News Review

GMC challenged on feeding and hydration

Leslie Burke, a 44 year old disability rights adviser who suffers from congenital cerebellar ataxia, has sought a High Court judicial review of the General Medical Council (GMC) guidelines on withdrawing food and fluids.

Under the current guidelines, Witholding and Withdrawing Life-Prolonging Treatments: Good Practice in Decision Making, doctors can remove artificial nutrition and hydration (ANH) from a patient who has become permanently incompetent and has a severe medical condition with a poor prognosis. Doctors must judge whether the ANH causes more burden than benefit to the patient and, in consultation with the patient's relatives, take into account what the patient would have wanted.

Cerebellar ataxia is a degenerative disorder that is likely to leave Mr Burke in need of ANH. He fears that doctors could withdraw artificial feeding against his wishes when he can no longer communicate and wants to see the existing guidelines outlawed: 'Physically my body will deteriorate, but I will be mentally alert the whole time. I may not be able to communicate, and it takes two to three weeks to die when hydration and nutrition is withdrawn, and I will be acutely aware of that every single day and physically not able to do anything about it.'

The GMC guidelines regard ANH as medical treatment, in line with the ruling in the Tony Bland case. But Mr Burke claims, 'It is not treatment - it is a matter of human dignity. We need food and drink.' He argues that withdrawal is incompatible with the European Convention on Human Rights, which enshrines the right to life. Ultimately, he would like the GMC guidelines to be withdrawn, but hopes the council will at least reconsider its recommendations.

Dinah Rose, the lawyer representing the GMC, said his fears were unfounded but that one issue raised is whether doctors should be compelled to 'provide treatment which they believe to be of no benefit to a patient or not in a patient's best interests.'

In addition, Lord Joffe's 'Patient Assisted Dying Bill' has been reintroduced into the House of Lords as the 'Assisted Dying for the Terminally Ill Bill'. It has passed a second reading and will be considered in detail by a Select Committee. (Independent 2004; 26 February, bbc.co.uk 2004; 23 February)

Human clones in South Korea

Scientists in Seoul, South Korea have reportedly cloned 30 human embryos. These embryos have been sustained to the size of 100 cells, the furthest stage of development so far reported in the scientific press. They have simultaneously called for a ban on reproductive cloning.

The cloned cells were able to differentiate to give various tissue types, but only one of the embryos yielded pluripotent cells from which a stem cell line could be cultured. Ironically, this embryo had both DNA and egg from the same woman, so was not created in the same way as Dolly the sheep, which had DNA and egg from different animals. The other cloned embryos were thought to contain chromosomal abnormalities. A team in Massachusetts, USA succeeded in creating a cloned embryo last year, but it did not reach the stage at which stem cells could be extracted. The aim of such work - so called 'therapeutic' cloning - is to produce matched tissue types for transplantation into patients with conditions such as diabetes and Parkinson's disease.

The lead Korean researcher, Woo Suk Hwang, acknowledged the difficulties in creating embryonic stem cell lines, but maintained that the study demonstrates that it is technically possible to create cloned embryos.

Some fear that this development will pave the way to cloning embryos for live birth - an aim that American scientist, Panos Zavos, is pursuing. He visited the UK earlier this year and announced that he had successfully implanted a cloned embryo into a woman. The attempt was later reported to have failed. However, he has so far refused to publish any details of his experiments and serious concerns have been raised about creation of a cloned child, not least because of the risks involved with such cellular manipulation. Dolly the sheep was the result of 277 previous attempts at cloning an animal, and her early death may have been due to premature aging. (New Scientist 2004; 12 February, Reuters 2004; 12 February, Telegraph 2004; 14 February, BMJ 2004; 328:421)

NHS to offer one free IVF cycle

The NHS is to fund one IVF treatment cycle for subfertile women in England under the age of 40, by April 2005. This falls short of the three cycles recommended by the National Institute for Clinical Excellence (NICE), which would cost an estimated £85m a year in England and Wales. Health Secretary John Reid, who made the announcement, commented that such a transition could not be implemented 'overnight', and he refused to put a time scale on full implementation of the guidelines. In Scotland three cycles of IVF are routinely provided with married, childless couples given priority.

