Monday, December 6, 2010

Forced to be Free: the Ethics of Mandatory Vaccination

“In order then that the social compact may not be an empty formula, it tacitly includes the undertaking, which alone can give force to the rest, that whoever refuses to obey the general will shall be compelled to do so by the whole body. This means nothing less than that he will be forced to be free…”

-- Rousseau, the Social Contract (italics added)

Introduction

Vaccines are considered a major public health achievement by the overwhelming majority of the scientific, medical, and political communities around the world. The Centers for Disease Control (CDC) in the United States keeps statistics on the number of infectious diseases reported each year. The CDC has determined that the rates of infection for many diseases which formerly plagued Americans, such as smallpox, diphtheria, measles, mumps, polio, rubella, and tetanus have decreased 98-100% since the policy of widespread vaccination against these diseases was declared constitutional by the United States Supreme Court in the 1930s, and adopted in the 1960s. Among this group of eradicated and nearly eradicated diseases are the deadliest and the most contagious pathogens known to man: smallpox and measles.

Smallpox has a mortality rate of up to 90% in virgin populations during outbreaks, such as Native American populations after European contact, and measles is so contagious that during the pre-vaccination era all Americans were infected at least once during their lifetime, and the annual morbidity in the 20thcentury was over 500,000(Roush, 2007). The total number of deaths in America attributed to measles in 2005 was 66, a 99% decrease from the 20th century average. However, measles continues to claim the lives of 345,000 around the world annually in areas such as Africa and south-east Asia where vaccinations are not available (Campos-Outcalt, 2010). Other diseases for which vaccines have been developed include pertusis, hepatitis A, hepatitis B, invasive pneumococcus and varicella. Significant decreases (ranging from 73-84%) in the number of cases of these diseases have also been reported since the beginning of widespread vaccination (Achievements in Public Health: Impact of Vaccines Universally Recommended for Children, 1999).

These diseases, which had previously claimed the lives of millions of Americans during outbreaks, have now been brought within clinically manageable levels. No other public health campaign (improved sanitation or access to clean water, etc.) can account for the observed decrease in infection rates and deaths. However, despite the overwhelming evidence in favor of universal vaccination, a significant percentage of the American population continues to resist a mandate that all receive vaccinations against preventable infectious diseases in order to attend public school, travel internationally, join the military, work in health care, etc. In this paper I will explore some of the reasons for this resistance and attempt to show that mandatory public vaccination has been thoroughly supported as a sound policy by the medical establishment, and is morally acceptable when considered within a modern bioethical framework.

Thimerosal Controversy

The controversy behind mandatory childhood vaccination and the potential link to autism, and other neurodevelopmental diseases (NDDs), has been an area of heated debate since the publication of an article by Dr. Andrew Wakefield in the British peer-reviewed medical journal Lancet in 1998, which first supported this linkage (Wakefield, 1998). The controversy centered on a chemical called thimerosal, a mercury-based organometallic, formerly used as a fungicide and preservative in many vaccines, including the vaccine for mumps, measles, and rubella (MMR). The theory held that repeated vaccinations in childhood amounted to excessive heavy metal (mercury) exposure, the effects of which could be seen clinically in the rise of autistic spectrum disorders (ASDs), multiple sclerosis, and other NDDs. This article was published near the time that a joint investigation by the CDC and the Food and Drug Administration (FDA) had recommended removing methyl-mercury from all consumer products. As a precautionary measure, the CDC required vaccine manufacturers to remove thimerosal, which contains ethyl-mercury (different and significantly less toxic than methyl-mercury), from all vaccinations, except some strains of influenza (FDA, 2010). Although purely a precautionary measure, this was perceived by some in the media, the medical field, and alternative medicine as “evidence” that vaccinations were responsible for the rise in reported cases of autism (Baker, 2008).

This claim was picked up by a group of independent scientists in the United States, Drs. David and Mark Geier, who published several articles in the following decade in attempt to establish a link between heavy-metal exposure, hyperandrogenism (elevated levels of testosterone) and autism. Using this premise, they developed and patented a treatment using the drug Lupron® (a gonadotropin agonist used to treat precocious puberty, and to chemically castrate sex offenders) together with chelation therapy (used to increase excretion of heavy metals in the urine) to treat autism. They offered this “miracle” therapy to the parents of dozens of autistic children, who paid tens of thousands of dollars on average for several weeks of doses high enough to leave their children permanently sterile, but reported marked improvements in the children’s cognition and behavior (Geier et. al., 2006).

The Geiers have also been called as expert witnesses in hundreds of federal court cases seeking damages from vaccinations (Stewart, 2009) through the Vaccine Injury Compensation Program (VICP). However, their work has been thoroughly rebuked by the scientific community as containing serious methodological flaws, and being impossible to interpret or reproduce (Parker et. al., 2004). Also, their testimonies in federal court have been stricken from the records due to their conflict of interest and lack of required expertise in the neurological field (de los Reyes, 2010). Other studies done in the fields of epidemiology and pharmacokinetics which seek to establish a link between vaccination and autism have shown similar discrepancies and been wholly discredited by the scientific community (Parker et. al., 2004). Later, better designed studies, published in journals such as Lancet, employed case-control methods to compare 1294 cases and 4469 controls from populations of the same sex, age, and general practice to establish a link between the MMR vaccine and an increased risk for autism and other NDDs, but found no association (Smeeth et. al., 2004).

