Breathtaking

Breathtaking - Asthma, Ethics, Money


Some of Australia’s most eminent doctors and scientists from Sydney University have been caught conning unwitting asthma patients into dangerous tests of lung devices – without saying these were experimental. TRAC’s unique inside detective story exposes for the first time in Australia this insidious racket and its cover-up by unethical medical companies, university researchers and health officials.

Our investigations (below) led to reforms and now a formal review by the Federal Government science watchdog, the Australian Research Integrity Committee. It will report in 2022.


Click here for a more technical version of article in the online journal "For Better Science".

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: tracproductions@gmail.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.


THE RACKET

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.

SPIRO PD Device

RESMON FOT Device

Alone at home I was floored after blowing into the Resmon and Spiro PD devices. Wearing a nose clip, I suffered an explosive build-up of air pressure in my skull , impacting the brain's occipital lobe. This controls vital life functions.


IMPACTS OF UNETHICAL TESTING

My former immunity and resilience to heat and smoke was gone, making the extreme temperature events and the 2019/20 bushfire crisis and 2020/21 Covid threat more dangerous. It hit family life and work. I was moving to more gentle journalistic and creative drama projects. That stopped.

My parents, Tom and Dot Cockburn in the UK

The fallout harmed my family and work. I no longer drive. Unable to fly, my mother and I would not meet again as we had planned to. She died in the UK in 2019. I was born with asthma and at times was not expected to live. My mother and father with our GPs got me through horrific days and nights of childhood asthma attacks. This story is for them and my family and our Sydney GP for their skills and patience.


It was British writer John Le Carre's novel and film The Constant Gardener that first dramatically exposed the unethical racket. His fictional portray, with stars Ralph Fiennes and Rachel Weisz, showed the horror and greed of a company and researchers using unwitting poor patients in Africa to test experimental drugs. I knew John for a long time. We shared our experiences of medical rackets before his novel went to the big screen. I should have known better when I was asked onto Sydney University trial. But, I trusted my lung consultant and Sydney University.


A WEAK SPOT

But the clinal trial con had a weak spot. It worked only as long as those involved could hide the experimental status of the two devices. And this, remember, was public information held by the federal medical regulator, the Australian Therapeutic Goods Administration [TGA] which must test and approve all pharmaceutical and medical products before public use. Everyone has a right to know the TGA user status of all products that its approves for use - even by making a simple phone call.

If the trial devices’ experimental TGA user status got out, then all of the other trial violations by the Woolcock, Sydney University, SLHD, and now the TGA, would inevitably spill out, too.

PLAYED LIKE A PINBALL

To keep the secret, I was played like a pinball, flicked from one organisation to another for the answer a question no one dared to answer: were the devices experimental? The cover-up extended to the Therapeutic Goods Administration head office in Canberra. Rattled, a TGA manager, Freya Waddington-Moon, at one point emailed me: ‘To confirm this [TGA device status], please contact the device manufacturer directly.’

The TGA had, in writing, just wrongly handed control of key public health information to a foreign company, when its duty was to give it to a patient.

It would be another three years, and 19 emails later, before the TGA finally admitted that it wrongly withheld this information.


Only in June 2022, did Prof John Skerritt, Australia’s Deputy Health Secretary and TGA National Manager, admit that the TGA denied me public health information about the trail devices that it should have rightly given me. With regard to the conduct of his staff, Prof Skerritt 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. However, I am satisfied that no staff have deliberately provided you with false information or withheld relevant information.’ [Attached 21/6/22 Prof John Skerritt letter].

Response Skerritt to Cockburn re TGA staff - Signed 21 June 2022.PDF

Once again, 'not deliberate'. The TGA's incompetence he admits to - if that's what it really was - is frightening. I think it was deliberate. The information was repeatedly withheld during an exchange of 19 emails with the TGA - a figure Prof Skerritt points to in his letter with some annoyance.

It is worth noting, at the time the clinical trial abuse was happening at the Woolcock in 2018, five of its teenage female patients were sexually assaulted by at the Woolcock Institute by its doctor supervising treatment for their chronic sleep problems. In 2020, Dr Ali Khorami was found guilty of sexual assault and jailed. The Woolcock Institute was desperate to keep the lid on this second unethical clinical trial scandal and one involving its most senior staff.

