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New Cannibal Markets

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Jean-Daniel Rainhorn
, 
Samira El Boudamoussi

Part 5. The Human-Product-Banking Industry

Selling Donations: Ethics and Transfusion Medicine

Jean-Daniel Tissot, Olivier Garraud, Jean-Jacques Lefrère e Jean-Claude Osselaer

Testo integrale

1What is blood, what are blood products, and what are derived medications from blood? Many different representations are associated with blood transfusion (Garraud and Lefrère 2014a), and 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 in our memories and have definitively changed our appreciation of global safety. Nevertheless, many questions remain open in 2014: What are the residual risks of transfusion? What is the real security of blood transfusion? What are the costs of the blood transfused for a patient? What are the ethical issues that the transfusion medicine community has to face?

2Blood transfusion is one aspect of human solidarity. Millions of blood donations are made every year throughout the world, either to save or to support life. The blood components include fresh-frozen plasma, platelet concentrate, red blood cells, whole blood, and blood-derived preparations. The World Health Organization recognizes that achieving self-sufficiency “in the supply of safe blood components based on voluntary, non-remunerated blood donation, and the security of that supply are important national goals to prevent blood shortages and meet the transfusion requirements of the patient population.” Voluntary, non-remunerated blood donation is an important ethical aspect of blood transfusion (Garraud and Lefrère 2014b).

3The idea of taking blood from one individual to infuse it into another is very old and was developed by the ancient Egyptians. The origin of the word “transfusion” stems from the ancient Latin transfundo, which initially meant to pour from one vessel to another. Its acceptation was extended early to two different notions: the corruption of a population by mixture with foreigners, with sexual and hybridization connotations, and the transfer of a debt. Both sexuality taboos and the notion of debt were thus initially present in the word transfusion (Tissot and Lion 2013). Hence, the concept of transfusion (transfer of the vital spirit or idea) was present before transfusion (transfer of blood between two individuals).

4Many important discoveries highlight the story of modern transfusion medicine, including the identification of ABO blood groups by Karl Landsteiner, the anticoagulation of blood preparations using citrate, technologies allowing fractionation of proteins from plasma, and plasmapheresis for collecting large volumes of plasma. However, the perception of the transfusion medicine picture has been completely modified by the major crises arising from transmission of HIV by transfusion and the identification of hepatitis C virus as the agent of non-A non-B hepatitis.

Principles of modern transfusion medicine

5The main concerns of national health authorities for blood and blood components are to maintain an adequate blood and plasma supply for patients requiring transfusion and to ensure the appropriate use and warrant the safety of blood products, together with the prevention of transmission of infectious diseases. At the European level, numerous initiatives related to the blood and plasma sectors have been undertaken since 1989 (Directive 89/381/ECC), with recommendations and directives about the quality and safety for the collection, testing, processing, storage, and distribution of human blood and blood components (Directive 2002/98/EC and the relevant implementing Directives 2004/33/EC, 2005/61/EC, and 2005/62/EC), as well as traceability requirements and notification of serious adverse reactions and events (hemovigilance).

6Many important questions remain: What are the needs, and how are terms such as “shortages” and “self-sufficiency” defined? What is a “voluntary unpaid donation” and how do we understand “compensation” or “remuneration”? These questions are true challenges for the future of transfusion medicine, and the answers may originate from legislative decisions, from the economy of the needs of the market, and/or from ethical considerations.

Globalization, merchandizing (between cannibalism and vampirism)

  • 1 www.srf.ch/player/tv/videoembed?id=72df5a1d-2195-4c81-8567-c6ed2d1aef9c&width=624&height=351&mode= (...)

