Healthcare Magazine (issue - 38)

Issue 38 2017 www.asianhhm.com
Are We Getting It Right?
Regulation vs.
Innovation
Top Challenges Facing IoT/ IoH
How we can overcome them?
The Prospects of Cancer Care
in Asia
Integrated services

Foreword
Prasanthi Sadhu
Editor
Innovations and Regulations
in Healthcare
Bridging the Gap
key ideas from the staffs that result in both
operational efficiencies and improved clinical
care, thus benefiting both service providers
and consumers.
In some cases, delays in products
reaching the patients could also be affected
by the knowledge gap between innovators
and regulators. Inorderto avoid such delays,
regulatory bodies have to take certain
measures. The FDA Center for Devices and
Radiological Health (CDRH) has taken steps
in this direction by establishing mechanisms
to provide additional reviewer training via
programmes such as the Experiential Learning
Program (FDA, 2016b) and the Network of
Experts (FDA, 2016c). It is also evident that
these measures are not enough and FDA
needs to explore new methods for evaluating
and regulating products to make approvable
products available to patients without any
delays.
In the cover story of this issue titled
‘Regulation vs. Innovation - Are We Getting
It Right?’, we look at how the regulatory
environment has had a significant impact on
the introduction of innovative new healthcare
products.
Healthcare systems around the world have
been grappling with challenges of meeting
the ever-increasing demand for better care.
Innovation and technological advancements
have played a key role in improving care.
However, innovation does not necessarily
limit to new products or technologies. More
often than not innovation can happen around
organising or executing things, aided by
technology.
While care providers have continued
to adopt new technologies in the form
of modern medical devices and newer
treatment approaches, innovation tends to
be bogged down in this highly regulated
sector. The gap between regulation and
innovation needs to be bridged for innovation
to flourish and help businesses thrive. The
first step in driving innovation to succeed is
clear and consistent communication across
the organisation. People or teams responsible
for innovation need to be in constant
communication with legal and regulatory staff.
If the regulatory and compliance challenges
are understood and mitigated at the ideation
or early stage of a project, there is a better
chance of success. From an organisational
perspective, healthcare technology innovators
can look at some interesting examples.
Companies like Intermountain Healthcare,
Kaiser Permanente and Providence Health
& Services etc. are known to have established
innovation centres in-house to bring forth

2 Asian Hospital & Healthcare Management ISSUe - 38 2017
22
Contents
HEALTHCARE
MANAGEMENT
06 Managing and Delivering Healthcare
Looking forward to challenges
R B Smarta, Managing Director, Interlink Consultancy
12 Recruiting Medical Staff
It is the culture not the money
Jeff Thompson, CEO Emeritus and Executive Advisor, Gundersen Health System
Samuel E Thompson, HR- Consultant, Gundersen Health system
18 Reactive, Acute Care to Proactive and
Preventive Care
By engaging patients
Tim Morris, Product & Partnership Director, Europe, Middle East,
Asia Pacific, Elsevier
MEDICAL SCIENCES
22 Diabesity (Diabetes & Obesity)
Newer surgical options shaping up!
Pradeep Chowbey, Executive Vice Chairman, Max Healthcare
28 The Prospects of Cancer Care in Asia
Integrated services
Yew Oo TAN, Specialist in Medical Oncology, Farrer Park Medical Clinic
32 Trends in Indian Cancer Market
Suresh Ramu, CEO & Co-Founder, Cytecare Cancer Hospital
FACILITIES & OPERATIONS
MANAGEMENT
44 Environmental Safety in Hospitals
Neven Saleh, Assistant Professor, Biomedical Engineering Department
Egyptian University
INFORMATION
TECHNOLOGY
52 Top Challenges Facing IoT/ IoH
How we can overcome them?
Kiersey Simon, Co-founder and COO, Bluedrop Medical
56 Books
32
Cover Story38
Christopher Milne
Associate Professor and Director of Research
Center for the Study of Drug Development
Tufts University School of Medicine

Vivek Desai
Managing Director
HOSMAC INDIA PVT. LTD., India
Sandy Lutz
Director
PricewaterhouseCoopers
Health Research Institute, USA
Peter Gross
Chair, Board of Managers
HackensackAlliance ACO, USA
Pradeep Chowbey
Chairman
Minimal Access, Metabolic and Bariatric
Surgery Centre
Sir Ganga Ram Hospital, India
John E Adler
Professor
Neurosurgery and Director Radiosurgery and
Stereotactic Surgery
Stanford University School of Medicine, USA
AdvisoryBoard
A member of
Confederation of
Indian Industry
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HEALTHCARE MANAGEMENT
The growing demand for the quality healthcare and
the absence of delivery mechanisms pose a great
challenge, the key growth inhibitor includes fastest
growing population and informal costs. Healthcare
industry should be able to carry out planning,
monitoring and controlling the delivery system in
affordable cost. In response new service models,
delivery plans, accountability between provider and
citizens is essential for effective delivery system.
R B Smarta, Managing Director, Interlink Consultancy
Managing and
Delivering Healthcare
Looking forward to challenges
T
he growing demand for the
quality healthcare and the absence
of delivery mechanisms pose a
great challenge, the key growth inhibitor
includes fastest growing population and
informal costs. Healthcare industry should
be able to carry out planning, monitoring
and controlling the delivery system in
affordable cost. In response new service
models, delivery plans, accountability
between provider and citizens is essential
for effective delivery system.

7w w w . a s i a n h h m . c o m
A healthcare system is the
consortium of people, institutions
and resources that deliver healthcare
services; the sector involves hospitals,
the pharmaceutical industry, the
health insurance industry and medical
technology industry. According to
WHO, health services include all
services dealing with the diagnosis
and treatment of disease, or the
promotion, maintenance and
restoration of health. The challenge
in the delivery of service depends on
the way inputs are organised and
managed to improve access, coverage
and quality of the services to be
provided to the users as well as
providers. To have a well delivered
health services management, leadership
plays a crucial role along with good
management for quality service
delivery and advanced technology
that will bridge the gap of accessibility
and coverage of healthcare services to
patients for reaching desired health
outcomes.
Looking Forward to Challenges
The challenges are faced at each
level of system, starting from data
management, treatment, patient
follow up, providing services,
payment, etc. Inadequate quality
standard, unfavourable delays in
passing the government bills and
various reasons make our market
commercially unfavourable for
indigenous players. The challenges can
be enlisted as,
The rising population and awareness•
is leading to increase in demand of
health services
The rising informal cost of health•
services needs to be controlled
Affordability of new technology•
by the common man should be
ensured
Focusing on providing quality•
service to ensure higher customer
experience.
Medical insurance plans should be
encouraged and out of pocket expenses
should be reduced. New government
policies should be up taken that will
ensure less cost towards health serv-
ices. Also, focus should be provided
towards providing free medical serv-
ices to patients suffering from diseases
like tuberculosis, whereby a common
man can afford and take benefits
of health services. In case informal
costs are enabled then the poor man
doesn’t care about health leading to the
transmission of the epidemics. Also
policies and plans should be made for
elderly age group so as to avoid infor-
mal costs.
New technologies like Electronic
Health Records (EHRs) help in
maintaining patient data securely
and, whenever needed, the authorised
person can view the details instantly
like scanning the patient history,
prior treatments, which acts as a
reference that will help in diagnosis
and prescription of medicines quickly.
Telemedicine would help in bridging
the gap between the patients and
doctors across the world and provide
better service from long distance.
The quality of care can be measured
looking based on hospital admission
rates, patient feedback forms, length
of stay, service provided to patients,
hospital disbursements, equipment’s
and technologies used, physicians
visits, outpatient care and spending,
home care service and cost, etc.
Health Services the Countryside:
A clear dissimilarity in health status
is observed between developed and
developing countries, based on
mortality rates, including infant
mortality, young and child mortality
and maternal mortality. With the help
of organised plan and infrastructure,
Challenges
Affordability
Accessibility Awareness
Quality
of health
services
Figure 1

Inadequate quality
standard, unfavourable
delays in passing
the government
bills and various
reasons make our
market commercially
unfavourable for
indigenous players.
illnesses can be treated and deaths
can be prevented. The account of
expenditure spent on health services
and quality provided should be
accountable and effective management
in delivery of health services should be
provided.
The needs of rural population are
quitedifferentwhencomparedtourban
areas. The reason for this may be the
difference in geographic, demographic,
socioeconomic, workplace, and
personal health factors. As we know
the urban areas are polluted leading
to breathing illness and lifestyle
diseases are prominent among urban
population. The rural populations
mostly include baby boomers, GenX
and children below the age 20, as most
of the working population migrates to
cities for employment.
The healthcare services are provided
by public and private sector. Public
sector in the healthcare industry is
cost effective and affordable and
provides services to urban as well as
rural regions. The technologies used
are not as advanced as in private sector
but as per the need of the patients
the government tries to cope up. The
private sector is a well supplier of
quality medical help, but is restricted
to the urban populations’ areas and is
expensive. Although the demand from
rural areas is more they are more profit
oriented and since there is no asurety
about profit, these providers don’t see
rural areas as a potential investment.
The lack of economic investment leads
doctors to work in foreign countries.
There should be a way out and we
need to standardise all our procedures
and build clinics in the rural areas to
improve efficiency. Another problem is
lack of effective payment and insurance
procedure.
Application of Telemedicine in
rural areas: Two primary methods are
involved in telemedicine: real-time
telemedicine, and store & forward
telemedicine. In real-time telemedicine
the electronic telecommunication
allows healthcare providers and
patients to send and receive health-
related information instantly. The
most commonly used method for this
is videoconference calls. This leads
to rural population seeking more
information from healthcare providers
and significant reduction in waiting
time period. In store & forward
telemedicine, by means of emails,
fax data is provided to the healthcare
providers which they can access later
as per their time availability. Due to
long distance travel, many of the health
services are unable to reach rural areas
but telemedicine is one of the best
ways to deal with it.
Pathway to Impact Healthcare:
The process of healthcare delivery
can be distributed in two parts:
behaviour of professionals, and
participation of people. Diagnosis
of the illness including diagnostic
procedure, diagnostic equipments, and
treatment consists of recommendation
of treatment, follow up to reassess the
health. The participation of people
includes promotion, advertising,
utilisation of the health services,
satisfaction with the provided services,
and participation in decision making.
In India majority of home healthcare
services are delivered by community
healthcare workers. The advantage
in India is the services are more cost
effective just the need is the workers
should be effectively skilled.
Now-a-days the joint family
system is vanishing, and job and other
priorities are leading minimum care
being provided to old people sick at
home. A pathway can be designed to
support people who have experienced a
Budget
Effective
and
efficient
Impact
Improved care
standards
and patient
satisfaction
Delivery
system
Health worker
productivity,
supply
management,
pocurement
Levers
for
change
Facility,
equipments,
supplies, on
time drug supply
distribution,
waiting time
Overall Pathway to Impact Health System
Figure 2

