Category: Science

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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
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
Philosophy Science

The Art of Science

“When all was finished, it cannot be denied that this work has carried off the palm from all other statues, modern or ancient, Greek or Latin; no other artwork is equal to it in any respect, with such just proportion, beauty and excellence did Michelagnolo finish it.”  

Giorgio Vasari, 1550
Michelangelo’s David, 1501-1504

David, the breathtaking masterpiece by Michelangelo, represents the pinnacle of Renaissance sculpture, the result of countless hours in practice, planning, and observation of human forms.  Carved from a single massive block of Carrara marble which had been discarded by other sculptors, Michelangelo’s creation embodies confidence and power.  The body’s position, the facial expression, and even the veins popping in the neck all betray a determined youth on his quest to slay a giant.  You can learn a lot of anatomy, physiology, and psychology by studying David.  But nobody would confuse the statue with a living man.  

And why not?

This statue never moves, it is twice the size of a man, and it feels like cold stone instead of flesh.  Its proportions are wrong, perhaps intentionally so.  Cut it open, and you will find dust instead of a beating heart.  Michelangelo’s David is not a man.  It is just a model that provides ways to think about man.

Science is like that.  Like art, science is a creative endeavor.  Scientists do not discover truth any more than Michelangelo discovered David inside the stone.

For example, Sir Isaac Newton did not discover the law of gravity; he invented it.   His model replaced Aristotle’s 2,000-year-old idea that things fall because they seek their natural place in the universe.   Newton proposed that bodies attract each other in proportion to the product of their masses and inversely to the square of the distance between them [Fg = G(m1m2)/r2].  Both ideas explain why a cannonball dropped from a tower goes down, but only Newton’s model explains why the moon hangs in perpetual freefall around the earth.

Newton’s invention is elegant and useful, even taking men into space, but it is not true.  For example, Newton’s model fails to explain the wobbly orbit of Mercury.  To correct the deficiencies of Newton’s theory, Albert Einstein invented a model of gravity in which objects bend the unified field of spacetime, pushing them towards each other.  Although Einstein’s Theory of Relativity explains the paradoxical orbit of Mercury, even his invention has shortcomings.  In the subatomic world of Fermions and Bosons, Einstein’s theory just doesn’t work.

A model does not have to be universally true to be useful.  Despite its many limitations, science does two things incredibly well.  First, it shapes what you believe by informing on what is not true.  This is because the scientific method is an iterative process that tests ideas against independent observations.  Second, brilliant scientists compile observations into theories of various aspects of the universe.  In this way, scientists and artists have much in common.  Both create models that provide ways to conceptualize the complex, stimulating new thoughts and ideas.

Scientific models should not be confused with truth.  Truth is all around you, in nature.  Scientific models are ways to think about nature when you close your eyes, when your viewpoint is obstructed, when you cannot see nature clearly.  Scientific models are merely shadows like the ones on Plato’s cave.  The Allegory of the Cave described the art of science long before scientific principles were articulated.

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
Science Vaccine

Medical Publications Bow to a Political Narrative Causing Loss of Public Trust

Publications in top-tier medical journals must comply with a narrative.  As a prerequisite for publication, authors must affirm that universal vaccination is the best response to pandemic, and that the benefits of vaccination outweigh any harm it causes.  Even articles that describe vaccine injuries must minimize their risks in deference to the goal of universal vaccination.  This misuse of the medical literature suborns the mission of journals to a political agenda, squandering the trust they once enjoyed.

I noticed this trend during research for these blogs.  Here are a few examples to give a flavor of the narrative.

  • In a recent review of clotting complications caused by vaccine published in Journal of Stroke and Cerebrovascular Diseases, Kakovan et al. end their article by saying, “Finally, since the advantages of COVID-19 vaccination outweigh the risk of stroke or any other neurological complication, the public should be reassured that the vaccination program is still the best way to combat COVID-19.”  The article gives no support for this conclusion.  It is as if the authors knew that homage to this dogma was the price of publication.
  • In a Reviews in Medical Virology article presenting data showing that vaccination causes a 13.6 times increase in myocarditis among 16-19 year-old males, Faziollahi et al. conclude that these complications are “rare,” missing this obvious data signal.  
  • “The very low prevalence of this complication of vaccination, however severe, relative to the benefits of preventing Covid-19 (a condition with 1 to 2% mortality and potential long-term sequelae) must be emphasized.” Clines and Bussel in New England Journal of Medicine.
  • “Independent safety reviews by regulatory authorities of available clinical and real-world evidence have concluded that the benefits of AZD1222 outweigh the potential risks.”  Falsey et al. in New England Journal of Medicine.
  • “The thromboembolic complications do not represent a contraindication to complete the vaccination cycle…” and “The vaccination for SARS-Cov-2 is essential to overcome the pandemic…” Serrao et al. in Journal of Thrombosis and Thrombolysis.

