Consistency of Financial Interest Disclosures in the Biomedical Literature: The Case of Coronary Stents

Background Disclosure of authors' financial interests has been proposed as a strategy for protecting the integrity of the biomedical literature. We examined whether authors' financial interests were disclosed consistently in articles on coronary stents published in 2006. Methodology/Principal Findings We searched PubMed for English-language articles published in 2006 that provided evidence or guidance regarding the use of coronary artery stents. We recorded article characteristics, including information about authors' financial disclosures. The main outcome measures were the prevalence, nature, and consistency of financial disclosures. There were 746 articles, 2985 authors, and 135 journals in the database. Eighty-three percent of the articles did not contain disclosure statements for any author (including declarations of no interests). Only 6% of authors had an article with a disclosure statement. In comparisons between articles by the same author, the types of disagreement were as follows: no disclosure statements vs declarations of no interests (64%); specific disclosures vs no disclosure statements (34%); and specific disclosures vs declarations of no interests (2%). Among the 75 authors who disclosed at least 1 relationship with an organization, there were 2 cases (3%) in which the organization was disclosed in every article the author wrote. Conclusions/Significance In the rare instances when financial interests were disclosed, they were not disclosed consistently, suggesting that there are problems with transparency in an area of the literature that has important implications for patient care. Our findings suggest that the inconsistencies we observed are due to both the policies of journals and the behavior of some authors

Transgenic Agriculture: Biosafety and International Trade

We stand at the threshold of a new century that will bring novel methods of producing foods, industrial materials, pharmaceuticals, and other products important to society and industry.2 Today\u27s session will, therefore, address a subject of great importance: the introduction of genetically modified crops, livestock, micro-organisms, and other substances into agriculture and related fields, made possible by American and foreign corporate biotechnology

Reporting of conflicts of interest in guidelines of preventive and therapeutic interventions

BACKGROUND: Guidelines published in major medical journals are very influential in determining clinical practice. It would be essential to evaluate whether conflicts of interests are disclosed in these publications. We evaluated the reporting of conflicts of interest and the factors that may affect such disclosure in a sample of 191 guidelines on therapeutic and/or preventive measures published in 6 major clinical journals (Annals of Internal Medicine, BMJ, JAMA, Lancet, New England Journal of Medicine, Pediatrics) in 1979, 1984, 1989, 1994 and 1999. RESULTS: Only 7 guidelines (3.7%) mentioned conflicts of interest and all were published in 1999 (17.5% (7/40) of guidelines published in 1999 alone). Reporting of conflicts of interest differed significantly by journal (p=0.026), availability of disclosure policy by the journal (p=0.043), source of funding (p < 0.001) and number of authors (p=0.004). In the entire database of 191 guidelines, a mere 18 authors disclosed a total of 24 potential conflicts of interest and most pertained to minor issues. CONCLUSIONS: Despite some recent improvement, reporting of conflicts of interest in clinical guidelines published in influential journals is largely neglected

Pulmonary talc granulomatosis mimicking malignant disease 30 years after last exposure: a case report

<p>Abstract</p> <p>Introduction</p> <p>Pulmonary talc granulomatosis is a rare disorder characterized by the development of foreign body granuloma secondary to talc exposure. Previous case reports have documented the illness in current intravenous drug users who inject medications intended for oral use. We present a rare case of the disease in a patient with a distant history of heroin abuse who presented initially with history and imaging findings highly suggestive of malignancy.</p> <p>Case presentation</p> <p>A 53-year-old man reported a 4-month history of increasing dyspnea and weight loss. He had a long history of smoking and admission chest X-ray revealed a density in the right hemithorax. Computed tomography confirmed a probable mass with further speculated opacities in both lung fields suspicious for malignant spread. Biopsies obtained using endobronchial ultrasound-guided aspiration returned negative for malignancy and showed bronchial epithelial cells with foreign body giant cell reaction and polarizable birefringent talc crystals.</p> <p>Conclusion</p> <p>This case demonstrates a rare presentation of talc granulomatosis three decades after the last likely exposure. The history and imaging findings in a chronic smoker were initially strongly suggestive of malignant disease, and we recommend that talc-induced lung disease is considered in any patient with multiple scattered pulmonary lesions and a history of intravenous drug use. Confirmation of the disease by biopsy is essential, but unfortunately there are few successful proven management options for patients with worsening disease.</p

