Author: Kevin Homer, MD

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

Categories
2023 COVID-19 Testing Vaccine

Emergency Use Authorizations in a Post-Emergency World

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

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

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

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

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

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

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

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

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

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

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

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 decisions, controverting evidence is ignored, dissenting voices are ridiculed, open debate is suppressed, talking points are distributed, conclusions 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. 

A 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 COVID-19 Science Vaccine

Vaccination Does Not Prevent Long COVID

Infections by SARS-CoV-2 can cause acute COVID-19 which may last up to four weeks.  Post COVID Conditions, also known as Long COVID, are health consequences that persist or develop more than four weeks (or twelve weeks, according to WHO) after infection.  Individuals who have had acute COVID-19 are at risk for Long COVID.

According to government health agencies, Long COVID prevention is another reason to get vaccinated.  Without offering any evidence, or even a plausible mechanism for why it might be so, the CDC says that “people who did not get a COVID-19 vaccine” are more likely to develop Long COVID.  Health+ Long COVID, a report sponsored by HHS and released last month, contains the recommendation to “promote vaccination as a preventative measure for Long COVID.”  NIH even encourages unvaccinated people to get vaccinated after recovering from COVID-19 because it “may prevent Long COVID.”  But there are good reasons to doubt that any of this is true.

Long COVID can follow mild or asymptomatic infections by SARS-CoV-2.  Although there may be more than one pathway to Long COVID, autoimmunity is responsible for some, if not most, cases of Long COVID.  The intensity of the initial disease does not matter.  Mild or asymptomatic infections can stimulate the autoantibodies that cause Long COVID.  Even if you believe that vaccination reduces severity of COVID-19—I am not saying you should—there is still no reason to believe that vaccination can prevent Long COVID.

Recent studies back this up.  According to an article published in Nature last month, vaccination status does not modify the risk of Long COVID.  Instead, Long COVID correlates to the number of SARS-CoV-2 infections a person has, regardless of vaccination status.  Even though vaccination cannot prevent Long COVID, it may make it worse.  

Think about how autoimmunity causes Long COVID.  Once the immune system is stimulated to recognize the spike protein of SARS-CoV-2, the immune system may attack the body’s own cells.  Whether by an accident of nature or by design, antibodies to spike protein cause autoimmune disease in some people.  It does not matter whether the antibodies are formed in response to vaccine or natural infection, the effect is the same.  Vaccination injuries can look like Long COVID.

Dr. Marivic Villa, a Florida pulmonologist who has treated thousands of COVID patients in The Villages, agrees.  According to a recent publication, Dr. Villa says, “The signs and symptoms profile and clinical presentation of long-haulers from moderate to severe natural COVID infection, and individuals vaccinated three to four times, are almost indistinguishable from one another.”  The formation of autoantibodies by either natural infection or vaccination connects Long COVID to vaccine injuries, consistent with Dr. Villa’s observation.  She concludes, “Halting this vaccination is the highest emergency!”

Long COVID has White House attention.  This focus seems timed to perpetuate the emergency, just like the government distribution of free tests earlier this year.  These substandard tests, purchased by the government and mailed to anyone with a U.S. address, were bad laboratory medicine, saved no lives, and have not been missed since funding ran out.  But the program stirred up COVID activity, keeping the crisis going.  And it enriched test suppliers.

Similarly, attention to Long COVID is a pretext to extend the emergency powers of the executive branch by combining a tragic reality with bad medicine, unsupported by honest science.  And it enriches vaccine manufacturers.  

Every case of COVID-19, every SADS death, every victim of Long COVID, and every individual injured by vaccine is a life lost or damaged by the tragedy of the pandemic.  Long COVID cannot become just another excuse to promote vaccine.

Categories
2022 COVID-19

The Never-Ending Emergency

I have been quiet lately, not wanting to add to COVID saturation.  The issues of the pandemic are well known—viral origin, vaccine safety, early treatment, repurposed therapeutics, pharma windfalls.  The word is out, everyone has an opinion, and most have dug in.  One way or another, we have all learned to cope with a virus that is here to stay.  

From this state of uneasy equilibrium, I must ask why we are still in a declared state of COVID-19 emergency.  Maybe we need to start with the meaning of emergency.

Many years ago, a good friend of mine was pulled over.  The officer invited him to the back of the car, put him in handcuffs, and hauled him to jail.  A check of his license plates revealed a warrant for his arrest, except it was a mistake.  My friend had done nothing wrong.  A clerical error associated his plate number with someone else’s warrant.  Nonetheless, he found himself in the county jail.  On the wall of the cell was a dirty red button, and under the button was a sign, “Press for emergency.”  He felt entitled to press the button.

