What is FDA's policy on blood donations from men who have sex with other men?
Men who have had sex with other men (MSM), at any time since 1977 (the beginning of the AIDS epidemic in the United States) are currently deferred as blood donors. This is because MSM are, as a group, at increased risk for HIV, hepatitis B and certain other infections that can be transmitted by transfusion.
Why doesn't FDA allow men who have had sex with men to donate blood?
FDA's primary responsibility with regard to blood and blood products is to assure the safety of patients who receive these life-saving products. FDA uses multiple layers of safeguards in its approach to ensuring blood safety, which include donor screening and deferral based on risk factors, blood testing for markers of infection, inventory controls, and deferral registries. The use of these multiple layers helps to assure the safety of the products in the event that one layer fails.
A history of male-to-male sex is associated with an increased risk for exposure to and transmission of certain infectious diseases, including HIV, the virus that causes AIDS. Men who have had sex with other men represent approximately 2% of the US population, yet are the population most severely affected by HIV. In 2010, MSM accounted for at least 61% of all new HIV infections in the U.S. and an estimated 77% of diagnosed HIV infections among males were attributed to male-to-male sexual contact. Between 2008 and 2010, the estimated overall incidence of HIV was stable in the U.S. However the incidence in MSM increased 12%, while it decreased in other populations. The largest increase was a 22% increase in MSM aged 13 to 24 years. Since younger individuals are more likely to donate blood, the implications of this increase in incidence need to be further evaluated.
Is 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.
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.
Are there other donors who have increased risks of HIV or other infections who, as a result, are also excluded from donating blood?
Intravenous drug abusers are excluded from giving blood because they have prevalence rates of HIV, HBV, HCV and HTLV that are much higher than the general population. People who have received transplants of animal tissue or organs are excluded from giving blood because of the still largely unknown risks of transmitting unknown or emerging pathogens harbored by the animal donors. People who have recently traveled to or lived abroad in certain countries may be excluded because they are at risk for transmitting agents such as malaria or variant Creutzfeldt-Jakob disease (vCJD). People who have engaged in sex in return for money or drugs are also excluded because they are at increased risk for transmitting HIV and other blood-borne infections.
Why are some people, such as heterosexuals with multiple partners, allowed to donate blood despite increased risk for transmitting HIV and hepatitis?
Current scientific data from the U.S. Centers for Disease Control and Prevention (CDC) indicate that, as a group, men who have sex with other men are at a higher risk for transmitting infectious diseases or HIV than are individuals in other risk categories. From 2007 through 2010, among adult and adolescent males, the annual number of diagnosed HIV infections attributed to MSM increased, while the numbers of infections attributed to other risks among males decreased. Among adult and adolescent females, the annual number of diagnosed HIV infections attributed to injection drug use and heterosexual contact both decreased.
Isn't the HIV test accurate enough to identify all HIV positive blood donors?
HIV tests currently in use are highly accurate, but still cannot detect HIV 100% of the time. It is estimated that the HIV risk from a unit of blood has been reduced to about 1 per 2 million in the USA, almost exclusively from so called "window period" donations. The "window period" exists very early after infection, where even current HIV testing methods cannot detect all infections. During this time, a person is infected with HIV, but may not have enough virus or have developed sufficient antibodies to be detected by available tests. For this reason, a person could test negative, even when they are actually HIV positive and infectious. Therefore, blood donors are not only tested but are also asked questions about behaviors that increase their risk of HIV infection.
Collection of blood from persons with an increased risk of HIV infection also presents an added risk to transfusion recipients due to the possibility that blood that has already been collected and is being stored in a blood bank may be accidentally given to a patient in error either before testing is completed or following a positive test. Such medical errors occur extremely rarely, but given that there are about 17 million Whole Blood and red blood cell donations collected each year in the USA, they can occur.
How long has FDA had this MSM policy?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. FDA’s current policy has been in place since 1992.
FDA 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.
Doesn't the policy eliminate healthy donors at a time when more donors are needed because of blood shortages?
FDA realizes that this policy leads to deferral of many healthy donors. However, FDA's MSM policy minimizes even the small risk of getting infectious diseases such as HIV or hepatitis through a blood transfusion. Due to the generosity of millions of eligible donors, the blood supply in the US has been very stable.
Would FDA ever consider changing the policy?
FDA's primary responsibility is to enhance blood safety and protect blood recipients. Therefore 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. Although scientific evidence has not yet demonstrated that blood donated by MSM or a subgroup of these potential donors does not have a substantially increased rate of HIV infection compared to currently accepted blood donors, FDA remains willing to consider new approaches to donor screening and testing. If those approaches can assure that blood recipients are not placed at an increased risk of HIV or other transfusion transmitted diseases, FDA will consider a change to its current policy.
The Health and Human Service’s Advisory Committee on Blood Safety and Availability (ACBSA) met to discuss the FDA MSM deferral policy on June 10-11, 2010. During that meeting, the ACBSA heard presentations and engaged in deliberations on the current MSM deferral policy. The Committee was asked to determine if there were sufficient data to support a change in policy at this time, or, if needed, to identify areas of further study that would establish a sound scientific basis for a change in policy. The committee found the current donor deferral policies to be suboptimal in permitting some potentially high risk donations while preventing some potentially low risk donations, but voted in favor of retaining the existing policy, and identified areas requiring further research.
In response to the ACBSA recommendations, HHS is in the process of conducting additional studies that aim to address the following questions:
- How does the risk of blood transmissible diseases in the current donor population related to risk factors in donors?
- What is the root cause of the Quarantine Release Errors, the accidental release of blood not cleared for use that occur at blood collection centers and potentially put the blood supply at risk, and what mitigations can be considered?
- Do potential blood donors correctly understand and properly interpret the current standard questionnaire used to obtain donor history? What motivates men with MSM behavioral history to donate blood and would MSM be likely to comply with modified deferral criteria?
- Would an alternative screening strategy for MSM (and potentially other high-risk donors) assure blood safety?
When the results and data from the studies are available and potential policy revisions are brought forward for consideration, HHS intends to provide opportunities for discussion in a public forum.