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  • A 2017 research project found that only 6 out of 18 FDA-approved blood glucose monitoring (BGM) systems tested were accurate
  • Each day BGM systems are used by millions of people with diabetes to help them self-manage their condition, and avoid devastating and costly complications
  • Thousands of similar smart devices support the prevention and self management of other chronic lifetime conditions, whose prevalence levels are high
  • The increasing demand for healthcare, its escalating costs, and rapidly evolving technologies are driving the growth of such remote self-managed devices
  • The most valuable aspect of such devices is the data they produce
  • These data tend to be under valued and under utilized by healthcare providers
  • This has created an opportunity for giant technology companies to enter the healthcare market with a plethora of smart devices and start utilizing the data they collect to enhance patient outcomes and lower costs
  • Giant technology companies could dis-intermediate GPs and re-engineer primary care
 

Digital blood glucose monitors and the disruptive impact of giant tech companies on healthcare


A 2017 research project, which tested 18 FDA-approved digital blood glucose monitoring (BGM) systems, which are used daily by millions of people with diabetes to check the concentration of glucose in their blood, found that only 6 were accurate. The research, led by David Klonoff of the Diabetes Research Institute at San Mateo, California, was funded by Abbott Laboratories.
 
This Commentary describes both traditional and next-generation BGM systems, and Klonoff’s research. The Commentary suggests that BGM systems are just one part of a vast, global, rapidly growing market for consumer healthcare devices, and argues that the most valuable aspect of these devices is the data they collect. With some notable exceptions, healthcare professionals do not optimally utilize these data to enhance care and reduce costs. This has created for an opportunity for technology companies to enter the healthcare market and re-engineer primary care. The one thing, which might slow the march of giant technology companies into mainstream healthcare, is the privacy issue.
 

Traditional and next-generation BGM systems
 
Traditional BGM systems
Regularly, each day, BGM systems are used by millions of people with diabetes to help them manage their condition. Managing diabetes varies from individual to individual, and peoples with diabetes usually self-monitor their blood glucose concentration from a small drop of capillary blood taken from a finger prick. They then apply the blood to a chemically active disposable 'test-strip'. Different manufacturers use different technology, but most systems measure an electrical characteristic, and use this to determine the glucose level in the blood. Such monitoring is the most common way for a person with diabetes to understand how different foods, medications, and activities affect their condition. The challenge for individuals with diabetes is that blood glucose levels have to be tested up to 12 times a day. People obliged to do this find finger pricking painful, inconvenient and intrusive, and, as a consequence, many people with diabetes do not check their glucose levels as frequently as they should, and this can have significant health implications. If your levels drop too low, you face the threat of hypoglycemia, which can cause confusion or disorientation, and in its most severe forms, loss of consciousness, coma or even death. Conversely, if your blood glucose levels are too high over a long period, you risk heart disease, blindness, renal failure and lower limb amputation.
 

Next generation BGM system
Abbott Laboratories Inc. markets a BGM system, which eliminates the need for routine finger pricks that are necessary when using traditional glucose monitors. Instead of finger pricks and strips, the BGM system, which measures interstitial fluid glucose levels, comprises a small sensor and a reader. An optional companion app for Android mobile devices is also available. The sensor is a few centimetres in diameter and is designed to stay in place for 10 days. It is applied to the skin, usually on the upper arm. A thin (0.4 mm), flexible and sterile fibre within the sensor is inserted in the skin to a depth of 5 mm. The fibre draws interstitial fluid from the muscle into the sensor, where glucose levels are automatically measured every minute and stored at 15-minute intervals for 8 hours. Glucose levels can be seen at any time by scanning the reader over the sensor. When scanned the sensor provides an answer immediately. It also shows an 8-hour history of your blood glucose levels, and a trend arrow showing the direction your glucose is heading. The device avoids the pain, and inconvenience caused by finger-prick sampling, which can deter people with diabetes from taking regular measurements. In the UK the system costs £58 for the reader, plus £58 for a disposable sensor, which must be replaced every 10 days and from November 2017 have been available on the NHSAbbott Laboratories is a global NASDAQ traded US MedTech Company, with a market cap of US$86bn; annual revenues of US$21bn, and a diabetes care division, which produces annual revenues of some US$600m.
 
Klonoff’s research on BGM systems

BGM systems used by Klonoff and his team for their research were acquired over-the-counter and independent of their manufacturers. All were tested according to a protocol developed by a panel of experts in BGM surveillance testing.
 
Klonoff’s research specified that for a BGM system to be compliant, a blood glucose value must be within 15% of a reference plasma value for a blood glucose >100 mg/dl, and within 15 mg/dl of a reference plasma value for a blood glucose approved” a BGM system had to pass all 3 trials.  Only 6 out of 18 passed by achieving an overall compliance rate of 95% or higher. 

 

The FDA
Klonoff’s findings add credibility to patients’ concerns about the accuracy of BGM systems, which triggered responses from both manufactures and the US Food and Drug Administration  (FDA). Manufacturers suggest that increasing the accuracy of BGM systems would raise their costs, and reduce their availability, which patients do not want. The FDA tightened approvals for BGM systems, and in 2016 issued 2 sets of guidelines, one for clinical settings, and another for personal home-use. The guidelines only apply to new products, and do not impact BGM systems already on the market. So while the FDA’s tighter accuracy requirements are a positive change, there are a significant number of less-accurate BGM systems still on the market. 
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The convergence of MedTech and pharma and the role of biosensors

 

Next-generation BGM systems
Next generation BGM systems use ‘sensing’ technology, and have the capacity to automatically track and send blood glucose readings to the user’s smartphone, then onto their healthcare provider through the cloud where they can be amalgamated with other data. Analytics can then track an individual’s data, and compare them to larger aggregated data sets to detect trends, and provide personalized care.

