Guidelines but No Guidance: vs. FDA

Author:Leland Traiman
Position:University of California, San Francisco; FNP 1984 Stanford University School of Medicine, Primary Care Program

I. Introduction II. Background III. Letter To The FDAIV. Conclusion


    Leland Traiman,BSN 1981 University of California, San Francisco; FNP 1984 Stanford University School of Medicine, Primary Care Program; wrote the Berkeley Library Relief Act of 1980, the only progressive property tax in California to circumvent Proposition 13 (Jarvis-Gann); chaired City of Berkeley's Domestic Partner Task Force, 1984, writing the world's first Domestic Partner policy enacted into law; Founder and Director of Rainbow Flag Health Services, the only Gay sperm bank, 1992-present; successfully lobbied against, first the California Health Department (1996), then the FDA (2004), when they tried to make it illegal for Gay men to be sperm donors; successfully lobbied California for inclusion of "designated (sperm) donors" into California Health and Safety Code 1644.5 in 1997. Thanks to the love and support of my parents, Marcel & Shirley Traiman, my husband, Stewart BlandÛn, M.D., and our children Julian and Rosalinda. Special thanks to the staff of The Journal of Gender, Race & Justice.

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I Introduction

As a registered nurse and family nurse practitioner who practices at the only sperm bank in North America that actively recruits Gay and Bisexual sperm donors, I am deeply concerned about the draft Guidance Document published by the Food and Drug Administration (FDA) on May 25, 2004, which advises banning men who have had sex with other men within the last five years from being sperm donors.1 The FDA claims that its purpose in issuing this draft Guidance Document is to protect the public against HIV and other diseases.2 Unfortunately, its rationale is not only unjustified, as current laws and practices already provide such protection; it is also misleading. In issuing this draft Guidance Document, the FDA has forsaken its role as a protector of public health and embraced a grievously bigoted and discriminatory position. The problem is, as the Supreme Court stated, criminalization of homosexual conduct leads to pervasive discrimination against Gays and Lesbians in both the public and private realms.3

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II Background

Rainbow Flag Health Services & Sperm Bank (aka is a unique business. We recruit donors whose identity will be revealed to the mother when the child is three months old. The moms must call the donor by the child¥s first birthday. Many donors have continuing contact with the children. Although the children know the donor is their genetic father, they also know the donor is not their parent. Many adults are confused by this, but it never fails to amaze me that all of the children understand who their parents are. The model for this is open adoption where children may have continuing contact with their birth parents. Children know the difference between their real parents (the people who are raising them) and their birth parents (the people with whom they share a biological connection). Similarly, donors at Rainbow Flag, like birth parents, have neither custody rights nor financial obligations to their biological children but often play the same role that an uncle or godfather might in the children¥s lives.

Although we have some heterosexual clients, Rainbow Flag primarily serves individual Lesbians and Lesbian couples who believe that children have a right to know their biological fathers while they are going up. Most of our donors are Gay men who have chosen not to raise children themselves but still wish to procreate and have contact with their biological offspring. Many Lesbians, fearing misunderstanding from heterosexual donors, prefer Gay donors. Symbiosis. Rainbow Flag Health Services & Sperm Bank is one of a handful of fertility services and sperm banks that does not discriminate on the basis of sexual orientation with regard to both donors and recipients.

If the Food and Drug Administration¥s proposed draft Guidance Document4 is finalized with its present recommendation intact, to exclude Gay donors (men who have had sex with another man in the last five years), it will not stop Rainbow Flag (or anyone else) from using Gay donors because Guidance Documents do not have the force of law.5 But it will affect us; it already has. Many doctors and fertility clinics, unaware that the Guidance Document does not have the force of law (and mistakenly believing that it has been finalized), have refused to accept sperm from our bank. To date, a careful explanation of the facts has reversed these decisions, but we are not so foolish to think that we will continue to be 100% successful. With regard to Gay sperm donors, scientific fact has little to do Page 615 with the FDA¥s draft Guidance Document.6 The Guidance Document¥s very existence will be another excuse for those who wish to discriminate against Lesbians and Gay men.

The excuse the FDA gives in issuing new regulations and suggesting a ban on Gay donors in its draft Guidance Document is to protect the public against HIV and other diseases.7 The facts suggest otherwise. Since the HIV antibody test started being used in 1985, only one woman has been infected as a result of a medically supervised insemination.8 In 1986 a heterosexual donor who was infected with HIV was not tested because it was assumed, since he was heterosexual, he did not need to be tested.9 Indeed, both the draft Guidance and the regulations, which are simply a reiteration of what sperm banks already do, are completely unnecessary. This case was best stated by David Plotz in his article for the New York Times on May 19, 2005:

This is a case of government trying to solve a problem that no longer exists-because the free market already solved it. Customers insist on safety and health, and banks compete vigorously to satisfy them. Banks have replaced fresh sperm with frozen, in order to have time to quarantine the sperm and retest the donor for H.I.V. They screen not only for H.I.V., but also for gonorrhea, syphilis, hepatitis and sexually transmitted diseases that most of us have never heard of. Sperm banks force donors to pass a panel of genetic tests for cystic fibrosis, Tay-Sachs disease, Fanconi anemia and other awful abnormalities. Banks take exhaustive medical histories, perform elaborate personality tests and require high standards of personal behavior. At California Cryobank, America¥s leading sperm collector, less than 5 percent of donor applicants make the cut. I would bet that the pool of American sperm donors-which includes gay donors who have passed all of these screens-is smarter, healthier, cleaner-living and...

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