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Healthy Skepticism International News

October 2002

CHAPTER ONE: INTRODUCTION

The controversial issue of doctors’ involvement with pharmaceutical promotion has been the subject of debate and deliberation for many years. In more recent years this debate has intensified as pharmaceutical promotion has diversified and expanded, creating new and more complex ethical dilemmas (Chren et al., 1989: Westfall, 2000).  The issue is now a subject of interest not only for doctors but also for allied health professionals, professional organisations, researchers and policy advisers.

In contemporary medicine, a complex symbiotic relationship is said to exist between doctors and the pharmaceutical industry (Backer, Lebsack, Van Tonder & Crabtree, 2000).  Whether this relationship is ultimately beneficial or detrimental remains contentious for some doctors (Backer et al., 2000; Beary, 1996).  To other doctors the relationship is detrimental, and each potential benefit such as drug samples, gifts, meals, treats and educational materials, remains problematic and has more to do with influencing physicians’ prescribing than with good patient care (Westfall, 2000).  Few issues in medicine have initiated heated debate as the controversy over the interaction between the pharmaceutical industry and the medical profession (Wazana, 2000).

Even though empirical studies have objectively demonstrated the adverse effect of pharmaceutical promotion on the prescribing habits of medical professionals (Caudill, Johnson, Rich & McKinney, 1996; Chren & Landefeld, 1994; Orlowski & Wateska, 1992; Wazana, 2000), many doctors are still involved with pharmaceutical promotion, seeing pharmaceutical representatives, and receiving gifts and samples.  In this study, the ethically dilemmatic relationship between doctors and pharmaceutical promotion is explored by discursively analysing the ways in which general practitioners understand and manage the inherent ethical controversies of their involvement with pharmaceutical promotion.  Common sense ideologies informing their talk on pharmaceutical representatives, gifts and samples are analysed, as are the rhetorical and linguistic devices utilised in their accounts.

1.1           PHARMACEUTICAL PROMOTION

1.1.1.        GENERAL OVERVIEW

Each year immense sums of money are spent worldwide on pharmaceutical promotion.  Recently, annual spending by pharmaceutical companies has increased markedly in each successive year.  Estimates of the money spent on ‘direct-to-doctors’ promotion in the USA currently stands at US$11 billion per year (Susman, 2001), with each physician receiving $8,000 to $13,000 per annum (Wazana, 2000).  Compelling argument for the effectiveness of pharmaceutical company promotion on prescribing is the continued spending of billions of dollars on drug detailing to doctors each year (Steinman, Shlipak & McPhee, 2001).

Of the large number of new drugs promoted to doctors by pharmaceutical companies annually, very few constitute a major advance in chemotherapeutics.  A French review of new drugs from 1981-2000 demonstrates this most clearly, with only 7 (0.31%) of the 2,257 drugs produced being evaluated as major therapeutic innovations.  Of these 2,074 new drugs, eighty two percent were evaluated as having no additional clinical value or worse (Table 1) (J. Lexchin, personal communication, September, 2001).  Further to the therapeutic value of new drugs, serious adverse side effects are often not detected until the drug is in clinical use (Jones, Greenfield & Bradley, 2001).  When deciding whether to use the new and often more expensive drugs rather than established drugs, doctors need to balance the relative benefits of delaying use and depriving patients of beneficial effects, or exposing patients to potentially dangerous side effects (Jones et al., 2001).  Potential adverse effects of new drugs are compounded by pharmaceutical promotion, as ‘earlier’ prescribers of new drugs have larger patient lists and rely primarily on commercial sources of drug information (Jones et al., 2001).

