B i o N e w s 208

Week 12/5/2003 - 18/5/2003

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C O N T E N T S:

1 C O M M E N T A R Y

* Will the Hashmi ruling mean a free-for-all?

2 N E W S D I G E S T

* Details of Hashmi decision
* Manchester to host UK genetic database
* HFEA code to prevent embryo destruction without consent
* UK gene therapy report published
* Adult stem cells may be as good as embryo cells
* Gene clue in asthma research

3 R E C O M M E N D S

* Television, conferences and further reading

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1 C O M M E N T A R Y

* WILL THE HASHMI RULING MEAN A FREE-FOR-ALL?:

This week's BioNews reports on the latest news about the Hashmi family, who were recently given leave to continue with an embryo screening which might provide life-saving treatment for their son, Zain. A Court of Appeal ruling in April gave them the go-ahead, but details of the three judges' decision has only just been made public. The overriding message from the appeal court was: there will be no 'free-for-all'. But what exactly do they mean by this?

The legal case turned on the matter of whether the Human Fertilisation and Embryology Authority (HFEA) had the powers to grant a license for the procedure to take place in the first place. Although embryo screening (or preimplantation genetic diagnosis, PGD) for serious genetic conditions has been available to UK couples for some years, the Hashmi's request for treatment went one step further. They want not only to make sure that their next child is free from the inherited condition which affects their son, but also to ensure that that child would be a matched tissue donor for him. The HFEA considered this to be a reasonable request and, ultimately, the Court of Appeal agreed. So why all the talk of preventing a free-for-all?

The judges were keen to stress that Parliament did not intend for the HFEA to license PGD for any reason. And so, according to Lord Justice Schiemann, `If the decision of the Authority is upheld in the present case it does not mean that parents have a right to in vitro fertilisation for social selection purposes'. What the court did not want to sanction was the use of PGD for non-medical reasons such as sex selection, although this is not something the HFEA [has shown any desire to] necessarily wants to license.

However, the ruling must surely mean that couples in the same position as the Hashmis, who want PGD for their prospective child as well as to help an existing child, will also be given permission to go ahead with treatment. The HFEA might treat applications on a case by case basis, but it nonetheless has to be consistent and fair. This is good news for other couples who want to maximise the health and well-being of their current and future children.

- Juliet Tizzard, Progress Educational Trust

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2 N E W S D I G E S T

* DETAILS OF HASHMI DECISION:

The UK Court of Appeal gave detailed reasons last week for its decision in April to allow Raj and Shahana Hashmi to proceed with IVF treatment with embryo tissue typing in order to attempt to have a child who could save their existing son, Zain. Zain has thalassaemia, an inherited blood condition, which might be able to be cured by a transplant of umbilical cord blood stem cells from a sibling with matching tissue. None of the Hashmis' other children are a tissue match for Zain.

The three appeal court judges stressed that their decision did not mean 'a free for all' in cases of this type. In allowing the appeal by the UK's Human Fertilisation and Embryology Authority (HFEA) against an earlier decision in the High Court, in which it was ruled that the authority did not have the power to authorise the tissue typing procedure, Lord Justice Schiemann said, 'it does not mean that parents have a right to in vitro fertilisation for social selection purposes'. He added that Parliament was 'not opposed in principle to doing to an embryo any of the things which are likely to happen to it if the decision of the Authority is implemented'.

Lord Phillips stated that 'IVF treatment can help women to bear children when they are unable to do so by the normal process of fertilisation. Screening of embryos before implantation enables a choice to be made as to the characteristics of the child to be born with the assistance of the treatment'. He added 'whether and for what purposes such a choice should be permitted raises difficult ethical questions. My conclusion is that parliament has placed that choice in the hands of the HFEA'.

The Hashmis will begin their third attempt at IVF this week, under the care of Nottingham's CARE at the Park hospital.

* MANCHESTER TO HOST UK GENETIC DATABASE:

The University of Manchester will host the UK Biobank, a project that aims to collect DNA samples and medical information from up to 500,000 volunteers aged between 45-69 years. The £45 million undertaking, jointly funded by the Medical Research Council, the Wellcome Trust and the Department of Health, will look at the role of genes and environment in health and disease. It hopes to identify factors involved in common diseases such as heart disease, cancer, Parkinson's disease and diabetes.

