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The European Alliance for Responsible R&D and Affordable Medicines transparency of clinical trials and good governance should be included in the EMA (European Medicines Agency) extended mandate

13 Sep

In occasion of the ongoing trilogues on the European Medicines Agency (EMA) extended mandate, Members of the European Alliance for Responsible R&D and Affordable Medicines urge the Council to ensure the new Regulation enhances clinical trial transparency and upholds good governance.    As explained in a letter published today, it is crucial that information on [...]

What has evidence based medicine (EBM) done for our patients? We do not know. We must abandon it

18 Sep

We must admit that: a / “if the final objective of EBM (Evidence Based Medicine) is to improve patients-populations’ health, do we have evidence of succeed in this objective?” No, b / is EBM harming patients-populations’ health? We do not know. Evidence-Based Medicine (#EBM) has not demonstrated any impact on patients’ health. It is honest [...]

Making use of the Food and Drug Administration briefing documents to reconsider the safety of the antipsychotic sertindole

2 Sep

Sertindole (Serdolect in the world, Zerdol in Germany) is an atypical antipsychotic agent, schizophrenia. Sertindole side effects include cardiac problems as prolongation of QT interval, arrhythmia and sudden deaths (higher than for other atypical antipsychotics). The FDA analysis of SCoP, made public in April 2009, estimated the hazard ratio for sudden cardiac death with sertindole [...]

Overdiagnosis as an extreme form of length-time bias. Breast cancer screening as an example

14 Oct

Overdiagnosis is an error of prognosis. Overdiagnosis is not an error of diagnosis. Overdiagnosis is a “true positive” diagnosis. We cannot distinguish between overdiagnosis cancer and non-overdiagnosis cancer. In this presentation the focus is on the vision of overdiagnosis as extreme form of length-time bias, and the research lines which might help in the future [...]

Minimum data set in General Practice: definitions and coding

31 Jan

A minimum basic data set (MBDS) was designed and used in general practice. The most important purpose and need for establishing such a data set is to assist in the provision of patient care. MBDS is designed to meet common needs for many general practitioners. Minimum means that individual programmes or the GP are free [...]

Trials of improve care for the elderly

7 Mar

Clinical randomized trials are experimental situations where some patients might received excellent care. What happens after the end of the trial? This a key ethical question should be answered in all proyects and programs of clinical trial.  Trials of improve care for the elderly. Gérvas, J., Pérez Fernández, M. N Engl J Med. 1996; 334: [...]

Logical graphical representation of medical activity

20 Dec

The health system has four functions: 1/ health protection, 2/ health promotion, 3/ health prevention, and 4/ care of diseases and helping to die. In this text there is a proposal for a graphical representation that helps in understanding the medical activity. Logical graphical representation of medical activity. Gérvas, J. Diciembre 2011. Download English version here.