Opinion | Politicians are dreaming of a “Manhattan Project-style effort” to develop and distribute a coronavirus vaccine “for most Americans by year’s end.” To accomplish this dramatic cut in vaccine development time, “the program will pull together private pharmaceutical companies, government agencies and the military.” Normal vaccine development time is significantly longer.
Fourteen potential coronavirus vaccines are vying to be selected as the winner of “Operation Warp Speed.” Government will shield pharmaceutical companies from liability for damages that their vaccines may inflict. Taxpayers will reimburse companies for development costs for vaccines that don’t make it to market.
If you’re cheering the government for cutting red-tape, think again. Liability shields for crony capitalists and no cost for failure policies guarantee errors will be made. Without market safeguards significant injuries to human beings are highly likely. Errors will be exacerbated if medical tyranny prevails with legal mandates requiring the COVID-19 vaccination for employment and travel.
Haven’t we learned there was no such thing as efficient food distribution in the Soviet Union? Haven’t we learned there was no such thing as a safe East German Communist Trabant automobile? There is no such thing as efficient and safe, centrally planned pharmaceutical development. As we will see later in this essay, the last time government sought a “warp speed” vaccine, dead and paralyzed vaccine recipients were the tragic consequences.
Limits on Liability
Pharmaceuticals, including vaccines, have benefits and costs. We don’t have to resolve our cognitive dissonance by denying the benefits of vaccines or denying the harm they can do.
Faced with “challenges to vaccine orthodoxy, scholars, commentators, and public health officials are quick to characterize dissent as mere propaganda of ‘anti-vaxxers,’” writes law professor Efthimios Parasidis in his Boston University Law Review article “Recalibrating Vaccination Laws.”
Parasidis wrote his essay a mere three years ago. Could he have imagined what is happening today, just a few years later? A group affiliated with the FBI is labeling those who question the vaccine orthodoxy as a “threat to national security.” In a similar vein, California State Senator Dr. Richard Pan claims that those demanding an end to lockdowns and those who question vaccines “have the same message: We want you to get sick.” Demonizing dissenters is rhetoric straight out of a totalitarian playbook. People who threaten “national security” and who “want you to get sick” will be ideal “devils” for politicians to blame when their own policies fail.
Parasidis wrote that such tactics obfuscate safety and legal issues, “Focusing contemporary vaccine policy debate on anti-vaxxer rhetoric detracts from adequate consideration of important vaccine-related issues.” In his article, Parasidis points to both “the health benefits of vaccines” and “the shortcomings of the legal framework governing immunizations.”
The shortcomings of the legal framework to which Parasidis refers stem from the National Childhood Vaccine Injury Act of 1986 (Vaccine Act).
The Vaccine Act granted pharmaceutical manufacturers broad legal immunity from lawsuits for vaccine injuries. Further, Parasidis writes, “once a vaccine is approved and made available to the public, a manufacturer does not have a statutory obligation to actively collect and analyze safety and efficacy data, nor are manufacturers obligated to update vaccine formulas in light of new scientific advancements.”
On top of the protections in the 1986 Vaccine Act, vaccine manufacturers have received additional liability protections under a February 2020 declaration by Alex Azar, Secretary of Health and Human Services. Azar claims his authority to make such a declaration is granted by the Public Readiness and Emergency Preparedness Act (PREP Act).
Azar’s order makes “immune from suit and liability…to all claims of loss,” for all those who “manufacture, distribute, administer, prescribe or use” any treatments or vaccines. Administer a rushed-to-market vaccine to healthy individuals at no particular risk from COVID-19 and the government will shield you from liability. Lobby to make the vaccine mandatory and government will shield you from liability.
Noted vaccine advocates and developers such as Dr. Paul Offit have expressed alarm that “warp speed” developers might ignore standard vaccine development safeguards. “Remember,” Offit cautioned, “You’re giving this vaccine, likely, to healthy people — who are not the people typically dying from this infection.”
