Telling Both Sides

I got an e-mail the other day from a journalism student, asking for an interview. "I'm currently trying to write an article for my advanced reporting class about the lax relationship of the FDA and the industry since the passage of the Prescription Drug User Fee Act." When I wrote back, I suggested that maybe he'd end up with a better story if, instead of starting with the assumption that FDA had grown lax, he began by asking whether it actually had.

Patrick Clinton

Coming to a conclusion before doing the research is a classic reporter's error. It's no surprise when a student falls into it that trap, especially when approaching a topic as complex as drug regulation. What's disappointing is to see how the mainstream media are committing exactly the same error in covering the recent flaps over antidepressants, Vioxx, and the like.

For example, a recent story in the Washington Post maps out a critic's case against FDA: The number of adverse events reported to the agency is up. At the same time, the number of withdrawals of major drugs is down compared with the period 1996-2001. The number of warning letters on advertising has dropped. Obviously then, drug safety is going to hell in a handbasket.

I hardly have to point out what's wrong with this "evidence." The number of adverse events reported to FDA is supposed to be up, as FDA has improved its reporting system and demands more postmarketing studies. If anything, the worry is that there still aren't enough adverse events being reported. The number of withdrawals may be down, but it's down from a four-year period when withdrawals were unprecedentedly high. And as for warning letters on advertising, the comparison the Post made is with the period immediately following the introduction of direct-to-consumer advertising. If things worked as they should, the number of warning letters ought to be dropping as companies learn the rules. The facts may be facts, but when you get right down to it, they don't tell us much.

To be fair, the Post noted at least some of the problems with the numbers—in the same pro forma way that the newspapers print the convicted killer's "I didn't even have a gun, and, besides, it wasn't loaded." The accusation was the news. The rest was just "getting the other side."

Getting both sides of a story is important, but you have to be smart about figuring out what the two sides are. When I read the papers these days, it seems many of them have decided that it's the industry and the FDA on one side, and the embattled defenders of patients on the other. Fair enough, but there are two other sides that are equally important, and as near as I can tell, only one of them is getting to speak.

Maybe that's because the two sides don't represent two different groups of people: they represent two competing ideas within almost all of us. One idea is that safety is the only thing that matters, and we should never have to take a risk when we take our medicine. The other is that when our own health is at stake, we should be able to make our own decisions about medicines, and the government should butt out.

A complete contradiction? Sure. But that seems to be how people really think. They'll howl that Vioxx was left on the market too long, then they'll turn around and howl when Amgen, convinced that its experimental drug for Parkinson's disease is both ineffective and dangerous, halts trials and cuts off patients from further supplies.

People are entitled to contradict themselves, of course. And ambivalence can be the basis of sound policy. (What is FDA's risk-management approach if not an attempt to respond to our desire to have it both ways?) But people need to understand that the conflict in the Vioxx case and others is not just between the industry and its gadflies. It's a conflict within.

Patrick Clinton is Pharmaceutical Executive’s editor-in-chief and can be reached at pclinton@advanstar.com.