Large rapidly growing remote self-managed device market

Although BGM systems address a vast global market, they represent just one part of a much larger, rapidly growing, remote monitoring market to help prevent and self-manage all chronic lifetime conditions, while improving healthcare utilization, and reducing costs. In 2015 some 165,000 healthcare apps were downloaded more than 3bn times. Of these, 44% were medical apps, and 12% were apps for managing chronic lifetime conditions. Today, mobile devices enable people to use their smartphones to inspect their eardrums, detect sleep apnoea, test haemoglobin, vital signs such as blood pressure, and oxygen concentration in the blood. This is a significant advance from the early precursor of activity tracker and step counting.

Chronic lifetime conditions
21st century healthcare in developed countries is predominantly about managing chronic lifetime illnesses such as diabetes, cancer, heart disease and respiratory conditions. These 4 diseases have high prevalence levels, relatively poor outcomes, and account for the overwhelming proportion of healthcare costs. For instance, in the US alone, almost 50% of adults (117m) suffer from a chronic lifetime condition, and 25% have multiple chronic conditions. 86% of America’s $2.7 trillion annual health care expenditures are for people with chronic health conditions. This chronic disease pattern is replicated throughout the developed world, and has significant healthcare utilization and cost implications for public and private payers, individuals, and families.
 
Healthcare providers tend not to optimally utilize data

Although personal remote devices are increasingly important in the management of chronic conditions, the data these devices create are underutilized, despite their potential for improving outcomes and reducing costs. This is partly because doctors and health providers neither have the capacity nor the resources to exploit the full potential of these data; partly because doctors tend to resist technology to improve doctor-patient interactions, and partly because remote healthcare devices have not been validated for clinical use. 

Validation
Although health professionals tend to prefer to use more expensive medical grade devices, which ensure data validity, but often drive up costs, research validating the data collected by remote self-managed devices for clinical use is beginning to emerge. In 2016 Analog Devices, a US multinational semiconductor company specializing in data conversion and signal processing technology, and LifeQa private US company with advanced bio-mathematical capabilities, announced a joint venture to establish whether data from wearable’s are accurate enough for clinical use.
 
A study published in 2017 in the journal Nature Biotechnologyprovides some validation for data derived from apps to be used clinically. Using ResearchKit, an open source framework introduced by Apple in 2015 that allows researchers and developers to create powerful apps for medical research, the 6-month study enrolled 7,600 smartphone users who completed surveys on how they used an app to manage their asthma. Researchers then compared these patient-reported data with similar data from traditional asthma research, and found that there were no significant differences. Although there still remains some methodological challenges, the findings gave scientists confidence that data derived from an app could be reliable enough for clinical research. If data from self-managed remote monitoring devices are validated, then such devices could be used to unobtrusively and cost effectively enter the daily lives of patients to collect meaningful healthcare patient data, which could be used to enhance outcomes. Early research adopters of ResearchKit include the University of Oxford, Stanford Medicine, and the Dana-Farber Cancer Institute.

 
Giant technology companies entering healthcare market
 
The increasing validation of data generated by mobile devices and the continued underutilization of such data by health providers has created an opportunity for giant global technology companies to enter the healthcare market by: (i) developing and marketing self-monitoring devices directly to consumers, (ii) collecting, integrating, storing and analysing data generated by these remote devices, and (iii) supporting research initiatives to validate data from remote devices for clinical use.
 

Apple Inc.
Just one example of giant technology companies entering the healthcare market is Apple Inc., which has a market cap of about US$1tn and 700m users worldwide. In 2017, Apple announced that it has been testing a BGM system, which pairs with the company’s existing Watch wearable. In August 2017, the US Patent and Trademark Office officially published a series of 50 newly granted patents to Apple. One covers an invention relating to health data, and more specifically to a smartphone that computes health data. 
 
The technology involves emitting light onto a user’s body part and measuring the amount of light reflected back. This data can then help to determine body fat, breathing and even emotional health. This, and other patents issued to Apple fuel rumors that the company is preparing to turn its flagship smartphone into a predominantly healthcare-focused device.

 
Takeaway
 
Given the size and momentum of technology giants entering the healthcare market, and given the powerful demographic, technological, social and economic drivers of this market, it seems reasonable to assume that in the medium term, giant technology companies are well positioned to dis-intermediate primary care doctors, and re-engineer primary care. One thing that could slow this march, is the question of privacy. Health records are as private as private gets - from alcohol or drug abuse to sexually transmitted diseases or details of abortions: things we may never want to reveal to employers, friends or even family members. Significantly, these data are permanent, and privacy at this point is non-negotiable.
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  • 'Drunkorexia' is a growing and dangerous trend among young people to eat less, purge or exercise excessively before binge drinking
  • Purging prior to drinking includes vomiting, laxatives or self-starvation
  • The intention is to save calories for binge-drinking
  • 41% of 18 to 24 year olds in a 2016 survey of 3,000 say they are not concerned about their overall health
  • Health providers are wasting millions on traditional healthcare education
  • Experts say we need to rethink how to encourage people to assume greater personal responsibility and accountability for their health
  • Healthcare providers have failed to leverage ubiquitous technologies and people’s changed lifestyles to engage and educate patients
  • To reduce the burden of drunkorexia healthcare providers will need to gain a better understanding of patients’ behaviors and ubiquitous 21st century technologies

