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The Fertility Show, Manchester Central, 24-25 March 2018

Issue 665 (16 July 2012)


Welcome to BioNews by email, published by the Progress Educational Trust, providing you with news, comment and reviews on genetics, assisted conception, embryo/stem cell research and related areas.

Visit the BioNews website at where you can subscribe for free to receive BioNews by email in one of three formats, and search the archive of more than 6,000 articles.





News Digest




Concerns about the consultation on the future of the HFEA

16 July 2012

By Rachel Cutting

Chair of the Association of Clinical Embryologists

Appeared in BioNews 665
After over twenty years as an instrumental part of the fertility treatment sector, the Human Fertilisation and Embryology Authority (HFEA) is under threat as the Government pushes ahead with plans to reduce the number of arm's-length bodies. The move is part of a wider initiative to cut NHS administrative costs by more than a third by 2015.

The first step of the review process, which was proposed by Lord Howe, is a formal public consultation (reported in BioNews 663). The consultation aims to seek views on whether:

  • all functions should transfer to the Care Quality Commission (CQC) (apart from research which would pass to the Health Research Authority) and the HFEA would be abolished, or;

  • all functions should transfer as above but a limited number of functions would transfer to organisations other than the CQC, or;

  • the HFEA should retain its functions and deliver further savings.

The Government's preferred option is the first. But here at the Association of Clinical Embryologists (ACE) - the professional body representing clinical embryologists in the UK and abroad – we have grave concerns about dissolving the HFEA. As such, we are joining other organisations such as the British Medical Association, the British Fertility Society and the Royal College of Nursing to ensure our views are heard by completing the consultation.

Since Louise Brown, the first IVF baby, was born in 1978, we have not only seen unprecedented advances in the technology used in fertility treatment, leading to ever improving outcomes, but public acceptance of fertility treatment has also grown. The HFEA has played a pivotal role here through both its regulatory and public-facing presence, supporting hundreds of thousands of people in the UK through their fertility journeys.

Over the last 20 years, the HFEA has developed robust regulatory mechanisms. These well-defined processes and safeguards have enabled practitioners in the UK to pursue areas of research and practice that have been much harder to engage elsewhere.

What's more, the expertise the HFEA has accrued means it is uniquely equipped to deal with highly sensitive and emotive issues that can arise during fertility treatment. Indeed, it has debated and ruled on a number of high profile, highly sensitive issues such as sex selection, payments to sperm and egg donors, and 'saviour siblings' (where an embryo is selected to be a tissue match for a sick sibling).

While we acknowledge that the CQC already registers a wide range of NHS and independent health care providers, ACE is not convinced that the CQC is well placed to fulfill the current role of the HFEA. The HFEA's specific function is to ensure that the Human Fertilisation and Embryology Act is enforced and that fertility centres work within this complex legislation. To move the core functions of the HFEA into the CQC may result in a loss of the expertise and experience which the HFEA has worked long and hard to establish.

This move could also expose patients and clinics to an increased risk of error or incident during an inevitable and potentially lengthy period of transition. An example of this is data collection - the CQC does not routinely collect large volumes of data on a scale that is currently submitted by fertility centres. It is essential that accurate data is held, especially with respect to donor-conceived children.

Beyond the questionable effect dissolving the HFEA would have on efficiency within the sector, there is also the impact that losing the HFEA could have on patients. It is trusted as the industry body that regulates treatment and helps patients put their hope and trust in the fertility centre they choose for their treatment. And ultimately, patient safety must be paramount.

To lose the expertise of the HFEA and the level of public confidence it has established, will not help fertility centres continue to develop and offer their patients the best possible standards of care. In fact, it is likely undermine the good work done to date and deny patients the support they need when they need it most.

But that is not to say that the process could not be improved. ACE of course supports reviewing and improving the regulatory process to make NHS systems more efficient. And in truth, most of us working in the sector would welcome a more efficient approach to inspection and licensing.

As such, it is essential that alongside this consultation, work is done to review how the process could be improved. Work led by the professional bodies is underway to suggest how the regulatory process should be bettered and the stronger relationships between the sector and the regulator will hopefully lead to a positive future.

An alternative proposal could be to align the CQC and HFEA, maintaining the HFEA brand and expertise rather than dissolving it altogether. Both inspection processes could be amalgamated into one, reducing the inspection burden both to clinics and inspectors. This would fulfill the Government's three aims: strengthen the effectiveness of regulation in this area; clarify the regulatory landscape for service providers; and reduce the complexity of the regulatory landscape.

The consultation period ends on 28 September and the final decision is due to be made later this year. ACE would encourage as many people as possible to contribute to this important review process.



