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Scientific Research: Far West or workshop for social progress?

This introduction was intended merely to arouse the curiosity in you on the subject of the next session: " Research ethics: focus on pharmaceutical research". 

The topic of research ethics is very broad, so we thought to begin with an issue in itself very complex: the genesis of a drug.
Often in our clinical practice we ask ourselves: which of these two drugs to give to such a patient? Am I sure of the effectiveness of this drug? Will he tolerate it well? What is the most cost effective drug?
However, probably few times we ask the most basic question: "What is the criterion by which a molecule is tested? What are the springs that push a company or a researcher to study a drug for a given disease? What are the priorities?" And again: "What are (if there are!) the ethical principles that guide pharmaceutical research? Are they always followed? Which role the patient plays in medical research?"

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A Challenge for every student: own your sense of professionalism

One of the most trying challenges for a biomedical student is to reach and own a high level of professionalism. In our field more than in others, being a professional is vital for the kind of responsibility we are charged with: we deal with people’s health, maybe the most precious gift of all.

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“Drug Market and Human Rights”

One of the most awkward features of our modern society is people discrimination based upon healthcare rights and free access to treatments. A large part of mankind suffers and dies due to foreseeable and preventable causes, for diseases perfectly curable by the modern medicine and pharmacology. Numbers for this injustice are terrifying: according to the last WHO report, in poor countries people die 10 times more than in industrialized nations, and this factor becomes 100 if one considers people between 0 and 10 yrs, and 300 if only newborns are taken into account. A complex problem, produced by a series of concomitant causes often acting together with a dramatic synergic effect. Among these factors, we enumerate for sure drug-related market strategies aiming mainly at achieving private financial profits, although this means to bypass and often trample down the human rights.

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Origin and Commercialization of Drugs

Drug’s registration with the Agenzia Italiana del Farmaco (AIFA) or the European Medicines Agency (EMEA) is also needed during the “clinical experimental” phase of the drug. After registration, the drug may be placed in the market. Let’s now see how research works in practice: the time from the discovery of the molecule to registration can reach up to 10 years or more. The costs of all this research are around €1Bn. We now realise how expensive it is for a pharmaceutical company to invest in research; it’s really expensive.

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I am Fernanda Morrone and I have been teaching for twelve years at the Pontifical Catholic University of Porto Alegre, which has about 3,000 enrolled students. I am the director of the Pharmacology Laboratory, where 25 doctoral, masters and undergraduate level students work, as well as a number of other professors. We do research on new pharmacological treatments. 

In a culture that is marked by competition and individualism, I try to teach the students the importance of establishing a relationship with their patients and of collaborating with colleagues.
Therefore, I feel that I have to be the first one to live this out. Every day, when I go to the university, I know that I am going to listen to everyone, without making distinctions, by putting the other person before my own interests. I try to share ideas with the other professors, as well as financial resources, and this way of operating is contagious. In the laboratory, the students work not only their own research projects, but each one helps the others with their projects when needed. In this way, the articles that are published are a result of this collective effort, which however does not exclude the personal responsibility that each one has in them.

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We would like to start from ‘that’ inclined plan which leads us gradually to fulfil ourselves as health workers, or our training to become so.

I am sure that most of us have embarked on this journey with great enthusiasm, driven by the desire to quickly become a good doctor, a good nurse, a good physical therapist and so on, but I suppose also that each of us has already experienced the moment that this enthusiasm is restrained by the first difficulties, when it seems that our goal becomes a real challenge.

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My name is Joseph and I am doing my Research Doctorate in Biology at the University of Bari. My experience in the laboratory, which still continues today, began about two years before writing my graduate thesis, while doing an internship in an immunology lab.
Since the very first months of this experience, I was struck by an attitude that the researchers I was working with naturally displayed, but which I did not like at all. In fact, there was an extreme jealousy between them over the protocols that were optimized for the experiments for which one was responsible, or over the “recipes” of strange reagents used. This was certainly due to the intense work of reading numerous scientific publications on the part of those researchers, and this explained the total attachment they had to their protocols. A while later, when I had established more confidential relationships with them, they explained to me, almost with a smile, that there is generally a lot of jealousy over these protocols because they give the researcher an exclusive importance, so that “one cannot do without him/her.”
I, who during my previous 5 years of university, had tried to live my studies with detachment: from my own notes or the professors’ lecture notes. I was used to a sharing among my colleagues that I could no longer find in the laboratory.

