Review Vox Sang 1992;63:1-5
R. W. Ben1 W G. van Aken Blood Programme, International Federation of Red Cross and Red Crescent Societies (Head: Prof. R . W. B e d ) and Central Laboratory, Netherlands Red Cross Society (Head: Prof. W. G. van Aken), Amsterdam
Gift or Good? A Contemporary Examination of the Voluntary and Commercial Aspects of Blood Donation
................................................................................................. Abstract The safety and ethical aspects of blood donation are examined in the light of current legislation and practice. The advantages and disadvantages of voluntary and paid donation are looked at in view of recent data concerning risk factors in various potential donor groups. It is concluded that voluntary, nonremunerated blood donation remains the safest and most ethical means of securing the blood supply.
...........
The debate about voluntary versus paid blood donation has continued unabated for more than 20 years. The economists provided the initial combat forces, with Cooper and Culyer [l]arguing for blood to be regarded as a marketable good, and on the opposite side the convinced socialist Richard Titmuss [2] contending that blood donation was one of the last remaining acts of altruism in an increasingly welfare state. Practitioners of transfusion medicine fell in behind one or other force, the traditional voluntary not-for-profit organizations aligning themselves under the Titmuss banner, and those involved in the commercial plasma industry supporting the marketablegood side. Battles were fought, manifestos published, and little ground changed hands. New flurries of conflict occurred whenever a screening test became newly available for a potential transfusion-transmissible infection (TTI). Whenever such data were available for comparison, it seemed that the markers for the particular infection were higher in the commercial group of donors than in the voluntary group. A major victory for the supporters of voluntary donation came with the recent issue of Directive 89/381 of the
Received: January 28, 1992
European Economic community which stated, inter alia, ‘Member States shall take the necessary measures to promote community self-sufficiency in human blood or human plasma. For this purpose, they shall encourage the voluntary unpaid donation of blood and plasma and shall take the necessary measures to develop the production and use of products derived from human blood or human plasma coming from voluntary unpaid donations’. It seemed that the authorities were convinced of the increased efficacy of voluntary non-remunerated donation, whether on ethical or safety grounds or both is not known. The counter attack from the commercial firms has been predictably strong, claiming that the EEC Directive is incapable of implementation in most of the European countries required to comply. For example, Germany relies to a considerable extent on paid donation. Allied with this stand has been the claim that commercial donors give voluntarily, not under coercion, and that their blood is as safe as blood collected in the voluntary sector. (Francophones - among them J.-P. Soulier - have consistently pointed out the ambiguity of the English word
Prof. R. W. Beal Red Cross Blood Transfusion Service 301 Pirie Street Adelaide. SA SO00 (Australia)
01992 S. Karger AG. Basel ooJ2-9007/92/0631~1 $2.7510
‘voluntary’ in this context, and prefer the French ‘bCnCvole’ or ‘altruiste’. The former does not translate comfortably into English, and while the latter does, the concept of altruism is not commonly understood in English. The Oxford Dictionary definition of altruism is ‘regard for others as a principle of action; unselfishness, concern for other people’). A definition of voluntary, non-remunerated donation has been accepted by the International Society of Blood Transfusion and the Council of Europe. It was recently incorporated in a resolution passed by the VIIIth General Assembly of the International Federation of Red Cross and Red Crescent Societies. This definition states: ‘Voluntary non-remunerated blood donors are persons who give blood, plasma or other blood components of their own free will and receive no payment for it, either in the form of cash, or in kind which could be considered a substitute for money. This includes time off work, other than reasonably needed for the donation and travel. Small tokens, refreshments and reimbursement of direct travel costs are compatible with voluntary, non-remunerated donation’. This paper addresses the perceived and documented advantages of the voluntary, non-remunerated donor system (in practice, unpaid) and the disadvantages of the commercial donor system.
