18 • OUT & ABOUT NEWSPAPER • APRIL, 2006
FDA holds workshop on blood donor criteria Gay men continue <strong>to</strong> <strong>be</strong> prohibited from donating blood by David Miller News Writer T<strong>he</strong> Food and Drug Administration (FDA) conducted a public workshop entitled “Behavior-B<strong>as</strong>ed Blood Donor Deferrals in t<strong>he</strong> Era of Nucleic Acid Testing” on March 8, 2006. T<strong>he</strong> workshop provided an opportunity for public discussion on t<strong>he</strong> scientific b<strong>as</strong>is for <strong>be</strong>havior-b<strong>as</strong>ed donor deferral criteria, and t<strong>he</strong> value of t<strong>he</strong>ir continued use now that nucleic acid b<strong>as</strong>ed tests (NAT) are available for certain transfusion-transmissible agents. Blood Banks, such <strong>as</strong> t<strong>he</strong> American Red Cross, state that “those who are at incre<strong>as</strong>ed risk of <strong>be</strong>coming infected with HIV are not eligible <strong>to</strong> donate blood.” One of t<strong>he</strong> key “risk” points t<strong>he</strong>y disqualify eligibility for is if you are a male, and have had sex even once with anot<strong>he</strong>r male since 1977. Many are understandably upset by t<strong>he</strong>se discrimina<strong>to</strong>ry standards. For a clearer picture of t<strong>he</strong> hypocrisy surrounding <strong>be</strong>havior b<strong>as</strong>ed blood donation guidelines, consider this: <strong>he</strong>terosexual males who frequent prostitutes simply have <strong>to</strong> wait 12 months and are t<strong>he</strong>n eligible <strong>to</strong> donate. But t<strong>he</strong> American Red Cross points t<strong>he</strong> finger back at t<strong>he</strong> governing body on t<strong>he</strong> issue, t<strong>he</strong> FDA. T<strong>he</strong> FDA states that one of t<strong>he</strong>ir responsibilities is <strong>to</strong> ensure that t<strong>he</strong> U.S. Blood supply is <strong>as</strong> safe <strong>as</strong> possible, and that means a lifetime deferral for men who have had sex with anot<strong>he</strong>r man. Many feel this is extremely homophobic, especially in a time w<strong>he</strong>n HIV infections are growing at alarming rates in t<strong>he</strong> <strong>he</strong>terosexual community and even more rapidly in t<strong>he</strong> African American population. T<strong>he</strong> FDA <strong>be</strong>lieves that donor deferrals b<strong>as</strong>ed on geographical, medical and <strong>be</strong>havioral fac<strong>to</strong>rs <strong>as</strong>sociated with an incre<strong>as</strong>ed risk for exposure <strong>to</strong> transfusion transmissible infectious dise<strong>as</strong>es are a first line of defense against introducing newly emerging infectious agents in<strong>to</strong> t<strong>he</strong> blood supply. In t<strong>he</strong> p<strong>as</strong>t, <strong>as</strong> tests were developed <strong>to</strong> detect evidence of infection with such agents, <strong>be</strong>havioral and ot<strong>he</strong>r risk-b<strong>as</strong>ed deferrals were generally retained <strong>to</strong> provide additional protection, particularly for imperfect tests and imperfect inven<strong>to</strong>ry management. As more advanced tests <strong>be</strong>come available, particularly t<strong>he</strong> highly sensitive and specific NAT tests capable of directly detecting infectious agents in blood at very early stages during infection, a question arises w<strong>he</strong>t<strong>he</strong>r specific risk fac<strong>to</strong>r b<strong>as</strong>ed deferrals, such <strong>as</strong> donations from gay males, should <strong>be</strong> modified or even eliminated. T<strong>he</strong> workshop featured presentations by national and international experts from government and academic institutions and industry. T<strong>he</strong> discussions included current practices in t<strong>he</strong> United States and abroad regarding blood donor deferrals b<strong>as</strong>ed on high-risk <strong>be</strong>havior, comparison of selected tissue donor deferral policies <strong>to</strong> blood donor deferral policies, <strong>be</strong>havioral risks for transfusion-transmitted dise<strong>as</strong>es, residual risks of infection from transfusion, and potential alternative approac<strong>he</strong>s <strong>to</strong> donor screening and testing. “T<strong>he</strong> meeting w<strong>as</strong> a chance <strong>to</strong> look at t<strong>he</strong> state of science in light of t<strong>he</strong> question of w<strong>he</strong>t<strong>he</strong>r t<strong>he</strong> FDA might support changing t<strong>he</strong> donor policy and modify what h<strong>as</strong> essentially <strong>be</strong>en an indefinite, or lifetime, donor deferral of men who have had sex with men since 1977,” said Richard Klein, t<strong>he</strong> HIV/AIDS Program Direc<strong>to</strong>r for t<strong>he</strong> Food and Drug Administration. “Most of t<strong>he</strong> meeting centered on examination of how blood donation is managed, <strong>be</strong>havioral risk deferral policies in Europe, t<strong>he</strong> effectiveness of screening technologies, effectiveness of questionnaires and self deferral (b<strong>as</strong>ed on risk fac<strong>to</strong>rs), and reviews of window periods, errors, and transfusion risks – and how t<strong>he</strong>y might change in t<strong>he</strong> age of nucleic acid testing, in addition <strong>to</strong> HIV, Hepatitis, HHV-8 virus, HLTV-l and ll, and emerging blood borne dise<strong>as</strong>es (e.g., vCJD).” A medical ethicist w<strong>as</strong> also included in t<strong>he</strong> discussions <strong>to</strong> ensure that t<strong>he</strong> social context of t<strong>he</strong> issue w<strong>as</strong> not lost. His responsibility <strong>to</strong> t<strong>he</strong> meeting w<strong>as</strong> <strong>to</strong> raise challenging points about t<strong>he</strong> moral and social impact and implications of t<strong>he</strong> <strong>be</strong>havior-b<strong>as</strong>ed deferral <strong>as</strong> it pertains <strong>to</strong> MSMs (male sex with male). It’s important <strong>to</strong> understand that this w<strong>as</strong> not a policy meeting, but a review of what <strong>to</strong>ols we have available now, and what we know about t<strong>he</strong>ir efficacy. T<strong>he</strong>re w<strong>as</strong> a considerable amount of data presented and discussion at t<strong>he</strong> meeting. FDA officials now must analyze t<strong>he</strong> data and consider possible policy changes. “I think this meeting moved us considerably forward on t<strong>he</strong> issue,” Klein concluded. � David can <strong>be</strong> reac<strong>he</strong>d at dmiller@outandaboutnewspaper.com NEWS • OUT & ABOUT NEWSPAPER • APRIL, 2006 • 19
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