Category: Ethics

Categories
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.”

Categories
2021 COVID-19 Ethics Vaccine

Break Free

The real division is not between conservatives and revolutionaries 

but between authoritarians and libertarians

–George Orwell, 1948

The President is losing patience.  Six quarters into the emergency, the FDA has authorized COVID-19 vaccines down to five years of age.  The CDC maintains these vaccines are safe and effective.  Vaccinations are mandated by powerful employers, high ranking generals, and top government officials.  Most of the medical community are on board.  Failure to comply costs income and freedom.   It’s intimidating.  Many have submitted to the pressure.  These policies have concentrated authority and power in a few “experts” who presume to know what’s best for everyone else.  It’s not just arrogance.  It’s slavery.

Slavery doesn’t need a plantation and rows of cotton.  Slavery occurs when one person owns the thoughts and actions of another.  Motives don’t matter.  Good intentions don’t justify coercion.  Masters who treat their slaves well are still slaveowners.  The core moral flaw of slavery is the notion that one person can own another.  Slaves exist to serve masters, not the other way around.  

Masters cannot make decisions in the best interest of their slaves.  The interests of the slaveowner always have precedence.  If you own my decisions, you own me.  You can’t make the best decisions for me because you don’t know what’s important to me.  The individual taking the risk must have decisive control.  Today’s public health policies transfer choice from individuals to powerful experts just like slaves surrender control to their masters.

We don’t need experts to understand the issues of the pandemic.  COVID-19 is bad.  Many people have died, more than should have.  But we’ve learned to identify those at risk.  Sound, compassionate public health policy would focus attention on the vulnerable and protect them with more than vaccines.  Instead, our masters are using only one tool and applying it universally. 

Vaccines have risks.  Many people have died, more than should have.  Vaccines were rushed to market with only a thin veneer of study and testing.  What we know of vaccine risks—myocarditis, blood clots, neuromuscular disorders, death—is scary enough.  What we don’t know is even scarier.  Some of these potential future problems can be deduced from the studies requested by the FDA in its COMIRNATY approval letter.   

Yet our experts cling to a universal vaccination policy that seems to be less in the public interest than in that of vaccine vendors.  Our impatient masters have cornered us into a company store where there’s only one shoddy product for sale.  We must break free.

America is founded on liberty.  Yes, our history is filled with cognitive dissonance on this point.  The institution of slavery is baked into our founding documents, right alongside guarantees of individual rights and freedoms.  But the understanding of liberty is also baked into Americans, so much so that we were willing to shed blood to purge slavery from our land, without the assurance that we could.  

We’ve reached a similar moment.  Echoing notes from the Gettysburg Address, history has given us the opportunity to purge a more occult and subversive form of slavery from our land.  Our public health policies have devolved to the coercion by the few over the lives of the many.  These policies have shifted from information to dogma, from recommendations to requirements.  Like the slaves of old, we must adopt the religion of our masters and submit to their commands.  Otherwise, we are promised discomfort.

To those subjected to these policies, my message is simple.  Resist this coercion like it’s slavery.  It is.

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.

Categories
2021 COVID-19 Ethics Science Vaccine

When We Lose Trust

There is a crisis of trust in America.  One manifestation is in healthcare.  For a century, the trust among Americans, their physicians, and institutions of public health built the most reliable healthcare system in history.  Today that trust is being undermined, and the entire system is in danger of collapse.  If we do not restore trust, we will suffer the reversal of a century’s gains in medicine. 

The Youngest Science, a collection of essays by Dr. Lewis Thomas, traces medicine’s journey from pre-twentieth century practices into the evidence-based practices of today.  Before this transformation, medicine was an unreliable mixture of traditional treatments like blood-letting and fanciful concoctions like snake oil tonic.  Transparency, empirical evidence, and patient collaboration were absent.  

Although there were many well intentioned physicians before the twentieth century, greedy hucksters and evil-doers thrived in this environment.  Quacks with phony credentials wagoned into town hawking the one-and-only genuine medicinal potion that promised to cure whatever ailed you, often accompanied by craftily staged demonstrations.  After selling as many worthless “cures” as possible, these predators escaped at night, leaving townsfolk poorer but in no better health.   People naturally feared being duped again.  Medicine could not progress in this environment.

