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Quality, safety, risks, and risk management are currently the leading words in transfusion medicine, and several approaches are necessary to correctly evaluate the fundamental basis of blood transfusion. Ethics is probably the most focused approach with which to examine the inconsistencies and conﬂicts of interest of the various stakeholders involved in the transfusion medicine ﬁeld. This research paper will present some aspects of ethics related to blood transfusion, particularly those involving blood donation.
Many questions emerge as soon as transfusion medicine is evoked in the public mind. The scandals of contaminated blood (human immunodeﬁciency virus [HIV] and hepatitis C virus [HCV]) are still remembered and have deﬁnitively changed our societal appreciation of global safety. Blood safety is based on ﬁve pillars: (i) infection related safety based on epidemiology and monitoring of infectious risk; (ii) immunological safety based on individualized or personalized transfusion medicine; (iii) safety in procurement, to ensure a robust blood component inventory; (iv) patient-focused blood management that aims to evaluate the needs of each individual patient; and (v) ethics. However, it is important to discuss the various ethical issues that the transfusion medicine community must face, because many different representations are associated with blood, with blood components, and with blood transfusion (Garraud and Lefrere 2014a). A search of the PubMed database using the two words “transfusion” and “ethics” yielded 801 entries (as of October 2014). The ﬁrst paper identiﬁed was published in 1961 and discussed the legal, ethical, and religious viewpoints of the transfusion of cadaveric blood. Most ethical aspects of transfusion medicine had already been addressed in the medical literature 40 years ago, and most of the main keywords involved in the ﬁeld of transfusion medicine were already in use. For example, one may cite the concerns of Jehovah’s witnesses (1964), refusal of blood transfusion (1968), the issue of religious faith versus medical ethics (1969), voluntary blood donation in France (1972), the concept of altruism (1972), the sacred blood gift (1974), blood doping (1975), and problems related to gift, exchange, and political economies of heath care (should blood be bought and sold; 1977). Even the question of blood as a comorbidity had already been addressed (1977). Since that time, society has faced the HIV scandal, followed by the HCV epidemics, and the transfusion medicine community focused all efforts towards infectious safety. Now, as thoughts about the economic and ethical aspects of transfusion medicine have emerged, concerns persist regarding quality, safety, risk, risk management, principle of precaution, and beneﬁt.
History And Development: Basic Aspects Of Blood Transfusion
The idea of taking blood from one individual to infuse it into another was developed by the ancient Egyptians. The word “transfusion” stems from the ancient Latin transfundo, which initially meant to pour from one vessel to another. Early on, its generally recognized meaning was extended to include two different notions: the corruption of a population by mixture with foreigners, with sexual and hybridization connotations, and the transfer of a debt (Tissot and Lion 2013). Hence, the concept of transfusion as the transfer of the vital spirit or an idea was present before the deﬁnition of transfusion as the transfer of blood between two individuals. Today, blood transfusion is one aspect of human solidarity, and millions of blood donations are made every year worldwide. Various blood components can be prepared from these donations, including fresh frozen plasma (FFP), platelet concentrates (PCs), red blood cell components (RBCCs), whole blood (WB), white blood cells (neutrophils), and blood-derived preparations. Since 2013, blood products have been included on the list of essential medicines established by the World Health Organization.
RBCCs basically have the capacity to carry oxygen, PCs protect against bleeding, and white blood cells combat infections. FFP is a complex mixture of a huge variety of proteins, playing a notable role in coagulation and immune defense. FFP can be used whole or can be fractionated into speciﬁc fractions with particular functions (e.g., clotting factors, immunoglobulins, albumin, ﬁbrinogen, etc.). The cell components are obtained through the collection of WB (split afterwards into a unit of RBCs, a unit of platelets, and a certain amount of plasma) or are speciﬁcally collected on an apheresis automat in order to directly separate one or several RBCCs, one or several PCs, and a certain quantity of plasma.
