Altman, Lawrence K. "Suspended Cancer Studies Get Limited Approval to Resume," New York
Times, 9 June 1994, p. A16.
Federal Health officials have resumed accepting patients in studies coordinated by the University
of Pittsburgh which were suspended on 4 April. The suspensions resulted from flaws discovered
in Pitt's procedures: audits of the 500 participating hospitals were not conducted according to
schedule and ineligible patients were accepted into the studied. Indeed, serious problems were
discovered at St. Luc's hospital in Montreal, Tulane University and LSU, New Orleans, and the
Memorial Cancer Research Foundation of Souther California, Los Angeles.
Pitt had, in fact, discovered some of the problems as early as 1990 but failed to notify the
National Cancer Institute. The institute had p[aid "at least $71 million for 32 breast and bowel
cancer studies that the University has coordinated of the last 30 years.
"The National Cancer Institute has said it intends to continue a large trial to evaluate whether
tamoxifen can help prevent the development of breast cancer among women. But in its
announcement yesterday, the institute did not give full authorization to enroll new women to the
prevention study. About 11,000 women have already been enrolled, but the study needs 5,000
more to meet its goal.
Officials at the University of Pittsburgh said they had received approval to resume interviewing
potential volunteers for the study and to assess their risks for breast cancer...
But the university has not received approval to resume the selection of new participants.
Resumption will depend of completion of a revision of the forms that women must sign before
entering the study saying that they have been informed of possible risks. Another condition is
that the hospitals must pass an audit check.
"Two federally appointed committees have urged resumption of the tamoxifen prevention trials."