                                                                                         
CategoryNumberPercent
Major therapeutic innovartion in ana area where previously no treatment was available70.31
Product is an important therapeutic innovation but has certain limitations672.96
Product has some value but does not fundamentally change the present therapeutic practice1928.51
Product has minimal additional value, and should not change prescribing habits except in rare circumstances39717.59
Product may be a new molecule but is superfluous because it does not add to the clinical possiblities offered by previous products available. In most cases it concerns a me-too product142763.23
Product without evident benefit but with potential or real disadvantages582.57
editors postpone their judgments until better data and a more thorough evaluation of the drug is available1094.83
Total2257100

Note: The total corresponds to new preparations or indications presented by drug companies to French doctors. It excludes over the counter products and range extensions (new dose strength, new form or presentations).
(J. Lexchin, personal communication, September, 2001, p. 52)

In Australia, the adverse effects of pharmaceutical promotion have been felt both within the Pharmaceutical Benefits Scheme (PBS) and the overall health care system.  An exponential growth in costs in recent years has threatened the financial viability of the PBS.  This has occurred primarily due to the increasing cost of new drugs and the number of prescriptions being written, rather than the total number of drugs on the list (Goddard, Henry & Birkett, 2001).  In addressing the future viability of the PBS, the prescribing practices of doctors are of primary concern, particularly improvement of the concordance of prescriptions with the PBS restrictions and better education in the ‘quality use of medicines’ (Goddard et al., 2001).  Enhancement of the recognition of “the basic conceptual framework … under[lying] modern medicine” (Goddard et al., 2001, p. 3), particularly the balance of ‘risk and benefit’ is essential.  Investigation of the pharmaceutical industry marketing methods is also recommended, especially the promotion of new indications for PBS-listed drugs outside PBS-listed indications and the lack of cost-effectiveness validation of new drugs (Goddard et al., 2001).  Examination of the relationship of the pharmaceutical industry with doctors and consumer groups is also strongly recommended to determine the extent of the adverse effects of inducements.  For example, Goddard et al. (2001) argue the need for research that analyses:

… the extent to which doctors and consumer groups are compromised by financial inducements from industry, whether these inducements distort the clinically appropriate and cost-effective use of medicines, and whether there is a need for government-initiated guidelines or regulations governing industry funding of medical and consumer organizations (Goddard et al., 2001, p. 4).

Goddard et al. (2001) conclude the only criterion for rational PBS policy should be whether the scheme delivers value for money; “whether the health benefits from pharmaceuticals … are worth the money being spent” (Goodard et al., 2001, p. 5).

Goddard et al. (2001) conclude the only criterion for rational PBS policy should be whether the scheme delivers value for money; “whether the health benefits from pharmaceuticals … are worth the money being spent” (Goodard et al., 2001, p. 5).

Furthermore this growth of the PBS has not been balanced by equitable growth in total health care expenditure, and in effect health monetary resources have been transferred from hospitals and community care to drugs (Mansfield, 2001).  Moreover, inappropriate use of these new, expensive and inferior drugs rather than older, cheaper and superior drugs has reduced the beneficial medical value of drugs (Mansfield, 2001).  ‘Signal failures’ or failure to provide adequate self-regulatory feedback within the health care system are suggested as part reason for the occurrence of inappropriate drug use, and improvement of both information and payment ‘signals’, and incentives to drug companies, doctors, hospitals, and government health officials are required to ensure more appropriate and beneficial drug use (Mansfield, 2001).

Guidelines governing pharmaceutical promotion are being implemented and continually reviewed worldwide, by both medical and pharmaceutical industry associations, in an effort to regulate the relationship.  Breaches to these regulations continue to occur however, due to little compliance and ineffective self-regulation.  Furthermore, the establishment of guidelines may act reprehensibly to legitimise and perpetuate a continuing adverse and unethical relationship.  For example, The Royal Australian College of General Practitioners (RACGP) recently adopted guidelines on the acceptance of gifts from pharmaceutical companies, but stated their reasons for adoption as being “to help protect doctors from public perceptions that pharmaceutical industry promotional tactics could influence prescribing impartiality” (Murphy, 1999, p. 8).  These guidelines rightly state patients should be the primary beneficiaries of any gift, and any gift received should be related to the general practitioners’ work (Murphy, 1999).  Unacceptable gifts of holidays, frequent flyer points, computers and cash are specified, as well as acceptable gifts of textbooks, modest meals, stethoscopes, notepads and pens (Murphy, 1999).  However, the public relations intent of these guidelines is evident from the explicit explanation of their adoption arising from a need for “openness” by general practitioners, the pharmaceutical industry, and also for patients, who may feel general practitioners were “benefiting in some way from gifts, or being guided in [their] … prescrib[ing]” (Murphy, 1999, p. 8).

