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At least 19 recordsLinked to original sources
PubMed2006

Why should we bother? Ethical and social issues in individualized medicine.

Individualized medicine, methodologically rooted in pharmacogenetics and pharmacogenomics, is now venturing into clinical application. Prescribing the right drug in the right dose to the right patient according to specific health needs and individual characteristics is a core mission of individualized medicine. The intrinsic values of this mission are so self-evident that--at first glance--the ethical and social issues raised by individualized medicine seem to be negligible. However, the translation of pharmacogenetics and pharmacogenomics into clinical routine not only requires the collection and evaluation of large amounts of individual genetic data, but also heralds the need for further clinical studies on the applicability of genotype-related pharmacotherapy. Both requirements raise a set of specific normative issues. We argue that ethical and social questions of the desirability and applicability of individualized medicine should be integrated in a reconstructive approach to biomedical ethics, which is guided by criteria of social accountability. As a first step, we analyse the ethical and social issues of individualized medicine in the transition to clinical practice, using social accountability heuristically and as an evolutionary approach. Since the pharmacogenetics and pharmacogenomics of neuropsychiatric disorders are among the most advanced fields of individualized medicine, as a second step we use depressive disorders to elucidate the specific, crucial ethical and social questions involved in assessing patients' situations, disease entities and phenotypes to relate them to genetic variations for the purpose of individualized drug regimens.

Ethics, Medical↗
PubMed2003

[Towards integrative postmodern individualized medicine in terms of hierarchic emergence].

The paper discusses the possibility and necessity for establishing a postmodern individualized medicine in terms of hierarchic emergence, a basic concept of contemporary system science. Through analysis of the strong and weak points of modern individualized medicine, personalized medicine and genomic medicine, the author found that Chinese traditional individualized medicine has its strong points in implementing whole (holistic) emergence and weak points in lower hierarchic emergence compared with the other three modern medical disciplines. Thus the author concluded that there are possibility and necessity to integrate the strong points of these medical systems for establishing a holistic and deepgoing patient-centered postmodern individualized medicine.

Humans↗
PubMed2004

Moving towards individualized medicine with pharmacogenomics.

Individuals respond differently to drugs and sometimes the effects are unpredictable. Differences in DNA that alter the expression or function of proteins that are targeted by drugs can contribute significantly to variation in the responses of individuals. Many of the genes examined in early studies were linked to highly penetrant, single-gene traits, but future advances hinge on the more difficult challenge of elucidating multi-gene determinants of drug response. This intersection of genomics and medicine has the potential to yield a new set of molecular diagnostic tools that can be used to individualize and optimize drug therapy.

Drug Design↗
PubMed2007

Treatment options and individualized medicine.

Although several drug targets are identified, current strategies in therapy do not take into account that patients vary in their response to drugs, both with respect to efficacy and toxic side effects. Whereas both clinical and histopathologic predictors of prognosis are established in some diseases, a better understanding of the molecular mechanisms that determine treatment response should play an important role in the development of individualized medicine. Treatment optimization will rely on the ability to adjust treatment algorithms for use in the individual patient based on the identification and validation of the factors that critically determine treatment outcomes, including diagnosis, disease phase and characteristics, organ functions, age, and gender. Although the analysis of a single genetic marker (e.g., CYP polymorphisms) may yield significant information that predicts drug response, the prediction obtained from the analysis of several genetic and epigenetic markers is potentially more powerful in selecting patients for effective therapy, whereas sparing those who would not respond or would suffer undesirable side effects. In this chapter, several relevant examples are presented.

Age Factors↗
PubMed2005

Central nervous system drug development: an integrative biomarker approach toward individualized medicine.