significant ‘event’ such as stroke, MI, or
a fractured neck of femur, and illnesses
which impact adversely on the person’s
ability to live independently. Pathway
can be designed focusing on delivering
the time-limited interventions to those
needful.
The National Association for Home
care & Hospice says that 7.6million
population is permanently disabled
and chronically or terminally ill in the
United States, and they receive home
careservices.Themajorityofpopulation
receiving home care services is over the
age of 65, and they need support from
someone to take care of them. As time
is a limitation, family members are not
able to pay enough attention and at
such times home care services becomes
useful.Also, it costs less compared to
hospital stays, and provides access to
a full range of services for people who
need medical services throughout the
recovery process.
Pathway to Impact Home
Healthcare:
This can be divided into three stages.
First is the entering stage, followed
by receiving stage, and last, leaving
stage. The entering stage may can be
subscripted by service user themselves
or a family member. The referral is
followed by a needs assessment which
targets both health and social care
needs. The service user is enrolled into
the services and an integrated care plan
is designed, that includes a formal
document that describes the services
to be provided and the appropriate
intervals. The receiving stage involves
the personalised care delivery package
combining informal, formal care;
technologies like telehealth can be
applied here. Documentation is a
vital part of any process and has to be
monitored for needs of patient care.
If a case needs medical supervision,
then the patient is readmitted to the
hospital. The leaving stage involves
discharge from the service or transition
into term care service.
Management for Delivery of Health
Services:
Hospital organisations and other
health care firms have to deal with
complex structures and situations in
order to develop and impart strate-
gies that will lead to positive change.
The determinants of organisational
performance consist of three vari-
ables: strategies, implementation
Discharge from
hospital
Coordination / revision
of intial integrated
care plan
Onsite /
home
provision
of informal
healthcare
Onsite /
home
provision
of social
healthcare
Onsite /
home
provision
of formal
healthcare
Remote
provision
of health &
socialcare
(telehealth)
Initial integrated
care plan
Enrolment to home
care services
Assessment for needs
of patients care to
provide home care
Discharge from
hospital impending
Documentation of
home care provided
Monitoring /
reassessment of
patients care needs
Readmission
to hospital
Transition into term
care service
Disenrollment from
home care service
Figure 3

capability, and environment. Before
implementing strategies, it is important
to know the root cause of the prob-
lem. Organisation can improve health
outcomes by applying strategies at vari-
ous levels, starting from own system
management and at the level
of individual health facili-
ties. Reducing the waiting times
of patient at health centres will save
time of every individual involved in
process. The following points can be
applied for the same: (1) retraining
and skilling the registration and medical
recordsclerks,(2)relocatingthecashiers,
(3) adding up general practitioner, and
(4) establishing a clinician for triaging
the most severe cases to the emergency
area and retaining the less severe cases
in the outpatient department. Applying
innovative strategies to improve service
delivery such as new community-based
organisations and workers, facility
autonomy, results-based financing, and
new information technologies will help
in strengthening the healthcare system.
According to the WHO, health
services are people centred and inte-
grated, and are difficult to achieve.
They support countries in implement-
ing and developing policies, reforming
strategies, designing and formulating
guidelines. Patient centred services
include diagnosis and treatment and
other clinical aspects of healthcare
services, whereas integrated health
services involves management and
delivery of safe and quality health serv-
ices. Designing the pathways for vari-
ous healthcare services by assessing
the needs of healthcare providers and
expectations of users, applying them
in day-to-day life will make processes
smooth and easy to follow. Integra-
tion of modern technologies like EHR,
telemedicine in health services will save
time, and provide excellent service to
healthcare users.
References are available at www.asianhhm.com
Strategies
Environment Implementation
Capability
Organisational
Performance
R B Smarta has designed management agendas for profitable growth, relevant
expansion, launching new concepts, ideas and projects for National and Global
clients in Pharmaceuticals, Nutraceuticals and Wellness. Being in the industry for
more than 4 decades & in consulting as a pioneer for 3 decades, he has a
perfect blend of industry and consulting best practices. He has added value and
impact on performance of wide variety of clients, inclusive of start-ups to national and
multinational corporate. His firm Interlink has created valuable insights and depth of
knowledge in its knowledge bank, along with its consultants and associates.
Figure 4
A u t h o r B I O

It is the Culture not the Money. The competition to
recruit, and the great advantage to permanently
retain the best medical staff is not accomplished
by money or flashy perks. It takes clarity of
purpose, lived values, and real communication.
The payoff is efficiency, quality and growth.
Jeff Thompson, CEO Emeritus and Executive Advisor, Gundersen Health System
Samuel E Thompson, HR-Consultant, Gundersen Health system
Recruiting
Medical Staff
It is the culture not
the money
E
ngagement starts before the first
day of work. The competition to
recruit and the great advantage
to permanently retain the best
clinicians is not accomplished by
money or flashy perks. It takes clarity
of purpose, lived values, and real
communication.Thepayoffisefficiency,
quality and growth.
The shortage of high quality
medical staff can be a crushing blow
to a strong hospital or health system.
Even in times of plentiful staffing, the
highest functioning and most collegial
providers may be in short supply. Your
ability to compete, grow and serve
the mission of improving the health

The competition
to recruit, and the
great advantage of
permanently retaining
the best medical staff
is not accomplished
by money or flashy
perks.
and well-being of your communities
will be impossible without a high-
performing engaged medical staff.
There are many who are seduced
into believing that it's all about the
money. All I need to do is pay big
and out - 'perks’ the competition and
then you'll be in the driver seat. The
data would imply that money is a
week glue. Although you may be able
to recruit some high performing staff
members their ability to deeply engage
in the broader responsibilities of the
organisation will be limited if the only
hook is their paycheck. Similarly ,
better benefits are attractive and can
get people interested but studies show
that not only are pay and benefits just a
baseline consideration that ultimately
will not keep great staff engaged, it
also leaves you vulnerable to a bidding
war with other like-minded big pay for
your talent strategists.
Researchers would point out
you do need adequate pay that is
viewed as fair and responsive to both
economic pressures and individual
accomplishments. The benefits package
has to be generally competitive and
consistent with a long-term view of
being part of a strong organisation.
These are necessary but not sufficient.
The pathway to much stronger
recruiting and retention is not
complicated it is just very hard
It doesn't start in the interview
room it starts in the boardroom. Clarity
is needed from senior most levels of the
organisation. What are the goals and
priorities of the organisation? Why
does the organisation exist? What is
the long-term vision and plan? What
will be the priorities for both short and
long term? All these are important part
of attracting individuals who are more
likely to help lead your organisation to
greater success.
If your goals are about crushing the
local competition, or being 1 per cent
better than you were before, or being
a little bit better than your mediocre
peers, it will not be inspirational for
anyone. And it certainly will not be
inspirational for the brightest, the best
or the hardest working. These natural
builders that you want to become
interested and engage will look deeper
at your organisation.
If your purpose is clear and the
vision of how far you want to go
in accomplishing that purpose is
inspirational, the next piece to be
consistent about is the environment
they will be working in. Notice that
we still haven't talked about how
much money they're going to be paid,
the call schedule, or the benefits. Of
course these will be important and they
all need to be discussed but if you're
aiming for builders that will help lead
the organisation forward, then we need
people that are interested in what the
values are and the likelihood that those
values will be lived every day across the
organisation.
You don't need a totally unique
set of values. It is not the words… it is
the consistency of action. They should
be clear, understandable, defined, and
most importantly, have a path forward
to have them lived by everyone
(especially the top most leaders)
Insightful candidates will figure
out pretty quickly if your values say
compassion but the staff don’t treat
each other well so it’s unlikely they'll
treat the patients well. If the value is
respect and no one treats anyone with
respect but it’s all rank based behaviour
they will figure that out immediately.
If integrity is one of the values listed ,
and the candidate is told to be careful
about the contract because the front
office can't be trusted, it is unlikely
you'll be able to recruit or engage the

best. The best performers have options
they can go to; in order to really
distinguish your organisation you
need to be clear about your values and
then live them consistently through
recruitment, orientation, evaluations
and every day practice.
Many organisations have
written this down so that it can be
implemented, not just talked about.
They developed a document called a
physician or medical staff compact.
This is not a contract but it is a
clear pathway for those looking to
start their career or build their career.
The organisation promises to deliver
all those things on the left side and
So now you have built a pathway
for physicians where the organisation
sets high outward looking goals that
serve a greater purpose, that aim for
excellence, and internally, it is known
how everyone is going to behave. Staff
will be supported by the structure and
clear promises from the organisation
but they will also have an obligation to
serve the mission and behave in a way
that is healthy for all.
There is no intention to imply
that it is easy to live these values or
deliver consistently on the compact.
You may have a high-energy member
of the medical staff team who behaves
very badly despite great quality
expects all of the medical staff to live
those things on the right side of this
document. This is a promise by the
organisation and a clear request and
expectation of the staff. It has been
argued that these rules will limit
interest and creative physicians might
not come to an organisation or stay
engaged.
That is not true. The highest
performing, most creative physicians
want to know where the guidelines
for behaviour. They are interested not
only in how they must behave but
how they'll be treated, how their staff
will be treated, how their families and
patients will be treated.

