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Ethicon Media Monitoring 5/8/2019
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MHRA's devices head to join outgoing CEO in retiring later this year
May 6, 2019 | Fierce Biotech
By Conor Hale
The medical devices director of the U.K. Medicines and Healthcare products Regulatory Agency has begun a monthslong timeline to retire from the position—the second top MHRA administrator to do so in the wake of Brexit after the CEO announced his own plans to step down last year. -
Director of devices to step down from the UK Medicines and Healthcare products Regulatory Agency
May 7, 2019 | Medical Plastics News
John Wilkinson to step down as director of devices at the UK Medicines and Healthcare products Regulatory Agency (MHRA) in October. -
Sling The Mesh announce protest plans
May 7, 2019 | Rochdale Online
Greater Manchester members of campaign group, Sling The Mesh, are protesting in Manchester amid fears that the UK is now in the grip of a pelvic mesh implant crisis. -
Making a value judgement
May 7, 2019 | Lab News
By Catherine Joynson
Bioethics has become a global endeavour – and a good thing too says Catherine Joynson. As we push the boundaries of what we do with biology, we need to ask ‘should we’ as well as ‘can we’…
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MHRA's devices head to join outgoing CEO in retiring later this year
May 6, 2019 | Fierce Biotech
By Conor Hale
The medical devices director of the U.K. Medicines and Healthcare products Regulatory Agency has begun a monthslong timeline to retire from the position—the second top MHRA administrator to do so in the wake of Brexit after the CEO announced his own plans to step down last year.
Devices head John Wilkinson will depart at the end of October. He joined the agency in 2012 after serving as chief executive of Eucomed, the European medical technology industry association.
During his time at the MHRA, Wilkinson helped lead the agency’s efforts on the new EU regulations governing medical devices and in vitro diagnostics that took effect in May 2017.
He also chaired the Competent Authorities Medical Devices Executive, which guides regulatory collaborations between EU member states and the European Commission, and had previously been named an officer of the Order of the British Empire for his contributions to the medical device industry.
“These decisions are never easy to make, and with a very heavy heart, I have now decided to step down from my role at the Agency,” Wilkinson said in an agency statement. “I felt that now was the right time for me to move on to the next stage of my life.”
“These last seven years have been a wonderful experience for myself and I am proud to have been associated with, and worked for, the regulator,” he said. “I would like to express my deepest gratitude to my Agency colleagues with whom I’ve worked—I leave knowing that their drive and commitment in protecting public health will continue unabated.
“It’s for others to judge for themselves the work I’ve done, but my aim has always been to ensure high levels of patient safety whilst creating the right environment for medical devices to develop at a pace which continues to improve people’s lives and contributes to a sustainable development of our health services,” Wilkinson said.
Meanwhile, the CEO of the MHRA, Ian Hudson, is set to make his own exit from the agency the month before; he announced a 10-month departure plan last November.
“I had always intended to reduce my total work commitment to enable me to pursue other things and perhaps have more of a portfolio career by the time I reached 60, which has now happened,” Hudson said at the time. “I feel the time is right for a new person to guide the agency and our work through its next phase, following the U.K.’s departure from the European Union next year.”
While the full implications of Brexit remain uncertain amid delays past its March deadline, it is still possible that both Hudson and Wilkinson will leave behind a regulator forced to operate independently from the European Medicines Agency.
The new leadership will have to cope with the effects of Brexit on medical product supply, approvals, importation and other activities, including the move of the EMA’s headquarters from down the street in London’s Canary Wharf over to Amsterdam.
https://www.fiercebiotech.com/medtech/mhra-s-devices-head-to-join-outgoing-ceo-retiring-later-year
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Director of devices to step down from the UK Medicines and Healthcare products Regulatory Agency
May 7, 2019 | Medical Plastics News
John Wilkinson to step down as director of devices at the UK Medicines and Healthcare products Regulatory Agency (MHRA) in October.
During his seven years at the MHRA, Wilkinson has been involved in several initiatives such as establishing the agency’s position on medical apps and developing European Union regulations for devices and in vitro diagnostics.
