Is Industry- Versus Government-Sponsored Research a Zero-Sum Game?

Conflict of interest in medical publishing exists when a participant’s private interests compete with his or her responsibilities to the scientific community, readers, and society. While conflict of interest is common, it reaches the level of concern when “a reasonable observer might wonder if the individual’s behavior or judgment was motivated by his or her competing interests”1. Having a competing interest does not, in itself, imply wrongdoing. But it can undermine the credibility of research results and damage public trust in medical journals. 
 In recent years, the extent of conflict of interest in medical journal articles has been increasingly recognized. Medical journals and the popular media have published numerous examples of competing interests that seemed to have biased published reports 2,3,4. Organizations have expressed concern for the effects of conflicts of interest on research 5, publication 1,6,7 teaching8 and continuing medical and nursing education9.
 The World Association of Medical Editors (WAME) is one of the institutions engaged in this discussion. WAME was established in 1995 10, 11 to facilitate worldwide cooperation and communication among editors of peer-reviewed journals, improve editorial standards, and promote professionalism in medical editing 12. Membership in WAME is open to all editors of peer-reviewed biomedical journals worldwide; small journals in resource-poor countries are well represented. As of December 2009, WAME had 1595 individual members representing 965 journals in 92 countries. WAME has broad participation as there are no dues and WAME activities are largely carried out through the member list serve and the member password-protected website.
 In March 2009, WAME released an updated policy statement, “Conflict of Interest in Peer-Reviewed Medical Journals” 1. It details the issues WAME believes journals should address when establishing their own policies for conflict of interest. The editors of this journal thought that the issues were important enough to share with its readers. A summary of the statement is presented in the Table and the full statement 1 can be found on WAME’s website 12.
 How Does This Statement Differ From Earlier Conflict–of-Interest Statements?
 First, WAME expands the scope of competing interests. Other statements have been concerned almost exclusively with conflicts of interest related to financial ties to industry – companies that sell healthcare products. The assumption is that financial incentives are especially powerful and are not readily recognized without special efforts to make them apparent. WAME has extended the concept of financial conflict of interest to include the effects of clinical income. For example, physicians who earn their livelihood by reading mammograms or performing colonoscopies may be biased in favor of these technologies. WAME has also included non-financial conflicts of interest (or the appearance of one) related to scholarly commitment: “intellectual passion,” (the tendency to favor positions that one has already espoused or perhaps even established); personal relationships (the tendency to judge the works of friends/colleagues or competitors/foes differently because of the relationship); political or religious beliefs (the tendency to favor or reject positions because it affirms or challenges one’s political or religious beliefs); and institutional affiliations (the tendency to favor or reject results of research because of one’s institutional affiliations).
 Second, WAME did not prescribe a universal standard for when meaningful conflict of interest exists. Rather, it defined and recommended elements of conflict of interest policies and encouraged journals to establish their own standards. WAME left operational definitions and standards on the basic issues to member journals, recognizing that journals exist in very different contexts across the globe, standards for conflict of interest are evolving, and some journals already have well-established policies and standards. WAME does not presume to judge which conflicts require action and what the appropriate action may be, although its policy does offer factors to consider 1. Obviously, excessive concern for these and more comprehensive lists of possible competing interests could paralyze the peer review and publication process and is not feasible. Editors must make judgments as to the strength of the conflict, but to do so must have uncensored information. Similarly, readers need transparency about conflicts, and therefore editors should publish with every article all relevant author disclosures 1. 
 Third, WAME confirms the seriousness of failure to disclose conflict of interest by indicating that editors have a responsibility for investigating, and if relevant acting, if competing interests surface after a manuscript is submitted or published. The intent is that allegations of failure to declare conflicts of interest must be taken seriously by journals.
 Finally, WAME has addressed in a single statement the conflicts of interests threatening all participants in the research and publication continuum, including authors, peer reviewers, and editors. Conflicts between editors and journal owners, which might affect both the accuracy of articles and the credibility of journals, have been addressed in another WAME policy statement 13.
 What Can Be Done About Conflict of Interest in Medical Journals?
 Conflicts of interest cannot be eliminated altogether but it can be managed so that it has the smallest possible effects on journal content and credibility. The backbone of managing conflicts of interest is full written disclosure; without it, nothing else is possible. Currently, authors may not reveal all of their competing interests and even if they do, journals too often do not publish them 14, so there is plenty of room for improvement. Even so, disclosure alone is an imperfect remedy; editors still must determine whether a conflict has sufficient potential to impair an individual’s objectivity such that the article should not be published. Even more work may be needed on reviewers’ and editors competing interests, given their critical role as gatekeepers for the medical literature.
 No statement will solve the conflict of interest problem, nor will it ever be solved altogether. As understanding of the problem and its management evolves, journals should be given latitude to establish their own standards, matching their policies to the best standards of their discipline and culture. WAME believes journals should make these policies readily accessible to everyone. All of us—editors, authors, reviewers, and readers--should be paying more attention to conflict of interest than we have been. We hope this statement serves that purpose.
 