The American Medical Association (AMA) guidelines governing the limits on gifts received from pharmaceutical companies were adopted in 1992, but debate around these guidelines still continues.  For example, at a recent annual meeting of the AMA House of Delegates, the delegates rejected further review of the often-ignored guidelines despite urgent calls for review by other delegates (Susman, 2001).  This dilemma of what’s ethical and what’s not is debated at almost every semi-annual meeting, and the controversy is aptly reported by Susman (2001):

Many physicians are concerned the integrity of the profession is being undermined by seemingly uncontrolled largesse on the part of drug companies; other doctors rejected the idea that receipt of gifts from pens and note cards, to luxurious travel to attend continuing medical education sessions, would affect their prescribing habits (Susman, 2001, p. 9).

This dilemma of the largesse of pharmaceutical companies to the medical profession still exists irrespective of these guidelines limiting the value of gifts received from pharmaceutical companies to US$100 (Susman, 2001).  The delegates requesting review cited empirical research that physicians prescribe the promoted drug regardless of evidence of no more effectiveness than less expensive, older drugs, after pharmaceutical representative detailing (Susman, 2001).  These delegates were also concerned with a reported “escalation [in] what pharmaceutical companies are offering, and erosion of physician’s personal resolve not to accept gifts” (Susman, 2001, p. 9).  Studies indicating that the cost of marketing to physicians significantly contributes to increases in the overall cost of drugs paid by consumers, was also cited by the delegates as further reason for review (Susman, 2001, p. 9).

The Australian Pharmaceutical Manufacturers Association (APMA) Code of Conduct, regulating the promotional practices of members, is now in its 13th edition having been recently reviewed.  Pharmaceutical representative conduct is exclusively prescribed in one section of the code, but is cross-referenced to almost every other section as they relate to their promotional activities.  This code, while being prescriptive of proper promotion by APMA pharmaceutical company members and their employees, is inadequate in effectively regulating behaviour.  Promotional ingenuity and inadequacy of self-regulation of the code effectively reduces official reported breaches.  Further to this, promotion by pharmaceutical representatives is often difficult to assess and substantiate for breaches, primarily because of the verbal and interactive nature of the promotion, but also because of the interpersonal relationship established with doctors.

1.1.2.  the influence of pharmaceutical promotion on prescribing

Pharmaceutical promotion has been empirically proven to be effective in influencing the prescribing patterns of doctors (Avorn, Chren & Hartley, 1982; Berings, Blondeel & Habraken, 1994; Caudill et al., 1996; Chren & Landefeld, 1994; Haayer, 1982; Orlowski & Wateska, 1992).  The more reliant doctors are on commercial rather than non-commercial sources of information, the less rational they are as prescribers (Lexchin, 1989).  Both a positive attitude towards pharmaceutical promotion and evaluations of utility by doctors are also predictors of less rational prescribing (Berings et al., 1994; Haayer, 1982).  Low levels of scepticism (belief that a lower percentage of drug advertisements contain potentially misleading claims) and stronger belief that “my prescribing is improved by information from drug companies” are also predictive of less rational prescribers (Mansfield & Lexchin, 2000).

Further to these objective empirical studies, a qualitative study by Armstrong, Reyburn and Jones (1996) demonstrates through qualitative dialogue analysis, the subliminal and often irrational influences on the prescribing choice of doctors.  The drugs used in Armstrong et al.’s (1996) study to explore prescribing change were being actively and extensively promoted to general practitioners at the time, both commercially and non-commercially (Gill et al., 1996).  The following dialogue extract from the study exemplifies these irrational influences: “I read it in several places, but couldn’t tell you where.  The message has been pounded in over the last year … reading it again and again, so it must be true” (Armstrong et al., 1996, p. 950).