Advantages of Unpaid Donors - The first and most important ethical advantage is that
the unpaid donor becomes involved in an act of altruism, an action for others without thought of reward. The donor’s blood is seen as a gift, and as an act of generosity towards a person or persons less well off. It represents a cooperative act of commitment to the community at large, and while the donation remains anonymous, it nevertheless establishes the donor’s personal relationship to their fellows within the community. - The making of a blood donation has become for most so commonplace and such an every day matter that the uniqueness of making living tissue available for another has been forgotten as a result of frequency and familiarity. The voluntary unpaid donation is then still to be recognised and emphasised as a unique gift from one human to another, as with other organ and tissue donations. With one or two exceptions, notably in the near future factor VIII, blood and its components cannot be synthesised any more than can a liver, kidney or heart. Other human plasma proteins, including albumin, antithrombin 111,
2
Beallvan Aken
and von Willebrand factor, have been cloned and expressed, but the prospect of scaled up production for therapeutic purposes remains uncertain at present. - By becoming a regular voluntary blood donor, the individual concerned becomes part of the activities of his or her blood centre, and as an outcome, may be able to respond further (e. g. as a plasmapheresis donor) or assist in recruiting other donors. The commercial sector is increasingly aware of the importance of a personal rapport with their donors, and is actively working in this area. It is therefore increasingly important for the organizations recruiting voluntary unpaid donors to make sustained efforts to help their donors feel part of a committed group by hospitality, friendliness and comprehensible, readable information. If the customer is always right, how much more so the voluntary donor? - A further ethical consideration is that within the voluntary sector, the donor’s welfare is paramount, and is the primary objective of the blood transfusion service. It has been argued by those advocating long-term autologous storage of blood for personal use that the conventional blood services were ‘donor oriented’. Without compromising the safety of the recipient or staff in any way, it is to be hoped that this situation will remain so in the future. - Although it may not seem important to some, the capacity of a non-governmental organization (NGO), often a Red Cross/Red Crescent Society, to collaborate with governmental agencies responsible for support of transfusion services is seen as mutually advantageous to both parties, since neither the government or the NGO is involved in profit-making concerns. - Although left until last in this account of the pros of the unpaid system, the matter of safety is clearly the major advantage of one system and the perceived major disadvantage of paid donor system. The preceding points are essentially ethical, moral and subjective, as are some of the perceived disadvantages of the commercial system. The matter of safety is capable of measurement and documentation, and merits a separate section.
Relative Safety of Voluntary and Commercial Blood Programmes
Whenever a new (or newly recognised) disease is identified as a potential TTI and tested for, the levels of positive markers in the commercial sector exceed those in the voluntary sector. The commercial firms argue that they do the same tests as the voluntary sector, and that they do them at least as well, with quality assurance programmes
Gift or Good?
which meet the most stringent standards. This matter is not in contention. What is clear, and irrefutable on the basis of published evidence, is that the equally well-performed tests in the commercial sector define a population which clearly represents a greater risk to potential recipients. The evidence derived during the early days of hepatitis B screening showed that there was an increased risk of post-transfusion hepatitis following the use of blood and blood products from commercial sources [3-6]. Not long afterwards, there were similar findings in relation to non-A, non-B hepatitis of a ten-fold difference between commercial and voluntary blood programmes [7]. This evidence has been reinforced by early hepatitis C virus (HCV) antibody studies, which showed HCV positivity of 0.2-1.2% in ‘random’ blood donors from USA and three European Centres, 10-11% positive in commercial plasma donors and 45-70% positive in intravenous drug users (IVDUS) [8]. Similar findings have been published which emphasize the differences between non-paid and commercial donors [9]. A similar situation exists in relation to human immunodeficiency virus (HIV) status of donors to the commercial and voluntary systems. Although data are not easily acquired from the commercial sector, some interesting and alarming data emerged recently from a study of 2,921 IVDUS in Baltimore [lo]. Disturbingly, more than 20% had continued to donate blood after commencing intravenous drug usage. Most had continued giving after HIV screening was introduced, and the ratio of commercial: voluntary sector donation was 7.4:l (88.1 and 11.9% of a total of 437). While these data are disturbing for the voluntary sector as well as the commercial in relation to the permeability of the safety net, a sobering fact emerges: the chance of a donor in the window period slipping through the commercial screening procedure is at least 7-8 times greater than in the voluntary system. These data receive support from similar studies, with similar results [ll]. Other countries have produced similar data. In Mexico in 1986, the seroprevalence of HIV was 0.1% in voluntary donors and 7.0% in paid donors [12,13]. In a small Brazilian study of 100 beggars of whom 70 were professional blood donors, there were 5 (7%) with positives HIV tests [14]. A detailed medical history remains an important part of identifiying at-risk potential donors. A recent study [15] which examined pre-donation selection procedures concluded that at-risk donors who were asked direct history questions about AIDS risk behaviour, in addition to current health history questions, were more likely to be
