[ Feature ] Taking One for the Girls

Meina Lee tells APBN why boys might want to consider taking the

The idea of extending the “female cancer” jab to boys would make sense from Merck’s commercial point of view – more patients means more sales of the vaccine and a boost to the bottom line. It would also make sense from a public health point of view: with a larger percentage of the community immune to HPV, incidences of HPV and, by implication, cervical cancer should drop. But does it make sense from an ethical perspective? Calls to give mass vaccinations of to boys are primarily based on one undeniable truth: while Gardasil will deliver some benefits to the boys who are vaccinated, the greatest s millions of girls and young women around the world hold out benefit from vaccinating boys will be to girls in the community who their arms for their Gardasil vaccinations, public health experts are will be less likely to contract HPV already looking to the next phase of the “cervical cancer vaccine” A and therefore less likely to develop roll-out. And it’s raising a lot of interesting ethical questions. cervical cancer. We live in a cultural Gardasil is a medical and commercial Asia-Pacific biotechnology milieu that encourages medical success story. Developed by Australian of the Year and Jian Zhou, choices to focus on the effect on and manufactured by US pharmaceutical giant Merck, Gardasil’s sales of the individual patient concerned. A$200 million a year are expected in Australia alone. So how will doctors convince young Mass vaccination programs of Gardasil are in place or being planned men and parents of young sons of in various countries. While these programs currently extend only to girls, the benefits of the Gardasil vaccine some public health experts are calling for Gardasil to be given to boys as when the lion’s share of the benefits well. The question is, why? Males will never contract cervical cancer, this go to someone else? much is obvious. But they can be infected by – and, more importantly, pass on infection of – human papillomavirus (HPV) which causes over 70% The Story So Far of cervical cancers in women and is the very virus that Gardasil protects Gardasil works by preventing against. infection of four strains of HPV. With this in mind, Merck has been testing Gardasil in males aged Two of these four strains are known 9 to 26 in order to expand the vaccine’s label claims to this new group. The to cause 70% of all cases of cervical results are due to be announced some time in 2008. Among other things, cancer and the other two strains are the aim of the trial is to test the effectiveness of a male vaccine program on known to cause 90% of all cases of reducing cervical cancer rates in females. genital warts.

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marketed Gardasil as the “cervical cancer vaccine” rather than a vaccine In light of concerns for an STI. Parents may feel more comfortable signing on to the idea about Gardasil and its that they are protecting their young effect on promiscuity, it daughter from cancer rather than is also worth noting that preventing an STI. This marketing approach has been successful, a vaccine for a sexually perhaps too successful because now transmitted disease is Gardasil is now largely fixed with the reputation as a “girls’ vaccine”. It may already included in many be difficult to alter this reputation, childhood immunization if the vaccine were to be marketed programs, including in to males. The emphasis on Gardasil as Australia. a gender specific “cervical cancer vaccine” is also present in the promotional information given Harm in relation to Australia’s national The potential harms of Gardasil Until now, the most effective immunization program. The program vaccinations are relatively similar for way to control incidences of provides free Gardasil injections boys as for girls. The vaccination itself cervical cancer has been early to all girls and young women in risks minor physical side effects such detection by regular screening (Pap Australia aged 12 to 26. Although as redness, pain and swelling at the smears). Because Australia has a the Australian Therapeutic Goods injection site and mild fever. well-established national cervical Administration has approved the In terms of non-physical effects, screening program, it has one of the use of Gardasil in males aged 9 to the fact that young children will lowest mortality rates from cervical 15, the government only funds the be vaccinated against an STI has cancer in the world. Unfortunately, vaccination of girls (boys’ vaccinations generated fears that vaccinations will the greatest burden from cervical need to be paid out-of-pocket). encourage promiscuity or undermine cancer is in developing countries abstinence-only campaigns. In where cervical screening services can The Ethical Issues: Getting addition, fears were raised that be limited, making early detection Consent Gardasil would encourage women and treatment all the more difficult. Informed consent to medical to take fewer Pap smears under the This is where HPV such as treatment is a well-established misconception that cervical screening Gardasil may have the most benefit ethical requirement. Vaccines are was no longer needed. So far, there by preventing incidences of cervical not compulsory in Australia, so have been no studies showing that cancer in the first place. individuals (or parents of these these concerns have materialized, Unlike other vaccine-preventable individuals, if they are not old enough) at least in the context of girls’ diseases, HPV is transmitted by sexual need to agree to be vaccinated. As vaccinations. Nevertheless, since contact rather than casual contact. such, informed consent becomes an some of these concerns are likely Because Gardasil works to prevent important factor in relation to the to re-appear in the context of boys’ HPV infection, it is most effective if uptake of vaccines. vaccinations, ongoing discussion administered to individuals before For consent to be informed, and education of the relationship they become sexually active. For an individual must have enough between Gardasil, HPV and its this reason, in Australia, Gardasil knowledge and understanding of the associated diseases is necessary. has been approved for use in girls as facts to be able to assess the “pros and In light of concerns about young as 9. cons” involved in being vaccinated Gardasil and its effect on promiscuity, Although HPV is a sexually with Gardasil. A quick summary of it is also worth noting that a vaccine transmissible infection (STI), Merck these “pros and cons” are outlined for a sexually transmitted disease is has — quite understandably — below. already included in many childhood

