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1.  Interactions between Non-Physician Clinicians and Industry: A Systematic Review 
PLoS Medicine  2013;10(11):e1001561.
In a systematic review of studies of interactions between non-physician clinicians and industry, Quinn Grundy and colleagues found that many of the issues identified for physicians' industry interactions exist for non-physician clinicians.
Please see later in the article for the Editors' Summary
Background
With increasing restrictions placed on physician–industry interactions, industry marketing may target other health professionals. Recent health policy developments confer even greater importance on the decision making of non-physician clinicians. The purpose of this systematic review is to examine the types and implications of non-physician clinician–industry interactions in clinical practice.
Methods and Findings
We searched MEDLINE and Web of Science from January 1, 1946, through June 24, 2013, according to PRISMA guidelines. Non-physician clinicians eligible for inclusion were: Registered Nurses, nurse prescribers, Physician Assistants, pharmacists, dieticians, and physical or occupational therapists; trainee samples were excluded. Fifteen studies met inclusion criteria. Data were synthesized qualitatively into eight outcome domains: nature and frequency of industry interactions; attitudes toward industry; perceived ethical acceptability of interactions; perceived marketing influence; perceived reliability of industry information; preparation for industry interactions; reactions to industry relations policy; and management of industry interactions. Non-physician clinicians reported interacting with the pharmaceutical and infant formula industries. Clinicians across disciplines met with pharmaceutical representatives regularly and relied on them for practice information. Clinicians frequently received industry “information,” attended sponsored “education,” and acted as distributors for similar materials targeted at patients. Clinicians generally regarded this as an ethical use of industry resources, and felt they could detect “promotion” while benefiting from industry “information.” Free samples were among the most approved and common ways that clinicians interacted with industry. Included studies were observational and of varying methodological rigor; thus, these findings may not be generalizable. This review is, however, the first to our knowledge to provide a descriptive analysis of this literature.
Conclusions
Non-physician clinicians' generally positive attitudes toward industry interactions, despite their recognition of issues related to bias, suggest that industry interactions are normalized in clinical practice across non-physician disciplines. Industry relations policy should address all disciplines and be implemented consistently in order to mitigate conflicts of interest and address such interactions' potential to affect patient care.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Making and selling health care goods (including drugs and devices) and services is big business. To maximize the profits they make for their shareholders, companies involved in health care build relationships with physicians by providing information on new drugs, organizing educational meetings, providing samples of their products, giving gifts, and holding sponsored events. These relationships help to keep physicians informed about new developments in health care but also create the potential for causing harm to patients and health care systems. These relationships may, for example, result in increased prescription rates of new, heavily marketed medications, which are often more expensive than their generic counterparts (similar unbranded drugs) and that are more likely to be recalled for safety reasons than long-established drugs. They may also affect the provision of health care services. Industry is providing an increasingly large proportion of routine health care services in many countries, so relationships built up with physicians have the potential to influence the commissioning of the services that are central to the treatment and well-being of patients.
Why Was This Study Done?
As a result of concerns about the tension between industry's need to make profits and the ethics underlying professional practice, restrictions are increasingly being placed on physician–industry interactions. In the US, for example, the Physician Payments Sunshine Act now requires US manufacturers of drugs, devices, and medical supplies that participate in federal health care programs to disclose all payments and gifts made to physicians and teaching hospitals. However, other health professionals, including those with authority to prescribe drugs such as pharmacists, Physician Assistants, and nurse practitioners are not covered by this legislation or by similar legislation in other settings, even though the restructuring of health care to prioritize primary care and multidisciplinary care models means that “non-physician clinicians” are becoming more numerous and more involved in decision-making and medication management. In this systematic review (a study that uses predefined criteria to identify all the research on a given topic), the researchers examine the nature and implications of the interactions between non-physician clinicians and industry.
What Did the Researchers Do and Find?
The researchers identified 15 published studies that examined interactions between non-physician clinicians (Registered Nurses, nurse prescribers, midwives, pharmacists, Physician Assistants, and dieticians) and industry (corporations that produce health care goods and services). They extracted the data from 16 publications (representing 15 different studies) and synthesized them qualitatively (combined the data and reached word-based, rather than numerical, conclusions) into eight outcome domains, including the nature and frequency of interactions, non-physician clinicians' attitudes toward industry, and the perceived ethical acceptability of interactions. In the research the authors identified, non-physician clinicians reported frequent interactions with the pharmaceutical and infant formula industries. Most non-physician clinicians met industry representatives regularly, received gifts and samples, and attended educational events or received educational materials (some of which they distributed to patients). In these studies, non-physician clinicians generally regarded these interactions positively and felt they were an ethical and appropriate use of industry resources. Only a minority of non-physician clinicians felt that marketing influenced their own practice, although a larger percentage felt that their colleagues would be influenced. A sizeable proportion of non-physician clinicians questioned the reliability of industry information, but most were confident that they could detect biased information and therefore rated this information as reliable, valuable, or useful.
What Do These Findings Mean?
These and other findings suggest that non-physician clinicians generally have positive attitudes toward industry interactions but recognize issues related to bias and conflict of interest. Because these findings are based on a small number of studies, most of which were undertaken in the US, they may not be generalizable to other countries. Moreover, they provide no quantitative assessment of the interaction between non-physician clinicians and industry and no information about whether industry interactions affect patient care outcomes. Nevertheless, these findings suggest that industry interactions are normalized (seen as standard) in clinical practice across non-physician disciplines. This normalization creates the potential for serious risks to patients and health care systems. The researchers suggest that it may be unrealistic to expect that non-physician clinicians can be taught individually how to interact with industry ethically or how to detect and avert bias, particularly given the ubiquitous nature of marketing and promotional materials. Instead, they suggest, the environment in which non-physician clinicians practice should be structured to mitigate the potentially harmful effects of interactions with industry.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001561.
This study is further discussed in a PLOS Medicine Perspective by James S. Yeh and Aaron S. Kesselheim
The American Medical Association provides guidance for physicians on interactions with pharmaceutical industry representatives, information about the Physician Payments Sunshine Act, and a toolkit for preparing Physician Payments Sunshine Act reports
The International Council of Nurses provides some guidance on industry interactions in its position statement on nurse-industry relations
The UK General Medical Council provides guidance on financial and commercial arrangements and conflicts of interest as part of its good medical practice website, which describes what is required of all registered doctors in the UK
Understanding and Responding to Pharmaceutical Promotion: A Practical Guide is a manual prepared by Health Action International and the World Health Organization that schools of medicine and pharmacy can use to train students how to recognize and respond to pharmaceutical promotion.
The Institute of Medicine's Report on Conflict of Interest in Medical Research, Education, and Practice recommends steps to identify, limit, and manage conflicts of interest
The University of California, San Francisco, Office of Continuing Medical Education offers a course called Marketing of Medicines
doi:10.1371/journal.pmed.1001561
PMCID: PMC3841103  PMID: 24302892
2.  Conference Proceedings: “Down Syndrome: National Conference on Patient Registries, Research Databases, and Biobanks” 
Molecular genetics and metabolism  2011;104(1-2):13-22.
A December 2010 meeting, “Down Syndrome: National Conference on Patient Registries, Research Databases, and Biobanks,” was jointly sponsored by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at the National Institutes of Health (NIH) in Bethesda, MD, and the Global Down Syndrome Foundation (GDSF)/Linda Crnic Institute for Down Syndrome based in Denver, CO. Approximately 70 attendees and organizers from various advocacy groups, federal agencies (Centers for Disease Control and Prevention, and various NIH Institutes, Centers, and Offices), members of industry, clinicians, and researchers from various academic institutions were greeted by Drs. Yvonne Maddox, Deputy Director of NICHD, and Edward McCabe, Executive Director of the Linda Crnic Institute for Down Syndrome. They charged the participants to focus on the separate issues of contact registries, research databases, and biobanks through both podium presentations and breakout session discussions. Among the breakout groups for each of the major sessions, participants were asked to generate responses to questions posed by the organizers concerning these three research resources as they related to Down syndrome and then to report back to the group at large with a summary of their discussions. This report represents a synthesis of the discussions and suggested approaches formulated by the group as a whole.
doi:10.1016/j.ymgme.2011.07.005
PMCID: PMC3171614  PMID: 21835664
Down syndrome; registry; database; biobank; trisomy 21
3.  Challenges, Progress, and Opportunities: Proceedings of the Filovirus Medical Countermeasures Workshop 
Viruses  2014;6(7):2673-2697.
