March 16, 2001 (Washington) -- In 1997, British scientists cloned a sheep and named her Dolly. Did they do the world a favor, or did they open Pandora's legendary box of demons?
This is a question that medical ethicists have struggled to answer, while invoking images ranging from Nazi Germany to miracle treatments and virtual immortality. But some experts now say the question itself is largely academic because there is no way to prevent human cloning.
In fact, some experts say that even if scientists were to attempt to clone a human being in the U.S., there probably would be no legal barrier.
"It's clearly in the dark," Richard Merrill, LLB, a professor of law at the University of Virginia Law School in Charlottesvile, tells WebMD.
The debate centers on the Food and Drug Administration's assertion that it would have the regulatory authority to oversee any such attempt.
The FDA made the assertion in a 1998 letter to clinical researchers.
"Clinical research using cloning technology to create a human being is subject to FDA regulation," wrote Stuart Nightingale, MD, an associate commissioner of the FDA. "Since FDA believes that there are major unresolved safety questions pertaining to the use of cloning technology to create a human being, until those questions are appropriately addressed ... FDA would not permit any such investigation to proceed."
The FDA's claim is suspect for two reasons, says Merril, an expert on medical law. First, the agency has failed in the past to use such authority over similar fertility treatments, especially when applied on the individual level. And second, the extent of the FDA's authority depends on the extent of cellular manipulation involved in the cloning, which may be minimal depending upon the process.
"At the very least, the agency would need to go through some public process before coming up with legally binding regulation," he tells WebMD.
Of course, that debate may be academic as well.
According to the FDA, the agency is not aware of any U.S. attempts to clone a human being. "We have not authorized any trials in the U.S. Nor are we aware of any attempts being made in the U.S.," Brad Stone, a FDA spokesman, tells WebMD.
Then again, although President Bill Clinton did ban the use of federal dollars for human cloning in 1996, no existing federal law explicitly forbids U.S. scientists from making the attempt.
In 1997, the Clinton administration attempted to pass a federal ban, and a handful of federal lawmakers took similar stabs. But those bills have languished in Congress largely because of the fear that they, in effect, might also ban other forms of genetic research.
At the time, experts testifying before Congress warned that any legislation would have to strike a careful balance.
"It is important not to lose sight of the original motivation for the Dolly experiment," Harold Varmus, MD, then director of the National Institutes of Health, warned Congress. Besides being particularly valuable for medical research, the technology also one day may allow for such things as the development of organs for human transplants, he explained.
Since then, anticloning bills have been introduced in about 30 states and passed in four -- California, Louisiana, Michigan, and Rhode Island. Still, experts say that these laws are so riddled with loopholes that they would not ban cloning at all -- if just because the technique is evolving more rapidly than the laws can be written or passed.
So what would happen if a woman decided to clone herself, using her own eggs?
The FDA has yet to elaborate, choosing instead to rely upon the assertion it made in 1998.
"We still feel that the October '98 letter is in effect," Stone says.
Yet Americans may soon get a more detailed answer, thanks in large part to the growing concern on Capitol Hill.
Congress is now on a "fact-finding" mission led by Rep. James Greenwood (R-Pa.), who is chairman of the powerful House Energy and Commerce Committee.
In a recent letter to acting FDA Commissioner Bernard Schwetz, MD, Greenwood asked the FDA to outline its plans. Greenwood also asked the FDA to elaborate whether there are gaps in its statutory or regulatory authority that could interfere with the agency's ability to regulate human cloning.
"We're trying to gather detailed information about how the FDA intends to proceed," Pete Sheffield, a spokesman for the committee, tells WebMD.
The FDA is looking at the letter and will respond to it in a timely manner, Stone says.
In the meantime, other countries have started taking a more proactive approach.
In the next few months, the Canadian government is expected to draft legislation that would ban human cloning. And in Europe, various members of the European Union are now considering a ban proposed by one of the Union's councils.
In Italy, authorities are also considering revoking the medical license of an Italian fertility doctor, Severino Antinori, MD, who along with another American doctor recently promised to produce a human embryo within two years.
Denying allegations that it was prompted to take action by the media and religious groups, the Italian medical association said it would revoke Antinori's license because of ethical reasons.
It is too early to tell whether the U.S. will follow suit on any level. However, there are indications that medical professionals in the U.S. may be willing to take steps similar to their Italian counterparts should Congress fail to pass a ban.
The American Society for Reproductive Medicine, the professional association of fertility doctors, has stated adamant opposition to human cloning -- even as a treatment for infertility.
"We don't feel that science justifies it," says Sean Tipton, a spokesman for the group.
While cloning eventually may become a viable treatment for infertility, Tipton tells WebMD that the science is still too unpredictable. The scientists that clone animals often produce hundreds of deformed offspring before getting the process right, he points out.
But in the end, there may be little medical professionals or even the government can do to ban, prevent, or discourage human cloning.
Last fall, a Canadian-based cult, the Raelians, said it received $1 million from a wealthy American couple to make an attempt. And more recently, 600 couples signed up for Antinori's planned attempt, which he has said will take place in an unnamed country.
This rampant interest could mean that Pandora's box already is wide open -- even in the U.S., regulatory officials confess.
"If it happens, it appears that it would take place elsewhere. But of course, at any time, someone, somewhere, could be doing it in their basement," Stone says.