April 2019 digital edition

₹ 250.00 

VOL 5 | ISSUE 12 

PAGES 100 

APRIL 2019 

FUTUREMEDICINEINDIA.COM 

MALARIA 

STRIKES BACK 

A STEADY SPURT IN NEW CASES WARNS OF A RESURGENCE 

OF A CURABLE DISEASE FROM NEAR ELIMINATION 

EDUCATION CASE REPORT GENETICS OPHTHALMOLOGY 

DIPLOMA TO 

DEGREE 

A DELICATE 

TRANSLOCATION 

GENETIC PATHWAYS 

TO TACKLE 

PLASMODIUM 

TIP OF AN 

‘EYES’BERG?

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editor’s note 

editor’s note 

April 2019 / Vol. 5 / Issue 12 

Founder AUGUST & 2018 Editor / Vol: 5 / Issue: 4 

CH Unnikrishnan 

Executive Editor 

S Harachand 

Science Editor 

Dr Rajanikant Vangala 

Consulting Editors 

Dr Founder Shivanee & Editor Shah 

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Dear Doctor, 

Last week, on March 24, we observed World Tuberculosis Day. It 

was Dear started Doctor in 1982 with a vow to “Defeat TB: Now and Forever”. On 

the 25th of this month (April), the world will observe Malaria Day to 

recognize We know global you are efforts busy. to It control is always Malaria. reassuring But unfortunately, that the trust both and these faith of 

diseases hundreds are of on patients a comeback in your trail healing several touch geographies keeps you busy even in after this noble 

decades profession. awareness In the hectic building practice, through it’s quite well recognized natural that international 

you might miss 

campaigns. out on some of the latest developments in emerging medicine. In this era 

This of innovation, is also despite medical the fact science that is TB getting and Malaria redefined are easily almost curable by the with day. Old 

not-so-complex technologies treatments are being replaced using already by the available new in drugs, the blink and of both an eye. were Robots 

fairly and under artificial control intelligence and on the are decline taking till over recently. a good For part instance, of the the procedures, total 

number while of genomics Malaria cases and molecular worldwide science decreased unveil from the 239.3 mysteries million of in life further. 

2010 We to are 214.1 fortunate million to in 2015. have such But it breakthroughs started rising all as of they sudden help from specialists 2015 like 

onwards. you rise It above has gone the up expectations to 219 million of today’s in 2017. informed TB too is back patient. again as the 

No. 1 infectious killer, as we discussed in our March edition. This is scary! 

Where 

Similarly, 

are we 

it is 

going 

also 

wrong? 

a time when India is witnessing revolutionary growth in 

We dig out some alarming facts about the rising malaria cases in our 

healthcare industry, especially in the private sector, wherein an increasing 

cover story this time. Our scientific writers assess what technology has to 

number of doctors are taking up multiple roles of clinician, researcher and 

offer to arrest this dreaded bacterial resistance, including new concepts 

entrepreneur. This requires expansion of your focus to a wider canvas. In 

around exploiting biological processes such as getting mosquitoes to fight 

this context, it becomes important how a busy professional like you can 

Plasmodium by being refractory to the infection and so on. 

keep pace with these latest developments in a quick and easy way. 

In Straight Talk, this edition offers you a thought-provoking discussion 

on the still active debate on coronary stenting with Dr Patrick Serruys, the 

world At Future authority Medicine, on angioplasty. which is conceived and crafted by a team of senior 

Your journalists, interest scientists will also be and piqued doctors, by our a story aim on is Chennai’s to help you Maurice do just Lev that. and We 

Saroja are equipped Bharati Cardiac to bring Museum, you the home latest to from the largest the science collection of care of hearts from across in 

the the world world and in a an must-visit interesting for cardiac and convenient surgeons way, and pathologists. 

supplemented by the best 

of views and analyses from the masters in each field. We present you this 

Happy specialised readingknowledge vehicle that plugs you into the emerging world of 

care seamlessly. Come, let’s join hands in this information journey. 

CH Unnikrishnan 

editor@futuremedicineindia.com 

C H Unnikrishnan 

editor@futuremedicineindia.com 

www.futuremedicineindia.com futuremedicineindia FutureMedIndia 

AUGUST 2018/ FUTURE MEDICINE / 3

EDUCATION CASE REPORT GENETICS OPHTHALMOLOGY 

Vol 5 Issue 12 

April 2019 

₹ 250.00 


PAGES 100 

APRIL 2019 


MALARIA 

STRIKES BACK 

A STEADY SPURT IN NEW CASES WARNS OF A RESURGENCE 

DIPLOMA TO 

DEGREE 

A DELICATE 

TRANSLOCATION 

OF A CURABLE DISEASE FROM NEAR ELIMINATION 

GENETIC PATHWAYS 

TO TACKLE 

PLASMODIUM 

TIP OF AN 

‘EYES’BERG? 

56 

OPHTHALMOLOGY 

TIP OF AN 

‘EYES’BERG? 

REGULAR FEATURES 

06 Letters 

08 News updates 

32 Genetics 

38 Drug approvals 

62 Research snippets 

66 Hospital news 

72 Devices&gadgets 

80 Guidelines 

95 Events 

96 Calendar 

98 Holy grail 

68 

TECHNOLOGY 

INDIAN START-UP 

SET TO SHAKE UP 

GLOBAL MARKETS 

MagGenome aims to provide 

faster, easier and cheaper 

alternatives in the therapeutic 

domain using patented, 

magnetic nanoparticle-based 

technologies 

Columns 

16 TRIALOMICS 

Dr Arun Bhatt 

60 THE CELLVIEW 

Dr Rajani Kanth Vangala 

44 

STRAIGHT TALK 

“SURGERY VS 

STENTING 

DEBATE IS 

STILL 

VERY ACTIVE” 

Dr Patrick Serruys

48 

CASE REPORT 

EARLY INFANTILE 

EPILEPTIC 

ENCEPHALOPATHY 

A case illustrating how 

genetic testing proved to 

be a boon in saving the 

life of a girl child who 

was suffering from a rare 

neurometabolic disorder 

14 

EDUCATION 

DIPLOMA TO 

DEGREE 

Stakeholders hail the decision 

to convert 2,120 post 

graduate medical diploma 

seats to PG degree seats 

A critical attribute 

of next-generation 

vaccines will be 

improved durability 

of protection, 

Dr Ashley Birkett 

Director of PATH’s 

Malaria Vaccine 

Initiative 

76 

MAURICE LEV AND 

SAROJA BHARATI 

CARDIAC MUSEUM 

18 

COVER STORY 

COVER STORY 

MALARIA 

RISEN AGAIN? 

Global efforts to to contain the the 

curable disease suffers a a 

backlash setback as as cases number shoot of cases up in 

several shooting regions up in several regions

TECHNOLOGY CASE REPORT ORTHOPAEDICS SCIENTIFIC REPORT 

letters to the editor 

No 1 

INFECTIOUS 

KILLER AGAIN 

TUBERCULOSIS IS BACK TO THE FORE DUE TO MICROBIAL 

RESISTANCE AND A WANT OF NOVEL DRUG REGIMENS 

NGS BREAKS NEW 

GROUND IN TB CARE 

WHEN PARKINSON’S 

STRIKES EARLY 

Good work 

CHALLENGES OF 

SKELETAL TB 

₹ 250.00 


PAGES 100 

MARCH 2019 


GENETIC TARGET 

FOR CRC 

Hello 

I have been receiving copies 

for three months now. Enjoying 

the newly added content on 

First and Most unique. The 

cover story on TB has well 

depicted the current scenario 

of drug resistance and the 

situation in India. Keep up the 

good work. 

Rakesh Das 

Banglore 

Pleasant experience 

Hi 

The cover story was a succinct 

presentation of the situation 

of tuberculosis in the world 

and India. Had a pleasant 

experience reading the talk 

with Prof. Ada Yonath. 

Dr. Annie George 

Mumbai 

Useful tips 

Hi, 

I am writing to you with 

reference to your Case 

Report ‘Fighting off Swine Flu’ 

-appeared in the March issue. 

The complications developed 

in the patient of the referred 

case was one of the rarest 

even among the reported 

cases of Swine Flu infection. 

Hence, it is quite expected 

that even a well experienced 

clinician would find it difficult 

to handle. The help of ECMO 

support in such a situation 

that was well explained in the 

report was really appreciated. 

Well, i believe that case reports 

is one of the most useful 

segments in Future Medicine 

as far as the doctors are 

concerned as such medical 

tips will be proved most crucial 

at times in our practice. More 

importantly, these kind of 

experience sharing are not 

easily available in the public 

domain. So I find this column 

unique and a much sought 

after support for the medical 

profession. Really appreciate 

this first of its kind effort and 

my heart felt congratulations 

to the author and the team, 

who help putting this together. 

Best regards 

Dr Radheshyam Pratap 

Appaji 

Belgavi, Karnataka. 

Good presentation 

Hi 

I am a recent subscriber. 

Appreciate receiving my 

copy this month. Being a PG 

student I find the magazine a 

good source to stay updated. 

The content is great with a 

very good presentation. 

Vidha Maalik 

Kochi 

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news updates 

India brings more cancer 

drugs under price net 

India’s drug price watchdog has recently 

cut trade margins of 42 non-scheduled 

anti-cancer drugs sold under 463 brands 

to 30 percent in a move to address the 

spiralling cost of medicines used in the 

treatment of cancer. 

The National Pharmaceutical Pricing 

Authority (NPPA) directed manufacturers 

and hospitals to convey revised rates, which 

will be effective from March 8, based on the 

trade margin formula. 

The average out-of-pocket expenditure 

for cancer patients is 2.5 times that of 

other diseases. The move is expected to 

benefit 22 lakh cancer patients in the 

country and would result in annual savings 

of approximately Rs 800 crores to patients. 

The trade margin rationalisation for 

42 anti-cancer drugs was rolled out as 

a proof of concept, stressing on the new 

paradigm of self-regulation by the industry. 

The manufacturers of these 42 drugs have 

been directed not to reduce production 

volumes of brands under regulation, an 

NPPA release stated. 

The NPPA has issued the list of the 463 

non-scheduled anti-cancer drugs whose 

prices have to be reduced through trade 

margin rationalisation. 

As many as 57 anti-cancer drugs 

are under price control as scheduled 

formulations as of now. 

a restricted availability can 

cause an increase in maternal 

fatalities during childbirth, 

impairing the lives of 

thousands of innocent young 

mothers. It also said that 

reserving the manufacture 

of the drug for domestic use 

to the public sector “clearly 

is a statutory override” and 

is against the public interest, 

according to reports. 

IMA moves SC 

over oxytocin 

ban 

The Indian Medical 

Association has moved 

the Supreme Court against 

India’s ban on oxytocin, which 

is used to prevent excessive 

bleeding after childbirth. 

The health ministry 

through its notification in April 

2018 had restricted private 

firms from manufacturing 

and selling oxytocin, following 

widespread allegations of 

misuse of the drug in the 

veterinary field. 

As a measure to prevent 

the misuse of oxytocin, the 

government wanted to restrict 

the responsibility of supplying 

the drug to a public sector 

drug manufacturing company 

based in Karnataka. 

The decision, however, 

was contested in court by 

drug makers like Mylan and 

Neon Laboratories and 

patient activist group All 

India Drug Action Network 

(AIDAN). The Delhi High 

Court removed the ban citing 

various reasons in December 

last year. Following this, the 

government appealed the 

decision in the SC. 

IMA, in its petition filed 

in the SC, argued that the 

scarcity of the drug or even 

Kerala govt 

takes over 

Pariyaram 

medical college 

T 

he government of Kerala 

has decided to take over 

the Academy of Medical 

Sciences, Pariyaram, and 

Kerala Cooperative Hospital 

Complex. 

The state cabinet 

resolved to recommend the 

promulgation of an ordinance 

by the governor for the 

takeover of the institution. The 

meeting also ratified the draft 

bill for the takeover. 

Currently, the medical 

college has 1,938 employees 

and 2,500 students. The 

hospital has 1,000 beds and 

18 operation theatres. 

The Pariyaram Medical 

College Society had requested 

the government to take 

over the institution after it 

found itself unable to run the 

institution due to mounting 

debt burden. 

8 / FUTURE MEDICINE / April 2019

Through a recent order, 

the government informed that 

Pariyaram Medical College 

has finally been taken over by 

the state. The circular stated 

that as per the government 

order, all institutions under 

the Kerala State Co-operative 

Hospital Complex (KCHC) and 

Centre for Advanced Medical 

Services Ltd, including assets 

and liabilities, would now be 

with the state government. 

With this, it will now 

onwards be known as Kannur 

Government Medical College 

and administered along the 

line of other government 

medical colleges in the 

state. Earlier, 50 per cent of 

the seats were reserved for 

management quota. 

MP high court 

stays govt order 

raising OBC 

quota 

The Madhya Pradesh High 

Court stayed the state 

government’s ordinance 

increasing reservation for 

other backward classes (OBC) 

category. 

The state government had 

issued an ordinance on March 

8 increasing the reservation 

in the OBC category to 27 

percent from the earlier 14 

percent. 

In its justification, the 

government said that as 

The Bombay High Court 

has sought details on 

existing guidelines on 

conducting autopsies in 

private as well as state 

and civic hospitals across 

Maharashtra, particularly on 

post mortem examination 

conducted on female 

corpses. 

The HC bench, while 

deliberating on public 

interest litigation, asked 

the state government 

if it had issued any 

government resolutions 

(GRs) to set down autopsy 

guidelines. 

The PIL alleged that 

autopsies were being done 

by morgue attendants and 

sweepers instead of doctors 

in several civic hospitals. 

It was also common that 

male morgue attendants 

and sweepers conduct the 

PIL ON POST MORTEM 

High Court seeks autopsy 

guidelines on female corpses 

post-mortem examination 

on women. 

Queries under the Right 

to Information (RTI) Act 

revealed that due to the 

shortage of trained staff, 

doctors at civic hospitals 

were often assisted by 

morgue attendants, 

sweepers and assistant 

doctors for conducting the 

post-mortem, the petitioner 

informed the court. 

Replying to a question 

by the bench whether the 

government had issued any 

GRs for autopsies on female 

corpses, state lawyer said 

it was possible that often, 

due to shortage of doctors, 

or “reluctance of female 

doctors to go into morgues”, 

male doctors and assistant 

medical staff conduct 

autopsies on female 

corpses, reports said. 

Videograph all 

post mortems: 

TN HC 

The Madras high court 

has directed that all post 

mortems performed in the 

state should be videographed. 

The Madurai bench 

of Madras HC issued an 

interim order after a public 

interest litigation (PIL) raised 

questions on the credibility of 

post mortems performed at 

government hospitals. 

The PIL alleged that 

about 700 post mortem 

certificates of Government 

Rajaji Hospital (GRH) were not 

signed and they are yet to be 

sent to the concerned police 

stations. 

The petition also stated 

that even though two 

scientific officers have to be 

appointed in each of the 24 

government medical colleges 

in the state, the present 

strength is only three, reports 

said. 

April 2019 / FUTURE MEDICINE / 9

OBCs comprise around 52% 

of the total population of the 

state, therefore an increase 

in their quota was necessary 

to safeguard interests of the 

community. 

A division bench issued 

in an interim order on a 

petition filed by MBBS 

students who had appeared 

for NEET 2019 for admissions 

to postgraduate medical 

courses, challenging the state 

government’s ordinance on 

grounds that it breached 

provisions of Article 16(4) of 

the Constitution of India. 

The government’s 

move was violative of the 

50 percent cap on the 

reservation, as it led to the 

reservation in the state 

reaching 63 percent, the 

petitioners argued. 

Besides 14 percent quota 

to OBCs, Madhya Pradesh 

currently offers 16 percent 

reservation to scheduled 

castes (SC) and 20 percent to 

scheduled tribes (ST). 

The court directed the 

government not to provide 

reservation of more than 14 

percent for the OBC category 

in admissions made to 

colleges. 

The high court has also 

served a notice to the state’s 

department of medical 

education, seeking its reply on 

the matter. 

IMA to support 

‘End TB’ 

initiative in 

Bihar, Nagpur 

The Indian Medical 

Association (IMA), 

a national voluntary 

organization of doctors of the 

modern scientific system of 

medicine has spelled out its 

efforts to fight a battle against 

tuberculosis as part of the 

‘End TB’ program launched by 

the government of India. 

The IMA has been 

working with the government 

Abbott launches digital service 

to connect doctors and patients 

Abbott has launched 

a new digital health 

service in India as a part of 

its global a:care program. 

The a:care 

platform from Abbott’s 

pharmaceuticals business 

provides doctors and 

consumers with services 

and information to manage 

health issues. 

The digital service 

aims to bridge the 

communication gap 

between patients and 

doctors across multiple 

therapy areas. The platform 

supports people with a 

broad range of healthcare 

needs, from prevention to 

awareness, adherence to 

treatment and motivation. 

Using the platform, 

a doctor can get access 

to the latest science, 

medical education and 

patient support services, 

and consumers can 

access educational health 

information or participate 

in a motivational pointbased 

programme to help 

them adhere to treatments 

prescribed by their doctor. 

The a:care programme 

is also to help alleviate 

some of the pressure 

on growing healthcare 

systems around the world, 

according to Abbott. 

In many emerging 

markets, the number 

of doctors per 1,000 

people is often well below 

the Organisation for 

Economic Cooperation 

and Development (OECD) 

to develop strategies 

that effectively address 

the impediments in the 

management of the disease, 

especially the low notification 

average of 2.8. This means 

that doctors’ overburdened 

work schedules can serve 

as a barrier to providing the 

best care. 

The online portal 

is designed to allow 

consumers grant their 

doctor access to the 

health information they 

input online, privately and 

securely, while doctors 

can see patients’ medical 

adherence reports. 

The digital platform 

currently includes three 

specialty areas, namely 

diabetes, thyroid and 

osteoarthritis. 

In the first phase, a:care 

will address the needs 

of doctors and patients, 

while pharmacists will be 

included at a later stage. 

India is the first country 

in which Abbott launched 

its digital platform. It can 

also be found online at 

www.acare.co.in or as a 

web app downloaded from 

the Android Play Store. 

of patients. In addition, IMA 

will be holding a series of 

dedicated TB programs for 

medical professionals across 

Maharashtra. 

Mizoram passes 

bill to facilitate 

supply of 

cadavers to MC 

Mhe Mizoram government 

has passed a bill in the 

assembly to facilitate the 

supply of cadavers to the 

medical college in the state. 

According to reports, 

the Mizoram Anatomy Bill, 

2019, introduced by the state 

health minister was passed 

unanimously. 

The bill proposing to 

supply unclaimed bodies of 

deceased persons or donated 

bodies to teaching medical 

institutions was introduced 

due to a demand for corpses 

for the purpose of anatomical 

examination and dissection. 

After enactment, the bill 

would facilitate the availability 

of bodies for the Mizoram 

Institute of Medical Education 

and Research (MIMER), 

where the academic session 

started from August 2018, the 

minister said. 

MIMR is the first medical 

college established in the 

north-eastern state of 

Mizoram. 

MIMER has an annual 

intake of 100 students. 

OTC sale 

of topical 

hydroquinone 

banned in India 

The health ministry has 

prohibited the over-thecounter 

(OTC) sale of topical 

medications containing 

hydroquinone, a bleaching 


WHO pushes for strong regulations on human 

genome editing 

The World Health 

Organization’s new 

advisory committee on 

developing global standards 

for governance and oversight 

of human genome editing 

reached a consensus on the 

need of a central registry 

on human genome editing 

research. 

The committee asked 

WHO to immediately begin 

working to establish such a 

registry in order to create an 

open and transparent database 

of ongoing work on human 

genome editing. 

After agreeing to work 

towards a strong international 

governance framework in this 

area, the committee noted that 

it was irresponsible at this time 

for anyone to proceed with 

clinical applications of human 

germline genome editing. 

The committee has invited 

all those conducting human 

genome editing research 

to open discussions with 

the committee to better 

understand the technical 

environment and governance 

arrangements and help ensure 

their work meets current 

scientific and ethical best 

practice. 

The experts reviewed 

the current state of science 

and technology. They also 

agreed on core principles of 

transparency, inclusivity and 

responsibility that underpin the 

recommendations. 

The committee will 

operate in an inclusive manner 

and has made a series of 

concrete proposals to increase 

WHO’s capacity to act as an 

information resource in this 

area. 

Over the next two years, 

through a series of inperson 

meetings and online 

consultations, the committee 

will consult with a wide range 

of stakeholders and provide 

recommendations for a 

comprehensive governance 

framework that is scalable, 

sustainable and appropriate 

for use at the international, 

regional, national and local 

levels. The committee will 

solicit the views of multiple 

stakeholders including patient 

groups, civil society, ethicists 

and social scientists. 

“Gene editing holds 

incredible promise for health, 

but it also poses some risks, 

both ethically and medically,” 

said Dr Tedros Adhanom 

Ghebreyesus, WHO Director- 

General, in an official release. 

Regulatory needs for 

germline editing came to the 

spotlight late last year when 

a Chinese scientist claimed to 

have produced babies with 

edited genomes. WHO formed 

an expert panel to look into 

the scientific, ethical, social 

and legal challenges of human 

genome editing using the 

application of tools such as 

CRISPR-Cas9. 

Meanwhile, China is 

planning to introduce a 

regulatory system for genetic 

technologies as a measure 

to stem the global backlash 

triggered by the genome 

editing experiment, reports 

said. 

agent for reducing skin 

pigmentation. 

As per the new order, 

pharmacists cannot dispense 

ointments, creams and other 

dermatological applications 

that contain hydroquinone 

without the prescription of 

a medical practitioner with 

effect from April 1, 2019. 

The Central Drug Control 

and Standards Organisation 

under the health ministry 

has slapped the ban on the 

OTC sale of these products 

to curb their indiscriminate 

use as a whitening agent. 

The government action came 

following a recommendation 

by the Drugs Technical 

Advisory Board, the country’s 

highest drug advisory body on 

technical matters. 

The amendment to the 

Drugs and Cosmetics (D&C) 

Rules of 1945, India’s rule 

book on drugs and devices, 

to bring hydroquinonecontaining 

ointments under 

Schedule H, will come into 

force on April 1. 

Last year, the ministry had 

curbed the OTC sales of all 

pharmaceutical formulations 

containing steroids for 

external use by placing them 

under Schedule H of the D&C 

Act to stop their OTC sale. 

Even though 

hydroquinone is widely 

prescribed for the treatment 


Acupuncture to be 

recognized in India 

The traditional Chinese medical practice 

of acupuncture is likely to be recognised 

as an independent medical system in India, 

reports said. 

An inter-departmental committee was 

constituted on October 2016 for identifying 

new systems of medicine in the country as 

a part of the central government initiative to 

promote and regulate the alternative systems 

of medicine. 

In its report, the committee recommended 

that the acupuncture system, which is 

already recognised as a mode of therapy, 

can be accepted as an independent system 

of healthcare for the indications for which 

there is evidence and expertise for teaching, 

training and certification. 

Following this, the health ministry is now 

considering recognizing acupuncture as an 

independent system of healthcare in the 

country. 

of hyperpigmentation, 

leading regulatory agencies 

including that of the US, 

EU and Japan had raised 

concerns about its safety 

profile. The USFDA on June 

last year proposed a ban 

on all OTC preparations 

containing hydroquinone. 

India extends 

national 

AIDS control 

programme 

India’s National AIDS Control 

Programme-IV (NACP-IV) 

will continue beyond the 12th 

Five Year Plan for a period of 

three years from April 2017 to 

March 2020. 

The Cabinet Committee 

on Economic Affairs chaired 

by the prime minister 

has given its nod for 

the continuation of the 

programme. The total outlay 

will be Rs 6,434.76 crore. 

The programme targets 

to get more than 99% of 

the population HIV free, 

ensuring that over 70 lakhs 

of the key population will be 

covered annually through a 

comprehensive HIV prevention 

programme. 

Around 15 crore of 

the vulnerable population, 

including five crore pregnant 

women, will be tested for 

HIV in three years under the 

project. 

Two 2.32 cr units of blood 

will be collected at NACO’s 

supported blood banks during 

the period. Two crores 82 

lakh episodes of sexually 

transmitted infections will be 

managed and seventeen lakh 

of people living with HIV will 

be put on free anti-retroviral 

treatment by the end of the 

project period. 

Universal “test 

and treat” 

approach can 

cut down HIV 

House-to-house testing 

and immediate 

treatment can effectively 

reduce new HIV infections, 

according to the result of a 

large clinical trial. 

New HIV infections 

declined by 30 percent in 

southern African communities 

where health workers 

conducted house-to-house 

voluntary HIV testing. Infected 

people were also referred to 

begin HIV treatment as per 

local guidelines and offered 

other proven HIV prevention 

measures to those who tested 

negative. 

These results from the 

study called Population Effects 

of Antiretroviral Therapy to 

Reduce HIV Transmission 

(PopART), or HPTN 071, were 

announced recently at the 

Conference on Retroviruses 

and Opportunistic Infections 

(CROI) in Seattle. 

“The results of the 

PopART study suggest that 

conducting population-wide, 

home-based HIV testing and 

offering treatment to those 

diagnosed with HIV could 

help control the epidemic in 

certain settings,” said Anthony 


S Fauci, MD, director of 

the National Institute of 

Allergy and Infectious 

Diseases (NIAID), in a press 

statement. 

PopART study was to 

learn whether conducting 

HIV testing throughout a 

population and promptly 

offering treatment to all who 

test positive would reduce the 

rate of new infections in the 

population. 

The study took place from 

2013 to 2018 in 21 urban 

and peri-urban communities 

in South Africa and Zambia. 

Each community had an 

average of roughly 50,000 

residents for a total study 

population of about 1 million. 

The communities were 

clustered into seven groups 

of three — “triplets” — 

matched by geographical 

location and estimated HIV 

prevalence. 

The communities in 

each triplet were assigned 

at random to one of three 

study groups. The first group 

received annual house-tohouse 

voluntary HIV testing 

and counselling, linkage to 

care for those who tested 

positive and the opportunity 

to immediately begin 

treatment, and the offer of a 

suite of proven HIV prevention 

measures to those who tested 

negative. 

The second group 

received the same services 

as the first, except treatment 

was offered according to 

national guidelines. The third 

group served as a control and 

received HIV prevention and 

testing services according 

to the local standard of care 

as well as HIV treatment 

according to national 

guidelines. 

Medvarsity to 

offer digital 

education 

Medvarsity Online Ltd 

has joined hands with 

Lecturio.com, a German online 

medical education provider 

to impart technology-based 

healthcare learning for 

medical students. 

As a part of the 

partnership programme, 

Medvarsity can now offer 

Lecturio’s medical content to 

medical colleges in India. 

Lecturio’s platform and 

learning content combine 

modules from some of the 

best faculty around the world. 

This allows the institutions to 

make assignments matching 

their curricula. 

Lecturio’s learning 

methodology ensures the use 

of increasing time intervals 

between subsequent reviews 

of previously learned material 

in order to achieve long term 

memorization, as the doctors 

need to remember numerous 

medical facts. 

Digital learning is the new 

age learning methodology 

that enables students to 

grasp concepts quickly. It also 

engages in learning more 

readily, along with enhancing 

the instructional techniques, 

leveraging instructor time, and 

ensuring widespread sharing 

of knowledge. 

Medvarsity, a pioneer 

in online training, currently 

offers online courses for a 

range of healthcare-related 

subjects. By partnering with 

Lecturio, Medvarsity hopes to 

bring the e-learning content 

and platform by offering it to 

MBBS students in India. 

India-UK cancer research 

programme takes off 

The government of 

India has finally given 

its stamp of approval 

to the memorandum of 

understanding (MoU) 

between India and UK on 

cancer research. 

The 5-year bilateral 

research initiative by 

the Department of 

Biotechnology (DBT), 

Ministry of Science & 

Technology, India and 

Cancer Research UK 

(CRUK) was signed in 

November, 2018. 

Both CRUK and DBT 

will invest £5 million 

(approx. 45 crore) each in 

this 5-year pilot to focus 

on affordable approaches 

to cancer. 

The collaborative 

project will identify a core 

set of research challenges 

that address issues of 

affordability, prevention 

and care of cancer by 

bringing together leading 

Indian and UK experts 

across clinical research, 

demographic research, 

new technologies and 

physical sciences. 

The initiative will 

provide funding to 

develop new research 

alliances and undertake 

impactful research to 

enable significant progress 

against cancer outcomes. 

It sets forth a 

roadmap for catalysing 

collaborations that align 

the best researchers, 

scientists, healthcare 

organizations and 

institutions to a multidisciplinary 

research 

platform leading to high 

value, low-cost outcomes 

for cancer care. 

Through this initiative, 

the number of positions 

for doctoral-level, postdoctoral 

level researchers 

and early career scientists 

are expected to grow, 

according to the PM India 

website. 


education 

DIPLOMA TO 

DEGREE 

Stakeholders hail the decision to convert 2,120 post graduate medical diploma 

seats to PG degree seats 

In a significant development in 

the medical education sector in 

the country, the Medical Council 

of India’s (MCI) Board of Governors 

(BOG) has approved the conversion of 

2,120 postgraduate diploma seats to 

postgraduate degree seats from the 

academic year 2019-20. As per the 

notification issued by the MCI Board of 

Governors, the permission to convert 

post graduate diploma seats to degree 

seats is subject to the affiliation of 

additional PG degree seats by the 

concerned authority. The body has 

directed the respective institutes to 

obtain affiliation from the concerned 

affiliating university with regard to the 

enhanced intake capacity of the degree 

courses before admitting students. 

Karnataka has got the highest 

number of PG degree seats under 

the conversion. In Karnataka, 470 PG 

Diploma seats were converted to PG 

Degree seats and it was followed by 

Tamil Nadu with 461 seats. Andhra got 

a total of 164 PG Degree seats, Assam 7, 

Bihar 13, Delhi 20, Gujarat 140, Haryana 

13, Jammu and Kashmir 51, Jharkhand 

13, Kerala 55, Madhya Pradesh 113, 

THE DECISION IS ALSO 

LIKELY TO ADDRESS THE 

ISSUE OF THE SHORTAGE OF 

PG DEGREE SEATS 

Maharashtra 275, Puducherry 15, 

Rajasthan 44, Telangana 177, UP 79 and 

West Bengal 10. 

The decision to convert PG diploma 

seats into PG degree has been widely 

hailed by various stakeholders as they 

feel that it will benefit medical education 

in the country. They also observed that 

the move will help to produce more PG 

degree holders who are entitled to teach 

in medical colleges. 

Eligible to teach 

“The PG diploma holders are not eligible 

to teach in the medical colleges as 

per existing rules. PG diploma and PG 

degree students are doing the same 

job and getting the same experience. 

The only difference is that diploma is 


a two-year course and PG degree is a 

three-year course. PG degree holders 

can become teachers in the future, and 

it is recognized in the majority of the 

countries, but the PG diploma is not. 

