Do They Care If People Die?

Washington, DC -- Here's a chilling newspaper lead: "The government is on track to approve a new antibiotic to treat a pneumonia-like disease in cattle, despite warnings from health groups and a majority of the agency's own expert advisers that the decision will be dangerous for people." The drug, cefquinome, is from one of the few antibiotic families that remain effective against several serious human infections. Using drugs in livestock has been an almost certain mechanism to create drug-resistant disease strains --"super-bugs" -- that can ultimately infect humans. The American Medical Association, the FDA's own advisory panel, and the guidelines of the World Health Organization all oppose using cefquinone in livestock. The FDA is going to ignore them thank to a new, FDA "guidance document" (never commented on or reviewed by the public), that requires the Agency to defer to pharmaceutical companies.

What might be the origin of a government rule that requires the FDA to put human lives at risk, even though the drug in question is not even needed to treat livestock diseases? We don't know the story of this particular Advisory Opinion, because there is no public record of how such agency decisions are made. But a recent discovery that an industry consulting firm actually runs the federal agency that evaluates the causes of birth defects and other reproductive problems may shed some light on the Bush administration's attitude about public safety. Sciences International of Alexandria (SI), the consulting firm, runs The Center for Evaluation of Risks to Human Reproduction (CERHR), an agency which is nominally part of the National Institutes of Health. SI has worked for R.J. Reynolds, the tobacco giant, and also Dow Chemical, a major manufacturer of Bisphenol A (BPA). According to Environmental Working Group, hundreds of animal studies "show that BPA is toxic at very low doses, and the Centers for Disease Control has found BPA in 95 percent of people tested at levels that raise health concerns." (Environmentalists have particular reason to be concerned about Bisphenol A -- the chemical leaches from the polycarbonate drinking water bottles, like Nalgene, carried by many hikers.)

This week, the CERHR met to decide whether or not Bisphenol A should be classified as a reproductive toxin, so, in effect, a Dow Chemical consultant will be deciding whether to regulate a Dow Chemical product, and acting for the US Government as it does so.

Given this cozy arrangement in one part of the federal government, perhaps we shouldn't be surprised to find almost slavish obeisance to the desires of the pharmaceutical industry in another part. But how do these regulators sleep at night? After all, they know what they are doing, even if most of the public is kept in the dark.