SIUT Centre of Biomedical Ethics and Culture Pakistan December, 2013.pdf · Centre of Biomedical Ethics and Culture “It's my job to figure out what a ... shop for repair ... *Senior

Bioethics Links

Volume 9 Issue 2 December 2013

Centre of Biomedical Ethics and Culture

“It's my job to figure out what aphysician's price is. For some it's dinner at thefinest restaurants, for others it's enoughconvincing data to let them prescribeconfidently and for others it's my attentionand friendship...but at the most basic level,everything is for sale and everything is anexchange.”

This statement is from the testimony ofAhari, a

For many doctors, the MR's visits are theonly way they learn about new drugs. Indiandoctors depend on the MR for information onnew drugs, the indications, the dosages, whythey are better than other similar drugs, and soon. Naturally, this information package istailored to sell the drug, so the benefits areexaggerated , r i sks min imized andcont ra ind icat ions downp layed. Theinformation given by MRs in India will likely bedifferent from what is

1

former sales representative for thepharmaceutical company Eli Lilly, in litigationfiled by two data mining companies againstthe US state of New Hampshire. NewHampshire had enacted a law banning the saleof prescription data to drug companies.

Prescription data tells pharmaceuticalcompanies who the high prescribers of theirdrugs are. In countries like the US, it is easilycompiled through computerized databases. Incountries like India, it may still be collected inperson, by sales or medical representatives,while taking orders from each pharmacy fortheir drugs.

Medical representatives, or MRs, are thekey links between the medical professionaland the healthcare industry. MRs establishrelationships with doctors, pitch thecompany's drugs, plant the brand name in the

doctor's memory cultivate the 'key opinionmakers ' n sum they are the backbone of anUS$ 300 billion industry, an industry whosemarketing budget is one-third of sales revenueand more than twice of what it spends onresearch and development.

The medical representative

and. I

2

Continued on page 6

Centre of Biomedical Ethics and Culture, SIUT, Pakistan Page 1

The Drug Industry and Doctors: An Unholy AllianceSandhya Srinivasan*

*Consulting Editor, Indian Journal of Medical Ethics, freelance journalist and

researcher, India

In the lead article, Sandhya Srinivasan examines ethical issues in physician-pharmaceutical interactions with

particular reference to Pakistan and India, a theme from CBEC’s recent international conference on “Emerging

Ethical Issues” (December 6-7, 2013). Anika Khan’ report on the conference gives an overview of different

sessions while invited speaker, Marisa de Andrade, gives a personal account of her first visit to SIUT. In a different

vein, Aamir Jafarey describes the production and impact of teaching videos. Editor

s

CBEC

Adam’s apples. Lunch for physicians, hosted by

a pharmaceutical company. (Photo courtesy of Dr. Mohsin e Azam)

Pakistan

cbecSIUT

CBEC-SIUT: “The Bridge” over Troubled KarachiMarisa de Andrade*

“Help. Life. Hope. SIUT. Words thatmake a world of difference. Use your Zakat& Donations to reach out to those who can'tafford to live.”

These are the words on the bannerbefore me as I wait for my flight to board atQuaid- -Azam International Airport. When Ilanded in Karachi eight days ago, little did Iknow that I was embarking on a lifechanging journey that would allow me to seejust how these contributions literallybreathe life into the poor ill.

I thought I was going to CBEC SIUT togive a presentation on the 'corporatephysician' and bio-ethical dilemmas in theglobal arena, and gather data for a researchpaper on the interactions between doctorsand the pharmaceutical industry inPakistan. I was actually about to beeducated in emerging ethical issues in thebiomedical arena from world-classpresenters and learn a lot more abouthumanity.

