Categories
2023 Ethics Science

Shouldna Listened to That Doc

The American Medical Association (AMA) urges physicians to promote COVID-19 vaccines and bivalent boosters.  The AMA even supplies members with social media talking points and strategies to deal with vaccine detractors.  It is not the first time that my profession has endorsed a product that may be hazardous to your health.

For most of the twentieth century, the AMA turned a blind eye toward the dangers of tobacco use.  During the 1930s, 40s and 50s, tobacco companies paid handsomely to advertise cigarettes in AMA’s journal, JAMA.  In a 1948 editorial minimizing the ill effects of smoking and justifying tobacco advertising in its publications, JAMA noted that “cigarette business is a tremendous business,” as if the size of the bottom line can mitigate a conflict for an organization founded for the “betterment of public health.”

The connection between smoking and lung cancer was recognized early in the century.  At the same time, the AMA became increasingly dependent on money generated by tobacco sales.  Tobacco companies sponsored meetings of medical societies, setting up their booths alongside exhibitions of the latest medical treatments.  Free cartons were distributed at physician meetings.  Cigarette makers even paid for publication of pseudoscientific reports claiming the health benefits of their products.  

Doctors who opposed smoking faced ridicule from their colleagues.  Dr. Alton Ochsner, a renowned surgeon and sentinel voice warning of the dangers of tobacco, began publishing on the connection between smoking and lung cancer in the early 1940s.  His 1954 book Smoking and Cancer: A Doctor’s Report was negatively reviewed in prominent medical journals, characterized as a medieval model of logic that belongs in the nonscience section of a library.  Prior to his appearance on Meet the Press, Dr. Ochsner was told he could not discuss the relationship between smoking and lung cancer on air. 

Yet the mounting evidence was hard to ignore.  In 1954, JAMA stopped accepting cigarette advertisements and published an editorial rebuking tobacco company advertising practices.  But fives years later, a JAMA editorial was still skeptical of the evidence linking smoking to cancer, and a 1961 Nebraska State Medical Journal editorial dismissed the evidence as merely “statistical.”  Tobacco companies continued to sponsor state medical meetings as late as 1969.  By then most people were aware of the dangers of smoking.

In 1964, the Surgeon General concluded that cigarette smoking causes lung cancer and other life-limiting health conditions.  The next year, a warning label was required on packages of cigarettes.  By 1971, the government banned cigarette advertisements on television and radio.  Instead of taking the lead against an obvious threat to public health, the AMA asked for time and money to study the effects of tobacco.

Between 1964 and 1976, the AMA received more than $20 million from the tobacco industry to fund research.  Instead of using the money for smoking cessation programs, many of the funded studies focused on ways to make a safer cigarette.  To keep money flowing into its Education and Research Foundation the AMA delayed, stating in a confidential 1971 report that, “AMA is not prepared to make any statement regarding termination of the smoking-health research program.”  The report went on to complain that tobacco companies are “in arrears on 1970 contributions.”  The dependency on tobacco money created a political alliance between doctors and cigarette makers as their lobbyists joined forces in Washington.  

The delay benefitted tobacco sales and maintained the AMA’s “research” payments, but it angered Dr. Ochsner, who accused the AMA of being derelict.  The AMA called Dr. Ochsner’s position “extreme.”  However, name-calling could not stall the inevitable conclusion any longer.  In 1978 the AMA finally agreed with what most people had already realized: smoking causes lung cancer, and many other health problems.  The romance with big tobacco was over.

Or was it?

As late as 1982, JAMA publications were warned to steer clear of “politically sensitive” topics like tobacco use.  After most of a century of being on the tobacco dole, the AMA could not make a clean break.  The AMA portfolio contained investments in tobacco companies until the late 1990s. 

In 1998, the tobacco industry settled lawsuits filed by state governments with a massive Master Settlement Agreement.  In exchange for perpetual annual payments and tight regulatory control, the tobacco industry could continue to sell its products protected from future lawsuits brought by participating states and jurisdictions.  

But who really benefitted from the Tobacco Settlement?  Only 2.6% of the money has been used for smoking prevention and cessation programs.  Some states have used the tobacco money to fill budget gaps.  South Carolina gave money to tobacco farmers affected by a drop in prices.  Altria Group, a global tobacco company, is on the US News 10 best-performing stocks list.  Altria, Phillip Morris, and British American Tobacco have all grown annual dividends consecutively since the settlement.  According to Dr. Ed Anselm, “The most addictive thing about tobacco is money.”