On August 22–23, 2013, agencies within the United States Department of Defense (DoD) and the Department of Health and Human Services (HHS) sponsored the Filovirus Medical Countermeasures (MCMs) Workshop as an extension of the activities of the Filovirus Animal Non-clinical Group (FANG). The FANG is a federally-recognized multi-Agency group established in 2011 to coordinate and facilitate U.S. government (USG) efforts to develop filovirus MCMs. The workshop brought together government, academic and industry experts to consider the needs for filovirus MCMs and evaluate the status of the product development pipeline. This report summarizes speaker presentations and highlights progress and challenges remaining in the field.
doi:10.3390/v6072673
PMCID: PMC4113787  PMID: 25010768
Ebola; Sudan; ebolavirus; Marburg virus; marburgvirus; Filoviridae; filovirus medical countermeasures; Filovirus Animal Non-clinical Group; FANG
4.  B.M.A. Annual Meeting, Sydney, 10–16 August: Report of Proceedings 
British Medical Journal  1968;3(5616):485-492.
The One Hundred and Thirty-sixth Annual Meeting of the British Medical Association was held in Sydney from 10 to 16 August jointly with the Seventh Annual Meeting of the Australian Medical Association. Both meetings were associated with the Third Australian Medical Congress. It was the second Annual Meeting of the Association to be held in Australia, the previous one having been in Melbourne in 1935. Four plenary sessions were held on successive mornings, while meetings of various sections were held in the afternoons. An account of the first part of the Meeting is given below. The remainder will be reported next week.
Images
PMCID: PMC1986422
5.  Pan-Canadian REspiratory STandards INitiative for Electronic Health Records (PRESTINE): 2011 National Forum Proceedings 
In a novel knowledge translation initiative, the Government of Ontario’s Asthma Plan of Action funded the development of an Asthma Care Map to enable adherence with the Canadian Asthma Consensus Guidelines developed under the auspices of the Canadian Thoracic Society (CTS). Following its successful evaluation within the Primary Care Asthma Pilot Project, respiratory clinicians from the Asthma Research Unit, Queen’s University (Kingston, Ontario) are leading an initiative to incorporate standardized Asthma Care Map data elements into electronic health records in primary care in Ontario. Acknowledging that the issue of data standards affects all respiratory conditions, and all provinces and territories, the Government of Ontario approached the CTS Respiratory Guidelines Committee. At its meeting in September 2010, the CTS Respiratory Guidelines Committee agreed that developing and standardizing respiratory data elements for electronic health records are strategically important. In follow-up to that commitment, representatives from the CTS, the Lung Association, the Government of Ontario, the National Lung Health Framework and Canada Health Infoway came together to form a planning committee. The planning committee proposed a phased approach to inform stakeholders about the issue, and engage them in the development, implementation and evaluation of a standardized dataset. An environmental scan was completed in July 2011, which identified data definitions and standards currently available for clinical variables that are likely to be included in electronic medical records in primary care for diagnosis, management and patient education related to asthma and COPD. The scan, sponsored by the Government of Ontario, includes compliance with clinical nomenclatures such as SNOMED-CT® and LOINC®. To help launch and create momentum for this initiative, a national forum was convened on October 2 and 3, 2011, in Toronto, Ontario. The forum was designed to bring together key stakeholders across the spectrum of respiratory care, including clinicians, researchers, health informaticists and administrators to explore and recommend a potential scope, approach and governance structure for this important project. The Pan-Canadian REspiratory STandards INitiative for Electronic Health Records (PRESTINE) goal is to recommend respiratory data elements and standards for use in electronic medical records across Canada that meet the needs of providers, administrators, researchers and policy makers to facilitate evidence-based clinical care, monitoring, surveillance, benchmarking and policy development. The focus initially is expected to include asthma, chronic obstructive pulmonary disease and pulmonary function standards elements that are applicable to many respiratory conditions. The present article summarizes the process and findings of the forum deliberations.
PMCID: PMC3373278  PMID: 22536581
Asthma; Clinical practice guidelines; Clinical variables; COPD; Data definitions; Electronic health records; Electronic medical records; Knowledge translation; Respiratory data sets; Surveillance
6.  National Medical Association/National Institutes of Health Workshop on Violence and the Conduct of Research. Workgroup Proceedings, June 1-2, 1994. 
The physical, economic, and mental toll caused by violence in the United States has put tremendous pressure on American medical, political, religious, and social institutions. The impact in urban neighborhoods has been especially harrowing, forcing African-American organizations to address this domestic problem with ideas and suggestions unique to their philosophies and collective talents. This article contains general perspectives and commentary from physicians and social science experts who participated in a workshop sponsored by the National Medical Association, the National Institute of Drug Abuse, and the National Institute of Mental Health to discuss topics on violence, its health consequences, and the conduct of research in the African-American community.
PMCID: PMC2607952  PMID: 8907813
7.  Promoting the Usability of Online AMIA Symposium Proceedings 
A semi-automatic procedure that extracts metadata from MEDLINE was used to develop a search tool that facilitates online location and (free) access to full-text electronic documents from the Proceedings of the American Medical Informatics Association (AMIA) Annual Symposia (1997–2003). Log file analysis for six months showed steady use of the tool, with most queries originating from hosts in the US (60%), Canada (15.3%), Argentina (10.2%) and Australia (9.6%) for common informatics topics.
PMCID: PMC1560628  PMID: 16779295
8.  Medical Students' Exposure to and Attitudes about the Pharmaceutical Industry: A Systematic Review 
PLoS Medicine  2011;8(5):e1001037.
A systematic review of published studies reveals that undergraduate medical students may experience substantial exposure to pharmaceutical marketing, and that this contact may be associated with positive attitudes about marketing.
Background
The relationship between health professionals and the pharmaceutical industry has become a source of controversy. Physicians' attitudes towards the industry can form early in their careers, but little is known about this key stage of development.
Methods and Findings
We performed a systematic review reported according to PRISMA guidelines to determine the frequency and nature of medical students' exposure to the drug industry, as well as students' attitudes concerning pharmaceutical policy issues. We searched MEDLINE, EMBASE, Web of Science, and ERIC from the earliest available dates through May 2010, as well as bibliographies of selected studies. We sought original studies that reported quantitative or qualitative data about medical students' exposure to pharmaceutical marketing, their attitudes about marketing practices, relationships with industry, and related pharmaceutical policy issues. Studies were separated, where possible, into those that addressed preclinical versus clinical training, and were quality rated using a standard methodology. Thirty-two studies met inclusion criteria. We found that 40%–100% of medical students reported interacting with the pharmaceutical industry. A substantial proportion of students (13%–69%) were reported as believing that gifts from industry influence prescribing. Eight studies reported a correlation between frequency of contact and favorable attitudes toward industry interactions. Students were more approving of gifts to physicians or medical students than to government officials. Certain attitudes appeared to change during medical school, though a time trend was not performed; for example, clinical students (53%–71%) were more likely than preclinical students (29%–62%) to report that promotional information helps educate about new drugs.
Conclusions
Undergraduate medical education provides substantial contact with pharmaceutical marketing, and the extent of such contact is associated with positive attitudes about marketing and skepticism about negative implications of these interactions. These results support future research into the association between exposure and attitudes, as well as any modifiable factors that contribute to attitudinal changes during medical education.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
The complex relationship between health professionals and the pharmaceutical industry has long been a subject of discussion among physicians and policymakers. There is a growing body of evidence that suggests that physicians' interactions with pharmaceutical sales representatives may influence clinical decision making in a way that is not always in the best interests of individual patients, for example, encouraging the use of expensive treatments that have no therapeutic advantage over less costly alternatives. The pharmaceutical industry often uses physician education as a marketing tool, as in the case of Continuing Medical Education courses that are designed to drive prescribing practices.