Drunkorexia: a devastating and costly growing condition
 
Drunkorexia is using extreme weight control methods as a means to compensate for planned binge drinking. The French refer to it as alcoolorexie: l'ivresse sans les kilos. Manger moins pour être ivre plus vite et ne pas trop grossir. Drunkorexia is a term coined by the media to describe the combination of disordered eating and heavy alcohol consumption. The condition is gaining recognition in the fields of co-occurring disorders (people who have both substance use and mental health disorders), psychiatry, and addictionology. The term attempts to reconcile 2 conflicting cultures: binge drinking and a desire to be thin. The former involves ingesting significant amounts of unwanted extra calories, so people starve themselves in preparation for a night out drinking. Drunkorexia results in significant human costs from hypoglycaemia, depression, memory loss, and liver disease, and substantial and unnecessary costs to healthcare providers.
 
Experts argue that traditional methods to lower the burden of drunkorexia cost millions and are failing, and suggest there is an urgent need to, “rethink how we try and engage with people and try and encourage them to assume greater personal responsibility and accountability for their health.” This Commentary describes drunkorexia, reports some research findings on the condition, and suggests health providers would lower the large and growing burden of drunkorexia by leveraging ubiquitous technologies such as the Internet and smartphones.
 
Not an officially medical diagnosis

Drunkorexia is not an officially recognized medical condition. There is no mention of it in Mediline Plus, the US National Institutes of Health's online medical information service produced by the National Library of Medicine. It is not mentioned in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), which is published by the American Psychiatric Association, and popularly known as  “The Psychiatrist’s Bible”. Neither is the condition included in the World Health Organization's International Classification of Disease; nor in WebMD, the UK’s NHS online, NHS Choices, and the UK’s General Medical Council’s (GMC) website.
Signs and symptoms
 
Signs and symptoms include calorie counting to ensure no weight is gained when binge drinking, missing meals to conserve calories so that they can be spent on the consumption of alcohol, over-exercising to counterbalance calorie intake, and binge drinking to vomit previously digested food.

A dangerous condition

Despite evidence to suggest that more people are turning away from alcohol and becoming teetotallers, the prevalence of drunkorexia is increasing.

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Orthorexia: when eating healthily becomes unhealthy

It is a dangerous trend, especially among young people, which can lead to an array of physical and psychological consequences. For example, drinking in a state of malnutrition can predispose you to a higher rate of blackouts, alcohol poisoning, alcohol-related injury, violence, or illness. Drinking on an empty stomach allows ethanol to reach the blood system more rapidly, and raises your blood alcohol content often with dangerous speed. This can render you more vulnerable to alcohol-related brain damage. In addition, alcohol abuse can have a detrimental impact on hydration and your body's retention of minerals and nutrients, further exacerbating the consequences of malnutrition, and damaging your cognitive faculties. This can lead to short and long-term cognitive problems, including difficulty concentrating and making decisions, which ultimately can have a negative impact on academic and work-related performance. Drunkorexia also increases the risk of developing more serious eating disorders and alcohol abuse problems. As binge drinking is involved there is also a greater risk of violence, of risky sexual behavior, alcohol poisoning, substance abuse and chronic disease later in life.
 
Research

Although much of the research on drunkorexia is focused on university students, the condition is believed to be more widely spread. A challenge for researchers is the attitudes of university administrators and parents who are reluctant to admit that there is a problem either in their institutions or homes. The condition is often dismissed as a rite-of-passage. Notwithstanding, there have been a number of research studies, which suggest that drunkorexia is significant, growing fast and dangerous.
 
University of Missouri study

A 2011 University of Missouri study of the relationship between alcohol misuse and disordered eating, including calorie restriction and purging, suggests that drunkorexia is predominately a young women’s condition, which could affect their long-term health. The study found that 16% of respondents reported restricting calories to "save them" for drinking. 67% of students who restrict calories prior to binge drinking did so to prevent weight gain, while 21% did so to facilitate alcohol intoxication. 3 times as many women reported engaging in the behavior than men, and their stated motivations included “preventing weight gain”, “getting intoxicated faster” and “saving money”, which could be either spent on food or to buy alcohol. According to Victoria Osborne, Professor of Social Work and Public Health at the university, and lead author of the study, drunkorexia can have dangerous cognitive, behavioural and physical consequences. It also puts people at risk for developing more serious eating disorders or addiction problems.
 
Australian study

In an Australian context, a 2013 study surveyed 139 female university students, aged between 18 and 29 to examine compensatory eating and behaviors in response to alcohol consumption to test for drunkorexia symptomatology. 79% of respondents engaged in characterized drunkorexia behavior. The study also found that social norms of drinking, and the social norms associated with body image and thinness, impacted significantly upon the motivation for these behaviors.
 
University of Houston study

Findings of a University of Houston study on drunkorexia presented at the 2016 annual meeting of the Research Society on Alcoholism in New Orleans, found that 80% of the 1,200 students surveyed had at least one heavy night of drinking in the previous month, and engaged in drunkorexic behavior. The methods of purging prior to drinking include vomiting, use of laxatives or missing meals. The study also reported that the condition is not limited to the US, and is present in both men and women.
 
