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From the Sunday Herald

On the eve of a key cloning conference, we publish an open letter from the two pioneering scientists who aren't invited

INFERTILITY is reaching epidemic proportions throughout the developing world. Current developments in Assisted Reproductive Technologies (ART) mean there are numerous ways to treat specific causes of infertility. However, in cases where there are no gametes (sperm or eggs), the only alternatives offered to patients are sperm or oocyte (the immature female cell that divides to form an egg) donation. Many patients, how ever, do not want to use sperm or eggs from another person. Reproductive cloning can therefore play a very real part in the treatment of severe male or female infertility in couples that wish to have a biological child of their own.

Since our announcement in January that we intend to use reproductive cloning as a means to help infertile couples, we have received nothing but opposition from those in the animal cloning field. Because of the limited knowledge of these procedures in the scientific community, we have organised, hosted and attended meetings to discuss and debate the issues of human reproductive cloning. These have involved scientists from all over the world. How ever, the 'animal cloners' feel they have exhausted all possible technologies and have come to the conclusion that the tech nology is not safe to use in humans, and would like the world to believe this notion. Let's examine the facts .

Firstly, the poor cloning success rates noted by these animal cloners are mainly due to experiments that were poorly designed, poorly executed, and poorly understood and interpreted. They were mostly done in non-sterile and uncontrolled conditions. Also, when the animals died, the cause of death was unclear.

Ian Wilmut from Edinburgh's Roslin Institute and Rudolph Jaenisch from the Massa chusetts Institute of Technology (MIT) in Boston have stated repeatedly that the application of animal cloning to humans is extremely dangerous, not because of ethical and social implications, but because of its potential for failure. They say possible consequences include a very high incidence of developmental abnormalities in the human clones, large offspring syndrome (LOS), placental malfunctions, and, in newborn babies, respiratory distress and circulatory problems -- common causes of death. They also stated that the rate of success as a technique of assisted reproduction is very low, at less than 3%.

In an article in Time Magazine, Wilmut and Jaenisch state: 'Animal cloning is inefficient and is likely to remain so for the foreseeable future.' On the contrary, a number of studies have already shown high rates of development, in some cases matching or exceeding developmental rates seen in human IVF today. If history is any indication, one can expect that further refinements will improve efficiency rates.

Scientists have been reporting success rates of 32% in goats and 80% in cows since 1998, as opposed to the poor 3% success rate Wilmut obtained when cloning Dolly in 1996. Why is Dr Wilmut incapable of reviewing and grasping those facts that appear in scientific literature ?

Despite the overwhelming data showing how technological refinements yield improved success rates, Wilmut and Jaenisch still insist it is unsafe -- based upon their poor success using very crude techniques. One can only question the motives for their illogical arguments. Are they interested in working together with other scientists in developing and refining techniques to improve success rates for the future? Or do they have immense corporate interests and want to patent the technologies for themselves?

The Royal Society of Edinburgh, Scotland's Academy of Science and Letters is hosting a Debate on Human Reproductive Cloning tomorrow. Scientists from Roslin are on the panel, among others, who will represent the animal cloners. Of particular interest is that neither myself nor anyone from our Inter national Consortium for Human Therapeutic Cloning (ICHTC) has been invited to participate in what should be a healthy exchange of ideas between scientists. The meetings, described as a 'debate' appear to have only one side represented: the animal cloners. How can this be described as a debate? It is a monologue, not a debate. Was this an oversight on the part of the committee members? We think not. We have offered to participate and we have been denied because they do not agree with our viewpoint. This is a travesty, especially given that the so-called debate is held under the auspices of the Royal Society. Despite our disagreements with scientists from the Roslin Institute and others, we have always welcomed the chance to publicly discuss and debate the issues. This was very evident at our meetings at the National Academy of Sciences in Washington last August.

Animal cloning and its difficulties appear to be species-specific, and the data cannot be extrapolated with a great degree of accuracy to the human species. Also, according to Randy Jirtle and Keith Killian from Duke University Medical Centre: 'You hear over and over that we've cloned sheep, mice, cows, pigs and they've all had this problem of large offspring syndrome (LOS) and therefore you will also have these problems in humans. However, our data show you don't necessarily have these problems in humans. This is the first concrete genetic data showing that the cloning process could be less complicated in humans than in sheep.'

In A recent interview, Jaenisch openly conceded for the first time that 'the majority of failures in cloning are the consequences of inexperience on the part of the cloner.' In the past, he has tried to give the impression that failures were entirely a consequence of the cloning process itself, and that it was impossible to produce a normal, healthy clone. This is what we have been stating, very emphatically from the very beginning: that the deficiencies that have been used as arguments to stop human cloning have been due to incompetence and lack of expertise.

The incidence of develop mental abnormalities following natural sexual reproduction in humans is 3%, significantly higher when maternal age is over 40. But many potential parents accept these risks when they conceive a child. If human cloning is banned as a reproductive technique on safety grounds, we may find ourselves in the untenable position of having banned all techniques which suffer equal or higher risks -- even natural sexual reproduction with that 3% risk. It's a situation the majority of people would consider ridiculous.

It's quite evident to us as competent human reproductive specialists that with further advances in molecular biology involved in creating embryos, careful tailoring of culture conditions and appropriate screening methods, infertile couples will eventually be able to have healthy, genetically- related children through Somatic Cell Nuclear Transfer (SCNT) technology.

As Professor Robert Edwards, the great British scientist who helped create the world's first test-tube baby in 1978, so eloquently prophesied: 'Cloning, too, will probably come to be accepted as a reproductive tool if it is carefully controlled.' He, too, recalls being shunned by scientists such as those gathering at the Royal Society tomorrow, during meetings in Washington DC in 1978. Back then it was predicted that IVF would result in malformed babies and deaths. What happened in response to this Washington meeting? ' IVF exploded worldwide, abnormalities were the same or less than with natural conception. Many former critics are now pioneers of IVF. They have changed their spots. They might have delayed the introduction of IVF but their actions mostly harmed patients and ourselves,' said Edwards. We are certain reproductive cloning procedures will follow the same path.

As a final comment, if the Royal Society is interested in having a debate on human cloning, then let's have a debate and not a monologue. Let us learn from history.

Dr Panayiotis Zavos,

Professor Emeritus of Reproductive Physiology & Andrology, University of Kentucky; Director, Andrology Institute of America; Associate Director, Kentucky Center for Reproductive Medicine & IVF

Professor Severino Antinori

Professor of Physiopathology of Reproduction at the University Tor Vergata, Rome; President, Italian Society of Reproductive medicine; Scientific Director of RAPRUI Rome

 


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