Three models of change in prescribing practice, the Accumulation Model, the Challenge Model and the Continuity Model, were differentiated from the qualitative data.  Each model describes broad patterns of change-in-prescribing cues to which general practitioners were found to respond (Armstrong et al., 1996).  The Accumulation Model demarcates two factors of influence; the sheer weight of pressure in a direction, and the relative authority of the sources (Armstrong et al., 1996).  Sheer weight of influence is frequently experienced by doctors during ‘targeted’ promotional campaigns, in which large masses of information are presented to a target audience over a wide media, in both a concentrated initial time frame, and with repeated and extended presentations.  The relative authority of sources, such as the ‘respected’, ‘trusted’ or ‘reputable’ consultant (Armstrong et al., 1996), is also expertly utilised by pharmaceutical companies with the use of specialist ‘opinion leaders’ to influence prescribers.  Of these authoritative sources of influence Armstrong et al. (1996) also found personal experience to be one of the most powerful cues.  Pressure of being ‘up-to-date’ is another cue illustrated by Armstrong et al.’s (1996) study, where one general practitioner having judged a new practice partner as being more ‘up-to-date’, aligned his prescribing practice to that of the colleague.  This pressure is also used advantageously in pharmaceutical promotion with repeated chides and suggestions to doctors to keep ‘up-to-date’.

The Challenge Model describes the prescribing change following a dramatic event, such as a clinical disaster, or a conflicted clinical event (Armstrong et al., 1996).  This type of prescribing change is preceded by a lack of preparedness, in which rapid reassessment of prescribing policy is induced after a direct challenge (Armstrong et al., 1996).  Examples of this included general practitioners suddenly changing their prescribing after a locum changed patient prescriptions (Armstrong et al., 1996).  The reasons given for the sudden change were, in one case, because the general practitioner believed the locums were practising more ‘modern, mainstream’ medicine, and in another case, because the locum was more recently trained and so judged by the general practitioner as being more ‘up-to-date’ (Armstrong et al., 1996).

The previous two models of change are suggestive of a relative resistance of general practitioners to change; however, the last model of change, The Continuity Model, describes rapid prescribing change based on pre-existing preparedness to change (Armstrong et al., 1996).  One example of this is that of a general practitioner initiating use of an antifungal shampoo “after seeing a distinctive advertisement showing a man with mushrooms growing from the top of his head” (Armstrong et al., 1996, p. 951).  This general practitioner had been ‘looking out’ for an antifungal shampoo to prescribe, and realised for the first time that one was available after seeing the advert (Armstrong et al., 1996).  Three forms of The Continuity Model were differentiated according to contextual factors, with the more general contextual factor referring to the level of congruence between the potential change and the general practitioner’s ‘approach to practice’ (Armstrong et al., 1996).  The more specific contextual factors were responsiveness to ‘cost pressures’, and whether or not a new drug ‘made sense’ (Armstrong et al., 1996).

This study by Armstrong et al. (1996) serves to demonstrate the potential influence of pharmaceutical promotion to change doctors’ prescribing habits through non-rational prescribing cues, rather than rational and appropriately reasoned decision-making.

THE INFLUENCE OF PHARMACEUTICAL REPRESENTATIVES

The most effective way of changing the prescribing habits of doctors is through pharmaceutical representatives (Shaughnessy & Slawson, 1996).  Given that many doctors see pharmaceutical representatives regularly (on average four times a month (Wazana, 2000)), and a few (10%) see them quite often (Griffith, 1999), this is an important influence.  Traditionally, doctors have viewed pharmaceutical representatives as the most important source of information about new drugs (Lexchin, 1989; Lexchin, 1993).  This is not surprising given that pharmaceutical companies promote representatives as being faster at providing information to doctors, and at an earlier stage than other sources (Griffith, 1999).

However, using representatives as a source of drug information is not good practice for several reasons.  For example, when representatives detail a new drug to doctors immediately after approval, there are often no published comparisons with existing treatments or economic evaluations (Griffith, 1999).  More useful information is often available at a later stage, by which time representatives are detailing another new drug (Griffith, 1999).  Furthermore, information from representatives is often misleading and difficult to critically evaluate (Greenhalgh, 1997).  For example, representatives often present the results of uncontrolled trials as controlled trials, and surrogate end points as measures of therapeutic intervention, rather than primary outcomes (Greenhalgh, 1997).

