Ireland: Another Footballer Dies Suddenly

Tributes have been paid to a young Irish footballer following his sudden death on Wednesday.

Oisin Fields from Armagh died while playing football with his friends. His death has sent shockwaves across his local community and prompted an outpouring of tributes from those who knew and worked with him.

He had played for Navan Harps, which competes in the Lonsdale League.

The Belfast Telegraph reports: Mr Fields’ employer said he passed away while “playing football with his friends”.

His current team Navan Harps described being “devastated” at the loss of a “friend and teammate”.

“We extend our sympathy and support to all his family and friends at this time,” they said.

“Thank you to everyone who has expressed their condolences to the club and its players. We will pass them onto Oisin’s family in the coming days,” they added.

Mr Fields was widely involved in sport across the local area, including Gaelic football.

He was a former player at Pearse Og Armagh GFC, who said they were “saddened” to learn of his passing.

“We extend our deepest sympathy to his parents Antoinette & Tony and brothers Anton & Ronan. Our condolences are with the entire Fields’ family,” they added.

In a statement, the Lonsdale League said it was “shocked and saddened” to learn of Mr Fields’ “untimely passing”.

Federal Judge Quotes John Madison & JFK Then Orders FDA to Transfer Pfizer Vaccine Data to Public at Accelerated Rate

Transparency, accessibility, and advancement of medical research represent a driving force for TrialSite, and recently, the move for greater translucence scored a victory regarding accessing the Pfizer COVID-19 vaccine product data. TrialSite has followed the transparency case led by attorney Aaron Siri and his firm Siri Glimstad. A Freedom of Information Act (FOIA) matter, up until now the federal judge followed the calls for opaqueness, by ensuring comprehensive access to the Pfizer FDA application data at a snail’s pace—500 pages per month would make the entire trove available in 55 years. Then, after a back and forth in court, the FDA added insult to injury by proposing to extend the full download of the Pfizer data to 75 years. Representing the Public Health and Medical Professionals for Transparency (PHMPT), attorney Siri at first sought to secure the entire batch of data within 108 days, which just so happens to be the amount of time it took for the Gold Standard regulatory agency to review and approve Pfizer’s vaccine. As TrialSite’s Sonia Elijah has uncovered, numerous concerns were raised after review of just one currently available set of Pfizer vaccine safety documents. Now, the attorney reports the federal judge rejected the FDA’s latest aggressive moves for unacceptable opacity—the court has more closely aligned with Siri’s clients and compelled the regulatory agency to now accelerate the data transfer—from 500 pages per month to 55,000 pages per month! In making this proclamation, the judge referred to quotes from both James Madison and John F. Kennedy emphasizing important attributes of good government.

Make a Good Decision—Have the Proper Data

TrialSite suggests that this ruling represents a real opportunity for what can become an eventual improvement in the mission-critical risk-benefit analysis needed for determination of benefit, or risk of COVID vaccination with the Pfizer vaccine called BNT162b2, or “Comirnaty.”

The mass vaccination of very young children, for example, raises several important ethical questions that can only be properly addressed by a rigorous, independent, and unbiased risk-benefit analysis of the true benefits and costs of this vaccine. But without underlying comprehensive product data there can be no such independent analyses. 

As Siri reports himself, the latest ruling will make data available enabling independent scientists the ability to “offer solutions and address serious issues with the current vaccine program—issues which include waning immunity, variants evading vaccine immunity, and as the CDC has confirmed, that the vaccines do not prevent transmission.”

Mandate Elements

Bioethicists can make a strong case that forced mandates presuppose a few critical prerequisite factors, such as quality, safety, and effectiveness. In this case, a growing number of scientists, physicians, and health policy analysts, as well as political representatives, share concerns that the COVID-19 vaccines have failings that must be uncovered, analyzed, and better understood. The stakes are too high.

But who could deny that with a mandated medical procedure on hundreds of millions of people, that it’s right and proper that the regulatory agency involved allow for the transparency of underlying product documentation? Why would the FDA keep back critical COVID-19 vaccine data from the public when a substantial portion of that consumer base is coerced to engage in an unwanted medical procedure?

