Pharma Blog Watch

Waxman and Adaptive Trials (DrugWonks)
In his entry, Robert Goldberg discusses Rep. Henry Waxman's (D-Calif.) views on adaptive clinical trials. According to Waxman, "'Permitting drug companies to take shortcuts in their clinical trials poses real risks to Americans.' … 'An antibiotic that is no better than a placebo can't fight off an infection'," Goldberg writes.

"It's hard to know even where to begin. Non-inferiority trials are not shortcuts. And asserting that an antibiotic that is no better than a placebo equals non-inferiority trials is scientifically wrong," he continues.

"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," he writes. "I would argue that Waxman's micromanagement — if this FDA anecdote even has a glint of truth to it — borders on compromising the canons of science and the integrity of the entire drug evaluation process."