No grievance regarding vaccines is more serious than vaccine-injury. A mere possibility of vaccine-injury is insidious: what is meant to be a prophylactic life-saving procedure performed on a healthy recipient may end in his or her serious injury or death.
As pediatrician Dr. Robert Sears discussed in a public talk, the very idea of vaccine-injury is a hard one for doctors and public health specialists to accept, therefore, out of a need to protect their collective ego identity, the default position of the medical profession is denial of vaccine-injury.
It’s easy for medicine and public health to remain silent about or minimize the perception of vaccine injury. War metaphors in public health lead to the implicit acceptance of vaccine-injury as acceptable collateral in dealing in the war against infectious disease.
A hush-hush approach is the norm where it is not professionally acceptable for a public health official or doctor to acknowledge or discuss the reality of vaccine injury (and those who do are quickly disowned by their peers and professional organizations). A utilitarian argument is used to justify this course of action: more lives are saved than are lost so it’s not my problem, let the vaccine court deal with vaccine-injury.
Dismissing the vaccine-injured: collateral damage and vaccine fundamentalism
First and foremost, vaccine-injury is indeed real. It has been a real phenomenon since the inception of vaccination. Severe allergic reaction was recognized as an adverse effect to smallpox vaccination by scientist Clemens Peter Freihher von Pirquet and American pediatrician Bela Schic in 1906. It was real when in 1955 Cutter Laboratories released 120,000+ doses of polio vaccine that contained live polio, resulting in 100+ cases of polio paralysis and 5 deaths.
And it continues to be real to this day with the United States Vaccine Injury Compensation Program, a program run by the federal government which compensates those injured by vaccines. So far the program has paid out over 4 billion dollars.
Vaccine-injury is the dirty laundry of vaccine fundamentalism. The public health authorities' approach to vaccine-injury is a two-faced one. While it acknowledges that vaccine-injury can happen, in the very same breath, it proclaims vaccine injury is very rare and then goes on to make the claim that vaccines are safe and effective. The same doctors tasked with giving vaccines parrot the same talking points, many of which are developed by the public health agencies.
The premise of vaccine fundamentalism is thus: if vaccines are the way to win the war on infectious diseases, then vaccines themselves are too important to be deterred by the collateral damage of possibly infrequent vaccine injury. An emphasis to win the war would naturally lead to a competitive strategy where the means are developed to hide the extent of vaccine injury and to limit the liability resulting from those injuries.
The National Childhood Vaccine Injury Act of 1986 was this means. It had a number of important effects: 1) it created the Vaccine Adverse Events Reporting System (VAERS) which allowed individuals and healthcare professionals to report vaccine injury; 2) it created the vaccine court which is administered through the Department of Justice as a way to compensate those who have experienced vaccine injury; and 3) it provided liability protection to the childhood vaccine manufacturers for vaccine-injury.
While the Act created the means for reporting and compensating vaccine-injury, it did not create the impetus for public health officials nor vaccine manufacturers to investigate claims of vaccine-injury. Even when repeated injuries are observed time and time again, there is no research impetus to investigate the etiology behind why these injuries are occurring. After all, how is criticism possible when you have deprived your naysayers of good complete data, with which they could prove their case?
The war metaphor and vaccine fundamentalism lead to plausible deniability and lackluster in safety investigation as the default strategies for defending the public health agency’s vaccine program. The vaccine safety organization ICAN filed a lawsuit against the Department of Health and Human Services, to find out whether or not HHS has performed the biennial vaccine program safety oversight that they were required to do by the 1986 Act, which HHS has apparently failed to do for more than 30 years
Ironically, the granting of liability protection led to perverse incentives to increase the number of vaccines on the CDC schedule and to decrease the emphasis on vaccine safety. The 1990s saw a rapid increase in vaccine uptake and the expansion of the vaccine schedule starting with the Hepatitis B vaccine in 1991 and a startling rise in childhood chronic illnesses, including autism. Public health officials argue this concomitant rise is coincidental and that no strong evidence exists to tie the rise to increased vaccines. But how can evidence be found (apart from numerous personal accounts of vaccine injury and epidemiologic trends) when the very public health agencies tasked with the investigation of etiology are refusing to investigate it?
To further compound the collateral damage done to individuals and families of vaccine-injury, the vaccine-injured person or his or her family must be the ones to prove the vaccine injury. They are left to seek expert testimony in an area with already stifled research and negative peer-pressure for such professionals to serve as expert witnesses. This is difficult for a middle-class family with working and financial obligations and who likely does not have a background in medicine.