In the twentieth century, trust changed all this.  Beginning in 1906 with the Pure Food and Drug Act, the federal government developed institutions like the FDA, CDC and NIH to assure the safety and effectiveness of drugs and treatments.  State governments licensed physicians and established standards of medical practice.  Physicians organized, creating boards to prevent frauds from entering their ranks and abusing the trust of their profession.  By the end of the last century, healthcare providers were among the most trusted professions in the nation.  So much so that people were willing share intimate personal details with a stranger, as long as that stranger was a doctor or a nurse. 

Now we see an erosion in the trust at the foundation of the youngest science.  When trusted institutions like the CDC and FDA give incomplete or misleading statements, physicians lose a resource for reliable information.  This quickly translates to a loss of the trust that bonds patients and physicians.  As employers and political leaders displace physicians by claiming to be health experts, people are unsure who to believe.  We’re back in the nineteenth century again.

It didn’t have to be this way.  We could have leveraged medicine’s abundance of trust to lead us to recovery.   Our trusted institutions could have given physicians the tools needed to make meaningful risk-benefit calculations for patients.  But this would have required the acknowledgement that natural immunity is at least as good as vaccination in some COVID survivors, that vaccination is harmful to some individuals, and that vaccination does not prevent the spread of disease.  We could have determined which groups receive the greatest benefit from vaccination, and which groups are most likely to suffer adverse effects.  We could have guidance on measurable markers of immunity—what are the minimum protective antibody concentrations, and what levels are toxic—so that those at greatest risk of death from COVID-19 can determine whether they will benefit from vaccination or booster.  We could have real data on adverse effects of vaccines by age and health status, and we could have balancing data on risk of death by SARS-CoV-2 infections.  We are 18 months into the pandemic; we should have this information by now.  Instead, our public health institutions have adopted an incredulously monolithic policy, saying universal vaccination is our only way out, even though we know this policy violates the oath of my profession: Do no harm.

Our trusted health institutions, like our trusted political institutions, have failed to communicate a clear, achievable objective for the pandemic.  They have failed to demonstrate a connection between their policies and the achievement of this goal.  As a result, we’ve lost trust.  This crisis of trust has created a crisis of healthcare.

We must restore trust, together.  The health of our nation is at stake.

Categories
2021 Ethics Vaccine

What FDA Pfizer Approval Means

Today, the FDA approved the Pfizer COVID vaccine.  This vaccine is the first of the three vaccines authorized under EUA to achieve this status.  In this blog, I’ll highlight what this approval means.  Obviously, this is just a first look at the information released by the FDA today.  I’ve not studied the Full Prescribing Information in detail.  There may be more changes that I have overlooked; I will update you on these as they become apparent.    

First, let’s talk about what hasn’t changed.  

  • The vaccine has not changed.  There have been no modifications to the vaccine.  The vaccine that was injected before approval is the same as the vaccine given after approval.
  • The warnings on the vaccine label have not changed.  The Highlights of Prescribing Information issued with the vaccine approval have the same warnings that were listed for the pre-approval vaccine.  These include acute allergic reactions (anaphylaxis), myocarditis and pericarditis, syncope (fainting), altered Immunocompetence, and limitation of effectiveness.  Furthermore, Pfizer does not assure the safety of the vaccine in pregnancy or breast-feeding mothers.  
  • Vaccine experience is still limited.  Although Pfizer updated its clinical trial data to include many more patients, and has expanded the observation period over more time, there are still no long-term clinical trials to study potential adverse effects this vaccine may have three, five, or ten years down the road.  

So far, not much difference.  What has changed?

  • The vaccine is now called “COMIRNATY”.  If anyone understands why they chose this name, please let me know. It’s not obvious to me.  
  • Approval does not include 12-15 year-olds.  On May 10, the EUA for Pfizer vaccination was amended to include children down to 12 years of age.  This vaccine is now approved for individuals 16 years and older.  Children aged 12-15 may still receive the vaccination under a new reissued EUA.
  • Removal of statement warning of unknown future risks.  The previous Fact Sheet for Healthcare Providersincluded the following statement: “Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine.”  This statement is not present in the Highlights of Prescribing Information issued with this approval.  However, the Fact Sheet for Recipients and Caregivers still contains the following statement: “These may not be all the possible side effects of the vaccine. Serious and unexpected side effects may occur. The possible side effects of the vaccine are still being studied in clinical trials.”
  • The Pfizer COVID Vaccine is no longer “unapproved”.  This may not seem like much of a substantiative change, but the psychologic and motivational effect of this change will likely be significant.  Those advocating vaccine resistance relished referring to COVID Vaccines as “experimental” because, technically, they were.  Janssen and Moderna still are.  You can’t call the Pfizer COVID vaccine “experimental” anymore because, technically, it’s not.  This semantic change will embolden governments and employers to pursue vaccine mandates.

