Human growth hormone case study

Using this method, Zwickl et al. (1991) showed that different forms of human growth hormone produced significant differences in IgG titre in monkeys. These data were correlated with published reports which showed that the different growth hormones produced human antibody titres in the same rank order, i.e. pituitary-derived-hGH > methionyl-hGH > native hGH (Beirich, 1986 Milner, 1986 Albertsson-Wikland, 1987). In this case, the monkey studies had predictive value for immimogenic responses in humans. 

In a cohort study in 1848 British patients who received human pituitary-derived growth hormone from 1959 to 1985 (30 000 patient-years), there were two cases of colorectal cancer (0.25 expected) and two cases of Hodgkin s disease (0.85 expected) the standardized mortality ratios were 10.8 and 11.4 respectively (103). However, the number of cancers was small and the doses used were higher than typically today, and these results should be interpreted with caution. 

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