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The

Ethics

of Accepting

Gifts

from

Pharmaceutical

Companies

Lewis

H. Margolis,

MD, MPH

From the Department of Maternal and Child Health, School of Public Health, University of

North Carolina, Chapel Hill, North Carolina

ABSTRACT. How physicians respond to the promotional activities of the pharmaceutical industry is the subject of ongoing debate and controversy. This paper postulates that the acceptance of gifts in virtually any form violates

fundamental duties of the physician of nonmaleficence,

fidelity, justice, and self-improvement. The medical com-munity must articulate this position clearly, and it should act accordingly. Pediatrics 1991;88:1233-1237; ethics of gifts, ethics, marketing ethics.

Because the practice of medicine is linked

inex-tricably with pharmaceuticals, physicians should

examine carefully their relationship to the phar-maceutical industry. The purpose of this article is

to articulate an ethical framework for the behavior of physicians as they interact with this industry. First, the marketing activities of the industry are

reviewed briefly. Second, the professional role of physicians, with its inherent values, is analyzed as

a basis for determining ethical behavior in relating to the pharmaceutical industry. Finally, these val-ues and principles are applied to specific examples of pharmaceutical marketing activities.

PHARMACEUTICAL

INDUSTRY

MARKETING

To understand the role and responsibilities of

physicians in their relationship to this industry it is instructive to describe the nature of the

phar-maceutical industry’s marketing activities.

Accord-ing to the Pharmaceutical Manufacturers

Associa-Received for publication Feb 4, 1991; accepted Mar 7, 1991.

This is a revised and expanded version of a paper presented at

the annual meeting of the American Academy of Pediatrics,

Boston, Massachusetts, October 1990.

Reprint requests to (L.H.M.) Dept of Maternal and Child

Health, School of Public Health, University of North Carolina,

Chapel Hill, NC 27599.

PEDIATRICS (ISSN 0031 4005). Copyright © 1991 by the American Academy of Pediatrics.

tion, the more than 100 firms responsible for most

of the conventional (ordinarily termed “ethical”) pharmaceuticals in the United States had sales

greater than $50 billion in 1988. Association mem-bers employed nearly 160 000 people in the United

States of whom 23% were involved in medical

re-search and development, 28% in marketing, and 36% in production.’

The profitability of the pharmaceutical industry has been well documented in a series of hearings

conducted by the House Subcommittee on Health

and the Environment in 1985 and 1987.23 By two

of three common measures of profitability-return on sales (net income divided by sales) and return

on equity (net income divided by owners’ equity or book value)-the pharmaceutical industry ranks

very high among all industries.

Recent economic pressures on the industry,

how-ever, have been intense. Like other manufacturing

companies, the producers of pharmaceuticals can

earn profits in several ways. First, a company can

increase sales, that is, the number of prescriptions

written. This is most apparent when a new patent

guarantees a monopoly position for a limited period,

usually 17 years. Sales are limited only by the diseases for which a drug is effective. This type of

creativity, however, is expensive. Developmental and approval costs of a new drug increased from

$54 million in 1976 to $94 million in 1984 2,s171

In addition to increasing sales, a company can raise prices to earn a larger profit on each unit sold.

Drug prices have increased, but the rate of increase

has remained below the overall consumer price

index. Within the health component of the con-sumer price index, the rate of increase in the cost

of pharmaceuticals has remained below the rate of

increase for hospital or physician costs,2 perhaps

because strong competition from abroad constrains

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improve its efficiency so that each unit sold earns

a greater profit.

Because unit prescription sales have remained relatively stable during the past 10 years, manufac-turers have attempted several strategies to expand

their market shares. First, some recently have launched campaigns to advertise prescription drugs directly to consumers. Second, promotional

activi-ties directed at physicians have increased and in-tensified.