outcomes, a tremendous work ethic
and innovation well ahead of the
curve. But they are so disruptive to
other medical staff members and the
support staff that there is a constant
stream of complaints. Often senior
leaders in healthcare have looked the
other way and put a Band-Aid on the
problem that needed major surgery.
Short-term thinking would suggest we
can just ignore this and move on, the
clinician is too valuable to risk making
them unhappy. But a longer-term and
deeper look would show, and the data
would support the fact that this type
of behaviour affects the functioning
of other medical staff members, the
nursing staff and ultimately leads to
dissatisfaction, retention and quality
issues in an ever expanding circle. It
is not complex…it is just very hard
to keep that promise made by the
organisation in the compact. It takes
courage to be clear about your values
and address them. It takes discipline
to stick with your compact and your
guidelines even when there are some
compelling financial and even short-
term patient care issues that may
seem negatively affected. And finally
you need durability. When you make
these hard decisions for a long-term
plan there are always short-term
consequences that are going to result in
you getting a great deal of push back.
Building up that durability through
consistency and connections with like
minded leaders will be an important
part of your work.
As important as these cultural
buildings are, however, they are
insufficient without several other
factors.
Leaving communication to a
chain of command is a very bad
idea, it is an antiquated leadership
style and has never been effective in
business or healthcare. The chain of
command is often the weakest link
in a communication cascade. You
need to strike a balance on what is
the responsibility of the organisation
and what is the responsibility of the
staff member. What is expected of the
organisation is clear communication
in a timely fashion placed in multiple
areas of access. The responsibility of
the staff is to access the information
online, in person, or written forms
of communication that are offered.
It is a dual responsibility. Of course,
the medical staff is busy, of course
they are burdened with many tasks
and responsibilities, but they have to
take part of the responsibility to avail
themselves of the communication
offered.
Along with responsibility to be clear
comes the responsibility to manage
change. The compact clearly states that
you expect the medical staff member
to engage in change management and
be a leader in constant improvement.
You lose the staff and their insight if
the organisation doesn’t take seriously
the responsibility to use those
procedures and tools that will help
them thrive and not be crushed as the
pace of change increases. This is a huge
distinguishing feature between great
organisations and failing organisations.
It will be a competitive advantage for

those who can learn how to improve
the efficiency of the staff again. Long-
term, not short-term, thinking is what
is needed. Short-term thinking would
say ‘we don't want to take her out of
clinic to learn these computer things, I
am sure she will do fine learning along
the way.’ You save a few dollars but
end up with a frustrated, less efficient
staff for months or years. Short-term
thinking would say ‘no we don't
want to add another medical assistant
because of course that would add
some costs’, but if adding one medical
assistant increases the efficiency of the
medical staff member by 30 per cent or
40 per cent then the cost differential
is insignificant to the benefit in both
quality and revenue.
When you look at studies
about medical staff burn out and
dissatisfaction with the job, they rarely
lead with “I’d like my benefits 2 per cent
richer”, they talk about the persistent
struggle of change and support to help
accomplish the levels of quality and
efficiency they hope to meet.
One of our key responsibilities is
to give staff tools to help manage this
rapid change and the constant drive
for improvement. Lean management
systemshavetakenalotofnegativepress
with the weak comparison between
building cars and fixing people. To the
contrary, around the world, there is a
growing number of high performing
healthcare organisations proving
you can engage staff, lower costs and
improve quality at the same time.
(Look at Catalysis https://createvalue.
org/) Lean management practices
can engage the front line all the way
through the medical staff. They are
simple to use and many of the tools
are based on parallel principles that
clinicians learned in medical school.
For example, the A3 improvement
tool can be used by anyone with any
background but is engaging enough
to have the medical staff quickly
participate in improvement projects.
The form asks you to describe the
current state, very similar to a physical
and history. It asks to collect data
to support your position much like
looking at lab and x-ray material. It
asks you to describe the future state
and reevaluate the changes you make
on your way to that future state. It is
very consistent with how clinicians,
nurses and pharmacist train and makes
for an easy transition to a staff building
rather than staff crushing improvement
projects.
Finally organisations that function
very well invite the medical staff to
be a part of the leadership. Engaging
them rather than battling them results
is better outcomes for all. The models
may vary: physician CEOs or not,
physicians highly represented on the
board or not. The key is not who has
what title. The key is to build a great
AuthorBIO
Jeffrey E Thompson is executive advisor and chief executive officer
emeritus at Gundersen Health System. Thompson is a trained
pediatric intensivist and neonatologist, and served as Gundersen’s
chief executive officer from 2001 to 2015. After completing his
professional training in 1984, Thompson came to Gundersen with a
desire to care for patients and to teach. He was asked to serve on
Gundersen’s boards beginning in 1992 and was chairman of the
board from 2001 to 2014.
“Lead True, Live your values, Build your people, Inspire your
community”
environment for all staff, including the
medical staff. If the medical leaders
are willing to do that…then invite
them in and the leadership team will
be strengthened by their commitment
and insight. The rest of the staff will
be watching so the governance needs
to demonstrate that the organisation is
moving to serve the broader purpose,
it's accomplishing it's major goals and
that it's living by its values.
Several themes emerge from
this description on how to build an
environment that's more likely to
recruit and retain your clinicians.
First a dual responsibility on the
part of the organisation and on the
clinician to agree to set broad goals
focused on something bigger than
themselves or their pocketbook.
Next, a set of values that are both
clear, concise and consistently lived
across everyone in the organisation.
Acommunicationandimprovement
environment that is effective, efficient
and improves (not burns) the life out
of the staff member.
Finally , senior leaders chosen
by their actions consistent with the
purpose, goals and values and less so
by their previous background or title.
The competition to recruit, and
the great advantage of permanently
retaining the best medical staff is not
accomplished by money or flashy perks.
It takes clarity of purpose, lived values,
and real communication. The payoff is
efficiency, quality and growth.
References are available at www.asianhhm.com
Leaving communication
to a chain of command
is a very bad idea, it is
an antiquated leadership
style and has never been
effective in business or
healthcare.

A market intelligence leader delivering
research and consultancy for the Global
Healthcare Industry

Healthcare systems around the world are recognising
the need to move from fee-for-service to value-based
healthcare. This requires a focus on raising the quality
of care as the driver towards value rather than pure cost
reduction, as well as engaging the patient. It requires
a shift in understanding that patient engagement is
no longer the thing to do after the patient has visited
the hospital, but should be implemented from the very
beginning, before they visit the hospital, and even
taking it further back to managing population health.
Tim Morris, Product & Partnership Director, Europe, Middle East, Asia Pacific, Elsevier
Reactive, Acute Care
to Proactive and
Preventive Care
By engaging patients
coordinating care in an appropriate and
timely manner for the best outcome
for patients is becoming more complex
and difficult every day. This requires a
focus on raising the quality of care as
the driver towards value rather than
pure cost reduction, as well as engag-
ing patients. It also requires a shift in
understanding that patient engagement
is no longer the thing to do after the
H
ealthcare systems around
the world are recognising
the shift from reactive, acute
care, to proactive and preventive care.
This comes at a time when countries
are facing the challenges of an ageing
population, which in turn has an
impact on the healthcare system
with potentially unsustainable rise in
healthcare spending. Japan, Korea,
Australia and Singapore are some of
the fastest ageing nations in Asia, and
these countries are also experiencing a
transformation from fee-for-service to
value-based healthcare.
Ensuring that healthcare systems
continue to be sustainable, would inevi-
tably require better quality and more
cost-efficient healthcare services. As
patient expectations rise, accessing and

patient has visited the hospital, but
should be implemented from the very
beginning, before they visit the hospi-
tal, and even taking it further back to
managing population health.
Challenges in Today’s Healthcare
Landscape
It is not only the cost of healthcare that
we must consider – today’s healthcare
challenge is also the changing nature of
illness, with the disease burden shifting
from infectious to chronic diseases. The
World Health Organization (WHO)
estimates that 50 per cent of the global
burden of disease is chronic illness.
Chronic disease is also a significant
concern for countries in Asia, such as
Singapore. One in nine Singaporeans
have diabetes, and the numbers are
expected to grow due to a rising obes-
ity levels, and a lack of physical activity
and a healthy diet. For similar reasons,
China is experiencing a growing burden
of cardiovascular disease, a chronic
disease that has been on the rise for the
last 20 years and now the leading cause
of death in the country.
Chronic diseases require a different
approach that factors in the complexity
of the illness and frequent requirements
for proactive and planned integrated
care within a system that patients can
navigate. If unmanaged, such chronic
conditions frequently lead to poor
patient outcomes and hospitalisations
that are key drivers of costs to health-
care systems.
Increasingly, patients too
are demanding more clarity and
information from their healthcare
providers regarding medical diagnosis
and treatment, as well as or from the
Internet of Health Things (IoHT), to
allow them greater control on their
health and wellbeing.
Another obstacle to delivering
value-based care is the overwhelming
magnitude of medical information and
the ability to process all the knowledge
into actionable steps for better patient
outcomes. By 2020, medical informa-
tion is expected to double every 73 days.
If physicians were to read everything
of possible biomedical relevance, they
would potentially need to read around
6,000 articles a day.

