Why Informed Consent Matters in the 21st Century – NVIC Newsletter

By Barbara Loe Fisher

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Since I was asked to make a presentation about vaccine exemptions in 1997 at the Department of Health and Human Services in Washington, D.C., I have publicly defended the informed consent principle, which was defined as a human right at the Doctors Trial at Nuremberg in 1947. 1  Informed consent means you have the right to be fully informed about the benefits and risks of a medical intervention and the freedom to make a voluntary decision about whether or not to accept those risks without being coerced or punished for the decision you make.  Informed consent applies not just to risks taken by participants in scientific experiments, but also to risks taken by patients under the care of physicians. 2 3 4 5

Informed Consent Principle Applies to All Medical Risk-Taking

Today, when a person publicly advocates for informed consent protections in vaccine laws, an “anti-vaccine” label is usually immediately applied to shut down any further conversation. 6 7 Perhaps because a conversation about ethics opens up a wider conversation about freedom.

The right and responsibility for making a decision about risk taking rightly belongs to the person taking the risk.  When you become informed and think rationally about a risk that you or your minor child may take – and then follow your conscience – you own that decision. And when you own it, you can defend it. And once you can defend it, you will be ready to do whatever it takes to fight for your freedom to make it, no matter who tries to prevent you from doing that.

Never Do Anything Against Conscience

Albert Einstein, who risked arrest in Germany in the 1930’s when he spoke out against censorship and persecution of minorities, said, “Never do anything against conscience even if the State demands it.” 8

There is no liberty more fundamentally a natural, inalienable right than the freedom to think independently and follow our conscience when choosing what we are willing to risk our life or our child’s life for.

Because the journey we take on this earth is defined by the choices we make. If we are not free to make choices, the journey is not our own. The choices we make that involve risk of harm to our physical body, which houses our mind and spirit, those are among the most profound choices we make in this life.

Vaccine Risks Not Being Borne Equally By Everyone in Society

So, vaccination must remain a choice because it is a medical intervention performed on the body of a healthy person that carries a risk of injury or death. 9 10 And while we are all born equal, with equal rights under the law, we are not born all the same. Each one of us is born with different genes and a unique microbiome influenced by epigenetics that affects how we respond to the environments we live in. 11 12

We do not all respond the same way to pharmaceutical products like vaccines, so vaccine risks are not being borne equally by everyone in society.

Why should the lives of those vulnerable to vaccine complications be valued any less than those vulnerable to complications of infections? And why should people not be free to choose to stay healthy in ways that pose far fewer risks?    

Vaccines Carry Risks and Do Not Guarantee Protection

The act of vaccination involves the deliberate introduction of killed live attenuated or genetically engineered microbes into the body of a healthy person, along with varying amounts of chemicals, metals, human and animal RNA and DNA and other ingredients 13 that atypically manipulate the immune system to mount an inflammatory response that stimulates artificial immunity. 14

But there is no guarantee that vaccination will not compromise biological integrity or cause the death of a healthy or vaccine vulnerable person either immediately or in the future. There is also no guarantee that vaccination will protect a person from getting an infection with or without symptoms and transmitting it to others. 15

Vaccine Science Gaps, Doctors Cannot Predict Who Will React

Reports published by physician committees at the Institute of Medicine confirm that vaccines, like infections, can injure and kill people but that:

• very little is known about how vaccines or microbes act at the cellular and molecular level in the human body; 16 17 18 and
• the Institute of Medicine confirms that an unknown number of us have certain genetic, biological and environmental susceptibilities that make us more vulnerable to being harmed by vaccines, but doctors cannot accurately predict who we are; 19 20 and
• that clinical trials of experimental vaccines are too small to detect serious reactions before they are licensed; 21 22 and
• that the U.S. recommended child vaccine schedule through age six has not been adequately studied to rule out an association with allergies, autoimmunity, learning and behavior disorders, seizures, autism and other brain and immune dysfunction. 23

Yet, with these large gaps in scientific knowledge, government health officials direct physicians to vaccinate 99.99 percent of children regardless of known or unknown risks. 2425

Government Licensed Vaccines “Unavoidably Unsafe”

Therefore, vaccination is a medical procedure that can be termed experimental each time it is performed on a person. By extension, “no exceptions” mandatory vaccination laws create a de facto uncontrolled, population based scientific experiment that enrolls every child at birth and never ends, sacrificing an unknown number of vaccine vulnerable children.