Apparently, this judge came around to the significance and importance of this case. He “recognized the release of this data is of paramount public importance and should be one of the FDA’s highest priorities,” wrote Siri.

Interestingly, the federal judge quoted two former popular presidents in this latest hearing. Referring to James Madison, the judge for the United States District Court for the Northern District of Texas declared a “popular government, without popular information, or the means of acquiring it, is but a prologue to a farce or a tragedy.” This was followed by a quote from John F. Kennedy: “a nation that is afraid to let its people judge the truth and falsehood in an open market is a nation that is afraid of its people.”

As the data becomes available, TrialSite will collaborate with scientists to interrogate the trove for important data, insights, and breakthroughs—translated and streamlined and delivered in understandable, concise prose. One true hope—that Pfizer isn’t afforded the opportunity to redact too much of the information.

Major unreported protocol deviation in N3C COVID-19 vaccine trial

The National COVID Cohort Collaborative (N3C) Consortium is a US national enterprise to “aggregate and harmonize EHR data across clinical organizations in the United States”. The consortium comprises more than 600 individuals and 100 organization.

In a study led by Jing Sun, N3C was employed to investigate the effectiveness of COVID-19 vaccines. The study found that full vaccination provided a 24% improvement over partial vaccination for the prevention of COVID-19. The study also showed that hospitalized unvaccinated patients were at greater risk of severe disease than hospitalized full vaccination patients.

However, the original intent of the study was also to include an estimate of vaccine efficacy; the rate of COVID-19 diagnosis in the unvaccinated vs the rate in the fully vaccinated. That is apparent from a statement from the author in a comment to the article. However, no estimate of vaccine efficacy was provided in the article. Nor did the authors disclose the change to the protocol in the article. Furthermore, the trial protocol was not registered in ClinicalTrials.gov.

As mentioned above, the protocol deviation was disclosed in a comment to the article by the author, Jing Sun. I posed the following question to the author:

“Why not also compare the prevalence of COVID-19 in the pre vaccination and full vaccination groups? Such a comparison would provide an independent estimate of vaccine efficacy.”

Sun responded:

Thank you for your comment and interest in our research. In an ongoing study, we are evaluating the vaccine efficacy in N3C. The current study was completed and submitted before all components evaluating vaccine efficacy were available.”

Note the “pre vaccination” group in this article refers to the “unvaccinated” group. The discussion then continued by email with the author.

“I commented on your recent article in JAMA Internal Medicine. Do you intend to publish the results of the study on vaccine efficacy?” (Yim)

“Thanks for your comments. Yes, the study is ongoing and we do plan to publish it.” (Sun)

“You say that the study is ‘ongoing’, yet the study data collection period was December 10, 2020 to October 14, 2021. What exactly is it about the study that is ongoing?” (Yim)

Sun did not respond.

The omission of the vaccine efficacy result from N3C study is a troubling protocol deviation. It’s also troubling that a clinical trial of this magnitude (664,722 subjects) was conducted without registration of the protocol. There needs to be a full accounting. More importantly, the N3C vaccine efficacy result needs to be publicly disclosed.

Biography: Peter J. Yim, PhD is a computer scientist and educator. He has written extensively on COVID-19 science and policy. This includes a broad perspective on US government handling of COVID-19: Separation of Science and State.

The Global Disinformation Campaign Against Ivermectin in COVID-19 (Part I)

he tactics deployed by the pharmaceutical industry in their decades-long war on generic drugs reached a zenith during COVID-19… and have resulted in true crimes against humanity.

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

by Pierre Kory

Ivermectin, a decades-old, off-patent drug costing pennies to make, with an unparalleled safety profile and numerous manufacturers across the world, actually sits atop one of the largest and strongest clinical trials evidence base in history. The existing, massive amount of clinical trials data shows immense efficacy against COVID-19 in all its phases; prevention, early and late treatment, and long-haul syndrome (no actual trials in long-haul but rather extensive positive clinical experiences). Despite this inarguable (yes, inarguable) supportive evidence, no major Western or international health agency has recommended its use in COVID-19. Conversely, ivermectin has been officially adopted for early treatment in all or part of 23 “less developed” countries (39 if you include non-government medical organizations), and which include about 25% of the world’s population.

