ETHICAL ISSUES in the

RELATION of PHYSICIANS with

the PHARMACEUTICAL
INDUSTRY
ANGELICA D FRANCISCO, MD, MSc

GlaxoSmithKline fined $3bn after bribing doctors to

increase drugs sales
Sales reps in the US encouraged to mis-sell antidepressants Paxil and Wellbutrin and
asthma treatment Advair
The pharmaceutical groupGlaxoSmithKlinehas been fined $3bn (1.9bn) after admitting bribing
doctors and encouraging the prescription of unsuitable antidepressants to children. Glaxo is also
expected to admit failing to report safety problems with the diabetes drug Avandia in a district
court in Boston on Thursday.
The company encouraged sales reps in the US to mis-sell three drugs to doctors and lavished
hospitality and kickbacks on those who agreed to write extra prescriptions, including trips to
resorts in Bermuda, Jamaica and California.
The company admitted corporate misconduct over the antidepressants Paxil and Wellbutrin and
asthma drug Advair.
Psychiatrists and their partners were flown to five-star hotels, on all-expenses-paid trips where
speakers, paid up to $2,500 to attend, gave presentations on the drugs. They could enjoy diving,
golf, fishing and other extra activities arranged by the company.
GSK also paid for articles on its drugs to appear in medical journals and "independent" doctors
were hired by the company to promote the treatments, according to court documents.
Paxil which was only approved for adults was promoted as suitable for children and
Source:
http://www.theguardian.com/business/2012/jul/03/glaxosmithkline-fined-bribing-doctors-pharmaceuticals
teenagers
by the company despite trials that showed it was ineffective, according to

Year

2013

Company
Johnson & Johnson
[6]

Settlemen
t

Violation(s)

Off-label
$2.2 billion promotion/
kickbacks

Product(s)

Laws
violated

Risperdal/
Invega/
Nesiritide

False Claims
Act/FDCA

Abbott Laboratori
es

$1.5 billion

Off-label
promotion

Depakote

False Claims
Act/FDCA

Amgen[10]

$762
million

Off-label
promotion/kic
kbacks

Aranesp

False Claims
Act/FDCA

2010

GlaxoSmithKline[11]

$750
million

Poor
manufacturin
g practices

Kytril/Bactroban
/
Paxil CR/
Avandamet

False Claims
Act/FDCA

2010

Allergan[15]

$600
million

Off-label
promotion

Botox

False Claims
Act/FDCA

2012

[7]

2012

Source: https://en.wikipedia.org/wiki/List_of_largest_pharmaceutical_settlements

WHY THE CONCERN?

COST OF DRUGS

DRUG PROMOTION
DOCTORS = MEDICAL SALES
REPRESENTATIVE

WHO PAYS?

PATIENTS

PHARMACEUTICAL INDUSTRY
SPENDING ON MARKETING
THE GLOBAL PHARMACEUTICALS
MARKET IS WORTH US$300 BILLION A
YEAR, . COMPANIES CURRENTLY SPEND
ONE-THIRD OF ALL SALES REVENUE ON
MARKETING THEIR PRODUCTS ROUGHLY TWICE WHAT THEY SPEND ON
RESEARCH AND DEVELOPMENT.
Source: http://www.who.int/trade/glossary/story073/en/

FIDUCIARY CHARACTERISTIC
OF PHYSICIAN-PATIENT
ARELATIONSHIP
FIDUCIARY IS ONE WHO:
HOLDS

A SPECIALIZED KNOWLEDGE OR EXPERTISE

HOLDS THE TRUST OF OTHERS
IS HELD TO HIGH STANDARDS OF CONDUCT
AVOIDS CONFLICTS OF INTEREST
DOES NOT SEEK PERSONAL GAIN
IS OBJECTIVE
IS ACCOUNTABLE OR OBLIGATED (ETHICALLY AND
LEGALLY)
Source: AMA Module 1

EFFECT OF GIFTS ON
RESIDENTS

HAT PERCENTAGE OF RESIDENTS SURVEYED WERE CARRYING

EMS WITH A PHARMACEUTICAL COMPANY LOGO
R PRODUCT BRAND?
97% of residents surveyed were carrying
items with a pharmaceutical company logo
or product brand on them.
98% of residents surveyed had also eaten at
least one pharmaceutical company-provided
meal sometime in the previous 12 months.

