Covid-19 News

Prominent Australian Journalist Studying WUHAN Origins of COVID-19 Declaring Fauci Should Resign

Prominent Australian Journalist Studying WUHAN Origins of COVID-19 Declaring Fauci Should Resign

Sherri Markson, an awarded journalist, recently authored a book called What Really Happened in Wuhan, involving the Wuhan Institute of Virology and

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Sherri Markson, an awarded journalist, recently authored a book called What Really Happened in Wuhan, involving the Wuhan Institute of Virology and the origins of the COVID-19 pandemic. Based on extensive research, including interviews with purported “insiders” in Washington, DC, and China, the reporter suspects the pandemic arises out of a laboratory leak. The writer notes that although initially dismissed as a conspiracy theory, the lab leak hypothesis garners more attention.

In Ms. Markson’s book, the author suggests that White House chief medical officer and head of the National Institute of Allergy and Infectious Diseases (NIAID), Dr. Anthony Fauci, directly authorized funding for gain-of-function studies, that is, studies involving the genetic modification of viruses, such as the coronavirus, for ongoing research projects.

In the book, Markson also suggests that the previous Trump administration was likely warned earlier about the unfolding situation. In fact, Markson goes on the record based on her extensive research, “I think it’s very clear that there was a problem at the WIV in late 2019, I think that’s how the virus leaked.”

No definitive proof links the pandemic to WIV; however, mounting evidence points to lots of questionable gain-of-function research associated with U.S. and Chinese collaborators. Dr. Fauci is at the center of the controversy as he ultimately authorized the funding to China via the Eco Health Alliance.

Author Markson implied that Fauci was aware of this research—banned for a few years in America—and consequently recently lied in Senate committee hearings. The Australian journalist and author feels strongly that Fauci should resign.

Call to Action: For those interested in the book you can find a link here.

Amazon

Quote from THHuxleynew

Using the more accurate ONS census-based estimate gives you much lower unvaccinated population numbers, and hence higher infection rates.

Do you really believe only unvaccinated people leave the country? Your arguments are 1000% FUD. Age group 40..50 is 75% vaccinated! What do you believe is the relative impact of 2% change on the ratio given the fact that vaccinated & unvaccinated leave the country at the same rate?????

I really doubt your qualification. Only children believe in BCC that think (written answer on complaint) India is not worth reporting any more as people are not interested how they successfully did fight CoV-19.

What you post here only proves how much energy and money free masons invest into the daily cheating of the dumb?! UK population...

Letters to the Therapeutic Goods Administration

Letters to the Therapeutic Goods Administration

Note that views expressed in this opinion article are the writer’s personal views and not necessarily those of TrialSite. In Australia, up until Sept 10,

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Copy of TrialSite News Website Image - 2021-09-27T084727.646

Note that views expressed in this opinion article are the writer’s personal views and not necessarily those of TrialSite.

In Australia, up until Sept 10, 2021, doctors, including general practitioners, could legally prescribe Ivermectin, at their discretion. The main indications were for scabies, strongyloidiasis, headlice, trichuriasis, and ascariasis, and we know of its marvelous effect in reducing the burden and morbidities of river blindness and filariasis. Some Australian practitioners have never used the drug, and need education and assurance about its profile and safety. Since April last year, (2020) conversations about the potential use of ivermectin for treatment and prevention of COVID19 infection have multiplied. They have been vigorously suppressed in medical circles and in traditional and social media. However, the news has leaked out sufficiently that prescriptions have apparently increased 4-fold However on Sept 10, 2021. there was a sudden announcement by the Therapeutic Goods Authority (TGA), and its head, Professor John Skerritt shared below. What follows is my email interaction with Prof. Skerrit on this important topic.

New restrictions on prescribing ivermectin for COVID-19, were issued by the Therapeutic Goods Advisory (TGA)

Today, the TGA, acting on the advice of the Advisory Committee for Medicines Scheduling, has placed new restrictions on the prescribing of oral ivermectin. General practitioners are now only able to prescribe ivermectin for TGA-approved conditions (indications) – scabies and certain parasitic infections. Certain specialists including infectious disease physicians, dermatologists, gastroenterologists, and hepatologists (liver disease specialists) will be permitted to prescribe ivermectin for other unapproved indications if they believe it is appropriate for a particular patient.

These changes have been introduced because of concerns with the prescribing of oral ivermectin for the claimed prevention or treatment of COVID-19. Ivermectin is not approved for use in COVID-19 in Australia or in other developed countries, and its use by the general public for COVID-19 is currently strongly discouraged by the National COVID Clinical Evidence Taskforce, the World Health Organization, and the US Food and Drug Administration.

Firstly, there are a number of significant public health risks associated with taking ivermectin in an attempt to prevent COVID-19 infection rather than getting vaccinated. Individuals who believe that they are protected from infection by taking ivermectin may choose not to get tested or to seek medical care if they experience symptoms. Doing so has the potential to spread the risk of COVID-19 infection throughout the community.

Secondly, the doses of ivermectin that are being advocated for use in unreliable social media posts and other sources for COVID-19 are significantly higher than those approved and found safe for scabies or parasite treatment. These higher doses can be associated with serious adverse effects, including severe nausea, vomiting, dizziness, neurological effects such as dizziness, seizures, and coma.

Finally, there has been a 3-4-fold increased dispensing of ivermectin prescriptions in recent months, leading to national and local shortages for those who need the medicine for scabies and parasite infections. It is believed that this is due to recent prescribing and dispensing for unapproved uses, such as COVID-19. Such shortages can disproportionately impact vulnerable people, including those in Aboriginal and Torres Strait Islander communities.

There is only one TGA-approved oral ivermectin product, Stromectol ivermectin 3mg tablet blister pack which is indicated for the treatment of river blindness (onchocerciasis), threadworm of the intestines (intestinal strongyloidiasis) and scabies.

All medical practitioners can continue to prescribe oral ivermectin for the approved indications. However, prescribing of oral ivermectin for indications that are not approved is now limited to certain specialists.

Dr. Wendy Hoy Letter to TGA’s Professor Skerrit

12 September 2021

Dear Professor Skerrit and Colleagues,

Like many, I am surprised by the new TGA ruling on ivermectin. Each of the three points highlighted in the formal announcement can be robustly disputed. Ivermectin is easy and cheap to make, and, if Australian supplies fail, it can be imported from other countries. Safe dosing is a matter of education for health care providers and the public. Proponents of early antiviral treatment are not necessarily opposed to vaccines: they see these as potentially complementary therapies. Antiviral agents, employed in the primary care environment, can cover acute exposure to COVID19, prophylaxis after known, suspected or anticipated exposure, deficient vaccine supply, vaccine refusals, vaccine failures, new mutants and waning vaccine efficacy over time, (of which we are hearing more and more).

