Breathtaking Human Research Crime - TIME CODED SCRIPT

00.00 – 01.22 Music Theme [untitled free download]

00.00 SUPER Title:

Breathtaking Human Research Crime

by Robert Cockburn

00.04 envelope and Christmas card

00.15 – 00.36 a man uses an oxygen cylinder

00.14 COM:AN UNSUSPECTING PATIENT IS TRICKED BY HIS DOCTOR INTO TESTING EXPERIMENTAL LUNG DEVICE FOR A FOREIGN COMPANY

… AND LEFT WITH LIFE-CHANGING INJURIES.

NOW, FOR FIRST TIME ON SCREEN, WE GO INSIDE THE SECRET AND DANGEROUS WORLD OF HUMAN RESEARCH ABUSE.

00.36 SUPER TITLES:

Breathtaking Human Research Crime

by Robert Cockburn

TRAC Productions

00.40 SUPER:

A CHRISTMAS CARD

00.46 EXT Oxford University, UK

00.48 COM:BRITAIN’S OXFORD UNIVERSITY AT THE HEIGHT OF THE COVID 19 PANDEMIC.

00.52 STILL PIX Covid-19 experimental clinical trial volunteer and trial images

COM:CLINICAL TRIAL VOLUNTEERS ARE TESTING THE FIRST EXPERIMENTAL COVID VACCINE TO SEE IF IT WILL WORK SAFELY FOR MILLIONS OF PEOPLE.

VOLUNTEERS, ORDINARY PEOPLE, ARE THE VITAL, USUALLY UNSEEN, KEY TO EVERY NEW MEDICAL PRODUCT WE HAVE.

NEVER BEFORE HAD THE CLINICAL TRIAL PROCESS BEEN MADE SO PUBLIC – SHOWING THE TRUST NEEDED BETWEEN PARTICIPANTS AND RESEARCHERS.

01.22 MUSIC DOWN

01.22 SUPER: Prof Jon Jureidini, Adelaide University

01.22 Prof Jon Jureidini:‘It is inconceivable to me that anyone could think it was in any way acceptable to engage somebody in any kind of clinical trial or other research without informing them of that that’s what you’re doing.’

01.35 EXT People walking

01.42 EXTs Sydney, Opera House, Harbour Bridge

01.48 Sydney University frontage and inside quadrangle

01.46 COM: AND YET, INCONCEIVABLE AS IT SOUNDS…

… AT THAT TIME, A VERY DIFFERENT CLINICAL TRIAL DRAMA WAS PLAYING OUT AT THE UNIVERSITY OF SYDNEY - AUSTRALIA’S OLDEST AND MOST PRESTIGIOUS UNIVERSITY.

A DESPERATE EFFORT WAS UNDERWAY TO COVER-UP THE DARK SIDE OF HUMAN RESEARCH.

02.02 SUPER: Prof David Egilman, Brown University, USA

02.02 Prof David Egilman: ‘Injuring someone is injuring, whether you do it with a medical product or a baseball bat – it’s still an injury.’

02.11 Man walks into MRI room; lays on scanner bed

02.11 COM: A SERIOUS INJURY TO AN ELDERLY PATIENT THREATENED TO EXPOSE A DANGEROUS CLINICAL TRIAL SCAM.

02.18 Medica devices

02.20 COM:SOME OF THE COUNTRY’S MOST EMINENT DOCTORS AND SCIENTISTS HAD BEEN CAUGHT IN A STATE GOVERNMENT INVESTIGATION. THEY WERE TRICKING UNWITTING ASTHMA PATIENTS INTO TESTING EXPERIMENTAL DEVICES– WITHOUT SAYING THESE WERE EXPERIMENTAL OR EVEN THAT PARTICIPANTS WERE ON A CLINICAL TRIAL.

02.40 -Fake clinal trial forms

02.42 COM:THEY DID IT BY GETTING TRIAL PARTICIPANTS TO SIGN DANGEROUS FAKE CONSENT FORMS.

02.48 SUPER: Prof Patricia Murray, Liverpool University, UK

02.48 Prof Patricia Murray: ‘The well-being of a patient should be the main priority, but it seems like that is not awlays the case.’

02.59 Man looks at documents on desk

02.59 COM:THE DECEIT IS STAGGERING.

03.02THE SYDNEY CASE IS NOT UNIQUE. BUT IT IS EXTREMELY RARE TO SEE FROM THE INSIDE HOW A HUMAN RESEARCH SCAM WAS SET UP…

03.11 EXT Hospitals

03.15 COM:… BRILLIANTLY HIDDEN IN SYDNEY’S MAIN TEACHING HOSPITALS…

…AND SUBVERTING ALL PARTICIPANT PROTECTION SYSTEMS IN AN OFFICIAL COVER-UP THAT REACHED RIGHT INTO AUSTRALIA’S MEDICAL REGULATOR IN THE CAPITAL, CANBERRA.

03.20 EXT Australian Parliament House

03.26 Photo Montage of unethical trial doctors and scientists

03.26 COM:THE ELITE RESEARCHERS ALL BELIEVED THEY WERE ABOVE ACCOUNTABILITY AND WOULD GET AWAY WITH IT.

THEY NEARLY DID.

