Tuesday, July 02, 2013
The following is from the website of the Center for Disease Control (CDC). The page has since been updated, but they still hold to a policy of lifetime deferral for men who have sex with men (MSM). Their current policy can be viewed at http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/QuestionsaboutBlood/ucm108186.htm The graphics were taken from the CDC fact sheet on new HIV infections in the US. It can be viewed at http://www.cdc.gov/nchhstp/newsroom/docs/2012/HIV-Infections-2007-2010.pdf
What is FDA’s policy on blood donations from men who have sex with other 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. 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.
The policy is not unique to the United States. Many European countries have recently reexamined both the science and ethics of the lifetime MSM deferral, and have retained it. This decision is also consistent with the prevailing interpretation of the European Union Directive 2004/33/EC article 2.1 on donor deferrals.
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.
What is self-deferral?
Self-deferral is a process in which individuals elect not to donate because they identify themselves as having characteristics that place them at potentially higher risk of carrying a transfusion transmissible disease. FDA uses self-deferral as part of a system to protect the blood supply. This system starts by informing donors about the risk of transmitting infectious diseases. Then, potential donors are asked questions about their health and certain behaviors and other factors (like travel and past transfusions) that increase their risk of infection. Screening questions help people, even those who feel well, to identify themselves as potentially at higher risk for transmitting infectious diseases. Screening questions allow individuals to self defer, rather than unknowingly donating blood that may be infected.
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.
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 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 2000 fold higher than current repeat blood donors (i.e., those who have been negatively screened and tested) in the USA. 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.
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. While statistics indicate a rising infection rate among young heterosexual women, their overall rate of HIV infection remains much lower than in men who have sex with other men. For information on HIV-related statistics and trends, go to CDC’s HIV/AIDS Statistics and Surveillance web page.
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 made enough virus or developed enough 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 may 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. For these reasons, FDA uses a multi-layered approach to blood safety including pre-donation deferral of potential donors based on risk behaviors and then screening of the donated blood with sensitive tests for infectious agents such as HIV-1, HIV-2, HCV, HBV and HTLV-I/II.
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. Our current policy has been in place since 1992.
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.
Doesn’t the policy eliminate healthy donors at a time when more donors are needed because of blood shortages?
FDA realizes that this policy will defer 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.
Would FDA ever consider changing the policy?
FDA scientists continue to monitor the scientific literature and to consult with experts in CDC, NIH and other agencies. FDA will continue to publicly revisit the current deferral policy as new information becomes available.
On March 8, 2006, 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 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.
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. Scientific evidence has not yet been provided to FDA that shows that blood donated by MSM or a subgroup of these potential donors, is as safe as blood from currently accepted donors.
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.
1. Germain, M., Remis, R.S., and Delage, G. The risks and benefits of accepting men who have had sex with men as blood donors. Transfusion 2003; 43:25-33.
2. Busch MP, Glynn SA, Stramer SL, Strong DM, Caglioti S, Wright DJ, Pappalardo B, Kleinman SH; NHLBI-REDS NAT Study Group. A new strategy for estimating risks of transfusion-transmitted viral infections based on rates of detection of recently infected donors. Transfusion 2005, 45:254-264
3. Presentation at FDA Blood Products Advisory Committee Meeting, September 2000.
4. Soldan, K. and Sinka, K. Evaluation of the de-selection of men who have had sex with men from blood donation in England. Vox Sanguinis 2003; 84:265-273.