Sound explanations for decisions such as that enacted at midnight, Sept 11, would be of benefit to all. With many communications on this topic suppressed and censored, many GPs do not have opportunities to learn about agents that could reduce COVID19 severity and transmission, although they are expected to manage this condition in the primary care space. Our advisors at both state/territory and federal levels justify such suppression by citing lack of evidence of benefit of these agents. However, they have not disclosed what evidence among the current >65 existing reports they have reviewed, which ones they accept or reject, and how they reached those decisions. We do not know what value has been given to “real world experience” versus randomised controlled trials, and the wording of some replies to our enquiries suggest an undervaluing of reports from low and middle Income countries (LIMC) relative to those from “the developed world”. Moreover, we have seen no open discussions in our “developed world environment” that weigh potential risks and costs against potential benefits.

If more trials truly need to be done, let’s do them, here and now, in Australia, with national support, opportunity for nationwide participation and with open consultation and disclosure. If well done, we would quickly have answers about benefits in both vaccinated and unvaccinated persons and for prophylaxis as well as mitigation of disease severity. We surely have enough cases, and we have the monitoring systems in place to evaluate the outcomes properly.

Many parties would benefit from knowing that all possibilities were being discussed and handled in a fair and open manner.

Many thanks, Wendy Hoy AO FAA FRACP

Professor of Medicine, University of Queensland.

Professor Skerritt’s Response

Dear Prof Hoy

Thank you for your email. I respectfully disagree with the assertions you have made for the following reasons:

You wrote “Ivermectin is easy and cheap to make, and, if Australian supplies fail, it can be imported from other countries.”

Australia has had a recent national shortage for most of the month of August following a four-fold increase in prescribing in Australia from “normal” levels. Your assertion that this can be quickly fixed by ordering from overseas does not reflect an understanding of how medicines supply chains work in reality – it took 3 weeks for the national shortage to be resolved. Immediately after the national shortage there remained a local shortage of ivermectin in many pharmacies in western and southwestern Sydney. The consequence of this shortage was that people who had a desperate need for ivermectin because of infections such as scabies – quite often including those in residential aged care or in disadvantaged aboriginal communities – had delays in receiving this essential medicine.

You also wrote “Safe dosing is a matter of education for health care providers and the public”.

Unfortunately there have been a number of GOPs who have written prescriptions for doses 3-4 times higher than the approved daily dose of this medicine, and we are aware of individuals who have had to seek emergency department treatment as a result. Other individuals have simply taken several time the amount prescribed to them, or have attempted to illegally import this prescription medicine without valid approvals. While the new restrictions have been portrayed by some as an inappropriate constraint on the prescribing rights of GPs, it is important to emphasise that the RACGP president endorse TGA’s move and the RACGP has also issued warnings against inappropriate prescribing of this medicine.

You also wrote “ Proponents of early antiviral treatment are not necessarily opposed to vaccines: they see these as potentially complementary therapies. Antiviral agents, employed in the primary care environment, can cover acute exposure, prophylaxis after known, suspected or anticipated exposure, deficient vaccine supply, vaccine refusals, vaccine failures, new mutants and waning vaccine efficacy over time, (of which we are hearing more and more)”.

As a PhD-trained pharmacologist and head of the national medicines regulator I am well I am aware of the use of antivirals and how they complement vaccines for the purposes you outline. Indeed the TGA has approved several therapies for the treatment of COVID-19 to complement the vaccines and I am personally involved in regular pre-submission meetings with companies providing data on new antivirals for COVID-19. However, our lived experience, together with any scan of social media will demonstrate that there are a significant number of people who assert that ivermectin can be used instead of being vaccinated. This trend was repeated in the 100 or so emails and SMS texts I have received on ivermectin in recent days, with many assertions from the writers that vaccines are evil and/or they don’t work and ivermectin is instead the solution.

Finally, you wrote “Our advisors at both state/territory and federal levels justify such suppression by citing lack of evidence of benefit of these agents. However, they have not disclosed what evidence among the current >65 existing reports they have reviewed, which ones they accept or reject, and how they reached those decisions.”

Together with my senior medical staff I have personally reviewed the major published studies on ivermectin, and unfortunately many of the published studies suffer from bias or confounding factors. The most cited study on ivermectin and COVID-19 has been redacted by the journal in which it was published due to concerns re data fabrication. But I agree that there several other are studies underway and if these studies prove positive they could support a regulatory submission.

As we have indicated publicly for many months, the onus is for a sponsor to make a regulatory submission to the TGA as there is a legal requirement for there to be an entity responsible for product stewardship and establishing a supply of approved pharmaceutical product. We have also met with the major Australian proponents of ivermectin and provided them with detailed verbal and written information on the process and data requirements to make a submission to the TGA for regulatory consideration.

However, we believe that the recent decision, which was made on the advice of the Ministerially-appointed Advisory Committee for Medicines Scheduling, which includes subject matter experts as well as representatives of health departments from every state and territory, is the appropriate one.

John Skerritt-

Adjunct Prof John Skerritt FTSE FIPAA (Vic)

Deputy Secretary for Health Products Regulation

Department of Health

(The Health Products Regulation Group comprises the Therapeutic Goods Administration and the Office of Drug Control)

PO Box 100 Woden ACT 2606 Australia

Phone: (02) 6289 4200 Fax: (02) 6203 1265

Email: [email protected]

Dr. Hoy’s Response Email

17 September 2021

Dear Professor Skerritt,

Thanks for your recent letter in response to mine, in which I protested the change in arrangements in the prescribing of ivermectin by GPs. The answers to your comments are listed below. They follow the same lines as those of John Campbell from who supplies COVID commentary on a regular basis, with messages and interpretations that generally make good sense. (It is, of course, not the only information or media source we follow).

NATIONAL SHORTAGE OF IVERMECTIN

If a shortage of ivermectin arises, we can source more from compounding pharmacies. Prioritize ramping up of production here. If we cannot do that, then source some from the very plentiful supplies that can be ordered at a very cheap price from several overseas sources, employing regular quality controls checks for their integrity. But why could we not increase local supply? Many countries much less affluent than we, which have adopted the drug for COVID prevention or treatment within in the last year, have started to manufacture it locally themselves.

DOSING HAS BEEN EXCEEDINGLY SAFE

Ivermectin has an incredibly high therapeutic index

Dosage of certain agents differs according to the indications- an example the doses of colchicine required for Familial Mediterranean Fever vs gout. Most parasites need lower doses of IVM, the delta COVID strain apparently needs higher doses. Chances of overdoses are vastly increased when desperate people cannot obtain drug or advice from reliable sources. Pharmacists cannot intercept ingestion of horse medicine, but they can certainly question a prescription for extraordinary doses, written by an occasional ill-informed GP if it crosses their counters. Driving these processes underground can only make matters worse. The series of studies by Guzzo et al, over decades, are reassuring about relatively safety of doses of ivermectin that are much larger than the ones creating recent concern (1).