03.38 ‘Confidential’ NSW Health investigation letter

03.38 COM:A DAMNING 2019 INVESTIGATION PROVED MULTIPLE VIOLATIONS – YET NO ONE WAS HELD TO ACCOUNT AND ITS FINDINGS STILL REMAIN CONFIDENTIAL.

THAT MAY SOON CHANGE.

03.53 – 04.02 MUSIC

04.00 SUPER:

deliberately, negligently, recklessly

04.02 EXT Government office

04.02 COM:A SMALL, VIRTUALLY UNKNOWN FEDERAL GOVERNMENT COMMITTEE IS NOW INVESTIGATING CLINICAL TRIAL’S COVER-UP AND LACK OF ACCOUNTABILITY.

04.10 NHMRC logo

04.10 COM:IT IS PART OF AUSTRALIA’S NATIONAL HEALTH AND MEDICAL RESEARCH COUNCIL.

04.18 Confidential ARIC Government letter

04.21 MUSIC DOWN

04.18 COM:KNOWN AS ARIC – AUSTRALIA’S RESEARCH INTEGRITY COMMITTEE IS FOCUSING ON ALLEGED INVESTIGATION FAILINGS BY THE HEAD OF SYDNEY LOCAL HEALTH DISTRICT, AND THEN SYDNEY UNIVERSITY VICE-CHANCELLOR ,THAT THEY: ‘DELIBERATELY, RECKLESSLY AND NEGLIGENTLY BREACHED CODE OBLIGATIONS OF COMMUNITY TRUST, HONESTY, RIGOUR, FAIRNESS, RESPECT AND ACCOUNTABILITY.’ UNPRECEDENTED AT THIS HIGH LEVEL.

04.51 NHMRC logo

04.51 COM:ARIC HAS A POTENTIALLY MOMENTOUS CHOICE TO MAKE:

EITHER, IT CAN MAINTAIN THE COVER-UP,

OR, PUBLICLY EXPOSE THE SCAM AND RECOMMEND FULL ACCOUNTABILITY.

05.03 Image of Map of Australia, Africa

05.03 COM:AND THAT WOULD SET A PRECEDENT WITH IMPLICATIONS FAR BEYOND AUSTRALIA TO TACKLE THIS INSIDIOUS RACKET.

05.10 Image of ‘HEALTH/WEALTH’ letters

05.14 NHMRC logo

05.10 COM:IF THE GOVERNMENT DARES TO IN THE FACE OF HUGE UNIVERSITY AND MEDICAL INDUSTRY RESISTANCE.

05.17 Still Images Australian, US and UK universities

05.17 COM:BUT ALREADY, THE SYDNEY CASE IS GAINING INTERNATIONAL ATTENTION - AND CONDEMNATION - FROM MEDICAL FIGURES WHO WANT NOW TO CRIMINALISE CLINICAL TRIAL ABUSE AND ITS COVER UP.

05.31 Prof Murray:‘I found that quite shocking.’

05.33 SUPER: Prof Patricia Murry, Liverpool University, UK

05.33 COM:PROF PATRICIA MURRAY IS A BRITISH STEM CELL SCIENTIST AND A CAMPAIGNER AGAINST RESEARCH ABUSE.

05.34 Prof Murray working in lab; Murray media story

05.40 Prof Murray:‘I really think there should be consequences for individuals who withhold information.’

05.48 SUPER: Prof Egilman:

05.48 Prof Egilman:‘It’s clearly unethical and it may be illegal if it’s a device that’s done or a procedure or a medication that’s done without informed consent.

06.08 COM:PROF DAVID EGILMAN IS AN AMERICAN EPIDIMIOLOGIST.

HE WAS THE STAR WITNESS AGAINST MEDICAL GIANT JOHNSON & JOHNSON IN ITS BILLION-DOLLAR PAY OUT FOR ASBESTOS FOUND ITS BABY POWDER.

06.11 Egilman image: J&J news clips‘J&J was ordered to pay $55 million to Gloria Risterson…’

06.22 Prof Egilman: ‘Well, if people are harmed, I think criminal sanctions are merited, based on whatever the harm might be. Certainly if someone died in a cinical trial, as a result of the clinical trial, and was not told that they were in a clinical trial, and whatever was being used was experimental, that seems to me to be at the equivalent to at least a manslaughter charge.’

06.52 SUPER: Prof Jon Jureidini, Adelaide University

06.52 Prof Jon Jureidini:‘The people who participate in medical research, and who are making a sacrifice, and we have an obligation to them to be completely honest.’

07.03 COM:PROF JON JUREIDINI IS AN AUSTRALIAN PSYCHIATRIST WHO CAMPAIGNS AGAINST THE PHARMACEUTICAL ABUSE OF YOUNG PEOPLE.

07.12 SUPER: Dr Melissa Raven, Psychiatric Epidemiologist, Adelaide University

07.12 COM: AND DR MELISSA RAVEN OF ADELAIDE UNIVERSITY

SUPER ‘Dr Melissa Raven, Psychiatric Epidemiologist, Adelaide University’

07.16 Dr Raven:‘The regulations in Australia aren’t nearly strong enough to protect participants of trials. But furthermore, the regulations that we have are not well enforced. So, it’s a matter of weak regulations and very weak enforcement.’