According to a 1987 survey of the 25 largest pharmaceutical companies during the years 1982

through 1986, expenditures for marketing, in total dollars and percent of sales, exceeded those for research and development.3 Research and

develop-ment expenditures were 19.6% of total prescription sales of $63.6 billion, whereas marketing

expendi-tures were 20.2%.3.P’% It is not possible to state, a priori, what the percent of expenditures for either

of these activities should be. Companies that spend only 5% on research may wither away for lack of new products, or companies that spend 30% on research and development may find themselves un-able to educate the audience of prescribers about

the value of their products and similarly go out of business. The point is, however, that manufacturers

devote considerable resources to marketing.

Esti-mates of industry marketing expenditures range

from $5000 (Wilkes M, Shuchman M. New York Times Sunday Magazine. November 5, 1989:88) to $8000 per physician per year. Twenty years ago the ratio of physicians to drug representatives was

approximately 76:1; today that ratio is 31:i. The

return on these expenditures, and thus their con-tribution to profitability, is a direct function of the ability to influence physicians in the selection of their products.

Not only have marketing expenditures increased, but also the types of marketing have changed as well. According to Advertising Age,6 half of promo-tional funds is allocated to traditional techniques such as product advertising (24%), direct mail (6%), and detail staff (20%). The other half is allocated

to special events such as product-related exhibits at scientific meetings, symposia for select groups of

doctors, and an assortment of single-sponsor pub-lications ranging from monographs to newsletters, special interest magazines, tapes, and videocas-settes.6 A survey of 18 major firms revealed that expenditures for special events increased 14-fold

between 1975 and 1988.

In summary, pharmaceutical companies invest in the marketing of their products to influence the prescribing behavior of physicians. No absolute moral standard dictates that 10% or 15% or 40% of sales should be devoted to promotion, but the

po-tential conflict of interest between physicians and pharmaceutical manufacturers is clear. The

pri-mary interest of pharmaceutical companies is to

earn profits that both reward their shareholders

and, in the words of J. Huck, former chairman of the board of Merck and Co, enable companies to

develop “innovative therapies that extend life,

im-prove the quality and productivity of life, and

re-duce the overall costs of illness.”8 The primary focus

of physicians is to serve the best interests of their

patients. The motto of the Academy of Pediatrics-“For the Welfare of Children”-enunciates the professional interest of pediatricians.

PHYSICIANS

AND

PROFESSIONAL

ETHICS

Understanding the professional role of physicians provides the basis to analyze the relationship be-tween the pharmaceutical industry and physicians. According to Friedson,8 medicine manifests the two

core characteristics of professions: “prolonged

spe-cialized training in a body of abstract knowl-edge”8’77 to develop expertise or professional knowledge and “a collectivity or service

orienta-tion.”8’77 Physicians are expected to place the needs of patients before their own desires. For example, because physicians in the past felt obligated to treat all who sought their assistance, they would engage

in discretionary pricing whereby well-to-do patients

were charged more than low-income patients. This service orientation enabled physicians to provide

care regardless of the ability to pay.

From these core characteristics professional au-tonomy flows. The profession determines its own

standards of education and training, practice is

recognized legally by a license, most legislation is

shaped by the profession, and the practitioner is

relatively free of lay evaluation and control. It is

important to emphasize that “professionalism” can

exist only to the extent that the community at large and other occupations recognize and accept the

autonomy of those who claim to be professionals.

Friedson warns, however, that professional au-tonomy is flawed:

By allowing and encouraging the development of self-sufficient institutions, it develops and maintains in the profession a self-deceiving view of the objectivity and reliability of its knowledge and of the virtues of its

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the need for, let alone undertake, the self-regulation it

promises.SW3693l#{176}

In other words, the autonomy of medicine may allow physicians to justify their actions without regard for the opinions or standards of the com-munity at large. Professional autonomy may lead

physicians to believe that they are immune to in-tensive pharmaceutical marketing efforts.