'Manchester welcomes the opportunity to host this landmark project to determine the contributions of both nature and nurture to human health' said Bill Ollier, professor of immunogenetics. The university will be responsible for recruiting the participants in 2004, initial data and sample collection and co-ordinating the six regional participating centres. 'This announcement heralds the next phase of UK Biobank' said John Newton, the project's newly appointed chief executive.

The UK government is set to publish a white paper on genetics, intended to inject knowledge of the subject into the National Health Service, the Times Higher Educational Supplement reported last week. It is likely to propose putting more money into the treatment of genetic conditions, and lay the groundwork for more genetics research. It is also expected to address public concern about the social implications of new genetics knowledge.

* HFEA CODE TO PREVENT EMBRYO DESTRUCTION WITHOUT CONSENT:

The UK's Human Fertilisation and Embryology Authority (HFEA) is to amend its code of practice later this year to make sure that all people who have stored embryos following IVF treatment are informed before any of them are destroyed.

In December last year, a change to the law was called for by Margaret Grant, from Inverness, Scotland, after embryos that she created during IVF treatment with her former husband were destroyed without her knowledge or consent. Mrs Grant had become divorced from her husband in January 2001. Five embryos that had been created using donated eggs and her former husband's sperm had been stored at the clinic where the IVF treatment took place. But, when Mrs Grant tried to continue the IVF treatment after the divorce, she was told that the embryos had been destroyed at the request of her former husband. The hospital trust that governs the clinic used by Mrs Grant said that she was not told because the eggs used were not hers.

David Stewart, MP for Inverness, has been supporting her case and, in February, introduced a 10-minute rule bill to the UK Parliament aimed at changing the law to protect the rights of both partners involved in IVF treatments. Mr Stewart asked the HFEA to change its code of practice in order to prevent the same thing happening to other people.

While the bill was not actually passed by Parliament, the HFEA and health minister Hazel Blears met with Mr Stewart, and the HFEA has now announced that its code of practice will be changed. The change will mean that although women in the same situation as Mrs Grant would have to be informed, they could only prevent the embryos being destroyed by going to court. A spokesperson for the Authority said 'legally clinics must have consent from both parties to continue to store embryos for IVF treatment. If either partner withdraws their consent then clinics must destroy the frozen embryos. The HFEA has now given guidance to clinics that they must take all reasonable steps to inform both parties either in writing or by telephone that the embryos are going to be destroyed. This clarifies the position for the clinics and the patients undergoing infertility treatment'.

* UK GENE THERAPY REPORT PUBLISHED:

The UK's Gene Therapy Advisory Committee (GTAC) published its ninth annual report last week. It has also released a set of recommendations on gene therapy trials that use retroviruses, the technique used by scientists at the Necker hospital in Paris to treat an inherited immune disorder. Eleven boys with X-linked severe combined immune deficiency (X-SCID) underwent experimental gene therapy treatment at the French hospital, two of whom have since developed leukaemia. 'The success achieved by the French group in treating infants with X-SCID using gene therapy must not be overlooked' said GTAC chairman Norman Nevin. 'However, such trials must proceed with caution' he added.

Children affected by SCID have a faulty gene that means they have no working immune system, so their bodies cannot fight infections. Scientists at the Necker Hospital used a retrovirus to deliver a working gene to the immune cells in the bone marrow. Although the treatment was successful in nine of the boys, in two of the patients, the virus switched on a gene that triggered leukaemia. In the UK, doctors at Great Ormond Street Hospital in London have treated five X-SCID patients using a similar technique, none of whom have shown any leukaemia-type symptoms. A joint working party of GTAC and the Committee on the Safety of Medicines (CSM) met in March 2003 to review the safety of retroviral gene therapy trials. It recommended more research into gene therapy using retroviruses, and more long-term monitoring of patients in existing trials.

After weighing up the benefits and risks of the treatment, GTAC decided that 'it would be unethical to withdraw its approval of the UK X-SCID study'. But Nevin said that recruitment into the trials should only be on a case-by-case basis, and that an expert working group should be set up to review the safety of retroviruses.

