Vaccine Law & Policy Ross D. Silverman, JD, MPH SIU School of Medicine rsilverman@siumed.edu November 4, 2006

Outline • Background • Exemptions based on religious or moral grounds • Recent developments • Are we near the tipping point? • Policy Options • Vaccine Shortages, Bioterrorism & Avian Flu (c) 2006 RD Silverman

Brief HistoryU.S. Policy • Top Public Health Achievement of 20th Century • Mandatory for entrance into public schools, licensed day care and pre-schools (Head Start) • Variations from state to state (c) 2006 RD Silverman

Legal Authority to Require VaxDue Process & Equal Protection • Jacobson v. Massachusetts (1904)“[Liberty] does not import an absolute right in each person to be, at all times and in all circumstances, wholly freed from restraint. There are manifold restraints to which every person is necessarily subject for the common good.”197 U.S. 11, 14 • Zucht v. King (1922) - vaccination of children (c) 2006 RD Silverman

Religion & Vaccination - Judicial • Prince v. Massachusetts (1944)“Parents may be free to become martyrs themselves. But it does not follow [that] they are free… to make martyrs of their children.” 321 U.S. 158, 170. (c) 2006 RD Silverman

Immunization Law.Different. Public health is different • “Organized to provide an aggregate benefit to the health of all the people in a community.” (Gostin) Public health law is different • Police Powers • Courts loathe to review • Slow/subtle Immunization of children is different • Medical tx, preventive tx, patient & parental rights, privacy, state interests, informed consent Immunization law is different • legislatures pass laws, health departments & boards determine mandates & exemption process, schools enforce (c) 2006 RD Silverman

 law focus on individual rights  side effect concerns expanded exemptions  in exemption use/  enforcement Unprotected Pool Population Protections from Vaccine-preventable Infectious Disease (c) 2006 RD Silverman

Three States Recently In The News • New York – where does religion end and philosophy begin? • Wyoming – no investigation into beliefs • Arkansas – no religious exemption at all >> new vaccination law (c) 2006 RD Silverman

Turner v. Liverpool Central School District(S.D.N.Y., March 2001) Congregation of Universal Wisdom Two-pronged analysis for religious exemption - Is the belief religious? Genuinely and sincerely held? judge can’t assess credibility any arguably religious belief must be considered religious belief does not have to fall in line with any particular dogma, only genuinely and sincerely held. Although: No regular meetings Low parent knowledge of religion Parent history of inconsistent action regarding her beliefs Parent testimony re: vax “inconsistent and ever changing” Beliefs closely tied to chiropractic ethic Court ruled in favor of the parent and determined belief was religious What’s the difference between a personal belief and a religion?(Whatever the judge says it is.) (c) 2006 RD Silverman

LePage v. Wyoming &Jones v. Wyoming St. Dept. of Health(March 2001) • Wyoming statute: Waivers shall be authorized by the state or county health officer upon submission of written evidence of religious objection or medical contraindication to the administration of any vaccine. • Court: all the applicant must do is submit the form and the state must approve. State may not ask for reasons or investigate. (c) 2006 RD Silverman

McCarthy v. Boozman Boone v. Boozman(Arkansas 2002) • The provisions of this section shall not apply if the parents or legal guardian of that child object thereto on the grounds that immunization conflicts with the religious tenets and practices of a recognized church or religious denomination of which the parent or guardian is an adherent or member. • Courts: Unconstitutional. No religious exemption permitted for anyone. (c) 2006 RD Silverman

Parents with little exposure to illnesses Media interest Internet - health care info Distrust of government Globalism Cost of containment Increased use of opt-outs when available Smallpox side effects discussion The Tipping Point:One Media Event Away? (c) 2006 RD Silverman

State Enforcement of LawsRota et al, 2001, Hogan 2005 • Process to get exemption in many states easier than getting vaccinated • More complicated exemption process leads to lower exemption rates • 28 states – no authority to deny exemption request – only 16 states reported ever denying • 34 states did not require renewal of exemption • Only 9 states reported giving parents info about dangers of not vaccinating (c) 2006 RD Silverman

August 2, 2003 People weekly The tipping point? VACCINES HURT OUR BABY Katherine Zeta-Jones and Michael Douglas speak for the first time about their struggles following the mysterious, tragic illness of their daughter Carys, and why parents should think twice before saying “yes” to the next shot. (c) 2006 RD Silverman

Give individual freedom with one hand, take away public health protection with other (Colorado) • % of Religious exemptions dip slightly from 1987-1998; however, philosophical exemptions increase by 83% • Philosophical exemptions rise from 74% to 87% of total exemptions • Relative Risk for Measles 22x greater for child exemptors; 5.9 x for pertussis (however, 62x greater and 16x greater, respectively, for children of day care and primary school age) • Annual incidence rates significantly associated with frequency of exemptors • 11% of vaccinated children known to have contracted measles from exemptor (67% unknown exposure source) Feikin, et. al., JAMA 284:3145-3150 (2000) (c) 2006 RD Silverman

Additional vaccine issues: • Distrust of the vaccine system generally • Vaccine supply & liability • Bioterrorism • Anthrax • Smallpox • BioShield • Avian Influenza & Pandemic preparedness (c) 2006 RD Silverman

Conclusions • Exemptions in general, esp. moral, more frequently obtained • Blurring of line between “religious” and “philosophical,” coupled with little scrutiny of declarations, make exemptions easier to get even in states w/o “moral” grounds • Political & legal environment, while sympathetic to public health concerns, still underfunds public health and prioritizes individual interests over community health • Most protective political solution unlikely absent epidemic; therefore should fight for as robust an exemption process as possible • New & untested vaccines for use in emergency circumstances will place significant additional pressures on public health education efforts and risk goodwill • Distrust in vaccines undermines all types of public health & emergency planning (c) 2006 RD Silverman

Sources • Silverman RD. No more kidding around: restructuring non-medical childhood immunization exemptions to ensure public health protection. Ann Health Law. 2003 Summer;12(2):277-94. • Feikin DR et. al. Individual and community risks of measles and pertussis associated with personal exemptions to immunization. JAMA. 2000 Dec 27;284(24):3145-50. • Rota JS et al. Processes for obtaining nonmedical exemptions to state immunization laws. Am J Public Health. 2001 Apr;91(4):645-8. • Salmon DA et al. Knowledge, Attitudes, and Beliefs of School Nurses and Personnel and Associations With Nonmedical Immunization Exemptions. Pediatrics. 2004 Jun;113(6):e552-9. • Fredrickson DD et al. Childhood Immunization Refusal: Provider and Parent Perceptions. Fam Med. 2004 Jun;36(6):431-9. • Arkansas Statutes, § 6-18-702. Immunization. 2004. (c) 2006 RD Silverman

Vaccine Law & Policy Ross D. Silverman, JD, MPH SIU School of Medicine rsilverman@siumed.edu November 4, 2006