Leading doctors are warning that British children with cancer could suffer if they are no longer able to join Europe-wide trials of innovative new medicines as a result of the Brexit deal.
The Institute of Cancer Research (ICR) and the Royal Marsden NHS Foundation Trust say the best hope for some children with cancer is a clinical trial where a new drug is being tested. But because of the small number of children with the same cancers, the trials have to be run in many hospitals, often across Europe.
If the UK leaves the European Union and withdraws from the currently London-based European Medicines Agency which licenses new drugs, as expected, then pharmaceutical companies may choose to trial drugs just for children from countries in the EU. Children in the UK would lose out, and it could take years before they could get access to the newest treatments.
The ICR and the Marsden say EU regulations governing the way medicines are tested in children badly need reform to make companies trial more drugs in children, but the UK would be worse off without them.
“It is imperfect but it is all we have,” said Prof Louis Chesler, a consultant in paediatric oncology at the Marsden.
Children’s cancer is a very small field, he said. “The most effective way to run a clinical trial is to run a big one. If the regulations change and stop us working across European sites, that is a big problem for us,” he said.
The ICR and the Marsden, in their response to a European commission consultation on the future of drug regulation for children, are calling for changes so that drug companies cannot so easily obtain a waiver and duck the obligation to do trials in children once they have shown a drug works in adults.
A new analysis by the ICR shows that over the past five years (2012-2016) pharmaceutical companies were granted waivers from having to trial cancer drugs in children for 33 of 53 approved cancer treatments.
“By allowing pharmaceutical companies to use waivers to avoid trials in children so they can focus on adult treatments, the regulation is stifling progress and could be stopping children receiving a treatment that could save their lives,” said Chesler.
Prof Paul Workman, the chief executive of the ICR, said: “Children with cancer are currently missing out on the kind of innovative cancer treatments that are becoming increasingly common in adults because of outdated European rules that have failed to keep up with advances in science.
“We’ve been urging decision-makers to change the regulation for several years now, so that adult cancer drugs are tested in children whenever their mechanism of action suggests they could be effective.
“This is a real chance for reform to prevent the current out-of-date approach from being cemented for a decade. It could also be the last chance to make meaningful changes that apply across Europe, including the UK, before we leave the EU. It’s vital that whatever deal the UK does preserves access to Europe-wide clinical trials for children with cancer and avoids creating even longer delays in children accessing the latest cancer medicines.”
Dr Lynley Marshall, a consultant in child and adult cancer drug development at the Marsden, said families who are going through the trauma of caring for a child with cancer should not be alarmed. She pointed out that children with cancer in countries outside the EU, as far away as Israel and Australia, participate in some of the big treatment trials because of the difficulties of getting enough children with the same condition in one place.
She did not think fewer children in the UK with cancer would be included in trials. “I think it would be difficult to be categorical about it, but we will all be working very hard to ensure that there wouldn’t be,” she said.
GPs are missing vital opportunities to intervene and potentially save the lives of people experiencing domestic abuse, a leading charity has warned.
Two women are murdered every week in England and Wales by a current or former partner. The latest crime statistics show that 332 women and 78 men were killed by their partners or ex-partners between March 2012 and March 2015. An analysis of 24 domestic homicide reviews (DHRs) from murders committed over the same period show that in more than half of the cases examined, doctors missed vital opportunities to identify risks and seek help for the victim.
The research, by the charity Standing Together, also found that in 25% of cases GPs failed to make inquiries following disclosures or warning signs displayed by the perpetrator. Now it is calling for domestic abuse awareness training to be made compulsory after results from an initiative set up to help GPs spot the signs of domestic abuse found referrals to specialist services increased considerably when doctors’ surgeries had been given appropriate training.
As the only stakeholder group that consistently and actively engages with both victims and perpetrators, GP surgery staff play a crucial role in preventing murders. “Our research shows both parties are more likely to seek help or make disclosures to their GP than any other agency,” says Standing Together’s chief executive, Nicole Jacobs.
DHRs are multi-agency accounts of the circumstances in which the death of a person aged 16 or over has resulted from violence, abuse or neglect by someone they were related to, shared a household with or with whom they were in, or previously in, an intimate relationship. Murders between intimate partners accounted for the DHRs studied as part of a wider sample by the charity in partnership with London Metropolitan University. Of the victims murdered by a partner or former partner, 22 were women. The youngest was 20 and the oldest was 81. “When we use the term ‘missed opportunities’ we are talking about blatant warning signs that are indicative of domestic abuse,” Jacobs explains.
