APPENDIX
A
MaLAM
Subscriber
Address
Address
Address
Dear
MaLAM Subscriber,
Re:
Pharmaceutical representatives and gifts
Malam
is seeking to further investigate the impact and influence of pharmaceutical
promotion in medical practice, with particular emphasis on pharmaceutical
representative visits and gifts.
Focus
groups will be organised across the adelaide metropolitan area in the next few
months for malam subscribers to discuss these important and controversial
issues that are of relevance to all doctors.
Participants will be encouraged to discuss their personal experiences
of pharmaceutical representatives and gifts, and offer their thoughts and
opinions on these issues. Differences
of opinion and open debate will be encouraged.
The
focus groups will provide further valuable insights into the influence of
pharmaceutical promotion in the medical profession, and how doctors deal with
such promotion. Peter Mansfield
and Lynda Caudle, an Honours Psychology student at Adelaide University, will
be conducting the research. Information
provided in the study will be kept confidential and anonymous, and any
audiotapes destroyed after completion of the project.
Further inquiries regarding the study may be directed to Peter at MaLAM
or Lynda on 8276 5152. The
Psychology Department Ethics Subcommittee has approved the study and the
convenor, Dr Peter Delin, may be contacted on 8303 5007.
MaLAM
subscribers who participate in these focus groups will have the opportunity to
meet with Peter and other MaLAM subscribers in an informal and friendly
setting with light refreshments. We
will arrange times and venues to suit participants.
If you are interested in participating, please indicate your interest
below and fax this letter back to MaLAM on 8374 2245.
We look forward to seeing you at one of the focus groups!
We will also be sending out a short questionnaire soon to enable you to
provide written comments (whether or not you attend a focus group).
Yours
sincerely
Dr
Peter Mansfield
Ms Lynda Caudle
Director,
MaLAM
Honours Psychology, Adelaide University
Please
indicate if you are interested in attending a focus group:
|
Yes |
|
|
No |
|
|
|
Contact
telephone number(s) |
|
|
Contact
fax number |
|
Please
fax this letter back to MaLAM on 8374 2245
APPENDIX
B
PHARMACEUTICAL REPRESENTATIVE VISITS AND GIFTS STUDY
CONSENT
FORM
|
Name
of Researchers |
Ms
Lynda Caudle, Psychology Honours Student, Adelaide University Dr
Peter Mansfield, Director of MaLAM Dr
Peter Mansfield, Director of MaLAM Ms
Melissa Raven, Department of Public Health, Flinders University Assoc
Prof Martha Auguostinos, Psychology Dept, Adelaide University |
|||
|
|
||||
|
Name
of Supervisors |
||||
|
1.
|
I
consent to participate in the above study.
The nature of the study, including questionnaires or
procedures, has been explained to me, and is summarised in the
introductory letter I have received. |
|||
|
2. |
I
authorise the responsible investigators or the persons named above to
use these questionnaires or procedures with me. |
|||
|
3.
|
I
understand that: |
|||
|
|
a. |
I
am free to withdraw from the project at any time. |
||
|
|
b. |
The
project is for the purpose of research or teaching, and not for
treatment. |
||
|
|
c. |
The
confidentiality of the information I provide with be safeguarded. |
||
|
|
d. |
There
are no known adverse effects of these questionnaires or procedures. |
||
|
Signed: |
Date: |
|||
APPENDIX
C
In
this focus group we will be discussing pharmaceutical
promotion, with particular emphasis on the pharmaceutical
representative, gifts and samples.
For
the purpose of the focus group ‘gifts’ will include anything received as a
personal gift from pharmaceutical companies.
Examples of ‘gifts’ include the following:
Pens,
notepads and other stationary;
Medical
equipment and textbooks;
Lunches;
Dinners
accompanying educational seminars;
Travel
expenses and accommodation at conferences, symposiums etc;
Entertainment;
And
any other personal ‘gift’ received.
Participants
are encouraged to talk freely about their experience and opinion of pharmaceutical
representatives, gifts and samples.
We
hope you will enjoy the experience of participating in this focus group and
thank you for your involvement.