28 January 2013 - by Baroness Ruth Deech 
In January the Department of Health published its response to the consultation on proposals to transfer the functions of the Human Fertilisation and Embryology Authority and the Human Tissue Authority to the Care Quality Commission and the new Health Research Authority...
17 September 2012 - by Peter Thompson 
It's a busy week for the Human Fertilisation and Embryology Authority (HFEA). As we launch our government-commissioned public consultation on mitochondria replacement, we are in the midst of a public debate about who should regulate IVF and embryo research. We will publish our response to the Government's consultation on the HFEA's future later this week. This comment piece gives a taste of what we will be saying....
03 September 2012 - by Henny Braund 
The political debate around the Government's Arm's-Length Body Review has centred on whether any change will deliver greater accountability, financial efficiencies or cuts to services. For Anthony Nolan, a charity that helps provide stem cells for patients who need life-saving transplants, the review is more nuanced...
23 July 2012 - by Walter Merricks 
To many people concerned with donor conception - patients, parents, donors and donor-conceived people - the Government plans to abolish the Human Fertilisation and Embryology Authority (HFEA) sound extremely worrying...

09 July 2012 - by Professor Alison Murdoch 
Government intends to save money by improving the efficiency of regulatory bodies. Providers of fertility treatments also favour more efficient regulation as it would help them improve their own services. This common purpose - the need for improved efficiency - is reflected in the consultation announced by the government; the central question is how it should be achieved...
02 July 2012 - by Ayesha Ahmad 
The UK Government has launched a consultation on the future of the Human Fertilisation and Embryology Authority (HFEA) and Human Tissue Authority (HTA) amid proposals to transfer the regulators' functions elsewhere....
02 July 2012 - by Earl Howe 
Standards should never come into question, but it's clear to this Government that NHS administrative costs can be streamlined. That is why I set out proposals to change responsibility for regulating fertility treatment and human tissue last week...
02 April 2012 - by Dr Tamara Hirsch 
A recent report claims England's regulator of health and social care, the Care Quality Commission (CQC), is not at present ready to take on the functions of the Human Fertilisation and Embryology Authority (HFEA)...
20 February 2012 - by Victoria Kay 
The UK's fertility watchdog, the Human Fertilisation and Embryology Authority (HFEA), has amassed cash reserves of around £3.4 million from charges to the clinics it licenses, prompting calls for the money to be given back to those seeking IVF treatment....


Gloucestershire Primary Care Trust boosts IVF provision

16 July 2012

By Jessica Ware

Appeared in BioNews 665

Couples undergoing fertility treatment in Gloucestershire will soon have access to three NHS-funded cycles of IVF treatment instead of just one and eligibility criteria will be widened.

Changes are set to be implemented by October 2012, from which date women over 23 years old will have access to up to three cycles on the NHS. Previously, the minimum age requirement for patients was 30; the upper age limit of 39 remains the same.

The new policy is a joint venture between NHS Swindon and NHS Gloucester who up until now have had differing commissioning policies for fertility treatment. NHS Swindon allows three IVF cycles, compared to just one cycle currently commissioned by NHS Gloucester. The increase is expected to cost an extra £1.5 million per year, but this figure could be less depending on how the service is contracted.

From October, one policy will cover both PCTs and is largely in line with guidance issued by the National Institute for Health and Clinical Excellence (NICE) - although NICE has recently published a draft guideline stating that women up to 42 years old should be eligible for fertility treatment on the NHS.

NHS Gloucestershire has not said whether all of the proposed criteria will be applied to prospective patients, but the PCT's medical director Dr Liz Mearns said it 'will review its criteria for access to IVF treatment when NICE publishes its revised guidance, following the consultation process'.

Commenting on the announcement, Clare Lewis-Jones, chair of National Infertility Awareness Campaign, said: 'We hope that this increase from one to three cycles will be the first step towards full implementation of the NICE guideline in all PCTs, which will allow patients to access the level of treatment they deserve'.

NHS Gloucestershire | 17 May 2012
This is Gloucestershire | 23 May 2012


09 July 2012 - by Julianna Photopoulos 
The funding of fertility treatment in the UK is among the lowest in Europe, according to a new study presented at the European Society for Human Reproduction and Embryology's annual meeting in Istanbul...
02 July 2012 - by Louisa Ghevaert 
The inconsistent and inadequate provision of IVF treatment on the NHS is an unacceptable way to treat the one in seven UK couples (3.5 million people) currently affected by infertility...
28 May 2012 - by Mark Johnson 
From next year, local GP-led Clinical Commissioning Groups will take on the commissioning responsibilities of Primary Care Trusts, with the latter due to be abolished in April 2013. This now includes responsibility for commissioning fertility services such as IVF treatment...
16 January 2012 - by Jessica Ware 
The number of publicly funded IVF cycles dropped by nearly 14 percent this financial year in the UK, an investigation by the GP magazine Pulse has revealed...
31 October 2011 - by Rosemary Paxman 
An investigation by the Daily Telegraph has found that a fifth of PCTs are offering single women IVF on the NHS...


Woman sues US regulator for right to private donor's sperm

16 July 2012

By Ruth Retassie

Appeared in BioNews 665

A Californian woman is suing the US Food and Drug Administration (FDA) over its sperm donation policy.

The woman, who wishes to remain anonymous, is in a same-sex relationship and wants to conceive a child using a friend's sperm by home insemination. FDA regulations, however, require all sperm donors – including both those who donate through clinics and privately - to undergo medical tests, which the plaintiff claims restricts her freedom to have children.