The best guard against unsafe dosing is good education and support for GPs prescribing the drug, for the patients using the drug, plus pharmacy checks when dispensing, clear instructions, and a secure, safe, trusting relationship of patients, doctors/health care providers and pharmacists. This cannot be achieved if doctors are harassed, threatened and fearful, and discussion about the medicine is supressed, censored or distorted.

If we want to know how well the drug works and in what range of safe doses, let’s legitimise its use, do some trials in defined or controlled settings on dosage, duration, and drug combinations and comparisons. Meanwhile we must not let COVID19 positive people die at home untreated, when an available, cheap, relatively harmless drug which carries some promise has not been offered. Doctors take an oath to use all reasonable means to save a patient if standard treatments are failing, and if the additional therapy is not likely to make things worse. Here we have a ridiculously cheap drug, with decades of safe administration to billions of people, for which many studies show benefit: why would we not try it?

C. EARLY ANTIVIRAL TREATMENT COMPLEMENTS VACCINES

There is no conflict between early antiviral treatment and vaccination. I made this point in my first note. It is astonishing that proponents of early antiviral treatment are being branded uniformly as antivaxxers. Early antiviral treatment as prophylaxis or as treatment for early stage infection is an additional potential arm of COVID management- filling the current vacuum of therapies in the primary care space. It is not a substitute for other well accepted approaches. We all want early and effective treatment that could nip the disease in the bud, regardless of whether we have been vaccinated or not. Energies should be put into educating health care providers and the public about this, instead of framing them as competitors. We all know that vaccines take a while to raise effective immunity, do not create foolproof immunity, do not entirely prevent disease, or viral shedding or transmission, and that efficacy falls over time, boosters are needed, and COVID strains change. An additional medicine to deal with the virus on, or soon after, contracting it, is clearly needed, and ivermectin’s effects, (probably facilitated by zinc, doxycycline etc) in inhibiting viral entry into cell nuclei, and through anti-inflammatory and immunomodulatory effects are additional disease modulating pathways.

We should have a national discussion about the different interpretations of studies to this point, what different groups producing meta-analyses say about the approaches and inclusions/exclusion of studies by other groups, and especially the “cherry picking approach” of the Cochrane review. There is positive data from 33 nations around the world using IVM: a few bad apples in the 60+ reported studies don’t dash the credibility of the majority.

Meanwhile, in such a disastrous situation, let’s either apply IVM-based treatment widely for a while, or in identifiable regions or group, or quickly develop a series of trials for both prophylaxis and early treatment (e.g. dose finding, drug combinations etc); but please don’t suppress discussion or use of this promising therapy.

We ask you to reverse this decision. Perhaps a national advisory committee on antiviral therapy can be formed now and an honest, open dialogue and action plan can be established quickly.

Guzzo CA, Furtek CI, Porras AG, Chen C, Tipping R, Clineschmidt CM, Sciberras DG, Hsieh JY, Lasseter KC. Safety, tolerability, and pharmacokinetics of escalating high doses of ivermectin in healthy adult subjects. J Clin Pharmacol. 2002 Oct;42(10):1122-33. doi: 10.1177/009127002401382731. PMID: 12362927.

Thank you, Wendy Hoy

Wendy Hoy AO FAA FRACP

Professor of MedicineDaneil

Director, Centre for Chronic Disease

School of Medicine, Faculty of Medicine,

University of Queensland

Level 8, Health Sciences Building,

Royal Brisbane and Women’s Hospital

Herston, QLD 4029

[email protected]

04 04 04 2335

A Miracle Cure Too Good To Be True? A Closer Look At Proxalutamide

A Miracle Cure Too Good To Be True? A Closer Look At Proxalutamide

Earlier this year, a cancer drug became the latest addition to a growing list of antiviral drugs repurposed to

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Earlier this year, a cancer drug became the latest addition to a growing list of antiviral drugs repurposed to treat COVID-19. In April 2021, clinical trials in Brazil reported that proxalutamide had reduced mortality rates in hospitalized patients by 77%. Suzhou Kintor Pharmaceuticals, the pharma company which originally developed proxalutamide to treat prostate cancer, has since launched its own clinical trial in May to examine proxalutamide’s potential when treating the viral infection.

Some believe the results are just too good to be true. The Brazilian study is under investigation by the country’s National Research Ethics Commission with respect to irregularities in reporting trial deaths.

There is widespread concern that the effectiveness of proxalutamide as an anti-COVID-19 treatment, what President Jair Bolsonaro calls a ‘potential miracle cure’, is not supported by conclusive or reliable evidence. However, the theory underlying the use of proxalutamide to treat COVID-19 appears to justify the interest in it.

How does proxalutamide work?

Proxalutamide is an androgen blocker developed to treat prostate cancer through androgen-deprivation therapy. One of the many receptors that binds the COVID-19 virus is an enzyme called transmembrane protease serine 2 (TMPSS2), which is boosted by androgens. Interfering with the production of TMPSS2 through androgen blockers could suppress the ability of COVID-19 to infect the lungs.

The idea that androgens may play a role in COVID-19 infectivity is supported by the observation that men appear to be more susceptible to COVID-19 hospitalization.

Clinical trials on proxalutamide efficacy to treat COVID-19

Before the controversial Brazilian trial from April, preliminary trials were conducted in Brazil in October 2020, sponsored by Applied Biology and led by Dr. Flavo Cadegiani, MD, MSc, PhD, a board-certified endocrinologist and founder of the Corpometria Institute. These initial clinical studies reported a 91% reduction in hospitalization in men treated with proxalutamide. A total of 268 men with mild COVID-19 symptoms were separated into two groups: one received 200 mg/day of proxalutamide and the other received a placebo for 7 days. Hospitalization rates were evaluated at the end of 30 days, and the results were considered significant enough to lead to further study. Cadegiani went on to join Applied Biology as Clinical Director in December 2020, to assist in “rapid expansion in its clinical trials programs.”

In April, another trial began, which has since come under investigation. This study, also led by Cadegiani, was conducted across 8 hospitals in Brazil, reported a 128% increase in recovery rate and 77% reduction in deaths in patients treated with proxalutamide. A total of 645 COVID-19 patients, including women, were separated into two groups that received 300 mg/day of proxalutamide or placebo for 14 days. The recovery and mortality rates were evaluated 14 and 28 days after treatment. Patients treated with proxalutamide were discharged 3-7 days earlier than those given placebos, a significant change that could potentially reduce the burden of COVID-19 treatment for healthcare workers.