“What is your emergency?”  Came the voice out of the speaker.

“Well, you see, I shouldn’t be here…”  Click.  

The speaker went silent, so he pressed the button again.

“What is your emergency?”

“I believe there must be some mistak…”  Click.  He pressed the button again.   

“What is your emergency?”

“I need to make a phone ca…”  Click.  By now, he realized that his situation, however unpleasant, inconvenient, and unjust, did not constitute an emergency, so he prepared to spend the night alone in the cell, which he did.  The next morning the mistake was realized, and he was released, unceremoniously, with barely an apology, and no compensation for his 17-hour ordeal.

COVID-19 is like this.  It is unpleasant, inconvenient, and even unjust, but it not an emergency. At least not anymore.

This view has gained broad consensus across the political spectrum.  Most states have ended emergency measures, and California will join that list soon.  With a nearly veto-proof bipartisan majority, the US Senate voted to end the emergency earlier this month.  Even President Biden has said the pandemic is over.  Yet his administration promises to veto the Senate bill if passed and to extend the emergency declaration again next year.  All for an emergency that is as real as the tooth fairy.

And why not?  The emergency declaration has been the tooth fairy for many.

The COVID emergency is a bonanza for manufacturers of counter-pandemic measures—vaccines, tests, and drugs among them.  Not only does it give them an endless market for their products, but bypassing FDA approval saves them millions.  And they also receive liability protection for any product manufactured under Emergency Use Authorization.  No wonder the healthcare manufacturing sector never wants the emergency to end.

The American Hospital Association also lobbies for continuing the emergency, and for similar reasons.  Hospitals get a 20% bonus for treating COVID patients.  CMS relaxed regulatory standards during the emergency.  And there is funding for “building vaccine confidence.”  But none of this would happen without the consent of government.  

The executive branch of government has used COVID-19 as excuse for a power-grab.  During a crisis, citizens—including members of congress—are willing to temporarily cede power to the executive in exchange for steady leadership through the emergency.  The trouble is that the executive branch jealously clutches power gained during turbulent times once calm is restored.  History backs me up.  World War I gave us the Espionage Act of 1917.  September 11 gave us the Patriot Act of 2001.  And the COVID Pandemic gave us the Declaration Under the PREP Act for Medical Countermeasures Against COVID-19.

Last month, right on cue, Xavier Becerra renewed the emergency for the twelfth straight quarter, extending the government’s emergency powers into 2023.  Many of these “emergency” measures are difficult to connect to the pandemic.  For example, the CDC issued an eviction moratorium that had to be struck down by the Supreme Court.  HHS approved use of Medicaid funds to pay for food and housing in Massachusetts and Oregon.  The emergency is even the basis for President Biden’s proposal to forgive student loans.  The emergency has allowed the administration to short-circuit the checks and balances in normal policymaking processes, giving it autocratic power.

The emergency has become an institution.  Many are dependent on emergency measures, so there will be pain when the emergency ends.  But delay will only increase the suffering we must endure later.

The emergency is over.  Policies must stand on their own merits.  Normal processes must return.

Categories
2022 Vaccine

Immunizations for Vaccinations

Last week, CDC published an interim COVID-19 vaccination schedule that recommends unapproved COVID-19 vaccines for routine administration to children less than twelve years of age. This is the first time CDC has placed an unapproved vaccine on the childhood vaccination schedule, permanently transferring liability for these vaccines from the manufacturer to American taxpayers, even after the emergency ends.  Only Congress can change this now.

We knew this was coming.  The PREP Act Declaration issued by the Secretary of HSS more than two years ago granted immunity “from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration or use of a covered countermeasure” while the nation is under the COVID-19 emergency declaration.  “Countermeasures” include vaccines.

PREP Act immunity is not permanent.  When the emergency declaration is finally lifted, continued use of COVID-19 vaccines will expose the vaccine manufacturers to liability unless it becomes a “covered vaccine” under the National Vaccine Injury Compensation Program. 

What is a covered vaccine?

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.  

Those where not my words; they come directly from the HRSA website.  Once covered, the vaccine is protected for all recipients, not just children and pregnant women.  By recommending COVID-19 vaccines for children, the CDC transferred all associated product liability to the American taxpayer.