For more and more people, the stakes were getting higher to hide what had been done to the Woolcock's asthma participants. And there was another dimension to the cover-up.


ASTHMA IS BIG BUSINESS

But why would a small group of truly eminent health professionals put patients and their own reputations at such risk?

Asthma is big business in Australia. Around 2.7 million Australians have asthma, over 11 per cent of the population. In 2019, more than 400 people died from asthma. In a sudden, severe asthma attack there can be just minutes to get emergency help to survive. I know.

Australia’s unusually high rates of the disease offer a growing market for medical companies to test and sell products in. There is strong industry lobbying. One patient group, not wanting to be named, describes New South Wales as the ‘Wild West’ of medical device testing.


THE WOOLCOCK INSTITUTE

The Woolcock Institute

The Woolcock Institute’s website states that it: 'strives to improve breathing and sleep health globally through world-class research, clinical care and education'

E-mails and documents reveal those who were involved in the Woolcock/Restech trial and its cover-up:

Woolcock Executive Director Prof Carol Armour AM, described as an internationally renowned respiratory pharmacologist in asthma research; she is a Fellow of the Pharmaceutical Society of Australia and Associate Dean of Career Development at Sydney University Medical School.

Woolcock Research Leader in the Clinical Management Group, Prof Helen Reddel, a respiratory physician treating asthma and COPD; Chair of the Science Committee of the Global Initiative for Asthma; and the Woolcock’s voice and face on tv news.

Plus, Woolcock device clinical trial project leaders Dr Cindy Thamrin and Prof Greg King, Dr Farid Sanai, Dr Nicole Roche, Dr Claude Farah, Prof Matthew Peters and Dr Joseph Duncan and a student used. All are also a part of Sydney University, Australia’s oldest; Prof Peters and Dr Farah also work at Sydney’s Macquarie University.

The Woolcock concealed from participants its clinical trial partners Restech and COO Dr Alessandro Gobbi, and the Politecno di Milano University and Prof Raffaele Dellaca, and their receipt of trial participants’ data for research and financial benefits.


SLHD INVESTIGATION

In April 2019, the Sydney Local Health District [SLHD] began its investigation headed by its Chief Executive, Dr Teresa Anderson.


INTIMIDATION

With the SLHD investigation underway, Woolcock Executive Director Prof Armour wanted to get back the Restech FOT device from me. The devices were now incriminating evidence. When a phone call failed, she emailed me resorting to sarcasm then intimidation. She knew that the TGA user status of the trial devices should have have been sent in a one word answer. Instead, Prof Armour wrote: ‘I know that you have an enquiring mind and would love to learn more. However we are a small not-for-profit and as such we do not have people to investigate the areas which fascinate you.’

I'd recently come out of hospital emergency care for breathing difficulties.

That didn't stop Prof Armour from cutting off my breathing physiotherapy fees she owed in an attempt to force me to return the Resmon device, writing: ‘Once the FOT device, which belongs to us, and is not the object of your concern, is returned, I will transfer the funds.’

It was very much of concern to me, and to others, too.


SPIRO PD HISTORY REVEALED


The fraudulent nature of the Woolcock clinical trial participant Consent form was a part of my evidence to the SLHD investigation. The Consent form was littered with dangerous omissions and lies to fool potential participants before it was exposed and finally withdrawn in 2020.

Misleadingly called a ‘Study’, my Consent form made no mention that I was signing up to join a clinical trial. Furthermore, my trial Consent form stated:

‘I have been made aware of the procedures involved in the study, including any known or expected inconvenience, risk, discomfort or potential side effects, and of their implications as far as they are currently known by the researchers.’

I had not. Every word of this statement is blatantly and demonstrably untrue: it is written to induce a false sense of trust and security in the so-called ‘study’ and the researchers.

Again, had I known the truth about the devices, which I found for myself later, notably about the Spiro PD, I would never have signed what was a treacherous and invalid Consent form.

This falsehood in the Woolcock Consent form was soon confirmed. On 18/6/19 I was called to the SLHD clinical trial Investigation to be interviewed for 90 minutes by a panel of four experts. This was six days after my mother’s funeral. Its independent chair was Tasmania University’s head of medicine, Prof Ben Canny, who flew up from Hobart. [18/6/19 SLHD audio transcript available].