The high reduction in mortality rate shown in the Brazil study is not sufficiently explained by what we know about how the drug works. This has raised doubts regarding the trial’s results. Research on antiandrogens by other groups is ongoing; but pre-clinical trials studying the effect of androgen blockers on protecting cultured lung cells are inconclusive. This could indicate that the lungs are not the primary target of antiandrogens in COVID-19 treatment, or that further research is required to confirm the efficacy of drugs such as proxalutamide to treat COVID-19. If the lungs are not the primary target, it is possible that antiandrogens modify the severity of our body’s immune response to COVID-19, a factor that plays an important role in the latter stages of the disease. However, this is speculative at this point.

A third trial led by Suzhou Kintor Pharma and US based is ongoing. The company has not chosen to publish the identity of its lead scientist; but the clinicaltrials.gov site lists the trials lead as Zeid Kayali, California. He has since disclaimed the position. This, along with doubts surrounding the company’s decision to skip the initial Phase 1 and 2 trials and go straight to the final phase of clinical testing, has caused misgivings. The Kintor Pharma trial has 668 participants, and its estimated completion date is January 2022.

Based on as-yet unpublished interim results, Kintor Pharma is collaborating with Indonesian Etana Biotechnologies to roll out proxalutamide as a COVID-19 treatment in Indonesia. As of September 23, Indonesia records 2881 new cases and 160 deaths, bringing the total number of COVID-19 deaths to 141,114, suggesting the market for proxalutamide in Indonesia is viable.

Is proxalutamide a proven and effective COVID-19 treatment?

Among all repurposed drugs, proxalutamide records the highest recovery rates, but the fact that other antiandrogen drugs do not demonstrate comparable anti-COVID-19 effects strongly indicates that further research is required before commercializing proxalutamide in hospitals. It is also unclear how proxalutamide reduces hospitalization in the later stages of COVID-19, as it should primarily intervene in early stages of viral infection, making it more effective as a prophylaxis than a cure for COVID-19.

In September, the Brazilian Health Regulatory Agency, Anvisa, suspended the use of proxalutamide and banned all clinical studies on it. This, however, has not deterred doctors in Brazil from prescribing other antiandrogen drugs to COVID-19 patients, causing a lot of alarm among health authorities. Although the protective effect of antiandrogen therapy against COVID-19 is worth researching, it’s too early to declare it a ‘miracle cure’.

Ivermectin ban sparks row between medical professionals in Australia

Ivermectin ban sparks row between medical professionals in Australia

Conflict has arisen between Australian citizens, health practitioners, and professors after a recent decision to ban health practitioners

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Conflict has arisen between Australian citizens, health practitioners, and professors after a recent decision to ban health practitioners from prescribing ivermectin to COVID-19 patients. This most recent aggressive move by the Therapeutic Goods Administration (TGA) reflects a trend worldwide. National drug regulatory bodies are scrutinizing the drug even while in some cases public research institutes embark on large clinical trials. In the U.S. the National Institutes of Health (NIH) changed their ivermectin recommendation from use only for clinical trials to a more neutral stance (that is they do not recommend for or against due to lack of sufficient data). In the USA there is now concerted pressure indirectly from various government agencies (e.g. FDA and possibly NIH and CDC) to professional medical and pharmacy societies and boards to send out cautionary messages to their membership. In the USA that message is working as providers around the country share with TrialSite that it has become exceedingly difficult to fill an off-label ivermectin prescription. Australia has taken a far more aggressive tact—essentially banning GPs from prescribing for COVID-19.

What is Behind the Ban?

The Therapeutic Goods Administration (TGA), a regulatory body attached to Australia’s Department of Health, expressed concerns that people might opt for ivermectin instead of a vaccination. They also raised the possibility that members of the public could take the drug in unsafe dosages. Posts and news regarding the dosage of ivermectin allegedly indicated it was taken at dosages that may lead to harmful effects. According to the TGA’s statement, if not taken properly, the adverse effects of ivermectin could include “nausea, vomiting, dizziness, [and] neurological effects”.

Gerard Rennick, Liberal National Party (LNP) Senator for Queensland, shared his perspective on Facebook. In a social media post, Rennick said that he spoke to Professor John Skerritt, deputy secretary at the TGA, regarding the ban, and was told that the ivermectin dose of 12mg a day recommended for COVID could be unsafe. “I passed this information on to qualified experts who in reply have sent me a TGA Australian Public Assessment Report for ivermectin that was carried out in 2013,” Rennick wrote. The 2013 report concluded that dosages of up to 120mg did not result in harmful effects. This discrepancy made citizens skeptical of the TGA’s reasoning behind the ban of the drug.

While there is no formal connection to this TGA action, it is noteworthy that Merck has applied for provisional registration for Molnupiravir. TrialSite recently covered the move by the TGA opening the way for Merck to apply for provisional registration of Molnupiravir.

Professor Wendy Hoy, Director of the Center for Chronic Disease at the University of Queensland, told TrialSite: “There are a lot of new antiviral drugs in development, on the basis that we don’t already have a good treatment for early-stage COVID. If ivermectin were proven to be even half as effective as it seems to be, the case for developing these new antivirals would be profoundly weakened.”

Geoff Taylor, a retired professor from Curtin University, has been monitoring the progress of studies on potential COVID medications throughout the pandemic. “If the new antiviral drugs being developed for early-stage COVID are better than ivermectin, then that’s great – but if not, then we will need ready access to a cheap, safe, tablet-form antiviral with few side effects, and there is a strong case for continuing to consider the use of ivermectin,” he said.

The TGA remains firm on their stance regarding the drug. Professor Skerritt told TrialSite “We just haven’t seen evidence on ivermectin that is robust enough.” The TGA is also concerned about the false sense of security the drug gives saying, “People who may access ivermectin are not immune from suffering severe COVID. The biggest worry is that people may take ivermectin and feel ‘I’m ok, I’m not going to get COVID or spread it,’ and then they go into their communities and spread it and/or become sick themselves.”

Responding to the suggestion that this move by the TGA is limiting a doctor’s right to exercise their clinical judgement while prescribing medications off-label, Professor Skerritt explains that the decision is not unprecedented. “There are actually around thirty different active substances which general practitioners are not able to prescribe, either at all, or without an individual authorization from the Head of the Department of Health,” he explained.

A Cherry Picking of Evidence?

Critics say the TGA has failed to consider all available sources of evidence. “There’s a lot of data coming from lower-middle income countries, including India, Mexico, and Zimbabwe, that is being dismissed or ignored by the “developed” world, on the assumption that the data is inaccurate, incomplete, or has been manipulated for nefarious reasons.” Hoy explains.

