Category: 2022

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2022 COVID-19 Science Vaccine

Vaccination Does Not Prevent Long COVID

Infections by SARS-CoV-2 can cause acute COVID-19 which may last up to four weeks.  Post COVID Conditions, also known as Long COVID, are health consequences that persist or develop more than four weeks (or twelve weeks, according to WHO) after infection.  Individuals who have had acute COVID-19 are at risk for Long COVID.

According to government health agencies, Long COVID prevention is another reason to get vaccinated.  Without offering any evidence, or even a plausible mechanism for why it might be so, the CDC says that “people who did not get a COVID-19 vaccine” are more likely to develop Long COVID.  Health+ Long COVID, a report sponsored by HHS and released last month, contains the recommendation to “promote vaccination as a preventative measure for Long COVID.”  NIH even encourages unvaccinated people to get vaccinated after recovering from COVID-19 because it “may prevent Long COVID.”  But there are good reasons to doubt that any of this is true.

Long COVID can follow mild or asymptomatic infections by SARS-CoV-2.  Although there may be more than one pathway to Long COVID, autoimmunity is responsible for some, if not most, cases of Long COVID.  The intensity of the initial disease does not matter.  Mild or asymptomatic infections can stimulate the autoantibodies that cause Long COVID.  Even if you believe that vaccination reduces severity of COVID-19—I am not saying you should—there is still no reason to believe that vaccination can prevent Long COVID.

Recent studies back this up.  According to an article published in Nature last month, vaccination status does not modify the risk of Long COVID.  Instead, Long COVID correlates to the number of SARS-CoV-2 infections a person has, regardless of vaccination status.  Even though vaccination cannot prevent Long COVID, it may make it worse.  

Think about how autoimmunity causes Long COVID.  Once the immune system is stimulated to recognize the spike protein of SARS-CoV-2, the immune system may attack the body’s own cells.  Whether by an accident of nature or by design, antibodies to spike protein cause autoimmune disease in some people.  It does not matter whether the antibodies are formed in response to vaccine or natural infection, the effect is the same.  Vaccination injuries can look like Long COVID.

Dr. Marivic Villa, a Florida pulmonologist who has treated thousands of COVID patients in The Villages, agrees.  According to a recent publication, Dr. Villa says, “The signs and symptoms profile and clinical presentation of long-haulers from moderate to severe natural COVID infection, and individuals vaccinated three to four times, are almost indistinguishable from one another.”  The formation of autoantibodies by either natural infection or vaccination connects Long COVID to vaccine injuries, consistent with Dr. Villa’s observation.  She concludes, “Halting this vaccination is the highest emergency!”

Long COVID has White House attention.  This focus seems timed to perpetuate the emergency, just like the government distribution of free tests earlier this year.  These substandard tests, purchased by the government and mailed to anyone with a U.S. address, were bad laboratory medicine, saved no lives, and have not been missed since funding ran out.  But the program stirred up COVID activity, keeping the crisis going.  And it enriched test suppliers.

Similarly, attention to Long COVID is a pretext to extend the emergency powers of the executive branch by combining a tragic reality with bad medicine, unsupported by honest science.  And it enriches vaccine manufacturers.  

Every case of COVID-19, every SADS death, every victim of Long COVID, and every individual injured by vaccine is a life lost or damaged by the tragedy of the pandemic.  Long COVID cannot become just another excuse to promote vaccine.

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2022 COVID-19

The Never-Ending Emergency

I have been quiet lately, not wanting to add to COVID saturation.  The issues of the pandemic are well known—viral origin, vaccine safety, early treatment, repurposed therapeutics, pharma windfalls.  The word is out, everyone has an opinion, and most have dug in.  One way or another, we have all learned to cope with a virus that is here to stay.  

From this state of uneasy equilibrium, I must ask why we are still in a declared state of COVID-19 emergency.  Maybe we need to start with the meaning of emergency.

Many years ago, a good friend of mine was pulled over.  The officer invited him to the back of the car, put him in handcuffs, and hauled him to jail.  A check of his license plates revealed a warrant for his arrest, except it was a mistake.  My friend had done nothing wrong.  A clerical error associated his plate number with someone else’s warrant.  Nonetheless, he found himself in the county jail.  On the wall of the cell was a dirty red button, and under the button was a sign, “Press for emergency.”  He felt entitled to press the button.

