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State Medical Board Responses to an Inquiry on Physician Researcher Misconduct
Abstract
Misconduct in clinical research jeopardizes the integrity of medical science. Physician researcher misconduct that produces flawed results has consequences, including the subsequent inability of other physicians who rely on erroneous data to provide informed consent and/or accurate assessment of pharmaceutical and medical device efficacy and safety. This deviation from acceptable medical practice can directly harm patients. How state medical boards address this clinical problem is uncertain. To examine this issue, we asked 51 U.S. medical boards to search their databases for disciplinary action in response to physician researcher misconduct (PRM) from 1996 through early 2007. We compared their responses with data from federal agencies responsible for disciplinary actions against clinical researchers. Our results demonstrated: i) a high percentage (45 percent) of U.S. medical boards indicated that they did not have or could not provide access to data adequate to address whether or not disciplinary action for PRM had been levied in their states and ii) of respondents able to make relevant information available, we identified only 13 cases of physician disciplinary action for PRM. In contrast, several dozen examples of disciplinary action against physicians for serious clinical research misconduct could be readily documented in publicly accessible data from federal regulatory agencies.
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Recent scandals and controversies-such as the falsification, fabrication, and plagiarism of data in federally funded science; the manipulation and distortion of research sponsored by private companies; human embryonic stem cell research; cloning; and the patenting of DNA and cell lines-illustrate the importance of ethics in scientific research. This book provides an introduction and overview of many of the social, ethical, and legal issues facing scientists today. The book includes chapters on research misconduct, conflicts of interest, data management, mentoring, authorship, peer review, publication, intellectual property, research with human subjects, research with animal subjects, genetic and stem cell research, international research, and ethical decision making. The book also features dozens of real and hypothetical cases for discussion and analysis and introduces the reader to important research regulations and guidelines. Now in its second edition, this book synthesizes the diverse talents and experiences. This second edition of this book includes new chapters and cases and has been brought up to date on the latest issues and problems in research ethics.
Publication bias is the tendency on the parts of investigators, reviewers, and editors to submit or accept manuscripts for publication based on the direction or strength of the study findings. Much of what has been learned about publication bias comes from the social sciences, less from the field of medicine. In medicine, three studies have provided direct evidence for this bias. Prevention of publication bias is important both from the scientific perspective (complete dissemination of knowledge) and from the perspective of those who combine results from a number of similar studies (meta-analysis). If treatment decisions are based on the published literature, then the literature must include all available data that is of acceptable quality. Currently, obtaining information regarding all studies undertaken in a given field is difficult, even impossible. Registration of clinical trials, and perhaps other types of studies, is the direction in which the scientific community should move.
Authorship in biomedical publications establishes accountability, responsibility, and credit. Misappropriation of authorship undermines the integrity of the authorship system, but accurate data on its prevalence are limited.
To determine the prevalence of articles with honorary authors (named authors who have not met authorship criteria) and ghost authors (individuals not named as authors but who contributed substantially to the work) in peer-reviewed medical journals and to identify journal characteristics and article types associated with such authorship misappropriation.
Mailed, self-administered, confidential survey.
A total of 809 corresponding authors (1179 surveyed, 69% response rate) of articles published in 1996 in 3 peer-reviewed, large-circulation general medical journals (Annals of Internal Medicine, JAMA, and The New England Journal of Medicine) and 3 peer-reviewed, smaller-circulation journals that publish supplements (American Journal of Cardiology, American Journal of Medicine, and American Journal of Obstetrics and Gynecology).
Prevalence of articles with honorary authors and ghost authors, as reported by corresponding authors.
Of the 809 articles, 492 were original research reports, 240 were reviews and articles not reporting original data, and 77 were editorials. A total of 156 articles (1 9%) had evidence of honorary authors (range, 11%-25% among journals); 93 articles (11%) had evidence of ghost authors (range, 7%-16% among journals); and 13 articles (2%) had evidence of both. The prevalence of articles with honorary authors was greater among review articles than research articles (odds ratio [OR], 1.8; 95% confidence interval [CI], 1.2-2.6) but did not differ significantly between large-circulation and smaller-circulation journals (OR, 1.4; 95% CI, 0.96-2.03). Compared with similar-type articles in large-circulation journals, articles with ghost authors in smaller-circulation journals were more likely to be reviews (OR, 4.2; 95% CI, 1.5-13.5) and less likely to be research articles (OR, 0.49; 95% CI, 0.27-0.88).
A substantial proportion of articles in peer-reviewed medical journals demonstrate evidence of honorary authors or ghost authors.
