InfoMail for February 18, 2002

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Commentary by Vera Hassner Sharav

February 18, 2002 

FYI

The Fred Hutchison Center in Seattle WA has failed
three FDA inspections

The Seattle Times reported on Sunday that aleukemia study at the Fred Hutchinson Cancer Center has failed three FDAinspections –June 15, October 26, December 4. On Dec. 31, 2001, the FDA tookaction by issuing a Warning Letter to Dr. Dana Matthews.

The Times reported that Federal authoritiesand independent experts indicated that "such warning letters indicateserious problems" and are rare. An FDA official said "the letterreflects systemic problems with the way they approach clinical trials" atthe Hutchinson Center.

The letter lists 7 violations of federal regulationspertaining to patient safety. Among those listed were: failure "to providebasic elements of informed consent," to report deaths and other researchrelated adverse events, to inform patients about radiation doses, and to provide"accurate assessment of foreseeable risks."

The Times also reported that the FDAinspectors’ findings were not disclosed to an advisory committee that had beenconvened following allegations of ethical violations reported by the Times inits series, Uninformed Consent.

Another investigator in this study, Dr. Janet Eary, ofWashington University, also received a warning letter from the FDA.

FDA’s letters are available at:
http://www.fda.gov/foi/warning_letters/g2083d.pdf

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