidance, to match their strain of cannabis—known as the profile—to the condition that they have. Modern pharmaceuticals employ and promote the opposite approach, matching a pharmaceutical product to a condition—one size fits all, if you like. That’s not the way health should be. But both approaches should be available to the Australian people. 

I know the government and the opposition will point to the number of prescriptions written under the pathway scheme for medical cannabis and use that to mislead the public about the success of the current system. Before they make that ill-informed statement, I ask for an answer to the question the TGA refuses to answer: how many people who received a prescription for medical cannabis actually filled it? I’ll ask that again: how many people who received a prescription for medical cannabis actually filled it? My office is hearing from patients who could not afford the prescription, who could not find a chemist to fill it—often because supply was not available—and who paid out big money to get supply that was stale or even mouldy. I want to know how many people who used a medical cannabis product then suffered a side effect. I received a response to a question on notice around this last year. The answer, though, did not differentiate between legal and illegal supply. 

So many people have trouble with price or availability and they fill their prescription on the black market. Some of the black-market players run rings around the quality of the legal supply, and many others do not. On the volume of prescriptions written, though not necessarily filled, the rate of harm from medical cannabis is substantially below the rate of harm for many pharmaceutical drugs. Yet cannabis has not been embraced as an alternative treatment. It used to be the leading medicine in the medical almanac in the 1930s in America; it was No. 1. So why hasn’t it been embraced? Why has it been knocked out? Money talks. 

Restrictions to medical cannabis are more than directly regulatory. Other subtle hurdles make it difficult to access and use affordably, and that’s to the detriment of Australians’ health. Cannabis will never be approved because the cost of navigating the TGA system is so high that no cannabis supplier can afford it. The Legalising Cannabis Bill 2023 contains a new regulator which could function as a unit with the department. The Cannabis Australia National Agency, CANA, would employ people who know the plant and who know how it should and should not be used. That’s a blessing. CANA would set standards for use, sale, promotion, production and importation without the need for a sponsor. CANA could work with the department to understand the supply needs of the pathway scheme to issue formal guidance on profile and volume until such time as the industry develop the critical mass to do that themselves. This solves the pathways scheme’s biggest hurdle: the supply is patchy and the quality is often rubbish. CANA would license strains of cannabis and issue guidance for use through a new agency. I suggest the Greens could have used the existing Australian cannabis register, although that’s a small point. Regulation is necessary. Some of these insane new varieties of cannabis coming out of the United States have THC levels above 30 per cent. The cannabis that came to Australia during the Vietnam War was only three per cent THC. Over 30 per cent THC is insane, though perhaps useful for palliative care at best. 

At this point, One Nation and the Greens diverge. The bill allows home cultivation of six plants. One Nation cannot support home grow. There is a qualification here: our opposition to home grow can exist only if Australians have access to safe, cheap, tested, licensed and accessible product, with a prescription from a doctor or nurse practitioner filled through a chemist or other suitable agent and supplied on the Pharmaceutical Benefits Scheme, the PBS. One Nation introduced a bill which would have done just that, and it was roasted, including by the Greens, can I say. In an interesting example of karma, their bill met the same fate. 

The German government tried for two years, through 2022 and 2023, to introduce legislation which was similar to mine—sensible down-regulation of cannabis. They spent two years fighting entrenched interests, their own department and the Bundestag, the German parliament, and then lost patience. In a decision which could be characterised as ‘Stuff the lot of you’, the government simply legalised cannabis. That came into effect on 1 April this year. I’m pleased to inform the Senate that, in a country which is directly comparable to our country, Australia, legalised cannabis hasn’t caused the world to end. In fact, nothing harmful has happened. This was the same result in the Australian Capital Territory, which allowed home grow three years ago with the same result. No harm happened. In fact, nothing happened. And that is a problem. Legalising cannabis is supposed to help people treat medical conditions, reduce drug and alcohol addiction, reduce the presence of organised crime and chill. None of that appears to have occurred. Homegrown appeals to the small number of Australians within the cannabis community who know what they are doing and who have the land to home grow. For most Australians, regulated supply works better. At this point in the development of cannabis in Australia, regulated supply will help more Australians than home grow will. I’ll say that again. At this point in the development of cannabis, which is continuing, in Australia, regulated supply will help more Australians than will home grow. 

The cannabis community makes a mistake that I find quite frustrating. They judge the plant on the basis of their experience and knowledge. They advocate for open grow and use like it were nothing more than a herb. It’s not just a herb. As I said earlier, there are 1,000 different profiles, and that number is increasing. How does an average Australian, a typical Australian, with no or limited knowledge know which one is right, how to grow it properly, how to prepare it properly and how to store and use it correctly? A typical Australian doesn’t know that, and that suggests smoking the plant, which One Nation suggests is the worst way to take medicinal cannabis. The most scientific, the most accurate and the safest is to purchase a cannabis vaping solution and vape it. But I won’t go there further today. 

The other aspect of the bill One Nation cannot accept is the fines and jail sentences for minor breaches of the regulations. Seriously, six months in jail and 200 penalties earned, which is $36,000? On the other hand, children under 18 get off without a penalty at all. I get that the Greens are trying to raise the age of criminal responsibility, but a 17-year-old who starts a business growing and selling cannabis gets no penalty at all. One Nation questions that. This has not been thought through properly. 

Let me finish with a warning and an invitation. Increasingly, One Nation is tending to the German response. If you won’t allow sensible regulation, then no regulation it is. We need sensible regulation. One Nation is prepared to engage with the government and others across the Senate to achieve a sensible regulation of cannabis, including on the PBS. We continue to listen to the community, to the people, Queensland and Australia, because we want to achieve a sensible regulation of cannabis including on the PBS.  

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Labor Rejects Royal Commission into COVID

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Labor refuses to call a Royal Commission into COVID, because they’ve already been given $1 million in donations from Big Pharma.

One Nation is calling for a COVID Royal Commission now, to ensure we never repeat the same mistakes.

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Global Health Emergency or Corporate Payday?

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

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

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

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

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

Transcript

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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Labor Government’s Vape Ban

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This is my response to the Government’s Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024, which aims to ban vaping in Australia.

As a result of the measures already taken by the Government to ban vaping, organised crime is now moving into illegal tobacco and vape markets with horrific consequences.

This is not about selling our children a bergamot herbal vape; rather, it’s so they can sell vapes laced with hard drugs to get our youth addicted and reclaim the market share that vaping has cost them.

I’ve always maintained that the safety of vapes depends on the quality of the device and the liquid it contains. A more effective regulatory approach would have been to support a future Made in Australia by allowing Australian companies to produce legal, quality-tested and regulated vapes. This should include measures to keep these products out of the hands of children and to impose the same usage restrictions as those applied to smoking.

Instead, the Government is doing the bidding of the pharmaceutical industry, which views vaping—and medical cannabis which vapes often hold—as a threat to their profits and power.

This Bill will backfire badly.

Transcript

I’m speaking to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024. I note the government circulated 11 pages of amendments just an hour or so ago. The large number of amendments indicate the process of consultation was flawed, and concerns from senators have caused fundamental changes to this bill. Is it in, out, in or out? I hope the government learns a lesson from this and in future honours the spirit of genuine consultation. I hope it honours the committee process to produce a bill that doesn’t need last-minute, wholesale changes. 

