Date: Sun, 16 May 1999 07:42:29 -0700 From: Stephen Murray <keelung at ITSA.UCSF.EDU> Subject: proposed FDA regulations prohibiting MSMs from donating sperm
=46rom: Leland Traiman <leland at gayspermbank.com>
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The Food and Drug Administration (FDA) is trying to prevent gay men from having children.
At its Human Tissue Seminar on April 8, 1999 the FDA announced proposed regulations which would make it illegal for gay men to be sperm donors, block medical assistance for infertility and almost eliminate the possibility of having biological children. Outlining the regulations was the FDA's chief architect of the proposal, Ruth Solomon, M.D., Director of the Human Tissue Program, Office of Blood and Research and Review, Center for Biologics Evaluation and Research (CBER) of the FDA.
The regulations, due to be finalized by the end of 1999, will do two things. First, gay men would be banned from being anonymous sperm donors. Under these regulations heterosexual men may have multiple sexual partners and be acceptable. However, gay men in a long-term mutually monogamous relationship would not. Current fertility industry standards require anonymous sperm donations to be frozen and quarantined for six months, then donors are retested for HIV before their sperm is released for inseminations. The HIV window period; the time after infection until an HIV antibody test is positive, is one to three months. In 14 years of using the HIV antibody test, the Centers for Disease Control (CDC) could only point to one case of a man who appeared healthy and went beyond this window period. He did not turn positive for 2 years. He was heterosexual and specialized tests conclusively showed he was infected by his wife who was infected by an extra-marital relationship. (Morbidity and Mortality Weekly Report 1996; 45: 181-185). In light of the effective screening procedures already in place and because there is no scientific or medical basis for excluding gay donors, such as ban would be discrimination.
Secondly, it would force directed donors, men who wish to father children with a woman they already know, to freeze their sperm, quarantine it for 6 months and be retested for HIV before their sperm is used for insemination. Given the fact that only 1 out of 6 men (16%) have sperm that survives the freezing process well enough to meet the World Health Organization's minimum standard of fertility, this second rule will effectively prevent 84% of gay men from the possibility of having children. The only way that some of these 84% who have minimal survival after freezing may use their sperm is by expensive and invasive high tech fertility methods. The price for these methods range up to $12,000 per attempt with very low success rates. Health insurance rarely covers this and most will not have the money for such expensive and otherwise unnecessary procedures.
The FDA denies they are discriminating on the basis of sexual orientation. They do acknowledge that they exclude "men who have had sex with other men in the last five years" (MSM). "Now, that does not discriminate against gay men per se, but I can see how someone might interpret it that way," is a standard response.
On May 7, 1996 Tom Spira, M.D., Assistant Chief for Medical Science for the CDC, said, "I would not, categorically, want to exclude them (gay men) since we have appropriate testing. If you do so, I believe, you gain a false sense of security." Charles Schable, Chief of the AIDS Diagnostic Laboratory at the CDC, said, "If one is freezing the sperm and retesting the donor after six months the only reason to apply that criterion (MSM) to semen donors is homophobia." Both men stressed that they were speaking for themselves and not the CDC as the CDC has a policy advising against gay donors (MSM). Letters from the CDC admit they have no scientific evidence to support their policy but are simply following the "advice of a consultant panel."
The FDA does not have to come up with new sperm banking regulations at all. A California Health Department Subcommittee has completed work on proposed regulations, not yet enacted, which follows scientific evidence, protects public health and does not discriminate. California has already enacted a Health and Safety Code (Division 2 - Chapter 4.2 Section 1644.5), which specifically allows the use of fresh or frozen sperm for directed donation as long as the donor has been appropriately screened and the woman has been appropriately counseled about her risks. These two documents are a package that insures both our health and our rights. Dr. Solomon ignored the "California Plan" in devising the FDA's regulations.
The FDA's regulations would override California laws and would be a program of mass sterilization by regulation. They will deprive lesbians of the choice of having children with gay men. Banning gay men from being donors perpetuates the myth that AIDS is a gay disease. To protest these proposed regulations and to support the "California Plan" please write to the Department of Health and Human Services which oversees both the FDA and the CDC.
Secretary Donna Shalala
The U.S. Department of Health and Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20201
(202) 619-0257
Toll Free: 1-877-696-6775
e-mail: hhsmail at os.dhhs.gov
Please send us a copy of your letters at: leland at gayspermbank.com
signed/ Robert Kim, Staff Attorney, American Civil Liberties Union of Northern California bkim at aclunc.org
signed/ Jennifer Pittman, Policy & Program Associate, Gay and Lesbian Medical Association jpittman at glma.org
signed/ Kate Kendell, Esq., Executive Director, National Center for Lesbian Rights kendell at nclrights.org
signed/ Leland Traiman, R.N./F.N.P., Executive Director, Rainbow Flag Health Services & Sperm Bank leland at gayspermbank.com
signed/ Maura Riordon, Executive Director, Sperm Bank of California maura at thespermbankofca.org