The conversion of all PG diploma seats 

into PG degree seats will help to get 

more qualified postgraduate doctors,” 

said Dr Shivkumar Utture, President, 

Maharashtra Medical Council. He added 

that when there are more post-graduate 

qualified doctors, better treatment can 

be provided to patients. 

The decision is also likely to address 

the issue of the shortage of PG degree 

seats. “Considering the number of 

The Kerala government 

opposes the move 

due to the lack of 

reservation for Govt. 

doctors for PG degree 

courses. 

Rajeev Sadanandan 

Additional Chief Secretary 

Health, Kerala 

CONVERTED SEATS 

STATE 

NO. OF SEATS 

Karnataka 470 

Tamil Nadu 461 

Maharashtra 275 

Telangana 177 

Andhrapradesh 164 

Gujarat 140 

Madhya Pradesh 113 

Uttarpradesh 79 

Kerala 55 

Jammu and Kashmir 51 

Rajasthan 44 

Delhi 20 

Bihar 13 

Haryana 13 

Puducherry 15 

Jharkhand 13 

West Bengal 10 

Assam 7 

medical graduates coming out of the 

colleges every year, a sufficient number 

of PG degree seats are not available 

for them. The PG diploma course 

was conceived a long time back 

with a vision to create more 

postgraduates. The course 

had many disadvantages, 

which include a shortened training and 

a lack of research-based curriculum, 

among others. They are also not 

entitled to teach in medical colleges. PG 

diploma holders don’t get many of the 

entitlements that PG degree holders get, 

due to the difference of one year. When 

new medical colleges come up, there 

will be increased demand for trained 

manpower and the present decision 

will help to address the issue,”said Dr 

Jayakrishnan A V, Chairman, IMA Hospital 

Board of India, Kerala Chapter. He added 

that the existing facilities are enough for 

training more PG degree students. 

The PG diploma holders, who 

are not entitled to teach in medical 

colleges, have been demanding for a 

long time that they should be allowed 

to teach in medical colleges. However, 

the government and MCI did not agree. 

“There is a huge shortage of medical 

college teachers, and with the increase 

in seats, the issue can be addressed to 

some extent. Diploma holders will have 

to do an additional one-year course to 

become eligible to teach. Existing PG 

diploma holders should be provided 

an option to do their PG course,” said 

Dr. Alexander Thomas, President, The 

Association of National Board Accredited 

Institutions (ANBAI). 

Kerala opposes 

Meanwhile, Kerala, which has around 

100 PG diploma seats in government 

medical colleges, has refused to 

surrender all its PG diploma seats and 

convert them to PG degree seats. The 

government cited a lack of reservation 

for government doctors in PG degree 

courses. “At present, government doctors 

have a reservation for PG diploma 

courses. But there is no reservation in 

PG degree courses, which will deny 

government doctors an opportunity to 

do a postgraduate course. The state 

government opposes the move due 

to this lack of reservation,” said Rajeev 

Sadanandan, Additional Chief Secretary, 

Health, Kerala. He further stated 

that reservation can be provided to 

government doctors only by amending 

the MCI Act. 


column 

trialomics 

Should CTs include 

underprivileged patients? 

Challenges of inclusion of socioeconomically disadvantaged 

patients in clinical trials are unending 

DR ARUN BHATT 

Writer is a consultant 

on clinical research & 

development from 

Mumbai. 

arun_dbhatt@hotmail.com 

Over the last 15 years, the field 

of clinical trials (CT) grew when 

multinational pharma companies 

included Indian hospitals sites in global CT, 

as there was potential for fast recruitment 

of treatment naïve Indian patients. However, 

the majority of such patients treated at 

public hospitals were poor and had low 

literacy levels. Concerns about exploitation 

of socioeconomically disadvantaged patients 

in CT created a backlash, causing the 

government to strengthen regulations to 

protect CT participants. But the challenges of 

inclusion of socioeconomically underprivileged 

patients in CT are unending and merit 

thorough consideration from the perspective 

of the autonomy of the participants, and an 

assessment of benefits and risks. 

Autonomy means respect for the patient’s 

choices and decisions. This means the patient 

has a right to evaluate benefits and risks, and 

decide whether to take part in a CT. 

Participation in a CT gives a patient the 

direct benefit of receiving a new expensive 

therapy, which may be effective for a serious 

/ incurable condition like cancer or multi-drug 

resistant TB. There are also indirect benefits 

– better supervised medical care, direct 

access to physician-investigator, free medical 

management of inter-current illnesses and 

reimbursement of travel expenses for followup 

visits etc. 

The risks include serious adverse reactions 

such as injury or death, the inconvenience of 

investigations – lab, imaging, biopsy, frequent 

follow-ups etc. But the real risk is whether 1) 

the patient has understood the experimental 

nature of the CT, or there is a therapeutic 

misconception, with the patient believing that 

the aim of CT is to administer treatment rather 

than to conduct research. 

These patients are vulnerable, as informed 

consent (IC) to participate in a CT may be 

unduly influenced by the expectation of 

receiving benefits, or concerns about the 

consequences of refusal to participate in 

a trial. Competence to informed consent 

means the ability to understand and evaluate 

relevant information, make a rational decision 

without undue influence and convey consent 

or refusal to participate in a trial. As the 

socioeconomically disadvantaged are likely 

to be less competent in protecting their own 

interests, it is essential that others should be 

responsible for protecting their interests. 

The clinical researcher should justify the 

need for research in this vulnerable population, 

take steps to minimize the risks, provide 

additional safeguards, and invest time and 

effort in the consent process to explain the 

risks/inconveniences to the patient and/ 

or her legal representative in her language 

without resorting to coercion or offering undue 

inducements. 

The ethics committee should ensure 

that the investigator has considered and 

established adequate human protection 

measures before initiation, during the conduct 

and after the completion of the CT. The ethics 

committee should monitor the CT to ensure 

that additional safeguards, e.g., voluntary 

IC, audio-visual recording of IC process, free 

medical management and compensation for 

serious adverse events, compensation for 

travel, ancillary care for non-research-related 

conditions or incidental findings and post-trial 

access to new therapy or standard therapy, are 

available to patients. 

As Indian pharma industry is developing 

research-based new drugs, the inclusion of 

socioeconomically disadvantaged participants 

in clinical trials is unavoidable. However, this 

requirement can only be justified if such 

vulnerable patients are empowered, and their 

autonomy, rights, safety and wellbeing are 

protected. 


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cover story 

2010 

2011 

MALARIA CASES 

WORLD WIDE 

2010-2017 

After declining over the 

years, malaria cases started 

increasing since 2016 

Number of cases (000s) 

239,300 

229,500 


STRIKES BACK 

2012 

Global efforts to 

contain the curable 

disease suffers 

a setback as new 

cases shooting up 

in several regions 

2013 

S HARACHAND 

The latest numbers pertaining to malaria have raised 

the fear that the disease may be on a comeback trail 

in several regions of the world, wiping out the hardearned 

gains of yesteryears. 

Since 2010, fresh cases of malaria had been 

declining steadily, reflecting the high efficacy of the new 

artemisinin-based combination therapy (ACT) and other 

interventional strategies like vector control. 

The trend, however, started showing a reversal since 

2016. 

As many as 219 million cases of malaria occurred 

worldwide in 2017, compared with 217 million cases in 

2016. The ten highest burden African countries saw an 

219,000 

2014 

226,800 

2015 

2016 

2017 

221,400 

217,500 

216,600 

214,100 


estimated 3.5 million more malaria cases in 2017 than a year 

ago. While the African region claimed 92% of the cases, the 

South East Asian Region shared 5% and 2% of the disease 

burden respectively, according to The World Malaria Report 

2018 by the WHO. 

Children aged under 5 years accounted for 61% of the 

number of 435,000 deaths from malaria globally. 

Evidently, the human toll of malaria, and the global risk it 

still poses, remains unacceptably high. 

Experts cite several reasons for the stalled progress 

in eliminating the mosquito-borne disease in spite of the 

fact that the parasitic infection is completely curable and 

preventable. 

Resistance or ‘partial’ resistance? 

The threat of pathogens emerging resistant to artemisinin 

is one of the most challenging issues faced by some of the 

high-burden countries today. Artemisinin, a plant-derived 

lactone, is the cornerstone of global efforts to control malaria. 

Drug combinations with artemisinin as the anchor drug have 

shown over 95% efficacy in malaria caused by Plasmodium 

falciparum — the most commonly found infectious agent. 

The WHO recommends ACTs as the first and secondline 

treatment for uncomplicated P. falciparum malaria as 

well as for chloroquine-resistant P. vivax malaria. There are 

many advantages to using ACTs. The 

artemisinin quickly and drastically reduces 

the majority of malaria parasites by killing 

the protozoan at all stages of its life-cycle 

within the host, while the partner drugs 

in the combo clear the small number of 

parasites that remain. Tackling in different 

ways, ACTs, which are considered the 

most effective anti-malarial treatment 

today, ensure that no trace of the 

pathogen remains in the system posttherapy. 

The resilience of the malarial parasite 

is well known. In the late 1950s and 

1960s, the emergence of P. falciparum 

strains resistant to chloroquine and 

sulfadoxine–pyrimethamine was reported 

on the Thai–Cambodian border and 

spread across Asia and Africa, resulting in 

millions of deaths from malaria. 

Resistance to artemisinin class of 

drugs was first documented in Southeast 

Asia in 2008 and has been particularly 

menacing in the Greater Mekong 

Subregion (GMS) comprising Cambodia, 

Kelch 13 propeller domain mutations: 

The abode of resistance 

Drug combinations with artemisinin 

as the lead have become the 

first and second line treatment 

against malaria caused by Plasmodium 

falciparum. ACTs helped to bring down 

the incidence of malaria cases by 18% 

from 2010 to 2016. However, reduced 

clinical efficacy of artemisinin due to the 

emergence and spread of resistance 

raises the risk of retraction of recent 

gains achieved in reducing worldwide 

malaria burden. 

In regions where artemisinin 

resistance is prevalent, ACTs are failing 

fast. If the trend continues, malaria 

could become practically untreatable, at 

least in those parts of the world. 

Though there is no consensus on 

the biochemical targets of artemisinin 

or on the mechanism of action, the 

drug is considered a potent 

inhibitor of P. falciparum 

phosphatidylinositol 

-3-kinase (PfPI3K). 

Genome-wide association 

studies (GWAS) have 

revealed the genetic loci 

in P. falciparum parasite 

associated with artemisinin 

resistance. The resistance is 

caused by single nucleotide 

polymorphisms in the 

parasite›s kelch 13 gene. 

Single point mutations 

in the propeller domain of 

kelch13 after position 440 were 

associated with a mean increase 

in the parasite clearance half-life 

of 116%, studies revealed. Mutations 

in kelch13 gene are associated 


China, Lao People’s Democratic Republic, Myanmar, Thailand 

and Vietnam. 

GMS has already gained notoriety as the epicentre of 

antimalarial drug resistance. After generating resistant strains 

to chloroquine, sulfadoxine, pyrimethamine, quinine and 

mefloquine, this region has now spawned parasites resistant 

to artemisinins, researchers say. 

Though artemisinins have, relatively, been a new 

introduction in many parts of the world, the compound has 

been in use as monotherapies in western Cambodia for more 

than 30 years. It was during the early 2010s that public health 

authorities discovered that artemisinin resistance had emerged 

independently in multiple areas, along with resistance to ACT 

partner drugs. 

Signs of artemisinin resistance have developed in the 

African continent as well. A study carried out in 2010 at 

the Carlos III Hospital and the Network of Tropical Diseases 

Research Centres on the blood samples collected from 200 

patients with P. falciparum infection, who had come to Spain 

from eighteen African countries, suggested the appearance of 

strains related with resistance to ACT. 

Similarly, another study published by Centers of Disease 

Control and Prevention (CDC), US, to assess the emergence of 

artemisinin-resistant parasites in Uganda during 2014–2016 

using a newly developed ex vivo ring-stage survival assay 

with an upregulated “unfolded protein 

response” pathway that may antagonize 

the pro-oxidant activity of artemisinins, 

and selects for partner drug resistance 

that rapidly leads to ACT failures. 

Increased PfPI3K was linked with 

the C580Y mutation in P. falciparum 

kelch13 in resistant clinical strains of 

the bug. PfKelch13 is a primary marker 

of artemisinin resistance. Studies found 

that polyubiquitination of PfPI3K and 

its binding to PfKelch13 were reduced 

by the PfKelch13 mutation, which 

limited proteolysis of PfPI3K and thus 

increased levels of the kinase, as well as 

its lipid product phosphatidylinositol-3- 

phosphate (PI3P). 

PI3P levels are predictive of 

artemisinin resistance. Elevated PI3P 

induced artemisinin resistance in the 

absence of PfKelch13 mutations, but 

remained responsive to regulation by 

PfKelch13. Studies describe PI3P as the 

key mediator of artemisinin resistance 

and the sole PfPI3K as an important 

target for malaria elimination. 

They also identify Kelch13-propeller 

polymorphism as a useful molecular 

marker for large-scale surveillance 

efforts. 

The geographic distribution of 

these SNPs confirm that artemisinin 

resistance has emerged and spread 

STUDIES DESCRIBE PI3P 

AS THE KEY MEDIATOR OF 

ARTEMISININ RESISTANCE 

AND THE SOLE PFPI3K AS 

AN IMPORTANT TARGET FOR 

MALARIA ELIMINATION 

extensively in mainland Southeast 

Asia. The widespread availability of 

artemisinin monotherapies, poorquality 

artemisinin-based combination 

therapies and monotherapies 

containing subtherapeutic amounts of 

active ingredients and unregulated use 

of antimalarial agents, plus the unusual 

genetic structure of parasites in this 

region, may have contributed to the 

emergence of resistant parasites. 

Recent studies conducted in West 

Bengal found 4-5% of patients 

resistant to artemisinins. Researchers 

also report some previously unseen 

mutations in the kelch13 gene, which 

are critical to decreased artemisinin 

effectiveness. 

Genes other than kelch 13 are 

also suspected to be involved in P. 

falciparum resistance. Reduced ART 

susceptibility can be mediated by 

PfCoronin gene, a member of the 

WD40 — an actin binding propeller 

domain protein family, according to a 

recent study. 

PfCoronin has a seven-bladed 

propeller domain composed of WD40 

repeats and ß-propeller folds in its N 

terminus, which is structurally similar to 

the six-bladed propeller domain found 

in the C terminus of PfKelch13. 


(RSA) concluded that survival rates of parasites in some 

isolates were more than 10% higher. Similar rates have been 

closely associated with delayed parasite clearance after 

drug treatment and are considered to be a proxy for the 

artemisinin-resistant phenotype. 

Since India sits with Africa and SE Asia on either sides, 

the spread of resistant strains of the parasite is somewhat an 

imminent possibility. Already, sporadic cases of artemisinin 

resistance have been reported from the eastern region of 

India, the country’s malaria hotspot. A study conducted in 

West Bengal in isolates from 136 patients with P. falciparum 

infection obtained from April 2013 through March 2014 using 

ex-vivo RSA observed increased parasite clearance half-lives in 

14% of the patients. 

Artemisinin resistance is defined as a delay in the 

clearance of malaria parasites from the bloodstream following 

ACT. The artemisinin combo is considered less effective if it 

fails in clearing all parasites within a 3-day period. 

The WHO, however, describes the delayed clearance of 

the parasites as only “partial resistance” as the mechanisms 

of resistance developed by the parasites against artemisinin 

compounds affect only one stage of its cycle in humans, the 

ring stage. Hence, it is more appropriate to call the delayed 

clearance “partial resistance”, to highlight this time-limited and 

cycle-specific feature. 

Also, drug resistance, per se, did not contribute to the 

rising numbers of cases in GMS and Africa. “Between 2012 

and 2017, the reported number of malaria cases in GMS fell 

by 75% despite confirmed partial artemisinin resistance in 

5 countries and multidrug resistance in 4 countries. Malaria 

deaths fell by 93% over the same period. In Africa, artemisinin 

resistance has not yet been confirmed. The ACTs used as first 

and second line treatments are highly efficacious in all African 

countries,” says a spokesperson from RBM Partnership to End 

Artemisinin is extracted from the plant Artemisia annua 

‘High burden to 

high impact’ 

strategy to bring 

back malaria 

control on track 

Over 219 million new cases of malaria were 

reported in 2017, 2 millions more from 

217 million a year before. This was the second 

consecutive year that the numbers went up, 

reversing a trend marked by a steady series of 

advances in the fight against malaria since the 

turn of the century. 

With more than 400,000 people projected 

to die each year from the preventable and 

treatable disease, the WHO has called for an 

aggressive new approach to jumpstart progress 

against the disease. 

Without a major turnaround, we are very 

unlikely to meet the targets set by the Global 

Technical Strategy for Malaria 2016–2030 

(GTS), which calls for reducing malaria cases 

and deaths by at least 40% by 2020, at least 

75% by 2025 and at least 90% by 2030. 

The High Burden, High Impact approach 

was launched in November 2018 in 

Mozambique to infuse a fresh dose of vitality 

to global efforts against malaria. “The launch 

has provided momentum and has resulted in 

a growing commitment from malaria-affected 

countries, donor agencies and global health 

organizations,” says a spokesperson from RBM 

Partnership to End Malaria, which coordinates 

with WHO on the initiative. 

The RBM Partnership to End Malaria is 

the largest global platform comprising over 

500 partners - from community health worker 

groups and researchers developing new tools 

to malaria-affected and donor countries, 

Malaria, which coordinates with the WHO in the ‘High Burden 

to High Impact’ initiative launched in November 2018 to bring 

malaria control on track. P. vivax resistance to artemisinin is yet 

to be reported. 

Asymptomatic malaria and POC detection 

P. falciparum is the most prevalent malaria parasite in Africa, 

accounting for 99.7% of the estimated cases in 2017, as it is 

in South-East Asia (62.8%), the Eastern Mediterranean (69%) 

and the Western Pacific (71.9%). 

P. vivax is predominant in the Americas, representing 

74.1% of malaria cases. 


usinesses and international organisations. 

‘High Burden to High Impact’ is a 

country-led response, aimed to reignite 

the pace of progress in the global malaria 

fight, and is guided by the following 

principles: 

• Country-owned, country-led, and 

aligned with the GTS, the health-related 

Sustainable Development Goals (SDGs) 

and national health goals, strategies and 

priorities 

• Focused on high-burden settings. 

Able to demonstrate impact, with an 

intensified approach to reducing mortality 

while ensuring progress is on track to 

IN 2017, ALL 10 OF THE 

HIGHEST BURDEN AFRICAN 

COUNTRIES REPORTED A 

SURGE IN MALARIA 

CASES AS COMPARED TO 

THE PREVIOUS YEAR 

reach the GTS targets for reducing malaria 

cases 

• Characterized by packages of malaria 

interventions, optimally delivered through 

appropriate channels, including a strong 

foundation of primary health care 

Nearly 70% of the world’s malaria 

burden is concentrated in just 11 countries 

– 10 in sub-Saharan Africa (Burkina Faso, 

Cameroon, the Democratic Republic of the 

Congo, Ghana, Mali, Mozambique, Niger, 

Nigeria, Uganda and Tanzania) and India. 

These high-burden nations are home to an 

estimated 151 million cases of malaria and 

more than 275,000 deaths. 

In 2017, all 10 of the highest burden 

African countries reported a surge in 

malaria cases as compared to the previous 

year, ranging from an estimated 131,000 

more cases in Cameroon to 1.3 million 

additional cases in Nigeria. Only India 

marked progress in reducing its disease 

burden, registering a 24% decrease 

compared to 2016. 

Governments in affected nations have 

started working with WHO and the RBM 

Partnership to End Malaria to map out a 

way forward. 

The highest burden countries in Africa 

are in a process of leading their own High 

Burden High Impact approach, rallying 

their malaria community to overcome 

their unique challenges. Uganda held 

a meeting with stakeholders and has 

already accelerated high-level political 

engagement and taken steps to take 

forward each of the response elements 

based on an analysis of local context. Over 

the next two months, other high burden 

countries in Africa will follow the same 

path. Partners, such as the Global Fund 

and US President’s Malaria Initiative, are 

looking to align their support to countries’ 

strategic plans and priorities, according to 

RBM Partnership to End Malaria. 

The existing malaria prevention and 

treatment package, if optimally applied, 

will help to meet the targets. At the same 

time, WHO and partners will accelerate the 

development and introduction of 

more effective malaria control tools, suited 

to the challenging contexts faced by high 

burden countries. However, changing 

the trajectory of the disease will require 

far more than a smarter use of new and 

existing tools. Above all, it will demand 

high-level political leadership, country 

ownership and commitment from a broad 

coalition of stakeholders, states a WHO 

document. 

In places like India, where both P. 

falciparum and P. vivax are present, the 

burden of disease due to P. vivax is more 

difficult to be addressed because the 

parasite transfers to a dormant hypnozoite 

stage in the liver, which is currently 

undetectable and leads to relapses. 

Many people who are infected with 

malaria parasites remain asymptomatic or 

undiagnosed. The density of parasitaemia 

in many such cases will be so low that it 

cannot be detected with current routine 

Between 2012 and 2017, 

the number of malaria 

cases in GMS fell by 75% 

despite confirmed partial 

artemisinin resistance in 

5 countries. 

Spokesperson 

RBM Partnership to End Malaria 

Geneva 

diagnostic tools. Though they manifest no 

symptoms, they can transmit the infection 

to others. These so-called “infectious 

parasite reservoirs” pose yet another threat 

to bring the numbers down effectively. 

The lack of point of care (POC) 

diagnostic methods in endemic areas 

for detecting parasites in asymptomatic 

individuals, who are the reservoirs for 

transmission, forms another hurdle to the 

efforts towards the global elimination of 

malaria. 


Microscopy and rapid diagnostic tests (RDTs) continue to 

be the mainstay even though they have low sensitivity and 

specificity for the malarial parasite. Molecular techniques, 

as well as biosensing-based methods for a more accurate 

detection, quantitation and POC application, are urgently 

warranted. Nucleic acid-based detection methods with a high 

degree of sensitivity are yet to be put for routine applications. 

Biosensing technology has the advantage of suitability for offlab 

situations. 

Studies call for a multiplexed approach, in conjunction 

with biosensors, for malaria diagnosis, considering the high 

fatality rates associated with mixed infections. Besides better 

detection rates, multiplexed testing strategies reduce the risk 

of outbreaks. 

“Understanding trends in Plasmodium falciparum helps 

inform global policy and malaria control planning and 

implementation and surveillance initiatives,” says Dr Daniel 

Weiss, Director of Global Epidemiology at the Malaria Atlas 

Project, University of Oxford, UK. 

There are regions where progress against P. falciparum has 

stalled or reversed in recent years, underscoring the need for 

persistence in control efforts and efficient resource targeting. 

Complexities of malaria vaccine 

Lack of an effective vaccine to prevent malaria infection is 

also hampering efforts to eliminate the parasitic disease. The 

only approved vaccine as of today is RTS,S, a recombinant 

protein-based vaccine developed by PATH’s Malaria Vaccine 

Initiative and GSK. RTS,S, which targets P. falciparum, requires 

four injections. The use of the vaccine is not recommended 

in babies between 6 and 12 weeks of age due to its relatively 

low efficacy. 

More than 20 other vaccine constructs are currently 

being evaluated in clinical trials or are in advanced preclinical 

development, according to WHO. These candidate malaria 

vaccines target the different phases of the parasite’s life cycle 

such as pre-erythrocytic stage and erythrocytic stage, or are 

transmission blocking vaccines and anti-disease vaccination. 

Other than circumsporozoite protein (CSP) as used in 

RTS,S, the candidate vaccines are being worked under several 

technological formats including attenuated whole parasites, 

sub-unit vaccines, whole cell sporozoite vaccine, long synthetic 

peptide, adenovirus, plasmid DNA, merozoite surface proteins, 

apical membrane antigens, chimeric fusion proteins etc. 

The development of a vaccine for malaria has turned out 

to be a highly complex exercise owing to a host of challenges. 

Like other infectious agents, a natural malaria infection does 

not induce much immune protection. Only a partially effective 

immunity is acquired after repeated and prolonged exposure 

to malaria parasite over several years. This short-lived and 

highly stage- and strain-specific immunity does not provide 

complete protection against future challenge. 

“Malaria is caused by a different kind of pathogen – a 

parasite as opposed to a virus or bacterium. You have to take 

into account a more complex lifecycle. We don’t have any 

vaccines in human use against parasites. They transit between 

two organisms—humans and mosquitoes,” says Dr Ashley 

Birkett, Director of PATH’s Malaria Vaccine Initiative. 

The scientific community now understands that the 

magnitude of the immune response needed to protect against 

malaria is higher than that required for gaining immunity 

against other infectious agents such as bacteria. A related 

challenge is the induction of durably protective responses. 

Vaccine-induced immunity wanes over time, falling below the 

very high protective threshold more rapidly than observed 

with typical pathogens, resulting in renewed susceptibility. 

So, it is important to know how very high, or more potent, 

immune responses can be induced and provide protective 

immunity over the long term, he adds. 

Insecticides turn ineffective 

Vector resistance to insecticides further jeopardises efforts to 

contain the spread of the infection. The WHO Global Report 

on Insecticide Resistance in Malaria Vectors: 2010–2016 

showed widespread resistance by all major Anopheles 

species to pyrethroids, organochlorines, carbamates and 

organophosphates, the commonly used insecticide classes, 

across Africa, the Americas, South-East Asia, the Eastern 

Mediterranean and the Western Pacific. 

Of the 80 malaria endemic countries, resistance to one of 

the insecticide classes in one malaria vector was detected in 

68 countries. 

Pyrethroids are the only insecticide class currently used in 

insecticide-treated bed nets (ITNs). Resistance to pyrethroids 

was detected in more than two-thirds of the sites tested and 

was highest in Africa and the Eastern Mediterranean. ITNs 

continue to be an effective tool for malaria prevention. 

Inadequacies in funding; poor health systems 

One of the most challenging aspects of the long-haul fight 

against malaria is sustained financing. Efforts to counter 


the disease have been kept alive with steady 

and robust funding by international donors 

since 2010. With population growth and the 

emergence of resilient transmission patterns, 

existing levels of funding proved inadequate 

in recent years, especially in highest burden 

countries. Global funding for malaria control fell 

short of the estimated US$ 4.4 billion needed 

in 2017, with total funding estimated at US$ 

3.1 billion, representing a yearly shortfall of 

US$ 1.3 billion. Investment in malaria R&D too 

fell in 2016. At a total of US$ 588 million, it 

represented about 85% of the US$ 693 million 

needed every year for malaria basic research 

and product development R&D, as estimated in 

the Global Technical Strategy (GTS) for malaria 

2016-2030. 

Investment in malaria vaccine development 

too is limited. Most financing into the 

development of vaccines to combat malaria 

comes from the public sector. 

The fact that malaria affects some of the 

world’s poorest means that there is a limited 

‘market’ for investment from the private sector. 

In the meantime, financing for vector 

control products and diagnostics have 

significantly increased. 

Among the systemic and technical 

measures identified by the WHO to accelerate 

malaria control are inadequate performance 

of health systems, weak management 

of supply chains, an unregulated private 

health sector in countries like India, a lack 

of surveillance systems, monitoring and 

evaluation, a dearth of adequate technical 

and human resource capacities to scale up 

efforts, and insufficient tools to diagnose and 

Malaria is caused 

by a different 

kind of pathogen 

– a parasite, as 

opposed to a virus 

or bacterium. You 

have to take into 

account a more 

complex lifecycle. 

We don’t have 

any vaccines in 

human use against 

parasites. They 

transit between two 

organisms—humans 

and mosquitoes. 


Director of PATH’s 

Malaria Vaccine Initiative 

ARTEMISININ COMBO THERAPIES: 

STATUS OF EFFICACY 

TREATMENT OF P. FALCIPARUM 

OVERALL 

EFFICACY 

TREATMENT 

FAILURE RATES 

Artemether-lumefantrine 

98.2% >10% (occurred in four of the 

159 studies conducted) 

Artesunate+sulfadoxine-pyrimethamine 

97.7% >10% (occurred in eight of 

the 101 studies) 

Artesunate-amodiaquine 

98% 13.8% and 22.6% 

(two studies conducted in 

Cambodia in 2016 detected 

high treatment failures) 

Artesunate-mefloquine 

94.9% 12.5–49.1 

(high treatment failure rates 

were observed in seven 

studies conducted in Thailand 

between 2010 and 2013) 

Artesunate-pyronaridine 

96.9%. >10% (Two studies conducted 

in western Cambodia in 2014, 

10.2% and 18%), 

Dihydroartemisinin-piperaquine 

94.5% >10% (observed in 19 studies 

from Cambodia, Lao People’s 

Democratic Republic and Viet 

Nam.) 

Most studies show that the ACTs currently 

recommended in national malaria treatment 

policies remain effective, with overall efficacy 

rates of >95%. However, studies show 

treatment failure rates of >10% associated 

with treatments currently recommended in 

the national treatment policy. 

TREATMENT OF P. VIVAX 

Chloroquine 

97.4% 22% (Ethiopia) 

ACTs 

93.4% >10% (observed in four 

studies) 

SOURCE: WHO 


slug 

“Durability of protection a critical 

attribute of next-gen malaria vaccines” 

An international non-profit 

organization, PATH is a leader in 

malaria vaccine development. RTS,S, 

the most advanced vaccine candidate, 

has been developed by PATH Malaria 

Vaccine Initiative (MVI) in association 

with GlaxoSmithKline. Dr. Ashley Birkett, 

Director of PATH MVI, shares his views 

on the current status of the malaria 

vaccine pipeline, recent technological 

advances as well as issues that delay 

the development of an effective vaccine 

against malaria. Edited excerpts: 

What are the potential malarial 

vaccine candidates under PATH MVI 

and at what stages of development 

are they? 

We are pursuing a diverse portfolio 

of vaccine projects aligned with the 

goal of accelerating malaria (parasite) 

elimination. These projects share a 

common goal of trying to induce 

immune responses to block parasite 

transmission between humans and 

mosquitoes. 

The RTS,S vaccine will be introduced 

into three countries in Africa through 

a pilot introduction being coordinated 

by the WHO. We also have a research 

programme looking at a vaccine 

regimen using a fractional, delayed 

third dose of the RTS,S vaccine. There 

To block transmission, 

we are targeting ‘bottlenecks’ 

in the parasite life-cycle, 

when it circulates in relatively 

low numbers. These 

bottlenecks occur as the 

parasite transitions between 

its two hosts. 

is an ongoing phase 2b clinical trial 

evaluating this regimen in young 

children at two clinical research centres 

in Africa. We also have a number 

of early clinical projects looking 

at transmission blocking vaccine 

approaches, as well as a whole parasite 

approach. 

A critical attribute of nextgeneration 

vaccines will be improved 

durability of protection, compared to 

RTS,S, to minimize the requirement for 

repeat administration. 

