WHAT ARE THE ETHICAL ISSUES RELATED TO DEVELOPING NEW MEDICINES AND THEN CHARGING HIGHPRICES? - Мои статьи - Каталог статей

WHAT ARE THE ETHICAL ISSUES RELATED TO DEVELOPING NEW MEDICINES AND THEN CHARGING HIGHPRICES? Marcin Duszynski Dean of the Faculty of Management School of Business-National-Louis University Nowy Sącz, Poland Borodynia Nataliia In medical biology is impossible to conduct basic research and apply their results in the treatment without setting up experiments on human beings, known as "clinical studies" or "experiments on human beings." Such experiments are no substitute for research on tissues in vitro or in laboratory animals (including primates), because the body of the animal differs from the human in anatomical, physiological, and pharmacokinetic characteristics, as well as by the reaction of organs and systems of medicine. For example, it is known that morphine calms people and excites a cats, insulin is toxic to guinea pigs and hamsters, but absolutely indispensable in the treatment of people suffering from diabetes. In addition, some diseases are peculiar only to man, and they can not be modeled in laboratory animals. And even in studies in healthy volunteers is difficult to reliably reproduce those effects that will cause the drug in patients. Clinical trials on humans are a crucial kind of scientific activities, without which the receipt and selection of new, more effective and safer drugs, as well as "purification" of medicine from the old inefficient products. Recently, the role of clinical trials has also increased with the introduction of practical health principles of evidence-based medicine, the main one being the adoption of specific clinical decisions for patient treatment is not so much based on personal experience of the doctor as the basis of proven scientific evidence strictly controlled experiments. But, moreover, that the conduct of clinical trials is essential to the final stage of the case study, their conduct is unsafe and does not get lost on those who serve as material for such experiments. Any experiment carries a greater or lesser element of risk to the patient. The very nature of the relationship between the researcher and the subject is such that the objective of significantly different: while the first chapter in the corner - of new knowledge, then the second one, naturally - improved health status. This, of course, is not a question of cruelty, abuse or indifference to who is conducting an experiment, and objectively about the current conflict of interest that raises a number of legal, moral and ethical issues: whether it was permissible clinical experiments on humans, and if so, what should be restrictions and conditions for their conduct? How to reduce the potential risk to the patient, to ensure conditions of confidentiality? How to conduct genetic testing drugs on healthy volunteers? How to avoid the possible abuse of the research? How to organize the study, taking into account peculiarities of law and social conditions in different countries, as well as observe and protect the rights of persons who took part in them? These and many other issues require special attention and is the object of study of a new field of knowledge, known as bioethics. Under this general term, the introduction of the Van Rensselaer Potter in 1974, understands "the systematic analysis of human action in biology and medicine in the light of moral values and principles." Bioethics (sometimes referred to as biomedical ethics), which is now growing rapidly throughout the world, involved not only in research but also develop ways and means to resolve problem situations that arise in practical health care and new medical technologies. In recent decades, the world practice of promoting and protecting human rights all the more prominent place she occupies a very large part of those rights, which is implemented (or not implemented) in the field of biomedicine. This comprises, firstly, the problems arising when and where and when a person acts as a patient interaction with doctors and health services in general. Secondly, this includes everything that is related to the protection of human rights and dignity, when it is exposed to new medical technologies. Here it is often the subject - a party of biomedical experiments. However, in actual practice it is difficult to distinguish between ordinary medical care and high-tech medicine, because modern medical practice is increasingly intertwined with scientific experiments and testing new drugs and medical technologies for human beings. The main ethical and legal principles governing the conduct of clinical research have been articulated in the Declaration of Helsinki World Medical Association, adopted on 18 th General Assembly of the World Medical Association in June 1964, In 2000 came the fifth revised edition of the Helsinki Declaration of Human Rights, which formulated condition that all research participants must be convinced that in their case using the best known at this time "diagnostic and therapeutic methods. The same year saw the light of the UNAIDS publication - a guide "Ethical considerations in HIV vaccine research, which has been significantly redesigned in 2007 by WHO and the Expert Council to take into account recent developments, particularly in standards and access to care. "Now that there is a clear international recommendations for defining the conditions of community participation and ethical principles of research, there is hope that research - already under way, and only planned - will lead to the development of new and promising means of preventing HIV transmission, improve treatment and mitigation of the epidemic", - says