Category: COVID-19

Doctors Be Doctors

Some physicians are scientists, but most physicians are practitioners like me. There’s a difference. Right now, we need doctors to be doctors.

Scientists study disease and test treatments by applying the scientific method to clinical trial enrollees. The more scientists know about individuals in their study, the more likely that bias creeps in and pollutes the conclusions. That’s why the best clinical trials are large, randomized, double-blinded and placebo controlled. They are focused on populations instead of individuals. Subjects in a clinical trial are part of a science experiment; rather than receiving cutting edge treatment, they may be getting no treatment at all.

The scientific method requires strict discipline. Anecdotal data is anathema to true scientists, to the point that “anecdotal” has become synonymous with “unscientific” and “unreliable.” These words are often used pejoratively to malign the reputation of a report, an observation, or an individual. But it need not be so. Science is not the only path to reliable information.

Practicing doctors use a different method to understand disease and guide treatment. Practitioners look at patients one at a time and tailor treatment individually. The more that physicians know about their patients, the better their treatment results. These doctors watch the outcomes. Treatments that consistently produce better outcomes are favored over those that do not.

The experience of each encounter feeds back into a doctor’s therapeutic approach with other patients. For example, if a patient has a poor outcome after taking a particular drug, the doctor prescribing the drug will be less likely to prescribe it in the future. On the other hand, if a patient has a good outcome after taking a particular drug, the prescribing doctor will be more likely to use it when treating other patients. Communication of these experiences among doctors quickly optimizes treatments.

It is not science, but it is not wrong either. It is more like a search engine algorithm, like A/B market testing, or like crowdsourcing. These are effective methods of finding efficient pathways well known to the technology sector. It is AI, except it is not artificial; it is just intelligence. That is what it means to be a doctor.

Collectively, doctors are a massive learning machine, plowing through data one point at a time. It is not surprising that doctors can find new uses for old drugs. It is not surprising that these old drugs can have long established safety records, even if they are no longer patentable. It is not surprising that repurposed drugs can be effective treatments for COVID-19 despite the absence of supporting clinical trials.

Science is an important tool for understanding reality, but it is not the only way to find truth or effective therapies. Not all medicine is based in science; there is also art in medicine which values anecdote. Over-reliance on science eliminates the opportunity for people to benefit from the power of information collected by practicing doctors, one patient at a time.

Like any tool, science can be abused or manipulated. The integrity of science is the same as the integrity of the people doing science. People who oppose treatments based on the absence of supporting scientific data are bullies, misusing science to get their own way. These science chauvinists have let us down. Worse than that, doctors who have forgotten how to be doctors and who rely exclusively on science have let their patients down.

When all of this is over, when the world turns around, brave doctors will have to rebuild healthcare from scratch, earning public trust again, one patient at a time.

2021 COVID-19 Testing

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 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 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 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 COVID-19 Science Vaccine

Winning the War Against Therapeutic Nihilism

Post author By Kevin Homer, MD
Post date October 7, 2021
2 Comments on Winning the War Against Therapeutic Nihilism

Dr. Peter McCullough spoke to the Association of American Physicians and Surgeons at their annual meeting on Saturday, October 2. He gives a clear, easy to follow, scholarly perspective on the causes and treatments of COVID-19 and the safety and efficacy of COVID vaccines. It’s a little more than an hour long, but I recommend you stop reading this blog and watch it by clicking here. If you don’t have an hour to watch the video right now, here are my CliffsNotes version of Dr. McCullough’s talk, complete with video references.

There are serious safety concerns with COVID vaccines. Lapses in usual safety standards plagued vaccine development and distribution (8:10). Groups excluded from pre-authorization clinical trials are receiving vaccine (9:13), including pregnant women, women of childbearing age, COVID survivors, people with suspected COVID, and those with positive COVID serologies.

