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Relationships with the Biotechnology and Pharmaceutical Industries

This publication is made possible by an educational grant from Amgen Inc. and Wyeth Pharmaceuticals.


Introduction

General Principles of Ethics

Capacity and Informed Consent

Managed Care

Potential Industry Influences

Relationships with the Biotechnology and Pharmaceutical Industries 

Ethical Issues for Professional Societies and Organizations

Conclusion

References


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 Ethics and Rheumatology 

Preethi Dendi, MD, Shrey Desai, MD, Fred M. Jacobs, MD, JD, Gregory J. Rokosz, DO, JD, Jeanine H. Bulan, MD and Richard S. Panush, MD  
Department of Medicine
Saint Barnabas Medical Center
Livingston, NJ

Arthur Kavanaugh, MD
Division of Rheumatology, Allergy and Immunology
University of California-San Diego
La Jolla, CA

Paul L. Romain, MD
Department of Rheumatology
Cambridge Hospital and Harvard Medical School
Cambridge, MA 

Relationships with the Biotechnology and Pharmaceutical Industries

Medicine is humane science inextricably bound to an ethical lattice (1,2,3,15). Individual physicians and their professional association(s) are committed to promote the welfare of those they serve. They should affirm the moral imperatives from which authenticity and integrity derives by demanding the highest possible standards. Opportunities for professional associations and their individual members to accept monetary support and/or gifts, to generate income, and to “partner” with industry challenge our ability to recognize moral dilemmas and to subordinate self-interest to that of our patients.  

Medicine should not be primarily about our practices, institutions, organizations, research, careers, agendas, or perceived entitlements. It is about dedication and devotion to our patients and to their welfare even at personal and professional risk to profit, pride, and position (1,2,3, 15,16,17,18,19,20,21,22). 

Gifts

Gift exchange exemplifies the potentially problematic individual and professional relationships with industry. The use of “gifts” in this context reflects relationships from which personal or organizational benefit may accrue. Individuals are confronted with the allure of widely available gifts. There is general recognition that professional and personal gift exchange poses ethical conflicts to physicians and organizations, and that there must be codes of conduct to govern this. There is less guidance relating to broader relationships with industry and other commercial sources, but the professional and ethical issues are essentially the same as for gifts.” There likely will be growing government and public scrutiny of the relationship between medicine and industry.

 

Gifts are powerful symbols throughout cultures used to initiate and sustain relationships (1,3,18,19,21,22). This must be understood to appreciate discussion of their potential influence. Gifts are used ubiquitously to influence physicians. Companies are motivated by profit not altruism. Gifts cost money. Costs are ultimately passed on to patients without their explicit knowledge or consent. Accepting a gift may contribute to erosion of the perception that the medical profession serves patients’ best interests.

 

Acceptance of a gift establishes a relationship between the donor and recipient with a vague but real obligation. Offering a gift proffers friendship. Acceptance of a gift initiates or reinforces a relationship. Acceptance of a gift assumes social obligations of grateful conduct, grateful use, reciprocation, and response. While gift-giving is an act of apparent generosity it serves the self interest of the giver. Formal contracts can be dissolved but gift relationships are subtle and less defined.  

Gifts to physicians from pharmaceutical companies need to be considered in the context that reflects the fact that the ultimate goal of these companies is to increase profit to shareholders. 

Can Physicians Be Bought, Rented, or Influenced?

This information has been reviewed extensively elsewhere (1,3,18,19,21,22). Several ethical problems arise for individual physicians with regard to gifts (Table 1). Gifts obligate. Gifts influence behavior. And gifts violate the ethical precepts of distributive justice (unfairly allocating resources without patients’ knowledge or consent), beneficence (eroding physicians’ fiduciary relations as trustees of patients’ welfare above all else), nonmaleficence (transferring costs to patients and increasing costs of care), fidelity (obligating physicians to companies), and of self-improvement/professionalism (presuming an “entitlement” for subsidies or gifts as incentives for continuing education) (1,2,3,15,16,17,18,19,20,21,22). 

The quantity or quality of gifts is irrelevant. Individuals adopt those “notions that favor their own interests… drastically underestimate how strong their bias would be” (21). And “disclosure may have perverse effects”; “the implication for industry gifts is straightforward: they should be prohibited” (22). We may be learning much about drug (product) prescribing – our most common activity – from sources that stand to profit from our choices. We also may be abdicating our responsibility to educate ourselves impartially. 

The following are documented examples of industry influence on physicians:

  • Physicians’ prescribing habits reflect a preponderance of commercial over scientific influence (23).

  • Physicians’ requests to add drugs to formularies were strongly associated with physicians’ interactions with companies manufacturing the drug (24).

  • Of articles published in literature, more articles with drug company support than without were likely to favor the drug of interest (25).

  • Authors supporting calcium channel blockers during a recent controversy were more likely to have financial relationships to manufacturers than other authors (26).

  • Significant increase in physician prescribing followed all expense paid educational meetings at luxury resorts (27). 

To avoid any and all conflicting influences and to maintain the ethical standards deemed by our profession, gifts should be eliminated. This is the best way to avoid ethical dilemmas.