Unsolved:Luigi di Bella

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Luigi Di Bella (July 18, 1912 in Linguaglossa – July 1, 2003 in Modena) was an Italian medical doctor and physiology professor. In the late 1980s, he created a purported treatment for cancer that precipitated an international controversy.

Education

Di Bella graduated in medicine at Bari University, and worked as an army doctor in Greece (1941-1943). In 1948, he became a professor of physiology at the University of Modena, where he had been working since 1939.

Studies

In 1963 Di Bella began his studies about some types of blood cancer. During the late 1980s, Di Bella developed a cocktail of drugs, vitamins and hormones (Melatonin, ACTH and Somatostatin) which he argued would be useful in fighting cancer. Following national exposure in 1997 and 1998, several cancer patients from around Italy traveled to his clinic seeking access to his "miracle cure". In 1998 Italian medical authorities (Ministero della salute), declared his treatment to be without scientific merit.[1] The final rejection of Di Bella's method was expressed in a letter (written on 30 December 2005) by the Chairman of the Board of Health, Mario Condorelli, to Health Minister Francesco Storace: "The working group of the Board of Health considers that it has no evidence of the effectiveness of "multitherapy Di Bella" and therefore does not recommend a new clinical trial; this could be not only ineffective but also harmful to the patients by denying them (or procrastinating) access to anti-cancer drugs of proven effectiveness.".[2]

According to the American Cancer Society: "Available scientific evidence does not support claims that Di Bella therapy is effective in treating cancer. It can cause serious and harmful side effects. ... [These] may include nausea, vomiting, diarrhea, increased blood sugar levels, low blood pressure, sleepiness, and neurological symptoms."[3]

According to Di Bella's supporters the clinical trial carried out in 1998 is affected by a number of irregularities:

  • Usage of expired drugs: according to a report by the Carabinieri Anti-adulteration Unit signed by marshals Ciro Spiniello and Antonio Barrasso, 1048 patients received "a possibly imperfect drug no longer characterized by the initial therapeutical properties". The Public Prosecutor's Office in Florence, however, dismissed the case, since Di Bella had given no indication about the expiry date of the preparation and everything had been carried out according to the agreed protocol. Di Bella himself had declared that if kept away from heat and light the retinoid syrup was absolutely stable.
  • Incorrect dosages and preparations not conform to the instructions: some preparations contained up to 250 mg/l of acetone, a solvent that Di Bella claimed would invalidate the effectiveness of the compound. However, the Military Pharmaceutical Institute of Firenze (which had prepared the compounds) stated that the acetone was used according to Di Bella's indications, and that any remains could not be completely eliminated without destroying the retinoids as well in the process. For this reason as well the Public Prosecutor's Office dismissed the case, since acetone had been selected as the reagent of choice in the protocol agreed on by the Ministry and Di Bella. In addition, after a comparison between the drugs produced by the Military Pharmaceutical Institute in Florence and Di Bella's accredited pharmacy in Modena was carried out the Public Prosecutor's Office observed that the two preparations were essentially identical, therefore no differences could be observed in terms of effectiveness.
  • Patient selection: according to Di Bella the patients were already suffering from advanced-stage cancer, and had already been subjected to chemotherapy, which, according to the professor, "has a deleterious effect on the patient". However, among the admission requirements the very same agreed protocol provided for patients who were suffering from advanced-stage cancer. Some protocols, moreover, provided for patients who had not been previously treated with conventional therapies.


Publications

See also

  • Alternative cancer treatment

References

  1. "Evaluation of an unconventional cancer treatment (the Di Bella multitherapy): results of phase II trials in Italy". BMJ 318 (7178): 224–228. 1999. doi:10.1136/bmj.318.7178.224. ISSN 0959-8138. 
  2. Mario Riccio, Gianna Milano, Storia di una morte opportuna. Il diario del medico che ha fatto la volontà di Welby, Sironi Editore, Milano, 2008, ISBN:88-518-0106-1, ISBN:978-88-518-0106-9
  3. "Di Bella Therapy". American Cancer Society. http://www.cancer.org/treatment/treatmentsandsideeffects/complementaryandalternativemedicine/pharmacologicalandbiologicaltreatment/di-bella-therapy. Retrieved August 2013. 

External links