Blood Safety—At What Cost?

Blood is an intrinsic part of human life. It is something others need and it is each person's to give. Blood can be sold or given voluntarily out of a feeling of social obligation. The characteristics that make donated blood an expression of human altruism also make it a threat to human health. Blood products can be life saving but can also transmit life-threatening viral, bacterial, and parasitic infections from donors to recipients.

The provision of safe and adequate blood supply is an important component of national health requiring government commitment and support to ensure that blood and blood products are safe, accessible, and adequate to meet transfusion requirements.¹ The cornerstone of a safe and adequate supply of blood products is the recruitment, selection, and retention of voluntary nonremunerated blood donors from low-risk populations.² To identify these low-risk populations, reliable epidemiologic data on both prevalence and incidence of infectious diseases in the general population are required.

There are large inequalities in the distribution of safe blood; 80% of the world's population has access to only 20% of the world's safe blood supply.³ A lack of safe blood results in considerable mortality, with the major impact sustained by women with complications of pregnancy, trauma patients, and children with life-threatening anemia as a result of malaria.⁴ It is estimated that up to 150 000 pregnancy-related deaths could be avoided each year with greater access to safe blood.⁴

Presently fewer than 30% of countries have nationwide blood transfusion services and approximately 50% of donations are from family or paid donors—recognized sources of unsafe blood.⁴ Most developing countries do not screen donated blood for even the most common blood-borne infections. Unsafe blood accounts for 8 million to 16 million hepatitis B infections, 2.3 to 4.7 million hepatitis C infections, and 80 000 to 160 000 human immunodeficiency virus (HIV) infections each year.⁵

In this issue of JAMA, Heyns and colleagues⁶ describe policy changes instituted in 1999 to safeguard the blood supply of South Africa, a middle-income developing country. The disparities of access to health care between the rich and poor in South Africa mirror the global disparities between industrialized and resource-poor countries. South Africa has a liberal human rights oriented constitution, which outlaws discrimination on the basis of race, ethnic or social origin, sex, age, or sexual orientation. Prior to 1999, the South African National Blood Service relied on a pool of voluntary nonremunerated, predominantly repeat donors, along with universal serological testing for HIV-1 and 2, hepatitis C, and syphilis combined with HIV p24 and hepatitis B surface antigen testing. In 1999 public sector antenatal HIV seroprevalence was higher than 20% and the HIV prevalence reached 0.26% in the blood donor pool, with an estimated 26 HIV-infected units entering the blood supply in that year.⁶ A policy was instituted that involved closing donor clinics where HIV seroprevalence was high, providing educational materials to encourage self-exclusion of those with high-risk behaviors, and triaging donated blood by population profiling based on ethnicity, sex, and donation frequency. As Heyns et al point out, following introduction of this policy, HIV prevalence in donated blood decreased from 0.26% in 1999 to 0.04% in 2003. However, racial profiling was not universally used by all South African blood transfusion services during this period. For example, the Western Province Blood Transfusion Service, which supplies approximately 150 000 units of blood per annum in a province with an antenatal HIV seroprevalence of 13%, used a combination of other interventions, and the HIV-positive rate in donated blood decreased to 0.03% in 2004.⁷

As early as 1977, it was recognized that there was a need to redress the cultural and socioeconomic distortions of the regular blood donor pool to maintain the long-term sustainability of South African blood supply.⁸ The policy of racial profiling was highlighted in late 2004 when a nurse working for the South African National Blood Service was dismissed following her refusal to sign her employment contract because she did not agree with racial profiling as a means of determining high-risk blood.⁹ After it became public knowledge that President Mbeki's blood donation had been discarded as a result of the existing policy,¹⁰ a meeting between the Minister of Health and the National Blood Service was held on February 17, 2005, at which time it was determined to change the existing policy.

The structured blood safety policy outlined by Heyns et al⁶ was associated with a significant decline in HIV prevalence in the volunteer donors at the Inland Region of the South African National Blood Service during a period of increasing HIV prevalence in the general population. However this policy also resulted in disaffection of its black employees, increased reliance on donors from the minority-white population, stigmatization of the majority black population, and ultimately the loss of support of its policy by the national government.

As a result of consultations between the Minister of Health and the South African National Blood Service, a new policy for blood donation was instituted early in 2005, which uses first-time donations for the purpose of screening for transmissible diseases.¹¹ First-time donor plasma is quarantined and only issued after a second donation is clear of infection. Other blood products are sourced from repeat donors. All donations are screened for HIV and hepatitis B and C using nucleic acid technology. This new policy has resulted in a 10% increase (approximately US $15/unit) in the cost of blood transfusions.⁹

This crisis in South Africa highlights several ethical issues: the medical stigmatization of population groups by excluding them from the blood donor pool; the use of race in medical decision-making; and the relationship between public health medicine and society.

Exclusion of minority groups from donating blood and particularly the discarding of donated blood on the basis of racial profiling have been controversial and emotive issues. For example, in the early 1980s Haitians were identified by the Centers for Disease Control and Prevention as one of the 4 major at-risk groups for HIV/AIDS. The agency later removed Haitians from the list, but in 1990 the US Food and Drug Administration still refused to accept blood from Haitian donors because it was likely to contain HIV.¹² In April 1990, more than 50 000 Haitians and African Americans marched across the Brooklyn Bridge into Lower Manhattan to protest the policy of the administration, which finally lifted the ban on Haitian blood donations.¹³

Use of race in medical decision-making has been widely debated but remains controversial with polarization of medical opinions.^{14 - 15} Heyns et al⁶ describe a national blood triage policy in which race was used as a surrogate for unmeasured risk behavior variables. At best race is an imperfect surrogate that carries along with it many other associated variables, including language, culture, health beliefs, and, particularly in South Africa, socioeconomic status. The sensitivity surrounding the use of race to stereotype, discriminate, and rationalize differences limits its use for population profiling of public health risk.¹⁶ The sensitivities around race are great in South Africa, a country that has experienced institutionalized racism under apartheid for more than 40 years. Although racial classification was used to discriminate between blood donors, the recording of race did allow the magnitude of the discrimination to be monitored.

Furthermore, differentiation on the basis of race may constitute illegal discrimination in terms of the South African constitution unless it can be established that such discrimination is fair.¹⁷ Establishing fairness requires a balancing of the nature and extent of right infringed in an open democratic society based on human dignity, equality, and freedom and the purpose of the limitation. In this case, alternative nondiscriminatory means to achieve a safe blood supply (nucleic acid technology) were available and have been incorporated into the 2005 policy albeit at increased cost.

A further aspect highlighted by this controversy is the tendency of public health medicine to ignore the societal roots of poor health in favor of medical interventions, which operate further downstream.¹⁸ For example, it is easier to use more sophisticated screening technologies than address the underlying social inequalities.

The future of the South African National Blood Service will depend on recruitment of future generations of safe donors. A national program, “Club 25” encourages high school graduates aged 18 to 25 years to establish a donor culture, live a healthful lifestyle, and ensure safe blood for transfusion.¹¹ Initiatives such as this program attempt to address both ongoing downstream safety of blood together with upstream health promotion, thereby addressing blood safety at a social level. Health professionals are learning that promoting and protecting human rights may be essential for promoting and protecting health.¹⁸