HPV Mandates: Parents Trump Politics
Governor Rick Perry stunned the nation when he signed an executive order requiring girls in Texas to receive the human papillomavirus (HPV) vaccine before entering sixth grade. State legislators around the country, including Texas, have introduced bills to mandate the newly approved vaccine to prevent this sexually transmitted disease that canlead to cervical cancer. But Perry's action came without warning and launched an unprecedented backlash, from federal legislation to penalize states that mandated the HPV vaccine, to parents filing a lawsuit against the order. The numerous state bills have raised eyebrows, but the governor's mandate unleashed scrutiny and skepticism about the links between politics and healthcare. It also heightened sensitivity to the right of parents to determine their child's medical care.
The Best Prevention
HPV is the most common sexually transmitted disease in the Untied States, with about thirty subtypes. It is transmitted primarily by skin-to-skin contact involving genital touching (including oral sex). In most cases there are no symptoms; in some, genital warts and precancerous cells may develop. In 70 percent of those infected, the body's immune system effectively eradicates HPV within eighteen months, and in 90 percent, it is eradicated within two years. The younger the person, the quicker the immune system responds.
The virus can, however, lead to cancer. HPV is the primary cause of cervical cancer, the fourteenth most frequently occurring cancer in women in the United States.i In the past forty years, since the introduction of the Pap test, deaths from cervical cancer have declined 74 percent.ii Pap tests detect precancerous cells caused by HPV, which can be successfully treated; the survival rate is more than 90 percent.
The paramount means of preventing HPV for males and females is to avoid sexual contact with an infected person. This is best achieved by abstinence outside of marriage and faithfulness within marriage. Many parents prefer this method and message for their children, knowing the multiple benefits of sexually responsible behavior. Abstinence and fidelity provide greater emotional security, and freedom from fears of unwed pregnancy and ever-increasing disease risks.
But even those who make the best choices can contract HPV through sexual assault or from a spouse who brings the disease into the marriage. Even then, the HPV vaccine is a decision that parents prefer to be made by choice, not mandate.
The HPV vaccine, Gardasil, has been breathlessly touted as a 100 percent safe and effective vaccine that will eliminate cervical cancer. While it is the first vaccine for a virus that causes cancer, it will not eliminate all cervical cancer because it does not address all cancer-producing subtypes of HPV. Physicians currently screen for fifteen high-risk HPV subtypes. Gardasil prevents only four.
Doubts have been raised about early assurances of the absolute effectiveness and safety of the vaccine, especially for young girls. According to the National Cancer Institute, studies have shown that Gardasil can provide protection for four years.iii But what happens after that? Dr. Diane Harper, director of the Gynecologic Cancer Prevention Research Group at the Norris Cotton Cancer Center at Dartmouth Medical School, a leading researcher in the development of the HPV vaccine, calls the mandates "a great big public health experiment,"
Because we do not know how long the vaccine will last; we do not know that a small number of young girls will already be exposed to a cancer-causing HPV type at the time of their first HPV vaccine, a condition the vaccine will not cure; and we do not know whether these young girls will continue to pursue Pap testing at regular intervals throughout their adult life.
She says, "Given that we don't know how long the vaccine will last until Gardasil needs a booster, it makes no sense to mandate it."iv
In trials, the shot was given alone or in combination with the hepatitis B vaccine. Since it has been on the market, more than forty cases of Guillain-Barre syndrome (an immune disorder that causes tingling, numbness, and paralysis) have been reported in girls who received the HPV vaccine along with the meningitis vaccine.v Other reported complications include loss of consciousness, seizures, and joint pain.vi
Medical trials enroll only people who fit a designated profile. The true test of any drug or vaccine comes when it is used on a wider population. The chickenpox vaccine was not on schoolchildren's immunization schedule until several years after its approval. Yet the HPV vaccine would jump straight from carefully controlled trials to the general population of girls, all unique and with a variety of conditions.
Parents Know Best
Medical decisions weight risks versus benefits. Usually the patient or her guardian makes those decisions. Government officials can step in if a disease carries a public health risk. A student with tuberculosis will be barred from classes to protect other students. This rationale drives mandates fro vaccines that prevent diseases that can be easily spread through air or simple touch. One child can put a whole class in jeopardy. Vaccinating most people protects even those who have not been vaccinated, because it means fewer people carry the disease.
The HPV vaccine deals with a disease that can be caught only through intimate sexual contact. Clearly, this is a realm best left for parents, who strive to teach their children to make the best choices in living healthy lifestyles and whose unease about the vaccine went beyond this sensitive issue.