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more to gain from immunity to HPV In the case of HPV, the more people than men. This gender disparity in (male and female) who are immune Gardasil’s benefits suggests that to HPV, the better it is as it takes a degree of altruism would be the community as a whole closer to involved in a male’s decision to be that herd immunity threshold. vaccinated. In the past, the promotion of Altruism is not a factor which vaccines have tended to emphasize regularly comes into medical the benefits to the individual decision-making. However vaccines concerned, that is, the second kind are a special case as they have an “in- of benefit. However, promoting built” degree of altruism. It may not Gardasil for boys will likely involve immunization programs, including be widely publicized, but the basic the first kind of benefit (benefits in Australia. Hepatitis B is sexually goal of vaccines is — and has always to the community) playing a more transmitted (although it can also be been — improving the health of the prominent role. transmitted by other means) and the community as a whole and not the While it is unusual for vaccines vaccine is on Australia’s childhood particular individual. That is, like to be given primarily for the benefit immunization schedule. Promiscuity it or not, a vaccinated individual of others, Gardasil is not unique. concerns about Gardasil center on benefits the community a lot more The vaccine against rubella virus the fact that it is a vaccine for an STI than people realize. is a well-established part of many given during childhood. However, countries’ national immunization Hepatitis B vaccine injections are Two Kinds of Benefits programs. While the rubella vaccine recommended even earlier than Most medical interventions – a plaster prevents individuals from having the Gardasil vaccine (the earliest cast on a broken leg, painkillers for to suffer the (non life-threatening) injection is recommended as soon as a headache — benefit the treatment symptoms of rubella, it is primarily possible, after birth). recipient, first and foremost. given to prevent congenital rubella However, vaccines offer two kinds syndrome, a serious disease which will affect neither the girl nor the Altruism of benefits: benefits to the health boy vaccinated but the girl’s future Males will no doubt enjoy direct of the wider community and to the offspring. benefits from getting the vaccine. individual. Moreover, as a public Gardasil protects against genital health tool, community benefit is warts which, unlike other STIs, can infinitely more valuable. This benefit Implications Gardasil has been so successfully be unsightly and cause physical is achieved via a phenomenon known marketed as a “girls’ vaccine” that discomfort. The disease also invokes a as herd immunity. Herd immunity it may be a tough sell to convince certain social stigma and the condition provides a “sum more than its parts” males that they will directly benefit can be a source of psychological protection to communities, based on from getting it as well. As discussed stress. Research also suggests that the idea that if a sufficient proportion above, while there are direct benefits HPV might be associated with head of the community is immune to to males in relation to genital warts, and neck cancer as well as penile a transmissible disease, then that it isn’t clear whether the promise cancer, so vaccination against HPV disease will “die out” as there are of this protection alone is reason may have benefits which are not yet not enough people to circulate it in enough for males to get vaccinated. fully established. that population. People who aren’t Perhaps, then, a new “pitch” is However genital warts, unlike immune to a disease – because needed; one which also emphasizes cervical cancer, is treatable and they are medically unable to take the effects of getting vaccinated on not life-threatening. And the link a vaccine or choose not to — are the present and future health of between HPV and head or neck or protected by the herd that is. The women in the wider community. An penile cancer is still being researched precise percentage of the population honest appeal to altruism might work, while the link between HPV and that needs to be immune to reach not least because it accords with the cervical cancer has been understood herd immunity depends on the biological and epidemiological truth for some years. As such, it appears disease, but it is clear that the more about vaccines and herd immunity. that right now, women have much people who are immune the better.

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to lower rates of HPV and cervical cancer in females. It seems ironic that the greatest ally in the fight against cervical cancer could well be those who will never contract it and so have the fewest reasons to care. Our current decision-making models have little scope for considering the wellbeing of people other than ourselves. However, Gardasil for boys might provide us with an opportunity to consider another paradigm. n

Some may doubt the extent vaccines and to spark debate on how of altruism in the community. far we should consider the effect However altruism is alive and well of our medical decisions on others. in the context of non-therapeutic Appropriate models of consent will medical research. Such research, also need to be investigated in order compared to medical treatment, to harmonize the diverse bioethical involves even less direct benefit to and cultural approaches in the About the author research participants. If people can countries of the Asia-Pacific. For take part in medical research for little example, experts have suggested that Meina Lee has been involved or no benefit to them (or at times the administration of HPV vaccines in bioethics projects in both significant detriment), it suggests that should be done at 18 in India, rather Australia and the United States people may be more willing to take than at age 12 to 13 due to different on issues such as childhood part in a primarily altruistic exercise socio-cultural norms. diabetes education and the that involves some degree of direct withdrawal of artificial nutrition benefit as well. Conclusion and hydration. Education will also be central Vaccine decisions not only affect She is a practicing lawyer, to any vaccination campaign. While the health of the individual but the m e m b e r o f t h e H u m a n doctors and health professionals health of the whole community. And Research Ethics Committee are aware of the herd immunity careful consideration of the ethical at the University of Western benefits of immunization, the wider issues involved with vaccinations is Australia, and a deputy member community may not be. The societal central to their success as a public of the Human Research Ethics need to debate the acceptable “pros health intervention. Committee at the Western and cons” of a Gardasil vaccine for Gardasil provides a reminder of Australian Department of boys represents the opportunity the dual power of vaccines, as calls Health. to educate the community about begin for males to be inoculated

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