Who Runs the FDA?
So far, not the Bush administration.
Aug 5, 2002, Vol. 7, No. 45 • By MELANA ZYLA VICKERS
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."
For the purposes of getting the FDA bureaucracy to act, though, the quality of the analysis in the deadly fish reports didn't matter. After wire services and the nation's major newspapers carried the scare reports prominently, some on page one, political pressure mounted. By March 2002, the FDA had agreed to review its own brand-new advice, and with last week's decisions slid further still.
American women and indeed anyone who eats fish would have been far better served by an FDA working to hold its ground--with explanations of why the standards are tough enough, challenges to the rigor of the activist groups' research, and efforts to lay at the feet of Public Citizen and the Environmental Working Group the blame for confusing the public. That's a job for a politically appointed commissioner, someone who can dish out the heat rather than just take it.
The FDA rollover on mercury is reminiscent of another instance in which the agency has been bullied and Public Citizen has been involved. Namely, the false accusation that since 1993, when the FDA began charging user fees for pharmaceutical companies to get drugs approved, the regulatory agency has let a record number of deadly drugs slip into the market. The diabetes drug Rezulin and the diet pill Redux come to mind. The deadly drugs claim has been so widely covered--not least by a 13,000-word article in the Los Angeles Times in late 2000--that it has gained the veneer of respectability, scaring Americans away from new drug therapies.
Yet it's baloney. Between 1993 and 2000, nine new drugs were withdrawn for reasons of health risk, out of 259 drugs that were approved. That's a 3.5 percent withdrawal rate, and it's actually lower than the 4.1 percent withdrawal rate before user fees. Between 1985 and 1992, seven of 170 new drugs were withdrawn for reasons of health risk.
FDA insiders say they try to educate the public about such misrepresentation. They claim, for instance, that reporters who call about the drug approvals are always told the withdrawal rates have been lower, or similar, since user fees began. That doesn't come through in the mainstream coverage, though, suggesting the FDA's public-education efforts are no match for the aggressive tactics and media-darling status of the agency's detractors.
Activist groups aren't the only ones giving the FDA a trouncing. In June, a congressional committee sought to grill the agency about a controversial cancer drug called Erbitux, developed by ImClone Systems Inc. Since the FDA has no commissioner, lower-ranking FDA officials had to face the blast. By rights, these officials should be left to occupy themselves with the science of drug approvals, not the politics.
To be sure, the absence of a leader at the helm isn't the only reason the FDA is yawing. FDA insiders say that activist groups have their share of sympathizers within the agency and that the groups have been clearing paths of influence at the FDA for over 20 years. The mercury offensive is then just more of the same, and Public Citizen et al. are sure to redouble their efforts when the agency gets a commissioner rather than to go quietly. And if the FDA continues to wobble, it's going to be a bad time for worried pregnant women--and other Americans who rely on the agency for safe, speedy drug approvals and reliable information on the safety of medical treatments and food.
Melana Zyla Vickers is a senior fellow at the Independent Women's Forum and a columnist at TechCentralStation.com. Her research paper on this topic is available at IWF.org.