I note the bill amends the poison schedule, to downgrade vapes from schedule 4 to schedule 3, and adds conditions to their use in that listing. When I tried to do exactly the same thing—to downgrade medical cannabis and add conditions to that listing—I was told, ‘That’s a very strange thing to do,’ and my bill was not supported, in part because of that. Now they’re doing the very same thing that they said was very strange. 

In Queensland, vaping products with or without nicotine are illegal unless on prescription. Vapes are subject to the same laws as cigarettes or tobacco products as to where they can be used and the circumstances in which they can be purchased. Queensland law right now prevents children under 16 accessing or using a vape. Personal health and child welfare are rightly the responsibility of the states. Yet, once again, this government seeks to increase its powers in areas where it has no Constitutional authority. 

This bill amends the Therapeutic Goods Act 1989 and the Customs Act 1901 to limit the importation, domestic manufacture, supply, commercial and private possession, and advertising of non-therapeutic and disposable vaping goods. Over-the-counter sales at chemists will be permitted, and access to children under 18 will be via the Special Access Scheme. There are substantial differences in how possession for personal use and commercial use are handled, yet the bill does not specify this threshold, which will come later in regulation that we haven’t seen. Too much of this bill will come later in regulations. The government is asking us to trust their judgement on a bill that is a litany of bad judgement. The bill defines a vape as ‘anything that’s held out to be a vape’. It explicitly excludes the need for a lab analysis to prove that the item is in fact a vape. Much of the bill goes into the licensing arrangements for importation, manufacture, distribution and possession. 

The bill was developed after supposed consultation, yet the government’s reaching out to selected friends in the health industry who share the same commercial interests as informed this bill is not consultation. It’s an echo chamber of self-interest, as the substantial last-minute amendments now prove. Everyday Australians were not permitted to make a confidential submission. Their submissions had to be public and accompanied by a declaration of interests—something very few witnesses felt comfortable doing. In particular, this prevented personal stories of how vaping helped defeat a smoking or other addiction and weighted submissions towards self-interested corporate health providers and charities. 

The evidentiary burden of proof in the offences under the bill are reversed. This removes the common law protection that fault must be found before an offence has been committed. While the government may find contesting charges in a court of law tiresome, 800 years of common law rights should not be so lightly dismissed and disposed of. There’s no justification for reversing the burden of proof. For this reason I have submitted an amendment to this bill in the committee stage to restore the presumption of innocence enjoyed by all Australians since our country’s settlement. At section 41P(1), ‘vaping substance’ is defined as ‘any liquid or other substance for use in, or with, a vaping device’. There’s no nuance in the penalties. Possessing a vaping substance carries the same penalty as possessing a vape itself. 

People who make cakes, fudges, chocolates, lollies and similar products use the same flavourings as can be used in vape manufacture. Those flavourings shouldn’t be used in vapes. They may be considered safe for stomachs, but not for lungs. Yet they are used in illegal vaping solutions, and I’ve received complaints from bakers that, for this reason, Border Force are seizing shipments of flavourings. Under this legislation, a baker or confectionary manufacturer importing a food flavouring that can be used in vaping must first have it approved for use, despite its being in use for generations, and then obtain a licence to import or possess commercial quantities—of cake flavouring! The importer and probably their largest customers will need to keep records of their use of these potentially illicit food flavourings to ensure that organised crime is not supplied out the back door, with penalties of up to $3.8 million and/or imprisonment for seven years. This is serious business. 

I appreciate that this is not the intention of the bill. Yet it is the wording of the bill. I point out that the bill and the explanatory memorandum provide no guidance as to which goods should be permitted and which should not. The minister has complete power to make this decision. So far job losses from vaping prohibition are around 2,000, with 500 vaping stores already closed. The trade in vaping has now moved into the hands of organised crime, with a gang war breaking out in our capital cities to control the illicit vaping trade, as well as the illicit tobacco trade now that tobacco has been taxed to the point of idiocy. The bombings, ramraids, murders and violence so far in this underworld war are on the government, for breaking the government’s social licence to act fairly, honestly and reasonably towards the public. The best interest of the public has been replaced with the best interest of crony capitalist stakeholders. 

The last-minute deal with the Greens to add over-the-counter sales at chemists may serve to head off that outcome. Time will tell. The Pharmaceutical Benefits Scheme 2022 post-market review of medicines for smoking cessation found that 550,000 prescriptions were written for smoking cessation products in 2022. And get a load of this: these included varenicline, from Pfizer, costing $194 a prescription, which in the various formulations was responsible for 2,042 Australian adverse event notifications, including 55 deaths. And there is bupropion, from Aspen pharmaceuticals, which has had 2,100 adverse event notifications, including 22 deaths. The incompetence—does it stop? The post-market review says, ‘The mechanism by which bupropion enhances the ability of patients to abstain from smoking is unknown.’ So, we don’t know why it works. It’s killed 22 people—yet, prescribe it anyway! Just don’t let people buy their own vapes. We can’t have smokers quitting on their own, can we? 

The explanatory memorandum for this bill cites data from the Australian secondary school students’ use of tobacco and e-cigarettes report, which states that the proliferation of vaping across the community represents a severe public health concern. Vaping has been associated with severe public health effects relating to adolescent brain development, worsened pregnancy outcomes, cardiovascular disease, respiratory disease and cancer. Vaping also carries other health effects such as burns, seizures and poisoning. 

Let me deal with the last one first. Yes, illicit vapes do cause internal burns and cause external burns if they explode. They cause poisoning and seizures as a reaction to that poisoning. A poorly made vape will burn and put toxic chemicals into the user’s lungs. Unregulated vaping in the USA caused 28 deaths coming from the use of ethylene glycol, a popular substance in commercial baking. It’s considered safe to be eaten but not safe to be vaporised into the lungs. This illegal use of a legal substance is what caused the popcorn lung syndrome. Illegal vapes can contain thousands of substances we call ‘compounds’ when in legal products and ‘chemicals’ when not in legal products. There are, however, 7,000 chemicals in cigarette smoke—more than are found in a quality vape, not an illicit vape. Telling one side of the story never communicates an honest picture of the truth. It condemns you. It used to be possible to import quality vapes from New Zealand. The Labor government stopped this. Now we have unsafe, illegal vapes. Who knows what’s in them? The TGA’s tweets against vaping were community noted with a comprehensive bibliography of good science that counters their scare stories. I will reproduce those community notes with citations on my website for anyone who wants to educate themselves on legal, safe vaping. 

Is vaping a gateway behaviour to smoking or drug-taking? Actually, no; it’s not. On page 8 of the secondary school report, smoking rates amongst schoolchildren have fallen over the last five years. ‘Ever smoked’ is down from 17.5 per cent to 13.5 per cent. ‘Smoked in the past week’ is down from 4.9 per cent to 2.1 per cent—more than halved. This was in a period when vapes were readily available. Vaping is clearly working to reduce smoking rates. This is what has the quit smoking industry worried. 

The UK government’s periodic data review titled Nicotine vaping in England: 2022 evidence update found that 98.3 per cent of children who had not tried smoking did not try vaping. This means any increase in vaping rates is either in replacement of smoking or in conjunction with smoking. This data is in contrast to the secondary schools report which found that past month vaping alone was at 15 per cent. Let’s have a look at that. The study covered vaping as a generic class, including e-cigarettes and herbal vapes, which are a large part of the vaping market. Despite the effort put into this study, no attempt was made to analyse the vapes consumers were actually using, and no firm conclusion can be drawn as to the presence of nicotine or any other regulated substance. 

