Here's Henry Waxman waxing on and off about non-inferiority trials less then four months ago:
â€œPermitting drug companies to take shortcuts in their clinical trials poses real risks to Americans,â€ said Rep. Waxman. â€œAn antibiotic that is no better than a placebo canâ€™t fight off an infection. Worse, it can subject you to serious, even life-threatening side effects without any compensating benefit. Americans deserve to have confidence that an FDA-approved drug will be both safe and effective.â€
It's hard to know even where to begin. Non-inferiority trials are not short cuts. And asserting that an antibiotic that is no better than a placebo equals non-inferiority trials is scientifically wrong....
In any event, the fact that a member of Congress (along with Markey and Grassley) asking the GAO to investigate the FDA's use of trial designs is not politically correct science? How is this meddling any different than an OMB review of the methodology of climate change study methodology? It's worse.
Here's one effect of the Waxman peer review process...
Supposedly, FDA reviewers have sent signals that a drug intended to keep people alive whose transplanted organs are being rejected and have six hours to live on average should undergo placebo controlled trials to determine safety.
The best science possible? I would argue that Waxman's micromanagement -- if this FDA anecdote is even has a glint of truth to it -- borders on compromising the canons of science and the integrity of the entire drug evaluation process.