Here’s a letter to the Wall Street Journal:
FDA Commissioner Margaret Hamburg proudly notes that “What FDA requires is evidence that patients see a real benefit [from a proposed new drug or medical device], and that the benefit outweighs any risks” (Letters , Dec. 29).
Contrary to Ms. Hamburg’s suggestion, because tolerances for risk differ across individuals (as do assessments of benefits), there is absolutely no scientific evidence that can be discovered by officials at the FDA on whether or not a drug’s benefit – for all, most, or even many people – outweighs its risks.
Valid evidence on this front is available only by observing the voluntary actions of different individuals. If I choose to take drug X, then that fact is solid evidence that, for me, the benefit of X outweighs any risks to me of X. If my neighbor refuses to take drug X, then that fact is solid evidence that, for her, the benefit of X does not outweigh any risks to her of X. And both my neighbor and I – as far as the FDA or any other third-party can discern – are correct in our assessments and, therefore, should be left unmolested by the FDA to choose which medicines to take and which to avoid.
Donald J. Boudreaux