Why Public Health Agencies Cannot Depend on Good Laboratory Practices as a Criterion for Selecting Data: The Case of Bisphenol A

In their safety evaluations of bisphenol A (BPA), the U.S. Food and Drug Administration (FDA) and a counterpart in Europe, the European Food Safety Authority (EFSA), have given special prominence to two industry-funded studies that adhered to standards defined by Good Laboratory Practices (GLP). These same agencies have given much less weight in risk assessments to a large number of independently replicated non-GLP studies conducted with government funding by the leading experts in various fields of science from around the world. OBJECTIVES: We reviewed differences between industry-funded GLP studies of BPA conducted by commercial laboratories for regulatory purposes and non-GLP studies conducted in academic and government laboratories to identify hazards and molecular mechanisms mediating adverse effects. We examined the methods and results in the GLP studies that were pivotal in the draft decision of the U.S. FDA declaring BPA safe in relation to findings from studies that were competitive for U.S. National Institutes of Health (NIH) funding, peer-reviewed for publication in leading journals, subject to independent replication, but rejected by the U.S. FDA for regulatory purposes. DISCUSSION: Although the U.S. FDA and EFSA have deemed two industry-funded GLP studies of BPA to be superior to hundreds of studies funded by the U.S. NIH and NIH counterparts in other countries, the GLP studies on which the agencies based their decisions have serious conceptual and methodologic flaws. In addition, the U.S. FDA and EFSA have mistakenly assumed that GLP yields valid and reliable scientific findings (i.e., "good science"). Their rationale for favoring GLP studies over hundreds of publically funded studies ignores the central factor in determining the reliability and validity of scientific findings, namely, independent replication, and use of the most appropriate and sensitive state-of-the-art assays, neither of which is an expectation of industry-funded GLP research. CONCLUSIONS: Public health decisions should be based on studies using appropriate protocols with appropriate controls and the most sensitive assays, not GLP. Relevant NIH-funded research using state-of-the-art techniques should play a prominent role in safety evaluations of chemicals.

«Où, quand, et comment ?» : Évolution des conduites agressives en football et en hockey sur glace

RésuméCette étude a pour objectif d'observer l'évolution des actes agressifs dans deux sports d'équipes en fonction de facteurs situationnels (périodes de jeu, lieu de la faute, état du score) et du type d'agressions (instrumentales, hostile). 60 matchs professionnels de football et de hockey sur glace ont été filmés puis analysés à l'aide de grilles d'observation différenciant les deux types d'agressions. Les résultats révèlent que dans ces deux sports, les agressions instrumentales sont plus fréquentes dans les zones importantes du terrain (milieu ou défense) ou lorsque le score est serré. En revanche, les agressions hostiles ne varient pas (ou peu) selon ces facteurs. Les résultats sont discutés au regard de la théorie de l'apprentissage social et de l'hypothèse frustration-agression.AbstractThis study aims at examining observed aggression in two team sports as a function of situational triggers (periods, zones of field, games score) and of type of aggression (instrumental, hostile). 60 soccer and ice hockey games were recorded and analyzed using a grid that differentiates the two types of aggression. The results revealed that theses two sports, instrumental aggressions were more frequent in important zones of field (neutral or defensive ones) and in tied score situations. However, no difference was found for hostile aggression according to these factors. The discussion focused on the social learning theory and frustration-aggression hypothesis.

Response to comment on "the geometric structure of the brain fiber pathways".

In response to Catani et al., we show that corticospinal pathways adhere via sharp turns to two local grid orientations; that our studies have three times the diffusion resolution of those compared; and that the noted technical concerns, including crossing angles, do not challenge the evidence of mathematically specific geometric structure. Thus, the geometric thesis gives the best account of the available evidence.

Comment faciliter la consommation de protéines après un bypass gastrique [How to facilitate protein consumption after gastric bypass?].

After a gastric bypass, covering protein needs is impossible. This deficit is co-responsible for several postoperative complications so it is essential to inform, prepare and train every patient candidate for such an intervention. To increase protein intake, it is important to work on two different aspects: on the one hand on food sources, targeting the richest food and, on the other hand, on food tolerance so that these foods can be consumed. In fact, gastric bypass induces not only a reduction in gastric volume, but also reduces the passage from the stomach to the intestine. Changes in feeding behavior are much needed to improve food tolerance.