Friday, May 21, 2010

Okay, Head's Up! -- Weekend Brain Teaser: "Dueling Definitions" of Osteoporosis


I am going to add to this post at some point over the weekend (if the commenters don't solve it themselves, prior to Sunday night), but see if you can figure out why Merck's definition of what constitutes the medical condition "osteoporosis" differs from the one the World Health Organization and the FDA both agree upon, and use.

Here's a hint: Merck's supposed definition has become important, in both (i) its marketing efforts, and (ii) in one of the pending "bellweather" trials -- due to begin jury selection on June 2, 2010 in Manhattan federal District Court, before Judge Keenan. I'll be back to add more, by Sunday late evening, if not before. Here is Merck's FDA-filed package insert copy -- at page 4, of 32 -- still apparently operative, to this day (despite FDA requests to revise the same, to bring it into conformance with the WHO osteoporosis definition):

. . . .Effect on bone mineral density

The efficacy of Fosamax 10 mg once daily in postmenopausal women, 44 to 84 years of age, with osteoporosis (lumbar spine bone mineral density [BMD] of at least 2 standard deviations below the premenopausal mean) was demonstrated in four double-blind, placebo-controlled clinical studies of two or three years’ duration. . . .

What's going on here? Answers soon. The W.H.O. definition:



No comments: