doctor pharma industry interaction

8/14/2019 Doctor Pharma Industry Interaction

1/161

Pharma Major

EthicalDoctor

Physician PharInteraction

Dr. Kishore Kumar UbrangalAssociate Professor,Dept. of Medicine,Yenepoya Medical College,Mangalore, Karnataka, [email protected]

22 Jan 2010

Association of Physicians of IndDakshina Kannada Chapter MeeMangalore


2/161

Doctors and Drug Companie On display in the relati

onship between doctors anddrug companies are thegrandeur and weaknessesof the medical profession- its noble aspirationsandits continuing inabi

lity to fulfill them.

Also on displayare the power, social contributions,

and occasional venality of a very profitableindustrywhose products contribute in importantways to the health and longevity of the (Americapeople but that at times employsmethodsthat aredeeply troubling and even criminal.

Blumenthal, David,The New England Journal of Medicine,351(18), 2004, pp1885-1890


3/161

Doctors and Drug Companie

Governmentalso plays a part as it tries withlimited successto help the profession staytrue to its own tenetsand to deter theindustry's most egregious excesses.

The spectacleis profoundly humanand, likemost such spectacles, seems never to end or

to lose its fascination .

Blumenthal, David,The New England Journal of Medicine,351(18), 2004, pp1885-1890


4/161

Times Of India, 14-01-2010


5/161

Times Of India, 14-01-2010


6/161


7/161


8/161

The 1976Gallup Poll in the US

concluded that doctors werefirst inthe public's perception of honesty aethics; todaythey are fifth.

No such poll has been conducted inIndia, but one thing I am sure of,doctors will not be in the first three.

Dr Narottam PuriExecutive DirectorNew Business DevelopmentMax Healthcare, New Delhi


9/161(CBS)


10/161

Trade vs Profession Medicineis not atrade to be learned, but

a professionto be entered.

A profession is described by a specializedbody of knowledge that its members mustteach and expand, by a code of ethics and aduty of service that put patient care aboveself-interest, and by the privilege of self-regulation granted by society.


11/161

Profession vs Industry(Trade a calling requiring

specializedknowledgeandoften long andintensive academicpreparation

a distinct group ofproductive orprofit-makingenterprises

From Merriam Webster Online; http://www.m-w.com/dictionary


12/161

Pharmaceutical Industry (USA $12-$18 billion annually

Just marketing to physicians (andresidents)

60 million visits annually bypharmaceutical representatives

$1.54 billion on continuing medicaleducations (CME) Papin.K, Oldani M J, Griffiths j : Gifts,

drugs, and theFDA: cross-disciplinaryperspectives on physician-pharmaceuticalinteractions, MedEdPORTAL,AAMC, 200


13/161


14/161

Thousands of Indian companiesproduce70,000 brandsof variousdrug formulations

compared toWHOs list of 250essential drugs.


15/161

Drug PromotionWHO definition:

All informational and persuasiveactivities by manufacturers,distributors to induce / influence thesale and use of medicinal drugs.


16/161

Drug Promotion A drug company's primary interestis to maximizesales of its product.

Physicians do not (or should not) share this goal,

they are the chief conduit for sales. Consequently,physicians have been the central targ

of marketing strategies, and they remain so evenafter the rise of direct-to-consumer marketing.

The pharmaceutical industry spends approximate$12 billion annually on gifts and payments tophysicians.

Studdert, David M.; Mello, Michelle M.; Brennan, Troyen A.The New England Jourof Medicine,351, 2004, pp 1891-1900


17/161Barefootscureamerica.com


18/161Barefootscureamerica.com


19/161


20/161October, 2007


21/161

Indian National Commission onMacroeconomics and Health, 2005


22/161


23/161


24/161


25/161


26/161


27/161

Where there is anirrational drug, then there isbound to beunethical promotion.

The codes which deal with the promotion of drugs: International Federation of Pharmaceutical Manufacturers (IFPMA)

code of Pharmaceutical Marketing Practices- updated in 1994

Criteria for medicinal drug promotion-prepared by World HealthOrganisation (WHO) in 1988

Guidelines on IFPMA Code of Pharmaceutical Marketing Practices-prepared by OPPI.

International Code on Pharmaceuticals-prepared by Health ActionInternational (HAI)


28/161

USABarefootscureamerica.com


29/161

Research spending vsDrug Promotion


30/161

How do doctors keep up withnew medicines?

A study in the UKfound that seniordoctors havent formally studied 85per cent of the drugs they prescribeto patients.

In India, with its 70,000 brandedformulations, the challenge is evengreater !


31/161


How do they decide whether a recent entrant isworth the hefty price tag or find out aboutundesirable side effects?

An study on drug promotion in India, beingconducted by the Forum for Medical Ethics:

indicates that most doctors not only acceptsizable gifts from pharmaceuticalcompanies, but also swallow skewedscientific information.

H d d k i h


32/161


Most rely on medical representatives,intuitionand sponsored conferencesatwhich participants are more interestedin drinking than learning,

Handpicked speakers at conferences andsponsored articles in journals can make

even pedestrian products sound likemiracle cures .

Dr V. Murlidhar of Sion Hospital, Mumbai ,Forum for Medical Ethics, NationalSeminar on Drug Promotion, Mumbai, Sept6, 2003


33/161

Role of medical representative Rather than serving as dispensers of scientific

information, have been reduced to spies andsalesmen.

