Son of Steve

It’s frustrating when Congressional subcommittees only seek advice from people who tell them what they want to hear.

Case in point, the testimony of Harlan Krumholz (of Yale) at yesterday’s House Appropriations subcommittee hearing – chaired by Rosa DeLauro.

Dr. Krumholz thinks that the FDA should have an "emergency response" plan to follow when new safety findings raise questions about whether a drug should remain on the market. According to Dr. Krumholz, "There should be clear protocols, processes …We should not be in 2010 saying we still don't have all the data. We don't have all the facts, and we're in the same place we were when this [the meta-analysis] came out."

Really? Didn’t the FDA summon an advisory committee?  And didn’t that advisory committee vote 22-1 in favor of keeping Avandia on the market?

But let’s not focus on the facts when rhetoric is so much more fun. Here’s what Representative DeLauro's had to say, “Whenever there is a question asked about the science surrounding a drug, FDA always appears "to act on behalf of the industry.”

That being said, the issue is -- Can the FDA "own" safety?

(The short answer is that it must -- and must work immediately with skill and diligence to achieve that goal.)

At present, politicians and pundits (not to mention trial lawyers) own safety. They're the ones talking about it. They're who the media goes to when they write about it.  

And what about the role of industry, the other group being flayed with the safety knout? What have we heard from them on the issue of safety? Some, but not enough.

Americans woke up the morning after the Vioxx recall and were amazed to discover that drugs have risks. Good lord. Who let that happen! Avandia, in that respect, was Son of Vioxx. And, like any sequel, new actors were brought in to spice up the story.  In this respect Dr. Krumholz can be dubbed “Son of Steve.”

When it comes to patient trust, it shouldn’t be a choice between politics and public health – but those battle lines are being drawn. Unfortunately complex systems make for bad media coverage, while simplistic, dramatic demagoguing makes for sexier headlines.

There’s an apt Japanese proverb that bears repeating – “Don’t fix the blame. Fix the problem.” Unfortunately, the recent FDA-bashing isn’t about making things better – it’s about making headlines.

It's time for the grown-ups to step forward and take charge of the debate on drug safety.