The genetic component of variations in human responses to pharmacological agents is called pharmacogenetics while the molecular basis for these variations are most often identified as pharmacogenomics. Pharmacogenomics as a field of scientific endeavor is so new that in the scientific literature the two terms are often used interchangeably. In fact, the search for new drugs at the molecular level start with the identification of variations in DNA sequences whose products produce alterations in the amino acid structure of the active (...) portion of a protein which are then identified with the clinical disorder in question. This process is just the reverse of standard pharmaceutical approaches which begin with exploration of the physiological and potentially the biochemical basis of the specific disorder under study. The completion of the first draft of the human genome in the first months of the new millenium has increased expectations that molecular genetic approaches to drug disovery and development will significantly shorten the time-frame of new drug testing, significantly reduce the level of adverse events and anable the design of drugs to treat those with unique disorders.Based on such rosy expectations and the potential economic opportunities afforded by those who obtain such patents, there has been a rush of patent applications both in the United States and in Europe by private industry and university laboratories conducting genomic research to secure the rights to specific DNA sequences and federal agencies attempting to place the control of such information in the public domaine. This paper will document and discuss from a historic prospective the public policy and bioethical issues associated with the availability of patents for drug development. (shrink)

The idea to sequence all 3 billion bases of the humane genome started in the late 80s and the project began in the early 90s. In June 2000, the first "draft" was announced and in February, 2001 the final sequence was published by Science and Nature. Many debates about the ethical, legal and social issues originated from the Human Genome Project. The main questions are? "who should have access to an individual's genetic information?"; "will the genetic information be used as (...) a discrimination tool?"; "is there any risk for a modern eugenics to arise, based on genetic information?"; "is genetic determinism back?" Total sequencing of the human genome allows for the development of new diagnostic tests for genetic diseases as well as new drugs based on the patient`s individual genotype. These are some positive and immediate results of the Human Genome Project. Several papers in the literature try to associate specific genes with complex traits of the personality, such as intelligence, moods, anger. There are some studies looking for evidence for the genetic determinants of alcoholism, drug use and abuse and other behavior problems. Although none of the papers has concluded that these traits are genetically determined, biological determinism, which does not take into account social and cultural influences, is present in some segments of our society, which find in science a support for these ideas. To forget or to neglet that a part, large or small, of what we are is influenced by the environment and to consider exclusively the genotype can bring serious consequences to society. (shrink)