They routinely strike deals with chemists tofind out what local doctors prescribe, andthen make their calls armed with thisinformation and gifts .

Forum for Medical Ethics, National Seminar on Drug Promotion, Mumbai,Sept6, 2003


34/161

Is your doctor a bunny, wolf,sheepor dodo? !

Classifying people as bunnies, wolves, sheepdodos may sound like a flaky party game.

But it's also serious business. "Medical representatives are sometimes train

to slot doctorsintofour groups:"

Dr Peter Mansfield , founder of Healthy Skepticism (an Australian generalpractioner, who for 20 yea rs has been trying to create global awarenessabout the reality behind the lab- coated facade)


35/161

Bunniesare doctors who care mostabout their patients,

Wolvescare most about money,

Sheepwant to keep up with other doctors, Dodosare those who are burnt out.

Once the doctor's motivation is clear,it's much easier to sell a new drug.

Dr Peter Mansfield, Healthy Skepticism


36/161


37/161

Unethical Drug Promotion-An EmergThreat For The Indian Society

National Seminar on Drug Promotion,Mumbai, India on 6 Sept, 2003

a study on the Promotional Practices ofPharmaceutical Firms in India,conducted by the Forum for MedicalEthics in collaboration with the DrugController General of India and theWorld Health Organisation (WHO)


38/161


Drugs are often promoted through dubious,even unethical practices .

This extends from sponsored conferences infive-stars to high-value gifts like motorcyclesand cars.

There are even cases where pharmacompanies have helped doctors set up smallnursing homes.

Dr Nobhojit Roy, Forum for Medical Ethics, National Seminar on DrugPromotion, Mumbai, Sept6, 2003


39/161


Breakthrough drugs that enter the market early arepromoted through scientific information.

But me too drugs and irrational formulations have tobe pushed vigorously, resulting in excessive sampling,lavish conferences and obscene gifts.

I recently heard of a pharmaceutical company

sponsoring the wedding of a doctors daughter. And itis a matter of time before they give the dowry aswell.

Dr R.K. Sanghvi, Indian Drug Manufacturers Association, National Seminar on DrugPromotion, Mumbai, Sept6, 2003


40/161

Gifts . Influence? "Social science research demonstrates that theimpulse

to reciprocate for even small gifts is a powerfulinfluenceon people's behavior.

Individuals receiving gifts areoften unable to remainobjective.... Receiving gifts is associated withpositivephysician attitudes toward pharmaceuticalrepresentatives. ...

McFadden, David W, Calvario, Elizabeth, Graves, Cynthia,The Devil is in the Details: The

Pharmaceutical Industrys Use of Gifts to Physicians as Marketing Strategy, Journal of Surgical Research , 2007, 140 1-5


41/161


42/161


43/161


44/161

Medical Anthropology Quarterly , Vol. 18, Issue 3, pp. 325356,


45/161

Effects Interaction with pharmaceuticalrepresentative (PR)

Positive perception of PR Formulary requests Prescribing

Gifts Getting gifts associated with attitude that gifts

dont matter High relevance gifts increase positive attitudeto PR

Wayzana, A. Physicians and the Pharmaceutical Industry. Is a gift ever just a giJAMA 2000; 283: 373-380 .


46/161

Effects Samples

Positive attitude toward PR Rapid prescription

Conference travel Increases formulary requests 4-10 fold increase in prescribing rate

Wayzana, A. Physicians and the Pharmaceutical Industry. Is a gift ever just a giJAMA 2000; 283: 373-380 .


47/161

Ex-reps speak outDuring training, I was told, when youre out todinner with a doctor, The physician is eatingwith a friend. You are eating with a client .

Shahram Ahari* The essence of pharmaceutical giftingisbribes that arent considered bribes .

Michael Oldani You are absolutely buying love.

James Reidy *Fugh-Berman A and Ahari S. PLoS Med.2007Apr 24;4(4):e150.

Elliott C. Atlantic Monthly. 2006Apr;297(3):82-93.


48/161

Inducements from pharmaceuticalcompanies to physicians, large orsmall, in any form, shape or size arenothing but a form oflegalizedbribery.

Murad M Khan,Professor & Chairman,Department of Psychiatry,Aga Khan University, Pakistan

Care for an clair?


49/161

Care for an clair?Actually, no, say some doctors to

the tasty ploys of drug reps

Hold on saying no to free goodies? Are thesepeople crazy? Orsome sort of pious upstartstrying to make everyone else look bad?

Especially the food, which after all comes frolocal cafes and restaurants what harm can alittle edible do, in the big scheme of things?

www.northcoastjournal.com/31-01-2008

Th f i l bili


50/161

Theory of unique vulnerabili Existing literature suggests that

doctors hold a range of views aboutgifts:

In generaldoctors readily accept giftsthat are smaller and socially moreacceptable.

Norris, Pauline, Herxheimer, Andrew, Lexchin, Joel and Mansfield, Peter. 2004.Drug Promotion: What we know, what we have yet to learn . WH, pg. 16


51/161

Only other doctors are influencedby gifts.

This theory of unique vulnerabilitysuggests that doctors are more willinto say that other doctors are

influenced more than they arethemselves, but this hypothesiswarrants additional research.