07.36 Image of Prof Wendy Rogers, Macquarie University, Sydney

07.36 SUPER: Prof Wendy Rogers, Macquarie University, Sydney

07.36 COM:PROF WENDY ROGERS LED THE GOVERNMENT REVIEW TO IMPROVE RESEARCH REGULATIONS.

SHE NOW ADMITS AUSTRALIA’S CLINICAL TRIAL SYSTEM IS SHOT.

07.46 Prof Rogers:‘The whole system is not fit for purpose.’

07.50 Image of Australia’s Human Research Code book.

07.50 Prof Rogers:‘It's a very messy system and it's all shrouded by secrecy as well, which I think makes it much worse.’

07.40 Robert studies papers on desk and uses oxygen

07.56 COM:REVEALED HERE ARE THE SYDNEY CASE DOCUMENTS AND EMAILS.

I KNOW THESE THINGS BECAUSE I’M THE CLINICAL TRIAL PATIENT WHO SUFFERED LIFE-CHANGING INJURIES. I’M AN AGE-PENSIONER AND ALSO A JOURNALIST.

I FOUGHT BACK TO FIND OUT WHAT HAPPENED TO ME AND TRY TO PREVENT ANYONE ELSE BEING HARMED THIS WAY.

08.22 Robert rides in taxi

08.22 Image of handcuffed hands holding a stethascope

08.20 COM:IT IS A UNIQUE INSIDE DETECTIVE STORY… INTO MEDICINE’S WORLD OF WHITE-COAT CORRUPTION.

08.26 Prof Murray: ‘‘I think it would be probably be quite surprising to most people if it was exposed.’

08.33 -08.40 MUSIC

08.35 SUPER:

SCAM & INJURY

08.38 oxygen cylinder tap

08.42 EXT Woolcock Institute

08.43 COM:SYDNEY UNIVERSITY AND ITS WOOLCOCK RESEARCH SITE HAD OTHER POWERFUL REASONS TO COVER UP WHAT THEY HAD DONE.

08.51 Media report of Woolcock Institute doctor jailed for patient Sexual Abuses

08.51 COM:IN 2020, THE WOOLCOCK INSTITUTE’S DR ALI KHORAMI DOCTOR WAS JAILED FOR SEXUALLY ASSAULTING FIVE TEENAGE FEMALE PATIENTS HE WAS MEANT TO BE TREATING FOR SLEEP PROBLEMS.

THE UNIVERSITY WAS DESPERATE TO AVOID ANOTHER PUBLIC SCANDAL – ESPECIALLY ONE INVOLVING ITS TOP INTERNATIONAL DOCTORS AND SCIENTISTS.

09.15 SUPER: Prof Wendy Rogers, Macquarie University, Sydney

09.15 Prof Rogers: ‘There’s been significant focus on exploitation of vulnerable groups.’

09.20 EXT Woolcock Institute

09.24 COM:IN DECEMBER 2018, MY ASTHMA CONSULTANT, SYDNEY UNIVERSITY PROF GREGORY KING, ASKED ME TO JOIN WHAT HE CALLED A ‘STUDY’ FOR WOOLCOCK INSTITUTE, THE UNIVERSITY’S RESEARCH SITE.

09.37 image of Prof Gregory King

[? + still pdf image that can be added if image of Prof King goes on too long?]

09.38 COM:HE WAS THE PERSON I TRUSTED TO KEEP ME BREATHING.

PROF KING NOTHING SAID NOTHING ABOUT A CLINICAL TRIAL OR THAT I WOULD BE TESTING TEST EXPERIMENTAL DEVICES.

THAT WAS JUST THE START OF THE SCAM.

09.54 image of Dr Farid Sanai

09.54 SUPER: Dr Farid Sanai

10.02 COM:TWO RESEARCHERS, DR FARID SANAI AND A STUDENT, KIERAN PATEL, CAME TO MY HOME WITH TWO DEVICES - THE ITALIAN RESMON DEVICE AND THE U.S. SPIRO PD HOME SPIROMETER.

10.02 Resmon and Spiro medical devices

10.08 COM:AND CONSENT AND INFORMATION FORMS.

10.12 Fake participant Consent form, Robert reads case documents on desk

10.12 COM:THE FORMS GAVE EVERY ASSURANCE OF THE STUDY’S SAFETY – WITH NO KNOWN RISKS AND A PROMISE TO PAY MY MEDICAL COSTS IN THE EVENT OF INJURY.

I SIGNED.

10.24 COM:AND ALMOST EVERY WORD OF IT WAS A LIE.

Prof Jon Jureidini, Adelaide University

10.27 SUPER: Prof Jon Jureidini, Adelaide University

10.27 Prof Jureidini:‘But how do we tell the difference between ones that are ethical and appropriate? If we’ve found this rotten apple, how many more rotten apples are there in the barrel of clinical research.’

10.34 Robert handles the Resmon and Spiro devices

10.35 COM:NEXT DAY, I FOUND OUT.

ALONE AT HOME, MY FIRST USE OF THE DEVICES LEFT ME FLATTENED, DAZED AND UNABLE TO BREATHE PROPERLY. IN A MATTER OF SECONDS, MY LIFE CHANGED.