One reason that physicians may be particularly susceptible to pharmaceutical industry marketing messages is that doctors' attitudes towards the pharmaceutical industry may form early in their careers. The socialization effect of professional schooling is strong, and plays a lasting role in shaping views and behaviors.
Why Was This Study Done?
Recently, particularly in the US, some medical schools have limited students' and faculties' contact with industry, but some have argued that these restrictions are detrimental to students' education. Given the controversy over the pharmaceutical industry's role in undergraduate medical training, consolidating current knowledge in this area may be useful for setting priorities for changes to educational practices. In this study, the researchers systematically examined studies of pharmaceutical industry interactions with medical students and whether such interactions influenced students' views on related topics.
What Did the Researchers Do and Find?
The researchers did a comprehensive literature search using appropriate search terms for all relevant quantitative and qualitative studies published before June 2010. Using strict inclusion criteria, the researchers then selected 48 articles (from 1,603 abstracts) for full review and identified 32 eligible for analysis—giving a total of approximately 9,850 medical students studying at 76 medical schools or hospitals.
Most students had some form of interaction with the pharmaceutical industry but contact increased in the clinical years, with up to 90% of all clinical students receiving some form of educational material. The highest level of exposure occurred in the US. In most studies, the majority of students in their clinical training years found it ethically permissible for medical students to accept gifts from drug manufacturers, while a smaller percentage of preclinical students reported such attitudes. Students justified their entitlement to gifts by citing financial hardship or by asserting that most other students accepted gifts. In addition, although most students believed that education from industry sources is biased, students variably reported that information obtained from industry sources was useful and a valuable part of their education.
Almost two-thirds of students reported that they were immune to bias induced by promotion, gifts, or interactions with sales representatives but also reported that fellow medical students or doctors are influenced by such encounters. Eight studies reported a relationship between exposure to the pharmaceutical industry and positive attitudes about industry interactions and marketing strategies (although not all included supportive statistical data). Finally, student opinions were split on whether physician–industry interactions should be regulated by medical schools or the government.
What Do These Findings Mean?
This analysis shows that students are frequently exposed to pharmaceutical marketing, even in the preclinical years, and that the extent of students' contact with industry is generally associated with positive attitudes about marketing and skepticism towards any negative implications of interactions with industry. Therefore, strategies to educate students about interactions with the pharmaceutical industry should directly address widely held misconceptions about the effects of marketing and other biases that can emerge from industry interactions. But education alone may be insufficient. Institutional policies, such as rules regulating industry interactions, can play an important role in shaping students' attitudes, and interventions that decrease students' contact with industry and eliminate gifts may have a positive effect on building the skills that evidence-based medical practice requires. These changes can help cultivate strong professional values and instill in students a respect for scientific principles and critical evidence review that will later inform clinical decision-making and prescribing practices.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001037.
Further information about the influence of the pharmaceutical industry on doctors and medical students can be found at the American Medical Students Association PharmFree campaign and PharmFree Scorecard, Medsin-UKs PharmAware campaign, the nonprofit organization Healthy Skepticism, and the Web site of No Free Lunch.
doi:10.1371/journal.pmed.1001037
PMCID: PMC3101205  PMID: 21629685
9.  Association of Medical Students' Reports of Interactions with the Pharmaceutical and Medical Device Industries and Medical School Policies and Characteristics: A Cross-Sectional Study 
PLoS Medicine  2014;11(10):e1001743.
Aaron Kesselheim and colleagues compared US medical students' survey responses regarding pharmaceutical company interactions with the schools' AMSA PharmFree scorecard and Institute on Medicine as a Profession's (IMAP) scores.
Please see later in the article for the Editors' Summary
Background
Professional societies use metrics to evaluate medical schools' policies regarding interactions of students and faculty with the pharmaceutical and medical device industries. We compared these metrics and determined which US medical schools' industry interaction policies were associated with student behaviors.
Methods and Findings
Using survey responses from a national sample of 1,610 US medical students, we compared their reported industry interactions with their schools' American Medical Student Association (AMSA) PharmFree Scorecard and average Institute on Medicine as a Profession (IMAP) Conflicts of Interest Policy Database score. We used hierarchical logistic regression models to determine the association between policies and students' gift acceptance, interactions with marketing representatives, and perceived adequacy of faculty–industry separation. We adjusted for year in training, medical school size, and level of US National Institutes of Health (NIH) funding. We used LASSO regression models to identify specific policies associated with the outcomes. We found that IMAP and AMSA scores had similar median values (1.75 [interquartile range 1.50–2.00] versus 1.77 [1.50–2.18], adjusted to compare scores on the same scale). Scores on AMSA and IMAP shared policy dimensions were not closely correlated (gift policies, r = 0.28, 95% CI 0.11–0.44; marketing representative access policies, r = 0.51, 95% CI 0.36–0.63). Students from schools with the most stringent industry interaction policies were less likely to report receiving gifts (AMSA score, odds ratio [OR]: 0.37, 95% CI 0.19–0.72; IMAP score, OR 0.45, 95% CI 0.19–1.04) and less likely to interact with marketing representatives (AMSA score, OR 0.33, 95% CI 0.15–0.69; IMAP score, OR 0.37, 95% CI 0.14–0.95) than students from schools with the lowest ranked policy scores. The association became nonsignificant when fully adjusted for NIH funding level, whereas adjusting for year of education, size of school, and publicly versus privately funded school did not alter the association. Policies limiting gifts, meals, and speaking bureaus were associated with students reporting having not received gifts and having not interacted with marketing representatives. Policy dimensions reflecting the regulation of industry involvement in educational activities (e.g., continuing medical education, travel compensation, and scholarships) were associated with perceived separation between faculty and industry. The study is limited by potential for recall bias and the cross-sectional nature of the survey, as school curricula and industry interaction policies may have changed since the time of the survey administration and study analysis.
Conclusions
As medical schools review policies regulating medical students' industry interactions, limitations on receipt of gifts and meals and participation of faculty in speaking bureaus should be emphasized, and policy makers should pay greater attention to less research-intensive institutions.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Making and selling prescription drugs and medical devices is big business. To promote their products, pharmaceutical and medical device companies build relationships with physicians by providing information on new drugs, by organizing educational meetings and sponsored events, and by giving gifts. Financial relationships begin early in physicians' careers, with companies providing textbooks and other gifts to first-year medical students. In medical school settings, manufacturers may help to inform trainees and physicians about developments in health care, but they also create the potential for harm to patients and health care systems. These interactions may, for example, reduce trainees' and trained physicians' skepticism about potentially misleading promotional claims and may encourage physicians to prescribe new medications, which are often more expensive than similar unbranded (generic) drugs and more likely to be recalled for safety reasons than older drugs. To address these and other concerns about the potential career-long effects of interactions between medical trainees and industry, many teaching hospitals and medical schools have introduced policies to limit such interactions. The development of these policies has been supported by expert professional groups and medical societies, some of which have created scales to evaluate the strength of the implemented industry interaction policies.
Why Was This Study Done?
The impact of policies designed to limit interactions between students and industry on student behavior is unclear, and it is not known which aspects of the policies are most predictive of student behavior. This information is needed to ensure that the policies are working and to identify ways to improve them. Here, the researchers investigate which medical school characteristics and which aspects of industry interaction policies are most predictive of students' reported behaviors and beliefs by comparing information collected in a national survey of US medical students with the strength of their schools' industry interaction policies measured on two scales—the American Medical Student Association (AMSA) PharmFree Scorecard and the Institute on Medicine as a Profession (IMAP) Conflicts of Interest Policy Database.
What Did the Researchers Do and Find?