7Globalization of the market, merchandizing of the human body as well as social inequalities must be taken into consideration when discussing blood transfusion. Whole blood can be considered a gift specially aimed to be the source of specific manufactured goods. However, collected (apheresis) plasma is considered a source material designated to the industrial production of blood-derived drugs. Thus, in many parts of the world, individuals are paid to be the source of plasma aimed to be transformed into medicines. Some aspects of the plasma industry have been particularly well described in a recent issue of the magazine Eco of the Swiss Television (in German).1

  • 2 www.humanite.fr/tribunes/les-multinationales-des-medicaments-derives-du-san-553905.
  • 3 questions.assemblee-nationale.fr/q14/14-51874QE.htm.
  • 4 www.pptaglobal.org/images/source/2014/SPRING/Individual_Articles/7_European_court_of_justice_turns (...)

8Plasma, in many countries, is a medicine, and the market is open to “non-profit blood services” as well as to commercial companies with the aim to do profits. In France, the war is open2, and the health authorities3 as well as justice4 will have to decide what should be done. Globalization is really present in the market of blood products, and commercial companies may be compared with the new vampires of neocolonialism. Production of intravenous immunoglobulins (ivIGs), a very expensive but very useful drug derived from human plasma, represents a fabulous market, and new indications for the product—such as a treatment for mild to severe Alzheimer’s disease—are being explored. The market is controlled; profits are the driving force in the domain. In summary, the plasma of poor young individuals will be collected and treated to produce the very expensive drugs such as ivIGs that may eventually be useful for the elderly rich of wealthy countries.

Ethics and transfusion medicine

9The hierarchy of ethical principles can differ among individuals in cases of conflicting values. There is general agreement that we should act for good, but the discussions usually start when we have to define what exists in terms of practical implications that we have to draw from a universally shared ethical aspiration. Indeed, the variability in ethical priorities not only links to the individual but is also (and more importantly) a product of cultures moving with time. The Universal Declaration of Human-Rights was typically an eighteenth-century product with effects that have persisted to today. This declaration included the so-called first-generation human-rights, including respect for one’s personal integrity (duty to respect another person’s integrity), freedom of opinion, freedom of religion, freedom of expression, and freedom of property. More recently, these obligations have been completed by the human-rights of the second and third generations, including the right to education, health (which would have been better defined as a right to medical treatments), housing, and work. These rights ask for a far more active contribution from society. Paradoxically, they may sometimes enter into conflict with the human-rights of the first generation (legal prohibition of racism or xenophobic speech may enter into conflict with freedom of expression, for example). This shift reflects a progressive transition from the concept of rule of law to the concept of the welfare state. The comportment of society through intermediating structures, whether professional, religious, familial, or geographical, was felt as an obstacle for upcoming liberation and capitalism, requiring free exchange and an anonymous labor force. To manage an ever-increasing phenomenon of poverty, a central welfare state had progressively to take over the union mechanism of solidarity presided over by charity and the private initiatives of the intermediate structures. Solidarity therefore has become quite anonymous and is no longer considered a gift but a prerogative, owed by the welfare state to the individual. Simultaneously, growing individualism has led to a culture in which self-accomplishment, free choice, and right to privacy are important tenets.

10Ethical values classically linked with transfusion are volunteering, making an unpaid contribution, anonymity, and donor liability. These ethical aspects are highly important. Two refer to the notion of solidarity (volunteering and gratuitousness), whereas anonymity and volunteering reflect a desire for privacy and donor liability derives from the moral obligation not to harm somebody else. Professionals in transfusion should optimally use these values to promote blood donation to provide the best possible care to recipients.

11Furthermore, epidemiological studies performed in the Western world have shown that blood obtained from volunteer, unremunerated donors contains fewer infectious markers than blood from paid donors. However, this finding does not necessarily have universal or eternal value (Ala et al. 2012). Therefore, we should ask ourselves what value we prioritize between non-paid blood donations or providing blood to patients in sufficient quantity. Ethical judgment includes the balancing of two values (that, in a given context, may be conflicting) and the duty to check for the practical consequences of a choice. However respectable, the expressions we give to values such as solidarity are linked to our culture and do not necessarily have a universal value (sometimes best intentions may lead to catastrophes). If prohibition of familial donations in African countries does not lead to a better and safer blood supply but paradoxically worsens already existing shortages, it’s reasonable to consider the ethical consequences of such a strategy.

