Nature Medicine | Spoonful of Medicine

The broader problem with HPV

A study presented at this month’s conference of the European Research Organization on Genital Infection and Neoplasia provided evidence that a widely-marketed cervical cancer vaccine might also stave off genital warts in young men. Gardasil, which immunizes women against the cancer-causing human papillomavirus (HPV), is also 90% effective in shielding young men from developing genital lesions caused by the four HPV strains it targets, scientists reported. The study was funded by the vaccine’s maker, Merck.

Health agencies in Australia and other countries have already approved Gardasil use for both males and females, but the US government has only cleared the vaccine for use in females. Merck is now seeking US Food and Drug Administration (FDA) approval for Gardasil’s use in preventing genital lesions among males ages 9 to 26.

Thwarting genital warts is an obvious boon—and there are other compelling arguments for extending Gardasil’s use to young men. HPV plays a role in oral, neck and other types of cancers affecting males. Furthermore, vaccinating boys might potentially curb the spread of the virus to young women, thereby reducing the burden of cervical cancer—the fifth deadliest cancer among women worldwide. And isn’t it only fair to vaccinate men and women for a disease both are responsible for spreading?

The idea may sound appealing, but concerns remain about Gardasil’s value—even for girls. And some reports have suggested that the vaccine might, in very rare circumstances, trigger serious illness among certain people. Additionally, exactly how long the immunity conferred by the vaccine lasts is unknown. Experts point out that the average follow-up time for patients in Gardasil’s clinical trials was about 15 months. There is also the argument that the vaccine, which costs about $375, may not be cost-effective for all of its target age groups.

Given the unresolved questions about Gardasil use in women, I think we should think twice about broadening its application to men at this time. What do you think?

mensign.JPG

Photo by CarbonNYC

Comments

  1. Report this comment

    Anne-Marie Ronsen said:

    Very good information!!!

    Keep up the fantastic job!

  2. Report this comment

    Girish Kotwal said:

    I agree with the careful broadening of the application of Gardasil to males in the sexually active age group without restricting it to a window of 9 to 26. Young males are a significant reservoir of HPV, and a major cause of the spread of the virus to females who suffer more severe and long term consequences. Merck currently has a monopoly over the HPV vaccine market and that does probably contribute to some extent to the high price. The success of Gardasil has resulted in several copy cat outfits that are trying to produce a cheaper and more broad protection versions of Garadasil. Just in my state, which is not exactly a biotech powerhouse, there are 3 biotech companies that are trying to develop a vaccine against other HPV capsid proteins like L2 which presumably provides a wider protection against several HPV strains. Multiply that by about 50 and there are 150 companies in the USA and worldwide that are probably trying to enter into the Gardasil-like market and so I predict in a year or two the price of Gardasil will be down to at least $100/person. I think it is worth every government’s healthcare obligations to its citizens to provide subsidized vaccines and I am glad that the Australian health agencies are taking a lead in providing both males and females

    with the vaccine. The side effects need to be carefully managed.

    I would like to declare my conflict of interest as a virologist and a humanitarian in watching the reservoir of pathogenic viruses being reduced for the future generations and I think that Gardasil ensures that. I do not have any stock in Merck. I am not looking for a job in Merck. I may have indirect investments that I am not aware of in Merck worth a few cents indirectly through my individual retirement account that has been rapidly diminishing. I am not aware of that and would not change my mind if I did not have any indirect investments. I will have no hesitation in being critical of some other Merck products but Garadasil is a historic first HPV vaccine that will reduce incidence of cervical cancer globally. It is in the league of HBV vaccine another Merck innovation which has done a great deal in controlling HBV infections incidence and liver cancer.

  3. Report this comment

    Sergio Stagnaro MD said:

    I am looking for further information on swedish legal events about the distressing recent situation, announced by London Time!