Guest post Medicine

Misinformed and Damaged – victim of unethical trial hits back

"I don’t ask TGA staff to risk their lives at work, only that they don’t risk mine and others’ lives by withholding public health information." - Robert Cockburn

An unethical clinical trial with asthma patients took place in Australia a few years ago. Participants were misinformed and tricked into testing experimental ventilation devices, which caused at least one of them serious injury. Unfortunately, such things are common and very rarely come out.

But that injured patient, Robert Cockburn, was also a journalist. Who then started to investigate, against a stonewall of silence, dishonesty, cover-up and even extortion. Below his guest post on my site.

Robert Cockburn

Misinformed and Damaged – victim of unethical trial hits back

By Robert Cockburn 

A unique Australian government review is highlighting the dangerous and unethical use of clinical trial participants by researchers and medical companies.  

The Australian Research Integrity Committee (ARIC) has the power to expose the arrogant disregard of some of Australia’s most eminent doctors and scientists for trial regulations and participants in a case kept confidential for over five years and with no one held to account. 

Between 2017 and 2020, the Sydney University ran a clinical trial where more than 30 unwitting hospital asthma patients were duped into testing experimental lung devices, without revealing that these were experimental. An incorrect clinical trial approval letter and invalid participant information and consent forms were issued by the university dean chairing the Human Research Ethics Committee which was actually meant to prevent such abuse. They betrayed all patients, scientists and health workers.

 Multiple safety and ethical violations were proven in a confidential 2019 Sydney Local Health District (SLHD) investigation [below]. Besides the experimental nature of the trial and devices, the university’s trial site, the Woolcock Institute of Medical Research, also hid from participants the names of the device makers, the involvement of the Italian university Politecnico di Milano, and that its spin-off company Restech Respiratory Technology of Milan co-owned participants’ trial data and was planning to make money out of this. 

Those responsible for the trial thought they had got away with it.

Now ARIC, the science watchdog, is examining the alleged refusal of Sydney University and its notorious Woolcock Institute to investigate, and of SLHD to properly investigate the trial’s research violations, its cover-up, and failure to hold anyone to account. 

 The focus is the investigation processes of SLHD Chief Executive Dr Teresa Anderson, Woolcock Institute Executive Director Prof Carol Armour and retired Sydney University’s Vice-Chancellor Prof Stephen Garton, and potential violations of the Australian Code for the Responsible Conduct of Research (The Code). The Review is unprecedented at this high level. 

 I was a trial recruit. I suffered life-changing respiratory and neurological injuries as a result, at one point needing hospital emergency care to revive my breathing. It was a particularly cruel and cynical thing for my doctor to do to me, an old-age pensioner with existing disabilities. As a journalist and a lead writer for the Public Library of Science Medicine (Bio at the end), and facing a wall of silence, I investigated, securing the initial flawed SLHD clinical trial investigation, and later the ARIC Review.

 Yet, it would take me another two years and two Freedom of Information (FOI) applications to identify the man who wrongly approved the Woolcock trial. This was Sydney University’s own Head of School and Dean of Pharmacy, Prof Andrew McLachlan. Prof McLachlan is Program Director of the National Health Medical Research Centre for Research Excellence in Medicines and Ageing. He is also employed by SLHD to practice at Sydney’s Concord Repatriation General Hospital. There he was Chair of the hospital’s Human Research Ethics Committee (HREC). As Chair, he had a duty to protect us participants from clinical trial violations. 

 Instead, Prof McLachlan approved and signed the inappropriate 2017 Woolcock Institute’s trial approval letter, wrongly claiming it met the National Statement on Ethical Conduct in Human Research (National Statement), and he approved the invalid participant Information and Consent forms. He opened the way for his Sydney University colleagues to wrongly recruit participants until they were stopped in 2020. 

 The false trial approval letter and invalid Information and Consent forms were replaced with re-written documents [above and below] (I wrote to Prof McLachlan asking him about his role in the clinical trial and inviting him to record a media interview with me. He did not reply.)

The corrected forms needed extra pages to cover all of the information wrongly withheld from participants. This is highlighted in yellow and includes the names of those running the trail, the devices and their makers, and the Politecnico di Milano and its staff. [below]

Until then the trial had no valid participant consent forms. Neither Woolcock or SLHD has said how many of the trial participants agreed to sign the new consent forms to remain on the trial.

My aim is to stop this insidious practice from harming any more vulnerable and trusting clinical trial volunteers who are vital to all medical advances.

