| Tanks for the memories: These tanks at an OHSU lab use liquid nitrogen to store embryos. |
IMAGE: TOM OLIVER
The regulations, which went into effect in May 2005, require extensive tests far in advance of any tissue donation. That has angered both right-to-lifers who want to rescue unused embryos for "adoption" and the medical community that wants to keep the federal government out of reproductive health.
If that odd alliance between anti-abortion and pro-choice forces weren't enough, consider this: According to most fertility-biz watchers, the new FDA rules were inspired by a push within the conservative movement itself to get the feds to crack down on the business of making babies the new-fashioned way, presumably because it mucks around with God's work.
"The central irony here is that the political forces behind this have been focusing on the right to life...and now more embryos will be discarded because of the regulations," says David Battaglia, lab director at Oregon Health & Science University Fertility Consultants. "This is another example of the FDA becoming a political tool. It's very disturbing."
The FDA may have stirred its own quicksand, because the agency didn't take into account a strange, relatively new byproduct of fertility treatment: embryo adoption.
More than 500,000 embryos are sitting on ice in American fertility clinics (including thousands at OHSU), the product of thousands of couples, and single women, plunking down an estimated $1 billion every year to plant seeds in empty wombs.
After treatment either succeeds or fails, many couples find themselves in the position of deciding what to do with their leftover frozen embryos.
Technically called "pre-embryos," the "seeds" are balls of six or eight cells—about 20 could fit on the head of a pin.
Often, the decision simply isn't made, meaning embryos sit in limbo. But new parents are opting increasingly to donate their would-be offspring to other couples who've had trouble conceiving. The Christian right, which supports such donations, likes to use another word: adoption.
And here's where the new rules throw everyone for a loop: The dicta place strict requirements for testing and screening on donations of any biological tissue, from corneas and livers to the eggs and sperm that go into making frozen embryos. And the tests must be done months in advance.
Amid an outcry over the new rules from the fertility industry, the FDA added an amendment exempting embryos donated by couples who use their own egg and sperm.
But most of the embryos submitted for donation (or "adoption," depending on your politics) aren't created by a man and woman who contribute their own ingredients to make a frozen fertilized egg.
Most consist of sperm from the would-be father and an egg from a donor—like the fertile young
college girls who can earn up to $5,000 for each "donation." These embryos, unlike those created solely by the man and woman who intend to use them, aren't exempt from the FDA's rules, and thus cannot be adopted.
The rules create a problem because a hopeful father who contributes his sperm to fertilize a donated egg, for eventual implantation into his own hopeful wife, doesn't start off considering himself a potential embryo donor. So he's unlikely to want to go through the extra expense and hassle of an additional battery of tests—all of which must be completed before he submits his sperm—in case someone else wants his leftovers down the road.
Eleanor Nicoll, a spokeswoman for the American Society for Reproductive Medicine, which helped draft the May 2005 rules, says she was unaware of the problem and that she thought the FDA should provide clarification.
OHSU's Battaglia says the FDA (which referred WW to its website for answers) has avoided persistent requests for such clarification. And Battaglia believes the American Society for Reproductive Medicine failed to fight for the needs of its members.