This action is an assault on many levels, but I want to focus on only one.  The recommendation applies to an unlicensed product.  No matter your opinion of FDA’s approval and licensing process, the process should be completed before a product is recommended for routine use.  An emergency use authorization does not apply to non-emergent administration.

COVID-19 vaccines are not approved for anyone younger than 12 years of age.  Furthermore, approved COVID-19 vaccines remain unavailable to Americans of any age—although that will probably change now that permanent immunity has been secured.  A vaccine that is not approved for children should not be recommended for children, and it has never happened before.  This is the first time that the recommendation for routine administration has preceded FDA approval.

FDA approval is a slow and laborious process with many critics.  Despite decades of attempts at acceleration, at the pandemic’s outset the FDA’s process was seen as a liability that put Americans at greater risk than citizens of other nations.  The fear that the FDA would slow down an effective pandemic response led to the emergency declaration by HHS and the use of Emergency Use Authorizations to bring new countermeasures to market.  Although careful, meticulous approvals can be painstaking, rapid approvals compromise safety.  I did not take an oath to eliminate frustration; I took an oath to do no harm. 

But what harm is there in vaccine?  Surely vaccines are the most benevolent of therapies, protecting against dread diseases while rarely causing harm.

This thinking is an example of association fallacy.  A risk-benefit analysis that favors some vaccines is not a favorable risk-benefit calculation for all vaccines.  Each vaccine must be carefully evaluated on its own merits.  The slow, methodical FDA approval process meets that standard.  Or at least I thought so.

FDA’s approval process has let us down, plenty of times.  Think of television commercials promising large litigation settlements to victims of injury by various drugs.  There will be no such advertisements for COVID-19 vaccine injuries since these vaccines have immunity under the law.  Unless the law changes.

Congress has the power to change law, and Congress has the duty to change bad laws.  

Although Congress did not directly grant liability protection to COVID-19 vaccine manufacturers, by passing the National Childhood Vaccine Injury Act of 1986, the 99th Congress created a loophole that gave the CDC power to shelter COVID-19 vaccine manufacturers from liability, setting the stage for what happened last week.

CDC’s actions are unprecedented.  Recommending an unapproved vaccine for children is reckless. Transferring product liability risk from manufacturers to taxpayers is corrupt.  Congress owns this.  Congress can change this.

The election for the 118th Congress is only days away, and early voting has already begun.  Please keep this in mind as you consider your vote.

Categories
2022 Vaccine

The Vaccine Is a Virus

mRNA Vaccine Lipid Nanoparticle

A virus is a sequence of genetic code wrapped in an envelope.  Viruses are classified by their envelope and genetic code configurations.  Since they do not possess independent means of reproduction, viruses are not technically alive, yet they yield to the primal force of life—the urge to propagate their genes.  To do this, each virus seeks a host, hijacking its means of reproduction to pump out as many copies of the virus as possible.  Each copy seeks its own host to infect, and the cycle repeats.  In this way, the virus and its genes live without being alive.

An mRNA vaccine is a sequence of genetic code wrapped in an envelope.  The genetic code is messenger RNA and the envelope is a lipid nanoparticle, but that does not change the similarity to a virus.  Like a virus, each mRNA vaccine particle infects a host cell, hijacks the cell’s means of production, and pumps out copies of the encoded spike protein.  

Both virus and vaccine introduce spike protein into the body.  When virus enters through the nose and upper airways, the spike protein on the virus causes an immune response and spike antibodies are formed.  A successful immune response clears the virus, but the immune memory lingers, spike antibodies and all.  Inoculation by mRNA vaccine is also an infection, except this infection occurs in the arm.  

We were told—and I wrote in this blog—that vaccine mRNA stays in the cells of the arm muscle and is broken down quickly, but that is not true.  Studies published this year have demonstrated vaccine mRNA in breast milk, blood, lymph nodes, liver, and skin.  Unlike spike protein from a mild infection, vaccine induced spike protein can be detected in blood up to four months after vaccination; from there, it can distribute widely throughout the body.  Clearly, the mRNA does not stay in the arm and is not broken down quickly.  Compared to natural infection, genetic COVID-19 vaccines are more likely to spread spike protein throughout the body. 

This wide distribution of vaccine is significant.  Every cell that ingests a lipid nanoparticle will express spike protein, marking the cell as an immune target.  As a result, the cell will die.  This process is a direct mechanism for adverse effects like vaccine-induced myocarditis.  When a heart muscle cell absorbs vaccine, the spike proteins generated incite inflammation that kills the cell.  If this happens to enough heart cells, the person will die—suddenly and unexpectedly.

