The Hippocratic dictum, “Do no harm,” is a widely accepted ethical principle, yet proposals that advocate mandatory vaccination for all except medical exemptions fail this test because they privilege the people who might be harmed by failure to vaccinate over the people who might be harmed by vaccination. The potential harms to these two groups of people creates an ethical dilemma that is not easy to resolve but one that most proponents of mandatory vaccination rarely address. First, mandatory vaccination proponents tend to dismiss the possibility that vaccines can cause unintended injuries and death by conflating claims of vaccine-induced autism with vaccine-induced injuries. Second, they claim that those with medical exemptions will be able to keep their exemptions, and those exemptions will be sufficient to prevent vaccine-induced injuries. Third, they make blanket statements about the safety of vaccines, while ignoring the evidence to the contrary. I’ll address each of these in turn. Ignoring the purported association with autism, there is substantial scientific and anecdotal evidence that vaccine-induced injuries do occur. The scientific literature that has conclusively established a causal link between vaccination and unintended injury has been reviewed by the Institute of Medicine (IOM) on numerous occasions, and their findings have been used by the National Vaccine Injury Compensation Program (VICP) (http://www.hrsa.gov/vaccinecompensation/index.html) to compensate those who have been injured or died. In 2012 the IOM published a report, “Adverse Effects of Vaccines: Evidence and Causality,” that “concluded the evidence convincingly supports 14 specific vaccine–adverse event relationships. Since the first VICP claims were filed in 1989, the US Court of Federal Claims has issued compensation awards for 3,540 of the 13,274 claims filed (26.7%). Approximately 7.4% of the awards were for deaths, or 265 people. Over $2.7 billion in compensation awards have been paid to petitioners, and over $109.3 million have been paid to cover attorneys' fees and other legal costs. As these data show, people are injured and killed by vaccines every year, and medical exemptions to vaccines are insufficient to prevent these injuries. Medical exemptions are granted only AFTER adverse reactions to vaccines have occurred. The requirements for medical exemptions are very stringent, and many doctors are reluctant to grant them because of the potential professional consequences. Consequently, they tend to err on the side of not granting them, meaning that some people who should have been granted them are not. A second source of evidence comes from reports contained in the national Vaccine Adverse Event Reporting System (VAERS) (http://wonder.cdc.gov/vaers.html) which contains many thousands of reports of illnesses, health problems and/or symptoms following vaccination. Adverse events range from pain and swelling at the injection site, fever, and headaches to anaphylaxis, encephalitis and other serious neurological disorders such as seizures and paralysis and even death. Although the VAERS database contains unverified reports that could have been submitted by anyone, the majority of

reports are submitted by physicians and presumably contain factually accurate information. Although VAERS data cannot be used to establish a causal relationship between vaccination and a temporally associated adverse event, VAERS data is used by the CDC and FDA for signal detection and hypothesis generation. Causal relationships between vaccination and adverse event is established during pre-licensure clinical trials and through the CDC-funded Vaccine Safety Datalink project. A second medical ethics principle that mandatory vaccination proposals violate is the principle of informed consent, which is particularly important when medical interventions such as vaccination can cause serious injury and death. Informed consent is a process for getting permission before conducting a healthcare intervention on a person. It involves open disclosure and a discussion between the health care provider and patient that results in a clear understanding of the facts, risks, benefits and likelihood of various consequences of an action (or inaction), and the need for informed consent applies to both medical treatments provided as part of routine clinical practice as well as research. In cases where individuals are unable to render informed consent, other persons, such as parents or legal guardians, are allowed to provide informed consent on their behalf. There is no US Federal legal requirement to establish informed consent prior to the administration of vaccines; however, that does not dismiss the ethical requirement for health care providers to provide care consistent with such principles. Mandatory vaccination for all but medical exemptions would violate this ethical requirement because there would be no requirement to obtain consent, informed or otherwise. Proponents of mandatory vaccination (to include existing vaccination requirements) argue that informed consent is not necessary because vaccination is for the greater good of society, and the risks of adverse reactions are so rare to virtually be non-existent. This is a classical example of utilitarianism, whose fundamental axiom is, “It is the greatest happiness of the greatest number that is the measure of right and wrong” (Jeremy Bentham, A Fragment on Government). Utilitarianism is a complex group of philosophical theories for which there are many supporting arguments. However, there are also many criticisms of it, not least of which it can lead to an “ends justify the means” mentality. Other criticisms include that it could ignore justice for individuals (innocent people could be punished for the greater good); it’s difficult and time-consuming to calculate utility; it’s nearly impossible to predict consequences or to maximize utility without favoritism; and it aggregates happiness, which is meaningless, because it is individuals who are happy, not mankind. Mandatory vaccination is a clear-cut example of many of these criticisms. The means is used to justify the end of protecting society from vaccine-preventable diseases, regardless of the harm it might cause to some people. Clearly one group of people is favored over another. Currently, there are few, if any, ways to reliably predict who will be harmed by a vaccine prior to its administration. For

