FDA proposes ban on sperm donations from gay men

by Eric Resnick
Cinncinati, Ohio

The U.S. Food and Drug Administration is proposing regulations which would prevent gay men from anonymously donating sperm, and make it more difficult for gay men to enter into an agreement with a woman to father a child.

“They are proposing a program of mass sterilization by regulation of the gay and lesbian community,” says Leland Traiman, executive director of Rainbow Flag Health Services and Sperm Bank in San Francisco, which is one of only two sperm banks that accepts gay donors.

The proposed regulations are part of an initiative to revise the way the FDA regulates all human tissue donations, emphasizing the safety of the donations and minimizing the spread of communicable diseases such as HIV, hepatitis B, and sexually transmitted conditions.

Traiman, a registered nurse and nurse practitioner, asserts there is “no medical need” to ban gay men from donating sperm since there have been no deaths or injury from such donations since the development of antibody tests.

Yet, at its April 8 Human Tissue Seminar, the FDA announced the proposed regulations, which are expected to be finalized by the end of 1999.

As evidence of need of these regulations, the FDA cites the case of one donor who appeared healthy at the time of donation and whose seroconversion period took two years. However, he was heterosexual and was infected by his wife, who became HIV-positive as a result of an extramarital affair.

“But if there was one, they think there could be others,” Traiman said, adding that the incident raised questions around the safety of sperm donations.

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 FDA points to the level of additional safety it would achieve by banning sperm donations from men who have sex with men.

“We have several levels of safeguards that are overlapping. The best product is accomplished by putting one safeguard against another, ” said Jay Epstein, M.D., the director of the Office of Blood Research and Review at the FDA’s Center for Biologic Evaluation and Research in Alexandria, Va.

“Men who acknowledge man-to-man sex remain both an identifiable high prevalence big incidence population for HIV and other sexually transmitted and blood transmitted diseases,” said Epstein. “This constitutes a population at increased risk based on that behavior.”

The proposed sperm regulations were modeled after those created for blood donations, which prohibit anonymous donations from men who have had any sexual contact with another man since 1977.

The Gay and Lesbian Medical Association has opposed the blood regulations officially since 1997, because, the group says, they lump all gay men together with no consideration for actual sexual risk factors, which may be higher for some heterosexuals than for some gay men.

“This is a little worse because sperm can be frozen and quarantined for six months, blood cannot,” said Jennifer Pittman, GLMA’s policy and program associate. “Thus, the deferral of HIV negative gay and bisexual men is not scientifically justified.”

The proposed regulations also ban donations from IV drug users and people who have sex for money or drugs.

But the FDA’s Epstein acknowledged that gay men who are monogamous and HIV negative would be prohibited from being anonymous sperm donors, all other factors being equal, because “men who have sex with men will become the deferrable risk factor.”

“Many people who give that history in fact are not competent at practicing safe sex,” Epstein added.

Epstein cites data from the Centers for Disease Control which shows men who have sex with men at 3-10 times more likely to have sex with an infected person than men who have sex with women.

“When you look at large groups, incidence among men who have sex with men is much higher,” he said.

When asked why no bans on reproductive tissue were being proposed for any other population that shows a higher rate of HIV infection than the general population—such as African-American women who live in inner-cities, Epstein replied, “Such persons do have additional risks, however, we do not base our policies on demography. We base them either on medical conditions or behavioral risk.”

He added, “We cannot base governmental policies on race, gender, or ethnicity. Nor do we base it solely on geography.”

Why the is it okay on the basis of sexual orientation? Epstein was asked.

Epstein replied, “No, it’s not orientation in terms of a group category. It’s that the behavior does have association with risk. The reason is if you choose as a lifestyle to have sex with men who have sex with men, your likelihood of encountering infected persons both for HIV, hepatitis B and hepatitis C as well as other sexually transmitted diseases is significantly higher than if you don’t.”

Epstein was quick to point out that there are no proposed exclusions for women who have sex with women. “There’s no discrimination because there’s no risk,” he said.

“This is the same agency that did the Tuskegee syphilis experiment on African-Americans without regard to ethical or humanitarian considerations,” asserts Traiman, “Now they have another inappropriate, incorrect notion in their heads on how to protect us from ourselves.”

