Resolution: S-21-20: SUPPORT OF EQUITABLE SCIENCE-BASED DEFERRAL CRITERIA FOR BLOOD & TISSUE DONORS UTILIZING INDIVIDUAL RISK BEHAVIOR & ASSESSMENT THAT IS CONSISTENTLY APPLIED TO ALL DONORS

[Valerie Lile]

WHEREAS, a blood transfusion is needed every 2 seconds in the United States^1,2,3 and a single donation can potentially save up to three lives^1,2; and

WHEREAS, only 38% of the population is eligible to donate blood and a mere 3% of those eligible actually donate^1,2; and

WHEREAS, even after joining a worldwide blood donor education and recruitment campaign in 2016⁴, the Red Cross continues to report annual blood shortages and has needed to intensify donor recruitment efforts every year^5,6,7,8,9; and

WHEREAS, blood collection centers have needed to implement cash-equivalent and other gift incentives for blood donation shortfalls that persist even after aggressive blood collection campaigns^{10,11,12,13,14}; and

WHEREAS, initial misunderstandings about HIV transmission and the lack of screening measures of the time period resulted in the issuance of an indefinite/lifetime deferral in 1985 that permanently disqualified men who have sex with men (MSM) from donating blood¹⁵; and

WHEREAS, the combination of improved donor recruitment practices and scientific advancements in blood screening have reduced the HIV transmission risk of blood transfusions from 1 in 450,000 in 1995^16,17,18 to 1 in 1.4 million in 2003^18,19,20; and

WHEREAS, the deferral for MSM blood donors was finally reduced to one year in 2015 with no negative impact on the incidence of HIV infection and, in fact, a decrease in HIV diagnoses by 2018^21,22; and

WHEREAS, the preexisting blood shortage has been severely exacerbated by the COVID-19 pandemic^{23,24,25,26,27,28}; and

WHEREAS, the severity of the blood shortage during the pandemic compelled further reduction of the donor deferral period temporarily to 3 months^29,30; and

WHEREAS, the United States cited safety data from countries like England, Scotland, Wales, and Canada that have already been utilizing a 3-month deferral for MSM blood donors^30,31; and

WHEREAS, antigen/antibody testing that is currently used by labs can identify HIV as early as 18-90 days after exposure and is the recommended test of the U.S. Centers for Disease Control³²; and

WHEREAS, advancements in HIV detection now include nucleic acid testing, which can detect HIV as early as 18-45 days after exposure³²; and

WHEREAS, all blood for transfusion in the U.S. is tested for an array of blood-borne pathogens including HIV³³ and the World Health Organization recommends universal screening in all countries³⁴; and

WHEREAS, any blanket time-based deferral for the entire MSM community is criticized for discriminating against and stigmatizing MSM blood donors despite currently available HIV detection methods^{23,35,36,37,38,39,40,41}; and

WHEREAS, high-risk sexual behavior among heterosexuals is not questioned during blood donation^37,41 despite decades of data indicating that the growing majority of HIV cases worldwide are attributed to heterosexual transmission^41,42,43,44; and

WHEREAS, all other blood donor deferral criteria are based on individual engagement in high risk behavior rather than applied to an entire group, such as a deferral for individuals who recently engaged in injection drug use rather than a blanket deferral for all drug users³⁰; and

WHEREAS, a behavior-based deferral has already been proposed as an alternative, known as the Individual Risk Assessment (IRA) model^30,36; and

WHEREAS, the IRA model combines the self-reported donor behavior survey with a health care provider’s assessment of each potential donor’s risk level based on their individual behavior history^30,36,45; and

WHEREAS, the IRA model still assigns deferrals for donors who engage in high-risk behaviors but applies it as a standard for all individuals without singling out MSM^36,46; and

WHEREAS, Italy, Portugal, and Spain are already utilizing the IRA model^36,46,47,48; and

WHEREAS, Italy noted an increase of blood donors since implementing the IRA model in 2001, with twice as many individuals donating blood in 2010 as compared to 1999 without any difference in HIV infection rates of statistical significance^36,46,47; and

WHEREAS, Italy’s long history of data using the IRA model is further strengthened by the fact that the Italian Health Ministry made it mandatory to screen donated blood by nucleic acid testing, the most advanced test currently available^36,46,47; and

WHEREAS, France, Argentina, and countries in the United Kingdom are taking similar steps towards gender-neutral policies and basing donor deferrals on risk practices^{49,50,51,52,53};

WHEREAS, the U.S. Food and Drug Administration (FDA) committed to evaluating blood donor deferral policy alternatives such as individual risk assessment in 2015¹⁵ but has not taken action; and

WHEREAS, the FDA’s Products Advisory Committee re-emphasized the need to study and develop individual risk assessment in 2019⁵⁴; and

WHEREAS, time-based deferrals for MSM blood donors are facing legal challenges and scrutiny^55,56,57; and

WHEREAS, in February 2020, Congressmen called on the FDA examine available data on the IRA model^51,52,53,58; and

WHEREAS, two bills have been introduced in Congress aimed at requiring the FDA to revise the blood donation policies to be equitable, based on based on current testing technology, and utilizing an individual risk assessment of sexual behaviors without regard to sexual orientation or gender identity^59,60; and

WHEREAS, the FDA finally announced, in December 2020, the launching of a study regarding the potential removal of blood donor restrictions for MSM, five years after the FDA first declared its intent to do so⁵⁴; and

