Broader Transparency on Risk-benefit Assessment of the Bial Trial in France.

On 11 January 2016, a Phase I trial of an experimental fatty acid amide hydrolase inhibitor for pain developed by Bial-Portela was halted after six healthy volunteers were admitted to the University of Rennes Hospital in France. One volunteer died and four suffered severe neurological injuries. It is a dreadful reminder of the Tenegero trial that also hospitalized six volunteers in 2006. Three major similarities were observed between the Tegenero and Bial trials. The first similarity is related to the dosing interval protocol. There is a lack of information about whether the multiple-dose regimen included adequate time intervals between individuals receiving the drug. The second similarity is on the dosing calculation that was based on the ‘no adverse effect level’ (NOAEL). The third similarity is observed in terms of how there was no prior publication of preclinical findings in the public domain before the start of both trials. There have been calls for the full release of the Investigation Medicinal Product Dossier and the Investigator’s Brochure, as these data are critical to maximize patient safety in the future and should outweigh considerations of commercial confidentiality. Likewise, it is necessary for the Brest Regional Ethics Committee to release its documents, which captured the risk-benefit assessment in approving the Bial trial, for external scrutiny.

Establishment of Ethical Assessment System in the Admittance of the Limitative Medical Technologies / 中国医学伦理学

Objective to establish an ethical assessment system in the admittance of the limitative medical technologies.Method:literature review and Delphi method are employed to adjust and set the structure,index numbers,and index weights of ethical assessment system of the limitative medical technologies.Result:An ethical assessment system in the admittance of the limitative medical technologies was established,which included 3 primary indices,11 secondary indices and 35 tertiary indices.There were 4 qualitative levels with different weights in tertiary indices,based on which the global grade and proposed-admittance criterion were obtained.Conclusion:Establishment of ethical assessment system in the admittance of the limitative medical technologies provides an ethical evidence for the assessment of clinical admittance of the limitative medical technologies with qualitative and quantitative approaches and class-setting evidence.

On the Ethical Assessment Basis of the Clinical Admittance of Limitative Medical Technologies──A Moral Criticism on the Rationality of Medical Technology / 中国医学伦理学

This paper analyzes the essential regulations in the rationality of the limitative medical technologies.The rationality of medical technologies is the unity of regularity and intention,implementation and humanism,technology and society.This is also the basis for establishing the ethical assessment of the clinical admittance of limitative medical technologies.