Tobacco use remains the number one preventable cause of death in the United States.  In the first fifty years after the Surgeon General’s 1964 report, more than 20 million Americans died of smoking.  How many of these deaths would have been prevented if doctors had not been conflicted by financial entanglements with the tobacco industry?

Money blinds objectivity.  When money drives decisionscontroverting evidence is ignoreddissenting voices are ridiculedopen debate is suppressedtalking points are distributedconclusions are delayed, and people die from a product with liability protection.  

The New York State Journal of Medicine published a retrospective of tobacco’s relationship to medicine in its December 1983 issue.  Flipping through the pages is enlightening.  Surrounding the articles describing the greed and politics of big tobacco are advertisements from medicine’s new love—big pharma.  Doctors have exchanged one bedfellow for another.

By endorsing irrelevant COVID-19 vaccines and poorly tested bivalent boosters, the AMA is pushing a product without concern for its potential negative health effects.  Like before, the medical profession lags behind public opinion.  According to recent Rassumsen Reports, 7% of vaccinated individuals report a major side effect, and nearly half of Americans believe that COVID-19 vaccines have caused unexplained deaths, about the same proportion who believed that smoking caused cancer in the 1960s while the AMA was studying the issue. 

conflicted profession cannot honestly evaluate data.  Nowadays, the pharmaceutical business is a tremendous business.  An organization benefitting from a product’s sales cannot be trusted to evaluate that product.  

If doctors could not recognize the health dangers of tobacco for most of the last century, why should we believe them when they say novel vaccines are safe and effective?

Additional Resources:
Categories
2022 Ethics Philosophy

A Life Well Lived

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

We lose the promise of a life well lived.

Categories
Ethics Science

Segregation

More than fifty years after the Civil Rights Act of 1964, America still struggles with segregation.  Irrational restrictions of freedoms are imposed on unfavored groups by those in power.  Is it legal?  Yes, unfortunately it is.  But it is not right.

First, some factchecks.  The idea that vaccinated individuals cannot contract COVID-19 is false.  The idea that vaccinated individuals cannot spread COVID-19 is false.  We know these ideas are false by the scientific method which compares ideas such as these to real-world observations.  We have several notable counterexamples.  President BidenJill BidenAnthony Fauci, and Justin Trudeau all recently contracted COVID-19 despite being fully vaccinated and up to date with boosters.  Anyone who contracts COVID-19 can spread it to others regardless of vaccination status.  To believe that vaccinated individuals cannot contract COVID-19 or spread it to others is to deny science.

Why did vaccines not produce promised protection?  There are many reasons.  For example, these have always been leaky vaccines.  But even more compelling, all vaccines and boosters available today target a virus that no longer exists.  COVID-19 vaccine targets were mapped in January 2020.  The virus has mutated many times since then.  Anyone who received these vaccines are potential transmitters of the current virus.  There is no scientific basis for segregation of the unvaccinated.

William L. Moore file photo from 1963. (scanned 02/07/03) Killed in Alabama April 23, 1963 Published April 24, 1963 Evening Sun Walks against Segregation Original Caption On Another March William L Moore was on his way to plea for passage of the public accommodation bill at the General assembly in Annapolis when photo was taken

Yet segregation exists.  For example, there is a large health care system that prevents some unvaccinated physicians from practicing medicine in its hospitals by terminating their medical staff membership and privileges.  It acts summarily, without due process, and without regard to appropriately submitted religious exemption petitions, the same religious exemption petitions which were accepted by other major health systems in the area.

Another example.  As part of its back-to-the-office initiative, a major area employer has corralled unvaccinated employees into a single floor, forbidding them to visit to any other floor of their downtown office building.

Although these actions are irrational and unscientific, they are legal.  In Biden v. Missouri, 595 U.S. — (2022),the U.S. Supreme Court upheld the CMS vaccine mandate, giving health care systems broad authority to adjudicate religious or health exemptions for workers who do not wish to be vaccinated.  Similarly, employers have broad legal authority to impose restrictions on employees, even irrational ones, so long as those restrictions are not based on a federally protected status such as race, color, religion, sex, or national origin.  We have been here before.

In Plessy v. Ferguson, 163 U.S. 537 (1896), the U.S. Supreme Court affirmed the practice of segregation by race so long as separate accommodations were equal, which, of course, they never were.  Prior to the Civil Rights Act of 1964, employers had broad legal authority to impose restrictions on employees, even irrational ones, even restrictions based on race, color, religion, sex, or national origin.