Theory of unique vulnerabilit

Norris, Pauline, Herxheimer, Andrew, Lexchin, Joel and Mansfield, Peter. 2004.Drug Promotion: What we know, what we have yet to learn . WH, pg. 16

Forum for Medical Ethics Society for studen


52/161

Forum for Medical Ethics Society for studenpractitioners and healthcare administrators

2004 In discussions organised in India, the theoryof unique invulnerability was confirmed.

When the audience was askedif going on adrug company-sponsored cruise would affetheir prescriptions towards the companysproduct,

the overwhelming majority saidno.

Roy, N,Who rules the great Indian drug bazaar?Indian Journal of Medical Ethics , 2004Jan-Mar;1(1):2-3.

Theor of niq e lner bilit


53/161

Theory of unique vulnerabilit

When askedif a sponsored cruiseinfluencedthe prescriptionpractices ofat least one doctor

they knew,an overwhelming majority wouldsay yes.

However,patientsdisapprove ofgifts other than samples.

Roy, N, Who rules the great Indian drug bazaar ?Indian Journal of Medical Ethics , 2004 Jan-Mar;1(1):2-3.

Th f i l bili


54/161

Theory of unique vulnerabili Comments from participants suggested a variety of justifications for their responses:

One doctor said that gifts are just a gesture tosay thanks for the time the doctors gives amedical representative.

Lets say, if a doctor sees three patients in 15minutes then the medical representative is justcosting him those three patients in his 15 minutetalk. So the MRs try to compensate by gifts, sinceobviously he cant compensate in cash.

Roy, N, Who rules the great Indian drug bazaar ?Indian Journal of Medical Ethics , 2004 Jan-Mar;1(1):2-3.


55/161


56/161

(Former) Indian President's( Dr. A.P.J. ABDUL KALAM) addresson the eve of Teachers' Day in India,2003 .

Talks about his 3 early teachers in life


57/161

Unsolicited Gift My father Janab AvulPakir Jainulabdeen, as

a teacher: My father taught me a

great lesson when Iwas a young boy. Whatwas that lesson?

It was just after Indiagot Independence.

The day my father waselected President ofRameswaramPanchayat.

Indian President's ( A.P.J. ABDUL KALAM ) address

on the eve of Teachers' Day in India , 2003

Th t th fi t ti I hi g


58/161

That was the first time I saw him very angryand also that was the first time I had got athorough beating from him. I got frightenedand started weeping. My mother embracedand consoled me.

Then my father came and touched myshoulder lovingly with affection and advisedme not to receive any gift without hispermission.



H d I l i H di h hi h


59/161

He quoted an Islamic Hadith, whichstates that, " When the Almighty

appoints a person to a position, Hetakes care of his provision. If a persontakes anything beyond that, it is anillegal gain.

Then he told me that it is not a good

habit.



A gift is always accompanied by some pur


60/161

A gift is always accompanied by some purand a gift is a dangerous thing.

It is like touching a snake and getting the poisonin turn.

This lesson stands out always in my mind evenwhen I am in my seventies. This incident, taughtme a very valuable lesson for my life. It isdeeply embedded in my mind.



I would like also to mention the writings in


61/161

I would like also to mention the writings inManu Smriti which states that " By acceptinggifts the divine light in the person getsextinguished".

Manuwarns every individual againstaccepting gifts for the reason that itplaces the acceptor under an obligation infavour of the person who gave thegift.

and ultimately it results in making a personto do things which are not permittedaccording to law.

Indian President's ( A.P.J. ABDUL KALAM ) address on the eve of Teachers' Day in India , 2003

I am sharing this thought with all of you


62/161

I am sharing this thought, with all of you,particularly the young ones, do not becarried away by any gift which comes wita purpose and through which one loseshis personality greatly.

Do you think, you can follow this in your life?I will be very happy if you can practice thissincerely.



Among the listeners there may be many


63/161

Among the listeners, there may be manyparents, many teachers and a large number ofstudents.

Every one of us in this planet creates a page inhuman history irrespective of who he/she is.

I realize my experience is a small dot in humanlife, but that dot has a life and light. Thislight, let it light many lamps.




64/161

Academic Medical Institution are themselves growing increasingly beholden toindustry....

Some have entered into partnerships with drugcompanies to set upresearch centersand teachingprograms in which students and faculty membersessentially carry out industry research....

When the boundaries between industry andacademic medicine become as blurred as they noare, the business goals of industry influence themission of the medical schoolsin multiple ways....

Dr. Marcia Angell, Editor in Chief, NEJM:342,1516-1518, 2000: Is Academic Medicine for Sale ?


65/161

CME The only people providing meaningful edufor doctors in developing countries are the d

companies,

The problem is: it isbiased education.

Dennis Ross-Degnan, Associate professor at Harvard who studies pharmacepolicy.


66/161

CME Drug Companiespay for 57 per centof American CME costs, either

through direct sponsorship or

exhibitor fees. Thespeakers are often opinion

leaders paid by Big Pharma ,sometimes thousands of dollars permeeting.


67/161

In such pharma-physicianrelationships,its difficult todistinguish between the genuineandthe deceptive, betweenthepursuit of knowledgeandthe

pursuit of profit.


