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  • A novel drug called niraparib which freezes tumours and can prevent ovarian cancer recurring is now available to NHS patients
  • Ovarian cancer is a silent killer: each year in the UK it affects 7,400 women and kills 4,100
  • Oncologists have called niraparib, which is taken as a daily pill, a “game changer
  • Approval of niraparib is predicated upon a clinical study that enrolled 553 patients with recurrent ovarian cancer
  • The endpoint of the study was progression free survival
  • The study reignited discussion about the relative merits of different metrices used to assess the efficacy of cancer therapies
  • Patient groups and some oncologists suggest health-related quality of life should be given more significance in the measurement of drugs
 
Niraparib made available on the NHS to halt the spread of ovarian cancer

There is some good news for women in Britain living with ovarian cancer. In June 2018 niraparib, a life extending drug, was recommended by the UK’s National Institute for Health and Care Excellence (NICE) for inclusion in the Cancer Drugs Fund, (CDF) which will make niraparib available on the NHS to women living with ovarian cancer, who already have had two or more courses of chemotherapy.  The drug, which was first marketed in the USA in April 2017, is the first PARP inhibitor (described below) taken as a daily pill to be approved in Europe that does not require BRCA mutation or another biomarker testing. (Women with harmful mutations in the BRCA1 or BRCA2 genes have a 10 to 30 times higher risk than normal of ovarian cancer). Niraparib is expected to benefit around 850 UK patients each year at an annual cost of about £58,661 for the 200mg daily dose or £86,786 for the 300mg dose; but is available to the NHS at an undisclosed discount. Some oncologists have heralded niraparib as a “game-changer” because it freezes tumours and can prevent ovarian cancer recurring for 12 to 16 months.
 
In this Commentary

This Commentary: (i) describes niraparib and how it halts the spread of ovarian cancer, (ii) summaries the findings of the clinical study, which is the basis on which niraparib has been approved, (iii) describes questions raised about the endpoints of clinical studies and the growing debate about a trade-off between progression free survival and health-related quality of life, (iv) briefly describes the epidemiology of ovarian cancer, (v) uses video of a leading oncologists to describe the standard of care for the disease, (vi) explains the reasons why ovarian cancer is frequently diagnosed late with more video contributions from leading clinicians, and (vii) emphasises and repeats the signs and symptoms of ovarian cancer in an attempt to help educate women and encourage them, whatever their age, to seek immediate attention from their primary care doctor if they have any tell-tale signs of the disease.
 
How niraparib works

Niraparib is one of a class of drugs known as poly(ADP-ribose) polymerase (PARP) inhibitors and is indicated for maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. Because of the high recurrence rates associated with ovarian cancer maintenance therapy, measured by progression free survival (PFS) rather than overall survival (OS), has become the appropriate treatment for this disease.  Niraparib is a targeted therapy, which uses agents to identify and attack cancer cells while causing minimal damage to normal cells. Such therapies attack cancer cells' nuclei that contain the programs, which differentiates them from normal healthy cells. Each type of targeted therapy works differently, but they all change the way a cancer cell grows, divides, repairs itself, or interacts with other cells.
 
NOVA clinical study

The approval of niraparib is predicated upon findings of an international Phase 3 clinical study called NOVA, which were published in the December 2016 edition of the New England Journal of Medicine. The study sought to evaluate the efficacy of niraparib versus placebo as a maintenance therapy for patients with platinum-sensitive, recurrent ovarian cancer. The double-blind study enrolled 553 patients with recurrent ovarian cancer, who had achieved either a partial or complete response to their most recent platinum-based chemotherapy. The primary endpoint of the study was progression free survival.

Researchers were keen to discover whether having a BRCA mutation affected how well the therapy worked. Approximately 66% of participants did not have BRCA mutations. Findings demonstrated that women with an inherited BRCA gene mutation saw the time to relapse increase from 5.5 months to 21 months compared with chemotherapy alone. Niraparib was also shown to help women without a BRCA mutation, doubling the length of time before recurrence from 3.9 months to 9.3 months. So, niraparib significantly increased progression free survival in patients with or without BRCA mutations as compared to the control group. The results of the study position niraparib as the first PARP-inhibitor to reduce the risk of ovarian cancer progression or death by 73% in patients with BRCA mutations and by 55% in patients without BRCA mutations. Research is ongoing.
 

More data needed
While the NOVA study represents a significant step forward more data is needed before all asymptomatic patients with recurrent platinum-sensitive ovarian cancer can be treated effectively with niraparib and other maintenance PARP inhibitors. The challenge for clinicians is to select the right drug for the right patient at the right time. To decide which patient receives PARP inhibition and at what point in her therapy is challenging and stands to benefit from further research. Until further research is undertaken on niraparib and other PARP inhibitors, patients with advanced ovarian cancer will continue to incur treatment related toxicity without definitive benefits. 
 
Quality of life versus progression free survival

The side effects from approved cancer therapies raise questions about the metrices clinical studies use to measure their endpoints. All drugs have safety risks. The sole reason why a patient would want to take a drug is because it: (i) improves survival, (ii) results in a detectable benefit, (iii) decreases the chances of developing complications or undesirable side effects. Primary endpoints in clinical studies should be something that are important to a patient and can be objectively measured. When clinical studies use surrogate endpoints, similar tests apply. Thus, clinically meaningful endpoints directly measure how a patient feels, functions, or survives and include overall survival (OS), progression-free survival (PFS) and health-related quality of life (QOL).
The NOVA study used progression free survival (PFS) as its primary endpoint. This is an accepted metric for maintenance therapy for advanced ovarian cancer and other metastasized cancers.  Employing PFS instead of overall survival as the primary outcome has the advantage that study completion can be quicker with fewer patients required and it is cheaper. While the NOVA study successfully demonstrated that niraparib helps to stop ovarian cancer returning, it failed to show that the drug reduces health-related quality of life for patients.
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After 20 years of the cancer drug Herceptin is less more?
There is some evidence to suggest that women with ovarian cancer might be willing to accept lower progression free survival for enhanced health-related quality of life. A study published the December 2014 edition of Cancer suggested that women with recurrent ovarian cancer were prepared to trade several months of PFS for reduced debilitating side effects of chemotherapy, which include nausea and vomiting. The most common adverse reactions to niraparib, which affect about 10% of patients, include thrombocytopenia, anaemia, neutropenia, leukopenia, palpitations, nausea, constipation, vomiting, abdominal pain, mucositis/stomatitis, diarrhoea, dyspepsia, dry mouth, fatigue, decreased appetite, urinary tract infection, AST/ALT elevation, myalgia, back pain, arthralgia, headache, dizziness, dysgeusia, insomnia, anxiety, nasopharyngitis, dyspnoea, cough, rash, and hypertension.
 
Ovarian Cancer

Epithelial ovarian cancer accounts for 90% of all ovarian tumours. It typically presents in post-menopausal women and is a significant challenge for gynaecological oncologists since most patients are diagnosed when the disease is already advanced and therefore have a poor chance of survival. The natural history of the disease is characterized by a high response rate to primary treatment of debulking surgery followed by platinum-taxane chemotherapy, which is quickly followed by early recurrence and a second-line treatment with platinum; then most patients experience further platinum-resistance and die from the disease. Although ovarian cancer is relatively rare - based on 2013-2015 data 1.3% of women are expected to contract the disease sometime in their lifetime -  it is the 7th most common cancer in women worldwide. In 2012 there were 239,000 new cases of the disease diagnosed globally. In the UK ovarian cancer is the 5th most common cancer in females, the 2nd most common malignant gynaecological disease and the 1st cause of death from gynaecological malignancy. The UK has one of the highest incidence rates of the disease in Europe, affecting some 7,500 women every year, and its survival rates are among the lowest. Every year 4,100 women in Britain lose their lives to the disease, which equates to about 11 women every day. Over the past 2 decades there has been a slowing of the rate of diagnosis of ovarian cancer in the UK, which is partly due to the large number of women having taken the oral contraceptive pill after it was made available on the NHS in December 1961 and is known to have a protective effect. According to the World Ovarian Cancer Coalition, over the next 2 decades the incidence rates of ovarian cancer worldwide is expected to rise by 55% and by 15% in the UK. This is mainly because: (i) post-menopausal women are living longer, (ii) populations are increasing, and (iii) there is a significant increase in the rate of urbanization.
 
