By Travis Walker for the BiolawToday.org blog.
Last December the Food and Drug Administration announced its intention to modify regulations for gay blood donors. Under the current rule, men who have had sex with other men since 1977 (MSM)[1] are barred for life from contributing blood in any form.[2] The new proposal would allow MSM to donate if they have not had sex with another man for at least a year.[3] While some view the recommendation as an improvement from “a national policy of discrimination,”[4] others see it as careless.[5] This post reviews the history of the MSM ban and the impact of change. Within the story of the MSM ban is a back-and-forth tension involving society and government.
In 1983, officials imposed the MSM ban when little was known about blood-borne illnesses.[6] Laboratories floundered early in the AIDS epidemic to make tests for GRID, and later HTLV-III. Because of national concern about the new illness and latency periods in diagnostic tests – the time in which a disease is present but not detectable in blood – the MSM ban became uniform in all donation centers. At the time of implementation, the Department of Health and Human Services estimated that 50 percent of MSM had HIV.[7] While the number is questionable because the government had “no [definitive] way of testing blood or plasma prior to March 1985,” the ban in the United States mimicked lifetime prohibitions adopted in many countries, “including France, Germany, Switzerland, Norway, and Denmark.”[8]
Since the 1980s, officials in the United States have rarely reconsidered changing the MSM donation ban. In 2000, a proposal failed to reduce the MSM bar to five years since sexual contact.[9] Following campus protests across the country in 2005, officials weighed a one-year ban.[10] Nevertheless, because testimony on public health proved inconclusive, no modification occurred.[11] Finally, in 2014 an advisory committee of the Food and Drug Administration recommended reducing the MSM ban to one-year,[12] noting however, “compelling scientific evidence is not available at this time to support a change” to “less than one year while still ensuring the safety of the blood supply.”[13]
Since the announcement, the proposal has received split reviews. Some herald the modification because the lifetime ban is “an ominous step towards further social, political, economic and even physical quarantine.”[14] Other groups contend the ban should be removed entirely to prevent stigma.[15]
Like the original ban, the modification applies only to MSM. Women who are bisexual or lesbian are permitted to donate without delay.[16] A person who has had sex with one or many hetero-partners can also give blood unrestrained.[17] Under the new rule, MSM may contribute blood as long as they are not “sexually active” – a line that excludes half of the gay population.[18]
Despite the advisory committee endorsement, concerns remain about the proposed change. The MSM ban is silent on monogamy and other important sexual practices, like protection, that affect disease contraction. Laboratory tests can also now find HIV in blood 9 days after a romantic encounter.[19] Because the policy modification calls for a one-year wait, some contend the ban is unfair[20] when compared to the treatment of other groups, and out of sync with lab result timeframes.
Calls of animus also come following same sex triumphs in military service and marriage. While criticism of the bar remains strong, the government relies on data that finds MSM are 40 percent more likely to get HIV than women who have sex with other women.[21] MSM also have double the potential to contract HIV than men who are intimate with women.[22] While MSM contract blood-borne illnesses more often than other groups, only an estimated 50,000 new HIV infections occur annually United States.[23] The absolute risk is therefore low when compared to the nearly 320 million people living in the United States.[24]
The advisory committee proposal follows modification in Europe. In 2001, Italy lowered its MSM policy without harmful impact. A National Institutes of Health study later found no significant rise in HIV transmissions, despite the introduction of MSM donors.[25] In the United States, quality assurance trims HIV risk from blood units to 0.0000003 percent annually.[26] All donors must complete an information form and are screened by staff prior to giving. Blood is then tested for markers of infection. Centers also reserve the right to destroy donations based on inventory or if a contributor is on a nationwide deferral list.[27]
