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Is patient engagement the new blockbuster drug? 

  • Patient engagement improves outcomes
  • The future is not a continuation of population based medicine
  • Personalized medicine requires effective patient engagement
  • Doctors are the main obstacle to enhanced patient engagement


If patient engagement were a drug, it would be front-page news, and malpractice for doctors not to use it. A significant and growing body of opinion believes that an effective way to scale care, and enhance outcomes is to develop patient engagement, but this requires a cultural and behavioral change on the part of doctors, which is not happening fast enough.
 

Low patient engagement means poor outcomes 

Each year payers spend billions on treating avoidable chronic lifetime diseases, yet the incidence of such diseases continue to escalate inflicting devastating personal, and social hardships on people and communities. Some wealthy regions of the world, such as the United Arab Emirates, where diabetes is spiraling out of control, have invested in “cathedrals” of diabetes healthcare staffed by experts, but still do not have the costly burden of diabetes under control. See, Diabetes threatens the future stability of the UAE
 

Tackling causes 

In other regions of the world, the treatment costs alone for avoidable chronic lifetime diseases are expected to bankrupt healthcare systems in the near future. The reason for this is simple. Despite eye watering investments in state-of-the-art treatment strategies, and despite some doctors’ initiatives to engage patients, no healthcare system yet has effectively engaged large proportions of patients living with lifetime chronic diseases, and successfully nudged them towards changing their diets and lifestyles, which are the root causes of a substantial proportion of such conditions. 

Dr Seth Rankin Managing Partner of a London based NHS primary care clinic, describes his efforts to engage patients living with diabetes in order to improve outcomes:

       
               (click on the image to play the video) 
 

Behavioral techniques 

Rankin’s endeavors to engage patients benefit from behavioral techniques, which explain how people behave, and encourages them to reduce unhelpful influences on their health, and change the way they think and act about important health related issues such as diets, lifestyles, screenings and medication management. See: Behavioral Science provides the key to reducing diabetes

Our new pathway of care borrows from the behavioral sciences and engages patients living with diabetes. It’s based on very simple technology, which can provide huge reach at low cost. We are keen to extend our pathway to other NHS Clinical Commissioning Groups, and would welcome support from well capitalized diabetes agencies,” says Rankin.
 

Doctors’ support critical

Rankin insists that, “Only when patients are meaningfully engaged in their own health will they continuously learn how to improve care for themselves”. Effective patient engagement enhances the connectivity between doctors and patients, and is a sound foundation for behavioral change. However, for patient engagement to be scalable and effective, it has to be supported by appropriate IT, and patient-generated healthcare information. 
 

Doctors control patient engagement

Patients gather healthcare information from the Internet, and this encourages and supports self-management, and enhanced understanding of prevention and risk. However, the quality of online healthcare information is patchy, and patients have difficulty differentiating between legitimate and bogus information. This is resolved when doctors’ engage with patients to help them with the interpretation. Some doctors welcome this opportunity, while others object. This gives doctors the upper hand. Even if the situation is improved by enhancing patients’ access to premium and reliable medical information, doctors still decide whether such information is introduced into patient care pathways. 
 

Improved healthcare

Objections from doctors suggest that online health information results in longer and fraught doctor-patient relationships, which are a costly waste of time. But this is not necessarily so. Evidence, such as that published in 2008 in Telemedicine and eHealth, suggests the opposite: that patient-generated healthcare information, and effective patient engagement can lead to better understanding of specific conditions and treatment options, enhanced medication management, reduced complications, reduced face-time with doctors, and reduced visits to A&E. Specifically, the 2008 paper’s findings report that online healthcare information resulted in: (i) 19.74% reduction in hospital admissions, (ii) 25.31% reduction in bed days of care, and (iii) 20 to 57% reduction in the onset of complications.
 

Takeaways

Despite evidence to suggest that patient engagement enhances outcomes and reduces costs, it is not happening at a rate and quantum to render it effective. The main obstacle is the attitudes of doctors who fear an erosion of their status. Only a significant cultural and behavioral shift on the part of doctors will change this, and open the door to the many other professional disciplines, such as behavioral economists, software designers, community leaders, data scientists and risk managers, who are well positioned to help healthcare and medicine deliver better outcomes for patients. 

The future of healthcare is not a continuation of population-based medicine with its one-size-fits-all therapies mediated by general practitioners. The future of healthcare is personalized medicine, which recognizes that patients and medicines are complex and adaptive, which require smart and adaptive systems. This includes greater patient engagement.

 
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The end of doctors 

  • A second technology revolution threatens the future of healthcare
  • Healthcare systems that ignore evolving technologies will collapse
  • Most healthcare systems are trapped by three basic failures
  • Doctors are the interpreters and not the processors of medical knowledge
  • Will a computer decide to turn off a life support machine?
  • Who owns the medical information on the Internet?


The role of doctors is about to change more than it has in the past two centuries, as the technology revolution enters a new era. 
 

Radical change 

This is the conclusion of Richard and Daniel Susskind in their book, The Future of Professions, published on 22nd October 2015 by Oxford University Press. They argue that, over the next 20 years, “the second future”, dominated by artificial intelligence (AI) and the Internet, will drive radical changes in healthcare systems, which will involve the transformation of how medical knowledge is made available.