To block transmission, we are 

targeting ‘bottlenecks’ in the parasite 

life-cycle, when it circulates in relatively 

low numbers. These bottlenecks occur 

as the parasite transitions between 

its two hosts: humans and female 

Anopheline mosquitoes. 

Some of these approaches would 

prevent mosquitoes that feed on 

infected humans from passing along 

malaria-causing parasites to new 

victims, while others would prevent 

the parasites from maturing and 

causing illness inside the human body 

and prevent onward transmission via 

mosquitoes. 

Can you briefly explain the 

mechanism of PATH’s mAb-based 

vaccines and how they are different? 

PATH has pioneered the testing of 

mAbs as interventions against infection 

by malaria parasite P. falciparum. 

Delivery of a mAb should be considered 

quite different from a conventional 

vaccine. With a conventional vaccine, 

the human immune system is trained to 

produce antibodies to prevent infection. 

With PATH’s mAb programmes, the 

antibody is delivered fully formed into 

the person. 

Would the mAb vaccines be 

therapeutic or preventive? 

PATH’s mAb programmes are 

directed at the prevention of infection 

and the prevention of transmission of 

the parasite. So, in this sense, they are 

inherently prophylactic. These mAbs 

treat effectively infections due to P. vivax and other nonfalciparum 

malaria parasites. 

India: Declining numbers 

Compared to 2016, India reported 3 million fewer cases in 

2017, marking a 24% decrease. Yet, fifteen countries in sub- 

Saharan Africa and India carried almost 80% of the global 

malaria burden. India, again, figures in the seven countries 

which accounted for 53% of all global malaria deaths. It has 

a share of 4%, after Nigeria (19%), Congo (11%), Burkina 

Faso (6%), Tanzania (5%), Sierra Leone (4%) and Niger 

(4%). India has shown a reduction of about 53% in malaria 

incidence since 2015. 

In India, malaria is a public health problem. The 

government launched the National Strategic Plan for Malaria 

Elimination (2017-22) under the National Vector Borne 

Disease Control Programme in 2017. The programme 

aims to eliminate malaria with a target to eradicate the 

vector-borne disease by 2027. The strategy outlines yearwise 

elimination targets in various parts of the country, 

depending upon the endemicity of the disease in the 

five-year period. 


would not be used to diminish the 

severity of an existing infection the way 

standard malaria drugs are used. 

RTS,S vaccine (or perhaps its 

enhanced version) was supposed to 

undergo extensive phase 3 clinical 

studies starting from 2018. What is its 

current status? 

A large-scale safety and efficacy trial 

for the RTS,S vaccine was completed in 

2014. That study involved nearly 15,500 

infants and young children across 

11 clinical research centres in seven 

African countries. 

This year, the vaccine will 

be introduced through national 

immunization programmes in parts of 

three African countries; Ghana, Kenya 

and Malawi will provide the malaria 

vaccine to young children in selected 

areas of high malaria transmission. 

This pilot introduction is a countryled, 

WHO-coordinated initiative. It’s a 

collaborative effort with Ministries of 

Health in the three countries and a 

range of partners, including PATH and 

GSK, the manufacturer of the vaccine. 

The pilot introduction will address 

several outstanding questions related 

to the use of the vaccine in real life 

settings, including how best to deliver 

the required four doses of RTS,S, the 

vaccine’s potential role in reducing 

childhood deaths, and its safety in 

the context of routine use. About a 

million children will receive this vaccine 

across the three countries. The pilot 

introduction will provide information to 


The pilot introduction of 

RTS,S vaccine will address 

several outstanding 

questions related to the use 

of the vaccine in real life 

settings, including how best 

to deliver the required four 

doses of RTS,S, the vaccine’s 

potential role in reducing 

childhood deaths, and its 

safety in the context of 

routine use. 

allow for a decision on possible wider 

use of the vaccine across Africa. 

Apart from CSP protein, is PATH 

exploring other potential vaccine 

targets in the malarial parasite? 

Yes, PATH has actively supported 

identification of new vaccine targets 

intended to induce immunity that 

blocks infection and/or transmission. 

Circumsporozoite protein (CSP) remains 

the most effective target of antiinfective 

immunity. We are actively 

pursuing several promising targets for 

inducing immunity to block parasite 

transmission, namely Pfs48/45, Pfs25 

and Pfs230. 

A vaccine offering lasting immunity 

against malaria still looks a bit far off. 

What are the major hurdles that come 

in the way of developing an effective 

vaccine against malaria? 

We’re learning that the magnitude of 

the immune response needed to protect 

against malaria is higher than is typical 

for gaining immunity against bacteria, 

for example. A related challenge is 

the induction of durably protective 

responses. Vaccine induced immunity [in 

malaria] wanes over time, falling below 

the (very high) protective threshold 

more rapidly than observed with 

typical pathogens, resulting in renewed 

susceptibility. We need to understand 

how we can induce very high, or more 

potent, immune responses that can 

persist and provide protective immunity 

over the long term. 

The majority of malaria cases are reported from the 

eastern and central part of the country and from states 

which have the forest, hilly and tribal areas. These states 

include Odisha, Chhattisgarh, Jharkhand, Madhya Pradesh, 

Maharashtra and some north-eastern states like Tripura, 

Meghalaya and Mizoram. 

Poorest still missed out? 

It remains a fact that malaria is preventable and treatable, 

despite the limitations of the current tools available. The 

bigger issue, however, is making these advancements reach 

the remotest hinterlands where the most deprived live with 

the least access to any form of interventions. 

“A large number of people in the high burden countries, 

such as Nigeria, Democratic Republic of Congo and 

Mozambique, still miss coverage of key interventions. 

Often, it is the hard-to-reach, the poorest and marginalized 

populations that are missing out. It is time to focus on 

countries that have stubbornly high numbers of malaria 

deaths and ensure that prevention and treatment is 

available to those in greatest need,” says the RBM 

Partnership spokesperson. 


cover story 

GENE DRIVE MOSQUITOES TO 

THWART MALARIA SPREAD 

Several approaches replacing vector populations with mosquitoes of the same 

species unable to populate are being tested in labs 

Finding conventional methods of malaria control 

insufficient to eliminate the disease, some researchers 

have turned to genetics to control the mosquito 

population. 

Malaria control schemes based on the concept of 

replacing vector populations with mosquitoes of the same 

species unable to transmit are currently being evaluated in 

several laboratories. 

Gene drive mosquitoes, many researchers consider, have 

tremendous potential to help eliminate malaria. 

In sexually reproducing organisms, most genes follow 

Mendelian rules of transmission in a 50:50 ratio. This means 

that of the two copies of every chromosome; any single 

copy of a gene normally has a 50% percent chance of being 

passed on to an individual’s offspring. This process of gene 

transmission is described as ‘fair’ and does not in itself 

change the frequencies of alternative genes in a population. 

The two copies are transmitted by an individual at the same 

rate that they were inherited by the individual. 

But there may be occasions wherein some genes are 

transmitted to more than 50% of the progeny. Gene drive 

refers to this process of preferential or biased inheritance 

from one generation to the next. Mendelian transmission of 

genes does not in itself lead to changes in allele frequency 

over time, whereas gene drive can. The most efficient gene 

drives might ensure an inheritance bias of nearly 100 percent. 

Here, the genetic sequence doubles in frequency. 

Gene drive is a natural process that has independently 

evolved many times in many species. There have been several 

documented cases of gene drives existing in nature, with 

selfish genes invading several different insect species. 

Now researchers have developed a technique that 

introduces a genetic element that cheats the normal rules of 

Mendelian inheritance. 

So, if we know the genes that are responsible for key 

mosquito traits, we can theoretically introduce a genetic 

modification into the insects, which reduces malaria 

transmission. Going by this principle, a wide diversity of 

synthetic gene drive systems has been proposed for vector 

control. 

Several multiple gene drive approaches have recently 

shown promise in laboratory settings. They include mosquito 

population replacement with introduced genes that limit 

malaria transmission, driving-Y chromosomes to collapse 

a mosquito population, and disrupting a fertility gene to 

achieve population suppression or collapse. 

A mechanistic, spatially explicit, stochastic, individualbased 

mathematical model is used to simulate each gene 

drive approach in a variety of sub-Saharan African settings. 

Each gene drive approach provides a tool for malaria 

elimination. 

In fertility gene drive approach, a selfish 

gene that spreads through a population 

through non-Mendelian inheritance 

is used. If the introduced driving 

gene disrupts a fertility gene, 

then its spread through a local 

vector population could suppress 


the population or even collapse it. Such an approach has 

been proposed using homing endonuclease genes (HEGs) 

and this approach has been demonstrated in the laboratory 

with HEGs and using CRISPR/Cas9 nucleases as well. 

In driving-Y approach, the Y chromosome in the 

modified male mosquito damages the X chromosomes 

in the germline, resulting in gametes that predominantly 

carry a Y chromosome. This approach has been successfully 

demonstrated through a series of lab experiments. It ensures 

that modified males have predominantly male offspring, as 

do their male offspring in turn. This could, eventually, lead to 

local population collapse. 

Population replacement is another gene drive approach. 

In this case, gene drive focuses on fixation instead of 

collapsing the local vector population. This introduced 

construct could knock out a gene required for mosquito 

infection by the parasite. Or it could knock out in a gene that 

provided a defence against parasite infection or facilitated 

onward transmission to humans. 

Once achieved, the impact of gene drive technology 

would stay for years after elimination. A successful gene drive 

construct would prevent any loss of impact due to pyrethroid 

resistance and would ramp down transmission potential 

regardless of vector feeding behaviours and bionomics, 

proponents of the technology aver. 

Driving genetic immunity 

In a Johns Hopkins University study on mosquitoes genetically 

modified to be more resistant to malarial parasite found that 

GM mosquitoes could possibly drive their genetic immunity 

into mosquito populations to which they are introduced. 

Genetic modification of a bacteria found in the gut of the 

mosquito could effectively kill off the malaria-causing parasite 

before it can develop properly, shows another study from JHU 

researchers. 

The researchers demonstrated that modulation of the 

microbiota of P. falciparum–resistant immune-enhanced 

GM mosquitoes renders them more competitive than wild 

type mosquitoes through mating preference in mixed-cage 

populations. 

The use of proper promoter-transgene combinations to 

modulate the mosquito microbiota can facilitate the spread of 

GM mosquitoes in a population, according to researchers. 

Even though work in the laboratory has provided a 

number of proof-of-principle demonstrations of key aspects 

of gene drive interventions for malaria control, they are yet to 

be put on field trials. 

Gene drive technology is currently being evaluated by 

regulators and other stakeholders. Gene drive constructs also 

pose several issues for regulators due to their novelty. 


BURDEN OF MALARIA 

219 million cases of malaria occurred worldwide in 2017, 

compared with 217 million cases in 2016 

AMERICAS 

1 

million 

ESTIMATED MALARIA CASES 

BY WHO REGION, 2017 

The area of the circles is shown 

as a percentage of the estimated 

number of cases in each region 

P. falciparum P. vivax 

74.1% 

4.4 

25.9% million 

200 

million 

31.0% 

69.0% 

EASTERN 

MEDITERRANEAN 

AFRICAN 

REGION 

0.3% 

99.7% 

SOUTH- 

EAST ASIA 

11.3 

million 

37.2% 

62.8% 

WESTERN 

PACIFIC 

1.9 

million 

28.1% 

71.9% 

DEATH FROM DISEASE 

435,000 

deaths occurred from malaria 

globally in 2017 

30 / FUTURE MEDICINE / April 2019 

61% 

countries 

accounted for 

approximately 

70% 

of estimated 

malaria cases 

and deaths 

globally. 10 in 

sub-Saharan 

Africa and India 

Children aged under 5 years are the 

most vulnerable group affected by 

malaria. In 2017, they accounted for 

61% (266,000) of all deaths 

Incidence of 

malaria came 

down by 53% in 

India since 2015 

INDIA SHARES 

4% 

of total malaria 

cases 

48% 

of vivax malaria 

cases

80% 

5countries 

accounted for nearly 

half of all malaria 

cases worldwide 

15 

countries in sub-Saharan 

Africa and India carried 

almost 80% of the global 

malaria burden 

25% 

Nigeria 

11% 

5% 

DR Congo 

4% 

4% 

Mozambique 

India 

Uganda 

MORE INCREASE, 

LESS DECREASE 

Incidence of malaria increases 

in most geographic regions 

10 7 0 1 2 

2 6 

3 4 5 

AFRICA 

AMERICAS 

EASTERN 

MEDITERRANEAN 

SOUTH- 

EAST ASIA 

WESTERN 

PACIFIC 

increase 

decrease 

INFOGRAPHICS: GOPAKUMAR K 

SOURCE: WHO 


genetics 

GENETIC APPROACHES TO 

TACKLE MALARIA 

Several promising technologies to interfere with malaria transmission are 

currently under different stages of development 

DR RAJANI KANTH VANGALA 

There are an estimated 3.2 billion 

people from 97 countries at risk 

of malaria infection, with 214 

million infections reported in 2015 

alone, resulting in 438,000 deaths. 

These statistics clearly indicate 

the need to develop strategies to 

overcome this infectious disease. 

Presently, malaria control mechanisms 

target mosquitoes with 

insecticides, after which 

they quickly acquire resistance 

due to the rapid and uncontrolled use 

of these agents. Apart from that, drug 

resistance by Plasmodium, combined 

with a lack of effective vaccine 

strategies, is leading to the fast spread 

THE COMPLEX LIFE OF 

PLASMODIUM PARASITE 

GIVES US A VERY IMPORTANT 

OPTION OF DEVELOPING 

TRANSMISSION BLOCKING 

METHODOLOGIES 

of the disease. 

The relationship of the malaria 

parasite with a vertebrate host starts 

with a bite of an infected mosquito, 

when sporozoites are introduced into 

the bloodstream through the skin. 

This means that the complex life of 

Plasmodium parasite is dependent on 

Anopheles mosquito for transmission 

to happen. This gives us a very 

important option of developing 

transmission blocking methodologies 

which could potentially help control 

and eliminate the disease. These 

methods vary from the classical vector 

control approaches like insecticides. 

Several new studies about 

genetically modified mosquitoes to 

block the transmission have also been 

reported. One of the first genetically 

modified mosquitoes reported 

was a variant of Aedes 


aegypti (Franz AWE et al. Insect Mol 

Biol 2009;18:661-672), resistant to 

the dengue virus. However, after 17 

generations, the genes that conferred 

resistance were mutated or silenced. 

These results clearly show the 

roadblocks in the development of 

transmission resistant vectors. 

Other strategies include 

paratransgenesis, which targets the 

genetic modification of the microbiota 

to influence the host’s response to 

the parasite. Different antiplasmodial 

paratransgenesis bacterial species 

have been reported, of which Asaia 

bogorensis have proven to be very 

beneficial (Damiani C et al. Microb 

Ecol 2010;60:644-654). Asaia densely 

populates the midgut, larval gut and 

reproductive organs of Anopheles 

mosquitoes. It can also be found in 

other vectors such as Aedes aegypti 

and Aedes albopictus, which serve as 

vectors for dengue, chikungunya and 

zika (Huges HL et al. PNAS 2014;111, 

12498-12503), suggesting that 

paratransgenesis can help in inhibiting 

a wide range of vector-borne diseases. 

Sporozoite vaccines 

Vaccination has been a successful 

strategy to overcome several infectious 

diseases in humans and animals. This 

PLASMODIUM ’S GENETIC 

DIVERSITY AND COMPLEX 

BIOLOGY HAS MADE IT 

DIFFICULT TO ACHIEVE LONG- 

TERM IMMUNE RESPONSES 

could also be a very cost-effective way 

in implementing prevention strategies 

for large populations, thus reducing 

disease burden and mortality. 

The lifecycle of malaria parasites 

is complex, and can be divided 

into three major phases -: preerythrocytic 

or liver,) asexual blood 

and mosquito sexual stage, all of 

which have been exploited for 

developing vaccines. With more than 

5,000 genes characterised by three 

genomes - nuclear, mitochondrial and 

apicoplastid, Plasmodium’s genetic 

diversity and complex biology has 

made it difficult to achieve longterm 

immune responses. Liver stage 

sporozoite (SPZ) vaccines, which 

induce sterile protection (Nussenzweig 

RS et al. Nature 1967;216:160-162), 

modulate T cell responses, preventing 

the advancement of the liver stage to 

the blood stage. 

Research on attenuated whole 

SPZ, which is now in early clinical 

trials, was started by French scientist 

Sergent in an avian model way back 

in 1910 (Sergent E. Comptes rendusde 

l’Academie des Sciences. 1910;151:407- 

409). In 1973, X-irradiated SPZ of 


Plasmodium falciparum was shown 

to be protective in humans when 

challenged with non-irradiated 

homologous strain transmitted by 

mosquito bites. After the success 

of these developments, scientists 

are also working on the new and 

more sensitive technology of 

chemoprophylaxis vaccination. This 

method uses non-attenuated, fully 

infectious SPZ from chemo-sensitive 

strains, which are administered along 

with effective antimalarial drugs. 

This induces a sterilizing effect even 

with very low doses of SPZ inocula 

in comparison to X-irradiated. The 

evolution of new genetic technologies 

like clustered regularly interspaced 

short palindromic repeats (CRISPR) 

and CRISPR-associated protein 9 

(CRISPR/Cas9) system (Singer M, 

Frischknecht F. Trends in Parasitology, 

2017;33:202-213, Singer M et al. 

Genome Biology, 2015;16-249) have 

helped to develop parasites that arrest 

late liver stages and exposes the liverstage-specific 

antigen for a broader 

and longer immune effect. However, 

more clinical studies are required to 

evaluate several obstacles, such as 

the delivery of PSZ vaccines in mass 

immunizations. 

Stage-specific targeting 

Targeting the pre-erythrocyte stage 

has resulted in several important 

outcomes and one such was the RTS,S 

vaccine. RTS,S consists of a virus-like 

particle (VLP) displaying hepatitis 

B surface antigen fused with a P. 

falciparum circumsporozoite protein 

fragment containing its central repeats 

and T-cell epitopes (RTS). A successful 

phase III clinical trial by Vandoolaeghe 

P and Schuerman L (Expert Review 

of vaccines, 2016;151:1481-1493) has 

shown that RTS,S has an efficacy of 

51.3% (95%CI 47.5-54.9) in 5-17 month 

children over 12 months, with 3 doses 

of vaccine. However, a fourth dose 

was administered to have long term 

protection. Although this represents 

a very important milestone, there 

remains a need to develop better 

SEVERAL METHODS OF 

VACCINE PREPARATION WITH 

INCREASED IMMUNOGENICITY 

ARE UNDER DEVELOPMENT 

strategies of doses and long-lasting 

efficacy against clinical malaria. People 

living in endemic areas are exposed 

to repeated blood stage parasites and 

develop protective antibodies over 

the years.This stage could also be 

very important as a target in vaccine 

development. This acquired immunity 

that prevents clinical episodes, as 

shown in Kenyan study cohorts, gives 

an almost 100% protection. However, 

the efficacy of merozoite antigen 

vaccines in interventional trials has 

been very poor. 

Several initiatives, like Malaria 

Vaccine Initiative (MVI) — with a 

roadmap to develop vaccines that 

interrupt parasite transmission (VIMTs) 

— are under way to developing better 

approaches for stopping transmission. 

In these cases, an immune response to 

stage-specific targets is needed in the 

human host. 

The target proteins selected for 

vaccine development include surface 

proteins of gametocytes and gametes 

(Pfg 27, Pfs 48/45, Pfs 2400 and Pfs 

230), zygote and ookinete (Pfs 25 

and Pfs 28) (Bousema T, Darkeley C. 

Clin Microbiol Rev. 2011; 24(2):377- 

410, Carter R. Vaccine 2001 21;19(17- 

19):2309-14, Tomas AM etal EMBO J 

2001;20(15):3975-83). Antigens from 

other stages, such as Ps 21, chitinase 

and alanyl aminopeptidase (AnAPN1), 

are also targeted. Among the 

transmission-blocking vaccines (TBVs) 

that have reached human clinical 

trials were Pfs 25 and its ortholog in 

Plasmodium vivax Pvs25. But they 

have not yet yielded any positive 

results. This could be due to several 

reasons, including poor production 

qualities of antibodies and low 

reactogenicity attributed to adjuvant 

formulations (Malkin EM et al. Vaccine 

2005;23:3131-3138, Wu Y et al. 

PLoS One 2008;3(7):e2636). Several 

methods of vaccine preparation with 

increased immunogenicity are under 

development, such as conjugation to 

Pseudomonas aeruginose exoprotein 

A (EPA) (Qian F et al. Vaccine 

2007;25:3923-3933), bacterial outer 

membrane protein complex (OMPC) 

(Wu Y et al. PNAS 2006;103:18243- 

18248), C4 bp oligomerization 

domain (IMX313) (Li Y et al. Scientific 

Reports 2016;6:18848) and modified 

lichenase carrier (LiKM) (Ogun SA et 

al. 2008;76:3817-3823). Along with 

these, new adjuvants such as GSKs 

liposomal ASo1, which incorporates 

TLR4 ligand MPL along with QS-21 — a 

derivative of saponin and Alhydrogel 

— may now pave the way for better 

TBVs. In other words, there are several 

novel technologies which are evolving 

and are in clinical trials, suggesting 

the possibility of better outcomes in 

tackling malaria in the future. 

The author is medical scientist and former 

director of SGRF, Bangalore 


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drug approvals 

Solriamfetol to treat 

narcolepsy, OSA 

The US FDA has approved 

solriamfetol (Sunosi) to 

treat excessive sleepiness 

in adult patients with 

narcolepsy or obstructive 

sleep apnea (OSA), Jazz 

Pharmaceuticals Plc said. 

Solriamfetol is a dualacting 

dopamine and 

norepinephrine reuptake 

inhibitor (DNRI) indicated 

to improve wakefulness in 

adults living with excessive 

daytime sleepiness due to 

narcolepsy or OSA. 

The drug is expected to 

be commercially available 

in the US following the 

final scheduling decision 

by the Drug Enforcement 

Administration (DEA). 

The FDA’s approval of 

solriamfetol is based on 

data from the Treatment 

of Obstructive sleep apnea 

and Narcolepsy Excessive 

Sleepiness (TONES) phase 3 

clinical programmes, which 

included four randomized 

placebo-controlled studies 

that demonstrated the 

superiority of the drug 

relative to placebo. 

The approval comes as 

Jazz is trying to reduce its 

reliance on its blockbuster 

narcolepsy drug, Xyrem, 

whose patents were 

declared invalid by a US 

appeals court in July. 

Atezolizumab 

plus chemo for 

extensive SCLC 

Roche said the USFDA 

approved atezolizumab 

(Tecentriq), in combination 

with carboplatin and 

etoposide, for the first-line 

treatment of adults with 

extensive-stage small cell lung 

cancer (ES-SCLC). 

This approval is based 

on results from the phase 

III IMpower133 study, which 

showed that atezolizumab 

in combination with 

chemotherapy helped people 

live significantly longer 

compared to chemotherapy 

alone. 

The atezolizumab-based 

combination also significantly 

reduced the risk of disease 

worsening or death compared 

to chemotherapy alone. Safety 

for the atezolizumab and 

chemotherapy combination 

appeared consistent with 

the known safety profile of 

atezolizumab. 

In the US, atezolizumab 

is approved in combination 

with bevacizumab, paclitaxel 

and carboplatin, for the firstline 


metastatic non-squamous 

NSCLC with no EGFR or ALK 

genomic tumour aberrations. 

In Europe, the 

atezolizumab and 

bevacizumab combination 

is approved for the initial 

treatment of people with 

metastatic non-squamous 

NSCLC, including people with 

EGFR mutant or ALK genomic 

tumour aberrations after the 

failure of appropriate targeted 

therapies. 

Atezolizumab is also 

approved by the FDA to treat 

adults with metastatic NSCLC 

who have disease progression 

during or following platinumcontaining 

chemotherapy. 

IMpower133 is a phase 

III, multicentre, doubleblinded, 

randomised placebocontrolled 

study evaluating 

the efficacy and safety of 

atezolizumab in combination 

with chemotherapy 

vs. chemotherapy vs. 

chemotherapy alone in 

chemotherapy-naïve adults 

with ES-SCLC. 

Atezolizumab is a 

monoclonal antibody 

designed to bind with 

a protein called PD-L1 

expressed on tumour cells 

and tumour-infiltrating 

immune cells, blocking its 


interactions with both PD-1 

and B7.1 receptors. 

Antibiotic 

combo for 

paediatric cUTI 

and cIAI 

Ceftazidime and avibactam 

(Avycaz) combination drug 

got expanded label indication 

to include paediatric patients 

3 months and older for the 

treatment of complicated 

intra-abdominal infections 

(cIAI) in combination with 

metronidazole and complicated 

urinary tract infections (cUTI) 

in US. 

This is the first FDA 

approval of a paediatric 

indication for cUTI and cIAI in 

more than a decade, Allergen 

said in a statement. 

The label expansion was 

approved based on results 

from two active-controlled 

clinical studies evaluating 

ceftazidime and avibactam in 

children or infants with cIAI or 

cUTI, as well as a single-dose 

pharmacokinetic study. In 

the cIAI study, the safety and 

efficacy of ceftazidime and 

avibactam (in combination 

with metronidazole) was 

compared with meropenem. In 

the cUTI study, the combo was 

compared with cefepime. 

In the paediatric cIAI 

study, the clinical cure rate 

at the test-of-cure visit in the 

intent-to-treat population was 

91.8% in the ceftazidime and 

avibactam plus metronidazole 

group and 95.5% in the 

meropenem group. Clinical 

cure rates for the predominant 

pathogens, Escherichia coli and 

Pseudomonas aeruginosa, were 

90.5% and 85.7%, respectively 

for patients treated with 

ceftazidime and avibactam plus 

metronidazole, and 92.3% and 

88.9%, respectively, for patients 

treated with meropenem. 

In the paediatric cUTI 

study, the combined favourable 

clinical and microbiological 

response rate at test-of-cure 

in the microbiological-ITT 

population was 72.2% in the 

ceftazidime and avibactam 

group and 60.9% in the 

cefepime group. 

Orphan drug 

status for 

saracatinib to 

treat IPF 

The US FDA has granted 

Orphan Drug Designation 

(ODD) for saracatinib, a 

potential new medicine for 

the treatment of idiopathic 

pulmonary fibrosis (IPF). 

Saracatinib is an 

inhibitor of src kinase which 

regulates broad cell functions 

including cell growth and cell 

differentiation. Saracatinib 

has completed phase I 

development. 

IPF is a chronic, progressive, 

irreversible and usually fatal 

interstitial lung disease which 

affects approximately 100,000 

people in the US. On average, 

patients who are diagnosed 

with IPF live between two and 

five years from diagnosis, given 

the limited medicines available 

to treat the disease. 

IPF is characterised by 

thickening and scarring of the 

interstitial tissue in the lungs. 

The cause is thought to be 

due to an abnormal woundhealing 

process that results 

in excessive tissue build-up 

in the lung. Pre-clinical trials 

of saracatinib showed that it 

inhibits fibroblast activity and 

collagen deposition, which are 

key features of lung fibrosis. 

Saracatinib is a small 

molecule, highly-potent and 

selective inhibitor of src tyrosine 

kinase. The potential new 

Brexanolone, first drug to treat postpartum depression 

Brexanolone (Zulresso) injection has 

been granted approval by US FDA 

for use in the treatment of postpartum 

depression (PPD) in adult women. 

This is the first drug approved by the 

FDA specifically for PPD, the agency said. 

Brexanolone has been given 

clearance with a Risk Evaluation and 

Mitigation Strategy (REMS) and is only 

available to patients through a restricted 

distribution programme at certified 

health care facilities where the health 

care provider can carefully monitor the 

patient. 

The drug is administered as a 

continuous IV infusion over a total of 

60 hours (2.5 days). Because of the 

risk of serious harm due to the sudden 

loss of consciousness, patients must be 

monitored for excessive sedation and 

sudden loss of consciousness and have 

continuous pulse oximetry monitoring. 

While receiving the infusion, patients 

must be accompanied during interactions 

with their child(ren). The need for these 

steps is addressed in a Boxed Warning in 

the drug’s prescribing information. 

The efficacy of brexanolone 

was shown in two clinical studies in 

participants who received a 60-hour 

continuous intravenous infusion of the 

drug or placebo and were then followed 

for four weeks. One study included 

patients with severe PPD and the other 

included patients with moderate PPD. 

The improvement in depression was 

also observed at the end of the 30-day 

follow-up period. 


Expanded use of insulin glargine 

and lixisenatide injection 

The US FDA has approved 

the expanded use of insulin 

glargine and lixisenatide 

injection (Soliqua 100/33) for 

patients uncontrolled on oral 

antidiabetic medicines. 

The injection was 

previously approved for 

use as an add-on to diet 

and exercise in adults with 

type 2 diabetes who are 

uncontrolled on long-acting 

insulin or lixisenatide. 

The FDA approval was 

based on data from the 

LixiLan-O clinical trial which 

showed, in adults with type 

2 diabetes uncontrolled with 

metformin and/or a second 

oral antidiabetic therapy, that 

treatment with the injection 

led to significantly greater 

reductions in blood sugar 

levels. 

medicine was discovered by 

AstraZeneca and has previously 

been in clinical development 

in oncology. Phase II trials for 

saracatinib in IPF have not yet 

commenced. 

EC clears 

alirocumab for 

patients with 

CV risk 

The European Commission 

(EC) has approved 

a new indication for 

alirocumab (Praluent) to 

reduce cardiovascular risk 

in adults with established 

atherosclerotic CV disease 

(ASCVD) by lowering lowdensity 

lipoprotein cholesterol 

(LDL-C) levels as an adjunct to 

correction of other risk factors. 

ASCVD is an umbrella term, 

defined as a buildup of plaque 

in the arteries that can lead 

to reduced blood flow and a 

number of serious conditions 

such as stroke, peripheral artery 

disease and acute coronary 

syndrome (ACS), which includes 

heart attack and unstable 

angina. 

The EC approval is based 

on data from ODYSSEY 

OUTCOMES, a phase 3 trial that 

assessed the effect of adding 

alirocumab to maximallytolerated 

statins in 18,924 

patients who had an ACS 

between 1-12 months before 

enrolling in the trial. 

Alirocumab is the only 

PCSK9 (proprotein convertase 

subtilisin/kexin type 9) inhibitor 

available in two starting doses 

as a single 1 milliliter injection 

(75 mg and 150 mg) once 

every two weeks and can also 

be administered as 300 mg 

once every four weeks enabling 

physicians to tailor treatment 

based on an individual 

patient’s LDL-C-lowering needs. 

Alirocumab inhibits the 

binding of PCSK9 to the LDL 

receptor and thereby increases 

the number of available LDL 

receptors on the surface of liver 

cells to clear LDL, which lowers 

LDL-C levels in the blood. 