However, given the large donor base, the Food and Drug Administration is reluctant to adopt a full repeal.[28] The government also seems mindful of pubic perception that any sample could be compromised.[29] Although latency periods continue to decrease, a fear remains that someone could donate before HIV is fully detectable. The blood industry is likewise cautious of financial impact. In the 1980s, a patient in heart surgery notably got HIV from a transfusion of blood.[30] A jury later found the American Association of Blood Banks (AABB) partially liable because it set standards for almost every center.[31] On appeal, the court found that AABB owed a duty of care.[32] It also determined that the breach of AABB guidelines was proximate to the AIDS developed by the patient.[33]
Gay advocates still contend that the MSM ban is unnecessary. Writing for NPR Steven Thrasher retorted, “there is no science — none — that suggests that, if a man had sex with another man in 1978, you couldn’t take his blood and safely screen it for HIV.”[34] A second point is important. MSM questionnaires have little benefit because “people lie about their sexual history in order to donate blood.”[35]
Despite opposition, officials with responsibility over the MSM policy contend that the ban is needed. Screening at centers reduces HIV to 1 for every 10,000 donors.[36] This is marginal compared to the U.S. population where 1 for every 500 people has HIV.[37] Notwithstanding, MSM practice has the same risk on blood contamination as injecting drugs or incarceration[38] – both of which are cause for blood donor deferral. Moreover, while MSM account for only 2 percent of the population, they represent over 70 percent of new HIV cases in the U.S. annually.[39] Last, the risk of MSM acquiring Hepatitis C is greater than any other group.[40]
While the new proposal is weighed, MSM in the United States continues to grow. A study commissioned by the Center for Disease Control found a 22 percent increase in MSM for ages 13 to 24.[41] Officials remain concerned about the ban because young men are the most active blood donors, and only half of MSM members in this group know about their positive HIV status.[42]
Finally, within the blood ban are other related impacts. Because a large number of platelets are generally needed, the Food and Drug administration permits pooling. Each unit has six times the contamination potential than a bag from a single donor under the same screening guidelines.[43] Because of this concern, public health officials favor the MSM policy. The government is also hesitant to use factor-based questions to screen potential donors. Gay and bisexual men who are African American account for double the HIV rate when compared to white MSM.[44] A blanket rule is preferred to alternative modifications that could invite strict scrutiny.[45] Because women most often contract HIV by sexual contact with men,[46] a policy targeting the practices of women could lead to intermediate scrutiny for gender.
While some call the announcement last December a victory for civil rights, others remain divided. Advocates of the policy modification cite the lack of civil rights and unequal treatment by the MSM ban. They also rely on improvements in laboratory testing and the lack of harm abroad. Opponents however question the need for modification and caution against adopting a policy with potential risk.
Under the current rule, men who have had sex with men since 1977 are barred for life from contributing blood in any form. The new proposal would allow MSM to donate if they have not had sex with another man for at least a year. While the Food and Drug Administration hopes to implement the rule after a period of public comment, [47] the modification may be another chapter in the back-and-forth story between MSM and the chance to donate blood.
[1] MSM is a universal term used to designate this group.
[2] Blood Donations from Men Who Have Sex with Other Men Questions and Answers, FDA, http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/QuestionsaboutBlood/ucm108186.htm (last visited Mar. 21, 2015).
[3] See Sabrina Tavernise, FDA Easing Ban on Gays, to Let Some Give Blood, N.Y. Times (Dec. 23, 2014), http://www.nytimes.com/2014/12/24/health/fda-lifting-ban-on-gay-blood-donors.html?_r=0.
[4] Id.
[5] See Mark Joseph Stern, End the Ban on Gay Blood Donation, Slate (Aug. 29, 2013 9:34 AM), http://www.slate.com/blogs/outward/2013/08/29/america_s_anti_gay_blood_donation_ban_is_hideously_homophobic_which_is_why.html.
[6] Tavernise, supra note 3.
[7] Adam R. Pulver, Gay Blood Revisionism: A Critical Analysis of Advocacy and the “Gay Blood Ban,” 17 Law & Sexuality 107, 117 (2008).
[8] Mike Darling, Banned for Life, Men’s Health (2013), http://www.menshealth.com/banned-for-life/.
[9] Pulver, supra note 7, at 118.
[10] See Steven Bodzin, Students Tap New Vein of Gay Issue, L.A. Times (July 10, 2005), http://articles.latimes.com/2005/jul/10/nation/na-blood10.
