Orthodox Reflections

As we all know by now, the FDA has approved the Pfizer COVID mRNA vaccine. Typically, vaccines take as long as 10-15 years to develop. The Pfizer vaccine was developed in less than a year and had the fastest approval time for a drug in U.S. history. The approval followed on the heels of millions of doses delivered under Emergency Use Authorization. Neither of these two events, the EUA or the approval, should have happened. The fact that they did illustrates how corrupt and immoral our medical system has become.

Emergency Use Authorization Should Never Have Been Granted

According to the FDA, “Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives.” We heard this over and over again last year – there were no treatments for the novel corona virus. People were dying. There was nothing anyone could do but go all-in at “Warp Speed” to develop vaccines. It was our only hope. We needed them so desperately, we couldn’t even wait for their clinical trials to be completed.

This was always a lie.  People died to maintain this lie.

Dr. Peter McCullough is an internist, cardiologist, and epidemiologist in academic and medical practice in Dallas, Texas. Dr. McCullough was key in publishing Pathophysiological Basis and Rationale for Early Outpatient Treatment of SARS-CoV-2 (COVID-19) Infection, the first synthesis of sequenced multidrug treatment of ambulatory patients infected with SARS-CoV-2 in the American Journal of Medicine and subsequently updated in Reviews in Cardiovascular Medicine. This paper was originally published in early 2020. In his testimony before the Texas Senate, Dr. McCullough describes how his attempts to educate doctors on treatment of COVID-19 faced unbelievable censorship and opposition. According to Dr. McCollough, there was seemingly no interest in treating COVID or developing therapeutics. You can watch his full testimony here.

Even early on, there was strong evidence for the successful use of monoclonal antibodies, HCQ, IVM, antibiotics, steroids, colchicine, and blood thinners to successfully treat COVID. This was months prior to the release of the vaccines. All of this critical information was suppressed and ignored in favor of a total focus on the development of experimental vaccines.

In this video, Dr. Ryan Cole explains just how crazy the situation with treatment has been:

The three-letter government agencies have practiced therapeutic nihilism. Apathy, complete apathy. If you get sick, go home. If your lips turn blue, then go to the hospital. If you can’t breathe, go to the hospital. When in the history of medicine have we said to someone, “Gosh, you have pneumonia, but once you’re sick enough to be hospitalized in the ICU, we’ll give you an antibiotic for your pneumonia”? It’s insanity. We as physicians have collectively lost our medical minds… The earlier you treat, the more complications you can reduce down the road… There is a treatment. Unfortunately, if there is a treatment for a disease, the federal government cannot approve a vaccine. By law, by rule.“

Dr. Cole also explains in his talk (please watch all of it) that Corona viruses are seasonal, and there is nothing that can be done to get rid of them. They simply run their course. Masks. lockdowns and social distancing are just so much theater. On the other hand, as Dr. Cole makes clear, we can absolutely reduce the risk of COVID-19 by improving human immune systems: “There is no such thing as cold and flu season. There is only low Vitamin D season. 70 to 80% of Americans are immunosuppressed because they are immune deficit because of low Vitamin D. 96% of ICU patients are Vitamin D deficient. Normal Vitamin D levels decrease your risk of severity and hospitalization for COVID by 90%.” You can also encourage people to lose weight, as obesity appears to triple the risk of hospitalization due to a COVID-19 infection.

Have you ever heard a member of any government “task force” encourage people to lose weight, improve their immune systems via Vitamin D supplementation, and seek early treatment for any COVID symptoms? No? Why is that?

Let me repeat – people were allowed to get ill and even die to preserve the lie that there were no treatments and no preventions for COVID-19. If the medical establishment had acknowledged the truth, then there could have been no emergency authorization for any of the COVID-19 vaccines. 