Meta-analysis of empirical studies (Wazana, 2000) have shown that doctors believe pharmaceutical representatives provide accurate information about their drugs, and could provide accurate information on established or alternative drugs.  Empirical studies by Roughead (1995) and Ziegler, Lew and Singer (1995) however, have found the information provided by representatives to be biased and inaccurate.  Roughead’s (1995) study of detailing to general practitioners, found that pharmaceutical representatives routinely provided information on indications, dosage and administration for their products, but provided minimal information on other areas, particularly risk factors.  Representative presentations were not balanced, in that positive claims were not balanced by information on side effects, contraindications and warnings (Roughead, 1995).  Drug information provided by representatives, when compared with the Australian Approved Product Information, was inaccurate in 39% of the presentations (Roughead, 1995).  Furthermore comparative data and information from scientific studies was also often incomplete, sometimes inaccurate, and largely used to promote the product benefits and diminish the risks (Roughead, 1995).  Zeigler et al.’s (1995) study of hospital lunchtime presentations by pharmaceutical representatives also found more than 10% of the information provided was inaccurate.

Non-rational prescribing and increased costs of prescribing have both been associated with pharmaceutical representative promotion.  Increased costs of prescribing have been demonstrated in several empirical studies (Caudill et al., 1996; Berings et al., 1994).  A dose-related effect was found by Caudill et al. (1996), in which frequency of use of information from pharmaceutical representative promotion independently predicted high prescribing costs.  Berings et al. (1994) also found that frequency of representative visits, and the evaluation of usefulness of the information provided were significant positive predictors of an increased tendency to inappropriately prescribe benzodiazepines.  Griffith (1999) also cites increased SSRI anti-depressant sales from pharmaceutical representative promotion, in comparison with the sales predicted from prescribing that is informed by non-promotional literature.

In Haayer’s (1982) study of general practitioners’ prescribing, less rational prescribing was found to be associated with a greater reliance and a positive attitude towards pharmaceutical representative promotion.  Peay and Peay’s study (1988) demonstrated non-rational prescribing effects of increased awareness, preference and rapid prescribing of new drugs associated with pharmaceutical representative promotion, while Bower and Burkett (1987) had previously shown an associated decrease in the prescribing of cheaper generic drugs.  Non-rational prescribing effects of formulary addition requests for detailed drugs, irrespective of minimal or no therapeutic advantage over existing formulary drugs, was also found to be associated with pharmaceutical representative interactions (Chren and Landefeld, 1994).

Further to these adverse effects of promotion on prescribing, exposure to pharmaceutical representatives has been found to be strongly associated with the belief of benefits of such interactions, and furthermore in the appropriateness of future interactions (Brotzman & Mark, 1993).  Given these adverse effects on the prescribing practices of doctors, the use of non-commercial sources of drug information to inform prescribing is imperative.  Furthermore, as there is an abundance of non-promotional, evidence-based information in useable form and on all major therapeutic advances, there is little or no need to see pharmaceutical representatives in order to keep up to date with new drug developments (Griffith, 1999; Mansfield, 2001).

THE INFLUENCE OF GIFTS

Meta-analysis of studies on pharmaceutical promotion (Wazana, 2000) has shown overall that receiving a gift, and the number of gifts received, is correlated with the belief by doctors that pharmaceutical representatives have no impact on prescribing behaviour.  Furthermore, receiving a gift of high relevance to medical practice has been shown to be associated with a generalised positive attitude to pharmaceutical representatives (Thomson, Craig & Barham, 1994).

Of the gifts received, samples, continuing medical education (CME) and conference travel were felt by doctors to exert more influence (55%) than promotional material (22%) (Wazana, 2000).  The effect of these gifts on prescribing practices has been demonstrated in many empirical studies (Chren & Landefeld, 1994; Orlowski & Wateska, 1992; Wazana, 2000).  Benefiting from pharmaceutical industry sponsored meals was associated with formulary addition requests and was found to be dose-related (Chren & Landefeld, 1994).  Accepting funding to attend a symposium was associated with increased formulary requests of the sponsor’s drug (Chren & Landefeld, 1994; Orlowski & Wateska, 1992) and this effect was found to continue two years post-study (Orlowski & Wateska, 1992).  The sponsor’s drug was found to be preferentially highlighted in pharmaceutical company sponsored CME, and associated with changes in prescribing practice (self-reported) in favour of the sponsor’s drug (Wazana, 2000).  Accepting pharmaceutical company honorarium to present data on a new therapy and receiving research support were independently associated with formulary addition requests for the sponsor’s drug (Chren & Landefeld, 1994; Wazana, 2000).