EFFECT OF GIFTS ON
RESIDENTS
WHAT
PERCENTAGE OF RESIDENTS SURVEYED ACKNOWLEDGE
THAT GIFTS AND MEALS INFLUENCED THEIR PRESCRIBING
PATTERNS?
91% of residents surveyed acknowledged
that gifts and meals influenced their
prescribing patterns.
As gifts influence prescribing patterns, they
decrease objectivity and increase the
possibility of prescribing based on decisions
other than the best interests of the patient.

GIFTS AND PERCEPTION

STUDIES FOUND THAT COMPARED
TO PHYSICIANS, PATIENTS WERE
_________ TO FIND GIFTS
ACCEPTABLE.
LESS LIKELY. COMPARED TO PHYSICIANS,
PATIENTS WERE MORE LIKELY TO FIND GIFTS
INAPPROPRIATE.

GIFTS AND PERCEPTION

OTHER STUDIES FOUND THAT COMPARED
TO PHYSICIANS, PATIENTS WERE _________
TO BELIEVE THAT GIFTS FROM INDUSTRY
BIASED PHYSICIANS DECISIONS ABOUT
PRESCRIPTIONS.
MORE LIKELY. COMPARED TO PHYSICIANS,
PATIENTS WERE MORE LIKELY TO BELIEVE THAT
GIFTS FROM INDUSTRY BIASED PHYSICIANS
DECISIONS ABOUT PRESCRIPTIONS OR THAT THE
PHYSICIAN MAY NOT HAVE THE PATIENTS BEST
INTERESTS IN MIND.

PATIENTS ATTITUDES ON
GIFTS TO MDS
Sample: 486 Patients
Type of Gift

Percent
Awareness

Not alright

Free drug
sample

87

7.6

Ballpens

55.3

17.5

Medical books

34.6

16.9

Infant formula

28.6

44.2

Dinner at a
restaurant

22.4

48.4

Coffee maker

13.8

40.7

Blake RL Jr, Early EK. Patients' attitudes about gifts to physicians from pharmaceutical companies.
J Am Board Fam Pract. 1995 Nov-Dec;8(6):457-64.

PATIENTS ATTITUDES ON
GIFTS TO MDS
32.5%

DISAPPROVE OF MDs ACCEPTING

PAYMENT BY PHARMACEUTICAL COMPANY OF
MEDICAL CONFERENCE EXPENSES
28-43% DISAPPROVED OF MDs ATTENDING
SOCIAL EVENTS SPONSORED BY
PHARMACEUTICALS
70% BELIEVED GIFTS INFLUENCE MDs
PRESCRIBING MEDICATIONS
64% BELIEVED GIFTS TO MDs INCREASE
MEDICATION COSTS

PATIENTS ATTITUDES ON
GIFTS TO MDS
CONCLUSION
APPROVAL RATES WERE HIGH FOR GIFTS
CONSIDERED TO BE TRIVIAL OR THAT HAVE
POTENTIAL VALUE TO PATIENT CARE;
DISAPPROVAL RATES WERE RELATIVELY HIGH
FOR GIFTS THAT HAVE SOME MONETARY VALUE
BUT HAVE LITTLE OR NO BENEFIT TO PATIENTS.
OPINIONS ABOUT GIFTS WERE RELATED TO
PERCEPTION OF EFFECTS ON PRESCRIBING
BEHAVIOR AND COSTS.

GIFTS AND PRESCRIBING

PRACTICES
IS THERE A POSITIVE ASSOCIATION BETWEEN
MEETINGS OF PHARMACEUTICAL INDUSTRY
REPRESENTATIVES AND PHYSICIANS, AND A
CHANGE IN PRESCRIBING PRACTICES?
YES. A POSITIVE ASSOCIATION WAS NOTED BETWEEN:
MEETINGS OF PHARMACEUTICAL INDUSTRY
REPRESENTATIVES AND PHYSICIANS, AND A
CHANGE IN PRESCRIBING PRACTICES
ACCEPTING FUNDING FOR TRAVEL OR LODGING
AND PRESCRIBING PRACTICES

PHYSICIANS AND GIFTS

GIFTS,

FREE MEALS, TRAVEL

SUBSIDIES, SPONSORED
TEACHINGS, SYMPOSIA
OBJECTIVE: TO IDENTIFY THE
IMPACT ON THE KNOWLEDGE,
ATTITUDES AND BEHAVIOR OF
PHYSICIANS
Wazana A. Physicians and the pharmaceutical industry: is a gift ever just a gift? JAMA 2000 Jan 19;283(3):373-80.

