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POLICY & REGULATION: New rules urged on hybrid animal-human experiments



                                  PART 1


------------------------------- GENET-news -------------------------------

TITLE:   NEW RULES URGED ON HYBRID ANIMAL-HUMAN EXPERIMENTS

SOURCE:  Thomson Reuters, USA

AUTHOR:  Ben Hirschler

URL:     http://www.reuters.com/article/2011/07/21/us-science-animal-human-idUSTRE76K7Q220110721

DATE:    21.07.2011

SUMMARY: "Scientific experiments that insert human genes or cells into animals need new rules to ensure they are ethically acceptable and do not lead to the creation of ?monsters,? a group of leading British researchers said on Friday. [...] Chinese scientists have already introduced human stem cells into goat fetuses and U.S. researchers have studied the idea of creating a mouse with human brain cells -- though they have not actually done so. Such controversial research needs special oversight, according to a report from Britain?s Academy of Medical Sciences on the use of animals containing human material."

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NEW RULES URGED ON HYBRID ANIMAL-HUMAN EXPERIMENTS

(Reuters) - Scientific experiments that insert human genes or cells into animals need new rules to ensure they are ethically acceptable and do not lead to the creation of ?monsters,? a group of leading British researchers said on Friday.

While humanizing animals in the name of medical research offers valuable insights into the way human bodies work and diseases develop, clear regulations are needed to make sure humanization of animals is carefully controlled.

Extreme scenarios, such as putting brain cells into primates to create talking apes, may remain science fiction, but researchers around the world are constantly pushing boundaries.

Chinese scientists have already introduced human stem cells into goat fetuses and U.S. researchers have studied the idea of creating a mouse with human brain cells -- though they have not actually done so.

Such controversial research needs special oversight, according to a report from Britain?s Academy of Medical Sciences on the use of animals containing human material.

Using animals with limited humanized traits is not new. Genetically engineered mice containing human DNA are already a mainstay of research into new drugs for diseases like cancer.

But Martin Bobrow, a professor of medical genetics at the University of Cambridge, who led the Academy?s working group, said there were three areas of particular concern.

?Where people begin to worry is when you get to the brain, to the germ (reproductive) cells, and to the sort of central features that help us recognize what is a person, like skin texture, facial shape and speech,? he told reporters.

His report recommends that government should put in place a national expert body, working within the existing system for regulating animal research, to oversee such sensitive areas.

British ministers said they welcomed the report and would consider its recommendations carefully.

Bobrow said other countries would need to follow suit with their own rules, as their scientists and regulators also recognized the need to address potential public concerns.

STEM CELLS

In addition to helping fight debilitating diseases, humanized animals have played a pivotal role in developing new treatments for infertility. They are also central to much stem cell research.

The world?s first clinical trial using neural stem cell therapy in stroke patients -- a joint project between Scottish researchers and British biotech company ReNeuron -- was only possible after first testing human brain cells on rats.

Robin Lovell-Badge, a geneticist at the Medical Research Council, said other important animal research models included a Down?s syndrome mouse with some 300 human genes and one with 95 percent of its liver derived from human cells.

A public opinion poll carried out for the report found general support for research into animals containing human material, if it was conducted to improve human health.

But there were serious concerns voiced about experiments involving the brain, the potential fertilization of human eggs or sperm in an animal, and giving animals human characteristics such as facial features or speech.

Attitudes also differed according to type of animal.

?If you come home and your parrot says ?Who?s a pretty boy?? that?s one thing. But if your monkey says it that?s something else,? said Christopher Shaw of the Institute of Psychiatry, King?s College London.



                                  PART 2

------------------------------- GENET-news -------------------------------

TITLE:   ACADEMY CALLS FOR ADDITIONAL OVERSIGHT OF SENSITIVE RESEARCH USING ANIMALS CONTAINING HUMAN MATERIAL

SOURCE:  The Academy of Medical Sciences, UK

AUTHOR:  Press Release

URL:     http://db.zs-intern.de/uploads/1311333632-ACHMpres.pdf

DATE:    22.07.2011

SUMMARY: "A new report by the Academy of Medical Sciences, examining the use of animals containing human material (ACHM) in biomedical research, identifies areas of sensitivity including cognition, reproduction or creating visual characteristics perceived as uniquely human and calls for additional oversight to ensure innovative science can flourish within clearly defined ethical boundaries with public support. [...] Although the great majority of such research does not raise new ethical or regulatory concerns, the Academy?s report indicates that the fast moving pace of this science, might lead to the development of types of ACHM that approach ethical or regulatory boundaries."