Today, computer systems can delve into vast amounts of patient data, identify trends and make more accurate predictions than doctors. Machines such as IBM’s Watson, which can attain high levels of intelligent behavior is already being used in medicine. In parallel, the Internet provides people with new and effective ways to build communities and share healthcare information. 
 

Never too big to collapse 

Some doctors argue that their activity will never change because it depends on deep expertise, creativity and strong interpersonal skills; none of which can be replaced by computer systems. Earlier, managers of global companies that dominated world markets made similar claims before there enterprises grew obsolete and collapsed.

Twenty years ago, the failure of global companies to meet transformational challenges resulted in 74% of them leaving the Fortune 500 as new technologies and innovations opened the way for agile start-ups and entrepreneurs. The list is long, but here are a few examples. Digital Equipment and Wang Laboratories, once leading computer firms, disappeared completely. Even resurgent giants such as Apple and IBM stared into the abyss of irrelevance, and made painful changes before clawing their way back to the top.
 



In the 1980s the advent of digital photography, software, file sharing, and third-party apps ended Eastman Kodak’s world market domination, during which time Kodak made breakthrough technologies, which included the Brownie camera in 1900, Kodachrome colour film, the handheld movie camera, and the easy-load Instamatic camera. Motorola, another global giant, that developed and built the world's first mobile phone, and dominated that market until 2003, failed to focus on smartphones that could handle email and other data; and as a consequence, rapidly lost share to newcomers such as Apple, LG, and Samsung.

 


 

Dr Devi Shetty, world-renowned heart surgeon, founder, philanthropist, and chairman of Narayana Health, India’s largest hospital group is viewed as the person who will have the biggest influence on 21st healthcare. Here he describes how information technology is set to radically change healthcare:

    
        (click on the image to play the video) 
 

Healthcare systems not immune

The Susskind’s agree with Shetty, and believe that healthcare systems, predicated upon antiquated patient-doctor technologies, face a similar demise to that of large companies that failed to adapt and change. The more successful healthcare systems will be those, that copy large companies who survived by collaborating with smaller, agile firms either as suppliers or partners. Rigid bureaucratic healthcare systems that find it more difficult to innovate will fail.
 

Three reasons for failure 

Failure to address three major challenges accounts for the failure of most healthcare systems. The first is the continued investments in failing antiquated systems, and the consequent failure to pursue fresher, more relevant ones. The second is psychological: healthcare systems and doctors fixate on what made them successful in the past, and fail to notice when something new is replacing it. The third challenge is strategic: healthcare systems that only focus on today, and fail to anticipate the future will fail.

Previous HealthPad Commentaries have illustrated these three failures by the billions spent on failing diabetes education programs over the past decade, while the incidence of the condition escalated. This is because diabetes education and awareness programs fixate on antiquated systems, and fail to embrace, smarter and more effective ones. See: Behavioral Science provides the key to reducing diabetes
 

The concentration of medical expertise

A doctor’s raison d'être is to provide solutions to problems that people do not have sufficient specialist knowledge themselves to solve. Previously doctors were the ‘processors’ of medical knowledge, but with medical information becoming ubiquitous, increasingly doctors are becoming the ‘interpreters’ of medical knowledge. Doctors are gateways to specialist medical information.

In most healthcare systems, doctors are a huge and increasing expense, a large proportion of them use antiquated methods, and the expertise of the best doctors is only enjoyed by a few. This is changing by technological innovators finding ways to make medical expertise more widely available. Also, technology is enabling clinical expertise to be broken down into smaller tasks, which can be better achieved with a machine; telemedicine is just one example.
 

Who owns medical knowledge?

Online healthcare information empowers patients and threatens doctors by providing people with medical knowledge that previously resided in the minds of doctors. Such knowledge, which can help to diagnose illnesses, is free, increasingly common, and controlled by users. An important unresolved question is, who owns this medical knowledge?
  

Takeaways

Doctors exist to provide solutions to medical problems. If technology provides better more reliable solutions, the need for doctors dissolves. However, the most convincing objection for the displacement of doctors is an ethical one. Is it morally wrong to leave the decision to turn off a life support machine to another machine?

The debate is just beginning. 

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Smart insulin and new hope for type-1 diabetes

  • A new smart insulin could improve the lives of people with type-1 diabetes 

  • The smart insulin is easier, faster, and more effective than current therapies

  • The new compound automatically activates in response to rising blood sugar

A new compound, Ins-PBA-F, referred to as ‘smart insulin’, could spare people living with type-1 diabetes the burden of frequently injecting, and constantly monitoring their blood sugar levels.

The new compound, developed by scientists from the University of Utah, USA, and reported in a 2015 edition of the Proceedings of the National Academy of Science, automatically activates when your blood sugar level soars, brings it back to normal, and remains in circulation for up to 24 hours. In the future, people with type-1 diabetes could inject the smart insulin once a day, or even less frequently, overcoming the need for constant self-monitoring, and insulin top-ups after meals.

 

Easier, faster and more effective

Researchers suggest that the speed, and chemical reactions of Ins-PBA-F normalizing blood sugar in diabetic mice is the same as in healthy mice responding to blood sugar changes with their own insulin. Ins-PBA-F could give a faster, more effective response to lowering blood sugar than the current long-acting insulin drug, and could be tested in humans in two to five years.
 

