Shoveling Shit At The FDA

Remember Mel Brook's Great Line From Blazing Saddles, "Gentlemen, we must protect our bullshit jobs". Unable to find gainful employ, rejects tend to wash ashore at the FDA. Protecting their sinecures, they smugly point out that 9901, Dendreon's Provenge Phase Three trial missed its surrogate endpoint. They wanted assurance that the results were no more than 5% likely to be random. Layman Ming would be humbled by his ignorance if he didn't know that the miss was two-tenths of one percent. So there was a 5.2% possibility that Provenge's results could be random. Ming would also demure if time to progression, the endpoint used wasn't designed to measure the delayed results of a vaccine. He would also keep quiet if he didn't realize that the 5% used as the measure is arbitrary. Why not 6% ? Maybe if we had six fingers on each hand, we'd have used 6%. Maybe we should round up or down to the nearest whole percent. No matter. This is "science". Please don't quibble that survival, for which the surrogate endpoint was used as a proxy shows good results. Go away Ming unless we can interest you in our latest chemo cocktail that shrinks tumors almost as fast as it does the host but doesn't extend survival. What we don't approve can't hurt us. Errors of ommission don't count. Statistics have saved our bullshit jobs. Ming wonders if organized requests that they lose their bullshit jobs would pique their scientific interest? Thank God Alexander Fleming did his work outside the purview of the FDA otherwise we'd still be waiting for penicillin.