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Immunization of Boys Against HPV: Neither Sound Ethics Nor Sound Public Policy (4000)

11/03/2011 Comments (25)

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On Oct. 25, 2011, the Advisory Committee on Immunization Practices (ACIP) recommended that all 11- and 12-year-old boys be routinely vaccinated against human papillomavirus (HPV). This questionable decision should make Catholics re-examine the issue of HPV immunization and redouble their efforts to build a culture of life, particularly in matters of health and health care. A little history is in order to put this decision into proper context.

In June 2006, the ACIP recommended routine immunization of girls against HPV to reduce rates of cervical cancer among women. About 12,000 women in the U.S. get cervical cancer each year, and HPV, a sexually transmitted disease (STD), is the main cause of cervical cancer.

There are several reasons why the Catholic Medical Association (CMA) has recognized that immunizing girls against HPV can be an acceptable public-health policy and an ethical option that individuals or parents may choose.

In reputable clinical trials, Merck’s Gardasil and GlaxoSmithKline’s Cervarix have been shown to be safe and effective at protecting against some three to five strains of HPV, respectively (out of more than 40 total genital strains), which cause most cervical cancer. Both drugs are expensive, at about $130/dose, with three doses recommended for complete protection.

Still, cost-effectiveness models have estimated that a program of universal vaccination of adolescent girls will cost $23,000-$45,000 per quality-adjusted life year (QALY) saved, which falls within a range generally deemed acceptable for preventive medicine.

HPV immunization can be an ethical option for individuals and parents to choose. Of course, no one should choose a means of protection in order to purposely facilitate immoral action. But the Church does not demand that individuals be made to suffer the full effects of their bad judgments. And healing and preventing diseases, no matter what their source, are acts of mercy.

While it is possible to screen for and treat cervical cancer without immunization, such interventions bring their own burdens. False-positive results during cancer screening cause significant emotional distress for an individual and a couple. And surgically removing precancerous lesions can cause increased rates of both preterm deliveries and cesarean-section deliveries.

However, even with the most generous interpretation of the public-health policy and ethical analysis, significant questions remain. For example:

— What is the long-term effectiveness of HPV immunization? No studies have yet been published on whether the vaccines confer immunity for an extended period, e.g., 15-plus years. Moreover, it is still not certain whether HPV immunity in the teenage years will truly reduce cancer rates 20-40 years later, when most cervical cancer develops.

— What is the real (not theoretical) cost-effectiveness of HPV immunization? Current cost-benefit ratios are based on 70%-75% of all girls being fully immunized. But less than 50% of girls have received even one dose of vaccine; only 33% have received all three.

— Will there be negative behavioral responses to the immunization campaign? If immunized girls improperly feel “protected” — engaging in more risky, immoral behaviors and failing to consistently receive annual pap smears — then HPV immunization will fail to deliver the hoped-for benefits.

Even if a case can be made for the routine immunization of girls (while always respecting the free and informed consent of parents and individuals), the same case cannot be made for boys.

ACIP officials attempted to put the best spin on their decision — appealing to the goals of preventing more cancers, “gender equity” and adding a layer of protection for girls. But key differences exist in terms of public-health goals and cost-benefit analysis.

For starters, while Gardasil can prevent some precursors to cancer resulting from male homosexual activity, these cancers are less common and generally more treatable than cervical cancer in women. Because of this, and because the marginal benefit to girls of immunizing boys is relatively limited, the cost of prevention would rise from $23,000-45,000 to hundreds of thousands of dollars per QALY. This makes no sense in terms of sound public policy. Nor is it in the best interests of one of the ACIP’s target populations — boys engaged in homosexual acts.

If immunized boys feel protected, and engage in more risky, immoral behavior, while seeking less medical attention, the consequences for their physical and moral health will be devastating.

The ACIP’s questionable decision illustrates some key individual and institutional failings that are bringing our nation to a point of crisis. On the one hand, the promiscuous sexual behavior of many individuals is creating an epidemic of STDs, including the symptomless disease of HPV, which causes cancer years after it has been contracted.

On the other hand, a technophilic approach to medicine, combined with a big-government approach to spending and intervening in family matters, will create an expensive, bureaucratic solution of questionable prudence to a problem that can be better met through formation in the virtues.

Ideally, the ethical evaluation of HPV immunization should be conducted in terms of reliable data and moral prudence, yet the real world of American health care and public policy is charged with a variety of agents and agendas.

For example, the ACIP recommended routine immunization of girls in June 2006, even though the first phase-3 trials of the HPV vaccine with clinically relevant end points weren’t reported until May 2007.

From the start, Merck engaged in a political full-court press to persuade states to mandate HPV immunization. And, as the Catholics for the Common Good has revealed, Merck has given hundreds of thousands of dollars to medical societies like the American College of Obstetricians and Gynecologists to help persuade key decision-makers to encourage HPV immunization. 

Most recently, these efforts culminated in a new law in California that permits children as young as 12 years old to accept HPV immunization without parental consent. 

Catholics should not recuse themselves from this debate. They should be engaged both in challenging the secular solutions that are being put forward and in creating alternatives that better protect human health and human life.

John F. Brehany, Ph.D., is executive director of the Catholic Medical Association. Maricela P. Moffitt, M.D., M.P.H., is president-elect of the Catholic Medical Association.

Filed under catholic medical association, hpv, human papillomavirus