National Academy of Sciences Committee on Science, Engineering, and Public Policy
Board on Life Sciences
Public Panel on Human Reproductive Cloning

August 7, 2001; [1:00 - 3:00] PM EDT; Main Auditorium of the National Academy of Sciences; Washington, D.C. ( CNN) --

Editor's Note: For the sake of the historical record, I accumulated two-and-one-half hours of video material from CNN, CNN-Headline News, FOX, ABC, CBS, NBC, and other news sources during this exceedingly heavy media day for cloning sciences [and that's with commercials stripped out!] A formal report of this meeting is expected to be published by the NAS at the end of September.

Chairman of the 12-Member Panel: Dr. Irving L. Weissman, M.D., Karel and Avice Beekhuis Professor of Cancer Biology, Cell, and Developmental Biology at the Stanford University Medical School, who originally identified the first human stem cells in bone marrow.

Main Speakers:

1. Dr. Sverino Antinori, MD, OB/GYN, Infertility Pioneer; International Associated Research Institute, Rome, ITALY; In 1994, he caused a stir when one of his patients, a 62 yo woman, became pregnant, proving it's the aging "seed and not the soil." In 1996, he caused another stir when another patient, a 59 yo woman this time, become pregnant with twins, another first. Work will begin for 200 couples in an un-named European (Mediterranean) country in November, and the first birth of a human clone is to be expected in the second-half of 2002 (presumably following the traditional nine-month gestation period).

2. Dr. Panos (Panayiotis) Zavos, Ph.D., Andrologist, Andrology Institute; former Professor in the Department of Animal Sciences, The University of Kentucky, Lexington, KY.

3. Dr. Brigitte Boisselier, Ph.D., Biochemist, former Visiting Professor of Chemistry at Hamilton College, Clinton, NY; Scientific Director of Clonaid, Inc. in The BAHAMAS; Bishop of the Raelian Movement of Geneva, SWITZERLAND and Quebec, CANADA

Panelists:

1. Dr. Rudolf Jaenisch, Ph.D., Professor of Biology of the MIT Whitehead Institute; Cambridge, MA; Specializes in mouse stem cells; [Speaking to Dr. Zavos] "You publish in Time Magazine, while I publish in Science."

2. Dr. Alan Trounson, Ph.D., Embryologist, The Monash Institute; AUSTRALIA; [Speaking to Dr. Boisselier] "Your assertion" [that you can predict a healthy birth with proper diagnostic tests] "is ridiculous. I don't think that is at all possible."

3. Dr. Ian Wilmut, Ph.D., Creator of Dolly the Sheep, Editor-in-Chief of the journal Cloning, Roslin Institute; Edinburgh, SCOTLAND; "Since we know that the animal failure rate is maybe 200:1, [18 percent of cloned mice die; 48 percent of cloned goats die], there can be expected to be a lot of human carnage along the way, if these people continue on their current path."

4. Dr. Alan Colman, Ph.D., Director of Research at PPL Therapeutics, Edinburgh, SCOTLAND

5. Dr. Singer "There are 42 human genes that are imprinted [and may be responsible for abnormalities of dysregulation?]"

6. Dr. Gallos, formerly with NIH(?).

7. Dr. R. Alta Charo, Ph.D., Member of many scientific/government commissions on reproductive technologies, Professor of Law and Bioethics, University of Wisconsin; Madison, WI.