The areas that Wilkinson focussed on were criticised prior to his arrival. At the time Wilkinson joined the MHRA in 2012, its response to the Poly Implant Prothèse (PIP) breast implant scandal was prominent in the media. A government report was published that exonerated the MHRA over the PIP scandal, however there was a call to, “take devices as seriously as medicines” in another published report.
The MHRA attempted to implement these regulations under Wilkinson’s appointment by actions such as working with the UK Foreign and Commonwealth Office in Brussels to push for regulations that would strengthen the oversight of medical devices across the EU and hiring clinical staff. The MHRA also attempted to improve the relationship it had with patients and the public.
Elaine Holmes, of the Scottish Mesh Survivors campaign group stated: "The agency is not an effective watchdog. It does not take our concerns seriously. We have written to it a number of times and telephoned it, but we get standard copy-and-paste replies. The agency does not listen to us.”
Additionally, Jackson Carlaw, a Scottish politician, during a parliamentary debate in 2016 stated: "I include the MHRA in my criticisms.
"When the public petitions committee took evidence from it, we learned that its detailed analysis amounted to three postgraduate students doing a desktop exercise for two weeks at a cost of £20,000."
The MHRA has promised to take a "more structured approach to proactive patient engagement and improved safety messaging."
As Wilkinson plans to depart, large criticism remains about the MHRA’s handling of the adverse events linked to vaginal mesh devices.
https://www.medicalplasticsnews.com/news/director-of-devices-to-step-down-from-the-uk-medicines-and-h/
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Sling The Mesh announce protest plans
May 7, 2019 | Rochdale Online
Greater Manchester members of campaign group, Sling The Mesh, are protesting in Manchester amid fears that the UK is now in the grip of a pelvic mesh implant crisis.
The growing mesh crisis has prompted campaigners to pressure the Government to carry out a retrospective audit to track the outcome of every single woman who has had a mesh operation in the last two decades. They say it is the only way to reveal the magnitude of suffering, and make the call for mesh implant operations to be banned unanswerable.
The protest, on Thursday 9 May, has been organised by Sling The Mesh, which has more than 7,500 members. Members of the group are suffering complications from a mesh implant operation to treat incontinence or prolapse, problems often caused from having babies. There are also members suffering following a hernia mesh operations.
Women will be outside the Hilton Hotel in Deansgate, Manchester, from 8am to 9.30am on Thursday 9 May to greet delegates arriving for the NICE 2019 annual conference. Women are protesting about new NICE mesh guidelines.
Professor Carl Heneghan, Director of the Centre for Evidence-Based Medicine at the University of Oxford is talking at the NICE 2019 conference in Manchester, where he will discuss the importance of including patient evidence to judge treatment effectiveness.
He said: "Twenty years after mesh was introduced we still have no understanding of its impact on women’s quality of life, the long-term complications and who has been harmed. It is therefore vital that NICE’s national registry starts with the thousands of women who have already had mesh. Vast numbers of patients are informing us how to improve healthcare; it’s about time we - the health system – listened”.
Joanne Lloyd, of Warrington, Sling The Mesh coordinator for the Manchester rally said: "There must be hundreds of women around the country, suffering and not being listened to.
“It's time for us to stand up and be their voice.
“NICE ignored patient evidence showing the catastrophic results when mesh goes wrong. Nobody knows the scale of suffering. The only way to get it is by a 20-year retrospective audit. It is morally wrong to carry on using mesh, harming more women, just to get evidence to prove how risky it is."
Kath Sansom, of March, Cambridgeshire, founder of Sling The Mesh, said: "On Thursday we are fighting for justice for every woman harmed by mesh and failed by the system. It has gone beyond institutional denial. It is institutional betrayal. The Government and NHS must step up to the mark and show proper leadership.
“First, they said mesh was safe, then it wasn’t.
“Then they contradicted the head of their own independent inquiry by backing NICE guidelines which did nothing but muddy the water further.
“Then they robbed women of a vital life-line by suspending mesh removal surgeries.
“Working in partnership with Thompsons Solicitors, we’ve already written to every NHS Trust urging them to ignore NICE's recommendations to carry on using mesh or face legal action. This is to stem the tide of the crisis, and prevent further patients from being put at risk.
