Altman, Lawrence K. "Panel Clears Fatal Studies of New Drug," New York Times, 3 June 1994,

 

Altman, Lawrence K. "Panel Clears Fatal Studies of New Drug," New York Times, 3 June 1994,
p. A20.

On 14 May the FDA took a firm stand in its position that the FIAU studies in the treatment of
hepatitis B were seriously flawed. That agency found the physicians in charge and the drug
companies which made the drug, at fault in the deaths on 5 patients.

Now, an NIH advisory committee has found "...no evidence of wrongdoing in studies of an
experimental drug..." This panel said its charge from Dr. Harold Varmus indicated that "a human
tragedy of such monumental proportions was likely to be explained by some error or errors in
clinical judgment or research process.

"But Dr. (David R.) Challoner (co-chair of the NIH committee) said the committee viewed the
disastrous results as a painful lesson in reminding the public of the unavoidable risks in human
experimentation. "

"Dr. Varmus and the committee said resolving the differences would probably have to await a
review that the Institute of Medicine of the National Academy of Sciences is expected to
undertake for the Department of Health and Human Services."

Very clearly, there are different interpretations of what happened.