About three quarters of current IVF treatments are paid for privately, and it is anticipated that the NHS will fund 70% of these procedures in the future. It is estimated that around one in seven couples experience conception problems. The chances of a successful birth in a single cycle of IVF are put at around one in four for women under 35 and one in six for women in the 35-40 age group. This rises to about 50% with three cycles. Clare Brown, Chief Executive of the Infertility Network, welcomed the guidance and said that she hopes it is fully implemented as quickly as possible.

Meanwhile, a study published in the British Medical Journal showed that children conceived through IVF and other fertility techniques are more likely to be premature, born by caesarean, admitted to intensive care or suffer fatal complications. (bbc.co.uk 2004; 25 February, Observer 2004, 22 February; Guardian 2004; 3 February)

Gender Recognition Bill

Transsexuals could soon be given full legal recognition of their 'new' gender, if the House of Commons passes new legislation. The Gender Recognition Bill arose in response to a landmark decision by the European Court of Human Rights, ruling that the UK's failure to recognise the new identities of two transsexuals violated their human rights, notably their right to respect for their private and family life and the right to marry. The Bill has already passed through the House of Lords.

A transsexual who has been living as his or her chosen gender for two years, and is expected to continue doing this, would be able to apply for a new birth certificate stating his or her acquired gender. An authorising body would be set up to handle the applications and decide on the applicant's gender by majority vote. It would not be necessary for the applicant to have undergone gender re-assignment surgery. The applicant would then be able to marry in their new gender.

Rosie Winterton, minister in the Lord Chancellor's Department of Constitutional Affairs, said: 'If democracies are measured by how they treat their minorities, then I believe it is right that the transsexual community be afforded the same rights enjoyed by the rest of us.'

The Bill has raised concerns within the Anglican Church about such wedding ceremonies being held in church buildings. Rev Rod Thomas, vicar of St Matthew's church in Plymouth, said, 'We could not in conscience approve of that. We would be obliged to allow our building to be used or we could be sued.' Some argue that the Bill should include a conscientious objection clause so that priests and registrars could opt out of conducting such ceremonies, but a proposed amendment supporting this clause failed to pass. (Guardian 2004; 24 February, 6 March, Hansard 2003; 18 December)

MMR debate rages on

Ten of the 13 doctors who co-authored an article questioning the safety of the measles, mumps and rubella (MMR) vaccine have retracted their support for the original publication in the Lancet in 1998. In it the paper stated a clear link between autism and the administration of the vaccine.

Dr Andrew Wakefield, the main author of the study, was found to have a conflict of interest in writing the article because he had previously received a grant from the Legal Aid Board in Britain to investigate a link between MMR and autism. Four or five of the twelve children involved in the Lancet study were covered by this legal aid. Parents involved in a legal case against MMR would only have been able to sue the vaccine manufacturers if Dr Wakefield's study had proved a link.

Since the publication, MMR uptake rates have fallen sharply, while the number of cases of measles has increased in the UK. Scientists are expecting an epidemic of measles in the near future, with the return of congenital rubella.

The editor of the Lancet, Richard Horton, was measured in his comments, saying that the retraction of support for the article was partial only, and that the original study warranted further investigation. However, Sir Liam Donaldson, the Chief Medical Officer in the UK, accused Dr Wakefield of 'peddling poor science', while reiterating that the MMR jab was completely safe. (Times 2004; 22 Feburary, Reuters 2004; 3 March, New Scientist 2004; 4 March, Datamonitor 2004; 5 March)

A headache for acupuncture

Two recent studies showed conflicting results on the efficacy of acupuncture in the treatment of chronic headaches. One study, conducted in the UK, stated that acupuncture was effective, while a German study suggested any benefit could be due to placebo.

