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Issue 839 (15 February 2016)

 

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 www.bionews.org.uk 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.

 

 

CONTENTS

Comment

News Digest

Reviews

 


 

Mitochondrial replacement techniques: US-style

15 February 2016

By Dr Peter Mills

Assistant Director, Nuffield Council on Bioethics

Page URL: http://www.bionews.org.uk/page_616974.asp Appeared in BioNews 839

On 3 February the US National Academies of Sciences, Engineering, and Medicine published a report on the ethical, social and policy considerations relating to mitochondrial replacement techniques (MRTs - a somewhat misleading description but one the authors defend in the report) (1). The report was written by a committee convened to advise the US Food and Drug Administration (FDA). This line of accountability may be significant.

The committee's report reflects many of the conclusions of the Nuffield Council on Bioethics' 2012 report Novel techniques for the prevention of mitochondrial DNA disorders: an ethical review and subsequently embodied in UK legislation and Human Fertilisation and Embryology Authority (HFEA) licensing guidance (2, 3). At its centre is the concern to minimise any risk to a child who may be born as a result of the procedure. It recommends, accordingly, that the safety and efficacy of the procedure should be established through preclinical research, and that it should be resorted to only in cases in which there is an undisputed risk of transmitting a severe mitochondrial disease.

As in the UK, the report recommends that the treatments should only take place in specialist centres, that patients should be given appropriate information and support, and that there should be long term follow-up of any children born. It is also welcome that the report takes the position that MRTs do not constitute a treatment for disease but an expansion of the reproductive options available to those who know themselves to be at risk of passing on a severe, inherited mitochondrial disorder. Neither of these is an unimportant thing but they are not the same thing (though there is much more to be said about this).

The recommendation that has inevitably attracted most attention, however, is that only male embryos should be transferred, an approach that was considered but rejected in the UK. There are two distinct lines of argument supporting this position, though the report equivocates between them.

One is that introducing the procedure first in male offspring allows its effects to be observed without the risk of any adverse outcomes being passed on to future generations (because mitochondria are inherited from the mother, through the egg). The report states clearly that this embodies a 'cautious' approach and constitutes permissible 'sex selection for medical purposes'. Another line of argument is that by stipulating that only male embryos are transferred, the supposedly more contentious prospect of germline modification is avoided. Again, this is clearly acknowledged in the report, which, like the earlier Nuffield report, calls for further public debate on this question.*

In the UK, in contrast, it was concluded that MRTs should not be used at all until preclinical research had shown that they were sufficiently safe and would not pose a significant risk to any offspring or their descendants. Where the US has a gradient, the UK has a threshold. Why?

MRTs are not obviously the sort of thing that lend themselves to investigation on the model of a conventional clinical trial. When MRTs are introduced they must be introduced as part of a treatment service; there will be no adjustment of the 'dose', no control groups; the treatment cannot be withdrawn if adverse effects are observed; and the consent conditions are both more complex (the invasive assisted conception procedure and the use of embryos in MRT require different and distinct kinds of consent) and lack sufficiency.

The US report, however, is framed – by the charge to the committee – as advice on 'the conduct of clinical investigations' of MRTs. One reason for this is the FDA's prior assertion of regulatory competence over the use of the products of MRT as 'human cells or tissues that are intended for implantation … into a human' (4) and, according to its own guidance, the requirement for an Investigational New Drug application to be made. But while, in this way, the FDA's risk-based regulatory mechanism may gain purchase on MRTs, it is not obviously a good fit for the purpose. Whereas in the UK we have a dedicated regulatory system that can respond to the multiple clinical, moral and social dimensions of assisted conception, no such system exists in the US. This is an important difference if, as the US report underlines, MRTs are about reproductive options and not about treating illness, and if, given rapid advances in genome editing, it is becoming increasingly difficult to hide behind safety concerns to avoid complex moral questions about germline modification.

There is an interesting coda on the question of transferring male embryos. Were a centre in the UK licensed to carry out this procedure – as one soon surely will be – the couple in question would be unable to elect to have only male embryos transferred, whatever their personal views about germline modification. (Such a preference would not be medically indicated – the procedure having been judged sufficiently safe by the regulators – and sex selection is not permitted in the UK for non-medical reasons). The UK has already accepted the permissibility of germline modifications; which germline modifications should be permitted must therefore be a matter of urgent and public debate.

