Thirty frontline doctors in Australia recently treated over 600 patients with Covid-19. The treatment strategy was ivermectin (IVM) with doxycycline and zinc. Five patients required admission to hospital for progressive Covid-19 symptoms. There were no deaths. In a similar number of contemporary Australian patients not treated with IVM, 70 were admitted to hospital and 6 died. This is consistent with world data bases: 31 randomised controlled trials show 62% benefit with IVM and 7 meta-analyses recorded a reduction in death between 57-83%. Experienced clinicians have moved on, to combine IVM with additional drugs, usually a broad-spectrum antibiotic such as doxycycline and zinc which has viricidal activity.
A logical conclusion would be that these results demanded attention. With “freedom- day” in NSW expected to be followed by increases in Covid-19 infections and hospital admissions, an IVM “roll-out” would be a logical outcome. That has not happened and one may well ask “why is that so?”. The mainline press continue to drive their ideology, failing to interrogate the evidence, and failing the public by promoting IVM as the antichrist. A complex set of events have come together. These events and how they affect Covid-19 management and patient outcomes, form the basis of this article.
FIRST, as patients were being treated in Sydney and Melbourne with the impressive results from mentioned earlier in this article, the Therapeutic Goods Administration (TGA) in Australia made an extraordinary move to shut down prescription of IVM by front- line doctors for the treatment and prevention of Covid-19. The TGA had form, as they made a similar ruling for hydroxychloroquine (HCQ), the other re-purposed off-patent drug shown to be effective in treating Covid-19. Importantly, the reasons given for the TGA decision, were not correct.
The main TGA concern stated was that IVM would confuse the public and lead to hestitation towards vaccination. That is incorrect. Doctors overwhelmingly support vaccination against Covid-19. The combination of safe and effective IVM, with a vaccination programme, will enhance viral clearance, reduce disease severity, reduce hospital admissions and reduce deaths.
However, “group think” quickly led to professional bodies such as the AMA uncritically accepting the TGA policy. Even the Australian Academy of Science weighed in with political support for the TGA decision, without evaluation of the science.
Then came the coup – regulatory body responsible for registration of doctors in Australia – the Australian Health Practitioner Regulation Agency – warned that prescribing, dispensing or even publicly discussing IVM, “compromised expected standards of practise”, leaving open disciplinary measures, which have since been enacted with doctors having their license revoked. A crescendo of progressive intimidation has ensued based on a failure to interrogate the data and understand the clinical circumstance, with perhaps a touch of group hysteria.
The CONCLUSION taken from these collective authoritarian decisions, is that medical choice is no longer the prerogative of the doctor-patient relationship in Australia. Bureaucrats for any reason, can decide and enforce medical issues without discussion with relevant medical experts. This is a problem throughout the Western world. Perhaps there is a light in the tunnel. A court in Nebraska, USA, recently ruled that prescription of IVM for Covid-19 is a matter for the doctor-patient relationship, not government.
THE SECOND DEVELOPMENT is a changing balance in evidence relevant to early treatment. Negative critique has been rebutted, and support has become stronger.
First, there has been a rebuttal of a misleading Cochrane report. Traditionally a “Cochrane” is considered the highest bar for drug efficacy and the outcome of a “Cochrane” has profound influence on acceptance. The existing “Cochrane” report on IVM was ambivalent. This became the basis for rejection of IVM, and the cry for “more studies”. The National COVID-19 Health and Research Advisory Committee, established to advise government on early treatment for Covid-19 took the Cochrane report as gospel. From there a trickle-down effect informed opinion of both professional and government organisations, with vigorous support from an uncritical media. Recently a group of respected non-aligned epidemiologists in the UK reviewed the Cochrane report. They found it wanting. They showed defects in method, an exclusion of data points and studies, and a failure to include substantive regional and national experiences where IVM had been successfully adopted. Cochrane had fallen for its own alarm bell of bias!
Not to be dismissed, IVM naysayers took a new tack: “play the man (or the woman) rather than the ball”. Their trick is to label IVM studies that do not fit their ideologic viewpoint as “fraudulent “, and medical supporters of IVM, as “new age quacks”. The value of the naysayers critique, indeed their motivation, has been challenged in detail (IVMMETA.com), failing on numerous counts, including an absence of evidence and use of misinformation. The conclusion was that these frivolous activities confined to a couple of uncertain studies (which are not included in quality meta-analyses) had no impact on the overwhelming data supporting benefit for IVM use for Covid-19.