The other study the government cited, Australian secondary school students’ use of alcohol and other substances, is alarming. It showed that 22 per cent of secondary school students had used alcohol in the past month, 10 per cent had used alcohol in the past week, and four per cent were engaging in risky drinking. Why aren’t we worried about that? What hypocrisy to introduce the world’s harshest legislation on vaping and ignore the elephant in the room: teenage drinking. Other drug use is down. Figures for ‘used in the last month’ show black market cannabis use down from 8.1 per cent to 6.6 per cent, hallucinogen use down from 1.1 per cent to 0.8 per cent, MDMA use down from 2.1 per cent to 1.1 per cent, pharmaceutical opioid use down from 1.9 per cent to 1.4 per cent, and cocaine use down from 0.8 per cent to 0.6 per cent. These small reductions are more significant than they appear. With 1.5 million Australians in the secondary school age group, every 0.1 per cent of reduction in hard drug consumption means 1,500 young Australians are not getting addicted to hard drugs. Across all types of hard drugs, the figure is over 50,000 lives saved from the misery of hard drug addiction. 

The scare campaign that vaping is a gateway to smoking and to hard drugs is fraudulent and designed to cover up the reverse, because the reverse is true. The committee did look at the use of vaping as a smoking cessation tool and concluded the evidence was inconclusive. So there is no reason to save vaping on that account. Poor judgement indeed. 

In their deliberations, the committee gave a thought of time to the quit smoking industry, which is funded at $500 million across forward estimates—half a billion dollars! This does not include the financial benefit of fundraising. That half a billion dollars is just the government’s contribution, yet quit smoking rates have been stagnating across the Western world. Firstly, that’s because the few people who still smoke have the money to afford smoking, want to smoke and will continue to smoke. Secondly, there are people for whom the current industry of gums, patches and financial blackmail is just not working. Some people have found that, where these other measures did not work, vaping did work. These are the people who will, no doubt, be forced back to smoking as a result of this bill. Imagine all those extra smokers to keep government revenue rolling in—all those extra smokers to keep the ‘quit smoking’ industry and taxpayer money for years to come. The financial impact statement for this bill doesn’t mention the increase in revenue from smokers being forced back to smoking. I imagine it will be substantial. 

Another failure in this bill is forfeiture. The easiest way to control vaping in schools is to allow teachers to seize vapes when they see them. That provision is not in this bill. Seizure is limited to commercial quantities seized with a court order or any good ‘seized by the control of customers at the border’. The one thing this bill could do to help control adolescent vaping is to allow teachers to seize vapes, and it doesn’t do that. I foreshadow my second reading amendment calling on the federal and state governments to sort out jurisdictional issues and give teachers the power to confiscate and destroy vapes brought into schools without a prescription. 

As a result of measures to ban vaping, organised crime is moving into the illegal tobacco and vape market with horrific consequences. This is not so they can sell our children a nice bergamot herbal vape; it’s so they can sell vapes laced with hard drugs to get our children hooked and to take back the market share vaping has cost them. I have said all along that vapes are as safe as the vape and the liquid inside. A better idea is to provide for a future made in Australia and allow Australian companies to produce legal, quality tested, regulated vapes and then ensure these are, firstly, kept out of the hands of children and, secondly, subject to the same restrictions on use as smoking. 

I look forward to the government monitoring the outcome of this hasty, incomplete bill closely and acting quickly if the outcome is not as expected. I think the outcome will bring horrific consequences, so please monitor this for the sake of our children. 

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COVID Royal Commission Now!

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It’s time for a Royal Commission into COVID – as recommended by the Senate Legal and Constitutional Affairs Committee Inquiry.

Before the last federal election, Anthony Albanese promised to hold a Royal Commission into COVID, yet once elected into government, he changed his attitude and now seeks to cover up government actions during COVID.

One Nation secured a Senate Inquiry to write Terms of Reference for a COVID Royal Commission. I am proud to say the Committee agreed this was the right course of action and recommended a Royal Commission be called. The Committee also set out an appropriate terms of reference – which are excellent – covering all aspects the public would expect to be examined.

It is time for the Prime Minister to stop shielding bureaucrats, the media and multinational pharmaceutical companies. The Prime Minister is making a mockery of the Labor Party’s legacy. PM Gough Whitlam initiated thirteen Royal Commissions during his tenure, and PM Bob Hawke called for eight. This current Labor government has only called for one, despite public opinion polls indicating over 70% support for a Royal Commission.

It’s time for the Labor Party to prioritise people over its donors in the pharmaceutical industry.

It’s time for the Labor Party remembered who they are.

It’s time for a Royal Commission into COVID now!

Transcript

On behalf of One Nation, I thank the committee and the secretariat for their marvellous work during this inquiry into a COVID-19 royal commission, work that resulted from a One Nation motion. Many submissions were received and witness testimonies taken. The report that Senator Scarr has just tabled is a faithful representation of their evidence and reflects some amazing work by the secretariat, him and the committee.  

Australia now has the recommendation that a royal commission into Australia’s response to the COVID pandemic be called, and it has appropriate terms of reference. So what happens now? To this point, the process has been one of which I’m proud. This Senate has held true to its fundamental function as the house of review. The Australian Parliament House website says of the powers of the Senate: 

Democratically elected, and with full legislative power, it is generally considered to be, apart from the Senate of the United States of America, the most powerful legislative upper chamber in the world. 

It’s time to use that power. Indeed, it’s our duty to use that power. It’s time to remind health care, the military and the bureaucracy: they do not run this country; the Australian people do. It’s long overdue to remind the crony communist establishment: they do not run this country, the Australian people do. And it’s time to restore trust in government and confidence in our healthcare practitioners, hospitals and medications. A royal commission is the only way to get to the truth, punish wrongdoing, praise the noble and set a future direction for pandemic preparedness in which the public can have complete confidence.  

Support for a royal commission came from every witness at the inquiry—a rare and overwhelming display of consensus and unity in what has been until now a highly contentious debate. The inquiry submission from Professor Scott Prasser was most helpful in guiding debate around a royal commission. He said:  

As then Justice Holmes, who chaired the 2011 Queensland Flood Commission of Inquiry observed there is an expectation in Australia for such inquiries following disasters: 

… contemporary society does not countenance a fatalistic approach to such inevitabilities, even if their occurrence is unpredictable. There is an expectation that government will act to protect its citizens from disaster, and that all available science should be applied so that nature and extent of risk is known, and appropriate action taken to ameliorate it— 

to protect people. Those who do not learn from history are doomed to repeat it. Remember these facts on Australia’s COVID response: half a trillion dollars was spent, economy and family livelihoods were smashed, freedom and human rights were stolen, and there were tens of thousands of deaths from injections approved yet not tested in Australia, with approval based only on Pfizer’s trial that was cut short after thousands of deaths and without the TGA seeing the patient-level data. 

The AstraZeneca vaccine was withdrawn last week. How the hell do the injected withdraw it from their bodies? The department of health still approves AstraZeneca now. Overnight, a peer reviewed journal published proof that the Pfizer vaccine was contaminated with mutant DNA at levels that are hundreds of times higher than safe levels. The Pfizer vaccine must be withdrawn on safety grounds immediately. This is all for a virus which the Chief Medical Officer advised me in writing in March 2021 was of low to moderate severity, less than some past flus, and had transmissibility similar to that of flu. That was in writing. Australia will not stand for repeating our COVID mistakes and COVID deceit. 