The view from the rooftop terraceoutside CBEC will haunt me forever. I talkincessantly, but for once I was speechless.Men, women, children, babies in makeshifttents were waking up on the pavementsbelow me. There were so many of themliving on the streets, making breakfast innon-existent kitchens; some still sleeping inthe littered lanes. I couldn't quite believethat among them were patients beingtreated at SIUT, who were possibly waitingfor kidney donors or needed dialysis orfollow up treatments on a daily basis. Theothers were with their families, who hadtravelled from afar to be by their sides. Iwondered how it was possible to work for ahospital surrounded by such pain andsuffering and witness this heart-breakingexistence every day. It all became clearwhen I was taken on a tour of the hospital

“This isn't a hospital; this is a

phenomenon.” “This is the only hospital inthe world where you can be treated withdignity if you are poor.” “Welcome to ourhospital.”

As I walked across 'The Bridge' andthrough the wards, I was greeted by smilingemployees who boasted about the place andtook ownership of its successes. Even thechefs raved about the nourishing and tastyfood they served their patients to help themget better quicker.

In the records department, I met humancomputers. They asked a doctor to translatefrom Urdu to English so I could know thatthey'd been there for many years and lovedtheir jobs. About a million patients benefitfrom various SIUT services every year andthese administrators manually input theirdetails into the paper filing system. Thedoctor later told me that if he asks for apatient's file by first name, he's often asked

as they endeavour to rememberthe specifics of each and every patient.Incredible.

It was in the paediatric nephrologydepartment that I was overcome withemotion as a mother of a young child sobbed,and another grasped her

e

-

.

‘which one?’


*Research Fellow, Institute for Social Marketing, University of Stirling, UK

Volume 9, Issue 2 (December 2013)

Bioethics LinksPakistan

cbecSIUT

Continued on page 5

rickshaw driver pushes another

rickshaw to a .

.

Lending a “helping foot”: a

shop for repair (Picture courtesy of DAWN newspaper)


Films and documentaries presentingethical issues are great ways of engaging

, but the perennial challenge is makingthe material relevant to local experience. AtCBEC, we have used videos as teaching aids forseveral years. The success of films as teachingtools convinced us to combine the impact ofvisual media with scripts that highlighted thenuances of ethical dilemmas faced in thisregion.

So far, we have produced six teachingvideos that are being successfully used atCBEC and in institutions across Pakistan and

. Our videos are available forstreaming or download, free of cost from ourwebsite and havebeen in India, Bangladesh, Sri Lanka,USA, Japan Germany

In July, 2013, I was invited to be part of atwo-day workshop in Dhaka at the icddr,b, awell known Bangladeshi research organization.In my four sessions during the workshop, Iexclusively used CBEC videos to initiatediscussion on different topics includinginformed consent, standard of care,vulnerability and scientific misconduct. Thesesessions were extremely well-received and themove from written cases to visual onesinitiated lively discussions. It was interesting to

note the commonality of issues within theregion and the similar ways they areperceived and handled. The CBEC video“Publish or Perish” covering scientificmisconduct seemed to hit a really raw nervesince most participants said they hadexperienced, at first hand, the kind of issuesthat were being portrayed in it.

CBEC film production, from scriptwriting to acting, is the combined effort of alot of novices. What makes this effortworthwhile is the positive feedback we havehad from all over Pakistan and across theworld. At many sites, unknown tous have used them and then provided us withgratifying feedback.

students

internationally

used, and Singapore.

teachers

(www. .org/bioethics)siut



cbecSIUT

Ethics Videos: A New Frontier for CBECAamir Jafarey*

Shooting CBEC’s sixth video, , on ethical concerns relatedto genetic screening within context of Pakistani culture

Hor choopo

Sessions nS ymposium,

Lahore

o Ethics, 12 Internationalhaukat Khanum Cancer S

th

*Associate Professor, Centre of Biomedical Ethics and Culture, SIUT, Karachi

The Symposium held at Shaukat KhanumHospital on November 29-30, featured a wellattended, half day session devoted to bioethics.Organized through the efforts of Dr. MariamHassan, clinical research officer at ShaukatKhanum and CBEC alumnus and Mr. AneelSagar from Shaukat Khanum, invited speakersincluded Dr. Farhat Moazam, Dr. Aamir Jafarey,CBEC alumnus Dr. Natasha Anwar, UK basedresearcher Dr. Marisa de Andrades and Dr.Robyna Khan of Aga Khan University, Karachi.