Rituximab gets 

EC nod for 

pemphigus 

Rituximab (MabThera) 

received approval 

from the EC for the 

treatment of adults 

with moderate to 

severe pemphigus 

vulgaris (PV), a rare 

condition characterised 

by progressive painful 

blistering of the skin and 

mucous membranes. 

Rituximab is the first 

biologic therapy approved 

by the EC for PV and the first 

major advancement in the 

treatment of the disease in 

more than 60 years, Roche 

said. 

The European approval is 

based on data from the phase 

III Ritux 3 trial, a randomised 

controlled study conducted 

in France, which evaluated 

rituximab plus a tapering 

regimen of oral corticosteroids 

(CS) compared to a standard 

dose of CS alone, as a firstline 

treatment in patients with 

newly diagnosed moderate to 

severe pemphigus. 

The primary endpoint 

of the study was complete 

remission at month 24 

without the use of CS for two 

or more months. The study 

demonstrated that 89.5% of 

people with PV treated with 

rituximab, in combination with 

short-term oral CS treatment, 

achieved complete remission 

without the use of CS for two 

or more months, compared 

to 27.8% of people with PV 

receiving CS alone, the current 


standard of care. 

The phase III multicentre, 

randomised, double-blind 

PEMPHIX study, evaluating 

the efficacy and safety of 

rituximab compared with 

mycophenolate mofetil (MMF), 

an immunosuppressant, in 

patients with moderate to 

severe PV, is ongoing. 

PV is the most common 

type of a group of autoimmune 

disorders collectively called 

pemphigus. 

EC clears 

pembrolizumab 

combo for 

mNSCLC 

P 

embrolizumab (Keytruda), 

an anti-PD-1 therapy, in 

combination with carboplatin 

and either paclitaxel or 

nab-paclitaxel, has been 

approved by EC for the firstline 


metastatic squamous nonsmall 

cell lung cancer (NSCLC), 

Merck announced. 


on data from the phase 

3 KEYNOTE-407 trial, 

which demonstrated that 

pembrolizumab in combination 

with chemotherapy significantly 

improved overall survival 

(OS) in adults with metastatic 

squamous NSCLC regardless 

of PD-L1 tumour expression 

status, reducing the risk of 

death by 36 percent compared 

to chemotherapy alone. 

In NSCLC, pembrolizumab 

is also approved in Europe 

for the first-line treatment 

Once-daily eye drop for 

glaucoma 

The US FDA has okayed 

new drug netarsudil 

0.02% and latanoprost 

0.005% ophthalmic 

solution (Rocklatan) for 

the reduction of elevated 

intraocular pressure (IOP) 

in patients with openangle 

glaucoma or ocular 

hypertension. 

The once-daily eye 

drop that is a fixed-dose 

combination of latanoprost, 

the most widely-prescribed 

prostaglandin analogue 

(PGA), and netarsudil, 

the active ingredient in 

netarsudil ophthalmic 

solution 0.02%, a first-inclass 

Rho kinase (ROCK) 

inhibitor specifically 

designed to target the 

trabecular meshwork. 

The diseased trabecular 

of metastatic nonsquamous 

NSCLC in combination with 

pemetrexed and platinum 

chemotherapy in adults whose 

tumours have no EGFR or ALK 

positive mutations. 

Pembrolizumab in 

combination with carboplatin 

and either paclitaxel or nabpaclitaxel 

significantly improved 

meshwork is considered 

to be the main cause of 

elevated IOP in openangle 

glaucoma and ocular 

hypertension. 

Aerie, the maker of 

the drug, plans to launch 

the drug in the US in the 

second quarter of 019. 

The FDA approval of 

is based on data from 

two phase 3 registration 

trials, MERCURY 1 and 

MERCURY 2. In these 

studies, the drug achieved 

its primary 90-day 

efficacy endpoint as well 

as positive 12-month 

safety and efficacy results, 

demonstrating statistically 

superior IOP reduction over 

latanoprost and netarsudil 

at every measured time 

point. 

OS, reducing the risk of death 

by 36 percent compared to 

chemotherapy alone. 

Pembrolizumab is an anti- 

PD-1 therapy that works by 

increasing the ability of the 

body’s immune system to help 

detect and fight tumour cells. 

The humanized monoclonal 

antibody blocks the interaction 

between PD-1 and its ligands, 

PD-L1 and PD-L2, thereby 

activating T lymphocytes which 

may affect both tumour cells 

and healthy cells. 

Emicizumab for 

haemophilia A 

without FVIII 

in EC 

Roche said EC cleared 

emicizumab (Hemlibra) for 

routine prophylaxis of bleeding 

episodes in people with severe 

haemophilia A without factor 

VIII inhibitors from EC. 

Emicizumab can be used 

in all age groups and can also 

now be used at multiple dosing 

options for all indicated people 

with haemophilia A, including 

those with factor VIII inhibitors. 


on results from the pivotal 

HAVEN 3 and HAVEN 4 studies. 

In the HAVEN 3 study in 

people with haemophilia A 

without factor VIII inhibitors, 

emicizumab prophylaxis led 

to statistically significant and 

clinically meaningful reductions 

in treated bleeds compared to 

no prophylaxis and compared 

to prior treatment with factor 

VIII prophylaxis in a prospective 

intra-patient comparison. 

In the HAVEN 4 study in 

people with haemophilia A 

with and without factor VIII 

inhibitors, emicizumab showed 

a clinically meaningful control 


of bleeding when dosed every 

four weeks. 

Emicizumab, was approved 

by the US FDA for routine 

prophylaxis to prevent or 

reduce the frequency of 

bleeding episodes in adults 

and children, ages newborn 

and older, with haemophilia A 

without factor VIII inhibitors, 

following Priority Review, in 

2018. 

Guselkumab 

injector for 

psoriasis in US 

Guselkumab (Tremfya), 

a single-dose, patientcontrolled 

injector, has been 

approved for adults with 

moderate-to-severe plaque 

psoriasis by US FDA. 

Guselkumab is a human 

anti-IL-23 monoclonal antibody 

developed by Janssen utilizing 

MorphoSys’s proprietary HuCAL 

antibody technology. 

In phase 3, multicentre 

and randomized ORION 

study, patient experience with 

the one-press injector was 

assessed through a validated 

Self-Injection Assessment 

Questionnaire (SIAQ), which 

evaluated patient experience. 

The efficacy and safety 

of guselkumab administered 

with one-press in patients with 

moderate to severe plaque 

psoriasis were also evaluated 

in the double-blind, placebocontrolled 

ORION study. 

EMA conditional 

okay for 

andexanet alfa 

EMA’s human medicines 

committee (CHMP) has 

recommended for granting 

a conditional marketing 

authorisation for andexanet 

alfa (Ondexxya) to be used as 

an antidote for adult patients 

taking the anticoagulant 

medicines apixaban or 

rivaroxaban, when reversal of 

their action is needed due to 

life-threatening or uncontrolled 

bleeding. 

Apixaban and rivaroxaban 

belong to a newer class of 

anticoagulants called factor Xa 

(FXa) inhibitors, which work by 

blocking the action of activated 

factor X, a substance in the 

blood that has a key role in 

making it clot. 

However, because 

anticoagulants stop the blood 

from clotting normally, patients 

taking them can be at risk 

of serious and uncontrolled 

bleeding, especially in 

emergency situations. Until 

now, there has been no 

specific antidote that could 

prevent the anticoagulant 

effect of apixaban or 

rivaroxaban once they have 

been given. 

Andexanet alfa is a 

recombinant protein that 

acts as a decoy for the direct 

oral FXa inhibitors apixaban 

and rivaroxaban in the blood. 

As a result, andexanet alfa 

neutralises the anticoagulant 

effect of these inhibitors 

The effects of the therapy 

were studied in 352 patients 

for safety and 167 patients 

for efficacy. Clinical efficacy 

is based upon reversal of 

anti-fXa-activity in healthy 

volunteers and interim results 

of study in patients with lifethreatening 

bleeding. 

Ondexxya enabled the 

reversal of the apixaban and 

rivaroxaban anticoagulant 

effect within 2 minutes of its 

administration. 

Priority review for dupilumab to treat severe rhinosinusitis 

Dupilumab (Dupixent) has been 

accepted for a priority review by 

US FDA as an add-on maintenance 

treatment for adults with inadequately 

controlled severe chronic rhinosinusitis 

with nasal polyps (CRSwNP). 

Patients with severe CRSwNP 

often experience recurrence despite 

previous treatment with surgery and/ 

or systemic corticosteroids. 

Currently, there are no FDAapproved 

biologic medicines to treat 

CRSwNP, a chronic disease of the 

upper airway predominantly driven by 

type 2 inflammation and characterized 

by polyps that obstruct the sinuses 

and nasal passages. 

Regeneron and Sanofi presented 

data from two pivotal Phase 3 trials 

evaluating the efficacy and safety 

of dupilumab when combined with 

standard-of-care corticosteroid nasal 

spray in patients with recurring severe 

CRSwNP despite previous treatment 

with surgery and/or systemic 

corticosteroids. 

Dupilumab is a human monoclonal 

antibody specifically designed to 

inhibit signalling of interleukin-4 and 

interleukin-13. The findings from 

these trials, as well as from prior 

trials in atopic dermatitis and asthma, 

demonstrate that both IL-4 and IL-13 

are two key proteins that play a central 

role in type 2 inflammation, which 

seems to underlie CRSwNP as well as 

several other allergic diseases. 

In the US, dupilumab is approved 

for treatment of adult patients with 

moderate-to-severe atopic dermatitis 

(eczema) that is not well controlled 

with prescription therapies used on 

the skin, or who cannot use topical 

therapies. 


straight talk 

“THE DEBATE ON WHETHER 

TO UNDERGO SURGERY OR 

STENTING IS STILL VERY, 

VERY ACTIVE” 

DR PATRICK SERRUYS is one of the 

greatest authorities on angioplasty 

and coronary stenting in the world 

today. Currently, he is the Director of 

the Clinical Research Program of the 

Catheterization Laboratory, Erasmus 

University and a recipient of ‘James 

Herrick Award’- the highest award 

of Clinical Council of American Heart 

Association. Dr Serruys is also the Head 

of the Interventional Department, Heart 

Center, Rotterdam for the past 20 

years. He talks about his experiences 

from the earliest days of angioplasty to 

the present time in an interview with 

DR SUMIT GHOSHAL. Edited excerpts: 

What are the most important milestones in cardiac 

stenting and later internal carotid artery stenting over the 

past 35-40 years? 

Before stenting, there was, of course, balloon angioplasty, 

in which Andreas Gruentzig was a pioneer. I first met 

Andreas Gruentzig in 1974 at a cardiology conference in 

Frankfurt where he was making a poster presentation in 

the hall outside the main auditorium. His poster depicted a 

technique for ligating the coronary artery in dogs. Initially, his 

success rate was just about 70 percent and by 1982 there 

were debates on topics like ‘Balloon angioplasty is going to 

disappear!’ Fortunately, John Simpson developed a steerable 

guidewire for angioplasty, and a few years later, Charlie Dotter 

came up with a nitinol (nickel-titanium alloy) spiral that could 

be used as a stent. 

Parallel to this, you had Dr Palmaz, an Argentine 

radiologist and Schatz, an American who were working 

together. Their first series of 100 had a 25 percent occlusion, 

until we figured out that we had to use aspirin and 

diclopidine as anti-platelet to avoid thrombosis. In 1994, I 

did the first randomised trial with the Benestent, which was 

approved by the US FDA the same year. 

Between 2000 and 2002, I had special access to the 

Cipher, and we organised the Havell trial, which was the 

first blind trial. There was zero restenosis in the Cipher and 

26 per cent in the bare metal stent. So that was really a 

critical moment in the introduction of the drug-eluting stent. 

Apparently, the coating was somewhat allergic, but it was 

quickly improved, and the results got better. 

One question which concerns a lot of physicians is: In the 

1980s, angioplasty was put forth as an alternative for open 

cardiac surgery, particularly for high-risk patients. Today, 

with minimally invasive cardiac surgery, has the importance 

of angioplasty and stenting gone down a little, say in the 

past five years? 

No, I think two things have happened. First, there was 

probably an excess of stenting and an excess of balloon 

angioplasty – an excess of stenting because it is easy 


is going to become important. 

When a plaque happens, it is not one 

plaque in one artery. There will be multiple 

plaques in one artery or there will be 

multiple vessels affected. How do you 

make the choice between one long stent 

and two short ones, particularly if the 

plaque is in a bifurcation of arteries? 

Initially, we had to depend on simple 

angiography. You got black and white 

shadows on a background; it’s what we call 

a luminogram and you judge visually and 

say it looks to be about 20 mm, you don’t 

measure. So, let’s put a 20 mm device. 

Today, it is much more precise and critical, 

so you have techniques like IVUS and OCT, 

and then you see the inside of the vessel, 

and you see where the vessel is more or less 

healthy. And that’s your landing zone, and 

defines the length of the stent very precisely 

in mm. So, there is a lot of precision 

introduced by the imaging techniques. 

treatment. But in the last 15 years, we realised that we should 

treat the lesions that really need to be treated. So, you have 

to do pressure wire studies and prove that this is the lesion 

which is ischemic. That has slowed down the use and misuse 

of the stent. That’s one thing. 

In countries like India and China, naturally, the people 

propose the PCI (percutaneous coronary intervention) and 

stenting and the patient often agrees because it is less 

invasive. In Europe, we have a dialogue with the patient, and 

we say, surgery may be more invasive but in the long term, it 

will be better. That debate is still very, very active and will take 

a few more years, or a decade, because in the meantime, 

pharma is coming back. What you have in pharma is PCSK-9, 

monoclonal antibodies against PCSK-9. And for the first time, 

not only can you block the progression of the disease, but you 

can also cause regression. So, I think that is something which 

Dr Patrick Serruys 

PHOTO: UMESH GOSWAMI 

Now for the patient, who has to pay for 

the procedure, the charges often depend 

on the number of stents that are put. So, 

the government will say you cannot charge 

more than Rs 8,000 or 10,000 per stent. 

But if the patient needs three stents, then 

that’s three times the number. How much 

does that play on a cardiologist’s mind 

when he takes the decision? 

It’s a very important question. Obviously, 

surgery is expensive, certainly in western 

countries where a surgeon can easily charge 

$10,000 to 20,000 for surgery. Then, there 

is the heart-lung machine, the perfusionist, 

the anaesthetist, three, four, five days in the 

hospital and so on. With angioplasty, there is 

no need for anaesthesia, no perfusionist, no 

heart-lung machine. We may need to sedate 

the patient a little bit. And you could put 

many stents in one session. So, in terms of 

cost-effectiveness, we are already more costeffective 

than the surgeon. Also, in Europe, 

mass production and purchase by large 

healthcare organisations have brought the 

stent prices down to about 250 Euros. Now 

the Indian government has also decided to 

put a price cap, which is a good thing. 

If I could take you in another direction, 

internal carotid artery stenting must have 


egun in the mid-1990s or so? 

Yeah, initially it was more or less the 

same story; first, there was surgery — that 

is endarterectomy — then came the stent, 

then good anti-platelet treatment, and then 

the protective filter so that there were fewer 

strokes during the implantation. It is a very 

well-established technique now. 

You know there was a stage in 

treatment protocols where you would inject 

streptokinase and urokinase within six hours 

of an impending stroke. 

It’s still there, very much there. Now 

there is Professor Erwich from Boston, as a 

combination of 5 mg of TPA with the mutant 

of urokinase, and in Rotterdam we are doing 

a study now with people who are being given 

these medications already in the ambulance. 

And then, we look at the patency when they 

arrive in the hospital. So, there is some kind of 

revival of thrombolytic therapy. 

Maybe not in five 

years, but in 

10-15 years, 

I think what is 

going to come 

into our lives is 

genomics. 

How do you see the next five years in 

terms of technology and the physicians’ 

expertise? 

That is a question which I get frequently. 

Maybe not in five years but in 10-15 years, I 

think what is going to come into our lives is 

genomics. You might remember when the 

Human Genome Project was a one-billiondollar 

project. But now in Rotterdam, a 

private lab offers the human genome in just 

1200 Euros, and you may get it in 

India at some point. They will not tell you 

what the gene means, you have to go to 

a doctor for that. And the doctor will tell 

you that this and this and this gene will be 

responsible for Alzheimer and this will be 

responsible for diabetes. It is much more 

complicated because you have epigenetic 

factors, so that you have [a situation that] 

some gene is upregulated or 

down-regulated. 


case reports 

EARLY INFANTILE EPILEPTIC 

ENCEPHALOPATHY-50 

A case illustrating how genetic testing proved to be a boon in saving the life of 

a girl child who was suffering from a rare neurometabolic disorder 

Six-year-old Mallika (name changed) was brought to 

the Department of Neurosciences, Bai Jerbai Wadia 

Hospital for Children in Mumbai, to consult regarding 

her year-long- history with epileptic seizures. Born to nonconsanguineous 

parents, with a normal delivery, Mallika 

was growing up as a normal child until she was 5 years old. 

One day, as she was playing, she suddenly developed a 

seizure and was unresponsive for 10 minutes. Such seizures 

continued to recur about twice every month since then. In 

addition, Mallika also started getting focal seizures about 

2 months after the first onset of seizures, which gradually 

progressed to general tonic-clonic seizures, focal seizures 

during sleep, and myoclonic jerks that resulted in falls. A 

couple of months earlier, Mallika also started complaining 

of being unable to balance while walking. Gradually this 

condition progressed to a point where she needed support 

while walking. On the whole, her condition was worsening, 

with an increase in the frequency of epileptic seizures, loss 

of milestones and cognitive and higher function regression. 

Her parents were worried as Mallika had already been treated 

with a wide array of available antiepileptic drugs, which were 

unable to effectively control the epileptic pseudo ataxia. 

Based on this clinical history, a team of doctors including 

pediatric neurologists Drs. Shilpa Kulkarni, Sonam Kothari, 

Anaita Hegde and Krishnakumar Shah at Wadia hospital 

debated on the treatment plan and a course of action for 

Mallika. Considering that Mallika’s seizures and ataxia were 

not being adequately controlled with the antiepileptic drugs, 

and with deteriorating cognitive milestones, it became 

imperative to understand the disease to provide suitable 

treatment. Mallika’s test results, including MRI, brainstem 

evoked response audiometry, ophthalmic evaluation etc, were 

all normal other than EEG, which was abnormal and showed 

epileptic discharges. 

The history and test results suggested that Mallika was 

most likely suffering from some form of neurodegenerative 

disorder or an epileptic encephalopathy. Epileptic 

encephalopathies are brain disorders that manifest at 

an early age and display similar symptoms as seen in 

Mallika. Multiform, intractable seizures, cognitive and 

neurological deficits and abnormal EEG are all characteristic 

features of epileptic encephalopathies. 

While most common causes of epileptic 

encephalopathies are structural 

abnormalities, there are rare, but potentially 

treatable ones caused due to deficiencies in 

various metabolic pathways. Such treatable 

epileptic encephalopathies often occur due 

to gene mutations, and depending on the 

gene mutation, different treatment options 

may be available. To determine if Mallika was 

suffering from such a metabolic disorder 

associated with epileptic encephalopathies, 

THERE ARE RARE, BUT 

POTENTIALLY TREATABLE 

EPILEPTIC ENCEPHALOPATHIES 

CAUSED DUE TO DEFICIENCIES 

IN VARIOUS METABOLIC 

PATHWAYS 

genetic testing was recommended, and her 

blood sample was sent for an epilepsy panel. 

Mallika was discharged from the hospital 

while awaiting the results from the genetic 

testing as the seizures were temporarily 

under control. 

Before the genetic test results were out, 

however, Mallika was admitted back to the 

hospital due to a decrease in oral intake. 

In the hospital, she went into refractory 

status epilepticus. Mallika was started on 

a ketogenic diet, which was unfortunately 

unable to control the seizures. Mallika was 

unable to think clearly or even recognize 

her parents. She again developed refractory 

status epilepticus and was moved to the 


intensive palliative care unit. To make 

matters worse, she developed Steven 

Johnsons syndrome, which is often a side 

effect of many anti-epileptic drugs. Steven 

Johnsons syndrome was treated via standard 

intravenous immunoglobulin. She was at her 

worst cognitive condition when the genetic 

test results arrived. The results indicated 

2 mutations in the carbamoyl-phosphate 

synthetase 2, aspartate transcarbamylase, 

and dihydroorotase (CAD) gene, indicative of 

early infantile epileptic encephalopathy-50. 

Early infantile epileptic encephalopathy-50 

is characterized by early-onset seizures 

and severe developmental regression as 

seen in Mallika. It is an autosomal recessive 

progressive neurodegenerative disorder 

EARLY INFANTILE EPILEPTIC 

ENCEPHALOPATHY-50 IS 

CHARACTERIZED BY EARLY- 

ONSET SEIZURES AND SEVERE 

DEVELOPMENTAL REGRESSION 

that occurs due to mutations in the CAD 

gene. The CAD gene encodes an enzyme 

required for the biosynthesis of pyrimidine 

nucleotides. Such a condition has been 

shown to be treatable by oral uridine. 

Uridine is not available in the Indian market 

and had to be bought through Amazon. Dr. 

Kulkarni reminisces that it took over a month 

to procure the drug, however, the effects 

were immediate. Within 48 hrs of starting 

oral uridine, Mallika’s seizures reduced and 

refractory status epilepticus was aborted. 

Today, Mallika is only on 2 antiepileptic 

drugs in addition to oral uridine, and while 

she is not yet cognitively normal, she is able 

to walk, and her speech is slowly recovering. 

Dr. Kulkarni would like to stress on the 

benefits of genetic testing, how this has 

revolutionized precision medicine for rare 

disorders, and how it is important to keep 

pursuing the right diagnosis to identify the 

right treatment options. 

DR SHIVANEE SHAH 


case reports 

DEALING WITH C1Q 

DEFICIENCY 

Primary immunodeficiency disease is quite common but often undiagnosed 

old Ciara (name changed) lived in Mauritius. 

She had been suffering from repeated skin 

13-year 

rashes and kidney and lung ailments since she 

was 2 years old and was diagnosed with systemic lupus 

erythematosus and class IV lupus nephritis. She was being 

symptomatically treated for her skin conditions, nephritis, 

as well as pulmonary hypertension. In spite of being 

treated with 12 different medications, including steroids, 

immunosuppressants as well as anti-hypertension pills, her 

condition was not improving. She had undergone multiple 

kidney biopsies which showed no improvement even after 

the medication. More recently, she had started facing a 

stiffening of her lower limbs, that was affecting her ability to 

walk. Ciara’s family were desperately trying to get appropriate 

treatment for her when they brought her to Bangalore from 

Mauritius in search of a paediatric immunologist. Here they 

were fortunate to consult the only Pediatric Immunologist in 

Bangalore, Dr Sagar Bhattad, at Aster CMI Hospital. 

After reviewing the case history, Dr Bhattad immediately 

recognized that, while the case was correctly diagnosed as 

systemic lupus erythematosus, this was in an unusual form. 

Systemic lupus erythematosus symptoms typically do not 

kick in until 8-10 years of age. However, in Ciara’s case, she 

had been suffering since she was 2. He concluded that there 

must be other underlying causes that needed to be identified 

for appropriate treatment. It so happened that Dr Bhattad 

had previously encountered 2 similar cases during his postgraduate 

training and had in fact written his MD thesis on 

the topic. This is why he was almost sure that the underlying 

reason was some form of primary immunodeficiency disease. 

Primary immunodeficiency diseases are disorders 

in which the immune system is weakened allowing for 

infections and other health issues. Typically, symptoms start 

during infancy and often worsen progressively. Multiple 

organs may be involved and it can eventually involve even 

the neurological system, often resulting in irreversible 

neurological damage. Majority of primary immunodeficiency 

diseases are inherited and caused due to mutations in the 

genes encoding for key proteins involved in maintaining 

immunity. Dr Bhattad, therefore, recommended genetic 

testing to confirm his suspicion and identify the cause of 

Ciara’s condition. 

It took 6 weeks for the results to come 

back, but it was worth the wait. Genetic test 

results confirmed that Ciara was suffering 

from a very rare complement deficiency, 

caused due to a homozygous mutation on 

exon 2 of the Complement Component 1q or 

C1q gene. C1q is part of a protein complex 

C1 that plays a key role in the innate immune 

system. C1 binds to antibody-antigen 

complexes to trigger the complement system 

during an infection, resulting in activating 

phagocytosis, inflammation, and subsequent 

lysis of bacteria. Thus, C1q forms an integral 

part of the immune system and a deficiency 

in functional C1q has been associated with 

C1 BINDS TO ANTIBODY- 

ANTIGEN COMPLEXES TO 

TRIGGER THE COMPLEMENT 

SYSTEM DURING AN INFECTION 

glomerulonephritis, recurrent skin lesions, 

systemic lupus erythematosus (SLE) or SLElike 

diseases. Ciara had a mutation that 

resulted in the loss of C1q protein, which 

explained her symptoms. 

While C1q deficiency is rare and 

treatment options are limited, a bone 

marrow transplant was done for this disorder 

for the first time in the UK in 2014 and fewer 

than 10 successful bone marrow transplant 

cases have been carried out worldwide since. 

Bone marrow transplantation comes with its 

own complications, the primary one being 

the availability of an HLA matched donor for 

the bone marrow. Thankfully, Ciara’s father 

turned out to be a perfect match and Dr 


Bhattad proceeded to plan and collaborate with Drs Stalin 

Ramprakash and CP Raghuram, bone marrow transplant 

experts at Aster CMI Hospital, to perform this transplant. 

Ciara was admitted to the hospital about 2 weeks prior 

to the transplantation so that all tests could be carried out 

and she could be closely monitored. She was again kept in 

the hospital for 2-3 weeks after the transplant to ensure 

that there were no adverse effects and she did not get any 

infections immediately after the transplantation. 

Many factors contribute to the success of transplantation. 

HLA donor matching and the underlying condition of the 

patient play major roles in success, and the patient must 

be closely monitored post the transfer of the bone marrow. 

These factors, along with the age and weight of the patient 

as well as kidney involvement, contribute to a decision on the 

medical treatment that follows transplantation. Due to Ciara’s 

kidney and lung involvement, medications were carefully 

planned. Complications were also anticipated as preexisting 

organ damage increases the risk of complications during and 

after the transplant, making the technique complex and one 

requiring meticulous planning. 

Ciara underwent successful transplantation and is doing 

very well so far. She will need to be closely monitored for 

the next 3 months and be on immunosuppressants for the 

next 6 months. Dr Bhattad calls it the ‘100 day’ period posttransplantation 

when there is a high risk of infection and 

chances of transplant rejection. However, 

after the ‘100 day’ period, the new bone 

marrow starts to function completely, and the 

immunosuppressant doses can be decreased. 

Aster CMI in Bangalore has a dedicated 

Immunology and Bone Marrow Transplant 

Unit (BMT) which encounters many children 

with immune deficiencies, as in Ciara’s case. 

Dr Bhattad reiterates that “Primary immune 

deficiencies are actually quite common, but 

often undiagnosed. It should particularly be 

considered in case of repeated infections 

and multiple hospitalizations, ideally before 

irreversible organ damage occurs. Awareness 

of such deficiencies is particularly important, 

especially now that the required diagnostics 

and therapeutics are available. Eyes see only 

what the mind knows.” 

Only when doctors start looking for these 

conditions in their patients will they be 

able to make an early diagnosis. Increasing 

awareness of these diseases is the need of 

the hour. 



case reports 

A DELICATE 

TRANSLOCATION 

On the daunting task of performing corrective surgery for arterial transposition 

on an underweight baby 

The formation of a fully developed human baby from an 

embryo involves a series of complicated cellular and 

molecular events spread over 40 weeks. These occur 

in precise synchrony to ensure that all tissues and organs 

are correctly formed from a single fertilized egg. Nature has 

also built in a fail-safe mechanism where any deviation in the 

embryological development process leads to an abortion of 

the foetus. Occasionally, for reasons that are not completely 

clear, babies are born despite structural anomalies. 

One such baby boy was born to Mrs Meena and Mr 

Vinod (names changed). Expectedly, both parents were very 

excited when Amol (name changed) was born. However, just 

days after he was born, the parents noticed that Amol was 

appearing blue, and took to him a local medical practitioner, 

where an echo was performed. The echo 

revealed a congenital defect in the heart 

where the aorta was connected to the right 

ventricle and the pulmonary artery to the left 

ventricle, instead of the other way around. 

This condition is called ‘transposition of the 

great arteries’ which results in altered blood 

circulation, that subsequently leads to a 

significant reduction in oxygen content in the 

periphery. This was what had caused Amol to 

appear blue. It has been well reported that 

such a condition, if left untreated, can lead 

to severe cardiopulmonary complications 

and even death. Amol’s echo report had 


also indicated that he had had a ventricular and atrial septal 

defect, and corrective surgery would be the only treatment 

option. 

Amol was then brought for a consultation with Dr 

Muthu Jothi, senior consultant and Paediatric Cardiothoracic 

Surgeon at Indraprastha Apollo Hospital, New Delhi. While 

the treatment option was quite clear, Amol weighed only 2.2 

kgs and was not an ideal candidate for the corrective surgery. 

Since such surgeries are performed on babies that are at least 

2.6 kgs and beyond, Dr Jothi and his medical team decided 

to allow Amol to gain some weight. During this time, the 

baby was placed under ventilator support in intensive care. 

However, even after a week, Amol did not gain much weight. 

Considering the precarious cardio-pulmonary status, doctors 

began considering the surgical option even though he was 

underweight. 

Surgery on an underweight baby carries a much higher 

mortality risk compared with that on a normal weight baby. 

Dr Jothi had to gently help the parents understand the 

risks involved. But since it was a ‘do or die’ situation, Mrs 

Meena and Mr Vinod put their faith in the hands of Dr Jothi’s 

team. The medical team went ahead with the surgery and 

performed the arterial switch surgery on Amol. Thankfully, 

Amol’s coronary anatomy was not problematic, and the 

delicate translocation of thin arteries could be performed 

without any further complications. 

Once the surgery was completed successfully, Amol was 

kept under ventilator support for a few days and continued 

on minimal medication, including antiplatelet therapy to 

prevent clot formation in the repaired vessels. The treatment 

is likely to be continued up to 3 months. While infections can 

occur post-surgery, the postoperative course is simple if the 

surgery has gone well and the child is likely to lead a normal 

life. 

There is no known cause for such anomalies. The 

age of the mother, consanguineous marriages, infections 

during pregnancy or excessive smoking or drinking during 

pregnancy may be risk factors. Anything that may cause 

the development of the heart to be arrested may result in 

congenital diseases, including the transposition of the great 

arteries. In Amol’s case, there was no known cause. However, 

such cases have been increasing and Dr Jothi says that he 

performs 5-6 artery transposition surgeries a month. 