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ACADEMY CALLS FOR ADDITIONAL OVERSIGHT OF SENSITIVE RESEARCH USING ANIMALS CONTAINING HUMAN MATERIAL

A new report by the Academy of Medical Sciences, examining the use of animals containing human material (ACHM) in biomedical research, identifies areas of sensitivity including cognition, reproduction or creating visual characteristics perceived as uniquely human and calls for additional oversight to ensure innovative science can flourish within clearly defined ethical boundaries with public support.

Important new opportunities to understand how the human body functions and the processes and treatment of disease are opening up thanks to the sophistication of techniques to incorporate human cells or genetic information into animals. These techniques are already widely used to refine research methods, creating animal models that better represent the human condition. They are also used to develop and produce new drugs and to lead the fight against life-changing conditions and debilitating diseases, including infertility, cancer, HIV and hepatitis.

Although the great majority of such research does not raise new ethical or regulatory concerns, the Academy?s report indicates that the fast moving pace of this science, might lead to the development of types of ACHM that approach ethical or regulatory boundaries. While the UK has one of the strictest systems of animal research regulation, scientists and the public agree that this must stay ahead of emerging research practices.

Professor Martin Bobrow CBE FRS FMedSci, chair of the Academy working group that produced the report said, ?This is a complex research area and there should be ongoing dialogue between scientists, regulators and the wider public to address emerging issues. Our report recommends that the Home Office puts in place a national expert body, within the existing stringent system of animal research regulation, to provide specific advice on sensitive types of ACHM research.?

The working group considered evidence from experts in academia, government, industry, animal welfare groups and professional bodies. An independent public dialogue programme, led by Ipsos MORI was commissioned to provide insight into how ACHM research is viewed by the public. This revealed that the majority of participants supported ACHM research conducted to improve human health or to combat disease. Professor Bobrow added, ?We suggest classifying ACHM research in 3 categories to determine the level of regulatory scrutiny required. The very great majority of experiments present no issues beyond the general use of animals in research and these should proceed under current regulation; a limited number of experiments should be permissible subject to scrutiny by the expert body we recommend; and a very limited range should not be undertaken, at least until the potential consequences are more fully understood.

The placement of research within this system should be regularly reviewed. We are not aware of research of the third type taking place in the UK today. We have started the conversation now so that future decisions can be made with the support of both scientists and the public. Experiments that were of concern to both the public and the scientific community focus on research studies involving modification of the animal brain that could potentially lead to human-like ?cerebral? function, experiments which might lead to fertilisation of human eggs or sperm in an animal; and modification of an animal to create characteristics perceived as uniquely human, such as facial shape, skin texture, or speech.

ACHM is widely used as a technique across the whole spectrum of scientific endeavour from neuroscience and reproductive biology to immunology. They are used to study human biological functions or diseases which cannot be accurately modelled in cell cultures or through computer simulation; where experiments using humans are unfeasible or considered unethical; and where modification of an animal either makes it more closely represent the human situation or allows human genes or cells to be studied within the context of a whole animal with appropriate developmental and physiological processes.

Some examples of ACHM include:

- Mice carrying human genes are widely used to study many diseases, including neurological and anxiety disorders, osteoporosis, heart disease and cancer.

- Goats which have a human gene incorporated in their genome are used to produce a human protein (an anti-thrombin) which is used to treat blood clotting disorders.

- Mice implanted with sections of human tumour are used in cancer research to study how cancers develop and spread, and to test new drugs and therapies.

- Introducing human stem cells into rats can provide an opportunity to study the human brain?s potential for repairing the damage caused by stroke.

- Mice which have their immune systems or livers reconstituted with human cells are used to study diseases such as HIV or hepatitis. Professor Sir John Bell FRS HonFREng PMedSci, President of the Academy of Medical Sciences commented, ?This is an area of research with real potential to deliver scientific advances and bring new treatments to the clinic. Several different UK regulators are involved in regulation of this research, and it is vital to ensure they are closely coordinated. The current transposition of the EU Directive on the use of animals in research provides an important opportunity for the Home Office to act on the Academy?s recommendations, and put in place a national expert body to advise on ACHM. I believe that the UK scientific community is well placed to raise international awareness of these issues and provide leadership in this challenging area of biomedical science.?

