Public Safety as a Priority
In 1983, the FDA implemented a lifetime ban on blood donations from people deemed to be “high risk” for potential HIV infection; this included men who have sex with men (MSM). At the time, HIV transmission and infection were not well understood and the tools available to detect the virus were rudimentary.
The priority of government regulation in blood banking is to ensure the safety of the blood supply and meet the needs of the healthcare industry for the advancement of public health. At the height of the AIDS epidemic, research suggested that the best way to protect the public was to limit risk at the point of donation. However, scientific advancements in diagnostics have changed the level of risk significantly.
The FDA recognized the impact of diagnostic tools and lifted the lifetime ban on MSM in 2015 and now implements a deferral period. This population is required to be abstinent for 12 months before donating blood. While this is a move in the right direction, it still over estimates risk at the expense of public health.
Technological Advances Change Risk Landscape
Currently, all blood donations are tested for possible HIV infection and the tools for detection have gone through several major advances. When HIV infection occurs, there are three major steps: 1) invasion of healthy cells by HIV, 2) recognition of the virus by the immune system, and 3) initiation of attack by the immune system against HIV. The battle waged by the immune system becomes inefficient overtime and AIDS is diagnosed. First generation testing for HIV measured the production of antibodies to attack the invading virus, which is the last step in infection, meaning an infected individual would show up as negative for HIV even if steps 1 and 2 were already occurring.
Innovation in detection is now passing the fourth generation of diagnostic tools. The point of reliable detection in the process of HIV infection is when the immune system is starting to realize there is an invader. Immune system cells in the first line of defense create a “snapshot” of the invading virus and send that information to another set of immune cells that specialize in fighting infections with the use of antibodies.
These “snapshots” are proteins called antigens and they are specific to every invader of the body (e.g., flu virus, HIV, E. coli). Modern testing targets the instructions (RNA) to create these “snapshot” or antigens. This means that HIV infections can be reliably detected 10-14 days after infection, well before the production of antibodies, which original testing required for a diagnosis. The Centers for Disease Control acknowledges these advances and promotes the expansion of their use.
Miscalculating Danger is a Public Health Mistake
The FDA requirement of deferral for blood donation by MSM excludes 3.9 million people. Taking into consideration both the eligibility and desire to donate blood, the current FDA regulations exclude approximately 219,200 pints of blood from being of use to the general public to meet healthcare needs. The American Medical Association, American Osteopathic Association, American Association of Blood Banks, and the American Red Cross have publicly requested that the FDA lift the ban entirely to better serve public health.
It is the duty of the FDA to ensure public health and safety through the implementation of regulations. However, these regulations should be informed by all relevant data and accurately assess risk. Forward thinking regulation of blood donations requires a focus on the standardization and implementation of reliable and accurate testing, not the exclusion of marginalized populations.