Such congenital defects may be picked up during prenatal 

testing as well. If there are any doubts during the prenatal 

ultrasound testing, fetal echo is recommended. If positive, 

parents are counseled and corrective surgery, soon after birth, 

is typically recommended. Abortion is only recommended in 

case the foetus has additional congenital complications. While 

a post-birth echo can typically identify all relevant anatomical 

details, minute details may be missed in case the coronary 

anatomy is complicated. Dr Jothi, like all surgeons, does not 

like surprises in the OT and would like to be well informed of 

all the anatomical concerns prior to the surgery. He, therefore, 

advocates the use of a CT angiogram for a 

more detailed evaluation before surgery. 

Corrective surgeries for congenital heart 

diseases are not easy procedures. The entire 

team, including surgical, medical, anesthaesia, 

nursing and the intensive care staff, have 

to work meticulously with an almost zero 

margin for error. Further, such surgeries can 

SURGERY ON AN UNDERWEIGHT 

BABY CARRIES A MUCH HIGHER 

MORTALITY RISK COMPARED 

WITH THAT ON A NORMAL 

WEIGHT BABY 

be expensive and even if the family is unable 

to afford the costs, there are alternative ways 

by which funds can be arranged. In Amol’s 

case, donations were accrued via MILAAP, 

which is a Bangalore-based crowdfunding 

platform. Dr Jothi is very proud that Apollo 

hospitals have never had to turn down a 

patient due to financial limitations, and 

routinely assists patient families in economic 

need through various resources. 



case reports 

GERIATRIC CHALLENGE 

A case of successful hip replacement in a 98-year-old woman 

Over the past several decades, life expectancy has 

been steadily increasing. As medical research and 

technology advance by leaps and bounds, they 

have been successful in pushing life expectancy to new 

heights. With an increase in the aging population come new 

problems, those that were previously not encountered during 

the younger lifespan. As more and more people cross their 

7th decade on earth, more and more people are likely to 

witness illnesses such as cardiovascular disease, cancer, type 

2 diabetes, cataracts, Alzheimer’s, arthritis and osteoporosis. 

Most of these illnesses come with their own set of cons and 

disabilities that can significantly affect the quality of life. 

Another problem associated with aging is the increased risk 

of falls. Falls may be due to many reasons, including poor 

eyesight or hearing issues, reflex or balance issues, weak 

muscles, blood pressure dips or even certain 

medications that increase dizziness. 

Falls are particularly more dangerous 

in older adults as bones tend to weaken 

with age due to osteoporosis and the risk 

of fractures increases. Healing is also a 

much longer process in the aged with a 

considerable impact on daily activities and 

the quality of life after a fractured bone. 

One of the most traumatic fractures is 

the fracture of the hip. It can immobilize 

the patient completely, making it difficult to 

perform day-to-day activities. Depending 

on the location and severity of the fracture, 

age and the overall health condition of 


heart attack or pulmonary embolism, during 

the surgery and these chances increase 

above the age of 75. The first 96 hours 

after surgery are very crucial and the entire 

medical team, including the anesthetist, 

cardiologist and orthopedic surgeon, are 

deeply involved. Dr Prabhu says that about 

80-85% of the patients do very well and 

recover quickly. However, it is necessary 

to weigh all the factors before deciding to 

perform the surgery, especially since not 

all patients would be able to survive the 

procedure. 

Thankfully, Lakshmamma did very well 

and was able to start walking a day after the 

surgery with the help of medical staff. She 

was kept in the hospital for about a week to 

monitor her condition. Today, a year after the 

surgery, she is walking and able to carry out 

her daily activities and Dr Prabhu is extremely 

happy to see that the hip replacement 

surgery was successful even at her age. 

the patient, orthopaedic surgeons need to decide the right 

treatment strategy. Hip fractures typically require surgical 

intervention, either in the form of repair or replacement. 

Repair can be done by metal screws and plates to hold the 

broken bones together until they heal. Partial or total hip 

replacements are needed if the fracture is beyond repair. 

Here is a case of Lakshmamma, who fractured her left 

hip due to a fall at 98 years of age. She was taken to consult 

Dr Vasudev Prabhu, Senior Orthopedic Surgeon, Apollo 

Hospitals, Sheshadripuram, Bangalore, who had previously 

treated her for another fall 10 years ago. Previously, she had 

undergone a hip surgery on the right hip with the insertion 

of a metallic plate and screws. However, this time, due to her 

age, Dr Prabhu decided to perform a total hip replacement 

surgery. “We had to assess the relative risks – Lakshmamma’s 

overall health condition, including osteoporitic bones, lung 

fibrosis and cardiac status, and whether she would be able to 

withstand the surgery.” 

The goal of the treatment is to relieve pain, mobilize the 

patient and enable her to perform daily activities such as 

going to the bathroom and back. If mobility is not achieved, 

the patient becomes bedridden and this increases the 

chances of getting bed sores and pneumonia. It was therefore 

imperative to perform the surgery on Lakshmamma as long 

as she was deemed fit to undergo the surgery. 

There are always chances of adverse events, such as a 

IT IS NECESSARY TO WEIGH ALL 

THE FACTORS BEFORE DECIDING 

TO PERFORM THE SURGERY, 

ESPECIALLY SINCE NOT ALL 

PATIENTS WOULD BE ABLE TO 

SURVIVE THE PROCEDURE 

Even though hip replacement surgeries 

can be expensive, costing about Rs 2 lakhs, 

they are more cost effective in the long run 

and have better long-term outcomes. The 

other alternative would require intensive 

care, which could easily run into 50,000- 

60,000/month in nursing care costs. Thus, 

most patients normally see the benefit of 

performing surgery. 

Dr Prabhu says “multi-specialty hospitals 

will be the need of the hour, as the geriatric 

population increases, and the medical team 

needs to be geared up for treating the aged. 

Today advanced treatments are available, 

and centres must be equipped to do 

everything under one roof.” 



ophthalmology 

TIP OF AN 

’EYES‘BERG? 

India is inching towards a dry eye disease epidemic, 

reveals a new study 

The incidence of dry eye disease 

is reaching alarming proportions 

in India, especially among urban 

folks, according to a recently published 

paper by Indian clinicians. 

Dry eyes, resulting from tear 

instability, is one of the common 

conditions people seek medical advice 

for. 

The number of such cases has 

registered an unprecedented increase 

in recent years, particularly among 

people living in Indian cities. 

“The prevalence of dry eye disease 

in urban India was roughly 30% in 

2018. Our recently published study 

on nearly 1.5 million individuals shows 

that this will increase at the rate of 

1.58% every year,” says Dr Pragnya 

Rao Donthineni, lead author of the 

study and consultant ophthalmologist, 

Cornea and Anterior Segment Services, 

Cataract and refractive services, 

L V Prasad Eye Institute, Hyderabad, 

Telangana. 

At this rate, 45% of India’s urban 

population will be affected by the 

dry eye disease by 2030. In other 

words, about 275 million people 

stand to suffer from this condition in 

urban India by the end of the next 

decade. 

As far as the rural Indian 

population is concerned, the 

prevalence of dry eye disease is yet 

to be ascertained. But the annual 

incidence rate is found to be close 

to 1.31%, which itself translates to 17 

million new patients every year. 

Dr. Pragnya and her team arrived 

at this conclusion after analysing 

millions of data records using the 


eyeSmart Electronic Medical Records 

(EMR) system developed by LVPEI 

researchers. 

Young men at higher risk 

After analysing the risk of the disease 

on the basis of gender and age, men 

were found to be at a higher risk in 

their twenties or thirties, while women 

were found more vulnerable in their 

forties and fifties. 

The study also found that apart 

from urbanisation, socio-economic 

affluence and professions like 

software-based vocations resulted 

in the prevalence of dry eye disease. 

Several other factors, such as 

geographic location, socio-economic 

status and the growth and ageing 

patterns of the population, also 

influence the incidence of the disease. 

New cases of dry eye disease are 

likely to increase with the economic 

boom, a large aging population, 

increasing urban-migration, a growing 

middle-class and a large corporate 

workforce, the study found. 

The spectrum of people affected 

by the disease is really wide. Not 

only the affluent, the unemployed 

and the retirees are equally affected, 

suggesting that psycho-social factors 

like depression and loneliness may 

also be contributory factors, avers Dr. 

Pragnya. 

As an important health issue, 

dry eye disease is getting increased 

attention worldwide. Studies from the 

United States and other parts of the 

world like Singapore and China have 

also reported this trend. 

A study conducted in Singapore 

showed that 1 in 20 adult Malay 

individuals developed dry eye disease 

over a period of 6 years. A largescale 

population-based study done 

by Reza Dana Et al. in the United 

States estimated that over 16 million 

individuals were diagnosed with dry 

eye disease in the US. 

Need for systemic approach 

Dry eye, which can have grave health 

consequences, is not taken seriously in 

RAISING AN ALARM 

The number of dry eye disease cases registered an 

unprecedented increase in recent years, particularly 

among people living in Indian cities 

2018 

The prevalence of dry eye in 

urban India was 

2030 

Urban population 

likely to be affected by dry eye 

30% 45% 

Dry eye disease should be 

made a mandatory part 

of annual health checkups 

and those detected 

with the disease should be 

referred to institutes that 

specialize in its treatment. 

Dr Pragnya Rao Donthineni 

Consultant Ophthalmologist 

Cornea and Anterior Segment 

Services, L V Prasad Eye Institute 

Hyderabad 

India. The condition is usually treated 

with over-the-counter lubricating eye 

drops. This poses a major impediment 

to detecting and treating the disease. 

We need to adopt a systematic 

approach that includes primary, 

secondary and tertiary prevention to 

tackle this disease. 

Primary prevention includes 

spreading awareness, particularly 

among vulnerable groups such 

as software professionals and the 

elderly. Secondary prevention includes 

screening these groups to detect 

those with sub-clinical disease, so that 

treatment can be initiated early. Finally, 

tertiary prevention involves managing 

the complications and advanced 

stages of the disease, which may 

require surgical procedures like corneal 

or stem cell transplantation. 

According to Dr. Pragnya, dry eye 

disease should be made a mandatory 

part of annual health check-ups and 

those detected with the disease 


should be referred to institutes that 

specialize in its treatment. 

VPEI researchers turned to the 

disease by happenstance as an incr 

easingly greater number of patients 

with advanced chronic dry eye disease 

were being referred to them over 

the last few years. “This alarmed us, 

because many of these patients had 

been suffering for years without proper 

diagnosis or treatment. We wanted to 

create evidence to educate not only 

the lay public but also the medical 

community about the magnitude 

and seriousness of this problem,” Dr 

Pragnya explains. 

Autoimmune triggers 

While the study looked primarily 

STUDY FOUND THAT NEARLY 

TWO-THIRDS OF THE 

AFFECTED INDIVIDUALS HAD 

SOME FORM OF AQUEOUS 

DEFICIENCY, WHICH 

INDICATES AN UNDERLYING 

AUTO-IMMUNE DISEASE 

at incidence, demographics and risk 

factors of dry eye disease, it also 

attempted to figure out clinical types 

that were prevalent in the Indian 

population. It found that nearly twothirds 

of the affected individuals had 

some form of aqueous deficiency, 

which indicates a possible underlying 

auto-immune disease (AID) like 

rheumatoid arthritis, lupus, Sjogren’s 

syndrome or pemphigoid. 

The role of AIDs in leading to 

progressive damage due to the 

worsening dryness of the eyes — 

which could even lead to severe visual 

impairment and blindness — is well 

documented. Therefore, those with 

aqueous deficiency dry eyes need 

additional systemic screening for 

underlying AIDs, which can not only 

affect vision but also the general wellbeing 

of the patients. 

Thus, it is essential to increase 

awareness not only among the general 

population, but also among other 

healthcare providers like physicians 

and rheumatologists, so that patients 

are screened to pick up the disease 

early. Simple tests can be incorporated 

into most of general ophthalmology 

clinics for this purpose. 

Apart from proper detection, 

strategies are required to deal with 

the condition, taking into account 

the enormity of the situation and the 

potential damage it can inflict. 

LVPEI, a tertiary eye care centre, 

has laid the foundations of a stateof-the-art 

dry eye clinic in one of the 

first initiatives in this direction. LVPEI 

offers the entire range of diagnostics, 

from simple office-based tests to 

advanced imaging modalities and 

systemic workups that include a 

rheumatological evaluation. 

It is also important to understand 

that dry eye is a complex condition. 

“We use the umbrella-term ‘dryeye-disease’, 

but it includes different 

sub-types, treatments for which are 

completely different. Once we have 

diagnosed the specific sub-type, we 

offer the patient a step-wise approach 

to well-being. Mild cases may recover 

with certain exercises, eye massages 

and drops, while more severe cases 

may need systemic medications or 

surgeries like corneal or stem cell 

transplantation,” says Dr Pragnya. 


column 

the cellview 

Can we make friendly 

mosquitoes? 

We need to understand the epidemiological effects of 

releasing modified mosquitoes 

DR RAJANI KANTH 

VANGALA 

The author is medical 

scientist and former 

director of SGRF, 

Bangalore 

Any organism, when challenged by any 

other, will try to protect itself. This is 

the natural order of self-preservation. 

Therefore, mosquitoes also have a natural 

mechanism to fight Plasmodium by being 

refractory to the infection. This fundamental 

biological aspect has been exploited to 

eliminate malaria, potentially making friendly 

mosquitoes (Ferreira MU et al. Clin Diag Lab 

Immunol 2004;11(6):987-95). There can 

be different strategies to make the vector 

plasmodium-resistant, the first approach 

is to replace the existing parasite-carrying 

mosquitoes with modified mosquitoes, the 

second is driven by an artificial gene, and 

the third by using modified microorganisms 

as delivery systems. The common step 

in all these methods is to use an effector 

molecule or gene to cause refractiveness 

to Plasmodium. An ideal effector would not 

modify the viability of the vector but target 

the parasite at different stages. Some of 

the interesting effectors identified so far 

include salivary gland and midgut peptide 

1 (SM1), which blocks recognition sites for 

sporozoites and ookinetes (Ito J et al. Nature 

2002, 417(6887):452-5) and the other one 

is phospholipase A2 (PLA2), which inhibits 

ookinete invasion (Zieler H et al. J Exp Biol 

2001;204:4157-67). 

The idea of replacing wild-type 

mosquitoes with a genetically modified 

one with a killing or disabling agent will 

usually need an intensive insect elimination 

in a given area. Apart from that, due to the 

unknown nature of genetic modifications 

that happen in modified mosquitoes, 

periodic and sustained release mechanisms 

will be needed. These steps make it highly 

costly and difficult to sustainably achieve 

targets. The gene-driven method, which 

aims at reducing one sex of insects to 

crush the population, uses transposable 

elements called “selfish genes” that use 

host DNA repair mechanism to develop the 

refractory system. Similar experiments were 

published with synthetic genetic elements 

and a homing endonuclease gene (HEG) 

called I-SceI, where it was demonstrated 

that the progeny of Anopheles gambiae can 

propagate genetic modifications. 

Successful, large-scale implementations 

of transmission blocking methodologies for 

malaria elimination are still further away 

in the future. However, several unique 

technologies are being developed with a 

lot of focus, generating a huge amount 

of knowledge. Better data collection and 

qualitative analysis of randomized clusters, 

with well-defined endpoints, should be 

the main objective of studies now. The 

ideal endpoint should be the reduction 

of human infection and to help in taking 

informed and early clinical decisions. Any 

approach involving genetic modifications 

will need a well-planned compartmental 

and mechanistic mathematical modeling 

for better outcomes. Furthermore, any 

technology developed must have long-term 

benefits with low costs for affordable mass 

implementation even in remote regions. 

Last, but among the most important 

considerations, are ethical development 

and the use of technologies for benefiting 

the patients. Education and population 

sensitization prior to implementation, 

touching upon the considerable 

epidemiological effects of releasing modified 

mosquitoes, are needed to really understand 

if we can make friendly mosquitoes. 


esearch snippets 

HIV remission reported 

for the second time 

giving hope for cure 

Ravindra K Gupta and others 

remarkably unveiled the 

possibility for achieving HIV-1 

remission through a less aggressive 

approach using hematopoietic 

stem-cell transplantation (HSCT). 

HIV remission has been achieved for 

the second time ever in a patient 

from London who had ceased antiretroviral 

therapy 18 months ago. 

The individual had been suffering 

from Hodgkin’s lymphoma and 

underwent a single allogeneic HSCT 

from a donor with two mutant 

copies of the CCR5 Δ32 allele. 

CCR5 is the major co-receptor 

for the cell entry of HIV-1 

and preventing their 

expression is key 

in preventing 

viral rebound. Antiretroviral therapy 

was interrupted 16 months after 

transplantation. Quantitative viral 

outgrowth assays showed no 

reactivatable virus and HIV-1-specific 

antibodies fell to comparatively 

lower levels. The first patient who 

achieved HIV remission, known as 

the ‘Berlin patient’, had undergone a 

similar transplantation twice, 

along with total body irradiation. 

Though the researchers suggest it 

would be premature to conclude 

that the patient has been completely 

cured, the data offers hope to the 

search for a long-awaited cure for 

HIV/AIDS. 

Source: Nature March 05, 2019 

https://www.nature.com/articles/s41586-019- 

1027-4 

Novel vaccine 

approach to address 

osteoarthritis pain 

I 

sabell S von Loga et al developed 

a new vaccine which demonstrates 

therapeutic efficiency of anti-nerve 

growth factor (NGF) antibodies in 

helping alleviate pain in osteoarthritis 

(OA) patients. NGF is a validated drug 

target for pain in osteoarthritis. The 

vaccine was developed from viruslike 

particles that were derived from 

cucumber mosaic virus (CuMV) and 

coupled to expressed recombinant 

NGF. The mice used in the study had 

underwent partial meniscectomy causing 

uneven distribution of weight across 

their lower limbs to induce osteoarthritis 

pain. Spontaneous pain behaviour was 

measured, and osteoarthritis severity was 

quantified. The cohort was inoculated 

either before surgery or once when pain 

was established. Rise in anti-NGF titre 

was readily observed in the vaccinated 

mice. Regular boosting with fresh vaccine 

was required to maintain the antibody 

level in the sentinel mice cohort. 

Researchers observed a reversal of pain 

behaviour through incapacitance testing. 

The study brings forth a novel vaccine 

strategy for the first time in helping 

reduce osteoarthritis pain. It potentially 


offers an easier alternative to pain which 

might help stop reliance of OA patients 

over painkillers. 

Source: Annals of the Rheumatic Diseases 

March 12,2019 https://ard.bmj.com/content/ 

early/2019/03/08/annrheumdis-2018-214489. 

info 

MRI sensor to detect 

calcium activity 

within neurons 

Ali Barandov et al developed a novel 

magnetic resonance image (MRI) 

based sensor that can detect calcium 

activity within neurons, allowing them 

to closely track brain activity. Calcium 

ions are essential in signal transduction 

in almost all cells including neurons. 

Measuring calcium concentration 

requires the need for an effective 

contrast agent that can allow for their 

accurate detection. The researchers 

thus developed a manganese-based 

paramagnetic contrast agent, ManICS1- 

AM, that is designed for easy permeation 

through the cell membrane. The contrast 

agent contains a manganese part that 

interacts weakly with magnetic fields. 

It also contains a calcium-binding arm 

called a chelator. Calcium levels were 

detected based on their binding activity 

with the chelator, which shields or 

exposes the manganese atom for MRI 

detection accordingly. This helps make 

the contrast agent appear brighter 

during imaging. The researchers tested 

the sensor in rats by injecting it into the 

striatum. Electrical activity was stimulated 

in the neurons of the striatum and 

the calcium response in the cells were 

measured. The study thus demonstrates 

a cell-permeable manganese-based 

MRI contrast agent that can help detect 

signaling events in deep tissue using 

MRI which can be utilized for a variety 

of applications in basic biology and 

biomedicine. 

Source: Nature Communications February 22, 

2019 volume 10, Article number: 897 (2019) 

https://www.nature.com/articles/s41467-019- 

08558-7 

IDH1 mutation makes 

gliomas more prone 

to treatment 

F 

elipe J. Nunez et al demonstrated 

in a study that low grade gliomas 

found to be frequently associated with 

mutation in isocitrate dehydrogenase-1 

(IDH1) genes may be effectively 

treated with a combination of radio 

and chemotherapy. The researchers 

discovered that the mutation in IDH1 

can help maintain genomic stability 

in tumours by enhancing DNA repair 

while making them less sensitive to 

radiation. The mice used in the study 

were genetically engineered to grow 

brain cancer cells that have the diseasecausing 

mutations in IDH1, along with 

commonly found co-occurring mutations 

in TP53 (tumour suppressor protein 53) 

and ATRX (alpha thalassemia/mental 

retardation syndrome X-linked gene). The 

mice were found to live longer compared 

Cathepsin S plays crucial in chronic lung disorders 

Donna M. Small et al unveiled the 

importance of enzyme cathepsin S 

(CatS) in the pathogenesis of chronic 

lung diseases like cystic fibrosis (CF), 

highlighting its role as a therapeutic 

target. CatS is seen to be upregulated in 

the lungs of patients with cystic fibrosis. 

The study used transgenic mice models 

expressing CF-like lung disease and were 

crossed with cathepsin S null control 

mice or treated with CatS inhibitor. 

Levels of active CatS were elevated in 

lungs of the CF mice model compared 

to the control mice. The crossed mice 

progeny exhibited decreased pulmonary 

inflammation, mucous obstruction and 

lung damage compared to the CF mice 

models. Pharmacological inhibition of 

CatS revealed a significant decrease in 

inflammation and damage to the lungs. 

Instillation of the enzyme into lungs of 

control mice resulted in an upregulation 

of mucin expression. Inhibition of CatS 

target, protease-activated receptor-2 

(PAR-2) also resulted in a decreased 

airway inflammation and mucin 

expression establishing the role of the 

receptor in CatS-induced lung pathology. 

The study thus demonstrates the 

significant role of CatS as a potential 

drug target in treating chronic lung 

disorders. 

Source: European Respiratory Journal 

2019; DOI: 10.1183/13993003.01523- 

2018 https://erj.ersjournals.com/content/ 

early/2019/01/02/13993003.01523-2018 


to the control mice whose tumours 

were programmed to have normal IDH1 

while still harbouring the mutations in 

TP53 and ATRX. The study found that 

the IDH1 mutation made glioma cells 

less aggressive and enhanced DNA 

repair through epigenetic up-regulation 

of the ataxia-telangiectasia–mutated 

(ATM) signaling pathway in the tumour. 

It was found that pharmacological 

inhibition of ATM restored the tumours’ 

radiosensitivity. The findings help 

explain the better survival of patients 

with gliomas possessing IDH1 mutation, 

despite being less sensitive to radiation. 

Scientists further evinced that the 

translation of these findings to patients 

could improve the therapeutic efficacy of 

radiotherapy and consequently survival 

in these patients. 

Source: Science Translational Medicine 13 Feb 

2019: Vol. 11, Issue 479, eaaq1427 DOI: http://stm. 

sciencemag.org/content/11/479/eaaq1427/tabarticle-info 

Retinal microvasculature can offer 

clues on Alzheimer’s 

Stephen P. Yoon et al brings forth 

evidence suggesting that analysing 

changes in retinal microvasculature 

may help in detecting cerebrovascular 

changes related to Alzheimer’s disease. 

The researchers enrolled and studied 

the retinas of over 200 individuals 

to see if there were any significant 

differences between those with 

Alzheimer’s and those without. The 

participants involved 39 AD patients, 

37 with mild cognitive impairment 

(MCI) and 133 control subjects. 

Researchers used a non-invasive 

technology called optical coherence 

tomography angiography (OCTA) to 

measure the blood flow in each of the 

layers of the retina. The results showed 

that people who had a healthy brain 

function had a dense microscopic 

network of blood vessels in the retina, 

which could be observed through an 

eye examination. This web-like network 

of vessels was much less pronounced 

in patients with Alzheimer’s disease. 

Alzheimer’s patients also a showed 

significant decrease in ganglion 

cell-inner plexiform layer thickness 

when compared with that of MCI and 

controls. The research would help 

in detecting AD much earlier before 

symptoms of memory loss are evident. 

Source: Ophthalmology Retina DOI: https:// 

doi.org/10.1016/j.oret.2019.02.002 https:// 

www.ophthalmologyretina.org/article/S2468- 

6530(18)30669-9/fulltext 

Amphotericin B 

restores host defenses 

in CF models 

Muralgia et al demonstrated that 

an antifungal agent amphotericin 

B, which is capable of forming ion 

channels in the cellular membrane of 

airway epithelial cells, could restore ion 

transport and antibacterial defences in 

cystic fibrosis models. Cystic fibrosis is 

usually accompanied with abnormalities 

in the ion-channel protein CFTR which 

cause problems in the transport of 

chloride (Cl−) and bicarbonate (HCO3−) 

ions in the epithelial cells that line the 

airways of lungs, resulting in a build-up of 

mucous in these airways. The researchers 

tested amphotericin B in vitro human 

cells derived from CF patients and in pig 

models of the disease. When added to the 

apical membrane of human airway cells 

of the in vitro model, HCO3− was secreted 

from the cells which increased the pH 

of the airway-surface liquid which was 

then restored to a normal volume when 

compared to cell samples that did not 

receive amphotericin B. The researchers 

also tested the drug in airway epithelial 

cells obtained from people with cystic 

fibrosis caused by different mutations, 

including ones that did not yield CFTR, and 

observed enhancement of antibacterial 

activity and decreased viscosity of 

airway-surface liquid when compared to 

untreated cells. The findings reveal that 

the host defences in cystic fibrosis airway 

epithelia can be restored independent of 

CFTR via unselected small-molecule ion 

channels. Thus, the treatment proves to 

be effective independent of the genome 

causing the disease. 

Source: Nature March 13,2019 https://www.nature. 

com/articles/s41586-019-1018-5 

—Compiled by Divya Choyikutty 


hospital news 

Apollo plans to set up 75 ‘Society Clinics’ 

in Hyderabad by 2022 

Leading hospital chain Apollo Clinics 

has recently signed a memorandum of 

understanding (MoU) with Apna Complex 

to establish about 75 society clinics 

among the residential communities of 

over 500 apartments in Hyderabad by 

the end of 2022. 

‘Society Clinics’ is one of the first of 

its kind concept being implemented in 

India. After setting up 75 such clinics in 

Hyderabad in the next 3 years, Apollo 

clinics and Apna Complex will expand 

its services to leading cities in India like 

Bengaluru, Pune, and Chennai. 

In addition to this, the Apollo Clinic 

also plans to extend the chain to eight 

more cities and over 500 centres in the 

next three years, reports said. 

The Society Clinics will offer a 

range of services such as consultation, 

diagnostics, health check packs, health 

screening, vaccinations, injections 

and basic life support, making quality 

healthcare and treatment. 

Apna Complex is apartment 

management and security solution 

provider headquartered in Bangalore. 

Wockhardt hospital starts keyhole 

heart surgery clinic 

Wockhardt Super Speciality 

Hospital, Mira Road has launched 

minimally invasive cardiac surgery 

(MICS) centre, in Mumbai. 

The MICS clinic will be run by Dr 

Manish Hinduja, Consultant Cardio 

Vascular & Thoracic Surgeon, trained in 

Ottawa, Canada. 

MICS or keyhole heart surgery is 

performed through a small incision, 

often using specialized surgical 

instruments. The incision is about 6 

to 8 centimetres instead of the 15 to 

20 centimetres incision required for 

traditional surgery. Open heart surgery 

was the only option available for 

surgeries such as bypass grafting, heart 

valve repair or replacement, closure of 

holes in the heart etc until the advent 

of MICS, according to Dr Manish. 

MICS does not require breast bone 

to be cut and overcomes the associated 

problems of pain and slow recovery. 

Heart attacks are responsible for 15.5% 

of all deaths in India and MICS CABG 

or keyhole bypass has emerged as an 

alternative to open surgery to patients 

suffering from coronary artery diseases. 

140-bed Aravind 

Eye Hospital opened 

in Tirupati 

The chief minister of Andhra 

Pradesh N Chandrababu Naidu 

inaugurated the Rs 100 crore Sri 

Venkateswara Aravind Eye Hospital in 

Tirupati, recently. 

The 140 bedded eye hospital 

would render 50 percent of its 

services on payment and the balance 

would be made 

available either 

free of cost 

or at a highly 

subsidized rate, 

reports said. 

The seven acres of land for the 

construction of the hospital was 

given on lease to the Tamil Nadu 

based Aravind Eye Care Systems by 

the Tirumala Tirupati Devasthanams, 

which governs the famous hill shrine 

of Lord Venkateswara at Tirumala. 

The Aravind Eye Care Hospitals, 

a World Health Organisation 

collaborating centre for prevention 

and control of blindness, now runs 

a dozen eye hospitals in Tamil Nadu 

and has one in the city of Tirupati as 

well. 


technology 

NANO-BIOTECH 

INDIAN START-UP SET TO 

SHAKE UP GLOBAL MARKETS 

MagGenome aims to provide faster, easier and cheaper alternatives in the 

therapeutic domain using patented, magnetic nanoparticle-based technologies 

C H UNNIKRISHNAN 

Nanotechnology has generated 

a great deal of interest around 

the world as it has impacted 

the way scientists think and come up 

with solutions. It has also influenced 

industrial areas and basic science 

research to the extent that numerous 

studies are being carried out across the 

globe in different disciplines associated 

with nanotechnology. 

Since nanotechnology deals with 

matter at the scale of one billionth 

of a meter (10 -9m ), where materials 

possess unique properties compared 

to their macroscopic counterparts, 

finding unique solutions to various 

scientific problems has become an 

achievable goal. Bio-medical science 

and engineering are two major 

fields that use nanomaterials as 

powerful tools in making revolutionary 

inventions. Nanomaterials have been 

designed for a variety of biomedical 

and biotechnological applications 

that range from drug delivery to 

magnetic hyperthermia, biosensors, 

enzyme immobilization and isolation 

of biomolecules. Nanobiotechnology 

also offers solutions in the detection 

of pathogens, tissue engineering and 

imaging for MRI contrast enhancement, 

among others. 

Futuristic no more 

Scientists from the academic and 

industrial backgrounds are investing 

IT IS NOT EASY TO FIND 

COMPANIES WHICH ARE 

SINGULARLY FOCUSED ON 

DEVELOPING TECHNOLOGY 

AND PRODUCTS IN THE AREA 

OF NANO-BIOTECHNOLOGY 

their efforts in nanotechnology in 

several countries including India. 

Government of India’s Department 

of Science and Technology (DST) 

established Nanoscience and 

Technology Mission (NSTM) during 

the 10th plan period (2002- 2007). 

As a result of the efforts led by the 

mission, India is today among the top 

five nations in the world in terms of 

scientific publications in nano science 

and technology. In the industrial sector 

in India, there are companies that have 

ventured into activities such as the 

synthesis of nano-materials and coating 

products. 

