June 14, 2001 (Washington) -- Is the frontier of the first cloned human just ahead, or does science have a ways to go before Dolly the Human?
No one knows for sure, and the government's authority to regulate the experimentation isn't crystal clear. That has a worried Congress eyeing legislation to outright ban human cloning.
In early 1997, word broke that Scottish scientists first cloned an animal from an adult cell -- the now world-famous sheep Dolly. Since then, the world has seen similarly cloned monkeys, pigs, cows, and mice.
Cloning people, to be sure, brings up some fearsome associations. Ron Gillespie, an official with the animal cloning firm Cyagra, says, "The first thing [people] think of when they heard 'cloning' is Hitler or Frankenstein."
Although cut off from the medical and scientific mainstream, human cloning advocates argue that the process would serve valuable public good. Not to mention they've seen passionate interest from thousands of bereaved parents who want their "perfect baby" back or from couples who cannot conceive their own children.
Brigitte Boisselier, PhD, a "bishop" in the UFO-centered Raelian sect, says that she is doing cloning research at an undisclosed location in the U.S. Funded by a wealthy couple who had lost a child, the operation is attempting to clone the parents' baby, who died at 10 months, using cells taken before the infant's death. The Raelian movement claims that life on earth was created by an extraterrestrial lab and that Jesus' resurrection was, in fact, a divine cloning.
The company, formerly called Clonaid, had advertised cloning services for $200,000 for wealthy parents. But Boisselier, who won't give the name of the new company, says that prices have yet to be set. "The only thing I'm saying is that it is proceeding as planned, and everything is going fine," she tells WebMD.
Meanwhile, Panos Zavos, PhD, founder and director of the Andrology Institute of America in Lexington, Ky., tells WebMD that he and his colleagues are close to getting a human clone. He predicts it will be "2002 for possibly having the first cloned embryos ready to be transferred, and 2003 as having a child born."
"The only interest we have is assisting couples that have exhausted all possibilities for them to reproduce, and cloning might be the only option that they have left," says Zavos. He says that he isn't charging couples who are interested in his potential service.
"We don't intend to get there by stepping on dead bodies and deformed babies," Zavos says.
But the FDA and lawmakers emphasize that Dolly was only created after nearly 300 attempts. And with the unexplained death earlier this month of a cloned calf at the University of Tennessee, some experts say that death and deformity would surely be part of any foray into cloning.
Art Caplan, PhD, director of the bioethics center at the University of Pennsylvania in Philadelphia, tells WebMD, "The [cloned calf's death] bodes ill for human experimentation. It would just be criminally loony to try human cloning." He says, "The only people who have come forward [to clone a human] ... are kooks, cranks, and con-men. There is no one of any scientific legitimacy or medical standing."
In fact, Caplan bets it will never happen: "I'd be willing to bet against all these pronouncements that cloning is imminent or that cloning is inevitable." But he says, "Somebody may give it a go because they want the PR, and they will wind up making dead or deformed babies. It will turn out to make unhealthy people and never turn out to have any use for reproduction."
Other experts say that cloning would have negative social impacts, since the asexual procedure would cloud the meaning of "father" and "mother" and confuse the family status of cloned children.
Meanwhile, the FDA has contacted Zavos and Boisselier, asserting that it has authority over their work and insisting that they must file special applications before initiating any research. But Zavos, who says he is doing his research overseas, tells WebMD, "They can't oversee [any research]. I have gotten the opinions of attorneys who know what this is all about, and they have said the FDA has absolutely no jurisdiction."
Last week, a U.S. House judiciary panel looked at human cloning, and lawmakers will revisit the question in a session scheduled for June 19. The hearing will examine a bipartisan bill from Reps. Dave Weldon, MD, (R-Fla.) and Bart Stupak (D-Mich.) to ban human cloning.
In 1997, former President Bill Clinton signed an executive order banning the use of federal funds for human cloning. But the Weldon/Stupak bill goes further, outlawing any cloning attempts, participation in cloning efforts, and any shipping or receiving of clones. Its penalties include a minimum $1 million civil fine.
But even prohibition may not stop the cloning efforts.
"There is a true demand for cloning," Boisselier says. "So many people would like to do it. If there is prohibition, it is going to be done -- hidden somewhere."
At the same time, she concedes, there should be some regulation. "You shouldn't be allowed to use the genes of somebody else without consent. You shouldn't do more than one or two clones of one individual," she says. Nevertheless, she insists, "It is part of individual freedom to use your genes as you want to."
And not everyone agrees an outright ban is the right reaction.
Alta Charo, PhD, a professor of law and medical ethics at the University of Wisconsin in Madison, tells WebMD that a ban isn't necessary yet. "We don't have any evidence yet that this is going to become widespread and that it's a widespread harm that needs federal legislation."
Caplan, similarly, says that Congress should pass legislation establishing a moratorium, or delay, on any human cloning until animal studies prove safety.
But he is pessimistic that lawmakers will be able to pass any legislation, since they are likely to attach measures on other matters, such as abortion and stem cells. "Abortion politics ruins things," he says. "Congress is showing no signs that it has learned anything from the past."
For similar reasons, Charo says that legislation is unlikely to pass. But she suggests a bill that simply clarifies that the FDA does have clear authority over any cloning research.
As another option, she mentions getting state regulators to step up to address the responsibilities of researchers or health professionals who "embark on something that is unproven, if it should result in a child with any kind of health problem."