10.57 Robert on MRI Scan bed; breathing oxygen

10.57 COM:AN EXPLOSIVE BUILD-UP OF AIR IN MY SKULL HAD CAUSED NEUROLOGICAL DAMAGE.

A FRIGHTENING CONDITION CALLED DYSFUNCTIONAL BREATHING WAS DIAGNOSED ALONG WITH DEBILITATING MIGRAINES AND HIGH BLOOD PRESSURE.

11.15 EXT Royal North Shore Hospital, Sign, ambulances

11.15 COM:I NEEDED EMERGENCY HOSPITAL CARE TO REVIVE MY BREATHING.

…RESPIRATORY PHYSIOTHERAPY TO LEARN TO BREATHE NORMALLY AGAIN.

AND HOME OXYGEN.

11.26 sunny landscape

11.26 COM: MY RESILIENCE TO HEAT – VITAL IN SYDNEY’S SUMMER TEMPERATURES – WAS GONE.

11.33 Robert on oxygen, an ambulance

11.33 COM:EVERY PART OF LIFE WAS RESTRICTED.

COM:A SEVERE ASTHMA ATTACK CAN LEAVE JUST MINUTES TO GET LIFE-SAVING EMERGENCY CARE.

11.40 an ambulance races

11.42 EXT Woolcock Institute

11.54 COM: NO ONE KNEW THIS BETTER THAN THE SYDNEY UNIVERSITY CLINICAL TRIAL TEAM.

11.50 Images of Dr Cindy Thamrin, Dr Claude Farah, Prof Gregory King, Prof Helen Reddel

11.50 COM:INCLUDING, Dr CINDY THAMRIN, DR CLAUDE FARAH, PROF GREGORY KING, PROF HELEN REDDEL, PROF MATTHEW PETERS, DR JOSEPH DUNCAN.

THE RISKS WERE STAGGERING.

11.57 – 12.10 MUSIC

12.00 Prof Egilman:‘If it’s experimental, it’s an invasion of your person.’

12.05 SUPER:

Dark History

12.05 Images of WWII Nazi concentration camp victims and Nuremberg Trial prisoners

11.05 COM: THERE IS A DARK HISTORY BEHIND TODAY’S CLINICAL TRIAL REGULATIONS.

12.16 SUPER: Prof Patricia Murray, Liverpool University, UK P

12.16 Prof Murray: ‘The history of clinical trials, the reason we have all the regulations, is because of what happened during World War Two, with the appalling and unethical research by the Nazis on people in concentration camps. And this led to the Nuremberg Code which set out ten guidelines which should be followed where human beings were taking part in research studies.’

12.47 SUPER: Prof David Egilman, Brown University, USA

12.47 Prof Egilman: ’Clearly those experiments were illegal and prosecuted under American law.’

12.54 Prof Murray:‘One of the most important things was the need for Informed Consent.’

13.00 Images of WWII Nazi Concentration camp victims

13.00 COM:THE SYDNEY UNIVERSITY TEAM TRASHED THESE BITTERLY FOUGHT FOR REGULATIONS AND ANY NOTION OF OBTAINING INFORMED CONSENT.

11.11 Prof Murray:‘Have we lost sight of the history going back to World War Two, that gave rise to the Nuremberg Code? I think, possibly, we have, yes.’

13.25 Sign for Concord Hospital

13.25 COM: AND IT WAS ABOUT TO GET WORSE.

13.28 Robert enters MRI scan room

13.31 COM: NONE OF THE OTHER PARTICIPANTS WERE TOLD ABOUT MY INJURY OR OF THE TRIAL’S SAFETY AND ETHICAL CODE VIOLATIONS.

13.35 SUPER: Prof Wendy Rogers, Macquarie University, Sydney

13.35 Prof Rogers: ‘The way that we do research has a lot of perverse incentives. The majority of research – medical research funding comes from private industry. There's a lot of pressure on universities and hospitals to bring in that money and you get inevitable conflicts of interest which can then play out in adverse ways, particularly for participants of trials.’

13.40 – 14.04 MUSIC

13.58 SUPER:

BIG BUSINESS

14.03 Sydney Harbour, Opera House; EXT pharmacy; pharmacy shelves; people walking

14.03 COM:ASTHMA IS BIG BUSINESS IN AUSTRALIA. UNUSUALLY HIGH RATES OF THE DISEASE HERE OFFER A LUCRATIVE COMMERCIAL MARKET - AND POTENTIAL CLINICAL TRIAL PARTICIPANTS.

14.10 Prof Rogers: ‘There's such competition, there’s international competition to get trials in your country and to present yourself as a research friendly site.’

14.23 NSW Government brochure cover; Robert at desk; CU brochure text

14.23 COM:THE NEW SOUTH WALES GOVERNMENT WANTS TO ATTRACT MORE FOREIGN COMPANIES TO TEST THEIR PRODUCTS BY WEAKENING CLINICAL TRIAL REGULATIONS

TC NSW GOVERNMENT 2018 BROCHURE COVER

14.35 Robert reads from brochure: ‘One fifth of businesses in the medical technology and pharmaceutical industry cite ‘government regulations and compliance as a barrier to innovation’.

14.45 EXT Woolcock Institute

14.46 COM:SOME, JUST IGNORE ALL REGULATIONS.

14.51Prof Murray : ‘Why do researchers disregard ethical codes? Well, many of the cases I’ve looked at involve companies. So, clearly, they want to make a profit from the product.’