As I travel through Queensland and listen to everyday Australians, I continue to hear of COVID harms. It’s clear that COVID may be over, yet the harm from our response continues. Businesses weakened during COVID and kept alive with JobKeeper payments are now failing in the recession that inevitably followed the big spend. Victorians have been hit with a COVID tax to pay for the state’s response, a tax making it harder for homeowners to keep their homes in the face of rising interest rates. In turn, rising interest rates are a function of the inflation caused when the Reserve Bank printed $508 billion to fund COVID measures. 

Our COVID response affected every life in this country and every corner of our economy. A quickie cover-up whitewash pseudo-inquiry into bureaucratic performance during COVID will not get to the truth of matters into which it’s not even looking. issues like unexplained deaths, which have started to increase again and are currently sitting at around 13 per cent, or 25,000 deaths a year. These are people who should not be dying—young people. In part, these people are dying of the side effects of the AstraZeneca vaccine that Craig Kelly specifically called out in 2021. Our health authorities claimed it was safe and effective until court cases caused AstraZeneca to withdraw the product worldwide, citing a fatality rate of 3.8 per 100,000 cases. Australia bought 56 million doses. 

The official death figures from COVID injections are a fiction. Evidence of this is the TGA’s refusal to provide independent verification of their case analysis. Reports of deaths and serious injuries from COVID jabs stopped being made in full early in the rollout. Medical practitioners who reported adverse events were inevitably harassed and threatened with punitive action from the Australian Health Practitioner Regulation Agency, who acted as the pharma police. Their actions in suppressing the truth of vaccine harm must be of special interest to the royal commission. 

Pfizer conducted aborted safety testing on a version of the vaccine they never used. The shots they did use were never safety tested, and this was the big lie: that the vaccines were tested and proven safe—a lie. ‘Safe and effective’ was not one lie; it was two. Pfizer are currently settling their lawsuits out of court, but for how much longer, as one successful lawsuit leads to another? Australia offered taxpayer funded immunity on these products. Remember: if criminal behaviour is detected from Pfizer, the immunity can be voided—behaviour like baiting and switching the test vaccines, covering up adverse events in the testing phase and erasing anyone with a serious adverse event from the trials as though they were never a participant. Ghost test sites were used, along with ghost participants who, miraculously, never had an adverse event. Window shifting was employed. Adverse events in person that was single dosed were counted against the unvaccinated, because one is not classified as fully vaccinated until after the second dose. How’s that for deceit? Likewise, even a person who was double dosed had their adverse event counted against the unvaccinated if it occurred within the first seven days for Pfizer and within 14 days for Moderna. 

Behaviour like this is why we have royal commissions with powers to compel witnesses and obtain documents that have been hidden behind redactions. There have been 54 royal commissions since the Menzies era. The Hawke-Keating government called eight and the Whitlam government called 13. The Abbott-Turnbull-Morrison government called eight. After so long in opposition, the Albanese Labor government has only found cause to call one. What a compliment to the quality of the last government! In all of that time, only one thing was done badly enough to call a royal commission. You on this side must be so proud! 

Prime Minister Albanese has turned his back on Labor Party history and seeks now to cover up for bureaucrats, multinational pharmaceutical companies and crony capitalist companies like Woolies and Coles. These companies implemented onerous staff vaccine mandates, required customers to behave like they were diseased and blasted out pro-vaccine anti-human propaganda over their PA non-stop for three years. It’s no surprise that their share register includes names like BlackRock, Vanguard and State Street. These same names appear in the share register of the pharmaceutical companies that profited from killing people in this country. 

These foreign predatory wealth funds appear on the share register of Australian media that contributed unending fear to drive the pharmaceutical response to COVID. The media also policed public opinion, destroying the careers of presenters, medical professionals and politicians, despite those opinions now being proven correct. Even worse, their opinions were known to be correct at the time these brave people were speaking out against the official narrative during COVID. Was COVID an evil exercise in crony capitalism, in racketeering for the benefit of foreign predatory wealth funds, or crony communism? Yes, it was. Those funds have ripped $5 trillion—trillion—from the pockets of everyday citizens around the world in the name of keeping us safe. What an eye-watering transfer of wealth, unprecedented even in wartime. Thanks to COVID, the rich are richer, while everyday citizens struggle with reduced wealth, unprofitable businesses and poor health. 

And yet the Labor government refuses to call a royal commission. You don’t care! Is this who the Labor Party has become—protectors of racketeering wealth funds and their parasitic, predatory billionaire owners? Is that it? One benefit of misinformation laws is that they may stop you calling yourselves the party of the worker when you are clearly the party of predatory billionaires—parasites. 

Prime Minister Whitlam called 13 royal commissions, Prime Minister Hawke called eight and this Labor government has called one. Talk about not being able to handle the truth. Your position defies history, it defies the will of the Senate and it defies the will of the people. Talk to anyone in the street; they’ll tell you they want this. Your position defies history. I urge the Senate to send a clear instruction to the Prime Minister that his quickie cover-up inquiry has fooled nobody—nobody. It’s time to begin the royal commission; it’s time to care about people, not corporate profits; and it’s time for this Labor Party to remember who they should be. I seek leave to continue my remarks. 

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Replace Health Pharmacrats With People-First Health Care

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One thing that has come out of the COVID response is how it’s exposed the pharmaceutical industry to more scrutiny from the public than ever before. More questions have been raised about the Therapeutic Goods Authority (TGA) and our Health Pharmacrats than ever before. Yet, what is the alternative?

In this parliamentary speech, I put it on record that we must look at the influence of pharmaceutical companies on the education system for medical professionals, and the relationships between pharma giants and former health department executives. The toxic, inhuman killer ‘pharmaceutical only’ model is failing Australian taxpayers. People are dying needlessly.

As an example, Albicidin is a natural antibiotic with clear potential to become our leading antimicrobial. It’s proven to not create resistance. Albicidin could be, and most likely is the answer to antimicrobial resistance. There are many others, but they don’t get patented. They don’t receive sponsorship and therefore they don’t get approved.

It’s time for an entirely new medical paradigm. One that puts humans first, not big pharma.

Antimicrobial resistance is the new climate change, allowing for control over agriculture, medicine and household and industrial cleaning, in the name of reducing use of antimicrobials. That’s why an alternative solution, using an antimicrobial that doesn’t cause antimicrobial resistance, is being ignored and quietly buried. It’s to protect globalist profits and to control people – and to hell with human and animal health and safety!

Globalists WANT control. Globalists NEED control to complete their agenda.

Australia needs a customer consumer advocate, or natural product advocate, to advance natural products that can’t be patented, yet are safe and effective treatments — products to be listed under Schedule 4 and offered under the PBS as frontline medicines. Not watered down products sold in supermarkets as complementary medicines so that their efficacy can plausibly be dismissed.

Instead of advancing people-first health care, our Pharmacrats are actively promoting mRNA vaccines and medications to the commercial benefit of big pharma. This is caused by “the patent cliff”, which refers to the expiration of patents on popular drugs, leading pharmaceutical companies to face intense competition from generic drug makers, dramatically reducing their profits. The new mRNA technology allows big pharma to replace off-patent drugs with newly patented mRNA drugs at prices that guarantee their profits for the next 30 years. Our health authorities are actively promoting this solution to the patent cliff, despite the myriad of adverse health outcomes from the mRNA vaccines.