The responsibilities of the professional in transfusion medicine

12Professionals have to meet ethical obligations on three fronts.

Obligations towards patients

13Because every patient has the right to receive the safest and most adequate product, donor testing should meet all legal and regulatory requirements and be in compliance with good clinical practice according to the currently available scientific evidence. After the so-called “contaminated-blood scandal” in France and in several other countries, a major effort has been made to translate into legal statutes what were until then simply the principles of good professional practice. The public interest in blood safety at that time was tremendous and, at first glance, it seemed indeed normal to lock everything into a framework of legally mandatory rules. In the long term, however, the legitimacy of this strategy appears less obvious: It may lead to a lack of flexibility, and one can wonder if the executive power of a given country is the best authority to give medical instructions and choose the most “appropriate” among several possibilities. Indeed, transfusion safety is of utmost importance, and one can be pleased that minimum blood safety is guaranteed by mandatory rules, but the risk of a tendency towards bureaucracy remains, one in which transfusion professionals could consider that their only obligation is to comply with an ever-increasing array of technical rules imposed by the health authorities.

14The aim of the whole process of donor selection and testing should always remain patient centered, leaning towards optimal safety (the ideal transfusion is not the transfusion that will never take place, but the transfusion given to a patient in conditions that maximize the benefit/risk ratio). The quality of donor selection is not necessarily proportional to the percentage of donor deferral. The perception of an increased risk should be based on scientific and epidemiological data, not on feelings that are sometimes more grounded in worries about possible litigation than concern about patient safety. A hiatus in regulation never can be an excuse not to do whatever is reasonably possible to protect a patient. Yet ethical requirements go far above even legal requirements. If, because of a lack of funding, pertinent safety measures cannot be taken, the professionals and the transfusion community as a group have the duty to build pressure on competent authorities and, if necessary, initiate a public debate.

15The question of what one can do to optimize safety depends, of course, on personal judgment; the same applies regarding the question of the optimal level of safety we can reasonably attain. Absolute safety cannot exist, and regardless of the degree of economic prosperity a society can reach, there will always be limits on what can be invented in additional safety. The ethical requirement is not to agree on every issue but to keep the questioning alive and the debate open.

16Furthermore, the moral duty of a transfusion professional is not only to deliver products that are as safe as possible but also to guarantee their delivery in a timely fashion. Very few hemovigilance systems contain information on the occurrence and the possible consequences of delayed transfusion as a result of product shortages. Similarly, if for reasons of safety and quality assurance a production facility cannot manufacture more products between Friday and Monday nights and if no alternatives are left, one can reasonably wonder whether such a facility, however compliant with national regulation, fulfills its ethical duties regarding the delivery of products such as granulocytes, with a maximum 12-hour shelf life.

17Finally, transfusion professionals have the moral obligation to safeguard as much as possible the transfusional (and obstetrical) future of a patient: Induction of anti-RH1 (anti-D) in a woman with child-bearing capacity is always considered malpractice, but protection of patients chronically transfused by packed red cells has not benefited from the same attention. The debate still remains on what is optimal protection: Should we protect all recipients or focus on patients who have already developed an antibody response? Even if absolute protection against any alloimmunisation is an impossible challenge, more could often be done to protect patients against preventable exposure to alloantigens. Even if not required by national regulation, this protection constitutes an ethical obligation for the transfusion physician.

Obligations towards donors

18Donors generously give their time and their blood, and they have the right to do it in optimal conditions of safety and comfort and to be treated with respect and tact in case of deferral. They also have the right to require the best possible use of their donation. According to a rule generally accepted in Western culture, the human body and its parts (including blood) cannot be the object of trade. Thus, at least in the Western world, blood donation should be voluntary and altruistic. It is probably wise, indeed, not to give financial compensation for a blood donation, especially not as long as epidemiological data show a lower prevalence of infectious markers in unremunerated vs. remunerated blood donors. The absence of remuneration, however, 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 a small gift as a sign of gratitude and friendship or making drinks or snacks available to them can hardly be seen as “payment” and is generally practiced. Nevertheless, several individuals are totally opposed, for personal ethical reasons, to any kind of rewarding, including special snacks created by well-known chefs.

