Donor breakthrough for cloning research

The Times
Feb. 14, 2006

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.

Egg donation, however, can cause fertility problems, and requires women to take drugs to stimulate their ovaries. This carries a risk of ovarian hyperstimulation syndrome, a complication that can, in rare cases, cause kidney damage and death. The guidelines from the Human Fertilisation and Embryology Authority (HFEA) will allow women to choose to take on these risks altruistically.

Such donations are already approved for the purpose of helping infertile couples to conceive, but not for medical experiments. Women who donate eggs for any purpose can be paid a token £15 plus expenses, though the HFEA has proposed increasing this to £250.

The rule change has been recommended by the HFEA’s ethics and law committee, in a document acknowledging a high risk of “possibly adverse publicity”. The decision is expected to be confirmed tomorrow by the authority.

It has angered embryo rights campaigners. Josephine Quintavalle, of Comment on Reproductive Ethics, said: “The journal Nature last week described egg donation as an ‘unpleasant, invasive process’ which can cause ‘life-threatening side effects’. How extraordinary then to find the HFEA endorsing donation at a time when scientists are at last acknowledging the significant risks associated with the process.”

Independent ethicists, however, said that the new rules disclosed to The Times included tough safeguards that should prevent exploitation.

Ainsley Newson, lecturer in medical ethics at the University of Bristol, said: “So long as women are made fully aware of these and are not put under duress, they should have every opportunity to participate.”

The rules permit the friends and family of scientists, or of patients with diseases that might potentially be treated using therapeutic cloning, to donate only after independent counselling to ensure that they are acting voluntarily. The clinicians responsible for collecting eggs and advising donors must not be involved in the research that will use the eggs.

The HFEA will also specifically ban one of the dubious practices that led to the disgrace of Woo Suk Hwang, the South Korean cloning pioneer found to have faked research.

Doubts about Dr Hwang surfaced when it emerged that he had used eggs donated by junior team members, creating the potential for coercion. Researchers in Britain will now be barred from donating their own eggs to their own laboratories, though they will be allowed to donate to different research groups.

The rules will permit teams at the University of Newcastle-upon-Tyne and the University of Edinburgh, which already hold therapeutic cloning licences, to recruit egg donors from a much wider pool of women.