by Robert Cockburn

In late January 2024 the Australian Competition and Consumers Commission deputy chair Catriona Lowe issued a warning to all Taylor Swift fans about ticket scams on her Eras Tour.

The ACCC’s National Anti-Scam Centre warning made global headlines and saved Swifties $198 per fake ticket. 

Meanwhile, across Canberra, a Department of Health and Age Care unit was finalising a secret report that would block scam warnings for thousands of Australians who risk testing the safety of experimental new medical products for us. The report, by the Australian Research Integrity Council [ARIC], somehow confirmed multiple human research violations of patients by eminent medical figures and institutions, and then let them off without any accountability. They falsified official documents, even faking invalid Informed Consent forms to scam unwitting severe asthma patients into testing undisclosed experimental devices for a foreign company.

Their scam permanently injured a disabled age pensioner.

The police should have been informed. Far lesser scams would be prosecuted. So desperate is the need to hide this Establishment scandal, a Non-Disclosure Agreement [NDA] was imposed to silence their victim - while the abusers flourish, one recently honoured with the AM Order of Australia.

What is going in Australia’s public health service?

I’m the injured age pensioner and also the journalist who exposed the Sydney University Woolcock Institute scam and cover-up to secure internal NSW and Federal investigations.

I am defying my NDA to reveal the scam and, worse in many ways, the cover-up as far the Health Minister in a toxic culture of lies and bullying that stops reporting of clinical trial abuse.

Now, the seven-year cover-up could end. The Prime Minister’s Office [PMC] has stepped in, and also the National Audit Office [NAO] after discovering clinical trial funding fraud at the National Health Medical Research Council. We might yet find out why Swifties get government scam protection while clinical trial volunteers taking risks for all of us get no scam warnings despite proven dangers.

Health Minister’s promise to ‘put the rights of older people first’

On November 1, Minister of Health and Aged Care Mark Butler launches his new Aged Care Act with a promise to ‘put the rights of older people first’ with transparency and accountability.

But his promise hides the Woolcock’s abuse of patients, including the elderly, and disturbing implications for our health system.

The Sydney University Woolcock Institute scammers targeted vulnerable patients from three Sydney teaching hospitals for their unethical trial: Royal Prince Alfred, Concord Repatriation and Royal North Shore, my hospital. More than 30 severe asthma patients were scammed into testing undisclosed experimental lung devices for a concealed Milan company, Restech, and the Politecnico di Milano. Approved and funded by the DHAC National Health Medical Research Council [NHMRC], they didn’t tell us we were being used for an experiment in a total denial of our rights and safety.

Falsified Documents

Woolcock and Sydney Local Health District [SLHD] staff falsified their clinical trial approval letter. They gave us invalid fake Informed Consent forms, later retracted. Informed Consent, the basis of Australia’s human research regulations, was created as the paramount protection for clinical trial participants after the Nuremberg trials of Nazis doctors who conducted horrific medical experiments on prisoners.

Woolcock’s replacement Informed Consent form required two extra pages to give participants the information earlier withheld.

The people and official bodies pledged to protect us, instead used their positions of power to subvert the patient protection system to facilitate our abuse. The case is not unique. Clinical trial abuse is being normalised. At stake is the integrity of the clinical trial system itself.

‘The whole system is not fit for purpose,’ Macquarie University Distinguished Ethics Professor Wendy Rogers - a lead architect of Australia’s human research regulations - told me, ‘It's a very messy system and it's all shrouded by secrecy. You get inevitable conflicts of interest which can then play out in adverse ways, particularly for participants of trials.’

Prof Rogers is one the few who dare to speak out to defend human research regulations.

The Woolcock trial caused me debilitating new conditions: dysfunctional breathing, migraine with blinding lights, brain fog; a need for costly home oxygen. I can’t drive. Crucially, my resistance to heat was lost for Sydney heat. I’m mostly home-bound. My life utterly changed.

My aim was to find out what happened, stop others from suffering, and identify all those responsible. I found more than I imagined. The cover-up spread across government, revealing a commercial takeover of clinical trials. A university student, thinking it acceptable, came to get my signature on the invalid Informed Consent form. The abuse and cover up was supported by an arrogant assumption of immunity, commercial favours, and fear among staff and students to report abuse.

The scammers seemed untouchable.

The case is attracting international attention. ‘I find that quite shocking,’ says Prof Patricia Murray at Britain’s Liverpool University, a leading stem cell scientist and award-winning campaigner against clinical trial abuse, ‘It’s certainly the case that the aims of companies is given priority over patient safety. There should be consequences.’

With a unique inside view, I secured NSW and Federal government investigations. But these were conducted under a bias system of self-regulation.

The Investigation

In 2019, Sydney Local Health District investigated its SLHD and Sydney University staff responsible:

lead clinical investigators Dr Cindy Thamrin and Prof Gregory King (my consultant), clinical trial manager Prof Helen Reddel, Dr Claude Farah, Prof Matthew Peters, Dr Farid Sanai. 

They gave participants experimental Resetech Resmon FOT home lung-measuring devices, adding unregistered US PM Healthcare home Spiro PD devices and concealing a history of user difficulties. They knew better than anyone the dangers during a severe asthma attack when minutes and fast ambulance can be a matter of life or death. I know. I’m grateful to the ambulance and A&E staff at Royal North Shore Hospital for saving me in 2016.