APPENDIX
D
1
Do
you see
pharmaceutical representatives, and if so, how
often do you see them?
2
What are your reasons for seeing
pharmaceutical representatives?
3
What do you see as the advantages
of seeing pharmaceutical representatives?
4
What do you envisage as the disadvantages
of seeing pharmaceutical representatives?
5
How would you describe the relationship
you have with the pharmaceutical representatives you see?
6
What do you think of the information
pharmaceutical representatives present to you?
a.
Do you think the information is accurate?
b.
Do you think the information is complete?
c.
Do you think pharmaceutical representatives present an unbiased
view of their product in the marketplace?
7
Do you think it is unethical
for doctors to see pharmaceutical representatives? or Do you think seeing
pharmaceutical representatives creates any ethical
problems for doctors?
8
Have you received a
‘gift’ from a pharmaceutical representative or pharmaceutical company, and
if so, what ‘gifts’ have you
received?
9
Are pharmaceutical company-sponsored lunches, dinners, samples, and
other ‘gifts’ and ‘hospitality’ harmless?
10
Do these ‘gifts’ constitute a bribe
or conflict of interest?
11
Are these ‘gifts’ given
freely with no ulterior motive?
12
What do pharmaceutical companies expect
in return for these ‘gifts’?
13
Do you feel obligated to
reciprocate in response to the ‘gift’ giving?
14
Is it unethical for doctors
to accept ‘gifts’?
15
Should pharmaceutical companies supply drug samples to doctors?
16
Should doctors and office staff use drug samples given by
pharmaceutical companies?
17
Does the use of drug samples for patients constitute an ethical dilemma
in medical practice?
18
Are you aware of the AMA
guidelines on pharmaceutical promotion?
19
Are the AMA guidelines adequate
in your opinion?
20
In
your opinion, is the current system of
self-regulation of the pharmaceutical industry by the APMA adequate?
21
What changes, if any, would
you like to see in the status quo of the provider-doctor
and doctor-consumer relationships?
FOCUS
GROUP QUESTIONS B
1
Do you think seeing pharmaceutical
representatives creates ethical
dilemmas for doctors?
NO
Justification
YES
Reasons
Issues:
Critical
appraisal ability
Ability
to recognise and counteract promotional influence
2
Do you think receiving ‘gifts’
creates an ethical dilemma for
doctors?
NO
Justification
YES
Reasons
SOMETIMES
– Hierarchy of moral weight
Issues:
Rational
prescribing
Persuasion
of doctor
Cost
to health care system
3
Do you think receiving samples
is ethically unsound?
NO
Justification
YES
Reasons
SOMETIMES
– Hierarchy of moral weight
4
Do you think pharmaceutical
promotion in Australia is currently adequately regulated?
NO
Reasons,
concerns and suggestions
YES
Justification
DON’T
KNOW
Issues:
AMA
position
Codes
of conduct – AMA and APMA
Breaches
of codes and reprisals
Number
of incidents of reported breaches
TGA
– Fully funded by the industry – government incentive scheme
FOCUS
GROUP ISSUES STATEMENTS
“Past
empirical studies have shown …”
“It
has been empirically proven that …”
“Some
doctors believe …”
“Some
people think …”
“It
has been stated that …”
1
Pharmaceutical
Representatives present unbalanced,
inaccurate and incomplete information favouring their own pharmaceutical
product.
2
Pharmaceutical
representatives utilise inherent social
influence techniques such as reciprocation,
consistency, social validation, liking, authority and scarcity (Cialdini,
2000).
3
The
objective of pharmaceutical
representative visits is to change
doctors prescribing habits.
4
Doctors
change prescribing habits in response
to pharmaceutical representative visits and gifts.
5
Pharmaceutical representative visits is an effective
and successful promotional technique, otherwise why would pharmaceutical
companies continue to use such an expensive method of promotion?
6
Reciprocity
is a powerful and socially inherent,
behavioural influence technique, well utilised by the pharmaceutical
representatives in the carefully cultivated context of the friendly,
amiable doctor-pharmaceutical representative relationship.
