Who's In Charge At the FDA?

  • by: |
  • 10/16/2007
A letter from the FDA to Peter Stark and Henry Waxman lies about the benefits of EPO.

It claims that there no quality of life benefits associated with use of EPO among cancer patients undergoing chemotherapy.

That is a lie. Andy von Eschenbach should -- if he is around -- as a cancer patient and oncologist have the guts to squash Richard Padzur's assault on EPO and stand up for the truth.

The FDA has even allowed Amgen to make QOL claims on the label. The current label for EPO allows for QOL benefits. And just because the FDA does not allow them because of Padzur's pique does not make it so. There will likely be revisions but not a total rejection.

So the claim there is no QOL benefit approved by the FDA is also a lie. The fact that the FDA sees no benefit in terms of survival at a biological level does not mean such a correlation fails to exist overall. Cancer death rates are down. They are down because of earlier screening and better drugs. Better drugs can only be used because of a reduction in RBC and a corresponding optimization of hemoglobin levels. Take away ESAs and guess what happens?

Why would the FDA capitulate to Stark and Waxman?

Where is the leadership? Politics as usual should not apply when lives are on the line. Stark, Waxman and Padzur are distorting science and -- working together -- seeking to gain control over regulatory processes for political purposes. Where is the courage to put a stop to it.

Andy, your phone is ringing.

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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