Margaret J. Kochuba, Public Health vs. Patient Rights: Reconciling Informed Consent With Hpv Vaccination

• Publication year: 2009

COMMENTS

PUBLIC HEALTH VS. PATIENT RIGHTS: RECONCILING INFORMED CONSENT WITH HPV VACCINATION

INTRODUCTION

Prior to June 21, 2007, eighteen-year-old Shannon Nelson was a healthy student-athlete who ran six miles a day, enjoyed art and music, and was preparing for college.¹This all changed when Shannon received a simultaneous vaccination with the human papillomavirus (HPV) vaccine, a chicken pox vaccine, and a meningococcal vaccine.²Shortly thereafter, Shannon experienced symptoms of tingling, numbness, and muscle weakness, which progressively worsened into paralysis from Guillain-Barré Syndrome (GBS)³and culminated in a twenty-two-day hospitalization.⁴No longer able to run or participate in the activities she formerly enjoyed, Shannon was forced to undergo physical therapy as she recovered from her illness.⁵

Shannon reported her experience to the National Vaccine Information Center (NVIC), a national nonprofit organization dedicated to educating the public about vaccine safety and protecting informed consent ethics in vaccination.⁶The NVIC has closely monitored Gardasil,⁷the HPV vaccine manufactured by Merck, Inc., which Shannon received, since its approval for use in females ages 9-26 in June 2006.⁸The NVIC has raised several questions about the safety and efficacy of Gardasil since its introduction to the market.⁹In particular, the NVIC called attention to the limited knowledge of the vaccine's safety and efficacy due to its abbreviated review by the Food and Drug Administration (FDA).¹⁰Additionally, its analysis of reports to the Vaccine Adverse Events Reporting System (VAERS)¹¹revealed worrisome complications among younger girls receiving Gardasil.¹²In August 2007, the NVIC raised another major concern by finding a significant correlation between the occurrence of GBS and the co-administration of Gardasil and

Menactra,¹³a meningococcal vaccine, as experienced in Shannon's case.¹⁴

In spite of these emerging concerns regarding Gardasil's safety and efficacy, twenty-four states and the District of Columbia recently moved to make HPV vaccination a mandatory prerequisite to public school attendance for young girls.¹⁵Virginia is currently the only state with a law requiring HPV vaccination for girls entering the sixth grade.¹⁶Texas enacted a similar mandate in February 2007 by executive order from the governor, which the state legislature subsequently overrode due to public controversy.¹⁷

Mandatory HPV vaccination raises a host of ethical, legal, and medical questions. One concern is that mandatory HPV vaccination is not justified by necessity, and constitutes an improper use of the state police power.¹⁸A second concern involves the uncertainties surrounding the vaccine's overall safety and efficacy.¹⁹This Comment argues that nondisclosure of the data showing deficiencies in safety and efficacy violates core principles of informed consent and undermines the recognized right of patients to make an intelligent and informed treatment decision.²⁰

This Comment first examines the tension between mandatory HPV vaccination and the state police power by analyzing the interplay between public health goals and patient rights. Part I explores the public health perspective on mandatory vaccination, including the history of mandatory vaccination in the United States and the constitutional basis that exists for government implementation of mandatory vaccination programs. Part I also analyzes the rationale used by courts to uphold mandatory vaccination schemes under the state police power, then applies this rationale to mandatory HPV vaccination, and concludes that mandatory HPV vaccination is an improper use of the state police power.

Part II of this Comment explores the varying standards of informed consent and how informed consent interacts with public health goals in the HPV vaccine context. Part II also argues that informed consent and patient rights are jeopardized by mandatory HPV vaccination, due to substantial deficiencies in the vaccine's safety and efficacy data, which are not adequately disclosed to patients. Part III analyzes the variations among proposed state legislation for mandatory HPV vaccination and argues that the designated exemptions are insufficient to protect patient rights.