WHEREAS, the indefinite/lifetime deferral for MSM blood donors in the United States endured for 30 years despite the standardization of blood product testing and advancements in medical knowledge of HIV/AIDS^33,61,62,63; and

WHEREAS, the FDA has demonstrated that changes to deferral standards are made only when compelled; and

WHEREAS, despite increased efforts in blood donor recruitment and blood shortage awareness, the rate of blood donations has actually been declining annually^{54,65,66,67,68}; and

WHEREAS, donor deferrals based on individual risk assessment has the support of the medical community, including blood collection centers^{37,39,69,70,71,72,73}; and

WHEREAS, donor deferrals based on individual risk assessment also has the support of the legal community^{36,55,56,59,60,74,75}; now, therefore, be it

RESOLVED, that the Student Osteopathic Medical Association (SOMA) support the use of equitable, science-based deferral criteria for blood and tissue donors utilizing individual risk behavior and assessment that is consistently applied to all donors; and, be it further

RESOLVED, that SOMA advocate to the American Osteopathic Association (AOA) to support the use of equitable, science-based deferral criteria for blood and tissue donors utilizing individual risk behavior and assessment that is consistently applied to all donors.

Explanatory Statement

Reform of donor deferral criteria for MSM blood donors is long overdue.  The history of this issue shows that government agencies responsible for revising these policies move too slowly to adequately reflect the advancements in technology and social norms.  The COVID-19 pandemic has forced government agencies in the right direction and it is important for SOMA to capitalize on this momentum to press for equitable change.  We ask that SOMA advocate to the AOA to specifically include this inclusive language.  While the AOA has policy affirming ongoing support for blood donations, existing policy refers broadly to educating the public about blood donor needs and encouraging colleagues and patients to donate.  It does not speak to advocating for the removal of any barriers that prevent our colleagues and patients from donating.  We feel this additional language is a necessary addition.

 

Relevant Existing Policies: (The policy number of any relevant existing policies provided for reference)

SOMA Policy:

1. S-19-34: ESTABLISH SOMA LGBTQ+ TASKFORCE
2. F-14-05: REMOVE FDA BAN ON ANONYMOUS SPERM DONATION FROM MEN WHO HAVE SEX WITH MEN
3. S-13-09: INCREASE THE NUMBER OF ELIGIBLE BLOOD DONORS

Policy of Other Organizations Named in the Resolved Statements (AOA/AMA/etc):

1. AMA Policy H-50.973: BLOOD DONOR DEFERRAL CRITERIA
2. AOA Policy H411-A/16: ORGAN AND TISSUE DONATION AND TRANSPLANTATION INITIATIVES – COMMITMENT TO

 

References:

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Political Affairs Task Force
Heather Jao, OMS II – Burrell College of Osteopathic Medicine
McKenzie Kneeling-Garcia, OMS III – Pacific Northwest University of Health Sciences College of Osteopathic Medicine
Sidra Ali, OMS II – Burrell College of Osteopathic Medicine
Varshini Venkatesan, OMS III – Midwestern University Arizona College of Osteopathic Medicine
Catherine Lower, OMS II – Alabama College of Osteopathic Medicine
Pauline Wiltz, OMS II – Pacific Northwest University of Health Sciences College of Osteopathic Medicine
Rachna Chaudhari, OMS III – Marian University College of Osteopathic Medicine
Aerial Petty, OMS III – Alabama College of Osteopathic Medicine
Austin Smarsh, OMS III – Alabama College of Osteopathic Medicine
Alesha Sands Foster, OMS III – Liberty University College of Osteopathic Medicine
Sarah Fagan, OMS III – Touro University College of Osteopathic Medicine – Nevada
Jenna Seely, OMS III – Pacific Northwest University of Health Sciences College of Osteopathic Medicine
Furzan Azam, OMS III – A.T. Still University College of Osteopathic Medicine
Maya Braden, OMS II – Michigan State University College of Osteopathic Medicine
Hannah Norton, OMS II – Campbell University School of Osteopathic Medicine
Trey Shaughnessy, OMS II – Michigan State University College of Osteopathic Medicine
Sahar Bhai, OMS II – Midwestern University Chicago College of Osteopathic Medicine
Matthew Braun, OMS II – Pacific Northwest University of Health Sciences College of Osteopathic Medicine
Trevor Belavek, OMS II – Michigan State University College of Osteopathic Medicine
Katherine Taylor, OMS II – Nova Southeastern University Dr. Kiran C. Patel College of Osteopathic Medicine – Tampa Bay
Jennifer S. Lee, OMS IV – Touro College of Osteopathic Medicine – Middletown

[Austin Smarsh<br>Michigan State University College of Osteopathic Medicine]

I’m only writing to correct my personal information on this resolution.

This says I’m an OMS-III from Alabama COM, but that’s incorrect.

Corrected info:
Austin Smarsh, OMS II – Michigan State University College of Osteopathic Medicine

[Briana Cervantes<br>MSUCOM]

I am speaking on behalf of myself. I support the spirit of the resolution. There is an overwhelming amount of references and I am wondering how many of these are necessary to support your whereas statements? I fear an overwhelmingly long resolution will not get the fair consideration it deserves at the AOA house. Is there a way this can be trimmed?

[Author]

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