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Minyan Mailbag: FDA: Process vs. Results


Process dominates all too often in situations where it should not, particularly in the approval of oncology drugs.

Prof. Miller-

I wanted to quickly comment on your excellent piece "
Dark Pools and the Tactical Side of Trading"

You make the assertion that the Food and Drug Administration should focus more on results than on process. I think you understand that, in fact, process trumps results. Without control of process, how do we know what is not so? While I'm not wholly convinced by the FDA's actions over the last few years, moving to "results-based" drug approval will not help.

Again, a fantastic piece; I hope that you continue to share your knowledge.

-Minyan Brad

Minyan Brad -

Thanks for the kind words.

You're right that the FDA cannot operate without some process. You can't know if a trial succeeds in demonstrating a benefit outweighing the side effects without applying some biostatistical process.

My point is that process dominates all too often in situations where it should not, particularly in the approval of oncology drugs. If we're talking about a drug that smooths wrinkles, by all means process it within an inch of its life because the benefit can be erased by even small risk.

The specific situation here is a prostate cancer drug whose only crime is a biostatistical picture that is not picture perfect. Nothing so sketchy as retrospective subgroups or anything. It's just a situation where the first Phase III trials of this class of medicine taught us a few things about how they work.

Prospectively defined (though secondary and therefore not assigned alpha) statistical analyses clearly and with excellent internal consistency demonstrate a durable 4.5-month survival advantage with no serious side effects after just three treatment courses. Side effects are fever and chills -- essentially a two-day flu with each of the three injections.

The only available drug with a survival benefit in this indication, Taxotere, has debilitating, durable side effects in exchange for less than two months of extra survival after four months of weekly treatment.

If you apply the same process as used in approving wrinkle creams, this drug will not be approved. That's not appropriate for an oncology drug and would represent putting process ahead of patients. That's why I say that to turn this drug down, it would be placing process ahead of patients.

Warm regards,
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