But it is not easy to find companies 

which are singularly focused on 

developing technology and products 

in the area of nano-biotechnology. This 


THE WIDE APPLICABILITY OF 

MAGNETIC NANOPARTICLES 

IS DUE TO THEIR 

RESPONSIVENESS TO AN 

EXTERNAL MAGNETIC FIELD, 

BIOCOMPATIBILITY, 

LOW TOXICITY AND 

COST-EFFECTIVE METHODS 

is what makes Chennai-based start-up 

MagGenome Technologies unique. Its 

story is inspiring and a perfect example 

of the transformation of applicationoriented 

academic research into 

successful commercial endeavours. 

MagGenome’s journey starts with 

founder and CEO Dr CN Ramchand. 

Though primarily a researcher in drug 

discovery and development who has 

headed research teams in several 

pharma companies, he was passionate 

about nanotechnology, especially 

magnetic nanoparticles. 

While working at the University 

of Sheffield, he published two highly 

cited articles in collaboration with 

the Institute of Experimental Physics 

at Slovak Academy of Sciences. 

They describe novel methods for 

immobilization of functional proteins 

on magnetic nanoparticles. It was a 

time when magnetic nanoparticles had 

caught the attention and interest of 

scientists around the world. The major 

reason for the interest was the wide 

applicability of magnetic nanoparticles 

compared to other nano-materials due 

to their responsiveness to an external 

magnetic field, biocompatibility, 

low toxicity, cost-effective methods 

of synthesis etc. Because of their 

magnetic responsiveness, these 

particles are easily controllable in 

both in vivo and in vitro applications. 

Additionally, the size of the magnetic 

nanoparticle is smaller than, or 

comparable to, that of a cell (10–100 

μm), a virus (20–450 nm) or a protein 

(5–50 nm). This makes magnetic 

nanoparticles ideal for futuristic 

applications in various fields related to 

engineering, environment and medical 

research. 

Academia to industry 

Graduate students of Dr Ramchand 

continued working on various biological 

applications of magnetic nanoparticles. 

They developed novel techniques and 

generated patents and publications, 

which later paved the way to the 


Nobel Laureate Prof Ada Yonath presented the certificates to the first batch of Biotechnology and Biopharma Skill Enhancement Programme (B2SEP) 

conducted at MagGenome, in February. The company, which gives much thrust for scientific skill development for junior researchers, also organised an 

interactive session with the Nobel Laureate for them. 

formation of MagGenome Technologies. 

These studies were conducted at 

major research institutions like M.S. 

University, Baroda, P.D. Patel Institute of 

Applied Sciences, Charotar University of 

Science and Technology, Changa, Slovak 

academy of science etc., and prominent 

scientists from these universities served 

as advisors. 

One of the major highlights of these 

technologies was the extraction of 

nucleic acids using bare (uncoated) iron 

oxide (Fe 3O4 ) magnetic nano-particles. 

Traditionally, DNA extraction from 

biological sources had been a tedious 

and time-consuming process, since 

these procedures included extraction 

using harmful organic solvents like 

phenol and chloroform. Later on, more 

expensive but quite efficient method 

of binding of nucleic acids to solid 

supports, such as silica-based spin 

columns, glass fibres, anion exchange 

carriers and modified magnetic beads, 

were developed and commercialised. 

But all these aforementioned 

technologies come with their own 

drawbacks and concerns. It is in this 

context that MagGenome Technologies 

took up the challenge of developing 

a cost-effective, environment-friendly 

and more robust nucleic acid extraction 

ANOTHER TECHNOLOGY OF 

GREAT POTENTIAL THAT 

MAGGENOME DEVELOPED 

WAS IMMOBILIZATION OF 

FUNCTIONAL PROTEINS ON 

BARE NANOPARTICLES 

system by taking leads from doctoral 

work at Dr Ramchand’s laboratory. As 

a result of further optimization and 

fine tuning, MagGenome was able to 

successfully launch its nucleic acid 

extraction kit in the market under the 

brand name XpressDNA kits. 

Another technology of great 

potential that MagGenome developed 

was immobilization of functional 

proteins on bare nanoparticles using 

an epoxy cross-linking method for 

which the company owns a patent. 

This type of cross-linking facilitates the 

entrapment of nanoparticles in the 

cross-linked protein matrix and in 

turn, accomplishes the immobilization 

of the protein. The immobilized 

protein and nanoparticles remain 

in direct association due to lack of 

polymeric coating. 

The technology remained unique 

and the products developed using this 

technology, such as immobilized affinity 

ligands and immobilized enzymes, are 

more advantageous than commercially 

available magnetic bead-based 

products. For example, affinity ligands 

XpressAffinity Protein A/G, which are 

used for purification of antibodies, offer 

more binding capacity and reusability 

than other commercial magnetic 

bead-based products, mainly because 

of the use of nanoparticles that offer 

a high surface area-to-volume ratio. 

Antibodies immobilized by this method 

are currently being used in multiple 

research level applications and further 

research is underway in developing 

more clinically relevant methodologies 

such as isolation of circulating tumour 

cells and early cancer diagnosis. 

Global recognition 

The start-up, promoted by US based 

science entrepreneur Sam Santhosh, 

Emerge Ventures head Mahesh 

Pratapneni and eminent clinician 

Prof S Arumugam, got incubated at 

SciGenom Lab in Kochi in 2014. Exactly 

after four years, it started operation 

from a new facility at Perungudi in 


Chennai. It didn’t take much time 

for the start-up to achieve muchneeded 

recognition not only at the 

national level, but also internationally. 

MagGenome was selected as one of the 

emerging start-ups from India in the 

nano-biotechnology area to showcase 

its products at the India Pavilion at BIO 

2017 International Convention at San 

Diego. Next year, it was again selected 

to present at the Startup Stadium at 

BIO 2018 International at Boston, 

an opportunity only a handful of 

start-ups from across the globe get 

every year. MagGenome is completely 

focussed on providing alternative, 

environment friendly and robust 

solutions to the challenges faced by 

life sciences researchers in India and 

abroad. 

Dr Ramchand, an academic 

enthusiast in most of his career life, 

spoke about what inspired him to enter 

a commercial venture. 

“I always had a keen interest in 

applied research even when I was 

in the academic setup. My initial 

research work was mainly focused on 

mental disorders like schizophrenia 

and also on the basics of novel drug 

discovery. However, I had many 

research collaborations in the field of 

nanotechnology, including the one 

with Slovak Academy of Sciences and 

others with MS University of Baroda 

and Bhavnagar University respectively,” 

he said. I was developing commercially 

viable techniques that have major 

applications in biotechnology through 

these collaborations. These projects led 

to several good patents, publications 

and some of my students were also 

able to finish their PhDs on these lines,” 

says Ramchand. 

“Later, I realised that the 

global market for the products 

that I developed over the years in 

nanotechnology is very big and there 

are only big multinational companies 

working in this field with nil or very little 

presence in India. Keeping these things 

in mind, I ventured into MagGenome, 

which is now the only company in 

India developing all these technologies 

locally and sells both domestically and 

overseas,” he added. 

“Finally, I would say that it was 

my passion to develop superior 

technologies with high commercial 

value and that has actually led me to 

think of such a high-end technology 

start-up,” quipped Ramchand. 

Breakthrough 

A major breakthrough the company 

envisages in the very near future is 

the development of an automated 

system for purification of monoclonal 

antibodies. The current market leader 

in this area is the AKTA protein 

purification system from the global 

technology giant, GE Healthcare. This 

instrument is used for fast protein 

liquid chromatography (FPLC), wherein 

We are already covering 

several hospitals in India, 

helping them to extract 

nucleic acid for rapid, 

DNA based diagnostics. 

Dr CN Ramchand 

Founder and CEO 

MagGenome Technologies 

proteins of various sizes can be readily 

purified using different types of 

columns. MagGenome is focused on 

developing an alternative to the AKTA 

system, in which the advantages of the 

magnetic nanoparticle technology can 

be utilised to develop a low cost, but 

robust and quick system for monoclonal 

antibody purification, mainly using 

affinity and hydrophobic interaction 

chromatography resins. 

There are also other multiple 

techniques being developed in 

MagGenome which will offer solutions 

to researchers in life sciences at 

various stages of biomolecule isolation, 

characterisation and downstream 

processing. 

According to Ramchand, these 

technologies that have been developed 

by him and his team at MagGenome 

will greatly benefit future research 

in this area and will have a greater 

impact in healthcare and several other 

industries. 

“The technologies that we have 

commercialized, and some other 

exciting technologies that are currently 

in the pipeline, have the potential to 

immensly benefit research, healthcare 

and industrial domains alike,” says 

Ramchand 

“We are already covering several 

hospitals in India, helping them to 

extract nucleic acid for rapid DNA 

based diagnostics. Similarly, our protein 

purification technology is outperforming 

most of the well-known products 

currently in the market. We are keen 

on extending this protein purification 

protocol in the therapeutic domain, 

which can be a game changer in times 

to come,” he added. 

With a growing bio-pharmaceutical 

market, magnetic nanoparticle-based 

automated protein purification will be 

one of the flagship technologies 

under the MagGenome umbrella. 

Other technologies which are 

currently in various phases of 

development include enzyme 

immobilization, protein extraction, 

waste-water treatment and 

nanoparticles as adjuvant vaccines. 


devices&gadgets 

Device to treat depression 

gets EU backing 

The European Commission has given 

its nod to BNA-Predict technology for 

treating people suffering from depression. 

BNA-Predict has been developed 

to predict responsiveness to both 

antidepressants and neurostimulation 

treatments and help physicians select the 

most effective antidepressant treatment and 

monitor treatment effect directly in 

the brain for patients suffering 

from depression. 

The use of BNA- 

Predict increases treatment 

effectiveness reduces 

healthcare costs as well as 

cuts down mortality from 

the disease, the company said in a 

statement. 

Over 50 million Europeans are suffering 

from depression, a devastating disease with 

significant social and financial impact on the 

community. Depression is the number one 

cause of disability and accounts for more 

than 30% of the total cost associated with 

brain-related diseases. 

Selecting the right treatment for 

depressive patients presents 

an enormous 

challenge for 

doctors and the 

success rate is 

less than 50%. 

to help them manage their 

disease. 

CCM is a unique electrical 

pulse delivered during the 

absolute refractory period, 

which is just after the heart 

contracts. In contrast to a 

pacemaker or defibrillator, 

CCM works by modulating the 

strength of the heart muscle 

contraction rather than the 

rhythm. 

CCM is the non-excitatory 

electrical pulses delivered by 

the implantable Optimizer 

device during the absolute 

refractory period of the heart 

cycle to improve systolic 

contraction of the heart. 

CCM system for 

heart failure 

approved in US 

Impulse Dynamics has 

received approval from the 

US FDA for its Optimizer Smart 

System for use in heart failure 

populations. 

The Optimizer Smart 

System is the first and only 

CCM (Cardiac Contractility 

Modulation) therapy device 

approved by the FDA to 

improve 6-minute hall walk 

distance, quality of life and 

functional status of NYHA 

Class III heart failure patients 

who remain symptomatic 

despite guideline-directed 

medical therapy, and those 

patients who are in normal 

sinus rhythm, are not indicated 

for cardiac resynchronization 

therapy (CRT) and have a 

left ventricle ejection fraction 

(LVEF) ranging from 25% to 

45%. 

Only 30 percent of 

moderate to severe chronic 

heart failure patients are 

candidates for CRT, which 

historically has left 70 percent 

of patients with few options 

Apple watch 

may detect 

AFib: Study 

An Apple Watch may be 

able to detect heart rhythm 

changes that subsequent 

medical tests confirm to be 

atrial fibrillation, says a new 

study. 

AFib is often undiagnosed 

since it might not cause 

noticeable symptoms, but it 

contributes to 1,30,000 deaths 

and 7,50,000 hospitalizations 

in the US each year. 

Results from the Applefunded 

study presented 

recently, at the American 

College of Cardiology Scientific 

Session in New Orleans, 

indicate that the wearable 

technology can safely identify 

heart rate irregularities. 

The virtual study with over 

4,00,000 enrolled participants 

to determine whether a mobile 

app that uses data from a 

heart-rate pulse sensor on the 

Apple Watch can identify atrial 

fibrillation. The condition often 


emains undetected. 

Participants had both an 

iPhone and an Apple Watch. 

A special app checked each 

participant’s heart-rate pulse 

sensor for an irregular pulse, 

intermittently. The participant 

would receive a notification 

and was asked to schedule 

a telemedicine consultation 

with a study doctor. Then the 

participant would be sent 

ambulatory ECG patches to 

record the rhythm of their heart 

for up to a week. 

Overall, only 0.5 percent 

of participants received 

irregular pulse notifications, 

an important finding given 

concerns about potential 

over-notification. Comparisons 

between irregular pulsedetection 

on Apple 

Watch and simultaneous 

electrocardiography patch 

recordings showed the pulse 

detection algorithm has a 71 

percent positive predictive 

value. 

Eighty-four percent of the 

time, participants who received 

irregular pulse notifications 

were found to be in atrial 

fibrillation at the time of the 

notification. 34 percent of 

the participants who received 

irregular pulse notifications and 

followed up by using an ECG 

patch over a week later were 

found to have atrial fibrillation. 

Since atrial fibrillation is an 

intermittent condition, it’s 

not surprising for it to go 

undetected in subsequent ECG 

patch monitoring. 

Fifty-seven percent of those 

who received irregular pulse 

notifications sought medical 

attention. 

BD’s venous 

stent gets US 

FDA approval 

The US FDA has granted 

premarket approval for 

the Venovo venous stent, the 

first stent indicated to treat 

iliofemoral venous occlusive 

disease, BD announced. 

The Venovo venous 

stent is a flexible nitinol stent 

specifically designed to reopen 

blocked iliac and femoral veins 

in order to maintain adequate 

blood flow. The Venovo 

venous stent is designed with 

a balance of radial strength, 

compression resistance and 

flexibility needed for the 

treatment of symptomatic 

post-thrombotic and 

non-thrombotic iliofemoral 

lesions. 

The broad stent sizing 

allows clinicians to treat large 

diameter veins and long lesion 

lengths. 

One-year results from 

the prospective, multicentre 

single-arm VERNACULAR 

trial involving 170 subjects 

demonstrated the safety 

and effectiveness of the 

Venovo venous stent for the 

treatment of symptomatic 

iliofemoral venous outflow 

obstruction. 

The clinical findings 

showed a weighted primary 

patency rate of 88.3 percent, 

with a 96.9 percent patency 

rate in non-thrombotic lesions 

and an 81.3 percent patency 

rate in post-thrombotic lesions 

at 12 months, exceeding 

the performance goal of 74 

percent. 

In addition, patients treated 

with the Venovo venous 

stent reported a statistically 

significant reduction in pain 

symptoms, according to the BD 

statement. 

Ortho’s dual slide 

testing platform 

under USFDA 

review 

O 

rtho Clinical Diagnostics 

has received CE Mark for 

Ortho’s Vitros XT MicroSlide, a 

new multi-test technology that 

allows labs to run two tests 

simultaneously. 

Ortho’s Vitros XT MicroSlide 

is powered by Digital Chemistry, 

Biotronik’s tachycardia devices get US FDA clearance 

Acticor and Rivacor highvoltage 

cardiac rhythm 

management (CRM) devices 

for treatment of patients with 

cardiac arrhythmias secured 

approval from US FDA, 

Biotronik said. 

The six new tachycardia 

solutions include Rivacor VR- 

T, Rivacor DR-T, Rivacor HF-T 

QP, Acticor DX, Acticor CRT-DX 

Bipolar and Acticor CRT-DX. 

The Acticor and Rivacor 

systems are designed to 

incorporate more diagnostic 

and therapeutic capabilities in 

smaller devices with extended 

battery longevity. 

This provides physicians 

with more comprehensive 

therapy options when 

treating cardiac patients with 

varying disease states and 

comorbidities. With a smooth, 

elliptical BIOshape, Acticor and 

Rivacor devices are the smallest 

and slimmest 3 Tesla (3T) MRconditional 

CRM devices on the 

market. 

The slim devices have 

rounded edges that lessen skin 

pressure and help to lower 

the risk of skin erosion while 

increasing patient comfort. 

Extended longevity—nearly 

15 years for VR-T, 13.5 years 

for DR-T, 14 years for DX and 

nine years for CRT—can lead 

to fewer device replacements, 

fewer procedures for patients 

reducing risks, complications 

and costs. 

The Acticor devices offer 

DX technology, which provides 

atrial diagnostics without an 

atrial lead. DX systems can 

detect silent atrial fibrillation 

for stroke prevention, enhance 

diagnostic accuracy for better 

clinical decision-making 

and allow for dual-chamber 

supraventricular tachycardia 

(SVT) discrimination to 

prevent unnecessary shocks. 

By reducing the number of 

leads in the device system, DX 

technology also enables faster 

procedure times, lowers cost 

and reduces complications. 

This intelligent CRT 

AutoAdapt programming 

automatically adjusts to 

changes in patient conditions, 

enabling real-time responsive 

care while saving time for 

physicians and hospitals. 


an optics technology that 

gleans significantly more 

information from each 

test than before, in less 

time and with less patient 

sample. 

It simultaneously 

performs two tests that are 

commonly ordered together 

from a single small blood 

sample. This improves lab 

productivity and turnaround 

time while simplifying inventory 

management and optimizing 

storage space. 

The individual, dual-test 

slides include paired assays 

for blood urea nitrogen and 

creatinine ratios; triglycerides 

and cholesterol; and glucose 

and calcium levels, all for 

use on the Vitros XT 7600 

Integrated System. 

Vitros XT MicroSlide is 

currently under review by the 

FDA. 

Malvern XRF 

spectrometers 

launched 

Malvern Panalytical has 

introduced the next 

generation of Epsilon 1 

X-ray fluorescence (XRF) 

spectrometers. 

The upgraded Epsilon 1 

integrates a high-power X-ray 

tube and a new detector, which 

together deliver a threefold 

improvement in sensitivity, 

along with rapid measurement 

capabilities. 

Trace metals in 

pharmaceuticals, foods, soils 

and metal ores can now be 

Ultrasound blood flow monitor 

gets FDA 510(k) clearance 

Sonavex received 510(k) 

clearance from the US 

FDA for its EchoSure device 

to deliver definitive blood 

flow data on demand. 

The EchoSure system 

combines 3D ultrasound 

imaging with advanced 

deep learning algorithms 

to automate visual and 

quantitative blood flow 

monitoring after surgery. 

Coupled with EchoMark 

bioresorbable markers, 

EchoSure eliminates 

the need for ultrasound 

expertise in order to 

measure blood flow. The 

EchoSure App enables 

surgeons to monitor 

quantified more quickly and 

accurately than ever before in 

an instrument of this size, the 

patients remotely from 

their mobile devices. 

“Putting ultrasound 

technology in the hands 

of bedside nurses for 

the first time may enable 

detection of a vascular 

compromise earlier than 

clinical observation alone, 

providing opportunities for 

more rapid intervention 

and improved patient 

outcomes,” said Devin 

O’Brien Coon, MD, Chief 

Medical Officer and 

President of Sonavex. 

EchoMark and EchoSure 

are both available from 

Sonavex for clinical use 

across the United States. 

company said in a statement. 

Epsilon 1 is available in 

a number of pre-calibrated 

versions which are dedicated 

to specific applications. 

The Epsilon 1 Lube Oil 

delivers ASTM 6481-compliant 

elemental analysis of 

unused lubricating oils; the 

Epsilon 1 Sulfur in Fuels 

quickly quantifies sulfur 

content in fuels according 

to ASTM D4294-10 and 

ISO 20847; the Epsilon 

1 Academia enables 

rapid characterization of 

unidentified samples, using 

Omnian software for analysis; 

and the integrated camera 

in the Epsilon 1 for Small 

Spot Analysis simplifies 

the investigation of very 

small objects, inclusions or 

inhomogeneities. 

US FDA expand 

mitral valve 

repair device 

indication 

T 

he US FDA has expanded 

indication to MitraClip 

device to repair a leaky mitral 

valve without open-heart 

surgery, Abbott announced. 

MitraClip is the first 

transcatheter mitral valve 

intervention therapy approved 

to treat select heart failure 

patients with clinically 

significant secondary, or 

functional, mitral regurgitation 

(MR). 

The MitraClip device repairs 

MR without open-heart surgery 

and is delivered to the heart 

through a small incision in the 

leg. The device clips portions 

of the leaflets, or flaps, of 

the mitral valve together to 

reduce the backflow of blood, 

restoring the heart’s ability to 

pump oxygenated blood more 

efficiently. 


devices&gadgets 

“We’re consciously investing 

a lot in the Indian market” 

The Indian medical devices and 

technology market has witnessed a 

phenomenal growth in the last few years, 

though regulatory and pricing scenarios 

have been quite challenging for the 

manufacturers and suppliers. While one 

of the important reasons for the market 

expansion has been a growing customer 

need due to increased awareness, the 

other has been the innovation that the 

agile manufacturers could bring to the 

market, keeping in mind the customer in a 

rapidly changing environment. 

Sushant Kinra, Managing Director of 

Carestream Health India Pvt. Ltd, one of 

the key technology players in this market, 

says his company sees an unparalleled 

opportunity to meet the growing needs of 

its customers in India and it is committed 

to providing the best customer experience. 

Excerpts from an interview: 

Which were the product categories 

that have seen a growth in 2018 in India 

and how was the year for Carestream? 

The year 2018 has been a phenomenal 

year for Carestream. We are proud to share 

that we have gained market share in all our 

product segments, particularly in our Digital 

Radiography (DR) portfolio. Carestream’s 

Digital Radiography portfolio offers a quick, 

easy and affordable way to transition to 

digital radiography and this has led to 

significant growth in this segment. We have 

our installations at premium sites, including 

important government sites as well. We 

have made several innovations within our 

digital portfolio and this has definitely been 

our success factor. 

Carestream India was recently 

recognised with “Great Place to work” 

certification by Great Place to Work 

Institute. Could you please elaborate on 

this certification process? 

Yes, for the second year in a row, 

we have been recognized and certified 

as a “Great Place To Work” based on a 

rigorous assessment conducted by the 

global research and consulting firm, Great 

Place to Work Institute. The assessment 

primarily evaluates 2 parameters, the Trust 

Index and the Culture Audit. Together, 

these parameters reflect the trust the 

employees have in the organization and its 

management, the camaraderie and pride 

in what the company does and what their 

contribution is to the big picture. 

I have always firmly believed that you 

are as good as the people in your team 

and those you work with, and our Great 

Place To Work certification is a validation 

for the same. We are extremely proud and 

will continue our drive towards excellence. 

David Westgate has been appointed as 

the new CEO for Carestream Health. How 

does he picture Carestream India on the 

global map? 

David Westgate was named the 

new Chairman, President and CEO of 

Carestream Health in July 2018. Since 

then, his focus is to deliver life-changing 

innovations for patients, customers, 

employees, communities and other 

stakeholders, and to grow our business 

for long-term success. On his visit to India, 

David had the opportunity to meet our 

team and some key stakeholders, which 

gave him an in-depth understanding of 

the future of health care in India. He also 

learned about the various opportunities 

being presented by the Indian government 

in the Healthcare Industry, Ayushman 

Bharat being a great example. He was 

happy to see Carestream India right on 

track. India is surely a land of opportunity 

Sushant Kinra 

and his visit to India provided valuable 

inputs on how to align India with the global 

strategy. 

What is your vision for Carestream 

India in the next few years? 

My vision for the years to come is to 

always be the leading service provider and 

the best in customer mind share when it 

comes to imaging solutions. 

The progress in technology is pushing 

us to think beyond our comfort levels 

and we must be more adaptive to these 

dramatic changes. We at Carestream 

will undoubtedly aim to be ahead of 

the game. We offer affordable digital 

imaging solutions that meet the needs 

of healthcare providers of all sizes, with 

targeted solutions not only for radiology 

but also for clinical specialty practices such 

as orthopaedic, chiropractic and veterinary 

clinics. Our scalable mini-PACS solutions 

deliver image access, management and 

storage capabilities well suited for all these 

environments and is a fantastic workflow 

solution for our customers in India. 

As we see an unparalleled opportunity 

to meet the growing needs of our 

customers in India and are committed to 

providing the best customer experience 

with all our products, systems and services, 

we’re consciously investing a lot in this 

market. 


MAURICE LEV AND 

SAROJA BHARATI 

CARDIAC MUSEUM 

The museum houses the largest collection 

of hearts in the world with immense 

relevance to pathologists 

NARRATION: C H UNNIKRISHNAN 

PHOTO: UMESH GOSWAMI 

A 

replica of Lucy, the female 

hominid species believed to be 

the first ancestor of the human 

race on earth, shares the vast room 

that houses some 8,000 human hearts. 

Though none of these hearts beat at 

present, they tell the story of many lives 

that help protect beating hearts. 

Maurice Lev and Saroja Bharati 

Cardiac Museum at Frontier Mediville, 

near Chennai, is a priceless pathology 

library with the world’s largest collection 

of biological specimens of hearts. It 

is also home to decades of clinical 

study with precise and comprehensive 

documentation of diseases of the heart 

across age groups. There can’t be a 

better class room for heart surgeons, 

physicians, medical students and even 

for the common public to learn about 

the heart, the first organ that develops 

in the body, in its clinical entirety. 

These hearts of different size, colour 

and shape that sit in the formalin glass 


Dr. Maurice Lev and 

Dr. Saroja Bharati 

(File photo) 

jars in the wide array of galleries in the 

museum — guarded with an ornate 

wooden door — span the embryonic to 

the adult to the old. Perhaps, Lucy is 

there to symbolize the first tick of the 

human heart on the planet. 

Rare Collection 

Opened in 2013, India’s first of its kind 

museum centers around the laudable 

and exquisite life work of Dr. Maurice 

Lev and Dr. Saroja Bharati, Director 

and Professor of Pathology, Rush 

Medical University, Chicago, who have 

spent many decades on the most 

systematic and accurate study of the 

heart with a precise and comprehensive 

documentation of diseases of all age 

groups. Later, they concentrated almost 

exclusively on congenital heart disease 

in children, according to the Museum 

director Dr Sarasa Bharati. 

“These hearts were collected since 

the 1970s by them for their extensive 

This monumental work 

is of great value to all 

those treating heart 

disease, i.e., both 

cardiac surgeons and 

physicians and certainly 

all pathologists. 

Dr Sarasa Bharati 

Director, Maurice Lev and 

Saroja Bharati Cardiac Museum 

study on various cardiac diseases. We 

have specimens of hearts here with all 

cardiac diseases across age groups,” she 

added. 

The museum is set up within 

Frontier Mediville, a 360 acre medical 

village located about 50 km away from 

Chennai. It is promoted by Frontier 

Lifeline Hospital and Dr KM Cherian 

Heart Foundation. 

Located at Gummidipundi in 

Tiruvallur district of Tamil Nadu, it is the 

only museum in the world with such a 

vast collection of hearts. 

“It is the largest collection of 

cardiac pathology anywhere in the 

country, possibly even the world,” said 

Dr Cherian, chairman, Frontier Lifeline 

Hospital and Frontier Mediville, in a 

recent interview. 

“It is the result of two major events. 

The first is the donation of the entire 

collection of biological heart specimens 

by Dr Maurice Lev and Dr. Saroja Bharati, 


avoid the conduction system during 

heart surgery. 

The museum also houses a large 

number of other diseased organs 

from humans, such as the respiratory, 

gastrointestinal, the genitourinary, 

skeletal, the central and peripheral 

nervous system, the endocrines, skin 

and soft tissue. 

Going Digital 

The Maurice Lev and Saroja Bharati 

Cardiac Museum is currently planning 

to digitize the documents along with 

the images of the bio-specimens that 

cannot be preserved infinitely. 

which they started collecting from 1946 

onwards. These collections were in 

exhibition at Chicago for many decades. 

The second is the most systematic 

translocation of this collection, along 

with the infrastructural support, from 

one continent to the other,” Dr Bharati 

recalled. 

According to Dr Bharati, the entire 

cost of shipment and transportation, 

along with insurance of a million dollars, 

was borne by Dr Cherian. 

“This awesome feat, the first of its 

kind in the entire world, is not likely to 

be repeated ever,” she added. 

Great Academic Relevance 

Marking their academic relevance, the 

careful and meticulous analysis of the 

heart specimens received from the 

US and other countries have been 

published in hundreds of peer-reviewed 

journal and books. 

“This monumental work is of 

great value to all those treating heart 

disease, i.e., both cardiac surgeons and 

physicians and certainly all pathologists 

and basic scientists as well, and 

perhaps to the whole society,” noted Dr 

Bharati. 

The museum, named after Maurice 

Lev and Saroja Bharati, spent about 

$100,000 to ship these specimens, 

excluding insurance. 

Drs Maurice Lev and Saroja Bharati 

are pioneers in studying anatomical 

and structural abnormalities in the 

conduction system. The highly complex 

microscopic anatomy of the system had 

been extensively studied by recording 

the findings on more than 300 hearts 

and by taking 1,500 sections from each 

heart. 

They had also made a detailed study 

of the conduction system of the heart in 

most animals known to man, from those 

of the elephant, the bull and the horse 

to that of the dog, cat, rabbit and even 

the snake. 

Interestingly, this mammoth work 

also forms the core of the museum. 

The results, which had been published 

in international peer-reviewed journals, 

would certainly help cardiac surgeons 

THE HIGHLY COMPLEX 

MICROSCOPIC ANATOMY OF 

THE CONDUCTION SYSTEM 

HAD BEEN EXTENSIVELY 

STUDIED BY RECORDING 

THE FINDINGS ON MORE 

THAN 300 HEARTS 

“We are now planning to digitize 

these bio-samples with full description 

of pathological analysis and other 

medical details in the larger interest 

of the medical profession around the 

globe,” says Dr Cherian. 

“But this is again an expensive 

project and we would explore some 

external support or help from the 

government for the same,” informed Dr 

Bharati. 

The digital version might help fit 

this marvelous collection of key human 

anatomical studies and the gallery on a 

digital stick. 

Still, Gummidipundi will be 

remembered in the medical world 

for this amazing piece of physical 

work. 

This is part of a series that features India’s 

First & Most Unique institutions, facilities, 

technologies, products etc in the medical and 

healthcare space. 


guidelines 

NICE GUIDELINES ON 

DIAGNOSIS AND MANAGEMENT 

OF COPD IN OVER 16S 

Consensus recommendations based on 

experience and on current practice 

Approximately 1.2 million people 

have a diagnosis of chronic 

obstructive pulmonary disease (COPD) 

in the UK[8]. Although there are 115,000 new 

diagnoses per year, most people with COPD are 

not diagnosed until they are in their fifties or older 

and many more people may remain undiagnosed. The 

UK has the 12th highest recorded deaths from COPD in 

the world, with an age-standardised mortality rate of 210.7 

deaths per million people between 2001 and 2010. 