“What is your emergency?”  Came the voice out of the speaker.

“Well, you see, I shouldn’t be here…”  Click.  

The speaker went silent, so he pressed the button again.

“What is your emergency?”

“I believe there must be some mistak…”  Click.  He pressed the button again.   

“What is your emergency?”

“I need to make a phone ca…”  Click.  By now, he realized that his situation, however unpleasant, inconvenient, and unjust, did not constitute an emergency, so he prepared to spend the night alone in the cell, which he did.  The next morning the mistake was realized, and he was released, unceremoniously, with barely an apology, and no compensation for his 17-hour ordeal.

COVID-19 is like this.  It is unpleasant, inconvenient, and even unjust, but it not an emergency. At least not anymore.

This view has gained broad consensus across the political spectrum.  Most states have ended emergency measures, and California will join that list soon.  With a nearly veto-proof bipartisan majority, the US Senate voted to end the emergency earlier this month.  Even President Biden has said the pandemic is over.  Yet his administration promises to veto the Senate bill if passed and to extend the emergency declaration again next year.  All for an emergency that is as real as the tooth fairy.

And why not?  The emergency declaration has been the tooth fairy for many.

The COVID emergency is a bonanza for manufacturers of counter-pandemic measures—vaccines, tests, and drugs among them.  Not only does it give them an endless market for their products, but bypassing FDA approval saves them millions.  And they also receive liability protection for any product manufactured under Emergency Use Authorization.  No wonder the healthcare manufacturing sector never wants the emergency to end.

The American Hospital Association also lobbies for continuing the emergency, and for similar reasons.  Hospitals get a 20% bonus for treating COVID patients.  CMS relaxed regulatory standards during the emergency.  And there is funding for “building vaccine confidence.”  But none of this would happen without the consent of government.  

The executive branch of government has used COVID-19 as excuse for a power-grab.  During a crisis, citizens—including members of congress—are willing to temporarily cede power to the executive in exchange for steady leadership through the emergency.  The trouble is that the executive branch jealously clutches power gained during turbulent times once calm is restored.  History backs me up.  World War I gave us the Espionage Act of 1917.  September 11 gave us the Patriot Act of 2001.  And the COVID Pandemic gave us the Declaration Under the PREP Act for Medical Countermeasures Against COVID-19.

Last month, right on cue, Xavier Becerra renewed the emergency for the twelfth straight quarter, extending the government’s emergency powers into 2023.  Many of these “emergency” measures are difficult to connect to the pandemic.  For example, the CDC issued an eviction moratorium that had to be struck down by the Supreme Court.  HHS approved use of Medicaid funds to pay for food and housing in Massachusetts and Oregon.  The emergency is even the basis for President Biden’s proposal to forgive student loans.  The emergency has allowed the administration to short-circuit the checks and balances in normal policymaking processes, giving it autocratic power.

The emergency has become an institution.  Many are dependent on emergency measures, so there will be pain when the emergency ends.  But delay will only increase the suffering we must endure later.

The emergency is over.  Policies must stand on their own merits.  Normal processes must return.

Categories
2022 Vaccine

Immunizations for Vaccinations

Last week, CDC published an interim COVID-19 vaccination schedule that recommends unapproved COVID-19 vaccines for routine administration to children less than twelve years of age. This is the first time CDC has placed an unapproved vaccine on the childhood vaccination schedule, permanently transferring liability for these vaccines from the manufacturer to American taxpayers, even after the emergency ends.  Only Congress can change this now.

We knew this was coming.  The PREP Act Declaration issued by the Secretary of HSS more than two years ago granted immunity “from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration or use of a covered countermeasure” while the nation is under the COVID-19 emergency declaration.  “Countermeasures” include vaccines.

PREP Act immunity is not permanent.  When the emergency declaration is finally lifted, continued use of COVID-19 vaccines will expose the vaccine manufacturers to liability unless it becomes a “covered vaccine” under the National Vaccine Injury Compensation Program. 

What is a covered vaccine?

For a vaccine to be covered, the Centers for Disease Control and Prevention (CDC) must recommend the category of vaccine for routine administration to children or pregnant women.  

Those where not my words; they come directly from the HRSA website.  Once covered, the vaccine is protected for all recipients, not just children and pregnant women.  By recommending COVID-19 vaccines for children, the CDC transferred all associated product liability to the American taxpayer.

