Allegations of patient deaths and conflicts of interest in a 13-year-long clinical trial at the Fred Hutchinson Cancer Research Center in Seattle, has prompted a class action lawsuit by 82 families, as well as promises of reforms by center officials.

The case revolves around Protocol 126, which ran from 1981 to 1993 and aimed to test whether removing T lymphocytes from bone marrow donated by tissue-matched siblings improved graft-versus-host survival rates in leukemia patients. Eight antibodies—including three produced by a now dissolved Seattle biotech company called Genetic Systems—were used to remove T cells. Normal transplantation success rate is around 50%, but with T lymphocyte eradication, the rates of rejection of donated marrow and of cancer relapse are reported to have increased dramatically. According to the newspaper reports from the court, 80 of 82 patients died, and at least 20 of these deaths were attributable to graft failures during treatment.

The families of two patients who died claim the center violated human-subject research ethics and consumer protection laws when it carried out the research. The lawyer for the families, Alan Millstein, also represented the family of Jesse Gelsinger, who died during a gene therapy clinical trial run by the University of Pennsylvania (Nature Med. 6, 6; 2000). And he has initiated a lawsuit on behalf of patients involved in a University of Oklahoma clinical trial shut down by federal officials last year (Nature Med. 6, 946; 2000).

Genetic Systems, which has since been sold to Bristol-Myers Squibb and no longer exists, is also named in the suit because several Hutchinson doctors either worked for or owned stock in Genetic Systems at the time of the trial. Hutchinson spokeswoman Susan Edmonds says that the center did not have a conflict of interest policy in place when officials became involved with Genetic Systems in 1981. She adds that the company was interested in commercializing the antibodies against sexual transmitted diseases, and that the firm was not directly involved in the transplant studies. The center has appointed a committee of independent experts to review the way it handles financial conflicts and informed consent.