WASHINGTON (Reuters) - The fertility technique that produced the world's first genetically modified babies came under criticism on Friday following the disclosure that two of 18 fetuses created with the method had a rare genetic disorder.
Officials at Saint Barnabas Medical Center in Livingston, New Jersey, where the technique was developed, said they do not believe the procedure -- in which part of the contents of a donor woman's egg cell is injected into an infertile woman's egg -- caused the incidence of Turner's syndrome.
A leading expert in the field also doubted that the technique was responsible, but said the doctors doing the procedure consistently have failed fully to inform the medical community about their activities.
"Why is (information) coming out in little dribs and drabs?" asked Dr. Michael Soules, president of the American Society for Reproductive Medicine and a University of Washington reproductive endocrinologist. "That makes me suspicious. Nondisclosure makes you ask, 'What are we hiding here?' even if they're not."
Soules joined other scientists who have criticized the ethics of the procedure. He expressed concern that the procedure tampers with the germ line -- the genes passed down to offspring -- with the doctors involved giving no indication that they have considered the consequences.
"What we're lacking here is a good, comprehensive clinical article on what they've been doing," Soules said.
Soules said he had "serious reservations and many questions. I don't know whether to condemn it or not. But I'd like the public to know that this is not standard treatment in the United States."
The use of so-called cytoplasmic transfer (also called ooplasmic transfer) is not being discontinued. "Right now, it's continuing to be used in an extremely limited number of patients, like it has been," said Robin Lally, director of public relations for the hospital.
TWO FETUSES WITH A GENETIC DISORDER
Turner's syndrome, which involves an inherited chromosomal defect, was found in the two fetuses, one of which was lost in a miscarriage seven weeks into the pregnancy and the other aborted, the hospital said in a statement.
Sixteen babies, the oldest of whom is 4, have been born using the procedure developed by doctors in the hospital's Institute for Reproductive Medicine, the statement said. The hospital has said those babies are healthy. It also said the method has been used by doctors elsewhere in America and in Taiwan and Israel.
The technique involves injecting a small amount of cytoplasm (the substance that surrounds the nucleus of a cell) from the donor egg into the infertile woman's egg and fertilizing the egg with the sperm of the father. The statement said the injected material replaces the missing or abnormally functioning components of the infertile woman's egg.
But the transfer can introduce genetic material from the donor woman's mitochondria -- structures involved in cellular energy production -- into the patient's egg. Two of the babies have been found to have genetic material from two women and the father -- in a sense leaving them with two genetic mothers.
The statement said all research involving the procedure met "stringent medical guidelines" set forth by the hospital's internal review board overseeing experimental procedures.
"Cytoplasmic transfer is only made available to an extremely limited number of couples who are counseled and provided with a comprehensive patient consent form that outlines the nature and outcome of this experimental protocol," the statement added.
Turner's syndrome is not a mitochondrial disease, but an anomaly seen more frequently in women with fertility problems and is common in early miscarriage, the statement said.
The hospital said it did not try to keep the incidence of Turner's syndrome a secret, saying it was explained in the patient consent form, mentioned in scientific conferences since 1999 and reported in a medical journal in March.
Turner's syndrome is disorder in women that inhibits sexual development and causes infertility and is caused by a missing X chromosome. It affects one out of 3,000 live births. Symptoms of the syndrome include short stature, webbing of the skin of the neck, absent or retarded development of secondary sexual characteristics, absence of menstruation, narrowing of the aorta, and abnormalities of the eyes and bones.
©Reuters May 18 2001 5:24PM