Drug tests encourage unneeded transfusions: study
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Some doctors are ordering unnecessary and potentially risky blood transfusions for cancer patients in order to make them eligible for research studies, researchers said on Wednesday.
Dr. Jeannie Callum of the Sunnybrook Health Sciences Center in Toronto and colleagues uncovered the case of a young woman with advanced cancer whose doctor ordered a transfusion even though her hemoglobin level was not low enough to require one.
Tests of new drugs and other treatments often require volunteers to have blood values within certain limits, and the patient’s doctor was trying to alter hers to make her eligible for a study of a new drug.
Callum’s team found two other cases at their hospital, involving different studies, they wrote in a letter to the New England Journal of Medicine.
“It’s not an unusual practice. That’s what surprised us,” ethicist Blair Henry, who helped write the letter, said in a telephone interview.
“Patients can develop fatal and life-threatening transfusion complications,” Callum said in an e-mail.
“These patients were transfused blood just to change the lab number for a few hours. In these cases, the patients only take risk, with no benefit. No patient (or their physician) should be placed in this situation.”
Callum said she does not know if the problem is widespread because most transfusion requests are not checked to see if they are appropriate.
Henry said such transfusions may ultimately be counterproductive.
“We’re concerned that tweaking patients up to a certain criteria for eligibility is providing data that may bias a trial in the sense that most of the population that may use the drug may not be at that level,” he said.
Letting sicker patients slip into a study could make a drug look less effective and more toxic than it actually is, Callum said.
The researchers recommend using less-risky treatments to improve errant blood values, careful review of eligibility criteria, and setting specific rules on whether a transfusion is an acceptable way to make a patient eligible for an experimental treatment.
“Patient safety must trump all decisions for such patients,” the researchers wrote.
“There should be few situations, if any, in which a patient receives a transfusion solely for the purpose of temporarily altering a laboratory value to gain admittance to a clinical trial.”
SOURCE: New England Journal of Medicine, online October 21, 2010.
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