Lesson from flu vaccine
Sunday, November 1, 2009 -
The production of swine flu vaccine is behind schedule, a result of a manufacturing process that took longer than expected. This would not have mattered if the Food and Drug Administration had given up its belt-and-suspenders supercaution - a fearfulness not limited to the FDA, but one that hobbles American life in many areas.
The vaccine contains no adjuvants, compounds that stimulate the immune system and thus boost the potency of the vaccine. Adjuvants are used in Europe without harm. A European dose of the vaccine is 3.75 micrograms; the U.S. dose is 15 micrograms.
Other instances of excessive vaccine caution vis-a-vis Europe could be shown, but this one makes the clearest point. Use of adjuvants would have quadrupled the number of doses available today, turning a shortage into a surplus.
The same exaggerated caution makes the FDA require a scary warning on foods irradiated to kill harmful microorganisms, a requirement that deters use of a technique in wide use in Europe.
It is the caution that leads the Environmental Protection Agency to require elaborate, unnecessary testing of crops genetically engineered to resist pests. (Here Europeans are more scaredy-cat than Americans.)
It is the caution that leads the Federal Railroad Administration to require passenger cars to be far stronger than Europeans judge necessary, thus helping to make rail service often too expensive to contemplate.
It isn’t just personal injury lawyers that have spread fear everywhere. An open political system that lets everyone, no matter how scared, have a say also helps. The only cure is an educational system that teaches how to evaluate scientific and technical questions. Alas, we see no sign of improvement on that score.




