Friday, September 18, 2009

Ethical Considerations Of Pharmaceutical Sales In The Primary Care Arena

The conflict of interest between pharmaceutical sales and the ethical practice of medicine has long existed. While pharmaceutical companies have lost much of their ability to financially incentivize clinicians, they continue to have undue influence over prescribing practice by means of "detailing." In an attempt to gain large market shares, these companies exploit this mode of medical information dissemination, creating enormous endorsement bias, and ultimately placing patients at the mercy of these manipulation tactics. Jonsen et al. have established the four topic method of ethical discourse which includes medical indications, patient preferences, quality of life, and contextual features. These topics allow for an intelligent discussion concerning the ethics of pharmaceutical business practices. The integrity of evidence-based medicine as well as the safety and welfare of patients are at risk. How clinicians respond to these pressures will have positive or negative impact on this medical ethics dilemma.

Thursday, September 10, 2009

Introduction

The conflict of interest between pharmaceutical sales and the ethical practice of medicine has long existed. Since the 1950s, educators, administrators, researchers, and clinicians have fought for corrective action (Podolsky & Greene, 2008). Pharmaceutical companies have spent approximately $21 billion dollars on marketing while 90% of this budget has gone toward directly influencing physician practice (Brennan et al., 2006). Physicians and other health care practitioners have a fiduciary duty to act in the best interest of their patients. Jonsen, Siegler, and Winslade (2006) define this duty as, "[owing] undivided loyalty to clients and [working] for their benefit" (p. 163). Furthermore, according to these authors, it is especially important that fiduciaries avoid financial conflicts of interest that "prejudice their clients' interest" (p. 163).

Now that pharmaceutical companies have lost much of their ability to financially persuade practitioners with large monetary gifts, the focus on ethics behind their influence has shifted more toward the issue of "detailing" (Huddle, 2008). "Detailing" is loosely defined as the process of face to face contact between a medical provider and drug company representative ("drug rep") for the purposes of educating the medical provider on all of the details of a particular drug, service, or device. Many argue that a conflict of interest still exists for patients, despite a cap on monetary incentives (Brennan et al., 2006; Higgins, 2007; Spurling & Mansfield, 2007). They contend that any gift, large or small, may still influence the decision making process of a medical provider, and thus conflict with the better interest of the patient. They often site social science research which has demonstrated the powerful impulse to reciprocate for even small gifts (Brennan et al., 2006). Indeed, from their standpoint, pens and lunches strongly count toward that influence. For those who seem to believe that little influence can be generated from such small gifts, the persuasion is thought to stem from the dissemination of biased information (Huddle, 2008). These conflicting viewpoints have stirred an ongoing battle between the unbiased better interest of patient care and the financial self-interest of multibillion dollar pharmaceutical companies. The integrity of evidence-based medicine and ultimately the safety and welfare of patients hang in the balance as the battle wages on.

Through the litmus of Jonsen et al. four topic method, the far reaching implications of this subject will be explored.

Friday, August 21, 2009

Medical Indications

Medical indications are defined as "the facts, opinions, and interpretations about the patient's physical and/or psychological condition that provide a reasonable justification for diagnostic and therapeutic interventions." (Jonsen et al., 2006, p. 14) The concepts of beneficence and nonmaleficence must be considered regarding what is medically indicated for patients. These concepts define what is necessary to create maximum benefit and avoid harm to the patient. The conflict of interest caused within the drug rep/provider relationship, through the use of detailing and gifting providers, sheds suspicion on what is truly medically indicated for patients. Clinicians often have enormous choices when it comes to what medicine or device they may chose for a patient. Unfortunately, many providers succumb to the pressures placed upon them by drug or device representatives when it comes to patient care. This may not be in the patient's best interest.

Evidence-based practice has emerged as the new standard of patient care. As such, many higher educational institutions have begun to shun pharmaceutical influence in the way they provide care for their patients. For example, Yale, Stanford, and the University of Pennsylvania have limited relationships between member healthcare providers and pharmaceutical companies (Higgins, 2007). Yet other institutions embrace these types of symbiotic relationships. At the forefront of this practice is the Weill Medical College of Cornell University, who recently opened the Clinique Skin Wellness Center (Higgins, 2007). Created mostly from a $4.75 million dollar grant from Clinique, the center justifies its existence through the education of skin cancer prevention. While this is a noble effort, physicians in this setting will find it difficult to convince patients the care they are receiving is unbiased (Higgins, 2007). In other words, providers in this setting might find it difficult to provide medically indicated and evidence-based care when that evidence points away from the use of Clinique products. What are the plans in case of therapeutic failure should Clinique products and educational materials bring detriment to patients? The probabilities of success of Clinique products should have been weighed against the larger body of evidence based medicine before this relationship of biased synergy was struck.