B. Timothy Walsh, a chair of the IRB that approved experiments in which fenfluramine, a now-banned diet drug, was given to healthy boys from ethnic minorities, defended his panel's decision last week before a Congressional hearing examining IRB effectiveness (see Nature 392, 747; 1998 & 393, 406; 1998.)
Walsh, who co-chaired the IRB at the New York Psychiatric Institute in Manhattan, told the human resources subcommittee of the House Government Reform and Oversight Committee that his IRB concluded that a single, oral dose of fenfluramine presented risks that were “minor at most”.
There was “no indication”, he said, that a single dose of the drug causes heart valve damage like that seen in adults who took it for months, prompting its recall in 1997, two years after the New York experiment was stopped.
He added that the study of aggression risks in the boys, aged six to ten years old, was a type of research “critical for our country”.
But Congressman Edolphus Towns (Democrat, New York) called the IRB's approval of the experiment “very, very troubling”. He produced an early proposal from the investigators in which white children were excluded; Walsh said the IRB required the investigators to change it to include all races.
Despite this, Towns complained, all of the study participants were black or Latino. “These children were chosen by design, not by chance,” he said. “If this case is indicative, the IRB process⃛ needs to be torn down and rebuilt from scratch, not reformed.”