Type-1 diabetes

According to the WHO, in 2014, 9% of all adults have diabetes, and an estimated 10% of these have type-1 diabetes, a significant proportion of which are children. Type-1 diabetes is an autoimmune disease in which the body kills off all its pancreatic beta cells, which produce insulin that regulates blood sugar. Without beta cells, the body’s sugar levels fluctuate wildly. Dr Sufyan Hussain, Senior Lecturer in Diabetes, Endocrinology and Metabolism at Imperial College, London, describes type-1 diabetes:

       

 

Unrelenting regimen

While insulin injections or infusion allow a person with type-1 diabetes to stay alive, and lead a full and active life, they neither cure the disease, nor necessarily prevent the possibility of the disease’s serious effects, which may include: kidney failure, blindness, nerve damage, heart attack, stroke and pregnancy complications. Traditional insulin therapies are a constant management challenge. Patients must carefully balance insulin doses with eating and other activities multiple times a day and night. Hussain describes the genesis, and benefits of insulin therapy:

    

 

Advantages of ‘smart insulin’

Without insulin, the body has no mechanism for moving sugar out of the blood and into cells, where it is used for energy. People with type-1 diabetes are completely dependent on their daily insulin injections for their survival, and have to check their blood-glucose level by pricking their fingers several times a day to assess how much insulin to inject. Any lapse or miscalculation in this unrelenting regimen can run the risk of dangerous high and low blood-glucose levels; both of which can be life threatening.

“In theory, with Ins-PBA-F there would be none of these glucose problems,” said co-author Dr Danny Chou, “A smart insulin drug that automatically activates in response to rising blood sugar would get rid of the need for top-up injections of insulin, and eliminate the danger of incorrect dosing”.

 

Takeaways

Ins-PBA-F closely mimics the way bodies return their blood sugar levels to normal after eating. According to Chou, “This is an important advance in insulin therapy. Diabetic patients still need to guess to some extent how much insulin they need. With Ins-PBA-F you would just inject it, and it wouldn’t matter if you overshot because its activity would stop when glucose levels get too low. Our smart insulin derivative appears to control blood sugar better than anything that is available to diabetes patients right now.”

 
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  • Promising animal study suggests a vaccine for type-1 diabetes
  • Harvard’s Dana Faber Cancer Institute endorses the study
  • Lab spent years detailing the molecular immune system's response to insulin
  • The therapy for type-1 diabetes is insulin, but there’s no cure
  • Living with type-1 diabetes is a constant challenge
  

A molecule that prevents type-1 diabetes in mice has provoked an immune response in human cells, according to scientists from the National Jewish Health and the University of Colorado. The findings, published in the 2015 Proceedings of the National Academy of Sciences, suggest that a mutated insulin fragment could be used to prevent type-1 diabetes in humans.
 

Strategies that work in mice often fail in humans 

Previously, researchers tried administering insulin to people at risk of the disease as a form of immunotherapy similar to allergy injections, but this didn’t provoke an effective response. John Kappler, Professor of Biomedical Research at National Jewish Health says, "Our findings provide an important proof of concept in humans for a promising vaccination strategy." In 2011, researchers from Harvard University’s Dana Farber Cancer Institute reported that Kappler’s strategy prevented type-1 diabetes in mice. However, strategies that work in mice often fail in humans.
 

Promising findings

Kappler’s findings suggest that an insulin fragment with a change to a single amino acid could provoke an immune response. The idea comes from work in Kappler's laboratory detailing the molecular immune system's response to insulin. This suggests that mutating one amino acid in an insulin fragment, and then presenting the insulin to the immune system, might provoke better recognition by the immune system.

Researchers mixed a naturally occurring insulin fragment, and the mutated insulin fragment with separate cultures of human cells. They found that human T-cells responded minimally to the naturally occurring insulin fragment, but relatively strongly to the mutated one. The human T-cells produce both pro-inflammatory and anti-inflammatory chemicals known as cytokines, and scientists believe that healthy immune responses balance pro- and anti-inflammatory factors. Autoimmune disease occurs when the pro-inflammatory response dominates.
                           

Type-1 diabetes

Type-1 diabetes is an autoimmune disease in which a person’s pancreas stops producing insulin, a hormone that enables individuals to get energy from food. It occurs when the body’s immune system attacks and destroys the insulin producing cells in the pancreas, called beta cells. The causes of type-1 diabetes are not fully understood, but scientists believe that both genetic and environmental factors are involved. Dr Sufyan Hussain of Imperial College, London explains:


     

      (click on the image to play the video) 

Type-1 diabetes most typically presents in early age with a peak around the time of puberty. Historically the condition has been most prevalent in populations of European origin, but is becoming more frequent in other ethnic groups. Kuwait, for example, now has an incidence of 22.3/100,000. India and China have relatively low incidence rates, but account for a high proportion of the world’s children with type-1 diabetes because of their large populations. 
 

