Impugning the Integrity of Medical Science

Abstract

THE PROFESSION OF MEDICINE, IN EVERY ASPECT— clinical, education, and research—has been inundated with profound influence from the pharmaceutical and medical device industries. This has occurred because physicians have allowed it to happen, and it is time to stop. Two articles in this issue of JAMA provide a glimpse of one company’s apparent misrepresentation of research data and its manipulation of clinical research articles and clinical reviews; such information and articles influence the education and clinical practice of physicians and other health professionals. The direct influence of for-profit companies on education and clinical practice has been well documented, so this Editorial deals primarily with clinical research. The articles by Ross and colleagues and by Psaty and Kronmal documenthowonecompany,MerckCwere not required by the journal in which the study was published todisclosetheir financialsupportorrelationshipwiththesponsor; did report their financial support or relationship with the sponsor,but the journal chosenot topublish thoseauthordisclosures; or did disclose their financial support, and those disclosures were published. However, it is clear that at least some of the authors played little direct roles in the study or review, yet still allowed themselves to be named as authors. Individuals, particularly physicians,whoallowthemselves tobeused in thisway,especially for financialgain,manifestabehaviorthat isunprofessionaland demeaningto themedicalprofessionandtoscientific research. The study by Psaty and Kronmal, which is based on analysis of published articles, information provided by the company to the US Food and Drug Administration (FDA), and the company’s own internal analysis, shows how Merck may havemisrepresented the risk-benefitprofileof rofecoxib inclinical trials involving patients with Alzheimer disease or dementia. The authors show that the company’s report to the FDA appears to have attempted to minimize the mortality risk by using an “as-treated” analysis, whereas an internal analysis conducted by the company several months earlier and using the correct intention-to-treat analysis provided evidence of a significantly increased mortality risk among patients assigned to receive rofecoxib. The authors also report that, for at least 1 rofecoxib trial, company documents reveal that there had been no data and safety monitoring board in place, thereby potentially endangeringpatientswhoparticipated in this study.Moreover, as Ross et al describe in their evaluation of this same trial (Figure 2 in their article), the data analysis for this study may have been completed before the academically affiliated authors were involved with the manuscript; this may not be surprising, given that 8 of the 11 authors named in the byline of the published article are identified as being Merck employees. Journal editors also bear some of the responsibility for enabling companies to manipulate publications. Some editors may allow articles and supplements to be published without requiring complete disclosure of individual financial support, and without requiring clear and complete disclosure of industry support of and direct involvement with research ar-