Why the committee made the recommendations 

The evidence showed that CT scans and chest X‐rays are accurate 

tests for identifying people who would test positive for chronic 

obstructive pulmonary disease (COPD) using spirometry, including 

people without symptoms. However, some of the CT and chest X‐ray 

techniques used in the studies are not routinely used in UK clinical 

practice. This limited how applicable the evidence was to the NHS, 

so the committee was unable to make a wider recommendation 

on using CT scans and chest X‐rays for diagnosing COPD. The 

committee therefore made recommendations on what to do if 

a CT scan or X‐ray that was performed for another reason 

showed signs of emphysema or chronic airways 

disease. 

There was no evidence on what to 

do for people who have emphysema 

or signs of chronic airways disease 

on a CT scan or chest X‐ray, but who 

have no symptoms. Because of this, 

the committee made consensus 

recommendations based on their 

experience and on current practice 

in the NHS. 

A. DIAGNOSING COPD 

The diagnosis of chronic obstructive 

pulmonary disease (COPD) depends 

on thinking of it as a cause of 

breathlessness or cough. The diagnosis 

is suspected on the basis of symptoms 

and signs, and is supported by 

spirometry. 

Symptoms 

1. Suspect a diagnosis of COPD in 

people over 35 who have a risk factor 

(generally smoking or a history of 

smoking) and who present with 1 or 

more of the following symptoms: 

• exertional breathlessness 

• chronic cough 

• regular sputum production 

• frequent winter ‘bronchitis’ 

• wheeze. 

2. When thinking about a diagnosis of 

COPD, ask the person if they have: 

• weight loss 

• reduced exercise tolerance 

• waking at night with 

breathlessness 

• ankle swelling 

• fatigue 

• occupational hazards 

• chest pain 

• haemoptysis (coughing up 

blood). 

These last 2 symptoms 

are uncommon in COPD 

and raise the possibility of 

alternative diagnoses. 

3. One of the primary 

symptoms of COPD is 


TABLE 1: MRC DYSPNOEA SCALE 

Degree of breathlessness related to activities 

Not 

troubled by 

breathlessness 

except on 

strenuous 

exercise 

Short of 

breath 

when 

hurrying or 

walking up 

a slight hill 

Walks slower than 

contemporaries on level ground 

because of breathlessness, or 

has to stop for breath when 

walking at own pace 

Stops for breath after 

walking about 100 

metres or after a 

few minutes on level 

ground 

Too breathless to 

leave the house, 

or breathless 

when dressing or 

undressing 

GRADE 

1 2 3 4 5 

Adapted from Fletcher CM, Elmes PC, Fairbairn MB et al. (1959) The significance of respiratory symptoms and the diagnosis of chronic 

bronchitis in a working population. British Medical Journal 2: 257–66. 

breathlessness. The Medical Research 

Council (MRC) dyspnoea scale (see 

table 1) should be used to grade the 

breathlessness according to the level of 

exertion required to elivcit it. 

Spirometry 

4. Perform spirometry: 

• at diagnosis 

• to reconsider the diagnosis, for 

people who show an exceptionally 

good response to treatment 

• to monitor disease progression. 

5. Measure post-bronchodilator 

spirometry to confirm the diagnosis of 

COPD. 

6. Think about alternative diagnoses or 

investigations for older people who have 

an FEV1/FVC ratio below 0.7 but do not 

have typical symptoms of COPD. 

7. Think about a diagnosis of COPD in 

younger people who have symptoms of 

SPIROMETRY CAN BE 

PERFORMED BY ANY 

HEALTHCARE WORKER WHO 

HAS HAD APPROPRIATE 

TRAINING AND HAS 

UP-TO-DATE SKILLS 

COPD, even when their FEV1/FVC ratio is 

above 0.7. 

8. All healthcare professionals who 

care for people with COPD should have 

access to spirometry and be competent 

in interpreting the results. 

9. Spirometry can be performed by 

any healthcare worker who has had 

appropriate training and has up-to-date 

skills. 

10. Spirometry services should be 

supported by quality-control processes. 

11. It is recommended that GLI 2012 

reference values are used, but it is 

recognised that these values are not 

applicable for all ethnic groups. 

Incidental findings on chest X‐rays or 

CT scans 

12. Consider primary care respiratory 

review and spirometry (see 

recommendations 1 to 11 of A) for 

people with emphysema or signs of 

chronic airways disease on a chest X‐ray 

or CT scan. 

13. If the person is a current smoker, 

their spirometry results are normal and 

they have no symptoms or signs of 

respiratory disease: 

• offer smoking cessation advice and 

treatment, and referral to specialist 

stop smoking services (see the 


NICE guideline on stop smoking 

interventions and services) 

• warn them that they are at higher 

risk of lung disease 

• advise them to return if they 

develop respiratory symptoms 

• be aware that the presence of 

emphysema on a CT scan is an 

independent risk factor for lung 

cancer. 

14. If the person is not a current smoker, 

their spirometry is normal and they have 

no symptoms or signs of respiratory 

disease: 

• ask them if they have a personal or 

family history of lung or liver disease 

and consider alternative diagnoses, 

such as alpha‐1 antitrypsin deficiency 

• reassure them that their 

emphysema or chronic airways 

disease is unlikely to get worse 

• advise them to return if they 

develop respiratory symptoms 

• be aware that the presence of 

emphysema on a CT scan is an 

independent risk factor for lung 

cancer. 

To find out why the committee made 

the 2018 recommendations on 

incidental findings on chest X‐rays or 

CT scans, and how they might affect 

practice, see rationale and impact. 

Further investigations 

15. At the time of their initial diagnostic 

evaluation, in addition to spirometry all 

patients should have: 

• a chest radiograph to exclude 

other pathologies 

• a full blood count to identify 

anaemia or polycythaemia 

• body mass index (BMI) calculated. 

16. Perform additional investigations 

when needed. 

17. Offer people with alpha‐1 antitrypsin 

deficiency a referral to a specialist 

centre to discuss how to manage their 

condition. 

Reversibility testing 

18. For most people, routine spirometric 

reversibility testing is not necessary as 

part of the diagnostic process or to plan 

initial therapy with bronchodilators or 

TABLE 2: CLINICAL FEATURES DIFFERENTIATING COPD AND ASTHMA 

COPD Asthma 

Smoker or ex-smoker Nearly all Possibly 

Symptoms under age 35 Rare Often 

Chronic productive cough Common Uncommon 

Breathlessness 

Persistent and Variable 

progressive 

Night-time waking with breathlessness and/or wheeze Uncommon Common 

Significant diurnal or day-to-day variability of symptoms Uncommon Common 

corticosteroids. It may be unhelpful or 

misleading because: 

• repeated FEV1 measurements can 

show small spontaneous fluctuations 

• the results of a reversibility test 

performed on different occasions 

can be inconsistent and not 

reproducible 

• over-reliance on a single 

reversibility test may be misleading 

unless the change in FEV1 is greater 

than 400 ml 

• the definition of the magnitude 

of a significant change is purely 

arbitrary 

• response to long-term therapy is 

not predicted by acute reversibility 

testing. 

19. Untreated COPD and asthma are 

frequently distinguishable on the basis 

of history (and examination) in people 

presenting for the first time. Whenever 

possible, use features from the history 

and examination (such as those listed 

in table 2) to differentiate COPD 

from asthma. For more information 

on diagnosing asthma, see the NICE 

guideline on asthma. 


20. In addition to the features in table 

3, use longitudinal observation of 

people (with spirometry, peak flow or 

symptoms) to help differentiate COPD 

from asthma. 

21. When diagnostic uncertainty 

remains, or both COPD and asthma are 

present, use the following findings to 

help identify asthma: 

• a large (over 400 ml) response to 

bronchodilators 

• a large (over 400 ml) response to 

30 mg oral prednisolone daily for 2 

weeks 

• serial peak flow measurements 

showing 20% or greater diurnal or 

day-to-day variability. 

Clinically significant COPD is not 

present if the FEV1 and FEV1/FVC ratio 

return to normal with drug therapy. 

22. If diagnostic uncertainty remains, 

think about referral for more detailed 

investigations, including imaging and 

measurement of transfer factor for 

carbon monoxide (TLCO). 

23. Reconsider the diagnosis of COPD 

for people who report a marked 

improvement in symptoms in response 

to inhaled therapy. 

Assessing severity and using 

prognostic factors 

COPD is heterogeneous, so no single 

measure can adequately assess disease 

severity in an individual. Severity 

assessment is, nevertheless, important 

because it has implications for therapy 

and relates to prognosis. 

24. Do not use a multidimensional index 

(such as BODE) to assess prognosis in 

people with stable COPD. 

25. From diagnosis onwards, when 

discussing prognosis and treatment 

decisions with people with stable COPD, 

think about the following factors that are 

individually associated with prognosis: 

• FEV1 

• smoking status 

• breathlessness (MRC scale) 

• chronic hypoxia and/or cor 

pulmonale 

• low BMI 

• severity and frequency of 

exacerbations 

• hospital admissions 

• symptom burden (for example, 

COPD Assessment Test [CAT] score) 

• exercise capacity (for example, 

6‐minute walk test) 

• TLCO 

• whether the person meets the 

criteria for long-term oxygen therapy 

and/or home non-invasive ventilation 

• multimorbidity 

• frailty. 


the recommendations on assessing 

severity and using prognostic factors, 

and how it might affect practice, see 

rationale and impact. 

Assessing and classifying the severity 

of airflow obstruction 

26. Assess the severity of airflow 

COPD IS HETEROGENEOUS, 

SO NO SINGLE MEASURE CAN 

ADEQUATELY ASSESS DISEASE 

SEVERITY IN AN INDIVIDUAL 

obstruction according to the reduction in 

FEV1, as shown in table 3. 

27. For people with mild airflow 

obstruction, only diagnose COPD if they 

have 1 or more of the symptoms in 

recommendation 1 of A. 

Identifying early disease 

28. Perform spirometry in people who 

are over 35, current or ex‐smokers, and 

have a chronic cough. 

29. Consider spirometry in people 

with chronic bronchitis. A significant 

proportion of these people will go on to 

develop airflow limitation. 

Referral for specialist advice 

30. When clinically indicated, refer 

people for specialist advice. Referral 

may be appropriate at all stages of 

the disease and not solely in the most 

severely disabled people. 

31. People who are referred do not 

always have to be seen by a respiratory 

physician. In some cases they may be 

seen by members of the COPD team 

who have appropriate training and 

expertise. 

B. MANAGING STABLE COPD 

NICE has also produced a visual 

summary covering non-pharmacological 

management and use of inhaled 

therapies. 

1. For guidance on the management of 

multimorbidity, see the NICE guideline 

on multimorbidity. 

Smoking cessation 

2. Document an up-to-date smoking 

history, including pack years smoked 

(number of cigarettes smoked per day, 

divided by 20, multiplied by the number 

of years smoked) for everyone with 

COPD. 

3. At every opportunity, advise and 

encourage every person with COPD who 

is still smoking (regardless of their age) 

to stop, and offer them help to do so. 

4. Unless contraindicated, offer nicotine 

replacement therapy, varenicline or 

bupropion as appropriate to people who 

want to stop smoking, combined with 

an appropriate support programme to 

optimise smoking quit rates for people 

with COPD. 

5. For more guidance on helping people 

to quit smoking, see the NICE guideline 

on stop smoking interventions and 

services. 

6. For more guidance on varenicline, see 

the NICE technology appraisal guidance 

on varenicline for smoking cessation. 

Inhaled therapy 

Short-acting beta2 agonists (SABA) 

and short-acting muscarinic antagonists 

(SAMA) 

7. Use short-acting bronchodilators, 

as necessary, as the initial empirical 

treatment to relieve breathlessness and 

exercise limitation. 

Inhaled corticosteroids (ICS) 

8. Do not use oral corticosteroid 

reversibility tests to identify which 

people should be prescribed inhaled 


slug 

corticosteroids, because they do 

not predict response to inhaled 

corticosteroid therapy. 

9. Be aware of, and be prepared to 

discuss with the person, the risk of side 

effects (including pneumonia) in people 

who take inhaled corticosteroids for 

COPD. 

Inhaled combination therapy 

Inhaled combination therapy refers to 

combinations of long-acting muscarinic 

antagonists (LAMA), long-acting 

beta2 agonists (LABA) and inhaled 

corticosteroids (ICS). 

The evidence on triple therapy 

(LAMA+LABA+ICS) is being reviewed 

as part of the 2019 update to this 

guideline. This update is expected to 

publish in June 2019. 

10. Do not assess the effectiveness 

of bronchodilator therapy using lung 

function alone. Include a variety of 

other measures such as improvement 

in symptoms, activities of daily living, 

exercise capacity, and rapidity of 

symptom relief. 

11. Offer LAMA+LABA to people who: 

• have spirometrically confirmed 

COPD and 

• do not have asthmatic features/ 

features suggesting steroid 

responsiveness and 

• remain breathless or have 

exacerbations despite: 

◦ having used or been offered 

treatment for tobacco 

dependence if they smoke and 

◦ optimised non-pharmacological 

management and relevant 

vaccinations and 

◦ using a short-acting 

bronchodilator. 

12. Consider LABA+ICS for people who: 

• have spirometrically confirmed 

COPD and 

• have asthmatic features/features 

suggesting steroid responsiveness 

and 

• remain breathless or have 

exacerbations despite: 

◦ having used or been offered 

treatment for tobacco 

dependence if they smoke and 

◦ optimised non-pharmacological 

management and relevant 

vaccinations and 

◦ using a short-acting 

bronchodilator. 

13. For people using long-acting 

bronchodilators outside of 

recommendations 11 and 12 of B before 

this guideline was published (December 

2018), explain to them that they can 

continue with their current treatment 

until both they and their NHS healthcare 

professional agree it is appropriate to 

change. 

14. Offer LAMA+LABA+ICS to 

people with COPD with asthmatic 

features/features suggesting steroid 

responsiveness who remain breathless 

or have exacerbations despite taking 

LABA+ICS. 

15. Base the choice of drugs and 

inhalers on: 

• how much they improve symptoms 

• the person’s preferences and 

ability to use the inhalers 

• the drugs’ potential to reduce 

exacerbations 

• their side effects 

• their cost. 

Minimise the number of inhalers and 

the number of different types of inhaler 

used by each person as far as possible. 

16. When prescribing long-acting drugs, 

ensure people receive inhalers they 

have been trained to use (for example, 

by specifying the brand and inhaler in 

prescriptions). 


the 2018 recommendations on inhaled 

combination therapy and how they 

might affect practice, see rationale and 

impact. 

Delivery systems used to treat stable 

COPD 

Most people with COPD – whatever their 

age – can develop adequate inhaler 

technique if they are given training. 

However, people with significant 

cognitive impairment may be unable to 

use any form of inhaler device. In most 


Post-bronchodilator 

FEV1/FVC 

FEV1 % predicted 

TABLE 3: GRADATION OF SEVERITY OF AIRFLOW OBSTRUCTION 

NICE guideline 

CG12 (2004) 

ATS/ERS 

2004 1 

Severity of airflow obstruction 

GOLD 2008 2 

NICE guideline CG101 

(2010) 

– – Post-bronchodilator Post-bronchodilator Post-bronchodilator 

Oral theophylline 

In this section of the guideline, the 

term theophylline refers to slow-release 

formulations of the drug. 

32. Theophylline should only be 

used after a trial of short-acting 

bronchodilators and long-acting 

bronchodilators, or for people who 

are unable to use inhaled therapy, as 

plasma levels and interactions need to 

be monitored. 

33. Take particular caution when using 

theophylline in older people, because 

of differences in pharmacokinetics, the 

increased likelihood of comorbidities 

and the use of other medications. 

34. Assess the effectiveness of 

theophylline by improvements in 

symptoms, activities of daily living, 

exercise capacity and lung function. 

35. Reduce the dose of theophylline for 

people who are having an exacerbation 

if they are prescribed macrolide or 

fluoroquinolone antibiotics (or other 

drugs known to interact). 

Oral mucolytic therapy 

36. Consider mucolytic drug therapy for 

people with a chronic cough productive 

of sputum. 

37. Only continue mucolytic therapy 

if there is symptomatic improvement 

(for example, reduction in frequency of 

cough and sputum production). 

38. Do not routinely use mucolytic drugs 

to prevent exacerbations in people with 

stable COPD. 

Oral anti-oxidant therapy 

39. Treatment with alpha-tocopherol 

and beta-carotene supplements, alone 

or in combination, is not recommended. 

Oral anti-tussive therapy 

40. Anti-tussive therapy should not 

be used in the management of stable 

COPD. 

Oral prophylactic antibiotic therapy 

41. Before starting prophylactic antibiotic 

therapy in a person with COPD, think 

about whether respiratory specialist 

input is needed. 

42. Consider azithromycin (usually 250 

mg 3 times a week) for people with 

COPD if they: 

• do not smoke and 

• have optimised nonpharmacological 

management 

and inhaled therapies, relevant 

vaccinations and (if appropriate) 

have been referred for pulmonary 

rehabilitation and 

• continue to have 1 or more of the 

following, particularly if they have 

significant daily sputum production: 

◦ frequent (typically 4 or more per 

year) exacerbations with sputum 

production 

◦ prolonged exacerbations with 

sputum production 

◦ exacerbations resulting in 

hospitalisation. 

43. Before offering prophylactic 

antibiotics, ensure that the person has 

had: 

• sputum culture and sensitivity 

(including tuberculosis culture), to 

identify other possible causes of 

persistent or recurrent infection 

that may need specific treatment 

(for example, antibiotic-resistant 

organisms, atypical mycobacteria or 

Pseudomonas aeruginosa) 

• training in airway clearance 

techniques to optimise sputum 

clearance (see recommendation 95 

of B) 

• a CT scan of the thorax to rule 

out bronchiectasis and other lung 

pathologies. 

44. Before starting azithromycin, ensure 

the person has had: 

• an electrocardiogram (ECG) to rule 

out prolonged QT interval and 

• baseline liver function tests. 

45. When prescribing azithromycin, 

advise people about the small risk of 

hearing loss and tinnitus, and tell them 

to contact a healthcare professional if 

this occurs. 

46. Review prophylactic azithromycin 

after the first 3 months, and then at 

least every 6 months. 

47. Only continue treatment if the 

continued benefits outweigh the risks. 

Be aware that there are no long-term 

studies on the use of prophylactic 

antibiotics in people with COPD. 

48. For people who are taking 

prophylactic azithromycin and are still 

at risk of exacerbations, provide a 

non-macrolide antibiotic to keep at 

home as part of their exacerbation 

action plan (see recommendation 122 

of B). 

49. Be aware that it is not necessary to 

stop prophylactic azithromycin during an 

acute exacerbation of COPD. 

To find out why the committee 

made the 2018 recommendations on 

prophylactic oral antibiotic therapy and 

how they might affect practice, see 


Oral phosphodiesterase‐4 inhibitors 

50. For guidance on treating severe 

COPD with roflumilast, see NICE's 

technology appraisal guidance 

on roflumilast for treating chronic 

obstructive pulmonary disease. 

Oxygen 

Long-term oxygen therapy 

51. Be aware that inappropriate oxygen 

therapy in people with COPD may cause 

respiratory depression. 

52. Assess the need for oxygen therapy 

in people with: 

• very severe airflow obstruction 

(FEV1 below 30% predicted) 

• cyanosis (blue tint to skin) 

• polycythaemia 

• peripheral oedema (swelling) 

• a raised jugular venous pressure 

• oxygen saturations of 92% or less 

breathing air. 

Also consider assessment for people 

with severe airflow obstruction (FEV1 

30–49% predicted). 

53. Assess people for long-term oxygen 

therapy by measuring arterial blood 

gases on 2 occasions at least 3 weeks 

apart in people who have a confident 

diagnosis of COPD, who are receiving 

optimum medical management and 

whose COPD is stable. 

54. Consider long-term oxygen therapy 

for people with COPD who do not 

smoke and who: 

• have a partial pressure of oxygen 

in arterial blood (PaO2) below 7.3 


kPa when stable or 

• have a PaO2 above 7.3 and below 

8 kPa when stable, if they also have 

1 or more of the following: 

◦ secondary polycythaemia 

◦ peripheral oedema 

◦ pulmonary hypertension. 

55. Conduct and document a 

structured risk assessment for people 

being assessed for long-term oxygen 

therapy who meet the criteria in 

recommendation 54 of B. As part of the 

risk assessment, cover the risks for both 

the person with COPD and the people 

who live with them, including: 

• the risks of falls from tripping over 

the equipment 

• the risks of burns and fires, and 

the increased risk of these for people 

who live in homes where someone 

smokes (including e‐cigarettes). 

Base the decision on whether longterm 

oxygen therapy is suitable on the 

results of the structured risk assessment. 

56. For people who smoke or live with 

people who smoke, but who meet the 

other criteria for long-term oxygen 

therapy, ensure the person who smokes 

is offered smoking cessation advice 

and treatment, and referral to specialist 

stop smoking services (see the NICE 

guidelines on stop smoking interventions 

and services and medicines 

optimisation). 

57. Do not offer long-term oxygen 

therapy to people who continue to 

smoke despite being offered smoking 

cessation advice and treatment, and 

referral to specialist stop smoking 

services. 

58. Advise people who are having longterm 

oxygen therapy that they should 

breathe supplemental oxygen for a 

minimum of 15 hours per day. 

59. Do not offer long-term oxygen 

therapy to treat isolated nocturnal 

hypoxaemia caused by COPD. 

60. To ensure everyone eligible for 

long-term oxygen therapy is identified, 

pulse oximetry should be available in all 

healthcare settings. 

61. Oxygen concentrators should be 

used to provide the fixed supply at 

home for long-term oxygen therapy. 

62. People who are having long-term 

oxygen therapy should be reviewed 

at least once per year by healthcare 

professionals familiar with long-term 

oxygen therapy. This review should 

include pulse oximetry. 



long-term oxygen therapy and how they 


impact. 

Ambulatory oxygen therapy 

63. Do not offer ambulatory oxygen to 

manage breathlessness in people with 

COPD who have mild or no hypoxaemia 

at rest. 

64. Consider ambulatory oxygen in 

people with COPD who have exercise 

ONLY PRESCRIBE 

AMBULATORY OXYGEN 

THERAPY AFTER AN 

APPROPRIATE ASSESSMENT 

HAS BEEN PERFORMED 

BY A SPECIALIST 

desaturation and are shown to have an 

improvement in exercise capacity with 

oxygen, and have the motivation to use 

oxygen. 

65. Prescribe ambulatory oxygen to 

people who are already on long-term 

oxygen therapy, who wish to continue 

oxygen therapy outside the home, and 

who are prepared to use it. 

66. Only prescribe ambulatory oxygen 

therapy after an appropriate assessment 

has been performed by a specialist. 

The purpose of the assessment is to 

assess the extent of desaturation, 

the improvement in exercise capacity 

with supplemental oxygen, and the 

oxygen flow rate needed to correct 

desaturation. 

67. Small light-weight cylinders, oxygenconserving 

devices and portable liquid 

oxygen systems should be available for 

people with COPD. 

68. When choosing which equipment to 

prescribe, take account of the hours of 

ambulatory oxygen use and oxygen flow 

rate needed. 

Short-burst oxygen therapy 

69. Do not offer short-burst oxygen 

therapy to manage breathlessness in 

people with COPD who have mild or no 

hypoxaemia at rest. 



ambulatory oxygen and short-burst 

oxygen therapy, and how they 


impact. 

Non-invasive ventilation 

70. Refer people who are adequately 

treated but have chronic hypercapnic 

respiratory failure and have needed 

assisted ventilation (whether invasive or 

non-invasive) during an exacerbation, 

or who are hypercapnic or acidotic on 

long-term oxygen therapy, to a specialist 

centre for consideration of long-term 

non-invasive ventilation. 

Managing pulmonary hypertension 

and cor pulmonale 

In this guideline, 'cor pulmonale' is 

defined as a clinical condition that is 

identified and managed on the basis 

of clinical features. It includes people 

who have right heart failure secondary 

to lung disease and people whose 

primary pathology is salt and water 

retention, leading to the development of 

peripheral oedema (swelling). 

Diagnosing pulmonary hypertension 

and cor pulmonale 

71. Suspect a diagnosis of cor pulmonale 

for people with: 

• peripheral oedema (swelling) 

• a raised venous pressure 

• a systolic parasternal heave 

• a loud pulmonary second heart 

sound. 

72. It is recommended that the 

diagnosis of cor pulmonale is made 

clinically and that this process should 

involve excluding other causes of 

peripheral oedema (swelling). 


Treating pulmonary hypertension 

73. Do not offer the following 

treatments solely to manage pulmonary 

hypertension caused by COPD, except as 

part of a randomised controlled trial: 

• bosentan 

• losartan 

• nifedipine 

• nitric oxide 

• pentoxifylline 

• phosphodiesterase‐5 inhibitors 

• statins. 

Treating cor pulmonale 

74. Ensure that people with cor 

pulmonale caused by COPD are offered 

optimal COPD treatment, including 

advice and interventions to help them 

stop smoking. For people who need 

treatment for hypoxia, see the section 

on long-term oxygen therapy. 

75. Oedema associated with cor 

pulmonale can usually be controlled 

symptomatically with diuretic therapy. 

76. Do not use the following to treat cor 

pulmonale caused by COPD: 

• alpha-blockers 

• angiotensin-converting enzyme 

inhibitors 

• calcium channel blockers 

• digoxin (unless there is atrial 

fibrillation). 



managing pulmonary hypertension and 

cor pulmonale, and how they might 

affect practice, see rationale and impact. 

Pulmonary rehabilitation 

Pulmonary rehabilitation is defined as 

a multidisciplinary programme of care 

for people with chronic respiratory 

impairment. It is individually tailored 

and designed to optimise each person's 

physical and social performance and 

autonomy. 

77. Make pulmonary rehabilitation 

available to all appropriate people with 

COPD (see recommendation 1.2.78), 

including people who have had a 

recent hospitalisation for an acute 

exacerbation. 

78. Offer pulmonary rehabilitation to 

all people who view themselves as 

functionally disabled by COPD (usually 

Medical Research Council [MRC] grade 3 

and above). Pulmonary rehabilitation is 

not suitable for people who are unable 

to walk, who have unstable angina 

or who have had a recent myocardial 

infarction. 

79. For pulmonary rehabilitation 

programmes to be effective, and to 

improve adherence, they should be held 

at times that suit people, in buildings 

that are easy to get to and that have 

good access for people with disabilities. 

Places should be available within a 

reasonable time of referral. 

80. Pulmonary rehabilitation 

programmes should include 

multicomponent, multidisciplinary 

interventions that are tailored to 

the individual person's needs. The 

rehabilitation process should incorporate 

a programme of physical training, 

disease education, and nutritional, 

psychological and behavioural 

intervention. 

81. Advise people of the benefits of 

pulmonary rehabilitation and the 

commitment needed to gain these. 

Vaccination and anti-viral therapy 

82. Offer pneumococcal vaccination and 

an annual flu vaccination to all people 

with COPD, as recommended by the 

Chief Medical Officer. 

83. For guidance on preventing 

and treating flu, see the NICE 

technology appraisals on oseltamivir, 

amantadine (review) and zanamivir 

for the prophylaxis of influenza and 

amantadine, oseltamivir and zanamivir 

for the treatment of influenza. 

Lung surgery and lung volume 

reduction procedures 

84. Offer a respiratory review to assess 

whether a lung volume reduction 

procedure is a possibility for people with 

COPD when they complete pulmonary 

rehabilitation and at other subsequent 

reviews, if all of the following apply: 

• they have severe COPD, with FEV1 

less than 50% and breathlessness 

that affects their quality of life 

despite optimal medical treatment 

(see recommendations 11 to 14 of B) 

• they do not smoke 

• they can complete a 6‐minute 

walk distance of at least 140 m (if 

limited by breathlessness). 

85. At the respiratory review, refer the 

person with COPD to a lung volume 

reduction multidisciplinary team to 

assess whether lung volume reduction 

surgery or endobronchial valves are 

suitable if they have: 

• hyperinflation, assessed by 

lung function testing with body 

plethysmography and 

• emphysema on unenhanced CT 

chest scan and 

• optimised treatment for other 

comorbidities. 

86. Only offer endobronchial coils 

as part of a clinical trial and after 

assessment by a lung volume reduction 

multidisciplinary team. 

87. For more guidance on lung volume 

reduction procedures, see the NICE 

interventional procedures guidance 

on lung volume reduction surgery, 

endobronchial valves and endobronchial 

coils. 

88. Refer people with COPD for an 

assessment for bullectomy if they are 

breathless and a CT scan shows a bulla 

occupying at least one third of the 

hemithorax. 

89. Consider referral to a specialist 

multidisciplinary team to assess for lung 

transplantation for people who: 

• have severe COPD, with FEV1 less 

than 50% and breathlessness that 

affects their quality of life despite 

optimal medical treatment (see 

recommendations 11 to 14 of B) and 

• do not smoke and 

• have completed pulmonary 

rehabilitation and 

• do not have contraindications 

for transplantation (for example, 

comorbidities or frailty). 

90. Do not use previous lung volume 

reduction procedures as a reason not to 

refer a person for assessment for lung 

transplantation. 




lung volume reduction procedures, 

bullectomy and lung transplantation, 

and how they might affect practice, see 


Alpha‐1 antitrypsin replacement 

therapy 

91. Alpha‐1 antitrypsin replacement 

therapy is not recommended for people 

with alpha‐1 antitrypsin deficiency (see 

also recommendation 17 of A). 

Multidisciplinary management 

92. COPD care should be delivered by a 

multidisciplinary team. 

93. When defining the activity of the 

multidisciplinary team, think about the 

following functions: 

• assessment (including performing 

spirometry, assessing which delivery 

systems to use for inhaled therapy, 

the need for aids for daily living and 

assessing the need for oxygen) 

• care and treatment, including: 

◦ pulmonary rehabilitation 

◦ identifying and managing anxiety 

and depression 

◦ advising people on relaxation 

techniques 

◦ dietary issues 

◦ exercise 

◦ social security benefits and travel 

◦ hospital-at-home/early discharge 

schemes 

◦ non-invasive ventilation and 

palliative care 

• advising people on selfmanagement 

strategies 

• identifying and monitoring people 

at high risk of exacerbations and 

undertaking activities to avoid 

emergency admissions 

• education for people with COPD, 

their carers, and for healthcare 

professionals. 

Respiratory nurse specialists 

94. It is recommended that the 

multidisciplinary COPD team includes 

respiratory nurse specialists. 

Physiotherapy 

95. If people have excessive sputum, 

they should be taught: 


• how to use positive expiratory 

pressure devices 

• active cycle of breathing 

techniques. 

Identifying and managing anxiety and 

depression 

96. Be alert for anxiety and depression 

in people with COPD. Consider whether 

people have anxiety or depression, 

particularly if they: 

• have severe breathlessness 

• are hypoxic 

• have been seen at or admitted to 

a hospital with an exacerbation of 

COPD. 

97. For guidance on diagnosing and 

managing depression, see the NICE 

guideline on depression in adults with a 

chronic physical health problem. 