The researchers compared information about reported gift acceptance, interactions with marketing representatives, and the perceived adequacy of faculty–industry separation collected from 1,610 medical students at 121 US medical schools with AMSA and IMAP scores for the schools evaluated a year earlier. Students at schools with the highest ranked interaction policies based on the AMSA score were 63% less likely to accept gifts as students at the lowest ranked schools. Students at the highest ranked schools based on the IMAP score were about half as likely to accept gifts as students at the lowest ranked schools, although this finding was not statistically significant (it could be a chance finding). Similarly, students at the highest ranked schools were 70% less likely to interact with sales representatives as students at the lowest ranked schools. These associations became statistically nonsignificant after controlling for the amount of research funding each school received from the US National Institutes of Health (NIH). Policies limiting gifts, meals, and being a part of speaking bureaus (where companies pay speakers to present information about the drugs for dinners and other events) were associated with students' reports of receiving no gifts and of non-interaction with sales representatives. Finally, policies regulating industry involvement in educational activities were associated with the perceived separation between faculty and industry, which was regarded as adequate by most of the students at schools with such policies.
What Do These Findings Mean?
These findings suggest that policies designed to limit industry interactions with medical students need to address multiple aspects of these interactions to achieve changes in the behavior and attitudes of trainees, but that policies limiting gifts, meals, and speaking bureaus may be particularly important. These findings also suggest that the level of NIH funding plays an important role in students' self-reported behaviors and their perceptions of industry, possibly because institutions with greater NIH funding have the resources needed to implement effective policies. The accuracy of these findings may be limited by recall bias (students may have reported their experiences inaccurately), and by the possibility that industry interaction policies may have changed in the year that elapsed between policy grading and the student survey. Nevertheless, these findings suggest that limitations on gifts should be emphasized when academic medical centers refine their policies on interactions between medical students and industry and that particular attention should be paid to the design and implementation of policies that regulate industry interactions in institutions with lower levels of NIH funding.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001743.
The UK General Medical Council provides guidance on financial and commercial arrangements and conflicts of interest as part of its good medical practice document, which describes what is required of all registered doctors in the UK
Information about the American Medical Student Association (AMSA) Just Medicine campaign (formerly the PharmFree campaign) and about the AMSA Scorecard is available
Information about the Institute on Medicine as a Profession (IMAP) and about its Conflicts of Interest Policy Database is also available
“Understanding and Responding to Pharmaceutical Promotion: A Practical Guide” is a manual prepared by Health Action International and the World Health Organization that medical schools can use to train students how to recognize and respond to pharmaceutical promotion
The US Institute of Medicine's report “Conflict of Interest in Medical Research, Education, and Practice” recommends steps to identify, limit, and manage conflicts of interest
The ALOSA Foundation provides evidence-based, non-industry-funded education about treating common conditions and using prescription drugs
doi:10.1371/journal.pmed.1001743
PMCID: PMC4196737  PMID: 25314155
10.  How Does Medical Device Regulation Perform in the United States and the European Union? A Systematic Review 
PLoS Medicine  2012;9(7):e1001276.
Aaron Kesselheim and colleagues conduct a systematic review to examine the strengths and weaknesses associated with approaches to medical device regulation in the US and EU.
Background
Policymakers and regulators in the United States (US) and the European Union (EU) are weighing reforms to their medical device approval and post-market surveillance systems. Data may be available that identify strengths and weakness of the approaches to medical device regulation in these settings.
Methods and Findings
We performed a systematic review to find empirical studies evaluating medical device regulation in the US or EU. We searched Medline using two nested categories that included medical devices and glossary terms attributable to the US Food and Drug Administration and the EU, following PRISMA guidelines for systematic reviews. We supplemented this search with a review of the US Government Accountability Office online database for reports on US Food and Drug Administration device regulation, consultations with local experts in the field, manual reference mining of selected articles, and Google searches using the same key terms used in the Medline search. We found studies of premarket evaluation and timing (n = 9), studies of device recalls (n = 8), and surveys of device manufacturers (n = 3). These studies provide evidence of quality problems in pre-market submissions in the US, provide conflicting views of device safety based largely on recall data, and relay perceptions of some industry leaders from self-surveys.
Conclusions
Few studies have quantitatively assessed medical device regulation in either the US or EU. Existing studies of US and EU device approval and post-market evaluation performance suggest that policy reforms are necessary for both systems, including improving classification of devices in the US and promoting transparency and post-market oversight in the EU. Assessment of regulatory performance in both settings is limited by lack of data on post-approval safety outcomes. Changes to these device approval and post-marketing systems must be accompanied by ongoing research to ensure that there is better assessment of what works in either setting.
Please see later in the article for the Editors' Summary.
Editors' Summary
Background
Medical devices—health technologies that are not medicines, vaccines, or clinical procedures—cover a vast range of equipment from the simple to the more complex. Medical devices are essential for patient care, and in the past decade, new devices have offered improved treatment alternatives for many diseases and conditions, leading to substantial growth in the US$350 billion medical device industry. However, new medical devices also pose substantial risks to patients, as shown in recent high-profile product recalls involving breast implants and artificial hip implants.
Why Was This Study Done?
Concerns about the safety of new medical devices have led to calls for greater testing of the safety and effectiveness of new devices before they come on the market and for improved monitoring of their performance after new devices have been approved for use by a regulatory body. In this study, the researchers systematically reviewed evidence about the performance of medical device approval and post-market surveillance systems in two of the most important world markets for medical devices—the United States and the European Union.
What Did the Researchers Do and Find?
The researchers performed a keyword search in Medline (a database of published biomedical literature) for all relevant articles, and supplemented this search with a review of reports on Food and Drug Administration (FDA) device regulation in the US Government Accountability Office's online database. Then they consulted with both US and EU experts and also conducted Google searches to capture reports by management consultant firms. The researchers included only those studies that reported empirical data, either qualitative or quantitative, about the characteristics, performance metrics, or effectiveness of device evaluation or post-market oversight in the US or EU.
Using these methods the researchers identified nine studies that focused on pre-market evaluation and timing, eight studies of device recalls, and three surveys of device manufacturers. Because of the variable quality and lack of outcomes from these studies and reports, the researchers concluded that these studies offered only limited insights into either the US or EU systems. But the available evidence does suggest that in the US, the FDA could improve oversight of device approval, for example, by following up on its commitment to reclassify high-risk medical devices and improve post-market surveillance of devices that are approved on the basis of limited data. The researchers also suggest that using recalls to measure the safety record of individual devices or classes of devices is flawed, as particular devices may be over- or underrepresented in recall data depending on the frequency of their use, design complexity, and the clinical manifestations of malfunction. In the EU, apart from a few studies addressing the timing of approval, the researchers found almost no robust data on device regulation. Some case reports suggested substantial dangers to patients in the EU from devices approved on the basis of limited data, but the researchers could not systematically compare the quality of studies used for device approval or post-approval safety outcomes between the EU and US, mainly because of the lack of transparency among the EU regulators (Notified Bodies).
What Do These Findings Mean?
These findings show that few studies have quantitatively assessed medical device regulation in either the US or EU, but the existing studies examined in this review suggest that policy reforms are necessary for both device approval and post-market evaluation of performance, including improving classification of devices in the US and promoting transparency and postmarket oversight in the EU. However, assessment of regulatory performance in both the US and EU is limited by lack of data on post-approval safety outcomes. Any changes to medical device approval and post-marketing systems should be accompanied by ongoing research and evaluation to ensure that there is an improved assessment of what works in either setting.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001276.
This study is further discussed in a PLoS Medicine Perspective by Sanket Dhruva and Rita Redberg
The WHO website has a comprehensive topic section on medical devices
Information on medical devices is also available from the FDA and the European Commission
doi:10.1371/journal.pmed.1001276
PMCID: PMC3418047  PMID: 22912563
11.  Promotional Tone in Reviews of Menopausal Hormone Therapy After the Women's Health Initiative: An Analysis of Published Articles 
PLoS Medicine  2011;8(3):e1000425.
Adriane Fugh-Berman and colleagues analyzed a selection of published opinion pieces on hormone therapy and show that there may be a connection between receiving industry funding for speaking, consulting, or research and the tone of such opinion pieces.
