Under the Influence: The Interplay among Industry,Publishing, and Drug Regulation

The relationships among academe, publishing, and industry can facilitate commercial bias in how drug efficacy and safety data are obtained, interpreted, and presented to regulatory bodies and prescribers. Through a critique of published and unpublished trials submitted to the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for approval of a new antidepressant, vortioxetine, we present a case study of the “ghost management” of the information delivery process. We argue that currently accepted practices undermine regulatory safeguards aimed at protecting the public from unsafe or ineffective medicines. The economies of influence that may intentionally and unintentionally produce evidence-biased—rather than evidence-based—medicine are identified. This is not a simple story of author financial conflicts of interest, but rather a complex tale of ghost management of the entire process of bringing a drug to market. This case study shows how weak regulatory policies allow for design choices and reporting strategies that can make marginal products look novel, more effective, and safer than they are, and how the selective and imbalanced reporting of clinical trial data in medical journals results in the marketing of expensive “me-too” drugs with questionable risk/benefit profiles. We offer solutions for neutralizing these economies of influence.     

Management support organizations and university partnership in nonprofit education,training and consultation

Over the last decade there has been a tremendous growth in the nonprofit sector. Local community centers and foundations are developing Leadership Institutes to educate and assist the burgeoning nonprofit sectors needs for education and consultation. Universities and colleges are also responding to the call for nonprofit education. Since 1990 there has been a 300% growth in universities offering concentrations in nonprofit education. This paper documents how Florida Gulf Coast University, the nation’s newest university, partnered with the Center for Leadership of the local community foundation to conduct a needs assessment of demand for graduate education, training, and consultation in the area of nonprofit management. The partnership began with three focus groups of key administrative personnel from local nonprofit organizations. The survey documented a preponderance of interest in marketing, fund raising and strategic planning across all agencies, regardless of size. Smaller agencies, with budgets of less than $500,000 (52% of the sample) tended to be primarily interested in education, training, and consultation activities involving fund raising and marketing. Comparatively larger agencies tended to be interested in assistance with computer technology, legal and ethical issues, and cooperation among nonprofit organizations. The survey also indicated that that was a high interest among agency staff and board members for a nonprofit management track within an academic degree program or a graduate certificate program in nonprofit management.     

我国药价虚高的形成机制分析及其治理途径

药价虚高是我国民生建设的一个大难题。国家多次推出降价政策措施,实行药品招标政策,但成效见微。究其成因,主要是公共卫生支出不足、政策利益冲突、药品监管不力、药价制度漏洞、委托代理扭曲,这五大层面形成了药价虚高的路径依赖。因此,从体制上彻底切断药价虚高的生存路径,才是根本的治理途径。其关键在于完善制度设计：实行医药分业,加大政府公共卫生支出,强化药品体制监督管理。     

企业技术创新中R&D部门与市场营销部门的界面管理

R&D(研究与开发)部门与市场营销部门的界面管理是顺利实现技术创新目标的前提条件和根本保证。R&D部门与市场营销部门的界面障碍主要存在于创新构思的产生阶段、难题解决阶段和创新实现及扩散阶段,其成因主要是专业化、信息粘滞、目标差异、文化冲突等。应建立适应R&D部门与市场营销部门界面管理的文化模式和管理机制,并加强信息沟通管理。     

行业特色高校的开放发展战略

行业特色高校前身都是隶属中央部委,后又被划转由地方政府管理的具有鲜明行业特色的高校。转制后其在规模、学科专业、科研等方面都做得越来越大,但特色却有所减弱。确立＂开放发展＂战略,突破原有的行业内部视野的束缚,由封闭办学转为适应市场经济需求开放办学,利用好行业和地方两个优势,是实现转型的关键。     

Care Management and Information Provision: Towards a Reasoned Method of Assessing the Range and Extent of Problems and Needs in Child-Care Social Work

Correspondence to Professor Michael Sheppard, Department of Social Policy and Social Work, University of Plymouth, Drake Circus, Plymouth, Devon PL4 8AA Summary The new managerialism associated with care management has, aswith other areas of health and welfare work, promoted ideasof efficient use of resources, quality assurance and the capacityto audit the work of welfare agencies. This approach placesa high premium on measurement, and emphazises a long-standingdesire to develop instruments the use of which would providethe basis for resource allocation. This paper presents a methodby which such data can be rigorously generated and analysed.It uses as its basis an instrument of established reliabilityand validity, designed to collect data on problems identifiedin clients in the child and family care social work group. Ituses a combination of principal component and cluster analysisto provide a clear picture of the nature and range of problemsand the grouping of cases with similar characteristics. Thesedata provide a quantitative basis upon which judgements aboutresource allocation can be made.     

