NHS England Criticised by Charity Over Hepatitis C

A major charity has criticised NHS England policy over a drug which cures sufferers of hepatitis C.

Addaction is backing a judicial review application brought by another charity, the Hepatitis C Trust, over NHS England’s decision to cap the annual numbers of people who gain access to drugs over costs.

Hepatitis C can be killed by the drugs in question, but the expense involved is rather costly.

This issue is considered particularly serious, as 160,000 people in England currently suffer from the chronic infection.

Simon Antrobus, chief executive of Addaction, was scathing in his assessment of the decision from NHS England, accusing the healthcare body of effectively putting people’s lives at risk.

“The decision by NHS England to limit access to treatment is manifestly unfair on a group of vulnerable people who suffer from a terrible disease. Those who are infected can go on to develop cirrhosis of the liver and liver cancer. Denying these people life-saving treatment is a potential death sentence for thousands.”

The cost of an eight-week course of ledipasvir–sofosbuvir, considered particularly effective, can cost in the region of £26,000, with a 12-week course costing nearly £40,000.

This figure can elevate still further, considering that this figure does not include VAT, and in many cases another medicine, ribavirin, is required as a supplementary treatment.

Ledipasvir–sofosbuvir is sold by Gilead under the brand name Harvoni, and NHS England argues that the potential costs to some sufferers, who may require a 24-week course costing nearly £80,000, is simply to excessive.

The decision from NHS England comes despite the fact that NICE has already recommended that hepatitis C sufferers should be treated with the new drug.

And Antrobus, while acknowledging the difficulties of the existing NHS climate, is scathing about the decision to neglect hepatitis C sufferers in this fashion.

“This is a terrible decision by the NHS, and it contributes to the fact that at present less than five per cent of people infected in England are accessing treatment. No one is denying that the NHS is under massive financial pressure, but it is both morally wrong to deny people this life-saving treatment and makes little financial sense, as the costs of treating someone with liver disease are significantly higher.”

Although the risk of death in England may be less than in the developing world, it is still notable that approximately 700,000 people die due to hepatitis C infection on an annual basis.

Indeed, the Hepatitis C Trust asserted that countries with significantly less resources than Britain have done more to tackle this debilitating condition.

“It would be good to see NHS England take seriously the United Kingdom’s international commitment to tackling hepatitis C. Around the world, countries with far fewer resources and far higher prevalence of the virus are matching their commitment with the improved diagnosis and greater treatment that is necessary to all but eliminate the virus,” its chief executive Charles Gore commented.

Responding to criticism, an NHS England spokesperson outlined the level of investment to which the organisation is already committed.

“The NHS’s single biggest new treatment investment this year is providing these high-cost treatments to thousands of people with Hep C, in accordance with Nice guidance. The NHS has successfully now treated thousands of patients with acute needs, and is now working on a phased basis to treat the far larger number of patients with chronic but not life-threatening Hep C.”

The spokesperson went on to explain the policy of the Department of Health, and how it impacts on drug purchases.

“The Department of Health have been running successful competitive procurements to secure the best prices they can. As prices come down we hope in future years to be able to expand treatments even further within the funding available, and the industry is now engaging in the discussions with us about how best to do this.”

 
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Chinese Oncologists Trialling Innovative Gene Editing Technique

As gene-editing becomes a more feasible part of healthcare across the planet, a new technique is being trialled for the first time in China.

This can be seen as indicative of the increasingly prominent role which China is playing on the world stage, as the world’s most populous nation becomes a major player in world affairs.

The groundbreaking gene-editing technique will be tested on humans for the first time, with Chinese oncologists trialling the innovation on lung cancer patients.

It is hoped that the new technique will enable a larger proportion of lung cancer sufferers to make a full recovery from the debilitating condition.

The team involved in the study hails from Sichuan University’s West China hospital in Chengdu, China, and intends to begin tests in August, according to the scientific journal Nature.

