News Review

Dolly's creator turns to humans

Professor Ian Wilmut, leader of the team that cloned Dolly the sheep, has announced his intention to clone human embryos for research.

At a conference in Berlin in October 2002 he told delegates that his laboratory, at the Roslin Institute near Edinburgh, would apply for a licence from the Human Fertilisation and Embryology Authority (HFEA) within the next six months. The proposed research will use the cell nuclear transfer procedure to make clones of patients with genetic disease. The resulting embryos will then be used to harvest stem cells which, in theory, could replicate indefinitely and act as a target for testing medicines to treat the disease.

The process will combine two technologies, animal cloning and human embryonic stem cell cultivation, both of which are still experimental and unreliable. Prof Wilmut's speciality is animal research, and the project will require collaboration with medical researchers and IVF clinics.

A limiting factor will be the supply of human eggs; there is already a shortage of eggs for IVF. The group are working on techniques to make the egg collection procedure less invasive than current practice in an attempt to encourage donations. Some have expressed fears that the poor may be exploited to obtain eggs for cloning experiments.

Current British law is often thought to have already changed to allow human cloning for such research purposes as this. This is not the case. The ProLife Alliance is still awaiting their appeal of a Court of Appeal judgement against them in January 2002, in which they challenged the law on cloning. The appeal should be heard by the House of Lords in April 2003, and Parliament has assured that no cloning will be licensed before the final outcome. (Guardian 2002;14 October:10, Scotsman 2002;10 October, ProLife Alliance press release 2002;12 October)

European Parliament calls for a ban on human cloning

Members of the European Parliament voted in favour of a total ban on human cloning on 21 November 2002. An amendment to the existing report on life sciences and biotechnology, which outlines a proposed strategy for member states, was approved by 271 MEPs with 154 voting against. The proposal urges member states to push for a total ban of the practice in their country.

The amendment specifically acknowledges the dignity of all human beings, whatever their stage of development, and calls for a universal ban on any form of cloning at the level of the United Nations. The vote was welcomed by pro-life organisations but signifies a clear rejection of the recent proposal put to the UN by France and Germany that sought only to ban cloning to produce babies, leaving the issue of therapeutic cloning for later debate. The UN has been attempting to draw up a convention to 'prevent practices which are contrary to human dignity' for the past year but has now been forced to delay its decision following opposition to the new proposal by a number of groups, including the USA and the Vatican. The Vatican's representative at the UN has stated that so-called therapeutic cloning, using embryos to develop treatments for illnesses such as Alzheimer's and diabetes, is even worse than cloning for reproductive purposes. Archbishop Renato Martino described therapeutic cloning as 'an even more serious offence against human dignity… since it involves human beings who are created in order to be destroyed.'

A spokesperson for the German lobby said it was 'regrettable' that a compromise could not be reached on drafting a treaty against cloning human beings while negotiations continued on other forms of cloning.

The UK remains the only Western country whose parliament has voted to allow the creation and destruction of cloned embryos for research purposes. (SPUC News Digest 2002; 21 November, Guardian 2002; 20 November, Yahoo! News 2002; 19 November)

Frozen eggs success

For the first time in Britain, a child has been born following IVF using a frozen egg. Helen Perry is the first woman to undergo IVF using one of her own frozen eggs. Baby Emily Perry is now six months old.

Previously the use of frozen eggs for IVF was banned in the UK because of concerns about the quality of eggs following the freeze-thaw process. However, following successes abroad (in the USA an estimated 30 women have given birth using frozen eggs), the UK ban was lifted in January 2000. The Midlands Fertility Clinic that treated Mrs Perry used an 'anti-freeze' chemical to protect the eggs from damage. Furthermore, a US clinic, presenting results to the American Society for Reproductive Medicine conference in Seattle, has reported unprecedented pregnancy rates using frozen eggs.

Egg freezing may be particularly useful for women who need treatments such as chemotherapy, enabling the storage of their eggs for future use with a partner or donor. Additionally, it overcomes any moral objections about 'spare' embryos. Young women pursuing careers may also utilise the technology to put their fertility 'on ice'.

Dr Gillian Lockwood of Midland Fertility Services, whose team made the breakthrough, said, 'The technology...will work just as well for the Bridget Jones generation who want to freeze their eggs to keep their reproductive options open…I think that egg freezing may come to be seen as the ultimate kind of family planning.'

An estimated 100 women currently have frozen eggs stored at the Assisted Reproduction and Gynaecology Centre in London, which has pioneered this treatment in the UK. (bbc.co.uk 2002;11 October, Times 2002;16 October)

New study questions IVF dangers

A new study from Western Australia has raised concerns about the increased risk of handicap for children born using infertility treatments.

