Breathtaking - asthma, ethics, money
© Robert Cockburn TRAC Productions 2022
What happens when the doctor you trust to keep you breathing, deceives you into testing experimental medical devices – without revealing these are experimental?
Potentially lethal, terrifying and life-changing injuries in my case. Then a wall of silence to block questions and accountability.
This unique and exclusive inside detective story exposes some of Australia’s most eminent doctors, scientists and officials from Sydney University, named below, who duped unwitting Sydney hospital asthma patients into testing experimental lung devices. Believing they were untouchable, from 2017 to 2020 they subverted the clinical trial and all patient protection systems, as no one dared to report them. They very nearly got away it, creating an official cover-up, reaching up to the national medical regulator, using deceit, intimidation and ultimately descending to farcical excuses.
So, even when an internal Sydney Local Health District investigation proved multiple safety and ethical violations against them, the report was buried, as it remains today. Revealed for the first time is the confidential SLHD investigation Summary of findings They include:
Wrongful withholding of public health information and known user difficulties with a trial device.
Wrongly concealing their secret trial partners who took and profited from participants’ data without our knowledge or consent.
Failure to provide medical contact in case emergency.
Incredibly, no one has been held to account.
That could soon change.
Five years on, the Federal Government science watchdog, the Australian Research Integrity Committee [ARIC] has stepped in. The ARIC National Health Medical Research Council [NHMRC} is conducting a rare official review of my allegations of failures by the then Sydney University Vice-Chancellor Prof Stephen Garton and its notorious Woolcock Institute, and SLHD Chief Executive Dr Teresa Anderson. The allegations include a cover-up and conflicts of interest in violations of the Australian Code for the Responsible Conduct of Research. The review is unprecedented at such a high level.
ARIC is considering that those involved: ‘deceitfully, deliberately, recklessly and negligently breached Code obligations of community trust, honesty, rigour, transparency, fairness, respect and accountability under its Principles of responsible research, Responsibilities of Institutions and Responsibilities of researchers.’
ARIC is due to report in 2022.
For the first time, the insidious racket of exploiting patients to test undisclosed experimental medical products, sadly common in poodeveloping countries, has been found in Australia and at its oldest and most prestigious university. ARIC has the power to publicly expose those responsible and to recommend fresh investigations that can hold them to account.
THE WRONG LAB RAT
They picked the wrong lab rat. I am an age pensioner with disabilities. I am also a journalist, formerly for the BBC and London Times, a contributor across Australian media, and a long-time investigator of medical abuses, also for The American Prospect, Private Eye, For Better Science and peered-reviewed Public Library of Science Medicine [Bio below].
Helped by family and friends, this is still the hardest investigation of all. Neurological damage from the clinical trial changed my ability to breathe and left a debilitating migraine condition. I needed physiotherapy to learn how to breathe again, extra steroid and Ventolin, emergency hospital care, blood pressure pills and costly home oxygen. Tests and treatment continue.
My ability to think and to write are slowed. Screen use is limited, as is my mobility, making life and work difficult. My writing is not elegant, bumpy in parts. But it is factual and functions to lay out documentary evidence of disturbing story that goes far beyond one bad trial.
The work is to see that those responsible are held to account and to stop others being harmed this way. It is a disturbing journey into the shady world of white coat corruption and its high-level protection.
Before continuing, it is worth noting the Australian Capital Territory Human Rights Commission factsheet on the “Right to Protection from Medical or Scientific Experimentation:
“Scope of the Right Section 10(2) of the Human Rights Act specifically prohibits involuntary medical or scientific experimentation – a prohibition which stems from Nazi experimentation in the Second World War, but remains relevant today.”
The Human Rights Act prohibition was disregarded by all involved in this case.
Following the damning secret 2019 Sydney Local Health District investigation, it took until 2012 to obtain, under Freedom of Information, the hidden identity of the SLHD Human Research Ethics Committee chair who falsified official trial documents to betray participants. He is a top Sydney University professor.
Finally, in 2022, Prof John Skerritt, Australia’s Deputy Health Secretary and head of the medical regulator, the Therapeutics Goods Administration [TGA], admitted to me that the TGA wrongly withheld from me public information about the trial's experimental devices [link to his letter below] .
