White Coat Underground

I was catching up again on my favorite periodical (Morbidity and Mortality Weekly Report—the Dengue Fever story is Awe.Some.) I came across the official recommendations for Gardasil for males. Gardasil is the vaccine produced by Merck that can protect women against infection by four strains of human papilloma virus (HPV). The vaccine has been shown to prevent genital warts and pre-cancerous lesions caused by the virus. The vaccine, in conjunction with Pap tests, has the potential to significantly reduce the incidence of cervical cancer.

Of course, HPV infections do not arise spontaneously on the female cervix. In heterosexuals, HPV is passed between male and female partners, but men, not having a cervix, do not suffer the same consequences. They do, however, get genital warts and sometimes develop penile, anal, and oral cancers due to HPV. Men who have sex with men are at even higher risk than men who strictly have sex with women.

So there are several potential advantages to vaccinating men against HPV: it can protect them against genital warts and certain cancers; and it can protect their partners. In October of 2009, the FDA approved the HPV vaccine for use in males. An analysis by the Advisory Committee on Immunization Practices (ACIP) published in a recent MMWR gives us some guidance into the use of the vaccine in males.

Studies show that the HPV vaccine is very effective at preventing genital warts in vaccinated men. In addition, vaccinated males were found to have a good antibody response to the vaccine. The ACIP did some mathematical modeling to assess the affect of vaccination on the overall population burden of HPV disease. They found that if greater than 80% of females were vaccinated, the cost/benefit ratio of vaccinating males was not terribly favorable. When fewer than 80% of females are vaccinated (which is the current case), there may or may not be a cost/benefit advantage to vaccinating males. Because of this, one recommended strategy for addressing the societal burden of HPV disease is to improve vaccination rates in females, who suffer the higher burden of this infection.

Using the data, they came up with a recommendation of optional vaccination of young males to reduce their personal risk for genital warts. After formulating their recommendations, further data has become available showing that the shot is very effective at reducing precancerous anal lesions in men who have sex with men. I would argue that this group should also be targeted for vaccination.

In sum, the data show that Gardasil is effective in females. They also show that it is effective at preventing genital warts in all men, and probably in preventing anal cancers in men who have sex with men. Given that men are usually the source of infection in women, we should keep an eye on the data and on the cost of vaccination to see if more widespread vaccination of males would be appropriate.

Comments

#1 Bill in NC
June 9, 2010

Here Gardasil’s $175/dose, with 3 doses required.

When I was in grad school Hep B vaccine was pushed heavily.

Since I already was married, I skipped on the $200+ cost (10 years later it still costs over $150)

Because of budget cuts, even the Tdap booster for adults now costs $62 (used to be free)

Until prices drop, I don’t think most states will be paying for Gardasil.
#2 Nathan Myers
June 9, 2010

Vaccination of men against HPV is an unambiguous Public Good far exceeding (even with risk of warts etc.) the value to the individuals vaccinated. While it’s easy to imagine lots of other ways to ensure boys get vaccinated — e.g. a campaign by women to demand certification before allowing contact — the simplest, most effective, and probably cheapest would be to dose everybody. For that you would need a National Health Service that can control prices for required treatments.

I will not be surprised when it turns out that HPV causes some cancer or other in men, nor when HPV vaccination suddenly thereafter becomes a priority. It’s too bad it will be too late for “us”; to do you any good, you need the vaccine before exposure, which means, practically, as a kid.
#3 PalMD
June 9, 2010

HPV does cause cancers in men: anal cancer, certain oral cancers, penile cancer.
#4 Ferhan Isis
June 9, 2010

A good idea? Well, I do suppose that we need an equal number of deaths of men caused by this totally useless drug as we have had deaths of women. Equality rocks!
This drug is totally useless.
#5 PalMD
June 9, 2010

Potatoes! Of furlong in height! Roodle!