Blood donations are generally intended for transfusion into another individual (referred to as an allogeneic or a homologous transfusion), which normally occurs in a context of mutual anonymity. A donor may also pre-deposit blood or blood products to cover his or her own prospective needs (autologous donation), notably for elective surgery. A third possibility is so-called directed donation, in which a donor gives blood to a particular recipient, notably when immunized patients need “rare” compatible blood. An alternative to this not-forproﬁt policy is “compensated donation,” often used in Africa, in which a recipient receives blood under the condition that one or several of his or her relatives make(s) donation(s) to compensate for the blood component being issued. Laws in most Western countries prohibit this type of donation because it does not respect the voluntary and anonymous basis of donation and is often considered as an impingement to solidarity. This position has been criticized, and some organizations, notably in Germany, pay blood donors. In addition, even in Europe, and more particularly if “rare” blood groups are needed, direct donation is organized between family members (most frequently brothers and/or sisters). Thus, many violations of the principle of the respect of voluntary and anonymous are already present, notably when medical issues take precedence over ethical issues. Finally, plasma for fractionation is partly provided by the plasma supernatant extracted from WB, but also arises from apheresis procedures. In some countries, the latter may lead to ﬁnancial compensation. The economics of plasma fractionation are complicated further by the fact that a number of plasma-derived proteins can be produced through the use of recombinant technologies, thus bypassing the need of source plasma.
Conceptual Aspects Of Blood Transfusion Ethics
The ethical obligation of both transfusion medicine physicians and clinical/medical laboratory scientists at blood transfusion facilities is to provide in a timely fashion, to any patient in need of blood, blood components that are safe and best ﬁtted to his/her clinical situation and to secure the forthcoming donations and/or further transfusion the recipient needs (notably by limiting the risk of alloimmunization). In order to accomplish this task, blood transfusion facilities must rely on donors, whose blood or blood components are collected in optimal conditions of comfort and safety, with the greatest respect for the donor and with the commitment of making the best possible use of this gift; special comforting must be provided to blood donor candidates who happen to be deferred. Initially, the transfusion physician or the blood transfusion facility should comply with social standards and expectations to create an atmosphere of conﬁdence and transparency, contributing prospectively to optimal safety and guaranteeing the sufﬁciency of the blood supply in the long term. Although blood and blood component donation is relatively safe, some donors may present secondary effects that must be explained to the blood donor candidate and that are traced in hem vigilance systems.
Although the ethical obligations of the transfusion physician are very similar to those of active physicians in other medical ﬁelds, they are particularly keen in the blood donation context and serve both the sick (patients/recipients) and the healthy (donors). The physician aims to match the needs, expectations, interests, and lawful aspirations of each category of individuals.
The Ethical Framework Of Blood Donation
The term globalization is increasingly used, notably in connection with economics (trade, transaction, capital, and investments). It is also used in relation to climate change, air pollution, and even overﬁshing. Globalization of the health market, merchandizing of the human body, and social inequalities must be taken into consideration when discussing blood transfusion. In the industrialized part of the world, most blood donors are unpaid volunteers (voluntary non-remunerated repeat donors; VNRDs) who donate blood for a community supply. Although many individuals donate as an act of charity, in countries that allow paid donation, some “donors” (who should sensu stricto be renamed “sellers”) receive some ﬁnancial compensation; in some cases, there are incentives other than money, such as paid time off from work. In developing or recently industrialized countries, where established supplies are limited, donors usually give blood when family or friends need a transfusion (directed donation/ reposition donors), with or without compensation.
Ethics And Donation
The WHO recognizes that achieving self-sufficiency “in the supply of safe blood components based on voluntary, non-remunerated blood donation, and the safety of that supply are important national goals to prevent blood shortages and meet the transfusion requirements of the patient population.” This issue is an important ethical aspect of blood transfusion (Dhingra 2013; Follea et al. 2014; Garraud and Lefrere 2014b; WHO Expert Group 2012; Lacetera et al. 2013; Rossi et al. 2011). The International Society of Blood Transfusion (ISBT) has also updated their ethical rules for blood donation and blood transfusion, which are available on the website of the society. Thus, the main concerns of national health authorities regarding blood and blood components are to maintain an adequate blood and plasma supply for patients requiring transfusion, to ensure the appropriate use and warrant the safety of blood products, and to prevent the transmission of infectious pathogens (Desborough and Murphy 2013; Herve et al. 2014). Epidemiological studies performed in the Western world have shown that blood obtained from VNRDs carries fewer infectious agents – as deduced from biological markers – than blood from paid donors. However, this ﬁnding does not necessarily have universal or eternal value (Ala et al. 2012). Data on the safety proﬁles of donors in Africa, Asia, as well as from Latin America show that the prevalence of infectious diseases (hepatitis, malaria, Chagas’ disease, HIV, etc.) is completely different when compared to that of the Western world. In addition, blood groups are very different in various ethnic populations. Thus, and taking into account that blood donation must be though in an era of a globalized movement of people, ethics of blood donations certainly will be challenged in the next near future. Therefore, one should ask which value is to be prioritized between securing nonpaid blood donations and providing blood to patients in sufﬁcient quantity. Ethical judgment includes the balancing of two values (which, in a given context, may be conﬂicting) and the duty to evaluate the practical consequences of a choice. While respectable, the philosophical substrate intended by the concept of solidarity is linked to one’s culture and is not necessarily universal (even the best intentions can lead to catastrophic events, in some cases). If prohibition of family donations (e.g., in Africa) does not lead to a better and safer blood supply, but paradoxically worsens already existing shortages, then the ethical consequences of such a strategy also merit consideration.