Complaining Our Way to Quality: Complaints, Contracts and the Voluntary Sector

The research on which this paper is based is part of a wider study of quality assurance and the voluntary sector. The focus of this paper is on complaints procedures, as part of quality assurance mechanisms, where voluntary agencies are the contracted service providers. The authors argue that, with the introduction of contracting and particularly with its further development, the way in which complaints mechanisms currently operate will need to be revised if they are to be an effective part of the quality assurance process.     

对注册会计师审计工作的几点思考

企业为增强市场竞争能力,让公众承认自己,对社会的监督已由被动变为主动,注册会计师在人员素质、审计道德、审计技术、审计结果等几方面应不断提高,并加强对企业的监督指导.     

Digital Gaming and Pediatric Obesity: At the Intersection of Science and Social Policy

Children and adolescents in developed countries are heavily immersed in digital media, creating an inexpensive, far-reaching marketing opportunity for the food industry and the gaming industry. However, exposure to nonnutritious food and beverage advertisements combined with the use of stationary media create a conflict between entertainment and public health. Using the popular digital gaming platforms advergames (online games that market branded products) and exergames (video games that involves gross motor activity for play) as exemplars, the following article provides an analysis of the negative and positive health impacts of digital gaming as they relate specifically to overweight and obesity outcomes for children and adolescents. Theoretical explanations including the food marketing defense model, persuasion knowledge model, and social cognitive theory are used to explain the influence of gaming on young players' health. Throughout the article, we discuss the role of public policy to encourage the development and use of health-promoting digital games as an innovative, effective tool to combat the pediatric obesity crisis.     

内部控制失效的成因及解决对策

我国大部分企业的内部控制尚处于初级阶段,主要表现为控制制度缺位、监控措施失效,原因在于缺少强化内部控制所必需的外部氛围,缺少严谨的法人治理结构,缺少增强群体凝聚力的企业文化底蕴。因此,必须创造良好的法治环境,建立分层分权的业务程序控制体系,强化会计控制与审计监督,并通过企业文化增强员工素质。     

Data Audit as a Way to Prevent/Contain Misconduct

Research misconduct is frequently in the media headlines. There is consensus among leading experts on research integrity that the prevalence of misconduct in research is at least 1%, and shoddy work may even go over 5%. Unfortunately, misconduct in research impacts all walks of life from drugs to human subject protections, innovations, economy, policy, and even our national security. The main method of detecting research misconduct depends primarily on whistleblowers. The current regulations are insufficient since dependence on whistleblowers manifests itself as an accidental hit or miss. No other endeavor in our society depends on such a poor system of discovery of misconduct to remedy it. Nearly a quarter of a century ago, I proposed data audit as a means to prevent/contain research misconduct. The audit has to protect the creative process and be non-obtrusive. Data audit evaluates the degree of correspondence of published data with the source data. The proposed data audit does not require any changes in the way researchers carry out their work.     

黑龙江绿色食品市场营销网络研究

建立和发展绿色食品营销网络对于推动我省绿色食品产业 ,实现战略升级 ,开拓国内外市场 ,促进结构调整和增加农民收入 ,扩大和提高我省绿色名牌产品和龙头企业的影响和市场竞争力 ,引导消费需求 ,推动区域经济的可持续发展具有重要意义。建立和发展绿色食品营销网络要从完善法律法规体系 ,加强市场管理力度 ;培育和发展批发市场和零售市场网络 ;加大扶持生产、加工、企业和加强市场准入等方面入手 ,其中转变观念和与世界市场规则接轨尤其重要。     

