Blood Doping and Entry into Clinical Trials for Chemotherapy
Posted Nov 12 2010 12:00am
A number of initiatives are underway by insurance companies to limit the type of chemotherapy that is delivered to patients to "standard" protocols. This should be interpreted to mean the use of chemotherapy that has been proven to be effective (see: The Oncology Concession Under Attack by Health Insurance Companies ). Appropriately, experimental drugs and combinations or drugs are best administered during clinical trials that are managed with research protocols. These always incorporate the clinical criteria for the admission of subjects to the study in order to create a homogeneous pool of subjects. Some patients (and/or their physicians) appear to be so anxious to participate in these trials that the patients are being administered blood and blood component transfusions for the purpose of meeting the clinical eligibility criteria for trials. This practice raises both ethical and patient safety concerns (see: Blood Doping Now a Problem in Cancer Trials ). Below is an excerpt from the article:
Three instances in advanced cancer patients over a one year period were reported by Jeannie L. Callum, MD, and colleagues at Sunnybrook Health Sciences Center in Toronto (Callum JL, et al "Transfusion for protocol eligibility" N Engl J Med 2010; 363: 1681-1682 .) "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. The first patient had an albumin level of 22 g/L but needed to be at 30 g/L to get into the trial and thus took a transfusion of 25% albumin. The second patient fell just under the required platelet count of 50,000 per cubic millimeter with a pretransfusion count of 48,000. The physician of a third 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 might have been handled otherwise, [the researchers] noted. Clinicians should try to correct the underlying laboratory value through other treatments first, such as treating anemia, they urged. Explore all possible other options, including looking for other trials at other institutions for patients who don't meet eligibility criteria, they added.
An obvious question is the motivation of the transfusing physicians in these three cases. Since the blood and platelet abnormalities were relatively mild in all three cases, one obviously suspects "blood doping", which is to say "touching up the patients" in order to qualify them for admission to the trials. Obviously and as stated in the letter, the organizers of cancer clinical trials need to be vigilant going forward about this practice. More importantly, the transfusing physicians need to accurately report the patent's transfusion history when entry is being sought into a trial.