The CDC and FDA have misled the public about vaccine safety. They minimized vaccine related deaths (14:14), and they have not provided periodic safety reports. Despite what is reported in the media, the FDA did not approve Pfizer-BioNTech COVID-19 Vaccine (22:10). The CDC manipulated data to support the “Pandemic of the Unvaccinated” narrative (29:15). Of Americans hospitalized patients with COVID during the delta wave, 23% have been vaccinated (32:20). The CDC and FDA have failed to emphasize that seniors suffer the most vaccine failures (30:20). Instead, they are focused on authorizing vaccines for children, a group that has a greater risk of hospitalization for vaccine-induced myocarditis than for COVID-19 (18:16). The CDC and FDA cannot be trusted to provide honest information about vaccines.

The universal vaccination policy must change. All vaccines have failed against the delta variant (26:45), and they have not stopped the spread of virus (23:57). Vaccines are forcing viral mutations (34:05); as vaccination rates increase, natural viral diversity decreases. Vaccines produce narrow, limited immunity (36:00), and vaccinating COVID survivors causes harm (49:19). Vaccinated individuals are as likely to spread virus as unvaccinated individuals (37:07). On the other hand, natural immunity is robust, complete, and durable (49:09). Natural immunity is the only backstop to virus spread (50:00).

Treatments, not vaccines, drive down COVID mortality (33:43). COVID-19 is a complex disease, but early home therapy is effective (38:30). Inadequate treatment is responsible for COVID-19 deaths (44:34). Many seniors have been abandoned by their doctors (45:47), but A Guide to Home Treatment of COVID-19, made available free by the AAPS, fills gaps in management (46:39).

People are losing human rights. Basic freedoms are now dependent on vaccine status (50:24). We need outrage over ineffective and unsafe vaccines (52:45), we need doctors to be doctors (54:35), and we need journalists who recognize that something is wrong (56:36), that there has been a suppression of treatment resulting in fear, suffering, loneliness, isolation, hospitalization, and death (56:50).

But my notes do not have the eloquence and power of Dr. McCullough’s own words. Please, click here and listen to five minutes, then stop when you want. If you can.

2021 COVID-19 Vaccine

Long COVID

COVID-19, the disease of the pandemic, has two pathways. In one pathway, viral infection directly causes the upper respiratory symptoms like runny nose, cough, fever, sore throat, and, in severe cases, pneumonia and respiratory failure. The second pathways is associated with some of the more confounding symptoms of COVID-19 like loss of taste and smell, myocarditis, pericarditis, cardiac arrhythmias, migraines, cognitive deficits, Guillain–Barré syndrome, Bell’s Palsy, and blood clots. These symptoms sometimes appear with infection, but often they emerge after the acute illness is over, and they may last a long time. This is what is known as “Long COVID.”

Long COVID doesn’t happen to everyone infected by the virus. It seems to affect women more than men, and the middle-aged more than the very young or the very old. But for those affected, long COVID can be painful and debilitating.

There are several ideas about what causes Long COVID. One plausible idea is that the immune response mounted to fight SARS-CoV-2 attacks the body’s own cells. In other words, Long COVID may be an autoimmune disease. Viewing this phase of COVID-19 as an autoimmune disease forms the basis for the use of drugs known to tamp down the immune response as an early treatment or preventative for COVID-19. These drugs may also help patients who are struggling with long COVID symptoms.

It’s intriguing that many vaccine complications overlap with long COVID symptoms. Vaccine fact sheets contain warnings for myocarditis/pericarditis, blood clots, and Guillain-Barré Syndrome. These are all immune-mediate processes—in other words, autoimmune disease from an immune system primed to attack your own body. Vaccination is designed to mount an immune response to the spike protein, the tool the virus uses to pick the lock on the door to your body. If Long COVID is an autoimmune response, it’s not surprising that vaccination may cause a similar response.

Another intriguing observation made by me and some of my colleagues, but one I’ve not found published, has to do with the timing of adverse effects of vaccination. I want to be clear that adverse effects of vaccination seem to be rare. Yet, complications occur. The observation is that people who’ve had COVID-19 before taking a vaccine seem to have adverse effects of vaccine immediately if they have them at all. Alternatively, people who have never had COVID-19 have adverse effects of vaccine weeks after vaccination if they have them at all. It makes sense that people who’ve had COVID-19 have an immune system primed for an immediate response, while those that have never been infected need time before the effects are seen.

