Category: 2021

More Testing Less Freedom

President Biden unveiled a new COVID initiative in a press conference this week. In addition to more COVID vaccinations, he promised more COVID testing. This is a bad idea which will create more fear and less freedom. Testing plays an important role in medical decision making, but indiscriminate testing can lead to harm. To be beneficial, the right test must be selected at the right time for the right reason. Let’s compare Biden’s testing plan against these three pillars of laboratory medicine.

The right test. The President promised free at-home tests. Although his speech was short on details, I think it is safe to assume he is talking about antigen tests which work much like at-home pregnancy tests. Antigen tests are fraught with technical and interpretative challenges, making it difficult to separate signal from noise. The result of increased antigen testing will necessarily be an increase in positive test results, many of which will be false positives. By contrast, PCR tests do a much better job of separating signal from noise. Although PCR test results are often misinterpreted, they have far fewer analytic false positives. President Biden’s plan increases availability of the wrong test.

The right time. There is no test for COVID-19, so the President’s call for increased “COVID” testing is technically incorrect. COVID-19 is a disease caused by SARS-CoV-2 infection. To have COVID-19, you must be infected by SARS-CoV-2 at the same time you have symptoms of a respiratory infection. Symptoms without SARS-CoV-2 infection is not COVID-19; SARS-CoV-2 infection without symptoms is not COVID-19. Why does this semantic detail matter? Because test timing is crucial to the diagnosis of COVID-19.

Test too early and an infectious person may have a negative result. Test too late and a person who is no longer infectious may have a positive result, no matter the quality of the test. This happens with PCR tests and antigen tests alike. Just like there is no morning-after pregnancy test, there is also no morning-after SARS-CoV-2 exposure test. Indiscriminate testing will lead to the wrong people isolating. There will be individuals who consider themselves safe because of a negative test result, and there will be individuals who disengage from society because of a positive test result. Both groups will be wrong because they test at the wrong time.

The right reason. Test results should drive actions; there is no other reason for testing. You should never test for curiosity, because you can, or to confirm a hunch. This is a testing trap that ensnares many of my clinical colleagues. By his call for “more testing,” it appears to have ensnared the President also. Before a test is performed, there must be a clear, distinct plan of action for each possible test outcome. If the actions are the same, the test should not be performed. The indiscriminate testing proposed will be used for the administration’s “vaccinate-or-test” plan. This is the wrong reason.

Vaccinate-or-test. In his press conference, President Biden reiterated his “vaccinate-or-test” plan to control social intercourse. His plan will fail to control viral spread since both of the plan’s foundational assumptions are false. The first assumption is that vaccinated individuals cannot spread infection, but it should be clear to everyone now that this is false. The second assumption is that individuals who test negative for SARS-CoV-2 cannot spread infection, but since the President proposes the wrong tests at the wrong time for the wrong reasons, this assumption is also false.

What will really happen because of the increased indiscriminate testing mandated by the President’s plan?

More Tests Less Freedom. When the wrong test is performed at the wrong time for the wrong reason, the absolute number of positive results will increase. Even though some of these positive results will be false and many will be insignificant, all these results will be counted as COVID “cases.” This is because early in the pandemic, the CDC changed its definition of a COVID-19 “case” from positive test and symptoms to positive test or symptoms. This “case” spike will be raised as a pitchfork to incite fear among Americans, and fearful people are more likely to turn loose of their liberty. Think I’m wrong? Consider this statement made by the President during his press conference:

And again, to folks who are not vaccinated: You may think you’re putting only yourself at risk, but it’s your choice. Your choice is not just a choice about you; it affects other people. You’re putting other people at risk — your loved ones, your friends, neighbors, strangers you run into. And your choice can be the difference between life or death.
Joe Biden, December 21, 2021

See where this is going? “Vaccinate-or-test” will morph into a “vaccinate-or-isolate.” More testing will result in less freedom and more discrimination.

A Better Way. There is another way. If you feel sick, stay home. Find a doctor who will give you early treatment for COVID-19, and test as directed by your doctor. If early treatment doesn’t work, seek higher care at a hospital. When you feel better, go back to your life. Wear a mask for a while if you are concerned about infecting others. These are all commonsense rules taught to us by our parents and used for generations.