This action is an assault on many levels, but I want to focus on only one.  The recommendation applies to an unlicensed product.  No matter your opinion of FDA’s approval and licensing process, the process should be completed before a product is recommended for routine use.  An emergency use authorization does not apply to non-emergent administration.

COVID-19 vaccines are not approved for anyone younger than 12 years of age.  Furthermore, approved COVID-19 vaccines remain unavailable to Americans of any age—although that will probably change now that permanent immunity has been secured.  A vaccine that is not approved for children should not be recommended for children, and it has never happened before.  This is the first time that the recommendation for routine administration has preceded FDA approval.

FDA approval is a slow and laborious process with many critics.  Despite decades of attempts at acceleration, at the pandemic’s outset the FDA’s process was seen as a liability that put Americans at greater risk than citizens of other nations.  The fear that the FDA would slow down an effective pandemic response led to the emergency declaration by HHS and the use of Emergency Use Authorizations to bring new countermeasures to market.  Although careful, meticulous approvals can be painstaking, rapid approvals compromise safety.  I did not take an oath to eliminate frustration; I took an oath to do no harm. 

But what harm is there in vaccine?  Surely vaccines are the most benevolent of therapies, protecting against dread diseases while rarely causing harm.

This thinking is an example of association fallacy.  A risk-benefit analysis that favors some vaccines is not a favorable risk-benefit calculation for all vaccines.  Each vaccine must be carefully evaluated on its own merits.  The slow, methodical FDA approval process meets that standard.  Or at least I thought so.

FDA’s approval process has let us down, plenty of times.  Think of television commercials promising large litigation settlements to victims of injury by various drugs.  There will be no such advertisements for COVID-19 vaccine injuries since these vaccines have immunity under the law.  Unless the law changes.

Congress has the power to change law, and Congress has the duty to change bad laws.  

Although Congress did not directly grant liability protection to COVID-19 vaccine manufacturers, by passing the National Childhood Vaccine Injury Act of 1986, the 99th Congress created a loophole that gave the CDC power to shelter COVID-19 vaccine manufacturers from liability, setting the stage for what happened last week.

CDC’s actions are unprecedented.  Recommending an unapproved vaccine for children is reckless. Transferring product liability risk from manufacturers to taxpayers is corrupt.  Congress owns this.  Congress can change this.

The election for the 118th Congress is only days away, and early voting has already begun.  Please keep this in mind as you consider your vote.

Categories
2022 Vaccine

The Vaccine Is a Virus

mRNA Vaccine Lipid Nanoparticle

A virus is a sequence of genetic code wrapped in an envelope.  Viruses are classified by their envelope and genetic code configurations.  Since they do not possess independent means of reproduction, viruses are not technically alive, yet they yield to the primal force of life—the urge to propagate their genes.  To do this, each virus seeks a host, hijacking its means of reproduction to pump out as many copies of the virus as possible.  Each copy seeks its own host to infect, and the cycle repeats.  In this way, the virus and its genes live without being alive.

An mRNA vaccine is a sequence of genetic code wrapped in an envelope.  The genetic code is messenger RNA and the envelope is a lipid nanoparticle, but that does not change the similarity to a virus.  Like a virus, each mRNA vaccine particle infects a host cell, hijacks the cell’s means of production, and pumps out copies of the encoded spike protein.  

Both virus and vaccine introduce spike protein into the body.  When virus enters through the nose and upper airways, the spike protein on the virus causes an immune response and spike antibodies are formed.  A successful immune response clears the virus, but the immune memory lingers, spike antibodies and all.  Inoculation by mRNA vaccine is also an infection, except this infection occurs in the arm.  

We were told—and I wrote in this blog—that vaccine mRNA stays in the cells of the arm muscle and is broken down quickly, but that is not true.  Studies published this year have demonstrated vaccine mRNA in breast milk, blood, lymph nodes, liver, and skin.  Unlike spike protein from a mild infection, vaccine induced spike protein can be detected in blood up to four months after vaccination; from there, it can distribute widely throughout the body.  Clearly, the mRNA does not stay in the arm and is not broken down quickly.  Compared to natural infection, genetic COVID-19 vaccines are more likely to spread spike protein throughout the body. 