Putting me at a disadvantage, SLHD denied me the investigation’s Terms of Reference, which were kept from me until after my investigation Panel interview. This broke the SLHD promise of transparency. But, I used this arduous session to interview the panel members for my own investigation, three of them from Sydney University. In private, after my interview, Prof Canny told me, rather vaguely, that the Resmon device I was given by the Woolcock was in fact switched by its staff to use for the trial, something I understood he did not want to say in front of other Panel members.

But during the panel interview something far more specific emerged about the Spiro PD home spirometry device.

I had earlier found out there was a history of problems with home spirometers: the Woolcock did not tell trial participants this as they should have. I had informed SLHD about a 2012 US trial (ClinicalTrials.gov Identifier: NCT01552031) done in collaboration with Restech, Politecnico di Milano and the Woolcock Institute to test the home FOT technique. Significantly, their report Summary opens with a criticism of user problems found with home spirometry devices, stating ‘Attempts of using more objective measurements such as home spirometers have been done but poor results were reported mainly due to the difficulties in performing a spirometric test without medical supervision.’

Again, clearly, trial participants should have been told this. We weren’t. But user problems with home spirometers were more widely known about and ‘well-recognised’.

At my 18/6/19 SLHD trial Investigation interview, on the panel was one of Australia’s leading respiratory experts, Prof David Barnes. Prof Barnes told me:

‘Home spirometers are an improvement on peak flow monitoring, it’s a more accurate way of monitoring, but it’s a more difficult device to use. That is well-recognised that a spirometer device has greater difficulties in use than a peak flow meter for example. It requires the patient to do a prolonged maximum expiration and, you know, it does just take a lot, in some people at least, a lot of instruction on how to do it…. This is maximum expiration from the first millisecond right through to the full breath out.’ [18/6/19 SLHD Investigation audio transcript]

Knowing its potential dangers for some users, the Woolcock Institute gave its trial participants the experimental Spiro PD to use without any warning. This broke the regulations but also the basic common decency towards the severe asthmatics they duped.

No one knew better than the Woolcock Institute staff about dangers faced by asthma patients. To me, their proven deceit is a white coat version of home invasion and assault occasioning actual bodily harm. Had a street gang given me these injuries, they would face a criminal court and jail for a violent crime.


SLHD INVESTIGATION DELAYS

SLHD CEO Dr Anderson delayed releasing her investigation findings and recommendations to me, and with them confirmation of the still withheld TGA user status for the two trial devices.


FEDERAL MINISTER INTERVENES

In an unprecedented move, Federal Health Minister Greg Hunt blew the whistle on his own Therapeutic Goods Administration [TGA] department for withholding information from me, and with it the wider trial cover-up. On Minister Hunt’s orders, the TGA wrote to me admitting that the TGA user status of both devices was experimental. The TGA was also obliged to note that those withholding this vital safety information from trail participants were violating the National Statement on Ethical Conduct in Human Research

Therapeutics Goods Administration letter September 2019

Investigation Findings

Shortly after the TGA’s admission, I received the delayed SLHD investigation findings. They are damning. The list of information wrongly withheld from trial information includes:

  • the experimental nature of the trial devices and of the trial itself

  • the trial’s registration status

  • participation of a concealed trial partner, Restech

  • transfer of participants’ trial data to Restech for its research and commercial benefit

  • co-ownership of participants’ trail data by the WI and Restech

  • known difficulties for patients using the Spiro PD

  • no medical contact was given in case of an emergency

  • the SLHD HREC should have obtained the missing trail information and told the Woolcock to give this to trial participants

SLHD recommendations were made to correct the invalid Woolcock trial participant consent and information forms and to inform all of the participants. The SLHD Concord Hospital Human Research Ethics Committee had re-write its original and unethical 2017 trial approval document to include the withheld information.

Had I known of any of these failings I would not have joined the Woolcock trial. Had their fraud and my injuries been done by a street gang, they would face arrest and a judge.


UNANSWERED QUESTIONS

Despite overwhelming public interest, the SLHD still keeps its investigation findings secret. The investigation Terms of Reference were narrow to exclude other aspects of known misconduct. The SLHD kept the ToR from me even when I attended a gruelling 90-minute investigation panel interview not knowing the scope of their questions. I secured their Terms of Reference a week later.