Dr. Robert Williams, analyzing the clinical trial data from Pfizer and Moderna, predicted in an article on Orthodox Reflections that the vaccines were ineffective and would fail. Dr. Williams showed that the actual risk reduction (efficacy) for Pfizer’s vaccine was less than 1% and for Moderna’s was 1.2%. Dr. Williams also made it clear why these facts were being ignored:

Compared to providing Covid-19 protection, these mRNA vaccines are much more effective in enriching their already wealthy pharmaceutical producers, or those who have heavily invested in them. For the public good, it would have made more sense, saved more money, more time and possibly more lives to have put research efforts into other potential Covid-19 treatments, such as Ivermectin, Melatonin, Vitamin D, even the highly controversial Hydroxychloroquin, or anything else that has shown any indication of being helpful either as a prevention or a cure.  Unfortunately, these are all inexpensive drugs with no hope of any appreciable returns for the pharmaceutical industry which relies on new innovations to garner profits, even if those innovations are of minimum benefit with the potential to cause great harm.

In the real world, the vaccines have failed to prevent both the transmission of COVID-19 and severe illness. To save lives and reduce hospitalizations, Governor DeSantis of Florida recently began opening monoclonal antibody treatment centers around the state to help those, including the fully vaccinated, who need treatment. Many critics attacked him for this move. At least one news article charged that he was promoting this treatment to enrich himself. Those in the journalistic and medical establishments not openly criticizing the governor’s efforts, chose to ignore them instead. Because of the controversy and suppression of information, it is a certainty that some people in the state suffered rather than receive a treatment that is safe, effective, and free.

But all that changed, literally overnight. On Aug 23, 2021, the EUA for Pfizer, conditional upon there being “no adequate and approved available alternatives,” was removed and FDA approval was granted. The next day, on August 24th, Dr. Anthony Fauci was suddenly praising the use of monoclonal antibodies:

COVID-19 sufferers can reduce their risk of hospitalization and death by up to 85 percent if they receive monoclonal antibody treatments in the early stages of their illness, Dr. Anthony Fauci said Tuesday.

 

The White House chief medical adviser said that using the lab-made antibodies to fight the virus before a patient is hospitalized can prevent the chances of severe illness by between 70 and 85 percent.

 

“It is important to emphasize that this must be done early in infection and not wait, of course, until a person is sick enough to be hospitalized,” Fauci said at a COVID-19 press briefing.

 

“That’s when you get the best effect. And again, being an underutilized intervention, we want people out there, including physicians as well as potential patients, to realize the advantage of this very effective way of treating early infection.”

 

Fauci said the treatment could significantly benefit certain at-risk groups, such as those over the age of 65, pregnant women and people with compromised immune systems.

 

“Bottom line is this is a very effective intervention for COVID-19. It is underutilized, and we recommend strongly that we utilize this to its fullest,” Fauci said.

It is incredible the difference a day can make in “the science.” Suddenly, early intervention and treatment have become a priority, whereas but a few moments before, they were an impossibility. A conspiracy theory, even.

Monoclonal antibodies treatment has been available longer than the vaccines. President Trump credited the treatment for his successful recovery last Fall. The only reason this treatment is “underutilized” (to quote Fauci) is because the governmental / pharma / medical complex actively avoided even discussing it. Until now. When it’s safe to do so because the Pfizer vaccine is “fully approved.”

Now that there is an “adequate, approved, and available alternative” vaccine (Pfizer), as well as at least one acknowledged, underutilized treatment for COVID, wouldn’t you expect the emergency use authorizations (EUA) for the Moderna and Johnson and Johnson vaccines to be withdrawn?

No, of course not. That would be silly. Especially since National Institute of Health (NIH) owns half the key patent for Moderna’s COVID vaccine and stands to collect half the royalties. Four NIH scientists filed their own provisional patent application as co-inventors. NIH regulations let agency scientists collect up to $150,000.00 annually in royalties from vaccines upon which they worked. So don’t expect the approval of Pfizer’s vaccine to inconvenience the availability of Moderna’s vaccine all that much. Or that of a major player like Johnson and Johnson.

FDA Approval of the Pfizer Vaccine Should Never Have Happened

Peter Doshi is the senior editor of the prestigious British Journal of Medicine. The BMJ is a weekly peer-reviewed medical trade journal published by the British Medical Association. On August 23rd, he penned a blistering indictment of the FDA approval of the Pfizer vaccine entitled: Does the FDA think these data justify the first full approval of a covid-19 vaccine? Doshi believes that normative procedures for approval were skipped and  that critical questions have been ignored in the breakneck race to approve the Pfizer vaccine. He even brings to light the fact that the former FDA Chief under the Trump Administration, Scott Gottlieb, currently serves on Pfizer’s Board of Directors.