screened out than those who underwent alternative health history interviews. The risk is clearly related to the fact that HIV plasma viraemia and antigenaemia occur prior to seroconversion in healthy plasma donors [16], and as Stramer et al. [16], point out, there are two reasons for the chances of HIV antigenaemia being higher in plasma donors than in whole blood donors. The interval between plasma donations (around 6 days) is far shorter than the 8 weeks between whole blood donations, and in this (and other) series, the demographic characteristics of the plasma donor are more like those of HIV-positive high-risk groups than routine whole blood donors. A recent study has shown that the prevalence of anti HTLV-I is ten-fold higher among paid plasma donors compared with whole blood donors [17]. Another study has emphasised that intravenous drug use is the major risk factor for HTLV-I1 infection [18]. Comparable data for HIV prevalence in voluntary and paid donors have been published from India [19,20] and Zaire [21]. The pattern has been so consistent that one assumes that when the next new, to be-tested-for TTI appears, the same sequence of figures will emerge.
Disadvantagesof the Commercial Blood System - The question of safety is the overriding quality -it is what makes voluntary donation safer and commercial/ professional donation less safe, and it is due to the different characteristics of the donor. The greater risk of TTI is the single most important differential factor. - A major concern with paid programmes is that they encourage exploitation of the blood donor, notably those of lower socio-economicbackground, and of differing motivation. The risk of exploitation and economic coercion is now not confined to commercial sale of blood, but is a problem for those transplanting organs [22]. The availability of blood and blood products in poor countries is restricted to that minority which can afford to pay. When, as in the past, these countries were in turn a major source of commercially fractionated plasma, the far from amply rewarded donor would not be in a position to receive blood or blood products if he or she needed them. - While the sad picture presented by many commercial blood programmes 20 years ago [23] is probably not consistent with some, at least, of today’s commercial operations, it is true that many of the donors continue to come from lower socio-economic backgrounds, where nutrition
3
is demonstrably less, where alcohol excess and drug abuse are more common, and where there is a greater temptation to falsify a medical history in the interests of being paid for blood. - The encouragement of malpractice as well as falsification of medical history is not confined to commercial programmes alone, but the monetary attraction is a driving motivation. - In a commercial setting, the blood itself is merely a marketable commodity, and the donor’s act a sale not able to be negotiated by the seller. There is lacking in a commercial transaction the sense of commitment and idealism inherent in the gift relationship. - There is no incentive other than financial for the donor to wish to feel part of a commercial organization where the profit is going to invisible share holders and not to the contributor. There will always be a difference between the interaction of a manufacturer and purchaser, with the sales person acting as the intermediary, and a donor and recipient, with the blood service having voluntary non-remunerated donors acting as the agent of both. - In developing countries, where there exist some joint venture plasma programmes, the venture tends to be given professional and developmental priority ahead of the local programme. In such programmes, albumin and immunoglobulin are returned to the donor country and the raw factor VIII sold to the highest bidder. Meanwhile, the local component programme languishes for lack of support and commitment. (This situation may change with the advent of a synthetic factor VIII.)
Although there are strenuous efforts being made by commercial plasma manufacturers to encourage a more attractive and different client&le,the ethical aspects inherent in the two systems do not appear likely to change in the near future. In spite of the best available test procedures, the safety of commercial donation appears still to be compromised by the higher-risk status of those recruited to the system. As noted on more than one occasion above, the unpaid donor system cannot risk complacency. It is up to them entirely to ensure that the voluntary donor is encouraged and assisted to remain a member of a unique and committed group of people around the world who help underwrite their country’s health programmes without thought of reward. Unpaid donors must be just as stringently screened as ever by history, selection and laboratory test, to ensure the safety of the donor’s gift to the recipient. The safety of blood and blood components continues to depend on several factors, including the recruitment of voluntary, unpaid donors, the self-exclusion of would-be donors belonging to risk groups, appropriate tests for the presence of viral and other infections, viral removal and inactivation of products where this is possible and appropriate and conservative use of blood and blood products. It is important to recall that the donation of blood by a voluntary unpaid donor remains the first and perhaps the most important variable in this chain.