Most frequently observed was a “lack of professional curiosity about relationships with partners or children’s fathers”, according to the report. In one case a woman reported having “an accident or fight” and had been punched, but “also had tenderness in the abdomen”. Another review found that a surgery failed to make inquiries after a patient attended the clinic with an ear injury that she said was not self-inflicted. “In these cases the GPs may have treated the physical injuries, but have not referred the person to specialist support. And they certainly did not note an instance of domestic abuse in the patient’s medical records. So when we say ‘missed opportunities’ we mean quite specific key indicators,” Jacobs adds.
In one case the offender rang the surgery requesting a home visit for an injection to ‘put [the victim] to sleep’
Six DHR reports also noted missed opportunities for GPs to ask the perpetrators about domestic abuse. In one case the offender even rang the surgery requesting a home visit for an injection to “put [the victim] to sleep”. He later presented with a painful shoulder, which he said was the consequence of him trying to “throw a bottle”, yet there was no follow-up. Another man presented injuries following three separate violent altercations, including one that involved assaulting a police officer – yet no further inquiries were made. And while one patient was “impulsive, controlling and had anger issues”, according to his GP, these were not considered to be risk factors in his relationship.
Lack of information sharing between GPs, emergency departments and mental health services was also cited as cause for concern. In one case a man told his GP he “felt angry and felt like destroying things” but was not asked about his family circumstances. Meanwhile, hospital records sent to the GP about the same man stated he had “consumed six cans of lager and phoned police to say he needed help or would kill himself and his girlfriend”. Yet there was no attempt by the GP, hospital or police to follow up.
More than 400 DHRs have been completed since they were made mandatory in April 2011. “These reviews are not intended to be about blame, but exercises in understanding the environments in which people made certain decisions and choices with a key purpose of making the future safer,” says Frank Mullane, founder of Advocacy After Fatal Domestic Abuse, which has guided 160 families through the process of a DHR. Mullane says he regularly sees issues around missed opportunities in GP surgeries. “It seems many GPs are inadequately informed about domestic abuse and may not be spotting the risk indicators. Many don’t know what to do if they suspect abuse, or if it is disclosed to them overtly, or inferred.”
However, there have been marked improvements where specialist training has been provided. The Identification and Referral to Improve Safety – or Iris – project has been commissioned in 34 areas in England and Wales since 2010 and is in more than 1,000 general practices.
Medina Johnson, Iris national director, says research shows patients in practices using the initiative were 22 times more likely to have a discussion about domestic abuse and that resulted in them being six times more likely to be referred to specialist services. They were also three times more likely to have domestic abuse noted in their medical records.
She explains: “GPs always say we are so busy, we only have 10 minutes and now you are asking us to do something additional. And we are, but it could save someone’s life. The simplicity of our message is: ask about domestic abuse, give an understanding response, offer a referral and make a note in the patient’s medical records.”
Under Iris, one specialist full-time worker can support up to 25 general practices, with each named worker conducting training as well as dealing with referrals. Gene Feder, the domestic abuse lead for the Royal College of General Practitioners, admits that some of the failures by GPs are “spine-chilling”. But he points out that the issue is far more complex because most domestic abuse is hidden and the presentation is far more subtle.
“I’m not trying to make excuses for GPs, but it’s hard to blame professionals when most have had zero to one hour of training around domestic abuse as medical students,” he says.
While guidelines from the National Institute for Health and Care Excellence (Nice) now recommend there should be training around domestic violence at every level, it remains minimal or absent in most medical schools.
Feder says that while Iris has good evidence on how doctors can respond safely to women disclosing abuse, the project was still working towards the best model for when patients disclose perpetration abuse. He adds: “The other thing is when you have male victims and female perpetrators – they are a minority, but men can also be victims and suffer serious mental health consequences.”
In some areas where Iris operates, such as Bristol and the east London borough of Hackney, there is sufficient funding for all general practices to be trained, but elsewhere the level of investment is insufficient to cover all surgeries.
The government has recently invested £2.4bn into primary care, part of which is to provide ongoing training for GPs. And last week Theresa May announced she will oversee the creation of a new law, the Domestic Violence and Abuse Act, to increase prosecutions across England and Wales and eradicate a postcode lottery in the way victims are dealt with by police forces. “There are thousands of people who are suffering at the hands of abusers – often isolated and unaware of the options and support available to them to end it,” says May.