(In the notorious Tuskegee Study, from 1933 to 1972, treatment was withheld from a group of African-American men with syphilis, to observe its progression.)

Traiman says “the chief architect” of the FDA proposal is Ruth Solomon M.D., the director of the Office of Blood and Research Review’s human tissue program.

“I saw Dr. Solomon last October and tried to engage her in a discussion on the medical and ethical issues around this proposal,” added Traiman. “But Dr. Solomon told me ‘I don’t want to talk to you any more. You’re a pest,’ so they aren’t interested in science or ethics. They are only interested in political heat.”

“Solomon and the others were so excited about these regulations they were practically salivating,” said Traiman. “This is because they are bureaucrats and regulations mean job security for them.”

The scientific evidence

In a letter, Tom Spira, M.D., assistant chief for medical science at the federal Centers for Disease Control in Atlanta first made it clear he was speaking for himself, not the CDC, when he said, “I would not, categorically, want to exclude [men who have sex with men as anonymous sperm donors] since we have appropriate testing.”

This opinion was reinforced by Charles Schable, chief of the CDC’s AIDS Diagnostic Laboratory. In a letter, he told Traiman, “If one is freezing the sperm and retesting the donor after six months, the only reason to apply [the MSM exclusion] criterion to semen donors is homophobia.”

Epstein acknowledged that the FDA is using CDC guidelines from May 1994 as the basis for these regulations. He also acknowledged that there is more current epidemiology data available since 1994. “But the majority of people with HIV are still gay men,” said Epstein, and, “men who have sex with men are at 3-10x higher risk than men who have sex with women.”

“To legally bar gay men from being sperm donors not only discriminates against these men, it erodes a woman’s right to choose how she wishes to create her family,” counters Traiman.

The proposed policy places no ban on “directed” donations--those in which the recipient is aware who the donor is and is counseled as to the risk factors.

The California Department of Health Services Subcommittee found the 1994 CDC guidelines inappropriate for use creating sperm banking regulations and removed the exclusion of gay men in 1996, when it became clear that the scientific evidence does not support it. The subcommittee concluded that exclusion of gay and bisexual men would open the state to litigation under the state’s reproductive rights laws.

The politics

“After California, I asked CDC to change their guidelines with reference to sperm donations,” said Traiman. “I was unofficially told that most on the committee wanted to change the guidelines, but were stopped by two senior members who, in effect, had veto power over the majority and that the decision not to change the guidelines was based on politics and not science.”

He added, “This suggests that this policy has carry-over from prior administrations.”

As with all FDA policies, these proposed regulations will not become law until Secretary of Health and Human Services Donna Shalala signs them.

Richard Socarides, White House liason to the GLBT community had little official knowledge of the proposed policy.

“I think a policy is in fairly early stages of development,” he said, “The leadership at HHS has not yet passed on it.”

“Secretary Shalala will take a very hard look at it. She is sensitive to the issues of discrimination and fairness for all citizens, but she will have to hear its proponents.”

Socarides pointed out that the current blood donation regulations were in effect prior to the Clinton administration and have not been re-evaluated either. “This sounds like an outgrowth of the blood policy,” he said. “Maybe something good out of this could be the re-evaluation of that regulation.”

All CDC guidelines are based on scientific evidence “whenever possible.” “However,” according to Kenneth Clark, M.D., of the CDC Division of AIDS Prevention, “in many cases and for many issues, scientific evidence is limited or lacking. In these cases, the CDC relies on the experience, judgement, and advice of a consultant panel.”

According to GLMA’s Pittman, this consultant panel was used to construct the guidelines the FDA is using.

“That is why they can’t come to a conclusion based on the facts,” she added, “and we cannot find out who was on that panel.”

The proposed FDA policy will be open for public comment sometime this summer.

Traiman vows a fight if this proposal becomes law. “I am prepared to break this law and fight it,” he said, “and they think Jack Kervorkian gave them trouble.”

Traiman has the support of the American Civil Liberties Union of Northern California.

Traiman says, “The FDA and CDC justified the Tuskegee syphilis experiments on black men, calling African-Americans ‘a notoriously syphilis-soaked race.’ Just change the words. They are now trying to call gay men ‘a notoriously HIV-soaked community’.”