The standard of care for ovarian cancer
 
Although advances in research and technology have contributed additional and sometimes more effective therapy options for women with ovarian cancer such as niraparib and other PARP inhibitors, both the American and European guidelines recommend surgery as the initial approach to ovarian malignancies. After surgery, adjuvant chemotherapy is mandatory in cases of suboptimal debulking, advanced stages, or early stages with a high risk of recurrence. Mike Birrer, Professor of Medicine at Harvard University Medical School, Director of Medical Gynecologic Oncology and also Director of the Gynecologic Oncology Research Program at the Massachusetts General Hospital Cancer Center describes the standard treatment for ovarian cancer. “Ovarian cancer is diagnosed surgically. It’s important that the patient undergoes proper diagnostic and staging procedures. This would include an exploratory laparotomy (a surgical procedure, which involves an incision through the abdominal wall to gain access into the abdominal cavity), which would then evolve onto a staging laparotomy, (to determine the extent and stage of a cancer), which would include a TAH (total abdominal hysterectomy), BSO (bilateral salpingo-oophorectomy, which is when either the uterus plus one ovary and fallopian tube are removed, or the uterus plus both ovaries and fallopian tubes are removed), removal of the ovaries and the uterus. The removal of the omentum (a layer of fatty tissue that covers the abdominal contents like an apron; the procedure to remove it is called an omentectomy, which involves removing the uterus, cervix, fallopian tubes and ovaries), and lymph nodes in the regiterial cavity, scraping of the upper abdomen and then a peritoneal lavage (a procedure to determine if there is free floating fluid, most often blood, in the abdominal cavity). This would give accurate staging for the patient and anything less would be considered less than the standard of care. Once the stage is established and the patient has an advanced stage of the disease, which has spread throughout the abdomen or outside the abdomen, the patient would then undergo further therapy. This would inevitably involve a combination of chemotherapy. The specific regimen would depend, in part, upon the surgical results.”  See video below.
 
 
Current options for ovarian cancer maintenance therapy

In addition to niraparib, current options for ovarian cancer maintenance therapy include bevacizumab and olaparib. The former is a monoclonal antibody designed to block a protein called vascular endothelial growth factor (VEGF). Some cancer cells make this protein and blocking it may prevent the growth of blood vessels that feed tumours, which can stop the tumour from growing. Notwithstanding, bevacizumab can only be given once and improves progression-free survival by just a few months. Olaparib is a PARP inhibitor, which blocks how PARP proteins work in cancer cells that have a BRCA gene mutation. Without PARP proteins, these cancer cells become too damaged to survive and die. In the first instance, olaparib was only approved in patients with a germline BRCA mutation, which accounts for about 10–15% of ovarian cancer patients. In 2014, when olaparib was approved in Europe and the USA, it was the first cancer treatment targeted against an inherited genetic fault to be licensed. Subsequently, evidence suggested that the drug could also benefit patients whose tumours have defects that are not inherited.
 
Non-specific signs and symptoms

The unresolved challenge for ovarian cancer is that in its early stage it rarely presents with any symptoms. Compounding this is the further problem that later stages of the disease may present few and nonspecific symptoms, which are commonly associated with benign conditions. Were ovarian cancer detected in its early stage when the disease is confined to the ovary it is more likely to be treated successfully. Ovarian cancer suffers from another challenge because screening for the disease in not an option, as we explain below. Further, often women do not know what symptoms to look out for and primary care doctors misdiagnose the disease especially in younger women. This results in about 80% of ovarian cancer cases being diagnosed late when 60% have already metastasised, which reduces the 5-year survival rate from 90% in the earliest stage to 30%. Signs and symptoms of ovarian cancer include abdominal bloating or swelling, quickly feeling full when eating, weight loss, discomfort in the pelvis area, changes in bowel habits such as constipation, and a frequent need to urinate.
 

A patient’s view
The 3 primary symptoms of ovarian cancer are bloating, feeling full and pelvic pain. Secondary symptoms include fatigue, bowel and urinary issues. In reality women don’t have all the primary symptoms and they may not have any of the secondary symptoms but may have a combination of the 2. The most prevalent symptom is bloating, especially if it persists. If this occurs women should immediately go to their doctors and ask for a CA-125 blood test. And whatever the outcome of the test they should also insist on a TVUS scan. There is no one easy method of diagnosing ovarian cancer and doctors sometime mistake the symptoms for something less serious like irritable bowel syndrome,” says an ovarian cancer patient. In addition to a pelvic examination, the 2 most frequent diagnostic tests for ovarian cancer are transvaginal ultrasound (TVUS), which puts an ultrasound wand into the vagina to examine the uterus, fallopian tubes and ovaries and the CA-125 blood test, which measures the amount of the protein CA-125 (cancer antigen 125) in your blood.
 
Late diagnosis

According to Christina Fotopoulou, Professor of Surgery at Imperial College London and Consultant Gynaecological Oncologist at Queen Charlotte’s Hospital NHS Trust , “Ovarian cancer is a very silent disease. It has a tumour dissemination pattern of very small nodules spread throughout the whole skin of the abdomen. In the beginning these nodules are so small that they go undetected. The nodules are only detected when they get larger and produce water. So, women with ovarian cancer get abdominal distention and water in their tummies, which prompts them to seek advice from their doctors. But then it’s too late because it’s already at a late stage of the disease.” See video below.
 
 
The ‘bar’ is too high to screen for ovarian cancer
 
Hani Gabra, Professor of Medical Oncology at Imperial College London and Chief Physician Scientist and Head of the Oncology Discovery Unit at AstraZenecaUK supports Fotopoulou and says, “Ovarian cancer is often diagnosed late because in many cases the disease disseminates into the peritoneal cavity almost simultaneously with the primary declaring itself. Unlike other cancers the notion that ovarian cancer goes from stages 1 to 3 is possibly a myth. In reality these cancer cells often commence in the fallopian tube with a very small primary tumour and disseminate directly into the peritoneal cavity. In other words, they go from the earliest stage 1 directly to stage 3, which renders screening a significant challenge. This is compounded by the fact that ovarian cancer is relatively rare in the population. So, to be effective a screening test would have to be extremely sensitive and extremely specific, which it does not have to be for commoner cancers. The combination of these makes screening for ovarian cancer extremely difficult to achieve.”
 
 
Takeaways

Ovarian cancer is a devastating disease, which is diagnosed more infrequently and often at a later stage. Patients are typically older, symptoms are non-specific and easily confused with a number of benign conditions. In its earliest and most curable stage, there may not be any physical symptoms, pain or discomfort. Standard treatment is radical and a harrowing experience for women diagnosed with the disease. About 85% of patients experience a recurrence of the disease after their first treatment cycle, which means that they often face repeated bouts of chemotherapy to keep the disease under control. In a significant proportion of cases even after a second round of chemotherapy the cancer can recur. Previously, at this point patients have had limited pharmacological help, but as research advances, this is beginning to change, and some novel and efficacious drugs are entering the market. Niraparib is one of the latest PARP inhibitors, which has demonstrated efficacy in the treatment of advanced ovarian cancer.
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  • Dementia has emerged as one of the biggest killer diseases of the 21st century
  • Studies suggest that moderate alcohol use significantly increases the risk of dementia
  • There are no treatments that slow or stop the progression of dementia
  • There are 50m people worldwide living with dementia, by 2050 there will be 132m
  • 0.85m people in the UK are living with dementia and this is expected to rise to 1m by 2025
  • Public policies alone are not sufficient to limit and control alcohol use
  • This increases the importance of a medical solution for dementia
  • Recent innovative research on neurodegenerative disorders provide some hope for future dementia sufferers
 
Alcohol use and dementia

Two significant recent studies described in this Commentary link alcohol use and the onset of dementia. One study published in the June 2017 edition of the British Medical Journal (BMJ) suggests that moderate alcohol use increases the risk of adverse brain outcomes and a steeper decline in cognitive abilities. The other, published in the February 2018 edition of the Lancet Public Health, suggests that excessive alcohol consumption is a significant risk of early onset dementia.

