Anil K. Mandal
Mandal Diabetes Research Foundation
Dr. Mandal is a native of India and a naturalized citizen of the United States. He is board certifi ed in Internal Medicine and Nephrology (kidney disease and hypertension). He is an author of 13 books and more than 250 published articles and abstracts on research in diabetes and kidney disease. He is a two-times Fulbright Scholar and a visiting professor in 23 countries that invited him to lecture on diabetes, high blood pressure, and kidney diseases.
Introduction: Th ere arc many grey areas and dilemmas in medical ethics in developed and developing countries aff ecting the morbidity and mortality of millions of patients. Present western philosophies and medical ethics arc based on monetary policies which unfortunately allows millions of people to die from starvation, pollution and lack of basic medicines eg in the treatment of malaria, tuberculosis, diarrhea etc. However, even in western countries there are ethical dilemmas discussed daily in public hospitals, for example on the selection of patients to be transplanted or to be put on haemodialysis machines or to be treated with very expensive drugs etc. Within this context a major infl uence is exerted on the public, patients, regulatory and international authorities worldwide by competing marketing mechanisms of international pharmaceutical companies and other monetary organizations. Typical examples are the swine fl u scare, the AIDS epidemic in developing countries, the rapid introduction and withdrawal of the drug rofecoxib, the introduction of the iron chelating drug defcrasirox, the diff erence in timing between FDA and EMEA on the approval of deferiprone etc. Methods: Investigation was carricd out on the mechanisms operating in regard to medicalethics in the UK NHS hospital system as to the selection criteria for the treatment of diff erent categories of patients where resources are limited. A review of drug development and in particular the historic development of the drug rofecoxib and its withdrawal following the report of cardiovascular toxicity including many fatalities was also investigated. Finally, the use of the provisionally approved iron chelating drug deferasirox was investigated with emphasis on the risk/benefi t assessment for diff erent categories of patients, the comparative toxicity and effi cacy and cost eff ects with the generic drugs deferoxamine and deferiprone and the overall eff ect on mortality and morbidity on thalassaemia and other transfusional iron loaded patients. Discussion: Th ere are many ethical issues and controversies in the selection criteria for expensive treatments and use of many drugs for diff erent conditions worldwide including chelating drugs for the treatment of iron overload in thalassaemia. Th ese arc mainly related to commercial interests, confl icting literature, rivalry between pharmaceutical companies, regulatory authorities, health authorities and academics. Western ethics are not applicable in developing countries where treatment resources are scarce. All these economic, controversial and ethical issues appear to aff ect the morbidity and mortality of patients worldwide. Conclusion: Th ere is a need for a broad consensus on the use of treatments and medicinal drugs independent of commercial and other interests for improving the treatment and survival of patients worldwide. In each ease a risk/benefi t assessment is necessary and transparent procedures should be followed for safeguarding the rights of all patients on an equal basis.