Gardasil Vaccinations for Boys?

If the boys don’t stand to benefit from the vaccine, then are we making boys into The Island? Well, that’s an awfully inflammatory way to start out, I grant you.  Here’s another inflammatory way to start out … would forcing boys to be vaccinated against their will but without any medical benefit to them, with the benefits accruing instead to girls, violate Roe v Wade? Our boy-bodies, ourboyselves?  For that matter, should pre-teen girls be forced to be Nudgily inoculated because their parents systematically underestimate the extent to which they will engage in sexual activity and have a tendency to acquire the disease?  Something here to offend almost everyone in this debate, if one takes it very far down to fundamentals.

Update: Thanks, Glenn, for the Instalanche! While I am thinking of this, please note that I am not the Dr. Kenneth Anderson, MD, Harvard Medical School, who is a real expert on vaccines and viruses and appears to have done some interviews and other media stuff on Gardasil.  I gather from a couple of comments that I have either tried some readers’ patience or else exceeded their attention spans.  There is not a lot of careful organization of this post, because I inserted paragraphs in between editing something unrelated; this is not my day job.  However, to the extent there is a structure, it is this:

  • (a) Opening that you might find clever or not, but is designed to raise at least three multiple, indeed really different, ways in which mandatory vaccinations of either all girls, or all boys, or all girls and boys, with Gardasil could raise liberty and rights issues.
  • (b) A short mention of what Gardasil is and why it was controversial back in 2006 when it was introduced, for those who haven’t closely followed it.
  • (c) An introduction to the current issue, which is the introduction of Gardasil as safe for boys for genital warts which, according to the WSJ news article, are rare and not a big deal (I gather from comments that readers dispute this factual claim), whereas the true reason for vaccinating boys is for the benefit of girls.
  • (d)  A discussion of the general issue of mandatory vaccination and why it is ethically justified for everyone who would benefit from what amounts to social insurance, and the wickedness of free riding, both as its own ethically bad thing as well as for the extra social social harms it causes by undermining the “herd immunity.”
  • (e)  A discussion of the special case of religious claims for exemption from mandatory vaccination which are also free-riding, and my undefended (because arising from another kind of argument) claim that we should no longer allow religious claims of exemption.
  • (f)  A shift in discussion from the general justification, even on libertarian grounds, for mandatory vaccination that benefits everyone to the special case of Gardasil, if one accepts the factual premise that it only benefits the girls, and not the boys.
  • (g) An argument that requiring the boys to be vaccinated in that case violates their rights, and uses them merely as means to other social ends of social utility.
  • (h) Consideration of a possible real-world counterexample in the form of other cases where we use a non-benefiting pool to benefit another group – rubella vaccinations; my suggestion is that it is not a good analogy.
  • (i) A final (undefended) claim that we would not be discussing this at all if the situation were flipped, and we were talking about mandatory vaccination of girls to prevent testicular cancers.
  • (j)  Then some side remarks, including a comment that one need not look at this from either a strong utilitarian or strong rights-based view; one might, for example, adopt views from Catholic social thought on the doctrine of love in the commonweal.

It might well be that the facts are different from what the WSJ news story quoted below suggests; in that case read this as a hypothetical around the question of whether it is permissible to require mandatory vaccination of one group in order to benefit another.  Several commenters have stated that men, gay men particularly, are at much greater cancer risk than the article says, for example.  I make no claim to being a doctor or public health specialist or expert in the facts of these medical issues.  So:

Gardasil is a vaccine against the sexually transmitted HPV virus that is a leading cause of cervical cancer in women.  It was approved by the FDA for use in women in 2006.