Never let test results make you afraid enough to let go of your freedoms.

2021 COVID-19 Ethics Vaccine

What If You Are Wrong?

I am not talking to President Biden, Rochelle Walensky, Anthony Fauci, or anyone else conflicted by political or material entanglements with the pharmaceutical industry. I am not talking to members of VRBPAC or ACIP, or principal investigators for NIH. I am not talking to Bill Gates, Mark Zuckerberg, or anyone who has made billions during the pandemic. I am not talking to anyone who has sold out. If you would do anything to hold onto your research grant, to keep your airline running, or to protect your fiefdom, I am not talking to you. I am not talking to media syndicates with synchronized messages. I am not talking to those cynical about the American dream who think “of the people, by the people, for the people” is naïve and passé twaddle. I am not talking to anyone numb to the pangs of conscience, sociopaths who prioritize greed and power over the lives of others. I am not talking to you because you are already lost. I have nothing to say to you.

I am talking to foot soldiers in the army of the people I am not talking to. I am talking to leaders who have power over people and policies. I am talking to those trying to keep their businesses safe for customers and employees. I am talking to hospital administrators responsible for protecting patients from harm. I am talking to doctors who care about the welfare of their patients. I am talking to elected officials trying to best represent their constituents. I am talking to leaders in the military and law enforcement who protect us from bad people. I am talking to dedicated scientists in public health agencies. I am talking to ethical small business owners. I am talking to HR directors responsible for a healthy and productive workforce. I am talking to all those who want to do the right thing. I know you are out there.

You are leaning on what has worked in the past. You steer a middle course. But as the pandemic evolves, the paradigms have diverged. It is no longer possible to keep one foot on the dock and the other in the boat; the middle ground is now under water. You have chosen the orthodoxy proclaimed by all the people I am not talking to. You feel safer there. Afterall, you are in a delicate situation. You know how things work. You are expected to be a good soldier and toe the line.

I’ve got a question for you. What if you are wrong?

You require vaccines for your employees, you urge boosters for your patients, because aggressive vaccination policies keep the public safe; the unvaccinated are a threat to the health of others. Vaccinate your employees, vaccinate your patients, vaccinate your children. Use the carrot, use the stick, but get it done. But what if universal vaccination will not eradicate the virus? What if the vaccinated can become infected and spread the virus to others? What if indiscriminate vaccination pressures the virus to mutate into more dangerous forms? What if antibody dependent enhancement causes devastating infections in the vaccinated?

You tell others that vaccines are safe and effective. You encourage your patients, your family, your friends to get boosted. Vaccine complications are rare, you say; COVID will shred your lungs, destroy the pleasures of taste and smell, and put you face down on a ventilator. But what if vaccine safety data has been deceptively manipulated? What if you learn of death spikes in populations after vaccines were introduced? What if there is collusion to suppress adverse vaccine safety information? What if the industry reports of vaccine efficacy deliberately leave out measures of absolute risk reduction?

You believe we must protect our children by early vaccination. But what do you do with the evidence that healthy children don’t die of COVID, that vaccination risks for kids far outweigh benefits, and that natural immunity in children is durable?

You say this crisis is no time to question the wisdom of our government’s healthcare policies. Afterall, they’ve been guided by the greatest minds on earth. But how do you feel when you learn that USA has more total per capita COVID-19 deaths than 90% of the nations on earth, and that during the pandemic, average lifespan of Americans has dropped by nearly 2 years, 8.5 times the rest of the developed world? How do you account for the thousands of physicians and scientists who have signed the Global Covid Declaration?

When the FDA tweets, “You are not a horse. You are not a cow. Seriously, y’all. Stop it,” you like it, you share it, but for sure you won’t prescribe Ivermectin or dispense it in your pharmacy. Afterall, there have been no adequately powered, well-designed, well-conducted clinical trials that support the use of Ivermectin in the treatment of COVID-19. You know that treatment for severe COVID is hospitalization, Remdesivir, steroids, and mechanical ventilation. But what if you learn that Remdesivir’s approval was based on inadequately powered, uncontrolled clinical trials that showed shortened hospitalizations instead of improved survival? What if you learned that early treatment keeps people out of the hospital? What if chloroquine prevents infection and spread of SARS viruses? What if the use of approved, off-label, unpatented, repurposed drugs by physicians is really generating the outstanding success rates reported by Front Line COVID-19 Critical Care Alliance, American’s Frontline Doctors, and the Pandemic Health Alliance? What if there has been a deliberate attempt to suppress alternative therapies for COVID-19? What if the leaders of institutions you have trusted for health guidance are manipulating you to enrich themselves and others?