15.20– 15.32 MUSIC

15.09 Prof Jon Jureidini: ‘I don’t think anything should surprise us when there’s huge amounts of money involved and money to be made. People will respond unethically. And the pharmacy and device industry have a huge history of unethical behavior.’

15.26 SUPER:

A WEAK SPOT

15.27 COM:BUT THEIR SCAM HAD A WEAK SPOT...

15.27 People cross busy street

15.35 Resmon device

15.27 COM: ...IT COULD WORK ONLY AS LONG AS THE EXPERIMENTAL STATUS OF THE TRIAL DEVICES REMAINED A SECRET.

15.41 People walking; case documents on desk; devices

15.41 COM:AND THIS WAS PUBLIC INFORMATION EVERYONE HAS A RIGHT TO ACCESS IMMEDIATELY FROM AUSTRALIA’S MEDICAL REGULATOR, THE THERAPEUTIC GOODS ADMINISTRATION – OR TGA.

15.51BCU Resmon makers plate on device

15.51 COM:IF THE DEVICES’ TGA USER STATUS WAS MADE PUBLIC, THE SCAMMERS’ COVER WAS BLOWN.

15.57 Australian Parliament Chamber, health minister Greg Hunt

15.57 SUPER: Greg Hunt, Australian Minister for Health, 2017 – 202015.43 People walking across concourse

16.00 COM: AND THAT WOULD START TO UNRAVEL THE EXTENT OF HUMAN RESEARCH ABUSE, HERE.

16.03 EXT TGA HQ, CANBERRA

16.03 COM:BUT THE TGA WAS STAYING SILENT

16.07 SUPER: Freya Waddington Moon, Therapeutic Goods Administration

16.07 image of TGA manager Freya Waddington Moon

16.07 COM:WHEN I ASKED TGA DEVICE MANAGER, FREYA WADDINGTON-MOON FOR THE DEVICES’ USER STATUS, SHE EMAILED BACK:

16.15 SUPER: Read by an Actor

16.11 email text from WADDINGTON MOON highlight and actor reads:

‘We are unable to confirm if the Resmon PRO Diary DEV53 TSIM 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.’

16.37 Restech site advert

16.37 COM:THIS WAS A LIE. AND BY SENDING ME FALSE INFORMATION, SHE WAS HANDING OVER A GOVERNMENT DUTY TO A FOREIGN COMPANY.

16.47 Prof Murray: ‘I think the problems we see now are… It’s certainly the case that the aims of companies is given priority over patient safety.’

17.00 CU of official document and magnifying glass

17.00 COM:I GOT ENOUGH INSIDE INFORMATION TO FORCE A RARE FORMAL CLINICAL TRIAL INVESTIGATION.

17.08 Dr Teresa Anderson image

17.08 SUPER: Dr Teresa Anderson

17.08 COM:THE INVESTIGATION WAS LED BY THE SYDNEY LOCAL HEALTH DISTRICT CHIEF EXECUTIVE, DR TERESA ANDERSON - ONE OF THE CLINICAL TRIAL SPONSORS.

HER HEADQUARTERS ARE HERE, AT SYDNEY’S KING GEORGE HOSPITAL.

17.15 King George Hospital, Sydney

17.15 COM:HER HEADQUARTERS ARE HERE, AT SYDNEY’S KING GEORGE HOSPITAL.

17.19 Trial devices

17.19 COM:THE DEVICES WERE NOW INCRIMINATING EVIDENCE.

17.25 EXT Woolcock Institute

17.25 COM:AS ANDERSON’S INVESTIGATION GOT UNDERWAY, THE WOOLCOCK INSTITUTE’S EXECUTIVE DIRECTOR, PROF CAROL ARMOUR, STEPPED IN.

17.29 Image of Prof Carol Armour, Woolcock Institute Executive Director

17.29SUPER: Prof Carol Armour, Director at Woolcock Institute of Medical Research

17.29 COM:AS ANDERSON’S INVESTIGATION GOT UNDERWAY, THE WOOLCOCK INSTITUTE’S EXECUTIVE DIRECTOR, PROF CAROL ARMOUR, STEPPED IN.

17.35 Corrected Consent Form

17.35 COM:UNDER THE PARTICIPANT CONSENT FORM, ARMOUR OWED ME FOR ALL MEDICAL EXPENSES RESULTING FROM THE EXPERIMENTAL TRIAL.

17.41 Resmon FOT device, Robert with Spiro

17.41 COM:SHE WANTED TO GET THE EXPERIMENTAL RESMON FOT DEVICE – NOW INCRIMINATING EVIDENCE.

AND TO GET IT, PROF ARMOUR CUT OFF MY BREATHING PHYSIOTHERAPY FEES UNTIL I GAVE IT BACK.

17.53 Image of Prof Armour and her email, with read text highlighted

17.53 SUPER: Highlight text

17.53 SUPER: Read by an actor

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

18.03 COM:THE WOOLCOCK’S PROMISE TO PAY MY FEES WAS ANOTHER LIE.

18.05 Robert with trial devices

18.05 COM:EXTORTION AND BREACH OF CONTRACT.

18.07 Prof Jureidini:‘… it would feel to be one of the most extreme transgressions of the obligation to behave ethically in a trial [Prof Jureidini cutaway]I would have thought that would end in a very negative outcome for the researchers.’

