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INDIAN JOURNAL OF
MEDIC AL ETHICS
Vol IX No 3 July-September 2012
(incorporating Issues in Medical Ethics, cumulative Vol XX No 3)
www.ijme.in
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Nurturing empathy
The recent focus in the media has been on doctors involved in varieties of
wrongdoing: sex determination tests and illegal abortions, illegal clinical trials
on innocent patients, allowing untrained attendants to do their work criminal
negligence in the disposal of medical waste, and the list goes on. Can healthcare
professionals argue that they are no different from others in an increasingly
corrupt society? No, they are expected to be dedicated, caring, and trustworthy,
no matter what social environment they live in. It is an occupational hazard,
based on the simple fact that medicine is a matter of life and death.
The guilty must be punished. However, the challenge is to nurture ethical
values in members of the profession. One approach is to introduce the medical
humanities into medical education, to open up the mind to imagination and
empathy, to enable one to enter the skin of the other, the patient, and feel
as she or he feels. This issue of IJME has medical humanities as its theme and
its vital importance is explored from the viewpoints of students, clinicians and
teachers, and coordinated by our guest editor, Radha Ramaswamy.
Other articles in this issue cover a range of subjects. Public health professionals
report on the devastation caused by sanctions in Syria. An editorial tackles the
deaths of healthcare workers caught in the cross fire between opposing forces
in war zones. Two studies look at the critical question of informed consent, one
among patients in a service-oriented hospital and the other among nurses
participating in a study, and finds lacunae in both settings. Another study
explores the inclination of nurses to support their patients, even from neglect
by other care givers, and asserts that institutions must support nurses who
advocate for their patients. A comment refutes the charges against a doctor
as false, challenging the tarnishing of a reputation based on insufficient
investigation. Others analyse the inevitable compromises made while framing
mental health laws, or when letting go at the end of life.
Contents
EDITORIALS
REPORT
ARTICLES
COMMENTS
ICMRs Ethical guidelines for biomedical research on human participants: need for clarification..................................................207
N Ananthakrishnan, Shanthi AK
BOOK REVIEWS
Cover: Original painting Clinic by kind courtesy of the artist, Sudhir Patwardhan
[ 141 ]
EditorialS
The noble intention of helping fellow human beings can have consequences that are both risky and life-threatening. Increasingly,
humanitarian health workers and the healthcare system in conflict zones are themselves becoming targets of assault. On January
5, 2012, Dr Khalil Rashid Dale, an International Committee of the Red Cross (ICRC) delegate working as health programme
manager, was abducted by unknown armed men while returning to his residence in Quetta, the capital of Baluchistan province
in Pakistan. While the perpetrators of the abduction maintained intermittent contact with various authorities, the beheaded body
of the kidnapped official was found in an apple orchard on April 29, 2012. It is now being revealed that the motivation for the
abduction and killing could be the ICRCs refusal to pay a ransom. Declining to pay a ransom for abducted staff is consistent with
the ICRCs security policy. Of special significance is the fact that the perpetrators of the crime were aware of the credentials of the
doctor, as he was travelling in a clearly marked ICRC vehicle (1).
Attacks on humanitarian healthcare providers are a less understood aspect of conflict, primarily because they constitute a smaller
proportion of the overall number of violent events. The consequences of these attacks are extremely drastic and disproportionate
in their impact. For instance, in January 2012, Medicins Sans Frontieres (MSF) closed down two major medical centres in the
Hodan district of Mogadishu, the capital of Somalia, following the killing of two staff members. The two 120-bed medical facilities
were the largest of MSFs 13 projects in Somalia. Their closure reduces the organisations presence in Mogadishu by half. Moreover,
according to MSF the facilities served an area with a population of 200,000 and had, since August 2011, treated close to 12,000
malnourished children, and provided measles vaccination or treatment to another 68,000 patients(2).
In the Sudan, MSF ran a primary healthcare centre in the town of Pibor in Jonglei state, and from there established two smaller
outreach clinics in the more remote areas of Lekwongole and Gumuruk, which are only accessible by plane or boat during the
rainy season. In July 2010, an armed group entered the Gumuruk clinic and stole boxes of the ready-to-use therapeutic food with
which MSF treats severely malnourished children. Three days later, more ready-to-use therapeutic food was stolen along with
medical equipment. Then, later in the month, four MSF staff members travelling by boat from Pibor to Gumuruk were robbed by
armed men. Following these three separate security incidents the organisation suspended all activities in Gumuruk and Jonglei
state. Apart from a smallministryof health facility in Pibor town, MSF was the only primary healthcare provider in this part of
Jonglei state, which is home to around 150,000 people (3). Already, a major consequence of the killing of Dr Khalil Rashid Dale
has been the suspension of the ICRCs health projects in Balochistan and the closure of a rehabilitation centre for the physically
challenged, functioning out of the Christian Hospital in Quetta (1).
However, non-state actors are not the only perpetrators of violence against healthcare providers. States themselves have engaged
in numerous acts that obstruct the provision of healthcare. In May 2009, the Sri Lankan army attacked the Mullaivaikal hospital
three times in the space of a week, killing more than 91 persons, including an ICRC worker (4). In June 2011, a police official in
Chhattisgarh accused the MSF and ICRC of facilitating the medical treatment of Maoist insurgents (5).
not outlaw the act of war. Rather, it provides a set of norms or a protection framework to be adhered to by the parties involved in
the conflict. Firstly, medical assistance is viewed as a neutral activity, which should be universally accessible to the wounded, sick
and prisoners of war. Second, these standards impose the duty on warring parties to not interfere with medical care for wounded
or sick combatants and civilians, and not attack, threaten, or impede medical functions (6). Moreover, warring parties must also
permit medical functions to have access to the sick and wounded, refrain from using medical facilities for military purposes, and
spare patients from violence, intimidation, or harassment (6). Lastly, the parties [must] respect principles of medical ethics; they
(the norms) forbid the punishment of medical personnel for adherence to ethical standards of the profession, and outlaw use of
compulsion against health providers to engage in acts that are inconsistent with medical ethics(6).
However, despite the existence of a normative framework enshrined in the Geneva Conventions, healthcare is under threat,
because of the limits to which the norm is internalised by the perpetrators of violent acts. There are certain fundamental
normative assumptions of IHL that are being challenged by the actual conduct of contemporary warfare. As a body of law,
international humanitarian law essentially evolved at a time when states were seen as the primary stakeholders in the conduct
of war. Even though the Addition Protocol II (1977) is applicable to Non-International Armed Conflict (NIAC), it still envisages
this type of conflict as military action which takes place in the territory of a High Contracting Party between its armed forces
and dissident armed forces or other organised armed groups which, under responsible command, exercise such control over a
part of its territory as to enable them to carry out sustained and concerted military operations (7). The last part of the clause
assumes, for instance, that once these conditions are met, the organised armed group will also be in a position to implement
the Protocol. However, in situations of state failure, the conditions of NIAC rarely fit such categorisation. It is extremely difficult
to determine, especially in the case of organised armed groups the degree of responsible command, the extent to which they
exercise control over territory and their ability to carry out sustained and concerted military operations. In many cases armed
actors, whether state or non-state, do not necessarily have fixed hierarchical organisational structures; nor do they actually control
discernible swathes of territory.
This leads us to the issue of implementation of IHL in conflict zones. In most instances, conflicts lead to breakdowns in existing
legal structures and ethical principles. Adherence to international law by armed actors is extremely difficult to enforce in the
absence of any centralised governing authority, this being a hallmark of contemporary conflict processes. For instance in 2010, the
internationally recognised transitional government of Somalia officially controlled a territory of eight square miles in the country,
which was limited to a part of the city of Mogadishu (8). The rest of the city and the country were considered disputed territory,
governed by warlords, militias and rebel groups. Another aspect of protection is that IHL only provides standards of conduct for
warring parties. There is no formal enforcement mechanism by which members of armed groups or state armed forces can be
held criminally accountable for their actions. While IHL can provide the basis of classifying certain acts as war crimes for future
criminal trials, the process of actually trying individuals for war crimes is a distinct political process which requires the creation of
international tribunals, the formulation of stringent rules of evidence and, above all, international commitment to the sustenance
of specific war trials.
Conclusion
The increasing use of force against healthcare facilities and medical personnel is an issue that requires systematic research.
The inescapable aspect of armed conflict is that there is a clear spillover of the political dimension into such a fundamentally
critical and non-aligned arena as health provision. The fact that modern day armed groups and state actors do not conform to
the standards and ethics enshrined in IHL with regard to protection of healthcare provision is echoed in the findings of an ICRC
report titled Healthcare in danger. The report concludes that the means to address this problem do not lie within the healthcare community; they lie first and foremost in the domain of law and politics, in humanitarian dialogue, and in the adoption
of proper procedures by State armed forces (10). However, attributing the solution to the political domain is not enough, as
it dissociates the issue of humanitarian healthcare from its own ethical responsibilities in conflict zones. Seen from the lens of
civilian protection, the onus of the protection of healthcare facilities must not be limited to state and non-state actors. Rather,
serious ethical reflection on the provision of humanitarian healthcare is required, which also takes into account the responsibility
of aid agencies towards vulnerable populations.
References
1. Shahid S. Body of kidnapped ICRC official found. Dawn [Internet]. 2012 Apr 30[cited 2012 Jul 3]; From the newspaper:[about 4 screens].Available from:
http://dawn.com/2012/04/30/body-of-kidnapped-icrc-official-found
2. MSF: Medicins Sans Frontieres [Internet]. New York: MSF; c2012. MSF closes two large medical centers in Mogadishu after killings of staff; 2012 Jan
19[cited 2012 Jul 3];[about 3 screens]. Available from: http://www.doctorswithoutborders.org/press/release.cfm?id=5733&cat=press-release
3. MSF: Medicins Sans Frontieres [Internet]. New York: MSF; c2012. Sudan: security incidents force MSF to suspend activities in Gumuruk; 2010 Jul 30 [cited
2012 Jul 3]; [about 3 screens]. Available from: http://www.doctorswithoutborders.org/news/article.cfm?id=4628&cat=field-news
4. Al Jazeera [Internet]. [place unknown]: Al Jazeera; c2009. Sri Lanka war hospital hit again;2009 May 13[cited 2012 Jul 3]; [about 5 screens]. Available from:
http://www.aljazeera.com/news/asia/2009/05/20095131040721771.html
5. BBC News South Asia [Internet]. UK: BBC; c2012. Bagchi S. Red Cross and MSF accused of helping India Maoists;. 2011Jan 21[cited 2012 Jul 3];[about 4
screens]. Available from: http://www.bbc.co.uk/news/world-south-asia-12247693
6. Rubenstein LS. Bittle M. Responsibility for protection of medical workers and facilities in armed conflict. Lancet [Internet].2010 Jan 23[cited 2012 Jul
3];375:329-40. Available from: http://www.jhsph.edu/sebin/y/h/Rubenstein_ProtectionofMedicalWorkersInConflict_Lancet2010.pdf
7. ICRC: International Committee of the Red Cross [Internet]. Geneva: ICRC;c2005. Protocol Additional to the Geneva Conventions of 12 August 1949, and
relating to the Protection of Victims of Non-International Armed Conflicts (Protocol II,8 June 1977); 1977 Jun 8[cited 2012 Jul 3];8p. Available from: http://
www.icrc.org/ihl.nsf/WebART/475-760004?OpenDocument
8. Dickinson E. How much turf does the Somali government really control? Foreign Policy [Internet]. 2010 Sep 23[cited 2012 Jul 3]. Available from: http://
www.foreignpolicy.com/articles/2010/09/23/how_much_turf_does_the_somali_government_really_control
9. Stoddard A, Harmer A, DiDomenico V. Providing aid in insecure environments: 2009 Update trends in violence against aid workers and the operational
response. HPG Policy Brief 34[Internet], 2009 Apr[cited 2012 May 4]. p 3.Available from: http://www.odi.org.uk/resources/docs/4243.pdf
10. ICRC: International Committee of the Red Cross[Internet]. Geneva: ICRC; c2005. A sixteen country study: healthcare in danger;2011 Jul 3[cited 2012 Jul
3];19p. Available from: http://www.icrc.org/eng/assets/files/reports/4073-002-16-country-study.pdf
Is there a problem?
