Ethnic labelling

The victory of the new KD hero appeared to remove the anxieties about the viability of a separate KD identity. A two-day state holiday was declared for the harvest festival, control of which was returned to the KCA a magnificent KCA cultural centre was built in Penampang which became the site for subsequent Sabah-level festivals the ethnic label Kadazan was again legitimated and the pribumi one buried, and the first moves were made to have Kadazan taught in schools. Yet these victories brought with them the seeds of further division. 

Love R (2001) Ethnic labels may not predict individuals responses to drugs. Lancet 358(9292) 1519... 

The results from an open-label, pilot study evaluating the efficacy of fluvoxamine for hypochondriasis were recently published (Fallon et al, 2003). The study sample included six Hispanics (subgroup unknown). Significant improvement (57.1%) was noted for the intent-to-treat group (eight out of fourteen) based on physicianrated and self-rated scales. The sample size was too small to identify differences in response or adverse effects by ethnicity. 

The language used in research studies suggests that scientists still grapple with labels to describe ethnic groups in a way that does not misinform or cause undue generalization of results. What is a Caucasian What does it mean to be Asian Research in pharmacogenomics will drive a re-examination of these labels in search of more meaningful descriptive terms. 

Bhopal, R., and L.W. Donaldson, "White European, Western, Caucasian, or What Inappropriate Labeling in Research on Race, Ethnicity, and Health," Am. J. Publ. Hlth., 88, 1303-1307 (1998). 

The effect of this reversal of the trend toward individualization is likely to increase burdens on the clinical trial process and on the submissions of NDAs and ANDAs. If customization is not practical through physician-patient trial and error experimentation, the submission of clinical data that defines effects and side effects specific to interactive medical conditions, ethnicity, gender, age, and genetic characteristics becomes all the more important. Unless a developer is willing to settle for a high-restricted label, significantly expanded and targeted clinical trials are the most likely response to the need for customized medication. 

The special populations covered in the following chapters include the four major demographic segments the elderly, women, children and major ethnic groups and although any smaller grouping of people or diseases may be labeled special , only renal and hepatic patients and orphan disease... 

An alternative method of getting PK data is to take a small extra sample of blood (and urine) at a child s regular scheduled visit when blood is drawn for routine blood work. The time of day of this sample is predetermined by the time of the administration of the medicine. If samples are obtained from many children, a weight-age-corrected, scatter-plot graph can be constructed and a PK profile be calculated. This is the pharmacokinetic screen method. A version of this method is also utilized to gather ethnic data for labeling in adults as well as children, and is called population pharmacokinetics . 

Wang et al. (2004b) then used the Starcevic et al. method to determine T metabolic clearance and production rates in normal men by stable isotope dilution and LC-MS-MS, to assess the influence of ethnicity and age. Subjects underwent a constant infusion of ds-T, serum (73-T concentrations were measured by LC-MS-MS and serum total T (= T + ds-T) was measured by RIA. There were no ethnic differences. Values were lower in older than younger men. This is the first report of the use of LC-MS-MS to quantitate labeled and unlabeled analogs of an anabolic androgenic steroid in a clearance study. The amount of... 

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