Dr. Natasha Anwar conducting a session at the symposium.

CBEC's international conference on“Emerging Ethical Issues” was held onDecember 6 and 7, 2013, at SIUT, Karachi.Covering three broad themes, the conferenceexplored different ethical issues in the areas ofpharmaceutical andresearch, geneticand deceased organ donation.

Held o two days, the conferenceattracted a diverse audience of physicians andnon-physicians with a common interest inemerging bioethical challenges. In addition tothe large number of health-relatedprofessionals, there were journalists,scholars, educationists and individuals fromvarious walks of life listen to speakersdiscussing ethical issues both in global andlocal contexts. A highlight of the conferencewas the mix of international speakers, some ofwhom were first-time visitors to Pakistan, andnational speakers, many of whom were alumniof CBEC's Postgraduate Diploma (PGD)program.

On day 1, Dr. David Healy, author of, gave a thought provoking

key-note address aboutthe influence of pharmaceuticals on medicalpractice, and the marketing - not only ofmedication - but of disease. Dr. Healy is aProfessor of Psychiatry at Cardiff University,UK and was visiting Pakistan for the first time,at CBEC's invitation. Also visiting Pakistan forthe first time was Dr. Marisa de Andrade,researcher associated with the University ofSt rling, UK. Dr. Andrade discussed the“Big Pharma” drive for profits with the help of“corporate” physicians in a global scenariowhere markets often consisted of the poor andthe vulnerable. Another international speaker,Ms. Sandhya Srinivasan who is associatedwith the Indian Journal of Medical Ethics andhas written extensively on ethical issues in

global research, spoke about ethical concernsin outsourced clinical trials in developingcountries. The morning session ended with atalk by Dr. Rana Muzaffar, molecular biologistat SIUT and PGD alumnus, who described theincreasing role of contract researchorganisations (CROs) global research andthe resultant ethical .

The post-lunch segment of the conferencecovered emerging ethical issues in the field ofgenetics with talks by three PGDalumni who have remained deeply involvedwith bioethical issues. Dr. Mariam Hassan,researcher at Shaukat Khanum Hospital,Lahore, spoke about genetic screening forhereditary disease

th ethical dilemmasthat arise in her own work, localcontext Dr. Natasha Anwar, oleculariolog at Forman Christian College

University, Lahore discussed ethical issuesarising from biotechnology that enabled themanipulation and copying of genetic material,followed by Dr. Jamshed Akhtar, aediatricurge at

who described the increase inbiobanking, and the ble ethical fallout.

industry health care andscreening and biobanking,

ver

who ed

to a large audience

a

i de

inchallenges

well-attended

s. Drawing upon personalexperience, she spoke of e

withins. a m

b ist

ps on, National Institute of Child Healthin Karachi

possi

Pharmageddon

Centre of Biomedical Ethics and Culture, SIUT, Pakistan

CBEC Conference: “Emerging Ethical Issues”

December 6 and 7, 2013Anika Khan*


Bioethics Links

Page 4

Pakistan

cbecSIUT

Continued on page 5

Dr. David Healy conducting the CBEC Forum “When Interests Conflict:

Physician-Pharmaceutical Interactions,” on December 7, 2013*Senior Lecturer, Centre of Biomedical Ethics and Culture, SIUT, Karachi

s

great live

,

made

:

-

a

donor programsmilieu

ofn h b

d s

on and asked me to check his files withurgency. I was surrounded by sick childrenand felt completely useless. The only thingI could do was nod and smile. They allsmiled back.

Faced with the stark reality that themajority of the patients at SIUT

below the poverty line, it's hard to imaginehow any individual or company could doanything to harm them further and it is thissentiment that I take back with me toScotland. My research interests lie ininvestigating how commercial interestsimpact on public health policy makingsometimes to the detriment of publichea l th . There is ev idence thatpharmaceutical regulations toprotect the interests of patients may beineffective and can be circumvented.

