The Times ODs at the FDA
The root of all pharmaceutical evil, the paper finds, is an industry user fee.
When a newspaper headline cowers in the corner like bashful partygoer, it's usually concealing the insecure newspaper story behind it. As a gregarious fellow, I usually do the right thing by introducing myself, taking the story by the hand, and saying, "It's all right, little fella, let me read you closely and see what the matter is."
I performed such a sociable act yesterday morning (Dec. 6) after spying the nebulous headline "At F.D.A., Strong Drug Ties and Less Monitoring" on Page One of the New York Times. The vague series rubric and subhead that followed—"REGULATION REDEFINED" and "The F.D.A. Shifts Focus"—only muddled the puddle for me. The headlines informed me that story was about the FDA, regulation, and change, but seeing as how the FDA is a regulatory agency and nothing is as permanent as change, this didn't really give me much to go on.
I purchased the article a cup of coffee and asked ever so gently if I could read it. The story blushed, sipped its drink, and allowed me to read to the jump. "That wasn't so bad," said I, "was it?" The story sighed and spread its pages to the inside jump where the 3,500-word piece occupied a full page.
There, the story's diffident thesis ultimately emerges: It seems that the drug industry and the government signed a financial pact in 1992 designed to accelerate the approval of new drug applications. The companies promised to contribute millions in user fees to fund the reviews, and in turn the government agreed to maintain its spending on reviews at 1992 levels (later amended to 1997 levels). The piece then spins its wheels for 3,500 words in an attempt to convince the reader that these user fees, which reached $200 million last year, can be linked to something that endangers the American public's health. But the timid piece never comes out and says so.
"Congressional financing has lagged the agency's escalating payroll costs," the article states, and "agency officials have been forced to shift dollars from other programs into new drug reviews" to meet the terms of the user fee agreement. This unexpected side effect of the deal, the article argues, has been the "shifting" of "the agency's focus on the reviews even beyond what the drug industry had negotiated."
The article never explains why it's the drug industry's fault that the agency hasn't convinced Congress to increase its funding. Nor does the Times ever say if the FDA's funding has fallen since the 1992 deal was inked, although it does peg the agency's current budget at $1.8 billion. But the article essentially places the onus on the user fee arrangement for the cuts in FDA programs that monitor the safety of approved drugs.
The "underfunded agency" story is a genre piece in Washington journalism. Every government agency is unhappy with its funding and can trot out at a moment's notice scary examples of how a paucity of funding has killed, maimed, or otherwise inconvenienced citizens. The Times casts Vioxx in the monster role, citing the views of observers who believe rapid review timelines mandated by user fees and reduced monitoring programs caused the Vioxx disaster.
The underfunded agency story usually includes examples of all the good the agency did when it was "fully funded." In the Times piece, the allergy drug Seldane serves this function. In December 1989, doctors encountered evidence that Seldane, the fifth most popular prescription drug in America, could cause serious heart arrhythmia when taken with antifungal drugs. Thanks to the miracle of full funding, the FDA investigated the interaction and got Seldane's makers to slap a label on the medication warning about its potential dangers. Reporter Gardiner Harris writes, "In 1997, the maker withdrew Seldane from the market because of the problem." One FDA source complains to Harris that today's agency is incapable of performing such safefy tests on approved drugs.
This open-and-shut case crumbles when you examine the back story. Seldane was introduced in 1985, which means it was on the market for almost five years before the FDA's fully funded drug investigators threw handcuffs on it. The Times explicitly states that Seldane was driven off the market in 1997 because of these safety issues documented by the FDA, but this isn't the case. Despite the medical warnings, Seldane remained the nation's second most popular allergy pill through 1996, according to this Associated Press story, with 6 million prescriptions written by physicians that year.
Seldane's makers, Hoechst Marion Roussel, didn't announce its plans to take Seldane off the market until 1997, when the FDA approved Hoechst's allergy pill Allegra-D. This Congressional Budget Office study suggests that Hoechst was gaming its patents when it withdrew Seldane. Seldane's patent was set to expire in April 1999 anyway, so why fight the FDA about it? If the FDA safety cops' showcase is the Seldane story, I feel sorry for them.
What about Vioxx? The FDA approved Vioxx in May 1999 and didn't document safety issues worthy of a ban until this year. That means the drug was on the market for about five years, roughly the same amount of time the fully funded safety cops took to blow the whistle on Seldane. If reduced budgets have slowed safety cops in their appointed rounds, the Times' Vioxx example offers no such vivid proof.
To be sure, the Times article cites anonymous "top agency officials" who dispute the idea that the user fee deal perverts the approval process. They tell the Times that the ratio of drugs withdrawn to drugs approved has remained steady for decades. But why aren't they speaking on the record? They're discussing ratios that should be publicly available, so what are they? While we're on the subject, how many drug labels were amended with stronger warnings before 1992, and how many after the 1992 user fee agreement went into effect?
The subdued hysteria of the Times article might lead you to believe that drug fast-tracking has resulted in an avalanche of new—and potentially dangerous—medicines. Not so. A Harvard-Michigan study from December 2003 found that millions in user fees from drug companies haven't sped the approval of new drugs any more than federal funding increases did in the past. The report also found no evidence that industry funding of fast-track approvals prejudices the process in favor of drug companies. Taking the wind out of the Times'huffing and puffing is this feature article published six years ago, in which GovExec.com critiqued the FDA pact with similar language. If the FDA user fee is news, it's old news.
The late Detroit News columnist Warren T. Brookes quarrelled with conservative journalists who believed the national press corps was liberal. In a 1989 Cato Institute lecture, he declared the press was biased but biased in favor of the state. Journalists, by and large, were "committed to the promotion of an ever more intrusive government presence in every aspect of our lives, except, of course, the press and the media themselves." The symbiotic relationship between the government and the media allowed the press to grow in power and importance whenever the government grew. The press corps' enduring commitment to the government's wisdom, he said, was "motivated by institutional self-interest." If Brooks were alive today, I suspect he'd use the Times story as a heavy-breathing example of his theory.
The FDA user fee may be a boon for drug consumers, a bane, or just a wash, but until the Times produces copy more worthy of a more outgoing headline—and a more declarative article—I remain agnostic.
Somewhere out there, somebody misses their Seldane, which the FDA ultimately drove off the market. Is that someone you? Drop me a line at firstname.lastname@example.org. (E-mail may be quoted by name unless the writer stipulates otherwise.)