Now, before we delve deeper into the workings of the most heinous disinformation campaign ever waged by the pharmaceutical industry in history (and also it’s most successful so far as 75% of the earth’s inhabitants still have not been recommended to use it to treat COVID), I will ask you not to just “take my word for it” but instead take you on a brief, guided tour of the insanely positive evidence base supporting the use of ivermectin in COVID-19.

Let’s go. First, the below “Forest Plot” was compiled by the anonymous expert research group at c19early.com (not enough can be said of the impact their meticulous work has had on COVID clinicians and scientists across the globe). Please visit their site, it is mind-blowingly impressive. The compounds listed in the rows represent the medicines with the most clinical trials evidence as of today, either by size or by number and are listed in order of potency against COVID.

Here is how to read and understand a Forest Plot: there is a thin grey line in the center, on either side of which are plotted squares which represent an estimate of the true size of the “treatment effect,” derived from an average of the treatment effects measured from all the trials performed of that medicine. If the box is squarely on the vertical line it means it is a treatment whose benefits have been found equal to its harms. In the above list, (with the exception of one) medicines with “positive” treatment effects are listed, meaning the benefits of treatment with these agents outweigh any potential or actual harms. No medicine on the list above, besides convalescent plasma (CP), indicates it is inferior to placebo (note that CP was the initial favored therapy of every single academic medical center in the U.S despite the fact CP has only ever been shown to be effective in hematogenous infections). In cases, such as with CP, due to the fact it’s harms outweigh it’s benefits, the box is plotted on the right side of the line and shaded in red. Conversely, the farther to the left of the vertical line that a box is plotted, the larger the measured impact on the clinical outcome tested. Green boxes indicate the effect estimate is based on at least 4 trials. Grey boxes and greyed out medicine names mean the estimate for that medicine is based on fewer than 4 trials. The thin horizontal line through each little box indicates the degree of precision, i.e. how confident we can be in the estimate of the treatment effect – narrow horizontal lines through the boxes mean the data in support is large and consistently positive and is “statistically significant” in favor of the medicine. The wider the line, the less consistent, or less amount of data can be relied upon to make the estimate. When the horizontal line through a box extends across the vertical gray line, this indicates that it is statistically possible that the true estimate may actually be in favor of placebo!

With ivermectin, what sets it apart from all the other compounds tested, is the sheer number of randomized and observational controlled trials that have been performed to date. It is #1 among the “green box” compounds given it has been tested in 73 controlled trials which include an unheard-of 56,804 patients. Why unheard of? Because never in history has a medicine been so thoroughly tested, with such consistent positive results, yet led to a situation where governmental agencies in highly developed countries call for even more placebo-controlled trials to be done.. and then slow walk to doing them. The ethics of giving a covid patient a placebo given this amount of supportive data are too miserable to contemplate this early in the article (fun fact – I was personally asked to try to help recruit patients for the ongoing University of Minnesota placebo controlled RCT. I got off the phone as fast as I could). Another not-so-fun fact: penicillin was mass deployed to great effect to all our troops for their battlefield injuries in World War II.. based on a case series of 157 patients where their bacterial infections overtly resolved without signs of toxicity during treatment. Not one RCT was done before this decision was made by military and medical leaders.

The only other medicine with a larger supportive evidence base is hydroxychloroquine (HCQ), especially when only the early treatment trials of HCQ are considered as that collection of trials results in an equally impressive position on the Forest plot (not shown). A tired topic I will explore later is the much parroted (and highly favored by Pharma) notion that “retrospective, observational controlled trials (OCT)” cannot be trusted as they are inferior to “proper, large, double-blind, randomized, placebo controlled trials (RCT).” This notion is not evidence based. Even the captured (I know, sorry) Cochrane Library knows this. They themselves have shown that, on average, over thousands of clinical trials, over decades of research, OCT’s and RCT’s reach the same conclusions. So stop with the false dichotomy. Pharma wants you to only trust in “large RCT’s”.. because they are the only ones with the cash to do them. That way, they can control the only medicines that get “proven” and thus adopted into guidelines.