*This question has been taken up in the current debates around genome editing, including a current Nuffield Council project: http://nuffieldbioethics.org/project/genome-editing/

SOURCES & REFERENCES
Washington, DC: The National Academies Press | 03 February 2016
 
Nuffield Council on Bioethics | 2012
 
3) The Human Fertilisation and Embryology (Mitochondrial Donation) Regulations (S.I 2015 No. 572) and HFEA Code of Practice (8th Edition), part 33 ('Mitochondrial donation').
| 2015
 
4) Title 21 Code of Federal Regulations (CFR), Part 1271.
| 
 

RELATED ARTICLES FROM THE BIONEWS ARCHIVE

11 July 2016 - by Dr Julia Hill 
The interaction between mitochondrial and nuclear DNA may have implications for health, metabolism and ageing, according to a new study...

08 February 2016 - by Kirsty Oswald 
Clinical investigations of mitochondrial donation are 'ethically permissable', says a panel of experts reporting to the US Food and Drug Administration...
05 October 2015 - by Dr John B Appleby 
A workshop organised to facilitate further in-depth ethical discussions about mitochondrial donation was recently held at the Centre of Medical Law and Ethics...
16 February 2015 - by Philippa Taylor 
In a recent Progress Educational Trust debate, 'Mitochondrial Donation: Is It Safe? Is It Ethical?', I spoke about the ethical issues raised by techniques to avoid the passing on of inherited mitochondrial disorders...
24 November 2014 - by Professor Peter Braude and Professor Robin Lovell-Badge 
A response to the open letter to the UK Parliament by Dr Paul Knoepfler...
08 September 2014 - by Dr Ted Morrow 
The regulatory path to clinical trials of mitochondrial replacement therapy was recently debated in the House of Commons. While scientists are still unsure how genes and genomes cause disease and impact on our physical appearance and personality, there are clearly misconceptions about mitochondrial genetics repeated during the debate that are not supported by current scientific evidence...

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Twin birth rate on the rise due to assisted conception

15 February 2016

By Dr Victoria Burchell

Page URL: http://www.bionews.org.uk/page_616264.asp Appeared in BioNews 839

The combination of increased use of fertility treatments and rising maternal age has caused a doubling in the rate of twin births in developed countries over the last 40 years, according to a recent study.

In England and Wales, the rate increased from 9.9 twins per 1000 births in 1975 to 16.1 in 2011, while similar increases were reported for the US (from 9.5 to 16.9), Germany (from 9.2 to 17.2) and France (from 9.3 to 17.4).

The increase is due to a higher incidence of fraternal twins, which arise when two eggs are released at the same time and fertilised by two different sperm. This event occurs more frequently in older women, and the authors think this partially accounts for the recent increase in twin births in developed countries.

The other reason for the increase, according to the study, is a 'sharp rise' in fertility treatments. In the early years of IVF it was commonplace to implant three or more embryos, resulting in high multiple birth rates by the year 2000. Ovarian stimulation by hormone treatments also increases the likelihood of two eggs being released at the same time.

'We're not sure if the rate will continue to rise, but the data is increasingly seen as a public health crisis', Gilles Pison, study co-author from the French National Institute for Demographic Studies, told the Independent.

In the report, published in Population and Development Review, the authors drew attention to the dangers associated with twin births compared to singletons: '[Twin babies] have lower birth weight, more complications at birth, and are more often born premature – all of which are associated with many long-term health problems.'

Multiple births also pose a risk to the mother, with an increased risk of health issues such as pre-eclampsia and postpartum depression.

The authors estimate the effect of fertility treatments on increased twinning rates to be on average 'about three times greater than the effect of delayed childbearing'. To address the high percentages of multiple births following medically assisted reproduction, many countries have introduced guidelines encouraging the transfer of fewer embryos following IVF.

Reflecting these changing practices, researchers observed a decline in multiple births in recent years in around a quarter of the countries studied. In the majority of countries however, including England and Wales, twin births have continued to rise.

