Merck Pushes for F D a Approval of Gardasil for Boys

Merck at it again

Merck, the manufacturer of the much-hyped vaccine Gardasil, has managed to get an FDA advisory committee to recommend expanding its use to young boys aged 9 to 26.  To my mind, there has been less than appropriate attention to long-term side effects in women; let alone for men.  Decisions are being made for children who will have to live with the consequences of such a vaccination for the rest of their life.  A decision in which they likely had little to no input.

A different sales pitch for men than women

While Merck’s aggressive campaign for women stressed the value of Gardasil as protection against cervical cancer, its current claims stress Gardasil’s efficacy in preventing male genital warts.  Granted the risk of cancer as a result of genital wart cells is reportedly less for men than for women; still the risks for men of throat and anal cancers do exist.  So why the focus on genital warts?  Surely better reasons for vaccination would be preventing HPV so that men didn’t pass it on to women.  Or better yet, why put the responsibility for prevention of and the spread of HPV solely on women?  At last check, STD infections were spread through equal participation of partners.

Cost effectiveness a factor in determining need for vaccination

Gardasil requires a series of three injections spread over six months.  The cost per series varies from about $360 to $500.  There has been discussion about the cost effectiveness of vaccinating boys.  Some debate that if enough women are vaccinated at age 12, there is no need to vaccinate men.  Others maintain that if Gardasil is cost effective in preventing cervical cancer, then it is equally cost effective for use on men to prevent throat, penile, and anal cancers.

The true question

While debates rage over cost effectiveness, the need to prevent genital warts in men, or whether vaccinations of women in sufficient numbers achieves the desired result, the key question still remains unresolved.  Gardasil was approved for use in 2006, just about three years ago.  Long-term side effects and safety have yet to be analyzed; indeed it is too soon to obtain enough data to evaluate this issue.  With all due respect and sympathy to the mothers and families affected, have we forgotten the consequences of a medication used to manage nausea?  Harmless enough, right?  Ask the mothers who received Thalidomide for that very reason.

Let’s not be too hurried or rushed by aggressive campaigning in determining what is best for our children.  Life altering decisions are being made, not by them, but on their behalf.  Gardasil may be all that Merck has promised; and again it may not.  Do we gamble our children’s futures on that kind of uncertainty?

That’s my point of view, I’d really like to hear yours . . .