Ethical issues concerning the relationships between medical practitioners and the pharmaceutical industry

CLINICAL ETHICS
CLINICAL ETHICS
Ethical issues concerning the relationships between
medical practitioners and the pharmaceutical industry
Paul A Komesaroff and Ian H Kerridge
RELATIONSHIPS INVOLVING medical practitioners and the
pharmaceutical industry raise serious concerns and
ABSTRACT
The Medical Journal of Australia ISSN: 0025-729X 4 February 2002
controversy within both the medical profession and the
• Medical practitioners and the pharmaceutical industry
176 2 118-121
broader community.1,2 Within the profession itself views
serve interests that sometimes overlap and sometimes
©The Medical Journal of Australia 2001 www.mja.com.au
differ sharply, from the conviction that the risks associated
conflict.
with such relationships are minimal to a concern that all
• There is strong evidence that associations between
Clinical Ethics
contact between doctors and industry involves compromise
industry and doctors influence the behaviour of the
and should therefore be avoided as far as possible.3 The
latter in relation to both clinical decision making and
relationship between the pharmaceutical industry and the
the conduct of research.
medical profession includes clearly desirable aspects (eg,
• In view of the risk of compromising relationships with
the cooperative efforts of industry, government and
patients and the integrity of the research process, doctors
prescribers in trying to achieve quality use of medicines)
must exercise care in their dealings with industry.
and less clearly ethically justifiable ones (eg, acceptance of
• The basic principles underlying the conduct of doctors
lavish gifts and money for entertainment expenses by
with respect to pharmaceutical companies should be
doctors).
openness and transparency.
• Clearly articulated procedures should be developed to
Sources of concern
deal with specific issues such as travel subsidies, receipt
Doctors and the pharmaceutical industry share a number of
of gifts, sponsorship of conferences and continuing
common interests. For example, both are concerned with
education activities, and dualities of interest arising
encouraging effective and responsible use of existing drugs in
in clinical and research settings.
treatment and care, monitoring of their use, and innovative
MJA 2002; 176: 118-121
research. However, the parties have different emphases and
focus on different stakeholders. Doctors are interested
from industry.5 The total amount spent on research and
primarily in patient care and scientific advance, while industry
development is much larger still.6
is interested primarily in commercial outcomes. The primary
In spite of these clear common interests and benefits of
stakeholder in patient care is the patient, whereas the principal
cooperation, concerns of an ethical nature have been
stakeholder in industry is the shareholder. The similarities and
expressed by both the medical profession and the
differences between participants and their interests create both
community. There are three main concerns:
a need for discourse and the potential for conflict.
s The possibility that associations between doctors and drug
The contribution made by industry to medical knowledge
companies may serve commercial objectives of industry and
and practice has been considerable. The cost of development of
acquisitive interests of clinicians rather than legitimate care,
a new drug is between US$300 and $600 million, most of
educational or research goals, thereby compromising the
which is provided by industry.4 Clinical research is also
primary ethical obligation of doctors to patients, dividing the
expensive: last year, in the United States, about US$6 billion
loyalties of doctors and undermining the basic trust on which
was spent on clinical research, of which 70% came directly
clinical relationships depend;
s The risk that drug promotion will inappropriately influence
doctors’ decisions; and
s The danger that industry involvement in research will lead to
Eleanor Shaw Ethics Centre for the Study of Medicine,
distortions in scientific evidence and prevent independent
Society and Law, Baker Medical Research Institute, Prahran,
assessment of data.
VIC.
These issues have been considered by professional bodies
Paul A Komesaroff, MA, PhD, FRACP, Director, and Ethics Convener,
Royal Australasian College of Physicians.
and other organisations, which have from time to time
Clinical Unit in Ethics and Health Law, Faculty of Medicine
developed guidelines and codes of conduct for their
and Health Sciences, University of Newcastle, NSW.
members.7-9 There has been disagreement about whether
Ian H Kerridge, MPhil, FRACP, FRCPA, Lecturer in Clinical Ethics.
voluntary codes are sufficient or mandatory rules are
Reprints will not be available from the author. Correspondence: Associate
needed,10,11 but the self-regulatory model has so far largely
Professor P A Komesaroff, Eleanor Shaw Ethics Centre for the Study of
prevailed in Australia. Last year, the Royal Australasian
Medicine, Society and Law, Baker Medical Research Institute, PO Box
6492, St Kilda Central, Melbourne, VIC 8008.