The authors think this increase may reflect the increasing number of women turning to fertility treatments and the continuing trend toward later motherhood.

'The number of treatments continues to increase, and the average age of women undergoing these treatments is rising,' the team write.

They suggest that better data should be maintained on the age and nationalities of women having twin births in order to keep track of the impact of policies and practices around medically assisted reproduction.

RELATED ARTICLES FROM THE BIONEWS ARCHIVE

03 May 2016 - by Anneesa Amjad 
A study has identified two gene variants that increase the likelihood of a woman having twins and could explain why twins appears to run in families...
22 February 2016 - by Ryan Ross 
The use of IVF technologies could be storing up future health problems for children born through the technique, according to an evolutionary biologist...

11 January 2016 - by Dr Katie Howe 
Children conceived using IVF and other fertility treatments are at no greater risk of developmental delays than children conceived naturally, according to a large US study...
26 January 2015 - by Purvi Shah 
A study has shown a decline in the rates of stillbirths and premature deliveries of babies conceived via assisted reproductive technology in four Nordic countries....
16 December 2013 - by Dr Jess Buxton 
Twins have long been an endless source of fascination to their family, friends and society, and also to scientists. This year, the topics of twins in genetics and twins in fertility treatment formed the two halves of Progress Educational Trust's annual conference...
09 December 2013 - by Dr Victoria Burchell 
A high level of twin, triplet and other multiple births in the USA may be down to a rise in fertility treatments like ovarian stimulation being used independently of IVF...
25 November 2013 - by Ari Haque 
A report from the Office for National Statistics (ONS) shows that the number of multiple births among women over 45 has increased by 23 percent in the past year. The increase is thought to be in part due to more older women using IVF treatment to conceive...

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Third of GPs back end to NHS IVF funding

15 February 2016

By Ryan Ross

Page URL: http://www.bionews.org.uk/page_616283.asp Appeared in BioNews 839

A third of general practitioners believe that the NHS should not fund IVF treatment, according to a recent poll.

The survey, conducted by the publishers of the medical magazine Pulse, and involving 1158 healthcare professionals, also revealed that a quarter of nurses and a third of healthcare commissioners felt that IVF should not be provided by the NHS.

One female GP, speaking anonymously to Pulse, commented: 'It is very complex, but personally I don't think infertility is a disease. I appreciate for some people it is and it's very stressful. But it concerns me that people feel that having a child is a right.'

Three-quarters of the professionals surveyed agreed that there should be a public debate over what medical treatments should be available from the NHS. The majority of respondents (75 percent) also said that homeopathy should not be offered, while around 40 percent stated that neither chiropody, acupuncture or osteopathy should not be provided by the health service.

Commissioners are currently tasked by NHS England and the Government to identify £22 billion in efficiency savings over the next five years.

Around one in six UK couples have problems conceiving naturally and a privately funded cycle of IVF typically costs around £5000.

The National Institute for Health and Care Excellence (NICE), advises that eligible women under the age of 40 be offered three cycles of IVF if they have not conceived naturally after two years. But some CCGs, such as Mid Essex CCG, no longer offer IVF at all, and many others now restrict treatment to one cycle despite being told by NICE to end geographical disparities in access to treatment (see BioNews 754 and 777).

Figures published recently by Fertility Fairness, which campaigns for equal access to IVF on the NHS, reveal that fewer than one in five CCGs are meeting the NICE guideline in full (see BioNews 826).

Dr Andrew Green, chair of the GPC's prescribing committee, told Pulse: 'When there is pressure on what you might call basic services, it's fairly understandable that people look to things that aren't life or limb and think "well that should be cut".'

However, he continued: 'If you look at the unhappiness, distress and indeed depression that can come from having difficulty starting families, it is difficult to say they should not receive treatment.'

Dr Richard Kennedy, gynaecologist and president-elect of the International Federation of Fertility Societies, was more critical, saying: 'The views of these doctors goes against the view of the World Health Organisation, which says that the ability to have a family is a human right.'

He added: 'The suggestion that infertility is not a disease is also fundamentally incorrect, with three quarters of infertility stemming from a medical condition. To reduce funding for fertility treatment, even in these constrained times, would not be appropriate. The provision for IVF in the UK is already well below the average for Europe, without reducing it further.'

