Safety, Efficacy, Morality

A wonderful medical breakthrough was announced last month. A new vaccine against the two types of human papilloma virus (HPV), which are responsible for thousands of cases of cervical cancer each year, has been shown to be 100 percent effective in blocking the virus. Each year more than 12,000 American women are diagnosed with cervical cancer, and more than 3,000 die of the disease. The advent of this new vaccine is a public health triumph and should be cause for celebration, right?

Not so fast, say some social and religious conservatives. For instance, Dr. Hal Wallis, head of the abstinence only sex education group the Physicians Consortium is worried that the vaccine might encourage people, especially unmarried teenagers, to be more promiscuous. "We're going to be sending a message to a lot of kids, I think, that you just take this shot and you can be as sexually promiscuous as you want and it's not going to be a problem, and that's just not true," said Dr. Wallis to the conservative religious group Focus on the Family.

Medical issues analyst for Focus on the Family Reginald Finger is now a member of the federal Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP). The ACIP provides advice and guidance to federal agencies and physicians on the most effective means to prevent vaccine-preventable diseases. Finger has long been a proponent of the benefits of virginity, but claims that he remains open minded about offering the new HPV vaccine to children and adolescents. 

The brewing values fight over the new HPV vaccine mirrors the U.S. Food and Drug Administration's (FDA) ongoing effort to regulate the sexual morality of American women. Nearly two years ago, a joint panel of the FDA's Reproductive Health Drugs Advisory Committee and Non-prescription Drugs Advisory Committee voted 23 to 4 to recommend that the FDA approve Barr Pharmaceutical's application to make the emergency contraceptive Plan B available over the counter. Plan B consists of two high-dose contraceptive pills that either interfere with ovulation or fertilization, or prevent implantation of a fertilized egg. It has no effect once an egg is firmly implanted in the uterine wall.

One of the panelists voting against allowing Plan B to be sold over the counter was evangelical Christian Dr. W. David Hager who wrote a minority report that apparently persuaded the FDA to reject the advisory panel's recommendations. Hager argued that Plan B shouldn't be approved for over the counter sale because the FDA didn't have enough information about how easier availability of Plan B would affect girls younger than age 16. In a sermon Dr. Hager later declared, "I argued from a scientific perspective, and God took that information, and he used it through this minority report to influence the decision. Once again, what Satan meant for evil, God turned into good."

Apparently following Satan's bidding, the FDA's scientific staff rejected Hager's rationale, pointing out, "The agency has not [previously] distinguished the safety and efficacy of Plan B and other forms of hormonal contraception among different ages of women of childbearing potential, and I am not aware of any compelling scientific reason for such a distinction in this case."

Sens. Hillary Clinton (D-N.Y.) and Patty Murray (D-Wash.) held up the confirmation of Lester Crawford as Commissioner of the FDA until they got a promise that the FDA would take action one way or the other on Plan B. Crawford was confirmed on July 18, 2005 and then broke his promise on August 26 when he delayed any action on Plan B by opening up an unprecedented public comment period on the drug. Frustrated by this, Susan Wood, the director of the FDA's Office of Women's Health resigned five days later. Crawford himself quit after barely two months as FDA Commissioner. The Plan B public comment period ended on November 1. 

Let's look at the inherent logic of applying "values" to the regulation of drugs and medical treatments. Religious conservatives believe that medical treatments like the HPV vaccine and Plan B encourage bad behavior. If such treatments are banned, they believe, fear of disease will reduce the temptation for people to behave badly.

So by that logic, shouldn't the search for treatments and cures for HIV/AIDS be halted? (I once expressed astonishment to a former employer who shall remain nameless that some Christians were claiming that AIDS was God's punishment for homosexuality. He replied, "Ron, how do you know that it's not?") If these people would just avoid bad behavior, they wouldn't get the disease. And again, according to this logic, shouldn't the FDA ban the hepatitis B vaccine because its availability encourages not only sexual promiscuity but injection drug use too? Note that the logic of such values regulations doesn't apply to just lust. There are other sins to go after. For example, the FDA should tell the medical profession and the public that it will not approve any medications that would help fight obesity. Any drug that allows people to eat their cakes and stay model slim clearly encourages gluttony.

Even more chilling is the prospect of turning the logic of values regulation on its head--why not morality vaccines? New treatments in development now might prevent people from engaging in some sinful activities in the first place. For example, researchers are hard at work on an anti-cocaine vaccineand an anti-nicotine vaccine. In the future, the nicotine and cocaine vaccines could be combined with little Billy's and Sue's MMR (measles, mumps and rubella) shots before age six, protecting them not only from viruses, but also from temptation. 

Federal agencies must reject the logic of values regulations. The FDA should stick to regulating medications solely on the basis of their quality, safety and efficacy—if even that. Bureaucrats should not be deciding whether or not people should be having sex, with whom they should be having sex, or what type of sex they should be having. If a medicine makes it safer to engage in an activity of which some people disapprove, so what? If anyone must be punished for putting his or her genitalia where other people think they shouldn't, then leave that regulatory decision up to God—or whatever agency is in charge of morals enforcement in the hereafter.