Why? These are important matters that can only be answered by a Royal Commission.

What should not wait for a Royal Commission is a system to incorporate affordable, natural remedies into our health approval process. This could be implemented immediately if the Pharmacrats were interested in providing people-first health care.

Transcript

Where’s the scrutiny on our health authorities? During COVID, drugs were rushed through that would never have been approved on safety and efficacy grounds, such as molnupiravir and remdesivir. Last year, these two inhuman pharmaceuticals cost taxpayers $1 billion. Alternatively, tried and tested drugs that are out of patent could have been used for a fraction of the price. Remember that our authorities and the mouthpiece media called ivermectin ‘horse paste’. The statist Left rushed to demonise anyone who defended ivermectin, because the control side of politics—the so-called Left—loves to follow orders. Ivermectin is a Nobel-Prize-winning antiviral for humans. Over 40 years, it has saved millions of lives. Around the world, it’s now been proven safe and effective as an early-stage treatment for COVID, as it always was.

Our health authorities demonised ivermectin to prevent early-stage treatment of COVID in order to build demand for an untested novel mRNA vaccine. How many died because of the long-term strategy that our health authorities followed and pushed—a strategy to use COVID as a cover to introduce a class of mRNA drugs that the public would have rightly baulked at and rejected? How many died from the side effects of mRNA technology—technology that was not tested in Australia and was not tested off the production line, for which the method of production was changed after overseas testing and approval and the fake trials were at best shambolic and at worst criminally negligent?

Why would our health authorities tolerate this? Simply because of a thing called the patent cliff. Pharmaceutical companies are profitable because they develop a new drug and then get a patent, exclusive sale of the drug for 25 years. Drug companies can afford to put that drug through the approval process because once it’s approved they add the approval cost to the selling price—kerching, kerching!

The system of drug patents has created a $2 trillion industry whose tentacles of influence extend to political parties, who happily accept donations, and to health authorities. Their tentacles extend to the USFDA and Anthony Fauci’s National Institutes of Health, who hold patents on drug processes they license to big pharma in return for hundreds of millions of dollars in personal royalties. Their tentacles extend to the World Health Organization, the United Nations and the World Economic Forum, whose young global leaders sit in this parliament.

This is influence that our healthy authorities cultivate while coveting lucrative careers in the pharmaceutical industry. For example, just eight months after approving Pfizer’s untested COVID injections, Professor John Skerritt, former head of the Therapeutic Goods Administration, the TGA, is now on the board of the pharmaceutical industry lobby group Medicines Australia. This isn’t the normal operation of a free-enterprise system that One Nation would support; this is a cabal of greedy, unprincipled, evil individuals treating everyday citizens as cash cows. They want everything you have for themselves, including your health.

The patent cliff is upon us. There’s increasing urgency—desperation—in the measures being rammed through government. Two-thirds of the revenue is from drugs being sold to you that are out of patent now or will go out of patent over the next five years. That threatens big pharma’s harvesting of humans for profit. Modern drugs, once out of patent, can be made for cents per tablet. India specialises in that. Australia used to, and we can do it again. The patent cliff threatens the entire pharmaceutical industry and stops the ability of chemical pharmaceuticals to do better than they do now, in terms of profit.

From where are the new patents going to come? I’m glad you asked, Mr Acting Deputy President: from mRNA of course. There are 400 new mRNA vaccines and drugs currently under development. Such is the expected volume of these things that two manufacturing plants are being prepared here in Australia. Our health authorities decided to press ahead with mRNA technology to save the pharmaceutical status quo—the pharmaceutical gouging of people to extract exorbitant profits. Patient harm apparently no longer matters.

Last week, a study of 99 million COVID-jab users, including in New South Wales and Victoria, found the product was not safe. The study was published by Elsevier, for more than 140 years the world’s leading scientific publisher and data analytics company. The study showed the following conditions were occurring above baseline levels: brain and spinal cord swelling, up 380 per cent; blood clots, up 320 per cent; Guillain-Barre syndrome, up 250 per cent; and myocarditis, up 278 per cent for Moderna and up 350 per cent for Pfizer. After a second injection, myocarditis was up a damning 610 per cent and pericarditis was up 690 per cent. I told you so four years ago. Many good people warned that COVID products were not tested, that they were experimental, and that forcing them on the general population was an insane, inhuman abuse of government power. Now look at those figures. It’s another area for a royal commission to investigate.

It’s time for an entirely new medical paradigm in this country and throughout the West. Pharmaceutical companies are embracing mRNA as their saviour because it can be patented. They can charge whatever they want for it, and compliant health bureaucrats like our TGA, acting out of self-interest, protect pharmaceutical companies from financial harm. The expert medical advice the TGA relies on comes either directly from drug companies or from advisers who have worked for big pharma, who have accepted research grants or sponsorship from big pharma, or who covet doing so in the future. After all, $29-million Sydney harbourside mansions don’t just buy themselves.

These are things that make for a royal commission. One thing that should not wait for a royal commission is a system for getting cheap, natural remedies into our health approval system. Australia needs an office of the consumer advocate to oversee complaints and the harm bureaucrats cause—bureaucrats who appear incapable of acknowledging odious and obvious adverse events. We need a customer consumer advocate or a natural product advocate to advance natural products that can’t be patented but are safe and effective treatments—products to be listed under schedule 4 and offered under the PBS as frontline medicines, not watered down and sold in supermarkets as complementary medicines so their efficacy can be dismissed. Albicidin, for example, is a natural antibiotic with clear potential to become our leading antimicrobial. It’s proven to not create resistance. Albicidin could be the answer, and highly likely is the answer to antimicrobial resistance.

Antimicrobial resistance is the new climate change, allowing for control over agricultural, medicine, and household and industrial cleaning in the name of reducing use of antimicrobials. That’s why an alternative solution, using an antimicrobial that doesn’t cause antimicrobial resistance, is being ignored and quietly buried: to protect globalist profits and to control people—and to hell with human and animal health and safety! Globalists want control. Globalists need control to complete their agenda.

Take another example: blushwood is an Australian native berry. It was shown, in a 2014 test, to kill skin cancer in just 10 days. Did our health authorities rush to understand this plant and bring a potentially lifesaving medication to market? No; they did not. Another one: conolidine is a natural treatment for severe pain. Ignored! Natural remedies include cannabis. Senator Pauline Hanson has led way, advocating for medicinal cannabis since 1996. I joined her, and now there are others.

A recent paper pointed out that natural products work differently to chemical products, yet our system for understanding and testing substance efficacy is geared to chemical drugs. The paper and system offer a new way of measuring efficacy that confirms plants like cannabis and conolidine do work, and explains how they work. The truth is this: currently only when a product is patented and presented as the TGA on a plate, ready for the TGA’s rubberstamp, does it enter our pharmaceutical system. I urge the Minister for Health and Aged Care to introduce a consumer natural products advocate to provide much needed supervision and accountability over our health authorities. Failing that, I ask the Greens to consider if the agency they’re establishing with the Legalising Cannabis Bill would be better suited to handle natural medications in general—those that the TGA refuse to handle in addition to cannabis.