Drug development for CNS disorders faces the same formidable hurdles as other therapeutic areas: escalating development costs; novel drug targets with unproven therapeutic potential; and health care systems and regulatory agencies demanding more compelling demonstrations of the value of new drug products. Extensive clinical testing remains the core of registration of new compounds; however, traditional clinical trial methods are falling short in overcoming these development hurdles. The most common CNS disorders targeted for drug treatment are chronic, slowly vitiating processes manifested by highly subjective and context dependent signs and symptoms. With the exception of a few rare familial degenerative disorders, they have ill-defined or undefined pathophysiology. Samples selected for treatment trials using clinical criteria are inevitably heterogeneous, and dependence on traditional endpoints results in early proof-of-concept trials being long and large, with very poor signal to noise. It is no wonder that pharmaceutical and biotechnology companies are looking to biomarkers as an integral part of decision-making process supported by new technologies such as genetics, genomics, proteomics, and imaging as a mean of rationalizing CNS drug development. The present review represent an effort to illustrate the integration of such technologies in drug development supporting the path of individualized medicine.

Animals↗
PubMed2003

Drug metabolism and individualized medicine.

Drug metabolism refers to the biochemical transformation of a compound into another more polar chemical form. Absorption, distribution, metabolism and excretion comprise an integral part in understanding the safety and efficacy of a potential new drug. Detailed in-depth knowledge of the Pharmacokinetics and Drug Metabolism of a new drug entity is considered a prerequisite to know the appropriate route of administration, correct dose etc. Sometimes there is (are) different/unwanted effect(s) of certain drugs in different populations. This is particularly true for the drug having narrow therapeutic index. Often these different effects are detrimental to an individual, thus termed as adverse drug reactions. After the raw draft of human genome has evolved, it has become increasingly clear that change(s) in the drug response between individuals, is due to the occurrence of genetic polymorphisms in the Phase I and II drug metabolizing enzymes, due to which distinct subgroups in the population differ in their ability to perform certain drug biotransformation reactions. The study about the occurrence of genetic polymorphisms in drug metabolizing enzymes is termed as Pharmacogenetics/ Pharmacogenomics. Pharmacogenetic characterization of particular drug can be both phenotypically or genotypically conducted in population groups. The study is very important to check the post-marketed drug withdrawal, if a particular percentage of population suffers from adverse drug reactions, and thus a lot of revenue be saved. The study also helps to find out Right Medicine for Right Individual or Individualized Medicine.

Animals↗
PubMed2003

An alternative way to individualized medicine: psychological and physical traits of Sasang typology.

BACKGROUND: Disease susceptibility and drug response of individuals are presumed to be different depending on their personality traits. The Sasang typology, a traditional Korean medical typology, explains the individual differences of vulnerability to pathology and proposes guidelines for the safe and effective use of medical herbs depending on individual traits. OBJECTIVE: The purpose of the present study was to evaluate psychologic and physical characteristics of Sasang types from the perspective of personality theory. DESIGN: After determining the Sasang type of 79 college students based on the Questionnaire for the Sasang Constitution Classification, the psychologic and physical traits of each type were analyzed by the Meyers-Briggs Type Indicator (MBTI) and Bioelectrical Impedance Analysis, respectively. RESULTS: Each of the Sasang types showed significantly different profiles based on the MBTI scores (generalized estimation equation, coefficient = 11.88, z = 2.13, p = 0.033) and could be distinctively classified based on their MBTI scores (discriminant analysis Wilks' lambda = 0.611, df = 8, chi(2) = 36.7, p < 0.001). Subjects with the So-Eum type (Introversion and Judging) and the So-Yang type (Extroversion and Perceiving) showed contrasting psychologic features. However, they had similar anthropometric characteristics. Subjects with Tae-Eum type had relatively higher body fat mass. CONCLUSION: Current results demonstrated distinctive personality traits associated with Sasang types using reproducible psychometric and anthropometric instruments. With further study, the Sasang typology could serve as a scientific tool for individualized and integrative medicine.

Adult↗
PubMed2004

Genetic variation and health; towards individualized medicine.

