Sponsorship Of Clinical Trials Research Articles

Intermezzo

Every 5 years a new editorial team is selected to lead the journal. As of July 1, Dr. Keith Lindor and team will handle all new submissions to HEPATOLOGY. The current editors will continue to be responsible for the remaining issues of 2006. Like the title of this page, we are going through the healthy intermission between editorial teams, a period when transitions can be smoothly conducted. In the theater, intermezzos can be an idle period or a time to revisit major themes of the play. Over the years, I have shared with the readers issues that are germane to the editorial/writing process. Rather than reiterating concepts expressed in previous Corners, I would like to reflect on the experience of a recent Editors Forum, where a capsule of such concepts was presented. Authorship. Our statistics indicate a median number of 8 authors per manuscript published in HEPATOLOGY. The journal endorses accepted criteria for authorship spelled out in the editors' statement (http://www.icmje.org/index.html): A substantial contribution to the conception and design of the study, to the acquisition and analysis of data, drafting the article or critically revising it, and providing final approval of the version to be published. A hypothetical case was presented based on a recent publication1: A chairman of a department requests a younger faculty member to include several colleagues who do not meet the criteria for authorship. The chairman's quid pro quo: Authorship in future studies from his/her counterparts, contributing to the well-being of the department by advancing the careers of others, avoidance of a clash with the hierarchical structure of the institution. But the correct behavior in this case is so clear that repeating the obvious seems redundant. Sponsorship of clinical trials. I tabulated 107 randomized controlled clinical trials in liver-related studies that were published in the period 2001-2005 in the New England Journal of Medicine, The Lancet, Gastroenterology, HEPATOLOGY or the Journal of Hepatology. Of these, 49.5% were supported by the pharmaceutical industry and the ratio was even higher for the first 2 widely-read general medical journals (13/17 trials). The relation between the pharmaceutical industry and clinical investigators is complex and under increasing public scrutiny.2 As voiced at the Hong Kong/Shanghai meeting, the hepatology community also scrutinizes investigators who fail to make a concerted effort to demonstrate their independence from the goals of the pharmaceutical industry. While the partnership between academia and the pharmaceutical industry can be drawn as an intersecting Venn diagram, I argued for the merits of two parallel circles, each with common but also different goals. Publication, an honor code. Several cases of violations of the honor code that surround scientific publication were discussed as was the role of medical journals in preventing such violations. In fact, every editorial office would become a virtual police station if a policy was adopted to verify critical statements within each manuscript. Such vigilance would include: establishing the reliability of the data, determining whether Human/Animal Investigation approval has indeed occurred, confirming that patient consent was informed, corroborating that all sources of financial support are provided, and ensuring that all potential conflicts of interest are disclosed. Accuracy in publication is a responsibility shared by every member of an investigative team and the honor code that surrounds publication should be preserved at all costs. Many more topics were discussed, including controversial aspects of manuscript review. I left with a hunger for more. In fact, I have proposed that an Editors Forum become an established activity of the annual meeting of our association, where many more issues could be publicly deliberated. At a time when the pace of scientific discovery in HEPATOLOGY continues to accelerate, it is useful to pause for such an intermission: Not an idle period but one that reaffirms the importance and value of the written word in all what we do.

Financial Anatomy of Biomedical Research

Public and private financial support of biomedical research have increased over the past decade. Few comprehensive analyses of the sources and uses of funds are available. This results in inadequate information on which to base investment decisions because not all sources allow equal latitude to explore hypotheses having scientific or clinical importance and creates a barrier to judging the value of research to society. To quantify funding trends from 1994 to 2004 of basic, translational, and clinical biomedical research by principal sponsors based in the United States. Publicly available data were compiled for the federal, state, and local governments; foundations; charities; universities; and industry. Proprietary (by subscription but openly available) databases were used to supplement public sources. Total actual research spending, growth rates, and type of research with inflation adjustment. Biomedical research funding increased from 37.1 billion dollars in 1994 to 94.3 billion dollars in 2003 and doubled when adjusted for inflation. Principal research sponsors in 2003 were industry (57%) and the National Institutes of Health (28%). Relative proportions from all public and private sources did not change. Industry sponsorship of clinical trials increased from 4.0 dollars to 14.2 billion dollars (in real terms) while federal proportions devoted to basic and applied research were unchanged. The United States spent an estimated 5.6% of its total health expenditures on biomedical research, more than any other country, but less than 0.1% for health services research. From an economic perspective, biotechnology and medical device companies were most productive, as measured by new diagnostic and therapeutic devices per dollar of research and development cost. Productivity declined for new pharmaceuticals. Enhancing research productivity and evaluation of benefit are pressing challenges, requiring (1) more effective translation of basic scientific knowledge to clinical application; (2) critical appraisal of rapidly moving scientific areas to guide investment where clinical need is greatest, not only where commercial opportunity is currently perceived; and (3) more specific information about sources and uses of research funds than is generally available to allow informed investment decisions. Responsibility falls on industry, government, and foundations to bring these changes about with a longer-term view of research value.