................................................................................................................................................... References 1 Cooper MH, Culyer AJ: The Price of Blood. London, Institute of Economic Affairs, 1968. 2 Titmuss RM: The gift relationship: From human blood to social policy. London, Allen&Unwin, 1971. 3 Goldfield M: Some epidemiologic studies of transfusion-associated hepatitis; in Greenwalt TJ, Jamieson GA (eds.) Transmissible Disease and Blood Transfusion. New York, Grune&Stratton, 1975, pp 141-151. 4 Alter HJ, Purcell RH, Holland PV, Feinstone SM, Morrow AG, Moritsugo Y: Clinical and serological analyses of transfusion-associated hepatitis. Lancet 1975;i:838-841. 5 Hoofnagle JH, Gerety RJ, Thiel J, Barker LF: The prevalence of hepatitis B surface antigen in commercially prepared plasma products. J Lab Clin Med 1976;88:102-113.
4
6 Koretz RL, Gitnick GL: Prevention of posttransfusion hepatitis: Role of sensitive hepatitis B antigen screening test, source of blood and volume of transfusion. Am JMed 1975;59: 754-760. 7 Prince AM, Brotman B, Grady GF, Kuhas WJ, Hazze C, Levine RW, Millian SJ: Posttransfusion viral hepatitis due to an agent or agents other than hepatitis B virus or hepatitis A virus. Impact on efficiency of present screening methods; in Greenwalt TJ, Jamieson GA, (eds.): Transmissible Disease and Blood Transfusion. New York, Grune & Stratton. 1975, pp 129-140. 8 Abbott: Slide presentation data.
Beallvan Aken
9 Dawson GJ, Lesniewski RR, Stewart JL, Boardway KM, Gutierrez RA, Pendy L, Johnson RG, Alcalde X, Rote KV, Devare SG et al: Detection of antibodies to hepatits C virus in US blood donors. J Clin Microbiol 1991;29:
551-556. 10 Nelson KE, Vlahov D , Margolick J , Bernal M, Tylor E: Blood and plasma donations among a cohort of intravenous drug users. JAMA 1990: 263:2194-2197. 11 Chitwood DD, Page JB, Comerford M, Inclardi JA, McCoy CB, Trapido E, Lai SH: The donation and sale of blood by intravenous drug users. Am J Public Health 1991;81: 631433. 12 Sepulveda J. Avila C, Dominguez JL: Control measures to prevent HIV transmission by blood products in Mexico (Abstract No 5128). Proc 4th AIDS Conf, Stockholm 1988, p 345.
Gift or Good?
13 Sepulveda J, Barcca M de L, Dominguez JL, Valdespuro JL: Prevention of HIV transmission through blood and blood products: Experiences in Mexico. Bull Pan Am Health Organ 1989:23:108-114. 14 Carvalho MI, Castillo-Branco L, Habib JGA, Galvao-Castro B, Pereira MS: HIV antibodies in beggar blood donors in Rio de Janeiro, Brazil (Abstract 5130). Proc 4th AIDS Conf, Stockholm, 1988, p 346. 15 Mayo DJ, Rose AM, Matchett SE, Hoppe PA, Solomon JM, McCurdy KK: Screening potential donors at risk for human immunodeficiency viruses. Transfusion 1991;31:46W74. 16 Stramer SL, Heller JS, Coombs RW, Parry JV, Ho DD, Allain JP: Markers of HIV infection prior to IgG antibody seropositivity. JAMA 1989:262:6&69.
