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Entries in Medical Trials (1)

Thursday
Oct212010

Blood Doping for Clinical Trial Eligibility?

Photo Caption - Getty Images(NEW YORK) -- Ethical and safety concerns have been raised by a Canadian group over cancer patients that have received blood transfusions for the sole purpose of meeting eligibility requirements.

Three such instances were reported in advanced cancer patients over a one-year period by Dr. Jeannie L. Callum and colleagues at Sunnybrook Health Sciences Center in Toronto, reports MedPage Today.

"We caution against this practice, given the risks of transfusion," they wrote in a letter to the editor that appeared in the Oct. 21 issue of the New England Journal of Medicine.

All three cases they reported involved patients trying to get into trials of novel chemotherapy agents by taking transfusions.

In one case, a physician of a patient ordered transfusion of a unit of red cells to raise her hemoglobin level from 8.3 g/dL to the required 9.0 g/dL for trial enrollment. These cases could have been handled differently, said Callum's group.

Clinicians should try to correct the underlying laboratory value through other treatments first, such as treating anemia, they urged.  Other options may include looking for trials at other institutions for patients who don't meet eligibility criteria.

"Patient safety must trump all decisions for such patients," the group said.  "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."

The group added that such ethical dilemmas could be avoided if researchers and institutional review boards were aware of laboratory values that could be manipulated by transfusions.

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