The lawsuit, filed by the campaign organisation Cause of Action on the woman's behalf, states this requirement is unfair because heterosexual couples do not have to undergo costly and time-consuming tests before they have intercourse. The lawsuit also claims the FDA is controlling what should be a private matter and the rules are 'unconstitutional to the extent that they operate to regulate noncommercial, sexually intimate choices and activity'.

The FDA requires all sperm donors to undergo urine and blood tests within the week of each donation, even informal or private donations, effectively treating non-commercial donors the same as fertility clinics and sperm banks, Cause of Action argues. Each infectious disease test ranges from $250- $500 and a physical examination costs around $300.

Cause of Action's chief counsel for regulatory affairs, Amber Abbasi stated: 'If there are donors like this who are not charging as a service, and not service as a business, the FDA should not be intervening'.

'This means the FDA can reach into your bedroom and tell you how to procreate. The FDA [is] taking the position that donors, even when there's no commercial element, are ''an establishment'', just like a sperm bank and have to register. This is a serious burden on the reproductive freedoms of both the recipient and the donor', she said.

However, other commentators have supported the FDA's efforts to ensure sperm donations are safe. Dr Mitchell Rosen, director of the University of California at San Francisco Fertility Preservation Center, said: 'What the FDA is trying to do is protect the people, that's their job'.

'From a medical perspective, you don't want to infect another individual, that would be the worst scenario you could possibly imagine', he said.

Abbasi countered that the concern is the FDA's overreach into private lives. 'We don't think the FDA's intentions are bad -they are trying to protect the public from communicable diseases', she said, 'but this is literally stepping between two people who have agreed to have a child; the FDA should not regulate that'.

Cause of Action | 02 July 2012
Sperm Donor Lawsuit Filed by Lesbian
Reuters | 11 July 2012
ABC News | 12 July 2012
SF Gate | 09 July 2012


04 March 2013 - by Tom Barrow 
A man from Louisiana is attempting to sue a fertility clinic after accusing his ex-girlfriend of stealing his stored gametes. Layne Hardin has alleged that former partner Tobie Devall 'bluffed' her way into obtaining two vials of his sperm, which she was inseminated with....
07 January 2013 - by Rosie Beauchamp 
A sperm donor in Kansas, USA, has been ordered to pay $6,000 in child support to a lesbian couple who he helped conceive a child with...
29 October 2012 - by Susan Imrie and Sophie Zadeh 
Professionals, policymakers and academics came together to discuss recent research on the making of child welfare assessments in the context of post-2008 changes to the Human Fertilisation and Embryology Act. Researchers explained their findings to an avid audience, one of which was that single women seeking reproductive assistance raise red flags for clinicians, clinic counsellors, and nursing staff...
24 September 2012 - by Tom Barrow 
The High Court has awarded a lesbian couple sole custody rights for a child conceived using donor sperm and a surrogate's egg after a three-year battle over parenthood...
03 September 2012 - by Dr Victoria Burchell 
A woman has called for legal changes to prevent a man from donating his sperm without his wife's consent....

30 April 2012 - by Antony Blackburn-Starza 
Thirteen vials of sperm are to be divided between two women after their relationship ended, a Canadian court has ruled. It ruled the sperm should be treated as property and divided between the former couple as other joint assets were upon separation....
20 February 2012 - by Natalie Gamble 
The family court has been making law on known donors, with a number of recent disputes between known sperm donors and lesbian mothers...
12 December 2011 - by Dr Nadeem Shaikh 
A man in the United States is reportedly being investigated by the US Food and Drug Administration (FDA) after offering his sperm for donation. Trent Arsenault, a 36 year-old computer security expert from California, has set up a website offering his sperm without charge to anyone who wishes to use it to have a baby....
18 August 2008 - by Dr Charlotte Maden 
Health officials in the US have placed a ban on imports of sperm from European men to protect Americans from the human form of mad cow disease. Stores of European sperm are now running out, causing problems for women wishing to use them. Before the ban, the...
08 May 2005 - by BioNews 
The US Food and Drug Administration (FDA) is introducing new rules about who can donate sperm. Men that have had homosexual sex within the five years prior to them wanting to make an anonymous sperm donation will be prevented from doing so, as the FDA says that gay men are...


'Outstanding' results in as-yet-unpublished arthritis stem cell trials

16 July 2012

By Dr Greg Ball

Appeared in BioNews 665

Two UK newspapers have hailed a potential treatment for osteoarthritis using a patient's own stem cells, although results from early studies in animals and patients are yet to be published.

The experimental technique was developed by Australian biotech company Regeneus and uses stem cells from the patient's fat tissue which are injected into affected joints. According to the Daily Express the technology has been 'startlingly successful in the treatment of osteoarthritis in pets'. Were it to be as successful in patients, the newspaper continues, it would delay 'the need for joint replacement by 10 or 20 years' and could stop disease progression entirely if diagnosed early.

However, these animal studies do not appear to have been published in a peer-reviewed publication. Results from an early clinical trial, which apparently took place last year at the Royal North Shore Hospital in Sydney, 'are not are not due to be published until 2013', according to the Daily Mail.