What are the values that are embedded in the

knowledge and service orientation of physicians that may guide their interactions with the indus-tries that complement the profession of medicine? One major theory of ethics, particularly relevant to

this discussion, is based on the articulation of rules or duties to guide conduct. The most prominent classical proponent of this theory was Kant, who

argued that one should “act in such a way that you treat humanity, whether in your own person or in the person of any other, never simply as a means,

but always at the same time as an end.”9”’6 This

theory holds that individuals are bound morally to observe various duties, independent of the conse-quences of action.

Probably the primary duty that helps to frame

the ethics of medicine is “primum non nocere.” To

do no harm, the duty of nonmaleficence, ordinarily

refers to the avoidance of harm to the physical and

mental health of patients, but it can be extended to

include the avoidance of any harmful action.

Physicians have a duty of fidelity, from which

stems the practice of confidentiality. Fidelity also

obliges a physician to be loyal to the interests of his or her patient, as well as to avoid deception.

Pediatric commitment to advocacy for children

stems from a duty of justice. Justice, equity, or fairness is the principle by which burdens and

ben-efits are allocated within a society. Philosophers

have argued for distribution on the basis of need, merit, equal share, market value, effort, and other

principles.’0 Much of the advocacy work of

pedia-tricians is based on the implicit understanding that

children have special needs; resources should be allocated to children accordingly.

Finally, physicians maintain a duty of

self-im-provement, or, in the words of W. D. Ross,

“im-proving oneself with respect to the intrinsic values

of intelligence and virtue.”9’23 Physicians have an

obligation to build upon their basic education by

attaining new knowledge and by continuing to cul-tivate the care and sensitivity with which they treat

patients and families.

Physicians may have additional duties in other

contexts, the most obvious being beneficence, the

promotion of the intrinsic value of patients in

pa-tient encounters. The four duties of

nonmalefi-cence, fidelity, justice, and self-improvement have particular relevance for defining interactions with

the pharmaceutical industry.

THE ETHICS OF GIFTS TO PHYSICIANS

Just as these duties guide physician interactions with patients and other professionals, so too can they guide encounters between physicians and

pharmaceutical companies. In a thoughtful essay

on doctors and drug companies, Chren and colleagues” clearly summarize the gift relationship.

“By offering a gift to another, a person is really

proffering friendship, a relationship.”3449

Accept-ing a gift is “accepting the initiation or reinforce-ment of a relationship, and it triggers an obligatory response from the recipient . ..the recipient

gen-erally assumes certain social duties such as grateful

conduct, grateful use, and reciprocation.”3’”9

Whether it involves a pen with a company logo or

a dessert reception at a professional meeting, the offering or exchange of gifts signifies a complex

relationship.

The duties of physicians can guide this complex

relationship in several ways. The first duty, to do no harm, should instruct physicians to reject these gifts for several reasons. Gifts ultimately are paid

for by patients through the costs of the drugs. To

the extent that such gifts represent costs over and

above the ordinary costs of research, production,

and marketing, gifts harm patients by increasing the cost of their care. In the extreme, one could

argue that the physician is stealing from the pa-tient, because the added costs are unrelated in any way to the service that the physician provides.

Although physicians are unlikely to prescribe clearly incorrect medications as a result of entice-ments by drug representatives, the extent to which

drug decisions are made on any ground other than what is best for the patient also constitutes harm.

The duty of fidelity is violated in several ways by

the acceptance of gifts. First, as the gift relationship

implies, acceptance of gifts makes physicians agents of the companies that have entered into that

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will-ing to disclose this gift relationship to their pa-tients, because deception also violates the duty of

fidelity.

The acceptance of gifts violates the duty of

jus-tice, particularly so for pediatricians who, as advo-cates for children, are likely to define justice as the distribution of resources on the basis of need. As

R. Fakes, a British physician, remarked, “. ..we are being given a meal which many of our patients could not afford but which they would appreciate much more.”2 Clearly, with 20% of children living in poverty,’3 physicians should not participate in practices that unfairly reallocate resources to

them-selves.

