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Medical device regulation challenges put children's surgeries at risk

Research led by Trinity College in Ireland has found that a regulation which came into effect in May 2021 with the aim of improving the oversight of medical devices in Ireland is leading to unintended consequences which may put some surgeries for children, and the treatment of rare diseases, at risk. The study has been published in the journal Pediatric Cardiology.

Medical devices include a great diversity of technologies, which are evaluated and approved in the European Union (EU) according to a revised law that came into effect on 26 May 2021, known as the Medical Device Regulation or MDR (EU 745/2017). It has a transition period that allows products that were approved under the previous rules (the EU Medical Device Directives) to continue to be marketed until 26 May 2024 at the latest. As a result of a series of unforeseen factors, there is a possibility that the MDR may result in products becoming unavailable, with the consequent risk of a loss of some interventions that are reliant upon those devices. Devices that are used for orphan or paediatric indications are particularly vulnerable to this.

The paper provides an example of one device, the Rashkind balloon catheter, first developed by Dr William Rashkind in 1966 to open the upper chambers in the heart in neonates with congenital heart disease. A number of these balloons were once available in Europe and now there is only one. This device may become unavailable next year. If this happens, it will not be possible to continue this procedure, and alternative surgeries or treatments are far less optimal. The paper also describes the timeline and cost of bringing the device to market in the EU, the US and Canada, and the cost and time needed to access the EU market has become much greater. 

Researchers believe there is now an urgent need for policy to be developed to protect essential medical devices for orphan indications and for use in children, to ensure that necessary interventions can continue, and to ensure a more sustainable system in Europe over the longer term.

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Source: Trinity College Dublin, 20 October 2022

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Why is Britain still lagging behind on cancer care?

Cancer patients in this country should have the best survival chances in the world. With its universal healthcare system and world-leading researchers, the UK should be able to offer every patient the knowledge and reassurance that their disease will be picked up quickly and treated rapidly, with the best that science can throw at it.

Yet Britain languishes towards the bottom of developed nations’ league tables of cancer performance. On nearly every metric this is one of the worst places in the western world to get cancer — and some experts fear that survival rates are about to go backwards for the first time in a generation.

Britain is now operating a “late diagnosis service” for the disease, a former UK cancer tsar has said, while waiting times are creeping up and up and nearly half of patients are diagnosed when their tumours have already spread, slashing their survival chances.

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Source: The Times, 22 October 2022

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Infected blood scandal: Victims to get £100,000 by end of month

About 4,000 UK victims of the infected blood scandal are to receive interim compensation payments of £100,000 by the end of this month.

It is being paid to those whose health is failing after developing blood borne viruses like hepatitis and HIV. It is also being paid to partners of people who have died.

Conan McIlwrath, from Larne in County Antrim, who is among the 100 or so victims affected in Northern Ireland said it was "very much welcomed".

"This is the first compensation that's ever been paid - anything prior has been support," he told BBC News NI.

All victims have campaigned for actual 'compensation' as they have said only this would acknowledge decades of physical and social injury, as well as loss of earnings and the cost of care.

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Source: BBC News, 22 October 2022

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Nurse recruitment drive launched by NHS England amid acute shortages

The NHS is launching an effort to recruit tens of thousands of nurses to help fill the record number of vacancies that low pay, Covid and heavy workloads have created across the service.

A multimedia blitz will try to raise nursing’s profile as a worthwhile career by featuring patients who benefited from nurses’ skills and dedication.

NHS England’s “We are the NHS” campaign will use radio, social media and cinema advertisements to portray nursing as a varied and fulfilling role that can change people’s lives.

It comes soon after NHS figures showed that the number of empty posts in nursing across hospitals, mental health, community care and other services had reached 46,828 – the largest number ever. That means that more than one in 10 nursing roles (11.8%) are unfilled across the service overall.

While the NHS is short of almost every type of staff, service chiefs say the acute lack of nurses is a key reason why so many patients are waiting so long for A&E, cancer treatment and other care.

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Source: The Guardian, 24 October 2022

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Racism a ‘very serious problem’ at NHS agency

The troubled agency that supplies blood to the NHS has a ’very serious problem’ with racism, a staff survey has revealed.

Six hundred staff at NHS Blood and Transplant were surveyed and the results have been summarised in an internal memo, seen by HSJ. 

It said 55% of respondents felt the problem of racism at NHSBT is “extremely or very serious”, while half had little confidence in the organisation’s recent efforts to tackle racial inequality.

