How Public Vaccine Policy Violates Our Right to Informed Consent

Public vaccine policy treats the entire population as subjects of a mass uncontrolled experiment without their informed consent.

In the mainstream discourse about the subject of vaccines, one issue that is never directly raised is the right to informed consent. This right is one of the most fundamental ethics in medicine, and yet the government and media treat it as uniquely irrelevant when it comes to this one particular pharmaceutical product. The reality is that public vaccine policy subjects the entire population to a mass uncontrolled experiment, and legislation mandating their consumption constitutes a serious threat to both our health and our liberty. The major corporate media, for their part, have chosen to take on the role, in dutiful service to the state, of policy advocacy rather than journalism.

So let’s remedy that failure by taking a serious look at public vaccine policy in the context of the right to informed consent. (While focusing primarily on the US population, the information that follows also bears relevancy for other countries.)

The Inadequacy of Pre-Licensure Safety Trials

We’re supposed to believe that somehow the science is “settled” on vaccines. But that belief is preposterous. The reality is that there is endless debate and controversy about vaccines in the medical literature. The major corporate media don’t even begin to scratch the surface in their reporting on vaccines. There are countless serious issues related to vaccination that the public have no idea about because health officials and the media refuse to even touch them. The news media just repeat the same routine talking points in virtually every broadcast or article on the subject, spitting out misinformative propaganda instead of educational content.

One thing most people don’t know about vaccines—because they are told neither by public health officials, nor by the major media, nor by pediatricians or others working within the medical establishment—is that they aren’t held to the same standard as other pharmaceutical drugs when it comes to safety. We’re supposed to believe as gospel truth that vaccines recommended by the US Centers for Disease Control and Prevention (CDC) have been extensively studied and proven safe and effective. But that’s just not true. In fact, one significant difference between how the US Food and Drug Administration (FDA) regulates vaccines versus other drugs is that pharmaceutical companies are not actually required to conduct long-term, randomized, placebo-controlled studies to demonstrate their vaccine products’ safety for use in human populations.

Nor do they do so. This can be seen simply by going to the FDA’s website and examining the manufacturers’ package inserts for vaccines licensed for use in the US market.

These inserts are required by law to disclose adequate warnings to consumers about the benefits and risks of the vaccine. Failure to provide adequate warnings is one of only two conditions under which a vaccine manufacturer can be sued in civil court for harms caused by vaccination. The other is failure to manufacture the vaccine according to specifications. Apart from failing on either of those counts, vaccine manufacturers have total legal immunity against vaccine injury lawsuits, which the government granted to them under a 1986 law designed to preserve existing public vaccine policy in the face of threats to vaccine supply resulting from injury lawsuits that were putting vaccine manufacturers out of business.

The law, the National Childhood Vaccine Injury Act, also established the Vaccine Injury Compensation Program (VICP), which is funded by an excise tax on every vaccine dose administered and effectively shifts the financial burden for vaccine injuries away from the pharmaceutical industry and onto the taxpaying consumers.

As an example showing how proper safety studies are not required to gain FDA approval, take the Hepatitis B (HepB) vaccine. There are two brands that are licensed in the US for use in infants, and this vaccine is typically administered to newborn babies on the very first day of their lives. The CDC recommends this universally, even though the vast majority of babies are not at significant risk of infection. (The virus is transmitted by bodily fluids primarily through sex or injection drug users’ sharing of needles, so unless the mother or another close household contact is a carrier, infection of the infant is an improbability.) The CDC also recommends the vaccine to women during pregnancy. This is so despite the vaccine containing aluminum, which is used to provoke a stronger immune response, but which is also a known neurotoxin. Until it was phased out of most childhood vaccines starting in 1999, the HepB vaccine also contained a preservative called thimerosal, which by weight is half ethylmercury, another known neurotoxin that, like aluminum, crosses both the placental and blood-brain barriers and accumulates in the brain.

Neither of the two HepB vaccines on the market recommended for use in both newborns and pregnant women were studied to determine the safety of these practices. The two vaccines are Merck’s Recombivax B and GlaxoSmithKline’s Engerix-B. Both products’ package inserts state explicitly that “no adequate and well-controlled studies” have been done to evaluate the vaccine’s safety in pregnant women. Merck did include infants in three clinical trials, but it included them with older children up to 10 years of age, rendering the results uninterpretable with respect to the safety of vaccinating babies. Furthermore, the studies included only 147 children, had no placebo control group, and had a follow-up period of only five days. Hence, the trials could not possibly have detected any but the most frequently occurring and immediate-term adverse events. GSK’s trials were larger, including 5,071 subjects. But once again, infants were included with healthy adults and children, there was no placebo control group for comparison, and the follow-up period was just four days.

