Category Archives: One Nation Party
Arrogant TGA head Dr John Skerritt ducks for cover as Roberts accuses him of vaccine impropriety
Federal Police should be investigating Professor John Skerrit’s onshore and offshore bank accounts. Former PM Scott Morrison accrued $52 Million while PM. How much has Bro John salted away? (https://cairnsnews.org/2022/02/23/scott-morrison-under-the-microscope/)
Senator ROBERTS: Can you tell me how many medicines were approved under the provisional approval pathway during the COVID period 1 July 2020 to date? My numbers are 13 vaccines and six drugs; is that correct?
Dr Skerritt: Are you talking specifically about COVID treatments and COVID vaccines?
Senator ROBERTS: No, any vaccines or drugs that have been approved using the provisional pathway.
Dr Skerritt: I will start with COVID vaccine treatments. There have been seven COVID vaccines and eight COVID treatments. I’ll just check whether I’ve got the numbers for other medicines during that period. You’re talking about the provisional approval pathway?
Senator ROBERTS: Yes.
Dr Skerritt: From 1 July this year there have been five provisional approvals. From the period 1 July 2021 to 30 June 2022 there have been 23. That would include those COVID treatments. What it does show is a lot of other medicines, such as cancer medicines, such as medicines for rare conditions, have also been approved. In the financial year 2021, from 1 July 2021 to 30 June 2022, there were five. Over the period you’re talking about, that would add up to 33.
Senator ROBERTS: How many drugs have been approved under the normal process during that same period?
Dr Skerritt: During the same period? I will add the three financial years and I’ll check my mental arithmetic. So 36 this current financial year, and 117. These are either new approvals or new indications approved. And 95 the year before. So, it is a significant percentage, but not most of them.
Senator ROBERTS: Is the maximum provisional approval period six years because it can take that long to get drugs approved under the old approval system?
Dr Skerritt: A provisional approval is only valid for two years and then the company either has to come back and show why they cannot obtain all the data within the period and apply for an extension.
Senator ROBERTS: No, the maximum provisional approval?
Dr Skerritt: They can apply for further lots of two years.
Senator ROBERTS: Is the maximum provisional approval—
Dr Skerritt: Overall the maximum period is six years, but it’s not six years off the bat.
Senator ROBERTS: It’s two years with extensions.
Dr Skerritt: They are possible extensions; they’re not guaranteed.
Senator ROBERTS: How much money do you save pharmaceutical companies by switching from full approval to express approval? I understand it’s hundreds of millions per approval?
Dr Skerritt: It actually costs the pharmaceutical companies more in regulatory fees for provisional approval.
Senator ROBERTS: No, I didn’t say regulatory fees. How much are you saving the pharmaceutical companies by giving them express or provisional approval rather than going through the six-year period for getting proper approval?
Dr Skerritt: No, you’ve misinterpreted the system. It’s not a six-year period to get full regulatory approval.
Senator ROBERTS: It varies. I accept that.
Dr Skerritt: Most of our approvals are submitted as a standard approval, especially, for example, if it wasn’t a public health emergency or it’s a drug that already has others in the same category. They’re submitted as a standard approval.
Senator ROBERTS: Dedicated trials for their drugs, I understand, can be hundreds of millions of dollars. How much time and money would they save by going express?
Dr Skerritt: We would not give a provisional approval to a medicine unless there were clinical trials.
Senator ROBERTS: How much money does it save if they do a provisional without doing a formal or normal approval process? How much money does it save the drug company?
Dr Skerritt: I don’t believe there are necessarily savings. The situation would be different for every drug. It’s really important to emphasise there were very extensive clinical trials for the vaccines and treatments that have been through provisional approval.
Senator ROBERTS: My understanding is that it can cost hundreds of millions of dollars to get the full approval process. Without the dedicated trial, they could save hundreds of millions of dollars per drug?
Dr Skerritt: I don’t necessarily agree with you.
Senator ROBERTS: When does the provisional approval for Pfizer expire?
