Categories
2023 COVID-19 Testing Vaccine

Emergency Use Authorizations in a Post-Emergency World

According to the U.S. Department of Health and Human Services (HHS), the COVID-19 Public Health Emergency will expire in May, but Emergency Use Authorizations and liability protection will continue after the emergency ends.

Early in the pandemic, we were told that Emergency Use Authorizations were necessary to make unlicensed, unapproved tests, vaccines, and treatments available during an emergency.  On January 31, 2020, the Health and Human Services Secretary declared the COVID-19 pandemic a public health emergency, paving the way for these products.  The secretary even invoked the liability protection of the PREP Act to encourage manufacturing of countermeasures.  Soon, the FDA began issuing Emergency Use Authorization letters which close with a notice that the authorization will terminate when the emergency is over.

Last month, the HHS secretary signaled his intention to end the emergency on May 11, 2023.  At the same time, the secretary assured us that Emergency Use Authorizations will not be affected.  According to the statement, “Existing EUAs for COVID-19 products will remain in effect under Section 564 of the Federal Food, Drug, and Cosmetic Act, and the agency may continue to issue new EUAs going forward when criteria for issuance are met.”

The Federal Food, Drug, and Cosmetic Act was amended several times by the Consolidated Appropriations Act, 2023 (see page 1339, for example).  Did these amendments give FDA authority to issue EUAs without an emergency?  I cannot tell you because, frankly, I get lost in the language.  HHS claims its authority for EUAs in the absence of an emergency declaration dates back a decade, to the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013.  Regardless, the intention is clear: EUAs will continue after the emergency is lifted.

And what will become of those PREP Act liability protections?  According to HHS, these will also continue, but only for a select group of manufacturers:

Currently, the amended PREP Act declaration provides liability immunity to manufacturers, distributors, public and private organizations conducting countermeasure programs, and providers for COVID-19 countermeasure activities related to a USG [United States Government] agreement (e.g., manufacturing, distribution, or administration of the countermeasures subject to a federal contract, provider agreement, or memorandum of understanding). That coverage will not be affected by the end of the PHE. However, PREP Act liability protections for countermeasure activities that are not related to any USG agreement (e.g., products entirely in the commercial sector or solely a state or local activity) will end unless another federal, state, or local emergency declaration is in place for area where countermeasures are administered. HHS is currently reviewing whether to continue to provide this coverage going forward.

Fact Sheet: COVID-19 Public Health Emergency Transition Roadmap, February 9, 2023

Manufacturers of EUA products that have an agreement with the US Government will continue to have liability protection.  Other manufacturers will not.  Collusion between the federal government and big businesses like this asymmetric post-emergency liability protection is the very definition of fascism.  

If Emergency-Use-Authorizations without an emergency seem illogical to you, you are not alone.  Even members of congress have assumed that EUAs will end with the emergency declaration.  

This is not just an assault on language and logic.  It is an assault on liberty.  

The emergency declaration will end soon, but the emergency power-grab will continue indefinitely.

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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.

Categories
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
COVID-19 Testing

Too Much Testing

Frustrated by misconceptions about SARS-CoV-2 testing, I began my career as an amateur blogger nearly two years ago.  I am motived by similar frustrations to write this blog today, but the source of today’s frustration is someone who should know better—the doctor to the President of the United States.

Joe Biden announced on Thursday, July 21, that he tested positive for COVID-19, despite being double vaccinated and double boosted.  Setting aside this fact as evidence that vaccination does not prevent future infection, that vaccination cannot eradicate the virus, and that current vaccinations stimulate immunity against the wrong target, I want to focus on the misuse of testing to perpetuate the COVID emergency.

On Wednesday the President’s doctor, Kevin O’Connor, DO, FAAFPannounced that Mr. Biden had repeatedly tested negative for SARS-CoV-2, and he lifted strict isolation measures.  But on Saturday, the doctor reported a positive antigen test.  He declared the President in relapse, blaming the same “Paxlovid rebound” that plagued Dr. Anthony Fauci during his infection in June.  In case you are wondering, Dr. Fauci also reports being fully vaccinated and up to date on boosters, and according to Dr. Fauci, his second round of symptoms were worse than his first.  In case you are also wondering, I had a single Janssen vaccine without booster ten months before my infection, and I suffered no “Hydroxychloroquine rebound” when I had omicron.  And I did not test.

Let me say this as plainly as possible.  