Judith Brodie, chief executive of the charity Arthritis Care, cautiously welcomed the news: 'This new stem cell therapy, if the trials continue to show success, could be transformational. While the long-term effects are unknown, and there should be caution due to the early stage of development, Arthritis Care welcomes progress in treating this painful condition'.

In osteoarthritis the cartilage in people's joints degenerates, causing pain and reduced movement. There is currently no cure and in severe cases joint replacement surgery is required. Regeneus' therapy aims to replace lost or damaged stem cells in the joint, reducing inflammation and promoting cartilage regrowth.

The company also reports success of its technology in a mouse model of rheumatoid arthritis. Professor Maree Smith, from the University of Queensland, who was involved in the as-yet-unpublished work said: 'A key finding was that secretions from a mixture of mesenchymal stem cells and adipocytes [fat cells] are more therapeutically powerful than secretions from mesenchymal stem cells alone'.

However, Brodie pointed out the complexity of arthritic disease and the need for more research, saying: 'At the moment stem cells are not the 'magic bullet' and they don't solve the underlying problem of osteoarthritis, which still needs to be addressed'.

In the UK as many as ten million people may have some form of arthritis. The Daily Mail reports that the NHS currently spends around £1 billion on knee replacement surgeries.


06 January 2014 - by Dr James Heather 
The largest genetic study of rheumatoid arthritis to date has found an additional 42 disease-associated locations in the genome...
18 March 2013 - by Reuben Harwood 
An experimental gene therapy that protects cartilage from wear and deterioration has been shown to slow the development of osteoarthritis in mice....
18 March 2013 - by Sarah Pritchard 
Stem cells taken from patients' own fat tissue could potentially be used to deliver treatments direct to brain tumours, say scientists after early laboratory tests...
07 January 2013 - by Dr Greg Ball 
Immune cells that can recognise and kill cancer cells have been grown from induced pluripotent stem cells (iPSCs)...

06 June 2012 - by Maren Urner 
A stem cell technique to treat the common bone disease osteonecrosis is being pioneered at Southampton General Hospital in the UK...
12 March 2012 - by Dr Rebecca Robey 
Stem cell therapy may remove the need for organ transplant recipients to have lifelong drug treatment to combat the risk of rejection, which would dramatically improve patients' quality of life...
05 March 2012 - by Cathy Holding 
A major clinical trial to investigate a stem cell treatment for chronic ischemic heart disease (IHD) – a leading cause of death around the world – has begun in the US...
21 November 2011 - by Dr Zara Mahmoud 
The world's first stem cell therapy to repair torn cartilage in the knee has been brought one step closer. Professor Anthony Hollander, co-founder of University of Bristol spin-out Azellon Cell Therapeutics, has just received funding of £65,000 to carry out clinical trials on the use of a patient's own stem cells for knee repair...
14 April 2009 - by Rose Palmer 
A team of scientists at Keele University are working on an injectable stem cell shot that will repair joints and bones anywhere in the body. The research was presented at the UK National Stem Cell Network annual conference in Oxford. Professor Alicia El Haj and Professor John...


US stem cell patients seek compensation for alleged fraud

16 July 2012

By Cait McDonagh

Appeared in BioNews 665

Six patients in California, USA, are suing a South Korean company and others for allegedly misleading them about the benefits of stem cell treatments sold to them.

The civil claim has been filed against stem cell company RNL Bio, alongside its Californian subsidiary Human Biostar, for the $75,000 the patients had spent on the treatments, plus punitive damages.

The group alleges that Human Biostar and its associates convinced them to travel to clinics in South Korea, China or Mexico to donate fat tissue from which stem cells were extracted and processed for therapeutic use. The patients claim they were told that stem cell treatments could cure their illnesses, which included diabetes, high blood pressure and insomnia, but they showed no signs of improvement. They also claim they were told the treatment could reverse the ageing process.

The patients have also questioned whether the stem cells were properly transported – they may have come from South Korea, through China, Los Angeles and Mexico before being injected.

This case highlights a growing area of concern amid allegations of fraud and safety concerns surrounding stem cell therapies. Dr Paul Knoepfler, associate professor at the University of California Davis Center for Neuroscience, explained there have been complaints about this kind of stem cell treatment for years - the US Food and Drug Administration and the Federal Bureau of Investigation have launched investigations into similar allegations - but this case is the first civil lawsuit for damages.

A decision in this case could have wide consequences for the stem cell industry; it may also add further to the debate surrounding different types of stem cell research and the US National Institutes of Health's guidelines for this.

Bernard Siegal, director of the Genetics Policy Institute, said 'any licensed clinician dabbling in stem cell therapies might face expensive lawyer's fees and economic ruin defending a civil claim for punitive damages that is not likely covered by standard medical malpractice insurance'.

The case could also have an impact on 'stem cell tourism', as international companies who currently operate within a regulatory grey area could be affected by a ruling if they were to market in the USA.

Siegal comments that 'the plaintiff's trial bar is well aware of the potential of this new lucrative speciality "cell therapy malpractice"'. Lawyers in the USA are already preparing for similar cases, and this decision may indicate whether we will see a new area of litigation.