A 21-year-old senior medical student is standing at the bedside of a patient in a general ward. The intern has been told that it is
important to pick up the patients hand, and look into his face, before asking any questions. He has seen his teacher do this. He
moves his hand stiffly, watches it go towards the patients hand, and pause, and in those few seconds, realises this is not going to
work. He gives up, and asks: Tell me what the problem is.
The young men and women who enter medical colleges in India are of above average intelligence, many are exceptionally bright,
and all yearn to do good. This is largely true, even though our entrance exams do not really test intelligence or aptitude, and these
young people stopped looking beyond physics-chemistry-biology at the age of 13, becoming little more than marks-scoring
machines. Miraculously, many of them survive these battles with their intelligence intact and clinging still to their desire to be of
service. The battle scars are there -- fear lies beneath the cool, dont care surface. There are countless doubts. Am I in the right
place? Am I good enough? But isnt this wrong? What should I do?
Not addressing these questions can be dangerous: to the individual medical student whose doubts gradually vanish, leaving him
numb, or worse, indifferent; to the patient who has to confront an emotionally stunted doctor; to the national healthcare scene
dominated by people who learned to leave their humanity behind years ago.
[ 144 ]
In this issue
We begin this issue with patient narratives. Put the patient first, says Usha Rajaram, who believes that true healing, especially in
cases of serious and long term illnesses, can only happen when the doctor acknowledges the patients need to seek emotional,
and psychological support from the doctor. Sunil Pandya narrates his experiences of the shift from being a neurosurgeon to a
patient, and his newfound perspective on illness, treatment, and hospitalisation.
The voices of medical students are next. The first piece by Jayesh Vira is a plea for help, underlining the undergraduate medical
students struggles to cope with the magnitude of the changes in his life as he enters medical college, and the need to revamp
the curriculum before introducing MH. Anvita Pauranik testifies to how medical education actually contributes to the gradual
erosion of empathy in students, and argues that a course based on the humanities will probably help, if faculty is suitably trained.
Neha Dangayach muses on the contribution of teachers, friends and patients to her evolution as a resident but concludes that a
formal course in the humanities can help medical students evolve into sensitive doctors.
These are voices from the ground. They need to ring in our ears as we ponder curricular changes.
The next set of four articles addresses the big question: Do we need a fundamental change in perspective or just additions to the
current syllabus? Navjeevan Singh graphically describes the oppressive systems suffocating the medical student, and suggests
how some of the challenges to introducing humanities-based programmes may be faced. Krishnakumar offers suggestions for
remedying the tragic disconnect between the realities of the healthcare needs in the country and the professional orientation that
students receive during their medical education Urging doctors to embrace the spirit of MH- of a bold inquiry into themselves
and their patients - Radha Ramaswamy makes a case for a flexible and creative approach to MH. Finally, Rama Jayasundar
[ 145 ]
describes the Ayurvedic approach to patient care, which integrates, instead of fragmenting, the patient, and emphasises wellness
over the cure of an illness.
In forthcoming issues
Future articles on this theme in IJME include: accounts of experiments in MH from four different colleges in India and Nepal that
vary in approach, content and methodology, providing a rich ground for creative and fruitful discussion; doctors narratives about
coping with doubts, guilt, and feelings of incompetence; a guide to curricular issues, and the MCIs thoughts on introducing an
MH programme in the undergraduate medical curriculum.
Preparing for MH
Medical education is the site where we see tremendous possibility for change. We need many and diverse voices to speak to us, so
that we may see what resonates for us.
A whole range of issues will appear before us as we start our journey on the road to MH. From large and abstract questions such
as Is a happier doctor a better doctor?, or Is kindness as important in a doctor as clinical competence? to decisions about the
nitty-gritty of implementation, about making MH courses voluntary or mandatory, about not overloading the already crowded
curriculum, and finding suitable resource persons.
We need to draw on a wide array of disciplines outside of medicine, and identify the inputs needed to challenge students as well
as excite and interest them. The courses need to be relevant to their development as medical professionals, and this relevance
needs to be identified as broadly and deeply as possible.
For example, while choosing literary texts, what kinds of texts do we look for? Is it necessary to identify texts that are directly
about doctors or patients or about illness? This is the more popular, instrumentalist approach to MH. But more and more medical
educators are arguing that all good literature is useful because it keeps the imagination alive (11). When a doctor faces a patient,
he often needs to makes an imaginative leap into the others thoughts and feelings. The same imagination helps him examine
places within himself where his attitudes and beliefs lie, hidden even from himself.
Lest we slip into the comfortable slotting of MH as the soft skills, there is a growing body of scholarship on India in the social
sciences and humanities that MH needs to draw upon (12). This will provide a valuable perspective, provide inputs that will help
medical students approach the ambiguities and dilemmas of their profession in a more informed way, and make them reflective
practitioners.
MH courses can be designed so they also provide opportunities for students to learn from their peers, patients, caregivers and
families. The classes need to be enjoyable, provide a friendly environment for exchange of ideas and debates, and be a safe space
for students to express personal views. A large hall, empty of furniture, where everyone leaves their shoes outside, and sits on the
floor in a circle, can dramatically alter the nature of the communication in the group. Small group discussions rather than lectures,
workshops, projects and presentations, reflection time, and regular oral and written feedback, could be useful features of an MH
course (13).
The approach, always, has to be flexible, and non judgemental. For example, imagine a formulaic communication skills course,
where Step 2 is: Take the patients hand in your own. This is no doubt a profoundly meaningful ritual for patient and healer (14).
Our hypothetical student in the scene described in the opening paragraph of this editorial, might however ask: What if it doesnt
come naturally to me, and I feel awkward picking up the patients hand?To condemn such a response as lack of empathy would
be as wrong as any attempt to teach it as if it were a communication strategy to be picked up mechanically.
Lastly, how does one handle assessment in such courses? Even after inputs from sociology, economics, public health and ethics,
is it possible for a student to give the correct answer to a question on abortion? The hard part for medical educators, and
students, will be to let go of the need for Yes/No answers. The standard kinds of assessments that test factual knowledge will
have to be abandoned, and so will impact studies to measure the effectiveness of such programmes. Does this mean we cannot
know whether these programmes are benefitting us at all? Not true. For, even though we may not be able to define or measure
kindness, we all recognise it when we see it.
Through the articles in this and subsequent issues of this journal we hope to generate questions and discussions such as these,
that will help us see MH for what it can truly be- beyond issues of medical and professional ethics, and beyond prosaically learnt
communication skills.
What next
In August, when the new term begins, lets see colleges take those first bold steps.
[ 146 ]
Call a meeting of everyone - hear students and faculty speak their minds freely on what they struggle with, on changes they
would like to see. Every voice counts.
Whos passionate about change? Who reads beyond medicine? Who has friends in the humanities departments, or hobbies they
would like to bring into the classroom? Form a team.
Let ideas come from everywhere; hierarchies can kill initiative.
Draw up a programme for the year. But let nothing be frozen.
Let Imagination, Flexibility and Fun be the key words.
Announce the first module, talk, screening, workshop. Take feedback always.
Call a meeting every month, after every term, and take stock; be ready to make mid course corrections, if necessary.
Lets try something different from the standard medical education programme.
And, in July 2013, lets all meet to share our MH stories.
Taking the first step, without knowing exactly what awaits us, is perhaps the most difficult. Maybe the real challenge is that
medicine is being asked to open itself to an outsider gaze.
But is there really an outsider here? Are we not united by a common purpose, beyond disciplinary boundaries? MH simply asks
that we reclaim the vision we once had, listen to the voice that whispers in our ears.
As the founder of the Centre for Community Dialogue and Change, I conduct workshops in Theatre of the Oppressed, a popular
community education tool, as part of the medical humanities programme in colleges.
Acknowledgements I am deeply grateful to Dr Amar Jesani and Dr Sunil Pandya for giving me an opportunity to guest edit this
special issue of IJME on Medical Humanities. It has been an amazing and invaluable journey. I am grateful to all the authors who so
readily responded to my request for articles, to all the reviewers, and to Meenakshi DCruz and Sandhya Srinivasan at the IJME for their
friendship and editorial support. I am grateful to my family, who greeted this new madness with their usual nonchalance, to the many
friends who gave generously of their time and ideas, and finally, to all the wonderful people out there doing MH, and writing about it,
from whom I have learnt and continue to learn so much.
References
1. Medical Council of India. Vision 2015 [Internet]. New Delhi: MCI; 2011 Mar [cited 2012 Jun 27]. Available from: http://www.mciindia.org/tools/
announcement/MCI_booklet.pdf
2. Supe AN, Burdick W. Challenges in medical education in India. Acad Med. 2006 Dec;81(12): 1076-80.
3. Zachariah P. Rethinking medical education in India. The Hindu [Internet]. 2009 Sep 9[cited 2012 Jun 27];Opinion: [about 3 screens]. Available from: http://
www.hindu.com/2009/09/09/stories/2009090954430900.htm
4. Snow CP. The Rede Lecture1959 [Internet]. New York: Cambridge University Press;1961 [cited 2012 Jul 4]. Available from: http://s-f-walker.org.uk/
pubsebooks/2cultures/Rede-lecture-2-cultures.pdf
5. Robinson K. Imagination and empathy. Dalai Lama Centers Speakers series event, Educating the heart and mind [Internet]. 2011 Nov 21[cited 2012 Jun
27]. Available from: http://www.youtube.com/watch?v=Yu2zcmb3yAQ&feature=relmfu
6. Medical Council of India. Regulations on Graduate Medical Education 2012 - Medical Council of India [Internet]. New Delhi: MCI; 2012[cited 2012 Jul 7]
Available from: http://www.mciindia.org/tools/announcement/Revised_GME_2012.pdf
7. Shapiro J. A sampling of the medical humanities. J Learning Arts [Internet]. 2006[cited 2012 Jun 27];2(1):Article 1. Available from: http://escholarship.
org/uc/item/58b5h3h9#page-10
8. Shapiro J. Walking a mile in their patients shoes: empathy and othering in medical students education. Philos Ethics Humanit Med. 2008 Mar;3:10.
9. Kirklin D. The Centre for Medical Humanities, Royal Free and University College Medical School, London, England. Acad Med. 2003 Oct;78(10):1048-53.
