Breathtaking
Asthma, Ethics, Money

Article and Treatment for a film

© Robert Cockburn TRAC Productions 2021


Summary

What happens when the doctor you trust to keep you breathing, deceives you into testing a device – without revealing it is experimental and for someone to make money out of you?

A terrifying and life-changing injury in my case, and a wall of silence to block questions.

Breathtaking is a unique inside detective story revealing how some of Australia’s most eminent doctors, scientists and officials conned Sydney asthma patients into testing experimental lung devices to profit an Italian company. Their audacious cover-up subverted the state and federal patient protection system right up to the national medical regulator in Canberra. All believed they were untouchable for their professional fraud, theft and then intimidation to keep the lid on.

But they picked on the wrong lab rat. Although arthritic, asthmatic and old, my investigating days over, I decided to find out what happened. And why such celebrated people would put their patients and their own reputations at risk. With my BBC and London Times reporting experience and help from a colleague at Oxford University, we dug out enough of the hidden information to secure a rare formal clinical trial investigation. As a journalist, I feel the obstructions were made greater.

Using recordings made inside the Sydney Local Health District [SLHD] investigation, plus e-mails, documents and interviews, we show how staff from Sydney’s famous Woolcock Institute of Medical Research and Sydney University ran a one-stop-shop to recruit more than 30 unwitting asthma patients from city hospitals, fixing official ethical paperwork and participant consent forms. It was to financially benefit Woolcock’s concealed trial partner, Milan device maker Restech.

With a top Australian and international cast, Breathtaking opens up the insidious and secret global racket of unethical medical companies and researchers who exploit vulnerable patients. For the first time we reveal the SLHD’s damning findings (below) that are still kept confidential despite an overwhelming public interest. The known user difficulties of one device were kept hidden from participants. No medical contact was given in case of emergencies.

Patients were recruited by Woolcock staff from three of Sydney’s leading teaching hospitals: Royal Prince Alfred, Royal North Shore and Concord Repatriation General. There remains fierce resistance to hold anyone to account. But that is changing after the shock discovery in May 2021 of the withheld identity of the one public official whose job it was to protect participants from such abusers and who instead facilitated their racket.

Prof Andrew McLachlan, Sydney University Dean of Pharmacy, chaired the trial’s SLHD Human Research Ethics Committee, giving the con his signed approval knowing its multiple safety and ethical violations. Prophetically, in a student You Tube interview, asked to name his greatest fear, Prof McLachlan declares: 'Being found out.' [See You Tube link below]

The con had a weak spot. It worked only by hiding the experimental status of the devices - and this is public information to be given to anyone who asks. So, how were they allowed to get away with it for so long? And why did a group of top professionals risk their patients and their reputations in this way?

Asthma is big business in Australia. Breathtaking discovers how industry lobbying results in compliant patient groups and media organisations. Defying the trend, two bold health ministers took ‘unheard of’ action to expose their own departments to end the cover-up.

Change and reform are underway here, and attracting international attention. In 2021, a breakthrough government-funded investigation will probe medical company activities in Australian hospitals.

The Woolcock, Sydney Health and Sydney University have now sent me written apologies for their failings. But why did they wait over a year to inform vulnerable volunteers about the violations in a farce of a bureaucracy that hid answers they had all the time?


Those involved betray all patients and health workers - including the ambulance crews and emergency hospital staff who have 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 keep our trust in this vital system.

TRAC would like to hear from volunteers on the Sydney Woolcock Institute trial CH62/6/2017-119 testing Restech and PM Healthcare devices, and concerned patients, health workers, researchers and officials. Please contact: tracproductions@gmail.com


Injury

On 27/11/18 my lung consultant Sydney University Prof Gregory King wrote to my GP noting a slight 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 breathing ability and my life changed.

Woolcock’s Dr Farid Sanai and a student 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. It has changed my ability to breathe, causing a condition called dysfunctional breathing and also the onset of migraines. I needed physiotherapy to learn how to breathe again, extra steroid and Ventolin doses, emergency hospital care, and costly home oxygen. Specialist tests and treatment continue after more than two years.

My parents, Tom and Dot Cockburn in the UK

The fallout harmed my family and work. Unable to fly, my mother and I would not meet again as we 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.


And it is for the late John Le Carre, a colleague, whose novel and film The Constant Gardener exposed the horror and greed of using unwitting patients in Africa to test experimental drugs. Having discussed the racket together, I should have known better. [see Patient Group & Media below].


A Weak Spot

But the con had a weak spot. It worked only as long as all those involved kept hiding the experimental status of the two devices. And this was public information held by the federal medical regulator, the Australian Therapeutic Goods Administration [TGA] which must approve all pharmaceutical and medical products. Everyone has a right to know a product's user status with a simple phone call.

If the devices’ TGA user status got out, then all of the Woolcock’s other unethical trial violations would 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 handed control of key public health information to a foreign company, and changed Australian foreign policy.

The secrecy stakes were getting higher. And no one at that stage had an inkling of who would finally blow the whistle.

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’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, as the SLHD investigation was now delayed.

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 Breathtaking. 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

Those who promote these farcical attempts to dismiss a research culture of patient abuse need to consider this:

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.’

The NSW 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 Group & Media Rejections

All of the patient groups and mainstream and specialist broadcasters and publishers I contacted have refused to publish the SLHD Woolcock/HREC investigation findings despite receiving key documents. This is disappointing. I have worked for many over the years.

The ABC rejected half a dozen story offers and with them my appeals to warn the other Woolcock trial volunteers who were still in the dark about its violations.

However, this didn’t stop ABC News interviewing me about British writer John Le Carre, a colleague, who died last December. They wanted to hear about John’s fictional novel and film The Constant Gardener - this dramatically exposed the use of poor unwitting patients in Africa to test a UK company’s experimental medical product. at the same time the ABC sat on the real experimental scam worked just minutes away from its Sydney studios. Here’s a link to my ABC News interview about John:

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 a member of our Breathtaking cast.


More Cases of Human Trial Abuses?

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 Complaints 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 am on 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 Council


Separately, the ARC’s Australian Research Integrity Council [ARIC] has opened the way to a review of these refusals to investigate the Woolcock and SLHD HREC. 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.

For more information contact: tracproductions@gmail.com

Breathtaking © Robert Cockburn TRAC Productions 2021