Approval was not without some controversy in 2006 – arguments over whether the manufacturer had overstated the extent and variety of protection, and whether the manufacturer’s massive spending on promoting the vaccine to health officials had shifted public officials’ objective judgment about safety and effectiveness.  There were independently arguments over the high monetary cost of the vaccine and its administration in relation to benefits.  This discussion skips over the monetary cost issues, the ethics of Merck’s campaign, and similar “money” issues.  However, this WSJ article describes that 2006 controversy this way:

After the FDA approved Gardasil’s use for girls and young women in 2006, the vaccine’s maker, Merck & Co., was criticized for lobbying aggressively to get states to make inoculation a requirement for pre-teenage girls. Its high price — $390 for the three-dose regimen — also came under attack …  The FDA ruling on Gardasil came the same day that the agency approved a rival vaccine designed to protect against cervical cancer in women. GlaxoSmithKline PLC’s Cervarix vaccine was approved for use in girls and women ages 10 to 25 …  While Cervarix, like Gardasil, protects against two HPV strains that are linked to about 70% of cervical-cancer cases in the U.S., the Cervarix vaccine doesn’t offer protection against the HPV strains that can cause genital warts.

I mention the 2006 controversy this despite having had a daughter get the vaccine; my wife and I thought it pretty clear that if you were a girl, the benefits outweighed the risks heavily even if it didn’t prevent against every form.  (And I mention this personal item because I don’t want anyone to think that I’m actually simply covertly opposed to vaccination, or to brand-new vaccines, etc.  I’m not, and whatever your views on that, I’m coming here from a standpoint of being perfectly comfortable with vaccination and, as discussed below, very willing to make vaccinations mandatory – and think it consistent with a generally libertarian outlook.) At least as the pediatrician explained it, for it to make a substantial difference, it needed to be given early on in adolescence, which, put more directly, before a girl became sexually active and might acquire the virus.  (Experts out there – and I am not one and only followed this via our pediatrician – can correct any of this.)

What’s new?  The vaccine has just now been approved for use in boys as well.  As the same Wall Street Journal story notes, there is controversy over whether boys ought to be vaccinated, whether there should be mandatory public health vaccination of boys, and whether there is a medical ethics question involved.  The controversy comes down to whether the vaccine benefits boys in any way except very minimally (fewer than 1% get the non-threatening genital warts, and of course none get cervical cancer).

Here is how the WSJ news story puts it:

The vaccine Gardasil won regulators’ approval for use in males, setting the stage for a debate over whether boys should routinely receive an inoculation used to prevent cervical cancer in women.

The Food and Drug Administration found Gardasil, which has been approved for use in females since 2006, to be safe and effective in protecting males from genital warts. Now, the Centers for Disease Control and Prevention must decide whether to recommend its routine use in boys, a move that could lead states to mandate inoculation and may prompt health insurers to pay for it. A panel of experts advising the CDC is scheduled to debate the matter next week.

The question isn’t straightforward, doctors and infectious-disease experts say, because boys may not directly benefit from being inoculated. Only about 1% of sexually active males in the U.S. develop genital warts, which can be irritating but aren’t life-threatening, but males’ vaccinations could help women because the sexually transmitted human papillomavirus (HPV) that causes the warts can lead to cervical cancer.

“Are boys — or their parents, more to the point — going to be altruistic and get a vaccine so it benefits somebody else?” said Steven Epstein, a Northwestern University sociologist who has been studying social issues surrounding the vaccine.

On the general question of requiring vaccinations, I am fully with Megan McArdle in believing that they should be mandatory and that people who decide to skip the vaccine for their kid on the basis that they can free-ride on others doing it, despite the (miniscule) risks, should not be allowed to do so.  Actually, although anyone who has read McArdle on this issue knows she feels strongly about it, I might feel even more strongly.  Free-riders of this kind are horrible people and the law should not just force their compliance, but penalize them in order to disincentivize their behavior.  And I believe that a Just God would give the parents who do so facial blemishes permanently spelling out Free-Rider across their cheeks.

As for the religiously motivated – that’s a more complicated social question.  A practice of accommodation could work so long as, but only so long as, it was limiting and indeed fairly self-limiting, to Christian Scientists without creating any implications for the social norms observed by the rest of us – that is, without altering the social expectations of the rest of us and without altering what is below described as “herd immunity.”  We could deal with the occasional Christian Scientist not doing the innoculations, partly because so small a number of free-riders – however sincerely religiously motivated – could be accommodated without creating a serious problem, and partly because the nature of the reason was not one that would cause social emulation.  That changed with the New Agers and the rise of new spiritual and religious practices – no doubt sincerely held – but with the result of free-riding and putting the larger community at risk.

