When a potentially dangerous adult drug is given to kids, here’s what passes for post marketing safety

When children are given adult drugs, how high should the bar be set on safety?

If you answered, “Very high!” then you probably wouldn’t fit in at the FDA.

A few years ago the agency approved the use of Celebrex in the treatment of juvenile idiopathic arthritis. But at the time, FDA officials “expressed concerns” about safety based on cardiovascular problems in adults who use Celebrex.

To address those concerns, Pfizer made a commitment to create a registry to collect long-term safety data on kids who used the drug.

But now — six years later — Pfizer has informed FDA officials that the registry has been discontinued due to “difficulties in patient recruitment.”

Recruitment? This is a registry for tracking data, not a clinical trial. They just have to gather data. They don’t have to convince parents to sign their children up for a study where they might receive a placebo.

Given the drug industry’s track record in blowing off post-marketing research, I’d guess that Pfizer made only the feeblest effort to get the registry off the ground. So, yeah, there were “difficulties.”

And what about the FDA’s “concerns” about the safety of kids taking this potentially dangerous medicine?

According to Medscape, the agency simply “okayed Pfizer’s decision.”

What? It got difficult, so you’re retracting your commitment? Okay!

Meanwhile, kids are out there taking Celebrex, and I’ve got a hunch that a few Pfizer executives have their fingers crossed, hoping it will all be fine.

Sources:
“Pfizer Stops Celebrex Safety Study in Children” Janis C. Kelly, Medscape, 3/13/12, medscape.com