May 20, 2005

FDA is trying to scare sperm banks away from gay men

by Eric Resnick

Washington, D.C.--The Food and Drug Administration is trying to stop artificial insemination with sperm of gay men by discouraging sperm banks from allowing it.

The agency�s new regulations for tissue donations, including sperm, take effect May 25.

Those do not include a gay ban.

However, a guidance the FDA is expected to approve shortly after the regulations go into effect will tell sperm banks to reject anonymous donations from men who have sex with men. Directed donations, where the recipient chooses the donor, are not included.

The guidance does not carry the force of law, as the FDA�s regulations do.

FDA spokesperson Julie Zawisza said the purpose of the guidance is �to tell the clinics and the tissue banks how to interpret the regulations.�

�The guidance is voluntary and has no force of law,� she added. �They are developed internally.�

�The regulation requires screening for HIV by asking questions,� said Zawisza. �The guidance tells what questions to ask.�

The guidance pertains to all tissue donations, not just sperm. It tells facilities not to accept donations from any man who has had sex with another man during the past five years, allegedly for the purpose of preventing the spread of HIV.

The guidance does not take other risk factors such as engaging in risky behavior or other statistically at-risk populations into consideration.

All anonymous sperm donations are frozen and quarantined for six months after an initial HIV test. Then donors are tested again before their sperm is released for inseminations.

Leland Traiman, a nurse who operates Rainbow Flag Health Services, a San Francisco sperm bank serving the LGBT community, has been fighting the FDA over the issue since 1999.

In 2000, Traiman, with the help of doctors from the Centers for Disease Control and the Gay and Lesbian Medical Association, successfully protested an attempt to write a gay ban into the law on the basis that with testing, there is no scientific justification for it.

Further, they argued that heterosexuals who engage in risky behavior were more likely to spread HIV than gay men who practiced safer sex, yet these heterosexuals were not banned.

Traiman wrote extensive comments on the policy, which made it into the Federal Register in 2004.

�If one is freezing the sperm and testing the donor after six months, the only reason to apply that criterion (banning gay donors) is homophobia,� wrote Traiman, quoting CDC�s chief of the AIDS diagnostic laboratory, Charles Schable.

�Equally disturbing,� wrote Traiman, �as perpetuating this unscientifically founded discrimination is the �false sense of security� the FDA gives the public by excluding gay men, regardless of their behavior, while approving almost all heterosexual men, regardless of their behavior.�

The FDA purposefully never uses the word �gay.� Instead, they use the term �men who have had sex with a man.�

This is because using the term �gay� would create a class of men that cannot be singled out for discrimination under two U.S. Supreme Court decisions. Romer v. Evans in 1997 struck down a Colorado constitutional amendment banning gay equal rights laws and Lawrence v. Texas voided sodomy laws in 2003.

�Use of �men who have had sex with a man� focuses on behavior rather than sexual orientation,� said Zawisza.

�Excluding MSMs does not discriminate against gay men, but simply excludes certain behaviors.�

Traiman counters, �The average citizen dismisses this argument as silly. Engaging in sex with another man is what defines gay men. To say that this does not discriminate against gay persons as a class is absurd.�

�The guidance would allow a heterosexual man who has had sex with an HIV infected woman to donate 12 months after his sexual encounter, but would not allow a gay man in a long term mutually monogamous relationship with an uninfected partner to donate until he had been celibate for five years,� wrote Traiman.

�Clearly, gay men are grouped in a punitive fashion with criminals such as IV drug users and prostitutes. Not only does the FDA lack any evidence for this classification on safety grounds, the Supreme Court has ruled that gay men are not criminals.�

Traiman concluded the letter by pointing out that the FDA itself, by 2004, had already begun confusing the regulations, which do not ban gay donors, with the guidance.

�Unfortunately, this guidance will be used as a tool of intimidation,� said Traiman.

Civil rights attorney Randi Barnabee agrees.

During her tenure in the Coast Guard, Barnabee was responsible for developing regulations under the federal process.

�This is a way for [the FDA] to avoid scrutiny,� said Barnabee, describing the federal process as also including public comment and expert input.

People, including those who operate sperm banks, �will think the guidance has more effect than it does,� said Barnabee. �It will have the same effect as the regulation.�

Barnabee added that individual FDA officials will interpret the two documents any way they want to.

Zawisza says the FDA sees no disparity or contradiction between the regulation and the guidance.

�If an FDA inspector visits a facility, it will be up to them to say if the regulations are being followed,� said Zawisza, �and up to the FDA to take action if they are not.�

�The regulation trumps the guidance,� said Barnabee.

�Any facility cited under the guidance should immediately seek an injunction in federal court and a constitutional claim.�

Traiman said he will do just that if his continued acceptance of gay donors is challenged by the FDA, but he is skeptical that other sperm banks will have the knowledge or the ability to fight such a fight, effectively shutting them down for gay men.

�The FDA information office wants to encourage the disinformation,� said Traiman.

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