10. Gupta R, Singh S, Kotru M. Reaching people through medical humanities-an initiative.J Educ Eval Health Prof. 2011;8:5. Epub 2011 May 20. Published
online 2011 May 20.http://dx.doi.org/10.3352/jeehp.2011.8.5 [cited 2012 Jun 27]. Available from: http://jeehp.org/Synapse/Data/PDFData/0144JEEHP/
jeehp-8-5.pdf
11. Verghese A. The Centre for Medical Humanities and Ethics: Q and A with Abraham Verghese [Internet].[date unknown] [cited 2012 Jun 27]. Available
from: http://www.abrahamverghese.com/images/Q-A%20Humanities%20in%20Medical%20Education.pdf
12. Zachariah A, Srivatsan R, Tharu S for CMC-Anveshi Collective Towards a critical medical practice: reflections on the dilemmas of medical culture today.
Hyderabad: Orient Blackswan; 2010.
13. Shankar PR, Piryani RM, Thapa TP, Karki BMS. Our experiences with Sparshanam, a medical humanities module for medical students at KIST Medical
College, Nepal. J Clin Diag Res [Internet]. 2010 Feb[cited 2012 Jun 27];4(1): 2158-62. Available from: http://www.jcdr.net/article_abstract.asp?issn=0973709x&year=2010&month=February&volume=4&issue=1&page=2158-2162&id=642
14. Ted- Ideas worth spreading [Internet]. [place unknown]: Ted; c2012. Abraham Verghese- A doctors touch; 2011 Sep [cited 2012 Jun 27]. Available from:
www.ted.com/talks/abraham_verghese_a_doctor_s_touch.html
[ 147 ]
[ 148 ]
Committee recommendations
The committees recommendations include punishment
of those found guilty of the various violations it lists -- the
companies marketing drugs that are banned in other countries,
the doctors who signed expert opinions for such drugs, and
the officials who gave a rubber stamp of approval to the sham.
The committee also calls for transparency in the approval
process: guidelines on selection of experts, declaration of
conflicts of interest, and experts opinions to be made public.
The committee notes that the current requirement of phase 3
trials on 100 patients, to look at the drugs impact on the ethnic
groups in India, is unscientific and therefore unethical. It is also
viewed by industry as a technicality, a matter of generating
paperwork though even this is bypassed when possible, as
the report reveals. The committee recommends that phase
3 trials in India for approval here have larger, representative
samples to detect any differences in the drugs metabolism in
various ethnic groups, and with more rigorous monitoring.
However, the notion that ethnic diversity is represented through
outward physical characteristics is scientifically questionable.
Nutritionists have suggested that differences in how drugs are
[ 149 ]
trials may not be permitted in the US. For the same reason, it
waived international ethical guidelines when they became
inconvenient to such requirements.
The US FDA is brought into this discussion because its
consequences are felt in India, when industry lays down the
agenda for drug approval and research, such as in encouraging
outsourced drug trials in India. The DCGI accepts data
submitted to the FDA towards marketing approval here. India
does not need to emulate the US FDA. Any suggestion that
money to meet staff and infrastructure shortages come from
industry should be opposed vigorously.
Government response
Many of the committees recommendations along with the
reports findings could result in a regulatory body that is
accountable to the people whose health and lives it is supposed
to protect. Given the extent of wrongdoing documented by the
committee, the findings justify action not only on the 39 cases
it investigated; approval documents for all drugs at least from
2001 to the present must be investigated. Indeed, transparency
at all levels of the approval process is a critical step in making
the organisation accountable to the public. The same is true of
the proceedings of ethics review committees which function as
regulators in drug trials.
However, the governments response to appoint yet
another committee to further investigate the findings do
not give confidence that the report will have an impact on
[ 150 ]
REPORT
132
33
24
18.1
17.1
14
12
164
44
29
20.2
19.3
16
13
482
107
71
65.4
58
45
32
three decades;
comprehensive vaccination coverage;
improved levels of literacy (particularly among women);
plans to address a rising incidence of non-communicable
Year
Egypt
Syria
Jordan
2008
82 (51-130)
46 (20-100)
59( 35-100)
2005
90 (56-150)
50 (22-110)
66 (38-120)
2000
110 (69-180)
58( 26-130)
79 (46-140)
1995
150 (94-240)
77( 34-180)
95(55-170)
1990
220 (130-350)
120(52-290)
110( 64-210)
[ 151 ]
Syria has provided free healthcare to all its citizens with a ceiling
for charges from private providers. The right to comprehensive
health coverage is guaranteed by the constitution with overall
coordination, management and provision of services falling
under the ministry of health. Despite external pressures to
fully commercialise the health sector, 80% of beds in the
country remain in the public sector; for outpatient facilities, a
fee-for-service system had been recently introduced. However,
private providers in the hospital sector have increased by 41%
since the economy was opened up in 2005, posing a threat to
universal access (4).
Price after
sanctions (SP)
1,700
3,100
250
800
13
30
615
675
Cheese 1 kg
80
180
Yogurt 1 litre
35
100
Sugar 1 kg
50
65
290
350
Milk 1 litre
20
55
60
100
Rice 1 kg
40
160
Eggs 30 eggs
80
200
Tea 250 gm
30
45
Tomatoes 1 kg
15
50
Price before
sanctions (SP)
From: http://www.hamafree.com/index.php?name=news&op=view&id=1208
(adjusted to May 2012 rates for rice, milk)
[ 152 ]
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[ 153 ]
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Sickening waste
Officials say a key problem in the area is dowry, and that even
a sugarcane cutter has to pay above Rs two lakh as dowry for
his daughter. Beed district has the lowest male-female sex
ratio among children under the age of six in Maharashtra,
at 801 female against 1,000 male children, according to the
2011 census. The government has responded to the scandal
by forming teams of doctors to tour the cities of Mumbai,
Pune and others to monitor ultrasound centres; by limiting
radiologists to two ultrasound facilities only; and by conducting
raids all over the state on these facilities.
[ 155 ]
Abstract
In this essay I speak about the need to put the patient first when
discussing the relationship between the patient and the doctor.
From my own experience of having been a cancer patient, I argue
that most patients appreciate and feel empowered by knowledge
about their illness if this knowledge is given sensitively. I also try to
explain why doctors need to recognise and respond sensitively to
the patients need to be healed, psychologically, as well, especially
in cases of serious or chronic illnesses.
I would like to talk about the patient-doctor relationship. Its
always talked of as doctor-patient relationship but I think one
needs to look at it from the point of view of the patient. It is
an important relationship when you are ill, perhaps the most
important relationship in your life at that point in time.
I have been ill many times, have undergone many surgeries, and
had lots of interactions with doctors. Besides deriving comfort
and knowledge from them, I have also been very interested in
seeing how they deal with patients.
The power equation between doctor and patient can never
be equal. Clearly, one feels at the mercy of, not just the doctor,
but the whole medical system. One feels like a body that they
are taking care of or, given the degree of specialisation, one
ends up feeling that each is looking at a particular organ, and
how these organs are put together is anybodys responsibility.
That is also because the whole breed of general practitioners
(GP) is becoming extinct. The doctor who takes complete
responsibility for you is a breed that has completely vanished.
Ultimately, its mainly the responsibility of the patient, who has
to look at different aspects of his or her body and decide that it
does work cohesively after all with no help from doctors.
The patient and doctor meet under trying circumstances- at
least as far as the patient is concerned. The context may be
just routine for the doctor. You may have made the choice to
meet the particular doctor. Sometimes, of course, the power of
choice is missing, and you go to the hospital and have to deal
with whoever you meet. The anxiety of the patient is born out
of the inequalities inherent in the situation. This is why its so
important to look at this relationship from the perspective of
the patient.
Im a cancer patient and I have been operated on for breast
cancer twice, with a gap of 18 or 19 years, and both times
it was vital to me that the doctors told me everything. But I
[ 156 ]
[ 157 ]
Abstract
As a neurosurgeon, it was a new experience for me to face the
consequences of an accidental falljust before I underwent simple
spinal surgery for relief from backache. This essaydescribes
how I was affected by the unexpected operations that followed.
The physical pain, the anxieties, small inconveniences and the
relatively free use of drugs such as antibiotics, that I might have
taken for granted in my patients undergoing surgery, now took
on a new meaning for me. My perspective on my illness as patient,
rather than as physician, and the special care given to me by
medical, nursing, and paramedical colleagues weretransforming
experiences. Based on these occurrences, I offer suggestions on
how we can improve our approach to patients.
It may sound ironic that a person who has performed several
spinal operations needed to have three himself in rapid
succession.
The beginning
Over June and July 2011, I developed pain travelling from the
lower back down the left lower limb, with progressive reduction
of the distance I could walk without pain. This was against a
background of longstanding psoriasis with associated changes
in the spinal column. My neurosurgery colleague examined me
and decided that surgery was necessary to relieve pressure on
a spinal nerve. I had expected such findings. As with any other
patient, there was apprehension about the surgery, especially
given my age (71 years). I prepared a document listing my
advance directives for my colleague and handed it over to him.
Briefly, it listed instructions in the event of complications from
anaesthesia or surgery that left me severely brain damaged or
permanently incapacitated. Such a document is not legally valid
in India, but I was confident that he would implement my wishes.
The operation was scheduled for August 29, 2011. My colleague
- to whom I had entrusted myself - sought the help of an
expert in endoscopic spinal surgery, currently practising in
Kolhapur. He kindly agreed to come to Mumbai and perform
the operation in our hospital.
Unexpected twist
The next morning before leaving for the operation theatre I
went to the toilet and emptied my urinary bladder. While
emerging from the toilet, I slipped on the wet floor and fell
flat on my back onto the floor. The central segment of the
spinal column (dorsal spine) bore the brunt of the impact. As
I lay on the floor, in considerable pain, I rapidly checked the
movements and sensations of the limbs and found them
Unwelcome side-effects
After each operation, the antibiotics prescribed caused a loss
of appetite but this was worse after the last operation. For over
13 days, I was unable to consume food. I could manage three
[ 158 ]
glasses of fresh fruit juice and water each day, and at best, a
small bowl of yoghurt. Eating a spoonful of any solid food made
me feel as if I had a huge ball of lead in my stomach. Even after
the antibiotics were stopped, this difficulty in eating persisted
for over a week.
The consequences were obvious. I lost a lot of weight and there
was thinning and weakness of muscles. This was most marked
in the muscles moving the hip and knee joints.
I also found myself choking with emotion with abnormal
frequency. Gratitude at the unfailing courtesy shown by ward
attendants, nurses and doctors; the thoughtfulness of visitors
who brought books for me to read; the plight of a friend whose
wife was being treated in a room two floors below mine for
a serious illness that was eventually to carry her away and
other similar instances brought me to the verge of tears and
I often had to stop in mid-sentence, to avoid embarrassing
myself and those around me. This persisted for some weeks,
even after I returned home. I am not sure about the cause. I
have witnessed it in patients undergoing serious operations,
such as on the heart. I wonder whether, in my case, it followed
a combination of prolonged pain and sleeplessness before
surgery, helplessness in the hospital, the need to rely on others
for help in simple tasks such as bathing, passing urine and
stools, standing and walking. I was also witness to my wife
taking leave from her research for weeks and spending all day
by my side, attending to my needs.
