Bill Keller Replies
The editor of the New York Times gives "Press Box" a piece of his mind.
The next sentence supports my notion that the story is really about underfunding: "As Congressional support sank since then, the agency has cut everything else but new drug reviews. In the past 11 years, spending on the reviews has increased to more than four-fifths of the budget of the agency's drug center from about half." If the sinking of congressional support doesn't qualify as underfunding, I don't know what does.
The journalistic language that signifies underfunding peppers the piece. Your reporter writes of the "slashing of laboratories," of laboratories "starved" of new equipment or "shut down." Programs have "gotten squeezed" or "ended," and financial constraints have forced the agency to cancel collaborations with academic drug-safety experts. We learn that one drug-safety project got funded only because the "agency has raided furniture and travel budgets," that new-drug reviews receive ample funding for travel and training but the drug-safety division got "two thirds less, which keeps most at home," and that "Congressional financing has lagged the agency's escalating payroll costs." Your reporter quotes an FDA report that laments that the FDA isn't adequately funded to collect reports of problems with drugs on the market.
Your reporter repeatedly links the 1992 formula to the slashing, starving, shut downs, squeezes, and raids—but he produces no evidence or describes no mechanism to explain how the one has caused the others; he only asserts. For example, at one point he writes, "None knew that the reason was that money had to be shifted out of their [safety] programs into new drug reviews to satisfy the requirements of the agreement and industry demands."
For a piece always kvetching about money, it is woefully short on hard budget numbers. In fact, the only hard number offered is FDA's current budget ($1.8 billion). The curious reader would logically want to know if the FDA budget gone up since 1992, stayed level, or gone down.
I've got the answer. According to the FDA press office, Congress appropriated $746 million in FY 1993 to the agency, and user fees kicked in another $36 million. In FY 2004, Congress appropriated $1.67 billion, and almost $250 million in user fees were collected. Even after you correctthe appropriated funds for inflation, the budget increase over the last decade is dramatic: $746 million in 1993 dollars translates into $949 million in 2003 dollars. FDA starved, slashed, or squeezed? I don't think so.
I'm glad you brought up Seldane. I won't dispute your claim that the agency had superior "mechanisms" in place in 1990 to answer safety questions, but isn't that merely a way of saying the safety division was better-funded back then?
You mischaracterize Seldane's decline and departure from the drug market. In 1996, Seldane was the second-most popular allergy drug in the United States. Not bad for a drug that the FDA had been pummeling as "unsafe" since the early '90s. You're right about Claritin overtaking Seldane, but I don't think health concerns were the main reason. As late as 1997, it was still considered safe enough to be sold by prescription in the United Statesand over the counter in several European countries, including the U.K. 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. Nor was Claritin the only new antihistamine introduced in the 1990s. Allegra, manufactured by Seldane's maker, Hoechst Marion Roussel, started digging into Seldane's market share when it was approved in 1996. According to Advertising Age (July 29, 1996), Hoechst switched its marketing support from Seldane to Allegra that summer in hopes of wresting the No. 1 antihistamine spot back from Claritin.
This Congressional Budget Office study suggests Hoechst started weaning itself from Seldane in 1996 because the drug's patent protection was set to expire in three years, making it a generic drug. It was in Hoechst's best interest for Seldane to be banned before it could go generic, especially if Allegra caught on, which it did. Now that Claritin is sold over the counter, Allegra runs neck and neckwith Zyrtec as the most frequently prescribed antihistamine. (See this article in Pharmacy Times and the accompanying chart.)
On your third point, I yield. I wish I could go back and rewrite that one sentence accusing the piece of the sort of "subdued hysteria" that would lead readers to believe fast-tracking has resulted in a flood of potentially dangerous drugs. That assertion is not in the article.
Still, I defy anybody to read the 3,500-word investigation and miss its gist that the Prescription Drug User Fee Act of 1992 is directly responsible for the reduction of monitoring programs, a move which has endangered the nation's health. That's the clear message in the story's first two paragraphs. They read: When federal drug officials suspected in 1992 that a popular allergy pill might cause heart problems, they turned to their own scientists. Their trial confirmed the danger, and the drug was pulled from the market.
When federal drug officials suspected in 1992 that a popular allergy pill might cause heart problems, they turned to their own scientists. Their trial confirmed the danger, and the drug was pulled from the market.
Eight years later, similar worries surrounded the arthritis pill Vioxx. But by then, the Food and Drug Administration had shifted gears, slashing its laboratories and network of independent drug safety experts in favor of hiring more people to approve drugs, changes that arose under an unusual agreement that has left the agency increasingly reliant on and bound by drug company money. Discovering Vioxx's dangers would take four more years.