THE HANDS OFF NEWS:

September 1, 2006 - The UK's sixth death related to egg harvesting: Reported on August 10th. The name of the young woman has not been released. In this case the cause of death may have been bleeding rather than ovarian hyperstimulation syndrome (OHSS), the most frequently occurring cause of death among those from whom eggs are harvested. However, one report did indicate that the bleeding was accompanied by kidney damage. This death is reported to be under investigation by the UK’s regulatory agency, the Human Fertilisation and Embryology authority. Interestingly, several of the reports have erroneously reported that no other deaths from egg harvesting are known to have occurred, or they mention only the most recent one or two deaths. There is no requirement for reporting such deaths in the US so rates are unknown. More

August 16, 2006 - The Road to Balanced Oversight: Earlier this year, an international group of scientists and others convened at Hinxton, England (see the related Policy Forum in this issue, p. 921), to address the moral challenges facing collaboration in human embryonic stem cell research that emerge from differences in national laws. Although a focus on embryo research is understandable, it is not the only area of science in which societies differ in values and laws. Scientists throughout the world work under different regulatory regimes governing human subjects, nonhuman animals, pathogens and biohazards, genetic modification of organisms and plants, and access to medical and public health records. In some cases, these differences reflect disagreements about ethically permissible conduct that approach the intensity of debates about the moral status of the embryo. More

August 10, 2006 - Safeguards for donors: Clashing perspectives on the ethics of the donation of human eggs for research purposes are likely to complicate international collaboration — whether stem-cell researchers like it or not.

What price a human egg? The question provokes a variety of emotions and responses. Some will argue that an egg has no monetary value when it is just one of those ovulated each month by billions of women and that perishes unfertilized. Others might contend that the same egg is priceless — because it could, if introduced to the correct sperm, form the seed of a new person. Others still will find it morally problematic even to pose the question, on the grounds that it treats human cells as merchandise. More

July 1, 2006 - After the Hype: What Dolly the sheep really did for us, (from New Scientist Print Edition. Subscribe and get 4 free issues)

"STUPENDOUS" and "mind-boggling" were just two reactions to the birth of Dolly, the first mammal cloned from an adult cell, 10 years ago this week. Suddenly, the idea of herds of identical prize bulls, or sheep producing medicines for humans in their milk, seemed wholly plausible. Then there was therapeutic cloning, which would provide genetically matched human tissue to patch up even the most seriously ill patient.

A decade on, much of that excitement has vanished and cloning is in the doldrums. Creating genetic replicas of animals has proved so difficult that it is only used when large profits beckon, and therapeutic cloning has not got off the starting blocks. So is that it? Were those high hopes just an illusion?

The field has obviously not been helped by the controversy it stirred up. Thoughts of cloned humans and discarded embryos generated moral, religious and political outrage. In the US, restrictions on federal funding for stem-cell research have stunted development. Then, last year, the exposure of South Korean researcher Woo Suk Hwang as a fraud set the field back several years. Cloning has also turned out to be more difficult than anyone originally thought (see "Therapeutic cloning set back by hype and fraud"). As well as being technically challenging it faces fundamental problems such as a shortage of human eggs, which unless solved will limit what can ever be achieved.

Such issues have persuaded some researchers to rethink their ideas of therapeutic cloning. The process depends on nuclear transfer, in which the nucleus of an egg is replaced by that from a patient's cell. The egg is encouraged to divide until it forms a blastocyst, from which embryonic stem cells can be collected. These ESCs, which have the same genes as the patient, can in theory transform into any of the body's cell types. It is an elegant idea, and should eventually be achievable in people - though with Hwang's work discredited only one group has reported creating a human blastocyst, and that died before ESCs could be collected.

The scarcity of human eggs has, however, convinced some that individualised therapeutic cloning is a non-starter. They talk instead of setting up ESC banks from normal, fertilised embryos. Though the match provided by these cell banks is not perfect, it should be close enough for most individuals.

If hopes for cloning are being lowered, prospects remain bright for stem-cell research in general, much of which does not depend on cloning. There have been successes in transforming ESCs into everything from insulin-producing cells for diabetics to heart-muscle cells for treating heart-attack patients. The Californian company Geron has plans to treat spinal injury with cells created from human ESCs. Using unmatched tissue in the central nervous system should not be a major problem because immune reactions there tend to be weaker than elsewhere in the body. Geron also believes the cells themselves may be resistant to attack by the immune system.