The burden of information overload
and the expectation from providers to
rapidly incorporate all relevant evidence
into practice is likely to negatively
impact the quality of care and result in
poor and even catastrophic outcomes
for patients.
Damage Caused by Variability in
Care Delivery
Standing in the way of high value
care is variability. Variability in care
delivery means that a subset of patients
(often a large subset) experience poorer
clinical outcomes while paying the
same healthcare expenses. Variability
in care delivery also leads to spending
with reduced benefit. Variability in
healthcare takes many forms, but it can
be segregated broadly into knowledge
and operational variability.
Knowledge variability poses the
greatest threat to the quality and cost
efficiency of health and healthcare
delivery, and is more challenging to
identify and address. With an explosion
in the rate of medical information
growth coupled with the slow adoption
of research findings into clinical practice,
more often than not physicians don’t
know what they don’t know.
Operational variability is when
healthcare systems, physicians, nurses
and other clinicians deliver care differ-
ently and, as a result, experience
variations in outcomes. Variability
arises, for example, when a physi-
cian’s handwriting results in the nurse
or pharmacist misreading the prescrip-
tion and compromising the patient’s
safety.
The complexity of today’s healthcare
system means that not all operational
variability is so easily countered. As
healthcare reform drives us from
acute, reactive care toward proactive,
preventativecare,operationalvariability-
and the clinical and financial risk
it generates-is prone to metastasising.
One of the primary reasons is the care
itself is rapidly moving out of traditional
settings, such as hospitals and physician
offices, to large retail pharmacy chains,
and patient homes. The roles and
responsibilities of providers are also
expanding, with greater clinical care
responsibilities shifting to nurses and
to patients themselves. Such a rapidly
changing, multiple-provider system
creates room for operational variability
and subsequent patient risk and cost
inefficiency.
Fortunately, today’s technologies
represent a great leap forward in
accessing high-value care information
and guidance at all points of
care. Within traditional care settings,
integrated Electronic Health Records
(EHR) systems can reduce some
operational variability. But in reality,
EHRs serve only as a vehicle to deliver
current, credible, evidence-based
information. In order to truly address
new challenges appearing as our entire
healthcare delivery model evolves,
Clinical Decision Support (CDS) is
the most impactful answer to the vast
and destructive problem of variability in
care delivery.
CDS solutions deliver evidence-
based and current information specific

The World Health
Organization (WHO)
estimates that 50 per cent
of the global burden of
disease is chronic illness.
AuthorBIO
Tim Morris has nearly 30 years of healthcare experience from
delivering care within a busy London Emergency Department, as
a nurse, through to Product & Partnerships Director at Elsevier a
world-leading provider of information solutions. His experience in
developing and delivering clinical decision support solutions for
healthcare has included both primary and secondary care. Within
Elsevier, he works with an international team of expert clinicians and
technologists to drive current credible evidence based decision
support at the point of care.
to the patient’s clinical history to the
physician, enabling him or her to make
the best decision. One such example is
clinical pathways. While definitions and
approaches to development are numer-
ous, a commonly shared goal of clinical
pathways is the longitudinal reduction
of operational variability as patients
move from care setting to care setting
and from provider to provider.
‘Push & Pull’ CDSS
The majority of today’s CDS are ‘pull’
solutions (clinical reference and diag-
nostic reference), requiring providers
to interrupt their workflow to research
answers to their clinical questions.
On the other hand, ‘push’ solutions
feed current, credible, evidence-based
information specific to the patient’s
clinical history and current clinical
status directly to the physician at the
point of care. Elsevier’s Order Sets for
Physicians and Care Plans for Nurses
are powerful forms of ‘push’ CDS
solutions, designed not only to answer
questions that physicians and nurses
usually ask, but also to answer critical
questions that they don’t know they
should be asking. For instance, even
when a physician fails to appreciate
that a cancer patient should undergo
blood testing for a genetic syndrome,
an order set can push this evidence-
based suggestion to the physician.
Best practices can be pushed to nurses
to drive quality and cost efficient care
regardless of the nurse’s experience (or
lack thereof). Health screening, medi-
cation, and other credible preventative
and care maintenance information can
be pushed to patients, their family, and
even their care taker.
A combination of ‘pull’ and ‘push’
CDS offers the greatest opportunity to
empower physicians, nurses and other
providers to provide the safest, highest
quality, most cost-efficient healthcare.
There are many ‘push’ and ‘pull’ CDS
solutions to implement and add based
on the specific needs and strategies of
individual population health providers.
They can be added in a modular fashion
– order sets, reference solutions, care
plans, drug information, and nursing
skills.
The Multiplier Effect
Even with the best physicians, nurses and
‘push’ and ‘pull’ CDS solutions in place,
if patients are not engaged and invested
in making decisions about the care they
receive, then the cost of care is still going
to increase. Discharged patients who
do not take their medications, do their
physiotherapy, will be readmitted. This
can have a multiplying effect on costs,
hospital beds and mortality.
It is important to transfer that aware-
ness of care consistency to patients as
well, standardising their approach and
letting them understand the care that
they should be given.
There are many ways to educate and
engage patients. There are interactive
and ‘entertaining’ online tools, which
use videos and cartoons to make boring
information interesting to read or watch.
One such example is Health Nuts
Media’s1
“Huff & Puff: The Asthma
App”, which has improved the paediatric
pulmonology patient experience at
University of California, Los Angeles
(UCLA). Appropriate educational
opportunities for patients and their
families are now readily available on
television, tablets, computers and
mobile devices. The videos have also
significantly reduced the amount of
time that clinicians and nurses spend
on patient and caregiver education,
including post-visit phone calls.
In order to improve the health of
our populations and reduce the costs
of care, we must make a 180-degree
philosophical and cultural shift away
from reactive, acute, inpatient care to
proactive, outpatient, preventative and
maintenance care. Additionally, when
we measure value-based care, we not
only need to be measuring the cost of
care in our hospitals, we need to be
looking at long-term care of patients
outside hospital walls and measuring
that as well.
Patient engagement, no longer is a
nice to have. It is no longer just a clini-
cal follow up after a patient has visited
a hospital. Patient engagement should
start from pre-hospital visits; it should
be educating patients before they arrive
and actually taking it even further back
to population health. It is about manag-
ing health and well-being before people
become ill rather than having to worry
about patients being discharged from
the hospital. Only then will we truly
see improved outcomes at a population
health level.
1 http://healthnutsmedia.com/

MEDICAL SCIENCES
Newer surgical options shaping up!
Diabesity
(Diabetes & Obesity)

The need for optimal integration with holistic approach (lifestyle
modification + pharmacotherapy + bariatric surgery) is the current
road to management of obesity. Bariatric surgery has gained popularity
worldwide to treat the diabesity ( obesity + diabetes) twin epidemic. The
measure of postoperative outcomes of bariatric surgery are assessment
indicators which improve the clinical practice. However, the need to make
the society aware about obesity as a metabolic disorder, and to control
and improve the co-morbidities associated with the combined approach of
medical and surgical intervention is the voice of the medical fraternity.
Pradeep Chowbey, Executive Vice Chairman, Max Healthcare
MEDICAL SCIENCES
O
besity is a major global
economic problem. It is
a complex disorder and a
major health risk factor linked to
cardiovascular disease, stroke, cancer,
hypertension, diabetes, and mortality.
Large scale developmental activities
and urbanisation in India have
brought significant changes in lifestyle
and dietary habits in the growing
population. According to WHO
survey, worldwide obesity has
doubled since 1980. The studies
reveal obesity is killing three times
as many as malnutrition. Obesity is a
global burden on society which has a
potential to destroy Nations medically
and economically. The prevalence of
both type 2 diabetes and obesity has
globally increased and attributed to
adoption of sedentary lifestyle and
dissemination of the western diet.
Diabetes is also complex. No
one knows this better than the
physician managing this entity of
myriad presentations. It is also well
known that despite best efforts by the
treating doctors, a large segment of
this population struggles to bring the
disease under control. There are several
lines of evidence that inflammation
of fat directly causes obesity and
diabetes. Inflammation begins in the
fat cells themselves. Fat cells are the
first to be affected by the development
of obesity. As fat mass expands,
inflammation increases. Diabesity
causes inflammation. Insulin and leptin
resistance impair glucose metabolism.
When fat cells become insensitive
to insulin, they can’t store any more
glucose and hyperglycemia results.
Dr. Francine Kaufman coined the
term diabesity (diabetes + obesity) to
describe them. Diabesity can be defined
as a metabolic dysfunction that ranges
from mild blood sugar imbalance to
full-fledged type 2 diabetes. Diabesity
is a constellation of signs that includes:
• Abdominal obesity
• Dyslipidemia (low HDL, high LDL
and high triglycerides)
• High blood pressure
• High blood sugar (fasting above
100 mg/dL, Hb1Ac above 5.5)
• Systemic inflammation
• Increase formation of blood clots.
The harmful impacts of obesity
and diabetes are grave and
multiple; extending beyond the
physiological to damage
also the emotional and
psychological health of patients.