Lung cancer is a particularly big killer in China, with a two-pronged assault on public health having a massive impact.

Firstly, due to the rapid industrialisation of the Chinese nation, the levels of air pollution in some regions of the country are extremely dangerous.

Researchers estimate China endured 2.8 million cancer deaths during 2015 and 4.3 million new cancer cases, with lung cancer the most common of all.

“Cancer incidence and mortality have been increasing in China, making cancer the leading cause of death since 2010 and a major public health problem in the country,” researchers noted.

Secondly, China is the world’s largest consumer of tobacco, with 350 million people in China smoking regularly, and the country producing nearly half of all the world’s tobacco products.

It is this climate which has caused scientists and clinicians in China to seek new and innovative ways to treat lung cancer in particular.

Known as Crispr, the technique entails finding, removing and replacing specific parts of the DNA of individuals.

Those selected for the trial will already have received chemotherapy and radiotherapy, with these proving ineffective.

The Crispr technique adds a new genetic sequence, which is designed to help the patient’s immune system destroy the cancer.

Naturally this is a very technical undertaking, and the effectiveness of the approach and ultimate results are very much cloudy at the current time.

There are also moral concerns about gene-editing, despite the fact that Crispr could see the creation of pest-resistant crops and new cures for serious diseases such a signal-cell anaemia.

Supporters of gene-editing suggest that it differs significantly from genetic modification by not being hereditary.

Naturally everyone involved in the study will have volunteered, and also it must be said that their chances of survival otherwise are basically zero.

Healthcare campaigners and researchers in the UK will be observing the Chinese experiment particularly closely, as the Human Fertilisation & Embryology Authority in Britain approved an application from the Francis Crick Institute to use gene-editing on embryos earlier this year.

This research has yet to receive ethical approval, as the debate over gene-editing continues.

 
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US Report Suggests Health Gadgets are Poorly Regulated

Medical gadgets have been a notable and increasingly prominent addition to the health landscape in the last few years.

Yet despite the benefits of such technology there is currently a distinct lack of legislation and regulation related to them.

In the United States, legislators are currently tackling this issue, with the Obama administration addressing the paucity of guidance for manufacturers of such devices.

It is well known among American government experts that the federal patient privacy law known as HIPAA (Health Insurance Portability and Accountability Act of 1996) has not kept pace with wearable fitness trackers, mobile health apps and online patient communities.

This was noted in a recent damning and delayed government report, which was actually supposed to have been compiled by the end of 2010.

Yet the US Department of Health and Human Services has frustrated many observers of both the technology and healthcare industries in the United States by failing to provide specific recommendations, despite being asked for them by the federal government.

The existing Health Insurance Portability and Accountability Act, the landmark 1996 patient-privacy law, only covers patient information kept by health providers, insurers and data clearinghouses, as well as their business partners.

Technology such as Fitbit falls outside of this legislation, yet enables users to store a huge amount of personal health information and data.

The new report has been compiled by the Department of Health and Human Services’ Office of the National Coordinator for Health Information Technology, in conjunction with other agencies, and notes that there is a legislative gap related to health devices.

“Health privacy and security law experts have a reasonably clear idea of where HIPAA protections end, but the layperson likely does not. Moreover, even entrepreneurs, particularly those outside the health care industry…may not have a clear understanding of where HIPAA oversight begins and ends,” the report observes.

But the authors of the report nonetheless suggest that it is an important milestone in the regulation of this industry, stating that readers can ultimately draw their own conclusions from the findings outlined in the text.

“At the end of the day, it’s a very complicated environment that we find ourselves in,” Lucia Savage, chief privacy officer at the Office of the National Coordinator for Health Information Technology, which took the lead on the report, suggested. “We believe we’re fulfilling our duties. If Congress has concerns about that, I’m sure that we will hear about them.”

A study conducted in 2014 assessed 600 of the most popular used health apps, and discovered that less than one-third have explicit privacy policies.