Living with type1 diabetes

Living with type-1 diabetes is a constant challenge. People with the condition must carefully balance insulin doses (either by multiple injections every day or continuous infusion through a pump) with eating and other activities throughout the day. They must also measure their blood-glucose levels by pricking their fingers for blood six or more times a day. Despite this constant attention, people with type-1 diabetes run the risk of high or low blood-glucose levels, both of which can be life threatening. People with type-1 diabetes overcome these challenges on a daily basis. While insulin injections or infusions allow a person with the condition to stay alive, they don’t cure the disease, nor do they necessarily prevent the possibility of the disease’s complications, which may include kidney failure, blindness, nerve damage, heart attack, stroke, and pregnancy complications. Richard Lane, President of Diabetes UK, and a person living with type-1 diabetes, describes some of the lifestyle changes associated with the condition:

       

        (click on the image to play the video)
 

Takeaways

While Kappler’s results don’t prove that the mutated insulin fragment will work as a vaccine in humans, they do demonstrate a response in humans consistent with the vaccination response in mice. "The new findings confirm that the painstaking work we have done to understand the unconventional interaction of insulin and the immune system has relevance in humans and could lead to a vaccine and a treatment for diabetes," says Kappler. 

 
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  • The scientific framework for understanding cancer has gone full circle
  • Cancer research is back where it began 60 years ago
  • Cancer mutations outsmart the smartest scientists
  • Challenges for cancer treatment go beyond biological complexity 
 

After sixty years of cancer research we’re back where we started. That’s according to MIT cancer scientist Professor Robert Weinberg, known for his discoveries of the first human oncogene (a gene that causes normal cells to form tumors), and the first tumor suppressor gene.

Writing in the journal Cell in 2014, Weinberg argues that, in the 1950s scientists viewed cancer as, “An extremely complicated process that needed to be described in thousands of different ways.” Then, scientists believed viruses caused cancer, which was proved wrong. In the 1980s cancer scientists developed the notion that the disease was caused by mutant genes. “This gave . . . the illusion . . . that we would be able to understand the laws of cancer formation the way we understand, with some simplicity, the laws of physics," says Weinberg. This was not the case. Over the past decade, scientists have returned to where they started in the 1950s, and view cancer as an extremely complex disease, “We are once again caught in this quandary: how can we understand this complexity in terms of a small number of underlying basic principles?", asks Weinberg.

 

Each cancer is unique

Victor Velculescu, Professor of Oncology at Johns Hopkins University, and internationally known for his discoveries in cancer genomics, stresses the uniqueness of cancer. “Between everybody that has cancer today, to everybody that's probably ever had cancer since the beginning of humankind, [each person] has had different molecular alterations in this disease,” he says. Adding to cancers complexity is the fact that the disease mutates over time, which means that people become resistant to specific drugs, and clinicians are obliged to search for other treatments. Professor Axel Walther, Consultant Medical Oncologists and Director for Research in Oncology at University Hospitals, Bristol describes the challenges of drug resistance for cancer patients:

     

 

Pathways

A significant advance in cancer treatment is the notion that random “errors” in our genes, which cause cancer could be simplified into specific pathways, which are the “rail tracks” within cells along which chemicals flow that keep cells alive and functioning. Genes are “stations” along these pathways. There are thousands of pathways, some known and others, unknown, and their breakdown causes cancer. Discovering these pathways provides an opportunity to block the progress of cancer, with appropriate drugs.

Professor William Nelson, a recognized leader in cancer research, and Director of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, says, the complexity of cancer means that, “Only rarely can a single drug block a single pathway.” Most cancers require a combination of drugs. Walther describes the challenges that the complexity of cancer pose for personalised medicine:

   

 

Cost factor

Challenges in cancer treatment go far beyond biological complexity. Increasingly, the cost of drugs is an important factor. Dr. Richard Pazdur, the FDA’s Cancer Czar, questions how much longer the FDA can remain blind to drug prices, and the growing debate over how to place an appropriate value on cancer drugs, which can cost US$100,000 or more a year. Earlier this year NHS England withdrew funding for 25 cancer drugs because the costs were too high.
 

Takeaways

Weinberg is not defeated by the notion that the scientific framework for understanding cancer has come full circle. Over the past 60 years of cancer research, many ideas have flowed from laboratories, and led to incremental advances in treating cancer, and this will continue.

 

 
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The importance of measuring the impact of diabetes care

  • Bill Gates says that measurement is key to reducing disease
  • Type-2 diabetes is the fastest growing health threat of our time, it is preventable, but not properly measured
  • Expensive diabetes programs fail to dent the burden of the disease
  • Taxpayers have a right to know the annual impact of diabetes care and education on the incidence, outcomes and costs of the disease
  • Healthcare agencies must agree and report clear goals that drive progress

Bill Gates is right. Measurement is central to the success of reducing the global incidence of diseases. Can we learn something from Bill Gates to help reverse the epidemic of type-2 diabetes: a preventable disease, which is spiralling out of control, and set to bankrupt healthcare systems?

Dr Syed Sufyan Hussain, Darzi Fellow in Clinical Leadership, Specialist Registrar and Clinical Lecturer in Diabetes, Endocrinology and Metabolism, at Imperial College London, describes the challenge:

      
             (click on the image to play the video) 
 

The UK

Similar to other developed nations, diabetes in the UK is the largest and fastest growing health challenge of our time. Since 1996, the number of people living with diabetes in the UK has more than doubled: 3.9 million people now have diabetes, another 9.6 million are at high risk of getting type-2 diabetes, and every year, that number is rising dramatically. If nothing changes, in 10 years time more than four million people in England will have diabetes. This suggests that current diabetes care programmes and education are failing.