Background
Even after the Women's Health Initiative (WHI) found that the risks of menopausal hormone therapy (hormone therapy) outweighed benefit for asymptomatic women, about half of gynecologists in the United States continued to believe that hormones benefited women's health. The pharmaceutical industry has supported publication of articles in medical journals for marketing purposes. It is unknown whether author relationships with industry affect promotional tone in articles on hormone therapy. The goal of this study was to determine whether promotional tone could be identified in narrative review articles regarding menopausal hormone therapy and whether articles identified as promotional were more likely to have been authored by those with conflicts of interest with manufacturers of menopausal hormone therapy.
Methods and Findings
We analyzed tone in opinion pieces on hormone therapy published in the four years after the estrogen-progestin arm of the WHI was stopped. First, we identified the ten authors with four or more MEDLINE-indexed reviews, editorials, comments, or letters on hormone replacement therapy or menopausal hormone therapy published between July 2002 and June 2006. Next, we conducted an additional search using the names of these authors to identify other relevant articles. Finally, after author names and affiliations were removed, 50 articles were evaluated by three readers for scientific accuracy and for tone. Scientific accuracy was assessed based on whether or not the findings of the WHI were accurately reported using two criteria: (1) Acknowledgment or lack of denial of the risk of breast cancer diagnosis associated with hormone therapy, and (2) acknowledgment that hormone therapy did not benefit cardiovascular disease endpoints. Determination of promotional tone was based on the assessment by each reader of whether the article appeared to promote hormone therapy. Analysis of inter-rater consistency found moderate agreement for scientific accuracy (κ = 0.57) and substantial agreement for promotional tone (κ = 0.65). After discussion, readers found 86% of the articles to be scientifically accurate and 64% to be promotional in tone. Themes that were common in articles considered promotional included attacks on the methodology of the WHI, arguments that clinical trial results should not guide treatment for individuals, and arguments that observational studies are as good as or better than randomized clinical trials for guiding clinical decisions. The promotional articles we identified also implied that the risks associated with hormone therapy have been exaggerated and that the benefits of hormone therapy have been or will be proven. Of the ten authors studied, eight were found to have declared payment for speaking or consulting on behalf of menopausal hormone manufacturers or for research support (seven of these eight were speakers or consultants). Thirty of 32 articles (90%) evaluated as promoting hormone therapy were authored by those with potential financial conflicts of interest, compared to 11 of 18 articles (61%) by those without such conflicts (p = 0.0025). Articles promoting the use of menopausal hormone therapy were 2.41 times (95% confidence interval 1.49–4.93) as likely to have been authored by authors with conflicts of interest as by authors without conflicts of interest. In articles from three authors with conflicts of interest some of the same text was repeated word-for-word in different articles.
Conclusion
There may be a connection between receiving industry funding for speaking, consulting, or research and the publication of promotional opinion pieces on menopausal hormone therapy.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Over the past three decades, menopausal hormones have been heavily promoted for preventing disease in women. However, the Women's Health Initiative (WHI) study—which enrolled more than 26,000 women in the US and which was published in 2004—found that estrogen-progestin and estrogen-only formulations (often prescribed to women around the age of menopause) increased the risk of stroke, deep vein thrombosis, dementia, and incontinence. Furthermore, this study found that the estrogen-progestin therapy increased rates of breast cancer. In fact, the estrogen-progestin arm of the WHI study was stopped in 2002 due to harmful findings, and the estrogen-only arm was stopped in 2004, also because of harmful findings. In addition, the study also found that neither therapy reduced cardiovascular risk or markedly benefited health-related quality of life measures.
Despite these results, two years after the results of WHI study were published, a survey of over 700 practicing gynecologists—the specialists who prescribe the majority of menopausal hormone therapies—in the US found that almost half did not find the findings of the WHI study convincing and that 48% disagreed with the decision to stop the trial early. Furthermore, follow-up surveys found similar results.
Why Was This Study Done?
It is unclear why gynecologists and other physicians continue to prescribe menopausal hormone therapies despite the results of the WHI. Some academics argue that published industry-funded reviews and commentaries may be designed to convey specific, but subtle, marketing messages and several academic analyses have used internal industry documents disclosed in litigation cases. So this study was conducted to investigate whether hormone therapy–promoting tone could be identified in narrative review articles and if so, whether these articles were more likely to have been authored by people who had accepted funding from hormone manufacturers.
What Did the Researchers Do and Find?
The researchers conducted a comprehensive literature search that identified 340 relevant articles published between July 2002 and June 2006—the four years following the cessation of the estrogen-progestin arm of the women's health initiative study. Ten authors had published four to six articles, 47 authored two or three articles, and 371 authored one article each. The researchers focused on authors who had published four or more articles in the four-year period under study and, after author names and affiliations were removed, 50 articles were evaluated by three readers for scientific accuracy and for tone. After individually analyzing a batch of articles, the readers met to provide their initial assessments, to discuss them, and to reach consensus on tone and scientific accuracy. Then after the papers were evaluated, each author was identified and the researchers searched for authors' potential financial conflicts of interest, defined as publicly disclosed information that the authors had received payment for research, speaking, or consulting on behalf of a manufacturer of menopausal hormone therapy.
Common themes in the 50 articles included arguments that clinical trial results should not guide treatment for individuals and suggestions that the risks associated with hormone therapy have been exaggerated and that the benefits of hormone therapy have been or will be proven. Furthermore, of the ten authors studied, eight were found to have received payment for research, speaking or consulting on behalf of menopause hormone manufacturers, and 30 of 32 articles evaluated as promoting hormone therapy were authored by those with potential financial conflicts of interest. Articles promoting the use of menopausal hormone therapy were more than twice as likely to have been written by authors with conflicts of interest as by authors without conflicts of interest. Furthermore, Three authors who were identified as having financial conflicts of interest were authors on articles where sections of their previously published articles were repeated word-for-word without citation.
What Do These Findings Mean?
The findings of this study suggest that there may be a link between receiving industry funding for speaking, consulting, or research and the publication of apparently promotional opinion pieces on menopausal hormone therapy. Furthermore, such publications may encourage physicians to continue prescribing these therapies to women of menopausal age. Therefore, physicians and other health care providers should interpret the content of review articles with caution. In addition, medical journals should follow the International Committee of Medical Journal Editors Uniform Requirements for Manuscripts, which require that all authors submit signed statements of their participation in authorship and full disclosure of any conflicts of interest.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000425.
The US National Heart, Lung, and Blood Institute has more information on the Womens Health Initiative
The US National Institutes of Health provide more information about the effects of menopausal hormone replacement therapy
The Office of Women's Health, U.S. Department of Health and Human Services provides information on menopausal hormone therapy
The International Committee of Medical Journal Editors Uniform Requirements for Manuscripts presents Uniform Requirements for Manuscripts published in biomedical journals
The National Womens Health Network, a consumer advocacy group that takes no industry money, has factsheets and articles about menopausal hormone therapy
PharmedOut, a Georgetown University Medical Center project, has many resources on pharmaceutical marketing practices
doi:10.1371/journal.pmed.1000425
PMCID: PMC3058057  PMID: 21423581
12.  Proceedings of the 2006 Annual Meeting of the Fetal Alcohol Spectrum Disorders Study Group 
Alcohol (Fayetteville, N.Y.)  2006;40(1):61-65.
