- The Washington Times - Thursday, May 20, 2004

The Food and Drug Administration yesterday announced a new rule that would prevent men who have engaged in homosexual sex within the past five years from making anonymous donations to sperm banks.

The new rules mirror Centers for Disease Control and Prevention guidelines that have been followed by most of the nation’s tissue and sperm banks for more than a decade. Even so, homosexual rights groups denounced the decision as “unscientific” and accused the Bush administration of discriminating against homosexuals.

“There is absolutely nothing about this proposal that’s based on science or medicine — this is a policy based on bigotry,” said Kevin Cathcart, executive director of the Lambda Legal Defense Fund. “The government’s recommendations are discriminatory and defy common sense.”

The new FDA rule, which goes into effect May 25, 2005, come as part of a five-year effort to expand its oversight of the growing tissue-donation industry and expedite the screening of new diseases before they can reach the donor pool.

Dr. Jesse Goodman, the FDA’s director of the Center for Biologics, Evaluation and Research, pointed out that the section on sperm donation represented “a very small part of the rule,” which deals mainly with the harvesting of bones, skin, corneas and other human tissue from corpses.

But he defended the decision to exclude anonymous sperm donations from active homosexuals, saying that men who have had homosexual sex have a higher risk for HIV infection than other segments of the population.

“I do understand their concern, and the desire of everyone to be donors,” Dr. Goodman said. “With regard to men who have had sex with men, the issue really is the higher incidence of HIV in that population.”

Homosexual rights groups countered that the FDA simply could require HIV testing of anonymous sperm donations, noting that new tests can detect HIV within 72 hours.

“There are already procedures in place to ensure that donated sperm is safe, no matter who donated it,” Mr. Cathcart said. “HIV affects every part of our nation’s population, and the FDA needs to realize that fact and stop treating gay men as the only people who contract HIV.”

Roberta Sklar, spokeswoman for the National Gay and Lesbian Task Force, accused the Bush administration of “ignoring scientific information and putting forth their own agenda to satisfy the extreme right-wing conservative voters.”

But researchers argue that HIV tests are not 100 percent reliable, even when they return prompt results. Like any test administered by people, it’s prone to human error.

In addition, it can take the human body up to six months to produce the antibodies that indicate a person is HIV-positive. Thus, in that six-month period, a negative test, no matter how quick the result, is not definitive, said Nicole Mandel of the University of California at San Francisco’s Center for HIV Information.

“We like to have a system in place where we don’t just rely on one thing. While there have been tremendous improvements in laboratory testing, they’re not foolproof,” Dr. Goodman said. “For that reason, we routinely exclude populations where sound scientific evidence shows that there could be a risk to the person receiving the donation.”

He insisted that homosexuals weren’t being singled out.

“We’re concerned about blood and tissue donors from the United Kingdom who may have been exposed to mad cow disease, so we may exclude donors who have been to Great Britain in the past six months,” Dr. Goodman said.

He also noted that the rule allows directed sperm donations, in which the recipient knows the donor and his medical history.

Bob Rigney, chief executive officer of the American Association of Tissue Banks, predicted that the effect on the industry would be “minimal.”

His organization has adhered for years to CDC guidelines on communicable-disease testing and medical and social history screening, which already includes excluding active homosexuals from anonymous sperm donations.

“We’re following the CDC guidelines right now, so this won’t have a major impact,” he said.

Of the roughly 150 U.S. tissue banks, 83 are accredited by his organization. More than 1 million tissue transplants are performed each year, he said.

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