• Z S Herman.
• Department of Clinical Pharmacology, Silesian University School of Medicine, Katowice, Poland. zbiklin@slam.katowice.pl
• Int J Clin Pharm Th. 2005 Jan 1; 43 (1): 43-50.

AbstractOwing to the great progress in clinical chemistry connected with utilization of applied mathematics, pharmacokinetics came into being. The unknown objective methods of research of drugs in human were discovered, among them controlled clinical trials (CCT). These new methodologies generated a new clinical discipline called clinical pharmacology (CPH) which has its roots in basic pharmacology but was applied in clinical specialties. This field is very young, recognized by World Health organization in 1970. Up to the 90s several enthusiasts developed quickly CPH. The scope and development of this discipline is presented in the first part of this article. At the end of the 20th century the science on drugs performed in humans was in the center of interest of the public as well as an object of great pressure of pharmaceutical industry, politicians, and the public. These phenomena started to influence CPH, practiced and taught in medical university faculties and patients care, unfavourably. Government, university authorities, non-profit organizations are not interested in supporting objective research in CPH on the highest academic level. The industry considers the mentioned studies as a threat for its profit. CCT was elaborated for objective comparison of effectiveness and efficacy of old (standard) drugs with the new approved substance. The main purpose of this type of study is a rejection of null hypothesis. Since 1990, these trials caused a strong movement toward evidence-based medicine. A few years ago trials were performed in independent academic centers. These studies were in experienced hands of the teams consistent of highly competent specialists of several fields of medicine. These centers contributed to the quality, intellectual rigor and impact of such clinical trials. But as economic pressure increases, this may belong to the past. Actually pharmaceutical companies curtailed the participation of academic centers in CCT to 40%. According to EU Parliament decision the pharmaceutical industry adopted the whole control of CCT. Politicians and society demand the instant application of new observations and discoveries into practice. Then new drugs approved in 2003 are mentioned. At the end, the general proposition to improve the Status of academic CPH and creditability of CCT is suggested: to develop essential studies on mechanisms of drugs on human being. The highest academic authorities, who understand the importance of CPH, have to discuss the necessity of funding of this type of research with university authorities, non-profit organizations and the Ministry of Health. To soften unavoidable conflict of interests, laborious discussions between academic scientists, pharmaceutic company authorities and governmental authorities are necessary. There is also an urgent necessity of new legislative acts. These proposals are very general and deficient. They were presented here to conclude this article on the present status of clinical pharmacology with the statement that the real threat for this discipline exists.

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