For another example, take the flu shot. Inactivated influenza vaccines are also recommended by the CDC for use in pregnant women, as well as infants as young as six months. Whereas it was removed from other vaccines routinely recommended for children, multi-dose vials of the influenza vaccine still contain mercury. As with the HepB vaccine, flu shot manufacturers disclose in their package inserts that safety and effectiveness of the vaccine have not been established in pregnant women. A systematic review of the literature in 2014 by the prestigious Cochrane Collaboration—an international organization specializing in this type of study, also called a meta-analysis—noted that the number of randomized controlled trials to determine the safety of vaccinating pregnant women was zero. A 2012 Cochrane meta-analysis found no good evidence that the flu shot is effective at preventing the flu in children under age three and “no usable data” on the safety of vaccinating children under two. Given the CDC’s recommendation for vaccinating infants as young as six months, the study authors stressed that studies to determine the safety and effectiveness of this practice are “urgently required”.

These and numerous other Cochrane reviews have also warned that many of the included studies were industry funded, and that industry funding has, unsurprisingly, been shown to bias results in favor of the products under study.

As a 2012 review published in the American Journal of Obstetrics & Gynecology noted, “prelicensure data on influenza vaccine safety and effectiveness during pregnancy is virtually nonexistent because of strict research guidelines that govern the participation of pregnant women”.

This raises an obvious question: If it is considered unethical to include pregnant women in clinical vaccine safety trials, how is it not also unethical to recommend that all pregnant women be vaccinated in the absence of clinical trials demonstrating that this is safe?

How does this not treat pregnant women as the subjects of a mass uncontrolled experiment without their informed consent?

The Inadequacy of Post-Licensure Safety Studies and Surveillance

Once vaccines get to market, they undergo additional study. However, a CDC recommendation renders vaccination “standard of care” and so randomized, placebo-controlled studies generally are not conducted on the grounds that it would be “unethical” to do so since it would deny the placebo control group the supposed benefits of the presumably safe vaccine. This, of course, is the logical fallacy of begging the question (presuming the proposition to be proven in the premise).

Consequently, most of the studies that the CDC cites to support its policy recommendations are retrospective observational studies. These types of studies are not as well able to control for all the innumerable variables that one must consider, and so, while they may be useful for determining whether an association exists between a vaccine and a given adverse event, they can neither prove nor disprove causality.

To illustrate, all of the studies the CDC cites to support its claim that “Vaccines Do Not Cause Autism” are observational studies. Ironically, one of the studies it cites is a 2004 review by the Institute of Medicine (IOM), which acknowledged that the hypothesis that vaccines administered according to the CDC’s schedule can contribute to the development of autism in children with a genetic or environmental susceptibility cannot be excluded by such studies. Furthermore, none of the studies cited by the CDC and reviewed by the IOM were actually designed to test that hypothesis, which, the IOM further conceded, could explain why they had failed to find an association!

Apart from the lack of proper safety studies for individual vaccines, there has never been a long-term, randomized, placebo-controlled study comparing health outcomes—including rates of allergies, asthma, autoimmune disease, neurodevelopmental disorders, and cancer—between children vaccinated according to the CDC’s routine childhood schedule and children who’ve remained completely unvaccinated. The CDC refuses to do this type of study.

Under the 1986 law granting legal immunity to vaccine manufacturers, due to the insistence of organized parents whose children had been injured by vaccines, a surveillance system was also established called the Vaccine Adverse Event Reporting System (VAERS). But this passive surveillance system is inadequate and not a reasonable substitute for properly designed safety studies, which vaccine manufacturers have little incentive to conduct, especially in light of their legal immunity against damages. One major problem with VAERS is the known underreporting of adverse events.

Both the Congress and the Department of Health and Human Services (HHS), under whose auspices the CDC operates and which also administers the Vaccine Injury Compensation Program, have acknowledged that reports to VAERS represent only a small fraction of actual adverse events. A study by the Agency for Healthcare Research and Quality (AHRQ), which also operates under HHS, found that adverse events from vaccines “are common, but underreported”, representing “fewer than 1% of vaccine adverse events”. The agency proposed a method to automate adverse event reporting rather than relying on passive reporting, but the project reached a dead end when the CDC refused to cooperate on its further development and implementation.

