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Lilly/Oclassen's FIAU

Executive Summary

Rep. Towns (D-N.Y.) requests an update from HHS Secretary Shalala, via a June 7 letter, on her plans to appoint an Institute of Medicine committee and an outside committee to review the FIAU (fialuridine) studies conducted by the National Institutes of Health in which several patients died. Towns asserts that Shalala's "failure to act has put HHS in the embarrassing situation of having two of its Public Health Service agencies render contradictory conclusions, eroding public confidence in HHS' ability to review objectively what happened in the tragic FIAU trials." The New York Democrat's reference is to a series of FDA warning letters issued in May that found fault with the sponsor's and investigator's reporting of adverse events and responses ,to drug toxicity ("The Pink Sheet" May 16, T&G-14) and a June 2 NIH advisory report ("The Pink Sheet" June 6, p. 9) that reviewed the investigators' conduct in the trials. Towns requests a response from the HHS secretary by June 24

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