When I was sent home on November 20, I was unable to climb
or descend a single step. I was taken from my room to my
friends vehicle on a wheelchair and lifted manually on to the
seat. On reaching home, I was helped to descend from the car,
placed on a chair and carried on the chair to my bed. You can
imagine my distress at the extent of my disability. Accustomed
to striding effortlessly, climbing several floors and brisk action,
I was reduced to a state where I needed help with the simplest
movement!
[ 159 ]
Some suggestions
Bathrooms and toilets, especially in hospitals and clinics,
must have tiles with surfaces that are not smooth and
reduce the chances of slipping and falling. The ill are
especially prone to such injuries. It is also necessary to
provide firmly anchored bars along the full lengths of the
walls of toilets and bathrooms that can be used by patients
to support themselves.
Looking back
In summing up, I am, surprisingly, not unhappy at having
undergone this experience. It has enriched me in many ways,
most of all by emphasising to me the vast stores of affection
and care available to me. These were lavished on me by my
colleagues in hospital, my wife, my children, other relatives and
friends. I am deeply humbled.
As a consequence of the severe loss of appetite during the last
fortnight or so in the hospital, I have become lean a welcome
development though I would not recommend this as a means
for losing weight!
[ 160 ]
My observations as a student
As an undergraduate, I have observed that the nature of these
[ 161 ]
activities.
patient management.
Once we have a class of students who have experienced such
programmes, they can be a positiveinfluence on their juniors.
Conclusion
These programmes and activities must be introduced in the
first year, building up to advanced training in the later years.
Whether we name these programmes medical humanities
or something else, they need to be relevant and useful to the
student, helping him address the problems which he faces
every day, during his undergraduate years. Only then will he
develop an interest in the medical humanities. And only then
will he be in a frame of mind to learn to be a good doctor.
Abstract
[ 162 ]
[ 163 ]
Abstract
Brought up in the traditional education system in a large teaching
hospital in Mumbai, India, I moved on to do specialisation in
neurology in the United States of America. The Indian system
of pre-medical education mandates early choices between the
humanities and the sciences and thus precludes a more wellrounded development of a student. Though medical humanities
is not taught as a subject as part of the medical curriculum in
India, listening to inspiring and learned teachers and the daily
interaction with scores of patients who are willing to submit
themselves to examination in the cause of medical education
is a humbling experience to a sensitive student. I see similar
willingness in patients in the United States. However, a formal
course in the medical humanities, including arts, literature, and
philosophy will surely enrich the experience of a larger number of
undergraduates and postgraduates learning the core subjects and
help in moulding a more rounded physician.
[ 164 ]
[ 165 ]
Abstract
Understanding the Medical Humanities (MH) and their role in
medical education is in its infancy in India. Students are initiated
into professional (medical) education too early in life, usually at
the expense of a basic grounding in the humanities, resulting
in warped intellectual growth. The author, arguing against the
wholesale import of foreign systems, advocates free inquiry
by medical educators to evolve a humanities programme
for medical students derived from our own cultural context.
This essay describes the early experiences of efforts to make a
beginning at the University College of Medical Sciences, Delhi.
The author reviews the various strategies used and the challenges
of introducing the subject to the current generation of medical
students.
[ 166 ]
examination and then get a job; and then you forget all
about what you have learned. Do you understand what
I am talking about? Isnt that what we all do?
-J Krishnamurti (1)
Background
Why do we need to educate medical students in the
humanities? Let me begin with an outline of the path to higher
education in India. Consider a childs trajectory from early
school to higher professional education. The school-going child
is encouraged to learn by rote. The ability to recite or reproduce
memorised text is rewarded at each step. Little effort goes into
developing the higher cognitive abilities of comprehension,
analysis, synthesis, and evaluation of knowledge.
At barely 15 years of age, the need to make a career choice is
thrust upon the hapless child. Our educational system assumes
precocity beyond the ability of most 15 year olds to decide
career paths for themselves. Perforce, ambitious parents make
the surrogate decision to prepare the child for a professional
career of their choice. Parents may know what is best for their
child in matters relating to food and friends, but they may make
the wrong choice considering the long-term consequences
that a professional career entails. On the other hand, few
adolescents are equipped for such a choice either.
Often, a childs preparation for a professional career begins
with enrolment in a coaching institution whose aim is to
equip aspiring young minds with a solitary skill: how to crack
the entrance examination of their choosing by honing their
ability to memorise. Then follows a hectic round of classes
tailored to the nuances of each separate entrance examination.
For the next four years, from the age of 15 to 18, when these
children should have been discovering themselves and their
world, their likes and dislikes, inclinations and attitudes, they
lead a blinkered existence with the solitary goal of entering
an engineering or a medical college regardless of the aptitude
required for these careers. We, the parents, teachers, and policy
makers, never inquire about our childrens true vocation or
interests. At 18, the rigours and demands of professional
education deny our adolescents the chance to grow, to
understand themselves, to come to terms with the world
around them, and to decide on their own course.
Far from bringing relief, the joy of those who succeed in
entering a professional course is destined to be short-lived.
Soon the realisation comes that the years of self-denial are
going to last a lifetime. The struggle worsens when parental
pressure to perform mounts. Many are told, Now that you are
here, at least continue and finish the undergraduate course.
There is no way out for the unfortunate trapped soul but to
continue. The heavy investments in intense coaching cannot
simply be discarded for a new career choice.
The misery does not end there. Three years into the MBBS
course, the spectre looms again post-graduate admissions
are on the horizon. Then follow another two-and-a-half years
of intense coaching, beginning in a critical phase of the MBBS
[ 167 ]
Medical? humanities
My hope and wish is that one day, formal education will
pay attention to what I call education of the heart. Just
as we take for granted the need to acquire proficiency
in the basic academic subjects, I am hopeful that a time
will come when we can take it for granted that children
will learn, as part of the curriculum, the indispensability
of inner values: love, compassion, justice, and
forgiveness (3).
What is meant by medical humanities (MH)? MH is an
unfortunate term that suggests that medical humanities
are different from the humanities taught in general arts
colleges. Use of this phrase propels us to find a medical angle
to everything that the medical student may have to do with
the humanities. In that sense, it is restrictive, and only serves
to perpetuate the myth that study of the humanities is not
essential to the student of medicine. That the medical students
interest in the performing arts, music, literature, history, culture,
and other similar subjects can only flourish when given a
medical twist is rather irrational thinking. Arguably, if the
learner has a basic foundation in the study of humanities, the
experience can be directed to unravelling the mysteries of
medical relationships. Currently there is a void in the students
minds created by the missing humanities education in their
school and college years. We need to fill this void. To grow, the
learner must be provided with a steady stream of knowledge,
the luxury of choice, and a non-threatening environment.
[ 168 ]
Conclusion
Students entering professional medical education in India are
disadvantaged by the lack of basic education in the humanities.
Introduction
This paper attempts to present a case for serious reforms in
medical education with the primary purpose of sensitising
future generations of medical graduates to what our society
actually needs from healthcare providers. It is not meant to be
a scholarly exploration of how healthcare should be provided
in our country from the point of view of policy makers or
professionals in the field of public health.
The first part of the article will broadly identify the major
failings in healthcare delivery to the average citizen. I will then
try and identify how our present medical education system fails
The core issue that underlies this crisis is that Indian healthcare
is not organised in accordance with societal needs. In most
countries with relatively good human development indices
[ 169 ]
Figure 1: This illustrates an example of the situation with coronary artery disease. Today, it has perhaps emerged as one of our significant problems
affecting a substantial proportion of the population. The disproportionately high compensations offered for procedure-based services contribute to
serious inequity. Most healthcare providers would prefer to be associated with services that offer the most compensation even if their services benefit
a smaller proportion of individuals.
(Cuba, Costa Rica and Sri Lanka are examples), the government
healthcare network supports much of the primary and
secondary level healthcare. This allows delivery of basic services
in accordance with healthcare needs and priorities.
[ 170 ]
Figure 2: This figure attempts to trace the roots of todays dysfunctional healthcare delivery system in India to the failings of its medical education. The
pool of todays doctors contributes to medical schoolteachers of tomorrow. Often the most successful among todays doctors become health policy
makers of tomorrow who then perpetuate the dysfunction.
[ 171 ]
Health systems
Governmental health systems: structure, organisation, and
shortcomings
Alternative providers: private sector, NGOs
Inequity in healthcare
actual impact
Other regulatory authorities: drug controllers, state medical
council
Regulation of hospital and clinics
industry
families
[ 172 ]
Conclusion
The crisis in healthcare in India today stems from a serious
disconnect between healthcare delivery and societal needs,
the roots of which can perhaps be traced back to seriously
flawed medical education. This can only be remedied through a
drastic restructuring, with thoughtful inputs from a wide range
of disciplines that includes sociology, economics, ethics and
public health.
References
1. Balarajan Y, Selvaraj S, Subramanian SV. Health care and equity in India.
Lancet. 2011Feb 5;377( 9764):505-15. Epub 2011 Jan 10.
2. Mahal A, Yazbeck A, Peters D, Ramana GNV. The poor and health service
use in India. Washington, DC: World Bank: 2001.
3. ODonnell O, van Doorslaer E, Rannan Eliya RP, Somanathan A, Adhikari
SR, Harbianto D, Garg CC, Hanvoravongchai P, Huq MN, Karan A, Leung
GM, Ng CW, Pande BR, Tin K, Tisayaticom K, Trisnantoro L, Zhang Y, Zhao Y.
The incidence of public spending on healthcare: comparative evidence
from Asia. World Bank Econ Rev. 2007; 21(1): 93-123.
4. Patil AV, Somasundaram KV, Goyal RC. Current health scenario in
rural India. Aust J Rural Health. 2002;10:12935. doi:10.1046/j.14401584.2002.00458.x
5. Gangolli LV, Duggal R, Shukla A. Review of healthcare in India
[Internet]. Mumbai: Centre for Enquiry into Health and Allied Themes.
2005[cited2012 May13], Available from: http://www.cehat.org/go/
uploads/Hhr/rhci.pdf
6. Yesudasan CAK, Behaviour of the private sector in the health market of
Bombay, Health Policy Plan.1994;9(1):72-80. doi 10.1093/heapol/9.1.72
7. Sengupta A. Medical tourism in India: winners and losers. Indian J Med
Ethics. 2008 Jan-Mar:5(1):4-5.
8. Rangan VK, Thulasiraj RD. Making sight affordable (Innovations case
narrative: The Aravind Eye Care System). Innovations.2007 Fall;2(4):3549.
9. Sethi PK, Udawat MP, Kasliwal SC, Chandra R. Vulcanized rubber foot for
lower limb amputees. Prosthet Orthot Int. 1978 Dec;2(3):125-36.
10. Bhuvaneshwar GS, Muraleedharan CV, Vijayan GA, Kumar RS, Valiathan
MS. Development of the Chitra tilting disc heart valve prosthesis. J Heart
Valve Dis. 1996 Jul;5(3):448-58.
[ 173 ]
Abstract
The need for curricular reforms, long overdue, is felt across the
board by all stakeholders, even if the nature of the needs, and
their articulations from different quarters, might vary. As we try
to address this urgent demand for change, and look hopefully
towards medical humanities as the shape this change might
come in, it is important that we carefully examine some of the
debates around it, and try to create a model appropriate to our
own context.
John Keats
Background
In September 2010, about 100 people, medical teachers
and students, administrators and policy makers gathered in
Mumbai (1) to discuss reforms to the medical curriculum. The
round table revealed a fundamental and glaring feature of
medical education in the country: students who enter medical
colleges with a desire to be good doctors seem to lose belief in
this possibility in the course of their education.