My injuries were caused by a build-up of air pressure in my skull, from a Valsalva Manoeuvre, using the trial’s home spirometry device. I have lost my ability to breathe normally, a disturbing condition called dysfunctional breathing requiring ongoing respiratory physiotherapy. It also caused a debilitating migraine condition. At times I need extra Ventolin, steroids and oxygen.

It began for me on 27 November 2018 at Royal North Shore. Prof Gregory King, who I trusted to keep me breathing, recruited me for what he called an asthma ‘study’. He made no mention of the experimental clinical trial and devices. On 5 December 2018, at home, I was flattened after using the trial devices. There was no emergency help. No one would answer questions about what had happened. 

Our family GP diagnosed the cause then referred me to ENT and neurological specialists.   

The Sydney University misconduct penetrated the Human Research Ethics Committee (HREC) and the Australian national regulator, the Therapeutic Goods Administration (TGA). Despite regulations, the two key patient protection systems were rendered useless.

 The cover-up relied on hiding the devices’ experimental status. When the Woolcock would not reveal the user status of their trial devices, I asked the TGA for the information. User status of medical products was issued by this national regulator, and it was public information to be freely available to anyone who asked. The cover-up spread to the TGA medical device unit. TGA official Freya Waddington-Moon was dishonest when she refused to confirm if the Resmon Diary was registered by the TGA for use in Australia: she replied by email ion 4 March 2019: 

‘We are unable to confirm Resmon PRO Diary DEV53TSIM 16 home respiratory testing device is included in the Australian Register of Therapeutic Goods (ARTG) and therefore has been evaluated by the TGA for safety, quality and effectiveness. To confirm this, please contact the device manufacturer directly.’ 

Ms Waddington-Moon’s claim was refuted later in 2019 in an unprecedented intervention by the Federal Health Minister who ordered the TGA to reveal the wrongly withheld experimental status of both trial devices (details below).

Only on 21 June 2022, did Prof John Skerritt, Australia’s Deputy Health Secretary, and former TGA National Manager, admit that I had been denied the TGA the public health information I should have rightly been given. Prof Skerritt wrote to me with regard to his TGA staff conduct:

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.’ [below].

At the time this was happening at the Woolcock in 2018, five teenage female patients were sexually assaulted by an institute’s doctor supervising treatment for their 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 scandal involving its senior staff.

My own case concerns the Woolcock Institute Clinical Trial CH62/6/2017-119, the Role of home telemonitoring of lung function using forced oscillation technique in assessing and predicting asthma control: a pragmatic, observational trial. It was approved by SLHD Concord Hospital Human Research Ethics Committee as HREC/17/CRGH/177. 

Funded by the National Health Medical Research Council Centre of Excellence in Severe Asthma, its Primary sponsor was Sydney Medical School, University of Sydney and Secondary sponsor the Woolcock Institute. Project Sponsors were Woolcock and SLHD.  The unethical trial was run using public funds at a public university to exploit patients and staff at Sydney’s three main public teaching hospitals: Royal Prince Alfred, Royal North Shore and Concord Repatriation General . 

In her damning trial investigation summary from 25 October 2019, Dr Anderson found safety and ethical violations of the National Statement on Ethical Conduct in Human Research [National Statement]. Information wrongly withheld from trial participants includes: 

  • the experimental nature of the clinical trial and its test devices 
  • concealing trial partners, Italian device maker Restech of Milan and the Politecnico di Milano, and wrongful use of participants’ trial data for research and commercial benefits
  • known patient user difficulties with an additional US PMD Healthcare experimental trial spirometry device
  • Participants were not given a contact to call in case of emergency. 

  The trial tested two experimental  home lung devices: Restech’s Resmon Diary FOT (forced oscillation technique) device using experimental software; and U.S. PMD Healthcare’s Spiro PD spirometer. 

Resmon Pro Diary (Image: Restech)

The Resmon device was a version being converted for home use. Trial participants were to test its new and still experimental home-use software which could beam user data by satellite to outsider researchers. We were the lab rats.

It took until 2020 before Woolcock and SLHD started to reveal what they were hiding to participants, and then only in part. The re-written participant Information and Consent forms from 13 January 2020 finally admitted, highlighted in yellow, that: 

‘The Resmon Pro Diary is not registered for normal use in Australia. It is a modified version of a device that is registered for use in Australia, i.e. with its software adapted for home monitoring use. The researchers submitted a Clinical Trial Notification (CTN) to the Therapeutics Goods Administration (TGA) on 2 October 2017, which allows them to use this device in Australia for medical research purposes based on assessment and approval by the authorised Human Research Ethics Committee.’