 Acknowledgment
 The authors wish to warmly thank the World Association of Medical Editors (WAME) Officers for their helpful comments on an earlier version of this editorial. Many thanks to President Margaret Winker (USA); Past President Michael Callaham (USA); Vice-President John Overbeke (Netherlands); Treasurer Tom Lang (USA); and Secretary Farrokh Habibzadeh (Iran). 
 The WAME Statement on Conflict of Interest in Peer-Reviewed Medical Journals was approved by the WAME Board in March 2009. Many thanks to the members of the WAME Ethics Committee and to the WAME Editorial Policy Committee for their insightful and helpful comments on an earlier version of the statement. Warm thanks to the WAME Board for their input and comments: Margaret Winker; Michael Callaham; John Overbeke; Tom Lang; Farrokh Habibzadeh; Adamson Muula (Malawi) and Rob Siebers (New Zealand).
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Commenting on Ten Recommendations for Closing the Credibility Gap in Reporting Industry-Sponsored Clinical Research

Resolving conflict of interest in public service is one of the key mechanisms for combating corruption. Its principles are defined in international legal documents. The United Nations (UN) Convention Against Corruption states that each State Party should strive, in accordance with the fundamental principles of its domestic law, to establish, maintain and strengthen systems that promote transparency and prevent the appearance of conflict of interest. All State Parties shall endeavour to establish, maintain and strengthen measures that promote transparency and prevent conflicts of interest, in accordance with the fundamental principles of their domestic law. The article raises the problem that the confusing legal regulation and the variety of situations that arise in public service result in public servants not always correctly identifying conflicts of interest, not avoiding conflicts of public and private interests, and persons who have ceased to work in the public service not complying with restrictions on work, restrictions on concluding contracts or using individual benefits, and restrictions on representation. The aim of this article is to reveal the peculiarities of the legal regulation of conflict of interest, to analyse means of resolving conflicts of interest in the public service and restrictions for post-public servants in Ukraine and Lithuania. The authors set out a number of tasks in the article: (i) to define the concept of conflict of interest in the public service; (ii) to identify means of resolving conflicts of interest in the public service in Ukraine and Lithuania; (iii) to compare the restrictions (limitations) for post-public servants in each country. The research methods employed included: (i) comparative method, comparing the regulations on conflict of interest in each country; (ii) generalisation method, to formulate conclusions; (iii) document analysis method, focusing on the legal acts and documents of Ukraine and Lithuania; (iv) statistical method, to reveal the number of investigation identifying conflicts of interest in public officials' activities. Keywords: Conflict of Interest, Public Service, Post-public Servants, Withdrawal from Decision-making, Restrictions, Limitations, Liability.

Can industry rescue the National Institutes of Health?

