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Wednesday, March 07, 2007

The HPV Vaccine Controversy, Circumcision in Africa, and Difficult Questions in Public Health

In this post I want to tie together two separate major recent news stories.  The first concerns Texas Gov. Perry's signing into law an executive order mandating shots for teenage girls of the Merck vaccine Gardasil as protection against the human papillomavirus (HPV) .

As Jim Fosset has reported on Bioethics.Net's blog, HPV is a serious public health threat causing some 10,000 new cases a year and over 3,500 fatalities.   Recent CDC figures published in JAMA  detected the two strands of the virus that cause cervical cancer in over two percent of the women in the United States, with an additional 10 percent or so being infected with other “high risk” forms of the virus.  Gardasil also vaccinates against two “low risk” HPV’s which are associated with genital warts and other low level cervical changes.   Regular PAP smears help detect HPV and cervical cancer, but low income women in particular are unlikely to afford or access the smears.

There is also some evidence that the vaccine will help reduce the incidence of anal cancer, particularly in gay men, which is also linked to HPV.

I want to put aside several interesting health policy questions (as to the cost of the vaccine, whether the roll out to mandatory vaccination occured too quickly), and focus on the bioethics controversy it has engendered.  Many parents were apparently upset with Gov. Perry because they believed that mandatory vaccination of young girls constituted an endorsement of teenage sexuality. 

Compare and contrast this problem with the issue of pushing circumcision in sub-saharan Africa as a way of decreasing the HIV infection rate.  One argument that has been raised against such an intervention is that it will lead to increased unsafe sexual activity -- although the reports I've seen so far (see, e.g., page 2 of this story) don't  support that claim.  A similar claim has been raised about the relationship between increasing HIV infection rates in San Francisco and the increased availability of antiretroviral therapy (ART), although I don't know about empirical work on the validity of this hypothesis.

Together these issues raise at least 2 interesting legal/ethical questions.

(1)  Should we draw a line between symbolic encouragement and actual encouragement of unsafe behaviors as grounds for opposing public health interventions?  If the the availability of the HPV vaccine really made it the case that teenage sexuality increased, should that be given more weight than the claim that it expresses a certain value that particular individuals may find noxious?  (my own intuition is that the two are apples and oranges, but I am curious what others think).  For those who are Rawlsians, I am particularly interested as to whether the two sets of reasons fall on the opposite sides of the public/private reason divide.  For those who believe in the "symbolic" harm argument (and I don't mean to use the term pejoratively) , I am also interested whether the availability of opt outs sufficiently deals with the problem?  Something that was muted in the controversy over the Texas HPV vaccination program as I understand it was that there would be opt-outs for opposing parents.

(2) Imagine (counter-factually) that the empirical claim obtains. For example,  imagine that the widespread availability of circumcision in Africa ends up (unavoidably) encouraging unsafe sex, and that the HIV rate remains flat while other STD transmission rates increases, or, worse, that the net result is an increase in HIV infections.  Is this a sufficient ground for denying funding to the initiative, or even something stronger( like a ban, at least for non-religious circumcision)?  One can imagine the claim of a particular individual who would have access to circumcision under the initiative but could not access it without it -- why should I suffer losing the "advantage" of the intervention just because, as an epidemiological fact, the aggregate effect of  the intervention is net negative?  What should we think about the strength of his claim?

Posted by Glenn Cohen on March 7, 2007 at 09:17 AM | Permalink

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Comments

Thanks Brian, your invocation of DOT therapy for TB is spot on. For those interested in the legal and ethical issues raised by DOT and more intrusive mechanisms, take a look at Rothenberg & Lovejoy, Something Old, Something New: The Challenge of Tuberculosis Control in the Age of AIDS, 42 Buff. L. Rev. 715 (1994), and, for example, City of Newark v. J.S., 279 N.J. super. 178 (1993).

You are right, the problem goes away if the intervention can be designed so as not to encourage risk-taking behavior. As I mentioned, the empirical data I've seen reported on circumcision in Africa seems to suggest that this is indeed the case there. But for those who claim that rising availability of ARTs has increased HIV infection rates in San Francisco (again, I am not knowledgeable enough on the empirical data to know the validity of this claim), there is some suggestion that even with strong public health education efforts and among a relatively affluent and well-educated population, the problem will persist. (Interestingly, the Posernians would say the problem here is that the individuals are *too* rational, the cost of risky behavior has gone down and they are adjusting their risk taking to the change in incentives).

I am also somewhat skeptical of the ability to effectively sanction or monitor high risk activities in these kinds of interventions and its deterrence function. Sanctions are problematic, particularly for an one-time intervention like circumcision, where it is not as though we will reverse the procedure. (One way around that problem might be to require those wanting to get the procedure to pay in to a "bank", from which they funds will have returned to them if they meet some behavioral targets at the 6 month, 1 yr, etc, mark). Even for something like ARTs there may be ethical qualms as well as medical fears (relating to drug resistance) in discontinuing treatment once it has begun.
Monitoring seems equally problematic. Even if we could compel testing as a condition of receiving the benefit, it is difficult to determine the vector of infection (did they get STDs/HIV from high risk activity, low risk activity, or some other source entirely).

I do not doubt that these interventions can reduce the problem of negative effects of public health interventions to some extent, but I still think in some cases some of these effects will persist. And from the point of view of a public health funder, say the Gates foundation or our own government, there is only so much funding to go around, and whether and how much to invest in a particular intervention will depend on expectations about net effects. So the normative question persists of whether the person denied access to an intervention (if only through the decision not to fund) has a claim to have been wronged in such a situation.

Posted by: Glenn Cohen | Mar 7, 2007 11:38:19 AM

Nice blog!

Posted by: Ibikunle | Mar 7, 2007 11:26:13 AM

Interesting questions, Glenn. I think question 2, especially, is difficult, but I think it's probably a false choice. We don't have to choose simply between allowing the individual patient to obtain protection and endangering public health generally. For example, we can attach lots of conditions to the choice to obtain protection -- and they need not be draconian.

"DOT" programs -- directly observed therapy -- are a good example. The idea is that, if you're taking a drug that requires steady administration over time, and that in the absence of such administration could result in the development of drug-resistant strains, we make the drug available to you only on the condition that a public health professional watches you take it every time. I've heard of both TB and HIV-cocktail DOT programs.

Alternatively, in your examples, we might require extensive education about risky behavior along with the treatment. Conceivably, we might even warn the individual that highly risky behavior could result in some kind of sanction, exposure to which is triggered by receiving treatment.

Obviously, these kinds of conditions are somewhat intrusive -- and in the sanctions hypothetical, highly intrusive. But they seem like a fairer balance between individual liberty and dangers to community than the other two options. What do you think?

Posted by: BDG | Mar 7, 2007 11:08:00 AM

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