Law, Ethics, and Public Health in the Vaccination Debates

Georgetown University Law Center Scholarship @ GEORGETOWN LAW 2015 Law, Ethics, and Public Health in the Vaccination Debates: Politics of the Measles Outbreak Lawrence O. Gostin Georgetown University Law Center, [email protected] This paper can be downloaded free of charge from: http://scholarship.law.georgetown.edu/facpub/1460 http://ssrn.com/abstract=2564724 Lawrence O. Gostin, Law, Ethics, and Public Health in the Vaccination Debates: Politics of the Measles Outbreak, JAMA Online (February 12, 2015), http://jama.jamanetwork.com/ article.aspx?articleid=2119391 This open-access article is brought to you by the Georgetown Law Library. Posted with permission of the author. Follow this and additional works at: http://scholarship.law.georgetown.edu/facpub Part of the Bioethics and Medical Ethics Commons, Health Law Commons, Health Policy Commons, Medicine and Health Commons, Public Health Commons, and the Public Policy Commons Opinion VIEWPOINT Lawrence O. Gostin, JD O'Neill Institute for National and Global Health Law, Georgetown University, Washington, DC. Corresponding Author: Lawrence O. Gostin, JD, Georgetown University Law Center, O'Neill Institute for National and Global Health Law, 600 New Jersey Ave NW, Washington, DC 20001 (gostin@law .georgetown.edu). Law, Ethics, and Public Health in the Vaccination Debates Politics of the Measles Outbreak day care facilities or public (and for most states, private) schools. The US Advisory Committee on Immunization Practices recommends a series of childhood vaccines, but only states can require them. Although conditioning school attendance on vaccinations dates back to smallpox, modern laws were enacted mostly in response to measles outbreaks in the 1960s and 1970s. Beyond childhood vaccinations, many states require meningococcal vaccines for incoming college students. States vary in the types of exemptions, rigor of the application process, and review mechanism.6 All school immunization laws grant exemptions for medical contraindications to immunization (eg, an allergic response or immune deficiency), which requires a physician’s certificate. All states except West Virginia and Mississippi also grant religious exemptions, with varying requirements regarding the sincerity, strength, and religious basis. Twenty states grant philosophical exemptions due to “personal,” “moral,” or “other” beliefs.7 Processes for obtaining nonmedical exemptions vary, with some states requiring only a signature on a preprinted form, whereas others adopt a more arduous process. Arkansas, for example, requires a notarized parental statement, counseling, and health department approval. State exemptions significantly influence vaccination rates and incidence of vaccine-preventable illness. In 2006, researchers found that states with easy nonmedical exemption processes had 50% higher pertussis rates.8 The measles outbreak reignited a In 2012, researchers reported nonmedihistoric controversy about the enduring cal exemption rates 2.3 times higher in values of public health, personal choice, states with easy administrative policies than those with difficult policies.9 In pracand parental rights. tice, exemptions for all reasons constiand neighborhood play dates. Online, people call tute a small percentage of total school entrants, but famithem negligent and criminal.”4 lies that opt out of vaccination tend to cluster within Although vaccine policy is politically divisive, the localized communities, with individuals sharing reliconsensus scientific view is that childhood vaccines are gious or philosophical beliefs. Clustering erodes herd imsafe and effective, among CDC’s 10 great 20th-century munity, facilitating disease outbreaks that can spread. achievements and a World Health Organization “best Mandatory vaccination is within the states’ police buy.” One estimate suggests that from 1924 to 2012, powers because of its public health importance. In 1905, childhood vaccinations prevented more than 100 mil- the Supreme Court in Jacobson v Massachusetts uplion cases of serious disease, with very rare adverse held a smallpox mandate: “We do not perceive that this effects.5 The ethical question, then, is whether par- legislation has invaded any right secured by the Federal ents’ rights to raise their children justify decisions that Constitution.” In 1922, in Zucht v King, the Court upheld place the community at risk. vaccine requirements as a condition of school entrance. Although medical exemptions are constitutionState Vaccine Mandates: Philosophical and ally required, philosophical and religious opt-outs are not. Religious Exemptions Because vaccine laws are generally applicable to all Every state mandates that children older than 5 years re- school-aged children and in the public interest, the courts ceive vaccinations prior to enrollment in state-licensed find no overriding right to religious freedom. Rather, The US Centers for Disease Control and Prevention (CDC) declared endemic measles eliminated in 2000, with rubella and congenital rubella syndrome eliminated in 2004.1 However, vaccine-preventable diseases (eg, diphtheria, pertussis, tetanus, measles, mumps, and rubella) are increasing, with some parents delaying or selectively immunizing their children and, at times, even opting out of having their child immunized. In 2014, the United States recorded a record number of measles cases—644 cases from 27 states, more than 3-fold higher than any previous year since 2000. As of February 6, 2015, the CDC has reported 121 measles cases in 17 states, mostly from an ongoing outbreak linked to an amusement park in Orange County, California. Most cases were unvaccinated (55%) or of unknown vaccination status (31%).2 The measles outbreak reignited a historic controversy about the enduring values of public health, personal choice, and parental rights. Senator Rand Paul expressed political support for private choice: “The state doesn’t own your children,” parents do.3 Media