Ineffectual rules or industry self-regulated codes of conduct may create aveneer of respectability in developedeconomies, but are virtually non-existentin the deve lop ing wor ld wheremultinationals flock to conduct clinicaltrials at a fraction of the cost.

In exchange, countries like Pakistanget 'gifts' in the form of corporate socialresponsibility pharmaceutical companiesplant trees in community gardens, whichdisplay their logos, instead of subsidisingmedicine for the poor. These promotionalactivities are classed as philanthropy, butit's when you witness genuine altruismthat you realise what the art of givingwithout flashing the label of charity is allabout.

I'm grateful to everyone at SIUT and inparticular those affiliated with CBEC forreminding me that there are good peoplein this world, and re igniting my passion forresearch in bioethics. I am now convincedthat there can be happiness and hope evenfor those who can't afford to live.

On Day 2 of the conference, Dr. AnwarNaqvi, urologist and Coordinator CBEC,opened the session with talk on organdonation, discussing the development oforgan donation programs in Pakistan andelsewhere, the banning of organ trade inPakistan and the problems faced indeveloping a deceased donor program. Dr.Farhat Moazam then described a studydone by CBEC faculty on local perceptionsabout deceased organ donation anddiscussed the difficulties inherent in thedevelopment of deceasedin the social and cultural of Pakistan.She was followed by Ms. SandhyaSrinivasan who presented the Tamil Nadumodel of deceased donor transplantation.Dr. Aamir Jafarey CBEC ended thesession with his talk on on eart eatingonation and continuing effort to redefine

death for the purpose of getting moreorgans from deceased donors.

The day ended on a cultural note with an'Ethics and Culture Hour' featuring well-known architect and social activist, Dr. ArifHasan, who traced the origins and historicaldevelopment of Karachi and described itsevolution in the last century from a small,orderly port city to a dense city teemingwith millions and battling multipleproblems.

Following the end of the open sessions,a CBEC Forum “When Interests Conflict:Physician-Pharmaceutical Interactions”was led by Dr. David Healywho spoke about the conflict betweenphysicians' duty to patients and theinfluence of the pharmaceutical industry onmedical practice

presented data showing how the resultsof clinical trials could be misrepresented.

on

from Wales, UK,

. Addressing a large groupof participants, he spoke of academic fraudand




cbecSIUT

“Emerging Ethical Issues”from page 4“CBEC SIUT: ‘The Bridge’ over...” from page 2

m

-

:

.

In 2003, the Forum for Medical EthicsSociety in Mumbai conducted open-endedinterviews with 15 senior executives in drugcompanies, 25 chemists and 25 doctors, andfocus group discussions with 36 medicalrepresentatives. The researchers write:

“The study provided a picture of whatmight be described as an

andated in, say, the US or UK.This 'continuing medical education' is

not the only benefit provided by the MR.There are also the small gifts pens,prescription pads and other stationery (withthe names of the company and its drugs).These 'brand reminders' are the basic tool inthe MR's armamentarium. Most doctorsbelieve that these do not influence their ownprescribing. But MRs hand them out for areason when the doctor picks up a pen toscribble out a prescription, s/he gets areminder of the company's brand ratherthan of another, or of a cheaper but equallyeffective

MRs also distribute free samples of thedrug they are promoting. These are a way topopularize the drug and also get feedbackfor further promotional material.

Pharmaceutical promotional practicesrange from brand reminders to prescribe thecompany's drug, to incentives to prescribethat have nothing to do with medicine: aircond i t ioners , wash ing mach ines ,microwaves, cameras, televisions, all-expenses paid trips to conferences orvacation spots, and more.

A survey of US physicians in 2003-2004 found that 94% of those who repliedto the questionnaire reported some type ofrelationship with the pharmaceuticalindustry. 83% had dined at a drugcompany's expense, 78% had accepteddrug samples, 35% had their costs coveredfor professional meetings or continuingmedical education, and 28% had receivedpayments for consulting, giving lectures, orenrolling patients in trials.