Then SLHD Chief Executive Dr Teresa Anderson AM headed the investigation. Her 25/10/19 Report Summary proved Woolcock staff committed multiple violations of Australia’s National Statement on Ethical Conduct in Human Research, wrongfully withholding vital trial information from participants, including:

•     the experimental nature of the trial and devices

•     the roles of Italian device maker Restech and the Politecnico di Milano and their use of participant data for research and commercial benefits

•     concealing known user difficulties with home spirometry devices

•     Not providing an emergency contact

Dr Anderson let off all those responsible. At a recorded meeting, I asked Dr Anderson why. Glibly dismissing any wrong-doing, she said: ‘I think sometimes people think that they have communicated well.’

Dr Anderson asks us to believe those responsible all thought they had told participants they were being experimented on, when they had not. Mass amnesia?

The full investigation report remains withheld despite overwhelming public interest.

The Summary omits damning evidence:

• With the investigation underway, Woolcock chief executive Prof Carol Armour AM cut off my recovery breathing physiotherapy fees owed until I gave back the experimental Resmon device. I kept it.

• In evidence of commercialisation, Therapeutics Goods Administration manager Freya Waddington-Moon wrongly withheld the trial devices’ TGA experimental status, telling me to ask the manufacturer [4/3/19]. Later, TGA chief Prof John Skerritt AM finally wrote to me: ‘I acknowledge that some of the information provided to you in 2019 regarding the registration status of the devices used in the clinical trial you participated in may have been incomplete or unclear.’  [email 21/6/22]

Ethics

Dr Anderson hid the identity of her Human Research Ethics Committee [HREC] Chair who wrongly approved the trial and its invalid Informed Consent forms. It took two years and two FoI applications to obtain the trial’s original falsified 2017 approval letter, which revealed SLHD HREC Chair Prof Andrew McLachlan AM, Sydney University’s head of pharmacy. Prof McLachlan, the last line of protection for participants, instead facilitated the abuse.

Disregarding repeated appeals, for several months the other participants were kept in the dark about the investigation and my trial injury in order to maintain their data flow to Milan. Participants did not get the corrected Informed Consent and Information forms until early 2020. 

But, fearing wider abuse, then NSW Health Minister Brad Hazzard sent my case to warn all NSW HREC chairs and the Office for Health and Medical Research to follow regulations ‘…ensuring that all essential information relating to a patient’s consent is communicated in the Patient Information Consent Form.’ [Minister’s letter to me, 6.1.20]

Integrity

In 2021, dissatisfied with Dr Anderson’s investigation I secured a rare NHMRC Australian Research Integrity Council review. But I had to sign the NDA to obtain my copy of ARIC’s secret report into the SLHD investigation, agreeing to keep its ‘Confidential Information strictly secret and confidential’.

After a three-year delay, NHMRC CEO Prof Steve Wesselingh sent me ARIC’s Report [5/6/24]. This almost entirely rubber-stamped Dr Anderson’s SLHD investigation, again confirming the violations and yet still letting off the abusers without accountability. It's conclusions somehow found ‘… no evidence to support claims’ of ‘bias.’ Prof Wesselingh stressed my NDA obligation of silence.

I broke my NDA, sending the ARIC report to colleagues and MPs and Senators on the Parliamentary Inquiry now shaping Australia’s first Human Rights Act.

Health Minister Butler supported the ARIC findings and doubled down on my NDA, writing to my local MP, via his Chief of Staff: ‘I note that Mr Cockburn has decided to disclose ARIC’s Final Report’, adding ARIC Reviews ‘are strictly confidential.’

Our family doctor has called to end my NDA, warning the effects are ‘...contributing to his health issues including asthma, dysfunctional breathing and migraine.’

The Minister must also contend with the National Audit Office [NAO] discovery of clinical trial funding fraud at the NHMRC. Its scathing 29/9/24 NAO Report ‘Fraud Control Arrangements in the National Health and Medical Research Council’ lists multiple failures, including one $2.6 million case of substantiated fraud by a research grant recipient. The NHMRC wrongly kept it from the Police. The NAO has given the HNMRC/Woolcock case to an ‘appropriate audit team.’

The big question: were NHMRC failures to protect our trial volunteers from negligence or fraud?

To expose the Woolcock scam and growing global clinical trial racket, in 2023 I made a film, Breathtaking Human Research Crime, with Prof Rogers and leading British and American medical figures, for my UK distributor, Journeyman Pictures:

Film link: https://www.journeyman.tv/film/8559

Trailer link: https://youtu.be/qLClFVEoHZ4

I sent the film in a direct appeal to the Prime Minister to end human research abuse and the cover-up that is preventing scam warnings for clinical trial volunteers (email 1/12/24). The Department of Prime Minister and Cabinet [PMC] sent my letter and film links to the Department of Health and Aged Care for ‘consideration’ [PMC email 6/12/24]. Surprisingly, an NHMRC media office invited my questions for an interview, then quickly replied: ‘NHMRC will make no further comment on this matter.’

No answers, but no denial. I have received no denials or cease and desist letters for my work.

‘Genuinely Sorry’

The Woolcock’s lawyer Simon Black wrote to me: ‘The Woolcock Institute is genuinely sorry for any distress which you experienced as a result of your involvement in the trial.’ He confirmed the Woolcock reformed its clinical trial conduct as result of the SLHD investigation.

I have no compensation. I would like payment for the work I did that the professionals failed to.

It was John Le Carre’s novel The Constant Gardener that dramatised the horrors of testing experimental medical products on patients in impoverished African shanty towns. Ironically, I knew John over many years after meeting in Beirut in the early 1980s. We discussed medical corruption when his novel went to the Hollywood big screen. But, I still missed my consultant’s scam.