8. Dr. Mark Siegler, M.D., Bioethics, Professor of Medicine at the University of Chicago, Chicago, IL

[ Editor's Note: It should be pointed out that cloning {Somatic Cell Nuclear Transfer (SCNT)} has been successfully accomplished with sheep (starting with Dolly four years ago and aside from being slightly overweight this ewe appears to be completely normal in all outward respects {However, we are unsure about her possibly shortened telomeres, and the potential life-shortening effects of this condition, but remember that this strain of sheep can typically live for 15 years, and we still have a long ways to go.} and has given birth to two different litters of normal lambs in the usual manner {by ram}), cows, goats, pigs, one celebrated gaur, and lots of mice (Honolulu Technique); the number of cloned animals now numbers in the thousands. However, despite our best efforts and seemingly adequate funds, no one has yet cloned cats, dogs, horses, rabbits, rats, or monkeys. My question is -- "Why not?" Other than the special problems with estrus in canines (bitches come into heat only twice a year or so) that I am aware of, I have no clue as to whether this is a problem of technique ( in practice) or a fundamental problem ( in principle). Do any of our readers know? Please get in touch, so we can discuss and/or publish your explanations.]

Ref. Nancy Gibbs, Andrew Goldstein, Matthew Cooper, and Michael Duffy, "Cloning: Where Do You Draw the Line?" Time Magazine (August 13, 2001).

Quote of the Day: "I have attended many scientific meetings over the years, but I have never seen such acrimony in a scientific meeting as this one." -- Elizabeth Cohen, CNN Medical Correspondent.

Renegade Researchers Tell Committee They Will Defy Any US Ban on Human Cloning
by
Ori Twersky

August 7, 2001; Washington, D.C. ( Reuters Health) -- Appearing before a panel of experts charged with advising the government whether to proceed with a moratorium on all human cloning, three scientists on Tuesday repeated their intention to clone a human despite the objections of Congress, the President or mainstream scientists. Dr. Panayiotis Zavos and Dr. Severino Antinori, who are working together, and Dr. Brigitte Boisselier said they would proceed with their previously announced plans because human cloning could play a large role in the treatment of infertility.

They made their comments before a National Academies Committee on Science, Engineering and Public Policy Board on Life Sciences, which was convened to write a report on the ethics and viability of human cloning in the US. "Infertility is a disease," said Dr. Zavos, who runs an infertility clinic in Lexington, Kentucky, and plans to partner with Dr. Antinori, an infertility specialist based in Rome. "I think that it's a fundamental right to mix your genes how you want," added Dr. Boisselier, a chemical engineer whose company Clonaid advertises cloning services on the Web. "If you want to reproduce yourself, it's your own choice."

Although it is unclear as to how far the research has progressed, Dr. Boisselier added in an interview with Reuters Health that a human clone could be seen within a year. Other scientists insist that there is still too much at stake to begin cloning people. "If the researchers were to proceed, then the expected results would be genetic abnormalities, spontaneous abortions and death," said Dr. Ian Wilmut, one of the researchers who cloned Dolly the sheep at the Roslin Institute and PPL Therapeutics in SCOTLAND. Dr. Wilmut noted that in every case of successful animal cloning there have also been a large number of deaths, abortions and complicating conditions such as respiratory, heart and circulatory problems. "One of the questions people who want to produce a human clone should answer is how would you treat a human with these results," he said.

During the sometimes civil, sometimes heated debate, others added that it still appears unethical to clone a person, despite recent improvements in the cloning technique. Although the technique is improving, researchers need more practice before it could be considered a viable human treatment, said Dr. Alan Colman, the Research Director of PPL Therapeutics.

The problem is that its almost impossible to screen for possible defective genes, explained Dr. Rudolf Jaenisch, a Professor at the Massachusetts Institute of Technology. "There is no way to predict whether a given clone will develop into a normal or abnormal individual," he told the panel members. However, these arguments did not appear to sway Dr. Zavos and the others, who pointed out that there have already been decades of research into assisted reproduction of humans. The three researchers added that they would halt their efforts if the technique proved ineffective or dangerous, and they chastised their fellow scientists for buckling to public opinion. "I am responsible person. My main concern is for the scientific community. We should be a compass of public fear. We should fight for this type of research in the right places," said Dr. Boisselier.