Diabetes is expensive, and current annual treatment costs alone are about £10bn - some 10% of the annual NHS budget - and 80% of this is spent on managing avoidable complications. For example, diabetes is the most common cause of lower limb amputations, and over 6,000 happen each year in England alone. The result is frequently devastating in terms of social functioning and mood, and poses a considerable cost to healthcare providers, while the financial burden on patients and their families can be enormous.

The total annual costs of diabetes, which includes both direct and indirect costs, such as the loss of earnings because of illness, are difficult to measure, but are estimated to be about £24bn per year. If nothing changes, these costs are projected to rise to nearly £40bn in 20 years. This further suggests that current diabetes care programmes and education are failing. 
 

Doing more of the same 

In its 2015 State of the Nation Report, Diabetes UK (DUK), a large and influential charity, urged the UK Government and NHS England to do more in order to ensure that people with diabetes get the support and education they need to manage their condition. However, if the UK government and NHS England do more of the same, nothing will change, and diabetes will continue to escalate, destroying lives and costing billions. Let us go back to Bill Gates.
 

Measures to drive progress

I’ve been struck again and again by how important measurement is to improving the human condition. You can achieve amazing progress if you set a clear goal and find a measure that will drive progress toward that goal . . . . This may seem pretty basic, but it’s amazing to me how often it is not done,” says Gates.

The UK government, NHS England, Public Health England and DUK do not share an agreed set of indicators, which measure and report on the impact of diabetes care and education. Given that each year billions are spent on diabetes, these agencies should be obliged to report annually on the impact that their diabetes care and education programs have on the prevalence, outcomes and costs of diabetes. Let us return to Bill Gates, and his efforts to reduce the global burden of HIV.
 

Bill Gates 

The 2013 annual report of the Melinda and Bill Gates Foundation stresses that it, “Enhances, the impact of every dollar invested by improving the efficiency and effectiveness of our HIV program, [which] supports efforts to reduce the global incidence of HIV significantly and sustainably, and to help people infected with HIV lead long, healthy, and productive lives. The global incidence of HIV has declined 20% since its peak in the mid-1990s.” 

Now, tweak the above paragraph to create a gold standard annual report of the state of diabetes in the UK. The government, NHS England, Public Health England and DUK, “Enhances the impact of every pound invested in diabetes by improving the efficiency and effectiveness of our diabetes programs and education [sic], which support efforts to reduce the UK’s incidence of diabetes significantly and sustainably, and to help people living with diabetes to lead long, healthy, and productive lives. [Notwithstanding,] since 1996, the UK’s incidence of diabetes has increased by 110%, complications have increased by 115%, and annual treatment costs have increased by at least £2bn.”
 

Changing demographics

In the above paragraph we used indicative numbers to show direction. Some, but not all, of the reported increases can be explained by demographic changes. For example, over the past 20 years, the UK’s population has increased by 5.5 million and aged, and now more than 18% are over 65, and this cohort is rising. According to the Office of National Statistics, 60% of the population increase is due to immigration. David Coleman, a professor of demographics at Oxford University, suggests that this mass influx of migrants has given the UK, Europe’s fastest-rising percentage of ethnic minority and foreign-born populations, and by 2040 foreigners and non-white Britons living here will double and make up one third of the UK population. 

This has important healthcare implications because type-2 diabetes is more than six times more common in people of South Asian descent, and up to three times more common among people of African and African-Caribbean origin. Studies show that people of Black and South Asian ethnicity also develop type-2 diabetes at an earlier age than people from the White population in the UK, generally about 10 years earlier. All these factors have a knock-on affect for healthcare. According to the Institute of Economic Affairs the changing demographics in the UK has created a “debt-time bomb’ that will require the end of universal free healthcare. 
 

Takeaways

Diabetes plays a prominent role in the health of the UK, and not all of its rising burden can be explained by changing demographics. The escalating burden of type-2 diabetes can be reduced and prevented by effective management and education, which engage people living with, or at risk of diabetes, and changes their behavior. Current education programs fail to do this. 

Instead of asking the government and NHS England to, “do more”, is it not time for those responsible for diabetes care to learn from Bill Gate, and, agree and report annually, measures that inform on the impact that diabetes care and education is having on the incidence, outcomes and costs of diabetes? 

 
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  • Experts describe new prostate cancer study as the disease’s ‘Rosetta Stone’

  • Prostate cancer kills nearly 11,000 men each year in the UK alone

  • Men with untreatable prostate cancer could benefit from standard drugs

  • Study opens black box of genetics to treat previously untreatable cancer

  • Mediterranean diet lowers mortality risk for men with prostate cancer

A new UK-US cancer study could transform prostate cancer treatment, and give hope to sufferers whose cancers have become resistant to treatment. Experts’ hail the study as “incredibly exciting and ground breaking”. According to Professor Johann de Bono, of the Institute of Cancer Research, London, who led the British team, the study opens up a new era of treatment, in which men will be given drugs tailored to their tumours. 

Cancer is lethal when it metastasises and becomes resistant to drugs. The study, published in the journal Cell in 2015, involved 150 men close to death whose prostate cancers had spread throughout their bodies, and were not responding to available drugs. 
     

Prostate cancer’s ‘Rosetta Stone’

The research has opened up a black box in cancer genetics, and changes the way we think about and treat prostate cancer. Now that doctors have a map of which mutations to look for, they could search for them using a £200 test. 