That may seem like a deliberately provocative statement
to make, but that is not the intention. From what students at
this round table shared, and based on formal and informal
interactions with medical students and faculty over the last
year and a half (2), it would appear that the definition of a
good doctor undergoes drastic reshaping in the course of
medical education, mostly resulting in a whittling down of
the comprehensive original image. Often this happens in
deference to what is loosely referred to as the demands of
the time- which includes the strong influence of available
role models, the prevailing medical culture , and the inability
of the curriculum or medical teachers to satisfactorily address
students experiences of anxiety, disillusionment or doubts
[ 174 ]
The preparation
Some suggestions as we prepare ourselves for this unfamiliar
task:
1. A meeting of all students (not just those who will be in
the programme) and interested faculty to brainstorm the
question: Who is a good doctor? Compile a list of qualities
prioritised by the group. This will help give direction to the
process of framing the syllabus.
2. Identify major areas for study. Each person narrates a real
incident from their time in medical college that posed a
conflict, raised questions or created doubts. Generate a list
of unresolved questions and conflicts that plague medical
students through their years of training. This will help
identify issues that an MH programme can address.
3. Set down the objectives of the MH programme, first broadly,
and then more specifically as they will be addressed in a
particular institution. These could include:
a. helping learners to become aware of, and understand
the impact of class, caste, gender, language and other
socioeconomic and cultural factors on illness, how
patients and their families respond to illness, and how
they, as doctors, interact with patients and their families.
[ 175 ]
The programme needs to be learner-centred, and learnerfriendly. Identifying learner needs has to be a continuing
process throughout the course, mandating learner feedback
throughout.
Conclusion
Sir William Osler, one of the greatest medical teachers of all
time, said: The whole art of medicine is in observation
to educate the eye to see, the ear to hear and the finger to
feel(9) The kinaesthetic feel of that statement says it all.
It is high time we learned to integrate the different dimensions
of our personalities. Let us try to be whole, again, as we are
meant to be.
References
1. Wadia LC, Vishwanathan R, Mavani M. Reforms in medical education to
promote accessible and affordable healthcare for all[Internet]. Mumbai:
Observer Research Foundation. 2012 Feb. [cited 2012 Jun 18]. Available
from: http://zeeba.orfmumbai.org/file/read/1911/reforms-in-medicaleducation-to-promote-affordable-and-accessible-healthcare-for-all
2. Centre for Community Dialogue and Change. Promoting theatre of the
oppressed in education [Internet]. Bangalore: CCDC India; c2011-2012.
Workshops; 2012 Jun [cited 2012 Jun 18]; [about 2 screens]. Available
from: http://www.ccdc.in/theater-oppressed-workshops
3. Kirklin D. The Centre for Medical Humanities, Royal Free and University
College Medical School, London, England. Acad Med. 2003 Oct;78
(10):1048-53.
4. Bonebakker V. Literature and medicine: humanities at the heart of health
care: a hospital-based reading and discussion program developed by
the Maine Humanities Council. Acad Med. 2003 Oct;78(10): 963-7.
5. Wellbery C. Do literature and the arts make us better doctors? Fam Med.
2000 Jun;32(6):376-8.
6. Lenahan P, Shapiro J. Facilitating the emotional education of medical
students: using literature and film in training about intimate partner
violence. Fam Med. 2005 Sep;37(8):543-5.
7. Zachariah A, Srivatsan R, Tharu Susie, editors. Towards a critical medical
practice: reflections on the dilemmas of medical culture today. Hyderabad;
Orient BlackSwan; 2010, p ix-x.
8. Shankar PR. A voluntary medical humanities module at the Manipal
College of Medical Sciences, Pokhara, Nepal. Fam Med.2008 JulAug;40(7):468-70.
9. Osler W. The hospital as a college. In: Aequanimitas, with other addresses
to medical students, nurses and practitioners of medicine. Philadelphia: P
Blakiston;1906:327-42.
[ 176 ]
Abstract
Ayurveda, the indigenous medical system of India, has integrated
the concept of interconnectedness into its understanding of health
and disease. It considers the human body as an indivisible whole
with a network of interrelated functions, mind and consciousness,
wherein a disturbance in one part will have repercussions in other
parts as well. The key to health is for these factors to maintain
stability since disease is seen as a perturbation in this network.
Ayurvedic treatment aims not only at removal of disease, but also
at the restoration of the equilibrium of bodily functions.
The centuries-old science of Ayurveda, apart from being a holistic
form of medicine, also clearly defines the student-teacher and
doctor-patient relationship. It sets high ethical standards of
professional and personal integrity for the doctor, teacher and
student. In addition to being technically skilled and well-read in
the science, practitioners of Ayurveda must be compassionate
and empathetic. Students of Ayurveda are taught the importance
of compassionate caring for patients and maintaining personal
integrity.
Introduction
The societal impact of ill health is on the rise, with some
diseases affecting not only the health of individuals but also
that of a nations economy with their increasing healthcare
costs (1). There is a growing consensus that the current system
of healthcare should shift from its technology, doctor and
hospital-oriented approach to a more patient-oriented system
(2-4). It is also being realised by a population weary of synthetic
chemicals (5, 6) that conventional western medicine alone
cannot handle the mushrooming of diseases, underscoring the
need to widen the scope of healthcare to include alternative
medical systems. All these inevitably bring into focus the
patient-centric traditional healthcare medical systems like
Ayurveda. The growing interest in Ayurveda is not only
because it is free of synthetic chemicals, but also because of its
integrated approach to health and disease (7).This article, while
outlining the perspective of Ayurveda, also seeks to highlight
how it approaches the patient as a complex and complete
human being, addresses health and disease from a larger
perspective, and empowers people to be responsible for their
own health. The article also briefly outlines medical ethics as
enshrined in Ayurveda.
[ 177 ]
[ 178 ]
honest.
Students are trained in the skills of observation, reflection,
analysis and understanding of the science, the self and others.
Formal training is considered an essential requirement to be a
physician. However, it is only with years of practice, observation
and constant study that a physician can aspire to be worthy of
the profession. Students are advised that as physicians, they
should never share information about a patient with others
(17a). It is pertinent to note that these values have not only
current relevance but also universal applicability.
Conclusion
As the world faces increasing chronic, psychosomatic stress
and lifestyle-related disorders, medical scientists are beginning
to realise the importance of an integrated approach to health
and healthcare. Ayurveda, with its holistic perspective and
integrated approach to health and disease, emphasis on diet
and lifestyle activities, and time-tested clinical practices can
play an important role in healthcare, especially in India. The
experience and expertise accumulated in Ayurveda over
[ 179 ]
Articles
Abstract
A qualitative study using in-depth interviews was carried out
among patients and doctors working in a private hospital in Tamil
Nadu, to understand perceptions of informed consent. Audiorecorded interviews were transcribed verbatim and a framework
analytical approach was used in analysis. Emergent themes
ranged from perceptions on informed consent, and discussing
health concerns and decision making, to information provided by
and expectations from doctors, and suggestions for improvement.
Most patients were unfamiliar with the kind of information
provided in the informed consent process; a few felt that the
information was inadequate. Decision making about surgery was
left mostly to the doctor. Poor literacy in patients was seen as a
barrier to effective communication by doctors. Developing local
language versions of consent forms supported by audiovisual aids
is needed for patients to take a proactive role in their treatment
process, and for doctors to be receptive to patients needs and
capacities.
Introduction
Informed consent has increasingly become a major topic of
discussion and debate. While the need for client participation
in healthcare decision making has been acknowledged, its
implementation has been varied and individualistic. Haas (1)
says that while some variations in this process are appropriate
as circumstances can differ, others result both from confusion
about these issues and passive resistance to new demands.
Although the informed consent process is followed in most
medical settings, evidence of patients experiences of the
consent process remains limited.
Studies from developing countries show that patients view
written consent as ritualistic and bureaucratic. Some feel
frightened or pressured to give consent (2,3). According
to Moazam (4), the unquestioned authority of the medical
profession and a fatalistic belief among the population about
illness and death leave patients open to exploitation. She
identifies a lack of awareness of individual rights and redress
through the judicial system, which is not easily accessible.
Consequently, the risk of exploitation of patients by healthcare
professionals is real. Perez-Moreno (5) analyses the quality
of information provided prior to anesthaesia and surgery
in 300 patients and found that a majority of patients had
poor knowledge of surgical and anaesthetic risks. Concerns
Methods
A cross sectional study using in-depth interviews was carried
out in the department of surgery of a large private tertiary level
hospital in southern Tamil Nadu. Ethical clearance was obtained
from the Institutional Review Board (IRB) of the hospital.
Using purposive sampling, consenting Tamil speaking adult
patients admitted to undergo surgery and doctors working
[ 180 ]
Analysis
All interviews were audio recorded, and transcribed verbatim.
Those carried out in Tamil were first transcribed verbatim
and then translated into English, to allow for analysis using
a qualitative software. A framework analytical approach was
used for data analysis (9). This process, involving a number
of highly interconnected and iterative stages, began with
data immersion. This was followed by a series of other stages
involving identifying a thematic framework: sifting through
the data, identifying meaningful and relevant quotes; placing
the quotes under the appropriate thematic category; mapping;
and finally interpretation. Each transcript was coded inductively
by two independent researchers (SK and RM). After coding 3
interviews, the coders compared the coding schemes each had
developed, resolved any differences in coding and developed
a common coding framework that was used to code all other
interview transcripts. Once all the interviewswere coded,
segments of text that were related to a common theme were
pieced together and in this manneremergent themes were
identified. The qualitative analysis was done using NVIVO.
Themes of analysis
The themes that emerged were:
Perceptions of informed consent
Information provided by healthcare providers to patients
Perceptions on discussing health concerns and decision
making
Expectations from the healthcare facility/providers
Suggestions for improving consent procedures
Results
Demographic characteristics
[ 181 ]
doesnt matter and that they dont really want to know. They
say, If you say it has to be done, then I will do it.
(Doctor, male, 50)
I keep the patient informed, if they (relatives) dont want me
to tell the patient, then I will not tell them what the disease
is, but I will tell (the patient) everything else. But I do tell the
family members that within 48 hours they need to inform
the patient and that if they do not do so I will. Before the
operation we make sure that the patient knows the diagnosis
and the likely outcome.
(Doctor, male, 55)
Some patients find it difficult to understand the concepts.
For them we draw and show them; I simplify it so they can
understand. We have a generic form which is applicable for all
kinds of operations but issues like the risks, complications we
have to write and fill in the form.
(Doctor, female, 22)
I feel in our country the burden on the doctor is much more
than in other countries. Here quite often the doctor is forced
to decide for the patient. Many patients do not have the
knowledge and they will tell us, You tell me what is the right
thing to do. Most of the time they (patients) dont even know
what procedure they have undergone. They dont know about
complications, they dont even know the diagnosis. Sometimes
it can be extremely difficult.
(Doctor, female, 30)
[ 182 ]
Discussion
Culture and informed consent
The findings from this study revealed that an understanding
of informed consent among the study participants could
at best be termed moderate, but was for the most part
inadequate. Implicit faith combined with a deep and abiding
respect for doctors and the fear that asking questions to the
doctor would be seen as rude behaviour acted as deterrents
to patient participation. These cultural influences cut across
different sections of society and being educated did not
imply being proactive. Interestingly, this implicit faith in the
medical profession (Fig.) is observed in most societies (4,
10,11). Doctors, for the most part, believed in communicating
key issues to patients but often found poor literacy levels
and language barriers prevented effective communication.
