The U.S. Food and Drug Administration (FDA) is considering promulgating regulations for sperm banks that would ban Gay men from being anonymous donors and make it more difficult for Gay men to father children with a woman they already know, according to a group of activists and sperm bank directors.
In a May 17 letter sent to 300 Gay and alternative publications, the authors of the letter say the regulations under consideration would bar any man who has had sex with another man in the preceding five years from being an anonymous sperm donor.
The FDA proposals would have an impact not only on anonymous donors but also directed donors — men who wish to father a child with a woman they know and who have tested negative for HIV and other diseases — as well as Lesbians, many of whom prefer known donors to be Gay men, according to sperm bank officials.
Currently, there is no requirement for freezing and quarantine of the
sperm donation of a directed donor, and fresh (unfrozen) sperm can be used.
But the rules being considered would require both Gay and straight directed
donors to have their sperm
frozen and quarantined for six months, and then be re-tested for HIV
before their sperm can be used. According to the letter writers, only one
in six men have sperm strong enough to survive the freezing process well
enough to be useable for insemination. Applying the proposed test-freeze-quarantine-test
rule on directed donors, too, they said, would "effectively prevent" 84
percent of Gay male directed donors "from the possibility of having children."
(The sperm of those 84 percent
might be made suitable for insemination, noted the letter writers,
but only through expensive high-tech methods.) "Under these regulations,"
the authors say, "heterosexual men may have multiple sexual partners and
be acceptable. However, Gay men in a long-term, mutually monogamous relationship
would not."
Currently, there are no national regulations governing sperm donors,
only guidelines from the Centers for Disease Control and Prevention (CDC).
Fertility industry standards, according to the letter’s authors, require
anonymous donors to be tested
for HIV antibodies, after which their sperm donations are frozen and
quarantined for six months. Donors are then re-tested for HIV antibodies
before their sperm is released for insemination.
The HIV "window period" — the time between the moment HIV enters a person’s
body and the person’s immune system begins to produce antibodies to HIV
(and, thus, tests positive on the HIV antibody test) — is one to three
months. That, the
letter notes, is much less than the six-month quarantine for sperm.
If the sperm donor tests negative on both tests, then the retest confirms
with considerable certainty that the original sperm donation was HIV-negative.
"In light of the effective screening procedures already in place," the letter says, "and because there is no scientific or medical basis for excluding Gay donors, such a ban would be discrimination."
In a 40-minute interview yesterday with the Blade, FDA officials confirmed
that a proposal drawn up the agency — and which must be approved by Health
and Human Services Secretary Donna Shalala before being announced — would
bar men who
have had sex with men in the last five years from being anonymous donors.
In explaining why FDA is considering the regulations, Dr. Jay Epstein, of the FDA’s Center for Biologics Evaluation, said the incidence of sexually transmitted diseases (STDs), including HIV, is still "very high" among Gay men.
But Epstein asserted, "We do not ban a class of people. We ban individuals
who have particular behavior risk histories. There’s no categorical labeling
of the population. I know people feel that way, but … we’re focusing on
behavioral risk factors that are
established in the scientific literature."
Epstein said the FDA believes that a combination of screening — to exclude
Gay men and other high-risk individuals, like men who have had sex with
prostitutes in the previous five years — followed by testing of sperm donors
who have made it through
the screening process is the most effective way to bar transmission
of STDs, including HIV.
"We want the best possible screening and we want the best possible testing," Epstein said.
But the authors of the May 17 letter argue that screening out all Gay
men as anonymous donors, including healthy ones, is discriminatory. One
signer, Maura Riordan, executive director of the Sperm Bank of California
in Berkeley, a nonprofit
facility where two-thirds of the clients are Lesbian, says the rules
being weighed by the FDA would mirror those of the most restrictive state
in the country, New York.
"By saying that, even if a man tests negative and his samples are screened and cleared, that we still can’t use him," Riordan says, "even if he’s participating in mutual masturbation with another man, that doesn’t make sense to me."
Kate Kendell, executive director of the National Center for Lesbian Rights, also signed the May 17 letter.
"The folks at the FDA would have to have never read a newspaper in 20 years or be hopelessly ignorant and misguided, to think that excluding Gay men as donors in any way makes a sperm bank any more safe," said Kendall.
Robert Kim, an attorney with the American Civil Liberties Union of Northern California, said that, having a ban only on men who have sex with men "gives a false sense of security with respect to the donated sperm."
"It’s really unsafe sexual behavior on the part of any person that you should look for," said Kim.
