The Public Policy

Mr. Kaine, Veto That Bill!

Gardasil may be good for Merck -- but is this HPV vaccine good for Virginia girls?

By 3.23.07

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There's nothing wrong with a drug maker publicizing its products and their benefits, but the lure of lucrative government contracts can prompt them to play fast and loose. In lobbying state lawmakers to make its latest vaccine mandatory, Merck has greatly exaggerated both the threat of a disease, and the ability of a drug to prevent it.

The drug in question is Gardasil, a vaccine for four types of human papillomavirus, two of which are responsible for 70% of cervical cancer cases. The FDA approved Gardasil last year for use against HPV in females aged 9 to 26.

Late last month, the Virginia legislature passed a bill requiring all Virginia girls to be vaccinated against HPV before entering sixth grade. Governor Tim Kaine told the Washington Post that he plans to sign the bill, but he hasn't yet done so. Maybe he's having second thoughts -- which he should, considering the most recent data on HPV and Gardasil -- but if he doesn't veto the bill by midnight on Monday, it will automatically become law.

Virginia is only one in a series of states considering similar mandates, which are quite a boon for Merck, as Gardasil is one of the most expensive vaccines on the market. With a price tag of $360 for a series of three shots, vaccinating Virginia's sixth graders would cost about $19 million a year.

Gardasil is not all it's cracked up to be. A recent study in the Journal of the American Medical Association finds that among women ages 14 to 24, the rate of all 37 types of sexually transmitted HPV combined is 33.8% -- much lower than the 50% figure cited on Merck's website. More importantly, the rates for HPV 16 and 18 -- the two types responsible for 70% of all cervical cancers -- are astronomically lower: only 1.5% and 0.8%, respectively.

And even among those cases, American Cancer Society guidelines published last month report that most HPV infections, even carcinogenic ones, resolve without treatment. Approximately 75% of infections in adults and 90% of those in adolescents disappear on their own.

It's worth noting that the American Cancer Society sees its fight against cervical cancer as a success story even without Gardasil. When detected early through Pap testing, the survival rate for the disease is over 90%.

In short, even without the vaccine, when early detection methods are used, the number of girls who are actually at risk of dying of cervical cancer from HPV 16 or 18 is extremely low. Most of the time, the body takes care of the virus without any help whatsoever.

Under these circumstances, is the Virginia legislature really prepared to spend untold millions administering this vaccine? In truth, it may well cause more harm than good.

What if the vaccine lulls young women into a false sense of security? Gardasil only protects against the viruses responsible for 70% of cervical cancers, and women may not realize the necessity of regular Pap tests even when they've been vaccinated. When women go for an annual Pap test, they are getting a general check-up, not just a test for cervical cancer. As a result, many pre-cancerous conditions for anything from cervical cancer to breast cancer may go undetected, before it's too late.

Merck's drug trials followed women who received Gardasil for an average of less than three years, so we know little of how long the immunity lasts or the long-term risks that may be associated with it. Children vaccinated in middle school could potentially lose their immunity by the time they were seniors in high school.

Only last week, the New England Journal of Medicine reported similar problems with the chickenpox vaccine. Not only did the incidence of illness among those vaccinated against chickenpox increase over time, so did the severity of the illness itself.

And what if some horrible side effect were to materialize later? The possibility isn't as far fetched as you might think. In 1976, swine flu caused only one documented death in the U.S., but the vaccine administered by government mandate seriously injured or killed hundreds. It turned out that the vaccine caused Guillain-Barre Syndrome, a rare paralytic disease similar to polio, with a 5% fatality rate and a 10% rate of permanent paralysis.

Mandatory Gardasil vaccinations certainly brighten Merck's future, but it's not so clear that they're in the best interest of Virginians. As a result, many pre-cancerous conditions may go undetected before it's too late. In all but the clearest cases, health risk assessments should be left up to individual families, not only because making such determinations rightly rests with families, but because it's simply not sensible policy to experiment on such a large portion of our population all at once.

Mandating HPV vaccinations would bring Merck huge profits, at the expense of ordinary Virginians -- or at least at the expense of Virginia's little girls.

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About the Author

Sigrid Fry-Revere is director of bioethics studies at the Cato Institute.