And policies on Apple and Google mobile phone platforms “may be inconsistent, not articulated to individuals, or simply ignored by web developers skirting the rules that operating system developers attempt to impose on them,” according to the recently published report.

This can be considered of particular concern to the UK healthcare system, considering the recent public-private partnership between Google and the NHS.

The new US report can be seen as a stepping stone to the safeguarding of this crucial area of technology.

 
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Fifty NHS Hospitals to be Spared Waiting Time Targets

Over 50 hospitals in England have been granted permission to ignore key waiting time targets owing to their extreme financial difficulties.

The decision is part of an overall package of measures which have been taken by NHS bosses following the £2.5 billion deficit accumulated by NHS trusts during the previous financial year.

Fines for missing targets in A&E, cancer and routine operations have been scrapped altogether as part of the initiative.

The decision to relax targets has already been strongly criticised by the Patients Association.

The chief executive of the organisation, Katherine Murphy, suggested that the initiative would ultimately have a negative impact on the efficacy of NHS operations.

“This is the slippery slope back to the bad old days of never-ending waiting times and uncertainty – with patients left endlessly on A&E trolleys and waiting for life-changing operations. Where is it all going to end?”

But regulators have set up what is described as a ‘failure regime’, with the most incompetent trusts in the country entered into this programme.

The government will place senior managers in hospitals struggling to deliver adequate service, in order to help produce plans to improve the situation.

Five trusts – Barts Health in London, Croydon Health Services, Maidstone and Tunbridge Wells, Norfolk and Norwich Hospitals and North Bristol – have already been informed that they will be parachuted into this system.

And another 13 trusts across the country are threatened with the same prospect if they fail to demonstrate significant and rapid improvement.

Commenting on the issue, NHS England chief executive Simon Stevens indicated his belief that the current period is a critical one for the future of the NHS, and one at that will effectively make or break the health service.

“Precisely because the pressures across the NHS are real and growing, we need to use this year both to stabilise finances and kickstart the wider changes everyone can see are needed.”

But Nigel Edwards, of the Nuffield Trust think tank, believes that the measures taken will be rather trivial in and of themselves, and that more must be done in order to ensure that the health service is placed back on the appropriate footing.

“My big worry is what happens next. I fear that in order for hospitals to virtually eradicate their deficits the next steps could be a series of brutal service reductions and bed closures – which will shock an unprepared public.”

Many trusts and hospitals have been struggling to meet targets related to some of the most critical aspects of the healthcare process, and will welcome this decision.

Although it will inevitably draw some criticism, equally many healthcare experts have suggested that government targets have been too stringent.

 
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UK Breast Cancer Research Symposium Proposes New Breast Cancer Approach

Two studies presented at the UK Breast Cancer Research Symposium suggest that research into oestrogen receptors may be critical in treating breast cancer.

It is believed that understanding this may be key to explaining why some forms of breast cancer do not respond adequately to treatment.

The research has already been praised by healthcare experts as groundbreaking, and it is hoped that it will significantly inform the scientific response to the disease going forward.

In the first study, scientists at the University of Pittsburgh analysed non-inherited mutations in the ESRI gene across 122 samples of breast cancer tumours.

Researchers discovered that there are significantly more mutations in secondary samples when this process is conducted.

While it is early to draw firm conclusions on the subject, this nonetheless suggests that primary breast cancers containing ESRI mutations could be an early indication that tumours are resistant to common cancer treatments.

Although scientists are still working to understand the issue, it is hoped eventually that this breakthrough could help doctors understand whether patients will be resistant to certain treatments before cancers become unresponsive to medication.

Further trials are planned to develop this technique still further.

Dr Steffi Oesterreich, who led the research, was enthusiastic about the potential of the study, and explained the results and their significance.

“The ESR1 gene has a very important role in the process by which cancers spread from the breast to elsewhere in the body. Research on the way this gene mutates will help us to identify the cancers which will relapse, and also those which will not respond to our current treatment. It shows how, in the future, new extremely sensitive technologies could give us an ever more detailed picture of what is going on inside a patient’s breast cancer and how the cancer is responding to treatment.”

