Is it Cloning? U.S. experiment in China – Baltimore Sun
Fri, 17 Oct 2003
Concern has been raised about unauthorized US initiated human experiments conducted offshore. One such experiment is said to come “perilously close to human cloning.”
The debate prompted the chief scientist of a biotech company in Singapore to note: “If a German researcher is found to have conducted unauthorized stem cell work abroad, he can be held criminally liable when he returns.”
The FDA lacks similar enforcement mechanisms–such as exists in Germany today. FDA’s partial efforts to contain radical genetic human experiments has encouraged US Medical cowboys to sweep aside such niceties as medical research ethics and moral responsibility for avoiding potentially monstrous consequences.
The Baltimore Sun reports that an NYU professor “appeared to be dodging U.S. regulations that were designed to protect patients” by hiring a local Chinese scientist to conduct the “cutting-edge DNA transfer experiment” to impregnate an infertile Chinese woman.
Critics say the technique used “was perilously close to human cloning.” They note that “the reconstructed embryos contained DNA from three people – the mother, father and the donor of the egg.”
This radical experiment comes on the heels of other failed gene transfer experiments not successes. For example, a study confirmed this week that the gene therapy experiment that was used to treat two French children with an inherited immune system disease (SCIDS) activated a cancer-causing gene in the youngsters, leading to leukemia. See: http://www.cnn.com/2003/HEALTH/10/16/leukemia.study.ap/index.html
Supporters of the Chinese fertility experiment claim it is not an example of cloning: “The procedure is technically the same, but the origin of the nucleus is different. In cloning, you’re trying to reproduce an individual that already exists.”
The risks of this experiment go even beyond those to individual humans: “We are taking the risk there to introduce third-party DNA, and we don’t know, what are the consequences?” said Dr. Jairo E. Garcia, director of the in vitro fertilization program at the Johns Hopkins Fertility Center.
But in a culture dominated by an entrepreneurial ethos, no one calculates the risk of unintended adverse consequences.
Alan Colman, chief scientific officer of ES Cell International suggests: “one way to prevent scientists from circumventing regulations in their home country is to follow the German model. Germany holds its stem-cell scientists accountable no matter where in the world they do their research.”
It is unclear whether human pesticide experiments are permitted in Germany? If not, why are pharmaceutical /pesticide companies who conduct human pesticide experiments in other countries not held accountable? See: http://www.beyondpesticides.org/NEWS/daily_news_archive/2003/05_19_03.htm
U.S. science tested on humans abroad
Ethics: Debate surrounds the practice of shifting experiments overseas to circumvent U.S. regulations.
By Julie Bell and Michael Stroh
October 17, 2003
When Chinese and American researchers reported this week that they had used a cutting-edge DNA transfer to impregnate an infertile woman in China, they set off an ethical, political and scientific debate.
The reason: The American scientist turned his technique over to Chinese colleagues because they could try it without waiting for permission from the U.S. Food and Drug Administration.
The announcement touched a nerve in the scientific community. Should a U.S. researcher move experiments overseas to avoid regulations designed to protect human research subjects?
To some, the answer is clear. “I think in this situation, doing research in another country where the regulations are less protective of patients is not ethical. And there have been many situations before where that’s been made clear,” said Mildred K. Cho, associate director of the Stanford University Center for Biomedical Ethics.
But not everyone is so sure. The debate reflects divisions of thought in a fast-moving medical discipline where scientists are using the building blocks of biology to treat disease, create new human tissues to replace damaged ones and – in this case – spur development of new human life.
Critics argue that the nuclear-transfer technique doctors used to impregnate the Chinese woman was perilously close to human cloning. Others say it’s much more like the in vitro fertilization techniques widely used in U.S. clinics.
“This is clearly closer to the way they do traditional infertility treatment,” said Jonathan D. Moreno, director of the Center for Biomedical Ethics at the University of Virginia.
Moreno says the FDA might be going too far by requiring anyone who wants to transfer a mother and father’s DNA into a donor’s egg as part of a fertility treatment to apply to the agency for permission.
Like many ethicists, he sees a future of controversial research popping up in countries with less restrictive policies than the United States because biological and genetic information is easy and cheap to transfer.
Some foreign labs are already paying top dollar to recruit U.S. researchers, and countries that haven’t traditionally been seen as research powerhouses now have a growing number of highly trained scientists.
In their experiment, researchers from New York University and Sun Yat-Sen University of Medical Science in Guangzhou, China, took DNA from a prospective mother and father and transferred it into a hollowed-out donor’s egg whose own nucleus had been removed.
The reconstructed product was then transferred into the mother’s uterus.