68/161

Theproblem is compounded in most developingcountries bythe marriage of prescription anddispensing.

Sometimes doctors sell medicine to patients. Often, rather than pay doctors fees, patients

ask pharmacists to recommend a drug.

Prescription drugs are sold over the counterfreely and pharmacists find themselves therecipients ofrefrigerators and TVs.

Why the Intense Focus on theT hi I i i b h D


69/161

Why the Intense Focus on theTeaching Institutionby the DrugIndustry

?

Institutions:


70/161

Institutions: Residents/Medical Students ( old habits die

hard); leave institution sold on particularproducts

Centers of Influence (source of Champions,part of sales pitch)

Sales (quotas)

Formularies, protocols, guideline, etc.

Synergy between institution and community

Med Students Exposure to Drug


71/161

Med Students Exposure to DrugCompany Interactions

Lunch 96% Small, non-educational gift 94% Journal reprint 89% Snack 89% Grand rounds sponsored 86%

**Overall exposure is 1 gift or eventper week**Sierles, FS et al. Medical Students Exposure to and Attitudes About Drug Company Interactions .

A National Survey. JAMA 2005; 294: 1034-1042.


72/161

Med Students Attitudes

Grand rounds are educational 89%

Lunch & gifts OK b/c were poor 80%

Learn about new drugs from drug companies71%

Lunch & gifts OK b/c minimal influence 71%


73/161

Med Students Attitudes

School should ban reps 17%

Gifts or food from reps means Illprescribe their drug in future 31%

But fellow med students 43%

Drug company sponsored grand roundsare biased 67%


74/161

Resident Physicians behaviors

Samples influence residentsprescribing practices

Less likely to write-Unadvertised drugs Over the counter drugs

Adair, RF, Holgrem,LH.Do drug samples influence resident prescribing practice? Arandomized trial, The American Journal of Medicine . 2005 (118) 881-884.


75/161

Physicians attitudes

Not to mildly ethically problematic Pencil, pads $40 textbook $500 textbook for resident Dinner speaker w/o product mentioned Free lunch with or without drug

presentation $1000 unrestricted gift to dept

Brett, AS. Burr, W. Moloo, J. Are Gifts from Pharmaceutical Companies Ethically ProblematicSurvey of Physicians. Arch Intern Med . 2003; 163: 2213-2218.


76/161

Physicians attitudes

Mild-moderatelyethicallyproblematic

$40 golf balls Dinner w/product

mentioned favorably

Trip to resort


77/161

Physicians & Patients attitudes

Overall patients found gifts lessappropriate and more influential thanphysicians did.

54% of patients were aware ofpharmaceutical gifts to physicians

Gibbons, RV. Frank, JL. Blouch, DL. Jones, DL. Williams, FK. Lucey, CR. Kroenke, K.A Comparison ofPhysicians and Patients Attitudes Toward Pharmaceutical Industry Gifts . Journal of GeneralInternal Medicine. 1998; 13: 151-154.

Gift not appropriate


78/161

Gift not appropriatePatients Physicians

Trip 59% Dinner 47% Pocketknife 38% Lunch 23% Mug 23%

Drug sample 22% Large text 20% Pen 19%

Trip 75% Pocketknife 49%

Dinner 33% Large text 29% Drug sample 26%

Mug 18% Lunch 10% Pen 4%

Pharma Industry


79/161

Pharma Industry

Pawn in the Game ?

Medical Ethics Conflicts


80/161

Medical Ethics Conflicts. "No profession is more

fundamentally rooted in anethic than medicine".

There is general agreementthat there exists an"inherent conflict ofinterest betweenthephysician's role as atrusted healerand thephysician's role as abreadwinner earning aliving from the medicalknowledge and ministrationsapplied".

American College of Physician Executive Journal of Medical Management (March-April, 2005)

P f i li


81/161

Professionalism Integrity-honesty Excellence

Accountability Altruism Respect Duty

Thoughts onPharmaceutical Companys and Gifts to


82/161

gPharmaceutical Companys and Gifts toPhysicians

It's gotten to the point thatit's impossible notto partake of drug-company largesse when Iattend a conference.

Drug companies underwrite many of the talks, aeven the buses that move us from lecture tolecture at no charge carry ads for popular drugs.

Sure, I'll turn down the theater tickets and boxseats at sporting events and the expensive tours,wine tastings, and meals, butit's impossible notto receive some form of freebie, howeverinadvertent.

Charles Atkins, M. D ., a psychiatrist, freelance writer, and member of the Yale clinical faculty.His novel, The Cadaver's Ball (St. Martin's Press), was released in 2005.


83/161

As I try to distance myself from thepharmaceutical companies,I'mconfronted withcomplex ethicalissues. Or maybe they aren't socomplex, but they make me squirm.

Charles Atkins, M.D ., a psychiatrist, freelance writer, and member of the Yale clinical faculty.His novel, The Cadaver's Ball (St. Martin's Press), was released in 2005.


84/161

Lantern of Diogenes:is Honest Physician"


85/161

gis Honest Physiciana 21st century oxymoron?

