further examine the nature and value of university-industry collaboration in medical research.
With the benefits of research collaboration and the expansion of financial relationships in other areas have also come conflicts of interest and evidence of bias. For example, in clinical research, unfavorable results in some major industry-sponsored trials have been withheld from publication, thus distorting the totality of the findings included in the scientific literature. These trials involved drugs commonly prescribed for arthritis, depression, and elevated cholesterol levels, among other medications (Wright et al., 2001; Gibson, 2004; Whittington et al., 2004; Kastelein et al., 2008). Not publishing negative results undermines evidence-based medicine and puts millions of patients at risk for using ineffective or unsafe drugs. One striking case involves the withholding of negative findings from pediatric clinical trials of the effects of selective serotonin reuptake inhibitors on depression (Healy, 2006; Turner et al., 2008). Findings were withheld so frequently that although one meta-analysis of the published literature (ACN, 2004) concluded that these drugs were safe and effective, another meta-analysis (Whittington et al., 2004) that took into account unpublished as well as published data concluded the opposite: that the risks outweigh the benefits for all but one drug in this class of antidepressants. A recent analysis found that more than half of the trials used to support Food and Drug Administration approval for the marketing of a drug or medical device had not been published within 5 years after approval (Lee et al., 2008). In addition, litigation has revealed documents that link bias in publications to financial relationships with pharmaceutical manufacturers (Steinman et al., 2006; Psaty and Kronmal, 2008; Ross et al., 2008). As discussed in Chapter 4, the statistical associations involving industry sponsorship do not prove causality, but they do raise serious concerns about undue industry influence and have prompted a range of responses, including the creation of publication protections in university-industry research contracts and the issuance of regulations and other requirements that the results of clinical trials be reported in clinical trial registries.
In medical education, it is particularly troublesome when a faculty member is a promotional speaker for a pharmaceutical, medical device, or biotechnology company or agrees to be listed as an author for a ghostwritten publication. This is because faculty members are expected to present unbiased information and objective assessments of the scientific literature and to help medical students, residents, and fellows develop life-long habits of exercising independent judgment and critically evaluating scientific evidence. They are also expected to serve as role models of professionalism. These expectations may be undermined by some financial relationships between faculty and industry and by failures to disclose such relationships.
In clinical care, patients need to trust that their physicians’ recommen-