The US Food and Drug Administration (FDA) issued new guidelines for sperm and tissue donors last week. The guidelines are intended to help prevent the transmission of communicable diseases, such as HIV (human immunodeficiency virus), when sperm, eggs, embryos, stem cells or other tissues are transplanted, but they appear to make all sexually active gay men ineligible as anonymous sperm donors. The new rules form part of a general move to tighten up procedures in screening and testing of all types of donors.
Current standards in the US fertility industry already require all anonymous sperm donations to be frozen and quarantined for six months, with donors being retested for HIV before their sperm is released for insemination. The state of New York and some fertility clinics already prevent gay men donating sperm because of some concerns about HIV transmission. The new rules state that men who acknowledge that they have had homosexual sex in the five year period before they want to donate sperm, will not be allowed to do so if that sperm would be used by strangers. But if they want to donate to family or friends, they will still be able to do so.
All potential donors will now have to be tested for HIV, hepatitis B and C, syphillis and Creutzfeld-Jacob disease (CJD). In addition to this, all potential sperm donors will have to answer a series of questions about their lifestyle, and must have additional tests for other sexually transmitted infections, including gonhorrhoea and chlamydia. As well as gay men, intravenous drug users will be stopped from donating, because of the increased risk of contracting HIV.
Dr Jesse Goodman, director of the Centre for Biologics Evaluation and Research at the FDA, said that the new rules are 'focused on ensuring that tissues from suitable donors are used'. They follow consultation with the US Centres for Disease Control and Prevention (CDC), which has records detailing the numbers of people who suffer serious infections after tissue transplants. But gay rights groups have expressed outrage, saying that the guidelines make assumptions about gay men: 'It's one thing to base these rules on legitimate scientific concerns, but it's another to reinforce baseless stereotypes', said Matt Foreman, executive director of the National Gay and Lesbian Task Force (NGLTF). Roberta Sklar, also of the NGLTF, called the FDA guidelines 'unscientific', adding 'there is a 72 hour test which would provide information as to whether a person was HIV positive, we know that even the International Red Cross accepts blood from men who have sex with men'. She added: 'This is another instance of the Bush administration ignoring scientific information and putting forth their own agenda to satisfy the extreme right wing conservative voters. It does not take in current scientific findings and recommendations'.
Sources and References
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Eligibility Determination for Donors of Human Cells, Tissues and Cellular and Tissue-Based Products
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Activists furious at limits on gay sperm donors
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FDA to limit sperm donors
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Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues and ?áCellular and Tissue-Based Products
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