While these attacks are irrelevant, the mainline press welcomed claims supporting their anti-IVM narrative. A publication by BBC News hit new lows in journalism, combining false conclusions with bias that included misrepresentation of a highly regarded epidemiologist, (summarised: IVMMETA.com). A recent article in the Sydney Morning Herald was little better, distorting the science with ideology and bias. The reporter involved has not responded to a request to host a debate on the topic. They never do!
Second, and more positive, is the accumulation of evidence supporting benefit from early treatment of Covid-19. Two recent compelling studies further support the value of both IVM and HCQ (“cancelled “ when used by President Trump, despite meta-analysis of 32 early-treatment studies showing 64% protection).
The first is a WHO study in Uttar Pradesh, India’s most populous state (230 million people). Medical teams visited 98,000 villages, providing “kits” containing IVM for the treatment of those with Covid-19 (similar to those used in the Australian study). Within 5 weeks, new cases had dropped by 97%. Meanwhile, in Kerala, another Indian state with 8% the population of Uttar Pradesh and not using IVM, recorded over 31,000 cases per day. Similar results are reported in areas of Peru, Mexico and many other regions.
A second recent study treated 8,300 French patients with HCQ. There was a 93% reduction in mortality. A meta-analysis by the same authors included 32,000 patients from 5 countries and showed early HCQ treatment reduced mortality by 69%.
The CONCLUSIONS here, are that Cochrane negativity can no longer dominate an argument about IVM use; the “nails” must be taken from the “HCQ coffin”; and IVM must be accepted in Australia as safe and effective treatment, capable of reducing the expected post-lockdown load on health systems.
THE THIRD DEVELOPMENT is the frenetic response by media and government, to an orchestrated campaign by the pharmaceutical giant, Merck, promoting its re-purposed antiviral agent, Molnupiravir, before significant data assessment has been completed. Merck is now joined by Roche and Pfizer with their versions of re-positioned “wonder drugs”. All have limited and conflicting data, yet make extravagant claims. These antivirals are less effective than IVM and none have acceptable safety profiles. However we see the Australian government making extraordinary claims and committing large sums of money to acquire these unproven oral therapies. Who can be advising government to allow such dubious claims and acquisitions, at the expense of IVM (and the Australian taxpayer)?
The hypocrisy and cynicism must be first be directed at Merck, but also at “the experts” led by Dr.Tony Fauci, government and of course the mainline media. Merck stated IVM had no clinical value days before receiving a US$300 million USA government grant to develop Molnupiravir. Available data suggests it provides an eight-fold less protection than that found for IVM in the Australian study. Merck had acquired Molnupiravir after it failed in other RNA virus diseases. Questions about undisclosed data remain to be answered. The drug is a “son-of-Remdesavir”, a RNA polymerase inhibitor with failed randomised controlled trials (RCT). At A$4,000 per course, it continues to be used in Australian hospitals. The Australian Government has bought 300,000 courses of Molnupiravir (the US government paid US$1,000 per course). This is beyond logic and not based on science! As the TGA prevented doctors prescribing IVM because it would reduce vaccination rates, the question is simple – “how will the TGA now differentiate between Merck’s Molnupiravir and IVM?”.
The elephant in the room for Molnupiravir is safety. The drug creates lethal mutants to terminate virus replication. Cell biologists express concern that some live mutants are released into the environment with resistance to vaccines. DNA mutations also occur, which could lead to disturbed growth and cross-generation transmission of genetic changes. The TGA will now have to wrestle with pressures from pharma and government, to register a drug with scanty clinical data and untested safety concerns, having denied the Australian public cheap, safe and more effective treatment with IVM. An interesting dilemma. Do follow this story line.
It is CONCLUDED that any argument against IVM or HCQ use in Covid-19 is not based on science. It is politically driven, in tune with the pharmaceutical companies profit motive. Who is pulling the strings?
THE FOURTH ISSUE is recognition that genetic vaccines have limited value. While doctors support the current vaccine roll-out, reported “danger signals” must be clarified. Both the DNA-vector vaccine (AstraZeneca) and mRNA vaccines (Pfizer and Moderna) behave as predicted by biology relevant to airways’ protection (something not understood by the vast majority of “experts”): short duration of protection limited to control of systemic inflammation, with little impact on infection of the airways.