Dementia is a chronic progressive disorder, which has emerged as one of the biggest killers and the only leading cause of death without a treatment that can slow or stop its progression. Of the 529,655 deaths recorded in the UK in 2015, dementia accounted for 61,686 (11.6%): the majority are women, 41,283, compared to 20,403 men.

 
In this Commentary
 
In this Commentary we outline how alcohol affects you, explain its misuse and describe some of the UK’s drinking patterns and their consequent costs. We then suggest that public policies alone, which are aimed at both the individual and population levels to reduce and control alcohol use in order to save lives and reduce healthcare costs, are insufficient. This shifts the burden of a solution for alcohol related dementia onto potential medical treatments. We describe dementia and provide a few epidemiological facts before describing the findings of the 2 studies. We suggest that the studies are significant because there are no effective treatments or cures for dementia despite the vast amounts of money spent on neurodegenerative diseases over the past 2 decades. We end by mentioning a couple of significant UK-based innovative dementia research initiatives, which signal hope for future dementia sufferers.

 

How alcohol affects you and its misuse

Alcohol is a dependence-producing psychoactive beverage, which has been widely used throughout the world for centuries. Problems associated with the consumption of alcohol have been around since the beginning of recorded history. There are 3 mechanisms by which alcohol can affect you: (i) alcohol has toxic effects on your brain and other organs and tissue, (ii) alcohol has intoxicating effects, which manifest themselves in physical and mental impairment and (iii) you may become dependent of alcohol, which means control over your drinking habit is impaired. Alcohol’s harmful impact is influenced by, (i) the volume you consume, (ii) your pattern of drinking and (iii) the quality of the alcohol. When your body takes in more alcohol than it can metabolize, the excess builds up in your bloodstream. Your heart circulates the blood alcohol throughout your body leading to changes in your body’s chemistry and normal functions. 

Studies have consistently suggested that heavy alcohol consumption is detrimental to health and a leading preventable cause of death. There is an increasing awareness of the harmful impact of alcohol misuse on individuals and societies. According to the 2011 World Health Organization’s (WHO) Global status report on alcohol and health, only about 50% of the world's population consumes alcohol, and most users are in the wealthier northern hemisphere countries, although alcohol use is increasingly becoming a problem in emerging economies. Eastern European countries have the highest consumption, riskiest patterns of drinking and the highest levels of alcohol-related deaths and disabilities. According to a February 2018 WHO report, an estimated 3.3m people a year worldwide die as a result of alcohol misuse, which accounts for about as much death and disability worldwide as tobacco and hypertension. 
 
Drinking in the UK and its costs
 
The latest available data suggest that the total alcohol consumption in the UK is 9.5 litres per person aged 15 years and older and 7.8 litres per person on average throughout the entire population in 2015. This forms part of a recent downward trend from a peak of 11.6 and 9.5 litres per head respectively in 2004 and positions the UK 16th out of the 34 OEDC countries. 21m people in the UK do not drink alcohol. According to NHS Digital, in 2014 there were 1.1m hospital admissions in England wholly or partially attributable to alcohol use: more than double the number recorded a decade earlier. In 2014 about 6,600 people in England died from causes related to alcohol and about 115,000 adults received specialist alcohol treatment. Treating alcohol related conditions is estimated to cost NHS England about £3.5bn per year: around 3.6% of its annual budget. About 6% of adults in England are dependent on alcohol. 195,000 prescriptions were written in 2014 by the NHS to treat alcohol dependence at a cost of £3.4m. Over the past decade these prescription costs, measured in 2014 prices, have increased by nearly 80% from £1.9m in 2004.
 
Public policies to curb alcohol use are insufficient

In May 2018, Scotland became the first country in the world to introduce legislation for minimum pricing on cheap, high-strength alcohol. The government said it was an endeavour to cut the consumption of alcohol and save lives. For several decades, similar alcohol reduction and prevention measures have been available at both the individual and population levels in the UK and elsewhere. The most effective include alcohol taxes, restrictions on alcohol availability, and drink-driving countermeasures. Despite the success of these policies, alcohol problems continue to present a major challenge to medicine and public health. In part, this is because population-based public health alcohol control policies tend to be overlooked in favour of approaches aimed at the individual and these have tended to be more palliative than preventative. It is reasonable to assume therefore that, in the near- to medium-term, alcohol related dementia will neither be significantly slowed nor reduced by public policies alone. This shifts the emphasis to a medical solution for alcohol related dementia.
 

Dementia

Dementia is an umbrella term, which describes a group of symptoms that impair your cognitive functions and behavioural abilities severely enough to interfere with your daily life and activities. It is a chronic, progressive and incurable disorder, which ranges in severity from ‘mild’, when it is just beginning to affect your functioning, to ‘severe’, when you depend completely on others for basic activities of living. Dementia involves damage of nerve cells in your brain, which can occur in several areas and affect people differently, depending on the area of the brain affected. Alzheimer's, a neurodegenerative disease, is the most common irreversible cause of dementia, accounting for 60% to 80% of all dementia cases.
The biggest risk factor for dementia is age. We are living in the age of the aged, which represents the successes of improved healthcare over the past century. There are some 50m people worldwide living with dementia. The total number of people with dementia worldwide is projected to increase to 75m by 2030 and 132m by 2050, with the largest proportion of these in low- and middle-income countries. There are 0.85m people diagnosed with dementia in the UK, with numbers set to rise to over 1m by 2025 and to 2m by 2050. 225,000 people in Britain will develop dementia this year. There is a similar story to be told in most wealthy developed countries. For example, in the US an estimated 6m people have Alzheimer's, which equates to 10% of people aged 65 and older. The current annual cost of dementia globally is estimated to be about US$1tr: 1% of global GDP. The annual cost of the condition in the US is US$259bn, which is expected to rise to US$1tr by 2025. Dementia costs the UK exchequer about £26bn each year.
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Dementia is not an inevitable part of ageing. The notion that dementia is a disease rather than a side-effect of aging has been around for 100 years. Early onset of the disease can begin when people are in their 30s, 40s, or 50s. For example, over 42,000 people under 65 have dementia in the UK. Age, family histories and heredity are factors of dementia that we cannot change. But lifestyle factors such as alcohol use are modifiable risks. There is no cure for the condition and no therapy that slows or stops its progression although some drug treatments may temporarily improve its symptoms.

 
The BMJ study

For some time, scientists have suggested that moderate alcohol consumption could delay the onset of cognitive impairments in ageing, but few studies have examined the effects of modest consumption of alcohol on the brain. This increases the significance on the BMJ study, which includes an analysis of the relationship between moderate alcohol consumption and dementia. Researchers from Oxford University  and University College London studied a cohort of 550 healthy adult civil servants over a 30 year period between 1985 and 2015. At the beginning of the study the average age of the cohort was 43 and none were dependent on alcohol. At regular intervals during the study tests were administered to assess participants’ levels of alcohol consumption and cognition. At the end of the study participants underwent an MRI brain scan, which enabled researchers to analyse correlations between average alcohol consumption, cognition and brain structure. Findings suggest that alcohol use is associated with reduced right hippocampal volume. The hippocampus is a small region of your brain associated with memory and spatial navigation. Poor memory is linked with small hippocampal volume as measured by an MRI scan. The more you drink, the more you are likely to have hippocampal atrophy, which is regarded as an early marker for dementia. Significantly, the study found that even moderate drinkers were 3 times more likely to have hippocampal atrophy than abstainers.