Further, the US Congress and Supreme Court have declared federally licensed vaccines to be “unavoidably unsafe,” removing civil liability from doctors who give vaccines and drug companies that sell vaccines in what has become a very lucrative multi-billion dollar business in the U.S. 26 27 At the same time, the federal vaccine injury compensation program created by Congress in 1986 that was supposed to be a no-fault alternative to a lawsuit – not instead of a lawsuit – has been gutted by federal agencies so that, today, almost no child receives compensation when they are hurt by vaccines. 28

Now, a global vaccine injury compensation program is being created to shield multinational corporations from liability for injuries caused by the hundreds of new genetically engineered vaccines governments will mandate in the future. 29 30 31 32 33 34

All this, while medical trade groups affiliated with industry and government join forces to lobby for removal of flexible medical, conscientious and religious belief exemptions from state health laws, 35 as was done in California in 2015, 36 so that those who refuse government endorsed vaccines for themselves or their minor children can be denied an education, employment, health care and other civil rights.

Utilitarianism Should Not Be Foundation of Public Health Law

In 1996, when I was in the Holocaust Museum in Washington, D.C. attending a conference on the role of physicians and scientists implementing public health policy during the Third Reich, I looked up and saw an inscription that took my breath away. It said, “the first to perish were the children…from these a new dawn might have risen.”

This commentary, which I originally presented in March 2017 at the inaugural meeting of Physicians for Informed Consent in California, 37 is dedicated to mothers and fathers, whose children died or became brain injured when the risks of vaccination turned out to be 100 percent.

I am arguing that the consequentialist theory of utilitarianism 38 39 40 is a pseudo-ethic that must be rejected as the moral foundation of public health policy and law so it can be replaced with a compassionate ethic grounded in respect for the human right to autonomy and informed consent to medical risk taking, including vaccine risk taking.

Pediatrician Censored for Reporting Infant Deaths After DPT Shots

I remember the day in the spring of 1982, when I was a young mother with a four year-old son struggling with the effects of a serious DPT vaccine reaction. I had just seen the NBC television documentary DPT: Vaccine Roulette 41 and was networking with parents of DPT vaccine injured children in the Washington, D.C. area when I decided to attend a press conference at the American Academy of Neurology to hear a young pediatric neurologist talk about his study in which two thirds of the babies, whose deaths were classified sudden infant death syndrome, had died within three weeks of a DPT shot.

This pediatrician was concerned that DPT vaccine may be a major unrecognized cause of early childhood death, including SIDS, and he suggested that more research be done. As soon as he finished, his physician colleagues launched a vicious attack on his professional expertise and personal integrity that left him physically trembling in a cold sweat. I had never seen anything like it.

During the break, I was approached by a PhD scientist who, at the time, worked for the National Academy of Sciences. This scientist asked me why I was there and I told him I wanted to know more about DPT vaccine because, when I was taking my baby to be vaccinated, I had no idea that vaccines – which were supposed to keep children healthy – could actually kill them.

He got this quizzical look on his face and said something to the effect that it only happens once in a million kids. And instinctively I said, but if a vaccine kills even one, how can all children be legally required to get it? He looked surprised, uncomfortable, and walked away mumbling something about vaccine benefits far outweigh the risks, and sometimes we have to make sacrifices for the greater good. 