But allowed only if we were informed that we were testing experimental CTN devices. But we were not. 

With the false HREC trial approval and invalid participant documents, the Woolcock Institute  used the Resmon trial to piggy-back the second experimental device, the Spiro PD, for testing. Getting the details was harder. On 21 January 2019, Dr Anderson wrote to me explaining that Spiro PD’s Australian user registration was canceled by its sponsor in February 2017. She wrote: ‘This was prior to the submission of the ethics application [of the research study in which I was a participant].’

 Dr Anderson claimed that the Woolcock’s undisclosed use of the experimental Spiro PDs was ‘lawful’ as they were purchased in 2015 before their deregistration. She added,

‘Advice from the TGA indicates that […] the registration is lawful and does not require notification under the CTN scheme.’       

Her claimed TGA ‘advice’ contradicts research regulations to inform trial participants of the registered or experimental status of medical products they test – as Dr Anderson confirmed in her 2019 trial investigation recommendations.

There is a history of problems with home spirometers which trial participants were also denied. I informed SLHD of a 2012 US trial (ClinicalTrials.gov Identifier: NCT01552031) collaboration of Restech, Politecnico di Milano and Woolcock Institute to test the home FOT technique. Significantly, its Summary opens with a criticism of user problems 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.’

User problems with home spirometers were more widely known. At my 18 July 2019 SLHD trial Investigation interview, one of Australia’s leading respiratory experts, Prof David 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 hearing audio transcript]

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

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. 

But, somehow, Dr Anderson concluded that the trial’s conduct did not violate the Australian Code for the Responsible Conduct of Research. Despite an overwhelming public need to know, Dr Anderson keeps her report and findings confidential – protecting individuals and institutions, including her SLHD Human Research Ethics Committee officials who wrongly approved the trial.  

She delayed revealing her findings to me.

It took an unprecedented intervention by Federal Health Minister Greg Hunt to end the cover-up and investigation delays. On 10 September 2019 he ordered his TGA department to write to me about the hidden experimental status of the trial devices, noting the violation of the National Statement. [below]   

Shortly after, Dr Anderson sent me her delayed SLHD investigation Summary. A casual dismissal of regulations and of common decency is evident. Those involved seem to think they were above accountability. When I asked Dr Anderson to explain the violations she found, she answered, glibly,

I don’t think it was intentional…. Sometimes people think that they have communicated well.

Later, in 2021, Prof Garton aped her answer, writing to me that his Sydney University staff’s trial actions were ‘not deliberate’ or ‘deceitful’ and that he would not investigate them.

Dr Anderson and Prof Garton ask us to believe that for over two years, Sydney University staff individually and collectively forgot to tell their trial participants they were on an experimental clinical trial. Their claims are risible and wrong. 

But, New South Wales Health Minister Brad Hazzard felt the need to go beyond Dr Anderson’s investigation recommendations. On 6 January 2020, he informed me that he had used my case to warn all NSW HREC chairs and the Office for Health and Medical Research to follow trial regulations ‘…ensuring that all essential information relating to a patient’s consent is communicated in the Patient Information Consent Form.’ [below]  

Minister Hazzard’s actions suggest concerns that wider abuses could exist. He is asthmatic. In his letter to me from 6 January 2020, Minister Hazzard urged ‘my continuing advocacy in the matter’. 

ARIC is considering allegations of multiple violations of the Australian Code by Sydney University, Woolcock Institute and SLHD. These include, that staff behaved ‘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.

Sydney University staff involved in the trial include:

  • Woolcock Executive Director Prof Carol Armour, a pharmacologist and Associate Dean of Career Development at Sydney University Medical School.
  • Woolcock trial Research Leader SYU Prof Helen Reddel.
  • Sydney University Head of School and Dean of Pharmacy Prof Andrew McLachlan who practices at Concord Hospital.
  • And Dr Cindy Thamrin, Prof Greg King, Dr Farid Sanai, Dr Nicole Roche, Dr Claude Farah, Prof Matthew Peters, Dr Joseph Duncan. 

A PhD student [name known] was used to install trial devices in participants’ homes and to obtain their signatures on the invalid Consent forms.  The use of a student is disturbing. It is abuse of power over a student and showcases that disregard of human research regulations and of patient safety is normal. 

My 4 December 2018 Woolcock Institute  trial contract states:

‘Every reasonable protection will be taken to ensure your safety during the course of the study. In the event that you suffer any injury as a result of this research project, hospital care and treatment will be provided at no extra cost to you.’