But Feder, who is also professor of primary healthcare at Bristol University and the architect of Iris, warns that the impact of any health initiatives on victims of domestic violence is likely to be severely constrained by threats to the funding of domestic abuse services – and GPs who are under huge pressure from the demands of an ageing population. Since 2010, 17% of specialist women’s refuges have closed due to funding cuts.
Domestic abuse charities insist that with hundreds of women being murdered each year by a current or former partner, it is vital to protect the funding needed to keep these important referral pathways open.
‘My stepfather was abusive and should have been sectioned’
Annabella Bell’s mother, Chloe, was murdered in January 2013 by her violent and mentally ill husband, three days before her 81st birthday.
The couple were registered at the same surgery in north London and Bell, a 59-year-old mental health practitioner from Newcastle, had contacted her mother’s GP in the south of England to warn them she was at risk. She explains: “My stepfather was becoming increasingly paranoid and delusional, believing there was a plot to kill him. He missed hospital appointments and my mother was asked to intervene, but this would make him very angry.”
The couple divided the house they were living in and used separate entrances, but Bell’s mother continued to suffer violence at the hands of her husband. Bell says: “I told her doctor I was worried about my stepfather, and my mother also went in to explain, but they continued to involve her in his health matters.”
Then both the hospital and GP failed to make inquiries after her mother presented with a black eye at A&E, a month before she was brutally murdered. Bell’s stepfather killed himself after the fatal attack.
Bell was left so traumatised by her mother’s death that she “struggles every day” and is unable to work. She says more should have been done to protect her mother. “I’m not saying he wouldn’t have killed her if the doctors hadn’t involved her, but I’m saying there should have been some kind of warning.”
She adds: “It’s textbook stuff, but people seem to miss it and then it’s too late because somebody is murdered. My stepfather was abusive and psychotic and should have been sectioned.”
One in four babies born in the UK are not receiving mandatory checkups from health visitors during the first two years of their life.
A fifth of babies do not receive the recommended reviews after they turn one, and one in four miss out at the age of two, according to the government’s commission on social mobility.
Health visitors, responsible for assessing a child’s early years development, are supposed to carry out checks straight after birth, at six to eight weeks, at one year and then at between two and two-and-a-half years.
However, the commission found that one in five children had not received the mandatory 12-month check by the time they reached 15 months old.
London children were the least likely to receive the right number of health visits, the report found, with fewer than half receiving the final two checkups.
A survey of parents found that the vast majority wanted the health visits to continue, with just 5% saying they did not feel they required advice during their first six months as a parent.
“Despite the conventional wisdom that parents fear interference from the ‘nanny state’, in reality many say that they welcome advice in the early years of their child’s life,” the commission said.
It said it was concerning that one in four two-year-olds did not have their health and education needs reviewed by a professional. “Despite this being a crucial period for families, there is still too little support for parents in the earliest stage of their child’s life. With the socioeconomic gap in outcomes emerging early, providing support to parents at this point could reap dividends for social mobility later on in life.”
The Conservative party’s 2010 manifesto included a key pledge to increase the number of health visitors. NHS Digital figures show the number of full-time or equivalent health visitors in England fell by almost 1,000 between October 2015 and August 2016.
In December a survey of health visitors by the Institute of Health Visiting found that 85% of respondents felt their workload had increased in the last two years. Some were having to look after between 500 and 1,000 children, when the maximum recommended is 250.
Labour said the commission’s figures showed the government was failing to invest in early years support. Emma Lewell-Buck, the shadow minister for children and families, said: “Becoming a parent for the first time is an exciting but scary time and it is shocking that not all parents are getting the support they need.
“The Tories promised more health visitors by taking away money from Sure Start Centres. Six years later we have lost over 700 centres and we are still waiting for the health visitors. The Tories have completely failed to invest these crucial early years.”
A spokesperson for Public Health England said: “Ensuring every child has the best start in life is one of our key priorities. We are supporting local authorities in commissioning services that support families and provide early help when needed.
“We are also working with councils to give health visitors professional guidance and leadership, as well as evidence of what works, to help them meet their public health responsibilities.”
The commission also said parents were finding it more difficult to access local children’s centre services, citing a 2015 survey which found more than 60% of children’s centre managers said they were cutting back on services to meet their budgets.
Government figures in December revealed that 156 Sure Start children’s centres had closed in England in 2015, almost double the number in the previous year.
“Dangerous” medical understaffing in hospitals is so rife that signs of illness are being missed, blood tests delayed and newly qualified doctors left in charge of up to 100 patients.