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The Challenges faced by the Educator: to be a teacher and a model

In trying to answer the fundamental question: “What is it that makes a good teacher in medicine?” we should consider the context in which the teacher nowadays performs his role as an educator.

Let us try to briefly outline the image of medicine in society:
- A rapid succession of scientific discoveries which are clearly important but which often express medicine as becoming always more technological, hence obscuring its human dimension based on relationships,
- The criticisms and almost daily polemics resulting from cases of malpractice that demand from us a change in the way medicine is practiced by some persons but at the same time obscures the commitment and the dedication of many good professionals,
- The constraints of a health system in which the doctor may feel deprived of his role in order to obey rigid economic and organisational criteria.
One could ask whether young people still want to want to take up this profession. Yet if we observe the numbers of applications for entry into the biomedical faculties, we could conclude that the numbers of those who would like to take up education in this field are very high.
Recently there has been some discussion as to whether the selection tests are still valid since they do not look into attitudes and motivations, but prefer a knowledge of notions that is isolated from the preceding educational process.

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Gamechu was a two year old child that arrived at the rural Ethiopian hospital where I worked because of an abdomonial mass. Immediately upon examining him I noticed that he was severely malnourished and in his abdomen I felt a hard mass that I suspected to be a tumor.

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How a drug is produced: the pharmacologist’s point of view

Drug production is a long process consisting of various steps, each with a well defined goal. Given the biological target, a specific candidate molecule has to be identified. A first basic pharmacological and biochemical screening allows to isolate among thousands molecules 20-30 leader compounds, namely the precursors of a real drug. As soon as chemical and physical features are defined, animal trials begin by testing acute and chronic toxicity; if a compound assigned to become a drug has shown a good efficacy and safety profile, clinical trials can start. Clinical trials are powerful tools to verify if novel drugs can be suitable for people; nevertheless, the relevance of a research can not justify a violation of human rights and dignity. After aberrant trials carried out in Nazi concentration camps the international scientific community has set up ethical rules for human trials: the Nuremberg Code (1949), in which is solemnly proclaimed that “subject’s voluntary consent is absolutely needful”, and the Declaration of Helsinki (1964, then updated in 2004), regulating the rights of humans involved in drug trials.

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The spiritual dimension in medicine

My book was published at the beginning of the year. Its title? Soul Matters: the spiritual dimension within healthcare.
Why write such a book? I am a GP (General Practitioner) and that means Family Doctor in Great Britain. We look after people from the womb to the grave. In Great Britain, most people are treated in the community. Only a minority ever see a specialist, few go to hospital – at least that would be the idea. We treat illness and disease but we also try to prevent them. Sometimes I have to go to visit someone at home usually because of the seriousness of the illness or the patient’s poor mobility. This is what happened with Molly – at least that is what I call her in the book. She is stricken with rheumatoid arthritis and her hands demonstrate its classical destructive pathology. She had three strokes with a legacy of unilateral paralysis. However what struck me about her was not the typical presentation of a rheumatoid arthritis case or of a cerebrovascular accident, but her tranquillity in the face of the tragic disintegration of her body. Molly’s case left me thinking and I wondered if I would have been able to face such illness in the way she did. I asked myself, “What inner resources do patients use to face illness?” Molly is only one of many examples. I subsequently did a qualitative study for a Master’s degree and researched this area and years later, the book emerged.

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E' online il nuovo sito web HDC!

nuovo sito web HDC 

Health Dialogue Culture

Health Dialogue Culture wants to contribute towards the elaboration of a medical anthropology inspired by the principles of the spirituality of unity which animates the Focolare Movement and by related experiences made in different countries.


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