FDA flubs flu preparedness?

Today's Washington Post makes playing connect-the-dots much easier than usual. Page A5 reports what administration officials told Congress is the reason for this year's flu vaccine shortage; right across from it, on page A4, is the continuation of a front page story that raises troubling questions about the administration's claims. The gist of what administration officials and the pharmaceutical industry told a House committee is that relying on the private market isn't working well; fixing the problem requires government propping up the pharmaceutical industry with these "solutions":
  • "[U]nspecified financial incentives to lure more drug companies to enter the high-headache, low-profit vaccine field." Read: corporate welfare for the pharmaceutical industry.
  • "[L]essing those companies' exposure to lawsuits from consumers." Right; having grieving parents sue you because you made a faulty vaccine that killed or seriously harmed their children is a threat to the bottom line.
  • "[I]ncreasing public recognition of the value of vaccines; and having policies to promote greater vaccination of people at low risk." At low risk? Yep, that's exactly what they mean: artificially driving up demand in order to goose the profitability of vaccine manufacturing.
Meanwhile, the Post also reports that U.S. health officials were informed back on September 13 that the manufacturing plant in northwest England on which we were relying for flu vaccines -- yup, all the eggs in one basket, as the article points out -- had contamination problems that would result in inadequate vaccine supply this season. Britain moved immediately to line up alternate suppliers. Not so with the U.S. Compare what records show with what U.S. health officials say in response: Records at Britain's Department of Health show that the plant's owner, Chiron Corp., warned officials of the U.S. Food and Drug Administration and the British Medicines and Healthcare Products Regulatory Agency on Sept. 13 that potential contamination problems remained unresolved at the plant . . . . British officials said there had been regular communication with American public health officials at the FDA and the Centers for Disease Control and Prevention since Aug. 26, when Chiron announced it would delay releasing supplies of the vaccine because about 4 million doses had been tainted. Jason Brodsky, an FDA spokesman, provided an agency statement disputing the British account, saying: "None of the Center for Biologics Evaluation and Research (CBER) staff who were in regular communication with Chiron since August 25, 2004, were notified by Chiron that there was an increased level of concern regarding the company's investigation of the bacterial contamination." So . . . none of the (1) CBER staff (2) who were in regular communication with the company (3) since August 25 were notified. What about CBER staff not in "regular communication" with the company? What about health officials other than those in CBER? Read more about it:
  • Glenn Frankel & Glenda Cooper, "Britain: U.S. Told of Vaccine Shortage; Flu Shot Records Contradict FDA," Washington Post, Oct. 9, 2004, at A1.
  • David Brown, "Fixing Vaccine Supply System: Task Will Not Be Easy, Say Health and Drug Industry Officials," Washington Post, Oct. 9, 2004, at A5.
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