Picture this:

You're the maker of a blockbuster painkiller. Sales are soaring ($2.5 billion in 2011); you're on top of the world.

Never mind that your painkiller could increase the risk of life threatening heart problems, including heart attack and stroke--and that the risk becomes greater if you use it long term.

And forget the finding that it may seriously harm the intestines, even causing bleeding or perforation (which can be fatal and can occur without warning).

Nah--those are just details. You're looking at the bigger picture.

That bigger picture involves widening your target to include kids. I mean, after all, kids get arthritis, too, so why should adults be the only ones reaping all the "benefits" of this top-selling drug?

And widening your pool of potential patients becomes even easier when the FDA gives you a free pass.

Of course, Celebrex was approved for use in children back in 2006 (around the same time it was suggested that long-term heart problems could come from use of the drug--lovely). The advisory panel that recommended approval also expressed concern that chronic use could introduce health risks. But in the "shoot first, ask questions later" world of drug approvals and the FDA, Pfizer didn't have to conduct a safety trial until after the drug was approved.

In a ridiculous twist, though, the FDA has released Pfizer from having to conduct the trial. So of course they've shut it down. Quit while you're ahead, right? Wouldn't want to uncover any problems with your cash cow.

Of course, there was another reason for the cancellation of the trial. It's kind of hard to get parents to sign their kids up as guinea pigs. No matter--Pfizer has gotten what they want--a seemingly magical assurance that their drug is safe. In the short period during which the study was active, they didn't see any major adverse effects, so why keep pushing for long-term results? They looked into their crystal ball and said they didn't expect to see any "clinically meaningful" results regarding adverse effects.

Maybe I'm missing something here, but isn't that sort of the point of a long-term study? Especially when advisers on an FDA panel have come right out and said they worry about long-term effects of a drug's use?

Besides, I'd like to think that drug execs have some semblance of concern for patients--especially kids. Wouldn't they rest easier if they had REAL proof that their drug is safe for long-term use, instead of just speculation?

But in the money-grubbing world that is the pharmaceutical industry, that's asking a lot. And meanwhile, only time will tell what's in store for kids who end up on an under-tested drug for pain management.

Related articles of interest:

NSAIDS increase stroke risk by 28 to 86 percent

Big Pharma shifts research overseas

The Medical "Hall of Shame" Top 5 Exhibits

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