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In 2003, the U.S. Food and Drug Administration (FDA) approved the "indication" for the use of recombinant (biosynthetic) growth hormone (rhGH) in the Deficiency of Idiopathic Short Stature (ISS) based on the following criteria: the child (1) has standard deviation of minus (-2.25) or greater for height-to-age; (2) "passes" a growth hormone stimulation test (GHST); (3) has no identifiable systemic or other conditions that cause the short stature; and (4) is not likely to reach the final height of 5'3" (males) or 4'11" (females).
"'Idiopathic short stature,'" also referred to as normal-variant short stature or short stature of undefined cause, is a diagnosis of exclusion. Implicit in the diagnosis is that systemic diseases including growth hormone deficiency, intrauterine growth retardation, genetic or syndromic causes of short stature, and other factors compromising growth, such as depression or psychosocial deprivation—have been excluded." "Idiopathic Short Stature," N Eng J Med. 2006 354:24, 2576.
Children with so-called normal variants of growth are the ". . . the largest group of short children, continuing efforts are underway to develop a rational categorization and the means of distinguishing between these children with an abnormality of the GH-IGF axis." Several groups of patients, including those with constitutional delay of growth and maturation, genetic or familial short stature, or heterozygous abnormalities of the growth hormone receptor have been identified; and are not therefore, within the ISS indication. "Additional causes of ISS will likely be identified at each level of the hypothalamic-pituitary axis." Williams Textbook of Endocrinology, 10th Ed., editors: Larsen, et al., Saunders (Philadlephia: 2003) at p 1062.
In the meanwhile, the ISS indication for the use of rhGH will continue to include both children with so-called normal varients of normal growth, and children who have underlying etiologies for short stature outside of any reasonable concept of normality. Nevertheless, a medical history disclosing exceedingly low percentile for height-to-age, and a exceedingly low or significantly decelerating growth velocity; physical examination; and, various biochemical test results, including low levels of a growth factor known as insulin-like growth factor-I (IGF-I), and one of its binding proteins, known as insulin-like growth factor binding protein-3 (IGFBP-3), can identify children who likely have an underlying etiologies for short stature.
An underlying etiology can usually be confirmed by the annualized increase in linear growth velocity upon a six month to a year trial of rhGH. During that period, the growth in child with an underlying etiology will far exceed the growth of a child who is not deficient in GH, thus demonstrating the need for and efficacy of rhGH.
Often overlooked in considering ISS, because the ISS indication is cast in terms of height, is the need to identify children likely to have an underlying etiology for short stature, which would make rhGH medically necessarily for proper growth and development. which rhGH can remedy, medical necessity for adequate levels of GH for growth and development. In those instances, is not always identified by a GHST. Those etiologies include conditions in which the a properly functioning pituitary does not receive the receive the neuroendocrine message to produce GH. It is, therefore likely that the ISS child who grows significantly with taking rhGH, needs rhGH for proper growth and development. —
by Webmaster June 7, 2007.