Category: Science

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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
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. 

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2022 COVID-19 Ethics Science Vaccine

Post-Pandemic Stress Disorder

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

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

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

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

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

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

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

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

How do we break this cycle?

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

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

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

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

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

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

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

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

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

Categories
2022 COVID-19 Science

Doctors Be Doctors

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

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

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

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

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

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

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

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

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

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

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2021 COVID-19 Ethics Science Vaccine

Censored

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

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

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

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

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

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

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

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

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2021 Philosophy Science

Belief and Knowledge

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

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

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

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

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

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

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

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2021 Philosophy Science

Stop Calling It Science

Medicine is my professional life.  Science is the language of medicine, or at least it used to be.  I’m not a scientist; I’m a practitioner.  But I love science, just like I love ideas.  Ideas separate humans from other living organisms, and ideas are often played out in the arena of politics.  I am not opposed to politics, but I am opposed to deception.  It is deceptive to hide behind the label of science to cover political actions.

I don’t believe today’s misuse of science is accidental.  Those doing it are too smart and too well educated to make that mistake.  Phrases like “follow the science” and “scientific close call” give an air of legitimacy to policies that are driven by agenda rather than facts and knowledge.  Counter examples are ignored; theories are not allowed to be disproven.

Today’s orthodoxy is defined by elite high priests who possess secret gnostic knowledge.  Scripture is what the priests say it is.  Ordinary people have no access their secret data.  Opponents of orthodoxy are labeled heretics, and some are vilified as examples to those tempted to stray.  There are rites that involve the letting of blood, and these rituals must be repeated periodically to maintain continued salvation.  Mass demonstrations of faith by believers prove their devotion to a movement that promises a second coming of pre-pandemic life sometime in the distant future, even though exactly when and how that will happen is vague.  Occasionally, human sacrifice is required to appease the gods, but those chosen for sacrifice must not complain.  The lambs must accept their fates willingly.  There can be no dissent.  Heterodoxy is not permitted in a nation whose motto is “In Science We Trust.” 

This is not science; this is religion.  Despite the first amendment to our constitution, our country is being turned into a theocracy, worshiping at the altar of “scientism.”  Scientism is being used as a tool to advance a political agenda, not a scientific one.  

Science is a process that establishes our best understanding of truth by disproving all that is false.  Someone says, “I have an idea,” and other scientists set out to prove it false by experiment.  “If your idea is true,” the experimenters say, “then my experiment should work out this way; since it worked out that way instead, your idea must be false.”  Experiments never prove an idea true.  “Scientific truth” is a probability not a certainty.  It’s subject to revision when someone invents a better idea, shifting our understanding into a new paradigm. 

Skepticism is integral to the scientific process.  When doubt is not allowed, it may be many things, but it’s not science.

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2021 COVID-19 Science Vaccine

Winning the War Against Therapeutic Nihilism

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

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

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

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

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

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

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

Categories
2021 Ethics Philosophy Science

A Physician’s Descent into the Abyss

Next to my wife and family, medicine is my life.  I go to work in a hospital almost every day, and while I’m there, I’m focused on the patients whose blood, fluids or tissues come to my attention.  I give them the very best I can, not perfectly, but humanly.  Many patients aren’t aware that pathologists exist, but if you’ve ever been on a Hero’s Journey involving cancer, you know who I am.  I was there at your jumping off point.  I’m the one who signed your biopsy report, giving you the information needed to face the monsters of your quest.  I’ve never personally experienced cancer, although both my wife and I have fathers who did, but I see cancer up close daily, and I frequently encounter those on the cancer journey.  

Here’s a short summary of the Hero’s Journey.  A hero candidate is called out of ordinary, mundane life to go on a quest. The candidate initially resists but is eventually drawn to the edge of the abyss and outfitted for the journey.  Descending into the darkness, the hero enters a fantastic, dream-like world where rules of ordinary life don’t apply.  Think Star Wars, Alice in Wonderland, or Odysseus in Hades.  Real dangers are encountered, and sadly, not all heroes survive.  But those that do come back to the ordinary world changed, and they share their wisdom with the generations.  Joseph Campbell’s masterful articulations of the Hero’s Journey demonstrate that this formula transcends cultures and epochs.  Cancer survivors know what I’m talking about because they’ve been on a Hero’s Journey.

Although I don’t feel much like a hero, COVID has sent me tumbling out of my ordinary world into an abyss.  My pre-pandemic world was based on trust.  Physicians are taught to think for themselves, but to doubt themselves at the same time.  More than anything else, our education and training teach us that we just don’t know enough.  There’s always someone smarter or intellectually more energetic, someone who dives deeper or stretches broader than we can ever hope to do.  Yet there’s something about this humiliating self-awareness that gives us the tools we need to help those in the ordinary world with their ordinary health problems.  We frequently consult trusted references, colleagues, and experts, and as we do, it slowly begins to make sense.  Experience gives us confidence, and that confidence is transferred to our patients.  Physicians become the handles patients hold onto when the earth drops beneath their lives.

