Gotta love them data!

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Drs. Marc Pfeffer and Marianne Bowler are commenting on the Supreme Court’s ruling in Matrixx vs. Siracusano, which upheld a lower court’s decision that a drug manufacturer must disclose to shareholders information regarding adverse effects, even absent any measure of statistical significance.  But the authors would like to go beyond the court’s mandate.  They advocate for “more open and better reporting” of any potential adverse effects (calling for drug companies to deliver any available piece of information “transparently,” e.g. directly to their desktop).

Individual manufacturers should not be in the position of determining what information is considered material for public dissemination.

No!  Academics should have first dibs!

And the potential size of the garbage pile doesn’t daunt them:

Sorting the wheat of true adverse drug effects from the chaff of biologic variability and chance associations is exceedingly difficult….However, in cases in which data showing initially seemingly unimportant imbalances eventually add up to a clear signal of an adverse action of a drug, transparent early reports could reduce the likelihood of litigious arguments concerning who knew what and when. Individual manufacturers should not be in the position of determining what information is considered material for public dissemination.

Umm, isn’t statistical significance precisely what is invoked to distinguish “unimportant imbalances” from “clear signals?”

The resulting flood of data, though likely to represent biologic noise rather than evidence sufficient to establish even “probable cause,” would contribute to the total mix of available information and might, under some circumstances, influence reasonable prescribers and patients to alter their treatment plans: a sommelier, for example, might consider any report of anosmia to be material.

The sommelier may reasonably refrain from taking Zicam on the basis of garbage data, but woe to the stable coronarian who would dare pass on an ACE inhibitor on the basis of the PEACE trial…

The logic of database doctors…It must be all this regression analysis…

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