Benenden’s National Health study
 
Healthcare group Benenden’s 2016 National Health Report suggests that drunkorexia is gaining ground among young people in the UK, and creating concerns among healthcare professionals. According to the study, young people in the UK prefer to eat less in order to “save” calories for alcohol consumption. Of the 3,000 people surveyed, 2 out of 5 (41%), between the ages of 18 and 24 said they eat healthily only to look good, but are not concerned about their overall health. According to the report, “Pressure to be slim, an awareness of exercising calorie control, and peer pressure to drink large amounts of alcohol are all factors in this phenomenon”, adding that a growing number of men are following this trend.

Survey participants were also asked general questions about healthy lifestyles. “By and large, the findings highlight that the public is in denial about how much they think they know about healthy eating, they claim to be near-experts, but when drilling down to real-life examples, the vast majority of respondents failed to choose the right answer to simple diet-related questions, or the healthier option when offered the choice between everyday food and drinks,” the report found.
 
There also seems to be a woeful lack of awareness about basic dietary advice, despite legislation and attempts by the food production and manufacturing industry. It isn't clear whether this is down to poor education or a lack of interest, but I think we need to rethink how we try and engage with people and try and encourage them to assume greater personal responsibility and accountability for their health," says Dr John Giles, Benenden’s medical director.

Traditional healthcare providers failing

Traditional healthcare providers continue to waste billions on failing traditional methods of engaging and educating patients. Increasing self-management of your health is relevant, especially as primary care resources are shrinking as the prevalence of drunkorexia is rapidly increasing. However, achieving effective education and self-management requires a fundamental transformation of the way healthcare is delivered. The majority of people living with drunkorexia regularly use their smartphones for 24-hour banking, education, entertainment, shopping, and dating. Health providers have failed to effectively leverage this vast and rapidly growing free infrastructure and people’s changed lifestyles to introduce effective educational support systems to enhance the quality of drunkorexia care, increase efficiency, and improve patient outcomes. Today, mobile technology is part of everyday life and people expect to be connected with their relevant healthcare providers 24-7, 365 days of the year from anywhere. 

Takeaways

A necessary pre-requisite for effective healthcare education to reduce the burden of drunkorexia is the actual engagement of people with the condition. Once patients are 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 healthcare education is delivered as it transforms the patient–educator relationship into a continuous, rich, collaborative partnership. 
 

 

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  • Many people still view China as a ‘copycat’ economy, but this is rapidly changing
  • China is:
    • Pursuing a multi-billion dollar-15 year strategy to become a world leader in genomic engineering and personalized medicine
    • Systematically upgrading and incentivizing its large and growing pool of scientists who are making important breakthroughs in the life sciences
    • Empowering and encouraging state owned and private life science companies to own and control the capacity to transform genomic, clinical and personal data into personalized medicines
  • The difference in national approaches to individualism and privacy confers an added competitive advantage to China and its life science ambitions
  • China’s approach to individualism and privacy issues could have implications for society


The global competition to translate genomic data into personal medical therapies

 

PART 2
 
China is no longer a low cost ‘copycat’ economy. Indeed, it has bold plans to become a preeminent global force in genomic engineering to prevent and manage devastating and costly diseases. Here we briefly describe aspects of China’s multibillion-dollar, government-backed initiative, to own and control significant capacity to transform genomic data into precision medicines. This is not only a ‘numbers’ game. China’s drive to achieve its life science ambitions is also advantaged by a different approach to ‘individualism’ and privacy compared to that of the US; and this could have far-reaching implications for future civilizations.

Uneven playing field
Genomic engineering and precision medicine have the potential to revolutionize how we prevent and treat intractable diseases. Who owns the intellectual property associated with genomic engineering, and who first exploits it, will reap significant commercial benefits in the future. However, genomic technologies are not like any other. This is because genetically modifying human genomes could trigger genetic changes across future generations. Misuse of such technologies therefore could result in serious harm for individuals and their families. On the other hand, over regulation of genomic engineering could slow or even derail the prevention and treatment of devastating and costly diseases. Establishing a balance, which supports measures to mitigate misuse of genomic technologies while allowing the advancement of precision medicine is critical. However, this has proven difficult to establish internationally.

Chinese scientists have crossed an ethical line
Chinese culture interprets individualism and privacy differently to American culture, and therefore China responds differently to certain ethical standards compared to the US and some other Western nations. Indeed, national differences were ignited in 2012 when Chinese researchers published their findings of the world’s first endeavors to modify the genomes of human embryos to confer genetic resistance to certain diseases. Because such modifications are heritable critics argued that the Chinese scientists crossed a significant ethical line, and this was the start of a “slippery slope”, which could eventually lead to the creation of a two-tiered society, with elite citizens genetically engineered to be smarter, healthier and to live longer, and an underclass of biologically run-of-the-mill human beings.

International code of conduct called for but not adhered to
2 prominent scientific journals, Nature and Science, rejected the Chinese research papers reporting world-first scientific breakthroughs on ethical grounds. Subsequently, Nature published a note calling for a global moratorium on the genetic modification of human embryos, suggesting that there are “grave concerns” about the ethics and safety of the technology. 40 countries have banned genetically modifying human embryos. In 2016, a report from the UK’s Nuffield Council on Bioethics stressed the importance of an internationally agreed ethical code of conduct before genomic engineering develops further.
 