In short, no proposed evidence for a link between autism and childhood vaccinations has withstood scientific scrutiny, and earlier this year Dr. Wakefield’s 1998 paper was formally retracted from the Lancet and his medical license was revoked after it was discovered he had fabricated the results of his study and committed other serious acts of academic dishonesty. These are examples of demagogues who preyed upon the distrust and anxiety of the public, in particular the vulnerable parents of autistic children, for personal monetary gain and fame. While a lack of evidence for a link between vaccinations and autism does not necessarily make such a link impossible, it does appear highly improbable. However, the link between vaccinations and improved public health is a fact that has significant evidence, a broad consensus, and a good track record. Given this evidence, one may well ask, “Why does the debate persist?”

Evidence Based Medicine

A strong trend in modern medicine, especially in primary care, is to incorporate the findings of current scientific studies into clinical practice in order to improve patient outcomes and health. However, physicians who seek to implement therapies and practices supported by evidence often encounter resistance among their patients, who do not understand the need for the prescribed therapy, or the science behind it. This disconnect between the physician and the patient can exacerbate the distrust the patient may already harbor for the medical establishment, including insurance companies and pharmaceuticals, which they may consider elitist or having ulterior motives (Slowther et. al., 2004). Alternative practitioners such as chiropractors and naturopaths, however, often recommend more “natural” remedies to their patients, which make more intuitive sense and in which the patient may feel more confident of success. Tapping into this vein of mistrust, some alternative practitioners have begun actively campaigning against childhood vaccination and modern medicine to varying degrees. In response to these campaigns against vaccination, immunization rates have dropped in recent years to 80%, by some estimates (de los Reyes, 2010). In connection with this, the rates of some preventable diseases, including pertusis, have climbed in recent years. It is believed this is a direct result of the anti-vaccination campaigns, and many public health officials worry that an outbreak of a more virulent pathogen, either by natural causes or by the enemies of the United States, may find us unprepared and cause considerable harm (Achievements in Public Health: Control of Infectious Diseases, 1999).

Physicians trained in modern medicine hold the position that to recommend a therapy not based upon scientific evidence, or to recommend forgoing an appropriate therapy based on such evidence is morally irresponsible. On the other hand, alternative practitioners have a broader definition of “evidence” which includes personal experience and intuition. While considering this debate, it is important not to lose sight of the social context in which it exists. Americans in general are a libertarian people. Their fierce defense of personal liberty has presented in the past with the side effects of severe paranoia and distrust of government, academia, and big business. In this context, a physician has a great responsibility to educate and persuade his/her patients, and the public, to follow sound medical advice, and to gain their trust; however, this is not always possible. It is apparent that, to a large percentage of the population, scientific evidence is irrelevant. This begs the question, “If someone does not believe in the efficacy of evidence, how can they be persuaded that they should?”

Ethics of Mandatory Vaccination

It has been said the definition of reality is that it exists whether or not it is believed. In the case of immunization, the jury is in, and has found that, despite what the plaintiffs may say or the public may feel, mandatory vaccination is a good idea. The preponderance of evidence for the benefits of universal vaccination exceeds the needed 51%, and has moved into the realm beyond reasonable doubt. Thus, this is a case where paternalistic action on the part of the government and medical establishment is justified, needed, and morally acceptable. Three systems of moral theory support this claim: utilitarianism, the Rawlsian theory of justice, and virtue ethics.
From a utilitarian perspective, individual autonomy must yield when the good of the many requires it. Dissenters on mandatory vaccination often appeal to the idea of “herd immunity”—that their exempt status will not affect the overall robustness of the population in an adverse way. However, studies have shown that even rates of 5-8% who opt-out of immunization put the entire population at significantly higher risk for outbreaks (de los Reyes, 2010). “Herd immunity” requires that the entire herd, to use that analogy, be immunized. If too many come to feel they are an exception, then, as Rousseau elegantly put it, the program becomes an “empty formula” for protecting the population.

The Rawlsian perspective places great emphasis on the “Liberty principle,” but also requires that one step behind the “veil of ignorance” to determine what is just. By performing this thought experiment in the case of vaccination, one may imagine a scenario in which another person, who chooses not to be vaccinated against a preventable disease, then contracts it, and also passes that disease to one’s self. Since the other person’s use of liberty impinges on the liberty of the self, this is unjust. In order to keep both free of disease, the other must be “forced to be free” (i.e. coerced vaccination), or must be kept away from the self, and all other vulnerable people. Rawls also makes room for differences in liberty and equality (the “difference principle”), as long as those differences benefit the worst off. Universal vaccination, even in spite of some individuals’ personal liberty, would bring needed medical services to vulnerable populations who are more likely to suffer in the case of an outbreak, and thus would benefit them.