Knoepfler Lab Stem Cell Blog | 05 July 2012
New Scientist | 13 July 2012
Nature News Blog | 06 July 2012
Health in the Global Village (blog) | 05 July 2012


15 July 2013 - by Nishat Hyder 
Davide Vannoni, head of the Stamina Foundation in Turin, Italy, and pioneer of a controversial stem cell therapy, has once again hit the headlines amid allegations of poor research methodology...

06 February 2012 - by Maria Botcharova 
A clinic in California has announced that its doctors are licensed and trained to carry out a stem cell treatment for chronic pain. Meanwhile, the US Food and Drug Administration (FDA) is pursuing a lawsuit against Regenerative Sciences, the company that developed the technique...
17 October 2011 - by Jessica Ware 
A US doctor accused of implanting stem cells into chronically ill patients pleaded not guilty at a court hearing on Thursday 13 October. Dr Ralph Conti, of Henderson, Nevada, has been accused of transplanting stem cells harvested from placental tissue into patients, at the direction of Alfred Sapse, who was falsely claiming to be a doctor....
26 September 2011 - by Dr Nadeem Shaikh 
Lawyers acting for two US scientists who sought to challenge the legality of a decision by the National Institutes of Health (NIH) to allow research on new embryonic stem (ES) cell lines have filed a notice of appeal. They seek to reverse the decision made against them by a district judge in July...
30 August 2011 - by Ayesha Ahmad 
A US businesswoman from Arizona has been convicted of selling unapproved stem cells over a period of several months....
11 July 2011 - by Nisha Satkunarajah 
New legislation to permit federal funds to be used for research on embryos, which would otherwise be destroyed following IVF, will be introduced to the US Congress....


Rare genetic mutation protective against Alzheimer's disease

16 July 2012

By Dr Linda Wijlaars

Appeared in BioNews 665

A rare genetic mutation, found in about one percent of Icelanders in a recent study, appears to protect against Alzheimer's disease and age-related cognitive decline. It is the first mutation found to act in this way and could be a target for future drug therapy.

The mutation is located in the amyloid-beta precursor protein (APP) gene and prevents the gene's product from forming the protein plaques that are typical of Alzheimer's disease.

Amyloid-beta plaques have long been the suspected cause of Alzheimer's disease, although researchers lack conclusive evidence; the plaques could in fact be a consequence of other biochemical changes associated with the disease. This study provides strong support that amyloid-beta plaques are the real culprits.

'If amyloid-beta plaques were confirmed as the cause of Alzheimer's, it would bolster efforts to develop drugs that block their formation in order to treat or prevent the ravaging condition', reports an article in Nature News, paraphrasing Dr Kari Stefansson, chief executive of deCODE Genetics in Reykjavik, Iceland, who led the research.

Dr Stefansson added that the study indicated 'that Alzheimer's, and the cognitive decline that awaits all of us if we survive long enough, seems to be mediated through the same mechanism'.

The mutation leads to a slightly different form of APP being produced. The altered section of this APP variant sits next to the site where enzymes split APP into the amyloid-beta proteins that form Alzheimer's plaques. The researchers think the mutation makes it more difficult for the cleaving enzymes, called BACE enzymes, to find the cleavage site.

'We've found the first protective mutation in Alzheimer's disease and provided proof of concept for using BACE inhibitors to treat the disease', Dr Stefansson told the Guardian. 'So if big pharma manages to develop an effective BACE inhibitor, it should probably be put into the drinking water of elderly people'.

Dr Stefansson said that he plans to use his company's platform to investigate rare mutations relevant to other diseases such as ovarian cancer and gout next. 'The rare variants are not going to explain a large amount [of disease], but they are going to provide very key mechanistic insights into how all of this happens', he told Nature News.


27 March 2017 - by Emma Laycock 
Radiolab explores the science, the uses and the ethics of CRISPR in this podcast that was two years in the making...
02 September 2013 - by Michelle Downes 
Age-related memory loss could be the result of low levels of protein in the brain, according to researchers at Columbia University Medical Center (CUMC)...
15 April 2013 - by Siobhan Chan 
Genetic variants linked to higher Alzheimer's disease risk in African-Americans have been found by a team at Columbia University, USA...
08 April 2013 - by Dr Linda Wijlaars 
Three new genetic markers for Alzheimer's disease have been identified, pointing to a less well-known mechanism to explain how the disease develops...
18 February 2013 - by Michelle Downes 
Hormone replacement therapy, used to treat the symptoms of menopause, may play a role in slowing the ageing process in women who carry a certain gene variant, claim scientists...

18 June 2012 - by Dr Linda Wijlaars 
A gene known to be found in many Alzheimer's patients has been linked to the way insulin is processed in the body. The finding could prove there is a link between Alzheimer's disease and type 2 diabetes, explaining why people with diabetes face a higher risk of developing Alzheimer's....
05 March 2012 - by Maria Botcharova 
An enzyme associated with memory loss can be blocked to reverse symptoms of Alzheimer's disease in mice, a study has shown...
20 February 2012 - by Dr Caroline Hirst 
Skin cells from volunteers with Down's syndrome have been turned into brain cells in order to provide a new model for researchers to study Alzheimer's disease...
11 April 2011 - by Alison Cranage 
International scientists including researchers at Cardiff University, UK and the University of Pennsylvania, USA have discovered five genetic variations associated with Alzheimer's disease. The findings are published in two papers in the journal Nature Genetics...