Chronic shortages of medics are also leading to those with little experience of some types of illness taking responsibility for wards full of medically needy patients, or with complex issues, whose conditions they know little about and do not feel qualified to give proper care to, including in intensive care and stroke and surgical units.
Related: A&Es are closing and doctors are leaving. It should be Jeremy Hunt who goes | The Secret Doctor
A survey of UK doctors, the results of which have been given to the Observer, reveals widespread concern that gaps in rotas were risking patients’ safety. Doctors said they were left stressed and in tears at being “pressurised” by managers to work more shifts to help hospitals cope with rising demand and said their relationships with patients were suffering.
One trainee surgeon said shortages meant a colleague in his first year of training was the only doctor in charge of more than 100 surgical patients overnight.
An elderly care registrar said: “I was the only medical doctor covering medical emergencies [and] cardiac arrests in the whole hospital, medical admissions, referrals from A&E [and] GPs, and the whole hospital for a medical opinion. It was frankly unsafe.”
Another doctor said: “I feel out of my depth.”
Pete Campbell, a hospital doctor in the north-east who undertook the survey with the assistance of the British Medical Association, said: “This survey is just a snapshot of medical understaffing, which is going on on a significant, worrying and dangerous scale. Doctors believe that these rota gaps pose a direct threat to patient safety because the time-critical work they do is put under pressure.”
Doctors’ leaders said the survey reflected worsening medical understaffing across the NHS. “The findings are yet another stark warning of the fragility of our health service. A demoralised, stressed and struggling workforce is not going to stay in the NHS for long. This situation is unsustainable,” said Professor Neena Modi, president of the Royal College of Paediatrics and Child Health.
Professor Jane Dacre, president of the Royal College of Physicians, said: “Patient care is being compromised by gaps in trainee rotas. This is a major challenge for the NHS and it is having a detrimental effect on the morale of both trainees and consultants. We need more doctors.”
One medic said that hospitals’ growing inability to have a full complement of doctors on duty meant “we don’t have time to review patients properly. [I am] constantly fighting fires as covering three people’s jobs, so never have time to think about a patient properly.”
In the survey, 395 doctors below the level of consultant described how rota gaps were affecting care. It also found that many medics fear the quality of care they could give patients was declining because so many are often so busy. The findings paint a stark picture of doctors having too little time to talk to patients about their conditions, discharge others, do routine checks on babies, or seek patients’ consent for procedures as quickly as they should.
The survey found that many medics feared that the quality of care they could give patients was declining because they were often so busy that they had less time to engage with them.
“Delayed care, sick patients getting unwell due to this, long waits, histories being taken too quickly to compensate and speed up the process, meaning critical pathologies have been missed,” said one. Doctor shortages are now so acute that, in some areas, emergency ear, nose and throat clinics and non-urgent operations have had to be cancelled at short notice, said respondents.
The survey found that 21% of rota gaps were not covered by any doctor, even a locum. Unfilled gaps result in the doctors on duty on wards becoming responsible for far more patients than usual. Another 18% of gaps were filled by staff agreeing to provide cover, often on top of an already heavy schedule.
The findings come soon after Grantham and District hospital in Lincolnshire closed its A&E unit overnight because it had too few doctors. In April, Chorley hospital in Lancashire downgraded its A&E unit to an urgent care centre for the same reason.
Last week the RCP, which represents many hospital doctors, warned that shortages of many specialist medics meant the NHS was “heading into an extremely difficult autumn”.
Anaesthesia and intensive care are facing particular shortages of doctors.
Unfilled slots are also jeopardising hospital finances and have caused the NHS’s bill for agency staff to hit £3.3bn a year in England.
The Department of Health declined to respond directly to the findings. A spokeswoman said: “We expect all parts of the NHS to make sure they have the right staff, in the right place, at the right time to provide the very best care for patients that is both safe and sustainable. That is why we have invested in the frontline and there are already 25,000 extra clinical staff on our wards since May 2010.”
Care of hospital sufferers is under risk because overworked frontline doctors are searching right after so several sick people that they are missing essential indications of sickness that could affect chances of survival, one of Britain’s most senior physicians warns right now.
Hospital physicians are running about “like a scalded cat” striving to search right after up to 70 elderly individuals at a time, far more than the highest of 20 regarded as necessary to make sure they acquire proper interest, the president of the Royal School of Physicians, Sir Richard Thompson, told the Guardian.