Professor Geeta Nargund, Medical Director of fertility clinic Create Fertility, argued that the expense of IVF was worsened by the variation in how much fertility clinics charge the health service. 'If this cost was standardised,' she claimed, 'it would reduce financial pressure on the NHS.'

Fertility Fairness has claimed that one of the barriers to many CCGs becoming NICE-compliant is the cost of IVF services. There is currently no national tariff in England for tertiary fertility services meaning that some CCGs are paying as much as £6000 for a single cycle of IVF while others are paying £1379.

RELATED ARTICLES FROM THE BIONEWS ARCHIVE

18 April 2016 - by Dr Mary Yarwood 
Bedfordshire Clinical Commissioning Group is consulting the public on whether to remove all funding for IVF treatment, apart from for special medical exceptions...
28 February 2016 - by Rikita Patel 
Somerset CCG has announced that its provision of NHS-funded IVF will be reduced from two cycles to one...

09 June 2014 - by Purvi Shah 
The Vale of York Clinical Commissioning Group has agreed in principle to fund IVF treatment for couples in the area, although a formal decision on the matter will be made at a later date....
10 December 2012 - by Ari Haque 
A couple who was refused fertility treatment on the NHS for being 'too old' has said it intends to challenge the decision in the courts, arguing that the decision amounts to age discrimination....
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...
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...

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Sure Genomics offers direct-to-consumer whole-genome sequencing

15 February 2016

By Kulraj Singh Bhangra

Page URL: http://www.bionews.org.uk/page_616324.asp Appeared in BioNews 839

US start-up company Sure Genomics has launched the first whole-genome testing service available directly to consumers, for a cost of US $2500.

The Utah-based firm will use whole-genome sequencing to create individual reports on characteristics such as drug interactions and responses, fitness, nutrition and ancestry.

The reports will also include information on BRCA1 and BRCA2 gene mutations, which can strongly predispose a person to breast and ovarian cancer.

'Our company is dedicated to making personal DNA information accessible, while providing an engaging platform to help foster deeper understanding of what our DNA says about ourselves,' said Warren Little, CEO and co-founder of Sure Genomics.

'Just one test provides a lifetime of discoveries, helping us make more informed decisions about our personal health – and potentially our future generations.'

Aside from the $2500 test fee, there is also a $150 annual subscription fee, which customers must pay to receive twice-yearly re-analysis of their genetic data.

In contrast to their competitors 23andMe and Ancestry, the company says it will not sell or share personal information about its customers.

However, from a regulatory standpoint, there is much ambiguity regarding whether Sure Genomics should be providing information on BRCA1 and BRCA2 since the Food & Drug Administration (FDA) has not cleared direct-to-consumer tests for these mutations.

The FDA previously came down heavily on 23andMe for its direct-to-consumer genetic health tests (see BioNews 733), and Anne Wojcicki's company is still only allowed to provide limited information on disease risk to customers in the US (see BioNews 825). It appears as if, initially, Sure will only be providing disease-risk information on BRCA1 and BRCA2 and states it intends to 'release additional reports after they meet all required FDA  regulatory standards'.

'We have been in contact with the FDA and we feel like we've built a system and process that would meet their requirements,' said Sure Genomics co-founder Rick White. '[Our] reports are going to be delivered in, I would say, an ultra-compliant manner,' he added.

The company also seems to be appeasing the FDA by having an in-house physician to prescribe the genetic testing. Those who make use of the service can also have a one-hour consultation with a genetic counsellor, although this is optional.

But Professor Mark Rothstein, from the University of Louisville, said he didn't believe the use of a prescribing doctor would influence the FDA. 'I don't think getting a doctor to order the test changes anything,' he told The Verge.

The FDA has previously expressed misgivings over direct-to-consumer genetic testing because of risks such as false-positives and -negatives, and concerns the results may lead patients to make decisions that adversely affect their health.

