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April 04, 2007

Sometimes Safety

by Peter Pitts

Can drug safety be a sometimes thing?

I pose this question based on the recent flurry of media stories on the need for new cancer treatments (see Sunday's NY Times Week in Review section) and the Abigail Alliance lawsuit that calls for greater patient access to investigational new drugs-- not to mention the debate over follow-on proteins.

(Remember, don't call them generic biologics. Words count.)

These are all important stories with significant subtexts -- most of which are entirely ignored by pols and pundits who prefer righteous indignation. Should we strive for new cancer treatment? Of course. Should patients have easier and broader access to investigational new drugs? I think yes, but there serious safety concerns that cannot just be ignored in the quest for a good headline. Follow-on proteins, same thing.

Don't get me wrong, I'm all for righteous indignation but, when it comes to drug safety, can you be for it before you are against it and still expect to be taken seriously?

Lots of well-intended verbiage in, for example Sunday's Times op-eds about the "need' without focusing on the "how," the "who," or the "how much." Many of these articles make it seem as though Big Bad Pharma is holding back on pursuing R&D for new cancer treatments because of concerns over profitability. Others blather on about Big Pharma sitting on potentially potent patents for the same reason -- with quotes from academic researchers who believe the translational gap is nothing more than the manifestation of a lazy pharmaceutical industry.

Sorry fellas -- ain't that easy.

I went through all of the articles (yesterday and today) and also did a Google search of how many times the FDA's Critical Path initiative was discussed.

Yup -- zero.

The Critical Path must not be paved with good intentions alone -- but some acknowledgement would be right and appropriate.

Posted by peterpitts at April 4, 2007 04:02 PM

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