Safety, Efficacy, Morality The FDA gets religion (SICK!)

[Guest guest]

Ronald Bailey

 

 

 

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 vaccine and 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.

Ronald Bailey is Reason's science correspondent. His book Liberation

Biology: The Scientific and Moral Case for the Biotech Revolution is now

available from Prometheus Books.

 

http://www.reason.com/rb/rb110405.shtml

 

 

 

" When the power of love becomes stronger than the love of power, we will have

peace. "

Jimi Hendrix