Monday, June 6, 1994
By Kris Herbst
ROCKVILLE - An NIH review panel, acknowledging that its findings will not satisfy "the scientific or general public," has concluded that the ill-fated clinical trials of fialuridine (FIAU) were undone by a "new and unique form of delayed drug toxicity", and that the deaths of five hepatitis patients appeared to be "an unavoidable accident."
The conclusions by the NIH Subcommittee to Review FIAU Studies put the NIH at odds with the FDA, which formally has warned the FAIU investigators and sponsoring companies that they violated reporting and protocol requirements that could have resulted in more cautious pursuit of the trials. (See BioCentury, May 23, 1994). Recipients of the FDA letters included Oclassen Pharmaceuticals, the biotech company that licensed the antiviral drug to Eli Lilly and Co. in 1992.
The NIH panel concluded that "it is unlikely that any of these reporting events were relevant or could have prevented the tragic outcomes, even were they significant, which is under dispute."
In an addendum to its report last week, the NIH panel also sniped at the FDA, complaining that the agency would not share its findings on the FIAU trials despite having completed its review of trial documents more than