SARS-CoV-2 tests are not tests of cure.  They can tell you when someone is first infected by the virus, and that is all.  They cannot tell you when someone is rid of disease and no longer infectious.  The diagnosis of COVID-19 requires evidence of respiratory disease and a positive test for SARS-CoV-2.  Either one without the other is not COVID-19.  Despite the CDC’s redefinition midway through the pandemic, there is no laboratory test for COVID-19.

There are two types of SARS-CoV-2 tests—PCR tests and antigen tests.  PCR tests are highly sensitive, but positivity can persist for up to three months after infection.  During this period, tests are not reliable to identify reinfection, since any positive might just be remnants of the old infection.  Antigen tests are much less reliable.  Although an initial positive antigen test may indicate infection, negative tests do not mean a person is free of infection.  This has not changed since EUA testing began in 2020. 

If the President is subjected to daily testing, he may be diagnosed with many relapses in coming weeks, but that does not mean he still has COVID-19.  For that, doctors must rely on clinical observations.  The President’s doctor should know this.  He must know this.

Testing is being misused to perpetuate the COVID-19 emergency in our nation.  This episode illustrates the dangers of testing misuse and overuse.   We need a return of common sense, as much among doctors as among the public.  Testing should be limited and focused.  

We all know when we feel sick.  If you do, stay home, and seek early treatment, because early treatment keeps you out of the hospital.   I used the Zelenko protocol when I had Omicron.

When you feel better, return to your life.  We do not need tests for that.

Categories
COVID-19

I Had Omicron

I am pretty sure I had Omicron in January.  I say “pretty sure” because I did not confirm infection with a PCR test.  By now you know why I think most of these tests are unnecessary.  It felt like a cold, and a rather mild cold at that.  Most people in my family had the same symptoms; I encouraged them not to test, and they did not.  I remember that people around me felt sick too—some took time off work, some blamed allergies.  I am pretty sure it was COVID.  

We were on vacation at the time, lest you worry I spread my infection to sick people, although I did take a flight home while still stuffy.  Masks on airplanes were still mandatory at the time.  

But I hedged my bets.  I took hydroxychloroquine for a week.  I tripled my daily vitamin D, did daily nasal washes, and started taking Dr. Zelenko’s Z-stack vitamins (I haven’t stopped taking those).  I never lost taste; I never lost smell.  It took me a month to shake the sniffles, but nothing else lasted more than 36 hours.  

My wife, Liz, never felt ill.  She has lupus and has taken hydroxychloroquine for years.  Maybe that is why.  

Back up a bit.  I am pretty sure we avoided COVID before then.  Liz and I were extra careful.  She has an autoimmune disease, and I work near sick people.  We weren’t taking any chances.  We cancelled vacation plans (not the vacations, just the plans), and found we could live quite comfortably—enjoyably, even—at home.  Alone.  We did not go out to eat.  We stopped shopping in the mall.  We became friends with Doordashers, the Amazon Delivery persons, and other deliverers of our on-line shopping selections—at an appropriate social distance, of course.  We picked up groceries curbside.  We went out rarely, and when we did, we masked religiously.

We both took Johnson and Johnson vaccines in March 2021, and my wife instantly had a lupus flare.  The migraines which she had previously experienced once a month became daily, painful affairs.  She had to change medications to a more powerful and (any surprise?) much more expensive drug.  She still has ringing in her ears and extra pain in her joints that she dates from the shot.  Migraines are no longer daily, but still more frequent than before.  I was skeptical of mRNA technology from the start, but I regret the decision to take a vaccine.

I am a curious person, and life had presented us with the opportunity to study something that had never been studied before.  I began measuring antibody levels in friends and colleagues who had made a variety of choices about vaccination and COVID precautions.  We identified some people who had had COVID but did not know it.  We identified people who had COVID after vaccine.  We learned early on that Moderna produces the highest immune response, and we learned that vaccine did not add much immunity to people who had disease.  Some people, including me, had little immune response to vaccine.

The antibody tests available then were not very good, and they kept changing, making it impossible to track serology over time.  That is why Liz and I joined the TXCares study.  After answering some questions, we measured the S-protein and N-protein antibodies in our blood three times over six months.  Here are our results:

S-antibodies (S-Ab) can come from either infection or vaccine, but N-antibodies (N-Ab) can come only from infection.  Since our S- and N-antibodies increased in February, I am pretty sure we had COVID in January during the Omicron wave.  