BACKGROUND: Pediatric endocrine diseases and their adult consequences depend on interactions of environmental exposure factors with the genetic makeup of the individual. Much has been learned over the past two decades about the genetic component in cases of monogenic (Mendelian) disorders due to drastic disruption of a single gene. The majority of children consulting a pediatric endocrinologist, however, suffer from conditions not attributable to a single gene. The nature and mechanisms of more subtle alterations at multiple different genes that are responsible for the genetic component of most human morbidity and mortality is now only beginning to be elucidated, largely thanks to the vast amount of information that is becoming available through the human genome effort. OVERVIEW: The purpose of this review is to describe 1. the nature of the information on health-related human variation that is coming our of the genome effort; 2. how this variation can affect biology; 3. which research approaches show promise in linking DNA variation to disease; 4. how this variation is organized in genomic blocks of linkage disequilibrium; and 5. how this knowledge may, in the future, allow clinicians to individualize management of a specific patient according to his/her genetic makeup.

Genetic Predisposition to Disease↗
PubMed1989

A science of individuals: medicine and casuistry.

Clinical medicine is the application of scientific principles, rules of thumb, and a store of practical wisdom embodied in narratives of individual cases to the care of a person who is ill. Physicians are taught to observe and report the individual case both as a means of fitting nomothetic generalizations to the given circumstances and as a way of refining those generalizations. This narrative construction of illness is a principal way of knowing in medicine. In this view, disease is not so much an entity as an identifiable chronological organization of the events of illness, and medicine, rather than a science, a rational science-using activity in the service of the ill.

Clinical Competence↗
PubMed2003

Individualized medicine - implementation of pharmacogenetic diagnostics in antidepressant drug treatment of major depressive disorders.

Antidepressant drug therapy is characterized by a high rate of therapeutic failure. There is increasing evidence that genetic factors are contributing to the inter-individual variability in antidepressant drug response. Genetic variability is described in both the pharmacokinetic part of drug action as well as in pharmacodynamic structures mediating drug effects. Genetic polymorphisms in drug metabolizing enzymes are well characterized and have large effects on oral clearances or elimination half-lives of antidepressant drugs. These differences can be compensated by adapting the individual dose to genotype in addition to other factors such as gender, weight, age, liver and kidney function. On the part of drug action, genetic variability is described in molecular structures of antidepressant effects. Several studies on response of antidepressants have revealed influences of polymorphisms in neurotransmitter receptors and transporters changing sensitivity of patients to treatment with antidepressants; however, results were often contradictory. A pharmacogenomic approach to individualize antidepressant drug treatment is recommended to be based on several levels: 1) identifying and validating the candidate genes involved in drug-response; 2) providing therapeutic guidelines; and 3) developing a pharmacogenetic test-system for bedside-genotyping.

Age Factors↗
PubMed2006

Cellular pharmacodynamics of immunosuppressive drugs for individualized medicine.

The therapeutic effects of immunosuppressive drugs are known to deviate largely between patients, but efficient strategies for the differentiation of patients who show clinical resistance to immunosuppressive therapies have not been established. Accordingly, a considerable number of patients receive treatment with immunosuppressive drugs despite the onset of serious side effects and poor responses. Cellular pharmacodynamics of immunosuppressive drugs in vitro using peripheral lymphocytes derived from each patient, an attractive way to distinguish resistant patients, is respected and has been applied to the carrying out of individualized immunosuppressive therapy. In this article, I summarize experimental procedures for assaying immune cell responses to immunosuppressive drugs in vitro, and highlight the relationship between cellular sensitivity to immunosuppressive drugs and the therapeutic efficacy of drugs in organ transplantation and several immunological disorders. I will also overview the molecular mechanisms and genetic bases for cellular and clinical resistance to immunosuppressive drugs. Lastly, the future clinical prospects for the application of in vitro drug sensitivity tests for "patient-tailored" immunosuppressive therapies are discussed.

Cells, Cultured↗
PubMedDate not supplied

Pharmacogenetics and the concept of individualized medicine.

