Why doesn't FDA allow men who have had sex with men to donate blood?
A history of male-to-male sex is associated with an increased risk for the presence of and transmission of certain infectious diseases, including HIV, the virus that causes AIDS. FDA's policy is intended to protect all people who receive blood transfusions from an increased risk of exposure to potentially infected blood and blood products.
The deferral for men who have had sex with men is based on the following considerations regarding risk of HIV:
- Men who have had sex with men since 1977 have an HIV prevalence (the total number of cases of a disease that are present in a population at a specific point in time) 60 times higher than the general population, 800 times higher than first time blood donors and 8000 times higher than repeat blood donors (American Red Cross). Even taking into account that 75% of HIV infected men who have sex with men already know they are HIV positive and would be unlikely to donate blood, the HIV prevalence in potential donors with history of male sex with males is 200 times higher than first time blood donors and 2000 times higher than repeat blood donors.
- Men who have had sex with men account for the largest single group of blood donors who are found HIV positive by blood donor testing.
- Blood donor testing using current advanced technologies has greatly reduced the risk of HIV transmission but cannot yet detect all infected donors or prevent all transmission by transfusions. While today's highly sensitive tests fail to detect less than one in a million HIV infected donors, it is important to remember that in the US there are over 20 million transfusions of blood, red cell concentrates, plasma or platelets every year. Therefore, even a failure rate of 1 in a million can be significant if there is an increased risk of undetected HIV in the blood donor population.
- Detection of HIV infection is particularly challenging when very low levels of virus are present in the blood for example during the so-called "window period". The "window period" is the time between being infected with HIV and the ability of an HIV test to detect HIV in an infected person.
- FDA's MSM policy reduces the likelihood that a person would unknowingly donate blood during the "window period" of infection. This is important because the rate of new infections in MSM is higher than in the general population and current blood donors.
- Collection of blood from persons with an increased risk of HIV infection also presents an added risk if blood were to be accidentally given to a patient in error either before testing is completed or following a positive test. Such medical errors occur very rarely, but given that there are over 20 million transfusions every year, in the USA, they can occur. That is one more reason why FDA and other regulatory authorities work to assure that there are multiple safeguards, not just testing.
- Several scientific models show there would be a small but definite increased risk to people who receive blood transfusions if FDA's MSM policy were changed and that preventable transfusion transmission of HIV could occur as a result.
- No alternate set of donor eligibility criteria (even including practice of safe sex or a low number of lifetime partners) has yet been found to reliably identify MSM who are not at increased risk for HIV or certain other transfusion transmissible infections.
- Today, the risk of getting HIV from a transfusion or a blood product has been nearly eliminated in the United States. Improved procedures, donor screening for risk of infection and laboratory testing for evidence of HIV infection have made the United States blood supply safer than ever. While appreciative and supportive of the desire of potential blood donors to contribute to the health of others, FDA's first obligation is to assure the safety of the blood supply and protect the health of blood recipients.
- Men who have sex with men also have an increased risk of having other infections that can be transmitted to others by blood transfusion. For example, infection with the Hepatitis B virus is about 5-6 times more common and Hepatitis C virus infections are about 2 times more common in men who have sex with other men than in the general population. Additionally, men who have sex with men have an increased incidence and prevalence of Human Herpes Virus-8 (HHV-8). HHV-8 causes a cancer called Kaposi's sarcoma in immunocompromised individuals.
Facebook
Twitter