She became pregnant with triplets, but none lived – the result of obstetric complications that researchers said were unrelated.
In an abstract of their findings presented to the American Society for Reproductive Medicine, the scientists said they detected no genetic defects or other problems in the fetuses they tested.
Scientists used a similar nucleus-swapping technique in creating Dolly the sheep. But in that case, a sheep’s own DNA was fused into a hollowed-out egg before being implanted, creating Dolly, an exact copy.
“There’s no fine line there,” said Dr. John Gearhart, a developmental biologist with the Johns Hopkins School of Medicine. He said the Chinese fertility treatment was not an example of cloning.
“The procedure is technically the same, but the origin of the nucleus is different. In cloning, you’re trying to reproduce an individual that already exists.”
But even some who agree with that assessment of the procedure are concerned about the fact that the NYU professor appeared to be dodging U.S. regulations that were designed to protect patients. They note that the reconstructed embryos contained DNA from three people – the mother, father and the donor of the egg.
“We are taking the risk there to introduce third-party DNA, and we don’t know, what are the consequences?” said Dr. Jairo E. Garcia, director of the in vitro fertilization program at the Johns Hopkins Fertility Center.
Researcher Jamie Grifo developed the procedure used in the Chinese experiment at NYU and tried it in 1998 on several patients who did not become pregnant.
He told The New York Times that he shared his knowledge with Chinese scientists after the FDA in 2001 began requiring anyone doing such experiments to apply for permission.
The application is similar to the one a pharmaceutical company must file before testing an experimental drug in people, something Grifo said was too time-consuming and expensive, and unlikely to be granted.
“We knew patients would benefit, and we did not want to see the research die,” he told the Times.
Dodging regulatory hurdles is not unheard of in medical research. In the United States, for example, it is unethical for scientists testing an experimental therapy to use placebos (sugar pills or drugs with inactive ingredients) on fatally ill test subjects if there are proven treatments available. But in recent years, critics have attacked U.S. pharmaceutical companies for testing therapies in the Third World, where regulations concerning placebos are less strict.
Some research institutions have been criticized for other lapses abroad that would not be tolerated here.
Malaria against AIDS
In 2000, the FDA ordered the Cincinnati-based Heimlich Institute to stop experiments in which Chinese AIDS patients were injected with malaria in an effort to kill the AIDS virus – a widely discredited treatment known as malariotherapy. The study was conducted in the 1990s on a small group of patients in collaboration with Chinese scientists.
The Bush administration’s strict, but hotly contested, regulations on embryonic stem cell research, imposed in 2001, have also prompted some scientists to move to countries such as the United Kingdom and Singapore, where regulations on stem cell work are less restrictive.
The globalization of biological and genetic research will provide fertile ground for ethical controversy in the future, according to John E. Pike, director of GlobalSecurity.org. One reason is the potential for big money in biotechnology today.
“Frankly, compared to most other scientific disciplines it’s a heck of a lot more lucrative,” Pike said. “You’re not going to get rich quick in physics. All the available get-rich-quick schemes in chemistry pretty much played out a century ago.”
In a globalized setting, some ethicists say, the simple presumption that American moral and regulatory standards are superior is dangerous ground.
Patient protection should always be paramount, said Laurence B. McCullough, a professor of medical ethics at Baylor College of Medicine. But he added, “The ethical and legal standards of the United States aren’t the last word on the subject. … In an ethically controversial area, there’s more than one way to manage the controversy.”
At NYU, Dr. Keith M. Krasinski, chairman of the medical school’s Institutional Review Board, said the university normally reviews all research on humans that it sponsors or that its faculty members conduct.
But he said the university’s approval wasn’t necessary in the Chinese fertility experiment because Grifo “didn’t conduct the research.”
“He didn’t supervise the research. He was never in China,” Krasinski added. “He’s not in trouble in any way.” He said Grifo is listed as a co-author in the research findings as matter of academic “courtesy.”
‘Think very carefully’
That reasoning is unlikely to satisfy many critics. Scientists “should think very carefully and be sure of their moral position when they go to a place like China to conduct research,” said Alan Colman, chief scientific officer of ES Cell International in Singapore, a biotech firm that does stem cell research.
Colman said one way to prevent scientists from circumventing regulations in their home country is to follow the German model. Germany holds its stem-cell scientists accountable no matter where in the world they do their research. If a German researcher is found to have conducted unauthorized stem cell work abroad, he can be held criminally liable when he returns, Colman said.
“At the end of the day, a scientist who goes abroad is often judged by his peers at home,” Colman said. “That’s very powerful pressure and I hope will make them think twice.”
Copyright (c) 2003, The Baltimore Sun
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