Silvio Garattini
rMH 9, 2009, 25-31
From a business- to a solidarity- oriented medicine
The distribution of pharmaceuticals and the growing size of the pharmaceutical industry throw up new problems regarding health-workers’ ethics. It is in fact the market that determines the orientation of the pharmaceutical industry that, being economically powerful, conditions the law, research (which neglects areas of research that are not profitable) and information (which takes on the form of promotion if not even propaganda) of the pharmaceutical world. The same European Agency for Medicine can not be the sole supervisors of the interests of the sick, being orientated towards serving the interests of the industry, indeed protected by the secret that covers acts regarding the authorisation of new pharmaceuticals and the lack of obligation to demonstrate the added value of new pharmaceuticals compared to pharmaceuticals already in existence for the same therapeutic purposes. The responsibility goes therefore to researchers, medics and scientific journalists to adopt a critical and cautious position in the independent arena of information and formation, promoting an “active” ethic, that protects and recovers values and encourages the passage from a business- to solidarity-oriented medicine.
Gianfranco Domenighetti
rMH 9, 2009, 32-39
Medicalization of life, sanitary communication and conflicts of interest
The sanitary systems are often characterized by conflicts of interest between the implicated parties (patients-citizens, suppliers of performances, producers of technology, administrators, politicians). From the offer’s side, sanitary practice is dominated by complexity, incertitude, asymmetry in information, the poor or un-measurable quality, of authoritarianism and the opacity in decision making, that give manufacturers, suppliers and prescribers and the sanitary services a revenue from a position unknown to the other economic sectors of large consume. It is capable of manipulating individual and social choices of citizens who, almost in their entirety, are orientated towards a greater psychophysical well being and life, rather than towards illness and death. In this context, dominated by industrial and professional marketing and by an asymmetric and “one-way” sanitary communication based solely on “good news”, are generated and consolidated conflicts of interests that aim towards a growth in the market and profits, to acquire and/or maintain “power” and to induce expectations on the efficiency of the medical-sanitary industry which go beyond all reasonable evidential need.
Giorgio Mombelli
Claudio Marone
rMH 9, 2009, 40-44
Conflicts of interest in clinical research
Conflicts of interest are by nature inherent in clinical research. They can not be eliminated, but rather have to be “regulated” in respects to the rights of patients access to reliable information and the freedom of choice regarding an eventual participation with research studies. Some central aspects of this question are discussed on basis of the work experiences of the authors in clinical activity and research, and their long militancy in the Ethical Committee. In particular, the contribution confronts problems posed by phase 3 studies, where the doctor in charge of the study is regularly confronted with conflicts between the interests of research (with its methods and its aims) and the well-being of the patient (with his illness and expectations). It is the doctor’s task to address and resolve such conflicts providing clear and balanced information to the patient. The patient’s consensus to participate is a free-choice act only if he has properly understood all the implications (positive and negative) of his involvement in the research study. The difficulties posed in particular cases of under-age patients or those incapable of discriminative choice are also considered. The attention is finally turned to the conflicts that characterize the publication of data: in this case as well, the conflict is structurally inscribed in the situation and asks therefore for guidelines but, above all, the researchers’ responsibility.
Walter H. Reinhart
Vincenzo Jacomella
rMH 9, 2009, 45-47
Liaisons dangereuses
The co-operation between doctors and the pharmaceutical industry, in existence since the production of pharmaceuticals at an industrial level, has become decisively intensified with progress in areas of diagnostics and therapy. There is therefore an ever closer reciprocal dependence between doctors and the industry, a kind of “
liaison dangereuse” and, in relation to it, there is a concrete danger that patients do not receive suitable treatment, but are submitted to a therapy subject to the influence of other factors, economic ones not being last. A guidance in a tangled and complex sanitary system, the
Guidelines of the Swiss Academy of Medical Sciences support researchers in their activity, offer criteria to the societies of medical discipline to direct training and, not least, invite each one to review their own cooperation with the industry and, if necessary, reject it.
Paolo Lualdi
rMH 9, 2009, 48-52
Inside the pharmaceutical industry
In the vast panorama of possible conflicts of interest in the pharmaceutical field, the author presents his reflections on some situations which he considers related to the limitation of the liberty of businesses in comparison to the small-medium pharmaceutical industries (PMI). The links between testers in research centres and some multinational firms often limit the possibilities of research and development of the PMI. Analogously, it’s possible that some officials or members of the regulatory agency commission have a privileged relationship with some firms, and can involuntarily damage others. The concentration in one single subject of the processes of production, authorisation, distribution and delivery to the patients, is increasingly creating evident conflicts of interest in pharmacists that operate in this system, greatly limiting competition, being ultimately of damage to patients.