Many questions remain unanswered:

  • How were the Woolcock and SLHD HREC allowed to get away with the con for so long and in such a highly regulated health system?

  • Why has none of those involved been held to account?

  • Is it time to criminalise medical company and research abuses and their cover up?

  • Why did it take an old asthmatic to do the job that so many professionals failed to do?


Yet, of the multiple ethical violations she found, SLHD Chief Executive Dr Anderson told me at a meeting: ‘I don’t think it was intentional. I think sometimes people think that they have communicated well.’

I asked if she was joking. No. Dr Anderson’s remark sums up the easy bogus dismissal of patient abuse and medical ethics in a world that had normalised this behaviour. To date, no one has been held to account for what happened.


'Being Found Out'

There the matter might have ended. But Dr Anderson’s 'not intentional' excuse cannot not explain the failure of her own Concord Hospital’s Human Research Ethics Committee whose job it was to find and stop these very violations.


Original 2017 Human Research Ethics Committee invalid trial approval [above]

Prof McLachlan's signature [below].

It took over two years and two Freedom of Information applications to obtain the Woolcock's original invalid 2017 Human Research Ethics 2017 Human Research Ethics Committee trial approval letter, and to find out who signed the the letter which was nearly my death warrant. The signatory was Prof Andrew McLachlan in his role as chair of the Concord Hospital HREC where he also works. He allowed asthma patients in his own hospital to be recruited for the trial. His invalid approval letter was rewritten in 2020 to include information withheld from trial participants.

Prof McLachlan is the Sydney University Head of School and Dean of Pharmacy and a member of its Charles Perkins Centre. He has refused to answer questions about his HREC role or to be interviewed for this article. But he does give interviews to students for You Tube videos about him. Asked in one to name his greatest fear, Prof McLachlan says: ‘Being found out.’

Prof McLachlan resigned from the Concord HREC some time before the SLHD investigation began. He was replaced by his Concord Hospital and Sydney University colleague and co-writer Prof David Le Couteur. I had sent my initial 2019 trial complaint to Prof Le Couteur. He, too, has not responded to my questions.

Sydney University

Given all of those involved are a part of Sydney University, I asked the University Vice-Chancellor Prof Stephen Garton to investigate his staff in the case. He is a Fellow of the Royal Australian Society for the Humanities. Confirming the Woolcock’s affiliation to Sydney University, Prof Garton wrote in May 2021, saying: ‘I apologise for any distress University staff may have caused.’ But, while also acknowledging the Concord HREC’s failings, he refuses to investigate his staff involved, claiming there was no ‘deliberate concealment’.

Prof Garton joined Dr Anderson’s ‘not intentional’ theory.

Their ‘not intentional/deliberate’ theory asks us to believe that these doctors and researchers and the ethicists meant to police them, all individually and collectively somehow forgot to tell participants they were on an experimental trial making money out of them for a concealed Milan company.

What was it then? An accident? A momentary oversight afflicting all of them for two years? This might fit legal and administrative requirements, but not reality.


Woolcock Sexual Abuses

This was also a time when the Woolcock Institute was desperate avoid to another public scandal. Also in 2018, a Woolcock Institute doctor sexually assaulted five female patients, aged from 16 to 19, while supervising their treatment for sleep problems. In October 2020, Dr Ali Khorami was found guilty of assaulting the women. He was jailed for six years. The judge said he had committed a ‘gross breach of trust’ and ‘….at a time when they were particularly vulnerable.’


NSW HEALTH MINISTER INTERVENES

By 2020, NSW Health Minister Brad Hazzard was so concerned by Concord Hospital HREC’s ethical violations that he wrote to me saying that he had sent my case to all NSW HREC chairs and the Office for Health and Medical Research as a warning to stick to the rules and ‘…ensuring that all essential information relating to a patient’s consent is communicated in the Patient Information Consent Form.’

Minister Hazzard is asthmatic. He urged ‘my continuing advocacy in the matter’.