PHYSICIANS AND GIFTS

INCREASING

REQUEST OF PHYSICIANS
FOR ADDING THE DRUGS TO THE
HOSPITAL FORMULARY
CHANGES IN PRESCRIBING PRACTICES
DRUG COMPANY SPONSORED CME
HIGHLIGHTED THE SPONSORS DRUGS

Wazana A. Physicians and the pharmaceutical industry: is a gift ever just a gift? JAMA 2000 Jan 19;283(3):373-80.

PHYSICIANS AND GIFTS

ATTENDING

SPONSORED CME EVENTS AND

ACCEPTING FUNDING FOR TRAVEL OR
LODGING FOR ATTENDING SYMPOSIA WERE
ASSOCIATED WITH INCREASED PRESCRIPTION
RATES OF THE SPONSORS MEDICATION
ATTENDING PRESENTATIONS GIVEN BY
PHARMACEUTICAL REPRESENTATIVE
SPEAKERS WERE ASSOCIATED WITH
NONRATIONAL PRESCRIBING.
Wazana A. Physicians and the pharmaceutical industry: is a gift ever just a gift? JAMA 2000 Jan 19;283(3):373-80.

CONFLICT-OF-INTEREST
A PERSON IS IN A CONFLICT OF INTEREST
SITUATION IF S/HE IS IN A RELATIONSHIP
WITH ANOTHER IN WHICH S/HE HAS A MORAL
OBLIGATION TO EXERCISE HIS/HER JUDGMENT
IN THAT OTHERS SERVICE, AND AT THE SAME
TIME, S/HE HAS AN INTEREST TENDING TO
INTERFERE WITH THE PROPER EXERCISE OF
JUDGMENT IN THAT RELATIONSHIP.
DAVIS, 1982

GIFT ECONOMY
COFFEE

MUGS, FREE
LUNCHES
PEN LIGHTS
KNAP SACKS
STETHOSCOPES
POCKET TEXTBOOKS

 FEW DOCTORS ACCEPT THAT THEY THEMSELVES

HAVE BEEN CORRUPTED. MOST DOCTORS BELIEVE
THAT THEY ARE QUITE UNTOUCHED BY THE
SEDUCTIVE WAYS OF INDUSTRY MARKETING; THAT
THEY ARE UNINFLUENCED BY THE PROMOTIONAL
PROPAGANDA THEY RECEIVE; THAT THEY CAN ENJOY
A COMPANYS GENEROSITY IN THE FORM OF GIFTS
AND HOSPITALITY WITHOUT PRESCRIBING ITS
PRODUCTS. THE DEGREE TO WHICH THE
PROFESSION, MAINLY COMPOSED OF HONOURABLE
AND DECENT MEN/WOMEN, CAN PRACTICE SUCH SELF
DECEIT IS QUITE EXTRAORDINARY. NO DRUG
COMPANY GIVES AWAY ITS SHAREHOLDERS MONEY
IN THE ACT OF DISINTERESTED GENEROSITY.
Rawlins, 1984

CODES

OF CONDUCT FOR PHARMACEUTICAL COMPANIES

DEVELOPED BY INDUSTRY ORGANISATIONS TEND TO BE VOLUNTARY
BUT ARE OFTEN BACKED UP BY COMPLAINTS PROCEDURES
MOST SUCH CODES PROHIBIT COMPANIES FROM GIVING DOCTORS
INDUCEMENTS TO PRESCRIBE THEIR PRODUCTS
MANY DOCTORS' ORGANISATIONS OFFER GUIDANCE ABOUT
COMMERCIALLY FUNDED RESEARCHJOURNAL EDITORS HAVE ISSUED
A STATEMENT AIMED AT PREVENTING SUPPRESSION OF
UNFAVOURABLE FINDINGS
GUIDANCE ON GOOD PUBLICATION PRACTICE FOR
PHARMACEUTICAL COMPANIES WAS LACKING UNTIL RECENTLY
DIALOGUE BETWEEN THE INTERESTED PARTIES IS NEEDED BEFORE
FURTHER GUIDANCE ON THE DOCTOR-INDUSTRY RELATIONSHIP IS
ISSUED
BMJ. 2003 May 31; 326(7400): 11961198.doi:
10.1136/bmj.326.7400.1196PMCID: PMC1126055
How to dance with porcupines: rules and guidelines on doctors' relations with dr
ug companies

4. SYMPOSIA AND CONGRESSES

C.ANY SPONSORSHIP PROVIDED TO
INDIVIDUAL HEALTHCARE PROFESSIONALS
MUST NOT BE CONDITIONAL UPON AN
OBLIGATION TO PRESCRIBE, RECOMMEND,
OR PROMOTE ANY MEDICINE.