[11] Pulver, supra note 7, at 118–19.
[12] See Press Release, U.S. Senator Chris Coons, Senator Coons Urges the FDA to Consider Further Changes after Gay Blood Ban Lifted (Dec. 23, 2014), http://www.coons.senate.gov/newsroom/releases/release/senator-coons-urges-the-fda-to-consider-further-changes-after-gay-blood-ban-lifted.
[13] Tavernise, supra note 3.
[14] Pulver, supra note 7, at 115.
[15] See, e.g., Dwayne J. Bensing, Science or Stigma: Potential Challenges to the FDA’s Ban on Gay Blood, 14 U. Pa. J. Const. L. 485 (2011).
[16] Steven Thrasher, New Blood Donation Rules Would Still Exclude Many Gay Men, NPR (Dec. 24, 2014 9:33 AM), http://www.npr.org/blogs/codeswitch/2014/12/24/370937993/new-blood-donation-rules-would-still-exclude-many-gay-men.
[17] Id.
[18] Tavernise, supra note 3.
[19] Id.
[20] Id.
[21] Thrasher, supra note 16 (citing Gay Men 44 Times More Likely To Get HIV, GMHC (Mar. 3, 2010), http://www.gmhc.org/news-and-events/press-releases/gay-men-44-times-more-likely-to-get-hiv).
[22] Id.
[23] HIV in the United States, AIDS.Gov, https://www.aids.gov/hiv-aids-basics/hiv-aids-101/statistics/ (last visited Mar. 21, 2015).
[24] U.S. and World Population Clock, U.S. Census Bureau, http://www.census.gov/popclock/ (last visited Mar. 21, 2015).
[25] See Suligoi B. et al., Changing Blood Donor Screening Criteria from Permanent Deferral for Men Who Have Sex With Other Men to Individual Sexual Risk Assessment: No Evidence of a Significant Impact on Human Immunodeficiency Virus Epidemic in Italy, PubMed.gov (June 2014), http://www.ncbi.nlm.nih.gov/pubmed/23867178.
[26] See FDA, supra note 2.
[27] A person may be deferred from donating based on medical history, travel, medication, and incarceration. See Eligibility, Medical History, and Deferral Information, Stanford Sch. of Medicine, http://bloodcenter.stanford.edu/donate/EligibilityMedHisDeferral.html (last visited Mar. 21, 2015).
[28] Thrasher, supra note 16.
[29] Id.
[30] See Kimberly J. Todd, Snyder v. American Association of Blood Banks: Expansion of Trade Association Liability – Does It Reach Medical Societies, 29 U. Tol. L. Rev. 149 (1997).
[31] Snyder v. Am. Ass’n of Blood Banks, 676 A.2d 1036, 1039 (1996).
[32] Id.
[33] Id. at 1055.
[34] Thrasher, supra note 16.
[35] Pulver, supra note 7, at 119.
[36] Steven Thrasher, Blood, Sex, and the FDA, Advocate.com (Oct. 9, 2009 10:00 AM), http://www.advocate.com/health/health-and-treatments/2009/10/09/blood-sex-and-fda [hereinafter Blood, Sex, and the FDA].
[37] Id.
[38] Thrasher, supra note 16.
[39] See FDA, supra note 2.
[40] Id.
[41] HIV Among Gay and Bisexual Men, Ctr. for Disease Control, http://www.cdc.gov/hiv/risk/gender/msm/facts/ (last visited Mar. 21, 2015).
[42] Thrasher, supra note 16.
[43] See Blood, Sex, and the FDA, supra note 34.
[44] See Thrasher, supra note 16.
[45] But see Michael Christian Belli, The Constitutionality of the “Men Who Have Sex with Men” Blood Donor Exclusion Policy, 4 J.L. Soc’y 315, 373-74 (2003) (arguing that FDA MSM policy fails to meet the rational basis test).
[46] HIV in the United States: At a Glance, AIDS.gov, https://www.aids.gov/hiv-aids-basics/hiv-aids-101/statistics/ (last visited Mar. 21, 2015).
[47] Tavernise, supra note 3.