Excerpt from LOS ANGELES TIMES article, "Warning: This Bill Could Make You Sick," by Al Meyerhoff and Carl Pope
March 21, 2006--The Food and Drug Administration recently announced that seafood contaminated by mercury--a heavy metal found in our oceans mainly as the result of burning coal--can be so hazardous that women "who are pregnant or may become pregnant" should avoid consumption. Mercury was present in fish at levels sometimes far exceeding the FDA's "action level."
So what "action" did the FDA take? Instead of seizing mercury-laden fish, as federal laws allow, it issued a press release; the seafood remained on market shelves.
AL MEYERHOFF, a former director of the Natural Resources Defense Council's public health program, is now a lawyer in private practice in Los Angeles. CARL POPE, the executive director of the Sierra Club, was one of the original drafters of California Proposition 65, requiring that companies either warn consumers of dangerous chemicals in foods or remove them. It was passed overwhelmingly by voters in 1986.
© 2006 Los Angeles Times
Bush and the Mad Scientists
The administration strikes again in its infuriating war against science.
By Chris Mooney
LOS ANGELES TIMES, September 20, 2005--[The FDA's decision to deny approval of "Plan B," the emergency contraception pill, for over-the-counter availability] may represent an 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....
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 join 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 was needed, the FDA claimed, on the pill's safety for women under 16....
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. Scientists writing in the New England Journal of Medicine ("A Sad Day for Science at the FDA") 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.
CHRIS MOONEY is Washington correspondent for Seed magazine and author of "The Republican War on Science" (Basic Books, 2005).
© 2005 Los Angeles Times