Diogenesis the best-known Cynic because hiseccentric ways attracted attention.For one thing, he spent most of his days living

in a barrel just outside the city-state ofCorinth (Greece, 400BC)

Diogenes believed thatpeople were fair and

just only to the extent necessary to obeyrules and laws.He reasoned that there is no such thing as

genuine honesty and integrity.Physician Executive , March-April, 2005 by Richard E. Thompson

Lantern of Diogenes: is "honest physician"


86/161

Diogenesflamboyantly made his point bycarrying a lightedlantern around town in broad daylight.

Curious people would ask, "Why do you need that lan

Diogenes would reply,"I am looking for an honest man.

We cannot summarily dismiss Diogenes' suggestion araving of a lunatic.

In ancient times and ever since,many people who thinkthey act ethically are, in fact, only law-abiding.

Obsession with money reduces the pool of truly ethic

people even further

g p ya 21st century oxymoron?

Lantern of Diogenes: is "honestphysician"21 ?


87/161

"Under the blazing sun of money, all othervalues shine palely , and the hero is thehoncho with the condo and the limo and lotsand lots of dough."

On the TV show, Dallas, someone askedruthless tycoon J.R. Ewing, " What's the secretof your success?"

"There's no secret ," replies J.R. "Heck, onceyou give up integrity, everything else is apiece o' cake."

ga 21st century oxymoron?

Physician INTEGRITY


88/161

Physician INTEGRITY Yes, there is a problem with physician

integrity but it is not of epidemicproportions .

For every doctor on the take, there areseveral who abhor these stains on thehonour of the medical profession .

Is honest physician an oxymoron in the21st Century?

The answer is NO .

Richard Johnson, American College of Physician Executive Journal of Medical Management (March-April, 2005)


89/161

A Paradigmis a set of assumptions, concepts, values, and practicesthat constitutes a way of viewing reality for the community

How a Paradigm is created !


90/161

g

A group of scientists placed 5 monkeys in a cage and in themiddle, a ladder with bananas on the top.

Every time a monkey went up the ladder the scientists


91/161

Every time a monkey went up the ladder, the scientistssoaked the rest of the monkeys with cold water.


92/161

After some time, no monkey dare to go up


93/161

, y g pthe ladder regardless of the temptation.

Scientists then decided to substitute one of the monkeys.The 1st thing this new monkey did was to go up the la


94/161

The 1st thing this new monkey did was to go up the laImmediately the other monkeys beat him up.

After several beatings, thenew member learned not to

climb the ladder

even though never knewwhy.

A 2nd monkey was substituted and the same occurred. The 1 st monkeyparticipated on the beating for the 2 nd monkey. A 3rd monkey was


95/161

participated on the beating for the 2 monkey. A 3 monkey waschanged and the same was repeated (beating). The 4 th was substitutedand the beating was repeated and finally the 5 th monkey was replaced.

What was left was a group of 5 monkeys that even though


96/161

never received a cold shower, continued to beat up anymonkey who attempted to climb the ladder.

If it was possible to ask the monkeys why they would beatup all those who attempted to go up the ladder


97/161

up all those who attempted to go up the ladder..I bet you the answer would be.

I dont know thats how things are done around here Does it sound familiar?

Dont miss the opportunity to share this with others as


98/161

Don t miss the opportunity to share this with others asthey might be asking themselves

why we continue to do what we are doing if there idifferent way out there.


99/161

"Only twothings are infinite: Theuniverse and human stupidity.

And I am not so sure about theformer."Albert Einstei


100/161

A Paradigmis a set of assumptions, concepts, values, and practicesthat constitutes a way of viewing reality for the community


101/161


102/161

OBAMA moving to White House with


103/161


104/161


105/161

No Comments!

AMSA:


106/161

S :American Medical Student Association

Endorses Objective sources of info Opposes

Gifts/gimmicks CME credit for drug company sponsored events Tracking of prescriptions

Believes Physicians remain financially independent of industry

UrgesPhysicians, students residents not take gifts No drug rep lunches No honoraria or compensation for consulting/advising

Supports Curriculum like this

http://www.amsa.org/about/ppp/pharm.cfm

Association of American MediColleges (AAMC) Guidelin


107/161

Colleges (AAMC) Guidelin(2001)

Minimize gifts

Each institution needs explicit guidelinesabout PR interaction

Curriculum on conflict of interest, interplayof MD-Pharm industry, influence ofmarketing

Geppert, CMA. Medical Education and the P harmaceutical I ndustry: A Review of Ethical Guidelines and Their Implications for Psychiat ric Training .A c a d e m i c P s y c h i a t ry 2007; 31:32-39.

American Medical AssociatioG id li Gif Ph i i


108/161

Guideline on Gifts to Physicia Gifts must have benefit to patients

OK if related to work (pens, pads) Textbooks, modest meals OK

CME OK If meets conference criteria To improve patient care

No gifts with strings attachedAmerican Medical Association Policy: E-8.061 Gifts to Physicians from Industry;http://www.ama-assn.org/apps/pf_new/pf_online?f_n=browse&doc=policyfiles/HnE/E-8.061.HTM

AMA guideline


109/161

AMA guidelineSome criticism Very open-ended

Not the most stringent guidelines


110/161


111/161

InternationalFederation ofPharmaceutical ManufacturersAssociations (IFPMA)

Code of Pharmaceutical MarketingPractices (revised in 2006)

IFPMA, 2006P ti l ti iti t b i t t with high


112/161

Promotional activities must be consistent with highethical standardsand information should be designed tohelp health care providers improve services to patients.