Israel was used as a “laboratory” for the Pfizer vaccine. Six months after vaccination, there was essentially no protection against infection or mild disease, although protection against severe disease remained at 85-90%. Thereafter a rapid and progressive loss of protection against more severe disease. Infected vaccinated and unvaccinated subjects have similar viral loads, and transmission capacity. Immunity following natural infection is better and more durable than that induced by vaccination. There is no sense in immunising those who have had Covid infection in the last 6 months. In an Australian context, by New Year 2022, it is estimated about 2 million vaccinated Australians will have lost protection against infection and mild disease. Infections will increase as borders are opened and we re-enter the international community. Our lock-down policy has limited the acquisition of natural immunity. Although we can expect high levels of infection with less severe disease, pressure on hospitals will increase. The experience of Israel and Iceland with high vaccination rates of 85% or more, provides a possible scenario for Australia. In Israel, with a population of less than 10 million, the “third wave” continues, with 1500 new cases and 30 deaths a day (at the time of writing). More concerning are reports of high Covid mortality in some jurisdictions, in older vaccinated subjects. Variants such as the further-mutated Delta variant in the UK will continue to appear, with unknown infectivity, response to current vaccines and pathogenicity.
Perhaps of greatest concern is the observation in the UK, and now in Sweden, that older vaccinated individuals have a higher incidence of Covid infection than those who are unvaccinated. At the same time others are describing a state of immune deficiency following vaccination with genetic vaccines. At this stage it is unclear as to whether this “deficiency” of the immune response is limited to the antibody response to Covid virus. This should not be a surprise to anyone who has done “Immunology 101”, as enhancing antibody (ie antibody that promotes infection, rather than limits it) is well recognised in RNA virus infections, and “antigen excess causing a downregulation of immunity” is a basic tenet of immunology. Forgotten by most, is that genetic vaccines cause a large unregulated amount of antigen (ie Spike protein) to be synthesised within the cells of the body, and the immune response will be a function of those unknown dynamics. These facts should be front and centre of regulators as they examine data to make decisions re “booster” shots. The duration of protection following boosters is completely unknown, as is whether genetic vaccine boosters distort the immune system with net suppression. Are we setting ourselves up for monthly boosters, higher incidence of infections, more serious adverse events, or even more concerning immune outcomes. We just do not know! If ever there was a need for safe , cheap effective oral therapy, now is it.
The concern for all genetic vaccines is the damage caused by uncontrolled release of toxic spike protein from cells throughout the body, and cell destruction due to T cells and antibody directed against spike protein, expressed on cell surfaces. It is too early to know if there are long term complications caused by injected mRNA due to displacement of physiological mRNA by synthetic “capped” mRNA in vaccines or prion disease such as Parkinson’s disease, due to “prion sequences” in the spike protein.
There are disturbing signals from reported severe adverse events and post- vaccination deaths across the globe. A high percent of these “signals” appear to have a causal relationship in subsequent analyses, reinforced by post-mortem reports showing specific tissue changes. Yet there is a push to vaccinate children under 12 who neither get severe disease, nor significantly spread it. The cost/benefit of immunising children has been widely critisised, while misinformation continues to be delivered through the press. Similar concerns persist with respect to vaccination of pregnant women despite short term data from Pfizer suggesting safety. Incidence of miscarriages remains unclear. Follow-up of infants must exclude complications due to placenta damage from spike protein and genetic changes due to injected mRNA.
To CONCLUDE, we cannot vaccinate ourselves out of the pandemic. Most deaths in England over the last 7 months from Covid-19 are in vaccinated subjects, and studies across 68 countries confirm increases in Covid-19 infections are unrelated to levels of vaccination. Booster shots with current vaccines come with little support, and possible enhanced toxicity as reported to the FDA. There is very limited data showing prevention of serious disease, with the data presented to the FDA by Pfizer focussed on “infections” not serious disease. Deaths from Covid in older immunised subjects due to “enhancing antibody” need to be confirmed and investigated further. These concerns need to be resolved before booster shots are widely used. Antigen-based vaccines such as NovaVax with its strong metrics on efficacy and safety, need to be considered. It is understood this vaccine will be available by year-end. Yet the Australian government continues to support genetic vaccines. State governments compete for priority to locally produce genetic vaccines. Who can be advising the politicians on such a concerning course?
HOW CAN THIS BE?