RELATED ARTICLES FROM THE BIONEWS ARCHIVE

03 July 2017 - by Cara Foley 
Approximately 22 percent of healthy adults carry mutations that are associated with disease, found the first ever randomised clinical trial using whole-genome sequencing...
23 January 2017 - by Kulraj Singh Bhangra 
Scientists have created a smartphone microscope attachment that can image and analyse DNA sequences...
18 April 2016 - by Elie Diner 
Scientists searching through nearly 600,000 genome sequences have found 13 'superhumans' who are symptom-free despite carrying mutations for severe childhood diseases...
21 March 2016 - by Ryan Ross 
A recent study has suggested that genetic tests to assess the risk of diseases like diabetes and lung cancer do little to motivate people to change their behaviour...
21 March 2016 - by Helen Robertson 
'Personalised medicine' is a term that's being increasingly used to describe the future of cancer treatment. But are we ready for the genomics revolution that comes with it?...

25 January 2016 - by Rikita Patel 
The US National Institutes of Health (NIH) has pledged over US$280 million over the next four years to genome sequencing targeting common and rare human diseases...
14 December 2015 - by Andelka M. Phillips 
There is now a huge range of direct-to-consumer genetic tests on the market, but the public ought to be wary of what exactly they are agreeing to when they sign up for these services...
16 November 2015 - by Lone Hørlyck 
The US Food and Drug Administration has sent warning letters to three gene-testing companies over the marketing and selling of what it claims are direct-to-consumer gene testing products without its approval...
22 October 2015 - by Julianna Photopoulos 
Genetic testing company 23andMe is relaunching its direct-to-consumer genetic tests in the USA, after receiving approval from the US Food and Drug Administration...
02 March 2015 - by Alice Hazelton 
Genome sequencing offers great potential for the effective diagnosis and future treatment of many conditions. But while the excitement continues to grow around the science, few have stopped to ask what patients, the ultimate end-beneficiaries of this technology, think...

HAVE YOUR SAY

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Scientists developing blood test to detect five early-stage cancers

15 February 2016

By Helen Robertson

Page URL: http://www.bionews.org.uk/page_616336.asp Appeared in BioNews 839

A blood test to diagnose common types of cancer is in development after researchers found that five forms of the disease share a telltale chemical signature.

Researchers at the US National Human Genome Research Institute found that tumours in colon, lung, breast, stomach and endometrium share a change in a gene called ZNF154. Knowing that DNA from tumours can circulate in the bloodstream, the team proposes it would be possible to detect this change and diagnose cancer from a standard blood test.

'We have laid the groundwork for developing a diagnostic test, which offers the hope of catching cancer earlier and dramatically improving the survival rate of people with many types of cancer,' said Dr Laura Elnitski, whose research group led the study, published in The Journal of Molecular Diagnostics.

In 2013, the research group analysed cancerous tumours from 13 different organs, and found that DNA methylation was commonly increased at ZNF154 in all tumour types. DNA methylation acts like a chemical 'dimmer switch' on genes: an increase in methylation causes a decrease in gene activity.

The current study focused on the possibility of using the enhanced methylation as a reliable indicator of cancer. The team compared 184 samples from five different tumour types with 34 normal, non-cancerous tissue samples.

'Finding a distinctive methylation-based signature is like looking for a spruce tree in a pine forest,' said Dr Elnitski. 'It's a technical challenge to identify, but we found an elevated methylation signature around the gene known as ZNF154 that is unique to tumours.'

Importantly, they found that this genetic change was consistent across the five different types of cancer, suggesting that it could be used as a universal cancer marker. The study also showed that the enhanced methylation was detectable even at very low concentrations in the blood, meaning that a blood test could be used to identify cancer from early-stage tumours.

Currently, diagnostic tools for cancer are reliant on physical examination, internal imaging and biopsies. Where blood tests are used, they are specific to a certain cancer type and require prior knowledge of suspected cancer.

Using a broader and more sensitive approach, as is hoped for the new blood test, would not only be less invasive, but also more likely to detect cancer at an earlier stage, when treatment is more effective.

The researchers are now focusing on developing the blood test as a diagnostic tool. They will need to confirm whether it outperforms existing methods of screening and diagnosis, notes NHS Choices. Characterising the rate at which it indicates cancer is present when the disease is not there – or misses cancer when it is present – will also be highly important.

'Their method of detecting this is very sensitive,' Professor Samuel Janes, honorary medical adviser to the British Lung Foundation, told The Telegraph. He added: 'We will have to wait and see if this actually works.'