Yet this mechanism may not explain all the adverse effects of vaccines.  Serious conditions such as acute myocardial infarction, Bell’s palsy, cerebral venous sinus thrombosis, Guillain–Barré syndrome, myocarditis, pericarditis, pulmonary embolism, stroke, thrombosis with thrombocytopenia syndrome, appendicitis, herpes zoster reactivation, neurological complications, autoimmune hepatitis, and autoimmune peripheral neuropathies have been reported.

Since these conditions have also been observed after SARS-CoV-2 infection, a common autoimmune pathway is proposed.  Whether introduced by virus or vaccine, spike protein shares features with molecules naturally found in the body.  There are enough similarities that antibodies to spike protein may cause disease.  The antibodies that remain after infection or inoculation are unable to distinguish between the harmless molecules of the body and viral spike protein.  The result is an attack on one or more parts of the body by the body’s own immune system. 

SARS-CoV-2 virus and mRNA COVID-19 vaccines share structural features and pathogenic effects.  Both consist of genetic material within a lipid envelope.  Both introduce spike protein to the body, and both stimulate antibodies against spike proteins and their lookalikes, which may damage one or more organs.  The adverse effects of vaccine can look like long COVID.

The vaccine is a virus, with one important difference.  The virus, you catch.  The vaccine, you take.

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
Science Vaccine

Irrelevant Vaccines and Untested Boosters

Until now, all COVID-19 vaccines and boosters available in America were engineered for the original strain of SARS-CoV-2.  Over time, mutations have made this target irrelevant.  Now for the first time, boosters and vaccines will have different formulas.  But beware.  Bivalent vaccines are the latest product of a corrupt system that threatens your health.

On August 31, the FDA authorized new bivalent boosters by Pfizer and Moderna for individuals 12 years and older.  At the same time, FDA withdrew the EUA for monovalent mRNA boosters for the same age group.  The next day, the CDC signed-off on the distribution of these new booster formulas.  There has been no change in Janssen’s monovalent booster authorization, and Novavax does not yet have a booster authorization.  The new bivalent boosters are unlicensed, unapproved, and—this part is new—untested in human trials.  More about that later.

The new boosters are called “bivalent” because they stimulate immunity against two different targets—the original SARS-CoV-2 strain isolated in January 2020, and the Omicron BA.4/BA.5 strains.  “Monovalent” vaccines have not changed; they only stimulate immunity against the original SARS-CoV-2 strain, now largely irrelevant.  Monovalent mRNA boosters are no longer available; all mRNA boosters are bivalent.  The newly authorized boosters are already listed on vaccines.gov, but unvaccinated individuals cannot get one.  You must receive a monovalent primary series vaccine before you can receive a bivalent booster.  

The bivalent boosters were brought to market so quickly because they bypassed FDA’s standard process.  Manufacturers were not required to present clinical trial data.  

We knew this was coming.  At its June 28 meeting, the FDA’s Vaccines and Related Biological Products Advisory Committee recommended that new booster formulations be authorized without examination of data by the FDA.

COVID-19 vaccine trials have been flawed.  The clinical trials for each of the four authorized vaccines lack long term follow-up.  All four vaccinated the control group so that we will never know of vaccine complications that occur more than a few months later.  FDA authorized and approved mRNA vaccines without knowing whether the vaccines cause birth defects or whether they are safe to give during pregnancy.  The mechanism of major adverse effects such as VITT or myocarditis is still unknown.  None of the trials showed that vaccination resulted in a reduction in all-cause mortality.   Despite these flaws, FDA has insisted on clinical trials before granting emergency use authorization.

Instead of addressing the flaws and tightening up the process, FDA has decided to do away with clinical trials altogether.

Dr. Paul Offit said he felt the fix was in.  “I’ve seen nothing like this,” he said.  “Both Moderna and Pfizer presented data during the June 28 meeting, and it was not compelling.”  Dr. Offit noted the lack of a control group in the scant data presented.  “That’s the obvious thing to do because that’s why you have control groups for your experiment, and I just found it odd that neither presented,” he added. “That bothered me.”

If this bothers Dr. Offit, it should bother you too.  Dr. Offit and I have had very different perspectives during the pandemic.  In an PBS interview last year, Dr. Offit said that vaccine opponents are the cause of pandemic deaths.  Dr. Offit has gone on record in favor of vaccine and mask mandates for school children.  As a member of the FDA’s VRBPAC, Dr. Offit has supported most vaccine and booster authorizations, until now.  Dr. Offit cast one of the two dissenting votes at the June meeting, and he was so bothered that he co-authored an Op-Ed shortly afterward.