A Comparison of DSM-IV and DSM-5 Panel Members' Financial Associations with Industry: A Pernicious Problem Persists

Lisa Cosgrove and Sheldon Krimsky examine the new competing interest disclosure policy of the American Psychiatric Association (APA) and report that DSM panel members still have considerable financial conflicts of interest

Improving the use of research evidence in guideline development: 4. Managing conflicts of interests

BACKGROUND: The World Health Organization (WHO), like many other organisations around the world, has recognised the need to use more rigorous processes to ensure that health care recommendations are informed by the best available research evidence. This is the fourth of a series of 16 reviews that have been prepared as background for advice from the WHO Advisory Committee on Health Research to WHO on how to achieve this. OBJECTIVES: We reviewed the literature on conflicts of interest to answer the following questions: 1. What is the best way to obtain complete and accurate disclosures on financial ties and other competing interests? 2. How to determine when a disclosed financial tie or other competing interest constitutes a conflict of interest? 3. When a conflict of interest is identified, how should the conflict be managed? 4. How could conflict of interest policies be enforced? METHODS: We searched PubMed, the Cochrane Methodology Register and selectively searched for the published policies of several organizations, We did not conduct systematic reviews ourselves. Our conclusions are based on the available evidence, consideration of what WHO and other organisations are doing and logical arguments. KEY QUESTIONS AND ANSWERS: What is the best way to obtain complete and accurate disclosures on financial ties and other competing interests? • Although there is little empirical evidence to guide the development of disclosure forms, minimal or open-ended formats are likely to be uninformative. We recommend the development of specific, detailed, structured forms that solicit as much information as possible about the nature and extent of the competing interests. How to determine when a disclosed financial tie or other competing interest constitutes a conflict of interest? • There is no empirical evidence to suggest that explicit criteria are preferable to ad hoc committee decisions when deciding if a disclosed financial tie is a conflict of interest. However, explicit criteria may make decision-making easier. When a conflict of interest is identified, how should the conflict be managed? • Descriptive studies suggest that appropriate management strategies are best determined on a case-by-case basis. Thus, WHO should use a wide range of management strategies to address disclosed conflicts of interest, with public disclosure of conflicts associated with each meeting as a minimum and recusal of conflicted individuals as the other extreme. How could conflict of interest policies be enforced? • Although there are no empirical studies of the enforcement of conflict if interest policies, descriptive studies of other organizations and institutions suggest that WHO convene a standing committee to review all financial disclosure statements prior to the commencement of committee meetings/hearings and to make management recommendations when necessary. A standard policy requiring all financial ties to be made public (i.e., recorded into the meeting minutes) should reduce the number of problematic cases. In instances where the conflicts seem intractable, a recommendation of recusal may be necessary to protect the greater interests of WHO and its constituents

Representation and Re-Presentation in Litigation Science

Federal appellate courts have devised several criteria to help judges distinguish between reliable and unreliable scientific evidence. The best known are the U.S. Supreme Court’s criteria offered in 1993 in Daubert v. Merrell Dow Pharmaceuticals, Inc. This article focuses on another criterion, offered by the Ninth Circuit Court of Appeals, that instructs judges to assign lower credibility to “litigation science” than to science generated before litigation. In this article I argue that the criterion-based approach to judicial screening of scientific evidence is deeply flawed. That approach buys into the faulty premise that there are external criteria, lying outside the legal process, by which judges can distinguish between good and bad science. It erroneously assumes that judges can ascertain the appropriate criteria and objectively apply them to challenged evidence before litigation unfolds, and before methodological disputes are sorted out during that process. Judicial screening does not take into account the dynamics of litigation itself, including gaming by the parties and framing by judges, as constitutive factors in the production and representation of knowledge. What is admitted through judicial screening, in other words, is not precisely what a jury would see anyway. Courts are sites of repeated re-representations of scientific knowledge. In sum, the screening approach fails to take account of the wealth of existing scholarship on the production and validation of scientific facts. An unreflective application of that approach thus puts courts at risk of relying upon a “junk science” of the nature of scientific knowledge