De Bono, extracted samples of the cancer from metastatic tumors, and analysed their DNA, which showed that 90% of the men carried genetic mutations in their tumors, which matched drugs already on the market. A third of the men studied had tumors suitable for treatment with new drugs called PARP inhibitors.

‘’We're describing this study as prostate cancer's Rosetta Stone because of the ability it gives us to decode the complexity of the disease, and to translate the results into personalised treatment plans for patients. What's hugely encouraging is that many of the key mutations we have identified are ones targeted by existing cancer drugs - meaning that we could be entering a new era of personalised cancer treatment," says de Bono.

According to de Bono, “We are changing how long these men are living. This gives me hope that I can make a difference for men dying of prostate cancer. There is still a lot of work to do. This is not a cure, but it is a huge step forward.” 
 

Prostate cancer

In an earlier Commentary we discussed the dilemmas men face when they have been diagnosed with prostate cancer. Prostate cancer is the most common cancer in men, and each day in the UK alone 110 men are diagnosed with the disease. Cancer begins to grow in the prostate, a gland in the male reproductive system, and develops slowly. Although it can be cured if diagnosed early, there may be no signs that you have it for many years, and symptoms often only become apparent when your prostate is large enough to affect the urethra. Here cancer expert Professor Karol Sikora describes the symptoms of advanced prostate cancer:

         
             
Once prostate cancer begins to spread it becomes difficult to treat, and each year nearly 11,000 men die of the disease in the UK. Treatment options include watchful waiting, surgery, radiation, hormone therapy, chemotherapy, biological therapy and bisphosphonate therapy.
 

Mediterranean diet

According to research published in the journal Cancer Prevention Research, a Mediterranean diet rather than a Western diet may improve survivorship for men diagnosed with prostate cancer.

This is welcome news because there is a dearth of evidence to counsel men living with prostate cancer on how they can modify their lifestyle to lower the risk of mortality. The new study from Harvard’s Chan School of Public Health, investigated the diets of 926 men with prostate cancer for an average of 14 years after their diagnosis, and in 2015 published their findings, which suggest that people living with prostate cancer who ate a predominantly Western diet, high in red and processed meat, fatty dairy foods, and refined grains, were two-and-a-half times more likely to die from prostate cancer, and had a 67% increased risk of all-cause mortality, compared with participants who followed a Mediterranean diet, rich in vegetables, fruits, fish, whole grains, and healthy oils. In comparison, men who follow a Mediterranean diet had a 36% lower risk of all-cause mortality.

Lead author Meng Yang suggests treating the findings cautiously, "Given the scarcity of literature on the relationship between post-diagnostic diet and prostate cancer progression, and the small number of disease-specific deaths in the current study.”
 

Dietary supplements and vitamins

Researchers continue to look for foods (or substances in them) that can help lower prostate cancer risk. Scientists have found some substances in tomatoes (lycopenes) and soybeans (isoflavones) that might help prevent prostate cancer. Studies are now looking at the possible effects of these compounds more closely. Scientists are also trying to develop related compounds that are even more potent, and might be used as dietary supplements. 
 

Takeaways

Some studies suggest that certain vitamin and mineral supplements (such as vitamin E and selenium) might lower prostate cancer risk. But a large study of this issue, called the Selenium and Vitamin E Cancer Prevention Trial (SELECT), found that neither vitamin E nor selenium supplements lowered prostate cancer risk after daily use for about five years. In fact, men taking the vitamin E supplements were later found to have a slightly higher risk of prostate cancer.

De Bono’s breakthrough in cancer genetics means that many men whose prostate cancer was thought untreatable could be given drugs that are already on hospital shelves. Some patients have already benefited, and are alive more than a year on, despite only having been given weeks to live.

 
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  • Immunotherapy drugs heralded as game changing cancer treatment

  • MD Anderson Professor Allison stripped cancer’s ability to evade attack

  • Nivolumab focuses on the environment around a cancer

  • Immunotherapy drugs are too expensive as sustainable treatments

  • The future is personalized medicine says cancer expert Karol Sikora

A new drug class that neither directly treats nor kills cancer is heralded as a game changer in cancer treatment. 
 

New hope for late stage cancer patients

In March 2015, the American Food and Drug Administration (FDA) awarded an expanded approval for Opdivo (nivolumab), to treat non-small-cell lung cancer, which is the most common type of lung cancer, and means lung cancer patients who have failed other therapies and have no other treatment options, have another shot at containing their tumors. In June 2015, the European Commission approved the same Bristol-Myers Squibb drug in a fast track assessment for previously treated advanced melanoma patients.

Accelerated assessment was given in Europe because Opdivo (nivolumab) qualified as a “Medicinal product of major interest from the point of view of public health, and in particular from the viewpoint of therapeutic innovation.” 

FDA and EU approvals of the drug Opdivo, opens the door for other, next-generation immunotherapies to treat advanced cancers. These are heralded as a new class of game changing drugs. But are they? 
 

The genesis

Because cancer is a result of your body’s own cells growing abnormally, your immune system is held back from recognising cancer as foreign and potentially harmful. This is important because without such checks your immune system would kill you.  

