I previously promised to give Bill Keller the last word in our FDA wrasslin' match, and when his reporter, Gardiner Harris, decided to inveigh as well, I decided to give the New York Times two last words. I won't respond to their comments here because a promise is a promise, but I don't think I violate my pledge by saying that I still think Keller and Harris are full of beans. I invite readers to reread the original Times article, my original critique from Dec. 7, as well as Keller's first shot and my response.
From: Bill Keller
Date: Jan. 7, 2005
Gardiner Harris has sent you a response to your Seldane argument, which I hope you'll post as an addition to our exchange. I think most readers will find it persuasive, as I do.
On the question of whether this article is essentially about the adequacy of the FDA's budget, I still think your argument is with someone else. Our article did not contend that the FDA was starving. Whether the growth of the FDA's total budget over this period was adequate to its responsibilities or not is an interesting debate, but it was not the thrust of our piece. The point was that, because of the 1992 change, so much of the budget is dedicated by mandate to approving new drugs that there has been a sharp retrenchment in the policing of drugs already on the market.
Regardless of what happened to FDA funding overall, the FDA's role in monitoring drugs already on the market was curtailed. And that matters. In the weeks since Gardiner's story, we've seen a continuing parade of studies questioning the safety of drugs that had already won the FDA's approval.
Every time I read about one I resist the temptation to call you up and say, "We told you so."
From: Gardiner Harris
Date: Jan. 7, 2005
Dear Mr. Shafer,
I had promised Bill to let him speak for us. But your stubborn insistence on being inaccurate prompted me to write.
We used the Seldane example to show that [the] FDA was once able to ask and answer questions about a drug's safety relatively quickly. You do not seem to dispute this central point but suggest that it's irrelevant since [the] FDA' s discovery that Seldane was unsafe did not affect that drug's sales. Thus, you seem to suggest, drug-surveillance efforts are not important.
The first point is untrue; the second is ludicrous. Here is an excerpt from a May 1, 1996, story in the Wall Street Journal:
The drug-interaction warnings have clearly hurt Seldane's sales, which have declined sharply to an estimated $550 million last year, said Hemant Shah, an independent analyst. Claritin's sales last year were about $789 million.
"If these interaction problems didn't exist, it would have been very difficult for Claritin to penetrate the market," Mr. Shah said.
Here's another story in the Journal from later that same month:
Seldane had almost 60% of the prescription antihistimine [sic] business in 1991 but only 21% by last month. It was hurt by reports in recent years linking it to irregular heartbeat—and even deaths—when taken with certain antifungals and antibiotics such as erythromycin. A rival, Hismanal from Johnson & Johnson, has the same problem.
Claritin hit the market in 1993 as doctors were looking for a safe alternative to Seldane and Hismanal. In ads to physicians, Schering-Plough pointedly notes that Seldane and Hismanal carry "black box" warnings.
Instead of safety concerns hurting Seldane and helping Claritin, you write, "I credit Claritin's rise to a couple of factors. It was a new drug, approved by the FDA in 1993. It was a very effective drug. And it was a heavily marketed drug. Advertising Age reports (March 16, 1998) that $200 million in direct-to-consumer advertising was spent on Claritin between 1993 and 1998."
New drugs rarely supplant older drugs unless they are demonstrably better or safer. Claritin did not win this battle because of its efficacy. Indeed, Claritin is a singularly ineffective drug (please see "The Claritin Effect," among many other stories, published in the Times on March 11, 2001). And while consumer advertising eventually became the fuel for Claritin's huge success, such advertising did not begin until 1997. By then, Claritin already dominated Seldane.
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.
You were right on one point. Claritin was introduced in 1993.
The implication of your critique seems to be that FDA pronouncements about the safety of drugs have little effect on their sales, and thus that drug-surveillance efforts by the agency are unnecessary and shouldn't be funded. In one of hundreds of examples that I could cite, Celebrex's sales tanked in the wake of a recent study that found that it may cause heart problems. And I can't imagine that any sane person would suggest in the wake of the Vioxx disaster that [the] FDA should not track the safety of marketed drugs.
As for your other points, I'll let Bill's response stand. The story's thesis was that, in part as a result of the 1992 deal, funding for new-drug reviews at the agency's drug center soared from 53 percent to 79 percent of its budget, squeezing out priorities like tracking the safety of marketed drugs. This is an important, original point that has become the focus of congressional suggestions for reform. I'm still not sure if you disagree with it.
I apologize for pointing out these problems with your critique. Having spent much of my career at newspapers ignored by media critics, I was delighted to have earned your attentions. But the drug industry and FDA are difficult to cover and can trip up even the best of us. Good luck in future critiques.