Where scientists call the shots

Advanced capabilities and lax regulation put Israel on the leading edge of cloning

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Despite the seminal nature of the research at the time and the ethical issues involved, the researchers did not obtain a permit from the appropriate committee of the Israeli Ministry of Health responsible for such research. Instead, it was approved by an in-house committee of the hospital where Itskovitz serves as head of the obstetrics and gynecology department; he and his team have argued that there was no need to apply to the Ministry of Health.

Today Itskovitz is at the forefront of a scientific pressure group lobbying the Israeli government and parliament for permission to clone human embryos. Itskovitz, with a small but highly influential group of doctors and scientists from hospitals and universities, took their lobbying to the Israeli parliament last year to prevent and thwart legislative attempts to limit cloning.

They appeared in front of the parliament's science committee as self-styled impartial experts, but most of them have many financial interests in cloning and stem cells. Itskovitz has applied to the U.S. Patent and Trademark Office for patents on his stem cell lines. Others have started biotech companies that aim to profit from stem cell research.

Itskovitz sees no conflict in his lobbying against cloning regulations. "The argument is pathetic,"said Dr. Itskovitz recently in response "It reflects an incredible lack of understanding. Every sane person who wants to advance science and save human lives wishes this research would be allowed. It is obvious that every academic institution has an economic interest in its own research but that is the state's interest as well."

There is no cloning research carried out in Israel on primates or other animals but controversial experiments are being carried out on women and human tissues in the field of fertility. In fact, doctors from Sheba Medical Center, near Tel Aviv, headed by Dr. Jacob Levron, were but a step away from cloning embryos: they have removed the cytoplasm, which surrounds the nucleus, of infertile women's eggs and replaced it with cytoplasm of a donor. While most DNA is in a cell's nucleus, some of it is in tiny kidney-shaped structures named mitochondria, which are in the cytoplasm. The Sheba Medical Center's technique produces babies that in effect have three genetic parents: the mother whose cell nucleus created the baby, the father whose sperm fertilized the egg, and the woman who donated the cytoplasm.

Other experimental techniques that raise ethical questions are also being developed. Doctors at Beilinson–Rabin medical center took female embryos, who were aborted late in pregnancy, removed the follicles from their ovaries and developed them into mature eggs. Gynecologists at Hadassah hospital in Jerusalem helped a 62-year-old woman to get pregnant using in vitro fertilization. Many hospitals are developing and implementing genetic screenings of embryos that enable one to avoid giving birth not just to babies with devastating diseases that result in early childhood death but also with traits such as infertility or deafness. All this research has been carried out without any public debate. The Ministry of Health, which grants research permits, published no reports on any of the controversial techniques it had approved. In fact, the entire decision making process is limited to a few individual researchers that take part in these committees.

Israel has highly advanced research capabilities, lax regulation and no monitoring mechanism for the cloning of embryos and human embryonic stem cells. A law passed by parliament in 1999, and renewed in 2004, forbids reproductive cloning for a five-year period. According to UNESCO, Italy and Russia are the only other countries to have temporary bans on cloning. Moreover, the law refers only to reproductive human cloning and there are no official state regulations, or even guidelines, on human embryonic stem cell research or on cloning human embryos.

Compared to the debates on cloning in Europe and the United States, the Israeli discourse is far more open to the possibility of human cloning. Reproductive cloning is not perceived as a taboo, and it is often condoned. A report published by the Academy of Sciences and Humanities' advisory committee on bioethics states that: "human cloning may one day enable an infertile couple to have a genetic twin for the father or the mother… where no other reproductive method is suitable."

A committee set up by the Ministry of Health to review genetic and cloning research, and to apply the international standards for ethical medical research which grew out of the 1964 Declaration of Helsinki, stated that "in principle" there is "no problem" to clone human embryos. The "Helsinki committee," which is appointed by the Israeli Ministry of Health, neither has the authority nor the ability to monitor or supervise the experiments it approves.

While there is no regulatory body that can monitor research, the research lobby demands the right to clone embryos immediately. They are lobbying the parliament and the medical establishment for a bill that will allow researchers to purchase eggs for research purposes. The aim is to make available the large number of eggs required for cloning. The bill proposes to cancel the current limitations that restrict egg donations solely to women who are undergoing infertility procedures and for the fertilization of another woman. The lobby of scientists and doctors warned members of parliament that without this change, Israel would face a setback in the progress of biomedical research.

"There are other sources for human embryonic stem cells research," said attorney Nira Lamay, who works with the Ombudsman for Future Generations in the parliament (whose task is to examine the implications of new and existing laws for coming generations). "Many of the potential implications of cloning were not examined—implications for women, for women's ova, for society, for the children that will be born. Today that place belongs exclusively to the scientists."

Tamara Traubmann is a science and health reporter with the Israeli daily Haaretz.
(Yossi Melman a senior commentator with Haaretz and a member of ICIJ contributed to this article.)

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