Professor James Allison, director of MD Anderson’s immunotherapy platform, which cultivates, supports and tests new developments of immunology-based drugs and combinations, is credited with ground-breaking research that stripped away cancer’s ability to evade attack by the immune system. Allison’s discoveries led to nivolumab to improve the survival rate of patients with metastatic melanoma, and his insights into the basic biology of immune system T cells is broadly applicable to a variety of cancers. 
 

How it works

These new drugs release the body’s own weapons: killer white blood cells called T cells, and have been likened to taking the brakes off the immune system so that it is able to recognise tumors it wasn't previously recognising, and react to destroy them.

Unlike traditional cancer therapies such as surgery, chemotherapy, radiation or the anti-cancer drugs, immunotherapy does not target the tumor itself. Instead, it focuses on the environment around the cancer, and releases a check on the immune system’s appetite for anything that it does not recognize, so the body’s own defences can recognize tumor cells as targets. Allison says, “This drug doesn’t treat cancer; it doesn’t kill cancer cells so you can’t inject it and expect cancer to melt away immediately because it won’t.” 

However, when nivolumab is combined with tumor-targeted treatments, it lowers the risk of recurrent cancers. It does this by training the body’s T cells to recognize specific features of tumors, just as they do for viruses and bacteria. Thus, the immune system itself is programmed to destroy any returning or remaining cancer.
 

Too costly

Although immunotherapies are generating excitement among cancer clinicians and researchers, clinical studies on melanoma patients show relatively modest prolongations of life, compared with historical norms, at significant costs. For example, the cost of Opdivo (nivolumab) for one patient is about £100,000 per year.

Speaking at the 2015 American Society of Clinical Oncology (ASCO) conference in Chicago, Dr Leonard Saltz from Memorial Sloan Kettering Cancer Center, New York City, suggested that new immunotherapies would cost more than US$1 million per patient per year at the higher dose currently being studied in many different cancer types, and warned, "This is unsustainable.... We must acknowledge that there must be some upper limit to how much we can, as a society, afford to pay to treat each patient with cancer . . As someone who worries about making cancer care available to everyone and minimizing disparities, I have a major problem with this: these drugs cost too much."
      

Takeaway

According to cancer expert Professor Karol Sikora the future of cancer treatment is personalized medicine rather than new immunotherapy products. Personalized cancer care takes into account the individual’s disease, and their personal circumstances. According to Sikora, “The extent to which treatment can be tailored to an individual has been limited by crude descriptions of their disease, and generic treatment options. Advances in genomics and drug responsiveness are leading to more detailed descriptions of a patient’s cancer and better-targeted treatments, which offer significant advantages over blunderbuss chemotherapies. Personalised medicine is the real future for all our patients. Forget the drug hype; this is where the real hope lies”

Here Mike Birrer, Professor of Medicine at the Harvard University Medical School, and Director of the Cancer Center at Massachusetts General Hospital describes personalised medicine:  

         
               

 
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DUK and HealthPad agree on the importance of diabetes education

  • Diabetes in the UK is spiralling out of control
  • People with diabetes are not receiving the care they need
  • Education for people living with diabetes must improve
  • CCGs need to increase the effectiveness of diabetes education
  • Policy makers must be more open-minded about digital health
  • Policy makers should prepare the UK for the digital future

 

DUK and HealthPad

Diabetes UK (DUK) and HealthPad are on the same page in recommending more effective education to reduce the escalating burden of diabetes. DUK insists that, “Clinical commissioning groups (CCGs) need to increase the availability and uptake of a range of diabetes education and learning opportunities”.


Managing My Diabetes

HealthPad has developed a cost effective digital diabetes education service specifically for CCGs to: (i) increase the connectivity between local health professionals and people with diabetes, (ii) enhance patients’ knowledge of the condition, (iii) propel people with the condition towards self management, (iv) slow the onset of complications and (v) reduce face-time with doctors, see: Reducing the burden of diabetes by online video.
 

The state of the nation 

DUK’s 2015 State of the Nation Report laments that the incidence rates of diabetes continues to spiral out of control, and people with diabetes is now at an all time high of 3.9 million, with a further 600,000 estimated to have undiagnosed type-2 diabetes. Further, 2015 National Statistical Office figures, show that 67.1% of adult males and 57.2% of adult females in the UK are either overweight or obese, and therefore at risk of type-2 diabetes. 

There is no way of preventing type-1 diabetes, which occurs as a result of the body being unable to produce insulin, and usually develops in childhood, affecting 10% of sufferers. However, type-2 diabetes is the result of bad diets and sedentary lifestyles, and is preventable with effective education. Left unchecked, diabetes can result in devastating health complications such as kidney and heart disease, blindness and amputations. Also, diabetes costs the NHS nearly £10bn each year, 80% of which is spent on managing avoidable complications.
 

Gaping hole” in effective education

DUK director of policy Bridget Turner said, "There is a gaping hole when it comes to diabetes education . . . . This is despite strong evidence that giving people the knowledge and skills to manage their diabetes effectively can reduce their long-term risk of complications . . . . We must get better at offering education to people who are living with diabetes." Dr Sufyan Hussain, a lecturer and clinical registrar in diabetes, endocrinology and metabolism at Imperial College and Hammersmith Hospital, London, has used HealthPad, a digital platform, to develop a portfolio of educational videos for people with diabetes. Here is one about insulin: 

      
                (click on the image to play the video)
 

Calling on the NHS

DUK said that it is “calling on” the NHS to do more. One difference between NHS England and HealthPad is the emphasis they respectively place on digital platforms for delivering diabetes education. Currently, digital platforms are not widely used by the NHS. One possible reason for this is because the NHS is a sanctuary for technophobes. Patients however are not technophobes. General attitudes towards digital healthcare are rapidly changing. The over 65s are becoming increasingly tech-savvy, and quickly adopting digital channels as a source for healthcare information. Research from the Office of National Statistics shows that, between 2006 and 2013, Internet use of the over 65s more than tripled, and their demand for digital health services grew significantly.

