FDA lets down parents and kids in post-marketing safety research

When children take drugs approved for adults, how high should we set the bar 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 six years later, Pfizer discontinued the registry due to “difficulties in patient recruitment.”

Recruitment? This wasn’t a clinical trial. They just had to gather data. They didn’t need to convince parents to sign up their children for a study.

Drug companies often blow off post-marketing research. I’d guess that Pfizer made only a feeble attempt to get the registry off the ground. So, yeah. There were “difficulties.”

And what about the FDA’s “concerns” about kids’ safety?

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

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

Meanwhile, kids are out there taking Celebrex. I have a hunch that 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