Information must be provided with objectivity,truthfulnessand in good taste and must conform to allrelevant laws and regulations.

Claims for therapeutic indications and conditions of usemust be based on valid scientific evidenceand includeclear statements with respect to side effects,contraindications, and precautions.

It also stresses that high standards of ethicalbehaviourshall apply equally tomarketingofpharmaceutical products in all countries, regardless ofthe level of development of their economic and healthcare systems.

60th World Health Assembly May 200


113/161

60th World Health Assembly, May 200

Member governments agreed an importantnew resolution on the rational use ofmedicines.

The resolution included a call on all membergovernments: to enact new, or enforceexisting, legislation to ban inaccurate,misleading or unethical promotion ofmedicines, to monitor drug promotion, anto develop and implement programmes thwill provide independent, non-promotionainformation on medicines.


114/161

New Industry Guidelines:PhRMA f J 2009


115/161

yPhRMA for Jan 2009

No non-educational items (pens, mugs)

No restaurant meals (ok = occ office meal Train reps to abide by regulations

Companies will note whether they intend tofollow these guidelines


116/161


117/161

Pharmaceutical Company Support foContin ing Medical Ed cation


118/161

Continuing Medical Education Continuing medical education (CME),also known asindependentmedical education (IME): Such financial support for CMEis intended to support

education on a full range of treatment options and not topromote a particular medicine.

Accordingly, a company should separate its CME grant-makifunctions from its sales and marketing departments.

Should be a bona fide educational program and that the financialsupport is not an inducement to prescribe or recommend aparticular medicine or course of treatment


119/161


120/161

A companyshould notprovide meals directly

at CME events, exceptthat a CME provider its own discretion maapply the financialsupport provided by acompany for a CMEevent to provide mealfor all participants.

PhRMA CME views


121/161

Since the giving of any subsidy directly to a healthcareprofessional by a company may be viewed as an inappropriate cash

gift, any financial support should be given to the CME provider,which, inturn, can use the money to reduce the overall CMEregist ration fee for all participants .

The company should respect the independent judgment of theCME provider and should follow standards for commercial supportestablished by the Accreditation Council for Continuing MedicalEducation (ACCME)or oth er entity that may accredit the CME.

When companies underwrite CME, responsibility for and controlover the selection of content, faculty, educational methods,materials, and venue belongs to the organizersof theconferences or meetings in accord ance with their guidelines.

The company should not provide any advice or guidance to the CMEprovider, even if asked by the provider, regarding the content orfaculty for a particular CME program funded by the company

Report by Institute of Medicine(partof the National Academy of Sciences


122/161

of the National Academy of SciencesUSA, 2009

A stinging indictment ofmany of the most common means bywhich drug and device makers endear themselves todoctors, medical schools and hospitals.

It is time for medical schools to end a number of long-accepted relationships and practices that create conflicts ofinterest, threaten the integrity of their missions and theirreputations, and put public trust in jeopardy,

IOMs report is even more damning than a similar onereleased last year by the Association of American MedicalColleges, which proposed tough new rules governing

interactions between companies and medical schools.

April 28, 2009

IOM report, 2009; USA


123/161

In the wake of the associations

report, manyschools and medicalsocieties toughened their policies.

With the I.O.M.s endorsement,issues that were once controversialnow are indisputable,

Conflicts of interest in medicine areno longer acceptable.Dr. David Rothman, president of the Institute on Medicineand a Professor at Columbia University

CME Subsidies IOM,20


124/161

CME Subsidies IOM,20 Among the most controversial of the institutesrecommendationsis a plan toendindustry influence

over medical refresher courses.

At present, drug and device makers provide abouhalf of the financing for such courses so thatdoctors can often take them without charge.

Even as they have acknowledged the need forother limits,many medical societies and schoolshave defended subsidies for education asnecessary.

Refresher Medical Courses :Dilemma over Funding


125/161

Dilemma over Funding Dr. Jack Lewin, chief executive ofthe American College of

Cardiology,2009:

As science progresses, its going to getharder and harder to get doctors tokeep pace, I think industry hassome responsibility toward education.

Refresher Medical Courses :Dilemma over Funding


126/161

Dilemma over Funding American Psychiatric Association:it would phase out industry financing for medical

refresher courses at its conventions.

IOM,2009:acknowledged that many doctors depended on

industry financing for refresher medical coursesbut said that the current system of funding isunacceptable and should not continue. The reportrecommended thata different system be createdwithin two years

Industry getaways


127/161

dust y getaways In fact, new, for-profit companies have arisen,called medical education and communicatio

companies, whose purpose is to provideeducational offerings to physicians.

These organizations are sometimessubsidiaries of public-relations firms that alsoconduct advertising for the pharmaceuticalindustry.

Blumenthal, David, Doctors and Drug Companies, The New England Journal ofMedicine,351(18), 2004, pp 1885-1890

Law Agencies enforcing Ethic


128/161

g g The law has begun to annex terrainpreviously controlled by professional ethic.

Andincreasing numbers of hospitals, healthcare systems, medical schools and evenstates are starting to institute restrictivepolicies.