Now, as then, misinformation fuels these irrational policies.  Now, as then, the same irrational arguments are heard: “Those people are unclean”; “They spread disease”; “It’s in their genes.”

Now, as then, legal does not make right.  Unscientific segregation, coerced consent, and irrational discrimination are unethical.  These are the methods of bullies and lynch mobs, not freedom loving patriots.

If you have been the victim of segregation, please share your story in the comments below.  The readers of this blog want to hear from you.

Categories
Ethics Science Vaccine

Against the Rules

FDA made significant changes to COVID-19 vaccines available in the United States last week.  In its recent actions, the FDA displays pattern of blatant rule breaking that indicates negligence and corruption.  Here are three examples.

Pfizer.  FDA gave license to vaccinate middle-schoolers twelve years and older with COMIRNATY by its supplement approval letter of July 8, 2022.  This approval was issued in response to Pfizer’s submission of pediatric Study C4591001 regarding safety and effectiveness of COMIRNATY in children 12 through 15 years of age.  However, Pfizer reports that this study relied on data from a trial using 16 to 25 year-olds conducted prior to Delta and Omicron surges, raising questions regarding its relevance.

FDA rules require manufacturers to inform FDA within 6 months of “a permanent discontinuance in manufacturing”, or “an interruption that could lead to a meaningful disruption in the supply of the product in the United States” (page 7, lines 208-210), even if the manufacturer decides to cease production for business reasons (lines 221-222).  COMIRNATY has never been available in the United States in the eleven months since initial approval.  I am not an attorney, but this seems like a meaningful supply disruption of the licensed product to me, which should trigger a reconsideration of the vaccine’s license.  An expansion of COMIRNATY’s license while the product is still unavailable violates the spirit, if not the letter, of FDA’s own rules.  Instead, the approval appears to be merely a merit badge providing a marketing advantage to Pfizer without changing that fact that no approved vaccines are yet available to Americans.

Novavax.  The predicted authorization of the all-protein Novavax vaccine happened with fanfare last week.  FDA’s press release welcomed the arrival of “another option” for Americans, and assured that “the American public can trust that this vaccine, like all vaccines that are used in the United States, has undergone the FDA’s rigorous and comprehensive scientific and regulatory review.”  I have issues with both statements.

The use of emergency use authorization to provide “another option” violates the rules governing emergency use authorizations.  The purpose of the EUA is to make products available when “there are no adequate, approved, and available alternatives.”  There are approved alternatives—COMIRNATY and SPIKEVAX—which are, by manufacturers’ choice, unavailable.  But adequate alternatives are available.  Search vaccine.gov to see whether you can find vaccines in your area.  If you cannot, please let me know. If you can, another unapproved option is unneeded.

The assurance of “rigorous and comprehensive scientific and regulatory review” is misleading, since that describes the approval process, not the authorization process.  EUA is for emergencies, like bailing water out of a sinking ship.  “Rigorous and comprehensive” describes a process to assure seaworthiness before putting the ship into water and results in a license to sail.  Novavax has no license. It has not been through a truly rigorous and comprehensive scientific and regulatory review.

Moderna.  Authorization letters require manufacturers to comply with section 502(a) and (f) of the FD&C Act, which prohibits false or misleading labelling.  Yet children ages 6 through 11 are to be vaccinated with Moderna Purple, which is labelled “BOOSTER DOSES ONLY” because Moderna Teal is still unavailable.  Unreliable labelling is a setup for medical error, which is why the rules prohibiting misleading labels are so clear.  Instead of insisting that Moderna relabel product before distribution, FDA issued a “Dear Healthcare Provider” letter, instructing caregivers to ignore the printed label.

Vaccine chart, updated July 16, 2022.

This is the current state of vaccines in America.  We did not get here honestly.  Instead, we got here by bending, twisting, and breaking the rules established to keep us safe.

FDA is a law enforcement agency that should respect rules.  If you come under FDA’s jurisdiction, you rigorously follow its rules and regulations because FDA has the power to shut you down.  Just ask Abbott Nutrition, the operator of the Michigan baby food plant forced to cease production earlier this year.  The resulting baby formula shortage is a serious emergency, yet there have been no emergency use authorizations for manufacturers racing to have new product approved.  Meanwhile, we still have an emergency declaration that short-circuits the process for vaccines.