RELATED ARTICLES FROM THE BIONEWS ARCHIVE

02 May 2017 - by Dr Loredana Guglielmi 
Blood tests for tumour DNA could predict relapse of the most common type of lung cancer up to one year before clinical signs show up on patient's scans...
24 April 2017 - by Meghna Kataria 
A blood test could swiftly detect gene mutations found in lung cancer, allowing faster commencement of treatment...
26 September 2016 - by Ebtehal Moussa 
A new gene therapy technique using microRNAs has successfully prevented the spread of breast cancer in mice...
12 September 2016 - by Meetal Solanki 
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09 May 2016 - by Rachel Siden 
Adding more genes to existing multi-gene panels that test for breast and ovarian cancer risk offers little clinical benefit, a study says...

09 November 2015 - by Kirsty Oswald 
Researchers have identified the genetic mutations that drive resistance to the hormone therapy abiraterone in patients with advanced prostate cancer...
09 November 2015 - by Ayala Ochert 
Scientists say it may be possible to track the progress of cancer – and cancer treatment – in real time from fragments of tumour DNA that are shed into the bloodstream...
14 September 2015 - by Isobel Steer 
A US startup called Pathway Genomics has launched the first commercial 'liquid biopsy' to identify cancerous mutations via a blood test...
01 September 2015 - by Hannah Somers 
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20 July 2015 - by Ceri Durham 
Abnormal results from a non-invasive prenatal test for fetal chromosome abnormality may indicate the presence of previously undetected cancers in some mothers....

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Stem-cell controversy unfolds in Sweden

15 February 2016

By Kirsty Oswald

Page URL: http://www.bionews.org.uk/page_616939.asp Appeared in BioNews 839

The world-renowned Karolinska Institute is at the centre of a scandal surrounding the conduct of stem-cell surgeon Paulo Macchiarini.

Last year, an investigation by the Institute, where Macchiarini is a visiting professor, cleared him of scientific misconduct following accusations from colleagues that he had falsified his results in scientific papers.

This week the vice-chancellor Anders Hamsten, who led that investigation, resigned after a television documentary broadcast in Sweden brought renewed interest to the details of Macchiarini's conduct.

The documentary provided evidence that Macchiarini had not informed his patients of the risks of his highly experimental trachea-replacement surgeries, several of whom died following the procedures.

'We are now endeavouring to investigate this information thoroughly and arrange an independent examination. But there is much to indicate that the judgement reached by KI last summer should be amended to scientific misconduct, which in plain language means research fraud,' Hamsten wrote in a piece for the newspaper Dagens Nyheter.

In January, an article appeared in Vanity Fair, in which Macchiarini's former fiancée claimed that he had falsified his qualifications and experience on his CV. Subsequently, the Karolinska Institute said they were launching an inquiry into the accuracy of the information Macchiarini had given them prior to his employment in 2010.

But less than a week later, a three-part documentary called The Experiments appeared on Swedish television. It revealed that Macchiarini may have misled patients by not notifying them of the risks of the procedure, and reassuring them that experiments in animals had been successful when in fact none had taken place.

The procedure involves the replacement of a damaged trachea with a polymer scaffold embedded with the patient's own stem cells that will then grow and form tissue to replace the trachea. Macchiarini performed three such procedures at the Karolinska Institute and its associated hospitals.

Two of the three patients who Macchiarini operated on at the Karolinska Insitute have since died, including the subject of a 2011 Lancet paper. The third patient is still alive but has been in intensive care since the surgery in August 2012.

The documentary also provided details about the case of one woman who died after Macchiarini operated on her in Russia, despite the fact that her trachea injury was non life-threatening and therefore did not warrant such a risky procedure.

Macchiarini was previously considered a pioneer of stem-cell medicine and something of a celebrity surgeon, claiming to have treated high-profile patients such as Pope John Paul II and the Clintons.

The Karolinska Institute has now dismantled his research group and said it would not be renewing his contract, which is due to expire later this year. The Institute has now relaunched its investigation into Macchiarini's conduct, but the Swedish Academy of Science has demanded this be transferred to the country's Central Ethical Review Board to ensure impartiality. The Academy is also seeking a retraction of the Lancet article, which omits the subsequent fate of Macchiarini's patient.