Finally, virtue ethics holds that societal roles are imbued with values and responsibilities that are unique and essential to the fulfillment of the role. Important roles to consider in this context are those of physician and patient, parent and child. In the case of the physician, the dictum “primum non nocere” (First, do no harm) demands that they themselves be vaccinated so as not to put their patients, who may be vulnerable to disease, in harm’s way. This extends to all who work in the medical field (van Delden et. al., 2008). In the case of a parent, whose duty is to love, protect, and nurture their child(ren), personal liberty and political views must not interfere with the safety, health, and well being of their child(ren). To put them at risk, simply to make a political point, goes against their responsibility and nature as a parent. To bring in deontology to the debate, Kant might say here that, in such a case, the parent is using the child as a mere means, and not as an end. Perhaps even Kant, the champion of personal liberty, would question the morality of such an act.

This raises an interesting question, that of moral agency. If, as Kant argued, children are not moral agents but subjects to their parents, what right does society have to tell the parents how to treat their children? But, ultimately, this is not a question of rights, but of values—communitarian vs. individualist. The difference between the two value systems is where the stress falls, on the whole or on the self. Once seen in this way, the decision to opt-out is exposed as egotistic, the decision to be vaccinated as altruistic. To return to the example of parent and child, we have already determined this is a case where society must act as parent. It is known that there are various parenting strategies—some effective, others ineffective—and the question is which to use? Instead of the permissive strategy often used, i.e. allowing the subject (child) to act at will and remove or reduce the consequences of those actions, consider the authoritative strategy; to allow for personal choice, but to inform the subject of the consequences and to be consistent in carrying them out. Agency cannot exist without accountability.

If a parent insists on opting their children out of vaccination, allow this, but inform them that their children will not be able receive the full benefits of citizenship: attend public school, travel outside the country, serve in the military, work in a service industry (especially health care), etc., and then follow through with those consequences. I doubt that parents, after being informed of this, would continue their opposition to this policy, knowing that by doing so they would be closing so many doors for their children. If persuasion and education are not sufficient to influence the entire public to accept universal vaccination, then society is not under the obligation to convince those who continue to dissent. The most important priority must be the protection of the whole, and this can be achieved via the gentle form of coercion described above. Freedom from disease is comparable in impact to freedom from tyranny, and sometimes members of society must be forced to remain free of both.

References

Achievements in Public Health, 1900-1999: Control of Infectious Diseases. MMWR 1999; 48(29): 621-629. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm4829a1.htm

Achievements in Public Health, 1900-1999 Impact of Vaccines Universally Recommended for Children -- United States, 1990-1998. MMWR 1999; 48(12):243-248. http://www.cdc.gov/mmwr/preview/mmwrhtml/00056803.htm

Baker, J. P. (2008). Mercury, vaccines, and autism: One controversy, three histories. American Journal of Public Health, 98(2), 244-253.

Campos-Outcalt, D. (2010, October 20) Vaccines: a Major Public Health Achievement, Presentation given during the Mini-Med School lecture series at the University of Arizona College of Medicine-Phoenix, Arizona.

de los Reyes, E. C. (2010). Autism and immunizations: Separating fact from fiction. Archives of Neurology, 67(4), 490-492.

Geier, D. A., & Geier, M. R. (2006). A clinical trial of combined anti-androgen and anti-heavy metal therapy in autistic disorders. Neuro Endocrinology Letters, 27(6), 833-838.

Parker, S. K., Schwartz, B., Todd, J., & Pickering, L. K. (2004). Thimerosal-containing vaccines and autistic spectrum disorder: A critical review of published original data. Pediatrics, 114(3), 793-804.

Roush SW. Historical comparisons of morbidity and mortality for vaccine-preventable diseases in the U.S. JAMA 2007;298:2155-2163.

Slowther, A., Ford, S., & Schofield, T. (2004). Ethics of evidence based medicine in the primary care setting. Journal of Medical Ethics, 30(2), 151-155.

Smeeth, L., Cook, C., Fombonne, E., Heavey, L., Rodrigues, L. C., Smith, P. G., et al. (2004). MMR vaccination and pervasive developmental disorders: A case-control study. The Lancet, 364(9438), 963-969.

Stewart AM. When vaccine injury claims go to court. NEJM 2009;360:2498-2500.

U.S. Food and Drug Administration. (2010) Thimerosal in Vaccines. Retrieved from http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/UCM096228

van Delden, J. J. M., Ashcroft, R., Dawson, A., Marckmann, G., Upshur, R., & Verweij, M. F. (2008). The ethics of mandatory vaccination against influenza for health care workers. Vaccine, 26(44), 5562-5566.

Wakefield, A. J., Murch, S. H., Anthony, A., Linnell, J., Casson, D. M., Malik, M., et al. (1998). Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children. Lancet, 351(9103), 637-641. (Retracted, 2010)

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