Globalization And Merchandizing (Between Cannibalism And Vampirism)
Globalization of the market, merchandizing of the human body, and social inequalities must be also taken into consideration when discussing blood transfusion. As already mentioned, WB can be eventually considered as a gift that is special in that it is a source of manufactured goods. Plasma collection by apheresis is more often the source of material designated for the industrial production of blood-derived drugs. Thus, in many parts of the world, individuals are paid to source plasma, which is then transformed into drugs. Some aspects of the plasma industry were particularly well described in a 2014 issue of the magazine Eco of the Swiss Television (available on the website of the Schweizer Radio und Fernsehen).
Plasma is considered a drug in many countries, and the market is open both to not-for-proﬁt blood services and to proﬁt-driven pharmaceutical companies. Globalization is really present in the market of blood products, and business-related companies may be considered the new vampires of neocolonialism. Therapeutic immunoglobulins (which are high-priced but useful blood derivatives) represent a quickly expanding market. The market has been controlled thus far; proﬁt is the driver in this domain. In other words, one may characterize the situation as follows: the plasma of poor young individuals will be collected and treated to produce very expensive drugs that may eventually be useful for the elderly of the richest countries. This disaster scenario (implying exploitation of vulnerable people) must be combated and condemned, because it violates all aspects of solidarity.
Obligations Towards Donors
Donors generously give time and blood; they have the “right” to do so in optimal conditions of safety and comfort, and to receive acknowledgement, and respectful explanation in case of deferral. They also deserve the best possible use of their donation and to receive all needed information. According to a rule that is generally accepted in Western culture, the human body and its parts (including blood) cannot be the object of any kind of trade. However, the absence of remuneration does not imply that donors cannot have their travel expenses reimbursed. Indeed, not doing so might lead to social discrimination against the poorer blood donors. Offering donors tokens as signs of gratitude and friendship and making soft drinks and snacks available to them can hardly be seen as “payment” and is generally practiced. Nevertheless, several individuals are entirely opposed, for personal “ethical” reasons, to any kind of reward, particularly special fancy entrées such as those created by well-known chefs. This extremist attitude is not easily understood by individuals having different cultural orientation. For instance, the Middle Eastern culture of gift exchange would probably not orient donors in Syria into thinking that they were receiving the gift in exchange for their altruism. On the other hand, a Syrian graduate student who donates blood in a Western context but receives nothing in return may tend to interpret the interaction as inhospitality.
Clarifying the issues mentioned above would greatly help in both the assessment and the interpretation of the notion of the “voluntary unpaid donor.” It also would decrease the risk of polemics and complaints about the interpretation of wording. The Nufﬁeld Council on Bioethics report on “Human bodies: donation for medicine and research” has provided speciﬁc terminology and a rubric, termed an intervention ladder, regarding transactions made in connection with human bodily material, including blood and plasma. All relevant information are well as updated reports are readily available on the website of the Nufﬁeld Council on Bioethics. Furthermore, a list of incentives has been published that includes the reimbursement of medical costs, compensation linked to loss of earnings, food vouchers, free physical checkup, time off from work (private and public sectors), reimbursement of travel costs, small tokens, refreshments, and other forms of incentives. Several notions such as “recompense” or “reward” have also been deﬁned: a recompense is a payment to a person in recognition of losses they have incurred, material or otherwise, and may take the form of either reimbursement of direct ﬁnancial expenses incurred in donating bodily material (such as train fares) or compensation for nonﬁnancial losses (such as inconvenience, discomfort, and time). A reward is a material advantage gained by a person as a result of donating bodily material, which goes beyond providing redress to the donor for the losses they incurred during the course of donation. If reward is calculated as a wage or equivalent, it becomes “remuneration.”
