American women should be forgiven a twinge of skepticism at this week's FDA approval of Lybrel, the new birth control pill that eliminates a woman's monthly period for as long as she chooses.
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Sally Kalson is a columnist for the Post-Gazette (skalson@post-gazette.com. 412-263-1610.) |
The FDA says the drug is ready for prime time. But if there's one thing we know by now about new drugs, it's how much we don't know about their long-term side effects. Even full clinical trials and scrupulous reporting cannot predict outcomes far down the line.
Equally vexing is how hard it has become to believe any assurances from any federal agency in the Bush administration. Certainly, the government has many talented people working in good faith, but the White House has often undercut them by putting cronies, hacks and ideologues in charge.
Americans want to be able to rely on the Justice Department, FEMA, the EPA, the CIA and the Defense Department to know what the heck they're doing when they appoint prosecutors, respond to hurricanes, assess environmental dangers, collect intelligence or launch a war. Alas, such has not been the case.
And they want to believe the FDA when it pronounces a new pill safe and effective. We have to depend on the experts to rule on such things, based on sound research, uncorrupted by industry influence, politics, ideology or religion.
Yes, we know experts are sometimes wrong, as they were, infamously, with thalidomide, the morning sickness pill that was found to cause severe birth defects, and Vioxx, the arthritis drug that Merck recalled due to increased heart risks. But we want to think of these as honest mistakes that came about despite everyone's best intentions, not colossal screw-ups driven by incompetents, suck-ups or foxes in the hen house.
We've learned a lot in recent years about the cozy relationship of regulators and the regulated. Dick Cheney handed over the nation's energy policy to the energy lobbyists, the pharmaceutical industry basically wrote President Bush's Medicare prescription drug plan, and the White House was trying to put a top manufacturing lobbyist in charge of the Consumer Protection Agency until he withdrew his nomination last week. We also know the FDA blocked over-the-counter sales of the morning-after birth control pill for years based on the "moral" objections of a Bush appointee, causing some highly respected scientists to resign in protest.
Such undue influence takes its toll on public confidence, until even good news from a federal agency can prompt a dubious response.
When a new vaccine like Gardasil receives FDA approval, promising to prevent a common sexually transmitted virus that can lead to cervical cancer, it should be cause for celebration -- and it has been in many quarters because cervical cancer is diagnosed in 9,700 American women every year.
Some 24 states and the District of Columbia have taken up proposals to require the vaccine for girls as young as 9. But this uncharacteristic rush to action prompted a backlash from religious conservatives who view the drug as a license for wanton behavior -- as if cancer were a suitable punishment for premarital sex.
Phyllis Schlafly wasn't the only one protesting. Some parents with no political or cultural agenda also reacted badly to Merck's aggressive marketing and worried about possible complications in the future. Their suspicion may not be in the best interests of their daughters, but it's understandable in an era when "government oversight" is becoming an oxymoron.
Lybrel, no doubt, will raise plenty of issues related to sexual politics and the culture wars: whether it's unnatural, essentially anti-female or counter to God's will; whether it's one more sign of self-indulgence or another step on the road to soulless human engineering.
Nobody will be able to call it an abortifacient, that's for sure. Maybe religious conservatives who put that label on other forms of birth control will see this as a palatable means of reducing unwanted pregnancies that lead to abortions. But probably not, since sex without a period is still sex, not abstinence.
Social and religious questions are one thing; safety is another. The FDA doesn't have a crystal ball, but it does have the tools of science at its disposal. Hope springs eternal that the agency is using them in the best interest of public health. But harboring a dram of skepticism isn't a bad idea.