ABSTRACT

INTRODUCTION

A troublesome past can cast a long shadow over any organisation, but especially one whose sole purpose is the health of a nation.[1] The Irish Blood Transfusion Service (IBTS) (formerly the Blood Transfusion Service Board) employs a rigorous screening policy of potential blood donors. Aside from the obvious paramount duty to maintain the safety of blood product recipients, the screening policies adopted by the IBTS embody the relics of unfortunate past incidents at the organisation. Specifically, two contamination scandals which were described at the time as “the worst ... in the history of the State”[2] blight the record of the IBTS and continue to cast a shadow over two decades later.

The first of these incidents occurred during the 1970’s and involved the infection of over 1000 women with Hepatitis C through contaminated anti-D blood products. Anti-D immunoglobulin derived from human plasma is typically given prophylactically to Rhesus D-negative mothers pregnant with Rhesus D-positive babies. In such situations, ante- or intra-partum mixing of maternal and foetal blood could trigger an immune response in the mother resulting in significant complications in later pregnancies. Anti-D immunoglobulin reacts with and neutralises any foetal red blood cells that enter the maternal circulation, before the mother’s immune system is triggered and sensitised. Even at the time, guidelines advised that individuals who had received a transfusion within the preceding six months were not eligible to donate. Unfortunately, a supply shortage caused these guidelines to be disregarded and plasma was obtained from donors who were concurrently undergoing plasma exchange therapy. Hepatitis C (known then as Hepatitis-Non-A-Non-B) ultimately entered the Anti-D blood product supply, infecting hundreds of recipients.

The second incident coincided with the emergence of HIV/AIDSand involved the supply of HIV-contaminated blood plasma concentrates to Irish haemophilia patients. Concentrates are so called as they are compiled using plasma obtained from thousands of donors. This pooling of donations greatly increased the risk posed to recipients as an entire batch could be contaminated by a single donation. In 1974, the Irish Department of Health granted a licence to American pharmaceutical company Travenol for the distribution of their concentrate product ‘Hemofil’.[3] The provision of a financial incentive for blood donations was at the time a common practice in the United States. The practice has since been abandoned for a number of reasons including the emergence of research suggesting that such remuneration attracted donors from high-risk populations (e.g. intravenous drug users). In addition, financial incentive meant certain donors wereless inclined to be entirely truthful when completing screening surveys in order to avoid rejection. In this instance, HIV-infected concentrates were imported and distributed among Irish haemophiliac individuals.[3]

The subsequent fallout from these events damaged the reputation of the IBTS enormously. It is therefore unsurprising that the organisation is reluctant to revise its lifetime deferral policy of MSM blood donation.

HIV/AIDS, THE MSM BLOOD BAN & CURRENT SEROLOGICAL TESTING

Deferral periods - defined restriction periods from the last time that an individual engaged in a risk behaviour to the time they regain eligibility to donate - are now common at blood transfusion agencies across the globe. The theory behind such deferral periods is that any donors infected with a blood-borne pathogen will have seroconverted by the time they are again eligible to donate. This significantly reduces the likelihood of donating within a “window period” between exposure and seroconversion. In 1985, as the full extent of the Acquired ImmunoDeficiency Syndrome (AIDS)epidemic was becoming apparent, the United States Food and Drug Administration (FDA) introduced an indefinite deferral period, i.e. lifetime exclusion on MSM blood donations.[4] Most other countries promptly followed suit. Given that so little was known about HIV (other than it predominantly affected sexually active gay men) and there were no available tests to accurately ascertain HIV status, most will agree this was an appropriate course of action.[5] The ban was introduced in 1985 as a temporary measure yet three decades later it is still in place in many countries. Today in Ireland, any man who has ever had sex with a man is excluded from blood donation for life.