I highly recommend you read the entire article, but here are some of the key highlights:

• The FDA should demand adequate, controlled studies with long-term follow up, and make data publicly available, before granting full approval to COVID-19 vaccines.
• Immunity provided by the vaccines is waning. Doshi writes, “And so the recent reports from Israel’s Ministry of Health caught my eye. In early July, they reported that efficacy against infection and symptomatic disease “fell to 64%.” By late July it had fallen to 39% where Delta is the dominant strain. This is very low. For context, the FDA’s expectation is of “at least 50%” efficacy for any approvable vaccine. Waning efficacy has the potential to be far more than a minor inconvenience; it can dramatically change the risk-benefit calculus. And whatever its cause—intrinsic properties of the vaccine, the circulation of new variants, some combination of the two, or something else—the bottom line is that vaccines need to be effective. Until new clinical trials demonstrate that boosters increase efficacy above 50%, without increasing serious adverse events, it is unclear whether the 2-dose series would even meet the FDA’s approval standard at six or nine months.”

• The U.S., and the world, are both awash in cases among the fully vaccinated. Even so, the proponents of the vaccine fall back on the defense that, “The original premise behind these vaccines was that they would substantially reduce the risk of death and severe disease and hospitalization.” But there is a glaring problem with that statement. The Pfizer trials were not designed to study severe disease. In the data that supported Pfizer’s EUA, the company itself characterized the “severe COVID-19” endpoint results as “preliminary evidence.” Hospital admission numbers were not reported, and zero COVID-19 deaths occurred. On preventing death from COVID-19, there are too few data to draw conclusions. We know the vaccines do not prevent infection or spread of the disease. At this point, we also don’t know if they actually lessen the severity of the disease or save lives.
• In August 2020, to address vaccine hesitancy, the FDA had “committed to use an advisory committee composed of independent experts to ensure deliberations about authorization or licensure are transparent for the public.” The FDA did not convene this advisory committee to discuss the data ahead of approving Pfizer’s vaccine.
• Approval is being granted only 13 months into an ongoing, two year trial, no reported data past 13 March 2021, with unclear efficacy, evidence of waning protection irrespective of the Delta variant, and limited reporting of safety data.

Dolshi finishes his article with the following:

Prior to the preprint, my view, along with a group of around 30 clinicians, scientists, and patient advocates, was that there were simply too many open questions about all covid-19 vaccines to support approving any this year. The preprint has, unfortunately, addressed very few of those open questions, and has raised some new ones.

 

I reiterate our call: “slow down and get the science right—there is no legitimate reason to hurry to grant a license to a coronavirus vaccine.”

 

FDA should be demanding that the companies complete the two year follow-up, as originally planned (even without a placebo group, much can still be learned about safety). They should demand adequate, controlled studies using patient outcomes in the now substantial population of people who have recovered from covid. And regulators should bolster public trust by helping ensure that everyone can access the underlying data.

The Pfizer vaccine, and the other COVID-19 vaccines, are failing to “stop the spread.” They are failing to prevent deaths. They are failing to prevent serious illness. There are substantial safety questions about them. Yet, Pfizer has been approved anyway.

And now we are planning a “booster” shot, for which there is practically no clinical data at all. No one actually knows if it will help or what the potential risks are for repeatedly injecting mRNA into your body.

But we are going to do it anyway. And despite all these questions, we are facing an onslaught of vaccine mandates from multiple levels of government and from private enterprises. The situation is simply madness.

In addition, we are now seeing the return of masks, lockdowns, quarantines, and mass testing. None of this worked. None of this will work. The virus is endemic. It has an animal reservoir. It will never go away. Take just a few minutes to listen as this doctor explains all that:

More COVID facts the CDC & Biden Administration doesn't want you to hear. pic.twitter.com/WRaLZtqC0f

— Sebastian Gorka DrG (@SebGorka) August 9, 2021

COVID-19 is a preventable, treatable illness. In the cases where prevention and treatment fail (or are withheld), it is not the young and the healthy that die from it. Those that die from COVID average 78.6 years of age (in some places older), and have an average of more than two serious co-morbidities. If we just stopped obsessing over “cases,” then the “pandemic” would be over. Positive PCR tests are not indictive of whether a person is actually sick or infectious to others.

