Dr. Barry Behr, Stanford University associate professor of obstetrics and gynecology, and director of Stanford’s in vitro fertilization lab, explains that the inept actions by the FDA are not isolated incidents. Fifteen years ago, recalls Behr, people were getting HIV from blood transfusions. In 2005, the FDA finally decided to react — creating so-called Donor Eligibility and Determination Labeling “to govern all transference of biological material from one person to the next.”
Sperm banking and in vitro fertilization labs must now adhere to these complex rules, Behr says, but “there has never been a case of anyone getting HIV from the transfer of reproductive material. They’ve also put unreasonable and nonsensical demands on reproductive clinics.”
In addition, by California law, all couples considering assisted childbirth must be screened for diseases like HIV, HDLV, syphilis, hepatitis and rubella. Save HIV and HDLV, all of these results can be ignored or waived — meaning one partner can sign a form saying they understand the dangers and want to go ahead anyway. This means that infected material is occasionally stored at the clinics and cryobanks. “The FDA demands that this material be held in a completely separate “biohazard” location in the cryotank,” says Behr. “This means we need more cryotanks, a separate labeling system and a ton more paperwork — and all of it is unnecessary. What they don’t seem to get is that every sample in the tank is still sharing the same liquid nitrogen. It’s like making people with a cough live on the same street, but using only one school bus to pick up the entire neighborhood.”
There is also further consternation at the FDA’s insistence that donors be rechecked every three months for sexually transmitted diseases during the period their gametes are for sale. While this may seem like common sense, cryobanks feel this is overkill whose only real consequence is to increase the cost of already costly sperm. Since the law went into effect, California Cryobank has raised its sperm sales prices by a minimum of $125 per ampoule (average purchase is seven to 10 ampoules).
“Every time the FDA passes another law,” says Rothman, “all they’re doing is restricting women’s reproductive freedom.” On May 5, 2005, the FDA banned sperm banks from using the sperm of any man who has had “gay sex” in the past five years — even though, again, there is no instance of AIDS being passed via purchased sperm. Considering Bush’s position on gay marriage and his administration’s history of meddling in scientific issues such as FDA drug approvals, the gay sperm ban left many in the industry uneasy. (Some critics even pointed out that eight days after the anti-gay-sex prohibition was implemented, Dr. W. David Hager, the Bush-appointed FDA adviser, vocal opponent of emergency contraception, abortion and premarital sex, and author of As Jesus Cared for Women, was accused by his ex-wife of repeated sodomy — a crime in his home state of Kentucky.)
Rothman says, “I don’t think the government belongs in our bedrooms. I understand that if the industry doesn’t establish a donor registry, pretty soon this is what’s coming. But I think the American public should rise up against it. By letting the FDA tell you whose sperm you can’t use, they’re in essence telling you whose sperm you have to use. And I don’t think we want the federal government deciding what kinds of kids the American public should be allowed to have.”
Unfortunately, since few in the industry share Rothman’s position on donor tracking — and almost no one on the cryobank side wants to see donor anonymity revoked — without some sort of governmental intervention, the dangers of accidental incest and hidden genetic disease will grow.
The truth of the matter is, as the famed physicist Freeman Dyson once pointed out, “If we had a reliable way to label our toys good and bad, it would be easy to regulate technology wisely. But we can rarely see far enough ahead to know which road leads to damnation. Whoever concerns himself with big technology, either to push it forward or to stop it, is gambling in human lives.”?
