What is the policy on blood donations from men who have sex with men (MSM)?
Men who have had sex with other men at any time since 1977, the beginning of the AIDS epidemic in the United States, are currently deferred as blood donors, under a policy of the U.S. Food and Drug Administration (FDA). MSM, as a group, are at higher risk for HIV, hepatitis B and certain other infections that can be transmitted by transfusion.
The policy is not unique to the U.S. Many European countries have recently reexamined both the science and ethics of the lifetime MSM deferral, and have retained it.
Why doesn't the 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. The 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 8,000 times higher than repeat blood donors. Even taking into account that 75 percent 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 2,000 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 can't 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 U.S. there are over 20 million transfusions of blood, red cell concentrates, plasma or platelets every year. Therefore, even a failure rate of one 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.
- The 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 U.S., they can occur. That is one more reason why the 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 the 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 U.S. Improved procedures, donor screening for risk of infection and laboratory testing for evidence of HIV infection have made the U.S. blood supply safer than ever. While appreciative and supportive of the desire of potential blood donors to contribute to the health of others, the 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 five to six times more common and Hepatitis C virus infections are about two 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.
Is the FDA's policy of excluding MSM blood donors discriminatory?
FDA's deferral policy is based on the documented increased risk of certain transfusion transmissible infections, such as HIV, associated with male-to-male sex and is not based on any judgment concerning the donor's sexual orientation.
Male to male sex has been associated with an increased risk of HIV infection at least since 1977. Surveillance data from the Centers for Disease Control and Prevention (CDC) indicate that men who have sex with men and would be likely to donate have a HIV prevalence that is at present over 15 fold higher than the general population, and over 2,000 fold higher than current repeat blood donors (i.e., those who have been negatively screened and tested) in the U.S. MSM continue to account for the largest number of people newly infected with HIV.
Men who have sex with men also have an increased risk of having other infections that can be transmitted to others by blood transfusion.
What about men who have had a low number of partners, practice safe sex, or who are currently in monogamous relationships?
Having had a low number of partners is known to decrease the risk of HIV infection. However, to date, no donor eligibility questions have been shown to reliably identify a subset of MSM (e.g., based on monogamy or safe sexual practices) who do not still have a substantially increased rate of HIV infection compared to the general population or currently accepted blood donors. In the future, improved questionnaires may be helpful to better select safe donors, but this cannot be assumed without evidence.
How long has the FDA had this MSM policy?
The FDA's policies on donor deferral for history of male sex with males date back to 1983, when the risk of AIDS from transfusion was first recognized. Our current policy has been in place since 1992.
The FDA has modified its blood donor policy as new scientific data and more accurate tests for HIV and hepatitis became available. Today, the risk of getting HIV from a blood transfusion has been reduced to about one per two million units of blood transfused. The risk of hepatitis C is about the same as for HIV, while the risk of hepatitis B is somewhat higher.
Would FDA ever consider changing the policy?
The FDA scientists continue to monitor the scientific literature and to consult with experts in CDC, National Institutes of Health (NIH) and other agencies. The FDA will continue to publicly revisit the current deferral policy as new information becomes available.
On March 8, 2006, the FDA conducted a workshop entitled "Behavior-based donor deferrals in the Nucleic Acid Test (NAT) era." The workshop addressed scientific challenges, opportunities, and risk based donor deferral policies relevant to the protection of the blood supply from transfusion transmissible diseases, seeking input on this topic. Participants were given the opportunity to provide scientific data that could support revising the FDA's MSM deferral. The workshop provided a very active, open and broad-based scientific dialogue concerning current behavior-based deferrals and explored other options that may be considered and the data needed to evaluate them.
The FDA's primary responsibility is to enhance blood safety and protect blood recipients. Therefore the FDA would change this policy only if supported by scientific data showing that a change in policy would not present a significant and preventable risk to blood recipients. Scientific evidence has not yet been provided to the FDA that shows that blood donated by MSM or a subgroup of these potential donors, is as safe as blood from currently accepted donors.
The FDA remains willing to consider new approaches to donor screening and testing, provided those approaches assure that blood recipients are not placed at an increased risk of HIV or other transfusion transmitted diseases.
UCSF Health medical specialists have reviewed this information. It is for educational purposes only and is not intended to replace the advice of your doctor or other health care provider. We encourage you to discuss any questions or concerns you may have with your provider.
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