When contacted for comment, a NHSBT spokeswoman said the results were “difficult to read” and added that “we are deeply sorry to those who have experienced negative behaviour”.

The issues over race and leadership come at perhaps the most operationally challenging period in NHSBT’s history.  It is struggling to find enough staff for its donation clinics, which meant it issued its first-ever “amber alert” over blood supplies recently. 

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Source: HSJ, 21 October 2022

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Health of nation study calls on millions to sign up

Researchers are calling on five million UK adults to join what they hope will be one of the biggest studies in the world, to create the most detailed picture ever of the nation's health.

The aim is it to find better ways to prevent, spot and treat illnesses like cancer and dementia early on. It will involve collecting health and genetic data and creating a long-term repository of health information.

Our Future Health is part-funded by government, industry and charities. They hope to get their first set of results in the next few years.

Chairman of the programme, Prof Sir John Bell, said the ambition is to use the results to fundamentally shift the focus of healthcare systems to earlier diagnosis and prevention.

Invitations will go out this autumn to more than three million people in London, West Yorkshire, West Midlands and Greater Manchester. Over time it will be open to all UK adults.

Volunteers will:

  • fill in questionnaires about their lifestyles and any health problems
  • have blood tests for measurements such as blood sugar and cholesterol
  • have their height, weight and blood pressure measured
  • take genetic tests
  • consent to share their NHS records.

According to the plans the information will be used in a number of different ways.

Scientists will collate and combine this information and store it so that people cannot be identified, building up a bank of health and genetic data.

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Source: BBC News, 24 October 2022

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‘Uncomfortable’ A&E model could be rolled out nationally

A patient flow model which involves moving A&E patients to wards “irrespective” of whether there are beds available, is under review for wider rollout by NHS England and is being endorsed by senior clinicians, despite safety fears, HSJ has learned. 

The Royal College of Emergency Medicine has said it would be “unethical” for leaders not to at least consider implementing some form of “continuous flow” model for emergency patients.

The approach has been been trialled recently by North Bristol Trust and at several London trusts. HSJ understands NHS England is considering the wider implementation of the continuous flow model, although no final decision has yet been made.

The calls come despite patient safety concerns about the model being raised by the Nuffield Trust think tank, who said the evidence for the model is “poor” and could spread risk to other parts of the hospital.

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Source: HSJ, 21 October 2022

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‘My cancer patients took priority’ says doctor suspended for working while Covid positive

A Harley Street doctor suspended for working while testing positive for Covid at the height of the pandemic has said that his patient’s cancer treatment took priority.

Dr Andrew Gaya was found to have “blatantly disregarded” the rules by going to work at a centre for patients with brain tumours after he tested positive for the disease.

The “highly regarded” consultant oncologist “dishonestly” misled colleagues that he was safe to work by keeping his positive test secret, a tribunal found.

Dr Gaya, whose work is at the forefront of tumour care and has been described as “world class”, said he defied Covid-19 rules because he believed “the risk of harm to his patient” in delaying treatment was “greater than the risk he posed”.

Now, the doctor of 27 years has been suspended for three months at a Medical Practitioners’ Tribunal.

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Source: The Times, 20 Ocotober 2022

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Care homes ignore lifting of Covid curbs and shut out visitors

Sarah was only allowed to see her 78-year-old mother through a small, double-glazed window that opened 2in at the bottom. There had been a Covid outbreak in her care home and her family were barred from entry, contrary to government guidelines.

But this was not December 2020. It was two months ago.

“It was just horrific,” said Sarah. “Mum said, ‘I feel like I’m in prison.’ And it was hard for us to disagree.” Sarah and her sisters kept pushing for visitor rights, offering to wear full PPE, but the home, which charged £1,050 a week, instead issued a 28-day eviction notice, saying they “could not meet the family’s needs”.

In March this year, all restrictions on care homes were lifted. In a Covid outbreak — two or more positive tests — “visits should happen in all circumstances”. Each resident is allowed one visitor, and this does not need to be the same person throughout the outbreak. However, privately run homes are not following government guidelines. 

“We saw a massive, tragic loss of life at the beginning of the pandemic among this demographic,” said Helen Wildbore, director of Relatives and Residents Association. “But now care homes have swung dramatically to the other extreme and they have become medically risk averse at the cost of people’s mental health and quality of life. We know people in isolation who have just given up the will to live, who feel like they have been abandoned.”