The situation of conflict of interest may appear in activity of every professional irre­spective of affiliation to public, private or nongovernmental sector. The consequences of conflict of interests is biased, subjective and nontransparent decision, improper fulfillment of prescribed duties, falling standards and decreased public trust not just in politicians or civil servants but in public institutions and government. The notion of conflict of interests varies but in this paper the following definition is used. Conflict of interest is a situation in which a person (in this paper politician or public official) has a private or other interest which is such as to influence, or appear to influence, the impartial and objective performance of his / her official duties. Research of this problem can be described as moving from legalistic towards more general understanding. The topic is interdisciplinary and can be analyzed from the political science, public administration, ethics or management perspective. Analy­ses of the practice allowed researchers to distinguish the third type of such conflict of interest – the apparent conflict-to the existing or potential conflict of interests. De­velopment of society and changed surrounding of government activity increased the potential risk areas (gift giving, hospitality, bribery, contracts, trading information, etc.) for such situation to appear. In the past few decades increasing perceptions of falling ethical standards in legislatures, executive or ordinary public officials activity (scandals, misbehavior) have led in many advanced democracies to the introduction of ethics frameworks for elected or appointed officials. In order to give priority to public interest and properly perform public duties some regulation can be applied. 1) Prohibitions on the perform­ance of certain functions, and/or the holding of certain positions or certain interests by public officials. 2) The establishment of duties of public officials to declare inter­ests they have, either generally or in specific cases. 3) Exclusion or self-exclusion of public officials from participation in decision-making processes or matters where they are subject to a conflict of interest. These regulations are generally established and implemented through three main instruments: civil service legislation, conflict of interest legislation and codes of ethics / codes of conduct. The historical development of Lithuanian society in XIX and XX century was not in favor to develop clear sense of drawing the line between public and private interest but during the interwar Lithuanian Republic period few attempts to prohibit such conflict of interest were taken. The legislation prohibited holding a few offices and to employ relatives. Some current Lithuanian legislation directly some indirectly (Public Service Act, Seimas’ Statute, etc.) try to control similar situation which may turn into corrupt acti-vity or misuse of public office for private or other interests. The first special legisla­tion prohibiting conflict of interests was issued in 1997. The Law on the Compatibil­ity of Public and Private Interests in the Public Service underwent three main correc­tions. The analysis of this legislation allows concluding that the main weakness was not corrected. The usage of the term “adjust” instead of “separation” might be under­stood as a compromise instead of taking the stricter position dealing with the issue. The Law seeks “to adjust private and public interests, to ensure that priority is given to public interests, to strengthen impartiality of decisions and to prevent corruption in public service” and applies to both public servants and politicians. Meanwhile in other countries legislative has more ambitious goal to ensue public interest priority. The analyses of seventeen codes of ethics and codes of conduct existing in vari­ous Lithuanian public institutions showed that their authors paid some attention to this issue. Some codes refer to existing legislation; some describe general principles for conduct or try to explain how to behave in such uneasy situations. There are fundamental differences between elected officials and civil servants which have major implications for conflict of interest regulation first of all due to their different roles, term of service. Some Lithuanian legislation regulating conflict of interests apply to politicians and civil servants, some differ. As in other democra­cies activity of civil servants are more regulated (Public service act, law on Pub­lic administration, Ethical rules of conduct, etc.). But existing legislation does not change the situation and can not increase public trust if is not understood and properly implemented.

*These authors contributed to the devlopment and review of this manuscript but are unable to endorse the request for NIH funding. On Sept. 20, 2011, the American Association for Cancer Research (AACR) released its inaugural AACR Cancer Progress Report to commemorate the