Liability shields warp decision-making and increase risk. Having to pay insurance premiums provides incentives to reduce risk. Think of insurance premiums on cars. Insurance premiums might help us decide against the sports car we have been coveting for years in favor of a sedate sedan. High insurance premiums for drivers involved in crashes or caught driving drunk or frequently speeding help those drivers make needed behavioral changes.
If the government indemnified us from damages from driving, risky driving would become more common. Those taking added risks would fool themselves with an illusion of competency. They might be indignant when charged with endangering others.
Libertarian law professor Richard Epstein has explored the problem in limiting liability. Writing about the 2010 BP Gulf of Mexico oil spill, he explained why “the best way to deter future spills is to expose drillers to the full costs of any mistake and not let any company without proper insurance near an oil derrick.”
Let’s rewrite Epstein’s observations: the best way to ensure vaccine safety is to expose pharmaceutical companies to the full costs of any mistake and not let any company without proper insurance near a human body.
Epstein was adamant:
The legal system should never allow self-interested parties to keep for themselves all the gains from dangerous activities that unilaterally impose losses on others—which is why the most devout defender of laissez-faire must insist, not just concede, that tough medicine is needed in these cases.
As Epstein explained, insurance companies are the best regulators:
“A tough liability system does more than provide compensation for serious harms after the fact. It also sorts out the wheat from the chaff—so that in this case companies with weak safety profiles don’t get within a mile of an oil derrick. Solid insurance underwriting is likely to do a better job in pricing risk than any program of direct government oversight. Only strong players, highly incentivized and fully bonded, need apply for a permit to operate.”
Epstein’s logic applies to the Vaccine Act. Pharmaceutical companies are highly incentivized to produce the safest vaccines when they are subject to the discipline of obtaining insurance coverage.
Those advocating in favor of liability shields say that protecting public health requires this waiver. Without the waiver, they claim, too few vaccines would be produced.
The case against liability shields is not a case against vaccines; it is a case against the distorted production of vaccines. Limits on liability override the risk-reducing incentives provided by having to pay insurance premiums and thus result in vaccines that are less safe than they would otherwise be.
Swine Flu Lessons
In his book, The Myth of Scientific Public Policy, economist Robert Formaini challenges the view that elite experts can evaluate public policy objectively “while remaining neutral on troublesome ethical issues.”
Formaini looks at lessons we should have learned from the 1976 swine flu outbreak. The outbreak began at Fort Dix, New Jersey. The flu outbreak was not unusual; it was winter, and in the close quarters of army barracks, respiratory illnesses and flu were common. Formaini writes, “The outbreak may have passed unnoticed except for a bet between two doctors about the nature of the disease.” Throat cultures were sent to multiple health organizations; the Centers for Disease Control (CDC) found swine flu.
The CDC asked Congress “for a $134 million program to vaccinate virtually every person within the United States.”
Formaini writes, “Private drug companies did not want to make the vaccine unless they were statutorily protected from liability from torts.” Congress granted such protection despite warnings from some such luminaries as polio vaccine pioneer Dr. Albert Sabin. Sabin “castigated the rush to vaccinate everyone and urged that vaccines be stockpiled for ‘high risk’ groups.” Sabin also derided “scare tactics” used to get people to vaccinate.
Within months, a swine flu vaccine was produced and approved. The CDC failed “to alert the public to any serious potential side effects other than a possible case of ‘mild’ flu.” Even a mild flu can lead “to fatal complications” for “high-risk groups.”
Within days, 33 people who received the vaccine died. Health officials refused to acknowledge the connection between the vaccine and the deaths. “Walter Cronkite chastised his media colleagues” for covering the deaths. Vaccinations continued, and an alarming number of Guillain-Barré syndrome cases, a known potentially fatal side effect of flu vaccines, appeared.