The US House of Representatives recently voted to ban cloning for any purpose, and President Bush is in the process of deciding whether government funding should be allowed for embryonic stem-cell research. Part of this debate is the issue of whether it should be permissible to create embryonic clones for medical research. Scientists on the panel insisted that there are significant distinctions to be made between reproductive cloning and cloning for research purposes [therapeutic cloning]. For example, while both types of cloning rely on largely the same initial technique, "embryos created for stem-cell harvesting would not be implanted into a human uterus," Dr. Jaenisch observed.

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Westport, Connecticut Newsroom: 203-319-2700.

Human Clone Promise Attacked
by
Philip Cohen
New Scientist,
No. 97 (August 11, 2001)

August 8, 2001; Two maverick scientists have unveiled their plan to produce the first cloned human baby by the end of 2002. Tempers flared as the pair faced those opposed to cloning humans at a scientific panel in the United States. While ethical and legal issues were discussed, safety emerged as the key issue, and the scientists' claims that they could detect abnormalities in a cloned embryo before implantation were roundly dismissed.

"It sounds as if [they] are likely to proceed with cloning in humans despite animal data that raises concerns and worries about it," says Mark Siegler, a doctor and ethicist at the University of Chicago. The panel was brought together by the National Academy of Sciences for a report exploring the use of human cloning in basic science and medicine, such as the creation of tissues for transplant.

Brave New World

One group led by Dr. Severino Antinori, an Italian fertility specialist, and his colleague Dr. Panos Zavos of the Andrology Institute in Kentucky formally announced plans to treat 200 couples suffering fertility problems starting in November. In a session characterized by angry exchanges with their critics, Antinori and Pavos told the panel how they intend to avoid the health problems often seen in animal clones by using cutting edge technologies such as pre-implantation genetic diagnosis which detects genetic defects, and ultrasound which can be used to monitor the development of the fetus in the womb.

Antinori said his team would begin creating cloned embryos "within a month or so." He also said he will restrict their cloning service to couples who are not able to reproduce through more conventional reproductive technologies. This could be, for example, because the man completely lacks the ability to produce sperm. "We are not perfect but we are trying to get there as perfect as we can," says Zavos. "If we cannot do it right, we will not do it."

Hidden Defects

That assurance did little to silence their critics. Dr. Ian Wilmut of the Roslin Institute in Edinburgh, whose team created Dolly the sheep, described two animals -- one sheep and one cow - that appeared healthy at birth but later died from lung and immune system disorders, respectively. These would have been nearly impossible to diagnosis in utero.

Jay Cross, a reproductive biologist at the University of Calgary in Alberta, CANADA said work by his lab showed that the genetic dysregulation in clones occurs in very specific and limited tissues. So plucking a cell or two for diagnosis, as Antinori's team described, would probably miss any defect.

"This is a needle in a haystack sort of issue," he says. "If it was possible to biopsy cells from a placenta or use diagnostic tests, why wouldn't we be using this today to improve the outcome of the IVF procedure?"

Deep Imprint

The other would-be human cloner, Dr. Brigitte Boisselier suggested her plans were more expansive and more advanced. She is a reproductive scientist at Clonaid, a company founded by the Raelian Movement (that believes that extraterrestrials started life on Earth and resurrected Jesus through cloning).

She says that cloning should be available to anyone who wants to use the technology. She also suggested her company had already produced cloned human embryos and developed a method to screen for "imprinting defects" in ten human genes. Imprints are tags on genes which some data suggests are disrupted in clones and may account for some of their health problems.

A number of scientists who were clearly sceptical pushed Boisselier on her claims of a technological advance. "I don't believe that's possible," says Alan Trounson of the Monash Institute. But the human cloners had little substantive to say in response to these criticisms. Instead, they tried to explain their caginess. Boisselier cited the privacy concerns of her company as her reason for withholding data, but says she hopes to publish her results soon. "I believe we know enough to proceed in human cloning," she said.

Zavos, when asked whether his work would be subjected to the normal process of peer review, said such oversight was not possible given a political atmosphere that has driven scientists to develop the technology in "clandestine" laboratories. "Are you going to arrest us or share our results?" says Zavos.