This wide distribution of vaccine is significant.  Every cell that ingests a lipid nanoparticle will express spike protein, marking the cell as an immune target.  As a result, the cell will die.  This process is a direct mechanism for adverse effects like vaccine-induced myocarditis.  When a heart muscle cell absorbs vaccine, the spike proteins generated incite inflammation that kills the cell.  If this happens to enough heart cells, the person will die—suddenly and unexpectedly.

Yet this mechanism may not explain all the adverse effects of vaccines.  Serious conditions such as acute myocardial infarction, Bell’s palsy, cerebral venous sinus thrombosis, Guillain–Barré syndrome, myocarditis, pericarditis, pulmonary embolism, stroke, thrombosis with thrombocytopenia syndrome, appendicitis, herpes zoster reactivation, neurological complications, autoimmune hepatitis, and autoimmune peripheral neuropathies have been reported.

Since these conditions have also been observed after SARS-CoV-2 infection, a common autoimmune pathway is proposed.  Whether introduced by virus or vaccine, spike protein shares features with molecules naturally found in the body.  There are enough similarities that antibodies to spike protein may cause disease.  The antibodies that remain after infection or inoculation are unable to distinguish between the harmless molecules of the body and viral spike protein.  The result is an attack on one or more parts of the body by the body’s own immune system. 

SARS-CoV-2 virus and mRNA COVID-19 vaccines share structural features and pathogenic effects.  Both consist of genetic material within a lipid envelope.  Both introduce spike protein to the body, and both stimulate antibodies against spike proteins and their lookalikes, which may damage one or more organs.  The adverse effects of vaccine can look like long COVID.

The vaccine is a virus, with one important difference.  The virus, you catch.  The vaccine, you take.

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2022 Ethics Philosophy

A Life Well Lived

Next to my wife and family, medicine is my life.  But can a life in medicine be a life well lived?

First some definitions.  To me, the difference between life and death is consciousness, and consciousness is awareness and activity.  Awareness and activity require memory of the past and projection into the future.  Maybe you disagree with these definitions, but stick with me for a few minutes.  

The arrow of time moves in one direction only.  The past is unchangeable, and the future is unknowable.  The point at which future turns into past is now, and now is where experience happens.  Experiences are the elementary particles of life.  

There are many kinds of experiences.  Some experiences are trivial, others are profound, and many are mutually exclusive.  Every life is filled with experiences, but which experiences make a life well lived?

Self-awareness—knowing who you are—guides the selection of experiences that separate a life without meaning from a life well lived.  But you may not be who you think you are.  For example, you are not the sum of your talents.  A virtuoso is not just a musician—that would be sad, just as sad as a talented doctor who is only a doctor.  You are not any degree, profession, certification, achievement, success, or accomplishment you may have earned. These are things you have done, not who you are.  

You are not your personality.  Personality describes a style comfortably worn, like a pair of jeans or a favorite coat.  You are much more than what you wear.  You are the core that your personality covers, the essence that is served by your skills and talents.  You are who you are wired to be.

A life well lived is a life filled with experiences that resonate with who you are.

Filling your life with experiences that match your essence puts you in flow, the state of complete immersion in an activity, where time is distorted, and joy is maximized.  This works regardless of your occupation.  I spend a lot of my time at work in flow.

I share the talents of many of my colleagues—determination, persistence, stamina, pragmatism, independence, and the ability to think logically—talents suited to medicine.  My Meyers-Briggs type is ENTJ, which makes me a bit atypical for a pathologist.  My education and training took more than half the life I have lived so far.  But none of these are who I am.

I am wired to help people have a better future.  Many people are wired the same way, and it sounds grander than it is.  I am wired for better, not for perfection.  My scope is people in my reach, not every person on earth.  This is who I am, whether I am a doctor, a neighbor, a husband, or a father.  

I earn my living as a pathologist, and my professional life is filled with experiences that connect people with information they need to have a better future.  My job takes me into worlds most people do not know exist.  When I look in my microscope, I see colors, shapes, and beauty.  I see heroes and villains, tension and resolution, turmoil and peace.   In these fanciful places, I find what people need.  I dig it out, distill it, package it, and deliver it, connecting people to it.  It is satisfying work because it is consistent with how I am wired.  Many times, I am arming someone on a hero’s journey, standing at the edge of the abyss.  Many times, I am helping my colleagues do what they are wired to do.  But my profession does not determine the value of my life; doing my job in a way that resonates with who I am is what makes my life fulfilling.  

