March 17, 2007, 7:50PM
Dose of reality
First, let's inoculate with the facts
Controversial Gardasil may be better for Merck than it is for Texas girls


By SIGRID FRY-REVERE


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 Texas lawmakers to make its latest vaccine mandatory, Merck has 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 cervical cancer. The federal Food and Drug Administration approved Gardasil last year for use against human HPV in females aged 9 to 26. By a veto-proof majority of 119 to 21, the Texas House of Representatives voted last week against mandating Gardasil for middle school-aged girls, but the Texas Senate has yet to weigh in on the issue, and Gov. Rick Perry is expected to veto the bill.

If he does — and the Texas Legislature doesn't have the votes to override his veto — then his earlier executive order mandating vaccination will stand.

These mandates would be 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 approximately 30 million middle school-aged girls in the United States would bring in more than $10 billion.

Gardasil is not all it is cracked up to be. A recent study in the Journal of the American Medical Association indicates that among women ages 14 to 24, the rate of all 37 types of sexually transmitted HPV combined is 33.8 percent — already a number much lower than the 50 percent figure sited on Merck's Web site. But the rates for the two types of HPV responsible for 70 percent of all cervical cancers (16 and 18), are far lower: only 1.5 percent and 0.8 percent, respectively.

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 cervical cancer is over 90 percent. Thus, when early detection methods are used, only around 0.2 percent of the girls being vaccinated are actually at risk of dying of cervical cancer from HPV 16 or 18 even without the vaccine.

Under these circumstances, are we really prepared to spend $10 billion administering this vaccine?

And while it's horrible that anyone at all should die of cervical cancer, the long-term risks that may be associated with Gardasil are totally unknown. Studies followed the women who participated in drug trials for an average of less than three years. What if some horrible unexpected side effect materializes?

This possibility isn't as far fetched as you might think. In 1976, swine flu caused only one documented death in the United States, but the vaccine administered by government mandate seriously injured or killed hundreds. It turned out that the vaccine caused Guillain-Barré Syndrome, a rare paralytic disease similar to polio, with a 5 percent fatality rate and a 10 percent rate of permanent paralysis.

Mandatory Gardasil vaccinations would certainly brighten Merck's future, but it's not so clear that they're in the best interest of American girls. In all but the clearest cases, health risk assessments should be left up to individual families, not only because making such determinations rightly rest with families, but because it's simply not sensible policy to experiment on such a large portion of our population all at once. What if, 10 years from now, we discover that the vaccine causes infertility or another form of cancer?

To add insult to injury, not only has Merck left Texas lawmakers in the dark about the myriad of possible downsides to mandatory HPV vaccination, it has actively lobbied and paid large campaign contributions to politicians willing to support such policies.

According to documents obtained by the the Associated Press last month, Merck donated $5,000 to Gov. Perry on the same day his chief of staff met with his budget director for an "HPV vaccine for Children Briefing."

To the casual observer, it looks a lot like Merck is paying politicians to do its bidding. Mandating HPV vaccinations would bring Merck huge profits, possibly at the expense of ordinary Texans — or at least at the expense of little girls.

Fry-Revere is director of bioethics studies at the Cato Institute, a Washington-based think tank with a libertarian orientation.



http://www.chron.com/disp/story.mpl/...k/4640022.html




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