The characteristics of scientific fraud and its impact on medical research are in general not well known. However, the interest in the phenomenon has increased steadily during the last decade. Biostatisticians routinely work closely with physicians and scientists in many branches of medical research and have therefore unique insight into data. In addition, they have methodological competence to detect fraud and could be expected to have a professional interest in valid results. Biostatisticians therefore are likely to provide reliable information on the characteristics of fraud in medical research. The objective of this survey of biostatisticians, who were members of the International Society for Clinical Biostatistics, was to assess the characteristics of fraud in medical research. The survey was performed between April and July 1998. The participation rate was only 37%. We report the results because a majority (51%) of the participants knew about fraudulent projects, and many did not know whether the organization they work for has a formal system for handling suspected fraud or not. Different forms of fraud (e.g., fabrication and falsification of data, deceptive reporting of results, suppression of data, and deceptive design or analysis) had been observed in fairly similar numbers. We conclude that fraud is not a negligible phenomenon in medical research, and that increased awareness of the forms in which it is expressed seems appropriate. Further research, however, is needed to assess the prevalence of different types of fraud, as well as its impact on the validity of results published in the medical literature.
NIH data indicate that annually seven million human subjects are enrolled in research sponsored by NIH alone. In addition, there are sixteen federal agencies and numerous departments outside NIH conducting experiments with human subjects. Moreover, the pharmaceutical industry spends 16 billion for NIH), thus, the total number of human subjects enrolled in research for both the public and private sectors can be estimated as high as nineteen million. I present data on the potential magnitude of adverse events in the United States among human subjects enrolled in research that appear to be unreported and unaccounted for. We obtained data from the Office for Human Research Protections (OHRP) through the Freedom of Information Act for the years 1990 to August 2000 regarding all Institutional Incident Reports (IRPTs) and a list of Compliance Oversight Branch Investigations (COBIs) involving Multiple Project Assurances (MPAs). In the ten years of reporting for nearly seventy million human subjects, there were only 878 IRPTs and 41 investigations. From the incident reports to OHRP, 44% involved adverse events. Those projects investigated for Multiple Project Assurances violations (41 such investigations) showed that 51% were suspended or terminated. The number of deaths reported to OHRP in ten years for the seventy million human subjects is merely eight. The anticipated number of deaths among the general population in seventy million (assuming subject's duration in trials is one month) is 51,000. The number of suicides and attempted suicides alone among the seventy million expected research subjects can be anticipated to be about 5,000. Therefore, the number of expected deaths should have been between 5,000 and 51,000. These numbers and percentages represent minimal numbers since they are not a result of random audits or investigations, but a result of self-reporting or an exogenous complaint. Despite the fact that these are conservative estimates, they represent a significant problem. The purpose of this paper is to present the potential boundaries and magnitude of the problem in the current use of human subjects in research. This is a call for responsible institutions to undertake a thorough evaluation of the problem in order to obtain accurate information. For the immediate future, strong actions need to be taken to increase the protection of human subjects enrolled in research. This precautionary policy is prudent in light of recent revelations and data from this investigation.
The BMJ published a paper by Ram B Singh in 1992. Doubts were raised about that paper and subsequent manuscripts submitted by the same author. In the absence of answers from the author, the BMJ tried to find a legitimate authority to investigate and adjudicate on its concerns, and failed. The BMJ decided it had no option other than to publish an article documenting its efforts.
Fraud in scientific research is a widespread problem. It can involve falsifying data or documents, or knowingly failing to comply with regulations protecting research participants. Fraud can be committed by individuals, institutions, or corporations; in the context of research, fraud often is motivated by considerations beyond financial gain. Institutional review boards (IRBs) are designed to ensure that researchers comply with human research subject protections, including conflict-of-interest controls, but IRBs may fail to do so if investigators avoid existing IRB processes or if IRB members do not take responsibility for addressting actual or potential conflicts of interest.
CONFLICT of interest in clinical research defies simple definition: one researcher's conflict of interest may be another's mutually beneficial working relationship.¹ Conflict of interest must be clearly distinguished from scientific misconduct. The generally recognized patterns that constitute misconduct in science include plagiarism, deception, falsification, and/or fabrication of scientific data. Scientific misconduct compromises the integrity of the biomedical research process.
On the other hand, conflict of interest involves a distinct subset of issues. Conflict of interest is defined by Webster's Third New International Dictionary as "a conflict between the private interests and official responsibilities of a person in a position of trust." Although conflicts of interest may arise in any research relationship, they are most likely to occur when a researcher enters into a financial arrangement with a profit-making corporation. In that situation, the researcher's dedication to the advancement of medical knowledge may collide with the researcher's desire to increase
In this article the anthors describe how Frenchay, a Bristol-based health authority, has established its own Total Quality Management approach for continuous improvement of patient care and customer Service.
