Childhood Immunization: When Physicians and Parents Disagree

SUPPLEMENT ARTICLE

AUTHORS: Joan Gilmour, LLB, JSD,a Christine Harrison, MA, PHD,b Leyla Asadi, MD,c Michael H. Cohen, JDA, MBA,d abstract and Sunita Vohra, MD, MSce,f Persistent fears about the safety and efficacy of vaccines, and whether a Osgoode Hall Law School, York University, Toronto, Ontario, immunization programs are still needed, have led a significant minor- Canada; bDepartment of Bioethics, SickKids Hospital, Toronto, Ontario, Canada; Departments of cMedicine and fPediatrics, ity of parents to refuse vaccination. Are parents within their rights Faculty of Medicine, University of Alberta, Edmonton, Alberta, when refusing to consent to vaccination? How ought physicians re- Canada; dFenton Nelson LLP, Los Angeles, California; and eCARE spond? Focusing on routine childhood immunization, we consider the Program for Integrative Health & Healing, Stollery Children’s Hospital, Edmonton, Alberta, Canada ethical, legal, and clinical issues raised by 3 aspects of parental vac- KEY WORDS cine refusal: (1) physician counseling; (2) parental decision-making; immunization, health knowledge, attitudes, practice, physician- and (3) continuing the physician-patient relationship despite disagree- patient relations, treatment refusal ment. We also suggest initiatives that could increase confidence in ABBREVIATIONS immunization programs. Pediatrics 2011;128:S167–S174 MMR—measles, mumps, and rubella CAM—complementary and alternative medicine www.pediatrics.org/cgi/doi/10.1542/peds.2010-2720E doi:10.1542/peds.2010-2720E Accepted for publication Mar 30, 2011 Address correspondence to Sunita Vohra, MD, MSc, Edmonton General Hospital, 8B19-11111 Jasper Ave, Edmonton, Alberta, Canada T5K 0L4. E-mail: [email protected] PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, 1098-4275). Copyright © 2011 by the American Academy of Pediatrics FINANCIAL DISCLOSURE: The authors have indicated they have no financial relationships relevant to this article to disclose.

Downloaded from www.aappublications.org/news by guestPEDIATRICS on October Volume 1, 2021 128, Supplement 4, November 2011 S167 Phoenix, a 24-month-old boy, is brought In this we article focus on routine child- Diekema and the American Academy in by his mother for his annual well-child hood immunization. Other types of vac- of Pediatrics Committee on Bioethics physical examination. The physician no- cine may raise different considerations, have noted that the risks to an tices that the child has yet to receive vac- depending on data about risks, benefits, unimmunized child living in a well- cination against measles, mumps, and and long-term effectiveness, goals of the immunized community are low rubella (MMR) and reminds his mother vaccination program, and other factors, (although not as low as the risks of the need to have her son immunized. but they are beyond the scope of this ar- when the child is immunized). Presum- The mother is hesitant and states that ticle.4–8 We consider the ethical, legal, ably, then, a decision to decline immu- she has heard of the links between MMR and clinical issues raised by 3 aspects nization may be tolerated. In their clin- and autism. Citing several recent cases of our scenario: (1) physician counsel- ical report they contrast this case with of measles in the community, the physi- ing; (2) parental decision-making; and the example of a child with a deep and cian stresses the need for the MMR vac- (3) deciding whether to continue the contaminated puncture wound who cine to protect the young child, because physician-patient relationship despite may suffer serious harm if not given a they may be in the midst of a measles disagreement. tetanus vaccine.10,11 Such cases, which outbreak. He tells her that mortality could be categorized as needing acute ETHICS rates range between 1 and 3 of every care, can be distinguished from immu- 1000 cases and that acute encephalitis, Communication and Counseling nizations, which would be considered preventive care. which may cause permanent brain dam- There is more than one way to under- ϳ 1 age, occurs in 1 of every 1000 cases. stand parents’ views about immuniza- Deciding Whether to Continue the The mother counters that her chiroprac- tion.9 Some parents have virtually no Physician-Patient Relationship tor has discussed the issue of vaccina- information, and when provided with tion with her, including the topic of data about harms and benefits, they Many physicians encounter parents vaccination safety. In addition, the chiro- usually (anecdotally) give permission who refuse vaccines for their chil- practor discussed immune function and for their child to be vaccinated. Other dren.12 Are these physicians ever ethi- noted that treatments such as spinal parents may have limited information cally justified in rejecting these fami- manipulation and nutritional supple- or incorrect information that can be lies from their practice? What reasons ments, although not an alternative to corrected by the physician, and yet might they offer for this decision? vaccination, may optimize her son’s nat- others have a great deal of information One reason might be their concern for ural immune function. The physician is and a firm philosophical stance that other children in their practice (eg, frustrated and tells her that he is not immunization is not what is best for that nonimmunized children might ex- comfortable with continuing care for their child. There are also divisions be- pose other patients to disease). This is Phoenix if she chooses not to listen to his tween complementary and alternative a real concern, but there may be other professional advice. The physician won- medicine (CAM) practitioners and children in the practice who have not ders what he could have done differently some physicians about the merits and been immunized for medical reasons to avoid this impasse. risks of vaccination. or for whom immunizations failed. To Routine childhood immunization is im- Physicians’ ethical duty is to assess protect their patients during out- portant to both individual and public how much information parents have breaks, physicians should organize health. It is strongly promoted by the and to explore the values and beliefs their practices to minimize risk of ex- World Health Organization and by gov- that underlie their views about immu- posure, which would be the best way of ernments, public health authorities, and nization. Physicians should then fill in protecting their patients and providing health professions worldwide.2,3 A ma- gaps in parents’ knowledge about po- care to all who need it (including those jority of parents have their children vac- tential benefits and harms associated who are not immunized). Another rea- cinated. However, persistent concerns with both immunization and choosing son that physicians might wish to ex- about the safety and efficacy of vaccines, not to immunize and make an evidence- clude particular families from their and whether immunization programs based medical recommendation. It is practice is because the families’ val- are still needed, have led a significant then the parents’ choice. ues and beliefs differ to a great extent minority of parents to refuse vaccina- from the physicians’, and they are not tion. Are parents within their rights Parental Decision-Making comfortable with families who choose when refusing to consent to vaccination? Parents have a duty to make decisions to reject their professional advice. How should physicians respond? in the best interests of their children. However, parents may accept or reject