The narrative is fully stated in this quote from an article published in Journal of Clinical Medicine to help practitioners provide “evidence-based counseling to their often-alarmed patients” who have new blood clots after vaccination.  Abrignani et al. conclude,

“All scientific societies emphasize the value of continuing vaccination programs to protect patients from severe forms of COVID-19 and to slow the circulation of the virus and its variants. Vaccine hesitancy risks regressing progress in infectious disease control. Abstention is not an option, as it results in a failure to assist a large population that remains in danger. Action, with increased vigilance, is the best solution in our public health mission.”

Medical journals should be places of conflict, where ideas clash, paradigms are upended, and the status quo is challenged.  The New England Journal of Medicine claims, “Our mission is to publish the best research and information at the intersection of biomedical science and clinical practice and to present this information in understandable, clinically useful formats that inform health care practice and improve patient outcomes.”  But the crossroads of biomedical science and clinical practice is not a static location, unchanging over time.  Without medical journals exposing dangers of established practice, physicians might never have learned that diethylstilbestrol treatment causes cancer or that thalidomide therapy causes birth defects.  

Today’s medical journals have devolved into a repository of orthodoxy where platitudes are exchanged among the sanctified.  They bow to a narrative that coincides with a political agenda, mocking the missions of these publications.  The trust accumulated from two centuries of diligence and integrity has been lost in a few months.

The erosion of trust does not stop with the journals.  It extends to my entire profession of physicians. Yet too few of my colleagues have acknowledged this trend.  Instead, most parrot the narrative to their patients.  Why?  Are they afraid they will never be published again?  Are they afraid they will be ostracized from the society of physicians and scientists?  Or are they just too lazy to observe and think for themselves?

Physicians have a sacred duty to the patient in front of them.  This duty requires honest observation, independent thought, and attention to the patient’s best interest.  Without these, we deserve the loss of public trust.

Categories
Science Vaccine

The Novafix

On Tuesday, June 7, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) will consider evidence supporting emergency use of Novavax COVID-19 Vaccine.  The outcome of these proceedings is nearly certain.  The committee’s endorsement will be followed by a swift EUA letter from the FDA and recommendation by the CDC.  The only uncertainty is how many times committee members will contradict previous statements in their sycophantic rush to fawn over this new all-protein vaccine.

FDA Placeholder for Novavax Fact Sheet, June 5, 2022.

FDA webmasters have already been hard at work, excavating a location for the new vaccine’s authorization documents.  Click here today and you will see the placeholder for the Novavax Recipient-Caregiver Fact Sheet.  Next week, the same link will bring up the actual documents.

Wall Street is also lining up behind the new vaccine.  According to a recent article published on Nasdaq.com, “So far, in all previous global regulatory approvals in other regions, there has been ‘minimal to no debate’ on the highly effective and safe credentials of the vaccine as shown in the 3 large-scale Phase 3 studies. And going by previous examples of such EUA FDA panels, following a positive vote by VRBPAC panelists, Mamtani [an analyst working for B. Riley Financial] expects a ‘prompt FDA approval.’”

The article continues, “Accordingly, Mamtani reiterated a Buy rating on NVAX shares, backed by a $181 price target. Investors stand to take home about 227% gain, should the target be met over the next 12 months.”  This is Mr. Mamtani’s recommendation, not mine.  I am a practicing pathologist and do not give financial advice.  I only reference this article to restate a previous point—this is about the money.

The fix is in.  As Wall Street proclaims this new vaccine “highly effective and safe,” expect committee members to opine at length that the new vaccine is new technology.  Since it does not use mRNA, it should be readily accepted by the unvaccinated holdouts by removing their objection to gene therapy.  Obsequious committee members will heap praise on the company for producing this missing piece to the pandemic puzzle.

Their praise will create a contradiction that undermines the committee’s credibility.  If the war on pandemic requires another vaccine, then the vaccines currently available must not be the panacea we were told previously.  To believe what the committee will say this week, we must stop believing that what the committee said previously about mRNA vaccines being “safe and effective.”  Maybe they are not safe enough or not effective enough.  Otherwise, why would a new vaccine meet requirements for emergency use authorization?  And if we must stop believing something they have said before, why should we believe them now?  This is not science.  This is politics.