Context.—
The proportion of investigators applying for clinical research grants
from the National Institutes of Health (NIH) who are physicians has declined
from 40% 30 years ago to 25% today.Objective.—
To recommend NIH policy changes that might encourage physician investigators
to undertake careers in clinical research, eg, patient-oriented research,
epidemiologic and behavioral studies, outcomes research, and health services
research.Participants.—
The NIH Director's Panel on Clinical Research comprised 14 physicians
from academia and industry, chosen by the director. They met in numerous closed
sessions and in 5 public meetings from July 1995 to November 1997.Consensus Process.—
In addition to expert opinion and pertinent literature, data sources
included the training characteristics of applicants to NIH who were funded
or not. Topics considered included financing of clinical research, recruitment,
training, and retention of future clinical investigators, conduct of clinical
trials, and peer review of clinical research. Consensus was reached and recommendations
were made in response to an interim report, widely circulated to the biomedical
community, written by members of the panel, which contained preliminary recommendations.Conclusions.—
The panel's final recommendations to NIH included maintaining at least
the present proportion of NIH funding for clinical research; continuing mentored
opportunities in clinical research for medical students; promoting clinical
research training by offering didactic courses and grant opportunities in
clinical research to nascent investigators emerging from specialty training
programs and providing partial salary support for mentors; restructuring study
sections that review patient-oriented research applications to include more
physicians; encouraging clinical investigators and basic scientists to work
closely together and weld collaborations between academic clinical investigators
and colleagues in pharmaceutical and biotechnology companies; and developing
a joint policy between academic health centers and NIH for the support of
clinical research and clinical research training.
Clinical Pharmacology and Therapeutics (1992) 52, 115–119; doi:10.1038/clpt.1992.119
Because of recent concerns about conflicts of interest and published research, the author analyzed 107 controlled clinical trials. Studies were classified as favoring either a new therapy or a traditional therapy, and as being supported by a pharmaceutical manufacturer or as being generally supported. Seventy-one per cent of the trials favored new therapies; 43% of these were funded by pharmaceutical firms. Of the 31 trials favoring traditional therapy, only four (13%) were supported by a pharmaceutical firm. There was a statistically significant association between the source of funding and the outcome of the study (p = 0.002). Few trials supported by pharmaceutical manufacturers favored traditional therapy; some reasons for this finding may include selection of drugs likely to be proven efficacious, Type II errors (false-negative studies), and fear of discontinuation of funding should such studies be submitted. Important clinical information may be lost if negative studies are not published.
Clinical trials may lead to conflicting results. We studied how different ways of reporting results affected physicians' recommendations. A questionnaire distributed to 148 general practitioners presented results of a clinical trial where a reduction of cardiac events and an increase of mortality was reported. Results were shown in four different ways--relative risk reduction, absolute risk reduction, percentages of event-free patients, number needing to be treated to prevent an event--as if they derived from different trials. A fifth presentation was the reduced rate of cardiac events along with the increased rate of mortality. Physicians were asked to estimate how much they would be willing to prescribe each drug. The mean agreement of physicians' decisions was 77 (28)% for relative risk reduction, 24 (28)% for absolute risk reduction, 37 (37)% for different percentages event-free patients, 34 (34)% for number need to treat, and 23 (28)% for events reduction and mortality for increase (p < 0.001 relative risk vs others). The method of reporting trial results and the completeness of information in the case of controversial results affects physicians willingness to prescribe.
To compare the quality, relevance, and structure of drug studies published in symposium proceedings that are sponsored by drug companies with 1) articles from symposia with other sponsors and 2) articles in the peer-reviewed parent journals of symposium proceedings; and to study the relation between drug company sponsorship and study outcome.
Cross-sectional studies of clinical drug studies published in symposium proceedings or their parent medical journals.
The proportion of articles with no methods sections (which are necessary to assess quality); methodologic quality and clinical relevance scores; and the proportion of articles with outcomes favoring the drug of interest.
Symposia sponsored by single drug companies had more articles without methods sections (10%; 108 of 1064) than did symposia that had other sponsors (3%; 58 of 2314) or symposia that had no mentioned sponsor (2%; 29 of 1663) (P < 0.001). The mean methodologic quality and relevance scores of articles were similar both by type of sponsorship and between articles published in symposia sponsored by single drug companies and articles from the parent journals. Significantly more articles with drug company support (98%; 39 of 40) than without drug company support (79%; 89 of 112) had outcomes favoring the drug of interest (P = 0.01).
