QED

The TGA, a Suitable case for Treatment

Australians have witnessed some bizarre edicts since COVID-19 arrived on our shores, gained a foothold and put the full nelson on the bureaucratic imagination, holding it firmly in the grip of perils both real and imagined. Queenslanders were told at one point they must wear masks at all times, even when alone in their cars. West Australians have found themselves sealed off from the world for months at a time, and in Victoria there was the daily spectacle of Premier Daniel Andrews casting himself as saviour and hero while his government’s negligence and general incompetence killed some 800 people, ended the political career of his health minister, shamed Victoria Police  and kept lawyers busy at an inquiry that managed to avoid asking any questions which might have sheeted home responsibility for the state’s hotel quarantine debacle.

But of all the weirdness perhaps the greatest tribute to the bureaucratic mind emerged on Tuesday from the Therapeutic Goods Administration in the form of a “cease and desist order” directed at a group of physicians who desire the freedom, now denied them, to prescribe hydroxychloroquine for the treatment of those coming down with the Wuhan flu.

The evidence continues to mount that, when administered early and in conjunction with zinc and antibiotics, COVID-19 can be stymied before it has a chance to put sufferers in hospital. Writing in Quadrant, Robert Clancy, Emeritus Professor of Pathology at the University of Newcastle Medical School and a member of the Australian Academy of Science’s COVID-19 Expert Database, put it this way:

… the data have moved on, and that science-based decisions can and must be made if lives are to be saved. Two drugs are effective: hydroxychloroquine (HCQ), and ivermectin (IVM) with most effective trials including nutraceutical, zinc and intracellular antibiotics. These antivirals have been available as antimicrobial drugs for many years. Their antiviral activity is due to intracellular processes that inhibit virus assemblage – HCQ reduces acidity within cytoplasmic vesicles, and IVM blocks communication between the cytoplasm and the nucleus, while both have many sites of action that impair the inflammatory response.

But it seems the Therapeutic Goods Administration knows better, or thinks it does. The Australian quotes a statement issued by a TGA spokesperson after the doctors of the Covid Medical Netork were warned their website‘s support for two low-cost, off-patent medications — the other is ivermectin — constitutes a form of advertising. Yes, really. Here is how the TGA explained itself:

The safety and effectiveness of these medicines for COVID-19 has not been established, and the use of unapproved treatments may cause serious adverse events, or inappropriately delay patients seeking definitive clinical care.

The National COVID-19 Clinical Evidence Taskforce, consisting of a large group of independent Australian clinical experts, is continuously updating treatment recommendations based on the best available evidence.

They are currently not recommending the use of ivermectin or hydroxychloroquine for COVID-19 treatment or prevention, outside of properly conducted clinical trials with appropriate ethical approval.”

The safety and effectiveness of these medicines for COVID-19 has not been established, and the use of unapproved treatments may cause serious adverse events, or inappropriately delay patients seeking definitive clinical care.

The National COVID-19 Clinical Evidence Taskforce, consisting of a large group of independent Australian clinical experts, is continuously updating treatment recommendations based on the best available evidence.

They are currently not recommending the use of ivermectin or hydroxychloroquine for COVID-19 treatment or prevention, outside of properly conducted clinical trials with appropriate ethical approval.

So much for Professor Clancy’s expertise, not to mention the hundreds of doctors backing the Covid Medical Network (CMN). What makes the arrogance of the TGA’s cease-and-desist order more reprehensible than its manifest ignorance is that, apart from threats of legal sanction, it did not even bother to respond when the CMN  laid out its case. That document can be read in full via this link.

COVID-19 can be managed, we now know, and its symptoms remedied. Just what, one must wonder, can be done to see the bureaucracy’s desk wallahs helping to address the problem rather than be part of it?

15 comments
  • Anthony

    When an organisation/body/group begins arguing its case using the words ‘safety’, and ‘care’, there is much cause for alarm!

  • rabel111

    Politicisation of the TGA is a major blow to academic independence of the Australian pharmceutical regulatory system. What other tga decisions have been affected by political or ideological belief rather than evidence?

  • yofus

    Likewise the AMA, completely politicised, are there any institutions left that are not now pretty well wholly leftist bent?

  • rod.stuart

    As a signatory to the Nuremburg Code in 1946 Australia denied government bureaucrats from interference in the relationship of physician and patient. In addition, Australia agreed that injection of any substance without INFORMED consent is tantamount to a war crime.
    The TGA being a guvmint outfit, does that make the guvmint a pack of war criminals? Probably does.

  • gareththomassport

    Yes yofus, the AMA, as well as all medical colleges and NGO’s appear to operate on the basis of political ideology, while at the same time bowing to the not-so-subtle influence of Big Pharma, whose lobbying powers have been honed over the years. Our politicians exist in the realm of winning the next election, and (Craig Kelly aside), seemingly have no interest in science.