And I thought to myself, but the benefits didn’t outweigh the risks for my child or for the babies who died after DPT shots in the study that young doctor tried to talk about before he was figuratively lynched for suggesting that DPT vaccine benefits might not outweigh the risks.

And why was my child’s health sacrificed without my knowledge or permission, and what is “the good” that is made greater by child sacrifice, and who defines it as “good”?

Playing DPT Vaccine Roulette with My Son’s Life

When I became a Mom in 1978, my son, Chris, was the light of my life. Happy, healthy and precocious, he was saying words at seven months,

speaking in full sentences by age two and identifying words in the books we read together every day. One doctor told me he was cognitively gifted.

But everything changed in 1980 when, within hours of his fourth DTP shot, I witnessed the eyes of my two and a half year old son roll back in his head and his head fall to his shoulder as if he had fallen asleep sitting up. I carried him, pale and limp, to his bed, where he did not move for hours. I thought to myself, oh, he is tired and just taking a really long nap, or maybe he is coming down with a cold.

And when I finally was able to wake him but he couldn’t sit up or walk or speak coherently, when he had terrible diarrhea and only stayed conscious for a few minutes before falling into 12 more hours of deep sleep, I did not understand that I had witnessed a classic post-DPT vaccine convulsion and  “hypotonic/hyporesponsive reaction and brain inflammation. 42 43 44 45  Chris was not just taking a really long nap, he was unconscious in his bed and could have died that day.

Image credit Lea Thompson, WRC-TV, Washington D.C. 1982

I did not know because my pediatrician had told me nothing about how to recognize a vaccine reaction, including symptoms of encephalitis – brain inflammation that has been a well-documented complication of vaccination for two centuries. 46 47 48 49 I did not know that the unusual local reaction after his third DPT shot was a warning sign or that our family history of severe allergies and autoimmune disorders could increase vaccine risks.  50 51 52 53 54 55 56

Even though I came from a family of doctors and nurses, had a college degree and had worked at a teaching hospital – like most parents back then I believed that vaccines were 100 percent safe and effective.

And in the following days and weeks, when Chris could no longer concentrate or do what we could do before, when his personality changed and he was constantly sick with ear and respiratory infections, diarrhea, new food allergies and severe weight loss, my family and I could not understand why Chris had regressed physically, mentally and emotionally and become a totally different child. His doctors told us there was no explanation and said I should take him home and love him.

Eighteen months later, when I, and millions of other parents in America, watched the Emmy award winning “DPT Vaccine Roulette,” 57 I called the TV station and asked if I could have copies of the medical literature used to anchor the documentary.

 And it was in my living room as I read case history descriptions of DPT vaccine injury and death in the pages of Pediatrics 58 59 60 and the British Medical Journal 61 62 63 and New England Journal of Medicine 64 that exactly matched the symptoms of brain inflammation I witnessed my son suffer that day, it was then I knew that physicians had been talking in medical journals for more than 50 years about the fact that pertussis vaccine could brain damage children, but no one had informed the mothers dutifully bringing their children for DPT shots legally required to go to school.

As I tried to help my son cope with multiple learning disabilities that included dyslexia, fine and gross motor skill delay, auditory processing and attention deficit, and short term memory delays so severe they confined him to a special ed classroom throughout his public school education, and as I interviewed hundreds of mothers for the book DPT: A Shot in the Dark, I came to know many families whose children had died or were much more severely vaccine injured than my child. 65 66

Chris has worked hard to compensate for his learning disabilities and he is a productive member of society today; but many vaccine injured children, tragically, are not. 67

My son is among the walked wounded in what has become an unprecedented and still unexplained chronic disease and disability epidemic now plaguing millions of children and young adults in America. 68 It is an epidemic of learning disabilities, ADHD, asthma, seizures, autism, diabetes, depression, and other types of brain and immune dysfunction marked by chronic inflammation in the body that has perfectly coincided with the tripling of the numbers of vaccines given to children – from 23 doses of seven vaccines starting at two months through age six in the early 1980s – to the current 69 doses of 16 vaccines starting on the day of birth with 50 doses given before age six. 69 70

In 1982, it was my curiosity about the truth of the matter that pushed me to research the science, policy, law, ethics, history and politics of vaccination and spend two decades participating in public engagement projects at the Institute of Medicine and Department of Health and Human Services, where I served as a consumer member on vaccine advisory committees at the FDA and CDC, 71 a journey that has now spanned half my life.

