HPV vaccine: Doctors welcome it but question mandate of anticancer shot
Ethicist says school access shouldn't hinge on being vaccinated
The vaccine that provides protection against four types of human papillomavirus (HPV), a leading cause of cervical cancer, is recommended by the Centers for Disease Control and Prevention and the American Academy of Pediatrics (AAP), but drives to mandate it for adolescent girls have created a storm of controversy.
While most health care associations have stated support for a vaccine that could curb the threat of cervical cancer, there are mixed views on the ethics of mandating the vaccine and making school attendance dependent upon it.
"Making school attendance conditional on HPV vaccination does not make sense, because girls who are not vaccinated pose no threat — as they would with communicable diseases such as mumps, measles, and polio — to other children attending school," says Paul Cieslak, MD, a communicable disease manager for the Oregon Department of Human Services and a member of the Wynnewood, PA-based Catholic Medical Association (CMA).
Texas Gov. Rick Perry issued an executive order in early 2007 mandating that vaccination with Gardasil (Merck & Co., Whitehouse Station, NJ) be a requirement for all girls entering sixth grade in his state. Getting lesser attention is the fact that the HPV vaccine is subject to the same exemption policies already in place in Texas, by which parents who want to decline the vaccine for their daughters for philosophical reasons may do so by completing a paper or on-line form.
At issue among parents, doctors, and legislators, however, are a number of ethical issues:
- Will vaccination against the sexually transmitted HPV lead to careless sexual practices due to a false sense of protection against sexually transmitted diseases (STDs)?
- Is the vaccine effective enough to warrant legislative mandate, and should it be tied to school admission?
- Do manufacturers overstep ethical bounds by advocating for legislation mandating their products, from which they stand to gain enormous profit?
Healthy prevention or hasty reaction?
According to the CDC, there are 40 types of HPV, and genital HPV is the most common sexually transmitted virus in the United States. About 20 million people in the United States are infected, and an estimated 6.2 million more get infected each year.
Gardasil is an inactivated vaccine that protects against four types of HPV — two types that the CDC says cause about 70% of cervical cancer, and two types that cause about 90% of genital warts.
Critics say the vaccine is too new to be mandated, that its effectiveness and safety aren't fully known. The CDC says the vaccine was tested in more than 11,000 girls and women worldwide, with few adverse effects (primarily soreness at the injection site) reported.
The 2007 childhood immunization schedule from the American Academy of Pediatrics recommends vaccination for girls 11 to 12 years old and "catch-up" immunization for girls age 13 to 18. The vaccine is given as three injections over a six-month period, and at $360 for the series is among the most costly vaccines on the market. Developed and sold as a vaccine against the HPV virus, Gardasil has been approved by the FDA to prevent cervical cancer in females between 9 and 26 years of age.
About 20 states are considering making the HPV vaccine mandatory, but Gov. Perry's executive order requiring the vaccine drew condemnation as well as praise.
"Requiring young girls to get vaccinated before they come into contact with HPV is responsible health and fiscal policy that has the potential to significantly reduce cases of cervical cancer and mitigate future medical costs," Perry said in a statement following the order.
A conservative Republican, Perry drew fire from his own party for what they viewed as mandating a vaccine that could promote sexual promiscuity — the argument being that by protecting against the STD women could let their guard down and neglect safe-sex practices and annual gynecological exams.
Harold Vanderpool, PhD, ThM, medical ethicist at the University of Texas (Galveston) Medical Branch, says to equate vaccination against a STD with sexual promiscuity "is a stretch."
"[A girl's] parents and her peers have more influence on her sexual decisions than the fear of cancer," says Vanderpool. "The legitimate ethical debate on this vaccine is about whether it should be mandated or optional; that's an issue we need to discuss as a society."
As critics weighed in on his executive order, Perry countered that the opt-out provision preserves parents' rights.
"Providing the HPV vaccine doesn't promote sexual promiscuity anymore than providing the hepatitis B vaccine promotes drug use," Perry says. "If the medical community developed a vaccine for lung cancer, would the same critics oppose it claiming it would encourage smoking?
"[P]arents need to know that they have the final decision about whether or not their daughter is vaccinated. I am a strong believer in protecting parental rights, which is why this executive order allows them to opt out."
(Editor's note: In late March, the Texas House passed a bill overturning Perry's order, and the Senate is expected to vote on it in late April. If the executive order is repealed by the Legislature, Perry will have the option to veto it; however, legislative support for overturning the mandate is expected to mean any veto could be overridden. In addition, State Attorney General Greg Abbott told some legislators that Perry's mandate of the HPV vaccine is "unenforceable," according to media accounts.)
Drug maker drops lobby efforts
Following a vigorous effort in Texas and other states to lobby legislators to mandate the vaccine, drug maker Merck & Co. in February announced it would curb its efforts.
Georgetown University Law Center's Lawrence Gostin, JD, director of the O'Neill Institute for National and Global Health Law, says it is inappropriate for pharmaceutical companies to lobby for something from which they will directly benefit, as Merck did for mandatory vaccination laws.
"[The HPV vaccine] is a marvelous public health intervention, but it should be part of a large-scale, national campaign to reduce the prevalence of sexually transmitted diseases," says Gostin.
The HPV vaccine offers the best protection when administered before a girl becomes sexually active. Girls can contract HPV as teenagers through sexual activity, and not develop cervical cancer until years later.
Though some opposition to the mandate — not the vaccine itself — suggests that requiring the vaccine for all girls could encourage risky sexual practices, most critics question whether states should be linking the vaccine to schools.
Ethicist John Brehany, PhD, STL, executive director of the Catholic Medical Association, says that while the CMA endorses abstinence outside of marriage, the fact that HPV is spread primarily by sexual contact does not render vaccination against it unethical.
"Healing and preventing diseases, no matter what their source, are acts of mercy and a moral good," Brehany says.
Less ethical, says CMA member Cieslak, is tying HPV vaccine compliance to school attendance.
"Raising vaccination rates is an important public health goal, but that doesn't justify every measure that might get us there," he says. "Depriving children of an education in the name of a broad public health goal isn't being fair to them."
Sources
For more information, contact:
- John Brehany, PhD, STL, executive director and ethicist, Catholic Medical Association. Phone: (712) 202-2283. E-mail: [email protected].
- Harold Vanderpool, PhD, ThM, professor, Institute for the Medical Humanities. University of Texas Medical Branch, Galveston. E-mail: [email protected].
- Centers for Disease Control and Prevention. Quadrivalent human papillomavirus vaccine: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2007; 56 (RR02): 1-24. Available on-line at www.cdc.gov. (Accessed 3/28/2007.)
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