It is possible to have a life well lived in medicine, but not because it is a life in medicine.  A life well lived in medicine is like any other life well lived.  It is a life filled with experiences selected to match the core of being.  Every life contains the promise of a life well lived.  My potential for a life well lived will continue even if my life in medicine ended today.

But there is a flip side, a warning especially for those who share my profession.

A life filled with experiences that conflict with being is a life of dissatisfaction and dysfunction.  Joy is lost. Boredom, anxiety, or both creep in.  This is where burnout happens, and it happens in medicine—a lot.

When physicians focus on the past or the future instead of the patient in front of them now, when we think about our image, prestige, or money instead of helping others, when we blindly follow what others tell us to do instead of observing and drawing conclusions ourselves, when we are not true to who we are, we lose it.  

We lose the promise of a life well lived.

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2022 COVID-19 Ethics Science Vaccine

Post-Pandemic Stress Disorder

Seasonal upper respiratory infections are not new, but we are responding with a new emotion—fear.  We have been traumatized by the pandemic, and that has created a unique form of post-traumatic stress disorder. Some of us will need treatment, but most of us can snap out of it.  How and when we conquer our fear will determine the world we give our children.

The normal brain is not like a security camera.  Instead of recording activity, sensations, and body conditions in a continuous moment-to-moment reel, typical memories are collections of patterns and associations.  Gaps between significant events are cut from our recollection.  A birdwatcher is more likely to remember rare species observed rather than the order or times birds are seen during an outing.

Intense emotions change the way memories are made.  These emotions need not be unpleasant; it is the intensity of feelings that matters.  During these moments, memories are seared into the brain in vivid detail.  It is more than what happened; the emotions of the experience become part of the memories.

Trauma is the body’s response to imminent danger.  The threat can be against your status, your self-image, or your very life.  Trauma does not require real danger; the perception of danger is enough.  If the threat seems real and the emotions intense, a traumatic memory can result.

Trauma changes the mind.  We have a primitive impulse to protect ourselves from harm.  When we encounter a situation that reminds of a past threat, we instinctively defend ourselves using the acute stress response—fight, flight, freeze or fawn.  Individuals triggered in this way can be combative, avoidant, catatonic, or irrationally conciliatory.  First recognized in World War I veterans as “shell shock,” this is the basis for our modern understanding of post-traumatic stress disorder.  

Collective trauma can change a generation.  Those who lived through the Great Depression endured a period of inescapable poverty.  Shantytowns sprang up as the number of destitute increased.  Those who survived this period abhor waste, hoarding items of little value because they fear running out.  Traumatized by their collective experience, many who grew up during this time could never shake their fear, and this fear limited their future productivity.  Known as the Silent Generation, this is the only generation of Americans to not produce a President.   

Trauma causes trauma.  The response to trauma by one person can cause a trauma in another person, creating a deteriorating spiral of disfunction.  For example, patterns of violence are often observed in families, passed from one generation to the next.  The traumatized may vow to never allow themselves to be threatened again, resulting in a display of power that threatens others, and the cycle perpetuates.  This is what the pandemic has done to us.

COVID-19 has been traumatic.  We survivors have lived through a mortal threat.  Most of us know someone—probably someone close—that succumbed to COVID-19.  Deaths associated with COVID-19 are still happening today, but not nearly at the rates of 2020.  We sought protection in vaccines and expensive new drugs, and we wanted to believe they could save us from this deadly threat.  Now our fear is exploited by unscrupulous leaders who tell us it will work only if we all believe.  Just as the virus posed a threat to our lives, the response by those in power poses a threat to our liberty.  Those who do not comply with the plan of protection do not deserve the fundamental rights of a human being.  They are not human—they are other than human.

How do we break this cycle?

First, we must put the threat in context.  Although a threat still exists, we have advanced in the fight against COVID-19.   Deaths from COVID-pneumonia this winter are comparable to deaths from community acquired pneumonia during pre-pandemic years.

Using 2019 US Census Bureau data and the weekly COVID mortality data for December 25, 2021 published on the CDC’s COVID Data Tracker, I calculate an overall annualized COVID mortality rate of 7.5 per 100,000 population, which is higher than the rate published on CDC’s website.  During the mild flu season of 2011-12, the annualized flu mortality per 100,000 population was 3.8, about half the current rate of COVID mortality.  But during the severe flu seasons of 2014-15 and 2017-18, the annualized mortality per 100,000 population was over 15, double the current rate of COVID mortality.  The current COVID-19 mortality rate is less than flu in a bad year.