In the years that have passed since these bans were introduced, serological testing has advanced exponentially.[6] Highly sensitive assays are used to detect the presence of various known blood-borne viruses and pathogens including HIV, Hepatitis B, Hepatitis C, Human T-lymphotropic virus and syphilis. In the case of HIV, extremely sensitive combination antigen/antibody ELISA assays can detect the virus as early as a week following exposure. Where infection is suspected, the Western blot test - considered the gold standard in HIV confirmatory testing-identifies specific proteins associated with the Human Immunodeficiency retrovirus which can be detected in blood as early as three weeks following initial exposure. Of most relevance to this paper is the fact that over 99% of those infected with HIV will demonstrate aseropositive test result within three months.6 In light of these advancements many now question indefinite deferral policies - indeed even the American Association of Blood Banks (AABB) have described them as“medically and scientifically unwarranted”.[7]

There is no denying that HIV/AIDS continues to affect a disproportionate number of MSM in Ireland compared to their heterosexual counterparts, statistics which are mirrored in most other Western countries. According to the latest figures released by the National Health Protection Surveillance Centre, MSM accounted for the highest proportion of new HIV diagnoses in 2013 as it has done every year since 2009. Of the total number of new diagnoses made, 131 were heterosexual while 159 were MSM.[8]

RISK BEHAVIOUR & THE DIVERSITY OF SEXUAL PRACTICE

Speaking on their own behalf as well as on behalf of the the American Red Cross, the AABB agree that to differentiate between disease transmission via male-male sexual activity and male-female activity on scientific grounds is irrational.[7] At the crux of this stance lies the fact that, among both hetero- and homo- sexual people, patterns of sexual activity are ontologically complex and diverse.[9]

A major criticism of blanket bans and homogenised risk groups are that they commit an ecological fallacy - that is, the drawing of conclusions about individual behaviour based on a group as a whole. Failure to disaggregate broad population-level risk groups means that the reported risk they embody is obscured relative to population level statistics. It is incorrect to infer that all men who have sex with men engage in high risk behaviour just as it is incorrect to assume that all heterosexual activity is low risk.[9,10]

Studies on risk rarely take into account MSM in monogamous relationships or those who engage in low risk activity and/or regularly use condoms. Examination of data reviewed by the Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO) reveals that half of MSM surveyed had no penetrative experience and almost 45% had only ever had one sexual partner.[11] Critics also point out that research often compares MSM and heterosexual males despite the fact heterosexual females are biologically at greater risk of infection from unprotected sex.9 Nevertheless, lifetime deferral persists: in the words of one member of the US FDA Blood Products Advisory Committee (BPAC), although it is “non-specific...(and)...overinclusive... it works... because it captures the high-risk subset”.[12]

According to the IBTS website, those donors who exhibit “a particularly high risk of carrying blood-borne viruses” are asked not to donate blood. They further state that the total MSM exclusion policy “is not based on sexuality or orientation, only specific actions.” If exclusion policies are (as the IBTS claim) truly based on specific high-risk actions, then their donor screening policy should reflect this: at present, it does not. Any man who has ever has sex with another man is excluded from donation for life even if both are negative for HIV and despite their sexual history or the potential risk of their sexual practices. In contrast, the deferral period for heterosexual donors who have knowingly engaged in unprotected sex with a person with HIV or hepatitis is only 12 months. Comparing the zero tolerance approach to MSM donors to that applied to risk-associated heterosexual behaviours, the difference is arguably inequitable.

Risk associated with heterosexual behaviour is rarely acknowledged or scrutinised in studies despite the fact that, as epidemiologist Geoffrey Rose stated, “a large number of people at small risk may give rise to more cases than a small number of people at high risk”.[13,14] For example, examination of a study by Sanchez et al. involving over 25,168 male American blood donors, shows that while approximately 17 contaminated donations could be attributed to MSM who did not defer appropriately (accounting for 6% of MSM donors), the number attributable to heterosexual donors was approximately 418 (approximately 1.7% of heterosexual male donors).[15] The percentage of MSM is evidently higher, however that of heterosexual donors is significant. Despite the high number of contaminated heterosexual samples, the MSM figures dominate policy discussion. In addition, there is concern that indefinite exclusion policies perpetuate the impression in the public psyche that HIV is a selectively "gay" disease, and that heterosexuals are somehow at lower risk of acquiring a sexually transmitted infection.[16]

DEFERRAL POLICIES ABROAD

When considering viable alternatives to the lifetime deferral policy, it is useful to look to other countries where deferral periods have already been revised. Leiss et al. highlight two benefits that such a policy change might bring about. First, revised deferral would lead to an increased pool of future donors. This pool would consist of newly eligible MSM donors and those who currently decline to donate due to disagreement with the perceived discriminatory nature of the current MSM lifetime ban. Second, there would be a social benefit in terms of a reduction of the stigmatising association of HIV and homosexuality.[17] Various studies also suggest that revision of deferral policies can reduce the risk of an infected donation entering the blood supply due to improved donor compliance.[10]