17 Canavaggio M, Leckie G, Allain JP, Steaffens JW, Laurian Y, Brettler D , Lee H: The prevalence of antibody to HTLV-1/11 in United States plasma donors and in United States and French hemophiliacs. Transfusion 1990;30: 780-782. 18 Lee HH, Swanson P, Rosenblatt JD, Chen IS, Sherwood WC, Smith DE, Tegtmeier GE, Fernando LP, Fang CT, Osame M, et al: Relative prevalence and risk factors of HTLV-I and HTLV-I1 infection in US blood donors. Lancet 1991~337: 1435-1439. 19 Singh YN. Malaviya AN, Tripathy SP, Chaudhuri K, Khare SD, Nanu A, Bhasin R: Human immunodeficiency virus infection in the blood donors of Delhi, India. J Acquir Immune Defic Syndr 1990;3:152-154.
20 Singhvi A, Pulimood RB, John TJ, Babu PG, Samuel BU, Padankatti T , Carman RH: The prevalence of markers for hepatitis B and human immunodeficiency viruses, malarial parasites and microfilaria in blood donors in a large hospital in south India. J Trop Med Hyg 1990; 93:178-182. 21 Jager H, Nseka K, Goussard B, Kabeya CM, Rauhaus G , Peyerl G , Salaun JJ, Rehle T, Korte R: Voluntary blood donor recruitment: a strategy to reduce transmission of HIV-I, hepatitis-B and syphilis in Kinshasa, Zaire. Infusionstherapie 1990;17:224-226. 22 Wight JP: Ethics, commerce and kidneys. Br Med J 1991;303:110. 23 Editorial: The Gift of Blood: a comparison of voluntary and commercial blood programmes. Med J Aust 1972;ii:6143.
R. W. Ben1 W G. van Aken Blood Programme, International Federation of Red Cross and Red Crescent Societies (Head: Prof. R . W. B e d ) and Central Laboratory, Netherlands Red Cross Society (Head: Prof. W. G. van Aken), Amsterdam
Gift or Good? A Contemporary Examination of the Voluntary and Commercial Aspects of Blood Donation
................................................................................................. Abstract The safety and ethical aspects of blood donation are examined in the light of current legislation and practice. The advantages and disadvantages of voluntary and paid donation are looked at in view of recent data concerning risk factors in various potential donor groups. It is concluded that voluntary, nonremunerated blood donation remains the safest and most ethical means of securing the blood supply.
...........
The debate about voluntary versus paid blood donation has continued unabated for more than 20 years. The economists provided the initial combat forces, with Cooper and Culyer [l]arguing for blood to be regarded as a marketable good, and on the opposite side the convinced socialist Richard Titmuss [2] contending that blood donation was one of the last remaining acts of altruism in an increasingly welfare state. Practitioners of transfusion medicine fell in behind one or other force, the traditional voluntary not-for-profit organizations aligning themselves under the Titmuss banner, and those involved in the commercial plasma industry supporting the marketablegood side. Battles were fought, manifestos published, and little ground changed hands. New flurries of conflict occurred whenever a screening test became newly available for a potential transfusion-transmissible infection (TTI). Whenever such data were available for comparison, it seemed that the markers for the particular infection were higher in the commercial group of donors than in the voluntary group. A major victory for the supporters of voluntary donation came with the recent issue of Directive 89/381 of the
Received: January 28, 1992
European Economic community which stated, inter alia, ‘Member States shall take the necessary measures to promote community self-sufficiency in human blood or human plasma. For this purpose, they shall encourage the voluntary unpaid donation of blood and plasma and shall take the necessary measures to develop the production and use of products derived from human blood or human plasma coming from voluntary unpaid donations’. It seemed that the authorities were convinced of the increased efficacy of voluntary non-remunerated donation, whether on ethical or safety grounds or both is not known. The counter attack from the commercial firms has been predictably strong, claiming that the EEC Directive is incapable of implementation in most of the European countries required to comply. For example, Germany relies to a considerable extent on paid donation. Allied with this stand has been the claim that commercial donors give voluntarily, not under coercion, and that their blood is as safe as blood collected in the voluntary sector. (Francophones - among them J.-P. Soulier - have consistently pointed out the ambiguity of the English word
Prof. R. W. Beal Red Cross Blood Transfusion Service 301 Pirie Street Adelaide. SA SO00 (Australia)
01992 S. Karger AG. Basel ooJ2-9007/92/0631~1 $2.7510
‘voluntary’ in this context, and prefer the French ‘bCnCvole’ or ‘altruiste’. The former does not translate comfortably into English, and while the latter does, the concept of altruism is not commonly understood in English. The Oxford Dictionary definition of altruism is ‘regard for others as a principle of action; unselfishness, concern for other people’). A definition of voluntary, non-remunerated donation has been accepted by the International Society of Blood Transfusion and the Council of Europe. It was recently incorporated in a resolution passed by the VIIIth General Assembly of the International Federation of Red Cross and Red Crescent Societies. This definition states: ‘Voluntary non-remunerated blood donors are persons who give blood, plasma or other blood components of their own free will and receive no payment for it, either in the form of cash, or in kind which could be considered a substitute for money. This includes time off work, other than reasonably needed for the donation and travel. Small tokens, refreshments and reimbursement of direct travel costs are compatible with voluntary, non-remunerated donation’. This paper addresses the perceived and documented advantages of the voluntary, non-remunerated donor system (in practice, unpaid) and the disadvantages of the commercial donor system.
