Es el paper “Neuraminidase inhibitors for preventing and treating inﬂuenza in healthy adults and children (Review) Copyright © 2012 The Cochrane Collaboration.” Es metodológicamente lapidario.
Está en http://www.thecochranelibrary.com/details/file/1440293/CD008965.html
We found a high risk of publication and reporting biases in the trial programme of oseltamivir. Sub-population analyses of the inﬂuenza infected population in the oseltamivir trial programme are not possible because the two arms are non-comparable due to oseltamivir’s apparent interference with antibody production. The evidence supports a direct oseltamivir mechanism of action on symptoms but we are unable to draw conclusions about its effect on complications or transmission. We expect full clinical study reports containing study protocol, reporting analysis plan, statistical analysis plan and individual patient data to clarify outstanding issues. These full clinical study reports are at present unavailable to us.
The authors have been unable to obtain the full set of clinical study reports or obtain veriﬁcation of data from the manufacturer of oseltamivir (Roche) despite ﬁve requests between June 2010 and February 2011. No substantial comments were made by Roche on the protocol of our Cochrane Review which has been publicly available since December 2010. Based on our assessments of the documents we could obtain, we came to the conclusion that there were substantial problems with the design, conduct and availability of information from many of the trials.
We have major reservations as to whether the evidence from the trial programmes we have reviewed so far is applicable in any way to clinical practice.
The concept of commercially sensitive information should be inapplicable to public health drugs.
We believe that methods for systematic reviews of regulatory information should be urgently developed.
El equipo de medicamentos esenciales de OMS se negó a incluir el oseltamivir en el listado de medicamentos esenciales por falta de evidencia de que fuera efectivo, solo pocos unos meses antes de la “recomendación” de la OMS de utilizarlo en la gripe por H1N1.
Hasta ahora no hay explicaciones satisfactorias ni de Roche, ni de la OMS, pero muchos países han gastado miles de millones de dolares de los escasos fondos de salud en un medicamento cuya eficacia no ha sido demostrada. Esto indica un nivel de impunidad alarmante, aunque no sorprendente.
Gracias Alicia Benítez por el trabajo.