Academic medical centers, private industry, and clinical trials: how do we achieve fairness, objectivity, and balance?

Abstract

The availability of funding for biomedical research frompublic sources is diminishing in industrialized nations.Many of these countries have historically committedenormous resources to the medical research process. Inthe US, the budget of the National Institutes of Health(NIH), which provides the majority of public researchfunding for clinical and basic science investigations, hasremained nearly unaltered for four consecutive years. Infact, the NIH budget has consistently been $28 billion(USD) for the last 2 years and is already projected toremain at this level for the next fiscal year, despite therising cost of research related to inflation in our economy[1]. As investigators, we must seek other funding opportu-nities to continue the acquisition of new knowledge at apace demanded by our patients.As clinical research funding becomes less of a priorityfor some governments, academic medical centers are morefrequently turning to private industry to sustain theircommitment to research. A recent survey of 122 majoracademic medical centers in the US revealed that 79% of allclinical trials were sponsored by private industry, and 76%of funding for clinical investigations came from private,for-profit companies [2]. The 4th Report of the HealthSelect Committee 2005 [3] reports that 75% of clinicaltrials reported in Lancet, the New England Journal ofMedicine,andtheJournal of the American MedicalAssociation are industry sponsored and that over 50% ofthese manuscripts may be ghost-written. It is unlikely thatthis trend of increasing industry-supported clinical researchwill reverse or even slow down.Medical school faculty, community physicians, hospitaladministrators, pharmaceutical and medical device compa-nies, and many other members of the health care commu-nity share a common, altruistic goal: we must provide thebest possible care for our patients. Few would disagree withthis assertion. Indeed, our dilemma arises from the otherresponsibilities that each of these entities maintains.These “other responsibilities” are the source of ourconflicting interests that can lead to ethical problems thatundermine our common goal of quality patient care.Certainly, those with faculty appointments must be aca-demically productive. In the US, community physiciansmust meet realistic reimbursement goals to sustain the ever-increasing cost of operating a medical practice. Those whomanage and direct hospitals must demonstrate financialstability to hospital boards and investors. Pharmaceuticaland medical device companies are beholden to shareholders and board members.Clinical investigators, research sponsors, peer reviewers,institutional review boards, department chairmen, andjournal editors are charged to ensure that research isconducted, analyzed, and published in a safe, objectivefashion with full disclosure of all possible conflicts ofinterest. Furthermore, it is equally important that theseentities ensure registration and/or publication of trials thatshow no benefit of a particular medication or medicaldevice.In the US, the academic community and the pharmaceu-tical industry are exploring innovative ways to allow patientcare to remain the priority, while allowing each member ofthe research team to realize his or her own secondary goals.It is encouraging that the problems associated withindustry-sponsored research have recently gained attention