The principal strength of the study is that it is a longitudinal observational analysis of a specific cohort, which yielded detailed information on long term alcohol consumption and cognition and confounding variables. These are “extra” variables, which are important to know in order to avoid bias. Because this was an observational study the researchers were unable to draw any conclusions on cause and effect. Notwithstanding, they were able to conclude that moderate alcohol use is associated with adverse brain outcomes and, “Alcohol might represent a modifiable risk factor for cognitive impairment, and primary prevention interventions targeted to later life could be too late.” In an editorial note in the same BMJ, Killian Welch, a consultant neuropsychiatrist at the Royal Edinburgh Hospital suggests the findings of the study, “strengthen the argument that drinking habits many people regard as normal, have adverse consequences for health.”

 
The Lancet Public Health study
 
The second study from The Lancet Public Health presents findings of a large retrospective study predicated upon data of more than 1m adults diagnosed with dementia between 2008-2013 from the French National Hospital Discharge database. These data provide details on all hospital admissions, including patient demographics, reasons and durations for hospital stays and treatments received. Findings suggest that being hospitalised with alcohol dependence or a health issue caused by continuous heavy drinking is a significant risk factor for dementia. Although the condition is more common in people over the age of 65, the study identified and examined 57,000 cases, which presented with the onset of dementia before 65. Of these, 57% were heavy drinkers, 39% regularly consumed alcohol and 18% had an alcohol use disorder as an additional diagnosis. “Heavy drinkers” were found to be more than 3 times likelier to develop dementia. Excluding alcohol-related brain damage, alcohol use disorders were still found to be associated with a 2 times greater risk of dementia.

According to Michael Schwarzinger, the lead author of the study, who is the director of the French Translational Health Economics Network and a researcher at the Universite Paris Diderot, France, “Chronic heavy drinking was the most important modifiable risk factor for dementia onset in both genders and remained so after controlling for all known risk factors for dementia onset.” While other studies have reached similar conclusions, some research suggest that drinking one or two units of alcohol a day - a small glass of red wine particularly - could be of benefit to brain health and slow the onset cognitive deterioration. Indeed, the Lancet Commission on dementia, associates light to moderate alcohol use with a healthier brain. Schwarzinger and his colleagues however are clear, “Our findings suggest the burden of dementia attributable to alcohol use disorders is much larger than previously thought . . .. Chronic heavy drinking leads to irreversible brain damage [and even] heavy drinkers who got sober didn’t have a lower dementia risk than their peers who remained problem drinkers. . . Additionally, clinicians should be better aware of the role of alcohol use disorders in dementia onset over the lifetime, which seems to be a risk factor often omitted.”
 
Why there is no cure for dementia

Over the past 2 decades pharmaceutical companies, biotech’s, governments, universities and charities have devoted vast amounts of money, time and effort to the dementia challenge, but without being able to develop any credible treatment let alone cure. This partly reflects the complexity of neurodegenerative disorders. The brain is a complex organ, which scientists are still endeavouring to understand. This lack of understanding is one of the main obstacles preventing the development of effective treatments for dementia. The disorder seems to present as a result of an intricate interaction of genes, lifestyle factors and other environmental influences. But, without knowing the exact mechanisms that cause damage, especially in Alzheimer's, it is impossible to target the disease process effectively.

In addition to our rudimentary understanding of the brain there are some specific challenges faced by researchers into neurodegenerative disorders. One is the blood-brain barrier, which is formed by brain endothelial cells, which protect the brain by preventing toxins from reaching it. This presents dementia researchers with a significant challenge because the blood-brain barrier also prevents treatments getting through to the brain and working effectively. Newer immunotherapy drugs, also known as biologics, are large complex molecules or mixtures of molecules, which because of their size and shape may only partly cross the blood-brain barrier. This suggests that dangerous doses would be needed for them to work effectively. And even if the biologics could penetrate the blood-brain barrier and target the proteins causing damage to brain cells, dementia is irreversible and may have started to develop decades before the presentation of symptoms and before the administration of drugs. Further, there is no test for dementia, which means the disorder is difficult to diagnose. This leads some health professionals to suggest that with no effective treatments, early diagnosis has no benefits. A significant proportion of those living with dementia have not received a formal diagnosis, which presents further challenges not least for clinical studies.

 
The amyloid hypothesis

For the past 2 decades dementia drug development has been dominated by the ‘amyloid hypothesis’, which suggests that Alzheimer’s can be treated by attacking the sticky plaques of beta amyloid protein that builds up in patients’ brains. The pharmaceutical industry has lost billions in failed development of drugs designed to target amyloid, and there is still no treatment that affects the underlying progression of the disease. In January 2018 Pfizer, the world’s largest pharmaceutical company, which has spent billions on dementia R&D, announced that it was pulling out of research into drugs to treat complex neurological disorders. Notwithstanding, many pharmaceutical companies, driven by the potential financial gains from finding a medicine that can arrest the disease of 50m people, continue to work on treatments for neurodegenerative diseases.
 
Innovative research endeavours that target dementia

The UK’s 2013 presidency of the G8, (an inter-governmental political forum comprised of the major industrialized democracies) focused on dementia. This resulted in the condition rising up global political agendas and the UK Government unlocking more money for research into neurodegenerative disorders. In 2015 the UK government with the help of JP Morgan, an American multinational investment bank, set-up the Dementia Discovery Fund, with an initial investment of £15m and the commitment from several big pharmaceutical companies to invest. The fund’s strategy was to raise £100m for dementia R&D and move beyond the amyloid hypothesis. It has invested in some 12 start-ups and projects investigating novel ways to stop or reverse the complex biological processes that lead to dementia. In November 2017 the Bill and Melinda Gates Foundation invested US$50m into the fund, which took its total to £130m. Other well-funded novel research projects include the UK Dementia Research Institute, which brings together the Medical Research Council, Alzheimer’s Society and Alzheimer’s Research UK in a £250m initiative involving more than 400 scientists, who are leading efforts to transform the treatment and care for people with dementia.
 
Takeaways

Dementia is a 21st century Damocles Sword positioned to bankrupt healthcare systems in the developed world. Dementia is a vast, fast growing global killer disease effecting about 7% of people living in wealthy nations and costing billions. Despite billions spent on dementia R&D over the past 2 decades there are no viable treatments to either slow or stop the progression of the disorder. Alcohol use has been suggested as a significant contributory factor for the onset dementia. Public policies to curb the use of alcohol are insufficient to significantly dent the vast and escalating burden of dementia. This shifts the emphasis for a solution to medicine. Despite the dearth of medical solutions, things are beginning to change with some recent novel research initiatives specifically targeting neurodegenerative disorders, which might help to lift the Damocles Sword
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  • People are using A&E departments as convenient drop-in clinics for minor ailments because they cannot get GP appointments
  • In January 2017 the British Red Cross said A&E was struggling with a "humanitarian crisis" to keep up with a rush of patients over  the winter
  • UK’s Prime Minister suggests that all GP surgeries should open from 8am to 8pm, 7 days a week 
  • Primary care in England is in crisis, fuelled by a large and increasing demand and a shrinking supply of GPs
  • 75% of GPs across 540 general practices over the age of 55 are nearing retirement, and newly trained GPs are seeking employment abroad
  • By 2020 there could be a shortfall of 10,000 GPs in England
  • Curing the primary care crisis would relieve pressure on A&E departments
  • A simple, cheap and easy-to-use online dashboard could help relieve the primary healthcare crisis
 
A smarter approach to the UK’s GP crisis
 
Could the vast and escalating primary care crisis in England be helped with a new and innovative online dashboard, which automatically sends short videos contributed by clinicians to patients’ mobiles to address their FAQs?
 
