BETHESDA, Md. — "Subject No. 4" died at 1:44 a.m. on June 14, 1999, in the immense federal research clinic of the National Institutes of Health.
The cause of death was clear: a complication from an experimental treatment for kidney inflammation using a drug made by a German company, Schering AG.
Among the first to be notified was Dr. Stephen I. Katz, the senior NIH official whose institute conducted the study.
Unbeknown to the participants, Katz also was a paid consultant to Schering AG.
Katz and his institute staff could have responded to the death by stopping the study immediately. They also could have moved swiftly to warn doctors outside the NIH who were prescribing the drug for similar disorders. Either step might have threatened the market potential for Schering AG's drug. They did neither.
Questioned later, Katz said that his consulting arrangement with Schering AG did not influence his institute's decisions. His work with the company was approved by NIH leaders.
Such dual roles -- federal research leader and drug company consultant -- are increasingly common at the NIH, an agency once known for independent scientific inquiry on behalf of a single client: the public.
Two decades ago, the NIH was so distinct from industry that Margaret Heckler, secretary of Health and Human Services in the Reagan administration, could describe it as "an island of objective and pristine research, untainted by the influences of commercialization."
Today, with its senior scientists collecting paychecks and stock options from biomedical companies, the NIH is no longer an island.
Interviews and corporate and federal records obtained by the Los Angeles Times document hundreds of consulting payments to ranking NIH officials, including:
* Katz, director of the NIH's National Institute of Arthritis and Musculoskeletal and Skin Diseases, who collected between $476,369 and $616,365 in company fees in the last decade, according to his yearly income-disclosure reports. Some of his fees were reported in ranges without citing exact figures. Schering AG paid Katz at least $170,000. Another company paid him more than $140,000 in consulting fees. It won $1.7 million in grants from his institute before going bankrupt last year.