By using the strategy of shifting the burden of proof, public health authorities are able to make the claim that most alleged vaccine injuries are anecdotal and coincidental. This would include vaccine court cases that do not lead to an award, self-reported reports to VAERS and parental concerns of a post-vaccination observation of uncontrollable crying for multiple hours. These observations are dismissed using negative language that include use of descriptions such as anecdotal, correlation without causation, or lacking in evidence.
The only vaccine-injuries seemingly recognized by public health authorities are those that have led to a compensation award from the vaccine court. The likely cases of vaccine injury is potentially much, much higher. Looking at the vaccine court statistics, from the period of 1998 until 2017, there were 1,200 claims filed for death and around 18,000 filed for injury. Only a small minority of vaccine injuries are tried in the vaccine courts. Various analysis of the vaccine courts (here and here) have shown them to be adversarial to those seeking compensation for vaccine-injury.
This leads to a systematic bias that deliberately undercounts the number of vaccine-injury cases. The actual number of vaccine injuries is likely to be much, much higher. An analysis done by author JB Handley, in his book “How to End the Autism Epidemic,” reveals a damning picture:
“In 2016, VAERS received 59,117 reports of vaccine adverse events including 432 deaths and 10,384 emergency visits. If those 59,117 reports were 1 percent of the actual total, that would imply there had actually been 5.9 million reportable adverse events from vaccines in a single year.”
Evidence suggests vaccine injuries are known by health officials to be underreported. A CDC-funded study “Electronic Support for Public Health–Vaccine Adverse Event Reporting System” done in 2007 by Harvard Pilgrim Health Care estimated that fewer than <1% of vaccine injuries are reported to VAERS.
War metaphors in public health and vaccine fundamentalism have led to a situation where the vaccine-injured individuals and families are themselves seen as enemies by the very public health systems that are meant to serve them. There are four injustices at play here: 1) the vaccine injury itself; 2) the denial by the public health systems of vaccine injury; 3) the adversarial nature of the government compensation system; and 4) the larger denial by society at large. Public health as a whole can do better from an ethical standpoint.
The ends justifies the means: ignoring conflicts of interests
In the drive to win a war on infectious diseases, resources need to be mobilized but an important overlooked question is: Who benefits from the policies being promulgated? One need not look far to realize that the vaccines market is a very financially lucrative market. A financial estimate reported by Bloomberg reports that the vaccine market is worth $58.4 billion. The Moderna CEO claimed that the COVID-19 vaccine alone could bring in $2 billion to $5 billion in peak annual sales for the company.
In the United States, the CDC Advisory Committee on Immunization Practices(ACIP) has the task of deciding what vaccines should be added and removed from the schedule. Their decisions carry considerable weight for both citizens who take the vaccines and the vaccine manufacturers who benefit from the captive market created by government mandates.
There is evidence that the CDC ACIP might be compromised by conflicts of interests with industry. A 2000 report by the US House of Representatives Committee on Government Reform reported:
“Members of the advisory committees are required to disclose any financial conflicts of interest and recuse themselves from participating in decisions in which they have an interest. The Committee's investigation has determined that conflict of interest rules employed by the FDA and the CDC have been weak, enforcement has been lax and committee members with substantial ties to pharmaceutical companies have been given waivers to participate in committee proceedings.”
Another report in 2009 by the Department of Health and Human Services reported serious ethical violations at the CDC. According to the NY Times reporting:
“The report found that 64 percent of the advisers had potential conflicts of interest that were never identified or were left unresolved by the centers. Thirteen percent failed to have an appropriate conflicts form on file at the agency at all, which should have barred their participation in the meetings entirely, Mr. Levinson found. And 3 percent voted on matters that ethics officers had already barred them from considering.”
In 2015, the British Medical Journal reported that:
“…the CDC does receive millions of dollars in industry gifts and funding, both directly and indirectly and several recent CDC actions and recommendations have raised questions about the science it cites, the clinical guidelines it promotes and the money it is taking.”
Vaccine fundamentalism has led to a situation where public health agencies do not adequately police themselves regarding conflicts of interest. If the goal is to win a war then the need to remove decision-making bias and to prevent regulatory capture takes a backseat thereby allowing entities who have huge money at stake on the outcome to improperly influence the outcome.
Does more vaccines equal better health? Is public health succeeding?
The question of whether public health is succeeding is fundamental because so much investment and effort has gone into vaccination at the expense of other lines of possible public health endeavors.
Public health agencies proudly proclaim vaccines as one of the greatest public health achievements of all time, boasting of the eradication of smallpox, elimination of polio and measles in the Americas and controlling incidence of a wide list of other infectious diseases. In the 19th century, infectious disease was rampant and deaths from such diseases were common.
