Drug Research and Development

Pharmacology, unlike some other basic science disciplines, has a unique status when it comes to potential conflicts of interest. The pharmaceutical industry combines a desire for discovery and development with profit-motivated marketing and sales goals. Although scientists and physicians share the desire for drug discovery and development and are motivated by the desire to contribute to scientific advancement and improved patient care, pharmaceutical companies are simultaneously under strong commercial pressures. Pharmaceutical companies are therefore willing to offer financial incentives to physician-researchers who conduct studies, recruit patients, or are helpful in product development and testing. In some cases, this financial support may compromise professional judgment in conducting, analyzing, or reporting research.

For example, often a pharmaceutical company will contract with a private physician to recruit patients into a drug study. While this arrangement frequently offers patients access to treatment that might otherwise be unavailable, the potential conflict may ultimately result in lack of objectivity in study design, data interpretation, and dissemination of research results. For example, a 1986 study in the Journal of General Internal Medicine found a statistically significant relationship between drug company funding and outcomes favoring a new therapy.

In addition, this kind of arrangement places the physician in a dual role as a clinician-researcher, with sometimes competing obligations to the drug company and the patient. The doctor assumes a position of responsibility to the company while simultaneously maintaining the usual duties to protect and benefit his or her patients. The physician's role as patient advocate can easily be compromised, since physicians also have a potentially competing interest in enrolling patients in the trial. In fact, patients may mistakenly believe that when their personal family physician suggests they enroll as a subject in a study, the doctor is suggesting enrollment because it is in that specific patient's interest to participate. However, the enrollment offer probably has little to do with that particular patient's care and more to do with the physician's desire to enroll subjects.

At minimum, the principles of autonomy and beneficence require that patients be told the source of funding for sponsored studies in which they are invited to enroll and advised of any potential conflicts between the physician's research interests and treatment recommendations.

Although disclosure to patients is important, patients are generally ill suited to assess how a potential conflict of interest actually affects their treatment. In addition to disclosure to patients, we need rigorous reporting requirements for those engaged in drug studies.

Institutions should implement clear policies, and professional guidelines should be developed, to prohibit relationships that place patient care secondary to financial gain.

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