DELAYED REFORMS

The Woolcock Institute was made to reform. Its lawyer wrote to me that the Institute was ‘genuinely sorry’, explaining: ‘Woolcock has implemented and committed to following such [SLHD investigation] recommendations and feedback in all clinical trials moving forward; and Woolcock has developed further procedures for clinical trials which address the issues considered in the investigation.’

Yet, months after the SLHD made its findings, the Woolcock was still keeping its trial participants ignorant of its ethical violations and the information it withheld, and keeping up their wrongful flow of trial data to Restech. Only in 2020 was the Woolcock finally obliged to send participants re-written clinical trial Consent and Information forms. The new forms required an additional two pages to cover all of the information withheld and the names of those involved, which it highlighted in yellow.

PARTICIPANT INFORMATION & CONSENT FORM V3 1 JANUARY 2020.pdf

The Concord Hospital HREC approval document was also rewritten with the information.


PATIENT GROUPS & MEDIA REJECTIONS

Australian patient groups, and media outlets have declined to publish the official investigation results the provision of key documents.

CHANGE FOR THE FUTURE

Minister Hunt and Minister Hazzard’s bold interventions for the trial participants are attracting local and international attention.

‘Unheard of,’ says Dr David Egilman, Prof of Family Medicine at America’s Brown University. Dr Egilman, who is editor of the Journal of Scientific Practice and Integrity and is an outspoken campaigner against medical industry and research abuse of patients.

Dr Egilman is one of several concerned scientists who gave support.


MORE CASES OF HUMAN RESEARCH?

Minister Hazzard’s warning to all NSW HRECs to follow ethical rules suggests there are possibly more clinical trial abuses to look for.

‘Sadly, there is too much evidence supporting a reckless disregard by researchers, corporations and government for the well-being of research participants, who take significant risks in the service of our health,’ explains cast member Prof Jon Jureidini, paediatric psychiatrist for Adelaide’s Women and Children’s Hospital and head of Adelaide University’s department of Ethical Mental Health.

Dr Melissa Raven, an Adelaide University psychiatric epidimiologist and policy analyst, tells us: ‘The myriad problems that have been documented with pharmaceuticals also occur with medical devices, including clinical trials with dodgy methodology and misleading participation information.’


APPALLING PATIENT COMPLAINT SYSTEM

I have so far had to deal with over 70 doctors, scientists, officials and lawyers from over 20 organisations. I had to learn to navigate a maze of medical and bureaucratic bodies in a system that is made virtually impenetrable to patients trying to bring legitimate complaints. No support person was given to help me through their processes. One government medical review body gave me the phone number of the Lifeline suicide helpline – not what I wanted. But it indicates that officials are well aware of the stress caused by a notorious system. The SAS and security services could learn from the secrecy and cover-ups I found in the medical research system.

Health Minister Hunt wrote that I could bring a professional complaint against Prof King to the Australian Health Practitioner Regulation Agency [AHPRA] and the Health Care Complaints Commission [HCCC]. The HCCC rejected my submission without investigating, and it falsely claimed this was a matter for the TGA, which the TGA promptly denied. So, the pinball game goes on.

But change is coming to end the disregard of medical ethics and clinical trial abuse. Health and science professionals are speaking out against medical companies and researchers who exploit often vulnerable patients.

In May 2019, Australia’s Royal Commission into Violence, Abuse, Neglect and Exploitation of People with Disability [DRC] asked me for full details of the Woolcock/SLHD case with ongoing updates. The DRC is due to report in 2023. It can subpoena documents and witnesses to testify.


GROUNDBREAKING INVESTIGATION

In 2021, a ground-breaking investigation starts into the ethical and legal issues raised by the way medical company representatives operate inside Australian hospitals. Significantly, it is the Government-funded Australian Research Council [ARC] supporting Sydney University’s Assoc/Prof Barbara Mintzes, and Sydney’s Macquarie University’s Dr Jane Johnson, Dr Brette Blakely and Prof Wendy Rogers in the Macquarie study. I was invited to join the Expert Advisory Panel.

Wendy Rogers, Professor of Clinical Ethics at Macquarie University is an international award-winning campaigner against human organ harvesting in China. A member of our cast, she says: ‘The pathways for introducing new medical devices into practice contain regulatory gaps. This weak regulatory framework can cause harm to patients.’


