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The Ethics of Paid Plasma Donation: A Plea for Patient Centeredness

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Abstract

Plasma protein therapies (PPTs) are a group of essential medicines extracted from human plasma through processes of industrial scale fractionation. They are used primarily to treat a number of rare, chronic disorders ensuing from inherited or acquired deficiencies of a number of physiologically essential proteins. These disorders include hemophilia A and B, different immunodeficiencies and alpha 1-antitrypsin deficiency. In addition, acute blood loss, burns and sepsis are treated by PPTs. Hence, a population of vulnerable and very sick individuals is dependent on these products. In addition, the continued well-being of large sections of the community, including pregnant women and their children, travelers and workers exposed to infectious risk is also subject to the availability of these therapies. Their manufacture to adequate amounts requires large volumes of human plasma as the starting material of a complex purification process. Mainstream blood transfusion services run primarily by the not-for-profit sector have attempted to provide this plasma through the separation of blood donations, but have failed to provide sufficient amounts to meet the clinical demand. The collection of plasma from donors willing to commit to the process of plasmapheresis, which is not only time consuming but requires a long term, continuing commitment, generates much higher amounts of plasma and has been an activity historically separate from the blood transfusion sector and run by commercial companies. These companies now supply two-thirds of the growing global need for these therapies, while the mainstream government-run blood sector continues to supply a shrinking proportion. The private sector plasmapheresis activity which provides the bulk of treatment products has been compensating the donors in order to recognize the time and effort required. Recent activities have reignited the debate regarding the ethical and medical aspects of such compensation. In this work, we review the landscape; assess the contributions made by the compensated and non-compensated sectors and synthesize the outcomes on the relevant patient communities of perturbing the current paradigm of compensated plasma donation. We conclude that the current era of “Patient Centeredness” in health care demands the continuation and extension of paid plasma donation.

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References

  • Anderson, L., Newell, K., & Kilcoyne, J. (1999). “Selling blood’’: Characteristics and motivations of student plasma donors. Sociological Spectrum, 19(2), 137–162.

    Article  Google Scholar 

  • Australian Department of Health (2006). The World Fractionation Industry. On https://www.health.gov.au/internet/main/publishing.nsf/Content/B3B4E1D741764DD2CA257BF000193A6F/$File/Chapter%203.pdf. Accessed on 13 August 2014.

  • Australian National Blood Authority (2012). Critieria for the clinical use of intravenous immunoglobulin. 2nd ed 2012. Available on http://www.nba.gov.au/ivig/pdf/criteria-second.pdf. Accessed on 25 July 2014.

  • Bavley, A. (2014). Blood and red ink: Hospitals perform fewer transfusions and blood banks feel the pain. On http://insurancenewsnet.com/oarticle/2014/05/03/blood-and-red-ink-hospitals-perform-fewer-transfusions-and-blood-banks-feel-the-a-498713.html. Accessed on 25 July 2014.

  • British Broadcasting Corporation (2013). Bain capital buys stake in UK government blood company. On http://www.bbc.com/news/uk-politics-23372989. Accessed on 11 August 2014.

  • Centers for Disease Control. (2008). HIV transmission through transfusion—Missouri and Colorado, 2008. Morbidity and Mortality Weekly Report, 59(41), 1335–1339.

    Google Scholar 

  • Centers for Disease Control. (2014). Fatal west nile virus infection after probable transfusion-associated transmission—Colorado, 2012. Morbidity and Mortality Weekly Report, 62(31), 622–624.

    Google Scholar 

  • Centre fédéral d’expertise des soins de santé (KCE) (2010). Comment assurer l’autosuffisance de la Belgique en dérivés stables du plasma? On https://kce.fgov.be/sites/default/files/page_documents/d20091027358.pdf. Accessed on 11 August 2014.

  • Curling, J., Goss, N., & Bertolini, J. (2013). The history and development of the plasma protein fractionation industry. Production of plasma proteins for therapeutic use (pp. 3–30). Hoboken NJ: Wiley.

    Google Scholar 

  • Duggan, P. S., Geller, G., Cooper, L. A., & Beach, M. C. (2006). The moral nature of patient-centeredness: Is it “just the right thing to do”? Patient Education and Counseling, 62(2), 271–276.

    Article  Google Scholar 

  • Dutch Minister of Health, Welfare and Sport (2012). Letter to the Dutch Parliament––Investigation of Sanquin’s cost allocation by Research Agency ConQuaestor. On http://www.pptaglobal.org/images/patientaccess/eu/Ministerial-Plan-for-Blood-Supplies-2012-2014.PDF. Accessed on 11 August 2014.