Dr Skerritt: The two-year period will be two years from the anniversary of the first approval. I would emphasise that in certain countries—
Senator ROBERTS: What is that date?
Dr Skerritt: The products are now fully approved.
Senator ROBERTS: What is the date of provisional approval expiry?
Dr Skerritt: For the very first approval, for 16 years and over, the two-year period finishes on 25 January 2023.
Senator ROBERTS: I have in front of me a document called the Australian Public Assessment Report for Tozinameran, from Comirnaty (Pfizer), dated December 2021. Is this the approval application for the paediatric version of the Pfizer vaccine?
Dr Skerritt: No, it is not. An Australian Public Assessment Report is a summary of the assessment that we did of the application. You mentioned Pfizer. The actual application is over 220,000 thousand pages of paper from Pfizer for that particular group of vaccines.
Senator ROBERTS: I reference page 61, which states:
Limitations of the current application data. Safety follow-up is currently limited to median 2.4 months post dose 2 in cohort 1, and 2.4 weeks for the safety expansion cohort.
What is the safety expansion cohort?
Dr Skerritt: Remember, also, this was going back to the time of approval. We now have hundreds of millions, actually more than a billion, people who have been vaccinated with that vaccine and experience going on since December 2020, when the first vaccination was done. The safety expansion cohort is in a clinical trial where individuals are monitored closely and the data reported back to regulators for periods of months, leading to years, after their vaccination.
Senator ROBERTS: Did you recommend this substance based on 2.4 weeks of safety testing or did you get more in? If so, over what period? How many months?
Dr Skerritt: Remember the initial approval from TGA was based on that two months of follow-up, but we also had the experience of other countries that had more than a month before starting mass vaccination campaigns. When we approved Pfizer on 25 January2021, we were in almost daily contact with the British, who by that stage had vaccinated millions of British people by 25 January 2021. Real-world evidence played a very important role in both the approvals and in the ongoing safety monitoring of these vaccines.
Senator ROBERTS: So you relied on data from other countries and you relied for periods of months, merely months. It can’t be more than six months, because there’s a gap between application and approval and to give time for collection of data and analysis. There should be years of data before we start putting this stuff into our children, yet it’s months.
Dr Skerritt: I disagree in the context of a pandemic and a public health crisis. Regulators globally felt that it was appropriate to do initial approvals—
Senator ROBERTS: You’re the Australian regulator.
Dr Skerritt: As the head of the Australian regulator, I would do precisely the same if I had my time again. The alternative would have been to leave Australians unvaccinated through the course of 2020, 2021 and 2022, and there would have been tens of thousands more Australian deaths.
Senator ROBERTS: Can I reference a letter from the Commonwealth Department of Health and Aged Care, signed by Radha Khiani, Director, Governance and Coordination section, in which the department makes this claim. The letter from 4 November 2022, just last week, states:
A large team of technical and clinical experts at the TGA carefully evaluated the data submitted by the sponsor. A treatment or vaccine is only provisionally approved if this rigorous process is completed.
This document concerned the use of Pfizer stages 2 to 3 cynical trial data in support of their application for provisional approval. Did the TGA check the stage 2 and stage 3 clinical trial data from Pfizer? Did you check it?
Dr Skerritt: We did check the phase 2 and phase 3 clinical trial data from Pfizer and we also took it to independent external medical experts as well as consumer representatives.
Senator ROBERTS: Referencing Freedom of Information No. 2289, in which the applicant requested a copy of the stage 2 and stage 3 clinical trial data, the TGA responded that the ‘TGA does not hold any relevant documents relating to the request’. That was a request for stages 2 to 3 clinical trial data.
Dr Skerritt: Without seeing what’s in your hand, I believe that you asked for individual patient data rather than the phase 2 and phase 3 clinical trial data. I can give you my word that we assessed the phase 2 and phase 3 clinical trial data; otherwise, what else did we do? Look at the colour of the label on the bottle? That is the main thing our team of several thousand clinicians look at in reviewing a new vaccine, the phase 2 and phase 3 clinical trial data. It is the centrepiece.