Two absurdities (crimes) must be highlighted in the above diagram – one is the sheer number of medicines with demonstrated efficacy, most costing under $5 a dose (and almost all with unparalleled safety profiles and/or “over the counter” status) that are still not recommended by any U.S or “western” health agency (with the exception of the state of Florida since the hire of Surgeon General Dr. Joseph Ladapo who has put together a terrific public health campaign supporting the use of a combination early treatment protocol which includes another FLCCC adopted drug, fluvoxamine).

Meanwhile our federal governmental health agencies, which I have argued repeatedly (and will for years until it stops) are so completely captured by the pharmaceutical industry that they have not advocated for any one of these “repurposed” compounds, even as a “precautionary principle” (meaning that even if the purported benefits may not be realized to the extent estimated, the risks are so small it is more likely best for all we employ them now in early treatment given the world is cratering). Their most unforgivable and absurd inaction is the deliberate ignoring of the critical role of Vitamin D in protecting against the worst outcomes of COVID, despite knowing full well significant portions of the U.S population is Vitamin D deficient. Even Anthony Fauci recommends to himself that he take Vitamin D… regularly. The data below was given to me by a Dr. Henele and is from work he published in 2016. Note the percent of the U.S population that is critically deficient in Vitamin D.

The second absurdity is found when looking at the plot with only the medicines recommended in the NIH’s COVID protocol circled. Note that the NIH protocol is adhered to by almost the entirety of the country’s hospitals (largely due to large add-on bonuses paid to hospitals when the protocol elements are used – I am not making this up). A “theme” should begin to emerge as you look at the circled, “recommended” medicines vs the non-circled, “non-recommended” medicines – every single one is massively expensive. Every single one. Note not one inexpensive drug is circled. How much more evidence do you need to prove that our agencies have been completely captured by the pharmaceutical industry?

Fun fact now that you are en expert in reading Forest Plot’s: Merck’s mutagenic new drug molnupiravir, after the highly positive results from their study’s “interim analysis,” published in a press release, instead found that, in the 2nd half of its one study, the data favored… placebo. Thus if the 2nd half was a stand-alone study (which it arguably could have been) it’s box would be firmly on the right side of the line. FDA still approved… while feigning concern. Unsurprising really.

Now, beyond the above 73 controlled trials supporting ivermectin, there are, in addition, numerous health ministries from around the world that deployed ivermectin in either the prevention or early treatment of COVID, among often very large populations. Each program’s report found that ivermectin use led to massive reductions in the need for hospitalization and/or death (Mexico CityUttar PradeshBrazilMisionesLa Pampas, PeruPhillipines, and Japan – I will do a deeper dive on these in a later post). The program in the city of Itajai, Brazil is both the largest study of ivermectin in the world (data from nearly 200,000 patients was carefully collected over a 6 month period) and most impressive. They found that, despite the fact that the 120,000 patients who agreed to take ivermectin every 15 days were older, fatter, and sicker than the approximately 37,000 that did not…they went to hospital 67% less frequently, and died 70% less frequently.. from all causes, not just COVID. The issue with ivermectin as a therapeutic in COVID.. has NOTHING to do with the science.

The issue with ivermectin is simply it’s price – it costs less than a $1 and represents the biggest threat to the immense and future profits of the pharmaceutical industry’s novel oral anti-viral drugs… as well as their vaccines.

The previous title holder of the largest threat to Pharma profits in COVID was the highly effective (and also anti-viral) drug hydroxychloroquine (HCQ). However, it lost that title after the 2020 war on HCQ was essentially won by Pharma (for now?), using tactics so sinister as to be unimaginable, and which I will not review here as that macabre war has already been expertly reviewed in incredible and highly referenced detail in the book “The Real Anthony Fauci” by Robert F. Kennedy Jr. His book, in my opinion, is a must read for all the globe’s citizens, as without it, no coherent understanding of the innumerable non-scientific actions and policies across the entirety of the developed (and majority of the undeveloped) world can be gained.