Dr Seth Rankin an experienced GP thinks it can. Click on the photo below to access a short video, which demonstrates how the dashboard works.

 
 
 

UK’s Secretary of State predicted the healthcare crisis
 
The UK’s Secretary of Health has frequently stressed the urgent need for more innovation in healthcare. In 2015 he said: “If we do not find better, smarter ways to help our growing elderly population remain healthy and independent, our hospitals will be overwhelmed – which is why we need effective, strong and expanding general practice more than ever before in the history of the NHS.
 
An easy and effective way to improve GP services

Most patients don’t remember half of what is said in short GP consultations. This is why videos are so important. Unlike doctors and pamphlets videos never get tired, never wear out, and are available 24/7, 365 days a year. Unlike the Internet, the dashboard provides premium reliable healthcare information, which easily can be consumed by patients and shared among family, friends and carers. The video content can be viewed many times, from anywhere, and at anytime. The dashboard is fully automated [see figure below], relieves GPs of a lot of unnecessary work, and importantly, reports on how patients’ use the different videos,” says Rankin; CEO of the London Doctors Clinic; and formally the managing partner of the Wandsworth Medical Centre, and co-chair of Wandsworth CCG’s Diabetes Group.
 
A fully automated dashboard to improve efficiency and increase the quality of care
 
 
Reducing unnecessary A&E visits

‘The dashboard uses videos of local healthcare professionals because both patients and doctors want to improve their connectivity. The dashboard is embedded with about 120 short, 60 to 80 second, talking-head videos, which address patients’ frequently asked questions. Research suggests that the average attention span for people watching videos on mobiles is between 60 to 80 seconds. The dashboard has been specifically designed to help increase patients’ knowledge of their condition, propel them towards self-management, slow the onset of complications, lower the number of unnecessary visits to A&E, reduce face-time with GPs, and enhance the quality of care,” says Rankin.
 
Essential behavioral techniques

The efficacy of healthcare education is enhanced by embedded behavioral techniques, which nudge people to change their diets and lifestyles, improve self-monitoring of their condition, and increase adherence to medications.  The HealthPad dashboard benefits from such behavioral techniques.
 
Part of comprehensive communications system

The dashboard has been developed by health professionals with significant patient input, and aims to get effective educational content to the largest number of people at the lowest price possible; and without requiring effort from health professionals to mediate or facilitate the flow of the knowledge. To achieve this the dashboard is not a “lock-in” system, but designed to be easily and cheaply re-engineered to integrate with various other communications systems, see diagram below. The only thing that the dashboard requires is a connection to the Internet. 
 

 
GP surgeries at saturation point

A 2016 study published in The Lancet suggests that between 2007 and 2014 the workload in NHS general practice in England had increased by 16%, and that it is now reaching saturation point. According to Professor Richard Hobbs of Oxford University and lead author of the study, "For many years, doctors and nurses have reported increasing workloads, but for the first time, we are able to provide objective data that this is indeed the case . . . . . As currently delivered, the system [general practice in England] seems to be approaching saturation point . . . . . Current trends in population growth, low levels of recruitment and the demands of an ageing population with more complex needs will mean consultation rates will continue to rise.”
 
More than 1m patients visit GPs every day

A 2014 Deloitte’s report commissioned by the Royal College of General Practitioners (RCGP) suggests that the GP crisis in England is the result of chronic under-funding and under-investment when the demand for GP services is increasing as the population is ageing, and there is a higher prevalence of long-term conditions and multi-morbidities.
 
Each day in England, more than 1m patients visit their GPs. Some GPs routinely see between 40 to 60 patients daily. Over the past 5 years, the number of GP consultations has increased by 60m each year, and now stands at about 370m a year. Over the same period, the number of GPs has grown by only 4.1%.
 
Stress levels among GPs are high and increasing

Deloitte’s findings are confirmed by of a 2016 comparative study undertaken by the prestigious Washington DC-based Commonwealth Fund, which concluded that increasing workloads, bureaucracy and the shortest time with patients has led to 59% of NHS GPs finding their work either “extremely” or “very” stressful: significantly higher stress levels than in any other western nation. GP stress levels are likely to increase.
 
In a speech made in June 2015, the UK’s Secretary of Health said, “Within 5 years we will be looking after a million more over-70s. The number of people with three or more long term conditions is set to increase by 50% to nearly three million by 2018. By 2020, nearly 100,000 more people will need to be cared for at home.” Dr. Maureen Baker, the former chair of the Royal College of General Practitioners (RCGP) has warned that, “Rising patient demand, excessive bureaucracy, fewer resources, and a chronic shortage of GPs are resulting in worn-out doctors, some of whom are so fatigued that they can no longer guarantee to provide safe care to patients.” And Dr  Helen Stokes-Lampard, the new head of the RCGP, warns that patients are being put at risk because they often have to wait for a month before they can see a GP.

 
Newly trained GPs are seeking employment abroad

Trainee GPs are dwindling and young GPs are moving abroad. According to data from the General Medical Council (GMC), between 2008 and 2014 an average of 2,852 certificates were issued annually to enable British doctors to work abroad. We now have a dangerous situation where there are hundreds of vacancies for GP trainees. Meanwhile, findings from a 2015 British Medical Association (BMA) poll of 15,560 GPs, found that 34% of respondents plan to retire in the next five years because of high stress levels, unmanageable workloads, and too little time with patients.
 
5,000 more GPs by 2020

In 2016 the government announced a rescue package that will see an extra £2.4bn a year ploughed into primary care services by 2020. This is expected to pay for 5,000 more GPs and extra staff to boost practices. When the Secretary of Health trailed this in 2015, doctors’ leaders did not view it as a viable solution. Dr Chaand Nagpaul, chair of the BMA’s GP committee, warned that, “delivering 5,000 extra GPs in five years, when training a GP takes 10 years, was a practical impossibility and would never be achieved.” In 2016, Pulse, a publication for GPs, suggested that the Health Secretary understands that he cannot deliver on his election promise of 5,000 new doctors by 2020, and is negotiating with Apollo Hospitals, an Indian hospital chain, to bring 400 Indian GPs to England.
 
Pharmacists in GP surgeries
 
In July 2015 the NHS launched a £15m pilot scheme, supported by the RCGP and the Royal Pharmaceutical Society (RPS), to fund, recruit and employ clinical pharmacists in GP surgeries to provide patients with additional support for managing medications and better access to health checks.
 
Dr Maureen Baker said, “GPs are struggling to cope with unprecedented workloads and patients in some parts of the country are having to wait weeks for a GP appointment yet we have a ‘hidden army’ of highly trained pharmacists who could provide a solution”. Ash Soni, former president of the RPS suggested that it makes sense for pharmacists to help relieve the pressure on GPs, and said, “Around 18m GP consultations every year are for minor ailments. Research has shown that minor aliment services provided by pharmacists can provide the same treatment results for patients, but at lower cost than at a GP surgery.”
 
Progressive and helpful move
 
The efficacy for an enhanced role for pharmacists in primary care has already been established in the US, where retail giants such as CVS, Walgreens and Rite Aid provide convenient walk-in clinics staffed by pharmacists and nurse practitioners. Over time, Americans have grown to trust and value their relations with pharmacists, which has significantly increased adherence to medications, and provided GPs more time to devote to more complex cases. Non-adherence is costly, and can lead to increased visits to A&E, unnecessary complications, and sometimes death. According to a New England Healthcare Institute report, Thinking Beyond the Pillbox, failure to take medication correctly, costs the US healthcare system $300bn annually, and results in 125,000 deaths every year. 
 