In 2017 an influential US science advisory group formed by the National Academy of Sciences and the National Academy of Medicine gave ‘lukewarm’ support to the modification of human embryos to prevent, “serious diseases and disabilities” in cases only where there are no other “reasonable alternatives”. The French oppose genomic modification, the Dutch and the Swedes support it, and a recent Nature editorial suggested that the EU is, “habitually paralyzed whenever genetic modification is discussed”. In the meantime, clinical studies, which involve genomic engineering, are advancing at a pace in China.

With regard to genome testing, western human rights activists have warned that China is targeting vulnerable groups and minorities to help build vast genomic databases without appropriate protection for individuals. Those include migrant workers, political dissidents and ethnic or religious minorities such as the Muslim Uighurs in China's far western Xinjiang region. Xinjiang authorities are reported to have invested some US$10bn in advanced sequencing equipment to enhance the collection and indexing of these data.


Different national interpretations of ‘individualism’
Individualism’, which is at the core of ethical considerations of genomic engineering, is challenging to define because of its different cultural, political and social interpretations. For example, following the French Revolution, individualisme was used pejoratively in France to signify the sources of social dissolution and anarchy, and the elevation of individual interests above those of the collective. The contemporary Chinese interpretation of individualism is similar to the early 19th century French interpretation. It does not stress a person’s uniqueness and separation from the State, but emphasizes an individual’s social; contract and harmony with the State. By contrast, American individualism is perceived as an inalienable natural right of all citizens, and independent of the State.

Further, American individuals are actively encouraged to challenge and influence the government and its regulatory bodies, whereas in China citizens are expected to unquestionably support the State. China is a one party state, where individuals generally accept that their government and its leaders represent their higher interests, and most citizens therefore accept the fact that they are not expected to challenge and influence policies determined by the State and its leaders. This difference provides China with a significant competitive advantage in its endeavors to become a world leader in the life sciences,

 
Human capital

By 2025, some 2bn human genomes could be sequenced. This not only presents ethical challenges, but also significant human capital challenges. The development of personalized medicines is predicated upon the ability to aggregate and process vast amounts of individual genomic, physiological, health, environmental and lifestyle data. This requires next generation sequencing technologies, smart AI systems, and advanced data managers of which there is a global shortage. Thus, the cultivation and recruitment of appropriate human capital is central to competing within the rapidly evolving international genomic engineering marketplace. The fact that China has a more efficacious strategy to achieve this than the US and other Western democracies provides it with another significant competitive advantage.

STEM graduates
Since the turn of the century, China has been engaged in a silent revolution to substantially increase its pool of graduates in science, technology, engineering and mathematics (STEM), while the pool of such graduates in the US and other Western democracies has been shrinking. In 2016, China was building the equivalent of almost one university a week, which has resulted in a significant shift in the world's population of STEM graduates. According to the World Economic Forumin 2016, the number of people graduating in China and India were respectively 4.7m and 2.6m, while in the US only 568,000 graduated. In 2013, 40% of all Chinese graduates finished a degree in STEM, over twice the share of that in US universities. In 2016, India had the most graduates of any country worldwide with 78m, China followed closely with 77.7m, and the US came third with 67m graduates.

University education thriving in China and struggling in the West
In addition to China being ahead of both the US and Europe in producing STEM graduates; the gap behind the top 2 countries and the US is widening. Projections suggest that by 2030 the number of 25 to 34-year-old graduates in China will increase by a further 300%, compared with an expected rise of around 30% in the US and Europe. In the US students have been struggling to afford university fees, and most European countries have put a brake on expanding their universities by either not making public investments or restricting universities to raise money themselves.
 

The increasing impact of Chinese life sciences
China's rapid expansion in STEM graduates suggests that the future might be different to the past. Today, China has more graduate researchers than any other country, and it is rapidly catching up with the US in the number of scientific papers published. The first published papers to describe genetic modifications of human embryos came from Chinese scientists

Further, according to the World Intellectual Property Organization, domestic patent applications inside China have soared from zero at the start of the 21st century to some 928,000 in 2014: 40% more than the US’s 579,000, and almost 3 times that of Japan’s 326,000.
 

China’s strategy to reverse the brain drain
Complementing China’s prioritization of domestic STEM education is its “Qianren Jihua” (Thousand Talents) strategy. This, established in the wake of the 2008 global financial crisis to reverse China’s brain drain, trawls the world to seek and attract highly skilled human capital to China by offering them incentives. Qianren Jihua’s objective is to encourage STEM qualified Chinese ex patriots to return to China, and encourage those who already reside in China to stay, and together help create an internationally competitive university sector by increasing the production of world-class research to support China’s plans to dominate precision medicine and life sciences.
 
Government commitment

In 2016, China announced plans for a multi-billion dollar project to enhance its competitiveness by becoming a global leader in molecular science and genomics. China is committed to supporting at least three principal institutions, including the Beijing Genomics Institute (BGI), to sequence the genomes of many millions.
 
In addition to investments at home, China also is investing in centers similar to that of BGI abroad. Over the past 2 years China has invested more than US$110bn on technology M&A deals, which it justifies by suggesting that emerging technologies are, “the main battlefields of the economy”. Early in 2017 BGI announced the launch of a US Innovation Center, co-located in Seattle and San Jose. The Seattle organization is focused on precision medicine and includes collaborations with the University of Washington, the Allen Institute for Brain Science, and the Bill and Melinda Gates Foundation. The San Jose facility, where BGI already has a laboratory employing over 100, supports its ambitions to develop next-generation sequencing technologies, which until now have been dominated by the US sequencing company Illumina.