I must emphasize that ivermectin is just the latest drug under attack during Pharma’s long-standing (and highly successful) war on off-patent, “no-longer-obscenely-profitable” medicines. Books have been written about the numerous, and often criminal actions that Big Pharma has employed to replace older off-patent medicines with newer, highly profitable, and often poorly tested drugs with either prospectively known dangers or quickly discovered dangers which they then criminally suppress or distort to preserve profits. When science supporting older, off-patent, often “repurposed” medicines (particularly in the lucrative environment of a global pandemic) becomes “inconvenient” to the financial promise of newer agents, the industry employs what are called “Disinformation” tactics, first invented and perfected by the Tobacco Industry, and now used to great effect by the Pharmaceutical (and many other) industries. These tactics are brilliantly and succinctly summarized in an article called The Disinformation Playbook written by The Union for Concerned Scientists. I encourage all to read. The 5 main “plays” from the playbook are listed below. If you are at all versed in the ivermectin in COVID saga (many FLCCC followers are), it should be easy to quickly come up with numerous examples of each nefarious tactic. I give some hints below..

1) The “Fake”: Conduct counterfeit science and try to pass it off as legitimate research (Dr. Andrew Hill)

2) The “Blitz”: Harass scientists who speak out with results or views inconvenient for industry (attacks on FLCCC founders)

3) The “Diversion”: Manufacture uncertainty about science where little or none exists (Dr. Andrew Hill/captured high-impact journals)

4) The “Screen”: Buy credibility through alliances with academia or professional societies (i.e. high impact medical journal influences)

5) The “Fix”: Manipulate government officials or processes to inappropriately influence policy (i.e. capture the health agencies by creating “revolving doors” between Pharma and government to ensure total synchrony in objectives amongst their leaders)

Given the Disinformation Playbook was last updated in 2018, it does not include newer, more nefarious tactics that industries have been able to deploy since the historic consolidation of financial power by just 3 multi-trillion dollar investment funds (Black Rock, State Street, and Vanguard). These three corporations have now acquired influential or outright controlling investment stakes in nearly every major corporation in nearly every industry. These investment managers power, particularly the power held synchronously over media companies, social media companies, and the near entirety of the pharmaceutical industry, has allowed even more fearsome tactics to be used in the near-global suppression of the efficacy of ivermectin (and HCQ) as they now:

1) CENSOR any mentions of supportive evidence in corporate, (a.k.a. “legacy”) media. Note that, besides the influence of these investment manager overlords, the global censoring ability of media was greatly helped by the “Trusted News Initiative (TNI),” an obscene (and either naively misguided or completely corrupt) effort by the most powerful journalism organizations in the world to band together to try to control the spread of “mis-information”. Yes, professional journalists decided they needed to control information in a pandemic. I am not making this up. Would an appropriate analogy be that a bunch of physician leaders decided they needed to spread disease in a pandemic?

2) CENSOR any mentions or discussions of efficacy on almost all social media – see explicit youtube “community” policy below as the most unsubtle example:

YOUTUBE COMMUNITY GUIDELINES

3) RETRACT positive papers from impactful medical journals (3 fully peer-reviewed and highly supportive scientific reviews of ivermectin have been retracted, either immediately prior to or post-publication (I was the lead author on the first one with my FLCCC colleagues)

4) BLOCK review and publication of positive trials of ivermectin in major medical journals (in my now global network of ivermectin-expert and/or ivermectin study investigator colleagues, all lament how their positive clinical trials or papers were rejected for review from all the high-impact (captured) journals, with Dr. Eli Schwartz’s highly sophisticated, expertly conducted, and immensely positive study from Israel being one of the most illustrative examples

5)PUBLISH numerous “hit pieces” within high profile print media outlets discrediting the science and/or the scientists who support the medicine. This is actually an example of the already described “Blitz” tactic, but in 2021, during COVID, using total media control, it was deployed by a division of Howitzers. A more recent and relatable example of “the Diversion” tactic was when the NFL used media hit pieces to go after the scientists (and their inconvenient science) after they began publishing and disseminating data about the high rates and disastrous impacts of chronic traumatic encephalopathy in retired NFL players.

