Degenerative neurologic disease in patients formerly treated with human growth hormone. Report of the Committee on Growth Hormone Use of the Lawson Wilkins Pediatric Endocrine Society, May 1985.

One or more lots of pituitary GH supplied by the NHPP may have been contaminated with CJD pathogen. If so, it is probable that the contaminated hormone was dispensed before 1978, and there is reason to believe that it was dispensed in the late 1960s. The contamination may have been limited to one lot of GH, but this is not known with certainty. Purification methods used by the NHPP since 1978 probably exclude the CJD pathogen, but this is not yet certain. The risk to patients treated since 1978, therefore, probably is low. There is no evidence to date that GH from either of the pharmaceutical suppliers has been or is contaminated. Purification procedures used by these sources also should exclude the pathogen. To exclude the possibility that they are contaminated with the CJD pathogen, 1 1/2 to 3 years will be required to test batches of the pituitary GH used previously. The experiment needed to show that the purification method used by NHPP excludes the scrapie agent will take up to 1 year. Planning for epidemiologic studies in patients treated with pituitary GH is under way. Biosynthetic GH prepared by recombinant DNA techniques has been in clinical trial in the United States for 3 1/2 years. It has been shown to be as effective as pituitary GH in promoting growth. However, it produces a higher incidence of GH antibodies than pituitary GH preparations do. Pediatric endocrinologists support the FDA in its effort to gather the information needed to approve biosynthetic GH for treatment of GH deficiency at an early date.