College of Physicians released new guidelines12 and the
paul.komesaroff@baker.edu.au
Australian Pharmaceutical Manufacturers Association
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CLINICAL ETHICS
issued a comprehensive code of conduct that provides
advertising and US$5 billion on sales representatives,15
detailed guidance to industry on such matters as drug
while expenditure per physician is believed to be over
promotion.13
US$8000.16
The question of divided loyalties
Advertising
An “interest” is a commitment, goal or value that arises out
Doctors generally perceive the way they practise to be
of a particular social relationship or practice. The
determined by knowledge and evidence, but it appears
possibility that dealings with drug companies might lead to
that they often fail to recognise commercial influences on
divided loyalties of doctors, or “conflict of interest”, has
therapeutic decisions and underestimate the subtle and
been an abiding concern, but identifying such conflicts is
pervasive effects of pharmaceutical promotion. It is
not entirely straightforward. One definition refers to
disquieting that some practitioners rely on pharmaceuti-
“either motives that caregivers have and/or situations in
cal company representatives for much of their drug
which we could reasonably think caregivers’ responsibilities
information. Although physicians often deny it, there is
to observe, judge, and act according to the moral
considerable evidence that advertising affects clinical
requirements of their role are, or will be, com-
decision-making behaviour.17 Contact with drug com-
promised …”.14 However, this approach understates the
pany representatives leads to prescribing of their drugs;18
crucial dependence of interests on particular relationships
physicians exposed to advertising are more likely to accept
and the need for public processes by which coexisting
commercial rather than well established scientific views;19
interests can be evaluated.
and drug company advertising is associated with an
It is common for relationships to be associated with
inability of some physicians to identify wrong claims and
several interests. Interests of medical practitioners include:
a propensity to engage in non-rational prescribing
s patient welfare;
behaviour.20
s community welfare;
s pecuniary interests (eg, consultancy fees, share holdings,
paid employment);
Gift giving
s advancement of career;
Gift giving is another widespread drug-promotion strategy.
s research grants;
A study from the University of Toronto showed that, over a
period of one year, psychiatry residents and interns
s hospitality;
attended up to 35 meetings and 70 drug lunches and
s participation in research.
received up to 75 promotional items and US$800 in gifts
When a doctor is engaged in a relationship with a
(although there was considerable variation).21 In another
pharmaceutical company, a duality of interests exists. It
study, of medical students, more than 80% had received at
can not be assumed that such a duality will constitute a
least a book and in some cases much more.22
“conflict” in each case — this will depend on the particular
circumstances, and often not everyone will agree anyway.
Although, as with advertising, physicians deny that gifts
Dualities of interest are common; conflicts relatively rare.
influence their behaviour,23,25 here, too, there is clear
Further, whereas the distinction between the two is
evidence to the contrary.17,25 A survey of 120 physicians in
sometimes clear-cut, at other times it may be subtle and
Cleveland, Ohio, showed that those who met with
depend on the nature of the relationship in question and
pharmaceutical representatives were 13.2 times more likely
the values of the community within which it occurs.
to request inclusion of the company’s products in their
Dualities of interest constitute “conflicts” only when they
hospital formulary; those who accepted money to speak at
are associated with competing obligations that are likely to
symposia were 21.4 times more likely to do so; and those
lead directly to a compromise of primary responsibilities.
who accepted money to perform research were 9.2 times
To establish whether a conflict of interest exists it is
more likely to do so. The authors concluded that there is a
necessary for the factual details to be declared and for the
“strong, consistent, specific and independent” association
community to have the opportunity to scrutinise the issues
between physicians’ requests that a drug be added to the
publicly.
hospital formulary and interactions with drug companies.26
Drug promotion
Support for travel
Promotion and marketing (including advertising, gift
There is also evidence that drug company support for travel
giving and support for medically related activities such as
expenses changes the prescribing behaviour of practition-
travel to meetings) make up a very large part of the
ers.17,26-28 Among the many studies that have demonstrated
activities of drug companies (consuming a quarter to a
such an effect, it has been shown that a physician who
third of their entire budgets, and totalling more
accepts money to travel to a symposium is 4.5–10 times
than US$11 billion each year in the United States alone).15
more likely to prescribe a company-sponsored drug after
There are no comprehensive figures available, but it is
such sponsorship than before (even though he or she may
estimated that, of this, about US$3 billion is spent on
believe in advance that prescribing behaviour will not be
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CLINICAL ETHICS
affected),27 and is 7.9 times more likely to submit a
Dualities of interest
formulary request for that drug than a physician who does
The central principle that should be adopted is that
not.26
arrangements between physicians and pharmaceutical
companies should be open and transparent. Dualities
Meeting sponsorship and continuing medical education activities
ought to be clarified and clearly declared in the relevant
Sponsorship of meetings is an important and difficult issue.
