Stigma, Blood Donors, and the FDA
January is National Blood Donor Month - a time to review FDA's blood donation policy, specifically restricting blood donations by MSM. With advanced diagnostics and blood shortages, is this prudent?
Read time - 4 minutes
Update: FDA has new proposed recommendations on the restriction of blood donation by men who have sex with men. There is a 60 days comment period on this proposed recommendation. The post below describes the current status and history of FDAs policy prior to January 27, 2023. I am hopeful of the new change to the policy.
From the unique lens of both a physician and a patient requiring chronic blood transfusions, there is no mincing of words here: blood donors are real-life superheroes. And, I have unwavering gratitude toward them.
With advances in science, biotechnology, and screening procedures, donating and receiving blood has become increasingly safe. Yet, the US is in a perpetual state of blood shortages. Currently, 50% of US community blood centers are operating at a 1-2 day supply, with 25% of community blood centers with a 0-1 day supply.
The supply of blood is dependent on many factors including:
necessary utilization
overutilization (or improper utilization)
wastage
disaster states - natural, public health, or otherwise
volume of routine blood donors
Policies affect each of these factors and there are tremendousefforts on sustaining a stable national blood supply. Policies around the judicious use of blood products and advances in bloodless surgery increase the availability of blood products. However, withonly about 3% of age-eligible people donating blood annually, the supply of blood products is almost entirely dependent on the volunteerism of routine blood donors. While we can encourage blood donation across all adults, policies that restrict blood donation as part of blanket bans are barriers. Case/Point: restricting blood donors from donating products for 12 months if they identify as a male who had sex with a male partner or a female who had sex with a male partner who had previously had sex with a male partner.
Who creates policies that regulate the volume of routine blood donors?
FDA. This agency has been at the center of regulating who can donate blood, how often, pre-donation screening, and other restrictions. We would expect that FDA would be in-step with its colleagues across the globe. However, for almost 40 years FDA’s policies on donors from the LGBTQ+ community have been considered non-evidence based, and even discriminatory.
What is the issue in plain English?
Before 2020, FDA required a deferral period of 12 months for those people who identified as:
male donors who have sex with male partners
female donors who have sex with a male partner who had sex with another male partner
for those with recent tattoos and piercing
In 2020, there was a critical shortage of blood products (2/2 COVID) the FDA adjusted its donor deferment policies by changing the recommended deferral period from 12 months to 3 months, for the same groups of people above. Even though these policies have been challenged and found to be non-evidence based in other nations.
In December of 2022, FDA promised to review its ADVANCE study and report back the results and final recommendation on change. Meanwhile, our peer nations like Italy, France, Greece, Germany, Austria, Costa Rica, UK, and Canada have already determined against blanket discrimination.
What is the American Red Cross’s position on this policy?
In a press release from Dec 2022, Red Cross made its position clear
“As such the Red Cross believes blood donation eligibility should not be determined by methods that are based upon sexual orientation and is committed to working with partners toward achieving this goal.”
Final Thought
This current FDA policy remains discriminatory and stigmatizing for these groups. And frankly, non-evidence based.
Hypothetical case examples: a male in a committed monogamous relationship with their male partner is restricted from donating blood for 3 months since last sexual activity. Whereas, a male who engages in unprotected sex with multiple female sexual partners (with unknown histories of STIs) is not subject to a restriction window for donating blood.
We need the blood supply to be safe and adequate. While we encourage blood donors to come forward routinely, FDA policies need to be updated urgently. We need to consider blood donor screening to be focused on sexual behavior as well as safe sex practices. We need to follow the example of the 40+ nations globally that have removed restriction windows for men who have sex with men.
Using sound clinical evidence base to create policy promotes trust. Building trust with the LGBTQ+ community leads to trust among patients and donors at large. Trust leads to more engagement. We must support a sweeping policy change by the FDA on the restriction of blood donations from these groups.
As a patient and a physician, it pains me to realize that antiquated, discriminatory practices have required decades of advocacy to consider change; meanwhile, comparative nations have moved into the modern world much sooner. I am encouraged as I read the letters and perspectives of physicians, professional organizations, and communities stepping up to advocate on behalf of this change. We must advocate for this change in parallel with these individuals and organizations.
It is likely that we may find ourselves or our loved ones in need of blood products in our lifetime. At that moment, our conscience may ask: how can I repay this debt?
Help advocate for positive change.
If you are eligible, donate.
Save a life.
“Whoever Saves One Life, Saves the World Entire” - Talmud (Sanhedrin 37a)
More reading: Axios, NPR, FDA Guidance on Blood, My Op-Ed in Medpage Today