A second study analysed genetic changes in more than 120,000 women.

Researchers were able to identify five distinctive genetic alterations which could influence the risk of women developing particular forms of breast cancer.

Commenting on the research, Dr Alison Dunning, who led the study, was positive about the potential for treatment that the results indicated.

“All five of the genetic variants we have found near the ESR1 gene affect the levels of oestrogen receptors in breast cells. This seems to indicate that if there are too few or too many oestrogen receptors then the breast cells are more likely to become cancerous.”

The University of Cambridge study discovered that genetic changes in oestrogen receptors can help inform clinicians of the risk of developing breast cancer, and even potentially aid prevention and treatment.

The charity Breast Cancer Now was effusive in its praise for the research, considering the results to be groundbreaking in the understanding and treatment of the debilitating condition.

“Both discoveries relating to the ESR1 gene show great potential to tailor treatment for patients and reveal more about the genetics of breast cancer risk. It is work such as this that will lead to steady improvement in the prevention, diagnosis and treatment of breast cancer in coming years,” chief executive of Breast Cancer Now, Delyth Morgan, commented.

 
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Great Ormond Street Hospital EU Warning on Research Funding

London’s Great Ormond Street Hospital has suggested that the exit of Britain from the European Union could reduce medical research funding and ultimately cost lives of vulnerable children.

The infamous organisation claims that leaving the European Union permanently will pose a serious risk to research funding going forward.

Great Ormond Street also believes that it will lose staff from the Eurozone and that established partnerships with healthcare institutions in Europe will be diluted.

But not all experts agree with the verdict of great Ormond Street, with one leading cancer specialist describing the claims of the hospital as hysterical.

Angus Dalgleish, professor of oncology at St George’s, University of London, who also represents Brexit movement Scientists for Britain, asserted that the claims made by great Ormond Street were a “gross overreaction and rather hysterical”.

Dalgleish went on to discuss what he deems to be a climate of fear.

“There are a lot of scare stories about people not wanting to come because we’re leaving the EU. I don’t think that will happen. There are a lot of us trying to make sure that when Brexit comes, that all the good bits will be left in place. It’s not going to be a break.”

Supporting the statements of Dalgleish, the universities and science minister, Jo Johnson, indicated the commitment of the government to scientific pursuits, stating that the Conservative party wants the UK to remain “a science powerhouse”.

Johnson stated that the government is fully committed to maintaining that position and “limiting some of the risks which the sector has identified.”

“We are more open and outward looking than ever before. We want to forge international collaborations with European partners and countries beyond the EU,” Johnson added.

The Department for Business Innovation and Skills has also indicated that there will be no immediate change to the funding of the Department of Science in the UK, and that this eventuality is not likely to materialise in the remainder of the decade.

Nonetheless, there will be a discussion about the access of Britain to European research and innovation funding.

In what could be described as an uncertain climate, Great Ormond Street Hospital has urged the government to secure a deal with Europe which protects research as soon as possible.

The hospital is also concerned about a potential brain drain as an ultimate result of Brexit.

Great Ormond Street has received £25 million in research funding from European Union sources since 2010, which the hospital divulges is equal to approximately 10% of its overall research budgets.

The chief executive of Great Ormond Street Hospital, Dr Peter Steet, suggested that the current situation with funding is critical, commenting that “for the vulnerable, very ill children we care for, every day counts.”

 
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Can Alcohol Really be Directly Linked with Seven Cancers?

A new study has suggested that even small amounts of alcohol consumed on a daily basis can have a significant impact on cancer rates.

The study comes from a review which summarises data from a range of previous studies in order to evaluate evidence regarding alcohol causing cancer.

Researchers found that existing evidence does indeed support a link between alcohol consumption and cancer at seven locations in the human anatomy, including the throat, gullet, liver, colon, rectum and female breast.