Genetically, Indians are susceptible
to weight accumulation, especially
around the waist. An obese individual is
much more susceptible to diseases such
as diabetes, hypertension, osteoarthritis,
snoring, infertility, polycystic ovarian
syndrome and increased chances of
cancer.
What Goes Wrong?
There is no doubt that there is direct co
relation between diabetes and obesity
and the more severe the obesity, the
more stubborn will be the diabetes
management for treating diabetes
associated with obesity.
Weight gain appears unavoidable
when patients with Type 2 diabetes are
commenced on insulin. Body weight
increases by 2Kg for each percentage
point decrease in HbA1C during
the first year. Gain in weight mainly
represents an increase in fat mass,
which enhances insulin resistance and
In the light of the escalating global
diabetes crisis, the need of the hour is
for the physicians and endocrinologists
to include surgical management in their
armamentarium against obesity. There
are wide modalities of treatment for
management of obesity. The pyramid of
managementofobesityinclude,lifestyle
modifications pharmacotherapy and
bariatric surgery. With increasing BMI,
the treatment modality changes. A BMI
of more than 32.5 is associated with
diseases such as diabetes, hypertension,
osteoarthritis, obstructive sleep apnea
etc. These bariatric surgeries have been
promising in ensuring good weight loss
and rapid resolution of co-morbidities.
In 1998, National Institute of Health
guidelines recommended bariatric
surgery in morbidly obese (body
mass index [BMI] ≥ 40 kg/m2
) or
patients with BMI ≥35 kg/m2
with
co-morbidities such as diabetes and
hypertension. The hindgut hypothesis
MEDICAL SCIENCES
increases the risk of obesity related
complications.
Causes of weight gain
Reduced glycosuria•
Anabolic action of insulin•
Fluid retention•
Hypoglycaemia and increased calorie•
consumption
Excess insulin administration•
Combination of obesity and muscle•
impairment: 'sarcopenic obesity'.
There is enormous scientific
evidence that weight loss inevitably
helps in resolving this condition. If
one needs to lose 10-20 kgs, it can be
done by healthy diet and lifestyle
changes. However, if one needs to lose
more than this, surgical intervention
must be considered.
Treatment
Treatment should focus equally on
remission of both diabetes and obesity
and needs to be widely publicised.

by Cummings etal., suggests that
insulinotropic gut hormones including
Glucagon Like Peptide-1 (GLP-1)
and Peptide Tyrosine Tyrosine
(PYY), are produced when nutrients
arrive at distal intestine, leading to
hyperglycemia reversal. The major
mechanism of the decrease in plasma
glucose after bariatric surgery is acute
negative calorie balance. The father of
bariatric surgery, Walter Pories pointed
out decades ago that acute negative
calorie produced same effect on blood
glucose that was produced by gastric
bypass itself. Surgical Treatment and
Medications Potentially Eradicate
Diabetes Efficiently (STAMPEDE)
Trial, the team has shown that patients
experienced positive outcomes at
one and three-year randomisation,
especially after gastric bypass and
sleeve gastrectomy procedures, which
they found to be superior to medical
therapy alone.
Bariatric surgical procedures
are increasingly being performed
for overweight diabetics. It is now
well known that weight loss surgery
leads to resolution of co morbidities,
especially diabetes, in a majority of
patients. However, it is important
to consider that these surgeries are
highly specialised needing a
multidisciplinary team which includes
surgeons with technical expertise,
anaesthetists and other paramedic
staff and most importantly the
treating physician for long term
follow up and management of these
patients. A Centre of Excellence in
metabolic and bariatric surgery is the
appropriate choice for undergoing
this procedure which not only has
the team with surgical expertise but
also state of the art infrastructure
customised for the morbidly obese and
round the clock care and support.
Even the International Diabetes
Federation endorsed the surgical
intervention in uncontrolled diabetes
with obesity (Diabesity)
Diabetics undergoing these
procedures have show a significant
improvement of diabetic status,
resulting in normal blood glucose
and HbA1c levels with immediate or
gradual discontinuation of diabetes
related medications or insulin.
There is extensive scientific
evidence that illustrates that
resolution of diabetes has been seen
in patients following a gastric bypass
surgery even before significant weight
loss occurs. The outcomes are also
driven by the duration of diabetes,
best results are seen if the duration is
less than ten years, however at all stages
the results are good and satisfactory.
In the given scenario of increasing
morbidity due to Type 2 diabetes,
bariatric intervention is emerging as a
promising cure. It provides exceptional
sustained weight loss and remission of
type 2 diabetes in addition to related
co morbidities and quality of life
improvements.
MEDICAL SCIENCES
Following weight loss surgery,
significant improvement has
been observed in obesity related
comorbidities. 64-100 per cent of
patients with Type II DM show
resolution or improvement of this
ailment. Similar observations are
noted in patients with hypertension,
where 25-100 per cent of patients
experience resolution or improvement
of disease. Dyslipidemia is shown
to improve or resolve in 60-100 per
cent of patients with this disorder.
Patients of sleep apnea preoperatively
also show substantial improvement.
Improvement is also documented in
patients with cardiac dysfunction,
gastroesophageal reflux, pseudotumor
cerebri, polycystic ovarian disease,
degenerative joint disease, stress
urinary incontinence severe venous
stasis, non-alcoholic hepatitic steatosis
and overall quality of life.
Benefits of weight loss surgery
Diabetes mellitus 77 per cent show•
improvement
Hypertension 62 per cent recover•
completely
High cholesterol 70 per cent showed•
decreased blood levels Arthritis
Majority improve Sleep apnea•
Lowered risk of cancer.•
Bariatric surgery is the most effective long term treatment
for obesity with the greatest chances for improvement and
even resolution of obesity- associated complications.
Surgical management of obesity is an option for those who
are classified as morbidly obese. A person with BMI of 37.5
or greater is known as morbidly obese. In addition, a patient
with a BMI of 32.5 or greater with one or more obesity
related diseases is also classified as morbidly obese.
Obesity (bariatric) surgery is a life saving surgery and must
not be confused with a cosmetic procedure like liposuction.

AuthorBIO
Pradeep Chowbey is Joint Managing Director, Chief – Surgery
& Allied Surgical Specialities and Director – Minimal Access,
Metabolic and Bariatric Surgery at Max Healthcare Institute Ltd.,
Saket, New Delhi (India). He is former Chairman of the Minimal
Access, Metabolic & Bariatric Surgery Centre, Sir Ganga Ram
Hospital, New Delhi, the first of its kind in the Asian subcontinent,
established in 1996. He is Founder President of Asia Pacific Hernia
Society (APHS). He is President - Asia Pacific Metabolic & Bariatric
Surgery Society (APMBSS) and President of Asia Pacific Chapter of
International Federation for the Surgery of Obesity and Metabolic
Disorders (IFSO). He is Honorary Member of German Hernia
Society at Germany, Indonesian Hernia Society at Bali, Indonesia
& GCC Hernia Society, Dubai, UAE.
Future Research and Advances in
Treatment of Obesity
The future promises good
optimal integration with holistic
approach (lifestyle modification +
pharmacotherapy + bariatric surgery)
in management of obesity. The
introduction of new implantable
neuro regulatory devices will
automatically detect the intake of
food and help in resolving the obesity.
It involves development of better
criteria to define need for surgery and
report results.
Conclusion
The last decade has seen surgical
treatment for morbid obesity emerge
from being the interest of only a few
surgeons and physicians to a well-
recognised surgical specialty. This has
been consequent to a rapid increase in
the incidence of obesity over the past
two decades catching the attention of
the medical and media community, as
well as emergence of minimal access
surgery as a technological advancement
in surgical sciences. Non-surgical
means of losing weight are effective in
achieving 5-15 per cent body weight
loss. It may be best to educate the
patient to the balance between amount
of weight loss and surgical morbidity
of various bariatric procedures. In
this context, although weight loss
following restrictive procedures is less
compared to the more complex, bypass
procedures, the benefit derived is greater
in terms of minimal procedure-related
morbidity. To optimise the outcome of
the procedure, bariatric surgery should
be performed on carefully selected
patients, in bariatric centres, specially
equipped to care for the obese, within a
broadly based, multidisciplinary setting
that provides lifelong postoperative
care.
“Diabesity is a public health
emergency in slow motion, Let us join
hands together to eradicate this weed
from the society.”
Bariatric surgery is an appropriate treatment for people with type 2 diabetes
and obesity not achieving recommended treatment targets with medical
therapies, especially with other major co-morbidities.
Surgery is an accepted option in people who have type 2 diabetes and a BMI
of 32.5kg/m2
or more.
Surgery should also be considered as an alternative treatment option in
persons with BMI 30 to 35 when diabetes is not controlled by optimal
medical regimen, especially with cardiovascular disease risk factors.
The IDF statement also states that in Asians, and some other ethnicities of
increased risk, BMI action points may be reduced by 2.5 kg/m2
i.e. 27.5 to
32.5 kg/m2
(for Indians in particular)
The International Diabetes Federation
position statement states
MEDICAL SCIENCES

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In Asia, the incidence of cancer cases is estimated
to increase from 6.1 million in 2008 to 10.6 million in
2030 due to ageing and growing populations, lifestyle
and socioeconomic changes. While there has been
significant innovations in cancer treatment that help
prolong a patient’s life and their quality of life, how can
patients be supported at every stage of their journey?
Yew Oo TAN, Specialist in Medical Oncology, Farrer Park Medical Clinic
The Prospects of
Cancer Care in Asia
Integrated services
A
sia is the world's most diverse
and populous continent; 4.5
billion of the world’s 7.6 billion
peoplelivethere,andthepopulationwill
increase to 5.2 billion by 2050 – with
China and India alone accounting for
37 per cent of the worldwide
population.
As a consequence of continuing
socioeconomic development and
increasing control of communicable
MEDICAL SCIENCES

