Conflict of interest policies in science and medical journals: editorial practices and author disclosures.

This study examines the extent to which scientific and biomedical journals have adopted conflict of interest (COI) policies for authors, and whether the adoption and content of such policies leads to the publishing of authors' financial interest disclosure statements by such journals. In particular, it reports the results of a survey of journal editors about their practices regarding COI disclosures. About 16 percent of 1396 highly ranked scientific and biomedical journals had COI policies in effect during 1997. Less than 1 percent of the articles published during that year in the journals with COI policies contained any disclosures of author personal financial interests while nearly 66 percent of the journals had zero disclosures of author personal financial interests. Nearly three fourths of journal editors surveyed usually publish author disclosure statements suggesting that low rates of personal financial disclosures are either a result of low rates of author financial interest in the subject matter of their publications or poor compliance by authors to the journals' COI policies.

An epistemological inquiry into the endocrine disruptor thesis.

For about a decade the term endocrine disruptor has become synonymous with a new research initiative that has been investigating the effects of hormonally active xenobiotics on biological systems. The scientific thesis behind the new research initiative is discussed and it is argued that there is a need for more emphasis on theory development and conceptual clarification that will give coherence to a field experiencing a rapid growth of empirical studies. Reflections on scientific methodology in this field will also help clarify whether endocrine disruptors symbolize a new etiology of chemically induced disease or represent variations of traditional chemical toxicology.

Scientific journals and their authors' financial interests: a pilot study.

BACKGROUND: The credibility of modern science is grounded on the perception of the objectivity of its scientists, but that credibility can be undermined by financial conflicts of interest. The US Public Health Service and the National Science Foundation issued regulations effective October 1, 1995, regarding the disclosure of financial interests in the submission of grant proposals. Several scientific journals have also established pertinent policies for authors and editors. The objectives of this study were: (1) to select a set of published articles and observe the degree to which a sample of authors hold a financial interest in areas related to their research that are reportable under current standards, and (2) to examine the hypothesis that significant numbers of authors of articles in life science and biomedical journals have verifiable financial interests that might be important for journal editors and readers to know. This paper measures the frequency of selected financial interests held among lead authors of certain types of scientific publications and assesses disclosure practices of authors and journals. METHOD: These objectives were applied to a pilot study of Massachusetts academic scientists who were cited as first or last author in at least one article published in 1992 in 14 leading journals of cell or molecular biology and medicine. We created a database of every original article published in 1992 by 14 leading life science and biomedical journals, supplemented by data sets consisting of (1) Massachusetts biotechnology firms, including their officers and scientific advisory boards, and (2) scientists listed as inventors on patents or patent applications registered with the World Intellectual Property Organization. RESULTS: We examined 1,105 university authors (first and last cited) from Massachusetts institutions whose 789 articles, published in 1992, appeared in 14 scientific and medical journals. Authors are said to 'possess a financial interest' if they are listed as inventors in a patent or patent application closely related to their published work; serve on a scientific advisory board of a biotechnology company; or are officers, directors, or major shareholders (beneficial owner of 10% or more of stock issued) in a firm that has commercial interests related to their research. Applying the criteria to the reference population of journals and Massachusetts academic authors, we measured the following frequencies for lead authors: 0.20 for serving on a scientific advisory board; 0.07 for being an officer, director, or major shareholder in a biotechnology firm, and 0.22 for being listed as an inventor in a related patent or patent application. The joint frequency of articles in the journals reviewed with a lead author that meets one of the three conditions is 0.34. CONCLUSIONS: One of every three articles in our sample has at least one Massachusetts-based author with a financial interest, and 15% of the authors in our sample have a financial interest relevant to one of their publications. For the year 1992, the rate of published voluntary disclosures of financial interest (as defined in our study) is virtually zero, but relatively few scientific and biomedical journals at that time required any such disclosure to journal editors and reviewers. Further research is needed to determine the effectiveness of mandatory disclosure requirements by some journals.

Financial interest and its disclosure in scientific publications.

Journal policies and requirements of funding agencies on financial disclosure of authors and grant applicants have divided editors and scientists who disagree on whether such policies can improve the integrity of science or manage conflicts of interest. Those opposed to such disclosure policies argue that financial interest is one of many interests held by scientists, is the least scientifically dangerous, and should not be singled out. Those who favor open reporting of financial interests argue that full disclosure removes the suspicion that something of relevance to objectivity is being hidden and allows readers to form their own opinions on whether a conflict of interest exists and what relevance that has to the study. The authors believe that the scientific community and the public will be best served by open publication of financial disclosures for readers and reviewers to evaluate.

Regulatory Oversight of Genetically Engineered Microorganisms: Has Regulation Inhibited Innovation?

/ Using detailed interviews with company representatives and researchers in the field, this paper examines the factors that might account for the slow pace of development of genetically engineered microorganisms (GEMs) intended for environmental release. We specifically analyzed the role of the regulatory system in shaping innovation. We identified at least two cases where industry decided to discontinue the development of a genetically engineered microbial product because of concerns over regulatory oversight. However, most often industry decisions to continue or halt development of GEMs were based on an evaluation of the particular product's efficacy and potential for profitability. Thus the inability of GEMs to perform up to expectations in the field, rather than the regulatory constraints, appears to be the factor responsible for the slow pace of development. KEY WORDS: Genetically engineered microorganisms; Biotechnology; Regulation of biotechnology; Innovation; Environmental release

Evaluating risk communication: narrative vs. technical presentations of information about radon.

This paper reports on an experiment to test the hypothesis that people respond better to risk communication that reflects more closely the conditions of their social and cultural lives. The experiment used the case of radon to determine whether technical or narrative forms of risk communication were more effective at drawing people's attention, imparting information, and modifying behavior. Two series of articles on radon were placed in the local newspapers of two Massachusetts communities. Homeowner attitudes, knowledge, and responses were monitored in baseline and follow-up telephone surveys. A third community was selected for comparison. The newspaper series were developed on the basis of previous research and six focus groups conducted with homeowners. The technical series presented authoritative, factual risk information, in the scientific style of the passive voice with generalized and impersonal language. The narrative series consisted of dramatized accounts of individuals making decisions about radon testing and mitigation, written in a more personal style. The findings from the focus groups confirm the results of previous studies, but the small size of the follow-up samples was a limiting factor in drawing definitive conclusions about the relative effectiveness of the two formats. The experiment demonstrates the difficulty of any risk communication effort on radon and underscores the need for good research design.(ABSTRACT TRUNCATED AT 250 WORDS)

Human gene therapy: must we know where to stop before we start?

Human genetic modification has begun without a clear consensus on where the moral boundary lines should be placed to insure that the technology of human genetic engineering is not abused. Two principal recommendations have been made for setting the boundaries. The first is between somatic cell versus germ-line correction; the second is between the amelioration of disease and the enhancement of traits. Each proposal involves a distinction and a rule. There is a dilemma in that the first case involves a well-grounded distinction but a dubious rule, while the second offers a more favored rule, but a fuzzy distinction.