Physicians have a duty as professionals to con-tinue “prolonged specialized training in a body of abstract knowledge,” that is, a duty of

self-improve-ment. That many physicians have not exercised

this responsibility adequately is evidenced by the fact that state regulatory agencies make licensure and/or recertification contingent on documentation of continuing education. This need for formal reg-ulation suggests that the legitimacy of physicians

as professionals is already suspect. The acceptance of, or the need for, the incentive of gifts to

partici-pate in continuing education also suggests that

physician regard for the importance of self-im-provement has eroded. Rejection of gifts is all the more important because physicians are quite

sus-ceptible to commercial (in contrast to scientific)

influences on prescribing.’4 Further, “education” that is acquired through commercial relationships may not be as effective as that acquired through noncommercial scientific presentations more de-pendent on a physician’s self-motivation.’5

Although companies and physicians share the

objective of furthering professional education, they

do not share the objective of promoting brand by-alty. Companies use glamorous sites such as ocean-side and mountain-top resorts to cultivate loyalty. They could provide the same education at a lower cost by sponsoring meetings at less enchanting locations. Because the resources utilized to promote brand or company loyalty ultimately come from patients, the acceptance of this type of company support violates the duties of nonmaleficence, fi-delity, and justice. If physicians want to combine continuing education with entertainment, they themselves should be responsible for the added

costs.

Although this duty-based assessment of the

eth-ics of gifts is fitting, some may argue that a utili-tarian analysis is more appropriate. Utilitarian the-ory holds that the consequences of one’s actions determine the right thing to do. Utilitarian models require individuals to foresee all outcomes of

ac-tions and to evaluate the consequences. Even when various duties are violated, if the overall

conse-quences are beneficial, the action is considered moral or ethical.

Under a utilitarian assessment of gifts, the out-come that society would seek to maximize would be improved health. It is possible that marketing prac-tices result in profits that drug companies then invest in the search for other highly effective prod-ucts. A utilitarian calculation may reveal that so-ciety is better off in terms of health as a result of these gift-generated profits. The major costs of this strategy, however, must be defined clearly before such a calculation is undertaken. First, the loss of

autonomy as physicians become the agents of phar-maceutical manufacturers could have several

det-rimental consequences. Their ability to evaluate products objectively would diminish; feedback pre-sumably is useful to manufacturers and to the

Fed-eral Drug Administration as new products are dis-seminated. Furthermore, physicians likely would

become less attuned to the needs of their patients

and more attentive to the manufacturers. As man-ufacturers search for new pharmaceutical needs and products, physicians, through their direct contacts with patients, are a major source of information. Another cost could be depreciation in the value of physicians as professionals, with a decline in the

putative healing benefits that flow from the practice of medicine as a profession.

CONCLUSIONS

It is apparent from this analysis that physicians ought to take umbrage at the acceptance of gifts in virtually any form, a position that is at variance

with the recent statement of the American Medical Association.16 The gift relationship undermines several of the fundamental duties, nonmaleficence,

fidelity, justice, and self-improvement, of physi-cians. Similarly, a utilitarian analysis suggests that the costs of this practice may exceed the benefits. The belief by physicians that they can remain ob-jective in the face of marketing efforts is likely to be a manifestation of the self-deception to which

professionals, in their search for autonomy, are susceptible.

What is acceptable practice within the ethical

framework that has been outlined? Because phar-maceutical companies share a societal interest in the development of well-educated physicians, sup-port for educational activities at teaching

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insti-tutions, therefore, should have complete control over the speakers and content of such activities.

Acknowledgment of company support, analogous to

commercials in the broadcast media or

advertise-ments in medical journals, is acceptable when it is clearly noted as such. Support for attendance at

conferences is consistent with the enhancement of knowledge, but it should also be administered

through institutions or medical societies and not

directly from companies to individuals. The

accept-ance of support for individuals, such as spouses, not

directly involved in the educational activity is ob-viously wrong because resources would be allocated to an individual who does not have patient care responsibilities.