Adverse drug reaction in patients causes more than 2 million hospitalizations including 100,000 deaths per year in the United States. This adverse drug reaction could be due to multiple factors such as disease determinants, environmental and genetic factors. In order to improve the efficacy and safety and to understand the disposition and clinical consequences of drugs, two rapidly developing fields--pharmacogenetics (focus is on single genes) and pharmacogenomics (focus is on many genes)--have undertaken studies on the genetic personalization of drug response. This is because many drug responses appear to be genetically determined and the relationship between genotype and drug response may have a very valuable diagnostic value. Identification and characterization of a large number of genetic polymorphisms (biomarkers) in drug metabolizing enzymes and drug transporters in an ethnically diverse group of individuals may provide substantial knowledge about the mechanisms of inter-individual differences in drug response. However, progress in understanding complex diseases, its negative psychosocial consequences, violation of privacy or discrimination, associated cost and availability and its complexity (extensive geographic variations in genes) may become potential barriers in incorporating this pharmacogenetic data in risk assessment and treatment decisions. In addition, it requires increased enthusiasm and education in the clinical community and an understanding of pharmacogenetics itself by the lay public. Although individualized medications remain as a challenge for the future, the pharmacogenetic approach in drug development should be still continued. If it becomes a reality, it delivers benefits to improve public health and allow genetically subgroup diseases thereby avoiding adverse drug reactions (by knowing in advance who should be treated with what drug and how).

Cytochrome P-450 Enzyme System↗
PubMed2004

Tests for finding complex patterns of differential expression in cancers: towards individualized medicine.

BACKGROUND: Microarray studies in cancer compare expression levels between two or more sample groups on thousands of genes. Data analysis follows a population-level approach (e.g., comparison of sample means) to identify differentially expressed genes. This leads to the discovery of 'population-level' markers, i.e., genes with the expression patterns A > B and B > A. We introduce the PPST test that identifies genes where a significantly large subset of cases exhibit expression values beyond upper and lower thresholds observed in the control samples. RESULTS: Interestingly, the test identifies A > B and B < A pattern genes that are missed by population-level approaches, such as the t-test, and many genes that exhibit both significant overexpression and significant underexpression in statistically significantly large subsets of cancer patients (ABA pattern genes). These patterns tend to show distributions that are unique to individual genes, and are aptly visualized in a 'gene expression pattern grid'. The low degree of among-gene correlations in these genes suggests unique underlying genomic pathologies and high degree of unique tumor-specific differential expression. We compare the PPST and the ABA test to the parametric and non-parametric t-test by analyzing two independently published data sets from studies of progression in astrocytoma. CONCLUSIONS: The PPST test resulted findings similar to the nonparametric t-test with higher self-consistency. These tests and the gene expression pattern grid may be useful for the identification of therapeutic targets and diagnostic or prognostic markers that are present only in subsets of cancer patients, and provide a more complete portrait of differential expression in cancer.

Delivery of Health Care↗
PubMed2006

Rheumatoid arthritis, a complex multifactorial disease: on the way toward individualized medicine.

With the availability of the human genome sequence and those of related species like chimpanzee, mouse, and rat, data driven research for tackling the molecular grounds of rheumatoid arthritis (RA), a multifactorial polygenic disease, can be considered a realistic challenge to the scientific community. A comprehensive research strategy is presented enabling the integration of multiple research efforts on studying autoimmunity by so called systems biology approaches. An integrative scientific concept is discussed of how to unravel molecular mechanisms of complex diseases by making use of state-of-the-art methodologies in functional and comparative genomics. A continuous interchange of data-driven and hypothesis-driven research is adjoined to determine the nature of rheumatic diseases with autoimmune background. Instead of studying single genes and proteins, RNA and protein microarray profiles are currently obtained in numerous research projects producing read-outs termed gene signatures rather than DNA and/or protein markers. A comprehensive study of the RNA, protein, and metabolite regimes is undertaken that eventually will lead to a "holistic" view of how all respective molecules, pathways and cells themselves interact with each other. Some of the above mentioned research aspects have already been studied by the authors, hopefully leading to new diagnostics and therapeutics in the future.

Animals↗