摘要：Objective. We examined the location of commercial plasma donation centers in the United States over the period 1980 to 1995 relative to the geographic distribution of risk behaviors associated with transfusion-transmissible infections. Methods. The census tract locations of commercial source plasma clinics were described by measures of neighborhood social disadvantage and the prevalence of illicit drug use and active local drug economies. Results. Depending on the measure of social environment used, commercial plasma clinics were 5 to 8 times more likely to be located in census tracts designated high-risk than would be expected by chance. Conclusions. Commercial source plasma clinics were overrepresented in neighborhoods with very active local drug economies. These patterns persisted after the links between human immunodeficiency virus and hepatitis C virus infections and plasma products had been established and may present risks to blood system safety. The contamination of fractionated plasma products led to an epidemic of infection with human immunodeficiency virus (HIV) and hepatitis C virus (HCV) in the worldwide hemophilia community in the early years of the 1980s. 1, 2 The consequences of that epidemic are well known. The World Federation of Hemophilia has reported that nearly half of individuals with hemophilia worldwide are infected with HCV, and 10% are infected with HIV. 3 In North America, approximately 65% of recent mortality among hemophiliacs has been related to HIV. 4, 5 The prevalence of HCV, which is associated with hepatocellular carcinoma, nears saturation in older hemophiliacs. 6, 7 The underlying causes and context of this epidemic have been the subject of controversy and civil litigation. 8, 9 Responses have ranged from public inquiries in Canada and the United States, to criminal convictions in France, to civil litigation in many countries. There has also been widespread reorganization of many transfusion services over the last 2 decades, including the termination of the Canadian Red Cross Society’s role in the provision of blood collection and distribution activities in that country. 10 The degree to which blood and plasma donors carry, or are at risk for acquiring, transfusion-transmissible infectious agents is an important determinant of the overall safety of blood products. Minimizing the risks associated with blood products is therefore a critical regulatory objective for blood collection and manufacturing agencies. A long-standing criticism of American source plasma collection—where plasma rather than whole blood is procured—is that risk is not minimized. Specifically, it has been suggested that commercial source plasma clinics (which pay donors for plasma) attract high-risk donors, 11– 13 and that commercial source plasma clinics are located near areas with a high prevalence of illicit drug use. 14 Although very limited data are available on infection rates of commercial donors, there is some information indicating higher seropositivity among commercial plasma donors relative to volunteer donors. In a secondary analysis of information submitted by plasma manufacturers in support of viral testing techniques, the US General Accounting Office (GAO) has reported that “test-positive rates for commercial plasma donors were substantially higher than those of volunteer whole blood donors, ranging from 2 to 20 times higher on the different tests.” 11(p7) The GAO proposed that these higher infection rates arise because “monetary incentives such as those offered by commercial plasma-collection centers may be tantalizing to some of those who are known to be at risk for infectious diseases, such as intravenous drug users and prostitutes,” 11(p7) but offered no evidence to support these arguments. Yet, the GAO statement is consistent with published studies of paid blood/plasma donation in cohorts of injection drug users conducted in South Florida 14 and Baltimore 15 that observed high rates of commercial blood donation in cohorts of street-recruited illicit drug users. In addition to the risk of commercial donation attracting high-risk donors, concerns have been raised about the location of paid blood donation centers in high-risk areas. 14 Donor recruitment in areas of high prevalence of transfusion-transmissible pathogens presents risks to blood safety arising from false-negative results in donation screening and from the transmission of pathogens for which no screening procedure is available. Although a number of commentaries have suggested that paid blood and plasma clinics are overrepresented in disadvantaged socioeconomic settings, no formal study of the geographic organization of commercial donation sites has been published. 12, 16, 17 The objective of this study is to describe the geographic location of commercial source plasma centers in the continental United States over the period 1980 to 1995. We examine evidence for the hypothesis that during the period 1980 to 1989, source plasma clinics were disproportionately located in areas with high rates of risk behaviors that are related to illicit drug use and associated with transfusion-transmissible infections. In addition, we consider whether location practices may have changed in the period 1990 to 1995. In describing current location practices in the commercial plasma industry, this work is relevant for evaluating the effectiveness of self-regulation by the plasma industry and also of governmental regulation of source plasma collection in the United States. This work may also have important international implications, as the United States is the chief supplier of source plasma and plasma-derived pharmaceuticals in the world market.