The FDA has compromised its rules related to vaccines.  It is a clear signal of negligence and corruption.  There is something pathologic at the FDA.

Categories
Ethics Vaccine

Why Vaccinating Kids Is an Emergency

This week the FDA’s Vaccines and Related Biological Products Advisory Committee will meet twice to consider COVID-19 emergency use authorizations for children.  On Tuesday, June 14 the committee will consider Moderna’s request to vaccinate children aged 6 through 17, and on Wednesday, June 15, the committee will consider requests from Pfizer and Moderna to vaccinate all children and infants down to six months of age.  Infants and children have the lowest death rate from COVID and the highest risk for adverse health consequences, so why is vaccinating children an emergency?

Kids die from COVID-19, but the death rate is astonishingly low, especially when compared to other childhood risks.  According to the American Academy of Pediatrics, between 0.00% and 0.02% of all COVID-19 cases in U.S. children result in death.  As of June 2, 2022, there have been 1,049 childhood deaths from COVID-19, total.  By comparison, in 2019 nearly 2,400 teenagers died in car accidents, and 1,250 infants died of SIDS.  Yet, any childhood death is tragic.  If vaccination reduces death from COVID-19, why not vaccinate our children to reduce even this tiny risk?

An honest risk-benefit analysis requires examination of both sides of the equation, so we must first look at the risks of vaccine in children.

Many of these risks are still unknown.  The kids who have been vaccinated have not grown up, entered the workforce, or had children.  Nevertheless, sobering data is emerging.  Vaccinated males between 16 and 19 years old have a 13.6 increase incidence of myocarditis compared to historical norms.  So far, there have been 52 deaths reported to VAERS after COVID-19 vaccine in children aged 6 months to 17 years.  Reports of blood clots in vaccinated children are beginning to surface, unsurprising since thrombotic vaccine risks in adults are well established.  According to data released by Pfizer, vaccination is associated with increased miscarriages.  Perhaps most compelling, the study funded by Pfizer and published in the New England Journal of Medicine to support vaccine administration in children shows no improvement in all-cause mortality (see table S2).

And we still have those risks of the unknown.  Read again how a seemingly harmless hormone caused cancer in the daughters of women injected with it.  

If it is hard to reconcile the risk-benefit in favor of vaccinating kids, there must be another reason for the push to do so.  Perhaps it is not a health emergency for children but a liability emergency for vaccine manufacturers.  Vaccine liability protection will evaporate once the COVID-19 emergency is lifted, but childhood vaccines enjoy special liability protection.  

Emergency Use Authorization makes unapproved products—vaccines, tests, treatments, and so on—available during a public health emergency when there is nothing approved that works.  Manufacturers do not want to be liable for unintended consequences of unapproved products. Although an EUA does not by itself provide product liability protection, there is a loophole.  The Secretary of HHS can issue a PREP Act Declaration which absolves manufactures from all liability except willful misconduct for claims “resulting from administration or use of countermeasures to diseases, threats and conditions.”

The HHS Secretary issued a PREP Act Declaration for COVID-19 that includes vaccines, granting liability protection for as long as the emergency lasts.  It has been extended 10 times.  But the emergency cannot go on forever.  The end game is permanent liability protection.  

In 1986, congress passed the National Childhood Vaccine Injury Act (NCVIA) which created the National Vaccine Injury Compensation Program, “a no-fault alternative to the traditional legal system for resolving vaccine injury petitions.”  If you can prove vaccine injury, you can ask for financial compensation from the fund rather than file lawsuit against the manufacturer.  This system is open to “any individual, of any age, who received a covered vaccine,” but there is a catch:

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

Heath Services and Resources Administration definition of Covered Vaccines.

Currently, COVID-19 vaccine manufacturers have liability protection because they are selling unlicensed products under emergency use authorization.  But once these products are recommended for routine administration to children or pregnant women, then vaccine liability protection will continue under the NCVIA, even when the emergency declaration is lifted.

Now we know why vaccinating children is an emergency.  At the same time, we have stumbled on the answer to a question I asked a few weeks ago.  Why does CDC recommend COVID-19 vaccines to pregnant women, despite the explicit Fact Sheet statements (see page 44) warning of the lack of safety data? 

The answer to both questions is the same.  Like vaccinating pregnant women, vaccinating children gives manufacturers a pathway to permanent liability protection.