Antibody tests are still not very good.  For example, I consider the change in N-protein levels from nil to barely detectable significant, even though our levels did not reach the arbitrary positive level of 1.  But at least these tests were consistent over time, and the results corresponded with our clinical history.

How do I feel now?  For starters, we are not scared of COVID anymore.  We do not mask (except at the hospital), we do not avoid people, and we shake hands again.  The only current lifestyle impact is the continued coercion to vaccinate.  If an activity requires a vaccine card, we avoid it.  That means we still do not travel internationally, and we do not patronize certain entertainment venues, including, regrettably, venues we once loved.  But that is it.  Otherwise, we are normal again.  Well, maybe not quite.  My wife’s lupus is worse, and I have a positive d-Dimer, but that is a story for another day.

Antibody levels consistently and reliably inform on immunity, yet they are spectacularly underutilized.  Perhaps this is because they are spectacularly inexpensive.  Consistent, reliable, and actionable information is not what the game is about right now.  If spike protein antibodies are a good thing, and I am still not sure they are, Liz and I have plenty to spare.  But we were going to have them sooner or later.  COVID is not going away until most of us catch the virus.  Vaccinated or not, most of us have.

Categories
COVID-19 Science Vaccine

Because I Say So

The fascists tell us what to think.  They expect us to follow arbitrary commands based on the strength of their word alone.

Case in point.  NPR recently published an article supporting the “Pandemic of the Unvaccinated” narrative.  The article claims there were nearly 319,000 excess deaths caused by the failure to universally vaccinate all adult Americans.  Why should we believe this?  “Because I say so.”

This chart from the article summarizes the report:

The lines charting actual and estimated deaths diverge in August 2021.   Actual deaths have steep slopes in October 2021 and January 2022, corresponding to the waves of delta and omicron variants.  The modeled deaths for the universal vaccination scenario show barely a bump during these times, implying that vaccination would have prevented delta and omicron fatalities.  Why should we believe this claim?  “Because I say so.”

The cumulative death data from COVID-19, reported by the CDC, shows that every state experienced a surge in death corresponding to delta and omicron, just at different times.  States with high vaccination rates had these waves; states with low vaccination rates had these waves.  Instead of vaccination rates, population density correlates better with COVID deaths.  New York City, a highly vaccinated area, has the highest cumulative COVID death rate, nearly 500 per 100,000 population.  Why believe that universal vaccination would have prevented deaths?  “Because I say so.”

The CDC Heat Map plots case rates and vaccination rates.  If vaccination prevents COVID, then the map should be colored red (high cases in areas of low vaccination) and green (low cases in areas of high vaccination).  Instead, there is lots of purple—high numbers of COVID cases in highly vaccinated regions of the country.  If COVID cases are highest in the most vaccinated regions of the country, why should we believe that universal vaccination would have saved lives?  “Because I say so.”

The NPR article goes on to perpetuate a pejorative stereotype.  Vaccination rates are lower in red states—read “Trump voters”—implying that Trump voters are just not intelligent enough get vaccinated.  The article suggests that people from blue states are more trusting of government, as if that is desirable.  It goes on to blame Republican-led states because they “underused other pandemic-fighting tools, such as mask and social distancing requirements,” ignoring that these pandemic-fighting tools were first implemented by the Trump administration.  Furthermore, today’s CDC COVID Data tracker shows COVID-19 Community levels are highest in the Northeast—blue states.  So why should we believe this red state/blue state narrative?  “Because I say so.”

The article commends Massachusetts, a highly vaccinated blue state, for its low rate of vaccine-preventable deaths.  However, the CDC’s data tracker shows an interesting and unexplained anomaly.  Miraculously, on March 14 nearly 4,000 fewer individuals had died from COVID in Massachusetts than were reported the day before.

MASSACHUSETTS
March 13, 2022: Total deaths 23,751, Death rate per 100k 345
March 14, 2022: Total deaths 19,981, Death rate per 100k 290
FLORIDA
March 13, 2022: Total deaths 73,152, Death rate per 100k 341
March 14, 2022: Total deaths 73,194, Death rate per 100k 341

On March 13, the Massachusetts death rate was higher than Florida.  On March 14, the Massachusetts death rate was lower than Florida.  Why the forensic audit and recount of the Massachusetts data, the result of which smoothed out a surge in the state’s reported COVID deaths?  Maybe the facts did not fit the narrative.  But we should believe the narrative anyway, “Because I say so.”

Who are you and where did you publish your data?