Are you sure that your actions, your decisions, your influence, your mandates are not harming people?

Your decisions affect the welfare, livelihood, and very lives of others. And you are not just deciding for us; you are deciding for our children too. And their children. And all that come after.

Maybe you have been deceived. But what if you are wrong?

2021 Ethics Vaccine

The Booster Trap

First, let’s clear up a misunderstanding. Some people think that a COVID booster is different from a COVID vaccine, but that’s not true. There is no difference between a manufacturer’s booster and its primary vaccine series. Both come from the same vial. There’s been no change in the formulas that were first authorized last year. Pfizer and Janssen boosters are even the dosed the same as a single shot from the primary series. Moderna boosters are half doses of a single shot from its primary series. Either way, the booster shot is just more of the same. If you want to fact-check me on this, read the FDA’s Fact Sheets for the Pfizer Purple, Moderna, and Janssen, the only available vaccines with boosters permitted in the U.S.

There are also those who believe that the vaccines available today are different that the vaccines that were given last winter, but that’s another misunderstanding. The original vaccine was targeted against the Wuhan strain, but even though that strain is no longer present in the community, vaccines given today are the same as the ones first authorized. There has been no change in vaccine formulas. You can fact check me by reading the FDA authorization letters for the available vaccines (Phizer, Moderna, and Janssen) which detail their regulatory histories.

Why the push for boosters? It turns out that the immune response induced by vaccine wanes significantly after 6 months. The booster is thought to drive antibody levels higher, and, the theory goes, it’s the antibody levels that protect the vaccinated from infection. Boosters have been authorized for all Americans over 18 years of age, 6 months after completion of an mRNA primary vaccine series (Pfizer and Moderna) or 2 months after the Janssen injection. Janssen’s booster interval is shorter because Janssen has the lowest immunogenic effect of the three authorized vaccines. Janssen-induced antibodies wane earlier.

Everything above this paragraph is an objective report of the current vaccine landscape. Now I’m going to predict the future. When I look in my crystal ball, here’s what I see coming.

Janssen will go from a single injection to a two-shot series, separated by 6-8 weeks. Then Janssen’s booster interval will be set at 6 months, just like the other vaccines. So far, only one booster has been authorized, but expect booster authorizations to go on an every six-month renewal cycle.

The definition of “fully vaccinated” will change to include a current booster. If it’s been more than six months since your last booster, your vaccination status will expire. It will take a computer to keep up with everyone’s expirations, so vaccine passports will be tracked on your smartphone. This passport will be connected to other data on your phone—where you go, what you tweet, who your friends are—to create a social credit score that will be used, along with your vaccine passport, to restrict or permit access to products, services, and transportation. Since your financial institutions are probably already connected to your smartphone, it will only take the flip of a switch to turn off access to buying power. That should incentivize citizens to maintain good scores.

And what about those boosters—will they ever change? Probably. The mRNA technology used in Pfizer and Moderna vaccines is a platform that can be adjusted rapidly to changing vaccination targets. As the virus mutates, these vaccines can be quickly reengineered to respond to the changes, perhaps even without additional FDA submissions. And it will be used for more than SARS-CoV-2. Other vaccine targets can be loaded on the platform to create a vaccination cocktail tailored to the pandemic du jour. And it will be used for more than vaccines. Other gene therapies can be mixed into the brew, all for your safety of course. You’ll be a much happier, more compliant, and easily manipulated citizen. The possibilities are endless.

What do you think of my crystal ball? Personally, I don’t like it very much. It’s not a world where I want to live. If my predictions become true, we lose the freedom to make personal choices. Free will, the essence of humanity, will be gone. That’s not for me.

We still have a choice. We can choose to go down this road of boosters without knowing where the road will lead, or we can recognize that vaccination will not eradicate this virus, no matter how many boosters we take. If boosters will not eradicate SARS-CoV-2, there must be another reason to inject the world with limitless mRNA sequences.

