Re: The CDC is wrong....would you want my blood?
by Bill R - Posted Fri August 18, 2006 @ 2:40 PM
I pulled the following from FAQ at the site below.
As a long time donor I see these questions as Job #1 in their attempt to assure a clean blood supply. If anyone or group feels descrimanated against that is an unfortunate result of this effort.
As a gay male, why am I deferred as a potential blood donor simply because of my sexual orientation? Furthermore, I am in a monogamous relationship. I am being discriminated against. Will this recommendation be removed any time soon?
In 1983, FDA recommended donor-screening procedures to exclude individuals at increased risk for transmitting Human Immunodeficiency Virus (HIV), the virus that causes Acquired Immunodeficiency Syndrome (AIDS). These recommendations have been updated periodically since then. The exclusion of potential donors based on certain sexual histories has been discussed often, and in-depth, by FDA's Blood Products Advisory Committee (BPAC). This panel of non-FDA independent experts continues to recommend the deferral of men who have sex with other men and their recent partners. This issue was discussed at the December 11-12, 1997, BPAC meeting. The committee voted to reconsider the current recommendations for deferral of men who have had sex with other men. However, at that time the committee did not specify what the specific recommendations should be. Data on the incidence and prevalence of HIV and other viruses in men who have had sex with other men and data on HIV positive blood donors were presented at the November 23, 1998, FDA Workshop on Blood Donor Suitability. A transcript from this workshop can be obtained from CBER's web site at:
The BPAC met on September 14-15, 2000 to revisit this issue. After much discussion, the BPAC recommended that men who had sex with other men since 1977 continue to be deferred from donating blood. A copy of the meeting transcript is available at:
A test for the antibodies to HIV (previously termed HTLV-III) was licensed by FDA in 1985 and has been used to screen blood donors since that time. Studies have shown that up to 2 months may elapse between the time of infection and the time the HIV antibody test is reactive. This period of time is often referred to as the "window period." Accepting men who have had sex with other men since 1977 as blood donors increases the likelihood for the collection of HIV-positive window period blood, because epidemiologic studies have documented higher incidence and prevalence rates in these populations. On March 14, 1996, FDA recommended donor screening with a licensed test for HIV-1 antigen, which has succeeded in further reducing the window period. In addition, almost all blood collections in the U.S. are tested for HIV RNA using investigational/experimental tests under the IND regulation. This probably decreases window period risks.
FDA continues to recommend that blood donors be informed of behaviors that potentially place them at increased risk for transmitting HIV. In addition, donors are informed that there is a time interval early in infection during which any test for HIV may be negative and an infection may still be transmitted. Providing donors with this information allows them to consider their behaviors and self-exclude from donation if they participated in any of the identified risk behaviors. Note that donors do not have to specify the basis for their decision to self-defer.
In an April 23, 1992, memorandum to all blood establishments entitled, "Revised Recommendations for the Prevention of Human Immunodeficiency (HIV) Transmission by Blood and Blood Products," FDA outlined updated policies for deferral of donors based on HIV-associated signs and symptoms, medical history, laboratory test results, and certain activities that place the donor at increased risk for HIV infection. Taken together, these control measures had been effective in reducing the risk of transfusion transmission of HIV to about 1 unit per million donations. However, since 2002, the routine use of nucleic acid testing (NAT) for HIV has even further reduced the risk of transfusion transmission of HIV to about 1 unit per 2 million donations. A copy of this memorandum can be obtained from CBER's web site at:
or by contacting CBER's Office of Communication, Training and Manufacturers Assistance at 301-827-1800.
In the above-mentioned memorandum, certain categories of high-risk behaviors are specifically mentioned, without further elaboration, as a basis for deferral: "men who have had sex with another man even one time since 1977," "men and women who have engaged in sex for money or for drugs since 1977," and "persons who have had sex with any person meeting (these) descriptions during the preceding 12 months," are all examples of such categories. Because there is a potential danger to blood safety in making the criteria for exclusion too specific, activities encompassed by each general area of exclusion have not been described. The April 23, 1992, memorandum also addresses a variety of high risk behaviors and medical conditions that are unrelated to sexual preference, including past or present drug use, hemophilia or other blood clotting disorders, being treated for syphilis or gonorrhea or receiving a transfusion, as well as asking whether a person has had a positive test for antibodies to HIV.
Although a potential individual donor may practice safe sex, persons who have participated in high-risk behaviors are, as a group, still considered to be at increased risk of transmitting HIV. Safe sex practices reduce, but do not eliminate, the risk of the transmission of AIDS. Several Centers for Disease Control and Prevention (CDC) studies have shown that many people who believe they are engaging in safe sex practices are not doing so, either because of poor technique (i.e., condom is incorrectly used) or lack of consistency (i.e., proper safe sex practices are not used at every sexual encounter). The August 6, 1993, Morbidity and Mortality Weekly Report (MMWR) will provide you with further information on this subject.
FDA believes that there is scientific justification for screening out all potential donors who are men who have had sex, even once, with another man since 1977, and for screening out the recent (within 12 months) sexual partners of such men. Since 1983, CDC and, the previously mentioned, BPAC have been advising FDA on high-risk categories as a basis for deferral of potential blood donors. Studies have shown that men with a history of male to male sex since 1977 may be infected with HIV and/or may have evidence of a lifestyle that potentially exposes them to HIV. In a recent "HIV/AIDS Surveillance Report" CDC's states that men who have sex with men account for the largest proportion (38%) of new AIDS cases reported in the United States from 1996-1997. Intravenous drug users (23%) are the second highest proportions of reported cases. Studies also show that men with a history of male to male sex since 1977 are also at increased risk of transmitting hepatitis viruses. For further information on CDC studies you may wish to contact:
Center for Disease Control and Prevention
1600 Clifton Road
Atlanta, GA 30333
FDA donor exclusion criteria are intended to utilize all prudent measures, which may reduce the potential risk for transmitting HIV and other infectious diseases. FDA's conservative approach, originates from several published sources and public discussions. This approach, consistent with external advice, has the potential to decrease transmission of HIV virus from entering the blood supply. FDA is very much aware that strict exclusion policies eliminate some safe donors in the attempt to maximally protect the nation's blood supply by deferring the largest number of donors at increased risk for HIV infection. FDA continues to review and discuss donor deferral recommendations within the public health service (FDA, CDC, and National Institutes of Health) and at open public BPAC meetings, scientific meetings, etc.