The review of ethical principles and the proposed terminology regarding transactions involving human bodily materials led the Nufﬁeld Council to envisage shifting attention away from the paid/unpaid donation dilemma towards making a distinction between altruistic and non-altruistic interventions. Altruistic interventions include information about the need for the donation of bodily material for the treatment of others or for medical research; recognition of and gratitude for altruistic donation through whatever methods are appropriate both to the form of donation and the donor concern; intervention to remove barriers and disincentives to donation experienced by those disposed to donate; and interventions as an extra prompt or encouragement for those already disposed to donate for altruistic reasons. Non-altruistic interventions include those offering associated beneﬁts in kind to encourage those who would not otherwise have contemplated donating to consider doing so, as well as ﬁnancial incentives that leave the donor in a better ﬁnancial position as a result of donating.
New Paradigm: The Gift Of Blood As A Benefit For The Donor
Scientiﬁc publications have clearly shown that blood donation may lead to iron deﬁciency with or without anemia. By contrast, blood donation may prove useful in individuals with high ferritin levels as a preventive measure of decreasing the risk of developing type II diabetes (Waldvogel Abramovski et al. 2013). Such ﬁndings, if conﬁrmed, could enhance donor recruitment. On the other hand, a certain number of blood donors say that they feel objectively “better” after donation. For some, to donate blood is almost a necessity; they are convinced that after a donation, their red cell mass increases constantly and that they will become “overﬁlled” without making a donation. In other cases, the feeling is only the psychological satisfaction of having done something positive (self-rewarding); it may also be a quest to be acknowledged and valorized by a nursing staff in a society in which more and more people lack any form of social esteem. Thus, in a substantial number of cases, the gift of blood is not without any secondary beneﬁt for the donor and therefore not strictly “gratuitous.”
The Multidimensional Aspects Of Ethics: Discrimination/Exclusion
Discrimination and exclusion form the obscure face of blood donation, as very interestingly evoked by Julien Green.
The paradoxes of the exclusion of men who have sex with men (MSM) are particularly difﬁcult to address without reﬂecting on the many and particular ethical aspects of the question. In July 2014, the European Court of Justice advised to overturn France’s ban on gay blood donors, and the advocate general indicated that France’s ban on blood donations from MSM – under the use of current documents, questionnaires, and medical interviews – violates European Union law. Protecting public health is a legitimate public policy goal; however, permanently excluding gay and bisexual men, but not heterosexuals who have unprotected sex (and therefore pose an HIV risk), from donating is indeed questionable. The advocate general also indicated that countries such as France should assess all prospective donors’ risk behaviors. The European Court of Justice is deliberating the case, and regardless of the answer, the question of exclusion will remain a concern of all individuals involved in the chain of events of transfusion medicine. Do people have the “right” – versus the “opportunity” or even the “chance” – to donate? It is certainly not an intent to exclude a number of donor candidates solely on the basis of the medical interview, especially because blood testing is performed in all cases – and in several (if not in many) countries – the results are even reinforced by nucleic acid testing, which is considered to narrow the risk period of transmissibility to 7–10 days depending on the technique. Deferral is aimed at securing the blood transfusion circuit and minimizing the risks for transfusion recipients. However, it is not the right of donation that should be discussed, but the right of patients to use donated blood. As such, blood donation could be accepted and would enter the circuit based upon repeated negative test results; however, it is a quality assurance principle – based on acknowledged analyses of many situations in many ﬁelds, including security as well as safety – to consider that it is unwise to expose a circuit to an acknowledged risk (which can be calculated on the order of magnitude of 5 10 6, as it is not theoretical but real, albeit minimal). All countries that apply this policy essentially decide to prevent the risk of breaching the safety of the circuit and to secure the inventory. Therefore, if this donation cannot be employed for patients, it could be used for other purposes such as fundamental research, validation of processes, or preparation of reagents (with the consent of the donor, of course); again, the quality assurance policy would require that totally independent circuits be established that never expose a patient to a possible – again, not a theoretical – risk. Nevertheless, calculations have recently been made based on alternate hypotheses; they indicate that the risk of discouraging donor candidates threatens the inventory more than the acceptance of a minimal risk, once it is accepted that “zero” risk never exists. Some countries have decided to accept blood from MSM donors provided that certain safety conditions (regarding safe sex) are met. Finally, an unaddressed question is: what is the opinion of the potential recipients: will they accept any blood or blood products collected from MSM or “at large” donors, including heterosexuals with some risk of harboring infections (Flanagan 2012)?
