Schroeder, who has worked for another company since 1975, later backed off his statement. He told UPI, 'I just didn't feel qualified to speak on something I didn't work on ... There's no one twisting my arm.'
Bressler criticized the company's 'sloppiness' on all three studies.
'The question you've got to ask yourself,' he said in an interview, 'is: Because of the importance of this study, why wasn't greater care taken? The study is highly questionable because of our findings. Why didn't Searle, with their scientists, not closely evaluate this, knowing fully well that the whole society, from the youngest to the elderly, from the sick to the unsick ... will have access to this product?'
Howard Roberts, acting director of FDA's Bureau of Foods, appointed a five-person task force to review the Bressler team's findings pending a decision on whether to throw out the three tumor and birth-defect studies.
Jacqueline Verrett, the senior scientist on the review team, said members were barred from stating opinions about the research quality.
'It was pretty obvious that somewhere along that line they (bureau officials) were working up to a whitewash,' she said. 'I seriously thought of just walking off of that task force.'
Verrett, now a private consultant, said that she and other members wanted to 'just come out and say that this whole experiment was a disaster and should be disregarded.'
But on Sept. 28, 1977, the panel reported that deviations between Searle's raw data and its FDA submissions were 'not of such magnitude' as to alter its conclusions.
Verrett said the bureau's intent seemed to be 'to tone down what was really found.' She noted the bureau felt pressure because safety concerns also had been raised about cyclamate, another alternative for the cancer-linked sugar substitute saccharin.
(In October, 1978, a year after ordering the review that helped get Searle's petition back on track, Roberts quit to become a vice president at the National Soft Drink Association. The NSDA's members later marketed a stream of NutraSweet-flavored diet soft drink products.
(Reached at NSDA, Roberts dismissed Verrett's criticism, asserting the task force report 'really was of no importance.' He said he had no concerns about the appearance of his taking an industry job, stressing he does not represent NSDA before the FDA.
('I sleep well at night,' he said.)
Negotiations for an additional, outside review of Searle's studies had begun with an Aug. 4, 1976 meeting between Searle and 10 FDA officials. During the meeting, Searle officials said they desired to help pick the consultant to perform the review, an internal FDA memo said.
Agency memos show the FDA soon was negotiating with the Universities Associated for Research and Education in Pathology for a half-million dollar, company-funded 'validation' of a dozen Searle studies.
The pathology organization's review concluded thatSearle's studies were authentic and the discrepancies largely inconsequential.
Adrian Gross, an investigative consultant to the 1975 task force, later said the 16-month review was 'at best irrelevant' because the group was limited to analyzing 'whether Searle lied about the data in its tests.'
'It was not our task to challenge the validity of the experimental methods, since the FDA had itself already accepted the methodology,' the group's executive director, Kenneth Endicott, said.
Jere Goyan, who was FDA commissioner in 1980, said he would have put less weight on the review than on the findings of FDA's task forces. Goyan also suggested that, after approving aspartame in 1974, the FDA's Bureau of Foods may have 'felt they had to keep their previous position.'
Regardless, the pathology group's findings carried major weight in the final approval decision. The chairman of the 1980 Public Board of Inquiry, Dr. Walle Nauta of the Massachusetts Institute of Technology, said the board had to rely on those findings because it was denied access to the task force reports by FDA officials.
'There was absolutely no way in which we could decide who was right here,' Nauta said. 'We simply had to accept the data as they stood.'
Nauta was joined on the panel by Drs. Vernon Young of MIT and Peter Lampert of the University of California at San Diego.
Before voting 3-0 to ban NutraSweet on the narrow cancer issue, the board itself was drawn into allegations of bias because two of the three members came from MIT -- as did Bureau of Foods chief Miller and several scientists involved in the controversy.
Between 1979 and 1982, four more FDA officials who participated in the approval process took jobs linked to the NutraSweet industry: Pape; acting FDA commissioner Sherwin Gardner; Albert Kolbye, who was associate director of the Bureau of Foods for toxicology, and Mike Taylor, an FDA lawyer who represented the bureau before the Board of Inquiry. All four denied any conflict of interest.
