Originally Published February 2001
Although the device industry and its advocacy groups have been largely silent, there is no lack of rhetoric as FDA awaits the next commissioner.
Last month in this space, I wrote about the future plans of the FDA commissioner under the heading "Agenda for the Century" and the subhead "Henney Pledges Good Science, Openness at FDA." The column was essentially a review of Commissioner Jane Henney's year-end speech before the National Press Club, which she called "FDA: Preparing for the 21st Century." In her talk, Henney maintained that the first of FDA's fundamental principles was to "ground decisions in science," and noted that 75% of recently surveyed consumers, health professionals, and industry representatives believed that FDA does in fact base its decisions on "good science."
A few hours ago, someone brought into my office the lead editorial from the day's Wall Street Journal, which ran under the heading "A 21st Century FDA," and the subhead "Unleashing Science." (The subhead was backed by a graphic image of a pretty little caduceus, implying that both wings and serpents were eager for the Journal to unleash them.) Given its title, one might have thought that the editorial was yet another account of the commissioner's speech. In fact, Henney was not mentioned in the piece at all, perhaps because, on January 18, she was dismissed by the Bush administration and given one day to vacate her office.
Rather, the Journal editorial, which concentrates on how a new commissioner should handle drug regulation but ranges somewhat wider, describes an FDA whose "ludicrous overreaching" is symptomatic of an "institutional compulsion to restrict and suppress," whose "staggering economics . . . are an insurmountable hurdle." As an example of the agency's megalomania and the depredations of class-action lawyers and "Nader-ite" groups, the Journal laments the fate of "a drug [used] to treat irritable bowel syndrome, called Lotronex, which sufferers call a miracle drug and which the FDA has just removed from the market because 70 people had bad experiences with it." Calls to several gastroenterologists reveal, in reality, that while no one dies from irritable bowel syndrome, the Journal's "bad experiences" included deaths from ischemic colitis; that Lotronex was far from a "miracle drug"; and that FDA was certainly justified in pulling it from the market. In another example, the Journal upbraids a tyrannic FDA because the agency has recently "forced hospitals to now file paperwork for secondary use of medical devices." Did someone forget to tell the defenders of free enterprise that the device industry had been pleading for such regulation for years?
It happens to be one of nature's elemental laws—and thus no surprise—that the editorial page of The Wall Street Journal congenitally veers away from objectivity. But why is the paper now bringing out the rhetorical big guns to paint a picture of FDA that ignores the significant reforms of recent years as well as the accomplishments of a commissioner who was liked and respected by industry? One suspects that it is all a smokescreen to obscure the fact that Henney was dismissed because of abortion politics: namely, because she concurred with years of scientific study—presumably science unleashed—that determined the abortion pill RU-486 to be safe and effective.
The Journal piece ends with a description of novel autologous cancer vaccines, and counsels "the Bush folks" to install someone at FDA "who understands these realities." Maybe they can find a medical oncologist and talented administrator with experience in academic medicine, clinical research, and government, who was also deputy director of the National Cancer Institute and president of the United States Pharmacopoeial Convention.
And maybe the Journal folks can retitle their editorial "A 19th Century FDA," and subtitle it "Unleashing Politics."