Such promotional practices are oftenassociated with high prescribing frequency,higher costs and lower prescribing quality,leading the authors of one review article torecommend that doctors “avoid exposure toin format ion f rom pharmaceut ica l

companies ”

generic.

A report by Consumers International notes:

Building a relationship

A serious concern in South Asia

3

4

… the pharmaceutical industry is poisedto focus on emerging markets, many ofwhich are located in developing countrieswith poor healthcare and insufficientregulatory infrastructure. Trends alsoindicate that a significant portion of thisattention will focus on marketing of drugs,and… doctors are a focus for this activity.

5

Continued on page 7




cbecSIUT

“The Drug Industry and Doctors...” from page 1

The Renee C. Fox Lecture in Medicine,Culture and Society, 2013

The University of Pennsylvaniaorganizes a daylong event each year tocommemorate the many academiccontributions of its Professor Emerita,renowned medical sociologist Dr. Renee C.Fox. The day is used to explore importantissues that lie at the interface of society andmedicine, and culminates with a lecture byan invited guest. The 5 lecture of this serieswas delivered by Dr. Farhat Moazam onOctober 15, 2013. The title of her wellattended talk was “We are the children of ourlandscape: Practicing medicine inPakistan.” In her presentation she used herclinical experience as a surgeon and herethnographic research on kidneytransplantation in Pakistan to highlightcomplex social and ethical issues that cansurface within hierarchical, family centeredand religious societies.

th

unholy alliance: manufacturers, chemists anddoctors conspire to make profits at theexpense of consumers and the public'shealth, even as they negotiate with each otheron their respective shares of these profits.”

In December 2009, the Medical Council ofIndia (MCI) amended its Code of MedicalEthics.

Medical practitioners may not receivegifts (of more than INR 1,000) from drug andhealthcare companies. Nor may they (or theirfamilies) receive or be reimbursed for travel,accommodation or other hospitalityincluding for attending medical educationprogrammes. (The MCI also felt it necessaryto mention that doctors were not permitted toaccept cash.) The code also bans doctorsfrom endorsing any products. Violations areto be punished with a censure or suspension.

Efforts to enforce the code have not beensuccessful. First, the MCI is not viewed as aguardian of medical ethics. Less than a yearafter the amendment, its president wasarrested on charges of corruption.

Second, any efforts to enforce ethicalpractice must contend with the IndianMedical Association (IMA). When the MCIsuspended office bearers of the IMA fortaking INR 22.5 million to endorse productsof PepsiCo and Dabur, the IMA immediatelygot a stay on the suspension.

Third, the industry, which has managedto fight off regulation of its promotionalpractices in India, has its supporters in highplaces. In April 2013, it was learned that theg o v e r n m e n t ' s d e p a r t m e n t o fpharmaceuticals had asked the MCI to amendits code of ethics and permit doctors toaccept three industry-sponsored foreign tripseach year.

The Pakistan Medical and Dental CouncilCode of Ethics is clear that physicians may

not accept gifts of any kind: “No inducement,gift or hospitality which may affect

judgment may be accepted.”( )

The Network for Consumer Protection inPakistan, a member of ConsumersInternational, surveyed 149 doctors, 100medical representatives and 99 medical storepersonnel and found that each doctor met anaverage of seven MRs daily. Doctors are“cultivated” through invitations to seminarsand retreats, sponsorship for conferences,drug launches in five star hotels and more.Gifts and 'incentives' ranged from stationeryto stethoscopes and books, to computers,club membership, air conditioners, cars, cashand home appliances. For some doctors,domestic cattle are an incentive to prescribe.

In Pakistan and India, 70% of healthcareexpenditure is in the private sector, a majorportion of this on medicines. Catastrophichealthcare spending pushes people below thepoverty line.

In these circumstances, doctors musttake special care to refuse favours frompharmaceutical companies. For their patients,it is a matter of life or death.