Paul Hunter is professor in medicine at the University of East Anglia and advisor to the World Health Organisation on Covid. Speaking before a committee of the British Parliament, he explained that it was time to change the way the data was collected and recorded as the virus is now endemic, “We need to start moving away from just reporting infections, or just reporting positive cases admitted to hospital, to actually start reporting the number of people who are ill because of Covid.  Otherwise we are going to be frightening ourselves with very high numbers that actually don’t translate into disease burden.”

We also know that tens of millions of Americans have already had COVID, most with mild to no symptoms, and now enjoy long-lasting natural immunity. Multiple studies prove that fact, including 15 you can read about here. One British study found that fewer than 1% of of those who previously had COVID caught it a second time. A new Israeli preprint shows vaccinated people were 13x as likely to be infected and 27x to have symptomatic infections as a matched cohort that was previously infected. This study was with Delta as the dominant variant. As time goes on, more and more healthy individuals will be graced with natural, long-lasting immunity, without the risks of vaccine side effects.

We do not need to obsess over COVID. We do not need to shut down our lives. We do not need to inject ourselves with experimental, unproven and possibly worthless vaccines.

So why are we doing this?

Medicine is Money

Our regulatory, corporate, political, and medical establishments are thoroughly and totally corrupt.

We can start our examination of this fact with the FDA. The FDA is essentially funded by the companies it is supposed to regulate and is run for their benefit, not the public’s. This is not a new issue. A paper entitled Institutional Corruption of Pharmaceuticals and the Myth of Safe and Effective Drugs published in the Journal of Law, Medicine and Ethics back in 2013 made the following case:

Over the past 35 years, patients have suffered from a largely hidden epidemic of side effects from drugs that usually have few offsetting benefits. The pharmaceutical industry has corrupted the practice of medicine through its influence over what drugs are developed, how they are tested, and how medical knowledge is created. Since 1906, heavy commercial influence has compromised Congressional legislation to protect the public from unsafe drugs. The authorization of user fees in 1992 has turned drug companies into the FDA’s prime clients, deepening the regulatory and cultural capture of the agency. Industry has demanded shorter average review times and, with less time to thoroughly review evidence, increased hospitalizations and deaths have resulted. Meeting the needs of the drug companies has taken priority over meeting the needs of patients. Unless this corruption of regulatory intent is reversed, the situation will continue to deteriorate. We offer practical suggestions including: separating the funding of clinical trials from their conduct, analysis, and publication: independent FDA leadership; full public funding for all FDA activities; measures to discourage R&D on drugs with few if any new clinical benefits; and the creation of a National Drug Safety Board.

Here is some shocking information published by Harvard:

The bar for “safe” is equally low, and over the past 30 years, approved drugs have caused an epidemic of harmful side effects, even when properly prescribed. Every week, about 53,000 excess hospitalizations and about 2400 excess deaths occur in the United States among people taking properly prescribed drugs to be healthier. One in every five drugs approved ends up causing serious harm, while one in ten provide substantial benefit compared to existing, established drugs. This is the opposite of what people want or expect from the FDA.

 

Prescription drugs are the 4th leading cause of death. Deaths and hospitalizations from over-dosing, errors, or recreational drug use would increase this total. American patients also suffer from about 80 million mild side effects a year, such as aches and pains, digestive discomforts, sleepiness or mild dizziness.

The FDA does such an amazing job that prescription drugs are routinely approved that provide little, if any, benefit compared to previously available drugs. Under the FDA’s watch, prescription drugs are the 4th leading cause of death. The shortcomings of the FDA were well established facts years before anyone had ever heard of “mRNA” technology.

The situation has only gotten worse since those articles were written. There is a revolving door between big business and regulators. Former FDA Chief under the Trump Administration, Scott Gottlieb, serving on Pfizer’s Board of Directors is just one example. The reverse also happens, with industry insiders being awarded government positions. This is a bipartisan problem, by the way. Just one example, the Obama administration appointed Michael Taylor, the previous vice president of Monsanto and a Monsanto lobbyist, to a high level advisory role at the FDA.