I don’t want to find out what that reason is, so I’m not going down that road. My humanity is too valuable to me.

2021 COVID-19 Vaccine

The Omicron Variant

A new variant is sweeping the globe. Today, the WHO designated the b.1.1.529 variant a Variant of Concern and assigned it the name Omicron, humorlessly passing on the opportunity call the new variant Nu. The Omicron variant, first identified earlier this month in South Africa, has already spread to Israel, Hong Kong, and Belgium, prompting travel restrictions by many countries.

There’s much more to learn about this variant, but reports so far suggest this is a highly mutated form with cluster mutations in the receptor binding domain, the portion of the spike protein where vaccine immunity is aimed. It’s reasonable to infer that these mutations may lead to increased vaccine escape. More breakthrough infections can be expected.

According to an article published in Nature yesterday, there are already anecdotal reports of reinfections and cases in vaccinated individuals. If the infectivity of Omicron is as least as high as Delta, expect Omicron to soon replace Delta as the dominant form in the U.S.

As the virus continues to evolve, the vaccines remain static. The vaccines available today were designed to provide immunity against the spike protein of the wild type strain identified in Wuhan in January 2020, but that viral strain has practically vanished. As the virus continues to move, individuals who are only protected by vaccination will be increasingly exposed to virus attacks.

Those who have been previously exposed to the virus can be expected to have broad immunity. Think of castle walls deflecting missiles launched from many directions and angles. Those protected by vaccine alone have neutralizing antibodies against the wild-type spike protein. Think of the protection provided by a slender pole. An attacker needs only move over a few feet to obtain a direct line of sight to the target. That’s why breakthrough infections are common, why vaccinated individuals can transmit the virus, why vaccinated individuals require hospitalization, and why vaccinated individuals die from COVID-19.

One more point about variants. The CDC now has four variant classes, listed from least to most significant: Variant Being Monitored (VBM), Variant of Interest (VOI), Variant of Concern (VOC), and Variant of High Consequence (VOHC). In April 2020 there were many variants on the VOI and VOC lists. However, as vaccination rates increased, all but one of these variants disappeared from the United States and were moved to the VBM list, including the Alpha variant responsible for the COVID-19 spike last winter. The Delta variant and its rare sublineages are the only remaining Variants of Concern.

As the virus continues to evolve, a variety of variants should be expected, but instead we find a monotypic variant population. This suggests unnatural manipulation, and this observation is coincidental with the continued push for vaccination by a first-generation vaccine. Could there be a causal relationship? Could the Omicron variant be a result of the vaccination policy advocated by national and international health organizations? We don’t know for sure, but it is plausible. What we do know is that this virus will be with us for some time. Universal vaccination will not eradicate SARS-CoV-2. We must look elsewhere if we are going to live with the virus.

Early treatment shows the most promise.

2021 Vaccine

Boosters for All

Yesterday, the FDA revised the Factsheets for Providers Administering Pfizer BioNTech (both Purple and Gray) and Moderna COVID-19 Vaccines, permitting boosters of these unapproved products to Americans 18 years of age and older because of an ongoing emergency. The FDA took this action without reconvening the Vaccines and Related Biological Products Advisory Committee, a panel of national health authorities.

Yesterday’s action overrules the recommendation made by the Advisory Committee at its 167^th meeting on September 17 when the panel voted 16-2 against the question, “Do the safety and effectiveness data from clinical trial C4591001 support approval of a COMIRNATY booster dose administered at least 6 months after completion of the primary series for use in individuals 16 years of age and older?” True, the previous question was for 16 and above, not 18 and above, but the spirit of the committee discussion was for targeted boosters, not blanket boosters.

According to the FDA press release issued yesterday, “The FDA did not hold a meeting of the Vaccines and Related Biological Products Advisory Committee on these actions as the agency previously convened the committee for extensive discussions regarding the use of booster doses of COVID-19 vaccines and, after review of both Pfizer’s and Moderna’s EUA requests, the FDA concluded that the requests do not raise questions that would benefit from additional discussion by committee members.”

This action comes days after Alex Berenson, formerly of the New York Times, reported an error in Pfizer’s publicly reported safety data. Initially, Pfizer reported that two vaccine recipients died during trials, compared to four placebo recipients. In a July update, the count was revised to 21 deaths among vaccine recipients compared to only 17 in placebo recipients.