Leland Traiman, owner and executive director of Rainbow Flag Health
Services and Sperm Bank in Oakland, Calif., and the organizer of the May
17 letter, said the directed donor rule being considered would "affect
Gay people much more than
straight people." The reason, Traiman said, is that the proposed regulations
exempt from quarantine and freezing donations from sperm donors who are
sexually intimate with the woman who is to receive the sperm donation.
Since very few Gay men are sexually intimate with the women they want to donate sperm to, Traiman says, their sperm would have to go through "this freezing and quarantine period, which only one out of six men’s sperm survives."
The FDA’s Epstein defended the six-month freezing, quarantine, and retesting requirement for directed donors, saying it is not sufficient to rely on sexual histories given by prospective donors, even if that donor tests negative for HIV when he first donates sperm.
"Say you are a Gay man," he says. "You donate for your known Lesbian friend. The problem may be that the partner of the semen donor has had an affair; this may be unknown to the sperm donor." The donor could test negative, but that could be because the test is given in the "window period."
Traiman and others maintain that the fact that the donor and recipient know and trust each other and that the donor tests HIV-negative affords sufficient protection against HIV transmission and is reason enough for the FDA to refrain from intruding into the private family planning arrangements of the two people.
But Epstein disagrees.
"We have to make tradeoffs," said Epstein. "The tradeoff here is that we’re protecting hundreds of thousands of women, probably against a fairly low risk … but the risk is not zero, and it can be significantly lowered by quarantine and retest."
In addition to Traiman, Riordan, Kendell, and Kim, the letter was signed by Jennifer Pittman, policy and program associate at the Gay and Lesbian Medical Association.
Once the FDA proposal is published in the Federal Register, the public
will have the opportunity to comment before the regulations are adopted.
Epstein said the agency would be "open" to making changes, but he said
he did not know when the
regulations would be published.
"If you have data that supports arguments, we tend to be more swayed [by data] than we are by opinions."
The FDA, Epstein asserts, has "understood and sought to address the concerns of the Gay male and Lesbian community. We do not think the six-month quarantine [for directed donors] is scientifically unsound, or that it creates an unreasonable burden."
Christopher Anders, the ACLU’s legislative counsel in Washington, says that in the April Federal Register the FDA gave a target date of June 1999 for formally proposing regulations that will include suitability of sperm donors.
Anders says the FDA has long been examining ways to regulate the sperm bank process. He says it is premature to comment on any possible FDA proposal.
"This is an extremely early stage in the rulemaking process," Anders says. "The FDA has not put out a proposed rule yet; when they do, there will be plenty of time for health care groups, for Gay/Lesbian groups and anyone else … to comment.
"Agencies are very often very willing to say they didn’t get it right the first time," Anders says. "We’ll be working, as will a lot of people, to encourage them to get it right."
But the letter signers are trying to head off the FDA before the proposal is published. "At that point, it’s already kind of late in the game," says Kim. "The key is to really have the public involved before something gets set in stone for comment."
Even without national regulations, there are only two sperm banks in
the country that accept Gay men as donors, activists say: Traiman’s for-profit
facility, which primarily serves Lesbians wishing to get pregnant, and
the Sperm Bank of California, where an estimated two thirds of the 300
to 400 women who come through the doors each year
are Lesbian.
A major reason why most sperm banks bar Gay men, Traiman says, are the CDC’s 1994 recommendations. These guidelines state that "regardless of their HIV antibody test results," men who have had sex with another man in the preceding five years should be excluded from donating organs or tissues, including sperm.
Among the states, only New York flatly bans Gay men as sperm donors, according to Riordan, although Maryland also places restrictions. But because New York women are such a large potential client pool, many sperm banks are licensed by New York and agree not to accept any Gay men as donors, says Riordan.
That policy, says Kendell of the National Center for Lesbian Rights, has made it very difficult for Lesbian couples — many of whom want to use Gay men as donors — to use a Gay male directed donor through a facility where the sperm is tested, frozen and retested.
"They end up using fresh sperm or sperm from a known donor who was not able to go through the testing," entailing "perhaps some risk," says Kendell.
Like other sperm banks, the 17-year-old Sperm Bank of California went along until a few months ago with New York’s ban on Gay donors. But Riordan says the state has now agreed that as long as she doesn’t ship Gay donors’ sperm samples to New York, she can keep her New York license, which she says "is seen as prestigious in the industry."
Now that her sperm bank is taking Gay men as donors, "we just feel like a weight’s lifted off [us]," says Riordan, who is a Lesbian.
But, she says, "It’s very discouraging to see the FDA leaning toward New York’s regulations. … If that happens, we’ll have to again bar men who have sex with men as donors."