The study found that infants born after IVF had a 9% chance of a major birth defect, while those born after intra-cytoplasmic sperm injection (ICSI) had an 8.6% chance. This is double that for natural conception - a control group of 4,000 fetuses showed a 4.5% chance of a major defect. This worrying trend was still apparent after figures were corrected for multiple births, maternal age and parity.

In a commentary on current infertility practices, Robert Winston, Professor of Fertility Studies at Imperial College, London, said that the new study should 'cause serious unease', and called for an improvement to follow-up studies. It is unlikely that there is anything specific to Western Australian practice that would cause this result, since the figures were derived from three clinics practising standard methods. Prof Winston's analysis of factors that might increase risk serves to highlight the many 'unknowns' of IVF practices - particularly embryo cryopreservation, methods of embryo culture and new techniques such as ICSI and cytoplasmic transfer.

In response to these new concerns, the HFEA and Medical Research Council (MRC) revealed on 22 October that they would embark on research to establish the long term ill effects of IVF. An estimated one million babies have been conceived worldwide since the landmark case of Louise Brown in 1978. A joint working party will first need to establish the best way of carrying out studies, which are expected to begin late next year. (Hansen M et al. New England Journal of Medicine 2002;346:725-730, Winston R, Hardy K. Fertility Supplement, Nature Medicine 2002;8:S14-S18 - available free for six months at www.nature.com/fertility, Guardian 2002;23 October:8; Reuters 2002;22 October)

New IVF regulations after embryo mix-ups

Two women underwent emergency treatment to remove embryos from their wombs after staff realised that the wrong embryos had been transferred during infertility treatment.

In total three women were affected by the blunder, which happened in April 2002. One patient received her own embryos, but those of poorer quality that would not normally have been used. Her healthiest embryos were implanted into another woman, and this second woman's embryos were given to a third patient. The error was spotted by the doctor and embryologist involved and immediately reported so that the women could be called back for emergency treatment.

An inquiry into the mix-up, which occurred at the Diana, Princess of Wales Centre for Reproductive Medicine at St George's hospital, Tooting found the centre to be 'chaotic', due to bad management and under-staffing.

Following the 'black twins - white parents' blunder of July 2002, the HFEA has imposed new regulations on fertility clinics in an attempt to prevent such mistakes occurring again. One of these includes mandatory protocols in which a second person must witness every crucial step in the procedure and sign the clinical notes. However, the instigation of such protocols may be beyond the financial abilities of many centres - the St George's hospital clinic has itself been forced to close due to a lack of resources. (bbc.co.uk 2002;4 November, Telegraph online 2002;5 November)

Deaf lesbian couple opt for a deaf child

A deaf lesbian couple in the USA have deliberately opted to have a deaf child by choosing a friend with familial deafness as a sperm donor.

The couple have the legal right to procreate with whomever they want, and in this respect the case raises no new difficulties. It has, however, sparked discussion over the extent to which such freedom of choice can be exercised using fertility technologies, which were initially developed to help couples avoid hereditary disease.

Members of the deaf community often find that deafness defines their cultural identity and see signing as a sophisticated form of communication. Having adapted their lives to deafness they may want a child who will easily fit into that lifestyle. A similar situation can arise with achondroplastic couples. Some couples have expressed a desire to use preimplantation genetic diagnosis (PGD) to select a deaf child - a process that many would see as a perversion of the technology's purpose.

Alternatively, a deaf couple in Australia have been allowed to screen out IVF embryos that carry a gene for deafness, a decision that has been criticised by ethicists there because it discriminates against deaf people and could pave the way for other extensions of PGD. (BMJ 2002;325:771-3, J Med Eth 2002;28:284-8, news.com.au 2002;21 September)

Abortion for 'serious handicap' brought into question

A Cambridge student has made allegations of unlawful killing after discovering a case of late term abortion for cleft palate in the official statistics.

Under s.1(1)(d) of the 1967 Abortion Act, abortion beyond 24 weeks is legal if there is, 'substantial risk that if the child were born it would suffer from such physical or mental abnormalities as to be seriously handicapped'. The definition of serious handicap remains a somewhat grey area in both the legislature and official guidelines. Rather, the Royal College of Obstetricians and Gynaecologists prefers to leave it to the doctor's discretion to decide what counts as a 'major handicap' in such circumstances.

