Washington -- Despite an attempt by the Food and Drug Administration to halt her efforts to clone a human being, the chief scientist of Clonaid said Saturday she was confident she would succeed soon. "The only thing I guarantee is that I want a very healthy baby, and I'll do all I can do so that this very healthy baby is presented to you soon," Brigitte Boisselier said. "If it's impossible to do it here, we'll do it abroad, and we'll move on and move on."
The French biochemist said she has faced unforeseen barriers. "I expected some scientific problems, but I had more federal problems, I should say, since the FDA indeed found us." Clonaid was founded in 1997 in the Bahamas by the Raelians, a religious group that contends extraterrestrials used genetic engineering to create life on Earth.
The Raelians were founded in France in 1973 and claim 55,000 members in 84 countries. The leader is known as Rael, the former Claude Vorilhon, who dresses in a white spacesuit-like uniform and says he spreads his message after encounters with creatures who came to Earth in a UFO. After stories were written about the group's cloning goals, the Bahamian government pressured the company to leave. It relocated last year to the United States.
"I believe that we indeed have been created by intelligent beings -- those beings coming from space ...," Boisselier said, acknowledging that many people regard her views with skepticism. "Usually, people have a little smile and say, 'Well, she's crazy thinking about that.' "
Investigators from the FDA arrived at Clonaid's lab in the spring, a few weeks after Boisselier testified before Congress that human cloning could be done safely, she said. U.S. News and World Report will report in next week's issue that a federal grand jury in Syracuse, New York, near Boisselier's home, has subpoenaed her phone records and other documents. Boisselier told CNN she has not been served with any subpoenas.
The FDA would not confirm that it visited the lab. A spokeswoman did confirm that the agency sent her a letter stating the FDA has jurisdiction over regulation of clinical research using human cloning technology. Boisselier said that, although she disagrees, she is reluctant to challenge the agency in court. "I want to concentrate my time, my energy, my money on science."
Although the FDA may know the company's whereabouts, Boisselier would not say where her lab is based nor how close it is to cloning a human. "The only thing I will tell: When the baby is born, you will know for sure." Boisselier said the company would continue to carry out research deemed acceptable by the FDA at its U.S. facilities, but would set up a second lab in another country "where it's legal to do the final step ... the human cell nucleus transfer."
In order to clone a human, scientists would remove the nucleus of an egg and extract its genetic material, leaving just its shell. Then the nucleus of a cell taken from the body of the person to be cloned would be transferred into the shell. With only the genetic material from the person to be cloned inside the shell of the egg, the cell would be jolted with electricity to activate cell division.
The embryo would then be implanted into a surrogate, who -- if the experiment were to succeed -- would carry the fetus to term. Still, she said, thousands of people support her: "A lot of parents, a lot of people who would like to be cloned." But after stories were written about the group's goals, the Bahamian government pressured the company to leave. It relocated last year to the United States.
Clonaid is funded by a man whose 10-month-old son died after a heart operation. The father, who has remained anonymous, wants DNA from his son to be used to create a clone. In 1997, when Dolly the sheep became the first mammal to be cloned from an adult sheep, cloning a human entered the realm of possibility.
The specter also raised concerns. "At least half, probably about three-quarters of pregnancies that are generated will be lost," predicted Dr. Jonathan Hill, assistant professor of animal reproduction at Cornell University. Other scientists are plowing ahead. In addition to the work at Clonaid, former University of Kentucky professor Panayiotis Zavos said he plans to clone a human within the next year.
But putting theory into practice is not easy: Cloning Dolly required 277 attempts. And it carries risks. Hill, who has cloned cattle, said the cloned calves are often sick and abnormally large. Scientists have cloned sheep, cows, goats, pigs and mice, but their success rate is as low as one live birth in 100 attempts.
Many bioethicists also oppose the efforts to clone humans. "If you go to the likes of Dr. Zavos, he will give you a dead baby, a defective baby or a deformed baby," said Art Caplan, director of the Center for Bioethics at the University of Pennsylvania. "We don't know how to do this."
Such talk has not deterred Boisselier, who said any pregnancy would be monitored and, should it go awry, "we will anticipate to do an abortion." Although the scientific and ethical hurdles may be daunting, the legal barriers are few: Only California, Michigan, Louisiana and Rhode Island ban public or private funding of cloning research.
There is a federal moratorium on the use of federal funding for research on cloning humans and many scientists abroad are abiding by a self-imposed moratorium on cloning humans. Several countries forbid cloning by law.