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GOP's HPV vaccination debate: Bioethicist Dr. Steven Miles explains vaccine's value

Texas Gov. Rick Perry was criticized during Wednesday's debate for his controversial 2007 executive order mandating HPV vaccinations.
REUTERS/Mario Anzuoni
Texas Gov. Rick Perry was criticized during Wednesday's debate for his controversial 2007 executive order mandating HPV vaccinations.

During Wednesday's Republican presidential debate, Texas Gov. Rick Perry was criticized by other candidates for his 2007 executive order in which he made human papillomavirus (HPV) vaccinations mandatory for all sixth-grade girls attending public schools in his state. (The Texas legislature overturned the executive order several months later.)

Since coming on the market in 2006, the HPV vaccine has been highly controversial, primarily because HPV is a sexually transmitted infection. According to the Centers for Disease Control and Prevention (CDC), an estimated 20 million Americans are currently infected with HPV, and 6.2 million become newly infected each year. HPV is associated with cancers of the cervix, vagina, penis, anus, head and neck, and with genital warts. Indeed, HPV is responsible for almost all of the 12,000 women who are diagnosed with cervical cancer each year in the United States. That cancer claims the lives of 3,700 American women each year. 

There are two HPV vaccines currently available: Merck’s Gardasil and GlaxoSmithKline’s Cervarix. Both protect against the two HPV strains that cause 70 percent of all cervical cancers. Gardasil also protects against HPV strains that are responsible for 95 percent of all cases of genital warts. The vaccines work only if women complete a three-dose series of shots before they become sexually active. For this reason the CDC recommends vaccinating girls between the ages of 11 and 12. 

HPV vaccination is not mandatory in Minnesota. But the Minnesota Department of Health has been charged with educating parents about the vaccine. In 2010, almost 38 percent of adolescent girls in the state had completed the three-dose series of HPV vaccines, up from 27 percent the year before. The national HPV vaccination rate in 2010 was 32 percent. 

On Thursday, I spoke about the controversy surrounding mandatory HPV vaccination with Dr. Steven Miles, professor of bioethics at the University of Minnesota. Here is an edited version.

Steven Miles
Steven Miles

MinnPost: What do you think of making HPV vaccines mandatory for young women age 11 and up, as Gov. Perry tried to do in his executive order?

Dr. Steve Miles: The history of mandatory vaccine laws go back to 1904 in the United States. It was addressed by the Supreme Court and basically seen as a legitimate health function of the government. Most states have mandatory vaccine laws, although the vaccines covered by those laws vary. The laws offer both a medical option out — for example, when people are allergic to the vaccine — and they also offer [opting out for] religious and philosophical objections. ... And then there are “soft” mandates that say every student shall be informed of the vaccine. Minnesota has that in regard to HPV.

MP: The leading objection to making the HPV vaccine mandatory has been from social and religious conservatives who believe that it will lead to more promiscuity, correct?

SM: Yes. The most interesting direct predecessor to this is the [1965] Griswold vs. Connecticut decision in the U.S. Supreme Court. At that time, there was a set of laws called the Comstock laws [that were] essentially against all forms of pornography and other sexually stimulating material. Within the framework of the Comstock laws, there were also laws in many states that forbid married couples from accessing contraception. It was felt that if reproduction was not a risk of every sexual encounter, then people would take sexual pleasure outside of marriage. Those rationales got blown apart in 1965.

The religious objections to HPV are similar in rationale to those for preventing people in marriage from getting access to contraception. The fear is that if people receive protection against this cancer then they are more likely to act in an endangered way. That’s both a religious judgment on sexual behavior and an empirical claim — and an empirical claim that is unsupported. There is no evidence that being vaccinated will have an impact on sexual behavior.

From my standpoint, the argument against the HPV vaccine is largely based on making a separate category for diseases that are related to sexual behavior. [It’s an attempt] to create a religious exemption for a standard public health measure. People should certainly have the right of conscientious objection. And I’m not aware of any state that has a mandatory [vaccine] law without one. So in that sense, I think this argument is somewhat of a red herring. And I don’t even think it’s a wise one because if you look at the families that trot their kids out for abstinence pledges, those kids sexually act like any other kid. In fact, they take more risky behavior — behavior that is more likely to expose them to HPV.

MP: OK. Let’s take the religious objections for a mandatory HPV vaccine off the table. What about the argument that the vaccine, which is expensive at about $120 per dose, isn’t necessary for most young women because of the annual Pap test, which can detect abnormal cells before they develop into cancer? Women who receive an HPV vaccine are still told to get an annual Pap test.

SM:  First of all, not all women get Pap smears. We’ve improved that recently with the Obama requirement that Pap smears be universally covered without deductibles. But nevertheless, people’s life circumstances do change [in ways that may keep them from getting an annual Pap test]. The HPV vaccine is another layer of protection.

Secondly, the Pap smear, while good, is not perfect. You’re basically relying on it to catch and excise tumors. The vaccine prevents those tumors. 

MP: What about the argument that with 46 million people uninsured in the United States and millions more underinsured, we can’t afford the billions of dollars that will be spent on mandatory HPV vaccines. Wouldn’t that money be spent better elsewhere?

