Commentary

Questions Remain on Gardasil

By Sigrid Fry-Revere
This article appeared in the Denver Post on March 22, 2007.

There’s nothing wrong with drug makers publicizing their 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 percent of cervical cancer cases. The U.S. Food and Drug Administration approved Gardasil last year for use against HPV in females aged 9 to 26. Texas, New Mexico and Virginia have all recently mandated HPV vaccination, and Colorado might be next.

Sen. Suzanne Williams, D-Aurora, is pushing Senate Bill 80, which would require that girls be given the HPV vaccine before they turn 12 or they would not be permitted to attend school.

With a price tag of $360 for a series of three shots, mandatory vaccination would be quite a boon for Merck. If all 11- and 12-year-old Colorado girls were vaccinated, the company could reap almost $150 million.

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 percent - much lower than the 50 percent figure cited on Merck’s website. More importantly, the rates for HPV 16 and 18 - the two types responsible for 70 percent of all cervical cancers - are astronomically lower: only 1.5 percent and 0.8 percent, respectively. And even among those cases, last month’s American Cancer Association guidelines report that most HPV infections, even carcinogenic ones, resolve without treatment. Approximately 75 percent of infections in adults and 90 percent 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 percent.

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

Under these circumstances, are we really prepared to spend untold millions administering this vaccine? In truth, the vaccine may very 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 percent of cervical cancers, and women may not realize the necessity of regular Pap tests even when they’ve been vaccinated. As a result, many pre-cancerous conditions may go undetected before it is 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.

And what if some horrible unexpected 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-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 certainly brighten Merck’s future, but it’s not so clear that they’re in the best interest of the public. In all but the most clear 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, all right, but they might well come at the expense of ordinary Coloradans - or at least at the expense of Colorado’s little girls.

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