Articles in symposia sponsored by single drug companies were similar in quality and clinical relevance to articles with other sponsors and to articles published in the parent journals. Articles with drug company support are more likely than articles without drug company support to have outcomes favoring the drug of interest.
State medical boards discipline several thousand physicians each year. Although certain subgroups, such as those disciplined for malpractice, substance use, or sexual abuse, have been studied, little is known about disciplined physicians as a group.
To assess the offenses, contributing factors, and type of discipline of a consecutive series of disciplined physicians.
Case-control study on publicly available data matching 375 disciplined physicians with 2 groups of control physicians, one matched solely by locale, and a second matched for sex, type of practice, and locale.
All disciplined physicians publicly reported by the Medical Board of California from October 1995 through April 1997.
Characteristics of disciplined physicians, offenses leading to discipline, and type of discipline.
A total of 375 physicians licensed by the Medical Board of California (approximately 0.24% per year) were disciplined for 465 offenses. The most frequent causes for discipline were negligence or incompetence (34%), abuse of alcohol or other drugs (14%), inappropriate prescribing practices (11%), inappropriate contact with patients (10%), and fraud (9%). Discipline imposed was revocation of medical license (21%), actual suspension of license (13%), stayed suspension of license (45%), and reprimand (21%). Type of offense was significantly associated with severity of discipline (P=.03). In logistic regression models comparing disciplined physicians with controls matched by locale, board discipline was significantly associated with physicians' sex (odds ratio [OR] for women, 0.44; 95% confidence interval [CI], 0.28-0.70) and involvement in direct patient care (OR, 2.56; 95% CI, 1.75-3.75). In the regression model with additional matching criteria, disciplinary action was negatively associated with specialty board certification (OR, 0.42; 95% CI, 0.29-0.60) and positively associated with being in practice more than 20 years (OR, 2.02; 95% CI, 1.39-2.92).
A small but substantial proportion of physicians is disciplined each year for a variety of offenses. Further study of disciplined physicians is necessary to identify physicians at high risk for offenses leading to disciplinary action and to develop effective interventions to prevent these offenses.
Clinical practice is changing rapidly. New cardiovascular drugs, antiinflammatory drugs, cancer chemotherapy, and other pharmacologic weapons are being added to physicians' therapeutic armamentarium virtually daily. Most clinical studies that bring new drugs from bench to bedside are financed by pharmaceutical companies. Many of these drug trials are rigorously designed, employing the skills of outstanding clinical researchers at leading academic institutions. But academic medical centers are no longer the sole citadels of clinical research. The past 10 years have seen the spectacular growth of a new research model. Commercially oriented networks of contract-research organizations (CROs) and site-management organizations (SMOs) have altered . . .
To determine the prevalence of, and attitudes towards, observed and personal research misconduct among newly appointed medical consultants.
Questionnaire study.
Mersey region, United Kingdom.
Medical consultants appointed between Jan 1995 and Jan 2000 in seven different hospital trusts (from lists provided by each hospital's personnel department).
Reported observed misconduct, reported past personal misconduct and reported possible future misconduct.
One hundred and ninety-four replies were received (a response rate of 63.6%); 55.7% of respondents had observed some form of research misconduct; 5.7% of respondents admitted to past personal misconduct; 18% of respondents were either willing to commit or unsure about possible future research misconduct. Only 17% of the respondents reported having received any training in research ethics. Anaesthetists reported a lower incidence of observed research misconduct (33.3%) than the rest of the respondents (61.5%) (p<0.05).
There is a higher prevalence of observed and possible future misconduct among newly appointed consultants in the UK than in the comparable study of biomedical trainees in California. Although there is a need for more extensive studies, this survey suggests that there is a real and potential problem of research misconduct in the UK.
There is little information about the prevalence of research integrity problems in the scientific literature. We sought to determine how frequently authors of published pharmaceutical clinical trials reported fabrication of data or misrepresentation of research.
We conducted a mail survey of 549 authors who had published reports of pharmaceutical clinical trials from 1998 to 2001 that appeared in the Cochrane Database of Systematic Reviews. We asked authors about fabricated data or misrepresentations of research in three contexts: the target study (the report from which their name was obtained), another study they had participated in, or a study that they personally knew about.