Advocates point out that thirty-seven hundred women die each year from cervical cancer. Yet the flu is responsible for thirty-six thousand deaths annually, and the flu vaccine is not mandated. The decision is left up to individuals.
Many of the mandates allow for parents to opt out. Parents in Texas pointed out that private schools follow the state vaccine mandate list but do not adopt the opt-out option. Children have reportedly been expelled from private schools, and some physicians will drop patients for not receiving mandated vaccines. Opt-outs place the burden on the parent to follow complicated procedures and explain themselves to government officials, who can exert pressure by asking such questions as "Do you want your daughter to get cancer?"
When the media first reported on the HPV vaccine, they assumed that pro-family groups would oppose the vaccine, and relied on the usual story line that religious groups were imposing their morality onothers by restricing medical breakthroughs and living in denial that kids will have sex (or, as the theme goes, "religion trumps science"), so they did not have a prepared narrative to explain the widespread, immediate and unified outcry. Some investigated to find out what prompted state officials to introduce mandates so quickly after the HPV vaccine's approval. What they found did fit an old narrative: financial ties between politicians and those who would benefit from the government mandates.
The first bill to mandate the HPV vaccine was introduced by Michigan state senator Beverly Hammerstrom. She was the former chairman of Women in Government (WIG), a group of female state and federal legislators, many of whom sponsored similar bills. Merck gave an undisclosed amount of money to WIG, and in 2006, the executive director of health policy and external affairs for Merck's vaccine division sat on the board of the WIG business council.
Merck conducted an aggressive state-by-state lobbying and ad campaign. News stories named legislators who received campaign contributions who received campaign contributions from Merck and noted that Governor Perry's former chief-of-staff is a lobbyist representing Merck. But this just opened the door. What was probably most persuasive was Merck's message: this vaccine prevents cervical cancer, and mandates are necessary to ensure it will be covered by government and private insurance.
Gardasil is the most expensive vaccine in history at $360 for a series of three shots. The costs of doctor visits can bring the total to over $900. Merck assured pro-family groups and doctors that it would market the vaccine through comprehensive efforts to educate stakeholders (physicians, parents, schools) with written materials and ads stressing primary prevention - sexual responsibility - and respecting parental consent.
But the lobbying campaign for mandates undercut this effort. If the vaccine is mandated, stakeholders have reduced motivation to be educated about HPV. Many parents will do whatever is necessary to get their daughters into school, rather than learning that HPV is 100 percent preventable through abstinence and fidelity, that the vaccine cannot prevent all strains of HPV or all cervical cancers, that the immunity is known to be effective up to only four years, that a booster may be needed even before the patient is sexually active, and that the safety for all population groups is yet to be determined.
Mandates are as much about requiring insurance programs to pay for a vaccine as they are about vaccinating the most people. According to Wall Street analysts, mandates would boost stales form $1 billion to $4 billion each year. Pap tests, on the other hand, cost about $60 each. African American, Hispanic, and Native American women have higher death rates from cervical cancer than white women, probably because they cannot afford Pap tests.vii Some note that health care dollars from insurance programs could be better spent on Pap exams than on immunizing large swatches of the population who are not at risk.
Texas legislators had many reasons to strike down the governor's mandate. But their rallying cry was that parents, not politicians, should make their children's medical decisions.
This article was published in Ethics & Medics, July 2007.
- i National Cancer Institute, "Cancer Advances in Focus: Cervical Cancer," http://www.cancer.gov/aboutnci/cancer-advances-in-focus/cervical.
- ii American Cancer Society, "Cervical Cancer: Prevention and Early Detection," http://www.cancer.org/docroot/CRI/content/CRI_2_6X_Cervical_Cancer_Prevention_and-Early_Detection_8.asp?sitearea=&level=.
- iii National Cancer Institute, "Human Papillomavirus Vaccine: Questions and Answers," question 9, http://www.cancer.gov/cancertopics/factsheet/risk/hpv-vaccine.
- iv Cindy Bevington, "research Adds to Vaccine Comments," fwdailynews.com, March 21, 2007, http://www.kpcnews.com/articles/2007/04/14/online_features/hpv_vaccine/hpv01.txt.
- v Ibid.
- vi Medical News Today, "HPV Vaccine Mandates Risky and Expensive," February 3, 2007, http://www.medicalnewstoday.com/medicalnews.php?newsid=62176.
- vii Cancer Research and Prevention Foundation, "Cervical Cancer Fact Sheet," http://www.preventcancer.org/healthyliving/cancerinfo/cervical.cfm.htm.
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