“Thursday’s protest is about standing up for the women whose lives have already been torn apart by mesh and who desperately need access to support, guidance and – crucially – the hope of a mesh removal that right now, just isn’t there.
“We say, don’t ‘temporarily’ suspend the removal surgery designed to alleviate women’s pain. Permanently ban the surgical mesh procedures that – in the vast majority of cases – are in fact the most high-risk option of a range of safer, better alternatives.”
Owen Smith MP, chair of the All Party Parliamentary Group into Mesh, said: “Thousands of women have faced life-changing injuries following mesh surgery and they must not be ignored by NICE or the NHS.
“For years I have called for a national registry of all mesh procedures and until we have accurate data on the complications associated with mesh, it should not be used.
“The new NICE guidelines fail to clearly outline that mesh should only be used once conservative methods have failed and when non-mesh surgery has failed. It is vital that a proper continence care pathway is established, with mesh surgery as a last resort.”
https://www.rochdaleonline.co.uk/news-features/2/news-headlines/127623/sling-the-mesh-announce-protest-plans
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May 7, 2019 | Lab News
By Catherine Joynson
Bioethics has become a global endeavour – and a good thing too says Catherine Joynson. As we push the boundaries of what we do with biology, we need to ask ‘should we’ as well as ‘can we’…
All good scientists will be aware that sometimes, perhaps even often, their research will have implications for people and wider society beyond the laboratory. Considering those implications – the potential benefits and harms – and how they fit with the values people hold important, is how bioethicists spend their days.
Bioethics has become a global occupation, with large amounts of academic research being undertaken across the world and government-appointed bioethics committees now in existence in many countries.
The UK is no different, and we have a thriving bioethics community. Something that sets us apart, however, is the absence of a state-run bioethics committee. There is some history behind this. In the late 1980s, the quest to map the entire human genome was gaining momentum, and the lack of a UK national bioethics committee to consider the ethical issues this raised was emerging as a problem. Parliamentary debates on abortion and embryo research took place without, according to the British Medical Journal, “a clear and authoritative source of professional advice or a collective lead on the wider ethical and policy issues”.1 Yet the government of the day were not minded to set up a national bioethics committee.
So, in 1991, the Nuffield Foundation established the Nuffield Council on Bioethics, an independent body tasked with clarifying the ethical issues raised by biological and medical research. Wellcome and the Medical Research Council joined the Nuffield Foundation as co-funders of the Council in 1993, and it has remained that way ever since.
At the Nuffield Council, we see ourselves as occupying a space between academia, industry and society on the one hand, and the world of policy making on the other. We have no political, religious, financial or other affiliations, yet we engage with all perspectives. We aim to offer pragmatic policy advice on complex bioethics problems and are not afraid to challenge the status quo. When we asked whether it might be ethical to compensate organ donors in order to increase organ donation rates, the Guardian accurately said “The Nuffield Council on Bioethics never shrinks from the unthinkable.”2
Genomethics
Genomics has long been an important focus for bioethicists. Most recently, genome editing techniques such as CRISPR-Cas9 have received global attention. In November 2018, it emerged that gene-edited twin girls had been born to a Chinese couple. The editing, it was claimed, had targeted the CCR5 gene, with the aim of introducing immunity to HIV and some other viruses. Shortly before this development, the Nuffield Council published the findings of a two-year inquiry on the use of genome editing in human reproduction. We examined the use of genome editing in the context of assisted reproduction to alter a DNA sequence of an embryo, or of a sperm or egg cell prior to fertilisation, with the aim of influencing the inherited characteristics of the resulting person, and future generations.After extensive consultation and deliberation, we concluded that the use of heritable genome editing interventions is not, in principle, morally unacceptable, so there is no reason to rule it out altogether. However, the circumstances under which its use could be morally permissible – including that there has been a sufficient opportunity for broad public debate, research has been done to establish standards of safety, and risks of adverse effects for individuals, groups and society as a whole have been assessed and mitigated against – do not exist at present, anywhere. We must therefore get appropriate measures in place now to secure a responsible path to innovation and, perhaps, uptake of this technology.3
We did not expect our findings to be applied to real-world events so soon. We strongly condemned the actions of the Chinese scientist responsible for editing of the genomes of the babies in China. My Nuffield Council colleague Peter Mills said “…it is a premature, inexplicable and possibly reckless intervention that may threaten the responsible development of future applications of genome editing.” Bioethicists around the world, including those in China, concurred that the actions of the scientist involved were unethical. The Chinese Government later said that the scientist acted “illegally and in pursuit of fame and fortune”,4 and it recently published draft regulations that require national approval for clinical research involving gene editing and other high-risk biomedical technologies.5 I wonder whether such expedient action would have been taken at a time before bioethicists had the powerful global voice that they do today.
