By Liam Mannix
Victoria’s Health Minister has asked the healthcare watchdog to investigate concerns about the operations of a complementary medicine provider that has been processing blood tests in an unaccredited laboratory and employed a disgraced former doctor as a technician.
The probe comes as leading scientists call for the urgent closure of a loophole in Australia’s research regulations that allowed human trials to be conducted without regulatory oversight.
The Age can reveal that Hawthorn-based non-profit the National Institute of Integrative Medicine, which conducts complementary medicine treatment and research, has been processing blood samples for a cancer test trial at a laboratory that is not accredited by the National Association of Testing Authorities.
The National Institute of Integrative Medicine building in Hawthorn. Credit: Penny Stephens
On Saturday The Age reported that the institute employed a former doctor as a technician in its hypothermia department six years after his registration was cancelled following the deaths of two patients. The family of a man who sought treatment from the organisation also complained to the Australian Health Practitioner Regulation Agency in 2016.
“Victorians deserve the very best care and any concerns about the quality and safety of treatment provided by privately operated services can be made to the Health Complaints Commissioner, so the appropriate action can be taken,” Health Minister Martin Foley said.
“I have asked Victoria’s Health Complaints Commissioner to investigate the issues raised in regards to this particular provider to ensure sick Victorians can feel safe and secure in the services they’re being provided.”
In an emailed statement, NIIM said it would co-operate with the investigation.
NIIM has conducted more than 2700 cancer blood screens as part of an ongoing clinical trial. The tests are being done at the “NIIM lab”, according to trial documents, but the institute is not accredited by the National Association of Testing Authorities.
Regulators said it was legal but unusual for clinical trials to be run from unaccredited laboratories.
“Where an in-house [blood test] has been used within a clinical trial and the results are reported to a clinician, then the Therapeutic Goods Administration usually mandates use of an accredited facility,” National Association of Testing Authorities general manager of compliance and governance Tony Vandenberg told The Age.
However, medical watchdog the Therapeutic Goods Administration had a different view, telling The Age that National Association of Testing Authorities’ accreditation was not a requirement for clinical trials.
David Hawkes, a University of Melbourne molecular virologist, said accreditation was important to show a laboratory had a “framework for quality”.
“Clinical tests being reported from non-accredited laboratories have no such assurances.”
By operating within a clinical trial, researchers are able to subject volunteers to drugs and devices that otherwise are banned for use on the public.
Cancer researcher Professor David Vaux.
The Therapeutic Goods Administration has no oversight of a trial’s design, safety, or whether it is ethical; that is the purview of a human research ethics committee appointed by the institution running the trial.
David Vaux, a senior cancer researcher and member of the US-based Centre for Scientific Integrity, said a loophole had been exposed in Australia’s scientific research regulations.
“It must be corrected urgently,” Professor Vaux said. “An organisation could set up its own human research ethics committee and approve its own clinical trials with essentially no oversight.
“Currently, if a human research ethics committee chooses to do so, it can approve clinical trials that would be in breach of the Nuremberg Code and the Helsinki Declaration that were brought in in response to atrocities by Germany before the end of the Second World War.”
The National Health and Medical Research Council requires ethics committees to self-report their compliance with the National Statement on Ethical Conduct in Human Research.
In 2020, according to research council documents seen by The Age, NIIM told the regulator it did not have all the required members. But when research proposals were reviewed, it told the regulator it did have enough members.
The National Health and Medical Research Council said it did not have the power to investigate clinical trials.
Ken Harvey, president of industry association Friends of Science in Medicine, who backed Professor Vaux’s calls for a review of clinical trial regulation, said the lack of oversight was troubling.
“The regulators don’t look. That’s the problem,” Dr Harvey said.
NIIM did not respond to questions about its unaccredited laboratory or the make-up of its ethics committee.
“The results of the trial you asked about have been published and we have no further comment to add,” a spokesman for the institute said.
“Questions about activities undertaken by the regulatory authorities named in your questions should be directed to those authorities.”
Do you know more? Email the journalist at liam.mannix@theage.com.au or securely at liam.mannix@protonmail.com.
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