On Aug. 7, 2023, the U.S. Food and Drug Association (FDA) revised rules and regulations for blood donation in the U.S. which uses individual risk assessment rather than generalized population risk. For many, this is brand-new news, but for many queer individuals, they have not been able to donate blood for most of their lives, due to their sexual preferences. Since the HIV and AIDS epidemic, this has been the harsh reality for queer men — until now.  

Human immunodeficiency virus (HIV) is a virus that attacks the body’s immune system and if left untreated it can lead to acquired immunodeficiency syndrome (AIDS).  The HIV epidemic began in 1981 when researchers noticed a spike in rare deadly diseases such as Pneumocystis carinii pneumonia (PCP) and Kaposi’s Sarcoma (KS), which are primarily associated with immune suppression.  Since the beginning of the epidemic, about 85.6 million people have been infected with the virus and 40.4 million people have died of HIV/AIDS.  The most common type of HIV is HIV-1 which is very easily spread and if left untreated, can quickly turn into AIDS, which has been able to be tested for since 1985.  HIV2 is a less common type which is much more difficult to transmit and takes much longer to turn into AIDS.  HIV-2 is found mainly in West Africa and makes up only .01% of U.S. cases and has only been able to be tested for since 1992.  After years of research about the virus, it was determined that all bodily fluids can transmit the disease, not just transmission through sexual contact.

Not only did the HIV epidemic affect the health of people, but it also caused harm to the LGBTQ+ community as a whole.  In a study done in 1985, it was reported that 80% of Americans said that it was “probably true” that most with HIV/AIDS were homosexual men.  The stigma around the group which was primarily affected by the epidemic, largely suffered from the societal rejection from something that was for most, out of their control.  In the same study, it was found that 28% of Americans said they had or knew someone who avoided going places where homosexuals might be present — by 1968, 44% of Americans agreed.  Since homosexuality was not largely accepted during this time, this caused a greater impact of violence and prejudice on the queer community. A poll done in 1987, indicated that around 43% of Americans believed that it was the homosexuals’ fault and that the HIV/AIDS epidemic was “God’s punishment for immoral sexual behavior.”  This stigma created judgemental views for those who did contract the disease, assuming that the men were “sleeping around,” which was largely looked down upon during the time.

The first bloodborne illness rules were formulated in 1985, 4 years after the start of the HIV/AIDS epidemic, putting a lifetime ban on blood for the group identified as “MSM,” meaning men who have sex with men.  Applicants were asked to provide their gender, sexuality and sexual practices.  The specific language used by the FDA was gay and bisexual — in the current era, this language is quite limiting to the wide variety of queer identifications. 20 years later, in 2015, the FDA reevaluated the ban, adding that MSM can donate if they are abstinent from sex for at least one year before donating. Then in 2020, the FDA shortened the “deferral” period to 90 days (or 3 months) of abstinence before donation.  Although these restrictions might appear reasonable to the common public, they still prohibited thousands of queer men from donating blood, causing a nationwide blood shortage during many mass-casualty incidents such as the COVID-19 Pandemic.

Sammi Shelton, a sophomore at Ida B Wells, is one individual who helped distribute an online petition as well as contributed to the email campaign last year on the subject.  Shelton directly contacted the CBER Ombudsman from the FDA regarding the three-month blood donation deferral and received a response from Lauren Connelly, PharmD, a Health Communications Specialist.  In her time of response, she mentioned the anticipated results from the FDA’s pilot study, ADVANCE, that would affect the decision by the CDC and FDA regarding blood-borne illness.  The name ADVANCE means Assessing Donor Variability And New Concepts in Eligibility, meaning that the study is meant to determine whether a new donor deferral timeline is possible while also maintaining a safe blood supply.  “The FDA will determine next steps including when and how results of the study may be made public,” said Connelly.  “We anticipate issuing updated draft guidance in the coming months incorporating key learnings from the ADVANCE study, as well as taking into account international developments in donor deferral policies.”

“The ADVANCE study is groundbreaking because it’s the first time a study is being conducted that could result in individual risk assessment for men who have sex with men to donate blood,” said Rita Reik, M.D., chief medical officer for OneBlood.  Currently, the results of the ADVANCE study have been released and played a large role in the revision of the blood donation deferrals.  

Since blood is already tested for HIV, Hepatitis C, syphilis and other blood-borne illnesses, the American Medical Association declared the exclusions are unnecessary given these advances in blood testing.  

Kevin B. Johnson MD, a professor of Pediatrics, Biomedical Informatics, and Science Communication at the University of Pennsylvania has been affected by the regulations directly and wrote an op-ed for the Philadelphia Inquirer in 2020 about his experience. Johnson, who has been in a married monogamous relationship for 17 years, was not able to donate due to regulations. “It is time to move quickly to a policy under which all donors are evaluated equally and fairly, and to encourage local blood collection facilities to comply with that policy,” Johnson wrote last year.  

The first Pre-exposure prophylaxis (PrEP) and Post-exposure prophylaxis (PEP) medications were approved for public consumption in 2012 as preventatives from HIV.  Besides abstinence and barrier contraception, prophylaxis is a crucial part of preventing HIV and other sexually transmitted diseases.  Although there are many benefits to this medical development, the use of the drug “makes it harder to detect the virus with our testing methods,” said Sarah Nassau MD, vice chair of Pathology and Laboratory Medicine at Lancaster General Hospital.  

The new regulations revised this year aim to shift from being identity-based to being based on an individual’s behavior.  By asking all donors about their recent sexual practices and partners, they hope that it minimizes potential bias and discrimination in the process of donating blood.  “Specifying the sexual orientation of the person rather than a behavior in which they engaged was discriminatory and not evidence-based,” said Judd David Flesch, MD, vice chief of Inpatient Operations in the Department of Medicine at Penn Presbyterian Medical Center and co-director of the Penn Medicine Program for LGBTQ+ Health.  

Questions for Potential Donors:

• Has a new sexual partner and engaged in anal sex
• Had had more than one sexual partner and has engaged in anal sex
• Taken medicines to prevent HIV (PrEP & PEP)
• Exchanged sex for pay or drugs or used non-prescription injection drugs
• Had sex with someone who has previously tested positive for HIV
• Had sex with someone who has exchanged sex for pay or drugs or used non-prescription injection drugs

Three-month delay period before giving blood:

• After a blood transfusion
• Receiving treatment for gonorrhea or syphilis 
• After most body piercings or tattoos not done with single-use equipment

Must wait a period of time after PrEP before giving blood:

• Three months after a pill dose
• One year after PrEP injection 

Eliminating harmful language and policies based on sexual orientation minimizes the stigma around being queer, and is a step toward a more inclusive and medical process that will treat all potential donors with equality and respect, while also keeping the blood supply safe. Although these new regulations have been put into place, it might take months to truly put them into order, due to the reworking of questionnaires and materials, training of staff, updating of computer systems and developing new policies and procedures.