On 7 February, Urban Lendahl, secretary general of the Nobel Assembly, which is based at the Karolinska Institute, also resigned as a result of the scandal 'out of respect for the integrity of the Nobel Prize work'. Lendahl had been involved in hiring Macchiarini to the Institute in 2010.

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07 August 2017 - by Rachel Siden 
The original paper promoting a new genome editing technology known as Natronobacterium gregoryi Argonaute (NgAgo) has been retracted...

09 November 2015 - by Dr Nicoletta Charolidi 
In the aftermath of the STAP stem-cell controversy, Waseda University has revoked the doctorate degree of the stem-cell scientist Haruko Obokata...
14 April 2014 - by Dr Greg Ball 
Dr Haruko Obokata, the lead author of two controversial stem cell papers that reported discovery of so-called STAP cells, has apologised for errors in her work...
07 May 2013 - by David O'Rourke 
A toddler has become the youngest person to receive a bioengineered organ, receiving a life-saving windpipe transplant made from her own stem cells...
11 July 2011 - by Dr Rebecca Robey 
Surgeons have successfully transplanted a synthetic organ into a human for the first time. In a groundbreaking operation, a cancer patient's windpipe was replaced with an artificial replica that had been grown using his own stem cells....
22 March 2010 - by Dr Vivienne Raper 
A UK child has become the world's first to receive a full windpipe transplant using an organ built from his own stem cells...

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US egg donor 'price cap' challenge settles

15 February 2016

By Chee Hoe Low

Page URL: http://www.bionews.org.uk/page_617181.asp Appeared in BioNews 839

A settlement has been reached between parties of a class-action lawsuit regarding compensation paid to egg donors in the USA.

The lawsuit was brought by two egg donors, who have since been joined by a further two donors, against the American Society for Reproductive Medicine (ASRM) and the Society for Assisted Reproductive Technology (SART). It claims that guidelines, first published in 2000, that state payments to donors in excess of $5,000 'require justification' and that sums above $10,000 are 'not appropriate' amount to an unlawful 'price cap' on the compensation payable to egg donors (reported in BioNews 826).

The guidelines are not mandatory but are widely followed by fertility clinics in the USA. Yet, despite the guidelines, compensation for donor eggs in the USA regularly reaches up to $75,000 dollars and there are even reports of six-figure sums being paid out.

Parties of the lawsuit have now reached a settlement, the Law Blog of the Wall Street Journal reports. According to the proposed settlement the ASRM has agreed to deleting the relevant provisions of the guidelines which place the 'price cap' on egg donor compensations. The organisations also agree to pay the claimants' legal fees of around $1.5 million. The claimants will also receive $5,000 each.

A California district court has been asked to preliminarily approve the terms and to order that the settlement be distributed to all members of the settlement class, namely all egg donors affected by the ASRM guidelines in the past, present and future. Members can then raise objections to the settlement, which will be heard by the court before the terms are finalised.

Ellen Meriwether of Cafferty Clobes Meriwether & Sprengel LLP who represented the claimants told Law360: 'We are pleased that we have been able to reach an agreement with the Defendants that, in our view, will benefit the class by removing a compensation guideline that Plaintiffs alleged violated the antitrust laws.'

SOURCES & REFERENCES
Law 360 | 01 February 2016
 
Law Blog, Wall Street Journal | 03 February 2016
 

RELATED ARTICLES FROM THE BIONEWS ARCHIVE

08 August 2016 - by Antony Blackburn-Starza 
Fertility clinics in Australia have been warned not to offer flat fees to egg and sperm donors, reports the Sydney Morning Herald...

02 November 2015 - by Lone Hørlyck 
Egg donors are suing the American Society for Reproductive Medicine and the Society for Assisted Reproductive Technology in a class-action lawsuit for setting a 'price cap' on compensation to egg donors...