This article describes the proceedings of the 2006 Annual Meeting of the Fetal Alcohol Spectrum Disorders Study Group (FASDSG), which was held in Baltimore, Maryland on June 24, 2006. The meeting was held in conjunction with the annual meeting of the Research Society on Alcoholism and was supported by a grant from the National Institute on Alcohol Abuse and Alcoholism. The 2005–2006 FASDSG officers, Daniel J. Bonthius (president), Heather Carmichael Olson (vice-president), and Jennifer Thomas (secretary-treasurer), organized the meeting. Nationally prominent speakers delivered plenary lectures on topics of newborn screening, ethics, and neuroscience. Selected members of the FASDSG provided brief scientific data (FASt) reports, describing new research findings. Representatives from national agencies involved in fetal alcohol syndrome (FAS) research, treatment, and prevention provided updates regarding priorities, funding, and agency activities. Presentations were also made by the 2006 Student Merit Award recipient and by the 2006 Rosett Award recipient. The meeting served as a forum for clinicians, neuroscientists, psychologists, social scientists and other professionals to discuss recent advances in FAS research and to identify the most important gaps in the understanding of alcohol-induced teratology.
doi:10.1016/j.alcohol.2006.09.003
PMCID: PMC1865502  PMID: 17157721
Fetal Alcohol Syndrome; Fetal Alcohol Spectrum Disorders; Ethanol; Prenatal; Teratology
13.  Overcoming burdens in the regulation of clinical research in children. Proceedings of a consensus conference, in historical context 
Background
Many investigators are concerned that the modes of implementation and enforcement of the federal regulations designed to protect children are unduly impeding pediatric clinical research.
Objective
To assess regulatory impediments to clinical research involving children and to develop recommendations to ameliorate them.
Participants
The Pediatric Endocrine Society and The Endocrine Society convened a consensus conference involving experts and stakeholders in patient-oriented research involving children and adolescents in 2008.
Consensus process
Following presentations that reviewed problematic issues around key regulations, participants divided into working groups to develop potential solutions that could be adopted at local and federal levels. Presentations to the full assembly were then debated. A writing committee then drafted a summary of the discussions and main conclusions, placing them in historical context, and submitted it to all participants for comment with the aim of developing consensus.
Conclusions
Recommendations designed to facilitate the ethical conduct of research involving children addressed the interpretation of ambiguous regulatory terms such as "minimal risk" and "condition" and called for the development by professional societies of best practice primers for common research procedures that would be informative to both investigators and institutional review boards. A call was issued for improved guidance from the Office for Human Research Protections and Food and Drug Administration as well as for the development by professional societies of a process to monitor progress in improving human subject research regulation. Finally, a need for systematic research to define the nature and extent of institutional obstacles to pediatric research was recognized.
doi:10.1186/1687-9856-2011-19
PMCID: PMC3276425  PMID: 22208165
Institutional Review Board; ethics; pediatrics; endocrinology; federal regulations; clinical research
14.  Proceedings of the Indo-U.S. bilateral workshop on accelerating botanicals/biologics agent development research for cancer chemoprevention, treatment, and survival 
Cancer Medicine  2013;2(1):108-115.
With the evolving evidence of the promise of botanicals/biologics for cancer chemoprevention and treatment, an Indo-U.S. collaborative Workshop focusing on “Accelerating Botanicals Agent Development Research for Cancer Chemoprevention and Treatment” was conducted at the Moffitt Cancer Center, 29–31 May 2012. Funded by the Indo-U.S. Science and Technology Forum, a joint initiative of Governments of India and the United States of America and the Moffitt Cancer Center, the overall goals of this workshop were to enhance the knowledge (agents, molecular targets, biomarkers, approaches, target populations, regulatory standards, priorities, resources) of a multinational, multidisciplinary team of researcher's to systematically accelerate the design, to conduct a successful clinical trials to evaluate botanicals/biologics for cancer chemoprevention and treatment, and to achieve efficient translation of these discoveries into the standards for clinical practice that will ultimately impact cancer morbidity and mortality. Expert panelists were drawn from a diverse group of stakeholders, representing the leadership from the National Cancer Institute's Office of Cancer Complementary and Alternative Medicine (OCCAM), NCI Experimental Therapeutics (NExT), Food and Drug Administration, national scientific leadership from India, and a distinguished group of population, basic and clinical scientists from the two countries, including leaders in bioinformatics, social sciences, and biostatisticians. At the end of the workshop, we established four Indo-U.S. working research collaborative teams focused on identifying and prioritizing agents targeting four cancers that are of priority to both countries. Presented are some of the key proceedings and future goals discussed in the proceedings of this workshop.
doi:10.1002/cam4.42
PMCID: PMC3797562  PMID: 24279005
Biologics; botanicals; cancer; chemoprevention; drug development
15.  Introduction to the Proceedings of the Avian Genomics and Gene Ontology Annotation Workshop 
BMC Genomics  2009;10(Suppl 2):I1.
The Avian Genomics Conference and Gene Ontology Annotation Workshop brought together researchers and students from around the world to present their latest research addressing the delivery of value from the billions of base-pairs of Archosaur sequence that have become available in the last few years. This editorial describes the conference itself and introduces the ten peer-reviewed manuscripts accepted for publications in the proceedings. These manuscripts address issues ranging from the poultry industry view of USDA genomics policy to the genomics of a wide variety of Archeosaur species including chicken, duck, alligator, and condors and their pathogens.
doi:10.1186/1471-2164-10-S2-I1
PMCID: PMC2966328  PMID: 19607650
16.  Advancing radiology through informed leadership: summary of the proceedings of the Seventh Biannual Symposium of the International Society for Strategic Studies in Radiology (IS3R), 23–25 August 2007 
European Radiology  2009;19(8):1827-1836.
The International Society for Strategic Studies in Radiology (IS3R) brings together thought leaders from academia and industry from around the world to share ideas, points of view and new knowledge. This article summarizes the main concepts presented at the 2007 IS3R symposium, providing a window onto trends shaping the future of radiology. Topics addressed include new opportunities and challenges in the field of interventional radiology; emerging techniques for evaluating and improving quality and safety in radiology; and factors impeding progress in molecular imaging and nanotechnology and possible ways to overcome them. Regulatory hurdles to technical innovation and drug development are also discussed more broadly, along with proposals for addressing regulators’ concerns and streamlining the regulatory process.
doi:10.1007/s00330-009-1370-1
PMCID: PMC2705708  PMID: 19277668
Interventional radiology; Molecular imaging; Device approval processes; Drug approval processes; Health-care quality; Radiology; Leadership
17.  Conflicts of Interest at Medical Journals: The Influence of Industry-Supported Randomised Trials on Journal Impact Factors and Revenue – Cohort Study 
PLoS Medicine  2010;7(10):e1000354.
Andreas Lundh and colleagues investigated the effect of publication of large industry-supported trials on citations and journal income, through reprint sales, in six general medical journals
Background
Transparency in reporting of conflict of interest is an increasingly important aspect of publication in medical journals. Publication of large industry-supported trials may generate many citations and journal income through reprint sales and thereby be a source of conflicts of interest for journals. We investigated industry-supported trials' influence on journal impact factors and revenue.
Methods and Findings
We sampled six major medical journals (Annals of Internal Medicine, Archives of Internal Medicine, BMJ, JAMA, The Lancet, and New England Journal of Medicine [NEJM]). For each journal, we identified randomised trials published in 1996–1997 and 2005–2006 using PubMed, and categorized the type of financial support. Using Web of Science, we investigated citations of industry-supported trials and the influence on journal impact factors over a ten-year period. We contacted journal editors and retrieved tax information on income from industry sources. The proportion of trials with sole industry support varied between journals, from 7% in BMJ to 32% in NEJM in 2005–2006. Industry-supported trials were more frequently cited than trials with other types of support, and omitting them from the impact factor calculation decreased journal impact factors. The decrease varied considerably between journals, with 1% for BMJ to 15% for NEJM in 2007. For the two journals disclosing data, income from the sales of reprints contributed to 3% and 41% of the total income for BMJ and The Lancet in 2005–2006.
Conclusions
Publication of industry-supported trials was associated with an increase in journal impact factors. Sales of reprints may provide a substantial income. We suggest that journals disclose financial information in the same way that they require them from their authors, so that readers can assess the potential effect of different types of papers on journals' revenue and impact.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Medical journals publish many different types of papers that inform doctors about the latest research advances and the latest treatments for their patients. They publish articles that describe laboratory-based research into the causes of diseases and the identification of potential new drugs. They publish the results of early clinical trials in which a few patients are given a potential new drug to check its safety. Finally and most importantly, they publish the results of randomized controlled trials (RCTs). RCTs are studies in which large numbers of patients are randomly allocated to different treatments without the patient or the clinician knowing the allocation and the efficacy of the various treatments compared. RCTs are best way of determining whether a new drug is effective and have to be completed before a drug can be marketed. Because RCTs are very expensive, they are often supported by drug companies. That is, drug companies provide grants or drugs for the trial or assist with data analysis and/or article preparation.