Dr. Hankins (Myers D., 2008). Diabetes - a worldwide epidemic, and "every diabetes" - a lifetime. On the treatment of diabetes and its complications in the United States annually spends 132 billion dollars. This is "perfect” disease for pharmaceutical companies. What is the meaning they invest in the search for cure of it? The more people with diabetes, the more money spent on the search for new drugs. Over the past 20 years, the concept of "sick with diabetes" radically changed, and the great role of pharmaceutical companies in these changes. Yes, they have received and are earning excess profits, but in the end, and patients win. "I believe that the development of blood glucose meters - a breakthrough to a good control of diabetes," - says, for example, Vicki Abbott (diabetes 1st type) (Myers D., 2008). Not everyone sees the situation in such a rosy light. "If companies spend on the search tool for diabetes at least as much time and money, how much they spend on the development of all the" devices and substitutes, "that a cure for diabetes has long been be found! - Says Chris Leahy (2nd type of diabetes) (Myers D., 2008). - But they are not interested in our healing. They want to put us on his hook and milk dries of us as much money!" Cynically or realistically this is a common perception among patients opinion? Member of the Consumer Protection Society, Larry Sasich (Myers D., 2008) calls to be less emotional. "The pharmaceutical industry exists under the laws of business. She has a limited time frame. In order to justify investors' funds and remain on the market, the company must develop a product to be sold, and sold out quickly. Yes, this is not necessarily the product fully meets the interests of the consumer. Consumers should be sure only that the company operates within the framework of business ethics. But business ethics and "ethics health" is often very different "New! Awesome! Best! In the dispute comes again, Chris (Myers D., 2008) (diabetes mellitus): these innovations are good for their manufacturers, but not patients. Member of the Consumer Protection Society, Larry Sasich (Myers D., 2008) says: "The reasons for the refusal of the company INGAP could be set, including the development of other similar drugs. If Lilly really found a potential cure for diabetes, the development, of course, would continue. Indeed, for such a drug they would have received anything! For Eli Lilly, much worse if other pharmaceutical companies will be able to find such a tool. Then the company will drown in money, but Lilly will still lose their business." April 27 British Channel 4 documentary "Death for the sake of drugs", which showed how far drug companies are ready to go for certification of their medicines and increase profits. This film caused a major stir. Pharmaceutical TNCs increasingly use the Third World countries as a place for testing new drugs, away from the strict inspectors Europe and America. TNCs use all methods and means of pressure for the sake of promoting their products on the market. Dr. Nancy Oliveri works pediatric hospital in Toronto one of the largest in the world. Oliveri looking for an alternative method of treatment of leukemia. Its patients suffer from anemia, they have to carry out a blood transfusion every few weeks. A side effect of this treatment is the destruction of the heart and liver. They need medication, rejected excessive iron. Today it requires a two-hour cleaning procedure. All of these methods and actions of Big Five, or as they are called Pharma - Mafia, are inhumane and repulsive in human terms. But do not think that the pharmaceutical mafia bosses all polls moral monsters (though many of them fit under this definition). The real reason for such inhuman acts - the market. This is the logic of capitalism. This demonstrates one example of the contradictions between private ownership of the means of production and the needs of humanity. This film beautifully shows how these soulless TNCs, and their relation to human life. Dominance in the market medications Big Five - the direct cause of the daily deaths of millions of people around the world. Jasna need to nationalization and the transfer under the democratic control of these giants. There is only one way to save lives. Today, the ethics of biomedical experiments - is not nothing but wishful thinking. There are worked out and tested methodology and practice of ethical and legal standards for such experiments, as well as structures and mechanisms are quite hard to monitor compliance with these standards. But modern medicine is becoming increasingly sophisticated and powerful, continuously empowering the most effective impact on the underlying structure of the human body - the processes of human reproduction, in his psyche, genetics, even in the process of dying. Often said, and not without reason, that many health effects faced by people today, are extremely aggressive. And, therefore, people need new legal mechanisms of protection. Without conducting clinical trials can not progress in the development of new drugs. But nothing: neither the interests of the scientist nor the interests of pharmaceutical companies, nor the interests of clinical pharmacology in general - should not be above the rights and interests of the person who is, in legal terms, a subject of study. Bibliography 1. Kuschenko V., 2008 Clinical studies. Available from: http://www.kardioforum.ru/info.aspx?id=28&l=1 [Accessed 22 August 2008]. 2. Myers D., 2008, Cure for diabetes? Companies producing "for" or "against". Available from: http://prodiabet.net/pages/policy/57/. [Accessed 26 April 2008].
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