AUSTRALIAN RESEARCH INTEGRITY COMMITTEE

Separately, the ARC’s Australian Research Integrity Council [ARIC] is now reviewing of the refusals to properly investigate the Woolcock and SLHD HREC ethical code violations. On 18/6/21, the ARIC advised me:

‘The Australian Research Integrity Committee [ARIC] secretariat at the Australian Research Council (ARC) has provided advice on the ARIC process to review the refusals to investigate Woolcock and HREC staff. This would occur under the Australian Code for the Responsible Conduct of Research.

‘Specifically, an ARIC review would require details of Sydney University’s refusal to investigate its staff. Given the medical aspect of the research in question the issue would be managed by the National Health and Medical Council [NHMRC] ARIC Secretariat.’


This is the Code which Dr Anderson and Prof Garton maintain has not been broken.


The ARIC also advised that the issue may be within scope of the Commonwealth Ombudsman.


DR DORA AKUNYILI

I’ve worked with a number of national regulators in their fight against the deadly counterfeit pharmaceutical drug racket. Nigeria’s regulator, the late Dr Dora Akunyili, a London University pharmaceutical scientist, never gave in to pressures by medical companies or organised crime gangs - even as she was shot at and her labs and offices bombed: see our Public Library of Science Medicine article [PLoS Medicine 2, e100] and our film The Malaria Parasites on this site. Dr Akunyili shows how to run a national regulator.

I don’t ask TGA staff or others to risk their lives for me, only not to risk mine and those of others they have a legal duty to protect.


In preparing this article I contacted the following people:

  • Sydney University Vice-Chancellor Prof Stephen Garton AM was informed of the article and film contents and declined a media interview.

  • Sydney Local Health District Dr Teresa Anderson AM was informed of the article and film contents and declined a media interview.

  • Prof Andrew McLachlan was informed of the article and film and did not respond to a media interview invitation.

  • Prof King was informed of the article and film and did not respond to a media interview invitation.

  • Dr Sanai was informed of the article and film and did not respond to a media interview invitation.

  • Prof Armour was informed of the article and film and did not agree to a media interview.

  • Other named Woolcock and Sydney University clinical trial staff Prof Helen Reddel, Dr Cindy Thamrin, Dr Nicole Roche, Dr Claude Farah, Prof Matthew Peters, Dr Joseph Duncan were informed of the article and film and did not respond to media interview invitations.

  • Freya Waddington-Moon’s refusal to provide medical device information was overturned by Health Minister Hunt who ordered the TGA to send me their TGA experimental status

  • Federal Health Minister Greg Hunt was informed of the article and film.

  • TGA head and Australia’s Deputy Health Secretary, Prof John Skerritt, was informed of the article and film and did not respond to a media interview invitation.

  • U.S. PMD Healthcare, Spiro PD did not respond to messages sent about the trial.

  • New South Wales Health Minister Brad Hazzard was informed of the article and film.

  • Dr Anthony Brown, was informed of the article and film. Dr Brown acknowledged problems with experimental device testing, but he declined a media interview.

  • Michele Goldman was informed of the article and film and declined a media interview.

  • The Lung Foundation was informed of the SLHD findings and did not respond.

  • Restech Respiratory Technology COO Dr Alessandro Gobbi and Prof Raffaele Dellaca of the Politecnico di Milano were Informed of the article and film. Dr Gobbi replied that their information was sent to SLHD; he did not respond to the media interview invitations.

  • ARIC was informed of the article and film: it responded with an expanded description of its role which was included in the text.

Robert Cockburn BIO:

I am a former correspondent with the BBC, The Times and The Observer, and a program maker for BBC, National Geographic and others. My medical industry investigations have also been for Middle East Health, BBC File on 4, The Guardian, Private Eye and The American Prospect. I have written for the Public Library of Science Medicine [PLOS Medicine 2, e100] to expose the cover-up of fake pharmaceutical drugs, with African medical regulators, Dr Dora Akunyili of Nigeria and Emmanuelle Agyarko of Ghana, and Oxford University doctors Prof Paul Newton and Prof Sir Nick White. Our film exposing child malaria deaths from fake drugs, The Malaria Parasites, is on: www.tracproductions.com


For more information contact: tracproductions@gmail.com

Breathtaking © Robert Cockburn TRAC Productions 2022