In his capacity at the TGA, Professor Skerritt has different reasons for discounting these sources of evidence. “Real world data certainly has a place, but there are more variables that can’t be controlled or accounted for,” he said, in a telephone interview. “As an example, the recent success in Uttar Pradesh follows an extraordinary spike in cases back in April-May. While it is possible that ivermectin has contributed to control of COVID in that situation, it’s also possible that the virus is now endemic in that community, with a majority of residents having recovered from COVID and showing natural immunity.”

Claims that the TGA is discriminating against ivermectin in preference for expensive, newer drugs were also denied. “That argument just doesn’t hold because dexamethasone, which is now used in every country worldwide in severely ill people with COVID, is also very cheap and a generic drug,” Skerritt explained. “We were delighted to endorse dexamethasone at the earliest opportunity when the evidence showed it was very effective.”

Professor Skerritt assured TrialSite that if strong enough evidence of ivermectin arises, the TGA are willing to lift the ban. “We’re already meeting with groups to discuss the use of ivermectin, and will consider each piece of evidence on its merits. We would require evidence from well-conducted trials that don’t have obvious sources of bias, in reasonable numbers of people.”

Meanwhile, GlaxoSmithKline’s monoclonal antibody product Sotrovimab has received regulatory approval from the TGA, making it the second COVID treatment to receive such approval. TrialSite recently covered the latest research results on Remdesivir, the other COVID drug approved by the TGA, which showed no clinical benefit. The Australian government continues to increase funding for research into new COVID treatments.

Quote from THHuxleynew

I am beginning to question FM1's sanity - when he thanks you for abusive and evasive answers.

Yea - it also crossed my mind, when FM1's downvoted my post, which attempted to back him against aggressive THHx posts...

Quote from Fm1

Pharma’s Culture War: Are Simple, Cheap & Effective Options Being Downplayed?

Nothing can be cheaper than a vaccine. If you get a mild case of COVID, the doctors will tell you to take decongestants and ibuprofen for a week or two. That will cost more than the vaccine. * A course of ivermectin or any of the other drugs that people think work will cost far more than the vaccine.

* I mean it will be more than $20, which is the approximate cost of the vaccine to the government. The vaccine is free to the person getting it.

Quote from Zephir_AWT

Anyway, the time plays against existing vaccine generation: it must be replaced with new one in similar way, like vaccines against flu, which get renewed each year. There is no reason for to believe otherwise.

That is incorrect. Influenza mutates much faster than COVID. Also, the COVID vaccine does a better job of targeting all existing variants than flu vaccines do. There are many different variants of influenza circulating. The vaccines given every year only prevent four varieties of the flu, and others circulate. Four is the most they can cover. Researchers have to guess which four are most likely to circulate months or a year ahead of time, when vaccine production begins. They do not always guess correctly.

Quote from Shane D.

I love the real world, metadata observations. We keep bringing up UP in defense of IVM use, but there have been other examples.

There are no examples of ivermectin working. All of the double-blind tests have been marginal or negative. What you call "real world" tests have no meaning and cannot prove anything, except in very rare cases with the drug is extremely effective. Even if you believe the reports from UP and elsewhere, they do not indicate that ivermectin is extremely effective. Only marginal at best, and the effects are more easily explained by other factors.

The history of medicine is littered with treatments that were widely believed to work, which actually did nothing. If double-blind tests do not show an effect, there is no effect.

Quote from Fm1

POTUS Program Prime the Pump for Boosters & Billions more to Pharma Vaccine Makers

This should be "billions less." As I said, the vaccines are far cheaper than any other drug treatment. That also applies to flu vaccines. The drug companies would get a lot more money for decongestants and other over the counter influenza treatments than they get from the vaccines. That is taking into account the fraction of the population that would be infected or hospitalized with the flu without the vaccines.

When you factor in other costs, such as work-days lost to flu, or lives lost to COVID (and things like life insurance payouts), vaccines are FAR cheaper for society as a whole. So even if vaccine makers are earning billions of dollars, overall it is costing society much less. It is worth handing over money to the vaccine makers. I would rather pay them than undertakers.

Quote from Zephir_AWT

But face-masks can be actually even bigger and more profitable business than vaccines.

Obviously they are! Anyone can see that. You take the vaccine once (or twice). It costs $20. You have pay $0.50 or $1 per disposable face mask, and lot more for the surgical grade ones. You have to wear them for as many months or years as the pandemic continues. It adds up to far more than the cost of a vaccine.

Quote

Obviously they are! Anyone can see that. You take the vaccine once (or twice). It costs $20.

Possibly. Total business in face mask was estimated to 74.90 billion for vaccines $245 billion. Vaccines also have bigger profit margin: moderna vaccine was designed in just two days. It's also most successful vaccine at the market- as if someone would wait with it for its opportunity. The m-RNA concept is extremely potent business model: you don't have to culture vaccine: the inoculated will make it itself. Sometimes I think, that Covid-19 pandemics was planned and carefully designed for to vindicate just m-RNA model.

Quote from Zephir_AWT

Total business in face mask was estimated to 74.90 billion for vaccines $245 billion.

I doubt those numbers. Anyway, individuals in the U.S. who wear masks (such as me) have spent far more than the cost of a vaccine.

Quote from Zephir_AWT

accines also have bigger profit margin: moderna vaccine was designed in just two days.

That makes zero sense. They may have designed it in two days but it took months and billions of dollars to implement the design. They had to build factories. They had to test the vaccines on tens of thousands of people in double-blind tests. Production costs are high. This is one of the most difficult high tech products ever made. It is amazing they can make it as cheaply as they do. See:

How Pfizer Makes Its Covid-19 Vaccine

Behind the scenes from starter cells to a finished vaccine.

www.nytimes.com

Quote from Zephir_AWT

Sometimes I think, that Covid-19 pandemics was planned and carefully designed for to vindicate just m-RNA model.

If that is a joke, it isn't funny. If you really think that, you are stark staring bonkers.

Norfolk doctor leading charge for controversial COVID-19 treatment

Norfolk doctor leading charge for controversial COVID-19 treatment

Ivermectin, a drug widely used to treat worms in horses and cows, is now at the center of a controversial debate over COVID-19 care.

www.wtkr.com

NORFOLK, Va. – Ivermectin, a drug widely used to treat worms in horses and cows, is now at the center of a controversial debate over COVID-19 care. A Norfolk doctor is leading an effort to make the drug a standard treatment for COVID-19 patients, even though government health agencies strongly warn against its use outside of clinical trials.

Dr. Paul Marik, a critical care doctor at Sentara Norfolk General and professor of medicine and chief of pulmonary and critical care medicine at Eastern Virginia Medical School in Norfolk, believes ivermectin helps kill the COVID-19 virus.

However, the Centers for Disease Control and Prevention, the Food and Drug Administration and the National Institutes of Health say there’s not enough data to prove ivermectin works against the virus. The World Health Organization joins the NIH, CDC and FDA, saying there’s not enough data from rigorous trials to prove ivermectin does more good than harm.