But this brings us to a few more things that haven’t changed.  I have argued that vaccine mandates are wrong strategically, wrong temporally, and wrong ethically.  There is nothing about FDA approval of vaccine that changes my opinion on this.  Ethical physicians have a duty to speak out on issues affecting patient safety, even and especially during a pandemic.  

The FDA can and has made mistakes in its approval process before.  It will again.  It may have in this instance; time will tell.  But if the FDA has bowed to political pressure to short-circuit this approval, the long-term consequences will be deadly.  Not just to the health and wellbeing of vaccine recipients, but also to the trust that is the cornerstone of America’s healthcare quality. 

According to the AMA Code of Ethics, individuals must participate in their personal healthcare decisions through the process of informed consent  which requires complete, clear, and honest disclosures of all known and potential risks and benefits.  Approved vaccines are not exempted from this moral obligation.  An article published recently in American Journal of Law & Medicine, states that “to be autonomous, decisions need to be based on full, accessible information and reached without coercion.”  No matter how well intentioned, coercion by government or employer cannot be part of informed consent process.  Not in the Land of the Free.  Not in the Home of the Brave.

Categories
2021 Ethics Vaccine

Vaccine Mandates Are Wrong

I’ve argued that vaccine mandates are the wrong objective at the wrong time.  In this article, I want to convince you that vaccine mandates are just plain wrong.  Wrong—as in the opposite of right.  That kind of wrong.

Wait, you say.  The name of the website is BetterPathology.com.  What gives a simple practitioner of pathology the right to lecture us on right and wrong?

Medical ethics is part of every physician’s education and training.  There are gray areas to be sure, but there are also bright lines that separate ethical from unethical practice, and every doctor knows where these lines are.  Every physician knows the elements of informed consent, and every doctor understands why the Tuskegee experiments were wrong.  There are aspects of vaccine mandates that should be troubling to all ethical physicians and all ethical Americans.

To the extent they are able, patients must participate in medical decisions.  Informed consent requires a doctor to explain in understandable language the risks and benefits of a recommended treatment, the risks and benefits of alternative treatments, and the risks and benefits of doing nothing.  It’s one thing to recommend the risks of a therapy when a patient’s natural disease leaves no other options.  It’s quite another thing to recommend a vaccine when the most significant consequence of refusal is job loss.  Threatening a young person to accept the risks of vaccine against his will smacks of Don Corleone’s “offer he can’t refuse.”  Coerced consent is unethical.

Once we lose the freedom to evaluate and choose risks for ourselves, we lose the liberties at the foundation of our nation.  When vaccines are mandated by a government or an employer, the right to choose what we want to put in our bodies is taken away from us.  When we lose this liberty, how long until we also lose the freedom to associate with those we wish, to worship as we please, to speak our minds, or to choose which path we wish for our lives? 

Vaccine mandates stigmatize dissent and erode individual liberty, separating society into vaccinated people and unvaccinated people.  The vaccinated will have freedoms while the unvaccinated will be denied freedoms.  Vaccinated individuals will have the freedom to eat at any lunch counter; unvaccinated folk will be seated outside in the back.  The vaccinated will be able to watch the ballgame from box seats; the unvaccinated will be forced into designated sections in the outfield.  There will be separate water fountains for vaccinated people and unvaccinated people.  There will be separate entrances into public establishments.  Vaccinated people will have unlimited job opportunities while the unvaccinated will find employment prospects limited.  The vaccinated will enjoy unrestricted travel in the mode and style of their choosing; the unvaccinated will have to ride in the back of the bus, partitioned by a plexiglass shield.  Ethical Americans, like ethical physicians, know the immorality of this type of irrational segregation which is based on the false premise that only the unvaccinated can make others sick.  

There have been some ugly chapters in our history.  Let’s not write a new one.