Population Level Effects of Mass Vaccination

Apart from the question of effectiveness in preventing the target disease and the risk of adverse events, there are numerous other factors that simply are not taken into consideration by those who are claiming to know what is best for us and exercising power over us to compel us to behave as they want us to. For example, in addition to individual effects, there are population effects. The same as irresponsible overuse of antibiotics has given rise to antibiotic-resistant “superbugs”, mass vaccination potentially can cause the evolution of viruses and bacteria into even more virulent strains. This is not merely hypothetical, but has been demonstrated in chickens mass vaccinated against Marek’s disease virus. Mass vaccination can also shift the risk burden for disease away from one subpopulation and onto another.

Among human vaccines, the pertussis vaccine provides a useful example. One fact the public is not being told is that, although the public is routinely told that they must vaccinate against pertussis to provide “herd immunity” to infants too young to be vaccinated, public health officials know perfectly well that the theory of vaccine-conferred herd immunity has been falsified. The FDA itself has shown in a study that the vaccine fails to prevent transmission, so that asymptomatic vaccinated individuals can still carry and spread the bacteria to others (and are more likely to be unaware that they are doing so and therefore less likely to quarantine themselves from other household members to protect the baby).

Additionally, the vaccine-conferred immunity is of very short duration, lasting only two to four years, resulting of a shift in the risk burden away from younger children and onto adolescents (so that, again, older vaccinated siblings pose a risk to infants in the household).

Another fact not being communicated to the public is that, due to mass vaccination, the pertussis bacteria, which causes whooping cough, has undergone a genetic shift so that today the dominant circulating strains are deficient in a protein called pertactin (PRN), which is an antigen component of the vaccine. This has contributed to the ineffectiveness of the vaccine, and in the words of the CDC based the findings of a study examining epidemics in Washington and Vermont, “vaccinated patients had significantly higher odds than unvaccinated patients of being infected with PRN-deficient strains.”

Another example of a population level effect of mass vaccination, already touched upon, is how it can shift the risk burden of the disease. For example, the measles vaccine has shifted the burden away from children, in whom it was generally a benign infection (in the US population), and onto those in whom it poses a significantly higher risk of potentially deadly complications: infants and adults. This is because vaccine-conferred immunity is inferior to natural immunity and not as long lasting, and, ironically, because vaccination has interrupted transmission so successfully. In the pre-vaccine era, the circulation of the virus provided a natural boosting effect to those who’d already had it as a child, thus protecting adults generally for a lifetime. Today, though, as vaccine immunity wanes, adults become vulnerable in the event of exposure. Infants are more vulnerable because mothers today are less well able to confer maternal passive immunity, antibodies transferred prenatally through the placenta and postnatally through breastmilk.

Evidence likewise indicates that vaccination against the varicella virus, which causes both chicken pox and shingles, has similarly caused a shift of the risk burden away from children, in whom is generally a mild illness, and onto adolescents and adults, for whom infection poses a greater risk. Due to the loss of natural immunologic boosting from repeated exposures, elderly people who had chicken pox as kids are at greater risk of the dormant virus reactivating and causing shingles. Rather than reconsidering its existing policy, however, the CDC’s answer was to just recommend, starting in 2008, that the elderly also get a newly developed shingles vaccine, too (this has since expanded to include younger adults, as well). A vaccine created to solve the problem created by another vaccine (similar to the practice of prescribing another drug to treat the symptoms caused by a drug previously prescribed to treat symptoms rather than to do anything to actually address the underlying cause).

In a study published in the prestigious journal Vaccine in 2013, a former CDC researcher and his coauthor, looking at CDC data, estimated that the CDC’s policy has not been cost effective, but has rather increased net health care costs. As they commented, vaccine-conferred immunity is “less effective than the natural immunity that existed in communities prior to licensure of the varicella vaccine. Hence, rather than eliminating varicella in children as promised, routine vaccination against varicella has proven extremely costly and has created continual cycles of treatment and disease.”

Other “Non-Specific Effects” of Vaccines

There is a term in the scientific literature used to describe the unintended consequences of vaccination, whether beneficial or detrimental: “non-specific effects”. One non-specific effect that has been found for the diphtheria, tetanus, and whole-cell pertussis (DTP) vaccine is an increased rate of childhood mortality.

The CDC used to recommend this vaccine for the US childhood population, but due to concerns about its safety, it was phased out in favor of a vaccine with an acellular pertussis component (DTaP). The DTP vaccine is still used around the world in developing countries, however, such as in World Health Organization (WHO) campaigns in Africa. There, researchers have found that the vaccine, despite being effective at reducing incidence of the target diseases, is associated with an increased mortality rate.