The review aimed to summarise data from published biological and epidemiological research, and meta-analyses that have pooled data, to evaluate the strength of evidence that alcohol causes cancer.

Correlations are believed to be strongest for those drinking heavily, but the study also indicated that even low levels of drinking can contribute to a significant proportion of cancer cases.

There is seemingly no safe level of drinking according to the study.

The author concluded that “there is strong evidence that alcohol causes cancer at seven sites, and probably others. The measured associations exhibit gradients of effect that are biologically plausible, and there is some evidence of reversibility of risk in laryngeal, pharyngeal and liver cancers when consumption ceases. The highest risks are associated with the heaviest drinking, but a considerable burden is experienced by drinkers with low to moderate consumption, due to the distribution of drinking in the population.”

However, despite the conclusions of researchers, it is important to be aware that the review did not reveal its methodology.

Conclusions must be considered largely the opinion of the single author behind the review, with more of a correlation than any causality having been proven.

The study was carried out by one researcher from the University of Otago, New Zealand, and was published in the peer-reviewed scientific journal Addiction.

Media coverage of the study has generally been fairly balanced and accurate, although the tone of reporting tended towards the indication that this is a new discovery, when it is in fact based on previous research.

Alcohol has been considered potentially carcinogenic for some time, but utilising observational studies to find links between the substance and cancer is still considered uncertain and somewhat controversial.

An obvious weakness of the study, apart from the lack of methods included, is that the author fails to describe how research was identified, as would occur in a systematic review.

It is also notable that the correlation was comparatively weaker for colorectal, liver and breast cancer.

While the research is certainly interesting, it is far too early to draw broad-based conclusions, and the jury is still very much doubt on the carcinogenic properties of alcohol.

Indeed, the author acknowledges the limitations of these observational findings, stating that “the limitations of cohort studies mean that the true effects may be somewhat weaker or stronger than estimated currently, but are unlikely to be qualitatively different.”

 
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MPs Call for NHS Bosses to be Tougher on Discharging

The hierarchy of the NHS in England has been accused by MPs of failing to be strict enough on an important area affecting mental health.

NHS bosses have been slack in tackling delays regarding medically fit patients being discharged from hospital, according to the Public Accounts Committee.

Commenting on the subject, the committee indicated that NHS England must make more effort to support hospitals in this critical area of patient well-being.

MPs suggested that officials are too ready to rely on excuses regarding care services run by councils, and indicated that there is considerable room for improvement in the way that this system operates.

And the politicians overseeing the issue also promised extra funding in order to address the issue.

Reporting from the committee comes hot on the heels of delays in discharges reaching record levels according to official figures.

It is often the case that community support services such as district nursing, carers or care home places, cannot be found for vulnerable patients.

The elderly have been particularly badly affected by this issue.

A recent report released by the National Audit Office estimated that delays are costing the NHS over £800 million annually, following a rise in the number of delays by over one-third in the past two years.

To put the figure into perspective, it is estimated that care in the community for such patients would cost under £200 million.

This is particularly detrimental for patients, the risk of infection escalates in older people affected by such delays during extended stays.

And the National Audit Office has even suggested that the worrying figures should be considered an underestimate, owing to the fact that the NHS measures delays only from the point patients are deemed ready for discharge.

The report instead indicates that delays waiting for this figure to be recorded, or in other procedures during stays in hospital, could extend delays further still.

This cross-party report urges NHS England is to do more to address the situation, suggesting that the organisation has shown what the MPs described as a “striking poverty of ambition”.

Meg Hillier, who chairs the committee, asserted that “blaming local circumstances for poor performance short-changes patients and is an unacceptable cop-out.”

In response to the report, a spokesman for the Department of Health outlined some of the investments in these services which have already been agreed and set aside.

“Local authorities will have more money – up to £3.5bn extra – for adult social care by 2019-20 and by 2020 we will be investing an extra £10bn a year so the NHS can introduce its own plan for the future and help fewer people go to hospital in the first place.”

 
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