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Podcast Review: Stuff You Should Know - How Personalized Medicine Works

15 February 2016

By Dr James Heather

Page URL: http://www.bionews.org.uk/page_617294.asp Appeared in BioNews 839

An offshoot of the popular 'edutainment' website How Stuff Works, Stuff You Should Know is an incredibly prolific biweekly podcast, with over 800 episodes recorded over the course of the last seven years. In fact, with over 100 million downloads on iTunes and a long history of receiving critical acclaim, I'm amazed that it's taken me this long to hear about it.

In the classic podcast format, every episode a topic is picked and discussed, in this case by two of the senior editors from the How Stuff Works team, Josh Clark and Chuck Bryant. In this recent episode, they covered a topic close to the heart of the BioNews crew – 'How Personalized Medicine Works'.

Personalised medicine – the idea of using individual characteristics to tailor a patient's therapy specifically to them, in order to maximise response or minimise side-effects – is increasingly being hailed as 'the next big thing' in medical treatment. However, as the two hosts admirably point out at the top of the show by quoting Hippocrates' famous adage that it is '...far more important to know what person the disease has than what disease the person has', this is not a new concept.

Over the course of forty minutes, Josh and Chuck take the listener on a whirlwind tour of personalised medicine, outlining the concept, how it's come about and giving us a few choice examples of current successes.

Key to the emergence of personalised medicine was the completion of the Human Genome Project, and the associated technological advances that followed. Being able to sequence our DNA, and compare it against reference sequences, doctors were never more able to stratify patients into different groups based on their biological makeup. This provides a path running opposite to the direction of most of modern medicine, in which – as the hosts report – a largely trial and error-based approach is used to apply findings from one group of people to another, in the hope what works for one will work for all.

The idea of using genomics to identify subsets of patients for a particular treatment is demonstrated in one of the examples which popped up during Josh and Chuck's conversation. Ivacaftor (sold under the name Kalydeco) is a very effective treatment for cystic fibrosis, but only for the few percent of patients who have certain mutations in the cystic fibrosis gene; if you don't have those mutations, the drug just won't work for you.

Other examples provided in the show demonstrate that personalised medicine isn't just about DNA. The breast-cancer therapy trastuzumab (Herceptin) binds to a protein that is found on the surface of some cancerous cells – but only in a fraction of people. Therefore, if you can find the patients whose breast-cancer cells do express this protein, you have found the people for whom trastuzumab might be effective. They also talk about a more bioengineering-type approach to personalised medicine, such as the development of artificial pancreases which could monitor a person with diabetes' sugar levels in real time, allowing them to give themselves the right amount of insulin at the right time.

Josh and Chuck cover a lot of ground, skimming across a number of the major highlights, in keeping with their mission to give people a decent grounding in a given topic. What's more, they do so in a very enjoyable way; they have an engaging, easy rapport and their frank and casual presentation style makes for enjoyable and digestible listening. It's as if they've distilled the essence of sitting in a pub with friends, amicably chatting over the stories of the day.

However there are a few downsides to this easy-going approach. With the pub-chat vibe they have cultivated, the largest problem is one of accuracy. As neither host is a necessarily an expert in the topics they discuss, and with at least one of them (I'm looking at you, Chuck) not always being that familiar with the details of the story at hand, I certainly caught a few inaccuracies and exaggerations that slipped through.

That is not to say the boys don't know their stuff or haven't done their research. In fact, during their discussion of DNA sequencing (which is technique that I make frequent use of in my own research) they displayed an impressively nuanced appreciation of some of the subtle and not-so-obvious downsides, such as the hidden cost of analysis and the dangers of commercial companies holding widescale genomic data.

I would have liked it if the conversation had touched on some of the barriers to or pitfalls involved with personalised medicine, such as regulatory barriers and technical hurdles to new treatments, or how we're going to need to start increasing the diversity of the people whose genomes we investigate if we want to be able to understand and treat the whole of human disease. However, both this and my resentment of the slightly annoying adverts are very minor complaints, weighed against a much greater store of enjoyment and stimulation.

All told, this episode was a pleasant romp through the topic, and it was only my pre-existing knowledge of this particular field that let me catch the tiny number of mistakes they made. The conversation was intelligent and illuminating, and the banter was flowing: the format works. In combination with the frankly stunning back catalogue of episodes covering an enormous range of topics means that my commute soundtrack is set for weeks.

SOURCES & REFERENCES

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