Author: Kevin Homer, MD

Kevin Homer has practiced anatomic and clinical pathology at a community hospital in Texas since 1994.

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
Ethics Science

A Pandemic of Fascism

In a recent post, I called those using the pandemic to increase wealth and power fascists.  Fascism is a charged word, but I used it deliberately.  Simply stated, fascism is the alliance between business and government to give wealth to the former and power to the latter.  The cost of fascism is borne by common citizens who pay with their money and freedom.

The word “fascism” has become a pejorative used to shut down debate by conjuring images of swastikas, concentration camps, and sieg-heil salutes.  True, a notorious example of fascism was its use by National Socialists in Germany to consolidate power and wealth around a monolithic cultural and racial ideal.  Nazism’s twisted utopian goals have been used by American leftists to brand their opposition as fascists, destroying the true meaning of the word.

Fascism is not a defining characteristic of the political right or the political left.  It is not even a tendency of one political party more than another.  It is a tendency of any politician who becomes intoxicated by power.  Realizing that a position in government can be stealthily misused for selfish ends, corrupt individuals entrusted to safeguard our interests easily find accomplices ready to deal for sure profits.  It is an unforgivable, treasonous violation of sacred honor and duty.

Fascists use a crisis to create panic, then demonize a segment of the population for causing the crisis.  By doing so, they trick many into mindless submission.  Today’s fascists have perpetuated the pandemic and castigated the unvaccinated, using fear to cover their true agenda.  Because they cannot prevail using honest, intellectual arguments, they resort to coercion, bullying, oppression, suppression, and ad hominem attacks.  Even violence is permitted if it furthers their cause.  There is an inevitable trail of pain and death in the fascists’ wake.

Think that is harsh?  First consider that those assuring the safety and efficacy of COVID vaccines are also those with most to gain by vaccine sales.  Then look at the 40% increase in death among working aged adults during 2021.  Look at the higher all-cause mortality among the vaccinated within Pfizer’s own clinical trial dataset.  Look at the thousands of suspicious deaths reported to VEARS.  Look at the attempt by FDA to hide Pfizer data from the public.  Look at the 13 times higher rate of myocarditis in young men aged 16 to 19 who have taken mRNA vaccine.  How do we account for these failures?

Perhaps COVID-19 is so new that the medical-industrial-regulatory complex could not have possibly anticipated these outcomes.  Perhaps in haste to bring a savior vaccine to market, they neglected to perform a thorough analysis of the data.  But is ignorance or willful neglect among those who claim the ability to interpret science—who claim to be science—acceptable?

Instead, perhaps they were fully aware of all the data and decided that the risks were worth the potential benefit anyway.  Decided for you.  Decided for you and as many other individuals as there are Americans.  This is what fascists do.  They decide for you, or rather they decide what is best for themselves and coerce you to comply.  Coercion like vaccine mandates, for example.

But weren’t vaccine mandates overturned by the Supreme Court?  Not quite.  The CMS mandate is still force.  Think about how it works.  

CMS refuses to pay for healthcare services rendered to Medicare subscribers unless most members of the provider organization are vaccinated.  Sure, some members of the organization can opt out of vaccination, so long as there are not too many of them, and so long as it is for a medical condition or religious objection.  “I don’t want the increased risk of myocarditis and death” is not an acceptable reason to decline the vaccine, the very vaccine which says in its factsheet, “The recipient or their caregiver has the option to accept or refuse Pfizer-BioNTech COVID-19 Vaccine.”  Some option, if you have spent the last 30 years of your life in education and training to be a neurosurgeon, and the alternative is unemployment.  That cognitive dissonance does not bother fascists.  What bothers them is precise use of language.

Nazis were masters of language distortion.  Sonderbehandlung (“special treatment”) meant execution, and die Endlösung (“final solution”) meant extermination of all Untermench (“sub-humans”). These terms facilitated polite conversation about horrific crimes at genteel dinner parties, while veiling a threatening sub-text—any individual who stands against fascist institutions can become an Untermench subject to Sonderbehandlung.