中国旅游业现状与入世对策的思考

中国旅游业处于成长期 ,产品正在形成规模 ,市场正在发育 ,旅游消费刚刚兴起。国家二元经济结构、体制转轨、温饱上升为小康、逐步扩大开放、民族文化传统、国民素质、法制建设状况 ,以及产业成长期等特征 ,都作用于中国的旅游业。加入WTO后我国旅游业机遇与挑战并存。当前要抓紧企业转制 ,加快市场化进程 ;要广泛与国际标准接轨 ,并汲取其成熟经验 ;要抓紧人员素质的提高。从根本上讲要发挥后发优势 ,加强产品开发、市场开发和法制建设 ,搞好政府宏观调控和市场化管理 ,坚持可持续发展 ,在战略上统筹好 ,在战术上扎实推进。     

高校人事工作中引入ISO 9000质量管理体系初探

ISO 9000质量管理体系为解决目前高校人事工作质量管理方面的问题提供了新的模板。介绍ISO 9000质量管理体系的概况,并从可行性和必要性两个角度分析了高校人事工作中引入ISO 9000质量管理体系的意义。     

新闻信息导向管理的调控原则

新闻信息导向管理调控,是新闻媒介行业或企业的经营者运用良好的计划、健全的组织、完善的机制、正确的运作方式、科学严密的控制程序以及有效的内部协调,使整个新闻信息资源发挥最大效能,从而完成媒介的使命,也是用最少的资源投入获得最大社会效益和经济效益的活动过程。新闻信息导向管理调控的原则是在国家新闻制度管理、法律规范体系管理、行业管理等根本原则指导下实现其功能作用的。它包括:适应受众需求的多样化、导向管理调控的程序化、信息反馈的经常化、报道质量评价的规范化、信息服务功能的多元化、信息取向整合的市场化、品牌形象的整体化和机制创新的系统化等项原则。     

Evaluating Social Work and Medical Practice with Black and Ethnic Minority Groups Using the Clinical Audit Model

Correspondence to Kish Bhatti-Sinclair, Department of Social Work Studies, University of Southampton, Highfield, Southampton SO17 1BJ, UK. Summary This paper is based on the External Audit-Ethnically SensitivePractice (EA-ESP) project which was undertaken within six primaryand secondary health care settings. This project is used asan example of how the clinical audit model can be used to monitorand review health and social work practice in the UK. The paperexamines quality, compares approaches to evaluation, and suggeststhat audit can be a useful tool for agencies in obtaining userand staff views on many areas of practice but in particularon equal opportunities, anti-racism and anti-oppression. Attentionis drawn to audit within broader evaluative and review approachesalready employed by social work academics and practitioners.The issue of quality and how it can be measured is consideredthrough an analytical comparison with approaches which employaction research and other evaluative means in the process ofreview. Audit is explored in the context of a growing need for the developmentof monitoring and review systems which provide evidence to supportand develop professionalism within social work. External auditis explored and compared to internal audit. Finally, the needfor the development of quality services in anti-racist and anti-oppressivework is highlighted and it is suggested that audit can be acost-effective and efficient way of achieving this.     

知识管理与企业管理创新

知识管理就是对知识资源进行有效管理的过程。知识管理的目标是使企业实现显性知识与隐性知识的共享,促进知识创新并最大限度地开发企业员工的智力资源。在实施知识管理中必须加强人力资源开发与管理,创建学习型组织,建立组织文化,变革组织结构。     

基于平衡记分卡的税务审计绩效评估研究

将原来应用于企业组织绩效评估的平衡记分卡方法引入税务审计绩效评估有助于改进税务机关的绩效评估工作,但是在应用时必须充分体现税务审计的公共性和非营利性。     

Data disclosure and data sharing in scientific research

Data sharing is examined for its bearing on (i) quality assurance and (ii) extensions of results in scientific research as well as (iii) part of a tradition of openness in science. It is suggested that sharing can be accomplished in a simple manner that is also sufficiently flexible to fit varying individual situations by asking authors of data dependent articles and grant proposals to footnote (a) whether they are willing to make their data available to others and, if so, (b) how the data may be accessed. Appendices report results from a survey of current policies and practices in professional societies and in Federal government fund granting agencies. Emphasis is on the social and management sciences.