Merck's Fosamax® -- The Making Of A U.S. Market, And A Legal Defense -- With A Keystroke

Here is the answer to my weekend brain teaser. The FDA and the W.H.O. both define "osteoporosis" as a bone mass density reading (measured by T-scores) of at least 2.5 standard deviations below the average, for pre-menopausal women. Because the number of women in the United States is very large, and the number of women aged 44 and beyond is also very large, we may safely assume that bone density is normally distributed over these populations, as a whole. See below, click to enlarge:



So -- when Merck arbitrarily chose to "move the goal posts in" (by just one-half of one standard deviation), with the stroke of a pen, it likely more than doubled the number of US women to whom it could push Fosamax^®. [The horizontal scale, in the above graphic, is set in numbers of standard deviations, from the average -- the center of that bell-curve. There were in 2008, according to the datasets of the US Census, more than 60 million US women aged 44 and beyond. So, based on several extrapolations, and assumptions, I think it would be reasonable to guess that Merck's "creative" re-defining of osteoporosis generated as many as 12 million additional potential customers for Fosamax.]

Moreover, of perhaps even surpassing importance, now that there are over 1,100 lawsuits pending -- against Merck -- for jaw and femur bone-death, allegedly caused by long-term use of Fosamax, this "moving of the goal posts" gave Merck a "healthier" base population, by including many, many women in its targeted market population that consensus standards (WHO and FDA) would say don't have osteoporosis, at all.

In fact, then -- not only did Merck likely double its US market, it also set up a "stacked deck" legal defense, as problems began to appear in longer term users of Fosamax. So that is why this bit of package insert will be an important part of the Boles v. Merck retrial, beginning June 2, 2010:

. . . .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 [NOT 2.5 standard deviations] below the premenopausal mean) was demonstrated in four double-blind, placebo-controlled clinical studies of two or three years’ duration. . . .

Now you know.

And, as irony would have it, it may ultimately turn out (five or ten years from now) that Merck's "creative" definition has, all these years later, greatly increased the number of claims for injuries it will face. This is likely so, because these "healthier" women will have been on Fosamax longer (at every age -- and there will be more of them), than would have obtained -- had only women with real osteoporosis been targeted for prescriptions by Merck. Odd. And sad.