Doctors specialising in acute medication are so stretched they are not able to devote the ideal minimum of 15 minutes investigating each patient’s signs since they have as well many sufferers to get round in a common seven-hour shift, he extra.
In an interview with the Guardian, he stated some physicians are facing caseloads during 1 shift of up to 70 sufferers, numerous of whom are medically challenging – what medical professionals get in touch with “multiply morbid”, older folks with problems this kind of as heart difficulties, diabetes and breathing problems at the same time.
“You attempt standing on your feet for seven hrs attempting to be on the ball, considering of the various problems, currently being wonderful to patients, for seven hrs. It truly is totally destructive. Not everyone has 70, but most people are seeking after well over 20,” Thompson, whose school represents most of the UK’s thirty,000 hospital medical doctors, except individuals in Scotland, explained.
“If you have got over 20 it becomes extremely hard. The care gets thinner and thinner. It signifies the advisor can not see the patient as significantly or indeed as early as they must do, so certainly the common of care is going to fall”.
Widespread understaffing, particularly overnight and at weekends, is posing a direct threat to patients’ security, he warned.
Acute medicine consultants are supposed to see newly-admitted sufferers within a few hrs. “So you can picture that anything might be missed because somebody hasn’t been there to lead the staff and to get a correct choice, so you can effectively envision things going wrong” because they have not seen them rapidly sufficient, Thompson mentioned.
Medical doctors below continual “strain and tension” end up investing as tiny as five minutes with some individuals. When that transpires “yes, you miss factors”. Physicians more and more do not have enough time to invest striving to tease out the particulars of each and every patient’s illness, he stated.
In a strongly-worded attack on ministers he accused the coalition of cutting the NHS budget despite repeated pledges, like from David Cameron, to defend it from the austerity programme. “In spite of what weasly words folks at the top say, money’s been taken out of the NHS.” He cited the £2.8bn that has been provided to social care in the past 3 years.
As a consequence, he claimed: “The NHS is beneath-doctored, underneath-nursed, beneath-bedded and beneath-funded. There are as well number of doctors to do the more and more massive work to a substantial common, and securely, and compassionately.”
A worrying quantity of hospitals, specifically smaller ones, face “significant” gaps in their healthcare rotas, said Thompson.
Health secretary Jeremy Hunt’s drive because the Mid Staffs scandal to make certain each and every patient has secure, substantial-high quality care is unachievable because the NHS has neither the resources nor the workforce required, Thompson mentioned. It wants “billions” of lbs far more a year to function appropriately, he claimed, and urged all political events to be brave and accept that actuality and commence doing work out in which additional funding need to come from.
His broadside is the most recent expression of increasing frustration among bodies representing NHS personnel at the tight budgets the services is under, which includes a £20bn “efficiency financial savings” drive, at a time of rapid growth in demand for healthcare.
The leader of the British Medical Association, Dr Mark Porter, said: “A lot of of Thompson’s remarks will be recognised by individuals operating in the NHS. Medical doctors are working tougher than ever before as all NHS solutions come under massive pressure from a combination of increasing workload, falling sources and staff shortages in key specialities.”
He also backed Thompson’s declare that the NHS price range has been lower. While ministers declare it has been ringfenced “in reality billions of lbs are currently being clawed back by the Treasury each year”. 4 years of shell out cuts had left NHS personnel feeling devalued and beneath attack”, extra Porter.
The chief economist at the Nuffield Believe in health thinktank, Anita Charlesworth, explained the coalition had fulfilled its guarantee to give the Department of Well being an inflation-linked “flat real” boost throughout every single year of this parliament.
But, she added: “It is clear that this is placing a developing strain on the NHS, most notably in the acute hospital sector. This is in spite of holding down the earnings of NHS employees. Following 2015 it is not sensible to expect the NHS to proceed to meet the demands of an expanding and ageing population inside of flat funding.”
Hunt has also demoralised the service’s 1.3m employees by “slagging off the complete of the NHS”, Thompson extra. “What he has accomplished is emphasise also considerably the bad care rather of emphasising the very good care” which most individuals obtain most of the time, he insisted.
A DoH spokesman responded that: “Patient security and care is a priority for the government and it is proper that we have high expectations for our NHS. Although the NHS is a single of the safest, most efficient healthcare programs in the planet we should by no means shy away from attempting to enhance requirements for patients.”
The NHS now has the highest ever quantity of professionally experienced clinical personnel considering that census records started, with plans in place to enhance it further, he stated, incorporating that there are now far more than 7,500 far more medical professionals operating in the NHS than in 2010.