* ADULT STEM CELLS MAY BE AS GOOD AS EMBRYO CELLS:

Scientists from the US biotechnology company Genzyme have published research that suggests that 'adult' stem cells may be more useful than was previously indicated. Scientists and pressure groups opposed to research on human embryos have asked on numerous occasions whether embryonic stem (ES) cell research is even necessary. There is some evidence that this may one day be the case but, until that day comes, it is generally believed that ES cell research is necessary in order to obtain knowledge and understanding about the properties of all stem cells and ways in which their growth may be directed.

Caroline Verfaille of the University of Minnesota, reported the discovery, in January 2002, of multipotent adult progenitor cells (MAPCs) - apparently capable of giving rise to all tissues in the body, just like ES cells. Also, in June 2002, a team of US researchers, again led by Catherine Verfaille showed that a type of adult stem cell derived from bone marrow (mesenchymal cells or MSCs) has many of the same characteristics as ES cells. MSCs also do not seem to trigger an immune reaction when transplanted.

Now, Genzyme has reported that MAPCs and MSCs may actually be the same type of cell, meaning that - with the properties of both types of cell added - they would have far more potential than was expected. New Scientist reported that if this is true, 'all of a sudden you have a non-controversial, highly versatile source of adult stem cells that can, in theory, be transplanted to anyone'.

* GENE CLUE IN ASTHMA RESEARCH:

A team of UK researchers has identified a gene involved in asthma and other allergies, which they say could lead to better treatment and understanding of the illnesses. The scientists, based at Oxford University, found that alterations in a gene called PHF11 affect the production of the proteins involved in an allergic response. 'Finding this gene adds a new dimension to understanding asthma and allergic diseases, but the understanding is still incomplete' said lead author William Cookson.

Asthma and other allergic conditions such as eczema occur when the body's immune system overreacts to harmless foreign substances, treating them as it would invading germs or parasites. The PHF11 gene appears to regulate the blood cells that produce Immunoglobin E, the antibody protein produced in large quantities during an allergic reaction. In turn, this triggers the release of the chemical histamine, which causes itching if present in the skin, and wheezing if produced in the lungs.

Cookson says that around ten different genes are involved in asthma, about half of which have already been identified. 'It is very likely that all the important genes will be found in the next three years' he said. But he stressed that 'the challenge of translating genetic findings into new treatments is, however, not trivial and will not be accomplished overnight'. The findings were published online last week in Nature Genetics.

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3 R E C O M M E N D S

* TELEVISION, CONFERENCES AND FURTHER READING:

'My sister is my son's mother' / The Guardian / 14 May 2003
Sisters Flora and Emma Davies explain how egg donation worked for them, in this edited extract from 'Inconceivable Conceptions: psychological aspects of infertility and reproductive technology' by Jayne Haynes and Juliet Miller.

'The DNA debate: Part 1 and Part 2' / The Times / 14 and 15 May 2003
Questions are put to Sir Paul Nurse, Professor Kay Davies and Professor Nick Hastie in this debate to mark the 50 year anniversary of the discovery of the double helix.

'Genes are so liberating' / New Scientist / 17 May 2003
Matt Ridley, author of 'Nature via Nurture', says that it no longer makes sense to talk of 'nature versus nurture' or 'genes versus the environment'. When it comes to human development, the two are inextricably intertwined.

'British Human Genetics conference' / 15-17 September 2003 / University of York, UK
The closing date for abstracts is 25 May 2003. Further information can be found on the conference website, or obtained from The Conference Office, British Society for Human Genetics, Clinical Genetics Unit, Birmingham Women's Hospital, Birmingham, B15 2TG, UK. Telephone/fax: 0121 627 2634 or email york2003@bshg.org.uk.

'Yerma's Eggs' / 28 May - 7 June 2003 / Riverside Studios, Hammersmith, London
An innovative new performance - conceived, written and directed by Anna Furse - exploring assisted reproduction technologies and bioethics. To book tickets, contact the box office on 020 8237 1111.
Three debates accompany the performances, chaired by Juliet Tizzard, director of Progress Educational Trust:
'Designer babies: myth and reality in embryo selection' / 31 May 2003 / 5pm
'IVF and the non-traditional family: gay couples, the older woman' / 3 June 2003 / 6.45pm
'Human cloning: genes, identity and ethics' / 5 June 2003 / 6.45pm

'Fifth international symposium on preimplantation genetics' / 5-7 June 2003 / Antalya, Turkey