On 17/8/22, in a potential breakthrough, the TGA announced it was for the first time seeking to take a role in regulating medical device clinical trials. It invites interested parties to contribute to its Consultation on Proposed Regulatory Changes for Clinical Trials of Medical Devices. For input use the TGA Consultation Hub link: https://consultations.tga.gov.au/tga/proposed-regulatory-changes-for-device-trials/
What is now required is mandatory provision of full clinical trial product information participants. Respect for existing regulations is clearly inadequate.
Previously, in my case, proven trial violations were airily dismissed by the heads of Sydney University, SLHD and TGA, as 'not intentional', ‘not deceitful’ or a 'misunderstanding.' ARIC is deciding on the veracity of their claims.
The evidence shows otherwise. Unique recordings made inside the SLHD investigation, official documents, e-mails and interviews, reveal how Sydney University staff knowingly ran a one-stop-shop to recruit asthma patients by fixing false official paperwork and invalid participant consent forms. It reveals their concealed Italian trial partners, Politecno di Milano and Milan device maker Restech who stole participants’ data for financial benefit.
This is hard slog, old-fashioned campaigning journalism, overcoming obstacles to win breakthroughs and reform. It secured the SLHD and ARIC investigations. In 2019, the Disability Royal Commission requested updated reports. The Federal and NSW Health Ministers unexpectedly blew the whistle on the cover up and began reforms, urging my ‘continuing advocacy’ against the racket. Concerned Australian and international scientists are now assisting
A more technical version of this article is on the online journal For Better Science. I’m now advising a university investigation on medical companies and hospitals. A film about the case is being prepared, and not without its farcical attempts at cover-up.
Big questions still need to be answered.
How did they get away with it for so long in regulatory system claiming to be the world’s best?
How many more cases of clinical trial abuse exist?
How much are the official investigations costing with over 70 doctors, scientists, officials and lawyers involved - bleeding cash form the hard-pressed health services?
Why did elite professionals risk not only patients but also their own reputations in this way? Why is there no Australian media coverage despite the provision of official documents in the public domain?
Who are the other unknown trial participants?
There’s a lot more work to do. This is about the misuse of public research money by public education and health institutions and staff to abuse patients in public hospitals.
I don’t know the other trial Woolcock participants or who quit the trial after its false documentation was revealed to them. Participants were recruited from Sydney’s leading teaching hospitals: Royal Prince Alfred, Royal North Shore and Concord Repatriation General.
I would like to hear from other participants on the Sydney Woolcock Institute trial CH62/6/2017-119 testing Restech and PM Healthcare devices, and from patients, health workers, researchers and officials who have concerns. Please contact: email@example.com
The key discovery came in 2021 which would stitch together the missing administrative link in the racket between Sydney University and Sydney Local Health District. Repeated Freedom of Information applications revealed the withheld identity of the SLHD official, the government official with a duty to protect participants, who instead facilitated the way for his university to abuse us. This showed how the racket was worked. It opened the way to an ARIC investigation.
He is Prof Andrew McLachlan, Sydney University Dean of Pharmacy and chair of the Woolcock trial’s SLHD Human Research Ethics Committee. Prof Andrew McLachlan signed the false trial approval letter and approved the invalid participant consent forms for his Sydney University colleagues. He had left a very public clue in a university You Tube video: asked by a student to name his greatest fear, Prof McLachlan declares: 'Being found out.' [You Tube link below]
The Woolcock, Sydney Health and Sydney University have sent me written apologies for their failings. Those responsible betray all patients and health workers - including the RNSH ambulance crews and emergency hospital staff who have twice revived my breathing.
Public trust in human clinical trials has never more important or public than in the search for today’s Covid-19 vaccines. Exposing abusers is essential to maintaining this vital system.
On 27/11/18 at a routine check, my lung consultant, Sydney University Prof Gregory King, noted an improvement in my asthma condition. It was an unusual and welcome development for a patient of my age. That day, Prof King asked me to join a Woolcock Institute ‘study’ to find my asthma triggers. I agreed. A week later, my ability to think and breath normally was wrecked. My life was changed.
Woolcock’s Dr Farid Sanai and a student had installed two lung measuring devices in my home: a Restech Resmon FOT Diary and, added to the trial, a US PM Healthcare Spiro PD spirometer. No one said that I was really on an experimental clinical trial to test the devices or that participants’ trial data was being beamed by satellite directly from our homes to Restech in Milan. I signed what turned out to be an invalid trial consent form.