  • 5 www.nuffieldbioethics.org/wp-content/uploads/2014/07/Donation_full_report.pdf

19Clarifying the issues mentioned above would greatly help in both assessing and interpreting 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”5 has provided specific terminology and the “intervention ladder” regarding transactions made in connection with human bodily material, including blood and plasma. A list of incentives was published which includes reimbursement of medical costs, compensation linked to loss of earnings, food vouchers, free physical check-up, time off from work (private sector), time off from work (public sector), 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 non-financial 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 “recompensing” the person for the losses they incurred in donating. If reward is calculated as a wage or equivalent, it becomes “remuneration.”

20The review of ethical principles and the proposed terminology about transactions of human bodily materials led the Nuffield Council to envisage shifting the 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 others’ treatment 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 and financial incentives that leave the donor in a better financial position as a result of donating.

21With the aim of seeking areas of shared consensus on what can be done by institutions and organizations to “facilitate” donation of human bodily material such as blood and plasma, the Nuffield Council suggested an “intervention ladder” as a tool for analyzing the ethical acceptability of different forms of encouragement for donating bodily material in various circumstances.

22If we consider the right of a donor to donate, this right appears not absolute and absolutely conditioned by the right of the patient to receive the safest product. Obviously, in the case of deferral, the donor has the right to be treated with utmost respect and attention: the donor came generously to help a fellow human being and does not have to leave the blood center with the feeling of social discrimination; an example might be males who have sex with males, who are deferred based on an increased rate of HIV prevalence (which is an epidemiological observation). Furthermore, deferred donors have the right to receive correct information. If some regulatory deferral criteria are mandatory, although without any satisfactory scientific instruction, this gap should be explained to the donors. The question of whether false-positive results should be communicated, and in what terms, is a matter of debate, especially in the absence of any scientific evidence that such a deferral effectively contributes to increased patient safety.

23Scientific publications tend to suggest that if iron deficiency should be admitted as a consequence of blood donation, the risk of developing certain diseases is less with low–normal than with high–normal iron stores (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 the donation. For some of them, to donate blood is almost a necessity; they are convinced that, after a donation, their red-cell mass increases constantly and that they will get “overfilled” without a donation. In other cases, the feeling is only the psychological satisfaction of having done something positive, if not that of being 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.” In our opinion, a distinction should be made between the “gratification” that remains inherent to the donation process (altruist interventions) and the “gratifications” that are completely extrinsic (non-altruist interventions).

24If a donor chooses to donate out of interest in the kindness of the nurses or esteem from the staff for having done something that might be life-saving, the donor will collaborate voluntarily on concerns of patient safety. In such situations, the fact of giving a small present or not or the value of the snack or beverage will not interfere with the trustworthiness of the answers to the questionnaire. If, on the contrary, a financial counterpart is offered for a blood donation, totally out of proportion with reimbursement or travel expenses, the risk exists that the monetary incentive becomes the principal if not the only motivation of a donor. In this case, the financial incentive will increase the chances of incorrect answers to the donor questionnaire.

Obligations towards society

25These obligations include giving the most correct information to both the authorities and the community, developing a hemovigilance organization to detect as far as possible more threats in transfusion practice, and allowing competent authorities to take preventive measures.

26Blood and blood components are economic items in a double sense. Not only do blood component production and transfusion represent a cost to society but also blood donors are available in a limited number. In this context, it is vital to ensure that the link between the transfusion community and public opinion remains optimally transparent. Public opinion is not the supreme ethical criterion, but 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 driving people in a given society. For the same reasons, it is a moral duty that the transfusion community remains loyal to society, giving information that is as correct and understandable as possible to the general public regarding issues such as blood supply and product safety. The so-called “contaminated-blood scandal” was not simply the result of assessment failures by some professionals, who do share their part of the responsibility, but who often have been denigrated in public opinion as scapegoats. What needed more examination were the true roots of system malfunctioning that allowed individual assessment errors to lead to consequences of this extent (Garraud and Lefrère 2013).