  • Stephen Due

    There is circumstantial evidence here and elsewhere that the TGA is sometimes acting, albeit unwillingly, or perhaps in some instances unwittingly, as a tool of the pharmaceutical companies and politicians.
    One problem facing the TGA is its inability to conduct its own research. It has to rely on research done by others, and very often that means research done by the drug companies – or at least such research as they choose to make public.
    In addition, political pressure against a preferred decision by the TGA can be strong. This again may be partly due to drug company influence. These powerful corporations are able to lobby politicians, directly and indirectly. They are known to provide funding and learning materials consumer groups, which in turn pressure politicians. Finally, the TGA is evidently obliged to endure presentations by drug companies, and may on occasion be pressured to the point of harassment to accede to their demands.
    I have no expertise in this area, but my impression is that the TGA on the whole does an excellent job, though it is sometimes let down by the Minister on controversial issues. One hopes that the TGA is able to establish and maintain a robust independence. On the issue of Covid treatment this would, however, be extremely difficult, given the pressures no doubt being brought to bear, as outlined above. Nevertheless it may just be the case that the TGA’s considered opinion is reflected in his situation. Some Covid treatments are, as the ABC would say, ‘controversial’.

  • Lawriewal

    I have wondered why it seems that there has never been a need for BOTH a “treatment” as well as a “vaccine “for wuflu.
    It has always been the “vaccine” that was the issue.
    These surely are complimentary needs in that BOTH would seem to be necessary in such a medical emergency.
    However, it appears that that as soon as ScoMo et al announced the BILLIONS of taxpayer dollars that would be made available to the huge PHARMA enterprises for the “vaccine”, the need of a treatment for those with wuflu became very low priority, dangerous and even illegal.
    Of course the fact that then president Trump got involved in this issue allowed the usual MSM Trump derangement syndrome to pile-up on the very concept of a “treatment”.
    Could it be that an immediately available, safe, low cost, effective “treatment” for those WITH the wuflu might have reduced the urgency for a vaccine and greatly lowered the TAXPAYER dollars available to the big PHARMA enterprises?

  • pgang

    Thanks for the link to their excellent web site.
    It’s not about ‘big pharma’ conspiracies. Drug companies are merely responding to a market opportunity. Are they surposed to say, ‘No, we don’t want all this money thrown at us?’
    As a bureaucratic organisation closely linked to ‘official’ COVID19 scaremongering and its subsequent economic and social destruction, the TGA has little choice but to see it through to the end. A treatment? Not possible. That would mean everything has been a lie.

  • Lawrie Ayres

    Jo Nova has at least two cases for the drugs in question. Mexico has been using Ivermectin with great success and called off a trial because the patients receiving a placebo were being unfairly affected. India put it’s faith in HCQ plus zinc and had at time of writing half the death rate of the US. Both countries, while advanced, are also poor so used available drugs that were also cheap. Craig Kelly brought this information to the attention of government and was chastised. What government will put it’s hand up and admit that many lives could have been saved but were not simply because it was blinded by bureaucrats. A class action could expose the failures both here and in Victoria.

  • Rebekah Meredith

    It seems that the alternate universe that is much of the world is not as unaware of Quadrant as I sometimes think. Today’s West Australian contains a piece running down the Liberal candidate for Upper Swan, Dave Nesbit, for comments he made on “online magazine Quadrant.” (Funny, I was just reading the print magazine this morning). It was quite amusing, reading about how we should be all concerned that any political candidate would think such crazy things as that cheap drugs could treat covid, “the global warming mythology” may not be true, and mainstream media is not necessarily to be trusted. Of course, these views are normal among Quadrant readers.
    But that would be jolly scary to plenty of people. We’re a fringe group, you know. Dangerous.

    • Roger Franklin

      Rebekah, if you saw Insiders on Sunday morn, you’d have been watching more of the same. One by one, in discussing Craig Kelly, each panelist rattled off a pro forma ‘discredited treatment’ — and there, in two short words, you have what’s wrong with the ABC-endorsed media elite. It’s not that they care about facts (they don’t). What they care about is enjoying each other’s mutual regard. They’re the cool kids in the playground, and to preserve that status they simply lock the gates and keep all the other kids out.

  • STJOHNOFGRAFTON

    The approach of the TGA in this matter is illogical, hypocritical and life threatening. Gene therapy preparations, euphemistically called vaccines which have bypassed regular animal testing, rushed into service in short order under emergency use authorisation (EUA), which give fait accompli indemnity to the drug compny, unwittingly, from those vaccinated and have unknown and possibly irreversible dangerous side effects are approved by the TGA. Illogically and ironically, however, safer, historically well proven and tolerated alternative therapies based on Hydroxychloroquine or Ivermectin regimes with proven efficacy in killing SARS-CoV-2 and curing the disease rather than only ameliorating symptoms but not conferring immunity like faux vaccines are forbidden as more effective, alternative treatments by dilegent and courageous doctors.
    What’s the likelihood that the TGA is more aligned to the big drug companies making these pretend vaccines than they are to the wellbeing of the Australian public. One is also entitled to query whether the TGA is in favour of INformed choice or CONformed ‘choice’ for Australians in the matter of treatment and eradication of the SARS-CoV-2 virus.

  • Peter Dare

    Perhaps the TGA have not heard that Donald Trump is no longer President of the United States.

  • AERT DRIESSEN

    The political infiltration and white-anting of Science and the Scientific Method is tragic and will set us back decades, also financially. First so-called climate change, which is what happens between ice ages, and now medicine.

  • talldad

    What’s the likelihood that the TGA is more aligned to the big drug companies making these pretend vaccines than they are to the wellbeing of the Australian public. One is also entitled to query whether the TGA is in favour of INformed choice or CONformed ‘choice’ for Australians in the matter of treatment and eradication of the SARS-CoV-2 virus.

    Of course. Government departments serve their clientele (refer Yes, Minister “Bed of Nails” episode). They do not serve the Parliament or the people.

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