Dear Dr. von Eschenbach:
Thank you for scheduling a briefing next Wednesday, March 22, 2006, for my Committee on Finance (Committee) staff regarding the clinical trial the Food and Drug Administration (FDA) approved for a blood substitute called PolyHeme, which is manufactured by Northfield Laboratories, Inc. (the PolyHeme Study).1 The PolyHeme Study was approved by local institutional review boards (IRBs) in 18 states - California,
Colorado, Delaware, Georgia, Illinois, Indiana, Kansas, Kentucky, Michigan, Minnesota,
New York, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, Utah, and Virginia -
and disapproved by an unknown number of IRBs. According to information posted at ClinicalTrials.gov, four of the thirty-one medical institutions participating in the PolyHeme Study have suspended recruiting patients, as of March 10, 2006.1
As chairman of the Committee, I request that the FDA officials, who will brief my Committee staff, come prepared to address in detail the issues and arguments raised in a letter published recently in The American Journal of Bioethics entitled, “An Open Letter to IRBs Considering Northfield Laboratories’ PolyHeme Trial," among other issues related to the PolyHeme Study.
Thank you for your full attention to this urgent matter. Should you have any questions please contact Dan Donovan at (202) 224-4515.
Sincerely,
Charles E. Grassley
Attachment available in printer-friendly version of this release
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1 http://www.clinicaltrials.gov/ct/show/NCT00076648?order=1
Source: Ranking Member’s News