Studies carried out in western countries have also shown that
patients understanding of their health condition, prognosis,
treatment and the risks involved were not complete owing
to their cognitive and emotional limitations (11-13). Some
doctors in our study believed that they should advise patients
[ 183 ]
Cultural influences
Faith in doctor/medical facility
Respectful of doctors, afraid to
ask questions for fear of irritating
doctor
Fatalistic acceptance
Dont want to know
Perceptions on importance of
IC
Difficulties in explaining to
patients
I am the doctor I know what is
best attitude
Do not want to unnecessarily
frighten patients
Understanding of
illness /disease
Seeking
information from
doctor
Understanding of
risks, benefits and
rights
Decision making
Diagnosis of
disease
Communication
to patient /family
Explanation of
risks and benefits
Aids in decision
making
Consent obtaining
process- signing the
informed consent form
Informed consent
[ 184 ]
what was actually described. The consent form that was used
consisted of a printed form outlining that the patient was
aware of the potential risks and had consented to surgery.
The meaningfulness of the written consent form has been
debated widely. Studies have shown that many patients do not
read the consent form, primarily because of their preference for
verbal information (3, 18). Many also find it hard to understand.
Most patients in India do not read the form because of poor
literacy. But more typically, it could be attributable to the belief
that the doctor knows best and will not deliberately harm me.
However, the use of visual aids like drawings and sketches
during consultations prior to surgery were found by patients
to be helpful. Research has shown that the use of decision aids
and supplementary educational material during the informed
consent processes improves patients comprehension and is
associated with patients increased knowledge about their
condition, low decisional conflicts and reduced use of elective
procedures (19, 20-22). Perhaps, the use of more structured
visual aids (flip charts, videos) could help patients understand
better, and instil the purpose and value behind getting
involved in their recovery process. This could be the way to go
forward in the future.
Who should obtain consent?
The question of who should obtain consent received a near
unanimous response. Most patients believed that their doctor
was the right person to take them through the consent process
and most doctors agreed with this view. Although it is true that
the consent process usually happens over several sessions,
the fact remains that most doctors work in very busy clinics
and quite often are not able to spend time with patients. For
patients, the need to emotionally connect with doctors, gain
their reassurance and have the doctor come down to their level
and explain the pros and cons in a less hurried atmosphere is
critical. Sanyal et al (23) reported that Indian patients are able
to comprehend and should be informed about the details of
their operation but highlighted that the informed consent
process should be a continuous one rather than a single event.
Physicians at the Temple University in the US identified several
challenges in direct relation to informed consent based on a
review of patient-doctor communications (24). Many of these,
like lack of clinician time, poor patient literacy, and language
and cultural issues, were cited by both the patients and
physicians in our study, which in turn suggests the need for the
development of consent guidelines that are more in keeping
with what patients want.
A limitation of our study was that we did not include a
government hospital or even another private hospital as
a comparison. The selected hospital by virtue of its strong
service-oriented philosophy cannot be considered reflective
of the situation that prevails in other hospitals. However, the
strength of the study lies in the use of qualitative methods,
which allowed patients and doctors to speak freely, thereby
lending credibility to the findings.
Conclusion
The doctor-patient interaction has been widely acknowledged
as an important factor influencing patient health outcomes
(25). Given this, it is imperative that the one-sided doctordominated relationship gives way to a more patient-centric
approach (26). The study findings highlight the need for
patients to take a proactive role in their treatment process, and
for doctors to be receptive to patient needs and capacities,
and provide information that can be easily understood. Such
a participatory relationship where treatment decisions are
made in an environment where patients feel free to air their
concerns, and where doctors understand and respect these
concerns, would be the most appropriate strategy towards
obtaining truly informed consent. This, combined with the
use of more structured visual aids could help patients better
understand the medical/surgical procedures they are about
to undergo. Perhaps, this would help set the stage for the
development of consent guidelines and strategies that are
culturally appropriate and reflect patient needs. As rightly
argued by Doyal (27), despite the potential limitations that
patients may have in understanding clinical information, the
onus is on healthcare providers to improve their methods of
communication, even to the extent of taking recourse to better
educational aids as a means of facilitating the informed consent
process and ensuring better understanding by patients.
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1
6
Abstract
For consent in biomedical research, it is essential that research
participants understand the need for research, the study
protocol, the risk and benefits of participation, the freedom
to participate or decline and the right to leave the study
at any time. A structured questionnaire was used to assess
understanding and knowledge among nursing trainees
participating in a cohort study investigating exposure and latent
tuberculosis at a tertiary care hospital. Data were collected for
138 participants. While 97% were aware of their enrolment into
a research protocol, only 78% could state that it was a study on
tuberculosis. Approximately two-thirds were aware of plans for
blood collection, but not all of them knew the timings or number
of samples. The majority (59%) participants had consulted others
before making the decision to participate, and only 73% felt
that their participation was completely voluntary. Even among
healthcare trainees, emphasis needs to be placed on testing both
the knowledge and understanding of participants to ensure the
principle and practice of truly informed consent.
Introduction
Informed consent is an integral part of ensuring respect for
participants in research. It is essential that research participants
understand the reasons why the research is being conducted,
the study protocol, the risks and benefits of participation and
[ 186 ]
Results
Methods
A cohort study designed by the Department of Pulmonary
Medicine, to study the incidence and prevalence of latent TB
infection in nursing trainees was carried out with institutional
review board and administrative approval at the Christian
Medical College, Vellore in 2008-2009. To initiate the study, the
principal investigator (PI) addressed the entire student body
to explain the concept, followed by separate sessions with
each class. Once again the PI or sub-investigator explained
the basis of the study and the methodology with the help
of a multimedia slide presentation. Their participation was
requested and their right to choose or decline participation
and to withdraw from the trial without citing any reason for
their decision was explained to them. The study described here
was a follow-on study regarding comprehension of informed
consent conducted as described below.
Participants
The total number of participants enrolled in the TB study in
2008 was 436, of which 350 students were present on the
rolls when this study on informed consent approved by the
Institutional Review Board in November 2008, was initiated after
[ 187 ]
135
101
108
88
Awareness of risks of
participation
86
Awareness of benefits of
participation
104
Awareness of freedom to
withdraw
77
Percent
(95% CI)
97.8
(93.8 - 99.5)
73.2
(65 - 80.4)
78.3
(70.4 - 84.8)
63.8
(55.2 - 71.8)
62.3
(53.7 - 70.4)
75.4
(67.3 - 82.3)
55.8
(47.1 - 64.2)
P value*
<0.0001
<0.0001
<0.0001
0.0015
0.0048
<0.0001
0.2015
Discussion
This study shows that even in a healthcare environment, the
understanding of participation in research and the processes
and nature of informed consent among participants can
be insufficient. In educational institutions, students can be
considered a vulnerable group where participation in research
should take place under the strict supervision of institutional
authorities and possibly, an IRB appointed committee to ensure
that participation is voluntary and free from coercion. Whether
data from nursing students at this institution are applicable
to nursing students in other institutions, or students enrolled
in other courses within the same institution, is not clear and
would require larger scale and more detailed studies.
For informed consent to be valid, participants should
understand the risks, potential benefits, procedures, and
alternatives. The International Conference on Harmonisation
(ICH) Good Clinical Practices guidelines list 20 items as essential
[ 188 ]
[ 189 ]
Abstract
This cross-sectional study among nurses at the hospitals of the
Tehran University of Medical Sciences aimed to investigate the
extent of involvement in patient advocacy practice among nurses.
Participants (n=330) were selected using proportionate systematic
random sampling. Data were gathered through patient advocacy
questionnaires and analysed using descriptive/inferential statistics.
The average of nurses patient advocacy practice was 3.848+
0.304 (possible range 1-5). One third of the participant nurses had
high scores in practising patient advocacy, two thirds of them had
scores in the medium range and 0.6% of nurses had low scores.
The majority of nurses (83.5%) declared their commitment to
patient advocacy as high, and 42.5% believed they had enough
ability to practise advocacy. Half of the participants claimed to
have faced problems following advocacy practices. The problems
that most participants reported included conflict with colleagues
and/or superiors, receiving oral/written admonitions, and shift
and/or ward changes. Patient advocacy scores were significantly
higher among female nurses, head nurses, and those who had
more commitment and ability for patient advocacy (p<0.001).
In contrast, nurses who worked in more than one hospital
simultaneously due to financial need (p=0.048), and experienced
conflict with superiors (p=0.047) scored less than others. The
nurses in our study carried out advocacy at acceptable levels and
adopted it as part of their own professional role. Nurses tended to
advocate for patients, but they faced many challenges in this.
Introduction
Nursing advocacy as a core value is a key component of the
professional nursing role (1). In the nursing literature, clients
vulnerability is explained as the main reason for advocacy
action (2). Many studies have shown that medicine has the
potential to restrict the autonomy of individuals, disabling
and dominating over people through bureaucracy, scientific
expertise and technology (3). The majority of patients exhibit
various degrees of vulnerability to such domination by virtue
of their illness, cultural, economic or educational background,
personality, and previous experiences with the healthcare
system.
According to Vaartio and Leino-Kilpi (4), advocacy is an integral
part of the role of professional healthcare practitioners in
promoting the well-being of patients. However, nurses show
greater commitment than other healthcare professionals in
involving themselves in patient advocacy (5, 6). It is suggested
Review of literature
According to Gaylord and Grace (12), nurses feel an ethical
obligation to advocate on behalf of their patients. Moreover,
they frequently describe their decisions and actions on behalf
of patients as being a patient advocate (13, 14). Advocacy has
been described in different ways. It can refer to protecting,
mediating, and acting for patients (15); safeguarding patients
from incompetence or misconduct of other healthcare
professionals (16); asking doctors questions on behalf of
patients, giving information, and maintaining patients privacy
during nursing procedures (17); helping patients to obtain
the necessary healthcare, assuring quality of care, defending
patients rights, and serving as a liaison between patients and
the healthcare system (18); safeguarding patients autonomy,
[ 190 ]
Methods
Design and sample
This cross sectional study was conducted in the hospitals
of the Tehran University of Medical Sciences in 2010. Nurses
with at least one years full-time work experience in clinical
practice and having an associate degree, or higher educational
preparation in nursing, were included in the study. We obtained
completed questionnaires from 330 out of 2,500 registered
nurses working in 14 hospitals, using systematic randomised
sampling according to the number of nurses in each hospital.
A researcher was present at the hospital units and delivered
the questionnaires to the participants. The nurses were
informed of the purpose and process of the study. Completion
of the questionnaires by the nurses was considered as implied
consent of the participants. We continued the sampling process
until the needed sample size was obtained. Thus, if the selected
nurse did not wish to participate or complete the delivered
questionnaire, we randomly selected the next nurse from the
list. The refusal rate was 3%.
