The drug regulator says a group of doctors is being investigated for promoting hydroxychloroquine as a treatment for the virus, against all scientific evidence
Australia’s TGA has not approved hydroxychloroquine as a Covid treatment, meaning doctors are breaking the law if they prescribe it for that purpose. Photograph: AlexSava/Getty Images
Trust the experts, we are told. Believe the science. But what happens when it is a group of eminent doctors who are behind the misinformation – and they back their claims with a superficially convincing bevy of peer-reviewed academic journal articles?
These are the questions raised by the existence of the Covid Medical Network – a company run by three Melbourne doctors that has been promoting the use of hydroxychloroquine as a treatment for Covid-19 in defiance of the public health authorities, the World Health Organization and most expert medical opinion.
The CMN also casts doubt on the reliability of tests for Covid – because they only tell you whether you are positive or negative for the presence of the virus, not whether you are infectious – as well as the need for and efficacy of the vaccines, and says wearing masks can be harmful to your health.
Australia’s medical goods regulator, the Therapeutic Goods Administration, has told the Guardian that the doctors are “under review” for possible breaches of consumer laws and the Therapeutic Goods Advertising Code that prohibit misleading advertising and advertising of prescription medicines. This is because the CMN promotes a cocktail of prescription drugs – including hydroxychloroquine and ivermectin – that are not approved for use to treat Covid-19 . The penalties can be severe.
As this article was being prepared, the CMN took down some of the material promoting hydroxychloroquine after a “formal cease and desist” letter from the TGA.
“We are currently consulting with our lawyers and the TGA regarding how best to provide the information in a manner that would not reasonably be construed as advertising the medications associated with the safe and effective treatment of early Covid illness,” the website said.
The doctors behind the CMN are practising regularly in Melbourne, including in aged care and our leading public and private hospitals.
The network does not believe it is disseminating misinformation but rather that it is performing a public service – putting out information it sees as backed by evidence. It claims “widely available international evidence and experience, which is now readily available” will eventually see medical authorities move to their position, which they describe as “now virtually beyond dispute”.
The CMN – or at least its leader, Dr Eamonn Mathieson – suggests that Australian and world health authorities are negligent in failing to keep up with the most recent research and guilty of “therapeutic nihilism” and malpractice in preventing sick people from being properly treated.
The CMN even invokes the name of that favourite target of US conspiracy theorists, billionaire Bill Gates, suggesting that Australian medical authorities should be regarded with suspicion because they have participated in research funded by the Gates Foundation.
Liberal MP Craig Kelly has praised US doctor Vladimir Zelenko, who promoted the use of hydroxychloroquine. Photograph: Mike Bowers/The Guardian
A recent CMN webinar includes the Liberal MP Craig Kelly interviewing American doctor Vladimir Zelenko, whose claim early in the pandemic to have successfully treated Covid patients with hydroxychloroquine was the inspiration for then president Donald Trump’s promotion of the drug.
“I consider you a true hero sir,” Kelly says to Zelenko – who has been banned by social media companies for spreading misinformation and criticised by the orthodox Jewish community in which he practised for allegedly exaggerating infection rates.
The interview was posted on 10 February – eight days after the prime minister, Scott Morrison, claimed to have “dressed down” Kelly for spreading Covid misinformation. At the time of writing it remains on the website, despite the TGA action.
Meanwhile, numerous interviews on Sky News with medical practitioners promoting hydroxychloroquine and criticising health authorities are claimed to have been “coordinated” by the CMN.
Doctors against Melbourne lockdown
The CMN came to prominence during Melbourne’s second wave of Covid infections when it organised an open letter, eventually endorsed by 500 doctors, asserting that government-imposed lockdowns were a greater threat to health than the virus, and calling for them to be immediately lifted.
Several of the doctors who signed the letter have told the Guardian that while they stood by their statements, they do not support other material on the CMN website, and in particular its promotion of hydroxychloroquine.
Prof Ben Mol is a specialist in obstetrics and gynaecology at the University of Adelaide. He said he agreed to sign the letter only after he had struck out a paragraph that promoted hydroxychloroquine. “It is just not true … it is clear that not only is hydroxychloroquine not effective but it is potentially harmful,” he says.
Mol says he is now worried by the material on the CMN website – while also being critical of some government information and the public health response to the pandemic more broadly. “I try to find a middle path.”