Senator ROBERTS: The freedom-of-information request then asked for ‘any documents confirming the process of analysing this data to a decision, including meetings, notes, dates and times’. Again the TGA replied, ‘We have no relevant documents.’ Did you review the stage 2 and stage 3 data or not, and, if you did, why did you tell this freedom-of-information applicant you did not have these documents? Which document is the lie? One of them is.
Dr Skerritt: I don’t have that document in front of me. We can review it on notice. But we reviewed the phase 2 and phase 3 clinical trial data at length.
CHAIR: This really needs to be the last one so I can share the call.
Senator ROBERTS: I just want you to think about this and confirm it or otherwise: and ‘the trail data contained sufficient proof the vaccines were safe and effective, sufficient to meet the criteria for provisional approval’; is that correct?
Dr Skerritt: Correct. Yes.
Who’s who of data breaches while Labor wants to put Australians into a one stop ID shop?
Senator Malcolm Roberts warns about the Labor and Liberal push for a national ID card containing all of your personal information.
He asked: “Have you noticed more and more data breaches lately? Some in the Government are using this as a reason to centralise everything into one Digital Identity. As the long list I read out proves, nothing is un-hackable.
“That’s a good reason why you SHOULDN’T centralise everyone’s data into one Digital Identity location. It would be a hackers dream, a one stop shop to steal your identity.”
Pauline says One Nation puts Australians first
Here we are on the eve of the Federal election and I’ve been blown away by the strong support our team has received all over Australia.
To all of our candidates, volunteers, members and supporters: thank you from the bottom of my heart for all of your efforts. It’s been an amazing campaign.
Our policies on housing, immigration, apprenticeships, cheaper PBS medicines, climate, tax reform and family law reform are enjoying a lot of support, with the Coalition happily adopting some of them itself on housing, medicine and apprenticeships.
We’ll address the housing crisis. We’ll reduce demand for housing by lowering immigration, and increase the supply of housing by banning foreign ownership of residential property like New Zealand and Canada.
We’ll demand reforms to ensure foreign-owned multinationals pay their fair share of tax. We’ve achieved some reforms in family law but we have more work to do to make the child support system fairer. We’ll continue to back a national apprenticeship scheme to drive the creation of a skilled Australian workforce, and we’ll revitalise TAFE colleges and re-open agricultural colleges. We’ll reduce the cost of PBS-listed medicines.
We’re demanding a Royal Commission into the management of the COVID-19 pandemic by all Australian governments, and we’re also going to push for a comprehensive inquiry into climate science to ensure that Australian climate policy is based on evidence instead of ideology and scaremongering, destroying our economy and many thousands of Australian jobs.
One Nation puts Australia and Australians first. This election is your opportunity to vote for a strong One Nation contingent in Parliament to fight for your rights and freedoms, and fight for a fair, free and prosperous Australian nation.
Repudiate WHO Treaty, put the LNP/ALP/ Greens last
by Alison Ryan
Now is the time for “sovereign states to exercise the right to repudiate” the WHO Treaty on Pandemic, Preparedness and Response. We need therefore to make our vote count this election by voting for the freedom parties and putting the major parties – Libs, Labour, Nationals, and Greens – in the very last boxes. These have long sold us out to global governance, created illegitimate laws, and aided and abetted the demise of our common wealth.
Take a look at the history of the UN WHO Constitution and its tenets.
CONSTITUTION OF THE WORLD HEALTH ORGANIZATION (1)
THE STATES Parties to this Constitution declare, in conformity with the Charter of the United Nations, that the following principles are basic to the happiness, harmonious relations and security of all peoples:
Health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity.
The enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic or social condition.
The health of all peoples is fundamental to the attainment of peace and security and is dependent upon the fullest co-operation of individuals and States.
The achievement of any State in the promotion and protection of health is of value to all.
Unequal development in different countries in the promotion of health and control of disease, especially communicable disease, is a common danger.
Healthy development of the child is of basic importance; the ability to live harmoniously in a changing total environment is essential to such development.
The extension to all peoples of the benefits of medical, psychological and related knowledge is essential to the fullest attainment of health.