Even though doctors have indicated ethical concerns with promotional gifts, with travel funding generating the most concern (48-75%) (Wazana, 2000), studies demonstrate that physicians commonly deny that enticements influence their prescribing habits (Caudill et al., 1996; McKinney et al., 1990; Orlowski & Wateska, 1992).  For example, in the empirical study by Orlowski and Wateska (1992) a majority of physicians stated their prescribing would not be influenced by the all-expenses-paid trip to a luxury resort to attend symposia.  The physicians “appeared to sincerely believe that any decision to prescribe a drug is based on scientific data, clinical experience, and patient needs, rather than on promotion by pharmaceutical companies” (Orloswki & Wateska, 1992, p. 271).  A few physicians however, admitted enticements might influence their prescribing by acting as an aide-mémoire, or through being convinced by exposure at the symposium of the uses or benefits of the promoted drugs they otherwise had not previously considered (Orlowski & Wateska, 1992).  These physicians were considered to be less “absolute in their denial” (Orlowski & Wateska, 1992, p. 271) of the influence of enticements and promotion.  Moreover, no physician considered they would prescribe the promoted drugs in reciprocation, or out of gratitude for the trip received (Orlowski & Wateska, 1992).  Findings of this study by Orlowski and Wateska (1992), however, support previous findings of an influence on prescribing habits, in that physician prescribing increased for both drugs of the study after accepting the pharmaceutical company sponsored all-expenses-paid trip (Orlowski & Wateska, 1992).  One of the study drugs increased in usage from a Mean 81±44 units before the symposium, to 272±117 units after (p<0.001), with the other drug also increasing from 34±30 units to 87±24 units (p<0.001) (Orlowski & Wateska, 1992). This increase in usage occurred regardless of the majority of physicians attending the symposia believing that such entitlements would not alter their prescribing habits (Orlowski & Wateska, 1992).

the influence of samples

Wolf’s (1998) review of sample medications given to a general practice over the period of a year found an extensive range of medication was offered.  Wholesale cost of the sample medications received was more than US$250,000, with one company alone providing US$100,000 of sample medication (Wolf, 1998).

Irrespective of such costs from the issuing of samples, many doctors still argue the merits of having samples for ‘needy’ patients and initiation of drug therapy.  It is often difficult however, to establish who are the ‘needy’ patients that would benefit financially from the supply of medication samples (Westfall, 1998).  Furthermore, although samples allow the trial of drugs for effectiveness and early side effects without patient-incurred costs, the use of samples for the initiation of drug therapy may induce doctors to prescribe ‘sampled’ medications or new, more expensive drugs over less expensive but equally effective alternatives (Morelli & Koenigsberg, 1992).

The generous provision of samples by pharmaceutical companies is intended to influence doctors to change their prescribing behaviour in favour of writing more prescriptions for their drug (Westfall, McCabe & Nicholas, 1997).  The effectiveness of drug samples in changing doctors’ prescribing has been demonstrated in several empirical studies (Peay & Peay, 1988; Siegal & Lopez, 1994; Thomson et al., 1994).  Accepting samples has been associated with awareness, preference and rapid prescription of a new drug (Peay & Peay, 1988).  Thomson et al. (1994) also found the provision of samples generates positive attitudes toward the pharmaceutical representative.  Siegal and Lopez’s (1994) study also demonstrated the effect of samples, where ample supply of calcium channel blockers was associated with a marked increase in the prescription of calcium channel blockers, despite evidence and recommendations for beta-blocker and diuretic therapy for hypertension.

1.2         medical ethics

The Australian Medical Association Code of Ethics (1996) (Appendix G) specifies the required standard of ethical behaviour in medical practice, and the principles are provided as guidelines for professional medical conduct.  The code specifies ethical behaviour in the relationship of the doctor with the patient, the medical profession, and society.  Many of these principles also relate to the relationship of the doctor with the pharmaceutical industry.  The overall intent of the code of ethics is to “encourage doctors to promote the health and well-being of their patients and prohibit doctors from behaving in their own self-interest” (Australian Medical Association, 1996, p. 1).