Why Was This Study Done?
Whenever a medical journal publishes an article, the article's authors have to declare any conflicts of interest such as financial gain from the paper's publication. Conflict of interest statements help readers assess papers—an author who owns the patent for a drug, for example, might put an unduly positive spin on his/her results. The experts who review papers for journals before publication provide similar conflict of interest statements. But what about the journal editors who ultimately decide which papers get published? The International Committee of Medical Journal Editors (ICMJE), which produces medical publishing guidelines, states that: “Editors who make final decisions about manuscripts must have no personal, professional, or financial involvement in any of the issues that they might judge.” However, the publication of industry-supported RCTs might create “indirect” conflicts of interest for journals by boosting the journal's impact factor (a measure of a journal's importance based on how often its articles are cited) and its income through the sale of reprints to drug companies. In this study, the researchers investigate whether the publication of industry-supported RCTs influences the impact factors and finances of six major medical journals.
What Did the Researchers Do and Find?
The researchers determined which RCTs published in the New England Journal of Medicine (NEJM), the British Medical Journal (BMJ), The Lancet, and three other major medical journals in 1996–1997 and 2005–2006 were supported wholly, partly, or not at all by industry. They then used the online academic citation index Web of Science to calculate an approximate impact factor for each journal for 1998 and 2007 and calculated the effect of the published RCTs on the impact factor. The proportion of RCTs with sole industry support varied between journals. Thus, 32% of the RCTs published in the NEJM during both two-year periods had industry support whereas only 7% of the RCTs published in the BMJ in 2005–2006 had industry support. Industry-supported trials were more frequently cited than RCTs with other types of support and omitting industry-supported RCTs from impact factor calculations decreased all the approximate journal impact factors. For example, omitting all RCTs with industry or mixed support decreased the 2007 BMJ and NEJM impact factors by 1% and 15%, respectively. Finally, the researchers asked each journal's editor about their journal's income from industry sources. For the BMJ and The Lancet, the only journals that provided this information, income from reprint sales was 3% and 41%, respectively, of total income in 2005–2006.
What Do These Findings Mean?
These findings show that the publication of industry-supported RCTs was associated with an increase in the approximate impact factors of these six major medical journals. Because these journals publish numerous RCTs, this result may not be generalizable to other journals. These findings also indicate that income from reprint sales can be a substantial proportion of a journal's total income. Importantly, these findings do not imply that the decisions of editors are affected by the possibility that the publication of an industry-supported trial might improve their journal's impact factor or income. Nevertheless, the researchers suggest, journals should live up to the same principles related to conflicts of interest as those that they require from their authors and should routinely disclose information on the source and amount of income that they receive.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000354.
This study is further discussed in a PLoS Medicine Perspective by Harvey Marcovitch
The International Committee of Medical Journal Editors provides information about the publication of medical research, including conflicts of interest
The World Association of Medical Editors also provides information on conflicts of interest in medical journals
Information about impact factors is provided by Thomson Reuters, a provider of intelligent information for businesses and professionals; Thomson Reuters also runs Web of Science
doi:10.1371/journal.pmed.1000354
PMCID: PMC2964336  PMID: 21048986
18.  Knowledge Structure of Korean Medical Informatics: A Social Network Analysis of Articles in Journal and Proceedings 
Objectives
This study aimed at exploring the knowledge structure of Korean medical informatics.
Methods
We utilized the keywords, as the main variables, of the research papers that were presented in the journal and symposia of the Korean Society of Medical Informatics, and we used, as cases, the English titles and abstracts of the papers (n = 915) published from 1995 through 2008. N-grams (bigram to 5-gram) were extracted from the corpora using the BiKE Text Analyzer, and their cooccurrence networks were generated via a cosine correlation coefficient, and then the networks were analyzed and visualized using Pajek.
Results
With the hub and authority measures, the most important research topics in Korean medical informatics were identified. Newly emerging topics by three-year period units were observed as research trends.
Conclusions
This study provides a systematic overview on the knowledge structure of Korean medical informatics.
doi:10.4258/hir.2010.16.1.52
PMCID: PMC3089837  PMID: 21818424
Medical Informatics; Knowledge Structure; Social Network Analysis; Co-word Analysis
19.  Tobacco industry influence on the definition of tobacco related disorders by the American Psychiatric Association 
Tobacco Control  2005;14(5):328-337.
Objective: The Diagnostic and statistical manual of mental disorders, third edition (DSM-III), published by the American Psychiatric Association (APA) in 1980, included the first official definitions by the APA of tobacco dependence and tobacco withdrawal. Tobacco industry efforts to influence the DSM-III were investigated.
Method: Searches of previously secret tobacco industry documents, primarily the University of California San Francisco Legacy Tobacco Documents Library and British American Tobacco collections. Additional information was collected through discussions with editors of DSM-III, and library and general internet searches.
Results: The tobacco companies regarded the inclusion of tobacco dependence as a diagnosis in DSM-III as an adverse event. It worked to influence the content of the DSM-III and its impact following publication. These efforts included public statements and private lobbying of DSM-III editors and high ranking APA officers by prominent US psychiatrists with undisclosed ties to the tobacco industry. Following publication of DSM-III, tobacco companies contracted with two US professors of psychiatry to organise a conference and publish a monograph detailing controversies surrounding DSM-III.
Conclusions: The tobacco industry and its allies lobbied to narrow the definition of tobacco dependence in serial revisions of DSM-III. Following publication of DSM-III, the industry took steps to try to mitigate its impact. These actions mirror industry tactics to influence medical research and policy in various contexts worldwide. Such tactics slow the spread of a professional and public understanding of smoking and health that otherwise would reduce smoking, smoking induced disease, and tobacco company profits.
doi:10.1136/tc.2004.010512
PMCID: PMC1748090  PMID: 16183984
20.  The inaugural European emergency medical dispatch conference – a synopsis of proceedings 
The inaugural European Emergency Medical Dispatch conference was held in Stockholm, Sweden, in May 2013. We provide a synopsis of the conference proceedings, highlight key topic areas of emergency medical dispatch and suggest future research priorities.
doi:10.1186/1757-7241-21-73
PMCID: PMC3848775  PMID: 24059651
21.  Smoking cessation, physicians, and medical office staff. Clinical tobacco intervention in Prince Edward Island. 
Canadian Family Physician  1998;44:2433-2440.
OBJECTIVE: To assess attitudes and self-reported behaviours of physicians and medical office staff in Prince Edward Island concerning clinical tobacco intervention (CTI). DESIGN: Mail survey of PEI primary care physicians and their medical office staff. Most surveys were not mailed back but picked up in person by research staff. SETTING: Primary care settings in PEI. PARTICIPANTS: All active primary care physicians in PEI identified in the Canadian Medical Association database and medical office staff. Respondents included 63/88 (71.6%) physicians and 59/88 (67.0%) medical office staff. Fifty-seven physicians and medical office staff surveys overlapped. MAIN OUTCOME MEASURES: Attitudes and self-reported behaviours in CTI. RESULTS: More than 70% of the time, 68.3% of physicians reported asking new patients about their smoking behaviour and 66.7% reported that they listen to and acknowledge patients' feelings and fears about stopping smoking. Close to half (43.3%) of physicians reported thinking about or planning to do more CTI. Physicians and medical office staff reported that staff had limited involvement in methods to cue smoking interventions. Only half (50.8%) of physicians reported that their offices are well set up to identify smokers and to help them quit smoking. Offices were well set up for CTI if physicians perceived that office staff had an active role in CTI and if follow-up visits were frequently arranged. CONCLUSIONS: This study identified apparent opportunities for improving CIT, particularly in the areas of physician training, involvement of medical office staff, and awareness of billing codes. This could improve the quality of preventive care for patients in PEI.
