Over at The American Prospect, Ezra Klein has a new article up -- his aim, in the main, is to debunk the myth that our current FDA system stifles real innovation.
To make his central point, he highlights Schering's Clarinex/Claritin example. And, yep -- that cha-cha looks alot like the precursor to the Schering's Zocor-to-Vytorin/Zetia "strategy".
Do go read it all, as there is much more in his fine article, but here is a snippet:
. . . .No one wants to be against "innovation." The word is practically a synonym for "awesome." And who wants to be anti-awesome?
But the problem with our health care system is that far too little effort is expended making sure the innovation is good innovation. Take the case of Claritin, the wonder anti-allergy drug. In 2001, loratidine, Claritin's active ingredient, went off patent. Generic producers streamed into the market. Many more people could access Claritin, or at least the compounds that made Claritin powerful.
Right on schedule, Schering, Claritin's producer, emerged with Clarinex. Now the active ingredient was desloratadine [see image at left], and it was said to be effective, for longer. There was little evidence of that. But it was eligible for patent protection, and Schering spent billions of dollars convincing doctors to prescribe it, and so they made profits and health care became a bit more expensive. That was bad, or at least useless and costly, "innovation." On the other side, there's much good innovation. And there should be some status quo bias in favor of protecting a system that does produce important advances. . . .
Specifically, Clarinex does have a longer half-life than Claritin. . . . but there's no proof that it relieves symptoms longer than Claritin. And that is largely "useless" innovation.
In my estimation, this is much the same as Vytorin/Zetia -- it lowers cholesterol numbers, but there is no evidence that its "gut" mechanism actually improves outcomes -- cardio-vascular morbidity risks -- as well as the 20 year-old (now available in generic form), tried and true, class of drugs called statins. Statins work by a liver mechanism, not a gut mechanism. And they have solid, peer-reviewed, replicated data to back their claims -- and, at one-twentieth the price, too.