The effect of pharmaceutical industry promotion and inducements on medical professionalism and the doctor-patient relationship are of ongoing ethical and moral concern (Chren, Landefeld & Murray, 1989; Westfall, 2000).  The symbiotic relationship between pharmaceutical companies and doctors benefits the doctor and the pharmaceutical company, but not the patient (Westfall, 2000).  Within this relationship, spending patients’ money without explicit knowledge or consent, alteration of the publics’ perception of medicine, and the establishment of obligation of the doctor to the pharmaceutical company are resultant from doctors receiving gifts.  All of these have serious ethical and moral implications (Chren et al., 1989).  Receiving gifts from pharmaceutical companies is regarded as ethically unjust, as patients’ money is being spent for their own and pharmaceutical companies’ gain, without the patients’ knowledge, consent or benefit (Chren et al., 1989).  Obligations resulting from receiving gifts may threaten the doctor-patient relationship, where the doctor’s role is to act as the patient’s agent, whose first consideration is the patient’s interests in all clinical decisions, including medication choice (Chren et al., 1989).  Gift obligations may also affect the character of the doctor, disturbing the personal balance between self-interest and altruism (Chren et al., 1989).

One resolution proposal by doctors to the ethical dilemma of inducements from pharmaceutical companies has been to charge pharmaceutical companies for their time, similar to patient appointment charging.  For example, a group practice in the USA recently priced the time spent with pharmaceutical representatives at US$65 for 10 minutes by establishing a ‘for-profit’ company to assign appointments for drug representatives, and then received money from pharmaceutical companies (Light, 2001).  In this way, doctors associated with the company did not receive money directly (Light, 2001).  The Chair of the AMA’s Council on Ethical and Judicial Affairs (CEJA) considered this fee-based system removed any ‘pretence’ from the physician-drug company meetings, and that “this setting up a commercial relationship, … might prove a refreshing approach, in that it’s a straightforward transaction” (Light, 2001, p. 2).  He further commented that this commercial system to access physicians might lead to “fewer of the sorts of concerns that CEJA or the AMA has, about the gifts and some things that aren’t related to the physician’s practice, like taking them to a ballgame” (Light, 2001, p. 2).  This solution however, would appear not to be informed by medical ethical considerations but rather by the angst of the AMA and its delegates over the ethical debate.

These ethical controversies and debate continue to exist.  At the recent AMA Delegates Annual meeting, where heated debate raged over a proposed review of the ethical guidelines on pharmaceutical industry promotion, a member of the Board recognised the problem that - “ethical policy can’t regulate anybody” (Susman, 2001).  This would appear to be so, given the lack of success of current self-regulating ethical codes of practice designed specifically to regulate the behaviour medical professionals, and the pharmaceutical industry and its representatives.  The same Board of Trustee member considered the level of resentment expressed by delegates toward review of the guidelines as indictment of an urgent need for further medical ethics education (Susman, 2001).

Medical ethics as core curriculum in medical undergraduate education, with continuation of ethics education through postgraduate, vocational training, and continuing education has recently been proposed by the Association of Teachers of Ethics and Law in Australia and New Zealand Medical Schools (ATEAM) (2001) in response to ethical concerns.  Despite arguments that ethics are personally, culturally and socially contextual with a diversity of values and perspectives, there are core skills and knowledge related to ethics that are fundamental in medicine (ATEAM, 2001).  The aim of ethics education is improved recognition and understanding of important ethical issues, and knowing how to make ethical decisions with an informed and properly reasoned foundation (ATEAM, 2001).  Ethics education components of knowledge, skills and attitudes are considered as individually important (ATEAM, 2001).  ‘Knowledge’ addresses the foundations of ethics and specific issues in ethics (ATEAM, 2001).  ‘Skills in ethics’ relates to specific skills of ethical awareness, moral reasoning, and ethical practice (ATEAM, 2001).  With respect to attitudes and professional values, which traditionally had been regarded as inherently moral and sound in the future physician, ATEAM (2001) now expresses concern of the “dehumanising and detrimental effects of institutional practice, and the medical education process itself” (ATEAM, 2001, p. 207) on such values.  These detrimental effects have led to recognition of the “importance of promoting humanistic qualities and behaviour in medical ethics education” (ATEAM, 2001, p. 207), and in so doing reduce “individual and cultural factors that may erode professional trust” (ATEAM, 2001, p. 207).