Researchers at Brown and Microsoft AI Health provided this data analysis, but not in a peer reviewed medical journal.  Instead, the data was “shared exclusively with NPR.”

Let me get this straight.  An ivy-league university, a big tech company, and a left leaning news organization are telling us, “Get your vaccination, get your booster, because I say so.”

Not good enough for me.  How about you?

Categories
COVID-19 Science Testing Vaccine

End Games

The pandemic is over.  Sure, a few hot spots remain, and SARS-CoV-2 continues to smolder as variants of the original virus, but this is our post-pandemic world.  COVID will never be eradicated; there will always be endemic disease where there are human communities.  But the worldwide pandemic, the catalyst for the “emergency”, has passed.  This emergency created an alliance between power hungry authoritarians and money hungry profiteers, resulting in a loss of individual freedom and massive wealth redistribution.  

This alliance has not ended with the COVID emergency.  Politicians and the industrialists will continue to conspire to secure the profits and power usurped during the past two years, and they will do this by playing games.  Get ready for the end games.

Many of these games will be played with emergency use authorizations (EUAs).   Medical devices and therapies developed during the pandemic continue to be available under EUA for as long as HHS Secretary determines that there is an emergency warranting use of unapproved products.  On April 12, 2022, Xavier Becerra renewed the declaration, extending the emergency into July.  But does anyone think that a true emergency still exists?  As COVID restrictions are lifted, the only reason for the continued “emergency” is to prolong the availability of these profitable medical devices and therapies. 

Manufacturers would rather operate under EUA than under FDA license because of relaxed manufacturing standards and minimal product liability, but the beneficiaries of the emergency know this state cannot not last forever.  They intend to ride the EUAs until the end, then jump over to FDA approval at the last possible moment so their profits continue after the lifting of the emergency declaration.

These end games are baked into the pre-pandemic language governing EUAs.  The Secretary of HHS is required to give adequate warning before terminating an emergency so that manufacturers may dispose of their outstanding inventory.  Last month, FDA issued draft language outlining a transition plan from EUA to approval for medical devices, including PPE equipment and diagnostic tests.  Expect similar plans for drugs and vaccines.  

Pfizer and Moderna have already pocketed approvals for COMIRNATY and SPIKEVAX without bringing these products to market.  Once the emergency ends, these vaccines will magically materialize.  But before the state of emergency is lifted, vaccines will be approved for all age groups, as will perpetual and unlimited boosters. 

The same will be true for other expensive, patentable COVID drugs such as Evusheld and bebtelovimab, drugs designed for pre-exposure and early treatment and now only available by EUA. Before the emergency is lifted, there will be a push for FDA approval by the same forces that conspire to prevent access to Hydroxychloroquine and Ivermectin which have been used for the same purposes.  The existence of these unpatentable drugs should have precluded EUAs for the profitable ones. 

Another game is being played with tests.  Early in the pandemic, the CDC quietly changed the definition of cases to mean a positive diagnostic test regardless of symptoms.  This change drives up the case rate numerator without changing the denominator.  These inflated test results will be used to prolong the emergency declaration for as long as possible, stretching the advantageous EUA business environment.  With few exceptions, SARS-CoV-2 tests are available by EUA, but these will be quickly approved before emergency is lifted, since direct viral tests are useful to perpetuate fear in a sensitized population. 

By the way, do not expect antibody tests to be approved any time soon.  Antibody tests should be the gold standard for assessing immune status—better than vaccination history, better than disease history.  But these tests are still shockingly primitive.  No interpretative standards have been developed, and few careful serologic studies have been undertaken.  And no wonder.  The potential clarity of antibody tests benefit neither the profiteers nor the authoritarians.

And what do the authoritarians get by playing these games with the profiteers?  Power.  In exchange for their friction-free money machines, businesses have facilitated the authoritarian’s assault on civil liberties.  Businesses use a variety of techniques to steal liberties from individuals.  Some of these liberties are surrendered freely by appeals to conscience and duty.  Other liberties are taken by coercion.  But when force is required, businesses provide the muscle.  Hospitals fire employees that refuse to comply with the CMS vaccine mandate.  Airlines enforced the CDC transit mask mandate, and may do so again.  Neither mandate is supported by evidence.

The current powerful alliance of big business and big government fulfills the criteria of fascism.  Americans have been here before.  To overturn this instance of fascism, we need coalitions of citizens committed to truth and individual liberty.  Our greatest hope is rekindling the American Spirit. 

Categories
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 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.