[ 191 ]
Study design
A questionnaire was developed based on the literature and
included the results of a previously conducted grounded
theory study on nursing advocacy (11, 29). The questionnaire
consisted of two parts. In the first part (16 items), 13 items
assessed the participants personal characteristics including
their age, gender, marital status, educational level, working shift,
work experience, position, whether they worked overtime on a
regular basis, and whether they had work experience in another
hospital. Two Likert-scale items assessed the commitment of
nurses and their ability for patient advocacy practice. One item
assessed the risks that patient advocacy participants reported
encountering. Nurses were asked to rate their own commitment
and ability for patient advocacy. They were also questioned as
to the consequences they faced in their work environment as
a result of being patient advocates. The second part consisted
of 40 items to assess the patient advocacy practices of nurses.
Some items included in the questionnaire were: giving the
patient information, clarifying doctors comments for patients,
answering patients questions, supporting patients decisions,
helping patients to obtain needed healthcare, devoting time
to listen to patients, protecting patients privacy, and acting
on their behalf. Each question used a five-point Likert scale,
extending from never to always. The possible range of scores
for patient advocacy practices was from 40 to 200. These
acquired scores were then divided by the number of questions,
so that the range of obtained scores amounted to between
one and five. Thus, the average scores of 1 2, 3, and 4 5 were
considered low, medium, and high, respectively.
Age
Frequency
22-30
110
37
31-40
124
41.8
41-53
63
21.2
Missing
33
Sum
330
100
Male
40
12.2
Female
288
87.8
Missing
Sum
330
100
Unmarried
138
42.3
Married
187
57.4
Divorced
0.3
Missing
330
100
1.5
Baccalaureate
degree
309
94.5
Masters degree
13
Missing
330
100
Gender
Marital
status
Ethical considerations
Sum
Associate
degree
Education
Data analysis
The data were analysed using descriptive and inferential
statistics such as independent t-test and one-way variances
(ANOVA) and were presented in frequency tables and crosstabs.
A p-value less than 0.05 was considered as significant.
Results
Data analysis revealed that the participants ages ranged from
22 to 55 years with mean and standard deviation (35.02
7.46). Participants personal characteristics were presented in
Sum
[ 192 ]
Frequency
Percentage (%)
0.6
Moderate
221
67.0
High
107
32.4
Sum
330
100
Low
Position
Capacity
for patient
advocacy
0.6
52
15.9
274
83.5
330
Frequency
Moderate
162
49.8
High
138
42.5
330
100.0
Sum
Experiencing
conflict with
superiors
Missing
Working in
more than
one hospital
100.0
25
3.689
0.313
Female
288
3.870
0.297
Missing
Sum
330
Nurse
255
3.816
0.296
Head
nurse
55
3.976
0.299
Supervisor
15
3.941
0.362
Missing
Sum
330
Low
3.075
0.601
52
3.656
0.279
274
3.892
0.286
Medium
Commitment
to patient
High
advocacy
Missing
Frequency
40
Gender
Degree of commitment
Male
330
Low
25
3.649
0.454
Medium
162
3.802
0.264
High
138
3.936
0.292
Missing
p<0.001
p<0.001
Sum
p<0.001
Sum
330
Yes
32
3.752
0.337
No
293
3.864
0.300
p=0.048
Missing
Sum
330
Yes
82
3.789
0.317
No
241
3.867
0.300
p=0.047
Missing
Sum
Significance
p<0.001
SD
7
330
[ 193 ]
Discussion
Nurses who participated in this study showed high (32.4
%), medium (67.0 %) and low (0.6%) participation in patient
advocacy practices. This finding is similar to the findings of
Ware et al (22) that a majority of nurses are active in patient
advocacy. In addition to this, Davis et al (21) found that 79% of
Japanese nurses have seen themselves as patient advocates. In
contrast to this, Kubsch et al (23) found the participant nurses
were involved in moral-ethical advocacy, meaning that nurses
upheld the patients values in decision-making, more often
than they participated in legal, political, spiritual or substitutive
advocacy (mean 2.83, possible range 15). From this, Kubsch
et al concluded that nurses participation in patient advocacy
was limited. It should additionally be noted that this finding
is also comparable with the findings of the qualitative study
conducted by Negarandeh et al (11, 29) in Iran. This finding is
important because the ICN code of ethics also emphasises
promotion of patient advocacy among nurses (8).
Participants in this study showed a strong commitment to
nursing advocacy. A similar finding was reported in the study
by Davis et al (21). OConnor and Kelly (9) state that professional
responsibility is a key trigger for advocacy. According to Bernal
(30), the primary obligation is to patients, rather than to
physicians or hierarchies within the hospitals. Negarandeh
et al (11) in their qualitative study report that all participants
perceive advocacy as one of their roles and obligations.
Moreover, the participants believed that patients are vulnerable
in hospitals.
As mentioned earlier, most of the participants in our study were
committed to patient advocacy, but only half of them were able
to achieve it. This inconsistency can be justified by the presence
of numerous barriers to patient advocacy in hospital settings.
Hanks (27) also writes that several studies report the work
setting as an influential factor in advocacy. Hellwig et al (18) and
Kohnke (31) believe that the greatest obstacle to advocacy is
the healthcare system itself, because client advocacy is basically
in conflict with the culture of the hospital system. Traditionally,
physicians have had a dominant position in Irans healthcare
system. Simultaneously, the majority of nurses who work in
public hospitals are novices with less than two years of work
experience. As a result, they cannot communicate confidently
with patients or advocate for them. Patients and nurses are
therefore easily placed in difficult situations. Hence, if advocacy
Conclusion
The results of our study reveal that Iranian nurses have an
inclination towards implementing patient advocacy. However,
their contribution as patient advocates is not acknowledged
in the Iranian healthcare system and they encounter multiple
obstacles. These limitations in Iranian hospitals can lead to
poor quality and negligence in care. Nurses should adopt
an advocacy role and act on behalf of patients because they
interact more closely with patients than other healthcare staff.
However, it was noted that the nurses sense of responsibility
for patients motivates them to act as patient advocates in spite
of the existing obstacles.
[ 194 ]
[ 195 ]
COMMENTS
Abstract
An examination of the intersection of legal and medical discourses,
particularly in the realm of mental health legislation, provides
a rich opportunity to clarify fundamental ethical conflicts. This
essay studies one such legal discourse, the draft amendments
to the Mental Health Act (1987), to demonstrate that the realm
of ethical decision-making is constrained not only by pragmatic
administrative, training and financial issues but also by the very
contradictions that are necessarily at the heart of any ethically
conducted project, however well intentioned and reasoned.
This essay will discuss the ethical and conceptual tradeoffs
required in policy-making and practice in legislation over
mental health. While it is accepted that ethical concerns
are central to all sides of the debate, tradeoffs are always
necessary. This is because the ethical domain in itself, contains
contradictions. As a starting point, the essay will use the
draft prepared by Soumitra Pathare and Jaya Sagade of
the Centre for Mental Health Law and Policy, Indian Law
Society, Pune prepared on behalf of the Ministry of Health
and Family Welfare, Government of India (1). Dated May 23,
2010, this document may be taken as a statement of the
contemporary state of affairs. This author is less interested in
taking sides or advocating particular reforms than in using
the recommendations and the Act to raise larger questions on
societal goals and ethical conundrums.
[ 196 ]
[ 197 ]
[ 198 ]
Conclusion
This essay has tried to highlight legitimate ethical dilemmas
where there are no easy answers. The opinions expressed here
are therefore necessarily tentativethat a final horizon of good
health governance would try and recognise the full variety
of human vulnerability, from substance abuse to personality
disorders to prisoner mental health exacerbated by the
institution of the prison. Yet this widening of compassion can
ill afford to belong exclusively to an ivory tower of reformers.
For the reality is that in India, where most patients/users are
in families, or homeless, we need to engage with popular
community perceptions (including fear, disgustand denial)
regarding the mentally afflicted. Of course the community is
not going to sit back and be educated; it will likely resist, or
turn indifferent, or hostile, or plead financial strain. Hence,
resources must be allocated for this battle over accumulated
religious, cultural and social perceptions. At any rate, it is
folly to expect the simple return of the mentally afflicted to
idealised notions of community or family. It is not yet clear if
such idealised notions of nurturing, welcoming communities
or family are the beginning of the problem or the beginning of
the solution.
References
1. Pathare S, Sagade J. Centre for Mental Health Law and Policy, Pune.
Amendments to the Mental Health Act,1987 [Internet]. New Delhi:
Ministry of Health and Family Welfare, Government of India; 2010[cited
2012 Feb 22]. Available from: http://www.wbhealth.gov.in/download/
amendments.pdf
2. Trivedi JK. Mental Health Act: salient features, objectives, critique and
future directions. Indian J Psychiatry [Internet]. 2009[cited 2012 Feb
22];51:11-9. Available from: http://www.indianpsychiatry.org/cpg2009.
asp
3. Sarin A. Amendments to Mental Health Act 1987: key controversies.
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[ 199 ]
[ 200 ]
Conclusion
Wherever clinical trials in India are conducted under
substandard conditions, these must be uncovered and laid
before public scrutiny; and if the facts speak against the
investigator, suitable disciplinary action instituted. This does
not mean that unfounded, misguided or vicious allegations be
propagated by doctors and laypersons in the media. It is time
that a mechanism was laid down for disciplining such vilifiers
for slander and libel.
The lay public does not understand the intricacies of clinical
trials in particular, and many medical matters in general. Editors
of journals (especially those as prestigious as MIMS) and of the
national dailies and TV networks carry a special responsibility
when reporting on them. It is up to them to explain the pros
and cons and double-check their statements. Few of them take
the trouble to contact the individual they are about to place
in the dock to obtain his version of the event(s) or scrutinise
the relevant documents. In the event, they end up accusing
innocent physicians and ruining their reputations.
The statement in an editorial in The Lancet (3) on cancer can be
applied on a wider basis: Many cancer patients are waiting for
new drugs and media reports on clinical trials are increasing.
The effect of mass media on the public is strong. In clinical
trials, specialized knowledge and technology are required.
The associated terms and skills differ from those of general
medicine and are not familiar to the public and the media.
If information on clinical trials is not properly shared among
researchers, patients and media, it can result in chaos
1. Nagarajan R. Indore docs flout clinical trial norms, earn lakhs. Times News
Network [Internet]. 2011Jun 3[cited 2012 Feb 15]. Available from: http://
articles.timesofindia.indiatimes.com/2011-06-03/india/29616513_1_
clinical-trials-quintiles-research-doctors
2. Dixit N. Indore psychiatrists admit to conducting drug trials on mentally
Ill patients. India Today [Internet]. 2012 Jan 23 [cited 2012 Feb 15].
Available from: http://indiatoday.intoday.in/story/indore-psychiatristsadmit-to-conducting-drug-trials-on-mentally-ill-patients/1/170264.
html
3. Yuji K,Narimatsu H,Tanimoto T,Komatsu T,Kami M. Sharing information
on adverse events. Lancet. 2011 May 14;377(9778):1654.
[ 201 ]
Abstract
Debates in India on end-of-life care assumed a new life after the
petition in the Supreme Court in the case of Aruna Ramchandra
Shanbaug, calling for withdrawal of life-sustaining therapy from
a patient in a persistent vegetative state. The Courts landmark
decision has led the way for discussing and developing guidelines
on various situations in end-of- life care. This paper discusses some
key concepts in end-of-life care medical futility, palliative care,
advance directives, surrogate decision making, physician assisted
suicideand euthanasia with reference to the guidelines of
various medical associations and decisions in Indian courts.