SM:  No. One of the features of the American health care system — and one of the reasons it’s so costly — is that we’ve savaged our primary and secondary care for high-tech therapies. Once a woman gets cervical cancer or vaginal cancer, or a man gets rectal cancer, at that point the therapies are really, really expensive. Overall, the United States would be much better if it retooled its entire health care system in favor of a working primary and secondary health care system to prevent these kinds of extremely costly tragedies.

MP: Another argument against mandatory HPV vaccination of young women is that men also carry this infection, yet we’re not asking all young men to have the vaccine. Why not? Why are women being asked to carry the burden here?

SM: I disagree with the CDC on this. If the drug prevents the carriage of HPV in men, and it prevents them from infecting either other men or women, then men, by all means, should be required to have it. 

During the early part of the HIV epidemic there was a huge controversy, a huge public panic about HIV-infected men infecting unsuspecting women. But at that point it was known that HPV caused cervical cancer. Yet even though we could identify men who were HPV-infected, there was no public outcry in regard to disclosure of HPV status to women. I think there is a double standard there. ...

So you’re right. Generally, our social policy is to make women disproportionally bear the cost of reproductive issues, including pregnancy and [sexually transmitted diseases].

MP: At the time Gov. Perry issued his executive order making HPV vaccination mandatory, one of his former chiefs of staff was a lobbyist for Merck. The press also reported that he had received campaign money from that pharmaceutical company. Isn’t one of the problems here the perception of conflict of interest?

SM:  The solution is campaign finance reform. But until we have that reform to eliminate all classes of conflicts of interest, we have to muddle through with this kind of problem rather than selectively pull the data. ... All candidates have financial conflicts of interest. And all the vaccines are made by large pharmaceutical companies, which are huge campaign donors. 

MP: Unfortunately, those financial conflicts of interest help feed public skepticism about vaccines.

SM: Well, a company like Merck has many, many different products. Vaccines are just one of them. On the other hand, they also make chemotherapies for treating cervical cancer. So to that extent, one could argue that if the vaccine is effective, it will decrease some of their other product lines.

MP: Should this have been a non-issue in Wednesday’s presidential debate?

SM: This was just more political showboating of a kind that discredits political campaigns generally. [During the debate], [Rep.] Ron Paul made an interesting comment about how the Republican Party has to stop taking its ideology off on an anti-science direction. This is a classic example of that. Governor Perry is certainly by no means a friend of science. His comments on global warming, for example, to my mind disqualify him from serious contributions to energy policy. But in this instance — regarding the HPV vaccine — he happens to be coincidentally correct.

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Comments (6)

The idea that a Pap smear is a good alternative to a vaccine that prevents the disease being tested for is ridiculous.

If you have a positive Pap, as with all screening tests, it means more invasive testing, and depending on results, minor or major surgery, such as removing part of the cervix. This can have effects on a woman's ability to carry a pregnancy to term.

Better to not get HPV in the first place, clearly.

Thanks, Susan. This is a fine, informative piece, and precisely the sort of thing that “family” news sources, print or otherwise, tend to tiptoe around because the crazies are the ones with the loudest and most persistent voices. Yes, there continues to be a double standard, but let’s at least make use of a standard, rather than saying to our daughters, “Good luck. Hope being a normal, sexually-active human doesn’t kill you.”

When this debate started four years ago the price was $100 per dose, $300 per series. Now it is apparently $120 per dose, $360 per series.

I have not heard any justification of the price and have heard absolutely not heard anyone question if this is "price gouging". The company making it has has hired associates of government decision makers and made donations to some "women's groups".

Why the very high cost for this vaccine? There are research and development costs but if mandated these should be spread over a far higher volume. If the maker is concerned about future legal claims? If so, is it safe enough to make mandatory with payment by the government and private insurance.

This seems like a situation where the price is high and "political" action is taken to mandate use of the specific product.

Dr. Miles and Ms. Perry failed to mention the Gardasil rDNA contamination controversy.

And neither expresses concern over the large number of deaths and injuries suddenly suffered by otherwise healthy teenagers after receiving the HPV vaccine. Note the vaccine injury cases in the Vaccine Adverse Events Reporting System, and at websites such as www.truthaboutgardasil.org.

A documentary on HPV vaccine injury, "One More Girl," is being filmed. Teens are posting their own HPV vaccine injury stories on YouTube, hoping some public health administrator might actually care to help.

It's easy and self-gratifying to anoint oneself as a valiant protector of public health. But the true health heroes are those who recognize a product's limitations and flaws, and are willing to fight industry resistance to consumer accountability and fair warranty protection.

To Mr. Lang (#4):
U.S. social policy has been to PROHIBIT the negotiation of best prices. New brand name vaccines and other exclusively marketed medicines cost **us all** whatever high price the U.S. market will bear.

In contrast most other countries (& our VA system) negotiate with the manufacturer... they ask for a wholesale discount while we pay top retail rates. Foolish? Indeed. Let's hope the Joint Select Committee on Deficit Reduction pays attention, because potential savings here are simply huge.

SOMEDAY our biggest payer with tremendous market clout, Medicare, will be empowered to negotiate drug prices on behalf of us all, but not until Big Pharma releases its stranglehold on the decision making of our elected officials.

The CDC's information on the vaccine seems abundantly clear, and their recommendations are made with due caution. Vaccines of one sort or another have been in use for a long time, and it's pretty straightforward to sort out the risks. The "social and religious conservatives" stuff strikes me as sophistry by some smart twenty-something with a degree in political science.