UK surgeons launch womb transplant charity

16 July 2012

By Dr Victoria Burchell

Appeared in BioNews 665

A charity has been launched to raise money for research that could allow the first womb transplants in the UK.

Uterine Transplantation UK was set up by a team of British surgeons who say they need £500,000 to finish testing the procedure. Only after tests in animals have been completed will they be able to apply for ethics permission to perform the surgery in patients.

Womb transplantation offers an alternative to surrogacy or adoption for thousands of women who are either born without a womb or have theirs removed due to birthing complications, cancer or other diseases.

A previous attempt at this surgery in 2000 failed because of a problem in the blood supply to the transplanted uterus. However, several improvements to the technique have been made and last August a 21-year old woman in Turkey became the first successful recipient of a womb transplant.

'We are confident, especially with a transplant abroad being carried out with the same methodology that we have recommended that within two years or so, given enough funding, we can begin helping women in the UK', said Mr Richard Smith, a consultant gynaecologist from Imperial College Healthcare NHS Trust and the Lister Hospital.

Mr Smith says he has been approached by 50 women who have or could have frozen embryos from IVF and who would like a womb transplant.

However, the surgery would not be without risk. The woman may be at increased risk of complications in pregnancy, including miscarriage, and it is not yet clear whether there could be adverse effects on the development of the implanted embryo. Like any transplant, the recipient will also need to remain on immunosuppressant medication to prevent rejection. To avoid long-term effects, the womb would need to be removed after one or two pregnancies.

Womb transplantation is not a life-saving operation, so some question whether such risks are justified. Professor Lord Robert Winston has said previously that the risks are not worth taking and some women may have to accept that, unless they adopt, they will never become mothers. 'There are some people who are not going to have a child and sad though that is, that has to be seen', he said.

Professor Charles Kingsland, spokesman for the Royal College of Obstetricians and Gynaecologists, said: 'Significant concerns need to be addressed to everybody's satisfaction before we go ahead and offer this as a viable option'.

London Evening Standard | 12 July 2012
Mail Online | 12 July 2012
Womb Transplant UK | 
Plea for womb transplant funding
Press Association | 12 July 2012
Daily Mail | 25 May 2012
Daily Telegraph | 12 July 2012


20 January 2014 - by Dr Rosie Gilchrist 
Nine women have received transplants of uteruses donated by their mothers or other living relatives in an ongoing trial of an experimental procedure at the University of Gothenburg in Sweden...
20 May 2013 - by Dr Anna Cauldwell 
Doctors have terminated the pregnancy of 22-year-old Derya Sert, the first woman to receive a womb transplant from a deceased donor....
15 April 2013 - by Antony Blackburn-Starza 
One of the first women to receive a womb transplant is pregnant, the treating hospital has disclosed. A spokesperson said that early test results were 'consistent' with signs of pregnancy....
24 September 2012 - by Ruth Retassie 
Two women in Sweden received uterus transplants from their mothers, with hopes it will allow them to conceive children of their own...

01 August 2011 - by Dr Morven Shearer 
Last month news broke of an experimental womb transplantation surgery planned for early next year. With it came the possibility of women with an absent or non-functioning uterus carrying a child to term (see Roberts, 2011)....
20 June 2011 - by MacKenna Roberts 
A British woman has agreed to donate her womb to her daughter if selected for an experimental womb transplant surgery to be performed by doctors at the University of Gothenburg in Sweden....
10 April 2007 - by Heidi Nicholl 
A Swedish team has successfully carried out womb transplants in sheep, leading to pregnancy. So far the researchers have worked on perfecting the technique of reconnecting the blood vessels and have removed and replaced the uterus in individual animals - known as autologous transplantation. The team removed and...
22 January 2007 - by Antony Blackburn-Starza 
Doctors based at the New York Downtown Hospital, have been given the go-ahead to begin screening women to undergo the first womb transplant in the US. The procedure will involve the removal and transferral of a uterus from a dead donor to a female recipient. After waiting...


Genome sequencing method promises higher accuracy with less DNA

16 July 2012

By Daryl Ramai

Appeared in BioNews 665

Technology that relies on less DNA to more accurately sequence people's genomes has been unveiled by a US biotech company.

In a paper in the journal Nature, Complete Genomics outlines how its 'long fragment read' technology produces few errors - one per 10 million DNA base-pairs, or 600 errors in an entire human genome – while using less tissue than previously required.

The technique is particularly relevant to non-invasive genetic sequencing of fetuses, and could have applications for screening pre-implantation embryos generated during IVF treatment. Furthermore, the technique enables separate sequencing of both maternal and paternal chromosomes to determine the degree of penetrance of genetic conditions.

Dr Rade Drmanac, Complete Genomics' chief science officer, said that the Nature paper demonstrated a 'ten-fold increase in accuracy' and that the technology 'is unmatched by any high-sensitivity method currently available'.

The company's shares closed up 44 percent on the day the technology was unveiled, with nearly 9.4 million shares of its stock exchanging hands. This will come as welcome news to the company which announced in June that it was laying off 55 staff after the company's net loss of $20.2 million in the first quarter of the year.