S168 GILMOUR et al Downloaded from www.aappublications.org/news by guest on October 1, 2021 SUPPLEMENT ARTICLE physicians’ professional advice, in- their substitute decision-makers and utory frameworks leave parents dis- cluding and beyond that related to im- consent to or refuse treatment on cretion to decide about consenting to munization, and still make good deci- their behalf, absent demonstrated ne- routine childhood immunizations. In sions regarding the health of their glect or unsuitability.17,18 Parents and one of the few Canadian legal cases in child. Respectfully disagreeing with guardians are to make decisions in the which the parents’ decision was chal- parents while continuing to treat their child’s best interests.17,19,20 However, lenged, the court held that refusing child provides an opportunity for the determinations about what consti- routine immunization did not provide physician to build trust and perhaps tutes “best interests” will differ and sufficient grounds for state interven- ultimately change the parents’ views are affected by value systems, reli- tion.30 If parents disagree about immu- about immunization. gious and other beliefs, perceptions of nization, however, Canadian courts As a general rule, physicians should risk and benefit, and other consider- have tended† to find in favor of the par- continue to care for children even ations. In recognition of these varia- ent who wants vaccination because it when their families reject immunizations, the law allows parents con- is in children’s best interests.31 Other- tion.10,11 However, if a physician truly siderable leeway in their decisions, wise, a legal challenge to a parent’s believes that he or she cannot con- provided that they, as the Supreme decision is unlikely to be successful tinue to provide care for a family, he or Court of Canada has stated, “do not ex- unless there is evidence of a greater she may end their relationship only af- ceed the threshold dictated by public need to protect either the child or the ter another physician has assumed re- policy, in its broad conception,”17 a community from vaccine-preventable sponsibility for the patient or the par- standard that depends heavily on fac- infectious diseases than is generally ents have been given reasonable tual circumstances, medical expertise, present with routine childhood vacci- notice that the physician intends to ter- and community values.21,22 nations.32 For instance, in Children’s minate the relationship.10,13 In the United States, all states have Aid Society of the Region of Peel v school-entry immunization require- T.M.C.H., the court authorized vaccina- LAW ments, although specifics vary among tion, despite parental refusal, of a new- them.23 As of 2010, all states permit born whose mother was a hepatitis Counseling and Informed Consent 33 medical exemptions, 48 permit reli- B carrier. Similarly, in the United Health care providers are legally gious exemptions, and 20 allow States, the American Academy of Pedi- obliged to obtain informed consent be- personal-belief exemptions.24 School atrics Committee on Bioethics has fore treating a patient. They must dis- immunization is not mandatory in all noted that when immunization rates close all material information about countries. For instance, in Canada, are high and disease prevalence is the treatment, its risks and benefits, only 2 provinces (Ontario and New low, the risk to others from small num- the alternatives (including nontreat- Brunswick) require proof of immuniza- bers of unimmunized children “does ment), and associated risks and an- tion for specified diseases before first- not usually pose a significant-enough swer patients’/parents’ questions.14,15 time admission to school,* and exemp- health risk to others to justify state Treating without consent, including 10(p1430) tions are available on medical grounds action.” vaccination, can give rise to civil liabil- and on grounds of religious belief or ity, professional discipline, and even Deciding Whether to Continue the conscience.25,26 However, children who criminal liability.16 When advising par- Physician-Patient Relationship have not been vaccinated can be ex- ents, health care practitioners should cluded from school during outbreaks Parents of young patients are entitled provide full and complete information to refuse treatment, even if strongly of vaccine-preventable diseases.25,27 In about the diseases targeted and the addition, public health legislation gen- recommended by physicians, provided risks and benefits of proceeding with erally authorizes required vaccination that doing so does not result in serious immunization or refusing it. 17,20 in the case of an epidemic or threat- risk to the life or health of the child. Physicians can discontinue profes- Parental Obligations ened epidemic of a communicable disease, but again, medical, religious, or sional services to a patient but, in When children are not yet able to de- conscience-based exemptions are al- †See Chmiliar v Chmiliar (2001), A.J. No. 838, 2001 cide about treatment, then according lowed.28,29 Thus, common law and stat- ABQB 525 (Q.B.) (parents disagreed about vaccina- to common law and in statutes that tion; 10-year-old son ordered vaccinated; 13-year- govern both consent to health care *Ontario imposes similar requirements for en- old daughter found not able to make voluntary de- trance into nurseries and preschools (see O. Reg. cision because of influence of mother’s irrational and child welfare, their parents or 262 made under the Day Nurseries Act, RSO 1990, c. fears, but vaccination not ordered because not in guardians are authorized to act as D.2). her best interests, given her age and opposition).