(BTW I’m fairly certain that one is Dr. Smart or whoever…)
#6 Ferhan Isis
June 9, 2010

What is it that you people want to force your medication on people who do not wish to take the stuff? I suppose you want to sterilize everyone too eh? OOOPS! They call that “family planning” now. I guess that commie terrorist van Jones was not so over the top afterall. Now it seems his dreams are coming true. Good luck trying to force it on me. I know some doctors who for the right amount of bribery could mark it down that I had my killer vaccines, when in fact I really didn’t. That may be wrong and illegal but in this evil fallen world of socialists, communists, and collectivism, we have to do what we have to do to evade the enemy and survive. In the end, individual liberty and individual freedom will always reign over slavery of the system.
#7 PalMD
June 9, 2010

What do you mean “you people”, Dr Smart?
#8 Katherine
June 9, 2010

Ugh. First the antivaccinationists want their kids to get measles encephalitis, now they want them to get anal cancer. Lovely.
#9 Ferhan Isis
June 9, 2010

“You people” refers to liberals. Not all liberals are the same though. Some are just political liberals while others are dangerous socialists who are advocating overthrow of the government, forced sterilization, one child policy, forced vaccination, etc. I feel that you may not be ne of these dangerous tyrants, but you do share a common denominator – atheism / liberalism. It starts there, and grows into more dangerous thoughts and actions.

“You people” was a label I gave to whoever might be advocating forced vaccination and forced sterilization on unsuspecting citizens.

You do not have to take offense at this phrase, but your ideology remains a close ally of this dangerous socialist ideology. Van Jones, Bill Ayers, Cass Sunstein, Maurice Strong, etc., are all “yoo people” types. They are dangerous thugs that should be closely monitored by the CIA and our military forces. It is these criminal tyrants that want to “change” our nation into the opposite of the 1776 founders/signers wanted. WE as Americans want individual freedom, not “collective” freedom. “Collective” freedom sounds like something out of Cuba or Iran.

My sincere belief is that anyone who wished to mass forced sterilization onto anyone should be taken out by our intelligence agencies. You never know when these people will have an “accident”. They are the true enemies of freedom and human rights.
#10 PalMD
June 9, 2010

Once your crazy rants advocate violence, your IP addy gets sent to the FBI and you get banned. Bye bye.
#11 catgirl
June 9, 2010

I decided to get the Gardisil vaccine recently, and to pay for it out-of-pocket if necessary because I could afford it either way. I actually had a high-risk strain of HPV when I was 17 and I wanted to reduce my risk of getting another strain. My insurance is very stingy and so I expected to pay for it completely, to the point that I didn’t even bother to call and check because I just assumed they wouldn’t pay. Well the doctor submitted the claim just in case and to my surprise, my insurance company fully covered all three doses. I’m sure there are plenty of insurance plans that won’t cover it, but it is certainly worth checking out if you are in the right age range and want to get this vaccine.
#12 Lycanthrope
June 9, 2010

How strange. I double-checked real carefully, but I couldn’t find the words “forced vaccination”, “sterilization”, “atheism” or “liberal” anywhere. Did we read the same article?
#13 PalMD
June 9, 2010

Yes, but you weren’t wearing your crazy goggles.
#14 becca McSnarky
June 9, 2010

*puts on crazy goggles*
Oh-ho, so we see how it is now. First, you call our nine year old daughters, (NINE year olds!!!!!111!!) little sluts, and make them get dangerous vaccines. Now you’re gonna tell us out little boys have to have the vaccine too- because they might go out and have perverted sodomy! HOW DARE YOU>!!!! You are COMPLETELY OBSESSED with sex you sicko pervert sinner!
/totally crazy

how’s that?
#15 Bing
June 10, 2010

May I recommend that we never again ever mention anal cancer? Pleeeeze?

Also, if I recommend people to be sterilized for the sake of the gene pool, will I get banned?

HJ
#16 David N. Brown
June 10, 2010

The anti-vax opposition to Gardasil follows predictable lines of offended cultural mores rather than science. In particular, it’s posited that protecting one’s self against an STD carries the “punishment” of not being able to have children when you want them.