  • Farrugia, A. (2010). Safety and efficacy of immunoglobulin: A guide for users, Assessors and Funders. Available on http://www.ipopi.org/uploads/news/id83/Safety_and_Efficacy_of_Ig.pdf. Accessed on 21 July 2014.

  • Farrugia, A. (2011). More blood, more life? Reflections on World Blood Donor Day–2011. The Indian Journal of Medical Research, 133(6), 573–576.

    Google Scholar 

  • Farrugia, A. (2013). Evolving perspectives on access to hemophilia treatment. Presented to the WFH Global Forum Montreal, September 26, 2013. Available on http://www1.wfh.org/docs/en/Events/GF2013/GF2013_Farrugia.pdf. Accessed on 22 July 2014.

  • Farrugia, A., Penrod, J., & Bult, J. M. (2010). Payment, compensation and replacement–the ethics and motivation of blood and plasma donation. Vox Sanguinis, 99(3), 202–211.

    Article  Google Scholar 

  • Flanagan, P. (2013). The ISBT code of ethics and the altruistic donor. ISBT Science Series, 7(1), 303–306.

    Article  Google Scholar 

  • Gitschier, J., Wood, W. I., Goralka, T. M., Wion, K. L., Chen, E. Y., Eaton, D. H., et al. (1984). Characterization of the human factor VIII gene. Nature, 312, 326–330.

    Article  Google Scholar 

  • Good, R. A., & Varco, R. L. (1955). A clinical and experimental study of agammaglobulinemia. Lancet, 75, 245–271.

    Google Scholar 

  • Greinacher, A., Fendrich, K., Brzenska, R., Kiefel, V., & Hoffmann, W. (2011). Implications of demographics on future blood supply: A population-based cross-sectional study. Transfusion, 51(4), 702–709.

    Article  Google Scholar 

  • Hartung, H. P., Mouthon, L., Ahmed, R., Jordan, S., Laupland, K. B., & Jolles, S. (2009). Clinical applications of intravenous immunoglobulins (IVIg)–beyond immunodeficiencies and neurology. Clinical and Experimental Immunology, 158(Suppl 1), 23–33.

    Article  Google Scholar 

  • Hershgold, E. J., Pool, J. G., & Pappenhagen, A. R. (1966). The potent antihemophilic globulin concentrate derived from a cold insoluble fraction of human plasma: Characterization and further data on preparation and clinical trial. Journal of Laboratory and Clinical Medicine, 67, 23–32.

    Google Scholar 

  • Isbister, J. P. (2013). The three-pillar matrix of patient blood management—an overview. Best Practice and Research Clinical Anaesthesiology, 27, 69–84.

    Article  Google Scholar 

  • Jones, P. K., & Ratnoff, O. D. (1991). The changing prognosis of classic hemophilia (factor VIII “deficiency”). Annals of Internal Medicine, 114(8), 641–648.

    Article  Google Scholar 

  • Kendrick, DB. (1964). The blood program in World War II. Available on http://history.amedd.army.mil/booksdocs/wwii/blood/chapter12.htm. Accesed on 21 July 2014.

  • Lacetera, N., Macis, M., & Slonim, R. (2013). Public health. Economic rewards to motivate blood donations. Science, 340(6135), 927–928.

    Article  Google Scholar 

  • Lenk, C., & Beier, K. (2012). Is the commercialisation of human tissue and body material forbidden in the countries of the European Union? Journal of Medical Ethics, 38(6), 342–346.

    Article  Google Scholar 

  • LFB (2010). LFB Launches Process to buy out Austrian Plasma Collection Group to support its International Activity. Available on http://www.lfb.fr/EN/lfb_launches_process_to_buy_out_austrian_plasma_collection_group_to_support_its_international_activity.html. Accessed on 21 August 2014.

  • Market Research Bureau. (2010). International directory of plasma fractionators 2010. Connecticut, USA: The Marketing Research Bureau Inc.

    Google Scholar 

  • Orange, J. S., Hossny, E. M., Weiler, C. R., Ballow, M., Berger, M., Bonilla, F. A., et al. (2006). Use of intravenous immunoglobulin in human disease: A review of evidence by members of the primary immunodeficiency Committee of the American Academy of Allergy, Asthma and Immunology. Journal of Allergy and Clinical Immunology, 117(Suppl 4), 525–553.

    Article  Google Scholar 

  • Pollack, W., Gorman, J. G., Freda, V. J., et al. (1968). Results of clinical trials of RhoGAM in women. Transfusion, 8, 151–153.

    Article  Google Scholar 

  • Pool, J. G., & Shannon, A. E. (1965). Production of high-potency concentrates of antihemophilic globulin in a closed-bag system. New England Journal of Medicine, 273, 1443–1447.

