CHARLOTTE, N.C. — Early on in the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) saw there were new challenges in the blood supply for donations. The FDA took a look at current guidelines on donations and made adjustments. The most notable was a reduction in the deferral period for gay and bisexual men, more commonly referred to by the FDA as men who have sex with men (MSM).
In April 2020, the FDA chose to reduce the deferral period from one year to three months. This means that MSM were allowed to give blood three months after their last sexual encounter with another man instead of having to wait for a year. That drop is the second time the FDA made adjustments to its MSM blood donation policy; during the beginning of the HIV/AIDS crisis in 1985, there was originally a lifetime ban on blood donations from MSM, but the 12-month deferral period was made policy in 2015.
While many healthcare and LGBTQ advocacy groups say it's a step in the right direction, Charlotte- and North Carolina-based advocates say it's still not near enough, even as the FDA and other groups continue calling for blood donations to save lives.
For Jermaine Nakia Lee, it's personal. He's one of the co-founders of Charlotte Black Pride, which advocates for the Queen City's Black queer community. He also lives with a serious condition that requires dialysis and, often, blood transfusions.
"There are people like myself who live with serious conditions and need blood who are afraid," he said, "that I could go to the hospital and be in a life-threatening situation and there may not be enough blood to go around."
At the beginning of the HIV/AIDS crisis, the blood ban was intended to reduce the risk of contracting HIV. But it's been nearly 40 years since the original ban was put into place, and advocates like Christina Adeleke with the North Carolina AIDS Action Network say the science shows HIV infections are rising in a different group of people that are not as confined as MSM.
"We're seeing an increase in HIV transmission through injection drug use, which impacts people regardless of their sexual orientation or their gender," she said.
Matt Comer, the communications director for Charlotte Pride, agrees with Lee and Adeleke. He says the FDA needs to look not at who a person is, but their own behaviors when looking at the policy he says is discriminatory.
"And so if we can get the FDA to, to modify these surveys, to zero in specifically on risk-based behaviors instead of identities, that's when this will no longer be discriminatory," said Comer.
When asked by WCNC Charlotte about any plans to review the current blood donation deferral policy, the FDA confirmed they were working on the Assessing Donor Variability And New Concepts in Eligibility (ADVANCE) study, which will enroll 2,000 MSM who could be willing to donate blood. Their full statement to WCNC Charlotte follows:
The FDA is responsible for protecting the public health by ensuring the safety of the blood supply, which depends on the implementation of donor screening measures that are based on available scientific evidence. We have made forward progress and have been actively engaged in reexamining the issue of blood donor deferral for men who have sex with men taking into account the current body of scientific info and are considering pursuing alternative strategies that maintain blood safety. Developing the scientific info that is needed to further change blood donor policies takes time & effort.
Because of the improvements in donor screening procedures and the use of a variety of new tests in the last few years, the blood supply is safer from infectious diseases than it has been at any other time. Blood establishments are required to test all blood donations for HIV, and certain other transfusion-transmitted infections, using an FDA licensed screening test. However, although licensed donor screening tests for HIV have a high level of accuracy and sensitivity, early in infection the virus itself or the antibodies against the virus might be too low to be detected. Such early infections, also called “window period” infections, can result in a false negative result. Consequently, the risks of obtaining false negative results from donations in the window period persists – potentially resulting in the release of contaminated blood products.
On April 2, 2020, FDA announced certain revised donor eligibility recommendations to help ensure that we have an adequate blood supply, while still protecting the safety of the nation’s blood supply. FDA revised the recommendations for reducing the risk of HIV transmission by blood products to harmonize most behavior-based deferrals for HIV risk. A summary of FDA’s recommendations and the rationale for the change to a three-month deferral period for MSM, women who have sex with MSM, individuals with recent tattoos and piercings, and people who have a past history of sex in exchange for money or injection drug use, can be found in FDA’s guidance, “Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products.”
As discussed in the guidance, the revised recommendations are expected to remain in place after the COVID-19 pandemic ends.
However, developing the scientific information that is needed to further change blood donor policies does take time and effort. FDA has made forward progress in this regard and has been actively engaged in reexamining the issue of blood donor deferral for MSM, taking into account the current body of scientific information, and we are considering the possibility of pursuing alternative strategies that maintain blood safety.
FDA remains committed to considering alternatives to time-based deferral by helping to generate the scientific evidence that is intended to support an individual risk assessment-based blood donor questionnaire. If you are not familiar, the Assessing Donor Variability And New Concepts in Eligibility (ADVANCE) study is intended to investigate whether donor deferral can be based on individual risk assessment. It is anticipated that this pilot study will enroll about 2,000 MSM who would potentially be willing to donate blood. This study, being conducted at community health centers in key locations across the United States, could generate data that will help FDA determine if a donor questionnaire based on individual risk assessment would be as effective as time-based deferrals in reducing the risk of HIV.
Additionally, FDA has sought public input to collect insights on how we might move to and test alternative deferral strategies, such as individual risk assessment.
We do not have a specific timeline for when these studies may be completed, but remain committed to gathering the scientific data that can support alternative donor deferral policies that maintain a high level of blood safety. Further information about the goals of the study can be found here.
Lee is glad the ADVANCE study is getting underway, but he still has to wonder why it's not possible to both lift the ban outright while the study continues.
"Why can't you do both things? Why can't you continue to study right? And then lift those archaic restrictions so that the estimated over 400,000 gay men who are eligible right now to give blood can give blood and get that in the system," he asked.
The FDA allows the public to comment on proposed changes to proposed regulations along with submitting petitions. This can be done online.
Contact Jane Monreal at jmonreal@wcnc.com and follow her on Facebook, Twitter and Instagram.