diseases, life expectancy in all Asian
countries has significantly increased.
The proportion of people aged 65 years
and above is likely to double from the
current 7 per cent by 2030. It is well-
known that cancer risk increases with
age. Changing lifestyles, increasing
urbanisation, changes in reproductive
patterns and diet, obesity, tobacco
use, alcohol, chronic infection and
increasing lifespans contribute to an
ever-increasing cancer burden and
changing cancer pattern in Asian
countries.
Based on GLOBOCAN estimates,
about 14.1 million new cancer cases
and 8.2 million deaths occurred in
2012 worldwide. It is estimated that
6.7million new cancer cases—39 per
cent of new cases worldwide—were
diagnosed among 4.5 billion persons
(48 per cent of the world population)
living in the fifteen most highly
developed countries in South, East,
South-Central and Southeast Asia:
Japan, Taiwan, Singapore, South
Korea, Malaysia, Thailand, China,
Philippines, Sri Lanka, Vietnam,
Indonesia, Mongolia, Pakistan, Laos,
and Cambodia.
The striking variations in ethnicity,
social norms, sociocultural practices
and traditions, socioeconomic
development and habits and dietary
customs there are reflected in the
patterns and burdens of cancer in
different regions of Asia. The pattern
and incidence of various cancers
in different Asian countries vary
significantly.
1.How has cancer care in Asia
evolved over the last decade?
The healthcare systems across Asia
are diverse and can vary from very
rudimentary to very sophisticated.
Likewise, the quality of cancer care
is also highly variable. However,
with increasing wealth and a growing
economy, across many Asian countries,
the quality of healthcare delivery
has improved in the past decade.
Likewise, cancer care across many
Asian countries has improved. Many
new cancer treatment facilities have
been built and an increasing number
of cancer specialists and paramedical
personnel are being trained. There are
still many populations where access to
good quality cancer services are not
possible or affordable.
2. What does it mean to have
integrated or holistic cancer care
services?
Integrated or holistic cancer services
are the key to successful management
of many cancers today. With the
advent of new surgical techniques,
development of sophisticated
radiation oncology technology and ther-
apies, as well as new drug treatments,
cancer treatments today require multi-
disciplinary teamwork to achieve the
best outcome for patients. The role of
other paramedical personnel to improve
the quality of life and psychological
support is now an integral component
of good quality cancer care.
3. When it comes to cancer care
– from diagnosis to treatment to
monitoring – how does the standard
of care in Asia compare to that in
other regions?
There is no Asian ‘standard of care’
since it is such a diverse continent,
but in developed economies such as
Japan, China, South Korea, Taiwan,
Hong Kong and Singapore there are
national guidelines or internationally
accepted guidelines for many cancer
specialists. These are used for
managing cancers from diagnosis
through to treatment and monitoring.
In fact, in these countries, there are
many established centres of excellence
where international clinical trials are
conducted. The outcome of these trials
has changed the treatment practice of
many cancers, such as lung, liver and
stomach cancers.
MEDICAL SCIENCES

4. How do you see integrated
or holistic cancer care services
benefiting the entire spectrum of
users – from patients to caregivers
to healthcare providers to the
overall healthcare system?
Many cancers among Asians, especially
East Asians, have different incidences,
causation and molecular profile. The
outcome of treatment has shown
distinct differences in responses
and it is increasingly important to
perform certain diagnostic tests on the
tumour to show the differences. The
healthcare providers and system must
be geared to support these important
diagnostic tests, in order to obtain the
best outcome for the patients. In line
with this, there must be integration
of the various healthcare providers in
approaching the treatment decision.
We are seeing the changing
burden of cancer in Asia, along with
appropriate management strategies.
Many Asian countries should plan
strategies that promote healthy
ageing via living healthy lifestyles,
tobacco and alcohol control measures,
Hepatitis B Virus (HBV) and Human
Papillomavirus (HPV) vaccination,
cancer screening services, and vertical
investments in strengthening cancer
healthcare infrastructure to improve
equitable access to services.
5. What about rural areas in Asia?
How can they equally benefit from
having access to integrated cancer
care services?
With improving economies, many
cancer patients living in rural areas
of Asia have better access to modern
diagnostic and treatment facilities.With
better transport and communication,
many cancer patients in various Asian
countries are expecting more accurate
diagnosis and treatment for their
cancers. A few patients with economic
means are travelling to regional cancer
centres across national borders to seek
better treatment for their cancers. This
trend of medical tourism will continue
as long as these centres of excellence
provide prompt, accurate, state-of-the-
art care at affordable prices.
6.What is the future of personalised
cancer care?
Today, many cancers such as breast,
lung, stomach, colorectal, lymphomas
and leukemias require precise
histopathological and often molecular
or genomic profiling to offer precision
medicine. Personalised cancer care
should now be called ‘Precision
Medicine’ as new drugs are prescribed
to stop cancer growth based on
certain molecular targets found in the
tumour or blood. With the explosion
in genomic medicine, the future of
Precision Medicine looks bright and
promising. The well-known side effects
of cytotoxic drug therapies such as
nausea, vomiting, hair loss and low
blood counts that many patients fear,
may become a thing of the past
7. What are the main factors in
providing successful integrated
cancer care services and can the
healthcare industry support this?
Foranyintegratedcancercareprogrmme
to be successful, the main ingredient
is the collaboration and cooperation
between the patient, healthcare
providers and industry. The industry
can be the companies that make the
instruments or the equipment for the
healthcare providers or pharmaceutical
companies. A symbiotic relationship
between the healthcare providers and
industry will ensure better integration
and holistic care for the cancer patients.
With rapid advances in technology and
better understanding of cancer biology,
more sophisticated instruments and
equipment, as well as targeted drugs or
immunotherapy,arerequiredtoincrease
the survival of many advanced cancers.
The tremendous advances in cancer
therapies in the past two decades have
been unprecedented and this is in no
small measure due to the collaboration
between healthcare providers and
healthcare industry.
A u t h o r B I O
Yew OoTan has been practising as a specialist
medical oncologist at Icon SOC Farrer Park
Medical Clinic in Singapore for more than
15 months. Prior to that, he was Professor of
Medicine at National University of Singapore
and he has been practising medical oncology
for more than 40 years.
MEDICAL SCIENCES
The proportion of
people aged 65 years
and above is likely to
double from the current
7 per cent by 2030.

The first systematic prospective evaluation of
valvotomy for mitral stenosis 1948-1952.
The Club which my book celebrates
was convened by Russell Brock in 1948.
The book includes a complete record of
the minutes of meetings of cardiologists,
radiologists, the clinical scientists of the
Medical Research Council unit, the thoracic
surgeons and anaesthetists. They report the
earliest consecutive series of intracardiac
operations until the end of the Clubs active
life in 1956. By then cardiopulmonary bypass.
In this introduction to ‘”The Heart Club”
I will deal with their work on mitral stenosis
as in intracardiac operation before the open
heart era.[1]
The surgical history of mitral stenosis
is well documented in terms of the ten
operations chronicled in Cutler’s “final
report” in 1929,[2]the moratorium of the
1930sand early 1940s[3] and then the “firsts” of Bailey,
Harken and Brock in 1948.[4] The discovery of the previously
unknown minutes of “The Heart Club” prompted me to
make a more detailed contextual history and I discovered
an admirable account of team working leading to Brock’s
first operations for mitral stenosis in 1948. The handwritten
minutes, penned by Ian Hill on September 13, 1948 includes
a note that the anaesthetist “Dr Rink commented on the
optimum position for anaesthetisation of mitral stenotics
undergoing operation.” Brock scheduled three patients for
operation in the in the ensuing fortnight.
The operations by Cutler in Boston in 1923, and Souttar
in London in 1925, were each followed by survival for several
years but Cutler’s subsequent six patients died within hours
or days of operation. The attitude in the medical texts
became progressively more set against surgery and the
physicians can’t be blamed for opposing the idea of surgery
as the 1920s Boston experience appeared to them to have
been an unmitigated disaster. Perhaps if Cutler had freed
the commissures rather than blindly cutting the leaflets,
things might have gone better but that we can never know.
The leading opinion in cardiology was firmly against any
further attempts.
It was Harken’s war time experience that Brock relied
on to believe that it was worth trying again. Dwight Harken
had done some of his training at the Brompton in 1939 and
impressed the London Thoracic surgeons. In 1944, with
their support, he was chosen as the surgeon in charge of
the 160th US Army Hospital, set up in huts near North Leach
in Gloucestershire, England in preparation for the D-Day
landings in June 1944. The following year Harken reported
the survival of all 134 soldiers from whom he had removed
bullets and shrapnel from in and around the heart. Another
chance presented by war provided the evidence that Brock
needed to embark on heart surgery. An exchange programme
set up between Guy’s and Johns Hopkins brought Alfred
Blalock to Guy’s where he operated on ten children with
Fallot’s Tetralogy. The systemic to pulmonary artery shunt
operation devised by Helen Taussig and Vivien Thomas
was adjacent to, but not on the heart itself but with the
evidence from Harken and Blalock, heart disease could no
longer be ruled to be beyond the help of surgery. With his
cardiological colleagues, and their names in alphabetical
order, the Club reported their first 100 consecutive patients
in 1952. The team are shown in the group photograph
taken on the roof of Guy’s Hospital.
Reference List
1 Treasure T: The Heart Club. ed 1st, London/New York, Clink Street, 2017.
2 Cutler EC, Beck CS: Present status of surgical procedures in chronic
valvular disease of the heart; final report of all surgical cases. Arch Surg
1929;18:403-416.
3 Swazey JP, Fox RC: The clinical moratorium: a case sudy of mitral valve
surgery; in Freund P, (ed): Experimentation with Human Subjects. New York,
George Braziller, 1970, pp 315-357.
4 Treasure T, Hollman A: The surgery of mitral stenosis 1898-1948: why
did it take 50 years to establish mitral valvotomy? Ann R Coll Surg Engl
1995;77:145-151.
The Heart Club

