An editorial of the prestigious journal British Medical Journal communicates a piece of news that has made headlines in the scientific environment. The IRCCS-Istituto di Ricerche Farmacologiche Mario Negri has withdrawn its membership in a project, Innovative Medicines Initiative (IMI), funded 50% by the European Union, aims to develop a drug ownedà of the GlaxoSmith&Kline (GSK).
The Mario Negri è withdrawn becauseé GSK claims for sé the right to grant or deny access to the data of the study and the control of their publication. GSK intends to exercise its control not only vis-à-vis the community; scientific research in general, but even by the same researchers participating in the study.
“The secret place on the results of the clinical trials – comments Silvio Garattini, Director of the Mario Negri – represents an undue spoliation of the rights of patients and doctors participating in the study: the data in the final them.”
The Mario Negri institute is not required for sé the propertyà data. “We never do – Garattini – becauseé it would be contrary to our ethical principles”. Notoriously, in fact, the Mario Negri Institute does not patented the discoveries of its researchers, but also makes immediately public, for the benefit of patients and of the communityà scientific.
The claims of GSK are even more unacceptable in the context of the IMI project. “The Innovative Medicines Initiative – precise Victor Bertelé that has participated in the negotiations with GSK – supports the European Union funds collaborative projects between industry and academy with the specific intent to promote innovation. The industry puts us at the raw product; but are the patients and the clinical scientists who develop it, to più with public funds”.
researchers at The Mario Negri, they only asked that those who participated in the study could at least access all of the data that were the basis for the publication. it Seemed absurd that you could be authors without having analyzed the results of all the patients.
“Instead, emphasizes, Guido Bertolini, Coordinator of the network of centres that would have had to conduct this study, we had to discuss with the lawyers of the house, the mother of GSK on quibbles specious of a draft agreement that essentially gave the company full control of the study, its results and the publication of these”. The fact this is inadmissible both for the researcher at the Mario Negri, both for the network of centers of intensive therapy, known as the GiViTI, that would have had to participate in the study.
The failure to reach an agreement with GSK involves the impossibilityà to the Mario Negri access to funds made available by the IMI. “This is a considerable economic sacrifice in times già sé these, concludes Garattini – but we could not abdicate our principles né betraying the trust of those who support our research”.
The issue raised by the Mario Negri institute is part of the problem is always più heard at the level of the community; international scientific: to ensure that the legitimate interests of the industry will prevail on the needà to plan, conduct, and evaluate the results of clinical research in independently to protect usò that più has a population, that is, the rights of patients.
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