Concerning Caspari et al: Pathogen Inactivation of Cellular Blood Products – More Security for the Patient or Less? Transfus Med Hemother 2003;30:261–263

Pathogen Inactivation of Cellular Blood Products – Still Plenty of Reason to Be Careful

“…Despite extensive studies of the manufacturer of the inactivated products we had serious doubts that a lower damage through the inactivated products had indeed been proven, and we have recommended, in accordance with European recommendations [2], caution when considering the introduction of the inactivated products. Schlenke et al [3] have then written an extensive response concluding that '[with pathogen inactivated platelets] there is an opportunity to improve patient security beyond that currently available by testing alone'. Thus, it is necessary to look again at the epidemiology, i.e.…”

“…the frequency and possible damage done by transfusion-associated infectious diseases on the one hand and the efficacy and the possible damage done by the pathogen-inactivation procedure on the other hand. Schlenke et al [3] claim that, according to Barbara et al [4], the residual risk per blood donation ranges from 1:86,505 to 1:249,750. However, at least in Germany, and probably also in other Northern European countries, the risk of HCV and HIV transmission is distinctly lower.…”

“…An additional concern is that the well-known and documented risk of mutagenicity and possibly cancerogenicity of psoralens is also present for a patient treated with an amosotalen-UVA treated blood product. Schlenke et al [3] pointed out that extensive animal studies, particularly those in p53-deficient mice, did not reveal any oncogenic activity. This sounds reassuring but it does not lead around the necessity to extrapolate a finding in a limited number of mice over several months to possibly millions of human recipients over a time period of 40 or more years.…”

“…life years saved, should be bought for the available resources. Schlenke et al [3] stated that traditional cost-effectiveness evaluation may not be a relevant benchmark for blood safety. They cite the NAT for HCV and HIV as examples.…”

“…There is no point paying more for a product which might even pose more risks than that currently in use. It is not clear whether the cost savings of not doing bacterial testing, CMV serologic testing and gamma irradiation as cited by Schlenke et al [3] modify this calculation any further. Therefore, Bell et al [19] in their paper of 'Cost-Effectiveness of Transfusion of Platelet Components Prepared with the Pathogen Inactivation Treatment in the United States' explicitly state: 'A critical assumption of the current analysis was that the IBS [the Intercept blood system] for platelets was 100% effective in the prevention of transmission of the pathogen used in the model and was not associated with adverse health effects.'…”