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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: Twitter: Dereklowe

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January 10, 2005

The Example of Claritin

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Posted by Derek

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.

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1. qetzal on January 11, 2005 11:56 AM writes...

The disagreements between Schafer and Keller seem a bit semantic to me. Keller says:

"The FDA may be underfunded or it may be overfunded, but the point of this story was that its regulatory mission was seriously distorted by a drastic reallocation of priorities under the 1992 formula—away from monitoring the safety of drugs already on the market and to the accelerated testing of drugs vying for market approval. The story is not about whether the FDA has enough, but about how it spends what it's got."

OK, but the clear implication is that safety monitoring is underfunded. Keller says to-may-to, Schafer says to-mah-to.

Assuming that's true, the big unanswered question is why?

The original article repeatedly blames the user fee agreement. But it never makes its case. The user fee agreement said Congress couldn't reduce funding for new drug approvals. OK, so approval efforts keep getting the same amount from Congress, plus they get new money from industry. How does that take money away from safety monitoring?

If total FDA funding hadn't kept pace, I could understand, but Schafer's numbers indicate otherwise. Adjusted for inflation, total Congressional funding has apparently gone up 75%. Add in user fees, and it's almost doubled. So they have twice as much money as before, and yet safety monitoring efforts have supposedly been slashed. Not just frozen, cut. Why is that? How is that due to the user fee agreement?

The only real clue from the article is this passage:

"But Congressional financing has lagged the agency's escalating payroll costs. To meet the "trigger" and keep fees flowing, agency officials have been forced to shift dollars from other programs into new drug reviews. This shifting has increased the agency's focus on the reviews even beyond what the drug industry had negotiated."

Why did payroll costs escalate so much that safety programs had to be cut? Were all those extra people hired just to speed approvals? If so, why? There's no indication the user fee agreement required it. If not, what are all those people doing? The article doesn't give a satisfactory answer. Instead, it offers quotes like this:

"'We get increased user funds and not increased appropriated dollars,' said Deborah Henderson, director of the office of executive programs in the F.D.A.'s drug center. "We have stolen from the labs and other parts of the non-user fee program.'"

That doesn't make any sense. Just because they get user fees to supplement approval efforts doesn't mean they also have to redirect other money as well!

Something is clearly missing here. The article, and many of those quoted in it, repeatedly claim or imply that the user fee agreement (and "close industry ties" in general) is reponsible for this situation, but that appears to be BS. Too bad the reporter didn't try to uncover the real explanation.

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2. M. Simon on January 13, 2005 12:20 AM writes...

I think putting the government in charge of drug regulation is the wrong way to go. Things get distorted by politics.

I add in a bit on why drug companies are in tthe lead in the Drug Free America campaign.

It is rent seeking pure and simple.

The Brown Acid - Quality Control in a Free Market

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3. M. Simon on January 13, 2005 12:23 AM writes...

Let me see if I can make the url more obvious:

The Brown Acid - Quality Control in a Free Market.

Hope that works better.


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