18.20 Robert with devices

18.20 COM:I KEPT THE TRIAL DEVICES.

18.22 EXT Parliament House, Canberra

18.22 COM:THE DEVICES WERE NOW VERY MUCH THE CONCERN OF AUSTRALIA’S FEDERAL HEALTH MINISTER, GREG HUNT.

18.28 INT Parliament House Chamber

18.28 COM:IN AN EXTRAORDINARY INTERVENTION, HUNT BLEW THE WHISTLE ON THE COVER-UP BY HIS OWN THERAPEUTICS GOODS ADMINISTRATION DEPARTEMENT - AND WITH IT, THE WHOLE SYDNEY UNIVERSITY SCAM...

18.31 Minister Greg Hunt speaking

18.31 SUPER: Greg Hunt, Australian Minister for Health, 2017 – 2020.

18.35 Roll TGA letter

18.37 COM:…BY ORDERING TGA TO GIVE ME THE EXPERIMENTAL DEVICE INFORMATION IT WAS HIDING.

18.42 Actor reads Highlighted Text:

‘The Minister has asked me to reply.

‘The two medical devices that you are seeking information about (i.e. Resmon Pro Diary Fot, made by Restech Respiratory Technology, Milan; and the Spiro-PD made by PMD Healthcare, PA, USA), are not currently included in the Australian Register of Therapeutic Goods.

‘Guidance on requirements for valid consent to participate in research can be found in the National Statement on Ethical Conduct in Human Research.’

19.23 Image of Dr Anderson

19.23 COM:SOON AFTER, SYDNEY HEALTH CHIEF DR TERESA ANDERSON SENT ME HER INVESTIGATION SUMMARY.

19.30 Dr Anderson’s Investigation Summary letter

19.29 COM:IT IS DAMNING. DR ANDERSON FOUND MULTIPLE SAFETY, ETHICAL AND DATA VIOLATIONS OF THE NATIONAL STATEMENT ON ETHICAL CONDUCT IN HUMAN RESEARCH.

19.41 SUPER: Robert Cockburn, Journalist

19.41 Robert:‘Did you feel offended at the findings in the Sydney University and Woolcock case... [National Statement on Ethical Conduct in Human Research covers] ...that they actually defiled your National Statement?

19.54 SUPER:Prof Wendy Rogers, Macquarie University, Sydney

19.54 Prof Rogers: ‘That’s probably not the language I would use, but it is very disappointing.’

19.59 Dr Anderson’s Investigation Summary, Pg 4, ‘CE Letter – Mr Robert Cockburn – October’

19.59 COM:THE INFORMATION WRONGLY WITHHELD FROM TRIAL VOLUNTEERS INCLUDED:

NOT TELLING US WE WERE ON A CLINICAL TRIAL

OR THAT THEY WERE TESTING EXPERIMENTAL DEVICES.

OR, THAT THE WOOLCOCK INSTITUTE HAD A SECRET ITALIAN TRIAL PARTNER, RESTECH...

...THAT THEY BEAMING OUR TRIAL DATA BY SATELLITE FROM VOLUNTEER’S HOMES TO THEIR OFFICE IN MILAN … TO MAKE MONEY.

20.27 Robert on oxygen; CU of Spiro device

20.27 COM:NOR WERE WE TOLD THAT ONE TRIAL DEVICE HAD A HISTORY OF USER DIFFICULTIES – THE AMERICAN SPIRO PD WHICH DID THE DAMAGE TO ME.

AND NO CONTACT WAS PROVIDED TO PARTICIPANTS IN CASE OF AN EMERGENCY.

AND THERE WAS SOMETHING ELSE.

THE HUMAN RESEARCH ETHICS COMMITTEE, MEANT TO PROTECT US, ALSO FAILED.

20.46 EXTs Sydney University and Woolcock Institute

20.58 – 21.05 MUSIC

20.46 COM:HERE WAS THE PROOF: SYDNEY UNIVERSITY AND SYDNEY LOCAL HEALTH DISTRICT WERE RUNNING A ONE-STOP SHOP, FIXING A FALSIFIED TRIAL APPROVAL AND FAKE PARTICIPANT CONSENT FORMS.

21.00 Image of handcuffed hands holding a stethascope; Pedestrians walking

21.00 COM:THEY WERE WERE BETRAYING PATIENTS AND HEALTH WORKERS ALIKE.

21.03 SUPER:

YOU’RE JOKING

21.07 Image of Dr Anderson

21.07 COM:AND DESPITE ITS OVERWHELMING PUBLIC HEALTH INTEREST, SHE KEEPS HER INVESTIGATION REPORT CONFIDENTIAL.

21.15 SUPER: Prof Patricia Murray, Liverpool University, UK

20.15 Prof Murray:‘I’ve seen cases where false information is included in applications for ethics and regulatory approval.’

21.24 SUPER: Dr Teresa Anderson

21.24 Image of Dr Teresa Anderson

21.30 COM:AT A MEETING, I ASKED DR ANDERSON WHY THE SYDNEY UNIVERSITY TEAM VIOLATED SO MANY RULES.

21.30 image of a generic meeting

21.33 COM:HER ANSWER IS RECORDED.

21.34 Image of Dr Anderson, background King George Hospital

21.34 SUPER: Voice: Dr Teresa Anderson

Radio wave graphic

21.34 Dr Anderson audio: ‘Do I think there was an intentional act to mislead? The investigation does not support that. I think sometimes people think that they have communicated well.’