example, there is no test that can be given to determine if someone would be harmed—-vaccine administration itself is the test, and sometimes, the adverse reaction doesn’t immediately happen, so linking the test to the result is difficult. In its 2013 report on The Childhood Immunization Schedule and Safety, the IOM stated, ““The committee found that evidence from assessments of health outcomes in potentially susceptible populations of children who may have an increased risk of adverse reactions to vaccines (such as children with a family history of autoimmune disease or allergies or children born prematurely) was limited and is characterized by uncertainty about the definition of populations of interest and definitions of exposures and outcomes. Most children who experience an adverse reaction to immunization have a preexisting susceptibility. Some predispositions may be detectable prior to vaccination; others, at least with current technology and practice, are not . . .” Finally, it is all too easy to misuse utilitarian ethics. Nazi Germany justified euthanasia, medical experiments, and the Holocaust based on the greater good of the German people, bolstered by the latest German scientific evidence. Even in the US, utilitarianism has been used partly to justify conducting scientific studies without informed consent, such as the Tuskegee syphilis experiment. In addition to the utilitarian argument, scientific studies are often used to justify mandatory vaccination. Vaccination proponents point out that that no scientific studies have yet determined that vaccines can cause autism, and that vaccines are generally regarded as safe. This argument is a weak one for several reasons. First, just because no studies definitively show that vaccines can cause autism doesn’t mean that none ever will. Plenty of studies have already linked vaccination with brain damage and disorders, of which autism is one, and the VICP has awarded a number of claims that include autism among the alleged injuries. In addition, as the 2013 IOM report pointed out, “Most vaccine-related research focuses on the outcomes of single immunizations or combinations of vaccines administered at a single visit. Although each new vaccine is evaluated in the context of the overall immunization schedule that existed at the time of review of that vaccine, elements of the schedule are not evaluated once it is adjusted to accommodate a new vaccine. Thus, key elements of the entire schedule – the number, frequency, timing, order and age at administration of vaccines – have not been systematically examined in research studies . . .” Scientific facts are revised all the time based on new research. For example, the CDC has revised the amount of lead considered to be safe five times since 1970, from 60 micrograms per deciliter of blood to 5. It is the very nature of scientific knowledge to change; as Samuel Arbesman points out in his book, all facts have a half-life. Furthermore, the nature of scientific knowledge is probabilistic, because most scientific conclusions are based on probabilities, with p < .05 being the gold standard. That still leaves room for false positives and false negatives. And even though medical researchers try to base their conclusions on statistical evidence, the researchers are inherently biased by their background, training,

experience, and affiliations. The peer review process is an attempt to eliminate bias, but reviewers and editors themselves are biased. Wakefield’s MMR-bowel disease study in autistic children was peer reviewed and published in the prestigious medical journal “Lancet”—until it was retracted. As the UK House of Common pointed out, there is “little solid evidence on the efficacy of pre-publication editorial peer review,” and John P. A. Ioannidis went so far as to say, “It can be proven that most claimed research findings are false.” Lastly, lest you should think I’m just some anti-vaxxer nut, I am a military retiree with 20 years of service and 3 deployments to war zones who received every major vaccine plus some, like anthrax. As a service member, I was subject to a mandatory vaccination policy; refusal would have resulted in court martial and punishment. In any case, at the time, I implicitly trusted that the government wouldn’t treat me with anything that was unsafe. I should have known better, because of the Agent Orange and other debacles, but after many Gulf War veterans began to experience symptoms that came to be known as Gulf War Syndrome, I began to doubt that the government had our best interests in mind. About 10 years after the first Gulf War, my wife and I had our first child. We followed the well-baby check-up schedule to a T, to include the required vaccines. At 4 months of age, our baby had an adverse reaction to her second DTaP injection. At that point, we researched the required vaccines and their potential side effects because our doctor failed to inform us of any potential side effects (and we had just assumed they were safe). I agonized over whether to give any more vaccines or to vaccinate our second child, given my general acceptance of government proclamations of safety, but I was also fearful of worse reactions, especially since our nephew is permanently disabled following the severe reaction to the seven vaccines he received at his 15-month well-baby visit which included DTaP. However, every parent cares more about their own child than all others, so my wife and I decided to forgo any further vaccines. We obtained a medical exemption for the DTaP vaccine for our first child but were not able to obtain one for any other vaccines. I firmly believe that every human being has a basic right to decide whether something goes into their body or not. And until there’s a test that can identify with 100% accuracy who would be harmed by receiving a vaccine, I am opposed to mandatory vaccination as being unethical and not fully justified by current scientific evidence.