The pandemic has changed all that.  Physicians feel compelled to take sides.  You either stand with most of your colleagues and friends, medical associations, and trusted institutions like the FDA and CDC, or you stand with what has made sense to you throughout your career.  The pandemic has made this an either-or proposition.  Like 1984, it’s a battle between your thoughts and the thought police; you either participate in the Two Minutes Hate enthusiastically, or you risk vaporization.

My trust in the CDC began to wane in May when, in contradiction to my education and training, the agency insisted on vaccination of COVID survivors.  My trust was further depleted when I realized testing would not be used to guide vaccination decisions despite years of established pre-pandemic practice.  Now, there is contradictory information published on CDC and FDA websites, and disregard for approval and authorization processes.  Yet even the act of pointing out these discrepancies separates you from the herd like a calf in a cutting horse competition.

I have decided to stand for truth with the confidence instilled by my education, training, and experience, no matter what. There’s a lot in that “no matter what”—isolation, ridicule, coercion.  But if you don’t have your thoughts, you don’t have your humanity.  Humans are not required to believe alike, but they are required to believe.  I am determined to crawl out of the abyss, humanity intact, back into the ordinary world, dragging as much trust with me as I can carry.

Maybe some of my colleagues will identify with what I’m saying.

Categories
2021 Ethics Science Vaccine

Deception

Misconceptions about COVID Vaccines are fueling vaccine mandates.  The CDC has contributed to these misconceptions by its recent statements and actions.  Trusted institutions and processes are now corrupted by a political agenda that has licensed vaccine mandates.  Next will be vaccine passports and social credit scores, resulting in the loss of human rights.

Last week, FDA published a new combined Vaccine Information Fact Sheet for Recipients and Caregivers About COMIRNATY (COVID-19 Vaccine, mRNA) and Pfizer-BioNTech COVID-19 Vaccine to Prevent Coronavirus disease 2019 (COVID-19).   This Fact Sheet explains the distinction between Pfizer-BioNTech COVID-19 vaccine and COMIRNATY (COVID-19 Vaccine, mRNA).  This document states that the two vaccines “can be used interchangeably,” but are “legally distinct” (see footnote 1).  COMIRNATY (COVID-19 Vaccine, mRNA) is an FDA-licensed vaccine for individuals 16 years old and older; Pfizer-BioNTech COVID-19 Vaccine is an authorized vaccine for individuals 12 years and older.  COMIRNATY inherits Pfizer-BioNTech’s EUAs; Pfizer-BioNTech is not grandfathered into CORMINATY’s license.

The new Fact Sheet also expands emergency use authorization for third shots (boosters) of both vaccines.  In doing so, the FDA followed the spirit, if not the letter, of its independent Advisory Committee Meeting on Vaccines and Related Biological Products Advisory Committee September 17, 2021 (watch following 7:42:00).  

On the other hand, the CDC’s information and guidance has been confusing and misleading.  On its website, the CDC ignores the legal distinction between the two vaccines so carefully parsed by the FDA, inaccurately lumping them under the label “Pfizer-BioNTech (COMIRNATY) COVID-19 Vaccine” and saying that the FDA approved this vaccine on August 23.  That’s not exactly true.  But the misinformation has taken root.  Even factcheckers are spreading the false claim that Pfizer-BioNTech and COMIRNATY vaccines are legally equivalent.  

Last week the CDC went further, recommending boosters for individuals not included in the FDA’s Emergency Use Authorization in contradiction to the CDC’s own Advisory Committee on Immunization Practices.  Dr. Rochelle Walensky, director of CDC, justified this action (watch following 27:57) by saying it was a “scientific close call,” (28:22) and that she would have voted in favor of the recommendations if she were part of the committee (28:36).  But she wasn’t part of the committee, and it wasn’t a close call.

Close calls are judgments made on the sports field, risk calculations during a game of chess, or complicated ethical determinations.  Close calls are decisions made with incomplete information, under the stress of time, that exceed our computation ability.  None of this describes science.  Science is a method that either disproves an idea or does not.  There are no “scientific close calls.”

The CDC overstepped its jurisdiction.  The FDA, not the CDC, issues emergency use authorizations. Yet now CDC guidance is at odds with FDA’s EUA, bypassing the safety afforded by this carefully thought-out process. 

There was a reluctance to embrace vaccine mandates until FDA licensed a vaccine.  On August 23, the FDA licensed a vaccine which is still not available.  Instead of giving us a licensed vaccine, the FDA gave us a license to mandate vaccines.  In August, the White House promised booster shots by September 20.  Last week boosters were made available under CDC guidance via a short-circuited process.  This is not science.  This is politics.

These are smart people who have studied logic and rhetoric at the finest colleges and universities in the land.  They should know better.  They do know better.  This is deliberate and bold deception.  Trusted instructions of science and medicine have been corrupted to further a political agenda.  Now that we’re out of the realm of science and in the world of politics, speculation runs wild.  My speculation is that someone wants to sell vaccines, and lots of them.  My speculation is that vaccine mandates will lead to vaccine passports and social credit scores which will eliminate our human rights.  No wonder there’s a crisis of trust in America.