Advantages of Unpaid Donors - The first and most important ethical advantage is that
the unpaid donor becomes involved in an act of altruism, an action for others without thought of reward. The donor’s blood is seen as a gift, and as an act of generosity towards a person or persons less well off. It represents a cooperative act of commitment to the community at large, and while the donation remains anonymous, it nevertheless establishes the donor’s personal relationship to their fellows within the community. - The making of a blood donation has become for most so commonplace and such an every day matter that the uniqueness of making living tissue available for another has been forgotten as a result of frequency and familiarity. The voluntary unpaid donation is then still to be recognised and emphasised as a unique gift from one human to another, as with other organ and tissue donations. With one or two exceptions, notably in the near future factor VIII, blood and its components cannot be synthesised any more than can a liver, kidney or heart. Other human plasma proteins, including albumin, antithrombin 111,
2
Beallvan Aken
and von Willebrand factor, have been cloned and expressed, but the prospect of scaled up production for therapeutic purposes remains uncertain at present. - By becoming a regular voluntary blood donor, the individual concerned becomes part of the activities of his or her blood centre, and as an outcome, may be able to respond further (e. g. as a plasmapheresis donor) or assist in recruiting other donors. The commercial sector is increasingly aware of the importance of a personal rapport with their donors, and is actively working in this area. It is therefore increasingly important for the organizations recruiting voluntary unpaid donors to make sustained efforts to help their donors feel part of a committed group by hospitality, friendliness and comprehensible, readable information. If the customer is always right, how much more so the voluntary donor? - A further ethical consideration is that within the voluntary sector, the donor’s welfare is paramount, and is the primary objective of the blood transfusion service. It has been argued by those advocating long-term autologous storage of blood for personal use that the conventional blood services were ‘donor oriented’. Without compromising the safety of the recipient or staff in any way, it is to be hoped that this situation will remain so in the future. - Although it may not seem important to some, the capacity of a non-governmental organization (NGO), often a Red Cross/Red Crescent Society, to collaborate with governmental agencies responsible for support of transfusion services is seen as mutually advantageous to both parties, since neither the government or the NGO is involved in profit-making concerns. - Although left until last in this account of the pros of the unpaid system, the matter of safety is clearly the major advantage of one system and the perceived major disadvantage of paid donor system. The preceding points are essentially ethical, moral and subjective, as are some of the perceived disadvantages of the commercial system. The matter of safety is capable of measurement and documentation, and merits a separate section.
Relative Safety of Voluntary and Commercial Blood Programmes
Whenever a new (or newly recognised) disease is identified as a potential TTI and tested for, the levels of positive markers in the commercial sector exceed those in the voluntary sector. The commercial firms argue that they do the same tests as the voluntary sector, and that they do them at least as well, with quality assurance programmes
Gift or Good?
