Patricia J. Byrns

Methodology for assessing drug-drug interaction evidence in the peer-reviewed medical literature

Abstract Objective The aim of this study was to create a methodology for evidence-based assessment of published drug-drug interaction information and presentation of that information in a standardized format. Background Inconsistencies in drug-drug interaction information among major medical compendia have been documented and are of major concern to physicians, pharmacists, drug utilization review (DUR) program operators, and patients. Most compendia fail to document their methodology for listing or rating the potential clinical severity of drug-drug interactions. Inconsistent information about drug-drug interactions can cause prescribing problems and variations, possibly increasing the incidence of morbidity and mortality. Methods The available literature (MEDLINE ® , EMBASE ® , International Pharmaceutical Abstracts) on systematic reviews, methodologic quality assessment of research articles, and causality assessment of adverse drug events was searched to identify the best practices for creation of an evidence-based drug-drug interaction information review process. A suggested format for standardized presentation of this information is described. Results The following 5-step process was created to assess published drug-drug interaction information: (1) search the medical literature for published drug-drug interaction information; (2) assess the relevance of the articles; (3) assess the quality of the articles; (4) assess drug-drug interaction causality; and (5) abstract the findings and present the evidence. Conclusions Evidence-based assessment of published drugdrug interaction information appears to be feasible and would help clinicians, DUR program operators, and patients. Assessment of this information on a large scale, however, will require significant resources and the resolution of a number of technical issues.

Primary Prevention Research in Suicide

At the American Association of Suicidology’s (AAS) 46th Annual Conference in Austin, Texas (http://www.suicidology.org/web/guest/education-and-training/annualconference), participants were challenged to address why there has not been more progress in reducing the rates of completed suicides (Berman, 2013). A draft of recommendations from the National Action Alliance for Suicide Prevention’s Research Prioritization Task Force was presented at the meeting and subsequently published in this journal (National Action Alliance for Suicide Prevention [NAASP], 2013a, 2013b). The purpose of this commentary is to address this challenge by emphasizing the importance of employing a disease etiology strategy that integrates molecular data with clinical data, environmental data, and health outcomes in a dynamic, iterative fashion. The recommendations of the Research Prioritization Task Force tackle important public health program issues and are embedded within seven key questions, summarized as: 1. Why do people become suicidal? 2. How do we better detect/predict risk? 3. What interventions prevent suicidal behavior? 4. What are the effective services for treating suicidal persons and preventing suicidal behavior? 5. How do we reduce stigma? 6. What are the suicide prevention interventions outside of health-care settings? 7. Which existing and new infrastructure needs are required to further reduce suicidal behavior? (NAASP, 2013b; Silverman et al., 2013)

Is the crisis in clinical research being effectively addressed

From 1979 to 1999, we were warned repeatedly by many of American medicines best known and most respected leaders of an impending “crisis” in clinical research. Data were provided to indicate that both the number of physician-scientists actively involved in the conduct of clinical research and the number of young people choosing to pursue careers as clinical investigators were clearly dwindling. Although that may have been true in the 1980s and 1990s, many of us have become increasingly optimistic about what appears to be occurring in the first decade of the twenty-first century. Data now suggest that many of the efforts designed to develop young physician-scientists are starting to reverse this decline. As indicated in their recent report, Drs. Ley and Rosenberg observed an uptrend in the number of first-time MD applicants for National Institutes of Health (NIH) grants.1From approximately 750 to 800 in the period from 1995 to 1999, they noted a steady increase in first-time MD applicants over the ensuing 4 years, reaching a peak of 995 applicants in 2003. Similar increases were also found for first-time MD-PhD applicants during this same period. They also observed an impressive increase in the number of R01 applications submitted by MDs (an increase from approximately 3,000 in 1998 to 4,409 in 2004), as well as for MD-PhDs (an increase from approximately 2,200 in 1998 to 3,859 in 2004). All of these numbers had not changed or actually declined during the preceding 5-year period (1995-1999). Although Drs. Ley and Rosenberg did not discriminate between clinical and nonclinical applications, the article in this issue of the Journal by Kotchen and colleagues does just that.2Furthermore, their data in Table 2 show that when compared with 1994, the number of clinical research applications in 2004 rose from 4,126 to 5,813, a …