What I have found fascinating, is that for every planted hit piece article discrediting the mountain of evidence supporting ivermectin as a therapeutic, the FLCCC is actually rarely mentioned. But why? I think it is because the FLCCC is a sizeable group of highly published physicians and researchers (Professor Paul Marik is actually the most published practicing ICU physician in the history of the specialty). Thus, it’s hard (but not impossible) to call us “fringe.” The last thing they want to do is call attention to our high degree of credibility. Instead they seem to be trying to destroy it using separate hit pieces (among other tactics) which has led to the recent loss of employment for three founding FLCCC members (Drs. Marik, Meduri, and yours truly have been forced to leave jobs or had their exemplary clinical and research careers ended (Drs. Marik and Meduri). An article on ivermectin that does not mention our organization does so purposefully so as not to give attention to credible support for its use given we are considered the foremost clinical experts on the clinical use of ivermectin in COVID in the world.

6) employ a coordinated media-government agency PROPAGANDA campaign;

August 26th, 2021: Pharma used their CDC to send out a “health advisory” to all 50 state Departments of Health, which they then sent to all the physicians licensed in their respective states (a terrifying example of the immense destructive power of a federal agency captured by pharmaceutical industry interests). The bulletin both;

1) depicted ivermectin as a dangerous drug by deliberately exaggerating reports of calls to poison control centers

2) cited the meaningless fact that it “is not FDA approved for COVID” as a reason it should not be used, hoping doctors may not realize that “off-label” prescribing is both legal and encouraged.. by the FDA.

Next,a quickly debunked (not quickly enough) planted media article in Rolling Stone appeared with an impressively click-bait-able headline describing emergency rooms so overflowing with ivermectin overdoses that our nation’s gunshot victims couldn’t get (obviously) needed care (even I clicked on it). The article then went viral across the world (thousands of media mentions) before the hospital could put out a statement saying it was 100% false. Gee, do you think Pharma hired a professional PR firm to pull that one off or did they just benefit from a serendipitous and lamentably lazy journalist’s error?

Then, in another terrifying example of the control of major corporate media.. for week after week every news broadcaster, pundit, and late-night talk show host prefaced the word ivermectin with the descriptor “horse de-wormer.” Over and over and over again (totally pissing off Joe Rogan who recovered from COVID with ivermectin as part of his combination protocol- hah!)

Then finally, in a coup de grace, in comes Pharma’s FDA proudly using twitter to associate ivermectin with, you guessed it, horses. Janet Woodcock, the acting Commissioner of the FDA, even sent out a congratulatory email to her team about the success of the tweet.

Was this a coordinated attack led by an expert team of brazen PR professionals who have a fondness for horses… or did it arise organically via a series of disconnected events?

If you are still not convinced of the former, I need to point out that this “series of disconnected events” had an uncanny sense of when to “roll-out.” The CDC’s Health Advisory was issued on August 26th. Look at the below chart and see if you can find any reason why it would start then? Recall that the advisory was ostensibly in reaction to false “reports of calls to poison control centers”. The below chart shows instead what was really going on at the time – hundreds, if not thousands of licensed medical professionals across the country were prescribing ivermectin like mad during the terrible, and deadly summer surge of the Delta variant. Was someone getting nervous that a “dirty little secret” was being rapidly discovered by American citizens and physicians? The answer is a definitive yes – thus triggering Pharma to nefariously try to “stuff the genie back in the bottle” by unleashing their terrifying disinformation propaganda campaign.

NUMBER OF IVERMECTIN PRESCRIPTIONS DISPENSED IN THE U.S OVER TIME

But check this out.. the good ole’ FLCCC, my little band of brothers and sisters, is somehow making a opening in the wall of information suppression and distortion as shown in the chart below (compiled by our data analyst and ivermectin expert, Juan Chamie). I say this makes us “the Bad News Bears” in the repurposed drug war.

I am going to stop here.. and call it PART I. Please subscribe below so you can be sure to get Part II where I will continue to detail the numerous and wide-ranging corrupt actions taken to suppress the knowledge of efficacy and restrict the use of ivermectin… across the world. There is way way more to this story (warning – paywall ahead on some articles, like maybe the 2nd half of Part II so please sign up!)