Educational activities, to the extent that they

improve the quality of care provided to patients, are the only activities for which support can be

justified. Pharmaceutical contributions have no

role to play in social activities. Sponsorship of

receptions or even the provision of light refresh-ments at meetings cannot be justified. Because such activities do not enhance the practice of medicine in general nor the relationship to patients in par-ticular, they have no legitimate place. Similarly,

gifts of even small office items, such as pens or

pads, are unacceptable.

Gifts for participation in clinical “research” in

which physicians are rewarded on a per case basis

undermine the legitimacy of physicians. This type

of payment often amounts to engaging the

physi-cian as an agent of the company in question,

vio-lating the duty of fidelity. Pharmaceutical

compa-nies that need information about the experiences of clinicians with their products can engage them

for this purpose, but there are institutional and

governmental protocols for such activities. In par-ticular, informed consent should be obtained for

such “trials,” and patients must be informed explic-itly about the remunerative relationship between

the practitioner and the sponsor company. The growing bureaucratization and

institution-alization of medicine, with threats to professional

autonomy in the form of managed care, governmen-tab regulation, and medical liability, may make

phy-sicians more vulnerable than in the past to the gifts of pharmaceutical companies. The rejection of gifts manifests a commitment to the best interests of patients. Physicians, affirming the ethical values

imbedded in their professional role, should abandon

the practice of accepting gifts from pharmaceutical companies.

ACKNOWLEDGMENTS

I am grateful to Pam Protzel for research assistance and to Linda Frankeb, Barry Roberts, and George Pickett

for critical readings of earlier drafts.

REFERENCES

1. Pharmaceutical Manufacturers Association. Annual Survey

Report. Washington, DC: Pharmaceutical Manufactures As-sociation; 1989

2. Subcommittee on Health and the Environment.

Prescrip-tion drug price increases. Hearing before the Subcommittee

on Health and the Environment; July 15, 1985; Serial No.

99-58

3. Subcommittee on Health and the Environment. Medical

devices and drug issues. Hearings before the Subcommittee

on Health and the Environment; April 8, 21, and May 4,

1987; Serial No. 100-34

4. Randall T. Kennedy hearings say no more free lunch-or

much else-from drug firms. JAMA. 1991;265:440-442

5. Levine J. Medical marketing. Incentive Marketing. August

1987;161:54, 56, 58, 93

6. Kangiliski J. Drug companies reach into mixed marketing

bag. Advertising Age. October 24, 1985;56:35-36

7. Huck J. Letter to the Subcommittee on Health and the

Environment. In: Prescription drug price increases. Hearing

before the Subcommittee on Health and the Environment;

July 15, 1985; Serial No. 99-58

8. Friedson E. Profession of Medicine. New York: Dodd, Mead

&Company; 1973

9. Appelbaum D, Lawton SV. Ethics and the Professions.

En-glewood Cliffs, NJ: Prentice-Hall; 1990

10. Beauchamp TL, Childress JF. Principles of Biomedical

Eth-ics. New York: Oxford University Press; 1983

11. Chren MM, Landefeld CS, Murray TH. Doctors, drug

corn-panies, and gifts. JAMA. 1989;262:3448-3451

12. Fakes RW. Doctors and the drug industry. Br Med J.

1986;293:1 170-1171

13. Bane MJ, Ellwood DT. One fifth of the nation’s children:

why are they poor? Science. 1989;245:1047-1053

14. Avorn J, Chen M, Hartley R. Scientific versus commercial

sources of influence on the prescribing behavior of

physi-cians. Am J Med. 1982;73:4-8

15. Soumerai SB, Avorn J. Economic and policy analysis of

university-based drug “detailing.” Med Care.

1986;24:313-331

16. Council on Ethical and Judicial Affairs. Gifts to physicians

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1991;88;1233

Pediatrics

Lewis H. Margolis

The Ethics of Accepting Gifts from Pharmaceutical Companies

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1991;88;1233

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Lewis H. Margolis

The Ethics of Accepting Gifts from Pharmaceutical Companies

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