Marik believes the data he’s reviewed on ivermectin designed for humans proves it can put a dent in the pandemic. He shared his views in a YouTube video viewed more than 200,000 times.

The buzz over ivermectin began with the study “The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro” released in June 2020.

News 3 investigates tracked down the ivermectin policies at some of our local hospitals and urgent care centers

Quote from Fm1

News 3 investigates tracked down the ivermectin policies at some of our local hospitals and urgent care centers

Like they "track down" criminals I suppose. They have a live report tomorrow. If I were a doctor in Norfolk prescribing IVM, I would go into hiding. There can not be any good come from an interview when the reporter starts off with "a drug widely used to treat worms in horses".

Quote from Shane D.

Like they "track down" criminals I suppose. They have a live report tomorrow. If I were a doctor in Norfolk prescribing IVM, I would go into hiding. There can not be any good come from an interview when the reporter starts off with "a drug widely used to treat worms in horses".

Dr Paul Merick, the most published peer reviewed critical care Dr. of all time, will make any doubting Thomas look quite foolish.

CNBC’s Squawk Box Host Declares Vaccines All But A Failure—Time for Antivirals to Carry Society out of the Pandemic

CNBC’s Squawk Box Host Declares Vaccines All But A Failure—Time for Antivirals to Carry Society out of the Pandemic

The antiviral wars heat up between Merck, Pfizer, and potentially Roche, as it becomes more apparent to broader segments of the population that a COVID-19

trialsitenews.com

The antiviral wars heat up between Merck, Pfizer, and potentially Roche, as it becomes more apparent to broader segments of the population that a COVID-19 eradication via mass vaccination won’t help society overcome the pandemic—even after hundreds of billions of taxpayer dollars have been spent. CNBC’s Squawk Box discussed this unfolding situation recently with ex-U.S. Food and Drug Administrator (FDA) Scott Gottlieb. Now on Pfizer’s Board, Gottlieb joined CNBC’s Joe Kernan to discuss Pfizer’s antiviral investigational product for COVID-19 currently in clinical trials. Kernan started the show by outright declaring that with so many vaccine nuances, the frustration mounts as it turns out the vaccine isn’t “the panacea we all hoped for….” The host further declared, “it’s not even close.”

With waning effectivity, the delta virus, and powerful viral load leading to rampant breakthrough infections and even breakthrough hospitalization, the Squawk Box host was noticeably honest about the current situation. Of course, Scott Gottlieb, with tenure at the FDA, offers some evidence as to the close dynamics between regulators and industry.

Gottlieb defended the vaccine, declaring that no one can be certain how long immunity will last, if a third jab will lead to longer immunity, or perhaps, whether the Pfizer vaccine regimen could evolve into an annual flu shot-like scenario. But Gottlieb also emphasized that the vaccine is accomplishing what developers set out to do: protect people from worse infections, hospitalization, and more. That statement is only partially true; the U.S. government allocated many tens of billions, if not considerably more, of taxpayer dollars into the mass vaccine strategy under the early assumption that the vaccine would strop viral transmission, leading to herd immunity.

This clearly isn’t the case. Meanwhile, POTUS vilifies the unvaccinated as the worldwide cause of viral strain mutation. The CNBC host undoubtedly understands the deep chasm growing in America—and he is clearly concerned. But the emergence of antivirals now can slowly supplant the vaccination strategy.

Antiviral Action

As TrialSite has emphasized during much of the pandemic, most COVID-19 cases remain mild to moderate and would benefit tremendously from early treatment, including safe and effective antivirals. The NIH should have focused on this drug class from the start—many experts called out for this approach. TrialSite shared when the NIH announced billions more would be spent on a few pharmaceutical companies, including Merck.

Clearing the Market of Ivermectin

One challenge faced by the pharmaceutical makers was the perceived nuisance called ivermectin. While dozens of studies have indicated some benefit worldwide, a couple of major clinical trials are now underway in America—one sponsored by the NIH/NIAID (ACTIV-6) and one by the University of Minnesota (COVID-OUT). Off-label physician prescriptions of ivermectin skyrocketed from about 3,000 per week before the start of the pandemic to nearly 90,000 per week most recently. Mass media, government health agencies, and the pharma industry (Merck) launched a highly orchestrated information war to vilify the drug—one that has been administered to hundreds of millions of people in the tropics to overcome certain parasite-borne diseases.

But ivermectin remained a threat to the industry as the inevitable race for antiviral treatments targeting COVID-19 led to the current smear campaign.

Squawk Box host Joe Kernan got the point of antivirals. Raising the possibility that a safe and effective pill taken a couple of times a day could interfere with viral replication, antivirals essentially turn COVID-19 into nothing more than a flu-like condition.

Trying to Catch Merck

It probably wasn’t a coincidence that the Pfizer Board member and forward FDA commissioner were on an investor show; Pfizer recently announced new details associated with its COVID-19 antiviral investigational therapy research program.

The company already forecasts $33 billion for its vaccine product alone—an unprecedented amount of money for one pharmaceutical product. Now the American drug producer goes for possibly several billion more in what would represent a very lucrative market.

TrialSite has chronicled the development of PF-07321332, Pfizer’s investigational SARS-CoV-2-3CL protease inhibitor antiviral therapy, specifically designed to be orally administered. So, it can potentially be prescribed at the first sign of infection or first awareness of exposure without requiring patients to be hospitalized. Protease inhibitors, like PF-07321332, are designed to block the activity of the main protease enzyme that the coronavirus needs to replicate. Co-administration with a low dose of ritonavir is expected to help slow the metabolism, or breakdown, of PF-07321332 for it to remain active in the body for longer periods at higher concentrations to help combat the virus.

Race for Post-Exposure Prophylaxis

Now Pfizer declares its intention to catch up with Merck and their Molnupiravir product presently in Phase 3 trials, including a household contacts study. In these studies, individuals in the home exposed to the pathogen can enter these studies to determine if the investigational product can work as post-exposure prophylaxis.

Merck has received $356 million in taxpayer money to support the development of Molnupiravir, as well as an additional government secured $1.2 billion procurement contract should the investigational drug be either authorized on an emergency basis or approved.

Pfizer announced the Phase 2/3 EPIC-PEP (Evaluation of Protease Inhibition for COVID-19 in Post-Exposure Prophylaxis) study to evaluate the investigational novel oral antiviral candidate PF-07321332, co-administered with a low dose of ritonavir, for the prevention of COVID-19 infection. This Phase 2/3 trial is part of a global clinical research program and is enrolling individuals who are at least 18 years old and live in the same household as an individual with a confirmed symptomatic SARS-CoV-2 infection.