Second, we must put the vaccine debate in context.  A recent MMWR report shows that individuals who were both unvaccinated and uninfected during the Delta wave had a higher incidence of hospitalization.  Vaccination keeps people out of the hospital, but at what cost?  

A critical analysis of Pfizer’s FDA submission data shows that vaccination is associated with two extra cardiac deaths for every COVID death avoided.  The same data shows that all-cause mortality is greater among those who received vaccine (15/22,000) than placebo (14/22,000).  By the way, if you want to review this data for yourself, search for Table S4 in the supplementary information.  Table S4 is referenced in the article, but it is not published there.  To paraphrase the Wizard, you are to pay no attention to the data behind the curtain.

Finally, we must let go of our fear.  Easy to say, hard to do.  Trauma has a way of working fear into your body; you cannot just eliminate it with the strength of your will.  Everyone’s specific path will be different.  Those most severely affected by post-pandemic stress disorder will need professional treatment; these individuals deserve our compassion.  But generally, we let go of unrealistic fears by realizing the monster is not scarier than other risks we face daily.

One way to do this is to give the fear a name—“name it to tame it.”  Calling out what scares us is a way to release unrealistic fears.  For example, COVID has caused many of us to be afraid of people who have different ideas about the pandemic, but when we realize this is a fear of diversity, it may be easier to let that fear go.  

We cannot expect everyone will choose the same course of action, but we must treat each other with respect anyway.  The same MMWR report that shows vaccination keeps people out of the hospital also shows that those with natural immunity are about half as likely to be hospitalized as those with vaccine-induced immunity alone.  Does that mean we should fear those who have avoided SARS-CoV-2 infection?  Of course not.  But neither should we fear the unvaccinated or unmasked.  Fear makes us vulnerable to manipulation designed to perpetuate the pandemic.  We must stand fearlessly against irrational one-size-fits-all policies.

The pain of the pandemic is present still.  The pandemic has taken lives.  Our pandemic response is breaking lives and destroying livelihoods.  Some of you may no longer fear COVID-19, but you still fear losing your job, losing access to medical care, or being ostracized for your beliefs.  We cannot let trauma trap us in pandemic forever.  What we do now determines the type of life we pass to the next generation.  

We love our children and desire to bequeath a better world to them.  We cannot make them spend their lives cleaning up this mess.  For the sake of our children, we must allow our traumatic memories to fade.

Categories
2022 Vaccine

Moderna’s Spikevax Approval Echoes Comirnaty

On Monday the FDA approved Spikevax, the second licensed COVID-19 vaccine.  But Spikevax will be as elusive as Comirnaty.  Even though the FDA press release makes it sound like Moderna is simply changing the name of its COVID-19 Vaccine to Spikevax, Moderna COVID-19 Vaccine will continue to be available under EUA just like Pfizer-BioNTech COVID-19 Vaccines.  As with Pfizer, FDA has approved a phantom vaccine while using EUA to shield Moderna from product liability.  Instead of protecting Americans, the FDA is double-dealing deceptively to benefit a large pharmaceutical company.

FDA issued two letters on January 31, 2022, both addressed to Michelle Olsen of ModernaTX, Inc.  The first letter permits the company to market its COVID-19 vaccine under the label SPIKEVAX.  FDA took this action without a referral to the Vaccines and Related Biological Products Advisory Committee because Moderna’s Biologics License Application (BLA) “did not raise concerns or controversial issues that would have benefitted from an advisory committee discussion.”  Which is not the same as saying the BLA does not raise concerns or controversial issues.

Potential concerns and controversial issues are detailed later in the letter as “Postmarketing Requirements/Commitments.”  These include studies to address the effect of the vaccine on children, due in 2024, and studies to determine the risk of myocarditis, due between June 2023 and October 2028.  The results of required studies on the effect of the vaccine on pregnancy will not be known until June 2024, but the product can be distributed just as soon as Moderna receives “a notification of release from the Director, Center for Biologics Evaluation and Research.”