Representations And Exclusions
Several types of donations are not accepted in many parts of the world, notably in Western Europe and North America: paid “donors,” intrafamilial transfusions, transfusions organized between friends or relationships, and donors who are MSM.
Let us think about the particular situation of blood donation and its relation with sexuality.
– Life is transmitted by sex; life can be sustained or supported (or, symbolically, transferred) by blood transfusion.
– Sex can kill humans, by transmitting various pathogens, such as HIV, HCV, hepatitis B virus, and Treponema pallidum; blood transfusion can kill recipients by transmitting various pathogenic agents.
It can be hypothesized that blood transfusion is a surrogate expression of sex. Therefore:
– Paying for blood that has been offered (by a donor) is shameful, amoral, or unethical (in most Western/Northern countries); paying for sex (even though this activity has a long tradition in human history) is still considered shameful and amoral. Without entering into complex considerations of paid or compensated blood (as opposed to freely donated), this kind of commercial relationship between the “donor” and the “recipient” (either straightforward by direct payment between the two individuals or indirectly through insurance) is evocative of the links between the sex worker and the client within the context of prostitution.
– Organizing transfusions within a family, between family members, is not accepted in many countries: having sex within a family, between family members, is prohibited (again, in Western/Northern countries). One of the suggested reasons for banishing intrafamilial blood donation is the risk of posttransfusion graft-versus-host disease (a problem that can be technically solved satisfactorily by the use of gamma or X-ray irradiation). However, such intrafamilial transfusion can be seen as an incestuous – and therefore taboo – relationship.
– Directed transfusions, transfusions organized between friends or relationships, are discouraged: by analogy, arranged marriages are discouraged in most Western societies. It is frequently argued that the relatives of a patient are not necessarily safer than regular donors, in terms of infectious risk burden. Thus, directed transfusions can resemble arranged marriages.
– Men who have sex with men may represent the expression of what has been called “an abnormal sexual orientation” that cannot transmit life, biologically speaking. Thus, even though the epidemiology of HIV and other sexually transmitted diseases differs quite signiﬁcantly between the nonheterosexual community and the so-called straight or heterosexual male population and argues for excluding MSM as blood donors, this type of exclusion is sensed as a moral judgment that dictates what is accepted and what is forbidden (evocative of original sin).
This analysis may help to provide some kind of answer for many ethical issues related to exclusion.
Although health systems have developed ethics, economics have their own ethics, as well. Blood products are very costly, and hospitals make every effort to limit the inappropriate use of such expensive blood components for clinical, ethical, and ﬁnancial purposes. In fact, blood or blood components obtained from VNRD are not sold. The price of these “goods” is in direct relation to all of the services and activities that are directly or indirectly required, from the promotion of blood donation to the transfusion of a blood component, and surveillance – a long chain of processes that are all controlled and traced.
Blood and blood components are considered economic items: they are necessary; they are costly; they are rare. The production and transfusion of blood components represent a cost to society (and can thus be considered “valuable”); in addition, the number of available blood donors is limited. In this context, it is vital to ensure that the link between the transfusion community and public opinion remains transparent. Public opinion is not the supreme ethical criterion; however, given that donor recruitment and loyalty are critical to maintaining the blood supply, it is important that the transfusion community understands the ethical values and motivations that drive people in a given society. Reciprocally, the transfusion community has a moral duty to remain loyal to society and to provide information that is as correct and understandable as possible to the general public regarding issues such as blood supply and product safety. Every decision in transfusion medicine should be based on critically examined scientiﬁc evidence and not merely on personal or collective opinion. Decisions should be inspired by a willingness to work towards optimal protection of both the blood supply and product safety and must not be beholden to the mere desire to avoid litigation. Every step that can reasonably be taken in donor selection or product testing or preparation should be encouraged. However, every measure of donor exclusion that is not based on sound medical evidence will only lead to further compromise of the blood supply.
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