Sorry, but the hours of writing are becoming too many – I don’t write fast, it takes me hours for each piece because I write, re-write, revise etc like an idiot- even though I know this stuff like the back of my hand because I have lived it every day for almost 2 years. Plus, I am no longer clinically employed since the hospitals don’t want me in their ICU’s anymore. Maybe I will make writing about the sad (but hopefully reparable?) state of medicine a new career until the old hospitals (or some new ones!) decide they want me back?

Check out Dr. Pierre Kory’s blog on Substack.

CDC Drops the RT-PCR Test as It Doesn’t Differentiate COVID-19 & Influenzas

The U.S. Centers for Disease Control and Prevention (CDC) after December 31, 2021, will withdraw the request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel, the assay first introduced in February 2020 for detection of SARS-CoV-2 only. The CDC is providing this advance notice for clinical laboratories to have adequate time to select and implement one of the many FDA-authorized alternatives. As it turns out, the CDC now acknowledges challenges with the PCR test for testing both for COVID-19 and influenza. The CDC seeks to make a combined test that could be used as an assay for influenza and SARS-CoV-2.

After December 31, 2021, the CDC will withdraw the emergency use authorization of the PCR test for COVID-19 testing. The CDC finally admitted the test does not differentiate between the flu and COVID virus.

The FDA shares more on its website for a list of authorized COVID-19 diagnostic methods. For a summary of the performance of FDA-authorized molecular methods with an FDA reference panel, visit this page.

In preparation for this change, the CDC recommends clinical laboratories and testing sites that have been using the CDC 2019-nCoV RT-PCR assay select and begin their transition to another FDA-authorized COVID-19 test. CDC encourages laboratories to consider the adoption of a multiplexed method that can facilitate the detection and differentiation of SARS-CoV-2 and influenza viruses. Such assays can facilitate continued testing for both influenza and SARS-CoV-2 and can save both time and resources as we head into influenza season. Laboratories and testing sites should validate and verify their selected assay within their facility before beginning clinical testing.

Another Family Sues to Use Ivermectin

In what is now a familiar story, another family is suing a hospital in Florida to allow ivermectin to be administered to a relative in Intensive Care. TrialSite has chronicled legal matter after matter dealing with hospitals not budging on rigid federal treatment protocols. The Florida Times Union reports that  Daniel Pisano, a 71-year-old man, was given a 5 percent chance of survival when he was hospitalized in the intensive care unit at The Mayo Clinic in Jacksonville, Florida. Pisano was admitted to the hospital on December 11th with Covid-19 and was put in the ICU on December 18th. On December 22nd Pisano was intubated and put on a ventilator.  

The Pisano family is now suing the Mayo Clinic to allow Jacksonville-based Dr. Ed Balbona to administer ivermectin to Daniel. Balbona is a doctor of internal medicine at Baptist Medical Center in Jacksonville. As TrialSite News has pointed out many times, ivermectin is controversial because of the drug’s status with the Food and Drug Administration. The agency continually recommends “more research” into the drug.

After Pisano was intubated, the family consulted with Dr. Balbona who then prescribed ivermectin, but the Mayo Clinic refused to administer the drug. The hospital wouldn’t allow Balbona to treat Pisano, noting that Balbona is not board-certified, not on staff at the Mayo Clinic, and is not permitted to practice medicine at their facility because it has “closed staff,” and all doctors there are Mayo employees.

FirstCoastNews reports at a December 30th emergency hearing, the attorney for the Mayo Clinic said the petition by the Pisano family is a “very difficult situation” but forcing the hospital to use a treatment not approved by its doctors would “set a dangerous precedent.” FirstCoastNews points out that in September, a judge in Florida ordered Baptist Medical Center South, also in Jacksonville, to administer ivermectin to a 70-year-old woman. So, administering the controversial drug in a Florida hospital is not without precedent.

The family’s emergency petition was denied by Circuit Court Judge Marianne Aho, who said in her ruling that the Pisano’s family lawyers have not proven “potential benefit to the patient of administering the requested treatment protocol will outweigh the potential harm to the patient of administering the protocol.” The judge also cited the fact Dr. Balbona is not on staff at the Mayo Clinic. The Pisano family lawyers then filed a motion for a rehearing and asked Judge Aho to recuse herself. Aho agreed because she had worked for one of the law firms representing the hospital.