4. SYMPOSIA AND CONGRESSES

D.ALL EVENTS SHOULD BE HELD IN AN
APPROPRIATE VENUE THAT IS CONDUCIVE
TO THE SCIENTIFIC OR EDUCATIONAL
OBJECTIVES AND THE PURPOSE OF THE
EVENT OR MEETING. COMPANIES SHOULD
AVOID USING EXTRAVAGANT VENUES OR
RESORTS.

4. SYMPOSIA AND CONGRESSES

E.HOSPITALITY SHOULD BE LIMITED TO
REFRESHMENTS AND/OR MEALS INCIDENTAL
TO THE MAIN PURPOSE OF THE EVENT AND
SHOULD ONLY BE PROVIDED:
1.TO PARTICIPANTS OF THE EVENT AND NOT
THEIR GUESTS; AND
2.IS MODERATE AND REASONABLE AS
JUDGED BY LOCAL STANDARDS.

4. SYMPOSIA AND CONGRESSES

F.COMPANIES SHOULD NOT PAY ANY COSTS
ASSOCIATED WITH INDIVIDUALS
ACCOMPANYING INVITED HEALTHCARE
PROFESSIONALS.

BMJ. 2003 May 31; 326(7400): 11961198.doi: 10.1136/bmj.326.7400.1196PMCID: PMC1126055

How to dance with porcupines: rules and guidelines on doctors' relations with drug companies
Elizabeth Wager, publications consultant1

IF AN INCENTIVE IS OFFERED TO A PHYSICIAN, ASK

THESE QUESTIONS:
IS THE INCENTIVE OF NOMINAL VALUE?
IS THE INCENTIVE OF VALUE TO PATIENTS OR
RELATED TO PRACTICE?
IS THE INCENTIVE OFFERED WITH NO STRINGS
ATTACHED?
WOULD YOUR PATIENTS BE PLEASED IF THEY
KNEW ABOUT THE INCENTIVE?

IF THE ANSWER TO ANY OF THESE

QUESTIONS IS NO, PHYSICIANS SHOULD
DECLINE THE GIFT.

American Medical Student

Associations PharmFree Pledge
I AM COMMITTED TO THE PRACTICE OF MEDICINE IN
THE BEST INTEREST OF PATIENTS AND IN TH
PURSUIT OF AN EDUCATION THAT IS BASED ON THE
BEST AVAILABLE EVIDENCE, RATHER THAN ON
ADVERTISING OR PROMOTION.
I, THEREFORE, PLEDGE TO ACCEPT NO MONEY GIFTS
OR HOSPITALITY FROM THE PHARMACEUTICAL
INDUSTRY; TO SEEK UNBIASED SOURCES OF
INFORMATION AND NOT RELY ON INFORMATION BY
DRUG COMPANIES; AND TO AVOID CONFLICTS OF
INTEREST IN MY MEDICAL EDUCATION. (AMSA, 2001)

References

American Medical Association Modules on What You Should Know About Gifts to
Physicians from Industry

Blake RL Jr, Early EK. Patients' attitudes about gifts to physicians from pharmaceutical
companies. J Am Board Fam Pract. 1995 Nov-Dec;8(6):457-64.

Goldacre B. Bad Pharma. Harper Collins Publishers, 2012.

Health Action International. Understanding and Responding to Pharmaceutical

Promotion: A Practical Guide
http://www.haiweb.org/10112010/DPM_ENG_Final_SEP10.pdf

Quan SF. , Do You Have A Minute? The Dilemma Posed by Physician Interaction with the
Pharmaceutical Industry J Clin Sleep Med. 2007 June 15; 3(4): 345346

Rodwin MA. Medicine, Money & Morals: Physicians Conflicts of Interests. Oxford
University Press, 1993

Wazana A. Physicians and the pharmaceutical industry: is a gift ever just a gift? JAMA.
2000 Jan 19;283(3):373-80.