This movement to extend medical ethics and health law education is regarded as imperative by Breen (2001), who considers “there is no lack of ethical and professional challenges for today’s doctors” (Breen, 2001, p. 183).  Proposed curricula changes are seen as having arisen in response to “community concerns about communication skills, attitudes, and common ethical and medicolegal problems” (Breen, 2001, p. 183) identified by consumer groups, healthcare complaints commissions and medical boards.  Breen (2001) identifies the recent challenges in medical ethics as arising from the corporatisation of medical practices with its potential adverse consequences for patient care, unrestricted and uncontrolled advertising, and the increasing dilemmas faced by doctors in their roles as both patient advocate and ‘public purse’ regulators.  These are new challenges and issues, not previously addressed in the training of currently practicing doctors, thereby obligating continuing medical ethics education after graduation (Breen, 2001).

1.3         ETHICAL DILEMMAS

The controversy of doctors’ involvement with pharmaceutical promotion has been the subject of debate and deliberation for many years.  This debate has intensified in more recent years as pharmaceutical promotion has diversified and expanded, creating new and more complex ethical dilemmas (Chren et al., 1989: Westfall, 2000).

The controversies debated by doctors are clustered around several issues, but differ primarily according to the position taken on the effectiveness of pharmaceutical promotion on influencing prescribing practices of doctors.  Debate over the influence of pharmaceutical promotion ranges from concedence of little if any influence, to wide ranging influences.  The position taken on the influence of pharmaceutical promotion by individual doctors has implications for the ethical controversies experienced by those doctors.  Doctors who maintain there is little or no influence on their prescribing often declare no personal ethical challenges to their involvement with pharmaceutical promotion.  In contrast, doctors who concede the possibility of pharmaceutical promotion influencing prescribing, and who maintain regular benefit from their largesse, may experience and deliberate over the inherent ethical dilemmas.  However, even if influence is not conceded, evidence of management of this dilemma may be evident in doctors’ talk about pharmaceutical representatives, gifts and samples as illustrated by the linguistic devices utilised in their rhetorical constructions to deflect an ethically problematic identity.

Although many studies have empirically demonstrated the adverse influence of pharmaceutical promotion on prescribing, few studies have investigated how doctors make sense of and manage the ethical dilemmas experienced through their involvement with pharmaceutical companies.  Michael Billig’s (1987; 1991; Billig et al., 1988) approach to arguing and thinking, based on common sense ideologies containing antithetical themes, will be used to analyse the dilemmatic themes emerging in the doctors’ dialogue on pharmaceutical representatives, gifts and samples and pharmaceutical promotion in general.  This approach, together with Potter’s (1996) stake and interest analysis, will be used to extricate the common sense ideologies and discourses drawn on by doctors in their talk.  This study will also examine the rhetorical and linguistic devices utilised by doctors in their discursive constructions of pharmaceutical promotion.  It is intended that this analysis will be valuable and productive in describing common arguments used by doctors to justify their involvement with pharmaceutical promotion.

 

 

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Cases of wilful misrepresentation are a rarity in medical advertising. For every advertisement in which nonexistent doctors are called on to testify or deliberately irrelevant references are bunched up in [fine print], you will find a hundred or more whose greatest offenses are unquestioning enthusiasm and the skill to communicate it.

The best defence the physician can muster against this kind of advertising is a healthy skepticism and a willingness, not always apparent in the past, to do his homework. He must cultivate a flair for spotting the logical loophole, the invalid clinical trial, the unreliable or meaningless testimonial, the unneeded improvement and the unlikely claim. Above all, he must develop greater resistance to the lure of the fashionable and the new.
- Pierre R. Garai (advertising executive) 1963