At times it seems the government is in business with the companies it is supposed to be regulating. As noted, National Institute of Health (NIH) owns half the key patent for Moderna’s COVID vaccine, stands to collect half the royalties, and employees of the federal government will benefit financially from the arrangement. Almost half the budget of the FDA comes from user fees paid by companies. That financing arrangement has made a huge difference in how the FDA operates. The following is from C. Michael White, a pharmacist and medication and dietary supplement safety researcher at UConn School of Pharmacy:

The Food and Drug Administration has moved from an entirely taxpayer-funded entity to one increasingly funded by user fees paid by manufacturers that are being regulated. Today, close to 45% of its budget comes from these user fees that companies pay when they apply for approval of a medical device or drug…Of the FDA’s total US$5.9 billion budget, 45% comes from user fees, but 65% of the funding for human drug regulatory activities are derived from user fees. These user fee programs must be reauthorized every five years by Congress, and the current agreement remains in effect through September 2022.

 

Changes in more recent years have also increased the number of standard new drug applications approved the first time around by the FDA from 38% in 2005 to 61% in 2018. In diseases where there are not many medication options for patients, the FDA has a priority review process, where 89% of new drug applications were approved the first time around and the approvals were completed in eight months in 2018. All this occurred while the number of new drug applications have been increasing over time.

 

Most recently, the COVID-19 pandemic has seen the FDA provide emergency use authorization for potential treatments in a matter of weeks, not months. The infrastructure and capacity to review the available information so rapidly is due in large part to the funding from user fees.

 

While the number and speed of drug approvals have been increasing over time, so have the number of drugs that end up having serious safety issues coming to light after FDA approval. In one assessment, investigators looked at the number of newly approved medications that were subsequently removed from the market or had to include a new black box warning over 16 years from the year of approval. These black box warnings are the highest level of safety alert that the FDA can employ, warning users that a very serious adverse event could occur.

 

Before the user fee act was approved, 21% of medications were removed or had new black box warnings as compared to 27% afterwards.

This isn’t just the fox guarding the henhouse. In the case of the FDA, the foxes own the henhouse outright.

The Pharmaceutical companies may not care about marketing unsafe, often worthless products to an unsuspecting populace. But they aren’t all bad. One thing you can say is – they are not stingy. They love to spread money around, particularly to politicians. Spending on pharmaceutical industry lobbying was a record $306 million in 2020.  There were 1,502 pharmaceutical lobbyists in 2020, 63.58% of whom were former government employees (including former members of Congress). It pays to have connections.

The whole system is rotten. Your government is for sale – both the politicians and the bureaucrats are on the take. It is to this den of thieves that you are trusting your own health, and the health of your family. 

But, many ask, why don’t journalists expose all this malfeasance harming the public? Some courageous few do, but those brave souls often end up unemployed and blackballed. The Pharma industry spending on advertising topped $6.58 billion in 2020. Particularly noteworthy in a year that saw U.S. advertising revenue drop by 13% overall. Over $4.58 billion of that was spent on TV. Ever wonder why the same pro-Pharma talking points seem to endlessly echo across the entire spectrum of media platforms? The media companies chasing ad dollars is one reason (though not the only one). You can buy a lot of loyalty for the kind of money Pharma companies throw around.

Between the advertising and the lobbying, the Pharma companies spend a lot of money selling, protecting, and positioning their products. Are the stakes really that high? You bet they are. Pfizer announced in July that it had sold $7.8 billion in COVID-19 shots in the second quarter of 2021 and raised its full year sales forecast for the vaccine to $33.5 billion from $26 billion. That forecast includes its cheery assumption that uptake of a booster shot will be widespread. The stock market loved that story. It is actually on Wall Street where the real action is, as COVID-19 vaccines have created at least nine new billionaires after shares in companies producing the shots skyrocketed. They have a combined net wealth of $19.3 billion.

So, so much money.

But there is another, less well known reason why Big Pharma, Big Tech, and media companies cooperate so well. They all belong to the same people – namely investors in BlackRock and the Vanguard Group, the two largest asset management firms in the world.

