Mandating the HPV Vaccine

As a debate on the issue rages across the country, Colorado lawmakers are considering legislation that would make a vaccine for human papilloma virus (HPV) mandatory for all school-age girls. HPV is responsible for 70 percent of cases of cervical cancer, which claims 3,500 lives in the U.S. each year. The vaccine, called Gardasil, is made by pharmaceutical giant Merck and was approved by the FDA last year. Legislation similar to Colorado’s has been introduced in 28 other states and the District of Columbia (and enacted by executive order in Texas), but there’s hardly a consensus on mandating the vaccine.

Concerns of some conservative and religious groups have been well publicized. They argue that requiring a vaccine for a sexually transmitted disease might somehow promote sexual activity. But others consider the point moot since vaccines guarding against hepatitus B are already widely required. And, as the co-sponsor of Colorado’s SB 80, House Republican Leader Mike May was noted as saying in a Denver Post editorial, “cancer is hardly a fair punishment for such behavior.”

But when a vaccine becomes a hot issue for legislatures nationwide, the question begs to be asked: Who’s behind the push?

In many cases, including in Colorado, it’s the bipartisan organization Women in Government, which has set up a Web site promoting government mandates for the vaccine.

According to a Rocky Mountain News article:

[state Sen. Suzanne] Williams said she learned of the vaccine through her membership in Women in Government, a national advocacy group composed of female lawmakers.

The Associated Press reported Wednesday that Merck has funneled money through Women in Government to promote the vaccine, which costs roughly $350 per three-shot regimen.

AP also reported that an official from Merck’s vaccine division sits on Women in Government’s business council, and that sponsors of many of the vaccine bills nationwide are members of Women in Government.

But Williams downplayed the connection, saying that by next year other companies are expected to have cervical cancer vaccines on the market.

Arthur Allen address Williams’ last point in a Baltimore Sun op/ed:

Because Merck competitor GlaxoSmithKline is coming out with a similar vaccine in about six months, it raises the presumption that Merck is cramming its vaccine down our throats (or rather, into our arms) in order to grab market share before the competition gets going.

Allen, the author of the book Vaccine: The Controversial Story of Medicine’s Greatest Lifesaver, says the rush to require the HPV vaccine is unprecedented, and that’s a reason to be cautious. But others argue that the making the vaccine mandatory (most states, include Colorado, would allow parents to opt out) would save thousands of lives. The vaccine has been proven to be 100 percent effective in immunizing against the two strains of HPV that cause 70 percent of cervical cancer.

Still, some parents are concerned that the vaccine may not be completely safe. According to the FDA, the small number of adverse reactions in clinical trials were mostly at the site of injection and not serious problems. But, even though the vaccine is approved for girls as young as nine, only about 4,000 of the 25,000 trial subjects were younger than 16. And the drug was only tested for efficacy, not safety, in some of those girls.

It would be nice to unconditionally believe the FDA when it says something is safe, but who can forget Vioxx, Merck’s osteoarthritis drug pulled from the market in 2004 after news of people dropping dead from heart attacks?

Another concern about the HPV vaccine is the cost. At $360 for the three-shot regimen, Merck stands to reap an almost $11 million initial windfall in Colorado alone. It’s not clear yet whether insurance companies will pay for the vaccine, but public funds will probably cover the cost for some low-income children. However, there are still about 60,000 uninsured children in Colorado who don’t qualify for public assistance. Of course, just because some families can’t afford it doesn’t mean the vaccine isn’t a good thing. But there is the argument that parents ought to be able to make their decisions about the HPV vaccine based on health, safety and moral concerns – not financial ones.

In addition to all the above concerns, there’s the libertarian argument that the government should stay out of citizens’ private health decisions, period.

While most people seem to agree the HPV vaccine is a lifesaving medical breakthrough, SB 80 probably won’t pass through the legislature without more controversy. The Senate Health & Human Services Committee gave it the OK on a 5-4 party-line vote, with Dems voting in favor. It will be heard in Appropriations Wednesday and will then go to the Senate floor.

HPV vaccine information from the Center for Disease Control

Gardasil approval and clinical trial report from the FDA

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