After encountering strong resistance and some allegations of conflicts of interest, a dozen or more states have abandoned the idea of requiring girls be given Merck’s human papillomavirus vaccine Gardasil. Only Virginia to date has mandated the vaccine, but California may be next.
In Texas and New York, Merck made campaign contributions to key players in advocating that the vaccine be mandated, and questions were being raised in the press and in prestigious journals such as the New England Journal of Medicine and the Journal of the American Medical Association.
In March, Assemblyman Ed Hernandez, D-Baldwin Park, pulled his bill mandating that seventh-grade girls in California be vaccinated against HPV, which can cause cervical cancer. That age was selected because Merck said Gardasil, to be effective, needs to be given before girls start having sex. The bill ran into considerable opposition inside and outside the Capitol.
Now back without much fanfare, the Assembly approved the Hernandez bill last month. It is scheduled for a hearing Wednesday before the Senate Health Committee.
The arguments against mandating Gardasil haven’t changed, but Hernandez’s bill has. In fact, it doesn’t even mention HPV or seventh-grade girls, but it broadens the scope of mandated vaccines and delegates the authority to compel childhood vaccination to the California Department of Public Health, which the Legislature created last year and came to life July 1.
Hernandez’s bill gives the final say on mandating vaccines recommended after Jan. 1, 2006, including Gardasil, up to the state public health officer, who heads the new agency. So now, instead of the Legislature making decisions that should be left up to parents, a new bureaucracy would get to make those decisions.
Gov. Arnold Schwarzenegger appointed Dr. Mark Horton the first state public health officer. Horton’s position on Gardasil is not hard to discern. Last January, a state-issued press release quoted Dr. Horton as saying, “Preteen Vaccines Week highlights California’s commitment to ensuring that our kids get immunized so they can avoid serious, but preventable infections and reach their full potential.” The release then lists the HPV vaccine as one of the vaccines the federal government recommends for all 11- and 12-year- olds.
The Hernandez bill allows parents to have their children opt-out of vaccinations if they meet certain requirements. But, as Karen England, executive director of the Capitol Resource Institute, a parental-rights group, put it, “An opt-out provision is simply the government telling me that they have taken away my parental rights, and in order to regain them I must file an affidavit with the school.”
Even the bill’s one redeeming feature, its prohibition against mandating vaccines until they’ve been on the market for five years, does little to assuage the scientific and practical concerns about mandating Gardasil.
The question shouldn’t be how effective is Gardasil. The questions should be: How necessary is it, and what unintended consequences may follow from mandating its use?
While approximately half of all females ages 14 to 24 have some form of HPV, a recent study in the Journal of the American Medical Association finds that their rate for carrying HPV16 and 18 - the two variations of HPV that Gardasil is so effective at preventing - are astronomically lower: 1.5 percent and 0.8 percent, respectively, of those teens and women.
And according to the American Cancer Society, most HPV infections, even the carcinogenic ones, resolve without any treatment at all. Approximately 75 percent of HPV infections in adults and 90 percent of those in adolescents disappear on their own. Furthermore, when the precancerous lesions that HPV can (but rarely does) cause are detected early through Pap testing, treatment is generally simple, and the survival rate for the disease is over 90 percent.
Cervical cancer is the world’s second-deadliest cancer for women, but only because women in developing countries don’t have easy access to regular Pap tests. Eighty-three percent of the world’s new cases and 85 percent of cervical-cancer deaths occur in developing countries. Unfortunately for Merck, that is not where the money is.
Gardasil could cause more harm than good by creating a false sense of security. Gardasil doesn’t protect against 16 or more types of HPV, responsible for 30 percent of cervical cancers, and women may not realize the necessity of continuing regular Pap tests even once vaccinated. As a result, many precancerous conditions may go undetected until it’s too late.
Drug trials on Gardasil followed women for an average of about three years, so we know little of how long the immunity lasts or the long-term risks that may be associated with being vaccinated. Children vaccinated at 12 could potentially lose their immunity before finishing high school.
Whether the order comes from the Legislature or a bureaucrat, mandating HPV vaccines in California may very well be in no one’s best interest except Merck’s.