As I’ve said before, the notion of “second-guessing” regulators is the rhetoric of company defense lawyers. The Vioxx litigation, for example, has involved many issues that have nothing to do with “second-guessing regulators.” I.E.

- using a variety of delay techniques to avoid the CV warning that was finally added as a “precaution” (the famous 14 months). (Along with calculating how much each day’s delay might award the company.)

- campaigns of intimidation against academic researchers and their universities.

- sending out “false and misleading” (FDA’s language) materials on Vioxx to physicians, for which Merck got formal warning letters twice - in 2001 and earlier.

- possibly acting _not_ to stop the VIGOR trial when some of its observers thought it should be.

- misleading statistical analyses of the AVANTAGe trial (which Merck says were innocent mistakes) which supported what we now know is the bogus 18-month claim.

And on. And on.

The “second-guessing” arguments serve to divert us from the essential patterns of conduct in cases like this. Once again:

1. What did a company know?
2. When did they know it?
3. What did they do about it?

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