25 Años del asunto Di Bella: ¿qué enseñanzas éticas nos deja?

  1. Álvaro Sanz Rubiales
  2. María Luisa del Valle Rivero
  3. Francisco Barón Duarte
  4. Elvira Morán Cuadrado
  5. Paula Molina Terrón
  6. Luis Alberto Flores Pérez
Journal:
Cuadernos de bioética

ISSN: 1132-1989 2386-3773

Year of publication: 2023

Volume: 34

Issue: 112

Pages: 269-278

Type: Article

More publications in: Cuadernos de bioética

Abstract

Twenty-five years ago, in 1998, the Italian Parliament approved to implement clinical trials in patients with advanced cancer to know the efficacy of an alternative cancer treatment that associated hormones, vitamins and, occasionally, chemotherapy proposed by Professor Luigi Di Bella. It was the answer to people demanding Public Health assume the cost of this therapy. Although parallel phase II trials in various tumors demonstrated the lack of activity, some professionals have continued to use this method since then and have published apparently promising results a few various scientific journals. This real example raises three interesting ethical scenarios. The first one is the ethics of alternative treatments proposed by medical professionals or from the academic field. In these cases, the difficulty in differentiating between hypothesis and real efficacy. This problem impacts on patients and relatives’ expectations who must face a potentially fatal disease with little or no hope of a cure with traditional treatments. The second scenario is the design and good practice in the development of clinical trials, which was also the subject of debate in relation to the Di Bella method. And the last one, the ethics of scientific publications. Di Bella’s followers published since 2000 12 papers with limited quality on series of patients treated with his method, the majority in a pay-per-publication journal of which Giuseppe Di Bella, son of Professor Di Bella, is included in the board of editors.

Bibliographic References

  • Alberto, P. «Thioproline (Norgamem): a useless drug in the treatment of squamous cell carcinoma». The European Journal of Cancer & Clinical Oncology. 1981; 17: 1061-1062.
  • Bohannon, J. «Who’s afraid of peer review?». Science. 2013; 342: 60-65.
  • Boram Han, B., Kim, B.J, Kim, H.Y., et al. «A retrospective analysis of the efficacy of low-dose metronomic cyclophosphamide for treatment in patients with low grade non-Hodgkin lymphoma». Blood. 2021; 138 (Suppl 1): 1361.
  • Brú, A., Albertos, S., García-Hoz, F, et al. «Regulation of neutrophilia by granulocyte colony-stimulating factor: a new cancer therapy that reversed a case of terminal hepatocellular carcinoma». Journal of Clinical Research. 2005; 8: 9-13.
  • Di Bella, G. «The Di Bella Method (DBM)». Neuroendocrinology Letters. 2010; 31 (Suppl. 1): 7-42.
  • Elguero, J. «El extraño caso del Norgamen y del Revercan». Anales de Química. 2018; 114: 219-222.
  • Gray, C. «Dr. Luigi Di Bella and the politics of elixirs». Canadian Medical Association Journal. 1998; 158: 1510-1512.
  • Italian Study Group for the Di Bella Multitherapy Trials. «Evaluation of an unconventional cancer treatment (the Di Bella multitherapy): results of phase II trials in Italy». The British Medical Journal. 1999; 318: 224-228.
  • Liberati, A., Magrini, N., Patoia, L., Pagliaro, L. «The Di Bella multitherapy trial. Randomised controlled trials may not always be absolutely needed». The British Medical Journal. 1999; 318: 1073-1074.
  • Metodo Di Bella. Portale Medico Scientifico della Fondazione “Giuseppe Di Bella”. [Publicación en línea]. «Pubblicazioni Scientifiche. <http://metododibella.org/Ppubblicazioni-scientifiche.html> [Consulta: 6/06/2023]
  • Müllner, M. «Di Bella’s therapy: the last word? The evidence would be stronger if the researchers had randomised their studies». The British Medical Journal. 1999; 318: 208-209.
  • Müllner, M., Evans, S.J.W. «Reply from author and statistical adviser». The British Medical Journal. 1999; 318: 1074.
  • Murad, M.H., Sultan, S., Haffar, S., Bazerbachi, F. «Methodological quality and synthesis of case series and case reports». BMJ Evidence Based Medicine. 2018; 23: 60-63.
  • Neuroendocrinology Letters. [Publicación en línea]. <https://www.nel.edu/> [Consulta: 6/06/2023]
  • Norton, L. «High-dose chemotherapy for breast cancer: “how do you know?” ». Journal of Clinical Oncology. 2001; 19: 2069-2070.
  • Passalacqua, R., Campione, F., Caminiti, C., et al. «Patients’ opinions, feelings, and attitudes after a campaign to promote the Di Bella therapy». The Lancet. 1999; 353: 1310-1314.
  • Raschetti, R., Greco, D., Menniti Ippolito, F., et al. «Criticism ignores standard methodology of cancer treatments». The British Medical Journal. 1999; 318: 1074.
  • Rosenthal, M.C., Saunders, R.H., Schwartz, L.I., et al. «The use of adrenocorticotropic hormone and cortisone in the treatment of leukemia and leukosarcoma». Blood. 1951; 6: 804-823.
  • Sanz Rubiales, A., del Valle Rivero, M.L., Flores Pérez, L.A. «Cuestiones éticas en la voracidad editorial». Revista de Bioética Latinoamericana. 2017; 20: 33-55.
  • Simini, B. «Di Bella cancer regimen becomes much ado about nothing». The Lancet. 1998; 352: 460.
  • Tirelli, U., Di Filippo, F. «Debate on Di Bella therapy». The Lancet. 1999; 354: 159.
  • Traversa, G., Maggini, M., Menniti-Ippolito, F., et al. «The unconventional Di Bella cancer treatment. A reflection on the Italian experience». Cancer. 1999; 86: 1903-1911.
  • Vallejo-Nágera J.A, Olaizola, J.L. La puerta de la esperanza, Editorial Planeta, Barcelona, 1990.
  • von Elm, E., Altman, D.G., Egger, M., et al. «The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies». The Lancet. 2007; 370: 1453-1457.
  • Weiss, R.B., Rifkin, R.M., Stewart ,F.M., et al. «High-dose chemotherapy for high-risk primary breast cancer: an on-site review of the Bezwoda study». The Lancet. 2000; 355: 999-1003.