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SAGHE Case Study

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Background
From 1958 and more than half a century cadaveric pituitary-derived human growth hormone (hGH) was available for replacement therapy until around 1985 when it was understood that a significant number of children treated with cadaver obtained hGH died because of Creutzfeldt-Jakob disease. Since 1985, drug manufacturers are using engineered bacteria to make recombinant human growth hormone (rhGH) with a higher purity but several short-term side effects.
Although these side effects are monitored, evaluated and controlled, the long-term side effects such as oncogenic effect remains the main concern and uncertain. While during the past decades, drug companies’ effort in influencing and pushing the market, patients and even healthcare …show more content…

Are children’s life in risk for an inch or two?

Background
Since 1984 when the first treatment with rhGH was started until today, short-term safety of rgHG replacement therapy is evaluated based on large groups of patients. The height gains results of the hormone on children with severe GH deficiency is generally satisfactory. However, in children with short stature due to other reasons, the height gains and changes in the quality of life is poorly evaluated and its clinical significance is also under controversy. Furthermore, the long term effect on neither of the groups has ever been evaluated and this is while the signals of oncogenic side effect such as the appearance of Leukemia or other cancers in European countries are worrying and questioning the safety of synthetic recombinant human growth hormone.

The aims of SAGhE study are to investigate long-term mortality and morbidity in near 30,000 young European adults who have been treated in childhood with rhGH. SAGhE will also include young adults’ height and quality of life evaluations in the research plan to determine how much benefit these young adults have been gained by this hormone therapy. This is especially very important because after all, the main reason that families and parents submit their children to growth hormone therapy is to gain height and improve their quality of life. The SAGhE study can help these parents to compare the results with the long-term side risks and make the

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