12
views
0
recommends
+1 Recommend
1 collections
    0
    shares
      • Record: found
      • Abstract: found
      • Article: found
      Is Open Access

      El peligroso negocio con la salud (2018) y Salud a la venta (2018): denunciando la corrupción en la investigación biomédica Translated title: The dangerous health business (2018) and The Bleeding Edge (2018): exposing corruption in biomedical research

      research-article

      Read this article at

      Bookmark
          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          Abstract

          RESUMEN Los documentales El peligroso negocio con la salud (2018) y Salud a la venta (2018) ponen de manifiesto el riesgo de corrupción que puede existir en el proceso de investigación biomédica, específicamente con el desarrollo y posterior aprobación de dispositivos médicos. Esta industria mueve millones de euros al año y por esto puede resultar gobernada por la lógica del lucro a expensas de lesiones, sufrimiento y muerte de pacientes que, con necesidad de utilizar dispositivos, reciben los que son rentables y no necesariamente los más eficaces o seguros. Este material audiovisual recopila casos que obligan a reflexionar sobre el sentido de la invención de dispositivos que debe ser el de mejorar el proceso de salud y enfermedad de las personas y no los bolsillos de los fabricantes. En ese sentido, las denuncias desde los medios de comunicación deben favorecer una autocrítica para que cada individuo sea capaz de reflexionar sobre sus acciones y se desarrolle en un futuro cercano un espíritu colectivo nuevo: sin corrupción.

          Translated abstract

          ABSTRACT The documentaries The dangerous health business (2018) and The Bleeding Edge (2018) highlight the risk of corruption that may exist in the biomedical research process, specifically in the development and subsequent approval of medical devices. This industry moves millions of euros per year and therefore can be governed by the logic of profit at the expense of injuries, suffering and death of patients who, with the need to use devices, receive those that are profitable but not effective and safe. This audiovisual material collects cases that require a reflection on the sense of devices invention that should be to improve the health-illness process of people and not the pockets of manufacturers. In that sense, complaints from the media should favor a self-criticism for each individual became capable of reflecting on their own actions and, in a near future, a new collective spirit without corruption be developed.

          Related collections

          Most cited references8

          • Record: found
          • Abstract: found
          • Article: not found

          Overview of the US FDA medical device approval process.

          Increasing barriers to medical device innovation in the United States including constrained financial resources and rising research costs require that physicians take on greater involvement in medical device development, evaluation, and regulatory processes. Such involvement requires that physicians understand basic aspects of the regulatory process for medical devices and recognize the myriad opportunities for involvement in these activities.
            Bookmark
            • Record: found
            • Abstract: found
            • Article: not found

            Appropriateness of collaborations between industry and the medical profession: physicians' perceptions.

            Physicians' ratings of the appropriateness of collaboration and of receiving payment for collaboration with the pharmaceutical and medical device industries may differ. We administered an anonymous, cross-sectional survey to a convenience sample of faculty and postgraduate physicians from all departments within the 11 hospitals affiliated with the Mount Sinai School of Medicine in New York City and New Jersey. We examined 12 collaborations with the pharmaceutical and medical device industries using 4-point Likert scales, ranging from very appropriate to very inappropriate. Surveys were distributed to physicians within 35 departments at 11 hospitals; 590 surveys were completed by physicians at 9 hospitals, yielding a 67% response rate. Physicians' assessment of appropriateness varied among the different collaborations, ranging from nearly all rating developing a drug or device (92%) and designing a drug/device trial (91%) as appropriate to fewer rating preparing a manuscript of a drug/device trial (60%) and recruiting patients for a drug/device trial (65%) as appropriate for physicians not involved in trial design. Physicians consistently rated receiving payment for collaboration as appropriate less often than they rated the collaboration itself as appropriate and ratings varied among the collaborations. For example, 81% rated receiving payment to develop a drug or device as appropriate, whereas 38% rated receiving payment to recruit patients for a drug/device trial when the physician was not involved in trial design as appropriate. Physicians' broadly perceived most collaboration with the pharmaceutical and medical device industries, and of receiving payment for collaboration, as appropriate.
              Bookmark
              • Record: found
              • Abstract: found
              • Article: not found

              PRE-MARKET CLINICAL EVALUATIONS OF INNOVATIVE HIGH-RISK MEDICAL DEVICES IN EUROPE

              Objectives: High-quality clinical evidence is most often lacking when novel high-risk devices enter the European market. At the same time, a randomized controlled trial (RCT) is often initiated as a requirement for obtaining market access in the US. Should coverage in Europe be postponed until RCT data are available? We studied the premarket clinical evaluation of innovative high-risk medical devices in Europe compared with the US, and with medicines, where appropriate. Methods: The literature and regulatory documents were checked. Representatives from industry, Competent Authorities, Notified Bodies, Ethics Committees, and HTA agencies were consulted. We also discuss patient safety and the transparency of information. Results: In contrast to the US, there is no requirement in Europe to demonstrate the clinical efficacy of high-risk devices in the premarket phase. Patients in Europe can thus have earlier access to a potentially lifesaving device, but at the risk of insufficiently documented efficacy and safety. Variations in the stringency of clinical reviews, both at the level of Notified Bodies and Competent Authorities, do not guarantee patient safety. We tried to document the design of premarket trials in Europe and number of patients exposed, but failed as this information is not made public. Furthermore, the Helsinki Declaration is not followed with respect to the registration and publication of premarket trials. Conclusions: For innovative high-risk devices, new EU legislation should require the premarket demonstration of clinical efficacy and safety, using an RCT if possible, and a transparent clinical review, preferably centralized.
                Bookmark

                Author and article information

                Journal
                rmc
                Revista de Medicina y Cine
                Rev Med Cine
                Universidad de Salamanca (Salamanca, Salamanca, Spain )
                1885-5210
                December 2020
                : 16
                : 4
                : 255-260
                Affiliations
                [1] Medellín Antioquía orgnameUniversidad de Antioquia Colombia
                Article
                S1885-52102020000400003 S1885-5210(20)01600400003
                10.14201/rmc2020164255260
                bd038436-1aea-4009-b1e0-c9124bccb243

                This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

                History
                : 02 February 2020
                : 25 February 2020
                Page count
                Figures: 0, Tables: 0, Equations: 0, References: 8, Pages: 6
                Product

                SciELO Spain

                Categories
                Originales

                ethics,ética,communications media,ethics in business,corruption,medios de comunicación,ética en los negocios,corrupción

                Comments

                Comment on this article

                scite_

                Similar content1,009

                Most referenced authors76