Informed opinion and active co-operation on the part of the public are of the utmost importance in the improvement of the health of the people.
Governments have a responsibility for the health of their peoples which can be fulfilled only by the provision of adequate health and social measures.
ACCEPTING THESE PRINCIPLES, and for the purpose of co-operation among themselves and with others to promote and protect the health of all peoples, the Contracting Parties agree to the present Constitution and hereby establish the World Health Organization as a specialized agency within the terms of Article 57 of the Charter of the United Nations.
(1) The Constitution was adopted by the International Health Conference held in New York from 19 June to 22 July 1946, signed on 22 July 1946 by the representatives of 61 States (Off. Rec. Wld Hlth Org., 2, 100), and entered into force on 7 April 1948.
Amendments adopted by the Twenty-sixth, Twenty-ninth, Thirty-ninth and Fifty-first World Health Assemblies (resolutions WHA26.37, WHA29.38, WHA39.6 and WHA51.23) came into force on 3 February 1977, 20 January 1984, 11 July 1994 and 15 September 2005
respectively and are incorporated in the present text.
Source: Basic documents: forty-ninth edition (including amendments adopted up to 31 May 2019), World Health Organization 2020, page 1
MEMBERS OF THE WORLD HEALTH ORGANIZATION (at 31 May 2019)
The Members and Associate Members of the World Health Organization are listed below, with the date on which each became a party to the Constitution or the date of admission to associate membership.
Australia*……………………………………………………………. 2 February 1948
* Member States that have acceded to the Convention on the Privileges and Immunities of the Specialized Agencies and its Annex VII.
Source: Basic documents: forty-ninth edition (including amendments adopted up to 31 May 2019), World Health Organization 2020, page 227
See: Withdrawal from the United Nations
Proposed Australia withdrawal – Pauline Hanson’s One Nation support Australia leaving the United Nation.https://www.smh.com.au/politics/federal/one-nation-policies-the-definitive-guide-to-the-views-of-pauline-hanson-and-her-senators-20161017-gs3z1s.html
One Nations says; We are a party that stands for Australia and Australian values. We defend our constitution and stand up against global agendas for the individual rights and fundamental freedoms of all Australians.
Senator Malcolm Roberts – Qld Labor destroys its own health system
Senator Malcolm Roberts giving Queensland Labor a serve for wrecking the state’s health system and destroying people’s lives and small business.
Defence Legislation Amendment will not allow foreign tanks to roll down Australian streets and be immune to liability
Last year the Defence Legislation Amendment (Enhancement of Defence Force Response to Emergencies) Bill was passed. Some have said it will allow foreign tanks to roll down Australian streets and be immune to liability. This is simply untrue. When reading all of the bill, we see that this is more about fighting bushfires than foreign troops and they DO NOT get immunity for any act of aggression against Australians. – from Senator Malcolm Roberts
Mark Latham fights back against tyrannical vax passports!!
Mark Latham has been the state leader of One Nation in New South Wales since November 2018, and was a previous leader of the Labor Party in December 2003. Mark comments on the pending covid passport legality, government bullying of the people and much more.
NSW Liberal Premier enacts martial law – Senator Malcolm Roberts
On many occasions in the last year I have addressed the Senate in regard to freedom as a counterbalance to medical tyranny. And I recently addressed the Canberra Freedom Rally, remotely. The side that is locking people up for the crime of being healthy, arresting protesters, pepper spraying kids, beating up grannies, banning books and electronic messages, censoring social media, sending threatening letters, forcing small businesses to close, urging people to dob in dissenters and banning safe drugs that have worked for 60 years are all on the wrong side of history.
In a frightening development, New South Wales has called in the troops to keep innocent, healthy citizens locked in their homes in what can only be called martial law. Recent freedom marches showed what happens to citizens who exercise their democratic right to protest. People are demonised, hunted down; the media vilifies them to discourage others from questioning the control state. If the government can decide who is free and who is not, then that is not freedom and no-one is free. A crisis will always be found to justify measures designed to protect the government, not the public—a crisis that is as is easy to create as turning up the PCR test from 24 cycles to 42, where a false positive is the most likely outcome, as has occurred.