98. For guidance on managing anxiety, 

see the NICE guideline on generalised 

anxiety disorder and panic disorder in 

adults. 

Nutritional factors 

99. Calculate BMI for people with COPD: 

• the normal range for BMI is 20 to 

less than 25 kg/m2 

• refer people for dietetic advice if 

they have a BMI that is abnormal 

(high or low) or changing over time 

• for people with a low BMI, give 

nutritional supplements to increase 

their total calorific intake and 

encourage them to exercise to 

augment the effects of nutritional 

supplementation. 

100. For guidance on nutrition support, 

see the NICE guideline on nutrition 

support for adults. 

101. Pay attention to changes in weight 

in older people, particularly if the 

change is more than 3 kg. 

Palliative care 

102. When appropriate, use opioids to 

relieve breathlessness in people with 

end-stage COPD that is unresponsive to 

other medical therapy. 

103. When appropriate, use 

benzodiazepines, tricyclic 

antidepressants, major tranquillisers and 

oxygen for breathlessness in people with 

end-stage COPD that is unresponsive to 

other medical therapy. 

104. People with end-stage COPD 

and their family members or carers 

(as appropriate) should have access 

to the full range of services offered by 

multidisciplinary palliative care teams, 

including admission to hospices. 

105. For standards and measures on 

palliative care, see the NICE quality 

standard on end of life care for adults. 

106. For guidance on care for people 

in the last days of life, see the NICE 

guideline on care of dying adults. 

Assessment for occupational therapy 

107. Regularly ask people with COPD 

about their ability to undertake activities 

of daily living and how breathless these 

activities make them. 

WHEN APPROPRIATE, 

USE OPIOIDS TO RELIEVE 

BREATHLESSNESS IN PEOPLE 

WITH END-STAGE COPD THAT 

IS UNRESPONSIVE TO OTHER 

MEDICAL THERAPY 

108. Clinicians that care for people 

with COPD should assess their need for 

occupational therapy using validated 

tools. 

Social services 

109. Consider referring people for 

assessment by social services if they 

have disabilities caused by COPD. 

Advice on travel 

110. Assess people who are using longterm 

oxygen therapy and who are 

planning air travel in line with the BTS 


111. Assess people with an FEV1 

below 50% predicted who are 

planning air travel in line with the BTS 


112. Warn people with bullous disease 

that they are at a theoretically increased 

risk of a pneumothorax during air travel. 

Advice on diving 

113. Scuba diving is not generally 

recommended for people with COPD. 

Advise people with queries to seek 

specialist advice. 

Education 

114. There are significant differences 

in the response of people with COPD 

and asthma to education programmes. 

Programmes designed for asthma 

should not be used in COPD. 

115. At diagnosis and at each review 

appointment, offer people with COPD 

and their family members or carers (as 

appropriate): 

• written information about their 

condition 

• opportunities for discussion with 

a healthcare professional who has 

experience in caring for people with 

COPD. 

116. Ensure the information provided is: 

• available on an ongoing basis 

• relevant to the stage of the 

person's condition 

• tailored to the person's needs. 

117. At minimum, the information should 

cover: 

• an explanation of COPD and its 

symptoms 

• avadvice on quitting smoking (if 

relevant) and how this will help with 

the person's COPD 

• advice on avoiding passive smoke 

exposure 

• managing breathlessness 

• physical activity and pulmonary 

rehabilitation 

• medicines, including inhaler 

technique and the importance of 

adherence 

• vaccinations 

• identifying and managing 

exacerbations 

• details of local and national 

organisations and online resources 

that can provide more information 

and support 

• how COPD will affect other longterm 

conditions that are common 

in people with COPD (for example, 


TABLE 4: SUMMARY OF FOLLOW‐UP OF PEOPLE WITH COPD IN PRIMARY CARE 

Mild/moderate/severe (stages 1 to 3) Very severe (stage 4) 

Frequency At least annual At least twice per year 

Clinical 

assessment 

Measurements 

to make 

• Smoking status and motivation to 

quit 

• Adequacy of symptom control: 

– breathlessness 

– exercise tolerance 

– estimated exacerbation frequency 

• Need for pulmonary rehabilitation 

• Presence of complications 

• Effects of each drug treatment 

• Inhaler technique 

• Need for referral to specialist and 

therapy services 

• FEV1 and FVC 

• calculate BMI 

• MRC dyspnoea score 

hypertension, heart disease, anxiety, 

depression and musculoskeletal 

problems). 

118. Be aware of the obligation 

to provide accessible information 

as detailed in the NHS Accessible 

Information Standard. For more 

guidance on providing information to 

people and discussing their preferences 

with them, see the NICE guideline on 

patient experience in adult NHS services. 



education and how they might affect 

practice, see rationale and impact. 

119. Advise people with COPD that the 

following factors increase their risk of 

exacerbations: 

• continued smoking or relapse for 

ex‐smokers 

• exposure to passive smoke 

• viral or bacterial infection 

• indoor and outdoor air pollution 

• lack of physical activity 

• seasonal variation (winter and 

spring). 

• Smoking status and motivation 

to quit 

• Adequacy of symptom control: 

– breathlessness 

– exercise tolerance 

– estimated exacerbation 

frequency 

• Presence of cor pulmonale 

• Need for long-term oxygen 

therapy 

• Person with COPD’s nutritional 

state 

• Presence of depression 

• Effects of each drug treatment 

• Inhaler technique 

• Need for social services and 

occupational therapy input 

• Need for referral to specialist 

and therapy services 

• Need for pulmonary 

rehabilitation 

• FEV1 and FVC 

• calculate BMI 

• MRC dyspnoea score 

• SaO2 


made the 2018 recommendation on 

risk factors for exacerbations and how it 


impact. 

Self-management 

120. Develop an individualised selfmanagement 

plan in collaboration with 

each person with COPD and their family 

members or carers (as appropriate), 

and: 

• include education on all relevant 

points from recommendation 117of B 

• review the plan at future 

appointments. 

121. Develop an individualised 

exacerbation action plan in collaboration 

with each person with COPD who is at 

risk of exacerbations. 

122. Offer people a short course of oral 

corticosteroids and a short course of 

oral antibiotics to keep at home as part 

of their exacerbation action plan if: 

• they have had an exacerbation 

within the last year, and remain at 

risk of exacerbations 

• they understand and are confident 

about when and how to take these 

medicines, and the associated 

benefits and harms 

• they know to tell their healthcare 

professional when they have used 

the medicines, and to ask for 

replacements. 

123. For guidance on the choice of 

antibiotics, see the NICE guideline on 

antimicrobial prescribing for acute 

exacerbations of COPD. 

124. At all review appointments, discuss 

corticosteroid and antibiotic use with 

people who keep these medicines at 

home, to check that they still understand 

how to use them. For people who 

have used 3 or more courses of oral 

corticosteroids and/or oral antibiotics 

in the last year, investigate the possible 

reasons for this. 

125. See recommendations 13 to 

21 of C for more guidance on oral 

corticosteroids. 

126. Encourage people with COPD 

to respond promptly to exacerbation 

symptoms by following their action plan, 

which may include: 

• adjusting their short-acting 

bronchodilator therapy to treat their 

symptoms 

• taking a short course of oral 

corticosteroids if their increased 

breathlessness interferes with 

activities of daily living 

• adding oral antibiotics if their 

sputum changes colour and 

increases in volume or thickness 

beyond their normal day-to-day 

variation 

• telling their healthcare professional. 

127. Ask people with COPD if they 

experience breathlessness they find 

frightening. If they do, consider including 

a cognitive behavioural component in 

their self-management plan to help 

them manage anxiety and cope with 

breathlessness. 

128. For people at risk of hospitalisation, 

explain to them and their family 

members or carers (as appropriate) 

what to expect if this happens (including 

non-invasive ventilation and discussions 


on future treatment preferences, ceilings 

of care and resuscitation). 

Telehealth monitoring 

129. Do not offer routine telehealth 

monitoring of physiological status as 

part of management for stable COPD. 


the 2018 recommendations on selfmanagement 

and telehealth monitoring, 

and how they might affect practice, see 


Fitness for general surgery 

130. The ultimate clinical decision 

about whether or not to proceed with 

surgery should rest with a consultant 

anaesthetist and consultant surgeon, 

taking account of comorbidities, 

functional status and the need for the 

surgery. 

131. It is recommended that lung 

function should not be the only criterion 

used to assess people with COPD before 

surgery. Composite assessment tools 

such as the ASA scoring system are the 

best predictors of risk. 

132. If time permits, optimise the 

medical management of people with 

COPD before surgery. This might include 

a course of pulmonary rehabilitation. 

Follow-up of people with COPD 

133. Follow-up of all people with COPD 

should include: 

• highlighting the diagnosis of COPD 

in the case record and recording this 

using Read Codes on a computer 

database 

• recording the values of spirometric 

tests performed at diagnosis (both 

absolute and percent predicted) 

• offering advice and treatment to 

help them stop smoking, and referral 

to specialist stop smoking services 

(see the NICE guideline on stop 

smoking interventions and services) 

• recording the opportunistic 

measurement of spirometric 

parameters (a loss of 500 ml or 

more over 5 years will show which 

people have rapidly progressing 

disease and may need specialist 

referral and investigation).t 

TABLE 5: FACTORS TO CONSIDER WHEN DECIDING WHERE TO TREAT 

Factor Treat at home Treat in hospital 

Able to cope at home Yes No 

Breathlessness Mild Severe 

General condition Good Poor/deteriorating 

Level of activity Good Poor/confined to bed 

Cyanosis No Yes 

Worsening peripheral oedema No Yes 

Level of consciousness Normal Impaired 

Already receiving long-term oxygen therapy No Yes 

Social circumstances Good Living alone/not coping 

Acute confusion No Yes 

Rapid rate of onset No Yes 

Significant comorbidity (particularly cardiac 

disease and insulin-dependent diabetes) 

134. Review people with COPD at least 

once per year and more frequently if 

indicated, and cover the issues listed in 

table 4. 

135. For most people with stable severe 

COPD, regular hospital review is not 

necessary, but there should be locally 

agreed mechanisms to allow rapid 

access to hospital assessment when 

needed. 

136. When people with very severe 

COPD are reviewed in primary care, they 

should be seen at least twice per year, 

and specific attention should be paid to 

the issues listed in table 6. 

137. Specialists should regularly review 

people with severe COPD who need 

interventions such as long-term noninvasive 

ventilation. 

C. MANAGING 

EXACERBATIONS OF COPD 

Definition of an exacerbation 

A sustained acute-onset worsening of 

the person's symptoms from their usual 

stable state, which goes beyond their 

normal day-to-day variations. Commonly 

reported symptoms are worsening 

No 

breathlessness, cough, increased 

sputum production and change in 

sputum colour. The change in these 

symptoms often necessitates a change 

in medication. 

Assessing the need for hospital 

treatment 

1. Use the factors in table 5 to assess 

whether people with COPD need 

hospital treatment. 

Investigating an exacerbation 

The diagnosis of an exacerbation is 

made clinically and does not depend on 

the results of investigations. However, 

investigations may sometimes be useful 

in ensuring appropriate treatment is 

given. Different investigation strategies 

are needed for people in hospital 

(who will tend to have more severe 

exacerbations) and people in the 

community. 

Primary care 

Yes 

SaO2

outine practice 

• pulse oximetry is of value if there 

are clinical features of a severe 

exacerbation. 

People referred to hospital 

3. In all people presenting to hospital 

with an acute exacerbation: 

• obtain a chest X‐ray 

• measure arterial blood gas 

tensions and record the inspired 

oxygen concentration 

• record an ECG (to exclude 

comorbidities) 

• perform a full blood count and 

measure urea and electrolyte 

concentrations 

• measure a theophylline level on 

admission in people who are taking 

theophylline therapy 

• send a sputum sample for 

microscopy and culture if the 

sputum is purulent 

• take blood cultures if the person 

has pyrexia. 

Hospital-at-home and assisteddischarge 

schemes 

4. Hospital-at-home and assisteddischarge 

schemes are safe and 

effective and should be used as an 

alternative way of caring for people 

with exacerbations of COPD who would 

otherwise need to be admitted or stay 

in hospital. 

5. The multiprofessional team that 

operates these schemes should 

include allied health professionals with 

experience in managing COPD, and 

may include nurses, physiotherapists, 

occupational therapists and other health 

workers. 

6. There are currently insufficient 

data to make firm recommendations 

about which people with COPD with 

an exacerbation are most suitable for 

hospital-at-home or early discharge. 

Selection should depend on the 

resources available and absence 

of factors associated with a worse 

prognosis (for example, acidosis). 

7. Include people's preferences about 

treatment at home or in hospital in 

decision-making. 

Pharmacological management 

Increased breathlessness is a common 

feature of COPD exacerbations. This is 

usually managed by taking increased 

doses of short-acting bronchodilators. 

Delivery systems for inhaled therapy 

during exacerbations 

8. Both nebulisers and hand-held 

inhalers can be used to administer 

inhaled therapy during exacerbations of 

COPD. 

9. The choice of delivery system should 

reflect the dose of drug needed, the 

person's ability to use the device, and 

the resources available to supervise 

therapy administration. 

10. Change people to hand-held inhalers 

CHANGE PEOPLE TO 

HAND-HELD INHALERS AS 

SOON AS THEIR CONDITION 

HAS STABILISED, BECAUSE 

THIS MAY ALLOW THEM TO 

BE DISCHARGED FROM 

HOSPITAL EARLIER 

as soon as their condition has 

stabilised, because this may allow 

them to be discharged from hospital 

earlier. 

11. If a person with COPD is hypercapnic 

or acidotic, the nebuliser should 

be driven by compressed air rather 

than oxygen (to avoid worsening 

hypercapnia). If oxygen therapy is 

needed, administer it simultaneously by 

nasal cannulae. 

12. The driving gas for nebulised therapy 

should always be specified in the 

prescription. 

Systemic corticosteroids 

Recommendations 16 and 17 of C are 

being reviewed as part of the 2019 

update to this guideline. This update is 

expected to publish in June 2019. 

13. In the absence of significant 

contraindications, use oral 

corticosteroids, in conjunction with other 

therapies, in all people admitted to 

hospital with a COPD exacerbation. 

14. In the absence of significant 

contraindications, consider oral 

corticosteroids for people in the 

community who have an exacerbation 

with a significant increase in 

breathlessness that interferes with daily 

activities. 

15. Encourage people who need 

corticosteroid therapy to present early to 

get maximum benefits. 

16. Prescribe prednisolone 30 mg orally 

for 7 to 14 days. 

17. It is recommended that a course 

of corticosteroid treatment should not 

be longer than 14 days, as there is no 

advantage in prolonged therapy. 

18. For guidance on stopping 

oral corticosteroid therapy, it is 

recommended that clinicians refer to the 

BNF. 

19. Think about osteoporosis prophylaxis 

for people who need frequent courses 

of oral corticosteroids. 

20. Make people aware of the optimum 

duration of treatment and the adverse 

effects of prolonged therapy. 

21. Give people (particularly people 

discharged from hospital) clear 

instructions on why, when and how to 

stop their corticosteroid treatment. 

Antibiotics 

22. For guidance on using antibiotics to 

treat COPD exacerbations, see the NICE 

guideline on antimicrobial prescribing 

for acute exacerbations of COPD. 

Theophylline and other 

methylxanthines 

23. Only use intravenous theophylline as 

an adjunct to exacerbation management 

if there is an inadequate response to 

nebulised bronchodilators. 

24. Take care when using intravenous 

theophylline, because of its interactions 

with other drugs and potential toxicity 

if the person has been taking oral 

theophylline. 

25. Monitor theophylline levels within 

24 hours of starting treatment, and as 

frequently as indicated by the clinical 


circumstances after this. 

Respiratory stimulants 

26. It is recommended that doxapram is 

used only when non-invasive ventilation 

is either unavailable or inappropriate. 

Oxygen therapy during exacerbations 

of COPD 

27. Measure oxygen saturation in people 

with an exacerbation if there are no 

facilities to measure arterial blood gases. 

28. If necessary, prescribe oxygen to 

keep the oxygen saturation of arterial 

blood (SaO2) within the individualised 

target range. 

29. Pulse oximeters should be available 

to all healthcare professionals involved 

in the care of people with exacerbations 

of COPD, and they should be trained 

in their use. Clinicians should be aware 

that pulse oximetry gives no information 

about the PaCO2 or pH. 

30. Measure arterial blood gases and 

note the inspired oxygen concentration 

in all people who arrive at hospital with 

an exacerbation of COPD. Repeat arterial 

blood gas measurements regularly, 

according to the response to treatment. 

Non-invasive ventilation (NIV) and 

COPD exacerbations 

31. Use NIV as the treatment of choice 

for persistent hypercapnic ventilatory 

failure during exacerbations despite 

optimal medical therapy. 

32. It is recommended that NIV should 

be delivered in a dedicated setting, 

with staff who have been trained in its 

application, who are experienced in its 

use and who are aware of its limitations. 

33. When people are started on NIV, 

there should be a clear plan covering 

what to do in the event of deterioration, 

and ceilings of therapy should be 

agreed. 

Invasive ventilation and intensive care 

34. Treat hospitalised exacerbations of 

COPD on intensive care units, including 

invasive ventilation when this is thought 

to be necessary. 

35. When assessing suitability for 

intubation and ventilation during 

exacerbations, think about functional 

status, BMI, need for oxygen when 

stable, comorbidities and previous 

admissions to intensive care units, in 

addition to age and FEV1. Neither age 

nor FEV1 should be used in isolation 

when assessing suitability. 

36. Consider NIV for people who are 

slow to wean from invasive ventilation. 

Respiratory physiotherapy and 

exacerbations 

37. Consider physiotherapy using 

positive expiratory pressure devices for 

selected people with exacerbations of 

COPD, to help with clearing sputum. 

USE PULSE OXIMETRY TO 

MONITOR THE RECOVERY 

OF PEOPLE WITH 

NON-HYPERCAPNIC, 

NON-ACIDOTIC RESPIRATORY 

FAILURE 

Monitoring recovery from an 

exacerbation 

38. Monitor people's recovery by regular 

clinical assessment of their symptoms 

and observation of their functional 

capacity. 

39. Use pulse oximetry to monitor 

the recovery of people with nonhypercapnic, 

non-acidotic respiratory 

failure. 

40. Use intermittent arterial blood gas 

measurements to monitor the recovery 

of people with respiratory failure who 

are hypercapnic or acidotic, until they 

are stable. 

41. Do not routinely perform daily 

monitoring of peak expiratory flow (PEF) 

or FEV1 to monitor recovery from an 

exacerbation, because the magnitude 

of changes is small compared with the 

variability of the measurement. 

Discharge planning 

42. Measure spirometry in all people 

before discharge. 

43. Re-establish people on their optimal 

maintenance bronchodilator therapy 


44. People who have had an episode 

of respiratory failure should have 

satisfactory oximetry or arterial blood 

gas results before discharge. 

45. Assess all aspects of the routine 

care that people receive (including 

appropriateness and risk of side effects) 


46. Give people (or home carers) 

appropriate information to enable them 

to fully understand the correct use of 

medications, including oxygen, before 

discharge. 

47. Make arrangements for follow‐up 

and home care (such as visiting nurse, 

oxygen delivery or referral for other 

support) before discharge. 

48. The person, their family and their 

physician should be confident that they 

can manage successfully before they are 

discharged. A formal activities of daily 

living assessment may be helpful when 

there is still doubt. 

Terms used in this guideline 

Asthmatic features/features 

suggesting steroid responsiveness 

This includes any previous, secure 

diagnosis of asthma or of atopy, a 

higher blood eosinophil count, 

substantial variation in FEV1 over time 

(at least 400 ml) or substantial diurnal 

variation in peak expiratory flow 

(at least 20%). 

Exacerbation 

A sustained acute-onset worsening of 

the person's symptoms from their usual 

stable state, which goes beyond their 

normal day-to-day variations. Commonly 

reported symptoms are worsening 

breathlessness, cough, increased 

sputum production and change in 

sputum colour. The change in these 

symptoms often necessitates a change 

in medication. 

Mild or no hypoxaemia 

People who are not taking long-term 

oxygen therapy and who have a mean 

PaO2 greater than 7.3 kPa. 


events 

Inspirations 2019 calls for increased 

awareness on TB 

Elimination of TB requires a lot of effort and patience, concur experts 

PHOTO: JOBIN V MATHEWS 

DIVYA CHOYIKUTTY 

Pulmonologists across Kerala 

gathered together at the first 

edition of ‘Inspirations2019’, 

organized by Inspire, Department 

of Pulmonary Medicine, Pushpagiri 

Institute of Medical Science and 

Research Centre and Kottayam 

Respiratory Society on March 24, 2019 

to commemorate ‘World Tuberculosis 

Day’. 

The conference highlighted 

the rise of a global epidemic of 

tuberculosis and the need for resilience, 

stressing the strategy undertaken by 

India to eliminate the disease, and 

demonstrated various modalities and 

diagnostic methods such as CB NAAT. 

“The convention was organized as 

a part of the 60th anniversary of our 

respiratory department and is aimed 

at creating awareness on tuberculosis 

among current practitioners and 

students,” said organising chairperson 

Dr P Sukumaran, President of 

Kottayam Respiratory Society and 

Head of Department of Pulmonary 

Medicine at Pushpagiri Medical College, 

Tiruvalla. 

TB is one of the top ten causes of 

death in the world today, and India 

has the world’s highest burden of TB, 

accounting for 27 percent of all cases 

and over 30 percent of all TB-related 

deaths. Still, India has committed to 

eliminating TB by 2025. 

“At the national level, India is still 

focusing on the diagnosis of all the 

patients, including those in the private 

sector. So the efforts that are currently 

followed would actually result in 

more patients being diagnosed by 

2025, rather than a reduction,” said 

former WHO consultant Dr. Sanjeev 

Nair, who is also Associate Professor, 

Department of Pulmonary Medicine, 

Government Medical College, 

Trivandrum. 

“To have an elimination strategy 

that is successful, we need to bring 

[TB numbers] to 5% of what was 

there in 2015. The WHO or UN target 

for elimination is by 2035, but India is 

trying to do something over and above 

what the world aims at, which is pretty 

ambitious. But it will take some more 

time, as it requires lots of work and 

patience,” he added. 

India being a high disease burden 

country has more cases of LTBI whose 

treatment still remains a problem. 

Latent tuberculosis infection (LTBI) 

is when a person is infected with 

Mycobacterium tuberculosis, but does 

not have active tuberculosis. 

The WHO has recommended on 

treating active TB alone in high disease 

burden countries like India. This calls for 

unattended cases of latent TB infection 

(LTBI) which would be left untreated 

making India’s near goal of eliminating 

TB farther. 

“In low TB prevalence countries 

like the US, LTBI needs to be treated 

because there is a risk of it developing 

into a progressive primary or secondary 

TB infection. Whereas in India almost 

40-60% of the population are already 

infected, and latent infection is also 

prevalent, thus we need to focus on 

treating the active patients first instead 

of focusing on the latent TB. While 

some certain subset of patients can 

be selected, as in HIV patients with 

latent TB infection,” said Dr. C P Muraly, 

Pulmonologist, Government Medical 

College, Thrissur. 

The event hosted a state level quiz 

programme exclusively on tuberculosis 

for postgraduates in pulmonary 

medicine and general medicine. 


calendar 

Upcoming conferences 

APRIL 

4-6 SPINE CONGRESS 

Spine Congress 

New Delhi 

5-7 ORTHOPEDICS 

3rd Annual Jaipur Shoulder 

Knee Course (JSKC) 

Jaipur 

6-7 DIABETES AND 

ENDOCRINOLOGY 

Decon 2019 - 5th International 

Diabetes & Endocrine 

Conference 

Coimbatore 

7 HEALTHTECH 

Hitcon South Gujarat 

Surat 

13-15 RARE AND UNDIAGNOSED 

DISEASES 

7th International Conference on 

Rare and Undiagnosed Diseases 

Gurugram 

19-20 WELLNESS AND 

HEALTHCARE 

National Conference on 

Healthcare Management 

(Symhealth) 

Pune 

26 HEALTHTECH 

Futuristic Healthcare Summit 

(FHS) 

Bengaluru 

27-28 GYNAECOLOGY 

Hysterectomy Summit 

Mumbai 

29-30 MEDICAL TRAINING 

International Conference on 

Medical & Health Science 

(ICMHS) 

Chennai 

MAY 

2-5 NEPHROLOGY AND 

UROLOGY 

ApEx-Cedars Sinai: The 10th 

Annual Nephrology Board 

Review Course and Urology for 

Nephrologists Workshop 

Mumbai 

3-5 MED EQUIPMENT 

MEDIKO India (MEDIKA) 

Hyderabad 

6-10 ONCOLOGY 

Cardiff-Tata Medical Center FRCR 

2B Oncology Course 

Kolkata 

23 CLINICAL TRIAL 

Annual Clinical Trials Summit 

(Clinical Trials Asia) 

Mumbai 

26-11 PHYSICAL THERAPY 

FM UQ: Functional Mobilization 

Upper Quadrant 

New Delhi 

23-24 CLINICAL GENETICS 

CRO/Sponsor Summit 2019 

Hyderabad 

31-2 NEUROLOGY 

Asian And Oceanian Myology 

Center Meeting (AOMC Meeting) 

Mumbai 

JUNE 


Annual Conference of the Indian 

Association of Gynaecological 

Endoscopists 

Ahmedabad 

8-9 OPHTHALMOLOGY 

National Conference on 

Community Ophthalmology 

Chennai 

28-30 EXPO 

India Med Expo (IME) 

Bengaluru 

JULY 

4-7 ANAESTHESIOLOGY 

9th National Conference of 

the Academy of Regional 

Anaesthesia of India 

Coimbatore 

5-6 MICROBIOLOGY 

World Congress on Microbial 

Infectious Diseases 

Goa 

5-7 DERMATOLOGY 

Dermatology and Allied 

Specialites Summit (DAAS) 

New Delhi 

20-21 CARDIOLOGY 

National Heart Failure 

Conference 

Kochi 

AUGUST 


Ophthall (OPH) 

Hyderabad 

3-4 SURGERY 

World Congress & Summit on 

Surgery 

New Delhi 


India International Optical & 

Ophthalmology Expo (IIOO 

EXPO) 

Hyderabad 


Echo Nagpur Summit 

Nagpur 

23-25 HEMATOLOGY 

Hope Asia 2019 

Kolkata 

SEPTEMBER 


33rd Annual Conference of AICC 

RCOG 2019 

Kolkata 

6-8 ONCOLOGY 

23rd Annual Conference of 

Pediatric Hematology Oncology 

Chapter (PHO) 

Varanasi 


10th National Annual 

Conference of Indian Association 

of Clinical Cardiologists 

Conference (IACCCON 2019) 

Kochi 

10-11 PAEDIATRICS 

World Pediatrics Conference 

Panjim 


World Heart and Cardiothoracic 

Surgery Conference (WHCS 

Heart Conference) 

Cavelossim 

10-11 PULMONARY CARE 

Pulmonary, Thoracic and Critical 

Care Conference 

Goa 

13-14 ONCOLOGY 

Indo Oncology Summit 

Bhubaneswar 

13-15 PSYCHOLOGY 

Fortis Annual Psychology 

Conference 

Gurgaon 

20-22 SURGICAL ONCOLOGY 

National Conference of Indian 

Association of Surgical Oncology 

(NATCON IASO) 

Kolkata 


Global Cardio Diabetes Conclave 

(GCDC) 

Mumbai 

30- NGBT 

Oct2 

2019 Nextgen genomics biology, 

bioinformatics and technologies 

conference 

Mumbai 

The announced dates of the conferences may change 



UPDATE YOURSELF TO THE 

NEW WORLD CONSISTENTLY 

DR R R RAVI 

Director & HOD, Dept of Neuro-Spinal Surgery, KG Hospital, Coimbatore 

Developing greater confidence in patients about the 

treatment is one of the prime responsibilities of 

a clinician. While this is a general principle to be 

followed by the medical profession in every case, it is of 

utmost importance in the branch of neuromedicine. This 

is because there is always a stigma associated with this 

branch of medicine, especially in case of surgeries on 

spine or brain, that the patient often ends up with some 

kind of side effect, such as paralysis or other impacts, 

post operation. 

Since it is a proven fact that the patient’s faith in the 

medical or surgical procedure significantly boosts the 

outcome, there are truly best results that are guaranteed 

with the best clinical practices as well. This is more so 

today with the advent of state-of-the-art technologies 

and products, both in diagnosis as well as treatments. 

But unfortunately, bad outcomes often get wider 

publicity, leading to added social stigma. At the same 

time, the best results are mostly kept under wraps. This 

should change. Good outcomes achieved through better 

skill sets, technologies and advancements in science 

should also get their due and be projected, in order to 

build confidence in the patient community. 

In order to facilitate this one requires wider exposure 

to the advanced world of science and technology and 

continued upgradation. 

I strongly believe that Indian doctors are no less to their 

counterparts in developed countries in terms of clinical 

skills and exposure to modern techniques. 

Since our own education system and the curriculum 

still needs improvisation, which is imminent, the ultimate 

responsibility to upgrade oneself lies with the doctor 

himself. And the best way to achieve this is to expose 

ourselves to the new world consistently. 

— As told to CH Unnikrishnan 


Sep 30 th - Oct 2 nd , 2019 - Mumbai, India 

REGISTRATIONS OPEN 

Early bird ends on 

15 th June, 2019 

Abstract submission 

ends on 1 st July, 2019 

NextGen Genomics, Biology, Bioinformatics and Technologies (NGBT) Conference is an international 

meeting organized by SciGenom Research Foundation (SGRF), a not-for-profit organization working to 

promote Science, Research and Education in India and rest of Asia. 

HIGHLIGHTS 

• Learn about cutting edge developments in 

genomics, biology, bioinformatics, drug 

discovery, plant and animal sciences 

• Network with scientists of global repute 

• Meet national and international genomics, 

biology and technology companies 

• Interact with leaders from drug industry 

• Explore collaboration opportunities 

• Scholarship opportunities for students to support 

their participation at the meeting 

KEY FOCUS AREA 

• Genomics technologies 

• Population genomics 

• Clinical/Medical genomics 

• NIPT/Liquid biopsy 

• Precision (personalized) medicine 

• Cancer genomics 

• CRISPR/CAS9 

• Gene editing 

• Signal transduction 

• Cancer immunology 

• Biomarkers 

• Drug discovery 

• Metagenomics 

• Plant genomics/sciences 

• Agriculture genomics/sciences 

• Veterinary genomics/sciences 

• Wildlife genomics/conservation 

100+ 

Speakers 

Ms. Ms. Kamalika Das Das 

+91- 8374 27 4074 

800+ 

Delegates 

ngbt2019@sgrf.org 

300+ 

Posters 

www.sgrfconferences.org 

100+ 

Scholarships & Awards

RNI Number KERENG/2012/44529

April 2019 digital edition

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