I. THE PUBLIC HEALTH PERSPECTIVE

A. Mandatory Vaccination and the State Police Power

The Tenth Amendment to the U.S. Constitution provides that any powers not expressly granted to the federal government or expressly forbidden to the states are reserved for the states.²¹These reserved powers, known collectively as the state police power, have been construed by the Supreme Court to include "inspection laws, quarantine laws, [and] health laws of every description."²²

In 1905, the Supreme Court upheld the first mandatory vaccination law in the landmark case of Jacobson v. Massachusetts.²³The Cambridge board of health ordered all inhabitants of the city to submit to smallpox vaccination because the disease was on the rise.²⁴Henning Jacobson brought suit, challenging the city's regulation as an unconstitutional exercise of authority over his person.²⁵The Supreme Court ultimately disagreed, holding that the state police power "embrace[d] . . . such reasonable regulations established directly by legislative enactment as will protect the public health and the public safety."²⁶The Court recognized the state police power as a constitutional basis for mandatory vaccination programs.²⁷

The Jacobson Court acknowledged that the state police power must be exercised reasonably and should be "justified by the necessities of the case."²⁸

In the context of that particular case, the Court found that the state of Massachusetts had several compelling justifications for mandatory vaccination, including the fact that smallpox was a highly prevalent disease in Cambridge at the time,²⁹and the commonly held belief among medical and legislative authorities that vaccination was "an effective if not the best known way in which to meet and suppress the evils of a smallpox epidemic that imperilled an entire population."³⁰

As the Jacobson Court noted, mandatory vaccination may serve crucial public health goals and be a legitimate exercise of the state police power under justifying circumstances.³¹Widespread vaccination of a population has the effect of creating herd immunity, which occurs when "a large proportion of group members are immune to a disease, [making] the group as a whole . . . resistant to attack."³²Herd immunity hinders the transmission of disease by increasing the population's overall resistance, which in turn protects the unvaccinated minority.³³By creating herd immunity, mandatory vaccination programs can impede the transmission of disease and effectively reduce or eradicate epidemics.³⁴

Many school vaccine mandates reflect the underlying goal of creating herd immunity because they require children to be immunized against highly contagious diseases, such as diphtheria, pertussis, influenza, measles, mumps, and rubella.³⁵However, the goal of herd immunity does not explain every vaccine mandate. Many states require vaccination against diseases that are not easily transmitted from person to person, such as hepatitis B,³⁶or those that are not transmitted at all, such as tetanus,³⁷based on a desire to protect the individual alone.³⁸For example, the tetanus vaccine is unable to create herd immunity and thereby benefit unvaccinated individuals or the community at large.³⁹This type of individualistic vaccine mandate is harder to accept under the rationale of Jacobson, a case that emphasized the need to protect the community as a whole, rather than the individual, as the basis for mandatory vaccination under the state police power.⁴⁰

A 1992 New York case, In re Christine M., reiterated the principle that necessity is required to legally justify a vaccine mandate.⁴¹In Christine M., a father refused to vaccinate his three-year-old daughter against smallpox despite a New York law requiring smallpox vaccination.⁴²At that time, there was a serious outbreak of measles in New York City which placed unvaccinated children at high risk for contracting the disease.⁴³By the time the New York Family Court decided the case, however, the measles outbreak had abated.⁴⁴

The court found that although "some risk [still] exist[ed] that Christine [would] contract measles, the urgency previously created by the epidemic or outbreak" no longer existed.⁴⁵The court declined to require inoculation of the child due to the fact that the urgent individual necessity, which existed during the measles outbreak, had diminished.⁴⁶

Christine M. and Jacobson illustrate that regardless of whether a state seeks to impose mandatory vaccination for the benefit of a single individual or for an entire community, a finding of necessity is required.⁴⁷The following section argues that the HPV vaccine is geared primarily toward protection of the individual, rather than the community; that it lacks the requisite characteristic of necessity; and that as a result, mandatory vaccination cannot be justified by the use of the state police power under the rationales of Jacobson and Christine M.

B. Mandatory HPV Vaccination Is Not Justified by Necessity

This section applies the rationale of Jacobson to the current public health debate over mandatory HPV vaccination. It argues that HPV is different from diseases previously combated by mandatory vaccination schemes because it is primarily sexually transmitted, and that this distinction weakens the state's argument for using the police power as a basis for mandatory HPV vaccination. This section further argues that because routine pap screening has the ability to detect and cure most cases of HPV prior to the development of cervical cancer, mandatory HPV vaccination is unnecessary.

1. Characteristics of HPV

HPV⁴⁸has been the subject of recent public health concern due to the disease's prevalence in contemporary society and its strong correlation with cervical...