Changing structure of China’s economy
Some suggest that China’s rise on the world life sciences stage will be short lived because the nation is in the midst of a challenging transition to a slower-growing, consumption-driven economy, and therefore will not be able to sustain such levels of investment; and this will dent its ambition to become a global player in genomic science. An alternative argument suggests slower growth forces China to act smarter, and this is what drives its precision medicine ambitions.

Between 1985 and 2015, China’s annual GDP rose, on average, by 9.4%. Fuelling this growth was a steady supply of workers entering the labour force and massive government led infrastructure investments. Now, because of China’s ageing population, its labour capacity has peaked and started to decline. Without labour force expansion, and investment constrained by debt, China is obliged to rely more heavily on innovation to improve its productivity. And this drives, rather than slows, China’s strategy to become a world leader in genomic technologies and personalized medicine.
 

China’s economic growth is slowing, but its production of scientific research is growing
Although China’s economy is slowing, it is still comparatively large. In 2000, China spent as much on R&D as France; now it invests more in genomics than the EU, when adjusted for the purchasing power of its currency. Today, China produces more research articles than any other nation, apart from the US, and its authors’ feature on around 20% of the world’s most-cited peer reviewed papers. Top Chinese scientific institutions are breaking into lists of the world’s best, and the nation has created some unparalleled research facilities. Even now, every 16 weeks China produces a Greece-size economy, and doubles the entire size of its economy every 7 years. Today, China has an economy similar in size to that of the US, and most projections suggest that, over the next 2 decades, China’s economy will dwarf that of the US.
 
Takeaways

China is cloning its successful strategy to own and control significant mineral and mining rights to the life sciences. Over the past 20 years China has actively pursued mining deals in different global geographies, and now controls significant mining rights and mineral assets in Africa and a few other countries. This allows China to affect the aggregate supply and world market prices of certain natural resources. Now, China is cloning this commercially successful strategy to the life sciences, and has empowered and encouraged a number of state owned and private companies to own and control genomic engineering and precision medicine. China’s single-minded determination to become a world leader in life sciences, and its interpretation of individualism and privacy issues could have far reaching implications for the future of humanity.
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  • In 2003 the US first discovered the genome and became the preeminent nation in genomics
  • This could change
  • World power and influence have moved East
  • China has invested heavily in genomic technologies and established itself as a significant competitive force in precision medicine
  • Ownership of intellectual property and knowhow is key to driving national wealth 
 

The global competition to translate genomic data into personal medical therapies

 

PART 1

Professor Dame Sally Davies, England’s Chief Medical Officer, is right. (Genomics) “has the potential to change medicine forever. . . . The age of precision medicine is now, and the NHS must act fast to keep its place at the forefront of global science.”
 
It is doubtful whether the UK will be able to maintain its place as a global frontrunner in genomics and personalized medicine. It is even doubtful whether the US, the first nation to discover the genome, and which became preeminent in genomic research, will be able to maintain its position. China, with its well-funded strategy to become the world’s leader in genomics and targeted therapies, is likely to usurp the UK and the US in the next decade.
 
This Commentary is in 2 parts. Part 1 provides a brief description of the global scientific competition between nation states to turn genomic data into medical benefits. China’s rise, which is described, could have significant implications for the future ownership of medical innovations, data protection, and bio-security. Part 2, which follows in 2 weeks, describes some of the ethical, privacy, human capital and economic challenges associated with transforming genomic data into effective personal therapies.
  
Turning genomic data into medical benefits
 
Turning genomic data into medical benefits is very demanding. It requires a committed government willing and able to spend billions, a deep understanding of the relationship between genes and physiological traits, next generation sequencing technologies, artificial intelligence (AI) systems to identify patterns in petabytes (1 petabyte is equivalent to 1m gigabytes) of complex data, world-class bio-informaticians, who are in short supply; comprehensive and sophisticated bio depositories, a living bio bank, a secure data center, digitization synthesis and editing platforms, and petabytes of both genomic, clinical, and personal data. Before describing how the UK, US and China are endeavoring to transform genomic data into personal medicine, let us refresh our understanding of genomics.

  
Genomics, the Human Genomic Project and epigenetics
 
It is widely understood that your genes are responsible for passing specific features or diseases from one generation to the next via DNA, and genetics is the study of the way this is done. However, it is less widely known that your genes are influenced by environmental and other factors. Scientists have demonstrated that inherited genes are not static, and lifestyles and environmental factors can precipitate a chemical reaction within your body that could permanently alter the way your genes react. This environmentally triggered gene expression, or epigenetic imprint, can be bad, such as a disease; or good, such as a tolerant predisposition. Epigenetics is still developing as an area of research, but it has demonstrated that preventing and managing disease is as much to do with lifestyles and the environment, as it is to do with inherited genes and drugs. If environmental exposure can trigger a chemical change in your genes that results in the onset of disease, then scientists might be able to pharmacologically manipulate the same mechanisms in order to reverse the disease.
 
DNA is constantly subject to mutations, which can lead to missing or malformed proteins, and that can lead to disease. You all start your lives with some mutations, which are inherited from your parents, and are called germ-line mutations. However, you can also acquire mutations during your lifetime. Some happen during cell division, when DNA gets duplicated, other mutations are caused when environmental factors including, UV radiation, chemicals, and viruses damage DNA.