The second letter reaffirms the Emergency Use Authorization for Moderna COVID-19 Vaccine.  This letter offers flimsy reasons for the persistence of the EUA.  For example, the letter states that

Although SPIKEVAX (COVID-19 Vaccine, mRNA) and Comirnaty (COVID-19 Vaccine, mRNA) are approved to prevent COVID-19 in certain individuals within the scope of the Moderna COVID-19 Vaccine authorization, there is not sufficient approved vaccine available for distribution to this population in its entirety at the time of reissuance of this EUA.

Footnote 11

Of course, there would be sufficient approved vaccine if FDA required Moderna to relabel existing inventory as “Spikevax.”  This option is not addressed in the letter.

The letter goes on to say that the scope of the license is a subset of the scope of the EUA, and that the EUA must continue so that vaccine is available in unapproved situations.  Of course, those situations could be addressed in an EUA that excludes the licensed situations, but that option is not considered in the letter.  

Finally, in language that seems to have been boilerplate from the Pfizer-BioNTech EUA, the FDA will allow Moderna COVID-19 vaccine to be administered to individuals 18 years under EUA because “there remains, however, a significant amount of Moderna COVID-19 Vaccine that was manufactured and labeled in accordance with this emergency use authorization.”  Does that mean that Moderna will stop manufacturing the EUA version of its vaccine and just consume inventory?  I doubt it.

According to its package insert, Spikevax is approved for adults 18 years and older as a two dose primary series.  However, like Comirnaty and Pfizer-BioNTech Purple, the revised Vaccine Information Fact Sheet about Spikevax and the Moderna COVID-19 Vaccine permits Spikevax to be used interchangeably with Moderna COVID-19 Vaccine. 

So now our vaccine chart looks like this:

Within a vaccine landscape that is more complicated than ever, we still do not have a licensed COVID-19 vaccine for Americans.

Categories
2022 COVID-19 Testing

Free Tests We Cannot Afford

A new crisis has been spawned by the pandemic.  This crisis was announced by the President in December, and it will consume more and more bandwidth in coming months.  It is the crisis of testing.  This is a fabricated crisis, unrelated to people’s health.  This crisis is a distraction designed to perpetuate the pandemic so that more of your wealth can be transferred from public coffers into the pockets of special interests.

On December 21, in the same speech that introduced the testing crisis, the President  announced an initiative to make 500 million free tests available to Americans.  These tests can be ordered “free of charge” at covidtests.gov, and they will delivered to your home by the US postal service.  Furthermore, the government has “incentivized” insurance companies to reimburse Americans for over-the-counter tests, up to eight tests per covered individual per month.

As Omicron burns through the country, it’s time for a dose of common sense.  Omicron is mild.  With over-the-counter medications and the advice of Front-Line doctors, most people can recover at home, without a test. 

Many people think that a negative test means that you cannot infect others, but that is not the case.  PCR tests have issues, but over-the-counter tests are antigen tests, and antigen tests are notoriously unreliable.  Using manufacturers’ submission data, over-the-counter tests have average sensitivity confidence intervals of near 70%, meaning that up to 30% infected people will have a negative test.  Results are influenced by timing and technique.  Test too early, and the confidence intervals can drop below 40%.  A negative test does not mean you cannot spread disease, and a positive test does not mean you will spread the disease.  Using test results to control social, educational, and business interactions will fail to stop the spread of the virus.  Relying on test results to determine who is sick and who is not is dangerous.

So why the push for testing?  Two reasons.  It’s a boondoggle, and it perpetuates the emergency. 

“Free tests” for all Americans are not really free to all Americans.  The government buys them with taxpayer dollars from companies that have little incentive to produce quality tests.  This is because the tests are available by EUA which eliminates the manufacturer’s liability.  There is no consumer protection for shoddy work, no matter how egregious.  Even more, these companies have a governmental market guarantee.  With the promise of four free tests per address, manufacturing test kits is the same as printing money.

But even worse is how indiscriminate testing adds to pandemic panic.  Every positive test raises the CDC’s case count, and rising cases fuel the pandemic, keeping the emergency active.  It should be clear to everyone that the emergency is over.  We have treatments, we have ventilators, we have vaccines, we have hospital beds.  The original emergency was two weeks to flatten the curve.  We’ve reached a status quo.  We may not like where we are, but here we are anyway.  It is no longer an emergency.