which meet the most stringent standards. This matter is not in contention. What is clear, and irrefutable on the basis of published evidence, is that the equally well-performed tests in the commercial sector define a population which clearly represents a greater risk to potential recipients. The evidence derived during the early days of hepatitis B screening showed that there was an increased risk of post-transfusion hepatitis following the use of blood and blood products from commercial sources [3-6]. Not long afterwards, there were similar findings in relation to non-A, non-B hepatitis of a ten-fold difference between commercial and voluntary blood programmes [7]. This evidence has been reinforced by early hepatitis C virus (HCV) antibody studies, which showed HCV positivity of 0.2-1.2% in ‘random’ blood donors from USA and three European Centres, 10-11% positive in commercial plasma donors and 45-70% positive in intravenous drug users (IVDUS) [8]. Similar findings have been published which emphasize the differences between non-paid and commercial donors [9]. A similar situation exists in relation to human immunodeficiency virus (HIV) status of donors to the commercial and voluntary systems. Although data are not easily acquired from the commercial sector, some interesting and alarming data emerged recently from a study of 2,921 IVDUS in Baltimore [lo]. Disturbingly, more than 20% had continued to donate blood after commencing intravenous drug usage. Most had continued giving after HIV screening was introduced, and the ratio of commercial: voluntary sector donation was 7.4:l (88.1 and 11.9% of a total of 437). While these data are disturbing for the voluntary sector as well as the commercial in relation to the permeability of the safety net, a sobering fact emerges: the chance of a donor in the window period slipping through the commercial screening procedure is at least 7-8 times greater than in the voluntary system. These data receive support from similar studies, with similar results [ll]. Other countries have produced similar data. In Mexico in 1986, the seroprevalence of HIV was 0.1% in voluntary donors and 7.0% in paid donors [12,13]. In a small Brazilian study of 100 beggars of whom 70 were professional blood donors, there were 5 (7%) with positives HIV tests [14]. A detailed medical history remains an important part of identifiying at-risk potential donors. A recent study [15] which examined pre-donation selection procedures concluded that at-risk donors who were asked direct history questions about AIDS risk behaviour, in addition to current health history questions, were more likely to be
screened out than those who underwent alternative health history interviews. The risk is clearly related to the fact that HIV plasma viraemia and antigenaemia occur prior to seroconversion in healthy plasma donors [16], and as Stramer et al. [16], point out, there are two reasons for the chances of HIV antigenaemia being higher in plasma donors than in whole blood donors. The interval between plasma donations (around 6 days) is far shorter than the 8 weeks between whole blood donations, and in this (and other) series, the demographic characteristics of the plasma donor are more like those of HIV-positive high-risk groups than routine whole blood donors. A recent study has shown that the prevalence of anti HTLV-I is ten-fold higher among paid plasma donors compared with whole blood donors [17]. Another study has emphasised that intravenous drug use is the major risk factor for HTLV-I1 infection [18]. Comparable data for HIV prevalence in voluntary and paid donors have been published from India [19,20] and Zaire [21]. The pattern has been so consistent that one assumes that when the next new, to be-tested-for TTI appears, the same sequence of figures will emerge.
Disadvantagesof the Commercial Blood System - The question of safety is the overriding quality -it is what makes voluntary donation safer and commercial/ professional donation less safe, and it is due to the different characteristics of the donor. The greater risk of TTI is the single most important differential factor. - A major concern with paid programmes is that they encourage exploitation of the blood donor, notably those of lower socio-economicbackground, and of differing motivation. The risk of exploitation and economic coercion is now not confined to commercial sale of blood, but is a problem for those transplanting organs [22]. The availability of blood and blood products in poor countries is restricted to that minority which can afford to pay. When, as in the past, these countries were in turn a major source of commercially fractionated plasma, the far from amply rewarded donor would not be in a position to receive blood or blood products if he or she needed them. - While the sad picture presented by many commercial blood programmes 20 years ago [23] is probably not consistent with some, at least, of today’s commercial operations, it is true that many of the donors continue to come from lower socio-economic backgrounds, where nutrition
3
is demonstrably less, where alcohol excess and drug abuse are more common, and where there is a greater temptation to falsify a medical history in the interests of being paid for blood. - The encouragement of malpractice as well as falsification of medical history is not confined to commercial programmes alone, but the monetary attraction is a driving motivation. - In a commercial setting, the blood itself is merely a marketable commodity, and the donor’s act a sale not able to be negotiated by the seller. There is lacking in a commercial transaction the sense of commitment and idealism inherent in the gift relationship. - There is no incentive other than financial for the donor to wish to feel part of a commercial organization where the profit is going to invisible share holders and not to the contributor. There will always be a difference between the interaction of a manufacturer and purchaser, with the sales person acting as the intermediary, and a donor and recipient, with the blood service having voluntary non-remunerated donors acting as the agent of both. - In developing countries, where there exist some joint venture plasma programmes, the venture tends to be given professional and developmental priority ahead of the local programme. In such programmes, albumin and immunoglobulin are returned to the donor country and the raw factor VIII sold to the highest bidder. Meanwhile, the local component programme languishes for lack of support and commitment. (This situation may change with the advent of a synthetic factor VIII.)
