Grounds for Gardasil

In five-year follow-up studies, "The efficacy was close to 99 percent" for Gardasil, the first vaccine to protect against two strains of HPV that can cause cervical cancer, says Stephen K. Tyring, M.D., Ph.D., professor of dermatology, microbiology/molecular genetics and internal medicine at the University of Texas Health Science Center, Houston.

"The vaccine has been proven safe and effective in tens of thousands of women" in its original carefully controlled study (Koutsky LA, et al. N Engl J Med. 2002 Nov 21;347(21):1645-1651), Dr. Tyring says.

But proponents acknowledge that public acceptance of mandatory vaccination will require further studies, as well as a measure of cultural change.

Why Merck pulled back on lobbying efforts

Pulling back

In late February, Merck shelved its support of lobbying efforts to make the vaccine mandatory after public objections arose in many states.

Opponents say Gardasil has not been sufficiently tested over time, and they worry about its possible effects in young, developing bodies. Also, they note that the vaccine will be expensive - the required three doses cost about $360.

Others fear that the vaccine - effective only when administered before exposure to HPV - may encourage sexual behavior. Still others point out that infection with HPV doesn't always lead to the development of cancer.

Proponents - including many dermatologists - say Gardasil's health benefits outweigh other concerns. They say state laws can be drafted to permit parents to refuse vaccination under certain conditions, and say insurers are more likely to reimburse the cost of a mandatory vaccine. They disagree that vaccination will automatically lead to promiscuity.

The controversy led Merck to pull back on corporate lobbying efforts.

Based on feedback from public health thought leaders, "It seemed as if there was a misperception about Merck's role in school requirements, and that it was probably best for us to remove ourselves from that discussion" so the company could return to the goal of getting as many women as possible protected from cervical cancer, says corporate spokeswoman Jennifer Allen.

Gender impact

Gardasil currently is in clinical trials for males, and all dermatologists interviewed by Dermatology Times say HPV vaccination should be given to all children - both girls and boys - before they become sexually active.