Italy has one of the shortest deferral periods exercised in the world excluding countries where no deferral period is in place. For over a decade Italy has used extensive assessment of donor sexual history (both heterosexual and homosexual) to ascertain risk and suitability.[18] Those demonstrating ‘risk’ behaviours (e.g. sex with a HIV-positive individual) are deferred for four months following which they are reassessed for eligibility. Lifetime exclusion only applies to those who have engaged in high risk behaviour such as intravenous drug use, sexual activity with sex workers, or sex with multiple HIV-positive partners. Crucially, studies have shown that the absence of an MSM ban “has not led to a disproportionate increase in HIV-seropositive MSM” donors.18

Twelve-month MSM donation deferral is now practiced in various countries including Australia, the United Kingdom (excl. N. Ireland), Sweden, Czech Republic and Hungary.[1] Lifetime deferral was reduced to one year in the United Kingdom (excl. N.Ireland) following recommendations from an advisory committee on the Safety of Blood, Tissues and Organs (SaBTO).[19] SaBTO concluded that the levels of risk associated with indefinite deferral and with 12-month deferral, were no different. Recent studies in Australia, where one-year MSM deferral has been in place since 1997, have found no evidence of increase in HIV transmission following the implementation of this policy.[20] Here, assessment takes into account not only MSM but heterosexual risk behaviour including males who have sex with prostitutes or intravenous drug users, and females who have sex with males from high-risk countries.[21]

Despite the number of countries adopting the policy, the available literature does not unanimously support 12-month deferral as a risk-free option. Although no exact figures are referenced, Leiss et al., (2008) postulate a “low incremental risk” associated with 12-month deferral policies that they deem an unacceptable increased risk to the safety of blood recipients.[17] They cite work by Germaine et al. which suggested an increase as high as 8% in infected donations should a one-year deferral policy be implemented.[22]

Beyond 12-month policies, five-year deferral periods are another option in place in various countries. Leiss et al., who expressed reservations about a 12-month deferral, note that there is no evidence of risk associated with a five-year deferral period, and thus this alternative passes “the risk hurdle”. Subsequent to the publication of this paper, a five-year deferral period was introduced in Canada.[5] Sanchez et al., also note that the risk posed by a male with 5-year deferral from MSM activity was comparable to that of a male who had never engaged in such activity.[15,17] New Zealand also operates a five-year deferral policy for MSM donors.[1]

RECOMMENDATIONS/CONCLUSION

Revocation or revision of policy in jurisdictions with a history of tragedy is especially difficult and proponents of change are likely to meet considerable resistance. [1]In light of its past, it is understandable that the IBTS is reluctant to consider alteration of its current donor restrictions. The aforementioned research and examples of policies abroad suggests that changes could be introduced to the IBTS screening process without compromising the safety and integrity of the blood supply.

First, the IBTS could consider shortening its MSM deferral period to five years. While opinions regarding 12-month deferral remain divided, research demonstrates a consensus that five-year deferral policies have no impact on risk. The lack of substantial evidence of increased risk associated with such a change calls into question whether it is necessary or appropriate to continue such an exclusionary policy, regardless of the state of the blood supply or financial feasibility. As Leiss and his colleagues (2008)  eloquently state: “there are very few rules involving noncriminal personal choices in our society that carry, as a penalty for violating them, a lifetime ban on being able to perform one of the noblest acts, namely, donating blood freely and without recompense.”[17](PP51)

The current prospective donor questionnaire could also be revised to facilitate a more comprehensive screen of high-risk donors based on sexual behaviour as opposed toorientation. In a paper regarding the efficacy of excluding population-based risk groups, Kesby and Sothernadvocate practice-based exclusion. They point out that the risk of disease transmission varies depending on three variables: the likelihood that an individual’s sexual partner is infected; the nature of sexual activity engaged in; and the frequency of exposure.[9] An accurate risk screen should therefore aim to establish such information from all prospective donors regardless of sexual orientation. Such a revision could only enhance the identification of risk donors, ultimately buttressing the safety of the blood supply.