Also, papillomavirus is NOT just an STD. I had a papilloma sprout on my foot when I was 8, and I still have a scar where it was cut off. I’d call a vaccine a fair trade for putting a child through surgery.
#17 DuWayne
June 10, 2010

I am rather interested in this, because of the possibility that vaccinating guys might reduce transmission to women. I understand that guys can get cancer from HPV as well, but it was my (very plausibly mistaken) understanding that this is relatively rare.

But I have also been given to understand that simply vaccinating group A to prevent transmission of something to group B is considered unethical. Assuming that what I was told is accurate, I am really curious about why that is so. I mean if there is more than an insignificant risk, I can see it possibly being unethical to mandate such vaccination. But I sure as hell don’t understand why this would be considered unethical as a matter of course.
#18 TGAP Dad
June 10, 2010

I think Ferhan Isis may be interested in some recent job openings with the Hutaree…
#19 Vicki
June 10, 2010

DuWayne: Based on something I recently read about anti-malaria efforts (in _Science_ magazine), the argument is that vaccinating people who cannot benefit directly can be unethical because if there’s any risk at all, the risk/benefit ratio can be considered infinite: say, 1 chance in a hundred thousand of a serious fever, divided by a benefit of nothing at all. The hypothetical being discussed was a vaccine that, given to people who already had malaria, would prevent them transmitting it further (if they were bitten by more mosquitoes). (I suspect a significant number of people would be willing to take the chance on a low risk with such a malaria vaccine, because the people who might benefit could include their relatives and friends.)
#20 Calli Arcale
June 10, 2010

DuWayne: the ethical issue is that all drugs (including vaccines) have a certain amount of risk to them. Though very small, this risk to the individual must be outweighed by the good they will do for the individual or a medical professional cannot ethically administer the drug. Exception: if the individual has a personal reason, and is willing to shoulder the risk to achieve a certain goal. That’s the basis of cosmetic surgery, and would also be the basis of a man deciding to get Gardasil to protect his future wife. He’s not doing it for himself; he’s doing it for altruistic reasons.

But altruism cannot be recommended, or it’s not really altruism. When they make recommendations about vaccines, they are usually thinking about the entire community, but they have to consider risk and benefit in terms of the individual. If Gardasil is only approved for cervical cancer, they cannot recommend routinely giving it to men, as they cannot benefit from it except indirectly, by not having a loved one develop cancer.

Approving Gardasil for penile cancer, anal cancer, mouth cancer, and genital warts changes the game. Those indications are all benefit to the individual male, so now the risk-benefit equation is unambiguous. He does benefit directly from the vaccine, and now it can be routinely recommended for males in certain risk categories, and perhaps eventually all males.

Regarding the totally specious “forced sterilization” claim above, the irony is that it is HPV which may sterilize people. Gardasil will protect the fertility of many woman. The treatment for cervical cancer is not only painful, it can eliminate a woman’s fertility. Even the *tests* for cervical cancer (cone biopsy) can cause problems for childbearing down the road, so precancerous lesions are really nothing to sniff at.
#21 Thascius
June 10, 2010

Calli: The risk/benefit ratio may still be ambiguous, depending on exactly how great the benefits are. Penile cancer is very rare (though I don’t recall the exact incidence off-hand), my understading is the other HPV cancers are quite rare in men overall (though as PAL notes men who have sex with men are at higher risk). So while the risks of Gardasil appear to be miniscule, if the benefits are equally small there wouldn’t be an indication for men outside of high risk groups to get vaccinated.
#22 Nathan Myers
June 10, 2010

It’s the relatively small benefit (reduced risk of something unlikely) to the male recipient that makes it important for the cost of the vaccination to be borne by society at large. A precise accounting would be to have each person he will ever have sex with, someday, pool with their future spouses to put the money up ahead of time, but that’s impossible. However, having society at large borrow to put the money up is almost the same thing. Those not at risk from exposure to him (because they’re adults now) don’t pay. Those at high risk –present girls, and their future spouses and children — do pay, eventually, and get full benefit.

