November 20, 2007

My colleague Ben Zycher and I attended a conference in D.C. last week on Transforming Health: Fulfilling the Promise of Research, co-sponsored by PhRMA and Research!America.

It was a fascinating event, but it underscored one word for me: Risk.

Academic researchers take risks by spending countless hours searching for new discoveries that may never pan out; companies spend hundreds of millions of dollars developing potential treatments that the FDA may never approve; and patients deal every day with health risks that accompany serious and life threatening diseases, and take more risks on side effects from medical treatment to treat those diseases.

But the patients, researchers and companies all know that quest for better treatments is worth all of the risks that must be bourne to bring them into existence.

FDA regulators, however, are not in the same boat as these other stakeholders. Their job is to avoid risks: avoid exposing us to risky drugs, avoid the risk of being criticized by the media or Congress when rare side effects turn up, and avoid the embarassment of being wrong when academics or others question their judgment.

These incentives drive the agency to be risk averse when evaluating new technologies and treatments that don't fit neatly into existing categories.

Can the FDA - in its culture, as an institution - adapt to the new sciences that are driving medical innovation, or will it remain risk averse, wedded to old formulas that are safe but that slow patients' access to more promising technologies and treatments?

It's a tough call. The science is going one way, but Congress is pushing the agency into a "safety first, last, and everything" mentality that is affecting how the agency approves new medicines.

Posted by Paul Howard at November 20, 2007 01:48 PM

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