Senate debates
Tuesday, 7 March 2023
Adjournment
Therapeutic Goods Administration
8:33 pm
Malcolm Roberts (Queensland, Pauline Hanson's One Nation Party) Share this | Link to this | Hansard source
In my capacity serving the people of Queensland and Australia, I note that during the last Senate estimate hearings, Adjunct Professor John Skerritt, Deputy Secretary, Health Products Regulation Group within the TGA, commented with clarity previously lacking in three years of health officials' testimony. Finally the truth. The Therapeutic Goods Administration, our TGA, did not check patient-level clinical trial data for the mRNA vaccines. Instead, it used documents that Pfizer supplied and modified after the United States Food and Drug Administration, the FDA, requested it. It's now very relevant to ask how diligent was America's Food and Drug Administration, the FDA—that's America's equivalent of our TGA—in overseeing drug approvals?
On 2 November 2021 the British Medical Journal, BMJ, published an article titled 'Covid-19: Researcher blows the whistle on data integrity issues in Pfizer's vaccine trial'. I'll quote from this article about whistleblower Brook Jackson reporting on the Texas trial sites:
A regional director who was employed at the research organisation Ventavia Research Group has told The BMJ that the company falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer's pivotal phase III trial. Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. After repeatedly notifying Ventavia of these problems, the regional director, Brook Jackson, emailed a complaint to the US Food and Drug Administration. Ventavia fired her later the same day. Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails.
These were provided to substantiate her allegations. Brook Jackson used FDA whistleblower provisions—and a lot of good that did her because the FDA dobbed her in to Pfizer anyway. She was fired, and her complaint was ignored—start of cover-up.
Minister, on 16 November 2022 the British Medical Journal published an article titled 'FDA oversight of clinical trials is "grossly inadequate", say experts'. In recent months a court ordered release of documents surrounding the FDA's approval of Pfizer's vaccine confirmed Pfizer's malfeasance. Known as the 'Pfizer papers' the FDA contested the release to the public. It wanted this information kept secret for 75 years. The Pfizer papers show the FDA knew or reasonably should have known at the time of approval that the clinical trials were incapable of supporting an approval. Let me say that again: the Pfizer papers show the FDA knew or reasonably should have known at the time of approval that the clinical trials were incapable of supporting an approval.
Pfizer then did this: their USA and European trial sites were getting so many adverse reactions that Pfizer had to cheat and at the last moment added 26 new trial sites in Argentina, recruiting 467 doctors almost overnight to create 44,000 new glowing patient records, overwhelming the legitimate bad data. In Argentina some sites and many patients do not appear to exist. Adverse events were hidden, and patients who were harmed or killed were removed from the data. That's what the United States Food and Drug Administration rubberstamped, and that's exactly what the TGA rubberstamped. And now every day Australians are dying.
I know people are tired of this whole thing. One Nation is as well, yet there is a far larger issue that has gone without comment, that is too monstrous to simply let go. It relates to why the TGA refused to have anything to do with an Australian developed conventional attenuated virus vaccine that would have been safe to use. Queensland university discontinued their conventional vaccines on spurious grounds with real conflicts of interest. This opened the door for an entirely new class of drugs and supposed vaccines, mRNA, medicine by gene editing. This was not about Australian patient health; it was about patents.
Over the last 15 years 47 market-leading drugs have aged out of patent, costing pharmaceutical companies $30 billion a year in lost sales, including drugs that made up to 42 per cent of Pfizer's drug revenue and 62 per cent of AstraZeneca's drug revenue. This patent cliff is set to get worse, with another 15 drugs—nine of the world's 20 top-selling drugs—due to expire this decade. Pfizer will face losing another $15 billion in annual sales.
The only way to replace so much revenue is with a whole new class of drug: mRNA. Four hundred mRNA drugs are currently in development. The manufacturing plants in Australia are already under construction, before the drugs have been tested. The problem for big pharma was how to get these radical gene-editing drugs accepted. Coincidentally, along came COVID—a miraculous opportunity to use the new, untested mRNA gene editing. The heavens aligned to wave mRNA technology through for humans and animals, untested, with no debate or scrutiny.
We now have an explosion of patient death reports and patient harm reports on the database of adverse events notifications, including 940 deaths before doctors gave into Ahpra's blackmail and stopped reporting vaccine or injection deaths. The actual deaths from COVID-19 injections are known to be grossly underreported due to Ahpra's threats to doctors and nurses. In 2022 there were 22,000 more Australian deaths than usual, and our health bureaucrats can't tell us why. Half are unexplained, and the other half are supposedly people for whom the mRNA vaccines did nothing—but led to their death. Yet the pharmaceutical industry's future is now secure for a generation. That, Minister, is a crime this government refuses to investigate.
Health bureaucrats' lies and government deceit directly and indirectly killed thousands of people. Thousands of Australians are dead. Bureaucrats' lies destroyed millions of lives and livelihoods. Unless the Albanese government takes prompt action it will be complicit with the Morrison government's crime. One Nation calls on the government to immediately enact a Senate select inquiry to identify the scope and terms of reference for a royal commission into state and federal governments' gross mismanagement of COVID.