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Genetics

Special report: Dim chance for global cloning ban

By M. Asif Ismail

Deep divisions within the international community, fed by religious views, economic interests and U.S. domestic politics, are hampering efforts to outlaw human reproductive cloning worldwide. Nearly all countries agree that reproductive cloning, or the creation of an identical human being through asexual reproductive methods, should be banned. But fewer than 30 of the 191 states recognized by the United Nations have outlawed researchers from attempting the procedure, according to UNESCO.

More than 150 countries have no law on the books that bars reproductive cloning, including many—like the United States—which have the scientific resources and facilities necessary to produce a human clone. In the absence of either national laws or an international agreement outlawing the procedure, researchers are developing techniques around the world—in South America and Asia—that could be used for reproductive cloning. In Europe, several countries have adopted laws banning reproductive cloning, but research continues, while in Israel, which has adopted a five year ban on the procedure, scientists work with little oversight and can easily transport the products of their research abroad.

Genetics

A human rights issue

By M. Asif Ismail

The 45-member Council of Europe, the oldest multilateral political organization on the continent, outlawed "[a]ny intervention seeking to create a human being genetically identical to another human being" by amending its Convention on Human Rights and Biomedicine.

The additional protocol to the treaty noted that such an action was necessitated by "scientific developments in the field of mammal cloning, particularly through embryo splitting and nuclear transfer."

Great Britain, whose biotech industry is the largest in Europe, is one of the many countries to adopt legislation on the issue. "The Human Reproductive Cloning Act," enacted in 2001, mandates up to 10 years of prison and an unlimited fine, if convicted of creating human clones. At the same time, the law allows research on cloning for therapeutic purposes with strict regulation. The Human Fertilisation and Embryology Authority regulates embryo research in the country.

In the other continental biotech giant, Germany, all embryo research is banned.

Other Western European countries that prohibited reproductive cloning include Austria, Belgium, Denmark, France, Iceland, Italy, the Netherlands, Norway, Portugal, Spain, Sweden and Switzerland.

"Issues of human genetics and bioethics in Europe have been widely accepted as human rights issues concerning human dignity and fundamental freedoms of the citizens," according to Emilia Ianeva, director of the Center for Human Rights at California State University, Hayward.

Genetics

Where scientists call the shots

By Tamra Traubmann

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."

Genetics

Favorable logistics

By Claudio Julio Tognolli

Brigitte Boisselier, a French biochemist and the chief executive officer of Clonaid, announced in March 2003 that her group would present proof of the first human clone at a parents' gathering in Brazil. She said that Clonaid would offer its services to couples wanting children, gay couples, people with HIV and those who had lost a loved one. Boisselier told reporters she was offering a special discount for human clones to Brazilian customers, approximately $200,000 per clone.

Clonaid, which advertises itself as the first human cloning company and is associated with the Raelians, the Montreal-based cult founded by former French broadcaster Rael, has never provided any proof substantiating the various claims it has made about human cloning.

The only evidence it offered was a photo released March 25, 2003, to the Brazilian press of a so-called human clone. The company claimed to have cloned five babies, with the help of Brazilians. Eve, allegedly the first baby clone, was born on December, 26, 2002 from a North-American couple; a second clone, the daughter of a Dutch lesbian, was born in January, 2003, the group claimed. Other clones, Clonaid said, were born in Japan and Saudi Arabia.

While such sensational announcements about a series of successful births of human clones have been greeted with widespread skepticism and doubt, Boisselier's press conferences helped to spread the notion that human cloning research is going on in Brazil.

An Associated Press report in March 2003, which quoted Boisselier as saying that her group had been invited to speak to the Brazilian parliament, said the legal climate in the country is more sympathetic to cloning.

Genetics

International cloning timeline

By Alexander Cohen

March 1996 – The United Kingdom's Human Fertilisation and Embryology Authority, the main government agency responsible for licensing U.K. embryo research, issues its first license for human embryonic stem cell research to the University of Edinburgh's Institute for Stem Cell Research.

February 1997 – Ian Wilmut and other scientists from Scotland's Roslin Institute announce the creation of the sheep Dolly, the world's first successful clone of an adult mammal.

March 1997 – Don P. Wolf and a team of researchers at the federally-funded Oregon National Primate Research Center announce that they have produced rhesus monkeys from cloned embryos, the first successful use of cloning-related technology in primates.

March 1997 – Citing the technology used to create Dolly as raising "profound ethical issues," President Clinton prohibits the allocation of federal funds for human cloning.

June 1997 – The Group of Eight, consisting of the United States, Canada, France, Germany, Italy, Japan, Russia and the United Kingdom, adopts a resolution agreeing on "the need for appropriate domestic measures and close international cooperation to prohibit the use of somatic cell nuclear transfer to create a child."

November 1997 – UNESCO adopts the Universal Declaration on the Human Genome and Human Rights. Article 11 specifically prohibits the reproductive cloning of human beings.

January 1998 – Physicist Richard Seed announces he has formed a team to attempt human cloning before the advent of legislation banning the technology.

January 1998 – The Council of Europe amends its Convention on Human Rights and Biomedicine to prohibit reproductive and therapeutic cloning of human beings. To date, the revised convention has been ratified and implemented by 14 countries.

Genetics

In Congress, a cloning stalemate

By M. Asif Ismail

Since Congress first mooted legislation on the issue in 1997 following the birth of Dolly, the first mammal to be cloned from an adult cell, some 44 bills have been introduced on the human cloning issue.

In the past three years, the House of Representatives passed two bills that would prohibit human cloning research, including one passed by the House in February 2003 that would have made attempts to clone a human embryo a crime, punishable by a 10-year prison sentence. Both bills have died in the Senate.