As the federal funding of basic biomedical research started to decline 15 years ago (on the heels of a dramatic doubling of the NIH budget) much blame was cast about. Elias Zerhouni, the NIH Director at the time, advocated a “Road Map.” He had consulted many advisers, and the general idea was arguably correct: to fund high risk/high reward projects that would not have otherwise been supported by the institutes. Despite this reasonable premise and Dr. Zerhouni's skill in branding and marketing the concept (as I once witnessed at a dinner meeting), the Road Map was claimed by some skeptics to be a ruse, designed to merely lubricate NIH funding of large laboratories at academic medical centers that were engaged in, or claimed to be engaged in, the translational zone between the lab and the clinic. The current NIH Director, Francis Collins, has been thoughtfully nuanced about the balance of basic and translational research in his portfolio. Like his predecessor, he is unpopular in some basic science hallways of academia where investigators see their proposals being turned down, but we should bear in mind that the recent NIH application success rates for basic research proposals are actually a bit higher than those for translational research. Moreover, there are data that indicate that NIH has lost something like 20% of its purchasing power in the past 15 years. Dr. Zerhouni was trained in medical physics and radiology. Dr. Collins is an internist/human geneticist and there are many, including me, who know that he has a strong, constitutional admiration for basic research. As the post-2003 decline in NIH award rates became so starkly vivid, many investigators began to look elsewhere, and thus came upon disease-oriented organizations they knew about but hadn't yet tried. And tried they did, driving up submissions and causing many such organizations to create a Letter-of-Intent first filter. This trend has raised the question, in my mind at least, as to how the private foundations should step in. From the perspective of basic biomedical research scientists like me, the answer is easy: please love all basic research in every domain of biology and medicine, including the field I work in and including my particular research program. The role of private philanthropy in biomedical science in the United States is a vast topic and beyond the scope of this editorial. In brief, we can recall with admiration all the Rockefeller Foundation accomplished, including the elimination of a major parasitic disease in the Southeast United States (1), the creation of the first American university devoted to medical science (2), and the inaugural and institutionally transformative funding of a biology research program at Caltech (3). The philanthropic axis of Andrew Carnegie took a different route, the creation of the Carnegie Institution of Washington (recently renamed the Carnegie Institution for Science), with numerous departments located in proximity to leading universities (4). (The Carnegie Institution did make occasional grants as well, a most historically important one being a 5-year award of $30,000/year to Caltech in the early 1920s in support of research in physics and physical chemistry.) In more recent times, Bill and Melinda Gates have created a tremendous philanthropy devoted to many unsolved problems in global health, Paul Allen has created an institute devoted initially to neuroscience but now all cell biology, and Priscilla Chan and Mark Zuckerberg have done the same, although with somewhat different but complementary goals. One cannot praise these visionary philanthropists enough. Although the record indicates that the spouses of John D. Rockefeller Jr. and Andrew Carnegie were supportive of their husbands' philanthropies, the coequal and perhaps even greater roles of Melinda Gates and Priscilla Chan must always be borne in mind. The mathematics/hedge fund guru James Simons has taken the Carnegie approach, setting up a research institute rather than becoming a funding body (5). Let us applaud him, too. Of course, there are many smaller foundations that focus on specific diseases. When I was starting out as an independent investigator, I received a 5-year salary award from the Leukemia Society of America (now the Leukemia-Lymphoma Society). My institution was happy, but I was surprised that this philanthropy was so liberal. I was not working on leukemia but rather on cell cycle control in HeLa cells, quite a stretch. Today, the disease-centered philanthropies play a large role. But, all this said, is there a need for more private philanthropy to support basic biomedical research? I say yes, and here's why. The first reason is that the U.S. government, despite having had decades of bipartisan support from Congress for both basic biomedical and clinical research, cannot direct the Mint to print more money. The NIH budget is negotiated in the context of a broader annual appropriation bill and is sometimes miscalled “entitlement legislation.” Needless to say, we investigators feel entitled, but that doesn't cause money to flow. And it will be tight for at least another decade, in my opinion. The second reason is that the various private foundations, blessed though they may be, will continue to fund large-scale projects or, at the other extreme, small projects that fit their particular disease focus. Let us hope both work, but this pattern leaves a big hole. This hole is a need for private foundations, either already in operation or ones to be formed, to be “NIH-like.” That is, to focus on the best basic discovery science. There are, in fact, a few foundations that like to see letters of intent or proposals that are “not ready for prime time” (i.e., NIH R01 applications) and are very broad in their appetites as regards the specific research field. We need more of these. How to address this goal? We are not present when most nascent foundations that might have a latent interest in biomedical science are in deliberations as to philanthropic ideas. (That a majority of the estate of Howard Hughes was left for the creation of a biomedical research institute was due to treating physicians in Boston who had his ear. We do not have such perches.) So I call upon all the major foundations and those that may arise from more recently acquired wealth to take the long-term view, combining any specific medical goal with some portfolio allocation for the most basic, curiosity-driven inquiries into the unknown. This would be a perfect harmony of goals, annealing all that the 20th century wealth-based foundations hoped to achieve with the Endless Frontier presciently envisioned by Vannevar Bush (6) and by visionary clinical investigators (7, 8). I close with what Tom Insel, the former Director of the National Institute of Mental Health, said about private foundations that fund biomedical research (5): “Yes, sure, they have a lot of money and they can put in a lot of money, but they can also take it away and put it somewhere else. My concern is that the generosity of Jim Simons will let the rest of us off the hook. Will we decide that science can be supported as a private endeavor, and forfeit our commitment to use taxpayer dollars for science?”