AUTHOR'S NOTE

In January 2015, Irish Minister for Health Leo Varadkar announced that he had requested a review of the deferral policies employed by the Irish Blood Transfusion Service. Minister Varadkar stated that he favours a one-year deferral policy but that any changes will be based on scientific evidence.

UCD Student Medical Journal

Reviewed by         Dr. Sinead McDermott

 Dr. John Lambert

1. Wilson K AKKJ. Three Decades of MSM Donor Deferral Policies- what have we learned? Int J Infect Dis. 2014; 18 1-3. v

2. Dail Eireann Debate. Report of the Tribunal of Inquiry into the Blood Transfusion Service Board. [Internet] Dublin: House of the Oireachtas; 1997 [updated 2011 May 21; cited 2015 Jan 2]. Available from http://debates.oireachtas.ie/dail/1997/03/20/00017.asp.

3.  Power M. Legal Responses to public crisis: Tribunals of Inquiry and the blood crisis in the Republic of Ireland. J Soc Crim. 2010; 1(2(36-63)).

4. Martucci J. Negotiating exclusion: MSM, Identity and blood policy in the age of AIDS. (40); 215-241.Soc Stud Sci. 2010; 40(215-241).

5. Cohen IG FJAE. Reconsideration of the lifetime ban on blood donation by men who have sex with men. JAMA. 2014; 312(4 (337-338)).

6. Gilbert M KM. Don’t wait to test for HIV. BCMJ. 2010; 52(6).

7. United States FDA. Blood Products Advisory Committee: Transcript, minutes of meeting, Bethesda, MD: FDA. 2006.[CITED2015 Jan 2] Available from http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4206t1.pdf.

8. HSE Health Protection Surveillance Centre. HIV in Ireland: 2013 Report. [Internet] Dublin: HSE. 2014 [cited 2015 Jan 2]. Available from http://www.hpsc.ie/A-Z/HIVSTIs/HIVandAIDS/SurveillanceReports/File,14651,en.pdf.

9. Kesby M SM. Kesby M & Sothern M. Blood, sex and trust: The limits of the population-based risk management paradigm. Health & Practice. 2014; 26 21-30.

10. Flanagan P. How should we assess risk behaviour when considering donor deferral? Reflections on the MSM deferral. Biologicals. 2012;40. 173-175.

11. Advisory Committee on the Safety of Blood, Tissues & Organs (SaBTO). Donor Selection Criteria Review. [Internet] United Kingdom: Department of Health. 2011. [cited 2015 Jan 2 ] Available from https://www.gov.uk/government/publications/donor-selection-criteria-review

12. Blood Products Advisory Committee 67th Meeting, Thursday September 14, 2000 transcript. US FDA Centre for Biologics evalusation and research, Department of Health and Human services. Available at www.fda.gov/ohrms/dockets/ac/00/transcripts/3649t1.rtf.

13. Galarneau C. Blood donation,deferral and discrimination: FDA Donor deferral policy for men who have sex with men. American Journal of Bioethics. 2010; 10(2).

14. Rose G. The Strategy of Preventive Medicine Oxford: Oxford University Press; 1992.

15. Sanchez AM SGNCea. Retrovirus Epidemiology Donor Study: The impact of male-to-male sexual experience on risk profiles of blood donors. Transfusion. 2005; 45.

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18. Suligo B PSRVea. Changing blood donor screening criteria from permanent deferral for men who have sex with men to individual sexual risk assessment: no evidence of a significant impact on the human immunodeficiency virus epidemic in Italy. Blood Transfus. 2013; 11 3(441-448).

19. Hurley R. UK lifts lifetime ban on gay men giving blood. BMJ. 2011;11(343).

20. Seed CR KPLMKA. No evidence of a significantly increased risk of transfusion-transmitted human immunodeficiency virus infection subsequent to implementing a 12 month deferral period for men who have had sex with men. Transfusion. 2010; 50 (2722-2730).

21. Musto JA SCLMKA&KJ. Estimating the risk of blood donation associated with HIV risk behaviours. Transfus Med. 2008; 18 49-54.

22. Germain M&SG. Men who have had sex with men and blood donation: Is it time to change our deferral criteria? J Int Assoc Physicians.2002 1: 86-88.