Most of the legislative initiatives so far have sought to prohibit one of the two types of cloning—reproductive cloning, the asexual creation of a human being through cloning technology, and therapeutic cloning, the use of cloning technology for medical research—or both.

There is widespread agreement in Congress that reproductive cloning needs to be outlawed. But a sharp difference over therapeutic cloning continues to cause a stalemate. Lawmakers have lined up in nearly equal numbers with the two broad coalitions that have been fighting it out on the issue.

One group, consisting mainly of pro-life organizations, religious conservatives and churches, considers any research on human embryos to be immoral. The other side— scientific and medical community, the biotechnology industry, and patients' rights groups—while denouncing reproductive cloning, oppose any restrictions on therapeutic cloning, claiming that the technology could potentially lead to treatment of life-threatening diseases.

The American Medical Association and the National Academy of Sciences have voiced their support for therapeutic cloning. But those in the scientific and medical world, by and large, also support a ban on reproductive cloning. At a recent meeting on human cloning, more than 60 national science academies called for a ban on attempts to create a human clone.

Genetics

Closing in on human cloning

By M. Asif Ismail and Agustín Armendariz

Although two successive presidents have publicly opposed human reproductive cloning, the federal government's aggressive funding of experiments in cloning technology in nonhuman primates is bringing human cloning closer to reality.

Since 1991, the Center for Public Integrity has found, the National Institutes of Health has given more than three dozen grants for cloning-related research in nonhuman primates such as rhesus monkeys, which are genetically close to Homo sapiens. And the agency is currently supporting—to the tune of $6.4 million—a five-year experiment specifically intended to remove obstacles in monkey cloning.

The research is relatively unregulated and has little public oversight. Some experts warn that it will ultimately bring human cloning closer to reality—unless clear laws are enacted to ensure that the knowledge gained from primate-cloning research is not replicated in human beings.

"People have to be aware of how close [cloning of nonhuman primates and human beings] are to each other," said Stuart Newman, a professor of cell biology and anatomy at New York Medical College.

"The animal cloning science is having a complete free ride," said University of Pennsylvania bioethicist Autumn Fiester. "Sky is the limit [for the science]—there is no regulation, no limitations placed on the science at this point."

The bulk of the government's largesse went to three researchers: Gerald Schatten, who helped produce the first genetically altered primate and received the five-year, nearly $6.4 million NIH grant mentioned above; Don Wolf, known for the creation of sibling rhesus monkeys from cloned monkey embryos; and James Thomson, one of the scientists who first isolated stem cells in human beings.

All three have strong ties to either of two NIH-funded National Primate Research Centers, one in Beaverton, Ore., and the other in Madison, Wis.

Genetics

Regulating cloning

By M. Asif Ismail

Having helped block federal legislation that would ban human cloning for therapeutic purposes, the biotechnology industry is lobbying a handful of state legislatures to pass bills that would legalize the controversial techniques. Five states are currently considering nearly identical measures that the Biotechnology Industry Organization (BIO), the industry's lobbying group, advocates; two other states, California and New Jersey, have already passed such measures into law.

The state bills faithfully duplicate word for word substantial portions of a BIO-backed bill that California adopted two years ago. Critics charge that the legislation is marked by "sloppy language" and ethical ambiguities. BIO's intention in backing the bills was made clear in an unsigned memo to members of its state government relations committee dated March 4, 2003.

"BIO is circulating the [California] legislation as a means of promoting its solution to enabling therapeutic technologies," the memo read in part. It goes on to note that opponents of unregulated cloning technology are battling state efforts to permit cloning human embryos to extract stem cells. "They understand the effort to create stem cell research at the state level."

Since 1999, BIO has spent $12.7 million lobbying Congress and the executive branch on a number of issues, including its effort to block legislation on human cloning. The trade association and its state affiliates have also backed state bills that legalize embryonic stem cell research, permit with some restriction the sale of embryonic and fetal material, and allow researchers to create embryos for the purpose of medical research.

Some of the state bills that BIO is backing outlaw reproductive cloning. However, while they ban researchers from performing human cloning experiments that would result in the birth of a cloned human being, they allow the development of cloning techniques that might lead to new treatments for diseases.

Genetics

Lobbying, old-time politics block legislation on human cloning

By M. Asif Ismail

In the spring of 1997, scientists at Scotland's Roslin Institute successfully reproduced a sheep using DNA from a single adult sheep cell. It was a spectacular breakthrough. But the birth of Dolly, the first cloned mammal in history, provoked outrage among anti-abortion activists and many bioethicists, and triggered a debate on the dangers of human cloning.

In the United States, public interest groups and religious organizations clamored for the federal government to regulate any research that would lead to human cloning. A CNN/Time magazine poll taken after the announcement of Dolly indicated that 89 percent of Americans agreed that it was "morally unacceptable to clone humans." President Clinton responded promptly by issuing an executive order on March 4, 1997, prohibiting the use of federal funds for human cloning, citing what he termed "profound ethical issues."

But the presidential action did not affect privately funded research. Meanwhile, the Scottish company owned by the Roslin Institute was bought in May 1999 by an American biotechnology firm, Geron Corp., bringing the possibility of human cloning closer to home for Americans. Subsequently, Japan, India and most European countries banned cloning or imposed laws supervising such research, while the United Nations, the World Health Organization and the G-7, seven top industrialized nations, called for an outright ban.

Yet nearly three years after Dolly, there still is no federal legislation in place in the United States to regulate or even supervise human cloning, though some states have acted.

What is perhaps the most complex scientific and moral issue ever faced by Congress has become the object of traditional inside-the-Beltway maneuverings. Campaign contributions, revolving-door politics and old-fashioned lobbying by the biotechnology industry have helped keep any sort of cloning legislation from being enacted.

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