Today’s fascists use a similar technique. The label “science” is applied to any flimsy hypothesis that supports their agenda, while opposing yet equally plausible ideas are discarded for lack of “clinical evidence.” They continue to insist, for example, on the zoonotic origin of SARS-CoV-2, dismissing as conspiracy the lab-leak theory or any possible connection to bioweapons research. They change the meaning of words like “vaccine” to suit their ends. “Safe and effective” really means “the issue is settled; stop analyzing the data.” The list is endless. Even the word “fascism” has been distorted, leaving us without language to describe what is happening. Once fascism takes hold, it goes viral, spiraling exponentially in a positive feedback loop. It is insidious. It is infectious.

Although the COVID pandemic has subsided, a Pandemic of Fascism remains.  It is a virus, and it is raging across the globe.  We need inoculations.

Fascism is a tool to consolidate power, transfer wealth, and reduce liberty.  Like SARS-CoV-2, it will never be totally eradicated.  It has lingered in our culture for eons.  But it must be minimized.  Like SARS-CoV-2, fascism must be beaten back to smoldering endemic levels.

Since fascism abhors individual liberty, fairness, honesty, clarity, and diversity, these must be our highest values.  They cannot be compromised, not even a little.  To recover from this instance of fascism, we cannot let our language be corrupted by Newspeak.  

Challenge all assumptions.  Take nothing for granted.

Categories
Science Vaccine

Novavax Uses Magician’s Tricks in Vaccine Study

My last blog described a phase 3 clinical trial for Novavax vaccine published in the New England Journal of Medicine.  Like a master stage magician, this study uses distraction, illusion, and manipulation to support its conclusions.  In this blog, I will blow away some of the smoke and expose the fraud.  

For example, the authors report that all-cause mortality among trial participants is “balanced”—a word probably selected for its positive connotation.  But in a vaccine study, balanced all-cause mortality is not desirable.   An effective vaccine prevents people from dying from disease, and a safe vaccine does not cause death from vaccine complications.  Instead of balance, a reduction in all-cause mortality in a large study population supports the claim of “safe and effective” vaccine.  When all-cause mortality is balanced, the vaccine is either ineffective, unsafe, or both.  Yet the authors leave the reader with the illusion that “balanced” all-cause mortality is a good thing.

The study concludes that the vaccine is effective.  While the data shows Novavax vaccine reduced SARS-CoV-2 infections, most of the infections prevented were mild.  The vaccine provided the best protection against the original strain, a strain that is no longer a threat.  It prevented “moderate-severe COVID” in a tiny fraction of participants, and it saved no lives.  Does that make it effective?

To answer that question, we must examine the other side of the equation.  We must ask whether these potential benefits are worth the cost of taking the vaccine.  Cost is measured in adverse effects.

Nearly 80% of the vaccinated, four times more than control, experienced adverse effects.  Although the reported adverse effects were mild, the monitoring period averaged only two months.

Safety cannot be proven in two months.  Because of the law of delayed consequences, observations over years, even decades, are needed to assure a substance is safe for injection.  It took generations to recognize the harmful effects of diethylstilbestrol, a synthetic hormone.  Yet this study eliminated the possibility of finding serious long-term vaccine complications by eliminating the control group after 3-4 months. 

Does this vaccine cause serious consequences 6 months after vaccination?  Is all-cause mortality higher in the vaccinated after a year?  We will never know because the researchers vaccinated the control group.  The study is corrupted.  The “A/B” test is now an “A/A” test.

Then, like a great magician, the authors substitute fake science for real science by stating that “hazard models have been proposed for subsequent analyses.”

The proposal to monitor for long term ill-effects with a “hazard model” mocks the clinical trial process.  If actual observation of the actual response to actual vaccines in actual human beings over time can be replaced by computer models, why ever bother with clinical trials?  Clinical trials are messy, expensive, and painful.  Sometimes they flop.  Yet clinical trials necessary to establish knowledge.  They cannot be replaced by “hazard models.”

This is not just bad science; this is anti-science.  Science requires strict adherence to the scientific method.  Anything else is wishful fantasy.  Or worse—a deliberate deception. 

We have seen these tricks before.  Eliminating control groups, hiding adverse findings, covering contradictory evidence with high gloss rhetoric, and cherry-picking data characterized Pfizer’s authorization studies.  These ruses are eloquently detailed by Robert Kennedy, Jr., in his book The Real Anthony Fauci.