Takeaway

People with complex conditions deserve to be seen by a GP who is not stressed and who can devote the time and attention they need. “Videos could play a similar role to practice-based pharmacists. Both deal with simple day-to-day patient questions, and relieve pressure on GPs, which allows them to focus their skills where they are most needed,” says Rankin.
 
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  • Diabetes UK’s (DUK) 2016 State of the Nation Report calls for diabetes education to be improved
  • Effective education can reduce the vast and escalating burden of diabetes and is significantly cheaper than treatment
  • Traditional diabetes education is failing miserably
  • DUK’s education only reaches a small percentage of people with diabetes
  • Self-management is the only realistic way forward to better diabetes management, but will require a transformation of the current patient-educator relationship
  • Could DUK play a leading role in this transformation?
 
Improving diabetes education to enhance patient outcomes
 
For the past decade at least, the charity Diabetes UK (DUK) has been “calling for governments to do more” to improve diabetes care in order to stem the vast and escalating burden of the condition. Currently, 4m people or 6% of the population are living with diabetes in the UK, and this is projected to rise to 5m by 2025. It is estimated that around 10% of the NHS yearly budget is contributed to the treatment of diabetes; which equates to £10.3bn a year.

The prevalence of type-2 diabetes (T2DM) in particular has been increasing rapidly, and is now one of the world’s most common long-term health conditions. Life expectancy on average is reduced by up to 10 years for people with T2DM. Experts say effective education can prevent the onset of T2DM, help with its management once diagnosed, and slow the onset of complications, such as heart failure, blindness, kidney disease and lower limp amputations. The 2016 DUK State of the Nation report called for diabetes education to be improved.

 
Traditional diabetes education is failing

In the video below Richard Lane, Ambassador and Immediate Past President of DUK, describes the significant improvements in diabetes education since he was first diagnosed in the 1970s, and briefly describes DAFNE (Dose Adjustment For Normal Eating), one of the official UK adult courses for managing type-1 diabetes. Also, a patient with type-1 describes how helpful she found some voluntary diabetes educational courses.
 
 

Notwithstanding individual successes, traditional diabetes education programs are failing to reach a sufficient number of people to be effective in reducing the overall burden of the condition. Only 2% of people diagnosed with type-1 diabetes and 6% with T2DM attend official diabetes educational courses. Each year there are 24,000 early deaths from diabetes-related complications, and also 7,000 avoidable amputations. DUK wants 50% of people living with diabetes to receive education over the next five years.
 
DUK's education and support

DUK spends about 50% of the money it raises annually on diabetes education. Of the £37m it raised in 2015 it spent £8.0m on its “Better Care Everywhere” program that works with healthcare institutions, “to make sure people had access to the 15 healthcare essentials”; £7.0m on its “Not Alone with Diabetes” program, which is its helpline; £1.5m “Reducing the Risk of Diabetes”, which is DUK’s participation in the National Diabetes Prevention Program; and £8.2m, “Growing the Impact of DUK’s Work”, which develops “networks of healthcare professionals,” to “work with local community groups and volunteers all over the country”: a total of £24.7m. 

Here we describe these expenditures as education and support services. 
Despite over £20m worth of diabetes educational and support services delivered by DUK each year, and the £10.3bn spent by the NHS on diabetes care and education, diabetes in the UK remains the largest and fastest growing health challenge of our time. “Diabetes is a very serious and complex health condition that requires constant self-management,” says Chris Askew, DUK’s CEO. 
 
A fundamental transformation is required

Increasing self-management is relevant, especially as resources for diabetes are shrinking as the prevalence of the condition is rapidly increasing, particularly among children. However, achieving effective self-management requires a fundamental transformation of the way diabetes education is delivered. 

It is projected that 66% of people in the UK will have smartphones by 2017. It seems reasonable to assume therefore that the majority of people  living with diabetes will have smartphones by 2017. People regularly use their smartphones for 24-hour banking, education, entertainment, shopping, and dating. Diabetes education has failed to effectively leverage this vast and rapidly growing free infrastructure and peoples’ changed lifestyles to introduce effective educational support systems to enhance the quality of diabetes care, increase efficiency, and improve patient outcomes. Today, mobile technology is part of everyday life and people expect to be connected with their relevant service providers 24-7, 365 days of the year from anywhere. 

Here is just one example of a simple evidence-based  dashboard designed to help re-engineer primary care management of diabetes by (i) increasing the connectivity between health professionals and patients, (ii) enhancing patient knowledge of diabetes, (iii) encouraging people to self-manage their condition, (iv) increasing the efficiency of GP clinics, and in the medium to longer term, (I) keep people out of A&E, and (ii) slow the onset of complications. 
 


Click on the image to see a demonstration of the dashboard
 

At very little cost, such a system could be rolled-out nationally through Clinical Commissioning Groups (CCG), integrated into GP clinics, and provide the basis of a national platform for diabetes education. Once patients and health professionals become engaged and familiar with the initial service offering, CCGs can bolt on additional services to further help people ward-off or manage their diabetes. This follows the model of digital champions, which succeed by using a core service to engage, and build a user base, and then add more services, so continuously increasing their users’ familiarity with their services. Engaging patients and health professionals any other way tends to fail.

The  diabetes education dashboard ensures that people either at risk of diabetes or living with diabetes will always be part of an educator-patient network, which should increase the variety; velocity, volume and value of educational healthcare information patients receive.

 
The escalating incidence of diabetes is not new

Data reported by DUK in 2015 revealed that over the past decade the number of people living with diabetes increased by 60%, and the charity’s leaders claimed that the public health situation in the UK with regard to diabetes is being allowed “to spiral out of control”. “Diabetes already costs the NHS nearly £10bn a year, and 80% of this is spent on managing avoidable complications,” said Barbara Young, then the CEO of DUK. Such findings, while shocking, are not new. 
 

The vast and escalating burden of diabetes

Tackling diabetes is important for the future of the NHS as there are over 4m people living with diabetes in the UK at present. This represents 6% of the UK population, or 1 in every 16 people. About 90% of the cases have T2DM. 90% of people with T2DM are overweight. Lifestyle changes and weight loss can help to prevent T2DM from ever occurring. Obesity is 40% more common among people living in deprived areas. 11.9m people in the UK are currently at risk of developing T2DM, but more than half could delay or even prevent a diagnosis by improved diets and lifestyles. This requires effective education that engages people and encourage them towards healthier lifestyles. About 10% of the cases are Type-1, which usually develops in childhood, and is often inherited. The NHS spends £10.3bn every year on treating diabetes, which equates to 10% of its entire budget. 80% of this is spent on diabetes medication. The annual indirect costs, such as productivity loss and informal care, are estimated to be £13bn. Effective education is cheaper than treatment.

 
The government will not spend more on diabetes

DUK’s repeated calls for the government to do more for diabetes care have been unsuccessful. This is largely because the NHS is struggling to cope with a surge in demand for care while suffering a major budget squeeze. In 2016, the government took back control of overspending semi-autonomous hospitals as part of its crackdown to tackle a NHS deficit of £2.45bn; the biggest overspend in its history.
 
DUK is a significant provider of diabetes education

To look at some aspects of DUK’s educational achievements we have taken a selection of extracts from its 2015 Annual Report. Against each extract is a short comment.

DUK:11,000 people learnt how to better understand and manage their condition through our Type 2 online education course.” 
 
COMMENT: This represents about 0.3% of the people in England diagnosed with T2DM.
 
DUK:Our care line supported 22,361 people who needed encouragement, information or someone to talk to”. 
 