Then there’s FDA’s response to a freedom of information act (FOIA) request on Pfizer’s COVID-19 vaccine. Instead of transparency, the agency filed a petition in U.S. District Court to delay its response for 55 years.

Vaccine chart, updated for new EUAs issued on November 19, 2021.

Up to now, I’ve just been reporting the news, but here comes commentary. These facts create a disturbing trend. What could they be hiding? I’m forced to one conclusion. The FDA and the pharmaceutical industry are colluding to coverup data and debate so they can sell vaccines. If you can reach another conclusion rationally, please tell me. I can’t.

The events of last week occurred in the open. Imagine what’s happening out of view.

2021 COVID-19 Ethics Science Vaccine

Censored

My most recent blog about vaccines for children was removed by LinkedIn because of a violation of LinkedIn’s Professional Community Policies. Although LinkedIn won’t tell me what specifically provoked removal of my article, I must have somehow run afoul of this sentence in their policy, “Do not share content that directly contradicts guidance from leading global health organizations and public health authorities.”

It’s not just LinkedIn. Twitter has a lengthy policy on COVID-19 tweets, including a ban on misleading information about “the safety or efficacy of treatments or preventative measures that are not approved by health authorities.” Referring again to “government health authorities,” Facebook’s policy explicitly lists examples of prohibited claims about vaccine effects such as “Bell’s palsy,” “blood clots,” “death,” or the emergence of a “new COVID-19 [sic] strain” with such authority that it would be an exquisite piece of satire if Facebook were not so sadly unaware of its naivety. I stopped looking for more examples of Big Tech’s holier-than-thou-know-it-all-ism quite confident that I could find as many as I wished.

The question is inescapable. When “health authorities” disagree, how does Big Tech decide which position is right and permissible, and which position is wrong and censorable? When an observation contradicts its orthodox viewpoint, Social Media labels it false and removes it. According to Thomas Kuhn in The Structure of Scientific Revolutions, unorthodox observations should be highlighted since they power the movement of scientific understanding.

But let’s not get into the science. Let’s talk about disagreements among government health authorities. About the same time that USFDA permitted Pfizer-BioNTech COVID-19 Vaccine for emergency use in children 5 to 11 years old, Taiwan halted plans for vaccinating those less than 12 years old, France’s Haute Autorité de Santé advised against Moderna vaccination for anyone less than 30 years old, Finland prohibited the vaccine in the same age group, and Denmark and Sweden prohibited its use in anyone under 18 years old. While other countries are restricting the use of mRNA vaccines in young people, USA is vaccinating preschoolers.

Outside government sponsored health organizations there is also disagreement about safety of vaccines in young people. Although 17 members of the Vaccines and Related Biological Products Advisory Committee voted that the benefits of vaccinating children aged 5 to 11 outweigh the risks, the opposite opinion is held by over 13,000 international physicians and scientists who have signed the Global Covid Summit Declaration II.

It’s clear there is a lack of consensus among “leading global health organizations” and “public health authorities.” Yet U.S. government officials are using intimidation, ridicule, and disregard for legal process to make it appear the issues driving its public health policy are settled. It’s just not true.

A vigorous public debate is needed, and social media could facilitate it. But social media is not content to be the platform for debate. Instead, it wants to control the outcome. Without years of deliberate study and armed only with a crash course in medical science, social media proclaims itself the ultimate health authority, deciding what observations are fit for public consideration and hiding the rest. Abandoning its journalistic legacy as the fourth estate, social media has become the stooge of government. Because the first amendment prevents it from doing so directly, the government is using social media as its proxy to restrict the speech of Americans.

It’s not funny. It’s no longer just our lives; the lives of our children are at stake. Just as physicians have a duty to “do no harm,” parents have a duty to prevent harm to their children. Quoting the best social media post I saw last week, “Don’t let your children die on the hill you refuse to fight on.”

