(c) 2006 RD Silverman Vaccine Law & Policy Ross D. Silverman, JD, MPH SIU School of Medicine...

(c) 2006 RD Silverman

Vaccine Law & Policy

Ross D. Silverman, JD, MPHSIU School of [email protected] 4, 2006

John McPherson


Outline

• Background• Exemptions based on religious or moral

grounds– Recent developments– Are we near the tipping point?

• Policy Options• Vaccine Shortages, Bioterrorism & Avian

Flu


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


Source: MMWR 45(RR-12);1-35, 09/06/1996

TABLE 1. The maximum number of cases of specified vaccine-preventable diseases ever reported for a calendar year compared with the number of cases of disease and vaccine adverse events reported for 1995 -- United States =================================================================================================== Maximum no. reported Year(s) Reported Percentage cases during maximum no. no. cases change in Category prevaccine era cases reported during 1995 * morbidity ------------------------------------------------------------------------------------------------- Disease Congenital rubella syndrome 20,000 + 1964-65 7 (-99.96) Diphtheria 206,939 1921 0 (-99.99) Invasive Haemophilus influenzae 20,000 + 1984 1,164 (-94.18) Measles 894,134 1941 309 (-99.97) Mumps 152,209 1968 840 (-99.45) Pertussis 265,269 1934 4,315 (-98.37) Poliomyelitis (wild) 21,269 1952 0 (-99.99) Rubella 57,686 1969 146 (-99.75) Tetanus 601 1948 34 (-97.82) Vaccine adverse events & 0 10,594 ------------------------------------------------------------------------------------------------- * Provisional totals. + Estimated because national reporting did not exist in the prevaccine era. & Total number reported to the Vaccine Adverse Events Reporting System (VAERS). ===================================================================================================


Herd Immunity


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


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.


Immunization Law. Different.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


in exemption use/ enforcement

expanded exemptions

side effect concerns

law focus on individual rights

Unprotected Pool

Population Protections from Vaccine-preventable

Infectious Disease


Exemption Laws 2004


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


What is “religion”?

How can religious beliefs be assessed?

Religion: Administrative Issues


What’s the difference between a personal belief and a religion?

(Whatever the judge says it is.)

• 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


Conclusions re: “Religion”

• Low threshold for exemption

• “Magic words”

• No discernable difference between religion & moral exemption


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.


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.


The Tipping Point:One Media Event Away?

• 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


John McPherson

Health professionalswith limited workingknowledge of manyvaccine-preventableinfectious diseases


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


VACCINES VACCINES HURT OUR HURT OUR BABYBABYKatherine Zeta-JonesKatherine Zeta-Jones and and Michael DouglasMichael Douglas speak for speak for the first time about their the first time about their struggles following the struggles following the mysterious, tragic illness mysterious, tragic illness of their daughter of their daughter CarysCarys, , and why parents should and why parents should think twice before saying think twice before saying “yes” to the next shot.“yes” to the next shot.

August 2, 2003



“If you build it…they will come.”


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)

0

2000

4000

6000

8000

10000

12000

14000

1987 1990 1994 1998

Religious Moral


Arkansas Students Requesting Exemptions from School Immunization

Exemption 2001-2 2002-3 2003-4 2004-5

Medical 110

20%

139

21.4%

64

8.4%

101

8.6%Religious 419

79.2%

512

78.6%

297

38.9%

366

33.4%Philosophic 0 0 403

52.7%

728

66.5%Rick D. Hogan, 2005


Michigan - Hard Policy Choices

0

10

20

30

40

50

60

70

80

90

1994 1995 1996 1997 1998 1999 2000

0.00

0.50

1.00

1.50

2.00

2.50

3.00

$ (millions)

Vax Rates %

% Exemptions

MI Dept. of Community Health


John McPherson


Additional vaccine issues:

• Distrust of the vaccine system generally• Vaccine supply & liability• Bioterrorism

– Anthrax– Smallpox– BioShield

• Avian Influenza & Pandemic preparedness


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


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.

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