Future ethical worries
We are always on the lookout for the latest developments in science to ensure we are anticipating bioethical issues that might arise in future. Listening to scientists themselves is vital, and it seems these issues cut across all areas of scientific research. We recently set out the developments that are currently in our sights in an interactive infographic. It covers seven themes: human reproduction; shaping human beings; beginning and end of life; health and society; food, farming and the environment; crime and security; and research ethics.One area we are actively pursuing at the moment is the increasing use of implantable medical devices. These devices include those that replace body parts such as hip implants, deliver medication such as insulin, and provide support to organs and tissues such as pacemakers. New medical devices emerge at a much higher rate than new medicines, and about 400,000 devices have been approved for use in the EU. Medical devices can improve quality of life for patients and can be lifesaving. However, regulation of medical devices has been criticised for being too lenient and lacking transparency.6
Some devices have caused serious side-effects after being used in large numbers of patients without, it is claimed, adequate testing. For example, hundreds of women who were fitted with a vaginal mesh implant to treat pelvic organ prolapse have been left with life changing injuries and complications. The European-wide system of regulation is meant to protect patients from this kind of harm, but it also aims to support innovation and growth. In this case, it might be that the latter took priority over the former.
As well as addressing concerns about safety, any changes to regulation in this area will need to account for the fact that devices are increasingly connected to other devices, or to other networks. The ‘internet of things’ expands possibilities for data gathering, monitoring and analysis, and for upgrading medical devices after implantation. But this might also make devices more vulnerable to error and attack. Famously, the former US Vice President Dick Cheney had his pacemaker’s wifi connection disabled to thwart possible assassination attempts.
It’ll only get trickier
A further factor to consider is the strong desire by patients to access innovative treatments, particularly if they are in a desperate situation or have exhausted all other options. Patients can be willing to take higher risks than usual if there is a possibility, even very slight, that a treatment could be effective for them. In a recent publication on patient access to experimental treatments, we highlighted the important responsibilities of healthcare professionals to support patients to make informed decisions about treatments for which evidence is limited.7Sometimes people ask us, after almost 30 years in the business, whether there are any truly new bioethics issues left for us to consider. We tell them that new discoveries and technologies constantly challenge us and can make past dilemmas seem simple in comparison. We are seeing the convergence of different advancements in research and technology to create novel questions. For example, in the February issue of this magazine, Axel Schumacher highlighted the potential of blockchain technology to be used by individuals in a highly controlled way to share, or even sell, their genome to others in light of the availability of cheaper and more advanced genome sequencing technology. The idea of a monetised DNA marketplace, managed by individuals themselves, turns previous debates about consent processes and breaches of privacy on their heads. The increasing use of artificial intelligence (AI) technologies in healthcare and research also raises new questions about, for example, the potential for AI to make erroneous decisions, the question of who is responsible when AI is used to support decision-making, and difficulties in validating the outputs of AI systems.8
In addition, these developments are occurring within changing social contexts. There is an increasing focus on the potential for science to drive economic growth, a rising influence of social media and online activity, variable levels of trust in institutions, and shifts in our understanding and expectations of areas such as data privacy.
Being responsive to these changes, and keeping abreast of the very latest scientific developments, will be keeping the bioethics community busy for some time to come.
Catherine Joynson is Assistant Director at the Nuffield Council on Bioethics
https://www.labnews.co.uk/features/making-value-judgement-07-05-2019/
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