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Biomedical subjects

Sheldon Krimsky

Publications and source records attributed to Sheldon Krimsky.

18 recordsLinked to original sources

Financial ties between DSM-IV panel members and the pharmaceutical industry.

BACKGROUND: Increasing attention has been given to the transparency of potential conflicts of interest in clinical medicine and biomedical sciences, particularly in journal publishing and science advisory panels. The authors examined the degree and type of financial ties to the pharmaceutical industry of panel members responsible for revisions of the Diagnostic and Statistical Manual of Mental Disorders(DSM). METHODS: By using multimodal screening techniques the authors investigated the financial ties to the pharmaceutical industry of 170 panel members who contributed to the diagnostic criteria produced for the DSM-IV and the DSM-IV-TR. RESULTS: Of the 170 DSM panel members 95 (56%) had one or more financial associations with companies in the pharmaceutical industry. One hundred percent of the members of the panels on 'Mood Disorders' and 'Schizophrenia and Other Psychotic Disorders' had financial ties to drug companies. The leading categories of financial interest held by panel members were research funding (42%), consultancies (22%) and speakers bureau (16%). CONCLUSIONS: Our inquiry into the relationships between DSM panel members and the pharmaceutical industry demonstrates that there are strong financial ties between the industry and those who are responsible for developing and modifying the diagnostic criteria for mental illness. The connections are especially strong in those diagnostic areas where drugs are the first line of treatment for mental disorders. Full disclosure by DSM panel members of their financial relationships with for-profit entities that manufacture drugs used in the treatment of mental illness is recommended.

Advisory Committees↗

Emergence of a scientific and commercial research and development infrastructure for human gene therapy.

A research and clinical subfield known as "human gene therapy" has grown rapidly since 1990, when the first human trials were approved in the United States. Using quantitative data, this paper describes and analyzes the research and commercial infrastructure, including academic centers, publications, intellectual property, and biotechnology firms, that has developed around the goal of discovering clinical applications for the modification and transport of DNA to somatic cells. Despite setbacks and few documented successes, the subfield of human gene therapy continues to serve as an influential clinical paradigm for the treatment of inherited and noninherited diseases.

Biomedical Research↗

The weight of scientific evidence in policy and law.

The term "weight of evidence" (WOE) appears in regulatory rules and decisions. However, there has been little discussion about the meaning, variations of use, and epistemic significance of WOE for setting health and safety standards. This article gives an overview of the role of WOE in regulatory science, discusses alternative views about the methodology underlying the concept, and places WOE in the context of the Supreme Court's decision in Daubert v Merrell Dow Pharmaceuticals, Inc (1993). I argue that whereas the WOE approach to evaluating scientific evidence is gaining favor among regulators, its applications in judicial processes may be in conflict with some interpretations of how the Daubert criteria for judging reliable evidence should be applied.

Causality↗

For the record.

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Periodicals as Topic↗