    Article  Google Scholar 

  • Price, H., Genereux, M., & Sinclair, C. (2013). Hyperimmune immunoglobulin G. Production of plasma proteins for therapeutic use (pp. 207–216). Hoboken NJ: Wiley.

    Google Scholar 

  • Radosevich, M., & Burnouf, T. (2010). Intravenous immunoglobulin G: Trends in production methods, quality control and quality assurance. Vox Sanguinis, 98, 12–28.

    Article  Google Scholar 

  • Robert, P. (2011). IVIG/SCIG: Global usage trends. Presented to The IPOPI Global Leaders Meeting 2011, November 4–5, 2011, London, England. Available on http://www.ipopi.org/uploads/Patrick%20Robert.pdf. Accessed on 22 July 2014.

  • Rossi, F., Perry, R., de Wit, J., Evers, T., & Folléa, G. (2011). How expanding voluntary non-remunerated blood donations would benefit patients, donors and healthcare systems? Vox Sanguinis, 101(2), 176–177.

    Article  Google Scholar 

  • Skinner, M. W. (2012). Haemophilia care–past, present and future from a patient perspective. Haemophilia, 18(Suppl 5), 3–5.

    Article  Google Scholar 

  • Stonebraker, J. S., Amand, R. E., Bauman, M. V., Nagle, A. J., & Larson, P. J. (2004). Modelling haemophilia epidemiology and treatment modalities to estimate the unconstrained factor VIII demand. Haemophilia, 10(1), 18–26.

    Article  Google Scholar 

  • Stonebraker, J. S., Farrugia, A., Gathmann, B., Orange, J. S., & ESID Registry Working Party. (2014). Modeling primary immunodeficiency disease epidemiology and its treatment to estimate latent therapeutic demand for immunoglobulin. Journal of Clinical Immunology, 34(2), 233–244.

    Article  Google Scholar 

  • UnitedHealthCare (2013). Intravenous immunoglobulin reimbursement policy. On https://www.unitedhealthcareonline.com/ccmcontent/ProviderII/UHC/en-US/Main%20Menu/Tools%20&%20Resources/Policies%20and%20Protocols/Medicare%20Advantage%20Reimbursement%20Policies/I/IVIg_02072013.pdf. Accessed on 25 July 2014.

  • Vaglio, S., Calizzani, G., Lanzoni, M., Candura, F., Profili, S., Catalano, L., et al. (2013). The demand for human albumin in Italy. Blood Transfusion, 11(Suppl 4), 26–32.

    Google Scholar 

  • Vincent, J. L., Russell, J. A., Jacob, M., Martin, G., Guidet, B., Wernerman, J., et al. (2014). Albumin administration in the acutely ill: What is new and where next? Critical Care (London, England), 18(4), 231. (Epub ahead of print).

    Article  Google Scholar 

  • White, G. C, I. I., McMillan, C. W., Kingdon, H. S., & Shoemaker, C. B. (1989). Use of recombinant antihemophilic factor in the treatment of two patients with classic hemophilia. New England Journal of Medicine, 320, 166–170.

    Article  Google Scholar 

  • WHO (2013a). The Rome Declaration on Achieving Self‐Sufficiency in Safe Blood and Blood Products, based on Voluntary Non‐Remunerated Donation. On http://www.avis.it/userfiles/file/RomeDeclarationSelf-SufficiencySafeBloodBloodProductsVNRD.pdf. Accessed on 11 August 2014.

  • WHO. (2013b). Towards Self-Sufficiency in Safe Blood and Blood Products based on Voluntary Non-Remunerated Donation–Global Status 2013. Geneva: World Health Organization.

    Google Scholar 

  • World Federation of Hemophilia (2012). Report on the annual global survey. Available on http://www1.wfh.org/publications/files/pdf-1574.pdf. Accessed on 22 July 2014.

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Authors and Affiliations

  1. Plasma Protein Therapeutics Association, Annapolis, MD, USA

    Albert Farrugia, Joshua Penrod & Jan M. Bult

  2. Department of Surgery, University of Western Australia, Crawley, WA, Australia

    Albert Farrugia

  3. Department of Science and Technology in Society, Virginia Polytechnic Institute and State University, Blacksburg, VA, USA

    Joshua Penrod

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  1. Albert Farrugia
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Correspondence to Albert Farrugia.

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Farrugia, A., Penrod, J. & Bult, J.M. The Ethics of Paid Plasma Donation: A Plea for Patient Centeredness. HEC Forum 27, 417–429 (2015). https://doi.org/10.1007/s10730-014-9253-5

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  • DOI: https://doi.org/10.1007/s10730-014-9253-5

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