“With the continued impact of COVID-19 around the world, we believe that tackling the virus will require effective treatments for people who contract, or have been exposed to, the virus, complementing the impact that vaccines have had in helping quell infections. If successful, we believe this therapy could help stop the virus early – before it has had a chance to replicate extensively – potentially preventing symptomatic disease in those who have been exposed and inhibiting the onset of infection in others,” said Mikael Dolsten, MD, Ph.D., Chief Scientific Officer and President, Worldwide Research, Development and Medical of Pfizer. “Given the continued emergence and evolution of SARS-CoV-2 variants and their immense impact, we continue to work diligently to develop and study new ways that our investigational oral antiviral candidate could potentially lower the impact of COVID-19, not only on patients’ lives, but also the lives of their families and household members.”

The EPIC PEP Study

The Phase 2/3 EPIC-PEP trial is a randomized, double-blind, placebo-controlled study and will enroll up to 2,660 healthy adult participants aged 18 and older. Participants will be randomly assigned (1:1:1) to receive PF-07321332/ritonavir or placebo orally twice daily for 5 or 10 days. The primary objective will assess safety and efficacy for the prevention of confirmed SARS-CoV-2 infection and its symptoms through Day 14. PF-07321332 is an oral antiviral SARS-CoV-2-3CL protease inhibitor, which has an encouraging pre-clinical profile, including potent in vitro antiviral SARS-CoV-2 and broad coronavirus activity. Results from the Phase 1 clinical trial demonstrated that PF-07321332 was safe and well tolerated.

In addition to this study, the global EPIC program consists of multiple ongoing clinical trials, including one in SARS-CoV-2 infected patients who are at high risk of severe illness (including hospitalization or death), which began in July 2021, and another in infected patients who are at standard risk (i.e., do not have risk factors for severe illness), which began in August 2021.

About PF-07321332/ritonavir

PF-07321332 is an investigational SARS-CoV-2-3CL protease inhibitor antiviral therapy, specifically designed to be administered orally so that it can potentially be prescribed at the first sign of infection or at first awareness of an exposure, without requiring patients to be hospitalized. Protease inhibitors, like PF-07321332, are designed to block the activity of the main protease enzyme that the coronavirus needs to replicate. Co-administration with a low dose of ritonavir is expected to help slow the metabolism, or breakdown, of PF-07321332 for it to remain active in the body for longer periods of time at higher concentrations to help combat the virus.

In March 2021, Pfizer progressed PF-07321332 to a Phase 1 study in healthy adults to evaluate the safety, tolerability, and pharmacokinetics of the investigational compound. In July, it progressed to a Phase 2/3 trial, EPIC-HR (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients), to evaluate efficacy and safety, in combination with ritonavir, in participants with a confirmed diagnosis of SARS-CoV-2 infection who are at high risk of progression to severe illness. In August, Pfizer initiated a Phase 2/3 trial, EPIC-SR (Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients), to evaluate efficacy and safety in participants with a confirmed diagnosis of SARS-CoV-2 infection who are at standard risk (i.e., do not have risk factors for severe illness).

PF-07321332 is the first orally administered coronavirus-specific investigational protease inhibitor to be evaluated in clinical studies.

There is no orally administered therapy currently approved for post-exposure or pre-emptive treatment of COVID-19.

Deleterious drugs in COVID-19: a rapid systematic review and meta-analysis

Abstract

Background Concerns have been expressed about a number of drugs that potentially worsen outcomes in patients with COVID-19. We sought to identify all potentially deleterious drug groups in COVID-19 and critically assess the underpinning strength of evidence pertaining to the harmful effects of these drugs.

Methods and findings We performed a rapid systematic review, searching Medline, Embase and two COVID-19 portfolios (WHO COVID-19 database and NIH iSearch COVID-19 portfolio) for papers and preprints related to primary studies investigating drugs identified as potentially deleterious. Primary outcomes were direct measures of susceptibility to infection, disease severity and mortality. Study quality was assessed using the National Heart, Lung, and Blood Institute quality assessment tools. Random-effects meta-analyses were used for data synthesis with further subgroup analyses where possible for specific outcome, study design, statistical adjustment and drug groups when two were combined. Sensitivity analyses were performed by removing any studies at high risk of bias and by publication status.

49 observational studies (15 peer-reviewed papers and 34 preprints) reported primary outcomes for eight drug groups hypothesised to be deleterious. Meta-analysis showed that acute inpatient corticosteroid use was associated with increased mortality (OR 2.22, 95% CI 1.26-3.90), however this result appeared to have been biased by confounding via indication. One subgroup analysis indicated an association between immunosuppressant use and susceptibility to COVID-19 among case control and cross-sectional studies (OR 1.29, 95% CI 1.19-1.40) but this was not found with cohort studies (OR 1.11, 95% CI 0.86-1.43). Studies which adjusted for multiple confounders showed that people taking angiotensin-converting-enzyme inhibitors (ACEIs) or angiotensin-II-receptor blockers (ARBs) required a lower level of care (OR 0.85, 95% CI 0.74-0.98). Furthermore, studies which combined these two drug groups in their analysis demonstrated an association with a lower mortality (OR 0.68, 95% CI 0.55-0.85).

Conclusions We found minimal high quality or consistent evidence that any drug groups increase susceptibility, severity or mortality in COVID-19. Converse to initial hypotheses, we found some evidence that regular use of ACEIs and ARBs prior to infection may be effective in reducing the level of care required, such as requiring intensive care, in patients with COVID-19.

Quote from Fm1

John Skerritt-

Adjunct Prof John Skerritt FTSE FIPAA (Vic)

Deputy Secretary for Health Products Regulation

Department of Health

(The Health Products Regulation Group comprises the Therapeutic Goods Administration and the Office of Drug Control)

PO Box 100 Woden ACT 2606 Australia

Phone: (02) 6289 4200 Fax: (02) 6203 1265

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At least this criminal mafia member is open and does not hide! May be he is just the messenger for the Australia FM/R Godfathers...

Quote from JedRothwell

A course of ivermectin or any of the other drugs that people think work will cost far more than the vaccine.

Of course! Ivrmectin costs 10cents/week 5.2$/year. A vaccine costs 70$ one shot including the doctor and in average 1'000$ for curing the damage. So you just mixed up the sides of the equation...

But you live in the mirror universe anyway. So its your reality....

Vaccine Mandates Could Lead to Healthcare Worker Shortages

Vaccine Mandates Could Lead to Healthcare Worker Shortages

Should nurses and doctors be required to get vaccinated against COVID-19? What are the rights of medical systems and educational organizations that

trialsitenews.com

Should nurses and doctors be required to get vaccinated against COVID-19? What are the rights of medical systems and educational organizations that directly impact the labor supply of the healthcare sector? How can an organization mandate such a policy? The answers to these questions are not black and white, as vaccine mandates in the workplace remain a hotly contested point of political discussion in the United States and the developed world.

