Cancer Prevention and Treatment Fund Responds to FDA’s Approval of Gardasil for Males

Diana Zuckerman, PhD, Cancer Prevention and Treatment Fund, October 16, 2009

FDA’s approval of Gardasil for males on the basis of such short-term data makes no sense.  The FDA should have required longer-term data.  Will the FDA tell parents how little we know about long-term safety or effectiveness, especially for boys but even for girls?  I am very disappointed in the FDA’s premature decision about Gardasil for boys.  There was no rush because there is no dangerous epidemic of genital warts in the U.S, and these warts often go away without treatment.  If the vaccine is not effective for more than a few years, it would be extremely expensive and of little benefit, adding to our skyrocketing medical costs instead of improving our health care.

In contrast, the approval of Cervarix makes sense because the vaccine seems to work more effectively for girls than Gardasil.  However, for all vaccines, we need better data on the risks compared to a placebo without the adjuvant.  That’s important, because the adjuvant used for vaccines can have serious side effects.