Shortly after that, the CDC director resigned, and government shelved the vaccination program.
Formaini raised pointed questions that should be asked again today in the rush for a COVID-19 vaccine. Among those questions were:
- Why did “experts immediately decide” that “universal vaccination was the only option?”
- “Why were the drug companies released from liability if the ‘risks’ were so small?”
- “Why was disengagement so difficult when the program’s consequences began to materialize?”
- “Who ought to have been liable for this policy?”
Today’s experts are like the experts in the 1970s who were full of hubris and overconfidence. Policy analysts who later examined the 1976 swine flu concluded among other things:
- “There was overconfidence by medical specialists in theories ‘spun’ from ‘meager evidence.’”
- “Conclusions were reached ‘fueled by conjunctions’ with pre-existing ‘personal agendas.’”
- “There often was ‘premature commitment’—deciding more than had to be decided.”
- There often was “insufficient questioning of scientific logic and implementation prospects.”
Distorted decision-making was driven by “rent-seeking” by public officials during this crisis where “the heads of bureaucratic departments or agencies,” sought expansion of “their personal empires within the government.”
Reading Formaini, it is easy to see the same mistakes of 1976 repeated in 2020. In his Meditations, Marcus Aurelius observed of politics, “All of this has happened before. And will happen again—the same plot from beginning to end, the identical staging.”
The late biochemist Roger J. Williams is famed for his study of the implications of biochemical individuality. His research explains the importance of understanding that “real people exhibit individuality and in a sense are always exceptional people.” Biochemical individuality explains why, for some, a coronavirus vaccine may help to maintain health; for others, it may prove deadly.
In his essay “Individuality and Its Significance in Human Life” contained in the Liberty Fund book Essays on Individuality, Williams writes: “Concerning the ubiquity of individuality, we can, I believe, accept without danger of contradiction the categorical statement that every human individual (even in the case of identical twins) is distinctive and different.”
Yet, in medicine, often only lip service is paid to individuality. We like “the idea of distinctiveness,” yet, as Williams observes, we are “all the time being ignorant about the character of the differences and perhaps even assuming they are inconsequential.”
Williams explores startling differences in our organs: “Although the textbook picture of the human stomach, for example, is well stereotyped, there are enormous variations in shape and about a sixfold variation in size.” Even the position of the stomach in the body may vary by up to eight inches.
Similar differences in size and position are found in livers and intestines. Should we be surprised, Williams asks, “that people exhibit individuality in their eating?”
Williams explains that “Each individual has a highly characteristic breathing pattern,” and “has a distinctive heart action.”
“Endocrine glands vary widely from individual to individual.” Williams adds that “our entire nervous system is subject to the same wide variation, which is not only anatomic but physiological as well.
If you’re thinking all these differences even out and most people are average, you would be wrong. The chance that we have an average anatomical makeup, according to Williams, is only about one in 1024.
Physiological individuality is also the norm. For example, there are up to “100 fold variations in the taste sensitivity of different individuals for such common substances as sugar [and] salt.” Nutritional needs vary up top fivefold for vitamins, minerals, and amino acids.
In short, Williams writes, “Whether we consider heart action, brain waves, circulation, breathing, the endocrine functions, the blood, temperature regulation, or a multitude of other facets of physiology, the story is the same—abundant evidence of individuality involving differences of great magnitude.”
Biochemical individuality has great significance for the administration of drugs or vaccines. Since body chemistries differ among individuals, reactions to pharmaceuticals also differ.
According to Williams, “Some specific chemical reactions may be taking place 10 times as fast in one individual as in another.” Consider that “Using objective tests 10.5 percent were intoxicated when the alcohol blood level was 0.05 percent, whereas 6.7 percent were sober when the alcohol blood level was eight times this high or 0.4 percent.”
There is no “normal man” for which a particular reaction is guaranteed.