Trends
inIndian
Cancer
Market
MEDICAL SCIENCES

Cancer patients need specialist care that
necessitates responsibility and is accountable
for the quality of the treatment. The last few
decades have seen considerable efforts made in
the treatment and prevention of cancer around
the world, but it still looms large over our lives,
especially in India for a multitude of reasons.
Suresh Ramu, CEO & Co-Founder, Cytecare Cancer Hospital
China and the USA with the maximum
number of cancer cases. Ignorance about
the disease, its symptoms and a delay
in visiting medical experts for a proper
diagnosis has increased the prevalence of
this illness which is anticipated to grow
by 30 per cent in the next 5 years.
Breast cancer is one of the most
common cancers to affect women
globally as well as India. Lack of
awareness contributes towards the
growing numbers every year. A majority
of oncologists have suggested cancer
literacy and amongst women especially
those between 40 and 60 years for
them to undergo a regular screening
schedule which would help detect
cancers in their early stages and assist
doctors to treat them effectively.
Cervical cancer caused by the
Human Papillomavirus (HPV) is
another common cancer among
Indian women and accounts for
12 per cent while oral cancer accounts
for 7 per cent of new cancer cases every
year. The three most common cancers
that affect men in India are Prostate,
MEDICAL SCIENCES
T
he physiology of each organ
in the human body is differ-
ent. Cancer diagnosis produces
varying impact on a cancer patient’s
life-emotional, social and financial.
Cancer is not just a disease. It’s a disease
that can become resistant to almost
anything. India is slated to become
the country with the maximum popu-
lace of individuals below the age of
40 years by the year 2020! Early diag-
nosis and regular screening tests could
alleviate much of the suffering and
death due to cancer.
All cancer patients face the difficulty
of making the right decisions regarding
their course of care. Cancer patients
need specialist care that necessitates
responsibility and is accountable for the
quality of the treatment. The last few
decades have seen considerable efforts
made in the treatment and prevention of
canceraroundtheworld,butitstilllooms
large over our lives, especially in India for
a multitude of reasons. The incidence of
cancer has reached mammoth numbers
with India being the third country after

Lung and Colorectal. Oral cancer is a
major health problem in India as in most
cases it gets detected only in the later
stages of the illness resulting in lesser
cure options and higher expenses. This
type of cancer is predominant amongst
the lower socio-economic classes of
the country, because of their high
addiction to tobacco, tobacco products
and tobacco substitutes. People residing
in rural areas are able to avail of
minimal health services and very few
medical personnel. This delays the
diagnosis of the illness leading to
inevitable tragic results. The urban
Indian women are affected more by
cancers of the uterus, ovaries and lungs
while men suffer cancers of the colon,
rectumandprostate.TheIndianCouncil
of Medical Research (ICMR) data has
explicitly cited the number of cancer
cases to increase at an estimated number
of 1.45 million new cases every year.
The fast-paced lifestyles, unhealthy
eating habits and addictions like
smoking and drinking are some of the
key factors attributing to the increasing
number of cancer cases.
India’s massive socio-economic
inequalities in access to healthcare
and other areas have led to a steady
increase in the number of cancer
cases throughout the country. There
is immense regional variation in
the occurrence of cancer in India.
The rural areas of India experience
large numbers of untreatable cancers
primarily because of a dearth of funds,
knowledge about the disease and
extremely poor treatment facilities.
As a country, India has a minimal
rate of public expenditure (1.5 per
cent of its GDP) on healthcare which
is the cause of the rising incidence of
various incurable illnesses, making
it a nation with the poorest amount
of expenses on public health care. A
severe shortage of trained medical &
health personnel and a lack of facilities
makes access to good treatment highly
challenging. The sedentary lifestyle
coupled with unhealthy eating habits,
consumption of alcohol and tobacco,
engender symptoms of various illnesses
and a lot of those leading to cancer.
A considerable amount of ongoing
research to provide affordable
treatment and mitigate the effects of
this disease is being complemented
by enhanced technology. Some of
MEDICAL SCIENCES

MEDICAL SCIENCES
the most notable new technologies
includes the Epigenetics treatment
which, like chemotherapy (although
less toxic), helps to transform cancer
affected cells to healthy cells.
To counter these cancer trends,
India has become the epicentre for
upcoming cancer speciality hospitals.
There are many leading hospitals in
India which are furnished with the most
advanced technology to treat cancer
patients effectively. There are multiple
hospitals founded by individuals who
have been veterans in the field of cancer
care and treatment, who have made a
huge difference with their scientific
approach and methodologies. Cutting
edge technology such as Cyclotron and
PET-CT have been introduced in the
Indian subcontinent.
Today, Indian hospitals are
more than equipped with the latest
technology and are at par with
international standards of care to treat
a multitude of cancer cases. Nuclear
medical oncology and molecular
oncology departments are not alien to
the top leading Indian hospitals which
utilise the most advanced technology
in the treatment of cancers. Today,
cancer treatment is definitely on par
and perhaps, in some cases, even better
than the existing treatments in some
countries across the globe.
Indian Council of Medical Research
(ICMR) has predicted that by the year
2020, India will witness more than
17.3 lakhs new cases of cancer and
more than 8.8 lakh Indians would die
because of it. Unfortunately, a majority
of the patients visit hospitals for
diagnosis or treatment in the advanced
stages of the illness. The need of the
hour is therefore heavy investments in
prevention techniques, vaccinations,
cancer awareness and screening, along
with a focus on clinical data research
and studies for developing better
cancer fighting techniques.
Today, medical researchers and
experts are more focused on health
literacy as a vast number of the rural
population is totally ignorant of the
onslaught of such diseases. Efforts by
government are being taken to slash
the prices of cancer drugs to make
them more accessible to the lower
socio-economic sections of society.
Pharmaceutical and biotechnology
companies are consistently working
on new research in the areas of
molecular treatment for varied cancer
pathologies.
Many R & D institutes are involved
in educational and screening efforts to
ensure prevention of disease at early
stage. Regenerative medicine such as
gene therapy and tissue engineering
have shown encouraging results with
wide range of cancers including lung
cancer, pancreatic cancer, protate
cancer, and malignant melanomas. At
least 12 companies across India are
in the process of developing liquid
biopsies to identify cancer cells and
tumours. Nanotechnology is being
actively resorted to by researchers
to selectively treat cancer cells
and enhance the efficacy of certain
treatments.
Some leading hospitals resort
to artificial intelligence based novel
breast cancer screening solutions.
Clinicians are now resorting to
machine learning which they believe
will enable them to develop patient-
specific cancer treatments by analysing
individual biology. Organ-specific
cancer treatment is another insightful
procedure which is gaining much
success in India. Next Generation
Photodynamic Cancer therapy
(NGPDT) is a new technology which
treats almost every type of cancer.
It uses the therapeutic properties of
light to kill the growth of cancerous
cells and is regarded as, perhaps the
Cervical cancer
caused by the Human
Papillomavirus (HPV) is
another common cancer
among Indian women
and accounts for
12 per cent while
oral cancer accounts
for 7 per cent of new
cancer cases every year.

Suresh Ramu is the Co-founder, CEO and a member of the Board of Directors
of Cytecare Hospitals. Ramu is also a Co-founder & Director of Cytespace
Research and Co-founder of Medwell Ventures. Prior to establishing Cytespace
in 2011, Ramu spent 10+ years with Quintiles Transnational. As Vice President
and Head – India, for Clinical Development Services, he managed all aspects of
clinical trials conduct in the country. Holding diverse senior leadership positions, he
was instrumental in creating two valuable assets for the organisation – the world’s
largest multi-shift data management operations to process clinical trial data, and
Asia’s largest cardiac safety lab.
A u t h o r B I O
her mobile to a specific number where
she will be assisted by specialist doctors
and,trainedpersonnelwhowilldiscuss,
understand and suggest an oncologist
at a cancer centre in close proximity to
the patient’s residence. This grid will
also help in fixing appointments for
the patients, update the patient for
her next visit and any tests which she
may have to undergo. The medical file
of each patient will be digitised which
will be a boon to the patient especially
in the case of second opinions. This
grid will also serve in the case of
other infectious diseases and specialist
treatment for the same. Doctors will
be able to document treatment plans
in real-time and patients will be able
to avail of specific treatment prescribed
to them in their city of residence.
Health camps to educate the masses
and making them aware of the disease
and its repercussions are imperative,
especially in the rural regions of a
country like India. Health literacy will
prove to be one of the most effective
measures towards containing this
dreaded illness. The commendable
amount of R & D in the treatment and
cure of cancer has made this disease
less of an ominous illness. Efforts are
being made to reduce the number
of tragedies. A choice of the right
hospital and the right treatment facility
which entails not only the requisite
treatments for illnesses like cancer, but
employs a humane approach to serve
them throughout their treatment is the
need of the hour.
most innovative treatment of this
century. This technology is being used
in China for the treatment of all except
blood cancer. Medical experts are still
researching the after effects of the
treatment and if proven consistently
positive, it may prove to be the best
ever treatment for cancer.
Digitisation in cancer care and
treatment is a positive step which has
been initialised by some of the leading
cancer hospitals of India. A digital
centre is being set up to connect all
108 hospitals that are a part of India’s
National Cancer Grid. This will enable
a cancer patient to make a call from
MEDICAL SCIENCES

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dose of information and knowledge – ﬁlled with
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best brains in hospital and healthcare industry,
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Technology, Equipment & Devices
Cover Story
ARE WE GETTING IT RIGHT?
Regulation vs.
Innovation