21.50 Robert audio: ‘You’re joking.’

21.52 King George Hospital signs

21.52 COM: THAT WAS ME, STUNNED BY SUCH CALLOUS AND LAUGHABLE DISREGARD FOR PATIENTS IN THE DEFIANCE OF HER OWN FINDINGS.

22.09 SUPER: Vice-Chancellor Prof Stephen Garton

22.09 Image of Prof Stephen Garton, background Sydney University

22.09 COM: REFUSING TO INVESTIGATE HIS STAFF, THEN SYDNEY UNIVERSITY VICE-CHANCELLOR PROF STEPHEN GARTON, CLAIMED THEIR ACTIONS WERE NOT DECEITFUL.

22.13 Email from Prof Stephen Garton, highlighted text read by an actor.

22.13 SUPER: Actor’s voice:

‘I’m sorry to hear that your participation in the trial was so upsetting.

‘There were no findings that there was any deliberate concealment of the information or other deceptive conduct on the part of the researchers of the researchers or anyone else.’

22.45 Images of TGA HQ and Prof John Skerritt

22.45 SUPER: Prof John Skerritt, Australia’s Deputy Health Chief and Medical Regulator

22.45 COM:THIS IS PROF JOHN SKERRITT, AUSTRALIA’S DEPUTY HEALTH CHIEF AND HEAD OF THE TGA. HE, TOO, WHO MAINTAINED THE ‘NO INTENT’ THEME.

Actor’s voice:

22.56 Prof Skerritt and his letter

22.56 COM:SKERRITT DID FINALLY ADMIT HIS STAFF WRONGLY WITHHELD PUBLIC HEALTH INFORMATION FROM ME.

23.00 SUPER: Actor’s Voice

23.00 an actor reads from letter:

‘I have looked into this matter and I am confident that there has been no misconduct by my staff….

… 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.’

23.05 Dr Raven:‘I think there are very significant guild interests that discourage people from talking about problems with research ethics, and that includes the medical profession. It includes researchers and academia generally. But it also includes the regulatory organisations, such as the NHMRC.’

23.33 Montage images of Sydney University research team

23.33 COM:HOW COULD SO MANY MEDICAL PROFESSIONALS ALL AT THE TIME HAVE ‘FORGOTTEN’ TO TELL THEIR TRIAL PARTICIPANTS THAT THEY WERE TESTING EXPERIMENTAL DEVICES?

23.42 Dr Raven: ‘There are processes for, say, doctors and researchers to report other colleagues who do behave unethically.’

23.53 National Statement on Ethical Conduct in Human Research

23.53 COM:IT IS FOR THE AUSTRALIAN RESEARCH INTEGRITY COMMITTEE, ARIC, TO DECIDE THE VALIDITY OF THEIR EXTRAORDINARY EXCUSES.

24.00 SUPER: Prof Wendy Rogers, Macquarie University, Sydney

24.00 Prof Rogers: ‘I would be shocked and disappointed if there are researchers in Australia who do not know of the importance of obtaining properly informed voluntary consent for participation in research.’

24.14 Robert at desk with documents

20.14 Roll Re-written corrected Trial Consent form, highlights in yellow.

24.14 COM: IT TOOK UNTIL 2020 FOR WOOLCOCK AND SYDNEY HEALTH TO TELL PARTICIPANTS WHAT HAD BEEN HIDDEN FROM THEM GOING BACK TO 2017 – AND THEN ONLY THIS CENSORED VERSION.

HIGHLIGHTED HERE IN YELLOW, THE REWRITTEN PARTICIPANT CONSENT AND INFORMATION FORMS NEEDED TWOEXTRA PAGES TO SHOW THE HIDDEN INFORMATION

24.39 Highlight text: ‘WHAT ARE THE RISKS OF TAKING PART?’

24.39COM:AND THE MOST DANGEROUS LIE?

DELIBERATELY CONCEALING A KNOWN HISTORY OF USER DIFFICULTIES WITH THE HOME SPIROMETER…

24.46 COM:...POTENTIALLY LETHAL TO AN ASTHMATIC.

24.50 Detail from original fake form.

24.50 COM:COMPARE THIS STATEMENTTO THE FAKE VERSION:

24.50 – 25.04 MUSIC

24.53 BUT STILL SOMETHING WAS MISSING.

24.57 SUPER:

FOUND OUT

25.00 EXT Sydney University

25.03 Prof Andrew McLachlan, You Tube student interview

SUPER:

‘Well, of course, feared. I would love to be feared.’

SUPER:

Sydney University Pharmacy Department Student You Tube

Prof Andrew McLachlan,

25.05 Prof McLachlan:‘Well, of course, feared. I would love to be feared.’

25.08 Robert at desk

25.08 COM:IT TOOK ANOTHER TWO YEARS AND TWO FREEDOM OF INFORMATION APPLICATIONS TO GET THE MOST CLOSELY GUARDED PIECE OF THE PUZZLE:

25.12 ROLL down the original 2017 falsified Trial Approval letter.

THE ORIGINAL FALSIFIED CLINICAL TRIAL APPROVAL – AND WITH IT, THE IDENTITY OF THE ETHICS OFFICIAL WHO SIGNED IT.