COMMENT: This represents about 0.6% of people in England living with diabetes.
 
DUK:5.9m visits to the Diabetes UK website in 2015 – almost 10 per cent more than the year before – giving people the opportunity to learn more about the condition, what we do and how to get involved.”               
 
COMMENT: The key question here is the quality of the visit to the DUK website. Questions include inter alia: What is the average ‘dwell time’ for each visitor to DUK’s website? How many repeat visits does the website receive? What is the average number of pages viewed by visitors to DUK’S website? What are the most popular website pages viewed? What are the least popular website pages? How many visitors to the website come from the UK? What percentage of the people who visit the website “get involved”? How long do they stay involved? What percentage of the website’s visitors register with the site?
                                            
DUK:15,196 people found out their risk of developing Type 2 diabetes at one of our Roadshows – and can now take steps to avoid it.” 
 
COMMENT: This represents about 0.1% of the people in the UK at risk of T2DM.
 
DUK: “Educated more than 17,000 healthcare professionals to better work with and support those living with diabetes.”
 
COMMENT: Is this cost-effective? Would not online engagement be more appropriate?
 
DUK:11,000 people registered to educate themselves about managing their Type 2 diabetes via our online course Type 2 Diabetes and Me.”
 
COMMENT: This represents about 0.3% of people in England diagnosed with T2DM.
 
DUK:11.9 million people in the UK are currently at risk of developing Type 2 diabetes, but more than half of those people could delay or even prevent a diagnosis . . . In 2015 we worked with NHS England and Public Health England to develop the NHS Diabetes Prevention Programme. This partnership has the potential to help people in England who are at high risk delay – in some cases even prevent – Type 2 diabetes, and is being watched by the rest of the UK with interest.
 
COMMENT: In 2015 the UK government's Public Accounts Committee (PAC) observed that the national prevention initiative, which costs over £35m each year, lacked urgency, and recommended that it should, “develop a better and more flexible range of education support for diabetes patients.
 
A HealthPad Commentary reviewed the national prevention program, described an innovative and successful US diabetes prevention initiative, and concluded that because the UK program employed 19th century technologies to address a 21st century epidemic it would likely fail. The Commentary further argued that preventing T2DM entails winning the battle against obesity, reducing poverty, and changing peoples’ diets and lifestyles. To do this, education programs need to employ modern behavior techniques to engage people and coax them to change their behaviour.
 

A further HealthPad Commentary, described the growing frustration of the government’s PAC and the National Audit Office (NAO) with the country’s diabetes establishment.
 
DUK: Our ‘Know Your Risk’ volunteers helped over 15,000 people find out their risk of Type 2 diabetes at one of our events, while our online tool was used over 240,000 times.”
 
COMMENT: This represents 0.47% and between 6 to 7.5% respectively of people living with T2DM in England.
 
DUK should report costs and outcomes not costs and the distribution of services

Two points about DUK’s statements of its educational achievements:
  1. The majority of the charity’s education and support services only appear to reach a small percentage of the total number of people either at risk of T2DM or those living with diabetes. We have drawn attention to the fact that a large percentage of people with T2DM are over weight and 40% of obese people reside in deprived areas of the UK. To be effective diabetes education must have the Heineken effect.
  2. For the past decade at least, the DUK has tended to report the costs and distribution of its education and support services. More relevant would be for the charity to report costs and the effects its services have had on reducing the burden of diabetes, slowing complications, improving efficiencies, and enhancing patient outcomes.
Diabetes education providers should adopt school performance measures

For years the UK’s state education service has been using pupil outcome measures to rate the performance of its schools. Why is this not the case for diabetes education? Can you imagine if year-after-year millions of children in England were failing their public examinations, and year-after-year education officers only reported the costs and distribution of their services?  Can you imagine if the public education services only taught a very small percentage of the children eligible for education and there was no information about children’s performance in examinations?
 
Would people accept an education report that said, “This year Worthy schools spent £20m on physics teaching, which only reached 0.3% of pupils who would benefit from the subject, and we have no idea what percentage of those that were taught either took or passed the recommended physics exams”?
 
Technologies facilitate and transform diabetes education

With failing education programs people with diabetes are being driven to self-manage their condition with inadequate support. Inexpensive and ubiquitous technologies facilitate this, and increasingly people are demanding tools that track weight, blood pressure, daily exercise and diet. From apps to wearables, healthcare technology lets people feel in control of their health, while also providing health professionals with more patient data than ever before. 
 
With more than 100,000 health apps, rapid growth in wearables, and 75% of the UK population now owning a smartphone, digital technology is well positioned to significantly improve diabetes education and management. Such technologies while ubiquitous, are ineffective if only used as an adjunct to traditional education. Traditional diabetes education programs have failed to introduce widespread digital support strategies, which significantly enhance the quality of care, increase efficiencies, and improve patient outcomes for the majority of people living with diabetes.
 
In the first video below Richard Lane describes how digital technology is helping people self-manage their diabetes. In the second, Lane and a patient diagnosed with T2DM suggest that the biggest challenge for diabetes care is actually engaging people who are either at risk of the condition or living with diabetes. Only once people are engaged do you stand a chance to raise their awareness of the disease, and encourage them to change their diets and lifestyles in order to slow the progression of the condition and even prevent it.
 
How can mHealth help in the management of diabetes?
 
What are the biggest challenges of diabetes care?
 
Changing the patient-educator relationship
 
Self-management of diabetes should not be viewed simply as developing a website and providing a portfolio of techniques and tools to help people living with diabetes choose healthy behaviours. A necessary pre-requisite for effective education to reduce the burden of diabetes is the actual engagement of people who are either at risk of T2DM or living with diabetes. (Where are the national diabetes registers?). Once engaged education should inform and empower people, and provide them with access to continuous self-management support. This is substantially different to the way traditional diabetes education is delivered as it transforms the patient–educator relationship into a continuous, rich, collaborative partnership. A future HealthPad Commentary will describe an innovative and cost effective Mexican mHealth program, which has radically changed the patient-educator relationship by encouraging people, who are either at risk of T2DM or living with the condition, to take ownership of their own health, and become an integral member of their care team.
 
Takeaways

Diabetes is an out of control killer disease, which experts belief could be stemmed, reduced and prevented with effective education that is significantly cheaper than paying for treatment. Current diabetes education programs are failing miserably, and the prevalence of the disease is increasing rapidly, especially in young children.

Diabetes education and support require a radical overhaul to prevent the disease from spiralling out of control and bankrupting the NHS. This needs leadership to shape and drive a new and effective diabetes engagement/education model. Could DUK provide this?
 
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  • Healthcare systems throughout the world are in constant crisis
  • Attempts to introduce digital infrastructure to improve the quality of care, efficiency, and patient outcomes have failed
  • Modern healthcare systems were built on the idea that doctors provide healthcare with meaning and power, but this is changing
  • Advances in genetics and molecular science are rapidly eating away at doctors’ discretion and power
  • People are loosing their free will and increasingly being driven by big data strategies
  • An important new book suggests that a biotech-savvy elite will edit people's genomes and control health and healthcare with powerful algorithms, and that people will merge with computers
  • Homo sapiens will evolve into Homo Deus
 
Future healthcare shock
 
This book should be compulsory reading for everyone interested in health and healthcare, especially those grappling with strategic challenges. Homo Deus: A brief history of tomorrow, by Yuval Harari, a world bestselling author, published in 2016 is not for tacticians responding to their in-trays, but for healthcare strategists planning for the future.

The book is published a year after an OECD report concluded that NHS England is one of the worst healthcare systems in the developed world; hospitals are so short-staffed and under-equipped that people are dying needlessly. The quality of care across key health areas is “poor to mediocre”, obesity levels are “dire”, and the NHS struggles to get even the “basics” right. The UK came 21st out of 23 countries on cervical cancer survival, 20th on breast and bowel cancer survival and 19th on stroke.