Notes for Editors

Academy of Medical Sciences

The independent Academy of Medical Sciences promotes advances in medical science and campaigns to ensure these are translated into benefits for patients. The Academy?s Fellows are the United Kingdom?s leading medical scientists and scholars from hospitals, academia, industry and the public service. The Academy?s independent study was funded by the Department of Health, the Department for Business, Innovation and Skills? Sciencewise-ERC programme Medical Research Council and Wellcome Trust, with support from the Home Office.

Study scope and terms of reference

The aim of the study was to: examine the scientific, social, ethical, safety and regulatory aspects of research involving animals, and non-human embryos, containing human material. The study?s term of reference were to:

-   Agree definitions for animals, and animal embryos, containing human genetic or cellular material.

-   Describe the current use of animals containing human material in medical research, and to anticipate future research directions and challenges for this work.

-   Assess future applications of research involving animals containing human material - including potential requirements for preclinical (animal) studies of candidate human stem cell therapies.

-   Address safety concerns surrounding the generation and use of animals containing human material in research, and to consider welfare issues which apply specifically to animals containing human material.

-   Explore societal and ethical aspects of medical research involving the creation of animals that include significant amounts of human material, and to develop a constructive public dialogue in this area.

-  Explore the current and future regulation of the use of animals and embryos containing human material for research purposes, including primary legislation, regulations and guidelines.

-   Draw conclusions and make recommendations for action. To avoid replication of previous work and debates, several wider areas were excluded from the study scope. These are not addressed in any depth:

-   Scientific or ethical issues relating to the general use of animals in research. 

- The use of human admixed embryos in research.

- Broader issues relating to the genetic modification in a wider sense and not involving human material, such as the genetic modification of animals, or plants, for agricultural purposes.

Working group members:

- Professor Martin Bobrow CBE FRS FMedSci (Chair) Emeritus Professor of Medical Genetics, University of Cambridge

- Professor Tom Baldwin, Editor, Mind, and Chair, Board of Studies of School of Politics, Economics and Philosophy, University of York

- Revd Dr Michael Banner, Dean, Trinity College, Cambridge

- Professor Peter Brophy FRSE FMedSci, Director, Centre for Neuroregeneration & Professor of Anatomy, University of Edinburgh

- Ms Tara Camm, General Counsel and Company Secretary, Plan International Professor Dame Kay Davies CBE FRS FMedSci, Head of Department, Physiology Anatomy and Genetics, and Director MRC Functional Genomics Unit, University of Oxford

- Professor John Harris FMedSci, Lord Alliance Professor of Bioethics, and Director, Institute for Science, Ethics and Innovation, The University of Manchester

- Professor Roger Lemon FMedSci, Sobell Chair of Neurophysiology and Head of the Sobell Department of Motor Neuroscience and Movement Disorders at the Institute of Neurology, University College London

- Dr Robin Lovell-Badge FRS FMedSci, Head of the Division of Stem Cell Biology and Developmental Genetics, MRC National Institute for Medical Research

- Professor Jack Price, Professor of Developmental Neurobiology at King?s College London

- Professor Terence Rabbitts FRS FMedSci, Director, Leeds Institute of Molecular Medicine

- Professor Martin Raff CBE FRS FMedSci, Emeritus Professor, MRC Laboratory for Molecular Cell Biology, University College London

- Professor Trevor Robbins FRS FMedSci, Professor of Cognitive Neuroscience, University of Cambridge

- Professor Nikolas Rose, Martin White Professor of Sociology and Director, BIOS Centre for the study of Bioscience, Biomedicine, Biotechnology and Society, London School of Economics and Political Science

- Professor Christopher Shaw FMedSci, Professor of Neurology and Neurogenetics, Institute of Psychiatry and Head of the Department of Clinical Neuroscience, Kings College London and Director of the MRC Centre for Neurodegeneration Research