I am not saying that Novavax is a bad vaccine.  Maybe an alternative to mRNA is a good thing, and maybe some individuals could benefit from this vaccine.  Since the data is incomplete, I cannot say.  What I can say is that this study about the Novavax vaccine is dishonest, yet it forms the foundation of Novavax’s EUA application.

And why is FDA considering an emergency use authorization for a new vaccine so late in the game?  Clearly, it is time to end the emergency.  We need to wind up emergency use authorizations.  EUA products should be licensed or discarded.  We do not need another EUA vaccine.

Maybe the FDA is considering EUA for “Novavax COVID-19 Vaccine, Adjuvanted” because it is the first COVID vaccine to show feasibility as a combination vaccine with flu.  Perhaps this was part of the game all along.

One more thing.  Novavax inadvertently debunked the claim that vaccination-induced immunity is superior to disease-induced immunity.  The “Novavax COVID-19 Vaccine, Adjuvanted” uses a proprietary protein “Matrix-M,” to present spike protein because it is thought to better resemble virus than other vaccines.  According to a company press release, “This arrangement mimics nature, helping your immune system recognize that target protein from different angles—the same way that your immune system would see the details of a real pathogen.”

Until now, we have been told that the immune effects of the real virus are insufficient.  We must have spike protein coating our own cells—the proposed mechanism of mRNA vaccines—to stimulate effective immunity, even after infection by real virus.  Novavax differentiates its vaccine from mRNA by its ability to mimic a “real pathogen,” implying that real pathogens stimulate the best immunity.  Of course, this was the dogma of medical science for eons, until 2020 when the buildup to mRNA vaccine release required a new theory of immunology.

Thank you, Novavax, for setting us straight on this point.

Categories
Vaccine

Control Group Eliminated in Study Funded by Vaccine Maker Novavax

On June 7, FDA’s Vaccines and Related Biological Products Advisory Committee will discuss an EUA request for a COVID-19 vaccine manufactured by Novavax.  If the EUA is granted, Novavax will become the fourth vaccine maker permitted to distribute vaccine in the United States.  

The “Novavax COVID-19 Vaccine, Adjuvanted” (aka NVX-CoV2373) claims to be different from any other vaccine on the market. It’s not mRNA, and therefore, not gene therapy.  Instead, it’s a “nanoparticle” covered in spike protein.  The nanoparticle, Novavax’s proprietary protein “Matrix-M,” is thought to better resemble virus than current vaccines.  According to a company press release, “This arrangement mimics nature, helping your immune system recognize that target protein from different angles—the same way that your immune system would see the details of a real pathogen.”

A study recently published in the New England Journal of Medicine, together with its supplementary appendix, presents results of a U.S. phase 3 clinical trial for Novavax vaccine conducted by dividing 25,000 participants into two groups.  One group received the full two-shot vaccine series, and the other group received two placebo injections.

To determine vaccine efficacy, participants were tested for SARS-CoV-2 infection after receiving vaccine or placebo.  Subsequent infection was identified in 77 individuals; most of these were in the placebo group.  Only 14 of these infections were considered “moderate-severe COVID,” and all of these were in the placebo group.  All infected patients recovered.  There were no deaths attributed to COVID in the study.

To study vaccine safety, the researchers solicited reports of adverse effects from participants.  Adverse effects were experienced by nearly 80% of vaccine recipients, four times the rate of placebo.  Most of these adverse events were mild.  The report claims that Novavax is not associated with the types of complications associated with other COVID vaccines:

“No episodes of anaphylaxis, no evidence of vaccine-associated enhanced Covid-19, and no events that triggered prespecified pause rules were observed. No episodes of the Guillain–Barré syndrome and no imbalance in myocarditis or pericarditis or in vaccine-induced immune thrombosis with thrombocytopenia were observed during the relatively short safety follow-up period reported here.”

How short was that safety follow up period?  A mean of two months.

Despite the promise to continue the safety review for 24 months, the authors admit:

“We implemented a blinded crossover approximately 3 to 4 months after the first vaccination series to allow all trial participants to receive NVX-CoV2373, after vaccine efficacy and required safety had been established and reviewed by the data and safety monitoring board.”

This crossover hides any potential long term adverse effects in the control group by eliminating the control group.  To make up for this deficiency, “hazard models have been proposed for subsequent analyses.”