Complete Genomics has found it hard to compete with Illumina, which has emerged as the clear front-runner in the burgeoning field of genomic sequencing. Added to this, the firm is currently defending two patent suits filed against it by its rival.

Talking to Forbes magazine, Complete Genomics' chief executive officer Clifford Reid admitted that 'in the research market our advantages are pretty limited. We have higher quality. But in the research market that doesn't matter very much. Researchers can work with lower quality data. That's really been a startling revelation to us that despite the community saying quality is everything quality really isn't everything'.

As a result, Complete Genomics has focused on the prospective clinical market. The company's statement accompanying the Nature paper includes a quote from George Church, professor of genetics at Harvard Medical School, claiming that 'in the not-too-distant future, failure to use [the kind of technology developed by Complete Genomics] when providing genomic diagnoses in patient care will be seen as unacceptably inaccurate'.


20 October 2014 - by Sean Byrne 
Illumina has announced the first three companies in its Accelerator Programme, designed to help genomics start-ups as other sources of funding grow scarce...
21 July 2014 - by Dr Sarah Testori 
Genetic Alliance UK held its annual conference to discuss and reflect on the advances in genomic sequencing and to ask (and answer) why is it important, and how can it help to improve disease treatment...
08 October 2012 - by Paola Quattroni 
A computer-based platform which looks to greatly speed up genetic analysis of tumours has been unveiled in the USA. Currently such analysis can take up to eight weeks, the new platform promises to deliver results in just 47 seconds...
10 September 2012 - by Emma Stoye 
Scientists have found that 80 percent of DNA in the human genome, previously thought to be of no use, have important functions...

09 July 2012 - by Dr Lux Fatimathas 
US researchers have for the first time sequenced the genome of a fetus using only a blood sample from the mother. It is hoped this new form of non-invasive sampling could allow doctors to screen for a range of genetic diseases prenatally, with minimal risk to the fetus...
30 April 2012 - by Ruth Saunders 
The standoff between Roche and Illumina, which provides services and equipment for genetic analysis, finally came to an end last week as the Swiss pharmaceuticals giant ended efforts for a hostile takeover bid...
27 February 2012 - by Ayesha Jadoon 
A handheld device for sequencing DNA on the move has been unveiled by UK company Oxford Nanopore. The single-use MinION tool resembles a USB drive in size and shape, and the company hopes it will be put into routine use by clinicians and researchers alike...
16 January 2012 - by Dr Zara Mahmoud 
A US biotechnology firm has unveiled an automated desktop DNA sequencer that can decode the sequence of the human genome in one day for as little as $1,000 (£650). Given its first public viewing at a consumer electronics show in Las Vegas, Life Technologies Corporation's Ion Proton sequencer uses microchips similar to those found in digital cameras...


TV Review: Health Explained - How to Make Stem Cells

16 July 2012

By Daniel Malynn

Appeared in BioNews 665

Health Explained: How to Make Stem Cells

BBC News Health, Thursday 21 June 2012

Presented by Dr Dusko Ilic

'Health Explained: How to Make Stem Cells', BBC News Health, Thursday 21 June 2012

As a viewer I do not ask for much from a show; just to be a little informative, maybe some whimsical anecdote - unfortunately I did not even get this from this short film. Instead, what I got was two and a half minutes of footage mostly of people opening doors and looking 'sciency' to weird music.

This short video is called 'How to make stem cells' but a more accurate title might have been 'Where to make stem cells'. The film did not explain what stem cells are, or why a line of stem cells is needed. It is just a tour looking at people who are looking through microscopes. Don't get me wrong, the funky sci-fi themed music really built up some atmosphere. But the commentary, which includes a run-through of the clothing worn in the lab, left a lot to be desired. Unless the intention was to make Guy's Hospital look like the medical fashion capital of the world - watch out Paris and Milan!

Dr Dusko Ilic from the Assisted Conception Unit at Guy's Hospital, London gave the briefest of explanations of how stem cells could be used in the treatment of heart disease and diabetes followed by an awkward ending in which Dr Illic and a colleague (in full white overalls) staring longingly into the camera before they walk through yet another door (for no obvious reason), before the film ends.

I am possibly being too harsh - there were elements of interesting scientific fact, including that embryos used in research at the clinic were donated following IVF and the description of how a colony of stem cells grows. But these were washed away by the sheer agony of viewing the film. I am all for using new media and accessible formats to engage the public about the sometimes misunderstood area of stem cell research. I am just not convinced that this formant really worked this time.