Another approach is to use the adult stem cells we all carry inside us. Researchers have recently found sites in the eyes and heart, for example, where stem cells collect, and efforts are now under way to use these cells to regenerate corneas and heart muscle.

Even the signalling chemicals that guide stem cell development may be of value as therapies. This week, researchers at the US National Institute of Neurological Disorders and Stroke report in Nature that injecting the right proteins into the brains of rats with stroke-like damage encourages adult stem cells to develop into cells capable of repairing the injuries (DOI: 10.1038/nature04940).

That is not to say that stem-cell researchers have all the answers. Far from it. The field is rife with anecdotal evidence and short on controlled studies. Identifying stem cells can be difficult, and the very existence of some types is still in question. We do not understand how some stem cells repair damaged tissue, nor can we always guide ESCs down particular developmental pathways.

Nevertheless, there are many encouraging avenues to explore and no obvious show-stoppers. Though little of this burgeoning field stems directly from the work on Dolly, her influence should not be downplayed. Dolly's creation sparked imaginations and changed people's ideas of what biology is capable of. That may be her lasting legacy.

August 7, 2006 - Sheep clonor supports human ban: A WORLD stem cell expert who helped clone Dolly the sheep has supported an extension of Australia's ban on therapeutic cloning.

Dr Alan Colman today said he had ethical issues about the present procedure of using embryonic stem cells for cloning.

The process was too labour intensive and required excessive human eggs for each embryonic stem cell, Dr Colman said.

"The ethical problem is not the embryo it is the human egg donor," he said. More

July 27, 2006 - Cloning team's IVF deal for eggs: (Note - Hands Off Our Ovaries is mentioned in this news piece) A UK fertility centre is being allowed to ask women undergoing IVF to donate eggs to therapeutic cloning research for cheap treatment for the first time.

The Human Fertilisation and Embryology Authority has issued a licence to the North East England Stem Cell Institute to permit the practice.

But the HFEA has also announced a consultation on the wider issues around egg donation for research.

There are concerns women could feel pressured to give over their eggs. More

June 30, 2006 - Mizmedi Loses in Lawsuit: The Seoul Central District Court ordered local fertility clinic Mizmedi Hospital to pay 60 million won to a woman who underwent ova extraction procedures for its failure to properly inform her about the potential risk of infertility.

The 52-year-old woman, a Korean-Japanese, filed a suit against Roh Sung-il, head of the clinic, along with stem cell scientist Hwang Woo-suk, claiming that she had not been informed about potential risks posed by the egg retrieval processes. More

April 21, 2006 - Misled Egg Donors Sue for Compensation: Two women who donated their eggs to now-disgraced cloning expert Hwang Woo-suk have filed a lawsuit against the state and two medical centers, claiming they had not been informed about potential risks posed by egg retrieval processes.

In the suit filed with the Seoul Central District Court Friday, the donors, including a 20-year-old identified as A, are each seeking 32 million won ($33,600) medical compensation against the state, local fertility clinic Mizmedi Hospital and the Hanyang University Medical Center.

The two hospitals collaborated with Hwang, a gene-scientist formerly employed by Seoul National University (SNU), on his studies on cloned human stem cells, recently exposed as fraudulent.

Civic groups, such as the Korea Women’s Association United (KWAU) and the Lawyers for a Democratic Society (Minbyun), plan providing consulting and financial support to the two throughout the trials. More

February 14, 2006 - Donor breakthrough for cloning research: BRITISH women are to be cleared to donate eggs solely for cloning experiments that promise new therapies for diseases such as Parkinson’s and diabetes, The Times has learnt.

New rules to be approved tomorrow will for the first time allow scientists to recruit donors who are not already having medical treatment, in procedures that carry potential health risks.

The decision by the Government’s fertility watchdog has stirred fresh ethical controversy about therapeutic cloning, as the new donors run the risk of damaging their health for no direct benefit to themselves.

While egg donation is critical to cloning studies, it exposes women to potential complications that can cause kidney damage or death. Until now, these hazards have meant that only patients already having IVF or other gynaecological operations have been permitted to donate eggs for research.

The revised regulations are intended to address a shortage of donated eggs that has hampered efforts to produce cloned embryonic stem (ES) cells, and could accelerate the search for new treatments.

Opponents say that this would put women at risk for the sake of speculative research.

Therapeutic cloning involves injecting the nucleus of an adult cell into an egg that has had its own DNA removed. The resulting ES cells would be genetically identical to the patient who provided the adult cell, allowing them to be transplanted to treat disease without rejection. More

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