This was a blatant lie. It was only about the scientists’ protection. And it got desperate.

I was pressured by Woolcock staff to return the incriminating experimental Resmon FOT device whose experimental status was still being hidden. By May 2019, with the SLHD investigation underway, Woolcock head Prof Armour tried to coerce me by cutting off my breathing physiotherapy fees she owed until she got the device back, emailing:

Once the FOT device, which belongs to us, and is not the object of your concern, is returned, I will transfer the funds.’ 

I retained both trial devices.

It was as if they had lost all sense that they were dealing with human beings. Dr Anderson did not include evidence of Prof Armour’s coercion in her findings. 

SLHD investigation recommendations reformed Woolcock trial procedures. A Woolcock lawyer wrote to me that it was ‘genuinely sorry’, confirming:

Woolcock has implemented and committed to following such [SLHD] 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, for several months after Dr Anderson made her findings, Woolcock trial participants were kept ignorant of the investigation and my injury, while it maintained the wrongful flow of their trial data to Restech. Only in 2020, after the TGA gave user approval to both trial devices, did the Woolcock send participants the re-written clinical trial Consent and Information forms to sign or reject, although still missing a lot of the investigation information. 

But, how did the TGA subsequently approve user registration of the Spiro PD after my trial injury, and did the SLHD investigation add to the documented evidence of its user problems? 

 Asked to explain the TGA’s questionable 2019 renewal of the Spiro PD ’s user approval, in his letter on 21 June 2022, Prof Skerritt noted that its TGA registration ‘was subsequently canceled by the sponsor on 5 August 2021.’ The sponsor’s reason for canceling was not given.  

Is it truly possible that TGA staff, like those at Sydney University, the Woolcock and  SLHD, also did not know they were withholding potentially life and death patient medical information they are paid to provide to the public? 

With unusually high rates of the disease, asthma is big business in Australia. In New South Wales, asthmatics provide a lucrative market and potential clinical trial participants for new products in what some say is a lax regulatory system. Dr Anthony Brown, head of patient group Health Consumers NSW, calls NSW ‘the wild west’ of medical device testing. He showed me the NSW Department of Industry brochure with proposals to attract more foreign companies to test products by further easing clinical trial regulations. 

 The medical industry lobby is powerful. Patient groups, including Health Consumers NSW and Asthma Australia, would not post the SLHD investigation findings when offered them, and neither would they post a list of questions members should ask before participating in clinical trials. Asthma Australia CEO Michele Goldman confirmed that “the nation’s peak consumer asthma body” carries adverts to recruit its members for clinical trials.

 Similarly, the Australian media has refused to release details of Dr Anderson’s investigation and its findings.

 It is not surprising how Sydney University fixed its unethical respiratory device trial. What is surprising is why such eminent people, some with international careers, ever took to rule-breaking when it was unnecessary. Perhaps, because they could and believed they were above the rules? I found one clue that Prof McLachlan felt he might have done something wrong. In a university interview on YouTube, a student asks him his greatest fear. Prof McLachlan says: ‘Being found out.’ 

Public trust in human clinical trials has never been more important than in the search for Covid-19 vaccines – or more public as scientists and vaccine volunteers became daily headline news to inspire hope. Such transparency is needed in all clinical trials. 

I don’t ask TGA staff to risk their lives at work, only that they don’t risk mine and others’ lives by withholding public health information.

Notes:

ARIC accepted as evidence my 21 November 2021 letter to its chair in which I record my work with the national regulator of Nigeria, the late Dr Dora Akunyili, a member of our PLoS Medicine fake drug writing team: 

‘Dr Dora, a London University-trained pharmacist, waged war on corrupt officials and organised crime gangs killing Africans with fakes. Her offices and labs were bombed. She survived a deadly gun ambush. Inspiring loyalty in her female staff (she thought men corrupt!), nothing could stop Dora from destroying fakes and disseminating public health warnings to save people.’ 

Dr Akunyili is widely celebrated for her courageous work for which she has received hundreds of international awards. She speaks about her work in our film The Malaria Parasites on: www.tracproductions.com

Disclaimers:

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.
  • 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. While acknowledging problems in experimental device testing, 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 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] exposing 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

I am preparing a film about the Sydney University case with an Australian and international cast. It is to expose companies and researchers who exploit vulnerable patients. TRAC Productions would like to hear from those with an interest, and from participants on the Woolcock Institute trial CH62/6/2017-119 testing Restech and PMD Healthcare devices. 

Contact Robert Cockburn:

 Email: tracproductions@gmail.com


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