I’m not going to go deeply into the reasons why the free-riders put more than themselves, or their own kids, at risk – my interest here is mandatory innoculations for boys who essentially don’t benefit from being forced to insure the girls.  Oh, heck, though – a quick note on it:  Arthur Allen explains how whooping cough spread in Boulder, Colorado, as the “herd immunity” – essentially, the likelihood that even if someone has the disease, they will not be able to pass it on – broke down.  As McArdle says:

Contrary to popular belief, vaccines do not work by protecting only vaccinated people. In a small percentage of cases, the vaccine doesn’t stimulate significant immune system response, and in most people the immunity wanes over time. Vaccination works by denying the disease “reservoirs” of unexposed people that give infection a toehold from which to attack the broader population. Buildings full of young children with a dubious respect for personal hygiene are a perfect place for disease to thrive; that’s why childhood vaccinations have been such a massive public health success. The broad concept is “herd immunity.” The object is not to make everyone immune, but to make a total lack of immunity very rare. That way, even if it manages to infect someone, the disease probably won’t encounter another victim. Herd immunity wiped out smallpox, virtually vanquished polio, and could eventually push other diseases into extinction.

That is, if we keep it. It doesn’t take many unvaccinated individuals to destroy herd immunity, which breaks down when the rate of non-vaccination reaches somewhere between 5% (whooping cough and measles) and 20% (rubella). These days, a host of health worries are causing more and more parents to keep their children unvaccinated, or partially vaccinated, due to worries that the vaccine causes autism, or that their child will be one of the very few whose systems respond badly to the vaccine. In states that let parents opt out of vaccination, 2.5% opted out in 2004. But because parents who opt out tend to cluster — ironically in affluent, educated areas — and in some communities, the percentage is already high enough to erode herd immunity. In 1976, the United States had 1,010 cases of whooping cough. By 2003, that figure was 11,647. Between 2001 and 2003, the disease caused 56 deaths, mostly among unvaccinated infants.

Many of the people in these new cases of unvaccinated children make religious claims; I don’t doubt their sincerity.  But I do not think that the community as a political order should be exempting anyone on religious grounds any more; that goes with a larger view I have that the religious accommodation movement has gone too far, which is a different question.

In this case, however – the case of the boys and Gardasil – the ethical question of mandatory vaccines for boys is not about the general question of opting out of the insurance pool as a free rider.  Rather, the ethical problem is that although the vaccine imposes some kind of risk, or some kind of cost, on the boys and their families, it does not confer any real benefit (I am simplifying with respect to avoiding the tiny number who get non-life-threatening genital warts).  Is it justified to make vaccination mandatory for a group that does not benefit?

A pure utilitarian argument would weigh up the total costs and benefits.  On that particular issue, studies have suggested that even taking all benefits and costs (including risks) into account, the benefits of having mandatory vaccinations of boys are not large enough to justify the vaccine’s substantial cost.  The drug company’s studies, unsurprisingly, have suggested otherwise.

However, that is not really the ethical issue.  As a general matter, we do not approach the question of what we can require of individuals and their corporeal selves from a strictly utilitarian basis.  In general, a liberal rights-based approach would ask on what basis we can overcome an individual’s liberty in his or her body.  It is all the familiar undergraduate ethics classes examples of snatching Joe or Jane off the street for their body parts; violation of their right to bodily integrity but utility maximizing.  We impose on rights in the case of certain social insurance arrangements because the individual also benefits; in general, however, we decline to do so where the individual does not stand to gain, including in the sense of being in the insurance pool where one has the possibility of gain.  One can make arguments about society, of which the boy is a part, having fewer horrible cancers – but that is conspicuously not how we mandate these things in other situations.

Indeed, I would have said that standard views of medical ethics as public policy would start from a very, very strong presumption that you can’t do things to one group of people’s bodies in order to benefit another group – notwithstanding the presumably marvelous benefits we could accrue from a bit of unconstrained medical experimentation on humans.  Isn’t this the subject of all those undergraduate ethics classes?