Haunted Manuscripts: Ghost Authorship in the Medical Literature

Ghost authorship occurs when an individual who contributed substantially to a manuscript is not named in the byline or acknowledgments. Ghost authors may be employed by industry to prepare clinical trial results for publication. An expert is then “hired” as author so as to lend an air of credibility and neutrality to the manuscript. Ghost authorship is difficult to detect, and most articles that have been identified as ghostwritten were revealed as such only after investigative work by lawyers, journalists, or scientists. P.A. Rochon was supported by an Investigator Award from the Canadian Institutes for Health Research. Ms. Ngai and Ms. Gold were supported by a Baycrest Summer Student Research Award. Dr. Gill was supported by a Canadian Institutes of Health Research Postdoctoral Fellowship. The authors would also like to thank the reviewers of this manuscript for their helpful comments and suggestions. Ghost authorship is ethically questionable in that it may be used to mask conflicts of interest with industry. As it has been demonstrated that industry sponsorship of clinical trials may be associated with outcomes favorable to industry, this is problematic. Evidence-based medicine requires that clinical decisions be based on empirical evidence published in peer-reviewed medical journals. If physicians base their decisions on dubious research data, this can have negative consequences for patients. Ghost authorship also compromises academic integrity. A “film credit” concept of authorship is one solution to the problems posed by ghost authorship. Other approaches have been taken by the United Kingdom and Denmark. A solution is necessary, as the relationship between authorship and accountability must be maintained.

65 oral Patient and family attitudes towards industry sponsorship of clinical trials

65 oral Patient and family attitudes towards industry sponsorship of clinical trials

The national institutes of health and their sponsorship of clinical trials

During 1987, the National Institutes of Health (NIH) celebrated their 100th anniversary. The NIH constitute the principal biomedical research arm of the the United States Government. The 1985 NIH budget was $5.1 billion; that amount represent s less than 2% of total U.S. health costs [1]. The NIH began as the one-room Laboratory of Hygiene in the Marine Hospital on Staten Island, New York, which was primarily a bacteriological laboratory. When the Laboratory was moved to Washington, D.C., in 1891, its name was changed to the Hygienic Laboratory. In 1912, the Laboratory was designated as part of the Public Health Service, which was authorized to study and investigate diseases of man and conditions influencing propagation and spread of disease and to issue publications on these topics [2]. Research grants to be awarded to outside institutions were first authorized in 1918 to support the U.S. Army's fight against venereal disease. A total of $400,000 was authorized for extramural awards during that year [2]. An Act of Congress in 1930 transformed the Hygienic Laboratory to the National Institute of Health. The Act also created fellowships for the agency and authorized the U.S. Government to accept donations for use in studying diseases and their prevention and cure. Also in 1930, 92 acres of land that eventually became the nucleus of the present 306-acre NIH campus in Bethesda, Maryland, was donated to the government [2]. The Division of Research Grants was established in 1946 as part of the effort to promote research into diseases and impairments of mankind. In 1948 the National Institute of Health became the National Institutes of Health, consisting of the National Cancer Institute (created in 1937), the National Heart Institute, the National Institute of Dental Research, the National Institute of Mental Health, the National Microbiological Institute, and the Experimental Biology and Medicine Institute. The NIH Clinical Center was opened in 1953 [1]. The NIH spent approximately 4% of its total budget on clinical trials between 1975 and 1979 [3]. The majority of these trials were funded through