Could these new genetic injections cause unforeseen harm?  Of course they can.  This blog has warned of the unintended consequences of new technology.  There are many examples in medicine of well-intentioned novel therapies having disastrous results, harming many more than they helped.  Again, Dr. Offit makes this point, “No one would have predicted myocarditis associated with mRNA vaccines. I don’t think anybody would have predicted this clotting problem so-called thrombosis with thrombocytopenia syndrome.  So, humble yourself.”  

It will be hard to prove that vaccines cause injury without methodical study.  And methodical study is what FDA is eliminating.  We may never know the harm caused by these boosters.

There is one thing for sure.  With 105 million doses of the new bivalent booster already on order, Pfizer is going to receive a large check from American taxpayers this fall—at least $3.2 billion.  Money and corruption are often found together.

Irrelevant vaccines and untested boosters are products of a corrupt system that intends to trap you in an unending cycle of injections, robbing your money before robbing your health.

I saw this in my crystal ball last year.

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 Biden, Jill Biden, Anthony 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
Testing Vaccine

Institutionalized Misconceptions

The CDC quietly changed its COVID guidance last week.  In an August 11 update to Isolation and Precautions for People with COVID-19, the CDC removed the vaccination advantage for ending COVID-19 isolation.  Now the CDC expects everyone to follow the same isolation guidance, regardless of vaccination status.  Yet even its newest guidance perpetuates myths that extend the COVID emergency unnecessarily.

Here is the new guidance.  If you suspect you have COVID-19, you should test.  Isolate until you receive your test result.  If your test is negative, end isolation.  Asymptomatic individuals with a positive test should isolate for five days and wear a mask for ten.  If your test is positive and you have symptoms, isolate for five days from the first day of your symptoms or for 24 hours after you are fever-free, whichever is longer.  Mask for ten days.  Better yet, mask until you have had two negative antigen tests 48 hours apart.

Previously, CDC recommended different isolation protocols depending on vaccination and booster status.  Now there is no difference, another tacit admission that the vaccinated and unvaccinated spread infection similarly.  This is a softening of its once bellicose “Pandemic of the Unvaccinated” position, and not the first time either.  In the last paragraph of a June MMWR report, the CDC admitted, “Despite the introduction of highly effective vaccines and medications to treat COVID-19, by the end of the study period, COVID-19 continued to cause substantial morbidity and mortality.”  Hopefully, this new direction will reduce fuel for those actively practicing health discrimination against the unvaccinated, or against the vaccinated but not up-to-date.

I am not holding my breath.  There continues to be a lot of momentum in that direction.

Despite this small positive, the new guidance continues to perpetuate misconceptions that have been institutionalized within the CDC.  Here are three examples.

There is a test for COVID-19.  The CDC confuses a SARS-CoV-2 test with COVID-19, something this blog has warned against since the early days of the pandemic, but which has become an institutionalized misconception at the CDC.  There is not a test for COVID-19.  Symptoms are necessary for diagnosis.  

Asymptomatic individuals should be tested.  Different guidance for those with and without symptoms implies a recommendation for testing asymptomatic individuals.  “Asymptomatic spread” is an unsubstantiated idea at best and deliberate fearmongering at worst.  Guidelines that promote asymptomatic testing perpetuate the myth that “asymptomatic spread” is a real concern, effectively prolonging the emergency.  Testing should be limited and focused.

Tests can determine when to end isolation. The updated guidance uses test results instead of symptoms to end of the isolation period.  This misconception relies on the assumption that an individual who has tested negative is unlikely to spread infection.  The fallacy of this assumption is embedded in the guidance, which requires two consecutive negative antigen tests to end masking.  Why two tests?  Antigen tests have low sensitivity, meaning lots of false negative results.  If the first test is not reliable, should the second test be any better?  “Past performance is no guarantee of future results.”—that works for investing and for testing.  The guidance might as well say, “Flip a coin every 48 hours; leave your mask on until you get two heads in a row.”  SARS-CoV-2 tests do not test for cure of COVID-19.  

Many people just ignore the CDC, but there are those who live in trauma and fear unnecessarily.  Misconceptions institutionalized by the CDC trap those individuals in a cycle of stress and panic.  It is time for sensible, uncomplicated, time-tested guidance.

If you feel sick, stay home.  When you feel better, get on with your life.

Stop scaring people already.