These observations bring up a couple of questions. Can vaccination cause an autoimmune disease like Long COVID? And if so, will treatments for Long COVID be helpful to those people?

There’s still so much we don’t know.

2021 COVID-19 Science Testing Vaccine

COVID Serology

The immune system is a big complex machine. Medicine tries to simplify the machine to make it understandable and to manipulate it to our advantage. That’s why we measure antibody levels in the blood. The measurement of antibody levels in the blood is called serology. Serology doesn’t measure the whole immune system, but we do it because it’s easy, and it gives us an idea of what’s going on.

Your immune system is stimulated by molecular structures that are not native to you. You could say that your immune system is xenophobic, reacting against foreigners. And your immune system has a long memory. Once stimulated, these memories allow your immune system to mount a defense quickly should that foreigner ever be encountered again. For many infectious agents, including SARS-CoV-2, this means the formation of antibodies which can be measured in your blood.

When you are infected by the virus, your immune system is exposed to all the molecules that make up that virus. Your immune system can respond to any of those molecules, including one special molecule: the spike protein. We need to understand what makes spike protein so special.

Contact between the spike protein on the SARS-CoV-2 virus and a cell inside the nose is the first step in the infection of our bodies by these tiny invaders. The spike protein is like a key that unlocks the vault, giving the virus access the interior of the cell. Once inside, the virus hijacks the cell machinery, converting it into a virus manufacturing plant. Thousands of copies of the virus are pumped out which infect neighboring cells, and the process repeats.

Antibodies to spike protein are special because they are neutralizing antibodies. Neutralizing antibodies get between the viral key and the cellular portals, acting like putty gumming up the keyholes. That’s why code for spike protein is the active ingredient in mRNA vaccines, and that’s why we should be able to measure vaccine response with spike protein antibodies. Other parts of the immune system are activated too, but these work after the virus has entered the body. At least that’s the theory.

How well does all this work? Imperfectly.

While vaccination may reduce the risk of future infection, it does not prevent it. Breakthrough infections occur. Maybe that’s because neutralization only happens when antibody levels are high enough. Or maybe neutralizing antibody levels fade within months of vaccination. Or maybe the small alterations in spike proteins of variants make vaccine-induced neutralizing antibodies less effective. Or maybe it’s a combination of all these ideas. We really don’t know.

And there’s the point. We really don’t know. We certainly don’t know enough to make universal vaccination the sole objective of our pandemic response. Vaccination is a tool that can be used to keep people alive, but it should not become the primary goal. Other theories need to be investigated to identify our best hope for survival.

For example, here’s a theory that should be investigated. Based on what we know about the immune response, natural immunity from COVID-19 should be more durable, more protective, and better for our communities than vaccine. Why? Natural immunity exposes the immune system to many different molecules, not just spike protein, making it more likely to sustain emergence of new variants. More durable immunity generates longer lasting herd immunity, reducing the size of subsequent disease spikes. At least that’s the theory.

How well does it work? We don’t really know.

Although other nations have found wisdom in this theory, the CDC has not permitted us to try it. Instead, the CDC stubbornly holds on to the universal vaccination idea, even vaccinating COVID survivors regardless of their antibody levels.

So how do we get out of this? We need data. We need answers to questions like what antibody levels indicate protective immunity? How long does natural immunity last? Is vaccine-induced immunity as protective natural immunity against variants? Can antibody levels be too high? What are the optimal antibody levels?

That’s why I’m excited about the Texas CARES Survey. This study sponsored by the UT Health Science Center at Houston, with testing by my friends and colleagues at Clinical Pathology Laboratories (CPL), promises to give us large cohort retrospective data on durability and magnitude of antibody responses after disease and/or vaccination, with matching outcomes. Although the study has met its initial enrollment goals, check back for results and more opportunities to participate.

Why has it taken so long to ask these questions?

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