PMCID: PMC2277983  PMID: 9839061
22.  The Role of Neuroactive Steroids in Ethanol/Stress Interactions Proceedings of Symposium VII at the Volterra Conference on Alcohol and Stress, May 2008 
Alcohol (Fayetteville, N.Y.)  2009;43(7):521-530.
This report summarizes the proceedings of the symposium VII on the role of neuroactive steroids in stress/alcohol interactions. The production of GABAergic neuroactive steroids, including (3α,5α)-3-hydroxypregnan-20-one (3α,5α-THP) and (3α,5α)-3,21-dihydroxypregnan-20-one (3α,5α-THDOC) is a consequence of both acute stress and acute ethanol exposure. Acute, but not chronic ethanol administration elevates brain levels of these steroids and enhances GABAA receptor activity. Neuroactive steroids modulate acute anticonvulsant effects, sedation, spatial memory impairment, anxiolytic-like, antidepressant-like and reinforcing properties of ethanol in rodents. Furthermore, these steroids participate in the homeostatic regulation of the hypothalamic-pituitary-adrenal (HPA) axis. Therefore, it is not surprising that neuroactive steroids are involved in ethanol/stress interactions. Nevertheless, the interactions are complex and not well understood. This symposium addressed the role of neuroactive steroids in both stress and alcohol responses and their interactions. Professor Giovanni Biggio of the University of Cagliari, Italy presented the effects of juvenile isolation stress on neuroactive steroids, GABAA receptor expression and ethanol sensitivity. Professor Howard Becker of the Medical University of South Carolina, USA presented evidence for neuroactive steroid involvement in ethanol dependence and drinking behavior. Professor Patrizia Porcu of the University of North Carolina, USA described a potential neuroactive steroid biomarker that may predict heavy drinking in monkeys and mice. These presentations provide a framework for new theories on the nature of ethanol/stress interactions that may be amenable to therapeutic interventions.
doi:10.1016/j.alcohol.2009.04.002
PMCID: PMC2778608  PMID: 19913195
neuroactive steroids; GABAA receptors; social isolation; C57BL/6J mice; DBA/2J mice; HPA axis
23.  Proceedings from the Scientific Symposium: Sex Differences in Cardiovascular Disease and Implications for Therapies 
Journal of Women's Health  2010;19(6):1059-1072.
Abstract
A consortium of investigator-thought leaders was convened at the Heart Institute at Cedars-Sinai Medical Center and produced the following summary points: Point 1: Important sex differences exist in cardiovascular disease (CVD) that affect disease initiation, diagnosis, and treatment.Implication: Research that acknowledges these differences is needed to optimize outcomes in women and men.Point 2: Atherosclerosis is qualitatively and quantitatively different in women and men; women demonstrate more plaque erosion and more diffuse plaque with less focal artery lumen intrusion.Implication: Evaluation of CVD strategies that include devices should be used to explore differing anatomical shapes and surfaces as well as differing drug coating and eluting strategies.Point 3: Bone marrow progenitor cells (PCs) engraft differently based on the sex of the donor cell and the sex of the recipient.Implication: PC therapeutic studies need to consider the sex of cells of the source and the recipient.Point 4: Women have a greater risk of venous but not arterial thrombosis compared with men, as well as more bleeding complications related to anticoagulant treatment. Several genes coding for proteins involved in hemostasis are regulated by sex hormones.Implications: Research should be aimed at evaluation of sex-based differences in response to anticoagulation based on genotype.Point 5: Women and men can have differences in pharmacological response.Implication: Sex-specific pharmacogenomic studies should be included in pharmacological development.Point 6: CVD progression results from an imbalance of cell injury and repair in part due to insufficient PC repair, which is affected by sex differences, where females have higher circulating levels of PCs with greater rates of tissue repair.Implication: CVD regenerative strategies should be directed at learning to deliver cells that shift the recipient balance from injury toward repair. CVD repair strategies should ideally be tested first in females to have the best chance of success for proof-of-concept.
doi:10.1089/jwh.2009.1695
PMCID: PMC2940456  PMID: 20500123
24.  Perceptions and viewpoints on proceedings of the Fifteenth Assembly of Heads of State and Government of the African Union Debate on Maternal, Newborn and Child Health and Development, 25–27 July 2010, Kampala, Uganda 
BMC Proceedings  2011;5(Suppl 5):S1.
Background
Out of 358000 maternal deaths that occurred globally in 2008, 57.8% occurred in continental Africa. Africa had a maternal mortality ratio of 590 compared to 14 in developed regions, 68 in Latin America and Caribbean, and 190 in Asia. This article reflects on the discussions held during the Fifteenth Assembly of the Heads of State and Government of the African Union on the reasons why the maternal mortality ratio is so high in Africa and what can be done to reduce it.
Methods
Methods employed included panel and open public discussions among the Heads of State and Government of the African Union. The article uses the WHO health systems strengthening framework, which consists of six pillars (information systems, leadership and governance, health workforce, financing, and medical products, vaccines and technologies, and health services) to describe the proceedings of the discussions.
Discussion
The high maternal mortality ratios in countries were attributed to weak national health information systems; leadership and governance challenges related to poverty, health illiteracy, poor transport networks and communications infrastructure, risky cultural practices, armed conflicts and domestic violence, dearth of women empowerment; inadequate levels of skilled birth attendants; inadequate domestic and external funding; stock-outs of consumable inputs; and limited coverage of maternal and child health interventions.
In order to accelerate progress towards MDGs 4 and 5, the Heads of State and Government recommended that countries should make maternal deaths notifiable and institutionalize maternal death audits; develop, fund and implement policies and strategies geared at improving maternal, newborn and child health; accelerate inter-sectoral action to address the broad health determinants; increase the number of skilled birth attendants; fulfil commitment to allocate at least 15% of the national budget to the health sector and allocate adequate resources to prevent stock-outs of essential medicines and reproductive health commodities; leverage health promotion approaches to raise national awareness; and ensure that there is a health centre within a radius of four kilometres equipped to provide good quality integrated maternal, newborn and child health services.
Conclusions
There was consensus among the discussants that there was urgent need to speed up actions for strengthening health systems to improve coverage of maternal, newborn and child health services; and to address broad determinants of women, newborn and children’s health for sustained improvements in health and other development goals.
doi:10.1186/1753-6561-5-S5-S1
PMCID: PMC3254895  PMID: 21810211
25.  Integrated diagnostics: proceedings from the 9th biennial symposium of the International Society for Strategic Studies in Radiology 
European Radiology  2012;22(11):2283-2294.
The International Society for Strategic Studies in Radiology held its 9th biennial meeting in August 2011. The focus of the programme was integrated diagnostics and massive computing. Participants discussed the opportunities, challenges, and consequences for the discipline of radiology that will likely arise from the integration of diagnostic technologies. Diagnostic technologies are increasing in scope, including advanced imaging techniques, new molecular imaging agents, and sophisticated point-of-use devices. Advanced information technology (IT), which is increasingly influencing the practice of medicine, will aid clinical communication and the development of “population images” that represent the phenotype of particular diseases, which will aid the development of diagnostic algorithms. Integrated diagnostics offer increased operational efficiency and benefits to patients through quicker and more accurate diagnoses. As physicians with the most expertise in IT, radiologists are well placed to take the lead in introducing IT solutions and cloud computing to promote integrated diagnostics. To achieve this, radiologists must adapt to include quantitative data on biomarkers in their reports. Radiologists must also increase their role as participating physicians, collaborating with other medical specialties, not only to avoid being sidelined by other specialties but also to better prepare as leaders in the selection and sequence of diagnostic procedures.
Key Points
• New diagnostic technologies are yielding unprecedented amounts of diagnostic information.
• Advanced IT/cloud computing will aid integration and analysis of diagnostic data.
• Better diagnostic algorithms will lead to faster diagnosis and more rapid treatment.
doi:10.1007/s00330-012-2510-6
PMCID: PMC3472054  PMID: 22699871
Radiology; Diagnostic techniques and procedures; Informatics; Algorithms; Efficiency; Organizational

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