You have a complete set of genes in almost every healthy cell in your body. One set of all these genes, (plus the DNA between them), is called a genome. The genome is the collection of 20,000 genes, including 3.2bn letters of DNA, which make up an individual. We all share about 99.8% of the genome. The secrets of your individuality, and also of the diseases you are prone to, lie in the other 0.2%, which is about 3 or 4m letters of DNA. The genome is known as ‘the blueprint’ of life’, and genomics is the study of the whole genome, and how it works. Whole genome sequencing (WGS) is the process of determining the complete DNA sequence of an organism's genome at a point in time.
 
‘The Human Genome Project’ officially began in 1990 as an international research effort to determine a complete and accurate sequence of the 3bn DNA base pairs, which make up the human genome, and to find all of the estimated 20 to 25,000 human genes. The project was completed in April 2003. This first sequencing of the human genome took 13 years and cost some US$3bn. Today, it takes a couple of days to sequence a genome, and costs range from US$260 for targeted sequencing to some US$4,000 for WGS. Despite the rapidly improving capacity to read, sequence and edit the information contained in the human genome, we still do not understand most of the genome’s functions and how they impact our physiology and health.

 
Roger Kornberg explains the importance of genomics
 
Roger Kornberg, Professor of Structural Biology at Stanford University, and 2006 Nobel Laureate for Chemistry, explains the significance of sequencing the human genome, “The determination of the human genome sequence and the associated activity called genomics; and the purposes for which they may be put for medical uses, takes several forms. The knowledge of the sequence enables us to identify every component of the body responsible for all of the processes of life. In particular, to identify any component that is either defective or whose activity we may adjust to address a problem or a condition. So the human genome sequence makes available to us the entire array of potential targets for drug development. . . . . The second way in which the sequence and the associated science of genomics play an important role is in regard to individual variations. Not every human genome sequence is the same. There is a wide variation, which in the first instance is manifest in our different appearances and capabilities. But it goes far deeper because it is also reflected in our different responses to invasion by microorganisms, to the development of cancer and to our susceptibility to disease in general. It will ultimately be possible, by analyzing individual genome sequences to construct a profile of such susceptibilities for every individual, a profile of the response to pharmaceuticals for every individual, and thus to tailor medicines to the needs of individuals.” See video below.
 
 
UK’s endeavors to transform genomic data into personal therapies

In 2013 the UK government set up Genomics England, a company charged with sequencing 100,000 whole genomes by 2017. In 2014, the government announced a £78m deal with Illumina, a US sequencing company, to provide Genomics England with next generation whole genome sequencing services. At the same time the Wellcome Trust invested £27m in a state-of-the-art sequencing hub to enable Genomics England to become part of the Wellcome Trust’s Genome Campus in Hinxton, near Cambridge, England. In 2015, the UK government pledged £215m to Genomics England.
 
DNA testing and cancer
DNA sequencing is simply the process of reading the code that is in any organism . . . It’s essentially a technology that allows us to extract DNA from a cell, or many cells, pass it through a sophisticated machine and read out the sequence for that organism or individual,” says David Bowtell, Professor and Head of the Cancer Genomics and Genetics Program at the Peter MacCallum Cancer Centre, Melbourne, Australia; see video below. “DNA testing has becomeincreasingly widespread because advances in technology have made the opportunity to sequence the DNA of individuals affordable and rapid  . . . DNA testing in the context of cancer can be useful to identify a genetic risk of cancer, and to help clinicians make therapeutic decisions for someone who has cancer,” says Bowtell, see video below.
 

What is DNA sequencing?


What are the advanteges of a person having a DNA test?

Need for National Genome Board
Despite significant investments by the UK government, Professor Davies, England’s Chief Medical Officer, complained in her 2017 Annual Report that genomic testing in the UK is like a “cottage industry” and recommended setting up a new National Genome Board tasked with making whole genome sequencing (WGS) standard practice in the NHS across cancer care, as well as some other areas of medicine, within the next 5 years.
 
USA’s endeavors to transform genomic data into personal therapies

In early 2015 President Obama announced plans to launch a $215m public-private precision medicine initiative, which involved the health records and DNA of 1m people, to leverage advances in genomics with the intention of accelerating biomedical discoveries in the hope of yielding more personalized medical treatments for patients. A White House spokesperson described this as “a game changer that holds the potential to revolutionize how we approach health in the US and around the world.
 

Data management challenges
The American plan did not seek to create a single bio-bank, but instead chose a distributive approach that combines data from over 200 large on-going health studies, which together involves some 2m people. The ability of computer systems or software to exchange and make use of information stored in such diverse medical records, and numerous gene databases presents a significant challenge for the US plan. According to Bowtell, “Data sharing is widespread in an ethically appropriate way between research institutions and clinical groups. The main obstacles to more effective sharing of information are the very substantial informatics challenges. Often health systems have their own particular ways of coding information, which are not cross compatible between different jurisdictions. Hospitals are limited in their ability to capture information because it takes time and effort. Often information that could be useful to researchers, and ultimately to patients, is lost, just because the data are not being systematically collected.” See video below.
 
 
 
China’s endeavors to transform genomic data into personal therapies

In 2016, the Chinese government launched a US$9bn-15-year endeavor aimed at turning China into a global scientific leader by harnessing computing and AI technologies for interpreting genomic and health data.  This positions China to eclipse similar UK and US initiatives.
 