In the U.S., observers could claim that the debate regarding vaccination mandates is settled given President Biden’s order that covers a swath of 100 million Americans, but this is far from the truth. TrialSite News conducted a short review of workplace vaccination policies in medical systems across several states. We also looked into the immunization policies for higher education programs for nurses, doctors, Allied Health professionals, and others who work in a clinical setting. The conclusion we reached is that vaccination mandate policies will directly harm healthcare workers who choose not to get vaccinated or are unable to for a variety of underlying reasons. Additionally, students enrolled in higher education clinical programs will be negatively affected for being barred from continuing their studies.

New York State Case Study

Gov. Kathy Hochul recently announced her administration’s contingency plan to address a possible shortage of healthcare workers when the statewide mandate for vaccinations implemented earlier this month enters into force. In a press statement, Hochul said that her plan is intended to “fight with every tool at our disposal.” The governor added: “I am monitoring the staffing situation closely, and we have a plan to increase our health care workforce and help alleviate the burdens on our hospitals and other health care facilities. I commend all of the health care workers who have stepped up to get themselves vaccinated, and I urge all remaining health care workers who are unvaccinated to do so now so they can continue providing care.”

The state’s mandate covers workers at hospitals, nursing homes, home care entities, hospice care, and adult care facilities. The rule enters force for hospitals and nursing homes on September 27, while the others are expected to be vaccinated no later than October 7. Data shows that 84% of the state’s hospitals are vaccinated, 81% of all adult care facilities staff, and 77% of all nursing home facility staff.

However, the governor is concerned that mandates will exacerbate an underlying healthcare labor shortage already haunting New York, which is why her plan includes utilizing executive emergency powers to declare a state of emergency due to a short-staffing crisis. She is preparing to activate National Guard units to support hospitals, consider deploying federal Disaster Medical Assistance Teams to aid understaffed hospitals, and plan to lobby leaders to expedite visa requests from foreign health professionals.

A hospital in upstate New York is already shutting down operating rooms due to a staff shortage caused by the mandates. Upstate University Hospital, one of the Syracuse area’s largest healthcare systems with over 6,600 employees providing care and trauma services, is shutting down 22 of its 35 ORs beginning September 27. The hospital made this move because of the anticipated healthcare worker shortages due to the mandates. “While Upstate University Hospital continues to ensure the best care for our patients, we are proactively taking temporary measures to focus on covid cases, as well as safely meet the critical care needs of the community,” stated Upstate.

Mandates and Current Shortages Across the Nation

Vaccine mandates will most likely worsen an already existent problem of hospital staff shortages. Becker’s Hospital Review notes this, citing the lack of nurses in the state of Idaho due to a surge in COVID-19 hospitalizations. The Idaho Falls Post Register cites comments from the Idaho Department of Health and Welfare Director, Dave Jeppesen, where he points out that the spike in hospitalizations is the leading cause of the shortages in the state. “The staffing shortage in Idaho has been long-standing,” he said. “What has changed is a massive increase in COVID-19 patients needing hospital care.”

Some rural healthcare systems across the country are experiencing shortages in personnel because of the government’s vaccine mandate. National Public Radio reports that the Goodall-Witcher Hospital in Clifton, Texas, may have to temporarily suspend baby deliveries because some of the hospital’s experienced obstetrics nurses and physicians notified the administration that they are not vaccinated COVID-19 and that many of them do not intend to get the vaccine.

“They are also near retirement age and a few of them have already voiced that, ‘I will just retire,’” said Adam Willmann, the chief executive officer of the Clifton-based hospital system, in an interview with National Public Radio. “And then a couple other nurses said, ‘Well, I’ll just go work for my husband’s construction company.’ “

Clifton is a small town in central Texas with a population of about 3,400. Goodall-Witcher Healthcare, the hospital’s countywide system of clinics, employs about 250 people. Vaccination among staff capped at roughly 70%.

American Hospital Association president and chief executive officer Rick Pollack recognizes that mandates may worsen staff shortages. He recently said, “As a practical matter, this policy may result in exacerbating the severe workforce shortage problems that currently exist.”

Pollack also made a plea to the Biden administration: “Consequently, given the critical challenges that we are facing in maintaining the resiliency of our workforce, and dealing with severe shortages…we call on the administration to work with us as partners in developing aggressive and creative strategies to address this matter to ensure that hospitals and health systems on the front lines of fighting the battle against COVID-19 have the necessary human resources to both win this battle and maintain essential health services for the patients and communities we serve.”

Higher Education Concerns

The concerns of the workforce shortage also impact higher education institutions and their immunization mandates on students who attend medical and nursing programs across the United States. Colleges and universities are adopting vaccine policies that require students involved in specific majors to get the covid-19 vaccine.

Regarding vaccine mandates in colleges and universities, the most noteworthy example is the controversy caused by Indiana University requiring immunizations for staff and students, with rare exceptions. The case was a siren call for medical freedom advocates, especially when a lawsuit was filed against the university administration and petitioned at the US Supreme Court. The high court decided not to block the mandate, insinuating that Indiana University reserves the right to issue such public health policies despite the potential violation of individual autonomy and other bioethical considerations.

Delaware Case Study

Local news website First State Update reports that a group of nursing students who attend Delaware Technical Community College (Del-Tech) is blowing the whistle on the college for preventing them from rejoining their nursing program because of the vaccine policy. According to the students, the college initially mandated that a negative COVID-19 test is necessary to continue with the clinicals required for graduation. The students complied, claiming that they were all healthy and experienced no symptoms. About a week or two into their clinicals, the college mandated that all students in the nursing program must be vaccinated by September 30. The students also claim that the college levied an impossible mandate on them and that they are being stripped of their ability to become nurses, despite passing all of their exams and meeting tuition requirements. Still, the school is forcing the students out if they do not get vaccinated by the cutoff date.

The crisis is a microcosm of the health freedom debate on vaccines on college campuses across the country. Upon review of Del-Tech’s immunization policy, it indicates that they do not “require health vaccinations for admission to the college.” The policy, however, states, “some majors, such as allied health and nursing, may require students to provide proof of immunizations prior to participating in program classes and/or clinicals.” Proof of immunization often includes proof of prior infection, but in the case of COVID-19 mandates across the nation, it does not.

Call to Action: It’s possible the nation will experience another surge in COVID-19 cases and hospitalizations, given the variants of concern, waning immunity from the vaccine, and uncertainty over the effectiveness and safety of booster shots. The nation is already experiencing a shortage of health workers, only to be compounded by those who lose their jobs due to the mandates. In the throes of an unpredictable pandemic, the administration, hospital administrators, and employers should consider if sidelining workers from patient care is really the right call for the greater good.