Vanguard and BlackRock are the top two owners of Time Warner, Comcast, Disney and News Corp, four of the six media companies that control more than 90% of the U.S. media landscape. Who else do they own? Everyone, including Pfizer. Vanguard is the top investor in Pfizer with BlackRock the second-largest stockholder. Together they control other Pharma companies as well. BlackRock/Vanguard also own shares of a long list of other companies, including Big Tech behemoths such as Microsoft, Apple, Amazon, Facebook and Alphabet Inc (Google). In all, they have ownership in 1,600 American firms, which in 2015 had combined revenues of $9.1 trillion. When you add in the third-largest global owner, State Street, their combined ownership encompasses nearly 90% of all S&P 500 firms. A Bloomberg report estimates that these companies in 2028 will have combined investments in the amount of 20 trillion dollars.

BlackRock and Vanguard, individually and combined, own enough shares at any given time to have serious control over Big Pharma, Big Tech, the legacy media, and a whole host of other companies in diverse industries. Ever wonder why everyone seems to sing from the same hymnal? Because a single set of mega-rich investors owns the entire church. 

This level of shared ownership and collusion makes libertarian defenses of “free market” economics particularly laughable. There is nothing “free” about this nightmare. This interlocking investment cabal should be rightly considered a government unto itself.

But what about hospitals and doctors? Many hospitals are non-profits, aren’t they run by good people willing to tell the truth?

Not really. Most non-profit hospital systems are actually investment firms that incidentally provide health care. An analysis of IRS filings revealed that non-profit hospital systems held more than $283 billion in stocks, hedge funds, private equity, venture funds and other investment assets in 2019. Of that, non-profit hospitals classified only $19 billion (7%) of their total investments  as principally devoted to their nonprofit missions rather than producing income. They may not pay taxes on their corporate earnings, but the individuals running the non-profit hospitals care very, very much about money. And they get paid handsomely for their efforts in getting more of it for their “non-profits.” If there is money in going with the flow, expect non-profit hospitals to go along to get along with no questions asked.

I won’t even bother to discuss for-profit hospitals. If the non-profit space is so money-driven, you can imagine what the real capitalists are willing to do.

And doctors? Most doctors today are captive to hospitals and medical groups owned by hospitals. They emerge from medical school in debt and broke. Most can never afford to launch their own practices. Their expenses are high, and far too many have multiple ex-wives getting big checks every month. It is common for doctors to live paycheck to paycheck, and so they do whatever the CEO of the hospital says. If he says push vaccines, that is what they do. If he says to diagnose as much COVID as possible, then every case is COVID. Most American doctors are not independent actors.

Doctors are also subject to discipline by medical licensing boards, some of whom have been strictly enforcing the official COVID narrative. Doctors who ask the wrong questions or go on record promoting “misinformation” can lose their jobs and even their right to practice medicine. Following CDC guidelines, even if doing so results in negative patient outcomes, is a much safer choice.

Given the pressures against them, it is actually a miracle that so many doctors continue to speak out in favor of rational science.

What about professional associations and other non-profits besides hospitals? Many medical trade groups are heavily funded by Pharma companies. Don’t expect too much objectivity from them.  Many other non-profits are mere front groups for the wealthy to earn socially-acceptable profits and spread influence surreptitiously. The Bill & Melinda Gates Foundation, for example, profits from its role in the pandemic response, as it has more than $250 million invested in COVID-19-related companies. Despite financial interests in the “solutions” they’re touting, the Gates Foundation has been regarded favorably in the media. Bill Gates, despite lacking any medical credentials, is a staple of talk shows dedicated to COVID-19, vaccines, and other health-related matters.

Given the totality of where we are in this society, it should be considered a miracle that any medical professionals, independent journalists, and maverick politicians are speaking out at all. 

Moral Leadership and Reform Are Needed

Judas sold Christ for 30 pieces of silver. The Apostle Paul reminds us in 1st Timothy, “For the love of money is a root of all kinds of evil…” We live in a fallen world where people given over to greed cause untold havoc. Yet, somehow, even sincere Christians seem to forget all that when someone in an official position makes a proclamation for the “common good.”  All of us, Christian and secular alike, need to accept a fact that many of us prefer to ignore – our regulatory, medical, corporate, and political systems are thoroughly corrupt and in need of massive reform. It is especially incumbent on those who are given office as “moral leaders” to see the truth for what is.

The time to speak out is now, because later we may not be able to.

Irene, member of the Greek Archdiocese and health care professional with over 20 years experience in practice and clinical education

If you are a pro-life Christian, you can file a religious exemption request for the COVID vaccines. Please visit this article to learn more.