- Professor Veronica van Heyningen CBE FRS FRSE FMedSci Group Leader and joint Section Head, Medical and Developmental Genetics Section, MRC Human Genetics Unit, Edinburgh



                                  PART 3

------------------------------- GENET-news -------------------------------

TITLE:   ANIMAL EXPERIMENTS RISE BY 1%

SOURCE:  The Guardian, UK

AUTHOR:  Alok Jha

URL:     http://www.guardian.co.uk/science/2011/jul/13/animal-experiments-rise

DATE:    13.07.2011

SUMMARY: "More than 3.7m scientific procedures were carried out using animals in 2010, an increase of around 100,000 on the previous year, according to data released by the Home Office. The rise is largely due to the production of more genetically modified mice and greater use of fish in basic biological and medical research. Excluding the 1.6m procedures involving the breeding of GM animals ? mostly mice ? the 2010 total was up by 1% from 2009."

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ANIMAL EXPERIMENTS RISE BY 1%

Home Office figures show that numbers of fish used have increased by 23%, but other animals decreased

More than 3.7m scientific procedures were carried out using animals in 2010, an increase of around 100,000 on the previous year, according to data released by the Home Office. The rise is largely due to the production of more genetically modified mice and greater use of fish in basic biological and medical research.

Excluding the 1.6m procedures involving the breeding of GM animals ? mostly mice ? the 2010 total was up by 1% from 2009. The number of procedures is not equivalent to the number of animals used ? one animal might undergo several procedures, and the act of breeding a genetically modified animal counts as a procedure in itself.

?If we exclude genetically manipulated breeding, there?s an increase of less than 1% in the total numbers,? said Judy McArthur Clark, chief inspector at the Animals Scientific Procedures Inspectorate of the Home Office. ?That?s largely due to the increase in the use of fish. Fish numbers went up by 23%, about 93,000 animals. That?s more than the 1% increase, which means there?s an accompanying decrease in other species.?

Professor Dominic Wells, of the neuromuscular disease group at the Royal Veterinary College, said one of the reasons that scientists are breeding more GM mice is because they have refined their procedures. ?Instead of creating animals that are adversely affected by the genetic modifications, we will very often keep two lines of mice, neither of which show an adverse phenotype until they are crossed. You can therefore generate precisely the number that you need in order to conduct that experiment. By breeding two lines we increase the number of animals used but we decrease the overall severity of what we?re doing.?

Primates, dog, cats and horses get special protection under the law and the total number of procedures on these groups was 19,773, around 0.5% of the total. Among the non-human primates, there was a 10% increase in procedures since 2009, though the number of actual animals used has dropped, according to McArthur Clark.

?The main change in the number of procedures is accounted for by new-world primates, such as marmosets, and the main reason for the increase is that it?s a very fluctuating figure. The baseline numbers are quite small ? one extra experiment or study in the year can actually have quite an impact on the numbers. Mainly these animals are used for collections of blood and tissue that are then used in pharmaceutical R&D. The number of old-world primates, macaques, the numbers have come down there, minus 2% on the numbers for 2009.?

Procedures using dogs dropped by 2% ? most of these were purpose-bred beagles mostly used in pharma development and safety evaluation - while the procedures on cats dropped by 32%.

There was also a fall of 11% in the number of animals used in toxicological tests, as a greater proportion of tests can now be used to satisfy more than one regulatory requirement.

Professor Roger Morris, head of the school of biomedical sciences at Kings College London, said 90% of his work was done with individual molecules and cells in culture. ?But real diseases are diseases of the whole body, and can only be studied in the whole body. To take the example of Parkinson?s ? a disease that is very common and devastating. Part of this disease is a dopamine deficiency in the neurons, but the underlying cause is a complex set of interactive problems, that probably involves an inflammatory or autoimmune component. Thus we need to understand the interaction between two very complex bodily systems ? the brain, and the immune system, to understand the defects causing this multi?tissue, multi?step disease. We can?t study that in tissue culture of individual cells.?

Barney Reed, senior scientist at the RSPCA, described the rise in procedures as ?astonishing?, pointing out that they equated to a 37% increase in animal use over the past decade. He also raised concerns over the implementation of a new EU directive on animal research into UK law that would legally allow the UK to drop its standards in many areas of inspection and practice in the use of animals. ?A watered-down law could mean laboratory animals in the UK being allowed to suffer ?long-lasting, unalleviated, severe pain, suffering or distress?, it could allow some animals such as dogs to be kept in even smaller housing, and some UK laboratories may not be visited by Home Office officials for years at a time ? this is simply unacceptable,? he said.