On Being a Mentor in Today’s Environment

Conflicts of Interest in Clinical Guidelines: Update of U.S. Preventive Services Task Force Policies and Procedures

Perspectives on interactions between paediatricians and the pharmaceutical industry

The study develops a framework for improving corporate governance mechanisms in Libya that takes into account its specific environment of weak formal enforcement and its corporate ownership structure, which is based on concentrated state ownership. The central goal of the research is to establish an adequate protection system for minority shareholders that can contribute to the development of an efficient and healthy commercial environment in Libya. To do so, the study examines the current solution for dealing with the conflict of interests between shareholders adopted by Libyan law under art 159 of Libyan Economic Activity Act (LEAA 2010): the minority shareholders’ actions. Using a social and economic analysis and a black letter approach, this study presents a novel analytical framework that formulates an appropriate solution for controlling conflict of interests between shareholders in Libya. To that end, the study addresses the following questions: how effective is the current mechanism for dealing with the conflict of interest between shareholders in Libya? What are the economic and social implications of the different proposed approaches? What elements determine which approach is preferable in Libya? And, finally, what are the challenges that the proposed law reform may face? To answer these questions, firstly, it is necessary to consider the general framework of corporate governance in Libya, examine the country’s current position as an economy in the early stages of transformation and analyse the potential impact of this transformation on corporate governance. Following this, I locate the dimensions of the conflict of interest problem between the minority and majority shareholders in Libya through analysing literature of corporate governance with regard to the minority-majority shareholder problem and applying it to the case of Libya. After that, I examine the efficacy of the current mechanism available in Libyan law (minority shareholders actions) as a solution for dealing with the conflict of interests between the minority shareholders and the majority shareholders in Libyan companies. However, the current approach is not appropriate for Libya for several reasons that relate to either the efficiency of the approach itself or its application and enforcement in Libya. After examining other possible solutions (e.g. a prohibition strategy), I propose the self-enforcing model as the most appropriate solution since it contributes to companies being able raise capital from investors, and it also lowers the number of conflict of interest transactions and makes a company’s transactions more efficient. Finally, the self-enforcing model does away with the need for external monitoring. However, this is not the end of the story; adopting such a model will inevitably lead to some potential risks (such as the risk that the minority shareholders may abuse their rights), which will require the formulation and adoption of new and specific strategies of corporate governance that are appropriate to Libya.

Education: “The process or art of imparting knowledge, skill and judgment; Facts, skills and ideas that have been learnt, either formally or informally.” — Wikipedia 1 The term profession is applied to those persons who have specialized and technical skill or knowledge which they apply, for a fee, to certain tasks that ordinary and unqualified people cannot ordinarily undertake. The term derives from the Latin: “to swear (an oath) …” . — Wikipedia 2 Let’s consider how we as cardiovascular medicine specialists spend our days in the care of people with cardiovascular disease. In the office or making rounds in the hospital, we prescribe drugs and order diagnostic tests; in the noninvasive laboratory, we obtain and interpret images of the heart; in the electrophysiology and cardiac catheterization laboratories, we program and implant devices in patients. When antithrombotic and fibrinolytic drugs are administered, and primary percutaneous coronary intervention is done using balloon catheters and intracoronary stents, lives are saved among patients with acute myocardial infarction. Response by Avorn and Choudhry see p 2221 The mortality risk from heart failure decreases and quality of life increases from the proper and appropriate use of angiotensin-converting enzyme inhibitors and β-blockers. Lipid lowering through the use of statin drugs saves lives and reduces serious cardiovascular complications such as myocardial infarction and stroke when properly prescribed to patients with a variety of manifestations of atherosclerotic vascular diseases. According to a recent publication by Ford and colleagues,3 deaths due to coronary heart disease in the United States declined substantially from 1980 to 2000, resulting in >340 000 fewer deaths in 2000. The authors attributed approximately half of this decline to changes in cardiac risk factors and half to the application of evidence-based therapies. An underlying theme in all of this is that the pharmaceutical, biotechnology, and …

Statement of Principles: APA-Industry Relationship

To date, the study of such categories as conflict of interest, real conflict of interest, potential conflict of interest is important in the field of public administration. After all, the work of the subjects of power in a real or potential conflict of interest interferes with the work of the enterprise, institution, organization. This negatively affects the efficiency, effectiveness of public administration, leads to negative economic and legal consequences. The object of research is the prevention and settlement of conflicts of interest. The purpose of the work is to analyze ways to prevent and resolve conflicts of interest. Research method – method of comparison, method of analysis. KEYWORDS: CONFLICT OF INTERESTS, REAL CONFLICT OF INTERESTS, POTENTIAL CONFLICT OF INTERESTS, PUBLIC GOVERNANCE.

Regulation of assisted reproductive technologies in the United States