Public health rightfully deserves the accolades for the fact now that infectious disease death is relatively rare. An examination of infectious diseases mortality done in JAMA reported the following:
“Infectious disease mortality declined during the first 8 decades of the 20th century from 797 deaths per 100,000 in 1900 to 36 deaths per 100,000 in 1980 … From 1938 to 1952, the decline was particularly rapid, with mortality decreasing 8.2% per year.”
The problem with vaccine fundamentalism lies in attributing the victory against infectious disease mortality solely to vaccination. The 8.2% per year decline in infectious deaths is telling because the effect is so large that it cannot be attributed to vaccination. In fact, this period of 1938 to 1952 is prior to the modern vaccination program. Other effects in the populace including better standards of living, clean air and clean water bear significant attribution for the above effect.
Vaccine fundamentalism leads to a revisionary history that over-emphasizes the role of vaccination thus leading to an overstatement of benefits. It is important to note that the mortality rates from infectious diseases dropped by over 90% prior to the beginning of the modern vaccination program with the development of the measles vaccine in 1963.
There is the larger question as to whether more vaccines leads to better health. The United States has one of the most aggressive vaccination schedules in the world. From birth to the age of 18, children receive over 68 doses from the full CDC recommended schedule. During the 1990s there was a tripling of the childhood vaccine schedule. Did the American populace accordingly achieve a tripling in health outcomes in the following decades?
A 2013 National Academy of Sciences report found that Americans live shorter lives and overall worse health than their counterparts in an analysis of 17 other countries. In a PBS interview, Dr. Steven H. Woolf, chair of the committee that wrote the report stated:
“The U.S. is doing worse than these other countries both in terms of life expectancy and health throughout their entire lives…The U.S. has been falling behind other high-income countries since 1980, with the trend showing continuing deterioration regardless of administration or social reform policies.”
A reversal is needed in the course of public health direction. Vaccine fundamentalism has led to the paradigm of more is better in public health, a policy which appears to have diminishing returns. Public health officials seem to embody the mindset that if it worked as a strategy in the past then certainly we just need to do more of it. This mindset is inadequate as we go forward into the 21st century.
Moving beyond vaccine fundamentalism: a new ecology for health
In the urgency to deal with the COVID-19 pandemic, public health seems to be running more and more quickly towards a cliff and exacerbating the problems above. The public health agencies pin their hopes on a COVID-19 vaccine and drive heavy responses to minimize incidence, including banning travel, barring children from schools, barring adults from work, etc. unless an individual has received the COVID-19 vaccine. But this approach is not working.
Public health has failed to account for the harms caused by its COVID-19 responses and this speaks to the great failures of reductionism and vaccine fundamentalism. Reductionism cannot capture the numerous facets of health that exist in a dynamic interplay between the individual, their genes and their environment.
On a biological level, new research indicates that the immune system works as a dynamic interplay between multiple systems: the innate system, the adaptive system, the interferon system, the microbiome and the nervous system. We ourselves are a complex ecosystem of human cells, bacteria in our microbiome and endemic viruses in our virome. This leads to the necessary conclusion: vaccine fundamentalism is an antiquated strategy for actual health.
But cannot replace one fundamentalism with another one. Public health needs to move beyond the fundamentalism paradigm in which public health is reduced to singular metrics and embrace a paradigm that is inclusive of a larger vision of what constitutes health.
Public health needs a new way of thinking that puts human dignity at the forefront instead of viewing the people who we are supposed to protect as mere vectors of disease. Individual choice, informed consent and free will are shunted as delusions that must be dealt with in order to win the war. To regain the trust of the public, public health must give up on the war mentality. The sustainable path is one in which public health is on equal footing with the individual as opposed to tyrannical dominance.
It’s time to give up vaccine fundamentalism and its war mentality. We need public health to wake up from the spell of vaccine fundamentalism and the war metaphors it pursues in its implementation. It is an insufficient paradigm from a previous time and it needs to be replaced with something else.
Health for both individuals and society is multi-faceted and exists in a greater ecosystem. We are both affected by microbes and our genes, but also by our environment, our choices, our cultural mores, our psychological states and our subjective assessments of our own well-being. Public health metrics should encompass these facts.
Let public health actually measure and drive actual health instead of mere vaccine uptake rate.
Nate Doromal is an activist and writer within the Vaccine Awareness and Vaccine Safety movement. He is a veteran software engineer, formerly with Google, who now works in finance. He holds an MS and an MBA in Computer Science from the University of Chicago. He holds an Executive MBA from the Smartly Institute. He was originally trained on vaccines and vaccine activism by Dr. Sherri Tenpenny in her Mastering Vaccine Info Bootcamp. He has also studied immunological science extensively with Dr. Tetyana Obukhanych through her Building Bridges Course.