By Lisa Seachrist

Washington Editor

WASHINGTON — Highlighting the enormous promise of cloning as a tool for medical research, Sens. Diane Feinstein (D-Calif.) and Edward Kennedy (D-Mass.) introduced legislation that would ban the cloning of human beings in the public and private sector for 10 years.

The Prohibition on Cloning Human Beings Act of 1998 prohibits for 10 years any person from attempting to clone a human being and preempts any state laws that are put into place. It calls on the National Bioethics Advisory Commission (NBAC) to complete two reports on the science and ethical issues associated with cloning and on whether the moratorium should be continued.

"The cloning of a human being today remains scientifically dangerous, morally unacceptable and ethically flawed," Feinstein said. "It may never be acceptable from a moral standpoint, but we do not know enough today to permit the cloning of a human being or to make a permanent determination about the dangers or potential use of this technology."

The legislation is roughly based on a bill President Clinton sent to Congress in June 1997, but no member of either chamber stepped up to sponsor it. Unlike legislation introduced by other members of Congress, the Feinstein-Kennedy effort explicitly lists the types of research that are excluded from the ban exempting the cloning of cells, tissues, DNA and animals.

Bill Does Not Ban All Cloning

Feinstein noted the legislation has very precise definitions and prohibits only the implantation of an embryo made through somatic cell nuclear transfer into a woman's womb for the purpose of creating a human being. For those who would defy the ban, the legislation gives the U.S. attorney general exclusive enforcement authority to assess fines of $250,000 or two times the gross gain or loss resulting from the violations.

"This legislation makes it illegal to produce human beings by cloning and establishes strict penalties for those who try to do so," Kennedy said. "But as important as what this bill does is what it does not do. It does not seek to use public concern about cloning to establish a back-door ban into human development."

Kennedy and Feinstein emphasized that cloning human cells and tissues could eventually lead to cell replacement treatments for people suffering from severe burns, in need of bone marrow transplants, or afflicted with Alzheimer's or Parkinson's diseases, or to helping regenerate severed spinal cords.

"The enormous potential of stem cell research is so important to the lives of patients and families afflicted with major diseases like juvenile diabetes, I implore Congress to think carefully and act prudently," said Douglas Melton, professor of molecular and cellular biology at Harvard University and father of a diabetic child. "In a rush to ban human cloning, a broad ban on cell research would have the unwanted consequence of prohibiting basic research that could cure disease by cell replacement."

Marian Damewood, medical director for the Women's Resource Center at the Greater Baltimore Medical Center and member of the board of directors for the American Society for Reproductive Medicine (ASRM), cautioned legislators to avoid the terms of the abortion debate when considering cloning legislation lest they stymie research into gene therapy, cancer and infertility.

"Any legislation that claims only to stop cloning, but defines a clone as created as soon as there is a zygote or embryo is not about cloning at all," Damewood said. "By prohibiting research at the zygote stage, we would be refusing to make many potentially dramatic research advances."

Sean Tipton, a spokesperson for ASRM, noted the Feinstein-Kennedy bill was the only one the society endorsed because both the House bill introduced by Vernon Ehlers (R-Mich.) and the Senate bill sponsored by Bill Frist (R-Tenn.) and Christopher Bond (R-Mo.) could open up the abortion debate once again.

Carl Feldbaum, president of the Biotechnology Industry Organization (BIO), said BIO doesn't endorse any cloning legislation at this point, but the organization is meeting with lawmakers who intend to propose cloning legislation as they did with Feinstein and Kennedy.

"[Feinstein and Kennedy] have certainly made a commendable effort," Feldbaum said. "Their bill is very precisely worded with the powerful intent to avoid any collateral damage to legitimate research. This bill could move cloning into a bipartisan issue gathering moderates from both sides."

Feldbaum said the lead in cloning legislation has been taken by partisans who are attempting to steer it into the abortion debate. He also pointed out that the cloning legislation is being considered during an election year, when individuals and parties are looking for issues that are significantly divisive in an attempt to distinguish themselves from their opponents.

"Now, we are into the pitfalls and vagaries of the election year that magnify these strong political battles," Feldbaum said. "We would have a better chance if [this debate] took place in an off year."

In a letter to all members of Congress dated Jan. 28, Feldbaum called on the lawmakers to resist the temptation of hasty legislation, noting that the FDA has the jurisdiction to regulate all human cloning efforts as they pertain to safety. In addition, he called on Congress to avoid using the cloning debate to reopen issues such as embryo research and definitions on when life begins.

Nevertheless, House Majority Leader Dick Armey (R-Texas) promised last Thursday to move quickly anti-cloning legislation in the House that would permanently ban human cloning. *