The Magazine

Who Runs the FDA?

So far, not the Bush administration.

Aug 5, 2002, Vol. 7, No. 45 • By MELANA ZYLA VICKERS
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NO SOONER had a meeting of Food and Drug Administration advisers broken up in suburban Maryland on Thursday than the food-safety alarm bells began ringing on the subject of mercury in fish: "Pregnant Women Should Avoid Tuna," warned an Associated Press story on Friday. "FDA advisers urge pregnant women to limit tuna intake," added MSNBC, compounding the anxiety of a population subgroup that's already inclined to do a lot of worrying.

The worrying will prove unnecessary, however. Absolutely nothing has happened in the world of tuna, fish in general, or medicine to warrant any additions to the FDA's already-strict warnings on mercury in fish.

Rather, the FDA's three-day meeting of its food advisory committee was in response to a development that, from its perspective, was far more dangerous and significant than new data: an attack from environmental groups calling the FDA's stand on mercury weak and demanding that it be revised.

Instead of standing by the scientific integrity of its highly publicized January 2001 warning that pregnant women should protect their babies by not eating any shark, swordfish, king mackerel, or tilefish and by limiting consumption of any other fish to about the equivalent of two tuna cans weekly, the FDA obliged the activist groups. It set up the meeting, and will in the coming months launch some scientific studies on tuna to add to the annual monitoring it does on American diets as well as change the wording of its fish advisory. This last action is the one that is getting the attention, yet it's perhaps the least significant of all: Where the FDA now tells women they "can safely eat 12 ounces (two small cans) per week of cooked fish, . . . shellfish, canned fish, small ocean fish . . . just pick a variety of species," it will in future use the word "tuna" explicitly--just in case critics are right that consumers don't think "tuna" when they read "canned fish."

The fact that the AP and MSNBC, among others, managed to misconstrue this decision as some new warning against tuna is precisely what the FDA should have worried about before caving to the pressure from activist groups. The agency was seemingly oblivious not only to the public alarm and confusion that its backpedaling could cause, but to the weak science behind the environmental groups' claims as well. What's worse, the FDA's response is but one example of the way the unsteady regulatory agency, operating without a commissioner since the beginning of the Bush administration, has tilted toward political pressure and away from scientific rigor.

Getting the FDA over a barrel in this manner is a great victory for the Washington-based Environmental Working Group and a Public Citizen affiliate called the U.S. Public Interest Research Group Education Fund. All the more so considering how little evidence the groups have managed to muster. Their arguments are presented in two papers, one published earlier this year, the other in April 2001.

The older paper, called "Brain Food: What women should know about mercury contamination of fish," argues that the FDA's tough, clear warning is insufficient and puts women at risk. "Brain Food" is based on a Centers for Disease Control study whose dominant finding is that average mercury levels in women are not of concern. That finding didn't matter, though, because in the details of the CDC study, the environmentalist authors found their pearl: a calculation showing that 10 percent of adult women have mercury levels that exceed the levels CDC considers safe. Inspired, the activists built their objections around this minor finding in a small study that has nothing to do with pregnant women or fish and that finds no problem with 90 percent of its subjects.

Not stopping there, the Environmental Working Group followed up with a paper arguing that transcripts of FDA meetings show the agency deliberately downplayed warnings about mercury as it devised its 2001 standards. The paper, constructed wholly of selective quotations, is made of even thinner fish flakes than "Brain Food." For example, on page two, the authors string together a private citizen's speculation about links between mercury and Attention-Deficit Disorder in her child with an FDA scientist's vague response. The authors imply falsely that the FDA makes a link between the controversial disorder and fish contamination.

The Environmental Working Group then goes on to exaggerate the CDC figure of 10 percent of women of childbearing age being at risk of elevated methylmercury levels. The group represents it as "ten percent of American women enter pregnancy with elevated methylmercury levels."