Now that the FDA’s vaccine advisory panel has given the nod to Gardasil for boys and men, the FDA is almost certain to approve the new market.
Although several panel members expressed concerns about the unknown duration of Gardasil’s protection against four strains of the HPV virus, only one member voted no. That was Vicky Debold, PhD, RN, who is the panel’s consumer representative.
"It would be a mistake to go forward and recommend that boys be encouraged to take this vaccine,” Dr. Debold said, “until we understand what's going on with the safety issues that [are] cropping up in girls.”
The value and safety of Gardasil have been increasingly questioned of late, notably this month in JAMA. The FDA has warned that the vaccine demonstrably raises the risk of syncope and blood clots, although it believes that the potential benefits far outweigh the risks. Drs. Sheila and David Rothman noted in JAMA that there was no data available about the vaccine’s effect on natural immunity, replacement diseases, or human behavior, such as ditching annual exams. They questioned the assumption that defeating HPV strains 16 and 18 will lead to a marked reduction in cases of cervical cancer. And they expressed concern that consumers were pushed to get the vaccine without being given the unbiased information necessary to properly weigh risks versus benefits.
Meanwhile, the vaccine has been associated with various serious side effects, including neurological and autoimmune conditions, in a small percentage of girls who’ve received one or more doses of the vaccine. No link, however, has been demonstrated at this point. (On the bright side for the parents of boys, autoimmune disease, which can be triggered in susceptible individuals by environmental factors, is less common in males than in females.)
“I would love my daughter and my son to get a vaccination that would prevent any kind of HPV, but it has to be at no cost, and I don't mean financial cost, I mean at no health risk cost," Dr. Jacques Moritz, the director of gynecology at St Luke's Roosevelt Hospital, told CBS news.
For boys, the vaccine has fewer potential direct benefits than for girls. The FDA was asked to consider only its efficacy for preventing genital warts, which affect about one percent of the population. Although the human papillomavirus can cause anal, penile, perineal and oral cancers in men, such cancers are very rare and are not as directly traceable to HPV—only about 40 percent of penile cancers, for instance, are related to HPV. Many boys and men will get the vaccine mostly as a way of protecting future partners. That gesture that can only be applauded by any woman.
As always, parents need to educate themselves about risks and benefits and honestly assess their individual lifestyles and family histories. One would expect the parent of a child with any family or personal history of autoimmune disease to be particularly cautious. On the other hand, an individual or the parent of a child with a lifestyle known to strongly increase incidence of persistent HPV infection—a poor diet including few fruits and vegetables, a smoking habit, many sexual partners, frequent sleep deprivation, lousy hygiene habits—might be more enthusiastic about the vaccine and less concerned about possible side effects. Males should also know that not being circumcised also substantially raises the risk of both transient and persistent HPV infections. Even a transient infection (some 95 percent of HPV infections are simply shrugged off, virtually always leaving behind natural immunity to that particular strain) can cause a persistent infection in a partner.
We are, hopefully, long past the days when we assume that what’s good for one person (or many) is good for every individual. In the case of Gardasil, none of the available choices are risk-free.
So what do you think? Will you as parents be getting Gardasil for your sons, and will men be getting it for themselves?