The UK study recruited 401 people who suffered severe headaches for several days a week. Patients were randomly allocated either to a group with conventional treatment, or to acupuncture as an alternative. They were asked to record the severity and frequency of attacks and usage of medication in a diary. This was done at the start of the study and repeated at three months and one year. While it was found that patients in the acupuncture group had 22 fewer days of headache per year, and needed 15% less medication overall, the study failed to mention what forms of conventional treatment the sufferers were taking. In addition, there was no control acupuncture group (so-called 'sham' acupuncture, where acupuncture needles are inserted at non-acupuncture sites in the body). Without this group, it was impossible to assess the placebo effect of acupuncture.

The German study by contrast involved half a million people, significantly higher numbers than the British study. All patients received conventional treatment, but were subsequently divided into three groups, with one group receiving conventional treatment only (medication), another having sham acupuncture, and the last having real acupuncture. The study showed that real and sham acupuncture yielded similar results, both better than conventional treatment. Professor Trampisch from Bochum University, one of the investigators in the study, concluded that this could not confirm the success of acupuncture, because real acupuncture should have shown a significantly better outcome than sham acupuncture if acupuncture was to be truly effective. (Vickers AJ et al. BMJ 2004; 16 March, Guardian 2004; 16 March)

Scientists doubt animal research

Many animal experiments may be of little benefit in treating human disease, according to scientists at the London School of Hygiene and Tropical Medicine. Writing in the British Medical Journal the authors claim that much research of this kind is poorly conducted and not thoroughly evaluated.

The London School of Hygiene group question the point of many experiments, citing examples where research has been badly designed or been unnecessary because of concurrent human trials. In reaching their conclusions, they carried out a systematic review of all animal experiments purporting to have clinical relevance to humans. They found many weaknesses and have called for a review of how animal testing is carried out.

Professor Ian Roberts, one of the authors of the report, commented that the same standards should be applied to animal research as to studies involving humans. He stressed that they are neither in favour of nor opposed to animal experiments.

Meanwhile Professor Colin Blakemore, Chief Executive of the Medical Research Council (MRC), noted that animal research has contributed to nearly all major medical developments; antibiotics, vaccines, heart surgery and kidney transplants were all first demonstrated and then further tested using animal models. He emphasised the MRC's policy of using animals only where it is strictly necessary and stressed that they are committed to developing alternatives to animal research.

The findings in the BMJ report have been welcomed by animal rights groups who are traditionally opposed to this sort of work. (bbc.co.uk 2004; 27 February, BMJ 2004; 328:514-517)

Opposition to polio vaccination

Two states in northern Nigeria, Kano and Zamfara, have pulled out of a mass immunisation programme against polio. The programme is led by the United Nations and aims to eliminate the disease by the end of 2005, by vaccinating almost 60 million children.

Both states are in areas with a large Muslim population, and are at the centre of a resurgence of polio. Half of all new cases in the world come from Nigeria. However, clerics in the two regions insist that the vaccine is part of a US plot to make the local Islamic women infertile. The governor of one of the states has said that the spread of the disease was 'the lesser evil' compared to several million people being made infertile.

The World Health Organisation (WHO) dismissed the claims of the clerics, but met with leaders in the areas where polio is still endemic to discuss potential areas of progress. Two other states in Nigeria, Niger and Bauchi, were also previously against the vaccination programme, but have now rejoined the campaign after careful consideration. (bbc.co.uk 2004; 26 February, AFP Journal Internet 2004; 26 February, 3 March)

And finally…

Maggots are now available from pharmacists to treat wound infections at home.

Prescriptions of maggots will be given, with district nurses redressing wounds and sealing in the maggots to feed on dead tissue. So far, 20,000 patients have used maggot therapy, in many cases removing the need for conventional treatment or surgery.

Dr Steve Thomas, one of the pioneers of this research at the Princess of Wales Hospital in Bridgend, Wales, said, 'We recognised there is a greater need for maggot therapy in the community.' (bbc.co.uk 2004; 20 February)