Bush and the mad scientists
THE LAMENTATION in the forthcoming New England Journal of Medicine is typical of a growing genre: complaints about the misuse of science by the Bush administration. It is merely the latest jeremiad, from a group of distinguished experts, about the loss of reason by our leaders. This particular editorial, titled “A Sad Day for Science at the FDA,” concerned so-called Plan B emergency contraception (the “morning after” pill), but it just as well could have been about the science of global warming or mercury pollution. Yawn. We’ve heard it all before.
There’s an inherent difficulty when it comes to sustaining outrage over how science gets continually misused in the Bush administration. The complexity of scientific disputation, paired with the intricacies of bureaucratic decision-making, make for a truly soporific combination. It’s tough to get past the latest scandal and see the big picture -- even when, as in this case, three distinguished doctors are writing that the Food and Drug Administration has made “a mockery of the process of evaluating scientific evidence, disillusioned scientists both inside and outside the agency, squandered the public trust and tarnished the agency’s image.”
Still, let’s try to muster whatever’s left of our outrage, because the Plan B episode truly demands it. It may represent a historic low for science-based professionalism at the FDA. And it presents an instructive case study in how the political abuse of science plays out in practice.
By any stretch, this decision should have been a no-brainer. The “morning after” pill, which blocks or delays ovulation, had already been approved for prescription use; the latest move merely concerned its availability over the counter. (Six states, including California, have made it available over the counter, but women must request it from the pharmacist.)
Given that the pill’s effectiveness in preventing a pregnancy depends on how quickly it is used after unprotected sex -- and that it meets the safety and ease-of-administration tests for over-the-counter products -- it makes obvious sense that simplifying access would help prevent unwanted pregnancies (and thus, presumably, abortions).
Two scientific advisory committees held a joint hearing to consider the issue. Committee members voted overwhelmingly (23 to 4) in favor of approval. The FDA expert staff was of a similar mind.
And yet in an extraordinary move in May 2004, the agency second-guessed its experts and its advisors and cooked up a dubious rationale for delaying approval of over-the-counter availability. More data were needed, the FDA claimed, on the pill’s safety for women under 16. Or course, no evidence existed suggesting a unique problem for this age group, and such age-based data have not been required to switch other drugs to over-the-counter availability.
The FDA suggested that the maker of Plan B could reapply for over-the-counter status with the proviso that girls 16 and younger would have to get a prescription. But when the company did that, the FDA delayed again. Early this month it said it now had to check the legality of the age rule.
As it happens, the “morning after” pill has been strongly opposed by many religiously conservative interest groups. In fact, there’s some evidence in the transcript of the hearings to suggest that the rationale cooked up by the FDA may have originally sprung from a controversial advisory committee member -- “As Jesus Cared for Women” author W. David Hager -- who provided one of the four votes against Plan B’s approval. When the agency didn’t like the overwhelming opinion of the advisory committees, it seems to have gone shopping for a more convenient scientific-sounding argument: “We need more data.”
In the end, the scientific data indicate that Plan B contraception is one of the safest drugs ever considered for over-the-counter sale. FDA decisions about drug approvals are supposed to be based on just such scientific data. If you want to derail such a decision, you have to undermine the science. That standard has not been met.
The abuses in the Plan B case have fundamentally called the FDA’s integrity into question.
“People who’ve been in the agency for decades say they’ve never seen anything like it,” Susan F. Wood, the former assistant FDA commissioner for women’s health who resigned over the Plan B decision, told me. The scientists writing in the New England Journal of Medicine agree. Although the FDA may previously have been accused of having too much bureaucracy or too close a rapport with the drug industry, they argue, it had at least “resisted political pressure to reflect a particular social policy or ideology.”
But not any more -- and that’s the really nasty thing about the current war on science. If you can get past the complicated details, you’ll see that it is undermining our government’s most central mission: to serve and protect us. This mandate cannot be fulfilled without an abiding respect for professionalism, expertise and the integrity of scientific analysis.