BOX 8-1

Cases and Controversies Involving Institutional Conflicts of Interest

After the 1999 death of Jesse Gelsinger during a clinical trial involving a gene transfer intervention conducted by a University of Pennsylvania research institute, various investigations raised questions about the university’s oversight of the study and the research institute (Stolberg, 2000; Steinbrook, 2008c). The university and several past and present officials had financial interests in the biotechnology company that developed the intervention. The company contributed $25 million to the research institute’s annual budget and had exclusive rights to develop products emerging from the trial and related research. In addition, the director of the institute, who was also the lead researcher, had founded the company and maintained a financial interest in it.

In 2005, reporters revealed that the Cleveland Clinic and its chief executive officer had undisclosed financial interests in a medical device firm (Armstrong, 2005). The firm’s heart surgery device was used at the hospital and was promoted by its surgeons. Patients were not informed of the conflicts of interest. The board of the Cleveland Clinic subsequently adopted new policies on institutional conflict of interest.

Amgen, the manufacturer of epoetin, a drug that increases hemoglobin levels, was the founding and primary sponsor of the Kidney and Dialysis Outcomes Quality Initiative carried out by the National Kidney Foundation (Coyne, 2007; see also Chapter 7). This project issued practice guidelines recommending an increase in the target hemoglobin level for patients with chronic kidney disease, which would entail the use of higher doses of epoetin and increased sales of the sponsor’s product.

In 2008, the chair of the Psychiatry Department at Emory University resigned that position after congressional investigators reported that he had failed to disclose the receipt of substantial consulting payments from pharmaceutical companies, in violation of university and federal government rules, and had also failed to comply with an agreement with the university that he limit such payments. One of the documents cited was a letter he sent to a university official pointing out that his multiple ties to pharmaceutical companies had benefited the university by attracting company funding for department career awards, an endowed chair, and other gifts (Harris, 2008).

with the institution may unfairly be called into question, even though they were not involved in the conduct that was criticized.

This chapter begins by defining institutional conflicts of interest and describing what has been documented about the extent of such conflicts. The discussion then reviews responses to institutional conflicts of interest

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