A few weeks ago I linked to Slate's Jack Shafer and his criticism of a New York Times article on the FDA. I had trouble seeing the point of that article myself, so Shafer's comments helped put my mind at ease.
Well, Times editor Bill Keller had some reaction to Shafer's attack, which (after an e-mail-induced delay) Shafer's now published along with his own rebuttal. It doesn't end there - Keller has still more words for him, joined by the reporter of the original story (Gardiner Harris) in one last Slate piece here. That's a lot of reading, admittedly, but it's interesting stuff, both for people who are interested in the FDA and the drug industry and for people who are interested in the New York Times.
Overall, I still come down more on Shafer's side of the argument. As much as I could make out, the original article seemed to be about how the FDA doesn't have (or use) the funds to monitor the safety of drugs any more, preferring to devote resources to getting new ones approved. (I know, I know, there are a lot of us in the industry sitting around tapping our feet and wondering where those resources must be going.) Keller and Harris dispute this interpretation, but I think that Shafer makes some good points.
But the exchange gets bogged down in the details of Gardiner Harris's original example, the mid-1990s safety problems with Seldane and the subsequent rise of Claritin in the antihistamine market. Shafer doesn't get this one very straight, and Harris finally says "Simply put, safety concerns about Seldane were the dominant force behind Seldane's fall and Claritin's rise in those early years. Anyone at Schering-Plough, Claritin's maker, would confirm this."
Well, as it happens, I was working at Schering-Plough in those days, and I have to say that Harris is right. There's something else that at first would seem to confirm Harris's thesis: Schering-Plough had a mighty long wait for Claritin to get approved. But I don't think it had anything to do with lack of funds. The drug was already over-the-counter in Canada before it made it out of the FDA here, about which there was much bitter comment, but that wasn't a general phenomenon.
In the long run, the delayed timing wasn't all that bad, since Seldane (and Hismanal) started having trouble early in Claritin's US lifetime, opening up a market opportunity that otherwise wouldn't have been there. That's the door through which Schering-Plough then famously rolled the fanciest direct-to-consumer advertising campaign that anyone had ever seen, which paid off very well indeed.
That's a point that I wish some critics of the drug industry would appreciate: companies spend money on advertising because they plan to make even more money than they spent. That's what advertising is supposed to do, y'know. In the end, Schering didn't have an answer for Claritin's patent expiration when that finally came, and the company went into the tar pit for a while. That was after I'd left, I should add - post hoc ergo propter hoc, doubtless.) But that shortfall wasn't for lack of trying during the 1990s, and much of the money that financed those research projects came from the mighty sales of Claritin.
Oh yeah - there's something that Gardiner Harris says in his letter to Shafer that I wish someone would pass on to, say, Marcia Angell. I like it so much that I should set it to music. Quote Harris: "New drugs rarely supplant older drugs unless they are demonstrably better or safer." How true, how true.