The article notes, however, other situations in which one group is vaccinated for the benefit of another group.  This is an interesting example, ethically (although reading the article closely, it frankly suggested to me the slightest hint of result-oriented jurisprudence and where some ethicists would like to see the Gardasil decision come out):

There are other diseases for which public-health authorities have required that everyone be vaccinated in the interest of protecting certain groups. All infants receive a shot for Rubella, or German measles, because of the risk of serious birth defects if a pregnant woman contracts the disease.

Now, someone can correct me if I am wrong, but I am not sure this is really the same situation as boys and Gardasil – and for reasons that are obvious enough that it makes me wonder whether a certain amount of cherry-picking casuistry is not involved.  But perhaps I don’t understand the facts sufficiently well and am merely saying ignorantly mean things.  But: the infants, unvaccinated, are at risk of contracting German measles; do I misunderstand that?  The disease might be much more serious and risky for pregnant mother’s or the babies they carry, and in fact be the motivating reason for vaccinating all infants at birth.  But still, the infants are at risk of the disease themselves.  At least in that sense, they are part of the insurance pool.  One can say that the 1% of boys who get genital warts are enough to make out the analogy with rubella, but I don’t think so.  And I am leaving aside any claimed psychological benefits of knowing that women, or women one is close to, such as mother, sister, girlfriend, wife, or daughter, are far less likely to get cervical cancer; such psychological benefits are not ordinarily taken as grounds for overcoming a right to personal bodily integrity.

So count me as opposed, unless I have quite misunderstood something relevant about the facts here, to mandatory vaccination for boys.  And opposed even though I have very strong feelings about the wickedness of parents who opt out of vaccinations for their own, and the appropriateness of going after them with punitive legal measures.

I don’t have a boy, so I can’t say with certainty what I would actually do – but as a form of altruism, if I had a son, I would like to think that I would opt for vaccination, because, despite my rights-based opposition to mandatory vaccination for boys, I do think it morally relevant that he is part of a larger community of men and women.  (Although I am not sure I understand how the herd immunity concept works here and what it means.)  And I would think that a Catholic communitarian might well think about the larger commonweal in terms of a human community that is neither purely about rights nor purely about utility – but really a third ideal of human community that depends upon love, love that is not really captured by Roe v Wade and concepts of property.  But I am not a Catholic, and ethically attractive as I find much parts of Catholic social teaching, I don’t find it attractive as a legal model, at least not as one of imposition.

(I will also add that I doubt very much we would be having a conversation about mandatory vaccination for non-benefiting boys if the situation were flipped, and it were instead about mandatory innoculations for girls to prevent testicular cancer in boys.  I have no evidence for this, one way or the other, so I don’t propose to pursue it further.)

*

As an aside, my daughter points me to a very beautifully and subtly astute novel, Never Let Me Go, by the great Kazuo Ishiguro, who also gave us The Remains of the Day.  That novel concerns a girl who realizes that her parents had her in order … umm, my daughter just now says that the novel is so much a work of indirection, though it indirectly concerns the topic of this post, I should not say anything further.  Well, here is the summary from Amazon, which respects the same view:

All children should believe they are special. But the students of Hailsham, an elite school in the English countryside, are so special that visitors shun them, and only by rumor and the occasional fleeting remark by a teacher do they discover their unconventional origins and strange destiny. Kazuo Ishiguro’s sixth novel, Never Let Me Go, is a masterpiece of indirection. Like the students of Hailsham, readers are “told but not told” what is going on and should be allowed to discover the secrets of Hailsham and the truth about these children on their own.

Offsetting the bizarreness of these revelations is the placid, measured voice of the narrator, Kathy H., a 31-year-old Hailsham alumna who, at the close of the 1990s, is consciously ending one phase of her life and beginning another. She is in a reflective mood, and recounts not only her childhood memories, but her quest in adulthood to find out more about Hailsham and the idealistic women who ran it. Although often poignant, Kathy’s matter-of-fact narration blunts the sharper emotional effects you might expect in a novel that deals with illness, self-sacrifice, and the severe restriction of personal freedoms.