Not all health providers are technophobes, and some acknowledge that the NHS has failed to make the most of digital technologies. Changes that these enlightened health providers suggest are contentious; because of the lack of competitiveness the NHS reflects its fragmented single entity, and NHS policy makers stress harmonization rather than competition. This results in the quality of healthcare in the UK becoming a postal code lottery. The NHS cannot expect to improve while there is still a lack of competition and such fragmentation.
               

Network effects

A significant challenge for the NHS is how to deal with digital healthcare platforms: the search engines and websites that constitute the metaphysical health providers in the digital age. What drives new healthcare platforms are economies of scale in gathering and distributing healthcare data and information, which patients want in order to manage their conditions better. The network effects of digital platforms result in more patients finding digital healthcare services ever more compelling. Platforms engage patients, and encourage them to return for updates and more information about their condition. 


Takeaways

It is time that the NHS started to assess the role that platforms can play in the delivery of healthcare. However, the NHS does not know enough to opine with confidence on digital health and the knowledge economy. This does not only result in NHS policy makers being unable to pick technological winners; it also means that technological losers are picking the NHS.

Healthcare and the educational needs of patients must to be conducted in a more open-minded spirit, not simply reflect the status quo, and fall prey to vested interests. The task of healthcare policy makers should be to prepare the UK for the digital future, not to try to stop it happening. 

 
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‘Deep sleep’ and palliative care

  • The UK has inadequate care for the terminally ill
  • France legalizes “deep sleep” for the terminally ill
  • Palliative care has traditionally been for people with cancer
  • Many people are denied choices at the end of life
  • The process of ageing, and dying has become medical experiences


Thousands of palliative care patients in England often fail to receive sufficient pain relief and respite from other distressing symptoms. These are the findings of a 2015 London School of Economics Report, which raises concerns since the need for palliative care is large, and rapidly increasing as the population ages, with people over 85 projected to double in the next 20 years.

The Report exposes significant gaps in services, poor communication and unclear roles and responsibilities. “Part of the problem is that palliative care has traditionally been for people with cancer, and there is currently a lack of suitable models of palliative care for people with non-cancer and increasingly complex conditions,” says lead author Josie Dixon.
 

Non-cancer patients miss out

Those who currently miss out include: people over 85, those living alone, people living in deprived areas, and black, Asian and ethnic minority groups.

Only just over 20% of UK hospitals offer 7-day a week specialist palliative care, and the quality of hospital care is rated lower than a care home or a hospice. Despite over 70% of deaths being due to causes other than cancer – including respiratory illness, circulatory conditions and dementia – people with non-cancer diagnoses still account for only 20% of all new referrals to specialist palliative care services.

More than 56% of people now die in a care home within a year of being admitted, up from 28% in 1997. "These statistics show that care homes have a growing role in caring for people who are dying, but they need more support from GPs and specialists than currently exists," Dixon says.
 

The US experience

Whitfield Growdon, who teaches at the Harvard University Medical School and practices as an oncology surgeon at the Massachusetts General Hospital, Boston, suggests that the family is the primary provider of end-of-life care, and a major contributor to palliative care programs: 


      
                          (click on the image to play the video)

 

France’s ‘deep sleep’

In March 2015 France passed legislation giving doctors new powers to place terminally ill patients in a “deep sleep” until they die, sparking controversy over whether euthanasia should be fully legalized. Polls show that 96% of French people support the “deep sleep” law, which will apply to patients who are conscious, but in “unbearable” pain, and whose treatment is not working or who decide to stop taking medication.
 

A President’s legacy

France legalised “passive euthanasia” in 2005, where treatment, needed to maintain life is withheld or withdrawn, but the government has refused to go further and allow full euthanasia, or assisted suicide, despite the huge public support. The new measures, passed by a comfortable majority in the National Assembly, will allow doctors to combine passive euthanasia with “deep and continuous sedation”.

The measure was a campaign promise by President Hollande who gave a commitment to allow the terminally ill afflicted by “unbearable” pain “to benefit from medical assistance to end their lives with dignity”. Anti-euthanasia groups criticised the legislation as “masked euthanasia”, but pro-euthanasia campaigners argue that it doesn’t go far enough, and would lead to terminally ill patients “dying of hunger or thirst”.
 

Takeaways

Ignorance, fear or anxiety about illness, death and dying can all have a negative impact upon our relationships with dying people. How can we better deal with the frailty of age, the onset of illness, and approaching death? In the 2014 BBC Reith Lectures, and in his latest book, Being Mortal: Medicine and What Matters in the End, Atul Gawande complains that we deny people choices of coping and autonomy at the end-of-life. People live longer and better than at any other time in history. But scientific advances have turned the process of ageing, and dying into medical experiences; matters managed by health care professionals,” says Gawande.

 
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