However, many would hold that cleft palate does not count as such. Joanna Jepson, who made the allegation, has herself had corrective surgery for a congenital jaw abnormality and said, 'To take away lives for that reason is completely abhorrent. Having been in that position myself, is society saying I should have died?' The Metropolitan Police are investigating Ms Jepson's allegation.

In another case at the Royal Victoria Infirmary in Newcastle, the option of aborting a twin boy in the late stages of pregnancy was considered because the child was diagnosed with a heart defect. The abortion would have been performed by injecting potassium chloride directly into the child's heart, and his dead body would then have been delivered at the same time as his living twin sister. However, several experts were against the termination, believing that the child had a good prognosis with surgery, and that the abortion would be psychologically detrimental for the 19 year old mother. The mother eventually refused the abortion. (bbc.co.uk 2002;28 October, Sunday Times 2002;10 November)

Abortion may increase women's mortality rate

A study examining the death records of 173,000 Californian women has revealed that those who had abortions were almost twice as likely to die in the two years following the operation.

The research linked death records to medical insurance payments for births and abortions. Women who aborted had a 154% higher risk of death from suicide, were 82% more likely to die by accident, and had a 44% higher rate of death by natural causes. Elevated mortality rates persisted for the eight year span covered by the study.

This follows a 1996 Finnish study that indicated a 252% higher death rate for aborting women compared to those who delivered, and 76% higher than those who had not been pregnant. (Nucleus 2002;July:20-27, Elliot Institute press release 2002;8 August)

Adoption extended to include co-habitees

The House of Lords has approved the government's Adoption and Children Bill after voting by 215 to 184 in favour of amendments to allow homosexual and unmarried heterosexual couples to adopt.

Prime Minister Tony Blair promised in February 2000 to lead a review of adoption policy amid concern over the number of children in care. The original white paper included no proposals for extending adoption eligibility, and Mr Blair is reported to believe that children are best brought up 'in a stable relationship by a mother and father'. The same-sex and co-habiting couples extension was inserted in the Commons by backbenchers on a free vote. Supporters of the amendments insist that extending adoption will increase the number of children that 'come out of care and find families', and is therefore in the interests of children.

A leading opponent in the Lords, Lady O'Cathain, expressed her disappointment: 'Vulnerable people need stability and permanence. They need a mother and a father. The last thing they need is to be used as trophies in a gay rights crusade.' Others have highlighted the instability of non-married relationships as reason to limit adoption to married couples only. Government figures indicate that cohabiting couples are 6.5 times more likely to split up than married partners. 'If a co-habiting couple wish to make a permanent long-standing commitment to the child, why not make a long-term commitment to one another?' questioned Lady O'Cathain. (Guardian 2002;15 October, guardian.co.uk 2002;6 November)

Gene therapy setback

A boy undergoing gene therapy for X-linked severe combined immunodeficiency syndrome (SCIDS) at the Necker Hospital, Paris, developed leukaemia in September 2002 as a result of the treatment.

The French case resulted in suspension of the gene therapy trial at the hospital, and has caused the UK's Gene Therapy Advisory Committee (GTAC) to recommend that additional measures be developed to protect patients. Two studies at Great Ormond Street Hospital, London, are closely related to the French trial.

Consultant Immunologist at Great Ormond Street, Professor Adrian Thrasher believes that the risks of others developing leukaemia are low: 'The problem in France has arisen because the transgene was inserted close to an oncogene and has activated it…However, it is almost certain that the leukaemia would have needed additional triggers, for example genetic predisposition and viral infection…'

After balancing the potential risks and benefits of the treatment, studies at Great Ormond Street will continue. The alternative options of therapy for these children are minimal, and there is a one year mortality of 20%. However, of the 600 therapy trials underway in the world, there is still little evidence that the practice works well for humans. (BMJ 2002;325:791)

Second doctor suspended over illegal organ trade

Jarnail Singh, a doctor from Nuneaton, Warwickshire has been found guilty of professional misconduct by the General Medical Council following claims that he encouraged the illegal trade of human organs from live donors in India. He has been suspended for six months and must also attend an education programme.

Evidence was given by two undercover journalists who had sought Dr Singh's advice on the pretext that one of them had a father in need of a kidney transplant. They said that he discussed the possibility of going abroad for a live donor transplant, explaining costs, disadvantages of surgery outside England, and how to avoid the authorities.

Furthermore, they claim, he indicated that he had facilitated such activites in the past and gave the impression that he would assist them in any way he could. He refused to accept the £5,000 payment they offered. Their original reason for approaching him was information that he had helped a previous patient, Darshan Singh, go to India for similar surgery. Mr Singh died after contracting an infection.