The management of Covid -19 in Australia requires re-shaping as we move into the next stage of the pandemic. It is easy to identify problems. It is more useful to recognise that the pandemic has opened cracks in the administration of medical practise. Transparency, communication, and flexibility, once strengths of our health system, are harder to find. Bureaucrats appear to make critical decisions for political reasons, while doctors are threatened with de-registration for supporting early drug treatment because it may affect vaccine roll-out. It is easy to conclude the system has been corrupted. The question is, who pulls the strings? Part of the answer is that transnational organisations such as WHO and mega pharmaceutical companies, have imprinted their political and commercial agendas all over the Covid-19 story. The genesis of their power play appears to reside in the terms of their “secret” contracts with national governments. From the inadequate “investigation” of the Wuhan source of infection; the refusal to admit that IVM was the reason for successful Covid-19 control in Uttar Pradesh and its suppression of all cheap, available early treatments, the WHO cannot be trusted to lead the world out of the pandemic. Pharmaceutical companies admit subverting any evidence supporting cheap medications that threaten their profits. Conflict exist at every level with cross-appointments between pharmaceutical companies and news agencies, government bodies with financial interests in pharmaceutical companies, and research grants from pharmaceutical companies. The FDA has long been a nursery for highly paid lobbyists and careers within the pharmaceutical industry. If an example is needed to illustrate how distorted the system has become, go no further than Merck’s promotion of Molnupiravir and the cynical support given by politicians, academics, and media, only weeks after “cancelling” cheap, available, safer, and more effective re-purposed drugs. Since the FDA in the USA became “funded“ through high application fees from the pharmaceutical companies, a shift in acceptance of expensive drugs offering little advantage over existing unpatented drugs has been noted.
What is difficult to understand is the “group-think” acceptance of the mantra promoted by “experts”, and by many professionals. In part this is due to the power vacuum in medical leadership that has occurred in recent years, while it may also reflect in part processes known to psychiatrists as cognitive dissonance and mass hysteria.
The medical profession in Australia was built on a proud tradition of excellence, with College systems and medical faculties led by the best of the best, providing trickle-down leadership based on respect, knowledge and experience. This leadership was tightly connected to primary care doctors. That has changed, with Colleges now reduced to a gate-way function geared to specialist accreditation, with “leadership” provided by bureaucrats. Medicine has been dissected by specialisation, losing its connections along the way. Academic medicine has lost the allure of earlier times in a post-truth world of political correctness, with fewer medical graduates entering PhD training programmes. Recruitment into research career paths is no longer an attractive option. Most specialists today, would not know the name of their College President, once the most revered of positions. The pandemic has enabled the “information vacuum” to be filled with a new breed of “experts” who either are not medically trained and thus cannot grasp the clinical imperative, or have a distant medical degree but are a long way from real-life medicine. This has facilitated promotion of influence-peddling by pharmaceutical companies with the goal of impacting Covid-19 management. The current situation manipulated by Merck to “cancel” IVM, replacing it with the less effective but patented Molnupiravir, should be a wake-up call. Yet this drug is lauded as the “breakthrough we all needed”.
An example of pharmaceutical company “vigour” occurred with the launch of new anti-psychotic drugs in the 1990’s. Companies manipulated a belief held by a few paediatricians and child psychiatrists that psychosis was common in young children, with funding and promotion, with strong media support. It took several thousand deaths before sanity was restored to gullible doctors, having never been lost by the children.
Uncritical acceptance of misinformation on IVM, driven by pharmaceutical companies to protect their vaccines and patented drugs, and strongly reinforced by academia, government and health authorities, leads to many unnecessary hospital admissions and deaths. The media has a concerning role in the propagation of misinformation, preferring to support an ideologic narrative, rather than to engage in responsible journalism. The appalling example by BBC News has been discussed.
This article is about a watershed moment in Covid-19 management. It is brought into focus by the TGA closing- down the legal use of IVM for Covid-19, while Merck promotes an inadequately documented, potentially dangerous and less effective (but patented and very expensive) “lethal-mutant” anti-viral. Not a squeak of concern from the mainline press. The moment is brought squarely into relief as health services face the pressure of handling infections that will follow “escape” from lockdowns. The limits of vaccination to control this “third wave” across the globe, demands drug support. How will the TGA and its advisers handle this crisis? How can a quality information trail be provided to politicians? The Nebraska court ruling for IVM noted above, has “gone viral” around the world. The question is, “will legal sanity be sufficient to counter the pharmaceutical lobby and pressures they will bring on regulatory bodies?”. We all must live in hope!
*Professor Robert Clancy ran the leading mucosal immunology research unit in Australia and focussed on protection against infection of the airways and the relevant immune response. He was awarded the first DSc from the University of Newcastle for that work, and an Order of Australia. That places him in a good space to comment on Covid from a mechanism viewpoint, which few others seem to do.