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 swastikasconcentration 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
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 Ethics Vaccine

Follow the Money

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

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

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

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

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

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

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

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

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

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

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

Categories
2021 COVID-19 Ethics Vaccine

What If You Are Wrong?

I am not talking to President Biden, Rochelle WalenskyAnthony Fauci, or anyone else conflicted by political or material entanglements with the pharmaceutical industry.  I am not talking to members of VRBPAC or ACIP, or principal investigators for NIH.  I am not talking to Bill Gates, Mark Zuckerberg, or anyone who has made billions during the pandemic.  I am not talking to anyone who has sold out.  If you would do anything to hold onto your research grant, to keep your airline running, or to protect your fiefdom, I am not talking to you.  I am not talking to media syndicates with synchronized messages.  I am not talking to those cynical about the American dream who think “of the people, by the people, for the people” is naïve and passé twaddle.  I am not talking to anyone numb to the pangs of conscience, sociopaths who prioritize greed and power over the lives of others.  I am not talking to you because you are already lost.  I have nothing to say to you.

I am talking to foot soldiers in the army of the people I am not talking to.  I am talking to leaders who have power over people and policies.  I am talking to those trying to keep their businesses safe for customers and employees.  I am talking to hospital administrators responsible for protecting patients from harm.  I am talking to doctors who care about the welfare of their patients.  I am talking to elected officials trying to best represent their constituents.  I am talking to leaders in the military and law enforcement who protect us from bad people.  I am talking to dedicated scientists in public health agencies.  I am talking to ethical small business owners.  I am talking to HR directors responsible for a healthy and productive workforce.  I am talking to all those who want to do the right thing.  I know you are out there.

You are leaning on what has worked in the past.  You steer a middle course.  But as the pandemic evolves, the paradigms have diverged.  It is no longer possible to keep one foot on the dock and the other in the boat; the middle ground is now under water.  You have chosen the orthodoxy proclaimed by all the people I am not talking to.  You feel safer there.  Afterall, you are in a delicate situation.  You know how things work.  You are expected to be a good soldier and toe the line.

I’ve got a question for you.  What if you are wrong?

You require vaccines for your employees, you urge boosters for your patients, because aggressive vaccination policies keep the public safe; the unvaccinated are a threat to the health of others.  Vaccinate your employees, vaccinate your patients, vaccinate your children.  Use the carrot, use the stick, but get it done.  But what if universal vaccination will not eradicate the virus?  What if the vaccinated can become infected and spread the virus to others?  What if indiscriminate vaccination pressures the virus to mutate into more dangerous forms?  What if antibody dependent enhancement causes devastating infections in the vaccinated?

You tell others that vaccines are safe and effective.  You encourage your patients, your family, your friends to get boosted.  Vaccine complications are rare, you say; COVID will shred your lungs, destroy the pleasures of taste and smell, and put you face down on a ventilator.  But what if vaccine safety data has been deceptively manipulated?  What if you learn of death spikes in populations after vaccines were introduced?  What if there is collusion to suppress adverse vaccine safety information?  What if the industry reports of vaccine efficacy deliberately leave out measures of absolute risk reduction?

You believe we must protect our children by early vaccination.  But what do you do with the evidence that healthy children don’t die of COVID, that vaccination risks for kids far outweigh benefits, and that natural immunity in children is durable?

You say this crisis is no time to question the wisdom of our government’s healthcare policies.  Afterall, they’ve been guided by the greatest minds on earth.  But how do you feel when you learn that USA has more total per capita COVID-19 deaths than 90% of the nations on earth, and that during the pandemic, average lifespan of Americans has dropped by nearly 2 years, 8.5 times the rest of the developed world?  How do you account for the thousands of physicians and scientists who have signed the Global Covid Declaration?

When the FDA tweets, “You are not a horse. You are not a cow. Seriously, y’all. Stop it,” you like it, you share it, but for sure you won’t prescribe Ivermectin or dispense it in your pharmacy.  Afterall, there have been no adequately powered, well-designed, well-conducted clinical trials that support the use of Ivermectin in the treatment of COVID-19.  You know that treatment for severe COVID is hospitalization, Remdesivir, steroids, and mechanical ventilation.  But what if you learn that Remdesivir’s approval was based on inadequately powered, uncontrolled clinical trials that showed shortened hospitalizations instead of improved survival?  What if you learned that early treatment keeps people out of the hospital?  What if chloroquine prevents infection and spread of SARS viruses?  What if the use of approved, off-label, unpatented, repurposed drugs by physicians is really generating the outstanding success rates reported by Front Line COVID-19 Critical Care AllianceAmerican’s Frontline Doctors, and the Pandemic Health Alliance?  What if there has been a deliberate attempt to suppress alternative therapies for COVID-19?  What if the leaders of institutions you have trusted for health guidance are manipulating you to enrich themselves and others?