Gilda Radners of the future shouldn’t have to die. Gene Wilders of the future shouldn’t have to lose their Gildas.
#23 Thascius
June 10, 2010

Nitpick-Gilda Radner died of ovarian cancer, not cervical. Gardasil wouldn’t have prevented that.
Leaving that aside, the main thrust of decision making in medicine is weighing the risks and benefits of the proposed intervention for the individual patient. Yes, we talk about herd immunity for most vaccines, but then for most vaccines the risk/benefit ratio is so far in favor there’s no room for debate. Schools require vaccinations so students won’t spread diseases to one another. But pediatricians (and parents) vaccinate so the child being vaccinated won’t get measles, pertussis, etc. I’m not saying men shouldn’t get the vaccination. But I also think (and I think this was PAL’s conclusion also) the data isn’t there yet for a blanket recommendation for all men to get Gardasil.
#24 D. C. Sessions
June 11, 2010

HPV does cause cancers in men: anal cancer, certain oral cancers, penile cancer.

Recent research suggests that head and neck (incl. throat) cancer incidence is increasing rapidly and that HPV is responsible for a large number of cases. Speculation is that this is due to oral-genital transmission — and unlike cervical and anal cancer, heterosexual men do not get a break.
#25 Isis the Scientist
June 11, 2010

Because of this, one recommended strategy for addressing the societal burden of HPV disease is to improve vaccination rates in females, who suffer the higher burden of this infection.

Assholes.
#26 PalMD
June 11, 2010

At this point the greatest risks of HPV infection are for women and MSM. There may in fact be an important social good in increasing vaccination not only in those people, but in those who serve as the primary vector of the disease, thereby encouraging a shared social responsibility and benefit.
#27 Epinephrine
June 11, 2010

Assholes.

Why? For trying to reduce societal burden of a disease? For mentioning that *one* way to do this is to improve vaccination rates in females? For having the pragmatism to realise that when trying to get people to vaccinate, it is easier to hit the desired vaccination rate among those who are more likely to suffer from the disease?

Look at vaccination rates for influenza – not great, though it can potentially affect everyone. Thanks to targeting the elderly, the rate is higher for the elderly. It is much easier to get those who are vulnerable (and who work with those who are vulnerable) to vaccinate than to try for universal vaccination (even though universal vaccination would doubtless be better at prevention). One doesn’t become an asshole by pointing this out, or by working in policy and realizing that the best approach to reducing the impact of HPV (given that vaccination is voluntary) is to target females.
#28 PalMD
June 11, 2010

@Epi

There are additional factors to consider other than just the epidemiology. Women should be given the tools (and Gardasil is one of them) to protect themselves, but often these tools are more properly viewed as responsibilities placed on women so that men do not have to be concerned with the consequences of their actions or inactions.
#29 Epinephrine
June 11, 2010

Thanks PalMD,

I agree that some view such tools as a woman’s responsibility (I am not one), but I don’t think that the above quote (nor the linked article) suggests that as the motivation behind the recommendation. In this instance I suspect it has much more to do with the practicalities of trying to get the public protected as well as the fact that we operate in a system that looks at the cost-benefit relationship, rather than an evasion of responsibility by males.
#30 Kim
June 11, 2010

The majority of the people I know who have “come out” about an HPV infection (I presume visible warts, but I don’t pry) have been heterosexual males. It’s certainly impacted them in self-esteem and partner selection, sometimes medical costs as well. I realize that in the grand scheme of things these aren’t the worst experiences a person can have due to an STD, but nonetheless if I were making decisions for my own son I would choose to vaccinate.
#31 JP
June 26, 2010

This has inspired me to go and get vaccinated for HPV. I don’t have HPV yet and I don’t want it. HPV and pneumococcal vaccines are the only common ones I haven’t gotten, mostly because I’m low risk for both.