Doctors Ordering Transfusions to Get Patients into Drug Trials

Canadian researchers say they've noticed a disturbing trend: Cancer doctors ordering unnecessary blood transfusions so that seriously ill patients can qualify for drug trials. In a letter published recently in the New England Journal of Medicine, the researchers report on three cases during the last year in Toronto hospitals in which physicians ordered blood transfusions that could make the patients appear healthier for the sole purpose of getting them into clinical trials for chemotherapy drugs. The practice raises both medical and ethical concerns, the authors say.

"On the physician side, you want to do the best for your patients," said co-author Dr. Jeannie Callum, director of transfusion medicine and tissue banks at Sunnybrook Health Sciences Centre in Toronto. "If these patients have no other options left to them, you want to do everything you can to get them into a clinical trial," she said. "But the patient is put in a horrible position, which is, 'If you want in to the trial, you have to have the transfusion.' But the transfusion only carries risks to them," she added.

A particularly serious complication of blood transfusions is transfusion-related acute lung injury, which occurs in about one in 5,000 transfusions and usually requires the patient to go on life support, said Callum. But besides the potential for physical harm, enrolling very sick people in a clinical trial can also skew the study's results making the drug perform worse than it might in patients whose disease was not as far along. The unnecessary transfusions were discovered by the Toronto Transfusion Collaboration, a consortium of six city hospitals formed to carefully review all transfusions as a means of improving patient safety, Callum said.