The hypothesized explanations for this again have to do with the differences between naturally acquired and vaccine-conferred immunity. Inactivated vaccines like DTP tend to bias the immune system toward humoral, or antibody, immunity at the expense of lost cell-mediated immunity, thus causing immune dysfunction that can increase the risk from other diseases that the vaccine is not designed to protect against. As the authors of a study published in the journal EBioMedicine in 2017 remarked, “All currently available evidence suggests that DTP vaccine may kill more children from other causes than it saves from diphtheria, tetanus or pertussis. Though a vaccine protects children against the target disease it may simultaneously increase susceptibility to unrelated infection.”

The influenza vaccine offers another good example of a non-specific effect, which is that getting an annual flu shot can actually increase your risk of getting the flu. While the vaccine is designed to protect against three or four viral strains by stimulating an antibody response, natural influenza infection confers not only humoral, but also a robust cell-mediated immunity. Unlike the vaccine, natural immunity offers cross-protection against not only the infecting strain, but other influenza strains as well, and evidently even against other viruses.

The Assault on Our Right to Informed Consent

The right to informed consent is one of the most fundamental ethics in medicine. In the wake of World War II and revelations about the Nazis’ use of humans for medical experimentation, the international community formally recognized informed consent as a fundamental human right. The Nuremberg Code established medical ethics principles starting with this: “The voluntary consent of the human subject is absolutely essential.”

This means, among other things, that the subject must be in a position “to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, overreaching, or other ulterior form of constraint or coercion”.

Additionally, the subject “should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision.”

The right to informed consent has also been codified in the 1966 United Nations International Covenant on Civil and Political Rights, which states under Article 7 that “no one shall be subjected without his free consent to medical or scientific experimentation.”

The updated 2002 edition of the International Ethical Guidelines for Biomedical Research Involving Human Subjects—guidelines promulgated by the World Health Organization (WHO) and the Council for International Organizations of Medical Sciences—states that, “For all biomedical research involving humans the investigator must obtain the voluntary informed consent of the prospective subject or, in the case of an individual who is not capable of giving informed consent, the permission of a legally authorized representative….”

This right is also codified in the Universal Declaration on Bioethics and Human Rights, adopted at the United Nations Educational, Scientific and Cultural Organization (UNESCO) in October 2005: “Any preventive, diagnostic and therapeutic medical intervention is only to be carried out with the prior, free and informed consent of the person concerned, based on adequate information…. Scientific research should only be carried out with the prior, free, express and informed consent of the person concerned. The information should be adequate, provided in a comprehensible form and should include modalities for withdrawal of consent….  In no case should a collective community agreement or the consent of a community leader or other authority substitute for an individual’s informed consent.” (Emphasis added.)

Yet substituting individual informed consent with state authority is precisely what the federal and state governments are doing when it comes to the practice of vaccination. When the state uses coercion to gain compliance, it constitutes an assault on this fundamental human right. Furthermore, neither medical professionals nor the major media are doing their duty by providing people with the knowledge they need to be able to make an informed choice, but instead are regurgitating deceitful vaccine propaganda to persuade or intimidate them into behaving as government bureaucrats would have them do.

The population is being bullied into compliance with dangerously shortsighted government diktats. Power hungry bureaucrats and technocrats treat vaccination as a one-size-fits-all solution despite great variability in individual risk both from the diseases the vaccines are designed to prevent and from the vaccines. They have no respect for individual rights or the doctor-patient relationship. California Senator Richard Pan, for example, considers doctors writing medical exemptions to state vaccine mandates as doing something that is “not the practice of medicine but of a state authority to licensed physicians”. Essentially, from his authoritarian perspective, “physicians are fulfilling an administrative role”. There is no room for informed consent. Doctors are not free to practice as they deem best for their patients, and informed consent for their patients is not an option.

But bureaucrats in Washington or state capitals simply do not have the knowledge required to be able to make that determination for other individuals. When it comes to our children, only the parents and their family doctor have the specialized knowledge of the child that is necessary to be able to do the individual risk-benefit analysis that required for informed consent.

Many who do choose willingly to comply with public policy do so because they unquestioningly believe the dogma they are told, that “vaccines are safe and effective”, and who therefore remain incapable of such a risk-benefit analysis. Not all vaccines are safe. Not all are effective. The risks and benefits are not the same for everyone. And the long-term unintended consequences need also to be considered.

Many others who are aware enough to question public policy still comply because there will be state retribution if they don’t. Informed consent is not happening. Consequently, public vaccine policy effectively treats the entire population as the subjects of a mass uncontrolled experiment with most people remaining unaware that they are being experimented upon by blind authoritarians trying to play God by controlling us.

It’s time for that to stop—and for mainstream journalists to start doing their jobs and reporting seriously on this critically important issue. The lives, health, and liberty of entire future generations of humanity are depending on it.

This article was originally published at Foreign Policy Journal.

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