Commentary

Mandatory Vaccines Help Drug Firms, Not Necessarily Consumers

By Sigrid Fry-Revere
This article appeared in the Tampa Tribune on March 20, 2007.

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 percent of cervical cancer cases. The 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 it looks like Florida might be next.

Two bills, one introduced in the Senate by Mike Fasano, a Republican from Pasco County and majority whip, and another introduced in the House by Ed Homan, a Republican from Hillsborough, would require 11- and 12-year-old girls to provide proof of vaccination for HPV to enter school. According to Fasano’s office, the Senate bill is on the education committee docket for today.

With a price tag of $360 per series of three shots, mandatory vaccination would be quite a boon for Merck. If every 11- and 12-year-old Florida girl were vaccinated, the company stands to reap almost $200 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 - a number already 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, the American Cancer Association guidelines reported last month 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 are actually 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. The only logical and cost-effective policy is to encourage regular Pap tests so cancer can be detected early if it ever materializes.

Under these circumstances, are we 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 percent of cervical cancers, and women may not realize the necessity of undergoing regular Pap tests even when they’ve been vaccinated.

Merck’s drug trials followed women who received Gardasil for an average of less than three years, so we don’t know either how long the immunity lasts or the long term risks that may be associated with it.

Mandatory Gardasil vaccinations certainly brighten Merck’s future, but it’s not so clear that they’re in the best interest of Floridians. 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.

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