TrialSite News has reported extensively on lawsuits against hospitals to allow ivermectin to be administered, including one in Illinois where a patient walked out of a hospital after the family sued to use ivermectin. In that case, the judge stated, “the benefits could outweigh the risks.” Often called a “horse drug,” TrialSite has covered the difference between the use of ivermectin in animals and in humans. If ivermectin is used and “the benefits could outweigh the risks,” why is the medical establishment so hesitant?  

Related

There is no Control of the Omicron Wave’ as Heavily Pfizer-Boosted Nation Shatters Infection Record

The omicron variant of SARS-CoV-2 rages now through the eastern Mediterranean nation of Israel as the reported number of cases hit a COVID-19 pandemic record of 17,362 new infections on Monday, January 5th.  As TrialSite just reported, a fourth booster program commences, targeting higher risk demographics such as the elderly and immunocompromised. This sweeping contagion, while seemingly milder in symptoms, demonstrates the limitations of the mass vaccination to eradicate SARS-CoV-2 strategy in this heavily vaccinated nation driven by a confluence of elite medical establishment officials and executives in regulatory agencies, national and international public health authorities, elite academic medical centers, and industry not to mention financiers and investors monetizing the pandemic and influential not-for-profits. TrialSite shared with community members that by October and November of last year, based on Israel Health Ministry data that the unvaccinated still faced a higher risk for severe infection, but we also reported on striking numbers of breakthrough infections leading to hospitalization. One Sheba Medical Center study opens up a Moderna arm—are there some underlying seeds of doubt concerning Pfizer-BioNTech’s BNT162b2?

The good news is that despite historically high infections, the death rate is very low, at least thus far, based on data from the COVID-19 Data Repository by the Center for Systems Science and Engineering (CSSE) at Johns Hopkins University. TrialSite cannot be certain what’s behind the lower death rate but more than likely, a confluence of factors from vaccination and growing natural immunity to the milder mutant could be an explanation. So, in that way, mass vaccine proponents will claim that the products made the pandemic milder but a fundamental underlying assumption for what is now hundreds of billions worldwide spent on vaccine-supporting programs was very much centered on pathogen eradication—something the vaccine products are failing to address. TrialSite reminds all that, worldwide, nearly 5.5 million Covid deaths are recorded. Many critical care physicians have argued all along that off-label use of a handful of repurposed drugs could have saved many lives.

Out of Control

Sharon Alroy-Preis, the nation’s top public health official, told Channel 13, “There is no control of the Omicron wave.”  The health minister continued, “Probably no one is protected from infection,” reports the president of Shaare Zedek Medical Center in Jerusalem.

Goal: Keep Economy Open

Avoidance of economic pain and suffering becomes a top goal of governments across the West as the realities of the situation settle in—meaning the transition to an endemic stage and learning to live with the SARS-CoV-2 pathogen. Prime Minister Naftali Bennett declared at a recent press conference, “It’s a different ball game altogether.”

Let the Boosts Begin

Regardless of vaccine limitation, the fourth boost program accelerates full throttle. Israel21c reports thousands started last week getting their fourth booster shot of the Pfizer-BioNTech mRNA-based vaccine since the government authorized use for healthcare workers, the elderly, and immunocompromised. The rationale for the decision? Protect the vulnerable from the imminent omicron wave. The decision was made prior to an important Sheba Medical Center study investigating the impact of a fourth dose on 150 employees at the academic medical center.

Israeli media reports that all those subjects that received three Pfizer-BioNTech doses five or more months ago now don’t have sufficient antibodies to respond to SARS-CoV-2.  

Concern with Pfizer-BioNTech Vaccine?

Interestingly, in this Sheba Medical Center study, led by the director of the Infectious Disease Epidemiology Unit, the study now expands, and a hospital spokesperson told Israel21c that they will embrace the Moderna mRNA-based vaccine on a separate group of study subjects. They will test if mRNA-1273 has a superior impact to resist omicron in healthcare workers that have already received three Pfizer-BioNTech doses.