At what point does life end in a meaningful way? That is as
ethically and politically fraught a question as: at what point
does life begin? What if the medical professional judges that
treatment is futile or even detrimental to the patients best
interests? And what if the family disagrees with the doctors
judgment? If a patients life has become intolerable, and he
or she freely requests medical assistance to end it, should
such intervention be allowed? Or is it tantamount to murder?
How are such decisions arrived at, balancing the principles of
autonomy, beneficence and non-malfeasance?
Medical futility
The starting point of such discussions is the concept of medical
futility, a notion that may seem abhorrent to many physicians.
However, in the course of caring for a critically ill patient, it
sometimes becomes apparent that further intervention is futile
it will only prolong the dying process.
Clinical paradigms of futile care may often involve life-sustaining
interventions for patients in a persistent vegetative state or
resuscitation efforts for the terminally ill (1,2). It is extremely
difficult to define the concept of futility in a medical context,
where a physician may determine that a therapy will be of no
benefit to a patient and is thus not to be utilised (3). People may
differ on their judgments of the utility, purpose and effectiveness
of an intervention and how the three balance out in medical
affairs (4). Claims of medical futility inherently involve a value
judgment, and an objective, standard definition of futility would
inevitably cause some patients to receive interventions, or to
die, according to judgments with which they may disagree
(5). Efforts continue to arrive at an optimum balance between
the judgment of physicians and the wishes of the patient. Yet a
working definition of the concept is necessary.
The American Medical Association Council on Ethical and
Judicial Affairs has recommended a fair process approach,
[ 202 ]
Advance directives
Advance directives, which empower patients to decide on
future treatments when they may lack the mental capacity
for decision making, have received legal and ethical sanction
for end-of-life care decisions in various countries. The three
general categories of advance directives may be written
statements or documents, oral statements made to providers
or family, or naming a proxy or surrogate to make healthcare
decisions. Healthcare ethics and law in several countries have
recognised these forms of advanced directives as an extension
of a competent persons autonomy, to be used in situations
when a person lacks competence or decision-making capacity.
Written directives have found favour all over the world and
three different types of advanced directives are presently in
practice:
living will an expression of a persons desire regarding their
[ 203 ]
USA, by virtue of its Death with Dignity Act, 1997, which has
now been followed by the states of Washington, Montana and
Hawaii. The Death with Dignity Act has allowed terminally ill
patients to request a lethal dose of drugs, under the condition
that two doctors confirm they have less than six months to live;
a mentally competent adult patient makes one written and two
oral requests at an interval of at least 15 days, and the doctors
are confident that the patient is not suffering from psychiatric
morbidity (39).
Euthanasia was legalised in the Netherlands by the Termination
of Life on Request and Assisted Suicide Act, 2002. The Act
states that euthanasia and PAS are not punishable if the
attending physician acts in accordance with the criteria for
due care; these criteria focuson the request being from a
mentally competent patient with unbearable and hopeless
suffering (40). Subsequently, Belgium followed in the footsteps
of the Netherlands by legalising the practice of euthanasia in
September 2002. However, the point to be noted is that PAS
and euthanasia have been legalised in both these countries
to be practised in very specific cases and under very specific
circumstances. Moreover, each case of euthanasia needs to be
reported to a regulatory commission for retrospective analysis
of compliance with legal provisions.
[ 204 ]
[ 205 ]
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B,Moreno R,Metnitz P;SAPS 3 investigators. End of life care practices in
282 intensive care units: data from the SAPS 3 database. Intensive Care
Med. 2009 Apr;35(4):623-30.
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support: frequency and practice in a Hong Kong intensive care unit. Crit
Care Med. 2004 Feb;32(2):415-20.
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Withholding and withdrawal of life support in intensive-care units in
France: a prospective survey. French LATAREA Group. Lancet. 2001 Jan
6;357(9249):9-14.
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treatment in a Lebanese intensive care unit: a prospective observational
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21;132(6):470-5.
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Inc;1992.
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in Oregon, 2001. N Engl J Med. 2002 Feb 7;346(6):450-2.
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LH. Euthanasia and physician-assisted suicide among patients with
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23;346(21):1638-44.
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127.800-127.897
Available
from:
http://public.health.oregon.
gov/PROVIDERPARTNERRESOURCES/EVALUATIONRESEARCH/
DEATHWITHDIGNITYACT/Pages/ors.aspx
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[ 206 ]
Abstract
The Ethical guidelines for biomedical research on human
participants prepared by the Indian Council of Medical Research
in 2006 came as a welcome step in the process of regulation of
research on human subjects, since clear cut Indian guidelines were
absent earlier. The guidelines have been accepted as the standard
operating manual by Institutional Ethics Committees (IEC) in
India. However, over a period of time, it has become obvious
that the guidelines lack clarity in certain areas and require to be
revised in the light of experiences of members in the IECs. Some of
these problems with the ICMR guidelines have been highlighted in
this paper to press for revision of the manual in the light of these
experiences.
Ethical guidelines for biomedical research on human participants
(1), published by the Indian Council of Medical Research,
is the standard document adopted almost exclusively by
ethics committees supervising research carried out on
human participants in Indian medical institutions. As such,
the guidelines have to be clear and comprehensive, and take
into account the special situation prevailing in the country.
At present, ethical issues in research in India do not get the
attention they deserve, particularly outside major full-time
research organisations. Utmost clarity is required to avoid
difficulties in interpretation, or shades of opinion not intended
by the ICMR. While serving as a member of the institutional
ethics committee (IEC) in several institutions, I have noticed
that there are several issues on which the guidelines are not
clear enough, or appear misleading, or do not give adequate
instructions, leaving scope for different interpretations
depending on individual situations. This comment seeks to
highlight such key issues. The figures in parentheses indicate
the page numbers where the issues are discussed in the ICMR
guidelines.
1. Trials on as yet non-approved drugs (35): The guidelines
state The proposed trial should be carried out, only after
approval of the Drugs Controller General of India (DCGI), as
is necessary under the Schedule Y of Drugs and Cosmetics
Act, 1940. The investigator should also get the approval of
Ethical Committee of the Institution before submitting the
proposal to DCGI. This sequence is wrong and irrational as
it expects the IEC to give approval, even if conditional, for
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[ 209 ]
book reviewS
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[ 211 ]
prayers are even more vital. The Sicilian literary Nobel Prize
winner, Quasimodo Salvatore, summed up the modern man,
Homo modernus et scientificus as Heartless, Loveless, and
Christless. Be it the crumbling West, the struggling Far East, or
the so-called emergent economies of the BRIC group Brazil,
Russia, India, China the GNP runs parallel to Gross National
Perversion in terms of crime, drug addiction, alcoholism, rapes
and murders. On a tiny nuclear scale, Ulhas Jajoo illustrates how
economic gains get rapidly matched by social decay. Given the
clout of money and the media, and of crass commercialism, this
may be the most difficult nut to crack. Gandhiji tried and failed.
The Gujarati poet-educationist Karsandas Manek sized up India
and its Indianness in a haiku, circa 1948.
Oh! Independence
Thou petal of freedom
We dunces
Chewed you up!
That Dr Jajoo has succeeded in rendering as many as 15 villages
healthy, and that too in a sustained holistic fashion, augurs well
for his welcome crusade.
Another title term rural needs elaboration. The inevitable
assumption is that things are alright with the urban areas,
a presumption belied by Indian urbanias fouled up air,
gutterised water, filth all around, food scarce and costly, and
social unrest and crime that seem to be chronically on the
upswing. That the investors and the political powers gleefully
collaborated in describing medical services as the health care
industry automatically gave the profession the right to seek
dollars-in-disease and see patients-as-profit. The kickbacks and
commissions have seen to it that whereas all other commodities
symbolising sophistication: mobiles, laptops, I-pads, computers
and TV screens, DVD players, all progressively come down in
[ 212 ]
[ 213 ]
[ 214 ]
Rodriguez S, Schonfeld TL. The organ-that-must-not-benamed: female genitals and generalised references. Hast
Cent Rep. 2012 May-Jun;42(3):19-21.
[ 215 ]
letters
References
The editorial by Dr Sanjay Nagral on the AMRI fire (1) does not,
amongst other things, point out the complicity of politics (in
this case of the CPI(M) party and the Left Front government)
with the private sector (in this case, the private health sector).
It also does not point out the neglect of the health sector
(retreat of public health institutions) during the three decades
of CPI(M) rule. Both issues have been widely reported by the
media. There is an underlying assumption in the current Left
discourse that the privatisation of the health sector and the
withdrawal of the public sector in health in India is a result of
the LPG (liberalization-privatization-globalization) policy. Here
is the example of both happening under the blessings of a Left
government. This has got implications for social analysis.
Secondly it has taken mostly philosophical analysis to bring
to the fore the power of images. In contemporary times the
work of Jean Baudrillard, amongst others, comes to mind. The
powerful use of images and simulations in late capitalism has
been highlighted by his work. Hence it takes philosophical
analysis and not commonsensical understanding to unearth
the complexity of the enchantment of modernity.
Moreover, many of the questions raised by the author
regarding safety issues and Indian society resonate in existing
analyses (both from the Left and the Right) of the continued
failure of the welfare state in India and the developing world.
The questions raised by the author are very familiar - they
become pertinent only when they indicate the need for a hardnosed class-based analysis and (behind that) a civilisational
analysis of the situation. It is only a complex of rigorous Marxist
analysis and a comprehension of the socio-cultural and moral
trajectory of a society or civilization which can give sensibility
to the questions raised.
Parthasarathi Mondal, Assistant Professor, Centre for the Study
of Developing Societies, Tata Institute of Social Sciences, VN
[ 216 ]
harm than good to the offices of public health they head. Then
only would we be practising true medical ethics in the care of
the community as a whole.
Pankaj Thomas, MPH student, School of Health System Studies,
Tata Institute of Social Sciences, Deonar, Mumbai 400 088, INDIA
e-mail: pankajthomas@gmail.com
References
1. Public Health Foundation of India [Internet]. New Delhi: PHFI; c 20062012. About PHFI. [date unknown];[cited 2012 Jun 13]. Available from:
http://www.phfi.org
2. Medical Council of India (MCI) [Internet]. New Delhi: MCI; c 2010. List
of colleges and courses as per First Schedule of the IMC Act. 2010;
[cited 2012 Jun 13]. Available from: www.mciindia/InformationDesk/
CollegesandCourses
3. Elsayed DEM. Public health and ethics: an overview[Internet]. Sudanese
J Public Health. 2007 Jul [cited 2012 May 14];2(3):146-51. Available from:
www.sjph.net.sd/vol2i3p146-151.pdf
4. Gupta A, Dadhich JP, Faridi MM. Breastfeeding and complementary
feeding as a public health intervention for child survival [Internet].
Indian J Pediatr. 2010 Apr[cited 2012 May 14]; 77(4):413-8. Available
from: www.bpni.org/Article/child-survival
[ 217 ]
[ 218 ]
[ 219 ]
[ 220 ]
Theme
Conference secretariat
Mumbai
Hyderabad
Panchalee Tamulee
Coordinator, Forum for Medical Ethics Society
401, Dalkhania House, B Wing, Behind State Bank of India
Nehru Road, Vakola, Santacruz East
Mumbai 400 055 INDIA. Tel: (91 22) 26406703
[ 221 ]
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