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Association of American Physicians and Surgeons, Inc.
A Voice for Private Physicians Since 1943
Omnia pro aegroto


Statement by Jane M. Orient, M.D., F.A.C.P.
Executive director, Association of American Physicians and Surgeons
Irving, Texas, Feb. 11, 2007

The Association of American Physicians and Surgeons objects to Governor Perry’s attempt to play doctor and parent to all sixth grade girls in Texas.

Merck’s heavy television advertising has not convinced most parents to buy or most pediatricians to stock Gardasil, the most expensive vaccine in history. So the Governor is going to force taxpayers to pay for it, and reluctant parents to accept it for their daughters.

Many parents have learned what Merck knows very well: that serious adverse effects of a product may not become apparent until years after the product has been approved and widely used. But Texans might not be aware that , unlike with Vioxx, Merck does not need to fear costly litigation if the vaccine turns out to cause arthritis or other diseases due to an overactive immune system. If the government mandates a product, the manufacturer is off the hook for liability. One sure effect of Gov. Perry’s action is to protect Merck against lawsuits.

The jump-rope ads are misleading. Gardasil is not a “cancer vaccine.” It protects against four of some hundred strains of a virus that causes genital warts. We hope that the vaccine will prevent cervical cancer because 70 percent of cervical cancers have been found to contain one of those strains, although 30 percent do not. But it is too soon to say for certain that the vaccine has prevented even one cancer. Studies have shown no Pap smear abnormalities in one group of subjects who received the vaccine, while a number of such abnormalities were found in control women. But it takes around 20 years for a cancer to develop, and the women have been followed for less than 5 years.

In a free society, people are allowed to take risks. The argument for forcing people to use protective measures is to prevent them from imposing risks on others. But this rationale is not being applied here. Almost every woman who has genital warts got infected by a man. If the Governor is serious about protecting little girls, he should be forcing men of all ages to take Gardasil.

Apparently, Gardasil hasn’t been proved safe in men. But most drugs that women take were primarily tested in men because, for very good reason, manufacturers don’t like to test drugs in subjects who might become pregnant. Gardasil has also been tested in very few young girls, and has not been proved safe in pregnant women. Almost any girl who is conceivably at risk for a sexually transmitted disease is also at risk of becoming pregnant.

The evidence for safety in Gardasil in men is just as good as the evidence for safety in young girls or pregnant girls. It almost certainly benefits men by protecting them against the nuisance of some types of genital warts and is highly likely to protect against some forms of penile or anal cancer. These cancers are rare, but then so is invasive cervical cancer in women who get periodic Pap smears. But remember, the main reason for mandating vaccines is to protect others: in this case, girls.

Girls who save sex for marriage, marry a man who shares their values, and remain in a mutually monogamous relationship are not at risk of genital warts or of a myriad other problems. Parents who doubt that their girls will reliably follow this path are free to try to protect them with Gardasil, But they should not overestimate the degree of protection.

Say you want to protect your child against the dangers of experimenting with fire. If there were a vaccine to prevent one kind of cancer that occurs 20 years after smoke exposure, you might or might not choose to obtain it. But if you expose the child to matches and to films promoting the fun and excitement of setting fires, and teaching methods for producing pyrotechnics, you shouldn’t be surprised if the child gets burned or burns your house down, even if he is 100 percent safe from smoke-induced cancer.

Cervical cancer is a fairly minor problem in the United States, especially if women get their recommended Pap smears, which they will still need even if vaccinated. The epidemic of sexually transmitted diseases is a major problem. Gardasil is of possible but still unproved efficacy against cervical cancer, but it might even exacerbate the larger problem. Its long-term safety is unknown.

Some parents think Gardasil is a great idea. However, a parent who wanted to protect a girl who is now 11 with Gardasil might well choose to wait two years, at which time the risks and benefits will be much better known. But Governor Perry knows best: no entry to sixth grade without proof of vaccination or exemption.

Governor Perry’s order is an outrageous violation of civil rights of girls and their parents. It imposes a medical treatment of unproved benefit and unknown safety on patients without informed consent. It forces this burden on girls who are unlikely to be at risk while exempting the entire class of individuals who generally transmit the disease: men and boys. It forces taxpayers or insurance subscribers to pay for what is basically a life-style disease.