This follows the case in August of London GP, Dr Bhagat Singh Makkar, who was struck off for similar claims. (Guardian 2002;15 October, bbc news online 2002;15 October)

Organ sales in Britain given new support

The government is considering paying donors for transplant organs, according to a Department of Health consultation paper.

The paper raised the possibility of a change in the law by asking the question, 'Should the prohibition of commercial dealings from living and/or deceased people remain? If not, why not?' At present it is an offence under the Human Organ and Transplant Act 1989 to take or receive money for supplying organs for transplant.

Professor Sir Peter Bell, vice-president of the Royal College of Surgeons, backed the move, which will be debated in Parliament next year. He said, 'Relatives giving kidneys…get the best results. We should be willing to consider paying them for the inconvenience, time off work and so on.' This suggests that the move will be more about compensation than payment, much like the system currently used for sperm donation. Compensation could be set at a level such that people are not deterred from donating because of inconveniences, without it being enough to encourage 'sales'.

Others fear that the move will lead to exploitation of the poor. Dr Liam Fox, shadow Health Secretary, said, 'We cannot have such an important issue treated with third world ethics.' (Times 2002;21 October, Metro 2002;21 October)

Live autopsy - mixed reactions

Professor Gunther von Hagens, the man who brought us Body Worlds - an exhibition of plastinated corpses in 'everyday' poses - has provoked further controversy by conducting the first public autopsy in London since the 1830s.

The autopsy was carried out on 20 November 2002 at the Atlantis Gallery in East London before a fee-paying audience of around 500; an edited version was later broadcast on Channel 4. The broadcast was preceded by a warning for those of a delicate nature, and sandwiched by a studio debate to 'put the event in its proper context', according to a Channel 4 spokesman.

Questions have been raised about the legalities of the autopsy. The Government's Inspector of Anatomy, Jeremy Metters, has ruled it illegal, as neither Prof von Hagens nor the Atlantis Gallery were licensed to carry out such a procedure under the 1984 Anatomy Act. Two police officers and an anatomical expert attended the autopsy to monitor the proceedings, and a report will be submitted to the Crown Prosecution Service. If found guilty, the professor could face a maximum three month prison sentence, or a fine. However, von Hagens was defiant, saying, 'If they want to lock me up for it, then let them. I have a briefcase of books which will keep me company if they decide to throw me in jail.'

The medical establishment has also criticised the event; the Royal College of Pathologists disowned the spectacle, and Dr Michael Wilkes, head of the British Medical Association's ethics committee also expressed disapproval. He said, 'I think it was a show rather than a lecture. I'm not satisfied there was sufficient educational value.' However, those involved in the autopsy defended it primarily on educational grounds, arguing that the public should understand about the procedure itself, and that people have a right to know about their bodies. Similarly positive views were held by some who attended, including one woman who added, 'We have become too sterile in our communities…we don't see death.' (Evening Standard 2002;20 November, 21 November, The Times 2002, 21 November)

Cannabis 'worse' than tobacco

A report from the British Lung Foundation has shown that the tar from cannabis cigarettes contains 50% more carcinogens than that from tobacco, and smoking three cannabis joints a day causes as much damage as smoking 20 cigarettes.

This may be partly due to the increase in inhalation volume when smoking cannabis - smokers inhale deeper and wait for longer before exhaling, increasing the amount of carbon monoxide and tar entering the lungs.

The report also shows that the health dangers of cannabis have increased since the sixties, due to higher amounts of delta-9 tetrahydrocannabinol (THC) in the cannabis consumed today. This means that previous clinical studies may underestimate its damaging effects. THC is the active chemical in cannabis that affects specific nerve receptors associated with pleasure, memory, thought, concentration, sensory and time perception, and co-ordinated movement.

Other evidence suggests that many people have misconceptions about cannabis smoke. A 2002 survey showed that 79% of children believed cannabis is 'safe', whilst only 2% correctly understood that there are health risks associated with smoking the drug. Similarly, many smokers choose cannabis over tobacco, thinking that it is safer for them. (bbc.co.uk 2002;11 November)

Belgium's euthanasia law claims its first victim

Belgium has followed its neighbour, the Netherlands, by legalising euthanasia on 23 September 2002. The first official case followed only a week later, and provoked an outcry after claims that it was an illegal publicity stunt.

39 year old Mario Verstraete, who suffered from multiple sclerosis, died from lethal injection on 30 September despite the legal requirement that a patient must request euthanasia at least a month ahead. Belgium's professional medical organisation has complained that the killing was illegal and is considering whether to take legal action. (Times 2002;23 September, Guardian 2002;9 October)