Are you sure that your actions, your decisions, your influence, your mandates are not harming people?

Your decisions affect the welfare, livelihood, and very lives of others.  And you are not just deciding for us; you are deciding for our children too.  And their children.  And all that come after.

Maybe you have been deceived.  But what if you are wrong?

Categories
2021 Ethics Vaccine

The Booster Trap

First, let’s clear up a misunderstanding.  Some people think that a COVID booster is different from a COVID vaccine, but that’s not true.  There is no difference between a manufacturer’s booster and its primary vaccine series.  Both come from the same vial.  There’s been no change in the formulas that were first authorized last year.  Pfizer and Janssen boosters are even the dosed the same as a single shot from the primary series.  Moderna boosters are half doses of a single shot from its primary series.  Either way, the booster shot is just more of the same.  If you want to fact-check me on this, read the FDA’s Fact Sheets for the Pfizer PurpleModerna, and Janssen, the only available vaccines with boosters permitted in the U.S.

There are also those who believe that the vaccines available today are different that the vaccines that were given last winter, but that’s another misunderstanding.  The original vaccine was targeted against the Wuhan strain, but even though that strain is no longer present in the community, vaccines given today are the same as the ones first authorized.  There has been no change in vaccine formulas.  You can fact check me by reading the FDA authorization letters for the available vaccines (PhizerModerna, and Janssen) which detail their regulatory histories.

Why the push for boosters?  It turns out that the immune response induced by vaccine wanes significantly after 6 months.  The booster is thought to drive antibody levels higher, and, the theory goes, it’s the antibody levels that protect the vaccinated from infection.  Boosters have been authorized for all Americans over 18 years of age, 6 months after completion of an mRNA primary vaccine series (Pfizer and Moderna) or 2 months after the Janssen injection.   Janssen’s booster interval is shorter because Janssen has the lowest immunogenic effect of the three authorized vaccines.  Janssen-induced antibodies wane earlier.

Everything above this paragraph is an objective report of the current vaccine landscape.  Now I’m going to predict the future.  When I look in my crystal ball, here’s what I see coming.

Janssen will go from a single injection to a two-shot series, separated by 6-8 weeks.  Then Janssen’s booster interval will be set at 6 months, just like the other vaccines.  So far, only one booster has been authorized, but expect booster authorizations to go on an every six-month renewal cycle.  

The definition of “fully vaccinated” will change to include a current booster.  If it’s been more than six months since your last booster, your vaccination status will expire.   It will take a computer to keep up with everyone’s expirations, so vaccine passports will be tracked on your smartphone.  This passport will be connected to other data on your phone—where you go, what you tweet, who your friends are—to create a social credit score that will be used, along with your vaccine passport, to restrict or permit access to products, services, and transportation.  Since your financial institutions are probably already connected to your smartphone, it will only take the flip of a switch to turn off access to buying power.  That should incentivize citizens to maintain good scores.

And what about those boosters—will they ever change?  Probably.  The mRNA technology used in Pfizer and Moderna vaccines is a platform that can be adjusted rapidly to changing vaccination targets.  As the virus mutates, these vaccines can be quickly reengineered to respond to the changes, perhaps even without additional FDA submissions.  And it will be used for more than SARS-CoV-2.  Other vaccine targets can be loaded on the platform to create a vaccination cocktail tailored to the pandemic du jour.  And it will be used for more than vaccines.  Other gene therapies can be mixed into the brew, all for your safety of course.  You’ll be a much happier, more compliant, and easily manipulated citizen.  The possibilities are endless.

What do you think of my crystal ball?  Personally, I don’t like it very much.  It’s not a world where I want to live.  If my predictions become true, we lose the freedom to make personal choices.  Free will, the essence of humanity, will be gone.  That’s not for me.

We still have a choice.  We can choose to go down this road of boosters without knowing where the road will lead, or we can recognize that vaccination will not eradicate this virus, no matter how many boosters we take.  If boosters will not eradicate SARS-CoV-2, there must be another reason to inject the world with limitless mRNA sequences.

I don’t want to find out what that reason is, so I’m not going down that road.  My humanity is too valuable to me.