I’m not offering medical advice on the examples I’ve used in this speech; I’m asking why the health department and medical schools first response is to the scalpel and the prescription pad instead of natural medications that cost a fraction of the price. We must have an independent office in the TGA with the budget to sponsor natural alternatives through the safety, testing and efficacy stages, and to have these promoted to doctors who most likely have never even heard of them.

We must look at the influence of pharmaceutical companies in the education system for medical people, in their relationship with former health department executives and their influence through advertising and sponsorship. The toxic inhuman killer ‘pharmaceutical only’ model is failing Australian taxpayers. People are dying needlessly. Stop so-called health authorities committing homicide, child homicide, infanticide. As a servant to the people of Queensland and Australia, I say call a royal commission now and make an immediate start on the obvious reforms to our health administration that we need.

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Pharma Exclusivity in TGA Processes a Barrier to Natural Products

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Before a drug or natural therapy can be approved by the “regulator” — the TGA — it must have a sponsor whose job is to pay the license fee, fill out the paperwork, and prepare safety and efficacy reports. These can be overseas because we no longer require local trials for new drugs. Drug companies are happy to develop new drugs and sponsor the applications because they have 25 years to get their money back from the patent which gives them exclusive rights to the product’s profits. After that, a product can be ‘generic’ or off-patent and any pharma company can make it.

Natural products such as cannabis and Aboriginal medicine from native plants cannot be patented which means nobody can afford to act as a sponsor. The result is the only thing doctors can prescribe are patented or ‘generic’ pharmaceutical drugs.

I asked why there is not an office of the consumer advocate who can sponsor natural therapies like Cannabis and Albicidin (a natural antibiotic). Instead, the TGA chose to speak about their program to re-purpose pharmaceutical drugs that have already been approved for different uses. This answer really shows the pharmaceutical mindset our health administrators have. The legislation needs to be changed to give natural products a path to market.

Transcript

Senator ROBERTS: Thank you. That leads to another point. It opens it up from this one. We have a system that says that, unless a product has a sponsor, it will never be approved. This isn’t the TGA system. They don’t write policy. This is a department and minister problem. There are multiple studies on the efficacy of medicinal cannabis for some conditions, and yet they’re not listed in schedule 4. There are 150 substances in Aboriginal medicine, yet only two have been commercialised, because natural products, even with postprocessing, can’t be approved by your system, because, without a patent, nobody will sponsor the product. Minister, why is there not a public advocate within the department that can bring natural remedies to the people under poison schedules 2, 3, 4 under the PBS where appropriate? 

Senator McCarthy: I will refer to the department. 

Prof. Lawler : As you highlighted and as we’ve discussed previously, the act does require a sponsor to bring medicines for evaluation. There are a number of reasons for this, and not least among them is the fact that, once a medicine is listed on the Register of Therapeutic Goods, there is a need for postmarket surveillance, pharmacovigilance, and safety and quality assurance, so it’s obviously very important that there be a point of accountability for these medicines. We are undertaking some work in terms of a repurposing initiative, and I will ask Mr Henderson to speak to that. It is about ways in which some of the medicines that are currently on the market can be used in other ways and how that might extend beyond the current sponsorship arrangements. 

Mr Henderson : As part of the last budget, the government approved funding of roughly $10 million over four years for the TGA to initiate a repurposing program for medicines. The context or the objective of that program is to incentivise sponsors—and non-pharmaceutical sponsors as part of that as well—to come forward with submissions to the TGA for medicines that are predominantly used off label. They are registered on the ARTG, the Australian Register of Therapeutic Goods, but for indications for which it may not have been feasible for low-population groups or niche population groups to have had a sponsor come forward in the past, so we’re looking to implement a program where we incentivise through waiving fees associated with the regulatory fees and charges as well as through working closely with our colleagues in the reimbursement space in relation to processes through the PBAC, pharmaceutical benefits and fee waivers. 

Senator ROBERTS: Thank you. So there may be some hope. 

CHAIR: We will return to this after the break. 

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Anti-depressants Highlight Failure of our Health Policy

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

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

Transcript

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

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

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

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

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

Senator ROBERTS: Thank you.

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The TGA are Administrators not Regulators

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Until a few years ago, new vaccines and drugs were required to have local safety testing and went through a process that took years. This ensured a high degree of safety. During the COVID period, the Therapeutics Goods Administration (TGA) waved approvals through for new technologies (e.g. mRNA injections) and new drugs in a matter of months. Included in this new streamlined approval process were Molnupiravir and Remdesivir.

Remdesivir was refused approval for 20 years owing to serious side effects in trials, including death. Molnupiravir also has a long history of failure. There are multiple studies out recently that show it is simply not effective against COVID, and yet this is the #1 drug on the Pharmaceutical Benefits Scheme. Australia spends $650m a year on Molnupiravir.

I asked why we approved a drug with so much evidence showing negative efficacy and fatal outcomes, including cancer, to replace the Ivermectin + Zinc combo, which costs a fraction of the price and has been proven safe and effective across many years.

I also raised the question of who supervises the supervisor — the TGA. “Nobody” was the response. That answer highlighted the overly cosy relationship between the international pharmaceutical movement and Australian pharmaceutical companies. The TGA requires further inquiry.

A Royal Commission is the only institution in Australia with the powers of inquiry to understand how the TGA has gone from regulator to administrator, seemingly with none of the customary vigilance.

Transcript

Senator ROBERTS: My questions are to the TGA, and these questions go to the approval for molnupiravir. This is a drug developed in 2014 to treat encephalitis. It was then repurposed for influenza but was discontinued after concerns it was mutagenic. Merck then bought the company and used their influence with regulators—such as the TGA, apparently—to have the product approved as a treatment for COVID. This was on the back of a single trial where the preliminary results supported the application but the final results showed that, if anything, it had negative efficacy. Given the weight of evidence, in study after study, that molnupiravir has zero to negative efficacy, why is it still approved?

Prof. Lawler: While one of our medical officers, Dr Kaye Robertson, comes to the table to respond, I would just highlight a couple of things. I take the comment that you made that the drug company used its influence on the TGA. There is a process that we follow, obviously, in the evaluation of all medications. Sponsors bring them for evaluation of safety, quality and efficacy, and that’s the process that is undertaken, rather than one of influence. I think it’s important to note that. In terms of the question you raised around why the medication is still approved for the indication that it has, I’ll ask Dr Kaye Robertson to respond to that.

Dr Robertson: The TGA considered the evidence to support the approval of molnupiravir from the dossier that was submitted by the sponsor, in accordance with our standard processes, and drew the conclusion that, at the time, the benefits outweighed the risks. In terms of the specifics of any subsequent information that has been provided to the TGA, I am actually not in a position to comment with certainty. This is not the area I work in particularly, and I think we would be best advised, if the senator pleases, to take this question on notice and provide you with further detail.

Senator ROBERTS: I appreciate your giving that offer and I will accept your offer for the question to be answered on notice. It does surprise me that approval was given on a single trial where the preliminary results supported the application but the final results showed that, if anything, it had negative efficacy. The weight of evidence, in study after study, shows zero to negative efficacy, so I’m amazed that it’s still approved. The approval required Merck to continue to provide ongoing safety data and testing around mutagenicity and interaction with the mRNA vaccines. Have they done that, and does the data justify retaining approval?