Financial Conflicts of Interest in Physicians' Relationships with thePharmaceutical Industry - Self-Regulation in the Shadow of FederalProsecution Studdert, David M.; Mello, Michelle M.; Brennan, Troyen A, The NewEngland Journal of Medicine,351, 2004, 1891-1900.

China


129/161

U.K.


130/161

June 10, 2009V t hi l li iti d

USA


131/161

Vermont passes sunshine law limiting drug compgifts to doctors

The Vermont law signed this week by Governor JimDouglas, bans drug companiesand manufacturers ofmedical devices and biological products, such asvaccinesfrom paying for gifts, including meals andtravel, to physicians, hospitals, nursing homes,pharmacists, and health plan administrators.

Any allowable payments drug companies make todoctors, such as those for legitimate educationalpurposes, will be posted in a database on a publicwebsite maintained by the Vermont AttorneyGeneral.

Information should be available starting in 2011.

The new law also closes loopholes that


132/161

The new law also closes loopholes thatled to poor compliance of previousVermont transparency legislationenacted in 2002.

A study published in the Journal of theAmerican Medical Association found thatunder the earlier law, 61 percent ofpayments by drug companies were noreleased to the public, and 75 percentof disclosed payments were missinginformation needed to identify therecipient.


133/161

December 03, 2009,


134/161

"Doctors, however, should receive: Items that provide a direct benefit tobenefits such as samples or anatomicalmodelsfor use in examination rooms andthings of value that indirectly benefitpatients by advancing physician learning orlegitimate research goals

Free samples of medicationsand pass themon to their patients, the report said.

December 03, 2009,

New Jersey Real-Time News

Say NO to Gifts..


135/161

Number of doctors are just saying no to drug-company promotions.

Some belong to No FreeLunch, an organizationthat asks doctors totake a pledge not toreceive drug-companyrepresentatives.

Admittedly, theirnumbers are small.

Say NO to Gifts..


136/161

American Medical Student Association (AMSA)hascollected a similar number of pledges among thenation's 68,000 med students, but that's twice asmany pledges as it had a year ago.

Minnesotahas already set limits on gifts, and threeother states are weighing similar bills.

Boston University's medical school, has instituted aban on all gifts and lunches from drug reps and allowsreps to visit only if invited.

Say NO to Gifts..


137/161

Some states are helping physicians intheir rebellion against such tactics.

Pennsylvania, has started somethingcalled an unsales force of trained,non-industry funded drug repswho goaround visiting medical practiceseducating providers about all drugsnew, old, generic.


138/161

AND SUSTAIN Pharma cos agree to code onfreebies


139/161

14 Jan, 2009 Delhi

At a meeting with pharmaceutical secretary,Ashok Kumar,company representativessaid,within a month, they would frame a uniformcode of ethics for the sectorthat will befollowed by all drug companies and theirassociations.

They requested the government to refrainfrom any legal interventionand leave thematter to be sorted out by the pharmacorporate bodies.

Pharma cos agree to code onfreebies


140/161

14 Jan, 2009 Delhi

While industry body, Organization ofPharmaceutical Producers of India (OPPI)had drawn up a code of conduct for marketingdrugs two years back, the IndianPharmaceutical Alliance (IPA)and otherassociations will now frame formal ethicalnorms.

If a member-company is found violatingthiscode, punitive actionwill be taken against it,sources said.

Till now, associations like OPPI and Indian DrugManufacturers Association (IDMA) have an

ti l d h h h t i


141/161

( )operational code, which has given rise to certain

grey areas andscope for misuse.

Significantly, for companies that violate theseregulations, there is a " public disclosure norm",which will disclose the errant companiesname,the drug involved and nature of complaints, all the associations' websites."This will be a great deterrent for violators as it

will tarnish their reputation and brand, which, ifthey deal globally, will have a multiplier effect,"the industry official stated

29Nov


142/161

Regulations, 2002

2009

TNN 11 December 2009


143/161

NEW DELHI:Pharma industry has submitted aself-regulatory code of conduct to the governmentthat curbs unethical sales promotion andmarketing expenses, bans non-medical and persogifts, payments in cash, freebies and all-expensepaid junkets for doctors and their families.

Industry body Organization of PharmaceuticalProducers of India (OPPI)has drawn up a code onthe insistence of government, which was concernedabout increase in unethical marketing practices andprescription drug promotions by pharma companies.


144/161


145/161


146/161

MEDICAL COUNCIL OF INDIANOTIFICATIONNew Delhi, the 10th December, 2009


147/161

No.MCI-211(1)/2009(Ethics)/55667

In exercise of the powers conferred bySection 33 of the Indian MedicalCouncil Act, 1956 (102 of 1956), the

Medical Council of India with theprevious sanction of the CentralGovernment, hereby makes the followingRegulations to amend the IndianMedical Council (Professional Conduct,Etiquette and Ethics) Regulations, 2002:



148/161

, ,No.MCI-211(1)/2009(Ethics)/55667

1. (i) These Regulations may be called the IndianMedical Council (Professional Conduct, Etiquettand Ethics) (Amendment) Regulations, 2009 -Part-I.(ii) They shall come into force from the date oftheir publication in the Official Gazette.