So, I offer you my perspective from that vantage point.

Philosophy: Love of Wisdom

Here we are in the 21st century, where the electronic communications revolution has created a virtual global public square on the World Wide Web,

where more than three billion people are talking to – and sometimes yelling at – each other about ideas, values and beliefs, just like they did in the public squares of ancient Athens and Rome, and in universities, newspapers, and on radio and television since then.

Throughout recorded history, people have disagreed with each other about how to answer big questions, like:

• Where do we come from?
• Are we only physical matter or do we have an immortal soul, a consciousness that survives physical death?
• What is truth and how can we know it?
• What is ethical behavior and how can we define it?

Most of the formal debates about these questions have been described in the history of philosophy, 72 which the ancient Greeks defined as “love of wisdom,” that included study of knowledge; reasoning; nature of being or metaphysics; aesthetics; and ethics.

The philosophy of science emerged as a separate discipline in the 18th and 19h centuries after mathematicians and astronomers mounted a successful challenge to the authority of organized religion.

Science Now Dominates, Affect Cultural Values & Laws

Since then, science has invaded and dominated every other branch of philosophy. As we are reminded every day in so many ways, science and math rule, and scientific evidence determines what is true and what is not. In fact, those who practice and submit to the authority of science insist that not only must science be used to define all truth, but leaders in science and medicine are authorities who should define “the good,” that is, define moral behavior and what kind of cultural values we should have, and what kind of beliefs we should be allowed to hold and teach our children, and what kind of laws should be passed in order to limit the ability of individuals to make “unscientific” choices that presumably endanger the public health and welfare. 73

That’s a whole lot of pressure for many physicians, who do not want to be put on a pedestal and required to exercise that kind of authority over the lives of fellow human beings because – first and foremost – it interferes with developing a relationship with patients based on mutual respect, trust and shared decision making.

But, the stark reality is that the scientification of every branch of philosophy has elevated prominent scientists and physicians promoting “consensus science” into positions of authority, whose judgment should never be questioned. Long held cultural values, such as respect for freedom of thought, speech, conscience and religious belief are being called into question, which, in turn, affects court decisions and the making of laws.

No where is this more visible than in public health law using the materialist philosophy of utilitarianism to legally require all Americans to use an increasing number of vaccines without their voluntary informed consent.

So how did we get here? How did science come to dominate how we define what is true and good for the individual and society in the 21st century?

Old Arguments About What Is True and Good

Although conversations about the meaning of life and what is good started before written history and is embedded in tenets of five surviving major religions – Hinduism, Buddhism, Islam, Judaism, and Christianity – it was the classical Greek philosophers who began recording the debate.  

Socrates, Plato and Aristotle believed that we are physical matter animated by a vital spirit, and we can use innate knowledge and reason to perceive what is good.

Epicurus disagreed and said humans are only physical matter and have no spirit or innate knowledge and that seeking pleasure and avoiding pain is the highest good and guide to moral behavior.

For 1500 years following the birth of Christ, the highest good was defined as knowing and loving God in western cultures adopting Judeo-Christian moral values –  until the Scientific Revolution when 15th and 16th century scientists Copernicus, Galileo, Newton and Francis Bacon developed methods for determining what is true that put the existence of God on trial, along with the definition of what is good.