A few weeks after the letter was published, CMN was established as a not-for-profit company with three prominent Melbourne doctors as directors.
The head of the group is Mathieson, an anaesthetist with a practice in Heidelberg who also works at the Mercy Hospital for Women and a range of Melbourne’s leading private hospitals.
Mathieson also heads the Australian Catholic Medical Association, which has campaigned against the banning of gay conversion therapy and the legalisation of euthanasia. In August last year, the association wrote to Morrison opposing the use of “aborted fetal cell lines” in Covid vaccines.
(Covid vaccines do not contain aborted foetal cells. Development of some vaccines used cells grown in a laboratory and descended from cells harvested from elective abortions in the 1970s and 80s.)
The Melbourne-based Covid Medical Network promoted hydroxychloroquine to treat coronavirus. Photograph: George Frey/Reuters
It is not clear whether all three of the doctors involved in the CMN endorse all of its views – even though they are directors of the company. Responding to questions from the Guardian, Mathieson says his fellow directors are “happy for me to be the spokesperson for the group and agree in principle with the sentiments of allowing combination antiviral treatments to be permitted for doctors to use to treat their sick patients in the early phases of Covid-19”.
The second director of CMN is Will Edwards , a prominent Melbourne foot and ankle surgeon notorious for his colourful personality and his reputation for surgical skill.
He has appeared on ABC Radio speaking about bunions, and is involved in the Australian Orthopaedic Foot and Ankle Society and the Medico-Legal Society of Victoria. He has a research degree in molecular biology and has taught anatomy at the University of Melbourne.
Edwards distanced himself from some of the more florid CMN claims when contacted by the Guardian.
He says he agreed to be involved because “I was concerned that the management of the current pandemic was less than ideal and that discussion of management options was being suppressed; I thought that was to the nation’s disadvantage”.
However, he says doctors have a duty to comply with government directions. As for hydroxychloroquine: “I am not sure that [it] is of great benefit.”
The third director of the CMN is Dr Mark Hobart, a GP in Melbourne’s western suburbs who also works in aged care. He has criticised the lockdowns and public health response, including in an interview on Andrew Bolt’s Sky News program. He did not respond to emails seeking comment.
Drug shows ‘no benefit’ against Covid
The core hydroxychloroquine claim of the CMN is that it is an effective treatment in the very earliest stages of infection when used with Zinc, Vitamin D, Vitamin C and a cocktail of other drugs.
The key reference providing support to this assertion is this article, the lead author of which is Dr Peter McCullough, vice-chief of internal medicine at Baylor University Medical Centre in Dallas, Texas. Zelenko is one of his 56 co-authors.
The article should be taken seriously, says Mathieson, because it is “peer reviewed”. The evidence is “now virtually beyond dispute,” he says.
But a check of the credentials of the journal in which it appeared – Reviews in Cardiovascular Medicine – reveals that McCullough himself is the editor-in-chief of the journal in which he has published.
On top of that, the peer review process was astonishingly quick. The paper was submitted on 28 November, accepted after revisions on 15 December and published just a fortnight later.
Baylor Scott and White Health, which runs the medical centre where McCullough holds his position, told me that the article “does not reflect the views of Baylor Scott and White Health”.
The article argues for each of the component parts of the recommended cocktail of drugs in turn.
The main support for the use of hydroxychloroquine is a paragraph that claims “a continuously updated synthesis of studies” showed convincing benefits from hydroxychloroquine, including benefits in 63% of cases when administered in hospital treatment, and benefit in all cases where it had been used in early treatment.
Four other studies are cited in support of this claim. There are problems with at least three of them, and only one talks about early treatment.
The first, an observational study of patients hospitalised with Covid, examined a range of risk factors and concluded that hydroxychloroquine was associated with lower death rates – but this study was sharply criticised in letters to the editor of the journal where it was published. An expert in the field described it as “just not plausible”, methodologically flawed and its conclusions therefore “invalid”.
Another of the cited studies was described by a later systematic review as having “a moderate or serious risk of bias”. The authors of this study did not respond to emails seeking comment.
Randomised control trials have demonstrated hydroxychloroquine has no benefit for reducing Covid outcomes, says US researcher Eli Rosenberg. Photograph: John Locher/AP
But most shocking of all, yet another of the cited studies concludes the opposite of what McCullough claims it says. Based on a study of 1,438 patients in New York, it found no benefit from hydroxychloroquine. The very small benefits detected were concluded to be statistically insignificant.