2021 Vaccine

Color Coded Vaccines

On October 29, the FDA removed the combined COMIRNATY/Pfizer-BioNTech Fact Sheet for Healthcare Providers. In its place, the FDA issued three new Fact Sheets for Healthcare Providers Administering Pfizer-BioNTech vaccines, one for each of the now three versions of the product which are distinguished by vial cap colors. Vaccine vials with purple caps are authorized for individuals 12 years of age and older and must be diluted before injection. Vaccine vials with orange caps are authorized for children 5-11 years of age and must be diluted before injected. Vaccine vials with gray caps are authorized for undiluted administration to individuals 12 years of age and older but are not available in the United States.

Sound complicated? It is. And it raises disturbing questions. But first, here’s an updated (and complicated) vaccine chart:

Now the questions.

Is there an FDA approved vaccine for children under 16 years of age?

No. COMIRNATY is FDA approved for individuals 16 years of age and older. Quoting from the Pfizer-BioNTech Orange Fact Sheet, “The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, Pfizer-BioNTech COVID-19 Vaccine, for active immunization to prevent COVID-19 in individuals 5 years of age and older.”

Why did the FDA approve COMIRNATY if it’s not available in the United States?

I don’t know for sure, but I can speculate. The FDA News Release on August 23 makes it seem as if Pfizer-BioNTech is an approved vaccine. This may be the reason for COMIRNATY’s approval—to provide a veneer of legitimacy to the authorizations for boosters and child vaccines that followed. The Fact Sheets are clear: Pfizer-BioNTech vaccines are not approved. Not for anyone.

Why is COMIRNATY not yet available?

In the emergency use authorization letter for Pfizer-BioNTech reissued on August 23, the FDA acknowledged that, “There remains, however, a significant amount of Pfizer-BioNTech COVID-19 vaccine that was manufactured and labeled in accordance with this emergency use authorization. This authorization thus remains in place with respect to that product for the previously-authorized indication and uses.” In other words, FDA will allow Pfizer’s inventory to be consumed under EUA before requiring production and distribution of COMIRNATY. By the way, you’ll have to go to web.archive.org to find this letter. I can no longer find it on FDA’s active website.

If COMIRNATY is not yet available because of Pfizer’s vaccine inventory, how does Pfizer manufacture two new versions (Gray and Orange) of its vaccine so quickly?

Good question. Is Pfizer just consuming inventory or is Pfizer producing new vaccine? I don’t know for sure, but it seems to me Pfizer is producing new vaccine.

Why did the FDA authorize Pfizer-BioNTech Gray if it’s not available in the United States?

I’m puzzled by this question. How can the FDA authorize use of an unapproved product for an emergency when that product is not available? If you have an idea, please tell me.

Are all COVID Vaccines experimental?

Yes. There is not an approved, licensed COVID vaccine available in the United States. All available vaccines are unapproved products permitted for emergency use only. It’s a big experiment. Vaccinated individuals are part of the experimental group. Unvaccinated individuals are part of the control group. We will analyze the results in a few years.

Can I or my child be forced to accept a COVID Vaccine?

No and Yes. Fact Sheets for Healthcare Workers Administering Vaccines say that the person administering the vaccine must disclose that “the recipient or their caregiver has the option to accept or refuse” the COVID-19 Vaccine. Fair enough, but this hasn’t prohibited vaccination by coercion. There are many people who have been forced to accept a COVID vaccine to keep their jobs, and people who refused vaccination have lost freedoms and employment. Coerced consent is and always will be unethical.

Are we sure Pfizer-BioNTech Orange COVID vaccines are safe for children?

No, and this is the most disturbing part of the October 29 actions. The CDC insists the vaccines are safe for children. But many prominent physicians have disputed this claim, saying that long term effects of vaccines on children are unknown. I agree. Without a time-machine, it’s impossible to know the future effects of vaccines given to children today. But I’m not the only one who thinks this way. At the 170^th meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee, Dr. Eric Ruben, Editor-in-Chief of the New England Journal of Medicine and temporary voting member of the committee, said, “We’re never going to learn about how safe this vaccine is unless we start giving it. That’s just the way it goes.” Dr. Ruben voted for authorization of experimental vaccines in children. Whatever you think of his judgement, at least he’s honest about the safety data. We don’t have any yet.