Downloaded from www.aappublications.org/news by guestPEDIATRICS on October Volume 1, 2021 128, Supplement 4, November 2011 S169 keeping with their professional obliga- views concluded that autism is not vaccination is particularly prevalent tions, must not abandon the patient. linked to MMR,58–60 and the medical among parents who also use Regard should be had to the legisla- journal that published the study re- CAM.23,76–78 61,62 tion, regulations, and policies in the ju- tracted it. In addition, the physi- Because it becomes even more diffi- risdiction in question if the physician cian/lead author Andrew Wakefield cult to communicate the importance of plans to sever the relationship. Gener- and 2 co-authors were the subject of immunization when a physician’s pro- ally, if initiated by a physician, the pa- professional misconduct proceedings. fessional opinion is contradicted by a tient or parents must at least be given In 2010, England’s General Medical CAM practitioner, it is important to ex- reasonable opportunity to arrange al- Council concluded that charges amine their views (in this scenario, 10,34,35 ternative services. against Dr Wakefield of conducting in- chiropractors). Chiropracty is among vasive research on children contrary the most frequently used CAM prac- Considering No-Fault to their best interests and without eth- tices and one of the most established Compensation ics approval, presenting results in a CAM disciplines in North America.79–81 dishonest and irresponsible manner, The Manitoba Law Reform Commission The Canadian Chiropractic Associa- and others had been proven. Another noted that “[p]arents are persuaded to tion “accepts vaccination as a cost- hearing concluded that these actions place great reliance in the integrity and effective and clinically efficient public constituted serious professional mis- safety of the routine childhood immuni- health preventive procedure for cer- conduct, and the council banned him zation system and to expose their tain viral and microbial diseases, as from practicing medicine.63,64 Despite healthy children to it,” protecting not demonstrated by the scientific com- this history, the scientific community only that child from disease but also con- munity.”82 Nonetheless, surveys of chi- in Britain has had little success com- tributing to the protection of the whole ropractors have revealed that many of bating misinformation about MMR in community.36 However, establishing le- them still have misgivings about the the media and has seen the number of gal liability for vaccine-related injury safety of immunization.83–87 One would children who receive the MMR vaccine through a civil lawsuit is difficult; most assume that a way to increase accep- plummet.65,66 The rates of immuniza- such claims fail.5,27,37,38 The United States tance of vaccinations would be education are reaching a point at which that and England have implemented adminis- tion and discussion with CAM practitio- if these levels persist, the United King- trative compensation systems for vac- ners. However, a randomized trial by 39–43 dom might once again face epidem- cine injury ; in Canada, only Quebec 88 67–69 Wilson et al revealed that neither 44–46 ics and/or the reemergence of en- has done so. Although benefits evidence-based teaching nor presen- demic measles,70 which is a harrowing available are broad, the need to estab- tations from polio survivors changed prospect that seems more grim when lish a causal link between the vaccine chiropractic students’ perceptions of considering the potential ripple effects and the harm suffered still limits eligi- immunization. In fact, the provaccine 47,48 throughout the rest of Europe and bility. Administrative compensation presentations may have even strength- systems can be structured with less even North America.71,72 These statis- tics also suggest that health care pro- ened antivaccine attitudes, which sug- stringent eligibility requirements than gests a need for different and unique needed to establish civil liability and fessionals and public health agencies have not yet learned how to communi- educational strategies. One reason for potentially compensate more claim- this failure may be that educational ants.49–54 No-fault compensation in cate effectively with parents about immunization. The occurrence of vaccine- programs have not addressed prac- those rare instances when serious in- titioners’ concerns, such as ques- jury occurs could ease concerns about associated adverse events cannot be 73,74 tions regarding safety of adjuvants participating and redress harm. denied, but they are rare, and given the overwhelming evidence in favor and preservatives used in vaccine preparation. Learning about CAM CLINICAL RESPONSE of immunization, medical authorities widely accept that vaccines provide practitioners’ questions and answer- Counseling and Education: safe, cost-efficient, and highly effective ing them could assist in assuaging Communicating With Patients and protection against infectious diseases. their concerns. CAM Practitioners Most parents recognize that immuni- Ultimately, physicians must inquire In 1998, a now infamous study linked zation is important for their children’s about their patients’ and parents’ be- the MMR vaccine to autism.55 The study well-being, but a significant number liefs in a respectful manner, maintain was retracted by almost all of the co- of them are also concerned about an open and understanding relation- authors,56,57 several comprehensive re- vaccine safety.75 This negative view of ship with families, and use their role in