Conclusion

27The reality differs from country to country and depends on historical and socio-economic perspectives. Thus decisions 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 not be beholden to the mere desire of avoiding 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.

28Communication with public opinion should be both professional and loyal. Professional, not because the form of the expression is more important than the content, but because the patient has a right to a benefit with maximal efficacy. Loyal, because in the long run, there is little advantage to being economical with the truth. Furthermore, if well informed, public opinion can be a highly valuable ally in influencing political decision-making. Finally, because of both medical and demographic evolution, the very last thing we can afford is a major confidence crisis among the general public towards the transfusion community.

Bibliografia

References

Ala, F., J. P. Allain, I. Bates, K. Boukef, F. Boulton, J. Brandful, E. M. Daxet al. 2012. External financial aid to blood transfusion services in sub-Saharan Africa: A need for reflection. PLoS Medicine 9(9):e1001309.

Garraud O., and J. J. Lefrère. 2013. Are there still myths in—or associated with—transfusion? Blood Transfusion 11(1):148–150.

—. 2014a. Blood and blood-associated symbols beyond medicine and transfusion: Far more complex than first appears. Blood Transfusion 12(1):14–21.

—. 2014b. Voluntary non-remunerated blood donation and reasons for donating: Is there room for philosophy? Blood Transfusion 12(Suppl. 1):S404–S405.

Tissot, J. D., and N. Lion. 2013. Myths: history, blood, sex and money. Blood Transfusion 11(1):1–3.

Waldvogel-abramovski, S., G. Waeber, C. Gassner, A. Buser, B. M. Frey, B. Favrat, and J. D. Tissot. 2013. Iron and transfusion medicine. Blood Reviews 27(6):289–295.

Note

1 www.srf.ch/player/tv/videoembed?id=72df5a1d-2195-4c81-8567-c6ed2d1aef9c&width=624&height=351&mode=inline&autoplay=true.

2 www.humanite.fr/tribunes/les-multinationales-des-medicaments-derives-du-san-553905.

3 questions.assemblee-nationale.fr/q14/14-51874QE.htm.

4 www.pptaglobal.org/images/source/2014/SPRING/Individual_Articles/7_European_court_of_justice_turns_focus_to_plasma.pdf.

5 www.nuffieldbioethics.org/wp-content/uploads/2014/07/Donation_full_report.pdf

Autori

MD, specialized in internal medicine, hematology and transfusion medicine. He is managing director of Interregional Blood Transfusion SRC, Switzerland. He is professor of hematology at the Faculty of Biology and Medicine of the University of Lausanne. His main research interests deal with iron deficiency, ethical issues in transfusion as well as storage lesions of blood products. He has authored about 200 scientific articles, and co-edited a book entitled L’Immortalité – Un sujet d’avenir.

Holds a MD and a PhD degree, along with a MSc in anthropology. He trained both in onco-hematology, and infectious diseases. He is tenured professor of immunology with the University of Lyon/Saint-Étienne (France) and specialized in transfusion medicine, with two major topics: transfusion and inflammation, and ethics in transfusion. He headed a regional blood center in France for twelve years and moved a year ago to the (French) National Institute for Blood Transfusion in Paris.

Held a degree in French literature and has contributed several books on French poets by the dawn of the 19th century. Besides, he held a MD and PhD and graduated in hematology, with specialization in transmissibility of viruses by blood and transfusion. He shared interest in humanities and particularly in blood in history (encompassing ethics). He was tenured professor of hematology (Paris V) and was the CEO of the (French) National Institute for Blood Transfusion.

Got a MD in 1982. He trained in internal medicine and clinical pathology, and is a specialist in clinical pathology (1993). He also holds special degrees in insurance law and forensic medicine. From 1992 to 2013, he was medical director of Mont-Godinne Blood Transfusion Service. He also was transfusion consultant at Mont-Godinne University Hospital, Université catholique de Louvain, Belgium.

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