Martin Walsh, head of the Home Office?s animals scientific procedure division, said he welcomed the EU directive because it would raise standards across the continent to the UK level. ?We?re ahead of the game in lots of areas. It?s not going to reduce the protection of animals in the UK.?

He added that the Home Office was also looking at ways to meet a commitment in the government?s coalition agreement, which pledged to reduce the use of animals in scientific research and end the testing of household products on animals. Officials hope to publish a consultation on their ideas before the summer recess of parliament, said Walsh.



                                  PART 4

------------------------------- GENET-news -------------------------------

TITLE:   GROWTH OF ANIMAL TESTS TRAILS SCIENCE FUNDING

SOURCE:  The Financial Times, UK

AUTHOR:  Andrew Jack

URL:     http://www.ft.com/cms/s/7cebc3bc-ad5f-11e0-bc4f-00144feabdc0,Authorised=false.html?_i_location=http%3A%2F%2Fwww.ft.com%2Fcms%2Fs%2F0%2F7cebc3bc-ad5f-11e0-bc4f-00144feabdc0.html&_i_referer=

DATE:    13.07.2011

SUMMARY: "The number of scientific experiments on animals has jumped to the highest level for three decades. However, academics and officials say such experiments are growing more slowly than the pace of high quality research. [...] The Dr Hadwen Trust for Humane Research, which said it was ?severely disappointed? with the increase, cautioned: ?Although the potential of genetic modification when applied to human therapies is very promising, the results gained from using GM animals to study human diseases have been disappointing.?"

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GROWTH OF ANIMAL TESTS TRAILS SCIENCE FUNDING

The number of scientific experiments on animals has jumped to the highest level for three decades. However, academics and officials say such experiments are growing more slowly than the pace of high quality research.

The Home Office?s statistics for 2010 showed 3.7m procedures carried out on 3.6m animals, with much of the rise coming from greater use of genetically modified mice and fish.

While mice represented 72 per cent of all animal procedures last year, there was a 23 per cent increase in the number of fish, which account for 13 per cent of the total. There was a 10 per cent rise in non-human primates, with testing in 3,585 macaque monkeys.

Judy MacArthur Clark, chief inspector of the Home Office Animals Scientific Procedures Inspectorate, said that while animal tests had increased by a third over the past decade, funding for related scientific work had doubled in the same period. ?The UK is a place where successful biological research is taking place,? she said.

However, the rise in absolute numbers to levels last seen in the 1980s sparked criticism from animal rights organisations, which called for greater efforts to enhance standards and for the coalition government to intensify its election commitment to the ?3Rs? of replacing, refining and reducing animal testing.

The Dr Hadwen Trust for Humane Research, which said it was ?severely disappointed? with the increase, cautioned: ?Although the potential of genetic modification when applied to human therapies is very promising, the results gained from using GM animals to study human diseases have been disappointing.?

The RSPCA, the animal charity, expressed concern that the UK might amend its regulations in line lower minimum requirements in a new EU directive, while the British Union for the Abolition of Vivisection said it could lead to a sharp reduction in laboratory inspections.

But Martin Walsh, head of the Home Office Animals Scientific Procedures Division, said no such reductions in visits were planned, while new proposals to meet the coalition?s commitments should be released later this month.

Prof Dominic Wells from the Royal Veterinary College said the value of testing was reflected by the high academic ratings given to science departments using animals in research, and their ?greater and greater international impact over the years?.

He said that the degree of suffering of animals tested was falling because of the use of multiple tests at earlier stages, and contrasted the numbers used in scientific experiments with the 1bn animals killed for meat each year in the UK.

While current Home Office statistics do not show the extent of animal suffering, Ms MacArthur Clark said that implementation of the EU directive would lead to these figures being released from 2015.

She conceded that regulators were sometimes reluctant to shift away from animal test results for medicines ?especially for the safety of sick people?. Other researchers said that where money had been provided through the government?s 3Rs programme, scientists had developed alternatives, as had happened for respiratory disease.