On November 2, 2011, Merck with seek approval from FDA, based on the small SHARP study, for a new indication -- on its Vytorin® combo-pill.
Friend of the blog, Marilyn Mann makes a succinct and cogent case against the approval. Do go read it all (longer version here), but here is a bit:
. . . .[B]ecause SHARP compared the combination of simvastatin and ezetimibe with placebo — there was no simvastatin arm — we have no way of knowing if ezetimibe contributed anything to the result. The FDA requires that combination drugs have additive effects over either drug alone. Merck has not shown that ezetimibe contributed anything to the effect in SHARP, so the new indication should not be approved. . . .
Stay tuned -- for the FDA Advisory Committee meeting -- I know we will.