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Source: The Times, 23 October 2022

You may also be interested to read these two original blogs posted on the hub:

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Thousands at risk as A&E queues stop NHS paramedics attending 999 calls

Paramedics in England cannot respond to 117,000 urgent 999 calls every month because they are stuck outside hospitals looking after patients, figures show.

The amount of time ambulance crews had to wait outside A&E units meant they were unavailable to attend almost one in six incidents.

Long delays in handing patients over to A&E staff meant 38,000 people may have been harmed last month alone – one in seven of the 292,000 who had to wait at least 15 minutes.

Of those left at risk of harm, 4,100 suffered potential “severe harm”, according to the bosses of England’s ambulance services.

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Source: The Guardian, 21 October 2022

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Struggling hospices fear demand for beds will grow as dying patients can’t afford to heat homes

The cost of living crisis could force dying patients to move into hospice beds as they can no longer afford to heat their homes, it is claimed.

The stark warning comes as the care sector faces soaring energy bills of its own, with the industry predicting a huge hike in costs next year.

Speaking about the impact the cost of living crisis is having on patients, Paul Marriot, Chief Executive of North East hospice St Cuthbert’s, said: “Here in the North East, for example, many of our patients are already on low incomes and the fact that they are ill increases their costs. The key thing is that they are in a time in life when they’ve got less choice around what they do about [costs]. So it’s not an opportunity for them to switch off the heating, it’s not an option for them, just to wear more clothes, it’s not an option for them to see it out until the spring, because they may not be here in the spring."

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Source: The Independent, 17 October 2022

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Urgent recall of contaminated antibiotic powder

Some batches of an antibiotic medicine called teicoplanin (brand name Targocid) are being urgently recalled in the UK because of possible contamination.

The two affected batches are labelled 0J25D1 and 0J25D2, say safety experts.

Patients and prescribers are being asked to check packs and stop using the medicine if it has either batch number.

Four patients so far have suffered high fevers just hours after being given a dose from these batches.

Other products containing teicoplanin are not affected by the recall.

The Medicines and Healthcare products Regulatory Agency (MHRA) says the two batches of Targocid 200mg powder for making a solution to take as an injection, by infusion or by mouth, were found to contain high levels of bacterial endotoxins - a toxic compound found in bacterial cell walls that can cause inflammation-related symptoms, high fever and, in very serious cases, septic shock.

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Source: BBC News, 21 October 2022

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Prescribing art and gardening for patients may be a waste of money

The “social prescribing” of gardening, singing and art classes is a waste of NHS money, a study suggests.

Experts found that sending patients to community activity groups had “little to no impact” on improving health or reducing demand on GP services.

The research calls into question a major drive from the NHS and Department of Health to increase social prescribing as a solution to the shortage of doctors and medical staff.

In 2019 the NHS set a target of referring 900,000 patients for such activities via their GP surgeries within five years.

Projects receiving government funding include football to support mental health, art for dementia, community gardening and singing classes to help patients to recover from Covid.

However, the study, published in the journal BMJ Open, said there was “scant evidence” to support the mass rollout of so-called “social prescribing link workers”.

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Source: The Times, 18 October 2022

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CQC taking ‘enforcement action’ against every fourth service it inspects

A quarter of services the Care Quality Commission has recently inspected required enforcement action from the regulator, its chief executive has revealed. 

Speaking at the launch of the regulator’s annual State of Care report, Ian Trenholm called for a “long-term, sustainable funding solution” from the government to aid a service that was ”genuinely struggling to cope”.

Mr Trenholm said “about a quarter of the services” the CQC has inspected in 2022 had resulted in it having to take “enforcement action”.

Examples of action taken against NHS trusts in the last year included enforcement measures placed on Nottingham University Hospitals, University Hospitals Sussex, and Princess Alexandra Hospital.

In response to a question from HSJ about the robustness of the CQC’s inspection regime following further care quality and safety scandals, Mr Trenholm said observers should not focus solely on the ratings given to trusts by the CQC as there was a lot ”work going on in the background, whether that’s enforcement or otherwise”.

He added the CQC had significantly increased the amount of information it was gathering in relation to concerns about services.

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Source: HSJ, 21 October 2022

 

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Warning for parents after rise in hospitalisations for flu in children under 5

Parents are being told to urgently bring their children forward for flu vaccinations as new data reveals the rate of hospitalisation and ICU admission for people with the virus is rising fastest among those under five years old.