coverage, however, has spurred a backlash against parents of unvaccinated children blamed for incubating a public health crisis. For instance, one report noted: “Their children have been sent home from school. Their families are barred from birthday parties jama.com 'RZQORDGHG)URPKWWSMDPDMDPDQHWZRUNFRPRQ (Reprinted) JAMA Published online February 12, 2015 E1 Opinion Viewpoint states grant religious exemptions and philosophical exemptions for political reasons, often in response to strong parental views. The Politics of Compulsory Vaccination Immunization has provoked popular resistance, often due to apprehensions about adverse effects in healthy children. Senator Paul referred to “many tragic cases of walking, talking, normal children who wound up with profound mental disorders after vaccines.”3 A 1998 report—since retracted as fraudulent—suggested a link between MMR vaccine and autism. Even though numerous studies and independent reviews of data have found no relationship between MMR vaccine and autism, concerns linger. Parents express a wide spectrum of concerns, including the right to raise their children, give informed consent, and the freedom of religion or conscience. A small fraction of parents categorically oppose vaccinations, but many others are concerned primarily with state mandates. For these parents, a “nudge” may be all that is required, such as being informed of the science and making exemptions for immunizations more difficult to obtain. The uptake of vaccines, moreover, is associated with perceived susceptibility to and severity of childhood diseases. The catch-22 is that because vaccines are such powerful tools of prevention, individuals are less inclined to vaccinate their children because they rarely see vaccinepreventable childhood diseases. A Tragedy of the Commons Parental decisions to opt out of immunizations can have a rational basis. Unvaccinated children avoid rare adverse effects, such as a serious allergic reaction. Moreover, if most children in the community in which they live are immunized, the unvaccinated child also benefits from herd immunity. The dilemma is that if a sufficient number parents act in their own interests by opting out of having their children immunized, then everyone is worse off. ARTICLE INFORMATION Published Online: February 12, 2015. doi:10.1001/jama.2015.1518. Conflict of Interest Disclosures: The author has completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported. REFERENCES 1. Papania MJ, Wallace GS, Rota PA, et al. Elimination of endemic measles, rubella, and congenital rubella syndrome from the Western hemisphere: the US experience. JAMA Pediatr. 2014;168(2):148-155. 2. CDC Health Alert Network. U.S. multi-state measles outbreak, December 2014-January 2015. E2 Parents objecting to vaccines often claim the right to informed consent, which is an important medicolegal value. However, consent should not override the rights of others to live safely in their communities. Unvaccinated children put the wider public at risk, violating a basic ethical principle of not imposing harms on others. If an individual’s right ends at the point that its exercise jeopardizes the safety of others, then should states allow parents to opt out? Certainly, states should continue to grant medical exemptions for children particularly susceptible to vaccine adverse effects. However, states do not have to grant philosophical and religious exemptions. The main consideration is whether eliminating exemptions could inflame public opinion, thus undermining vaccine policy. States would be unwise to overreact to the current measles outbreak by fining or imprisoning parents, or subjecting them to tort litigation, if they fail to vaccinate their children. Harsh penalties could fuel public opposition to vaccine policy. It may not even be necessary to entirely eliminate nonmedical exemptions. The wiser course could be to require a rigorous process for claiming the exemption, relying on behavioral economics to encourage compliance. There are good models of tougher standards, including requiring counseling; explaining the benefits of vaccines; requiring parents to sign an affidavit stating the reasons for opting out; and requiring health department approval. Placing a higher burden on the exemption process would make it more difficult for parents to impose risks on their children’s friends and schoolmates without their agreement. If exemptions were truly rare, as they should be, then herd immunity would operate. Everyone would be safer. The current system of generous opt outs virtually ensures that infectious disease outbreaks will continue, perhaps increasing in frequency and geographic scope. Childhood diseases that were once common but now rare could gain a foothold, becoming endemic once again. http://emergency.cdc.gov/HAN/han00376.asp. January 23, 2015. 3. Peters JW, Pérez-Peñafeb R. Measles outbreak proves delicate issue to G.O.P. New York Times. February 2, 2015:A1. 4. Healy J, Paulson M. Vaccine critics turn defensive over measles. New York Times. January 31, 2015:A1. 5. van Panhuis WG, Grefenstette J, Jung SY, et al. Contagious diseases in the United States from 1888 to the present. N Engl J Med. 2013;369(22):21522158. 6. Yang YT, Silverman RD. Legislative prescriptions for controlling nonmedical vaccine exemptions. JAMA. 2015;313(3):247-248. JAMA Published online February 12, 2015 (Reprinted) 'RZQORDGHG)URPKWWSMDPDMDPDQHWZRUNFRPRQ 7. National Conference of State Legislators. States with religious and philosophical exemptions from school immunization requirements. http://www .ncsl.org/research/health/school-immunization -exemption-state-laws.aspx. 2015. 8. Omer SB, Pan WK, Halsey NA, et al. Nonmedical exemptions to school immunization requirements: secular trends and association of state policies with pertussis incidence. JAMA. 2006;296(14):1757-1763. 9. Omer SB, Richards JL, Ward M, Bednarczyk RA. Vaccination policies and rates of exemption from immunization, 2005-2011. N Engl J Med. 2012;367 (12):1170-1171. jama.com