6

7

8

9

10

11

The Code of Medical Ethics in India

The problem is no different in Pakistan

or be seen

to affect

Conclusion

emphasis added

(References for this article are available in the online

version of Bioethics Links , Volume 9, Issue 2)




cbecSIUT

From fishing village to mega-city: Mr. Arif Hassan, architect and

social researcher, charts Karachi’s evolution at CBEC’s

Ethics and Culture Hour, on December 7, 2013.

“The Drug Industry and Doctors...” from page 6



cbecSIUT

Centre of Biomedical Ethics and CultureSindh Institute of Urology and Transplantation

5th Floor, Dewan Farooq Medical Complex,

Karachi 74200, Pakistan

Phone:(92 21) 3272 6338 Fax:(92 21) 3520 6738

Email: [email protected] www.siut.org/bioethics

Faculty for January 2014 Foundation Module:- Aamir Jafarey: Associate Professor, Centre of Biomedical Ethics and Culture, SIUT

- Anika Khan: Senior Lecturer, Centre of Biomedical Ethics and Culture, SIUT

- Sharmeen Khan: Corporate lawyer, Head of investigative compliance for a pharmaceutical company, Dubai

- Paul A. Lombardo: Professor, Georgia State University College of Law, USA

- M. Khalid Masud: Religious scholar, Member, Shariat Appellate Bench, Supreme Court of Pakistan

- Farhat Moazam: Founding Chairperson and Professor, Centre of Biomedical Ethics and Culture, SIUT

- Mohsin Naqvi: Religious scholar, Chief Consultant, Aga Khan Examination Board, Pakistan

- Bushra Shirazi: Associate Faculty, Centre of Biomedical Ethics and Culture, SIUT

- Abdul Wahab Suri: Member, Board of Studies of Philosophy at the Karachi University

- Arfa Sayeda Zehra: Professor of History, Forman Christian College University, Pakistan

PGD, Class of 2014

Habiba Sharaf Ali

Obstetrician/Gynecologist

ZMH, Karachi

Faiza Bashir

Researcher,

PMRC, Islamabad

Nazli Hossain

Obstetrician/Gynecologist

DUHS, Karachi

Faisal Rashid Khan

Psychiatrist,

AMC, Islamabad

S. H. Kolambage

Critical Care Specialist,

GH, Kalutara, Sri Lanka

Asma Nasim

ID specialist

SIUT, Karachi

Quratulain Omaeer

Basic scientist, Anatomy

Bahria University, Karachi

Ali Raza

Dental Surgeon

FDC, Sheikhupura

Faiz Ahmed Raza

Microbiologist

PMRC, Faisalabad

Altaf Ahmed Talpur

General Surgeon,

LUMHS, Jamshoro

Salman Ahmed Tipu

Urologist

AMC, Islamabad

On December 18, 2013, Drs. Moazam and

Jafarey conducted the first clinical ethics workshop

at KMU for fifty participants including clinicians,

nurses, physiotherapists and students from

Peshawar, Bannu, Kohat and Mardan. Using CBEC

videos and cases led to lively discussions. This

was followed by a CBEC research ethics workshop

for the second batch of Master in Health Research

students of KMU on December 19 and 20.

A

Since 2006, CBEC has successfully run a year long Postgraduate Diploma in Biomedical Ethics program

(PGD) for mid-career level healthcare professionals. In 2009, CBEC introduced a two year Master in Bioethics

program (MBE) for professionals in major primary fields including healthcare, social sciences, education, law, etc.

CBEC’s next academic year for PGD, Class of 2014 and MBE, Class of 2015 begins in January 2014. The

Foundation Module scheduled from January 20 to February 1, lays the grounding for students to understand the

connections of philosophy, religion, law, and humanities with human moral thought, and to begin thinking critically

about different aspects of contemporary bioethics.

CBEC Workshops at Khyber MedicalUniversity (KMU), Peshawar

Foundation Module for the New Academic Year

Documents

SIUT Centre of Biomedical Ethics and Culture Pakistan December, 2013.pdf · Centre of Biomedical Ethics and Culture “It's my job to figure out what a ... shop for repair ... *Senior