Private contractor must release study data

ILLINOIS–A private contractor that worked closely with the federal agency which hired it must provide nonexempt records to a reporter filing a federal Freedom of Information Act request, a federal District Court in Chicago ruled in early May.

The EMMES Corporation of Maryland must provide nonexempt National Cancer Institute (NCI) records to John Crewdson, a Chicago Tribune reporter, the court ruled. It noted that records Crewdson sought were located at EMMES rather than NCI, but it said that the agency had largely controlled the records.

NCI hired EMMES in 1994 to re-analyze data in a corrupted breast cancer study. The Tribune questioned the validity of the EMMES analysis and sought underlying data. NCI retrieved and released some of the records from EMMES but refused to produce others, saying it did not have possession of them. A special magistrate determined in February 1997 that the records were subject to the FOI Act but EMMES said it was not subject either to the FOI Act or the magistrate’s ruling. In the latest ruling the court held that EMMES must abide by the magistrate’s decision.

NCI had concluded in the early 1990s that a lumpectomy — removal of a breast tumor and surrounding tissue — is as effective in treating breast cancer as a mastectomy — removal of the entire breast. However, shortly after publication of the study, the Department of Health and Human Services’ research integrity office found corrupted data. Dr. Roger Poisson of St. Luc’s hospital in Montreal, who had 354 patients in the study, had included patients who did not meet study criteria.

The agency and another contractor began new analyses without Poisson’s patients, but gave the data to EMMES to reanalyze, directing it to “carry out, if possible, a precise validation” of the agency’s statistical analysis, and to “verify precisely,” that the results remain unchanged. (Chicago Tribune v. Dep’t of HHS; media attorney: Richard O’Brien, Chicago)