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At least 847 records · Page 47Linked to original sources
PubMed2000

International Conference on Harmonisation; guidance on E11 clinical investigation of medicinal products in the pediatric population; availability. Notice.

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "E11 Clinical Investigation of Medicinal Products in the Pediatric Population." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance sets forth critical issues in pediatric drug development and approaches to the safe, efficient, and ethical study of medicinal products in the pediatric population. The guidance is intended to encourage and facilitate the timely development of pediatric medicinal products internationally.

Child↗
PubMed2005

Racializing drug design: implications of pharmacogenomics for health disparities.

Current practices of using "race" in pharmacogenomics research demands consideration of the ethical and social implications for understandings of group difference and for efforts to eliminate health disparities. This discussion focuses on an "infrastructure of racialization" created by current trajectories of research on genetic differences among racially identified groups, the use of race as a proxy for risk in clinical practice, and increasing interest in new market niches by the pharmaceutical industry. The confluence of these factors has resulted in the conflation of genes, disease, and race. I argue that public investment in pharmacogenomics requires careful consideration of current inequities in health status and social and ethical concerns over reifying race and issues of distributive justice.

Drug Design↗
PubMed2005

[When is a clinical study non-commercial?].

A non-commercial study is a research project not aiming at the protection of a commercial institution's interests. The classification of a clinical study as non-commercial or commercial makes sense and is important especially for clinical research teams, ethics committees and hospital owners because of relevant differences in the image and cost fields. The support of non-commercial studies by commercial institutions like pharmaceutical companies is permissible, unless it is tied to conditions impairing impartiality in respect of design, publication of study results or ownership of the assessed data. Specific relationships between the investigator and a company of the health industry potentially profiting from the study results (e.g. major share holdings or financial dependences) favour the classification of a study as commercial. The reliable classification of a study as non-commercial is only possible if all aids and grants, all conflicts of interest and special agreements are disclosed.

Austria↗
PubMed2003

In the grip of the python: conflicts at the university-industry interface.

When the University of Toronto withdrew a contract it held with me in December 2000, it initiated a sequence of events that led to a public letter to the University from senior figures in the world psychopharmacology community protesting against the infringement of academic freedom involved and a first ever legal action, undertake by this author, seeking redress for a violation of academic freedom. The issues of academic freedom surrounding this case have been intertwined with a debate about the possibility that the selective serotonin reuptake inhibitor (SSRI) group of antidepressants have the potential to trigger suicidality in a subgroup of patients. Whether the SSRIs do trigger suicidality or not, exploration of this issue has given rise to a number of worrying sets of observations. First, in my view, there is evidence that pharmaceutical companies have miscoded raw data on suicidal acts and suicidal ideation. Second, this author also maintains that there is a growing body of examples of ghostwriting of articles in the therapeutics domain. Many of the tensions evident in this case, therefore, can be linked to company abilities to keep clinical trial data out of the public domain--this is the point at which the pharmaceutical python gets a grip on academia.

Conflict of Interest↗