Actions such as these have created a crisis of confidence in government, and that, fellow citizens, is on the Senate. We are the house of review. We’re tasked with a duty to ensure honesty, transparency and accountability in the government of the day. We have failed in that solemn duty, our duty to our constituents. We have failed those who are yet to vote, our children, who are now being injected with a substance that has not undergone meaningful safety testing. The Liberal, National and Labor parties have colluded to waive these measures through this place, reducing the Senate to the status of a dystopian echo chamber.
Each new restriction, although met with rightful public opposition, has not led to a re-evaluation but, rather, has led the government to crack down even further. The Morrison government is behaving like a gambling addict who loses a hand but doubles down instead of admitting error and walking away. With troops now on the streets, it’s frightening to contemplate where this will end. Everyday Australians are being deliberately demoralised to extract a higher degree of compliance. When COVID first arrived, there were few masks, and the experts and authorities told us masks were not necessary. Now, those same medically ineffective masks are used to condition people to fear and obedience. Crushing resistance crushes hope, and without hope we have no future.
Is it any wonder that small businesses are closing permanently? Every small business that closes is a family that was being provided for through hard work and enterprise. Who will look after those families now—the government? With whose money? The Reserve Bank, using electronic journal entries, can only create fiat money out of thin air for so long before it runs down our country. The government can only sell bonds until buyers stop coming forward. Then what happens? We will have no tax base left to pay government stipends to people who were once able to pay their own way. Since when has the Liberal Party, the supposed party of Menzies, been dedicated to making huge sections of the population totally reliant on the government for survival? The bad joke here is that the excuse used to justify the sudden rush to Marxism—public health—is moot. Death from all sources, including coronavirus and the flu, are at historic lows. Australia’s death rate in 2020 was less than in 2019, and 2021’s death rate is lower again.
We’re strangling Australia’s economic life and future for no reason. Power has gone to the heads of our elected leaders and unelected bureaucrats, who are exercising powers yet do not feel the consequences themselves.
Never in history has Lord Acton’s famous quote rung more true: ‘Power corrupts, and absolute power corrupts absolutely.’ It’s been calculated that the civil disobedience tipping point—which is the maximum capacity of the police to arrest people, of the jails to hold people and of the courts to process people—is in Australia around 100,000 people. Anything more than that and the system comes crashing down. Attendance at the freedom rallies last month shows we’re almost there.
No wonder the Morrison government has been scared into resorting to the refuge of tyrants—using the military to intimidate civilians into compliance and to mandating injections and threatening to rip away people’s livelihoods. Everyday Australians are seeing through the smokescreens of fear and intimidation. People now see that the costs of the restrictions to family and community exceed the medical cost of the virus. Everyday Australians have spoken. We will not be divided, we are united, we are one community, we are one nation.
Campaign to restore the Upper House in Qld should start now
The SSM plebiscite could have been hacked with a predictably skewed result. In any case Cairns News has a long-standing policy of ignoring the gender neutral campaign started years ago by the feminist movement, contemporaneously referred to as the ‘femminazi’ collection of dykes.
Canberra is infested with thousands in this clique. They sit in the multitude of offices found in the Prime Minister’s Department many drafting bills such as the SSM legislation which was passed yesterday in the Lower House.
This newsletter will continue to use the grammatically correct terminology of Mr; Mrs; husband; wife; de-facto; girl; boy; married couple; fisherman; waiter; waitress, ad infinitum.
Time after time Australia has been the guinea pig for the cultural revolution orchestrated by the United Nations and the
Dark Government which is largely unknown to the average Australian. The SSM continues the tradition paving the way for the seemingly normal people remaining on the planet. Every day Mormon lifestyles seem more attractive.
The growing fascism emanating from state parliaments will be evident to all when the Queensland ALP begins its legislative attack on the business and farming sectors during this term of parliament.