It is time we take down our emergency provisions and restore power to the people.  Stop obsessing, stop naming, stop testing indiscriminately.  Everyone knows when they are well and when they are under the weather.  It is time to use common sense about our new common cold.

We know what to do when we have cold symptoms.  Stay home from work, stay away from vulnerable family and friends, and take the vitamins and therapeutics recommended by Front-Line doctors.  Go to the emergency room if you have trouble breathing, if you do not get better, or if something feels different than a common cold.  

Fight corruption and help end the pandemic.  Test as directed by your doctor, not by your government.

Categories
2022 COVID-19 Ethics Vaccine

Follow the Money

This is the story of how conflicts of interest have compromised the integrity of our government’s public health policies, favoring special interests instead of the best interest of Americans.  

When the pandemic first washed over us, it knocked many of us off our feet.  Policymakers shot-gunned solutions in reaction to terrifying mortality rates, especially among the elderly.  We needed treatments, ventilators, hospital beds, and vaccines; we needed them fast.  We were in no position to bargain.  

This chaos created opportunity.  Handsome rewards were promised to those offering remedies for the unthinkable.  Quoting Robert F. Kennedy, Jr., “Nothing sells vaccine like panic.”  This has been especially true of Pfizer, the manufacturer of the Pfizer-BioNTech COVID-19 Vaccine.  

Who pays for Pfizer vaccines?  Not the vaccine recipients.  At least not directly.  According to the Wall Street Journal, the U.S. Government pays Pfizer $24 for every vaccine administered against an estimated cost of $1.20, a profit of at least $22 per shot.  Every first dose, every second dose, every third dose to the immunocompromised, every booster, every accidental dose to someone previously vaccinated—all generate $22 in profit.  OSHA mandates, CMS mandates, and reductions in minimum vaccination and booster ages increase the target market, sales, and profits.

The result is a windfall for Pfizer.  According to its third quarter SEC filings, Pfizer’s YTD revenue as of October 3 2021, soared to $57.7 billion, nearly doubling its $30.2 billion revenue for the same period in 2020.  At the same time, Pfizer’s net income more than doubled, up 224% from $8.3 billion to $18.6 billion through the third quarters of these years, working out to $3.32 per share of common stock.  

The same government that pays for the vaccines regulates the product and mandates its use.  This creates a conflict of interest on its face.  Furthermore, no one involved in assuring the “safety and efficacy” of vaccines has disclosed a potential conflict and recused themselves from participation in the debate, acceptance, and approval of Pfizer’s vaccines and its reimbursement system.  Are we to believe that not one has a financial interest in Pfizer?  

If we disrupt their money machine, companies like Pfizer threaten us with the loss of wonder drugs.  Research and development costs money, they tell us, and many drugs never make it to market.  Pills have a high price because pharmaceutical companies must recoup these costs.  Don’t mess with us, they say, or you will lose the gumball machines that dispense the new and improved drugs keeping you alive and happy.  

Husain Lalani, MD, MPH, a proponent of universal vaccination to eradicate SARS-CoV-2, together with colleagues Jerry Avorn, MD, and Aaron Kesselheim, MD, published a recent article in Clinical Pharmacology and Therapeutics which demonstrates that COVID-19 vaccines are the result of “decades-long taxpayer investments” prior to the pandemic.  Then we funded the clinical trials necessary to bring product to market. According to Dr. Lalani, “in total, over $18 billion dollars of US public funds have been invested in 6 [COVID-19] vaccine candidates.”  You and I have paid for these vaccines, so why don’t we own them, instead of Pfizer?

Under the guise of altruism, the pharmaceutical industry is robbing the public treasury while gouging its customers.  Government subsidies invalidate the industry’s justification for high drug prices.  It’s never been about your life and happiness; it’s always been about their bottom line.  The cost is spread across the population, like a tax.  The benefit is concentrated in a few companies and their shareholders, like special interest fraud.

The essence of capitalism is to assume risk.  Capitalists naturally seek to minimize risks and costs but using power and influence to offload them to the public is corruption.  It is easy to see.  Just follow the money.

Many see the pandemic as an opportunity to accumulate wealth and consolidate political power.  We need to love our freedoms more than we fear the loss of wonder drugs, more than we fear a germ.  Americans must stop bickering and start figuring out how to fight greed and evil.  The first step is to eliminate corruption.  Let’s start with the corruption we can see.

Categories
2022 COVID-19 Science

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.