11 June 2012 - by Dr Greg Ball 
Stem cell research isn't a topic you'd expect to see in a comic book, particularly when the aim is to give a realistic insight into the subject, avoiding hype and sensationalism. But that's exactly what 'Hope Beyond Hype', a graphic novel telling the story of stem cell research from discovery to therapy, intends to do...
12 March 2012 - by Professor Robin Lovell-Badge 
I am all for challenging dogma, but to do so requires robust evidence and carefully drawn conclusions. In the case of Professor Jonathan Tilly's much-trumpeted study on stem cells in ovaries that can give rise to eggs, I feel that both were missing...
27 July 2009 - by Ben Jones 
Many of the developments in the biosciences reported on in BioNews involve novel moral issues or further complicate existing ethical debates. While concerns about the efficacy or safety of a new therapy inevitably lead to calls for further action within the scientific community - more research, bigger studies, better analysis - ethical worries instead result in calls for non-specialist external validation, consultation exercises, public debate and engagement. While the public are put i
21 January 2008 - by MacKenna Roberts 
Scientists at the California biotechnology company, Stemagen, announced last week that they had successfully cloned the world's first human embryos, created from adult male skin cells. Although British scientists cloned human embryos two years ago, this is the first time that scientists have managed to grow such...


Website Review: Changing Futures

16 July 2012

By Marco Narajos

Project manager and literary editor of The MedSchool Project, Ashby School, Ashby-de-la-Zouch

Appeared in BioNews 665

Changing Futures

Developed by Nowgen

'Changing Futures', developed by Nowgen

Changing Futures is a website developed by young people as a project led by Nowgen. It contains free online resources, delving into cystic fibrosis (CF) and gene therapy, aimed at teenagers and teachers.

Public engagement in science, to me, is fundamental as it plays a huge role in creating the world's next generation of scientists. But not only that; public engagement allows greater access to topics that can be difficult to understand - that is the mission of Changing Futures.

Providing educational resources, especially for young people, can be especially difficult when the subject matter is diverse and complex. This I know first-hand from blogging about medical topics aimed at students. As a sixth-former hoping to study medicine at university, I sometimes find it hard to find resources that are kept simple enough to understand but detailed enough for me to learn something new.

For example, although there are numerous books on CF and gene therapy, I find there is little or no middle ground between brief explanations for children and medical books that are often too complicated. So while reading books to gain new knowledge is essential, for many complex topics, such as CF and gene therapy, creative resources - animations, interviews, music videos and video diaries - are needed.

This is where Changing Futures comes in. Changing Futures (aptly named with the same initials as cystic fibrosis) is an educational website filled with up-to-date information about CF and gene therapy, pitched at the perfect level.

The cystic fibrosis section of the website includes videos from experts explaining the science behind the condition. There are also interviews, including those with a patient adviser, a CF nurse specialist, and with two of the teenagers with CF who participated in the project. Their video diaries show what teenagers with CF go through in their daily lives - their daily routine, the physiotherapy involved and all the medication they are required to take. There is even a music video inspired by their physiotherapy exercises; although how the music is relevant to CF, I do not know!

Although the videos are very upbeat and uplifting, there is a serious undertone. The girls in the video diaries lead such different lives; and to think that there are around 9,000 people with CF in the UK alone, this is quite astounding. The videos are not only educational, but they also help non-CF viewers to reflect on their own lives. For those with CF, the video diaries may also serve as a reminder that they are not alone.

On gene therapy, the website features an interactive timeline with videos to explain each of the events listed. I found the video on liposomes most interesting as it relates to science when applied 'in the real world'. There are also videos on gene therapy made from teenagers' perspectives, which although more emotive than scientific, they do emphasise the issues experienced by people affected by CF.

The Teacher Zone on the Changing Futures website may also provide an invaluable resource for science teachers who wish to inspire young people to pursue science at university. As I run a medical club at school, I could make good use of the practical resources in the Teacher Zone to show others how to make their own mucus or how to extract DNA, for example.

As a student and as a teenager, I would definitely recommend this resource to anyone who wants to know more about CF and how it affects young people. Changing Futures is a great web resource that deserves a lot of kudos for bringing to light one of the UK's most common genetic conditions and creatively exploring gene therapy.



10 September 2012 - by Dr Greg Ball 
The Bourne Legacy sees a return of the Bourne franchise, only this time without its eponymous hero, but rather a whole new breed of biologically enhanced undercover CIA agents...

11 June 2012 - by Helen Brooks 
Is creating a life to save another immoral? That is the question the winners of the year 12 to 13 category of Nuffield Council's 'Box Office Bioethics' film competition attempt to answer....
28 May 2012 - by Dr Victoria Burchell 
As a promotional tool to advertise the research funded by the Wellcome Trust, this short film aims both to enthuse and to inform. In both respects it's relatively successful, combining clear and engaging explanations of two projects with smart graphics and shots of impressive-looking equipment. Unfortunately, a slow and rather confusing start may discourage some viewers from reaching the main messages, all of which are in the second half...
19 March 2012 - by Heidi Colleran 
The largest trial for a gene therapy for cystic fibrosis (CF) will begin in the UK this month. Coordinated by the UK Cystic Fibrosis Gene Therapy Consortium (GTC), 130 patients will be recruited and given working copies of the defective gene that leads to their condition...
27 July 2009 - by Ben Jones 
Many of the developments in the biosciences reported on in BioNews involve novel moral issues or further complicate existing ethical debates. While concerns about the efficacy or safety of a new therapy inevitably lead to calls for further action within the scientific community - more research, bigger studies, better analysis - ethical worries instead result in calls for non-specialist external validation, consultation exercises, public debate and engagement. While the public are put i



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