Virtuous circle
Transforming genomic data to medical therapies is more than a numbers race. Chinese scientists are gaining access to ever growing amounts of human genomic data, and developing the machine-learning capabilities required to transform these data into sophisticated diagnostics and therapeutics, which are expected to drive the economy of the future.  The more genomic data a nation has the better its potential clinical outcomes. The better a nation’s clinical outcomes the more data a nation can collect. The more data a nation collects the more talent a nation attracts. The more talent a nation attracts the better its clinical outcomes.
 

The Beijing Genomics Institute
In 2010 China became the global leader in DNA sequencing because of one company: the Beijing Genomics Institute (BGI), which was created in 1999 as a non-governmental independent research institute, then affiliated to the Chinese Academy of Sciences, in order to participate in the Human Genome Project as China's representative. In 2010, BGI received US$1.5bn from the China Development Bank, and established branches in the US and Europe. In 2011 BGI employed 4,000 scientists and technicians. While BGI has had a chequered history, today it is one of the world’s most comprehensive and sophisticated bio depositories.

The China National GeneBank
In 2016 BGI-Shenzhen established the China National GeneBank (CNGB) on a 47,500sq.m site. This is the first national gene bank to integrate a large-scale bio-repository and a genomic database, with a goal of enabling breakthroughs in human health research. The gene-bank is supported by BGI’s high-throughput sequencing and bio-informatics capacity, and will not only provide a repository for biological collection, but more importantly, it is expected to develop a novel platform to further understand genomic mechanisms of life. During the first phase of its development the CNGB will have saved more than 10m bio-samples, and have storage capacity for 20 petabytes (20m gigabytes) of data, which are expected to increase to 500 petabytes in the second phase of its development. The CNGB represents the new generation of a genetic resource repository, bioinformatics database, knowledge database and a tool library, “to systematically store, read, understand, write, and apply genetic data,” says Mei Yonghong, its Director.

Whole-genome sequencing for $100
The CNGB could also help to bring down the cost of genomic sequencing. It is currently possible to sequence an individual's entire genome for under US$1,000, but the CNGB aims to reduce the price to US$152. Meanwhile, researchers at Complete Genomicsa US company acquired by BGI in 2013, which has developed and commercialized a DNA sequencing platform for human genome sequencing and analysis, are pushing the technology further to enable whole-genome sequencing for US$100 per sample. China's share of the world's sequencing-capacity is estimated to be between 20% and 30%, which is lower than when BGI was in its heyday, but expected to increase fast. “Sequencing capacity is rising rapidly everywhere, but it's rising more rapidly in China than anywhere else,” says Richard Daly, CEO, DNAnexus, a US company, which supplies cloud platforms for large-scale genomics data.

The intersection of genomics and AI
Making sense of 1m human genomes is a major challenge, says Professor Jian Wang, former BGI President and co-founder, who has started another company called iCarbonX. Also based in Shenzhen, the company is at the intersection of genomics and AI. iCarbonX has raised more than US$600m, and plans to collect genomic data from more than 1m people, and complement these data with other biological information including changes in levels of proteins and metabolites. This is expected to allow iCarbonX to develop a new digital ecosystem, comprised of billions of connections between huge amounts of individuals’ biological, medical, behavioural and psychological data in order to understand how their genes interact and mutate, how diseases and aging manifest themselves in cells over time, how everyday lifestyle choices affect morbidity, and how these personal susceptibilities play a role in a wide range of treatments.

iCarbonX is expected to gather data from brain imaging, biosensors, and smart toilets, which will allow real-time monitoring of urine and faeces. The Company’s goal is to be able to study the evolution of our genome as we age and design personalized health predictions such as susceptibilities to diseases and tailored treatment options. iCarbonX’s endeavours are expected to dwarf efforts by other US Internet giants at the intersection of genomics and AI.

 
Ethical challenges

China’s single-minded objective to turn its knowhow and experience of genome sequencing into personal targeted medical therapies has made it a significant global competitive force in life sciences. However, precision medicine’s potential to revolutionize advances in how we treat diseases confers on it moral and ethical obligations. For personal therapies to be effective, it is important that genomic data are complemented with clinical and other personal data. This combination of data is as personal as personal information gets. There could be potential harm to the tested individual and family if genomic information from testing is misused. Reconciling therapy and privacy is important, because privacy issues concerning patients' genomic data can slow or derail the progression of novel personal therapies to prevent and manage intractable diseases. The stakes are high in terms of biosecurity, as genomic research is both therapeutic and a strategic element of national security. While it is crucial to leverage genomic data for future health, economic and biodefense capital, these data will also have to be appropriately managed and protected. Part 2 of this Commentary dives into these challenges a little deeper, and describes some of China’s competitive advantages in the race to become the world’s preeminent nation in genomics and precision medicine. 
 
Takeaways

Despite the endeavours of the UK and US to remain at the forefront of the international competition to transform genomic data into personalized medical therapies for some of the worlds most common and intractable diseases, it seems reasonable to assume that China is on the cusp of becoming the most dominant nation in novel personalized treatments. Notwithstanding, China’s determination to assume the global frontrunner position in genomic science might have blunted its concerns for some of the ethical issues, which surround the life sciences. To the extent that this might be the case the future of humanity might well differ significantly from the generally accepted western vision. 
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