S170 GILMOUR et al Downloaded from www.aappublications.org/news by guest on October 1, 2021 SUPPLEMENT ARTICLE providing continuing care as an oppor- of illnesses they are intended to pre- the diseases targeted should be de- tunity to educate families and continue vent.36 These observations help ex- veloped, potentially through rele- discussion. The best place to start plain the lack of confidence in child- vant educational institutions, regu- such conversations may be reminding hood immunization programs that latory bodies, and professional the family that physicians and parents underlies some parents’ decisions associations. share a common goal: the best inter- not to vaccinate. 5. Public educational campaigns ests of the child. However, when there 1. In advising parents, health care should also disseminate this infor- is no evidentiary basis for parental re- practitioners should provide full in- mation widely. fusal of a particular vaccine or when formation in clear language about 6. Policy-makers should consider re- the evidence establishes parental be- the risks and benefits of immuniza- forming compensation systems to liefs about a vaccine to be untrue, phy- tion and the diseases targeted10,95–98 introduce no-fault compensation if sicians should make those facts clear. and information on the efficacy and a child should suffer a vaccine- Parents who are unwilling to consent risks of alternatives, including vac- related injury. to vaccination may be prepared to ac- cine refusal. Information needs to cept a compromise (eg, vaccination be presented in a way that best sup- with a single component of a multiva- ports informed decision-making, ACKNOWLEDGMENTS lent vaccine, staggered doses, ad- which ensures that parents have Funding for this project was partially justed scheduling). Although some the necessary foundation for mak- provided by the SickKids Foundation physicians find this contentious, being sound decisions.99–105 (Toronto, Ontario, Canada). Dr Vohra cause it is not in keeping with current 2. Physicians and other clinicians received salary support from the Al- guidelines, others argue that some should tell parents when their be- berta Heritage Foundation for Medical vaccination is preferable to none.89–93 liefs about the vaccine in question Research and the Canadian Institutes RECOMMENDATIONS are unsupported or disproved by of Health Research. evidence. Parents, while taking medical advice We thank the anonymous pediatric chi- and statistical information about 3. Physicians can discontinue profes- ropractic reviewer for comments on risks, benefits, and likelihood of harm sional services to a patient but this article; all errors and omissions into account, are not making a deci- must comply with applicable legal remain our own. We also gratefully ac- sion about an aggregate group but and ethical requirements when sev- knowledge the contributions of Soleil about an identifiable life—that of their ering the relationship. Patients and Surette and Alison Henry for help in child, whom they are charged to pro- parents are entitled to refuse treat- literature searching and manuscript tect. They want to do their best to do so ment that a physician recommends; preparation, Maya Goldenberg and An- responsibly. However, people perceive however, not every such disagree- drew Milroy for bioethics research as- and weigh risk differently.94 In addi- ment should result in physicians sistance, and Osgoode Hall Law School tion, even after discussion, some par- discharging patients and families students (now graduates) Nicola Sim- ents may feel that they do not receive from their practices. mons, David Vitale, Kristine Bitterman, sufficient information about the risks 4. Educational programs for CAM and Janet Chong for assistance with and benefits of vaccines and the risks practitioners about vaccines and legal research. REFERENCES

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Downloaded from www.aappublications.org/news by guest on October 1, 2021 Childhood Immunization: When Physicians and Parents Disagree Joan Gilmour, Christine Harrison, Leyla Asadi, Michael H. Cohen and Sunita Vohra Pediatrics 2011;128;S167 DOI: 10.1542/peds.2010-2720E

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