The lead author of this study, associate professor Eli Rosenberg of the University at Albany, has confirmed that it is “incorrect to reference our study as supportive of Hydroxychloroquine benefit”.
Since he published that paper, he says, randomised control trials had demonstrated that “hydroxychloroquine has no benefit for reducing Covid-19 outcomes” at any stage of treatment, including people not hospitalised and those at risk of infection. “The sum of the evidence indicates that researchers and providers should spend little energy on this drug, in favour of therapeutics that show actual benefit or promise for benefit.”
Yet on this shaky foundation, McCullough recommended an “urgent pivot” to his recommended regime of drugs, and has promoted this view widely.
McCullough’s article has also been published on the website of the worthy-sounding Association of American Physicians and Surgeons – which is in fact an interest group with links to the Trump administration. The Trump-appointed head of the Department of Health and Human Services, Tom Price, is a member, as was Republican senator Rand Paul. The AAPS is well known for campaigning against President Barack Obama’s affordable care act.
It has previously published articles questioning the safety of the measles vaccine and falsely suggesting that women who have abortions are at a higher risk of breast cancer. The AAPS site currently promotes a booklet that gives a “step by step” guide to home-based Covid treatment as something that could “save your life”, as well as an article by its lawyer suggesting the recent US election was “tainted beyond repair”.
Approached by the Guardian for comment, McCullough said the issue in which his article was published was a special, prompted by the “urgency of the crisis”. It had an independent guest editor and “all papers … underwent peer-review in the full and usual extent and the paper was published after suitable revisions”.
It is true that the relevant issue of the journal had three guest editors – all of them sit with McCullough on the editorial board, and they are experts in exercise and sports medicine. The identity of the peer reviewers is confidential.
As for the doubts about the cited studies, McCullough suggests that is because of bias. He says “studies demonstrating therapeutic benefit have been under heavy criticism by those who espouse therapeutic nihilism, that is, offering no care for high-risk patients with Covid-19 and allowing them to suffer, succumb to hospitalisation and death.”
Asked specifically about his use of the Rosenberg study, he did not respond directly but referred the Guardian to another article, of which he was one of four co-authors, which has not yet been subjected to peer review. This article studied five randomised trials of hydroxychloroquine and concluded there was a 24% reduction in infection, hospitalisation and death. The criteria by which the five studies were selected for review was not described. The lead author declared past consulting work for manufacturers of hydroxychloroquine.
McCullough says: “The larger body of observational data for [hydroxychloroquine] in outpatient use is strongly positive and continues to accrue daily.”
The Lancet changes editorial policy after hydroxychloroquine Covid study retraction
Back in Melbourne, Mathieson has in his sights the National Covid-19 Clinical Evidence Taskforce, which brings together peak health professional bodies across Australia to assess emerging research and advise government. He claims its reasons for ignoring the McCullough paper and other evidence in favour of hydroxychloroquine is “difficult to fathom”. He says it is out of date, and fails to pay attention to observational studies.
The executive director of the taskforce, associate professor Julian Elliott, responded that it considered all reliable Covid-19 treatment evidence produced and published anywhere in the world, regardless of healthcare setting or phase of treatment. “We are not aware of any reliable evidence to support the use of hydroxychloroquine combination therapies … The taskforce maintains daily surveillance of Covid-19 research and rapidly updates the national guidelines as new evidence becomes available.”
Meanwhile, the TGA has not approved hydroxychloroquine as a treatment for Covid, meaning doctors are breaking the law if they prescribe it for that purpose.
McCullough claims this is an “illegal interference” in the relationship between doctors and patients.
The Australian Health Practitioners Regulation Agency, which is responsible for regulating the medical profession, says “it is vital that health practitioners only provide information about Covid-19 that is scientifically accurate and from authoritative sources, such as a state, territory or Commonwealth health departments or the World Health Organization”.
Meanwhile, the TGA says more robust, well-designed clinical trials are required before any drug can be considered an appropriate treatment option.
There is no sign of that happening, and no sign that evidence, expertise or science will prevent dubious studies being published, or change the minds of Mathieson, the doctors who follow him and the media figures giving him oxygen.