There is nothing new about the decades-old conflict between
regulation and innovation. By definition, innovation is new and
uncertain, and therefore risky, while regulation implies control, as in
control of the risk from new, untried products. Nonetheless, have we
now reached the point where controlling technology has become more
risky than allowing promising innovations into the medical marketplace
where they can be field-tested while providing access to patients willing
to accept the risk. This has been the dilemma that regulatory agencies
have struggled to address by ratcheting up their expedited review and
approval programs, efforts that will remain half-measures without rapid
retooling of the evidence base utilised for regulatory decision-making.
Christopher Milne, Associate Professor and Director of Research
Center for the Study of Drug Development, Tufts University School of Medicine
A
lthough prescription drugs comprise
a relatively small percentage of overall
healthcare expenditures, they nonetheless
represent the primary point-of-contact between
the majority of the population and the healthcare
system. While 62 per cent of Americans fill a
prescription in any given year, only 8 per cent
typically experience a hospital stay. Worldwide
the percentage of healthcare expenditures on
medicines ranges from 5-10 per cent in most
developed countries to as much as 60 per cent in
many developing countries. Thus, in an era when
healthcare systems worldwide are confronting
the dual challenge of cost-containment and
the critical need for breakthrough treatments a
primary concern for decision-makers is how well
our system is meeting the medical needs of the
population, and the role played by prescription
drugs. These challenges are increasing in scope
and complexity as the world confronts what the
World Health Organization (WHO) refers to as
the double burden of disease – the current crisis
with epidemics, even pandemics, of emerging
and re-emerging infectious diseases, along with
the growing contribution to mortality and
morbidity from Non-Communicable Disease
(NCD). A 2015 McKinsey report notes that in
Southeast Asia alone, they will experience a 29
per cent increase in the contribution of NCDs
to all-cause mortality by 2030 compared to
2005. At the same time, current expenditures on
public health are approximately 4-5 per cent of
GDP in China and India, compared to twice that
in most western European countries. A related
trend adding to these challenges evident when
looking at the worldwide output of New Active
Substances (NASs are the first approvals of novel
drugs anywhere in the world) over the last four
years (2013-2016), is that just two therapeutic
areas have dominated the last few years (see Figure
1 below).
Oncology has become dominant over the
last decade with cardiovascular and CNS disease
approvals falling far behind, while infectious
disease/vaccines has reached parity with oncology
just in the last few years. There are two over
arching reasons to be concerned about this trend.
The first is that the trend is not in sync with public
healthcare needs. While cancer is certainly a major
health problem, it is not the world’s number one
healthconcernintermsofmortalityandmorbidity,
while cardiovascular disease is the #1 killer in the
US in terms of overall mortality with the potential
to cause a substantial increase in premature deaths
in many developed and emerging market countries
in the near term. Nor is cancer the most urgent
need in terms of innovation, as half of new cancer
drugs are among the most novel of genomically-
targeted precision medicines and cancer therapy
is benefitting significantly from new advances
in immunotherapy as well. The second reason
for concern is that the trend runs counter to the
mission of national regulatory authorities (NRAs).
NRAs should be addressing unmet medical needs
with time and effort proportionate to the public
health impacts of the causative diseases within
the limits of their resources. If this is not being
done, then agency decision-making on priorities
and resource allocations should be examined, and
recalibrated if necessary.

The NAS approval trend is, however,
both troubling and perplexing in
another context. While NRAs control
how many and how fast products reach
the marketplace, it is the pharmaceutical
industry that controls what drug
candidates enter the development
pipeline. The two therapeutic areas that
have remained static in recent decades
– CNS and CVD – represent areas with
substantial market potential. Mental
health was tied with cancer as one of the
four most costly conditions in the US
during the decade of the 2000s, and the
American Heart Association estimates
that over 1/3 of Americans currently
suffer some form of CVD. Worldwide
CVD is considered the fastest growing
NCD health threat as obesity becomes
epidemic in developing countries
with a growing penchant for adopting
western diets that pre-dispose its
adherents to metabolic syndrome and
its disease sequelae. Meanwhile, WHO
projects that by 2020, depression will
be the second leading cause of disability
worldwide. Despite the enormous
market opportunity, however, the
number of NAS approvals in these
therapeutic areas have been static
or declining, with both therapeutic
areas together equaling less than half
the number of oncology approvals
from 2013 to 2016. At a time when
there is increasing availability of
prognostic and diagnostic technology
for CNS disorders, and promising new
approaches for CVD from regenerative
medicine and drug-device combination
therapy, the continued dominance
of oncology/immunology, at 20
per cent of novel drug approvals and
47 per cent of the pipeline (according
to a 2017 Pharma projects report) is
both economically and medically out
of balance. This “bunching up” of
the pipeline with oncology products
appears to some observers to be a waste
of resources as there is now a surplus
of competition in some relatively
narrow cancer indications. Moreover, a
SCRIP Pharma Intelligence analysis in
mid-2016 demonstrated that immuno-
oncology is one of the least successful
therapeutic areas in terms of Phase III
projects moving on to a regulatory filing
at only 40 per cent success (compared
to 58 per cent for all ~1500 products
analysed). While it is true that the
recent NAS dominance by oncology
approvals is largely a US phenomenon
(80 per cent of oncology approvals
among global NASs were US) the fact
that 50 per cent of NASs worldwide
originate in the US and that nearly
50 per cent of the global pipeline
is focused on oncology makes it a
global challenge going forward, i.e.,
the non-US output of NASs appears
to have a somewhat better balance of
therapeutic areas (see Figure 2), but it
is only half the story for the reasons just
discussed.
The Up and Down Side of FRPs
Economic dictates of supply and
demand, and what the market will bear,
explain some of industry’s high level of
interest in oncology drugs. Over the last
10 years, the average price for oncology
treatments has risen sharply. While
high prices act as a ‘pull’ incentive for
oncology research and development
(R&D) (i.e., they increase the likelihood
of sufficient return on investment and
thereby act as an R&D incentive),
regulatory initiatives aimed at speeding
development and review times serve as
an equally powerful ‘push’ incentive
(i.e., they lower the financial and
logistical barriers, and reduce the risk of
entering the field of research). Another
reason for industry’s focus on oncology
is that the enormous investment in basic
research by the US National Institutes of
Health has led to greater understanding
of the pathophysiology and genetic
mechanisms of many cancers, which
provides exciting new and fertile areas
for commercial product development.
Also, the field of cancer research, over
the years, has benefitted from a very
effective patient advocacy movement.
The American Cancer Society, for
one, has been described as “the single
most effective disease-based lobby in
American pharmaceutical regulation.”
Advocacy is by no means a negative
factor but it is a discriminating factor in
how resources are prioritised in both the
public and private sector. For example,
the US FDA employs a full panoply
of what the Center for Innovation
in Regulatory Science (CIRS) calls
Facilitated Regulatory Pathways
(FRPs): priority reviews (receive a six
month review time, compared to a
10-month standard review); accelerated
Number of NAS from 2013 to 2016 by Therapeutic Area
Figure 1

approvals (conditional approval based
on surrogate, or indirect measures
of benefit); fast track designations
(increased access to scientific interaction
with the FDA and rolling reviews of
portions of product application as
they become ready); and breakthrough
therapy designation – BTD (includes
fast track incentives and ‘all hands on
deck’ collaborative, cross-disciplinary
engagement by FDA). In the 2000s,
oncology drugs received 45 per cent
of all FRPs awarded by the FDA.
The relationship between regulatory
initiatives designed to speed access to
importantnewmedicines,andindustry’s
focus on oncology is supported by the
fact that if you look at the number of
oncology approvals during the ten-year
period before FRPs were implemented
(1984 -1993), oncology was not even
in the top five therapeutic areas for
US approvals. Another example of
the dramatic impact of advocacy and
in turn the dramatic incentivisation
effect of FRPs can be appreciated by
the efforts of a stakeholder group of
50 healthcare and labour organisations
who petitioned the US Congress to pay
attention to the needs in the area of
antibiotic resistance. The outcome was
the Generating Antibiotic Incentives
Now (GAIN) Act, allowing expedited
review and approval as well as 5 years
market exclusivity, which a USG
report in early 2017 stated was already
responsible for 101 designations and
6 approvals less than 5 years into the
programme.
While it’s not surprising that at
a time when the out-of-pocket costs
to develop a new medicine exceeds
US$1 billion, many companies
would be drawn to areas that receive
favourable regulatory treatment. An
analysis of drugs discontinued during
development from 2001 to 2011
showed that financial and strategic
factors were responsible for 56 per cent
of the discontinuations. Regrettably,
however, not every disease area can
have its own GAIN Act. Political will
and public advocacy are often lacking,
and resources at regulatory agencies are
finite. It is a zero sum game. The US
FDA itself has pointed out such an
imbalance can result in performance
deficits in one area of responsibility
to the detriment of another. This
consequence has also been supported
by the 2017 Pharmaprojects report
highlighting that the expansion of the
share of the pipeline by oncology was
resulting in other therapeutic areas
‘being squeezed out.’
Emerging Sponsors are the Future
The new drug research and development
paradigm is shifting rapidly from
traditional big pharma to venture
capital–backed small companies. An
emerging sponsor is defined by the
US FDA as the sponsor listed on the
FDA approval letter who, at the time
of approval, was not a holder of an
approved application in the Orange
Book or the regulatory management
system for the biologics license
application. Of new molecular entity/
new biologics approvals in 2011-12,
approximately 40 per cent were
from emerging sponsors. Emerging
sponsors share many of the same
characteristics as companies referred
to as start-ups, or small companies
with little or no experience getting
products into the marketplace. In early
2017, Pharmaproject reports that of
approximately 4,000 pharma firms with
active pipelines, 56 per cent have just
one or two products in the pipeline,
tacitly qualifying them as emerging
sponsors. It also noted that Asian firms
account for nearly 20 per cent of these
firms worldwide, up from 16 per cent
last year, and resulting not just from
expansion in China but region-wide.
These emerging sponsors are
critical to the future of innovation,
particularly in challenging areas of
R&D. For example, smaller companies
have emerged to fill the void in R&D
for CNS therapies. Similarly, they
are often the seedbeds of innovative
products and platforms in such critical
areas of unmet medical need as orphan
drugs. But, much of their pipeline
is at an early stage of development
and emerging sponsors come and go
quickly. The dramatic demise of orphan
drug sponsors has been chronicled in
the literature on the ‘valley of death’
(i.e., surviving from late discovery
through early clinical phase) but just
how dramatic an impact was suggested
by a Tufts CSDD study analysing the
NAS Therapeutic Area Breakdown by Country of First Launch, Excluding
the US, 2013 to 2016
Figure 2

Healthcare Magazine (issue - 38)

Healthcare Magazine (issue - 38)

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