Tuesday’s committee discussion will not recognize any of the problems with the Phase 3 trial published in the New England Journal of Medicine earlier this year.  They will not consider the failure of vaccine to reduce all-cause mortality, the high number of short-term adverse effects, or the elimination of the control group after two months.  They will simply parrot the study’s conclusion of “safe and effective” without critical examination of the study’s flaws, and without mentioning that the study that was funded by the vaccine maker.

By the end of the week, a new vaccine will be available to Americans.  The new vaccine will not met rigorous approval standards, but it will have the same manufacturer liability exemptions as the other EUA vaccines.  Novavax stands to make a lot of money with minimal risk.  However, there is little evidence that this new vaccine will create a health benefit for Americans.

Categories
COVID-19 Science Vaccine

Because I Say So

The fascists tell us what to think.  They expect us to follow arbitrary commands based on the strength of their word alone.

Case in point.  NPR recently published an article supporting the “Pandemic of the Unvaccinated” narrative.  The article claims there were nearly 319,000 excess deaths caused by the failure to universally vaccinate all adult Americans.  Why should we believe this?  “Because I say so.”

This chart from the article summarizes the report:

The lines charting actual and estimated deaths diverge in August 2021.   Actual deaths have steep slopes in October 2021 and January 2022, corresponding to the waves of delta and omicron variants.  The modeled deaths for the universal vaccination scenario show barely a bump during these times, implying that vaccination would have prevented delta and omicron fatalities.  Why should we believe this claim?  “Because I say so.”

The cumulative death data from COVID-19, reported by the CDC, shows that every state experienced a surge in death corresponding to delta and omicron, just at different times.  States with high vaccination rates had these waves; states with low vaccination rates had these waves.  Instead of vaccination rates, population density correlates better with COVID deaths.  New York City, a highly vaccinated area, has the highest cumulative COVID death rate, nearly 500 per 100,000 population.  Why believe that universal vaccination would have prevented deaths?  “Because I say so.”

The CDC Heat Map plots case rates and vaccination rates.  If vaccination prevents COVID, then the map should be colored red (high cases in areas of low vaccination) and green (low cases in areas of high vaccination).  Instead, there is lots of purple—high numbers of COVID cases in highly vaccinated regions of the country.  If COVID cases are highest in the most vaccinated regions of the country, why should we believe that universal vaccination would have saved lives?  “Because I say so.”

The NPR article goes on to perpetuate a pejorative stereotype.  Vaccination rates are lower in red states—read “Trump voters”—implying that Trump voters are just not intelligent enough get vaccinated.  The article suggests that people from blue states are more trusting of government, as if that is desirable.  It goes on to blame Republican-led states because they “underused other pandemic-fighting tools, such as mask and social distancing requirements,” ignoring that these pandemic-fighting tools were first implemented by the Trump administration.  Furthermore, today’s CDC COVID Data tracker shows COVID-19 Community levels are highest in the Northeast—blue states.  So why should we believe this red state/blue state narrative?  “Because I say so.”

The article commends Massachusetts, a highly vaccinated blue state, for its low rate of vaccine-preventable deaths.  However, the CDC’s data tracker shows an interesting and unexplained anomaly.  Miraculously, on March 14 nearly 4,000 fewer individuals had died from COVID in Massachusetts than were reported the day before.

MASSACHUSETTS
March 13, 2022: Total deaths 23,751, Death rate per 100k 345
March 14, 2022: Total deaths 19,981, Death rate per 100k 290
FLORIDA
March 13, 2022: Total deaths 73,152, Death rate per 100k 341
March 14, 2022: Total deaths 73,194, Death rate per 100k 341

On March 13, the Massachusetts death rate was higher than Florida.  On March 14, the Massachusetts death rate was lower than Florida.  Why the forensic audit and recount of the Massachusetts data, the result of which smoothed out a surge in the state’s reported COVID deaths?  Maybe the facts did not fit the narrative.  But we should believe the narrative anyway, “Because I say so.”

Who are you and where did you publish your data?

Researchers at Brown and Microsoft AI Health provided this data analysis, but not in a peer reviewed medical journal.  Instead, the data was “shared exclusively with NPR.”

Let me get this straight.  An ivy-league university, a big tech company, and a left leaning news organization are telling us, “Get your vaccination, get your booster, because I say so.”

Not good enough for me.  How about you?

Categories
Ethics Science

A Pandemic of Fascism

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Challenge all assumptions.  Take nothing for granted.