2021 COVID-19 Ethics Vaccine

Break Free

The real division is not between conservatives and revolutionaries

but between authoritarians and libertarians

–George Orwell, 1948

The President is losing patience. Six quarters into the emergency, the FDA has authorized COVID-19 vaccines down to five years of age. The CDC maintains these vaccines are safe and effective. Vaccinations are mandated by powerful employers, high ranking generals, and top government officials. Most of the medical community are on board. Failure to comply costs income and freedom. It’s intimidating. Many have submitted to the pressure. These policies have concentrated authority and power in a few “experts” who presume to know what’s best for everyone else. It’s not just arrogance. It’s slavery.

Slavery doesn’t need a plantation and rows of cotton. Slavery occurs when one person owns the thoughts and actions of another. Motives don’t matter. Good intentions don’t justify coercion. Masters who treat their slaves well are still slaveowners. The core moral flaw of slavery is the notion that one person can own another. Slaves exist to serve masters, not the other way around.

Masters cannot make decisions in the best interest of their slaves. The interests of the slaveowner always have precedence. If you own my decisions, you own me. You can’t make the best decisions for me because you don’t know what’s important to me. The individual taking the risk must have decisive control. Today’s public health policies transfer choice from individuals to powerful experts just like slaves surrender control to their masters.

We don’t need experts to understand the issues of the pandemic. COVID-19 is bad. Many people have died, more than should have. But we’ve learned to identify those at risk. Sound, compassionate public health policy would focus attention on the vulnerable and protect them with more than vaccines. Instead, our masters are using only one tool and applying it universally.

Vaccines have risks. Many people have died, more than should have. Vaccines were rushed to market with only a thin veneer of study and testing. What we know of vaccine risks—myocarditis, blood clots, neuromuscular disorders, death—is scary enough. What we don’t know is even scarier. Some of these potential future problems can be deduced from the studies requested by the FDA in its COMIRNATY approval letter.

Yet our experts cling to a universal vaccination policy that seems to be less in the public interest than in that of vaccine vendors. Our impatient masters have cornered us into a company store where there’s only one shoddy product for sale. We must break free.

America is founded on liberty. Yes, our history is filled with cognitive dissonance on this point. The institution of slavery is baked into our founding documents, right alongside guarantees of individual rights and freedoms. But the understanding of liberty is also baked into Americans, so much so that we were willing to shed blood to purge slavery from our land, without the assurance that we could.

We’ve reached a similar moment. Echoing notes from the Gettysburg Address, history has given us the opportunity to purge a more occult and subversive form of slavery from our land. Our public health policies have devolved to the coercion by the few over the lives of the many. These policies have shifted from information to dogma, from recommendations to requirements. Like the slaves of old, we must adopt the religion of our masters and submit to their commands. Otherwise, we are promised discomfort.

To those subjected to these policies, my message is simple. Resist this coercion like it’s slavery. It is.

2021 COVID-19 Vaccine

Vaccine Booster Update

The FDA reshaped the vaccine landscape last week, authorizing single boosters for Moderna and Janssen vaccines, and permitting boosters from all vaccine manufacturers regardless of the initial vaccine brand. Here is an updated vaccine chart, incorporating these changes.

The changes were discussed at the two-day Advisory Committee Meeting on Vaccines and Related Biological Products Advisory Committee, held October 14-15, 2021. EUA applications for single boosters of Moderna and Janssen vaccines were unanimously recommended (4:26:25). The committee heard a report on the NIH “Mix and Match” study (5:27:26), the basis for the booster interchangeability authorization, but did not vote. After this meeting, FDA approved booster interchangeability and updated Fact Sheets for Healthcare Providers Administering Pfizer, Moderna, and Janssen vaccines. These Fact Sheets still say there is “no information on the co-administration” of vaccines. The rules for interchangeability between primary and booster vaccines are based on the vaccine used for the primary series. By these rules, anyone over 18 years old can get a Moderna or Pfizer booster 2 months after an initial Janseen injection.

FDA Approval means that a drug, treatment, or medical device has been licensed by the FDA for a particular purpose. Contrary to what you may hear, approval is not a guarantee of safety and efficacy. Rather, it means that the item in question has been through FDA’s rigorous gauntlet designed to prevent worthless or harmful products coming to market in the United States. Approval is different from authorization. FDA Authorization means that a product is available by Emergency Use Authorization, also known as EUA. The EUA process is designed to speed availability of products in the U.S. during an emergency. “Off Label” is a term used to describe use of an approved drug or device for a purpose other than its express licensed intent. Off label use of drugs is common practice. “Not authorized” is a term used to describe use of a drug or device which has neither been approved by the FDA nor made available by EUA.