Dr Robertson: I have before me the AusPAR that was published in relation to the studies that assessed the risk of mutagenicity. We can provide that to you in our response. I am reading from that, and it says: ‘Molnupiravir and NHC were mutagenic in the bacterial assay (with and without metabolic activation). Molnupiravir and NHC were not genotoxic in in vitro and in vivo micronuclei tests, and in vivo mutation assay at the cII locus (in Big Blue Transgenic F344 Rats). Equivocal results were obtained in an in vivo Pig-a mutagenicity assay … Carcinogenicity studies are not generally required for drugs for short term clinical use. However, the sponsor has initiated a short-term carcinogenicity in … mice.’ This was put to the clinicians on the ACM and other invited experts regarding this matter. It was considered at the time that, on balance, the drug remained to have a positive benefit-risk balance.

Prof. Lawler: I thank Dr Robertson for that response. I’d also just add, Senator, that, because you’re asking for some quite specific currency and comprehensiveness of ongoing postmarket reporting, we’ll take that on notice and bring that information back to you.

Senator ROBERTS: Thank you. In 2023 molnupiravir was top of the pops, Australia’s No. 1 drug, costing taxpayers $654 million last year, at $1,125 a prescription. Molnupiravir is 26 times more expensive than the out-of-patent ivermectin-plus-zinc combo, which is about $40 per prescription. And that’s what molnupiravir replaced—proven, safe and effective. Why are you spending $654 million—on something that is highly questionable as to its efficacy and its safety—when $25 million would have done?

Prof. Lawler: I can’t speak to the specifics of the amount spent on molnupiravir, but I can certainly indicate that the second amount that you said—I didn’t catch the amount—

Senator ROBERTS: The ivermectin-plus-zinc combo is $40 per prescription, and the total for the year would have been $25 million.

Prof. Lawler: I think that the comparison is flawed, in that there is no credible, supportable evidence that ivermectin and zinc is an effective treatment. So I’m not convinced that you are—

Senator ROBERTS: There is no credible evidence? There are 100 papers.

Prof. Lawler: I’m not convinced that the comparison is sound.

Senator ROBERTS: You based the decision on molnupiravir on one paper, and you’re ignoring 100 papers proving ivermectin’s success. Does anyone question the process—

CHAIR: Sorry, Senator Roberts; I’m going to give Professor Lawler an opportunity to respond to that.

Prof. Lawler: I didn’t hear a question.

Senator ROBERTS: The question is this: does anyone question the TGA’s processes—

Prof. Lawler: Yes.

Senator ROBERTS: for approving drugs? How often do you evaluate them?

Prof. Lawler: Drugs are—

Senator ROBERTS: Who audits them? Is there an independent auditor?

Prof. Lawler: I’m not sure which question you would like me to answer.

Senator ROBERTS: All of them.

CHAIR: Professor Lawler, are you clear on the question placed? There is a mixture of questions and assertions moving around here, so let’s just step back and, Senator Roberts, please place a question.

Senator ROBERTS: The question is: how often do you scrutinise your process, and is there an external auditor who does that who is qualified to do it and to assess the process?

Prof. Lawler: The processes that we follow are continually informed by our international collaboration and also by significant interaction with stakeholders, particularly the advisory committees that we have in respect of the assessments and evaluations that we undertake for products. We also undertake, obviously, the premarket review and evaluation of medicines and other therapeutic goods, and we undertake significant postmarket surveillance of the goods as well. We have outlined in significant detail on previous occasions the postmarket surveillance that we undertake. I might ask Mr Henderson to add to that.

Mr Henderson: Senator, I think you asked about the number of submissions or medicines that we evaluate. Just for context, at the moment there are about 150 applications that the TGA is evaluating for both new medicines and changes to indications to current medicines.

Senator ROBERTS: What is the point of telling me that?

Mr Henderson: Sorry; I thought you asked that as part of your question.

Senator ROBERTS: No, I didn’t ask for the number. Who are your stakeholders? Do they include the sponsors?

Prof. Lawler: As a contemporary regulator, we have a broad stable of stakeholders. They do include industry. As with any regulator, we work to refine our processes to balance the appropriate observance of safety, quality and efficacy with appropriate access and streamlining processes to bring products to market with a minimum of inappropriate regulatory burden. We undertake annual stakeholder engagement surveys to understand the views of the TGA, and the three key stakeholder groups that we survey on an annual basis are industry; health professionals—and obviously it’s important we work with health professionals for a number of ways, in that they both inform us and are informed by our decisions—and the community. It is notable that the responses we get reflect that the TGA, among all groups, comes across as a recognised, understood and valued regulator in the Australian healthcare system.

We have other stakeholders with whom we interact. We obviously interact very closely with the state health jurisdictions, and this is for a number of reasons. Our decisions on a number of elements, such as scheduling, for example, which we’ve already discussed today, have a significant impact on the state and territory poisons legislation and how they’re implemented for the delivery of medicines. We also interact quite closely with expertise across the regulatory sector. We have a number of advisory committees, the membership of which incorporates consumer views and expertise and also those from the academic and research sectors.

It’s also important to note that we obviously have close relationships with our international collaborative regulators. We are part of the International Coalition of Medicines Regulatory Authorities and the International Medical Device Regulators Forum, and we also work closely with individual regulators such as the MHRA and the UK, European Medicines Agency and the FDA.

CHAIR: Senator Roberts, I will shortly rotate the call to Senator Rennick and then can come back to you. Is this a sensible place to pause?

Senator ROBERTS: I’ll make it a short one, and then you’ll come back to me. Spike proteins can enter the body in two ways in the context of COVID: from the virus itself and from the vaccines. What work has the TGA done on the health outcomes of the long-term retention of spike proteins by the body after the mRNA vaccines that you recommended? It’s been four years now, so some good old-fashioned science by the TGA must be available. Is there any assessment?

Prof. Lawler: As has been indicated previously, as with all regulators around the world, we undertake a significant program of post-market surveillance and pharmacovigilance. This includes having a clear and well-communicated preference for adverse events post the vaccine to be reported. Those are reported and entered into our database of adverse event notifications, and, along with examination of that and also in collaboration with partner international regulators, we are very much aware and alive to emerging safety signals and act accordingly.

Senator ROBERTS: But you haven’t done any studies on the retention specifically of the spike proteins? The COVID injections dramatically increased the spike protein. You haven’t done any studies of that?

Prof. Lawler: I’m happy to have any additional response, but what I would highlight is that our role as a regulator is to assess evidence that is brought to us, and we undertake that assessment in the evaluation.

Senator ROBERTS: So you don’t go looking for it?

Prof. Lawler: We utilise that evidence in the assessment and evaluation of products, and we utilise the pharmacovigilance and post-market surveillance exercises that I’ve highlighted.

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TGA is Rubber Stamping Approvals

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The Therapeutics Good Administration (TGA) has been established as an independent body to approve or reject applications for drugs, vaccines and medical devices. For many years, the TGA stood strong against pressure from the USA and pharmaceutical companies to shred our long-established approval processes that protected Australians from drug harm.

Recently that pressure won out and the TGA has adopted the language of pharmaceutical companies, especially as used by their lobby group, Medicines Australia. The result has been the fast tracking of drugs and vaccine-like products that would not have been approved under the old system.

I ask about the rate of approval -vs- rejection of drug applications. In the last 3 years, 140 drugs were approved. The Department dodged the question as to how many were rejected. Most likely this was because drug companies are allowed to withdraw their application rather than face rejection, so they can bring the application again. My information is less than a dozen applications have been “withdrawn”, suggesting the TGA is approving at a much higher rate than they have in the past.

