Off-Label as Samizdat

One of a series of posts about Off-Label

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In a pharmaceutical context, Off-Label refers to drugs being used in ways that are not approved by the regulators and cannot therefore be printed on the product label or officially promoted by the drug company. More generally, it refers to any unauthorized or emergent use of a product or service. In this blog posting, I shall explore the implications of off-label for knowledge management.

Robert Stern describes some of the difficulties involved in disseminating Off-Label research data. There are clearly some potential conflicts of interest, and doubtless sometimes there is natural suspicion of the motives of the drug companies. However, the result is that data describing the behaviour of certain drugs in certain contexts are not available.

This means that many good uses of drugs may be suppressed by regulators, or self-censored by drug companies in order to get speedy approval. In a separate post, Robert Stern quotes a physician as saying "Often the drug companies will under-dose their labeling to get it through the FDA." So does the physician have some other way of finding out an appropriate dose, or is it all done by trial and error?

If the official channels are blocked, how does the medical community share practical knowledge about Off-Label. Is this all done by unofficial samizdat and word-of-mouth?

There is a newsletter for sceptical patients called What Doctors Don't Tell You. Perhaps there should be, if there isn't already, a newsletter for doctors called What Drug Companies Don't Tell You.