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New Fertility Technique Raises Eyebrows

Procedure discouraged in U.S. stops short of cloning

TUESDAY, Oct. 14, 2003 (HealthDayNews) -- For the first time, researchers have succeeded in impregnating a woman using technology similar to that which is used in cloning animals.

Although the fetuses were born prematurely and died, the feat has raised ethical and other eyebrows. Not only was some of the technology similar to that used in cloning, but the procedure had been banned in the United States and as a result was conducted in China.

The results of the experiment are being presented Tuesday at the American Society for Reproductive Medicine meeting in San Antonio.

The researchers and other experts are adamant that this procedure cannot be compared to cloning.

"I don't think this is about cloning, and it shouldn't raise cloning-related worries," says Hank Greely, a professor of law at Stanford University in California. "This uses some of the same techniques used in cloning, but if it works it produces a baby that has half its genes from its mother and half from its father, just like normal reproduction."

"You can do a lot of things with that assisted reproductive technology," adds Dr. Giuseppe Del Priore, associate clinical professor of gynecologic oncology at New York University School of Medicine in New York City and part of the university's cancer fertility group. "It may be similar to cloning conceptually, but in every other way it has nothing to do with it. It's like a nuclear energy plant and a nuclear weapons plant. They're not the same."

Del Priore visited the hospital in China where the experiment was conducted, but was not a participant.

The research is troubling to some for other reasons, however, including whether the procedure is addressing a real problem.

"It's an interesting story about the fringes of assisted reproduction," Greely says. "We don't know whether the problem this technology is seeking to solve is a real problem. We don't know whether this possible solution would actually solve the problem if it is a problem, and we don't know what kind of safety risks are involved in the long run."

"It's certainly a plausible avenue, but it's not confirmed," he adds.

It's well known that as a woman ages, genetic problems can develop. These are problems that occur in the nucleus of the egg, which houses the mother's DNA. Some scientists also believe that things can go wrong with the cytoplasm, which is also inside the egg but outside the nucleus. The current experiment was predicated on the assumption that the cytoplasm needed to be replaced.

The researchers, based at Sun Yat-Sen Medical University in China, took an egg from a healthy donor, removed the nucleus, and then put genes from the mother and father into the empty egg. The egg donor did contribute some genetic material, namely the mitochondria, which provides energy. The resulting zygotes were eventually transplanted into the uterus of the mother who had contributed the genetic material.

Both this procedure and cloning involve something called "nuclear transfer." Cloning, however, uses one nucleus from an adult animal so that the resulting creature is genetically identical to the animal that supplied the DNA. This was not the case in the China experiment.

The 30-year-old woman who became pregnant ultimately lost both fetuses, though the researchers say this was not because of the initial nuclear transfer technique but because of inadequate obstetrical care.

The other troublesome aspect of this experiment is that it essentially bypasses U.S. Food and Drug Administration roadblocks on the procedure. Dr. James Grifo of New York University School of Medicine, who developed the technique, and a graduate student, John Zhang, formed a collaboration with Dr. Zhunag Guangtun of Sun Yat-Sen Medical University. Performing the same experiment in the United States would have required obtaining a time-consuming and expensive Investigational New Drug application from the FDA.

Grifo has said that he only supplied the information necessary to perform the experiment. And Dr. Keith Krasinksi, chairman of the Institutional Review Board (IRB) at NYU said that Grifo did not need the board's approval to do this research because he "didn't direct or conduct the research." NYU policy does not require a faculty member to seek IRB approval "unless the research is sponsored by NYU or one of its covered facilities or conducted under the direction of a faculty in connection with their institutional responsibility," Krasinski says.

"He said he transmitted information to them that enabled them to do it. That doesn't mean he conducted the research," Krasinksi adds.

Last week, China's Ministry of Health added its own voice to the chorus, imposing new rules specifically banning the nuclear-transfer technique. According to the Wall Street Journal, the investigators purchased human eggs, apparently in defiance of a Chinese ban on commercial trade in human eggs. In at least one case, the eggs were purchased for $1,000 from a migrant laborer.

"Particularly troubling here is that when the FDA has raised questions about whether we can do the research in the U.S., for him then to go overseas to do the research," Greely says. "It raises some concerns about someone trying to do something the FDA won't let him do in the U.S."

Yet others feel that this is how science advances. "This is a natural process of all scientific process. People are always going to resist innovative ideas," Del Priore says. "It's the usual exciting debate. It makes it fun."

More information

For more on how researchers make clones, try How Stuff Works. For a pro-cloning perspective, go to the Human Cloning Foundation. For more on assisted reproduction and infertility, visit the American Society for Reproductive Medicine.

SOURCES: Hank Greely, J.D., professor of law, Stanford University, Palo Alto, Calif.; Giuseppe Del Priore, M.D., associate clinical professor of gynecologic oncology, New York University School of Medicine, New York City; Keith Krasinski, M.D., chairman, Institutional Review Board, New York University School of Medicine, New York City; Oct. 13, 2003 Wall Street Journal
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