The authors then conclude “NVX-CoV2373 was safe and effective for the prevention of Covid-19.”

The study fails to report an honest cost-benefit analysis.  Although the study legitimately claims Novavax reduces susceptibility to a mild disease, it ignores data showing that cost of this reduction is the likelihood of short-term adverse effects, and it erases the possibility of finding long-term adverse effects which may be more serious than any benefit of taking the vaccine. 

Oh, one more thing.  Guess who is first on the list of supporters funding this study?  Novavax.

Surprised?  Me neither.

Categories
Vaccine

FDA Limits Janssen EUA

The vaccine landscape changed today.  To keep you up to date, here is a summary of changes and a new vaccine chart.

Pfizer

New Factsheets for Healthcare Providers have been issued for Pfizer Purple, Gray, and Orange vaccines.  The Pfizer family of vaccines are now authorized for two booster doses, the first of which may be given five months after a primary series in individuals 12 and older, and a second may be given four months after the first booster in individuals 50 and older and in individuals 12 and older with “certain immunodeficiencies” defined in the authorization letter as individuals “who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.”  Pfizer Orange is authorized for a third shot in the primary series for individuals 5 through 11 with the same “certain immunodeficiencies,” but not for boosters.  Each of these new factsheets (Purple, page 44; Gray, page 41; Orange, page 33) contain a statement I don’t remember seeing before: “Available data on Pfizer-BioNTech COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.”  Show this to your OB if you are pressured to get a vaccine while pregnant. I am unable to explain why CDC still recommends COVID vaccines for “people who are pregnant, breastfeeding, trying to get pregnant now, or might become pregnant in the future.”  These authorizations also extend the vaccine expiration dates. COMIRNATY, the only vaccine approved for individuals 16 and older, is still unavailable in the United States.

Moderna

Moderna vaccines now have a complicated color scheme.  The authorized Moderna COVID-19 Vaccine, and the approved SPIKEVAX (COVID-19 Vaccine, mRNA) both have red caps with a light-blue border.  These are given in full dose (0.5 ml) for primary series and half dose (0.25 ml) for booster.  The Moderna COVID-19 Vaccine also comes in a booster-only half-strength vial recognized by its dark blue cap with purple border given as a full dose (0.5 ml).  Presumably, this is to cut down on confusion between the primary series and booster dosing, but it has resulted in a very complicated updated authorization letter.  Moderna first boosters are authorized five months after the primary series for a first booster in individuals 18 and older, and four months later as a second boosters for individuals 50 and older and in individuals 18 and older with “certain immunodeficiencies,” defined the same as for Pfizer.  On page 29 of the Blue/Purple factsheet is the same warning issued for Pfizer: “Available data on Moderna COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.”  Moderna boosters may be preferred by your doctor since they are thought to produce the encouraged highest antibody response; I’m not convinced that is a good thing.  SPIKEVAX, Moderna’s approved vaccine, is still unavailable in the United States.

Janssen

FDA has limited its authorization for the Johnson and Johnsons vaccine.  There is a new Factsheet for Healthcare Providers that starts with a prominent warning about its blood clot complication.  Page 26 contains the familiar pregnancy warning: “Available data on Janssen COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.”  CDC recommends Moderna’s and Pfizer’s family of vaccines over Janssen.  The vaccine expiration dates have been extended.

Vaccine Chart, Revised May 5, 2022.

The FDA has announced a tentative schedule for it’s Vaccines and Related Biological Products Advisory Committee (VRBPAC).  On June 7, the committee will consider an EUA request for the Noravax COVID-19 Vaccine.  It will be live-streamed on FDA’s YouTube channel. 

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
Vaccine

Where Is the Evidence That Flu Vaccines Save Lives?

The prevailing presumption that flu vaccines save lives is based on faith in policymakers who are trusted to safeguard our health.  There is little evidence that this presumption is true.

Viruses are classified according to their size, shape, and the type of genetic material they contain.  Influenza viruses are Orthomyxoviruses, a family unrelated to Coronavirus.  Of the four known types of influenza viruses, infections by Flu A and Flu B cause most illness in humans.  Flu A is subtyped according to the type of H and N proteins on the viral surface.  Flu A(H3N2) and Flu A(H1N1) have been prevalent in recent years, but others have been significant in the past.  Just like SARS-CoV-2, influenza viruses mutate rapidly, so that different variants circulate each season.  