2. In the Indian Medical Council (Professional Conduct,Etiquette and Ethics) Regulations, 2002, thefollowing additions/modifications/deletions/substitutions, shall be, as indicated therein: -3 The following clause shall be added after clause6.7:-


( ) ( h )


149/161

No.MCI-211(1)/2009(Ethics)/55667

6.8 Code of conduct fordoctors and professionalassociation of doctorsin their relationship withpharmaceutical and allied health sector industry: 6.8.1 In dealing with Pharmaceutical and allied

health sector industry, a medical practitioner shalfollow and adhere to the stipulations given below:-

a) Gifts:

A medical practitionershall not receive any giftfromany pharmaceutical or allied health care industryand their sales people or representatives.


( ) 00 ( h )


150/161

No.MCI-211(1)/2009(Ethics)/55667

b) Travel facilities:A medical practitioner shall not accept anytravel facility inside the country or outside,including rail, air, ship , cruise tickets, paidvacations etc. from any pharmaceutical orallied healthcare industry or theirrepresentatives for self and family membersfor vacation or for attending conferences,

seminars, workshops, CME programme etc as adelegate .


N MCI 211(1)/2009(E hi )/55667


151/161

No.MCI-211(1)/2009(Ethics)/55667c) Hospitality:

A medical practitioner shall not accept individually any hospitalitylike hotel accommodation for self and family members under anypretext.

d) Cash or monetary grants:A medical practitioner shall not receive any cash or monetary

grants from any pharmaceutical and allied healthcare industryfor individual purpose in individual capacity under any pretext.

Funding for medical research, study etc . can only be receivedthr ough approved institutions by modalities laid down by law /rules / guidelines adopted by such approved institutions, in atransparent manner . It shall always be fully disclosed.


152/161

MEDICAL COUNCIL OF INDIANOTIFICATION

New Delhi, the 10th December, 2009


153/161

New Delhi, the 10th December, 2009

Thus, in accepting such a position a medical practitionershall:-(i) Ensure that the particular research proposal(s) has the due

permission from the competent concerned authorities .

(ii) Ensure that such a research project(s) has the clearance ofnational/ state / institutional ethics committees / bodies.

(iii) Ensure that it fulfils all the legal requirements prescribed formedical research.

(iv) Ensure that the source and amount of funding is publiclydisclosed at the beginning itself .


N MCI 211(1)/2009(Ethi )/55667


154/161

No.MCI-211(1)/2009(Ethics)/55667

(v) Ensure that proper care and facilities areprovided to human volunteers, if they are necessaryfor the research project(s).

(vi) Ensure that undue animal experimentationsarenot done and when these are necessary th ey are donein a scientific and a humane way.

(vii) Ensure that while accepting such an assignment a

medical practitioner shall have the freedom topublish the results of the research in the greaterinterest of the societyby inserting such a clause inthe MoU or any other document / agreement for anysuch assignment.


N MCI 211(1)/2009(Ethi )/55667


155/161

No.MCI-211(1)/2009(Ethics)/55667

f) Maintaining Professional Autonomy:

In dealing with pharmaceutical and alliedhealthcare industry a medical practitionershall always ensure that there shall never beany compromise either with his / her ownprofessional autonomy and / or with theautonomy and freedom of the medicalinstitution.


N MCI 211(1)/2009(Ethi )/55667


156/161

No.MCI-211(1)/2009(Ethics)/55667

h) Endorsement:

A medical practitioner shall not endorse adrug or product of the industry publicly.

Any study conducted on the efficacy orotherwise of such products shall be presentedto and / or through appropriate scientificbodies or published in appropriate scientific

journals in a proper way.



157/161

. g) Affiliation:

A medical practitioner may work for pharmaceutical and alliedhealthcare industries in advisory capacities, as consultants, asresearchers, as treating doctors or in anyother professionalcapacity.

In doing so, a medical practitioner shall always:(i) Ensure that his professional integrity and freedomare

maintained.

(ii) Ensure that patients interest are not compromised in any way.(iii) Ensure that such affiliations are within the law .

(iv) Ensure that such affiliations / employments are fullytransparent and disclosed .

Lakshman Rekha


158/161

One must remember that ethics, likebeauty, lies in the eye of thebeholder.

In the end, it is up to the individualdoctorto decide the boundaries thatprevent the damage to the patient,profession and society at large .

ETHICS IN DEALING WITH PHARMA INDUSTRIESDr. Shubhangi R. Parkar, Dr Trupti F Koli,

Dept of Psychiatry Seth G S Medical College & K E M Hospital Parel Mumbai

Doctor Industry Relationship : Changing scenar


159/161

Doctor Industry Relationship : Changing scenar


160/161

If the one who decides does not pay,and the one who pays does not decide,

will truth alone have a chance?

If the one who decides does not pay,and the one who pays does not decide,

and if the one who decides is paid,

will truth stand any chance?(Nobhojit Roy,

Who rules the great Indian drug bazaar?)

AcknowledgementsSlide Nos:


161/161

Slide Nos:

11,12,41,44,45,69,70,71,72,73,74,75,76,77,80,105,106,107,108,109,114

From the slide set:

Papin.K, Oldani M J, Griffiths j : Gifts,drugs, and theFDA: cross-disciplinaryperspectives on physician-pharmaceuticalinteractions MedEdPORTAL AAMC 200

doctor pharma industry interaction

Documents