context — to patients, research participants, hospital
There are clearly common interests between professional
committees, and so on. Whether they constitute conflicts
societies, which are usually responsible for organising
should not be left to the individuals concerned to decide,
conferences, and the pharmaceutical industry: the former
but to a process of informed public debate within the
stand to gain substantial funding from the pharmaceutical
setting in which the duality arises. Where conflicts appear
industry for their meetings and other activities, while, for
likely, special procedures should be devised to avoid
the latter, unparalleled opportunities are provided to
unacceptable outcomes.
showcase their wares. On the other hand, choices of
speakers and topics at meetings may have important
Drug promotion, including acceptance of gifts and travel support
implications for pharmaceutical companies, and, if these
Ideally, drug promotion should be restricted to the
are subject to influence from outside the professional
society, the kinds of impressions that people go away with
dissemination of well-founded data about specific prod-
may be significantly altered.
ucts. This would ensure reduction of costs of pharmaceuti-
Indeed, sponsorship of conferences has been shown to
cals to the consumer as well as reassuring the community
lead to bias in favour of the sponsoring companies’ drugs,29
about the independence of physicians, restricting excessive
with increases in prescriptions for sponsors’ drugs in the six
claims about the effectiveness of drugs and ensuring
unbiased assessment of evidence.
months after an event.30 Similarly, pharmaceutical support
for continuing medical education (CME) activities leads to
Benefits received from pharmaceutical companies should
increased prescribing of sponsoring companies’ prod-
leave physicians’ and scientists’ independence of judge-
ucts.21,27,29-31 This occurs even when the course content is
ment unimpaired. Various levels of advice have been
controlled by the society or institution and the drugs are
advanced to medical practitioners about accepting gifts.
These range from blanket rejection, to a gradient of moral
referred to by their generic names only.29
acceptability based on cost, to the principles that gifts
should not be excessive and should not influence decision-
Control of publication and research outcomes
making, to the test of whether the recipient would be
willing to have the arrangements publicly known.
The effect of drug company sponsorship on research and
We feel that the safest general principle for practitioners
publications is a major issue that will not be discussed in
to adopt is that they should err on the side of rejection of
detail here. Briefly, there are many ways in which research
gifts, even those of trivial value. Support for travel to
findings can be directed towards producing a desired
meetings (including conferences organised by professional
result,32 ranging from careful design of a trial and selection
societies and CME courses) should be restricted to those
of drug doses to selective reporting of results or actual
making formal contributions. Entertainment expenses
suppression of unfavourable outcomes.5 The prominence
should not be lavish, although it is recognised that ideas
of a publication can be enhanced by paying authors to
about what constitutes “lavishness” vary according to one’s
participate, or publishing non-peer-reviewed material as a
point of view. Access of drug company representatives to
supplement in a respected journal.33 Delays in the
students and health services should be limited. We believe
publication of unfavourable results are common, and it is
that there needs to be a cultural shift towards a lesser
speculated that the results of many clinical trials are never
published at all.34
Key recommendations
Guidelines for action
s
Dualities of interest should be publicly declared and
examined for the presence of a conflict.
Although opinions differ about whether voluntary guide-
lines or mandatory rules are the best way to monitor
s
Acceptance of gifts should be kept to a minimum.
potential conflicts of interest, no professional bodies or
s
Non-service-oriented gifts, including items of trivial
institutions have proposed a ban on interactions between
value, should not be accepted.
doctors and the pharmaceutical industry. Indeed, it is
s
Entertainment should not be lavish.
accepted that such a policy would not serve the interests of
s
Support for travel should be restricted to those making
any party. We feel that the most desirable approach is to
formal contributions to meetings/conferences.
develop an amicable relationship that allows healthy
s
Meetings should be organised by an independent
criticism and is based on clear, but non-coercive,
committee.
guidelines. This is the view adopted by the Royal
s
Research and publication should be guided by
Australasian College of Physicians.12 We have summarised
scientific and ethical rather than commercial values.
our key recommendations in the Box.
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expectation of entertainment, grand dinners, receptions
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