Where is the evidence that flu vaccines save lives?  The question is more difficult to answer than it seems at first glance.  The way that flu mortality is calculated and tracked has changed over the last hundred years.  Criteria for diagnosis of influenza vary, and the treatment of flu and its comorbidities has changed with time.  Vaccine formulations, strategies, and target prediction methods are constantly evolving.  These challenges frustrate the impulse to google the answer.  But I am going to try.

Using annual population estimates from the U.S. Census Bureau website and flu mortality from the CDC website, I calculated annual flu mortality rates for each of the ten flu seasons prior to the pandemic, and I compared these to flu vaccination rates published by the CDC for the same period (table 1).  I chose these years because of the relatively consistent data reporting during this time.  If flu vaccinations save lives, years of high flu mortality should have low vaccination rates, and years of low flu mortality should have high vaccination rates.   

I found that if vaccination impacts flu mortality, it is only one of several factors and probably not the most important.  The data shows an inverse correlation between vaccination rates and flu mortality for only six years (top chart, blue points, correlation coefficient = 99.5%), but adding the pesty outlier years to the data set results in poor linearity for the decade (correlation coefficient = 23.6%).  In three of these outliers, the mortality is lower than predicted by the vaccination rate (green points), but in one year, the mortality is higher than predicted by vaccination rate (red point).  The 2013-14 Flu season had the highest mortality rate (16.4 deaths/100,000 population) but a middling vaccination rate (53.7%, Mean 54.4%, Standard Deviation 3.1%).

More troubling is the poor relationship between vaccination rates and flu deaths among the elderly (table 2).  Individuals aged 65 and older are most susceptible to flu complications, yet it is hard to find any correlation between vaccination rates in these individuals and flu mortality (bottom chart, correlation coefficient = 36.8%).  While vaccination rates among the elderly were stable during the 10 years prior to pandemic, (60-70%, mean 65.6%), mortality rates varied wildly, between 22.6 and 100.7 deaths/100,000 population.

A few words of caution.  Drawing conclusions from ten data points is dangerous.  My data does not include the vaccination status of those who died from flu; maybe that information would show much higher mortality in those who did not receive vaccine.  But similarly, I have not considered the mortality rates of those who survived flu infections from previous seasons.  Perhaps natural flu immunity is more durable and protective than vaccine immunity.  This idea is supported by the surprising finding of negative excess mortality among elderly individuals during the 1918 “Spanish” influenza pandemic.  The same questions that can be asked about natural and vaccine-induced immunity for COVID-19 can be asked about influenza.  

I am not the first person to question the efficacy of flu vaccines, especially among the elderly.  According to studies often cited by policymakers, vaccination results in an astronomical reduction in flu mortality.  But not everyone agrees.  Analytic flaws resulting from confounding evidence and bias muddle these conclusions.  Tom Jefferson, an epidemiologist and editor of the Cochrane Acute Respiratory Infections Group, says plainly, “The large gap between policy and what the data tell us is surprising.”

Flu mortality has declined since 1900; however, the first part of this decline cannot be attributed to flu vaccines since they were not used before 1940.  Even after vaccines were widely available, they were unlikely the explanation for declining flu mortality.  A 2005 study funded by National Vaccine Program Office stated bluntly, “We could not correlate increasing vaccination coverage after 1980 with declining mortality rates in any age group.”

While overall flu mortality has declined since 1900, the proportion of deaths among those 65 years and older has increased.  Could this change be due to aggressive vaccination policies which have deprived young people of the opportunity to develop natural flu immunity, pushing their infections into later life when they are more vulnerable?  Is our financially conflicted health care industry deliberately creating pandemic paranoia by its annual warning of a resurgent Flu Apocalypse?

Of course, the absence of supporting data does not prove a proposition false.  I am not saying that flu vaccines do not save lives; they might.  But there is little compelling evidence generated by well-designed, bias-free, placebo-controlled studies.  The presumption that flu vaccines save lives is based on faith, not science.

Public officials paid to establish health policy have violated our trust, misusing the vaccine paradigm to generate windfall profits for the pharmaceutical industry.  From now on we demand hard data instead of platitudes.

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 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.