New figures published in the UK Health Security Agency’s (UKHSA) National flu and Covid-19 surveillance report show that cases of flu have climbed quickly in the past week, indicating that the season has begun earlier than normal.

According to the UKHSA, vaccination for flu is currently behind last season for pre-schoolers (12.1% from 17.4% in all two-year-olds and 12.8% from 18.6% in all three-year-olds).

It has also fallen behind in pregnant women (12.4% from 15.7%) and under 65s in a clinical risk group (18.2% from 20.7%).

Dr Mary Ramsay, director of public health programmes at the UK Health Security Agency, said: “Our latest data shows early signs of the anticipated threat we expected to face from flu this season.

“We’re urging parents in particular not to be caught out as rates of hospitalisations and ICU admissions are currently rising fastest in children under 5.

“This will be a concern for many parents and carers of young children, and we urge them to take up the offer of vaccination for eligible children as soon as possible.”

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Source: The Independent, 20 October 2022

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Families accept damages over Nottingham NHS endoscopy deaths

The families of three patients who all died after undergoing the same specialised endoscopy procedure have accepted damages from an NHS trust.

The patients all died after a procedure called an endoscopic retrograde cholangiopancreatography (ERCP) at Nottingham University Hospitals NHS Trust.

Following their deaths, a coroner issued a report calling for changes. The trust said improvements had been made.

William - known as Bill - Doleman, 76, Anita Burkey, 85, Peter Sellars, 72, and Carol Cole, 53, died in the space of about six months after undergoing the procedures.

An inquest found they died as a result of complications of the ERCP - where a tube is passed through a patient's throat to examine and treat possible gallstones and other conditions.

The families said they had accepted undisclosed damages from the trust over the deaths.

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Source: BBC News, 21 October 2022

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Cough syrup banned in Indonesia after spate of child deaths

Indonesia has temporarily banned all syrup-based and liquid cough medicines after the death of nearly 100 children from acute kidney failure since the start of this year.

Most of those affected are said to be below the age of six.

Muhammad Syahril Mansyur, the country’s health ministry spokesman, said: “Until today, we have received 206 reported cases from 20 provinces with 99 deaths.”

He added: “As a precaution, the ministry has asked all health workers in health facilities not to prescribe liquid medicine or syrup temporarily … we also asked drug stores to temporarily stop non-prescription liquid medicine or syrup sales until the investigation is completed.”

The ban, announced by the health ministry on Wednesday, applies to prescription and over-the-counter medicines. It comes after nearly 70 children died of acute kidney failure this year in the Gambia, linked to four brands of paracetamol cough syrup manufactured by India’s Maiden Pharmaceuticals.

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Source: The Times, 20 October 2022

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Russell-Cooke secures victory and £970k payout for Karen Preater in vaginal mesh negligence case

Russell-Cooke personal injury and clinical negligence partner Grant Incles recently represented Mrs Karen Preater in a clinical negligence case over vaginal mesh surgery performed on her at a hospital in north Wales in 2014. 

Wrexham County Court found in favour of Mrs Preater, and roundly dismissed allegations made by the defendant in this case, the Betsi Cadwaladr University Health Board, that the claimant had lied in the presentation of her case, as part of a Fundamental Dishonesty defence. 

Mrs Preater underwent vaginal mesh surgery in January 2014 - to which she had not been properly consented. The surgery itself was performed negligently and as a result she suffered a life-changing chronic pain condition. In late 2020, the defendant carried out intrusive video surveillance of Mrs Preater and trawled through her life on social media, proceeding to launch a defence of Fundamental Dishonesty pursuant to S.57 of the Criminal Justice and Courts Act 2015.

The defendant alleged that the claimant was seeking to lie to the Court about her ability to work and need for care and assistance which, if found to be correct by the Court, would have meant that Mrs Preater would have lost all of her claimed compensation, and which may well have led to an application by the defendant to have her committed to prison for her alleged dishonesty.

The case was fought to trial over seven days in July 2022. HHJ Howells found that Mrs Preater had not sought to deceive any party at any time and should be fully compensated for her grave suffering since being injured over eight years ago. 

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Source: Russell-Cooke, 4 August 2022

Court judgement:

22081101.Preater v BCUHB approved judgment dated 4 August 2022.pdf

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Statement from East Kent Hospitals' chief executive Tracey Fletcher

Tracey Fletcher, chief executive of East Kent Hospitals, said: "I want to say sorry and apologise unreservedly for the harm and suffering that has been experienced by the women and babies who were within our care, together with their families, as described in today’s report.