The actions of the TGA may have led to the spike in unexplained deaths and increases in serious harm to Australians. Only a Royal Commission will get to the bottom of their recent shift in process and the harm this may have caused to our health.

Transcript

Senator ROBERTS: I’m stunned that you wouldn’t study the long-term effects of COVID-19 spike proteins, given that the COVID injections cause the body to become a factory for the spike proteins. Let’s move on, though. The TGA website has a page entitled ‘Australian prescription medicine decision summaries’, which displays new drug approvals. 

CHAIR: Before you go on, Senator Roberts, you just made an assertion— 

Senator ROBERTS: I said I was stunned— 

CHAIR: They may not wish to, but I want to check if anyone from the department or the TGA wants to respond to the preamble before your question. 

Prof. Lawler : No, I don’t. Thank you, Chair. 

CHAIR: You’re okay? Alright. Senator Roberts. 

Senator ROBERTS: In terms of new drug approvals for calendar 2022, 2023 and 2024, three years—we’re in the third year—140 drugs were listed as approved. Is there a separate list of rejected applications? 

Mr Henderson : We do publish the medicines that are under evaluation as well as the medicines that are approved. Medicines are either rejected or—a lot of times medicines are withdrawn by the sponsor. 

Senator ROBERTS: Do you publish them? 

Mr Henderson : No, we just publish the number of medicines that have been approved as well as the medicines that are under evaluation. 

Senator ROBERTS: How many were rejected? 

Mr Henderson : I’ll need to take that on notice for those periods. 

Senator ROBERTS: Do you have a rough idea? 

Mr Henderson : I don’t know— 

CHAIR: If he’s taken it on notice, he’s taken it on notice. 

Mr Henderson : I’ll take it on notice. 

Senator ROBERTS: Thank you. Professor Skerritt was in charge of the TGA for most of that period. They approved 140 new drugs, and you don’t know how many have been rejected. Let’s go to plasmidgate. There were questions from several senators, including myself, at the last estimates relating to the scandal known as plasmidgate, which was the contamination of COVID injections with foreign DNA originating from E. coli bacteria used in the production process for making the COVID injections. Your answers on notice to all senators’ questions are essentially the same, which is ‘There’s no contamination,’ and you cast shade on the papers and persons who claim there is. Is this still your position? 

CHAIR: That seemed to be quite a personal reflection in that question. Who particularly were you talking about? 

Senator ROBERTS: There’s no personal reflection. It’s the TGA. 

CHAIR: The TGA? 

Senator ROBERTS: At last Senate estimates—and since, in answers to questions on notice. 

Prof. Lawler : Again, I apologise for having lost track of the question. There were a number of elements there. Could you repeat the question for me, and I can get the best person here to answer it. 

Senator ROBERTS: Sure— 

Mr Comley : Sorry, the essence of the question is, ‘Do you stand by the answers you’ve given to questions on notice related to contamination?’ and the answer is yes, we do. 

Senator ROBERTS: Okay. Have you tested a sample of these products in your own laboratory and have you personally assured yourself that there is no contamination in the COVID vaccines? 

Prof. Lawler : Thank you for the question. All vaccines that have been released have been tested by the TGA and have passed. 

Senator ROBERTS: How did you test the vaccines? Professor Skerritt told me he relied on the FDA, and the FDA said, before Professor Skerritt said that, that they relied upon Pfizer’s testing? What test did you do? 

Prof. Lawler : Could I just clarify that you’re talking about batch-release testing. 

Senator ROBERTS: I’m talking about COVID injections approval. 

Prof. Lawler : I’m trying to clarify whether you’re talking about the release of vaccines for use. 

Senator ROBERTS: I’m talking about the approval of the original COVID injections. Professor Skerritt told me that they were not tested here because you relied upon the FDA. The FDA had previously already stated that they did not do any testing; they relied on Pfizer’s testing, which was broken up. 

Dr Kerr : Thank you for the question. We do do our own testing. 

Senator ROBERTS: Did you test for contamination in the batches? 

Dr Kerr : Yes, we do test for contamination in the batches, including for residual DNA. 

Senator ROBERTS: And E. coli? 

Dr Kerr : The E. coli can be determined through a test called endotoxin testing. We do test for endotoxins, and all of the batches that have been released into the Australia market passed the endotoxin test. 

Senator ROBERTS: Attempts to examine batch-lot testing through freedom of information have resulted in documents that are 100 per cent redacted. I can flick the pages. You have the ability to put plasmid-gate to bed right now by publishing the results of your own testing without redaction. Will you provide to the committee that unredacted proof that there is no contamination? 

Dr Kerr : We publish the summary of our test results on the TGA website. One of those tests is contamination, and I can confirm that the batches are not contaminated with residual DNA or endotoxin. 

Senator ROBERTS: Thank you. Can we have a look at them? They’re on the website? 

Dr Kerr : Yes. 

Senator ROBERTS: I turn to blood clots. There’s an aspect of these injections that just doesn’t go away; in fact, it is becoming more common. Embalmers are reporting that bodies that they are embalming are affected by large blood clots. There are multiple videos and photos online. Dr John Campbell, a British doctor, did an excellent show recently on this. Have you looked at this issue? We know that it’s a problem with some of the injections. 

Prof. Lawler : Taking on board the fact that it’s difficult for us to corroborate or validate some of the comments that you made, I’ll ask Ms Kay to comment. 

Senator ROBERTS: I just want to know if you’ve looked at it. 

Ms Kay : We have not confirmed an association between mRNA COVID-19 vaccines and thrombosis, or blood clots. We have released an extensive list of the safety investigations that we’ve undertaken in response to a question on notice. I can provide that to you again so that you can see which safety signals we have investigated. I can’t tell you off the top of my head right now whether blood clots is one of those. 

Senator ROBERTS: Could you also tell me how you’ve done that evaluation? 

Ms Kay : Right, okay. 

Senator ROBERTS: You can take it on notice. 

Ms Kay : I can tell you now, if you like, how we detect safety signals and investigate them. We have a number of different approaches to detecting safety signals. A key mechanism for detecting safety signals is the statistical analysis of the adverse event reports that we hold in our database, where we look for unusual patterns of reporting that might indicate a new safety signal. We then undertake a medical assessment of those safety signals, and that medical assessment will determine the need for further investigation. That further investigation then takes into account a broad range of different sorts of evidence. We’ll look, in detail, at the adverse event reports within our database, as well as looking at published literature and information released by other regulators. Those investigations assess the strength of the evidence for an association between an adverse event and a vaccine. Where we find a likely association, we’ll take regulatory action, such as updating the product information to make that information available to health professionals. 

Senator ROBERTS: Can you tell me about the medical assessment? 

Ms Kay : The medical assessment of those statistical signals? Certainly. It’s an accepted approach in pharmacovigilance to undertake what’s called a disproportionality analysis, where we look for signals of disproportionate reporting of a particular adverse event with a particular exposure—a medicine or a vaccine. It’s also accepted in pharmacovigilance that those statistical signals need to be put through a medical assessment to understand whether they might have arisen through bias or whether there may be a signal there that needs to be further investigated. There are quite a number of different aspects that are considered in that assessment, and I’d be happy to provide you with that information on notice. 

Senator ROBERTS: Thank you very much. 

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