Harari pulls together history, philosophy, theology, computer science and biology to produce an important and thought provoking thesis, which has significant implications for the future of health and healthcare. Homo Deus, more than the 2015 OECD Report will make you think.
 
Healthcare’s legacy systems an obstacle for change

While a large and growing universe of consumers regularly use smartphones, cloud computing, and global connectivity to provide them with efficient, high quality, 24-hour banking, education, entertainment, shopping, and dating, healthcare systems have failed to introduce digital support strategies to enhance the quality of care, increase efficiency, and improve patient outcomes.

Why?

The answer is partly due to entrenched legacy systems, and partly because digital support infrastructure is typically beyond the core mission of most healthcare systems. Devi Shetty, cardiac surgeon, founder and CEO of Narayana Health, and philanthropist, laments how digital technologies have, “penetrated every industry in the world except healthcare”, and suggests doctors and the medical community are the biggest obstaclesto change.
 
 
Doctors’ traditional raison d'être is being replaced by algorithms

Notwithstanding, modern medicine has conquered killer infectious diseases, and has successfully transformed them, “from an incomprehensible force of nature into a manageable challenge . . . For the first time in history, more people die today from old age than from infectious diseases,” says Harari.
 
Further, modern healthcare systems were built on the assumption that individual doctors provided healthcare systems with meaning and power. Doctors are free to use their superior knowledge and experience to diagnose and treat patients; their decisions can mean life or death. This endowed doctors and healthcare systems with their monopoly of power and their raison d'être. But such power and influence is receding, and rapidly being replaced by biotechnology and algorithms.

 
Healthcare systems in crisis

This radical change adds to the crisis of healthcare systems, which lack cash, and have a shrinking pool of doctors treating a large and growing number of patients, an increasing proportion of whom are presenting with complicated co-morbidities. Aging equipment in healthcare systems is neither being replaced nor updated, and additionally, there is a dearth of digital infrastructure to support patient care.
  
A symptom of this crisis is the large and increasing rates of misdiagnosis: 15% of all medical cases in developed countries are misdiagnosed, and according to The Journal of Clinical Oncology, a staggering 44% of some types of cancers are misdiagnosed, resulting in millions of people suffering unnecessarily, thousands dying needlessly, and billions of dollars being wasted. Doing more of the same will not dent this crisis.
 
Computers replacing doctors
 
As the demand for healthcare increases, healthcare costs escalate, and the supply of doctor’s decrease, so big data strategies and complex algorithms, which in seconds are capable of analysing and transforming terabytes of electronic healthcare data into clinically relevant medical opinions, are being introduced.
 
Such digital infrastructure erodes the status of doctors who no longer are expected solely to rely on their individual knowledge and experience to diagnose and treat patients. Today, doctors have access to powerful cognitive computing systems that understand, reason, learn, and do more than we ever thought possible. Such computers provide doctors almost instantaneous clinical recommendations deduced from the collective knowledge gathered from thousands of healthcare systems, billions of patient records, and millions of treatments other doctors have prescribed to people presenting similar symptoms and disease states. Unlike doctors, these computers never wear out, and can work 24-7, 365 days a year.
 
The train has left the station

One example is IBM’s Watson, which is able to read 40 million medical documents in 15 seconds, understand complex medical questions, and identify and present evidence based solutions and treatment options. Despite the resistance of doctors and the medical establishment the substitution of biotechnology and algorithms for doctors is occurring in healthcare systems throughout the world, and cannot be stopped. “The train is again pulling out of the station . . . . Those who miss it will never get a second chance”. For healthcare systems to survive and prosper in the 21st century is to understand and embrace “the powers of biotechnology and algorithms”. People and organizations that fail to do this will not survive, says Harari.
 
The impact of evolutionary science on healthcare systems

Roger Kornberg, Professor of Medicine at Stanford University who won the 2006 Nobel Prize in chemistry, "for his studies of the molecular basis of eukaryotic transcription", describes how human genome sequencing and genomics have fundamentally changed the way healthcare is organized and delivered. “Genomic sequencing enables us to identify every component of the body responsible for all life processes. In particular, it enables the identification of components, which are either defective or whose activity we may wish to edit in order to improve a medical condition,” says Kornberg.



 
The new world of ‘dataism’

Harari’s “new world” describes some of the implications of Kornberg’s discoveries, and suggests that evolutionary science is rapidly eroding doctors’ discretion and freewill, which are the foundation stones of modern healthcare systems and central to a doctors’ modus vivendi. Because evolutionary science has been programmed by millennia of development, our actions tend to be either predetermined or random. This results in the uncoupling of intelligence from consciousness and the “new world” as data-driven transformation, which Harari suggests is just beginning, and there is little chance of stopping it.
 
Over the past 50 years scientific successes have built complex networks that increasingly treat human beings as units of information, rather than individuals with free will. We have built big-data processing networks, which know our feelings better than we know them ourselves. Evolutionary science teaches us that, in one sense, we do not have the degree of free will we once thought. In fact, we are better understood as data-processing machines: algorithms. By manipulating data, scientists such as Kornberg, have demonstrated that we can exercise mastery over creation and destruction. The challenge is that other algorithms we have built and embedded in big data networks owned by organizations can manipulate data far more efficiently than we can as individuals. This is what Harari means by the “uncoupling” of intelligence and consciousness.
 
We are giving away our most valuable assets for nothing

Harari is not a technological determinist: he describes possibilities rather than make predictions. His thesis suggests that because of the dearth of leadership in the modern world, and the fact that our individual free-will is being replaced by data processors, we become dough for the Silicon Valley “Gods” to shape.
 
Just as African chiefs in the 19th Century gave away vast swathes of valuable land, rich in minerals, to imperialist businessmen such as Cecil Rhodes, for a handful of beads; so today, we are giving away our most valuable possessions  - vast amounts of personal data - to the new “Gods” of Silicon Valley: Amazon, Facebook, and Google for free. Amazon uses these data to tell us what books we like, and Facebook and Google use them to tell us which partner is best suited for us. Increasingly, big-data and powerful computers, rather than the individual opinion of doctors, drive the most important decisions we take about our health and wellbeing. Healthcare systems will cede jobs and decisions to machines and algorithms, says Harari.
 
Takeaways

For the time being, because of the entrenched legacy systems, health providers will continue to pay homage to our individuality and unique needs. However, in order to treat people effectively healthcare systems will need to “break us up into biochemical subsystems”, and permanently monitor each subgroup with powerful algorithms. Healthcare systems that do not understand and embrace this new world will perish. Only a relatively few early adopters will reap the rewards of the new technologies. The new elite will commandeer evolution with ‘intelligent’ design, edit peoples’ genomes, and eventually merge individuals with machines. Thus, according to Harari, a new elite caste of Homo sapiens will evolve into Homo Deus. In this brave new world, only the new “Gods”, with access to the ultimate source of health and wellbeing will survive, while the rest of mankind will be left behind.

Harari does not believe this new health world is inevitable, but implies that, in the absence of effective leadership, it is most likely to happen.

 
 
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Sensor Kinesis Corporation

Biosensor technology

Hi-tech company that is developing proprietary, flexible microbiosensor integrated computer chips suitable for printing on many surfaces.

These chips which detect certain biomolecules can be linked to smart devices and shared via cloud technology.

SKC’s chips are being developed to detect and measure biological signals and data from humans and then use smart devices to transmit the information for analysis and storage.

These microbiosensor chips are also being developed for use as diagnostic devices for early detection of human diseases as well as pathogens in the food chain from the farm to consumer.

Early applications could include the efficient, accurate, and inexpensive detection of air and waterborne pathogens in restaurants, hospitals, and hotels.


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