"These families came to us expecting that we would care for them safely, and we failed them.

"We must now learn from and act on this report; for those who have taken part in the investigation, for those who we will care for in the future, and for our local communities. I know that everyone at the Trust is committed to doing that.

"In the last few years we have worked hard to improve our services and have invested to increase the numbers of midwives and doctors, in staff training, and in listening to and acting on feedback from the people who receive our care.

"While we have made progress, we know there is more for us to do and we absolutely accept that. Now that we have received the report, we will read it in full and the Board will use its recommendations to continue to make improvements so that we are providing the safe, high-quality care our patients expect and deserve.

"I want every family – whether they contributed to the investigation or not – to know I am here to listen to them, to learn and to lead our Trust in acting on this report. 

"I would like to thank Dr Bill Kirkup and the investigation team for their work. Today, our thoughts remain with those who have shared their experiences. We are grateful to them.”

Source: NHS East Kent Hospitals, 19 October 2021

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Further cuts will kill off NHS dental services, chancellor told

Jeremy Hunt has been told that any cuts to the health budget will in effect “kill” dental services across the UK and deny millions of patients access to a dentist on the NHS.

The chancellor has told members of the cabinet that “everything is on the table” as he seeks to find tens of billions of pounds in savings after ditching the economic plan of Liz Truss, who said on Thursday she was standing down as prime minister. Health is one key area expected to be hit.

But in an email to Hunt seen by the Guardian, the head of the British Dental Association (BDA) said in plain terms that because NHS dentistry had already “faced cuts with no parallel anywhere in the health service” over the last decade, any further reduction in funding could trigger its collapse.

“In blunt terms, NHS dentistry is approaching the end of the road,” Martin Woodrow, the BDA chief executive, wrote in the memo. “There is simply no more fat to trim, short of denying access to an even greater proportion of the population.”

In the memo to Hunt, Woodrow wrote: “Recent NHS England board papers confirm officials are euphemistically ‘taking steps to maximise access from existing resources’. We know what that means. Yes, we recognise the unparalleled pressures on public spending. Equally, we cannot escape the hard fact that a service millions depend on materially lacks the resources to underpin any rebuild.

“You have also spoken of the need for all departments to seek ‘efficiency savings’. Since the financial crash, NHS dentistry has faced cuts with no parallel anywhere in the health service, going into the pandemic with lower government contributions – in cash terms – than it saw a decade ago.

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Source: The Guardian, 21 October 2022

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Care substandard at 39% of maternity units in England, NHS watchdog finds

Two out of five maternity units in England are providing substandard care to mothers and babies, the NHS watchdog has warned.

“The quality of maternity care is not good enough,” the Care Quality Commission (CQC) said in its annual assessment of how health and social care services are performing.

It published new figures showing it rated 39% of maternity units it inspected in the year to 31 July to “require improvement” or be “inadequate” – the highest proportion on record.

Ian Trenholm, the CQC’s chief executive, said maternity services were deteriorating, substandard care was unacceptably common and failings were “systemic” across the NHS.

Its latest state of care report said: “Our ratings as of 31 July 2022 show that the quality of maternity services is getting worse, with 6% of NHS services (nine out of 139) now rated as inadequate and 32% (45 services) rated as require improvement.

“This means that the care in almost two out of every five maternity units is not good enough.”

The report said: “The findings of recent reviews and reports … show the same concerns emerging again and again. The quality of staff training, poor working relationships between obstetric and midwifery teams and a lack of robust risk assessment all continue to affect the safety of maternity services. These issues pose a barrier to good care.”

Staff not listening to women during pregnancy and childbirth is a recurring problem, Trenholm said. Their concerns “are not being heard” by midwives and obstetricians “in the way that they should”.

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Source: The Guardian, 21 October 2022

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Breast cancer patients in England face delays to reconstruction surgery

Women waiting for breast reconstruction surgery on the NHS in England face a “postcode lottery” of care, with some forced to wait more than three years, a damning report warns.

Two in five women (40%) waiting for breast reconstruction during the pandemic after having their breasts removed due to cancer faced a delay of 24 months or longer, according to research involving 1,246 women who either underwent reconstruction surgery or were waiting for it.