Although there are strenuous efforts being made by commercial plasma manufacturers to encourage a more attractive and different client&le,the ethical aspects inherent in the two systems do not appear likely to change in the near future. In spite of the best available test procedures, the safety of commercial donation appears still to be compromised by the higher-risk status of those recruited to the system. As noted on more than one occasion above, the unpaid donor system cannot risk complacency. It is up to them entirely to ensure that the voluntary donor is encouraged and assisted to remain a member of a unique and committed group of people around the world who help underwrite their country’s health programmes without thought of reward. Unpaid donors must be just as stringently screened as ever by history, selection and laboratory test, to ensure the safety of the donor’s gift to the recipient. The safety of blood and blood components continues to depend on several factors, including the recruitment of voluntary, unpaid donors, the self-exclusion of would-be donors belonging to risk groups, appropriate tests for the presence of viral and other infections, viral removal and inactivation of products where this is possible and appropriate and conservative use of blood and blood products. It is important to recall that the donation of blood by a voluntary unpaid donor remains the first and perhaps the most important variable in this chain.
................................................................................................................................................... References 1 Cooper MH, Culyer AJ: The Price of Blood. London, Institute of Economic Affairs, 1968. 2 Titmuss RM: The gift relationship: From human blood to social policy. London, Allen&Unwin, 1971. 3 Goldfield M: Some epidemiologic studies of transfusion-associated hepatitis; in Greenwalt TJ, Jamieson GA (eds.) Transmissible Disease and Blood Transfusion. New York, Grune&Stratton, 1975, pp 141-151. 4 Alter HJ, Purcell RH, Holland PV, Feinstone SM, Morrow AG, Moritsugo Y: Clinical and serological analyses of transfusion-associated hepatitis. Lancet 1975;i:838-841. 5 Hoofnagle JH, Gerety RJ, Thiel J, Barker LF: The prevalence of hepatitis B surface antigen in commercially prepared plasma products. J Lab Clin Med 1976;88:102-113.
4
6 Koretz RL, Gitnick GL: Prevention of posttransfusion hepatitis: Role of sensitive hepatitis B antigen screening test, source of blood and volume of transfusion. Am JMed 1975;59: 754-760. 7 Prince AM, Brotman B, Grady GF, Kuhas WJ, Hazze C, Levine RW, Millian SJ: Posttransfusion viral hepatitis due to an agent or agents other than hepatitis B virus or hepatitis A virus. Impact on efficiency of present screening methods; in Greenwalt TJ, Jamieson GA, (eds.): Transmissible Disease and Blood Transfusion. New York, Grune & Stratton. 1975, pp 129-140. 8 Abbott: Slide presentation data.
Beallvan Aken
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Gift or Good?
13 Sepulveda J, Barcca M de L, Dominguez JL, Valdespuro JL: Prevention of HIV transmission through blood and blood products: Experiences in Mexico. Bull Pan Am Health Organ 1989:23:108-114. 14 Carvalho MI, Castillo-Branco L, Habib JGA, Galvao-Castro B, Pereira MS: HIV antibodies in beggar blood donors in Rio de Janeiro, Brazil (Abstract 5130). Proc 4th AIDS Conf, Stockholm, 1988, p 346. 15 Mayo DJ, Rose AM, Matchett SE, Hoppe PA, Solomon JM, McCurdy KK: Screening potential donors at risk for human immunodeficiency viruses. Transfusion 1991;31:46W74. 16 Stramer SL, Heller JS, Coombs RW, Parry JV, Ho DD, Allain JP: Markers of HIV infection prior to IgG antibody seropositivity. JAMA 1989:262:6&69.
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