25.23 CU finger points signature of Prof Andrew McLachlan

25.27 You Tube interview

SUPER:

Your greatest fear?

Being found out

Student[de-identified]:‘Your greatest fear?

Prof McLachan:‘Being found out.’

25.31 Still You Tube image of Prof McLachan

25.31 COM:THIS IS PROF ANDREW McLACHLAN, CHAIR OF THE HUMAN RESEARCH ETHICS COMMITTEE WHO APPROVED THE 2017 FALSIFIED CLINICAL TRIAL LETTER...

25.43 Sydney University pharmacy sign. Prof McLachlan image

25.43 COM:AND MCLACHLAN IS ALSO HEAD OF SYDNEY UNIVERSITY’S DEPARTMENT OF PHARMACY.

THERE WAS NO INFORMED CONSENT OFFERED TO TRIAL PARTICIPANTS.

AND INSTEAD OF HONOURING HIS OFFICIAL DUTY TO PROTECT PARTICIPANTS, McLACHLAN INSTEAD FACILITATED THE SCAM FOR HIS SYDNEY UNIVERSITY COLLEAGUES – LEADING TO SERIOUS INJURY.

26.10 Prof Murray: ‘I get very disheartened when I see this sort of practice, because first and foremost harming patients, I think is indefensible.’

26.23 Robert on oxygen

26.23 COM:A SINGLE STROKE OF HIS PEN CHANGED MY LIFE.

26.25 SUPER:

Prof Wendy Rogers, Macquarie University, Sydney

26.25 Prof Rogers:‘All research involving humans in Australia must be reviewed and approved by a Human Research Ethics Committee, an HREC, before it can proceed. … And there are various criteria for membership for the HRECs. And the aim of the HREC is to identify any ethical flaws in the research and to make sure that these are addressed before the research proceeds...’

26.58 – 59 EXT Sydney University

26.59 Prof Rogers:‘...The members of the HREC are also employees of the institution and there are some sort of conflicts of interest built into the system.’

27.00 SUPER:

Prof David Egilman, Brown University, USA

27.00 Prof Egilman:‘I had a student who was a staff for me. And he was very impressed that in the United States you could make millions of dollars selling ethics…’ [Robert cutaway] I said, it’s great country.’

27.05 – 27.22 MUSIC

27.10 SUPER:

CHANGE

27.10 COM:SO, IF NOT THE GOVERNMENT OR UNIVERSITIES, WHO WILL PROTECT TRIAL PARTICIPANTS?

27.19 SUPER:

Prof Jon Jureidini, Adelaide University

27.19 Prof Jureidini:‘It’s true, sadly, that change is unlikely to come from within medicine, in terms of being more rigorous about the ethics of that we do.’

27.30 SUPER:

Prof Patricia Murray, Liverpool University, UK

27.30 Prof Murray: ‘In some of the cases it was only thanks to exposure in the media that some of these trials were prevented from going ahead.

27.39 For Better Science’journal headline: ‘Misinformed and Damaged’

27.39 Daily Telegraph story

27.39 COM:MY STORY WAS FIRST PUBLISHED IN THE GERMAN JOURNAL, FOR BETTER SCIENCE.

AND THEN IN SYDNEY’S DAILY TELEGRAPH NEWSPAPER.

27.47 Prof Egilman:‘In order to make real change, you need to really organize. Mass movement or something to campaign for legislation.’

27.03 Image of Prof Murray and her media story

27.48 COM:MEDICAL PROFESSIONALS HAVE TO BE BRAVE TO SPEAK PUBLICLY ABOUT THE HUMAN RESEARCH RACKET.

28.03 Prof Raven: ‘...Because people know that there will be consequences, that their careers might be harmed.’

28.15 – 28.51 MUSIC

28.10 Robert using Oxygen; montage of Sydney University doctors and scientists

28.10 COM:WILL THE GOVERNMENT’S INTEGRITY COMMITTEE TAKE THIS OPPORTUNITY TO RECOMMEND PROPER AND PUBLIC INVESTIGATIONS INTO THE SYDNEY UNIVERSITY TRIAL SCAM?

28.20 Oxygen tap turned off, flow meter needle goes to zero

… AND END THE ABUSE OF PARTICIPANTS IN MEDICAL TRIALS?

IF THEY DON’T DO THAT, WHY DO THEY EXIST?

28.30 Roll Credits

28.30 SUPER:

TRAC Productions

Those named in this report were invited to respond.

The Woolcock Institute of Medical Research was moved to Sydney’s Macquarie University.

Prof John Skerritt retired from the Therapeutic Goods Administration

Sydney Local Health District staff involved in the unethical clinical trial remain in their jobs.

CREDITS:

With great thanks to:

Jack, Jean, Linda, Mouine, Kareem, Jowana, Chris, Paul, Caroline, Billy, Liz, Dee, Doug, Bron, John

Dr Leonid Schneider, Kieran Gill, Natalie O’Brien

Cameras

Greg Barbera

Tom Cockburn

Editor

Noel Sadler

Skip Film Productions

Writer, Director, Producer

Robert Cockburn

Copyright TRAC Productions

Contact tracproductions.com

All additional footage remains the copyright of the original sources

28.50 Copyright Robert Cockburn TRAC Productions