7
All
‘gifts’,
from seemingly inconsequential to very substantial monetary value, engender an
effective reciprocity effect.
8
Samples are another form of gift
giving requiring reciprocity.
9
Samples are primarily
promotional, constituting a form of
DTC advertising, which has prompted recommendations for pharmaceutical
companies to eliminate the promotional packaging and include enough of the
drug in the sample to allow administration of a complete course of therapy (ie
antibiotics).
APPENDIX
E
Underlining
indicates words or parts of words which are stressed by the speaker.
:
make the prolongation of the sound immediately before (then:n); more
colons show longer prolongation (Ah:::)
¯
Marked rises and falls in intonation
?
A questioning intonation (there is no necessary correspondence with
utterances participants treat as questions).
.
A completing intonation (eg line 2) – (not necessarily a grammatical
full stop).
,
Eg line 6 marks a continuing intonation (not necessarily a grammatical
comma).
-
Eg Thanks- Tha:nksgiving) marks a noticeable and abrupt termination of
a word of sound.
[
]
Eg lines 2,3,8,9,10 and 11 mark the onset and completion of overlapping
talk.
=
One turn runs into another with no interval (Eg lines 1,2,9 and 11).
(Number)
Eg (0.5) the duration of a pause in tenths of a second; where there is
just a (.) in the bracket – pause is hearable but too short to measure.
°um°
Talk that is quieter than the surrounding talk
WHERE
Talk that is louder than the surrounding talk is capitalised.
®
Arrows
in the margin – pick out lines of transcript for discussion in the text; do
not mark features of delivery.
(
)
Transcriber doubtful of a word or phrase – placed in parentheses; if
no guess is plausible these parentheses are left empty.
((
))
Clarificatory comment is placed in double parentheses: ((laughs)) or
((stands up)).
[…].
Where material from tape has been omitted for reasons of brevity –
indicated by […].
(DE-JF/C2/S1:4)
Code at end of transcription – Extract from transcript produced by
Derek Edwards and Jon Fong (DE-JF). The
talk is from the second couple in the sample (C2) in their first session (S1)
and it appears on the fourth page of the transcript)
APPENDIX
F
The
Medical Lobby for Appropriate Marketing (MaLAM) was established in 1983 by Dr
Peter Mansfield, and became an international non-profit organisation of health
professional subscribers dedicated to MaLAM’s aims.
MaLAM’s
aims were:
(a)
To defend appropriate compassionate scientific medical care, health
professionals and the public from marketing practices which may be detrimental
to health;
(b)
To engage in dialogue with bodies involved in health-related marketing.
(c)
To provide a balance of information and practical opportunities for
action, which assist health professionals to act for the benefit of the
public;
(d)
To encourage bodies involved in health-related marketing to provide
reliable information to assist appropriate therapy;
(e)
To support appropriate compassionate scientific medical care;
(f)
To provide a Medical Lobby for Appropriate Marketing where:
‘Appropriate
Marketing’ refers to “health-related marketing with provision of
appropriate information to assist health professionals to provide appropriate
compassionate scientific medical care”
‘Medical
Lobby’ refers to “an organisation which conveys the concerns of health
professionals in ways that encourage ‘Appropriate Marketing’”.
MaLAM
subscriber’s received copies of letters, written by MaLAM and addressed to
pharmaceutical manufacturers on a monthly basis.
The letters stated questionable promotional claims, provided a summary
of scientific literature for comparison by the manufacturer and requested the
manufacturer’s evidence in support of the claim.
MaLAM subscribers agreeing with the concerns raised in each letter,
signed an accompanying support letter, and sent the letters to the
manufacturers concerned.
In
2001 MaLAM changed its name to Healthy Skepticism (www.healthyskepticism.org).
Its mandate essentially remains the same, but it is now operationally
different, and has an increased emphasis on education and enhancement of
healthy scepticism and critical appraisal skills in health professionals.
APPENDIX
G
AUSTRALIAN
MEDICAL ASSOCIATION POSITION STATEMENT: CODE OF ETHICS