The report by charity Breast Cancer Now also warned that some breast reconstruction services are still not operating at full capacity after temporarily pausing at the start of the Covid-19 pandemic.

It says there was a 34% drop in breast reconstruction activity in England in 2021-22 compared with 2018-19. The charity added that on top of the delays, women face a “postcode lottery” of care, with some women offered certain types of reconstruction while others are denied the same operation.

Breast Cancer Now called on NHS England to develop a plan to address the backlog of breast reconstruction services.

One woman told the authors of the report she waited for three and a half years for breast reconstruction surgery, while another said she “wants to move on with my life” but has no idea when her surgery will go ahead.

Baroness Delyth Morgan, the chief executive of Breast Cancer Now, said: “For women who choose breast reconstruction, it is a core component of their recovery – far from a solely aesthetic choice, this is the reconstruction of their body and indeed their identity after they have been unravelled by breast cancer treatment and surgery.

“We hear of patients affected by delays to reconstruction surgery and the significant emotional impact this has on them, including altered body confidence, loss of self-esteem and identity, anxiety and depression, and hindering their ability to move forward with their lives, knowing their treatment is incomplete."

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Source: The Guardian, 19 October 2022

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NHSE’s ‘institutionalised’ firing of CEOs contributed to ‘major service failure’

An “institutionalised” and “counterproductive” system of hiring and firing trust leaders was a contributory factor to care failings which caused the death of at least 45 babies an inquiry has concluded. 

The inquiry into maternity care at East Kent Hospitals University Foundation Trust, chaired by Bill Kirkup, discovered what it described as the latest ”major service failure” in NHS maternity care. It concluded that successive chairs and chief executives were “wrong” to believe the trust had provided adequate care for more than a decade and urged they be held accountable. But he added the churn of senior management had been “wholly counterproductive” for the trust.

His report said: “We have found at chief executive, chair and other levels a pattern of hiring and firing, initiated by NHS England. The practice may never have been an explicit policy, but it has become institutionalised. In response to difficult problems, pressure is placed on a trust’s chair to replace the chief executive, and/or to stand down themself."

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Source: HSJ, 20 October 2022 (paywalled)

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New national incident reporting system delayed amid fears of patient safety ‘disaster’

The deadline for the NHS to move to a new system for safety incident reporting has been delayed after widespread concerns the rollout could be a ‘disaster’.

A memo from NHS England to local teams yesterday, seen by HSJ, says the deadline to transition to the new “learning from patient safety events” database has been pushed back by six months to September 2023.

The creation of LFPSE is a key strand of NHSE’s safety strategy, along with the overhaul of how serious incidents are investigated. It aims to make it easier for staff across all healthcare settings to record safety events, as the service will be expanded to include primary care.

It will replace the current national reporting and learning system, a central database created in 2003 to help identify trends and maximise learning from mistakes. The new system is part of a national strategy that pledges to save 1,000 extra lives and £100m in care costs each year from 2023-24.

Multiple patient safety managers at local trusts had raised concerns to HSJ about the previous March deadline, with one patient safety lead saying it would have been a “disaster” if enforced.

Helen Hughes, chief executive of charity Patient Safety Learning, said NHSE also needs to change its way of working, as well as the deadline extension. She said:

“We believe that NHS England needs to seriously reconsider their approach to engaging with trust leaders and staff on this issue, so that improvements can be made to the new LFPSE service to ensure it has the best possible chance of success, and to enable patient safety improvement.”

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Source: HSJ, 20 October 2022

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Expert advisers urge FDA to pull pregnancy drug from market

An expert panel convened by the US Food and Drug Administration voted 14-1 on Wednesday to recommend withdrawing a preterm pregnancy treatment from the market, saying it does not work.

During the sometimes contentious three days of hearings, the drugmaker Covis Pharma, backed by some clinicians and patient groups, had argued there is evidence to suggest the drug, called Makena, might work in a narrower population that includes Black women at high risk of giving birth too soon.

But FDA experts and others said the data does not support such a view. In closing arguments, Peter Stein, director of the Office of New Drugs at the FDA’s Center for Drug Evaluation and Research, agreed on the urgent need for a drug to reduce the incidence of preterm birth — a leading cause of infant mortality in the United States. But he said the data indicates that Makena is not that drug.

Stein said, “Hope is a reason to keep looking for options that are effective,” he said. “Hope is not a reason to take a drug that is not shown to be effective, or keep it on the market.”

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Source: The Washington Post, 19 October 2022

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