Williams emphatically rejects the assumption of “every recognized treatise in the fields of biochemistry, physiology, pharmacology, and physiological psychology… that normal man, the prototype of all humanity, is the primary if not the exclusive object of study—he, above all is to be fathomed and understood.”
Caution is warranted. Previous attempts to develop “SARS coronavirus vaccines” led to “pulmonary” issues in animal testing. Vaccines against respiratory syncytial virus (RSV) led to enhanced disease response among infants and toddlers. “Frequent hospitalization” was the result; an unacceptable result since RSV illnesses are usually mild. Despite “expert” assurances to the contrary, medical research suggests receiving a flu vaccination “may increase the risk of other respiratory viruses, a phenomenon known as virus interference.”
The Greater Good?
Some might say, yes, mandatory vaccines may harm some, but the greater goal of protecting public health is worth the price. This “greater good” mindset led to the famed New York Times correspondent Walter Duranty covering up Stalin’s atrocities. Duranty was fond of saying, “You can’t make an omelet without breaking a few eggs.”
Immunization levels thought to generate herd immunity, “magic numbers,” have never been proven as public health historian James Colgrove reports in his book State of Immunity: The Politics of Vaccination in Twentieth-Century America.
In 2009, during another swine flu outbreak, in their essay, “Does the Vaccine Matter?” Shannon Brownlee and Jeanne Lenzer report of doctors challenging the medical orthodoxy about flu vaccines and antivirals. They provided evidence that “flu vaccines do not protect people from dying—particularly the elderly, who account for 90 percent of deaths from seasonal flu.”
Vaccination may have unintended psychological consequences as well. Brownlee and Lenzer observe a connection between vaccinating and “breeding feelings of invulnerability, and leading some people to ignore simple measures like better-than-normal hygiene, staying away from those who are sick, and staying home when they feel ill.” Feelings of invulnerability lead people to eschew responsibility and become potential breeding grounds for disease.
Nothing we can do will guarantee health, but there are steps we can take that tilt the odds in our favor. Sugar-laden diets suppress the immunological system, while exercise boosts it. This year, the average American will eat nearly 200 pounds of disease-promoting sugar and corn syrup and will consume only about 6 pounds of disease-fighting broccoli and a mere “2 to 3 cups of kale every year — one of the healthiest foods on the planet.”
Biochemical individuality explains why, for some, a coronavirus vaccine may help to maintain health; for others, it may prove deadly. Biochemical individuality also explains why there is no one best way to a healthy immune system. Some thrive on keto diets, while others thrive on vegan diets. Others seek a middle ground in a Mediterranean diet.
For some, perhaps those in crowded urban environments, taking a COVID-19 vaccine may seem like a wise choice. Individuals choosing to be vaccinated deserve the safest possible vaccine, a vaccine for which insurance companies insuring vaccine manufacturers will provide liability protection.
For those who wish to avoid a COVID-19 vaccine, fundamental natural rights guarantee that freedom. No individual should be forcibly injected with a vaccine because of policy mandates from self-interested and zealous “expert” decision-makers.
Williams is clear: “Among the myriad of potentialities with which every individual is born, there still are an infinite number of possibilities of development—provided this ability to order one’s own life exists.” “In medicine,” Williams writes, “recognition of the scope and importance of individuality is indispensable to progress.”
For a central planner, individuality is a meaningless idea. Central planners will ignore Williams’s admonition at our peril.
This article was reprinted with the author’s permission. It was originally published by the American Institute for Economic Research (AIER). Barry Brownstein is professor emeritus of economics and leadership at the University of Baltimore. He is senior contributor at Intellectual Takeout and the author of The Inner-Work of Leadership.
Note: This commentary provides referenced information and perspective on a topic related to vaccine science, policy, law or ethics being discussed in public forums and by U.S. lawmakers. The websites of the U.S. Department of Health and Human Services (DHHS) provide information and perspective of federal agencies responsible for vaccine research, development, regulation and policymaking.