The campaign to restore the Upper House should begin in earnest drawing its members from the existing number of state politicians without adding any more. – Gil Hanrahan
New electorate of Cape York looming after welfare vote dominates result
At least 4000 voters, solely dependent on government welfare payments to survive, have elected Labor in the seat of Cook, leaving the economic generators of the Far North floundering without a say in government.
To separate the disparate welfare influence from the southern half of the Cook electorate it has been suggested the creation of a new electorate would be more in the interests of maintaining a thriving agricultural and mining industry.
Plans to create a separate state seat of Cape York with a boundary drawn north of Laura will now escalate before the Labor Party is able to further entrench itself with welfare voters.
One proponent of a new seat is the patriarch of the north, Bob Katter, who said he had been approached in the past by indigenous leaders seeking support for a separate electorate.
There is no farming industry north of Laura, just a handful of viable cattle breeding properties locked in a continuing battle with federal and state environment departments, indigenous land rights encroachments, egregious mining exploration companies and a Labor Party determined to shut down the cattle industry.
During the election campaign, notorious Green lackey, Deputy Premier Jackie Trad, threatened land owners with a new round of Wild Rivers, more water storage restrictions and World Heritage listings over the remaining 50 per cent of the land area of the Peninsula not already languishing under conservation zones.
The world’s toughest vegetation management laws will be introduced under the guidance of two of the ALP’s in-house, rabid greenies, Trad and colleague Dr Stephen Miles.
If either possessed a modicum of political will, no help can be expected from so-called representative bodies such as Agforce or the Natural Resources Management (NRM) quangos which are dependent almost entirely on government funding to survive.
Agforce, the last bastion of the failed Liberal Party will struggle to attract membership or have any direct policy influence on a resurgent Labor Party, driven entirely by the trade union movement and the United Nations Agenda 30 to which Queensland is a signatory.
It will be an entirely political manoeuvre to protect the Far North from the flush of international socialism seeping from the confines of the Queensland south east corner which enjoys state government largesse at a ratio of 10 to one over the north.
It is only the cross bench in State Parliament which now can thwart the UN agenda pushed by the Marxists of the Queensland Labor Party seemingly aided and abetted by the flailing Liberals.
As one commentator quipped, “there are no Nationals in the Queensland parliament, just Liberals wearing Akubras.”
The electorate of Traeger, formerly Mt Isa until the unaccountable Electoral Commission tagged it with this misnomer, was held easily by Robbie Katter with 66 per cent of the primary vote.
In the campaign Katter warned the ALP that one of his first policy initiatives for the new parliament would be to create the new State of North Queensland.
This policy obviously resonated with the adjoining, redrawn electorate of Hill easily taken by his colleague Shane Knuth, in spite of the best attempts of the Electoral Commission to gerrymander Knuth from Parliament.
Hinchinbrook, joining Hill to the south also seems set to go to Katters Australian Party.
North Queenslanders will be assured of a tumultuous ride during this term of parliament, towards attaining their well-deserved, modernised statehood.
At the close of counting on Tuesday night, Labor held Cook with a margin of 2900 preferences.
ECQ staff at Mareeba office praised by candidate
Lui claims Cook but the ALP is not yet over the line
Anxious candidates across the state are awaiting the final counting of postal and absentee votes as ECQ staff work overtime to sort through the backlog.
One Nation, KAP and the LNP are waiting for the final tally to determine how many seats the ALP will have to form a majority.
The ALP has claimed the contentious seat of Cook stretching from Mareeba in the south to the PNG border in the north, however One Nation sources say the counting will not finish until Tuesday night when the final postal votes are counted.
The final postal and absentee numbers will have an impact on preference flows to the One Nation candidate Jen Sackley, who seems set to overtake the lead of the Labor candidate Cynthia Lui.
KAP candidate Gordon Rasmussen said either his preferences or those from the LNP would help One Nation get across the line.
“The staff at the Mareeba ECQ office have been outstanding with the counting and very helpful to scrutineers and I thank them for their great effort,” said Mr Rasmussen.
“Their integrity has never been in question but I am concerned about the reports of suspicious activities on Cape York Peninsula which happens after every election on the Cape.”