We received replies from 64% of authors with valid addresses. Two authors (1%) reported that the target article misrepresented the research. Almost 5% reported fabrication or misrepresentation in a study they had participated in the last 10 years, and 17% of authors personally know about a case of fabrication or misrepresentation in the last 10 years from a source other than published accounts of research misconduct.
Fraud and misrepresentation in clinical trials appear to be rare on a per-published report basis. However, they occur sufficiently frequently that scientists have a significant chance of participating in a project affected by fraud or misrepresentation during their research careers. These rates of exposure justify vigorous efforts to prevent research misconduct.
The United States has the most expensive health care system in the world, with per capita health expenditures far above those of any other nation. For many years, U.S. health care expenditures have been growing above the overall rate of inflation in the economy. A few experts have argued that high and rising costs are not such a serious problem. Most observers disagree with this view, pointing to the negative impact of employee health care costs on employers, the government budgetary problems caused by rising health care expenditures, and an association between high health care costs and reduced access for individuals needing health services. Several explanations have been offered for high and rising health care costs. These include the perspectives that high and rising costs are created by forces external to the health system, by the weakness of a competitive free market within the health system, by the rapid diffusion of new technologies, by excessive costs of administering the health system, by the absence of strong cost-containment measures, and by undue market power of health care providers. This article, the first in a 4-part series, discusses 3 perspectives on health care: 1) Are high and rising health care costs a serious problem? 2) Are rising costs explained by factors outside the health care system? 3) Does the absence of a free market in health care explain why costs are high and rising? The remaining 3 articles in this series address other perspectives on health care costs.
To discover what types of scientific misconduct are most likely to influence the results of a clinical trial.
Delphi survey of expert opinion with three rounds of consultation.
Non-industry clinical trial "community".
Experts identified from invitees to a previous MRC consultation on clinical trials. 32 out of the 40 experts approached agreed to participate.
We identified thirteen forms of scientific misconduct for which there was majority agreement (>50%) that they would be likely or very likely to distort the results and majority agreement (>50%) that they would be likely or very likely to occur. Of these, the over-interpretation of 'significant' findings in small trials, selective reporting and inappropriate subgroup analyses were the main themes.
According to this expert group, the most important forms of scientific misconduct in clinical trials are selective reporting and the opportunistic use of the play of chance. Data fabrication and falsification were not rated highly because it was considered that these were unlikely to occur. Registration and publication of detailed clinical trial protocols could make an important contribution to preventing scientific misconduct.
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.
Since 1992 the Office of Research Integrity (ORI) had reviewed investigations of scientific misconduct in research funded by the US Public Health Service (PHS). ORI defined scientific misconduct as "fabrication, falsification, plagiarism, or other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting, or reporting research".
The purpose of this study was to summarize the findings and administrative actions reported in ORI notices of scientific misconduct in clinical trials occurring between May 1992 and 2002.
Findings of misconduct were gathered from publicly available sources: the ORI annual reports and the NIH Guide to Grants and Contracts.
Clinical trials accounted for 17 (13%) of the 136 investigations that resulted in findings of scientific misconduct, and they were noted in 12 (11%) of the 113 brief reports of investigations closed with findings of no scientific misconduct. In clinical trials, the most severe sanction, debarment from US Government funding, was applied in six (35%) of the cases of misconduct compared to 79 (66%) of 119 cases from all other types of research combined. Of individuals cited for misconduct in clinical trials, three (18%) held doctorates in contrast to 81 (68%) in other types of research.
In clinical trials, junior employees may bear the burden of sanction for scientific misconduct. The most frequently applied sanction was the requirement that a plan of supervision of the sanctioned employees accompany any future application for funding which would include them. This imposition of sanction on an individual employee does not address possible causes of misconduct which may be inherent in the overall pattern of leadership, training and supervision in the trial. Furthermore, the definition of misconduct, as interpreted by the Departmental Appeals Board, excludes carelessness and other poor research practices that may lead to dissemination of more incorrect data than misconduct.
This paper discusses the experiences of the Office of Research Integrity (ORI) with issues involving complainants who make allegations of research misconduct. The paper describes the legal framework for complainant issues, the various roles of the complainant as the allegation of misconduct proceeds through the steps of investigation and resolution, how allegations of retaliation against the complainant are handled, the responsibilities of ORI and of the research institution where the alleged misconduct occurred, and ORI's experience with several cases of alleged retaliation. In each of these areas, the paper attempts to provide guidance to prospective complainants, research institutions, and other interested persons on effective ways to approach the various problems and concerns that arise, while maintaining a balance between the needs of the complainant, the accused, the research institution handling the allegation, and ORI.
Health Journal: Doctor report cards don't tell consumers whole story on care
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