Two key criteria for EUA are that an emergency exists, and there are no approved products to address the needs of the emergency. The continued availability of COVID vaccines under EUA is problematic on both points. First, as COVID-19 returns to endemic levels in many parts of the country, it’s debatable whether an emergency still exists. Once an emergency passes, and all EUAs, including the authorizations for vaccines, should be withdrawn. Second, there is an approved COVID vaccine: COMIRNATY. By approving a product that is not available in the U.S., the FDA has twisted itself into a pretzel. If the product is unavailable, it should not be approved. If the product is approved, EUAs for the other vaccines should be withdrawn. The FDA changes its call from heads to tails depending on how you flip the coin.

Expect two additional significant changes in coming weeks. The first will be the push to vaccinate children. The second will be the definition of “fully vaccinated” to include boosters. This will be followed by authorization for multiple boosters, meaning that you will always be just months away from losing your “fully vaccinated” status. Vaccine passports will then be a reality in the United States. Maybe that was the endgame all along.

Who would have thought this is where we would be 21 months ago?

2021 Philosophy Science

Belief and Knowledge

I am not a scientist, but I love science. I am not a theologian, but I love theology and the effects of spirituality on my life. Just like I am a practitioner of pathology, I am also a practitioner of faith. I am enriched by both.

Religion deals with matters of belief. Science deals with matters of knowledge. Both address the big questions of life—”Why are we here?” “Where are we going?”—but from different perspectives. One is not a backstop to the other. Beliefs are not morally inferior to knowledge, just as knowledge is not morally inferior to beliefs. Both are important, but they live in different realms. Innocently confusing science and religion leads to superstition, ignorance, or harmful conclusions. Deliberately confusing science and religion is a deception that robs us of material and spiritual treasures.

Falsification is a key distinction between belief and knowledge. A scientific claim is falsifiable, meaning it must make a prediction that can be tested by experiment. If experimental results are not what the claim predicts, then the claim is false. But if experimentation supports the claim, it’s not necessarily true; it simply might be true. The scientific process is a last man standing game. The longer a claim stands, the more likely it is to be true. At some point, when an idea becomes more likely than anything else, we call it knowledge. But knowledge is, and always has been, what is most likely true, not what is certainly true. We can only have scientific certainty about what is false.

Lack of certainty isn’t the only limitation of knowledge. There are scientific horizons, and we cannot see what’s on the other side. For example, the universe is most likely expanding, but expanding into what? We cannot know. If the universe is expanding, then it must have been smaller before, and even smaller before that, and so on until it’s a tiny universe holding all matter and energy. But what happened before that? We cannot know. What’s outside the event horizon of light, or the gravitational horizon of black holes? Does our physics work there? Can alternate universes coexist? We can hold beliefs about these things, but these questions are not in the realm of science. We have no applicable knowledge because we have no power to observe.

Science has significant limitations. We can never be certain about what science tells us, and there are some questions that are not open for scientific investigation. Religion also has limitations, but different ones. Religious claims do not have the requirement of falsification. Omnipotence is the ultimate answer for all religious questions. When there’s no experiment that can demonstrate an idea to be false, it cannot be science, but it can be religion. Science requires falsification; religion requires faith. Faith and beliefs are good things. They give us hope, purpose, and compassion. Science cannot.

Despite its limitations, science is a powerful tool that augments our understanding of reality. We cannot rely on science to give us quick answers, so during this pandemic, we must have faith—lots of faith. But we also must speed science along by testing as many ideas as possible, all at the same time. A pandemic response that clings to ideas which are demonstrably false and dismisses competing ideas without experiment is not based on science. It’s religion pretending to be science, and it’s dangerous. There are three explanations for nonsense disguised as science: foolishness, greed, and evil. I fear that all three are now hopelessly entangled.

Religion and science have important roles in our fight against the pandemic. Understanding the difference between them is a protection against deception. When someone says, “believe in science,” beware of fraud. Your life, your liberty, and your sacred treasures are at risk.

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