Although between the 16th and 19th centuries, Descartes, Locke, Kant, Hegel and other philosophers argued that humans are both physical matter and spirit and can use reason to understand scientific truth, as well as to perceive the natural law that serves as a guide to what is good, the materialist philosophers Hobbes, Hume, Bentham, Comte, Marx and Nietzsche argued that science proves there is no God or human spirit because we are only physical matter, and there are no absolute moral values but, rather, science can be used to define what is true and good.   

This included the idea that a mathematical equation can be used to judge whether or not an individual action, government policy or law is moral.

The authors of the U.S. Declaration of Independence agreed with the philosophers who argued that humans have a physical body animated by a soul or spirit, and that we can use reason given to us by God to perceive the natural law, which includes natural rights, that belong to all individuals and limit the authority of government.

The Bill of Rights in the US Constitution contains strong language protecting exercise of natural rights. 74 These have been defined internationally as human rights, including freedom of thought, speech, conscience and religious belief.  75 76

Utilitarianism: Mathematics, Vaccination & Public Health Rising 

But today, it is not respect for natural rights that guides public health policy in the U.S., it is the philosophy of utilitarianism, created by Jeremy Bentham, a 19th century British attorney and social reformer. 77 78 Bentham mocked the U.S. Constitution for mentioning God and affirming natural rights protected in the First Amendment.

Like Comte, Marx and Nietzsche who followed him, Bentham did not believe that man has a soul or innate intelligence, so he returned to the hedonistic Epicurean philosophy of maximizing pleasure and minimizing pain to define what is good.

Bentham’s utilitarianism uses a mathematical equation that judges the rightness or wrongness of an action by its consequences. Bentham said that an action is only moral or ethical if it results in the greatest happiness for the greatest number of people. With its emphasis on numbers of people, Bentham created utilitarianism primarily as a guide to state legislative policy, and vaccine cost-benefit analyses are rooted in utilitarianism.

Bentham was a contemporary of British physician Edward Jenner, who took pus from a cowpox lesion and scratched it onto the arm of a young boy in an effort to prevent smallpox. Jenner’s experiment, repeated over and over again in lots of people, created a live human-cow hybrid virus called vaccinia. 79

The new chemical industry took that vaccinia virus, added some chemicals and bottled it, selling it to doctors and governments. The mass smallpox vaccine campaigns that followed expanded the authority of a new branch of medicine focusing on population-based disease control, called public health. 80

19th century physicians were enlisted by government to give infants and children smallpox vaccine and were persuaded to look the other way when some of them died or were left permanently disabled after developing raging vaccinia virus infections and inflammation of the brain. Fully embracing the utilitarian rationale, public health officials viewed individual smallpox vaccine casualties as necessary losses to achieve the greatest good for the greatest number of people.

Utilitarianism Codified Into US Law: Jacobson v. Massachusetts (1905)

At the turn of the 20th century, utilitarianism was fashionable in intellectual and political circles. It was the philosophical argument used by attorneys in 1905 to persuade the U.S. Supreme Court to issue a utilitarian ruling in Jacobson vs. Massachusetts. 81

Lutheran Pastor Henning Jacobsen and his son had suffered severe reactions to previous smallpox vaccinations and Jacobsen argued that genetic predisposition placed him at high risk for dying or being injured if he was forced to get revaccinated. The court dismissed Jacobsen’s concern for his own health and life.

In a split decision with one dissenting vote, the Court that included Oliver Wendell Holmes, issued an opinion that would affirm the legal right for U.S. state legislatures to assign police powers to public health officials to restrict or eliminate individual liberty in order to “secure the general comfort, health and prosperity of the state.” 82

The Court maintained that all citizens can be compelled to receive smallpox vaccinations because the happiness and welfare of the majority outweighs the happiness and welfare of a minority. In other words, individual human sacrifice is ethical and legal if it is done for the common good.

Georgetown law professor and mandatory vaccination proponent Lawrence Gusting has described it as the most important Supreme Court opinion in the history of American public health law. 83

Eugenics: Eradicating the “Unfit” in Buck v. Bell (1927)

In 1927,