Is Biosynthetic Human Growth Hormone Safe?

I know I haven’t posted an entry for a long, long time. Sorry about that. But, I feel the need to discuss a recent article in the NYT (30 March 2021) written by Jane Brody, entitled “Growth Hormone May Not Be the Answer.” Over the years I have usually enjoyed reading her articles on a wide variety of medical issues, and have found them to be mostly well done. But, I do have a “bone to pick” with her about this article. It was a review of recent reports suggesting side-effects from using growth hormone injections in children, particularly those with idiopathic short stature (ISS). ISS is defined as short stature in children who are shorter than -2.25 SD (about the 1st percentile), and have predicted adult heights below 150 cm in girls and 160 cm in boys (for those of you who don’t like the metric system, those heights are 4 feet 11 inches in girls and 5 feet 3 inches in boys). Also, they can’t have a medical condition that should be treated in a different manner (I have no idea what that might be, other than a medical condition that does not respond appropriately to growth hormone injections). Anyway, Ms. Brody summarized a number of recent studies that suggested the limited benefit from growth hormone injections (on average a height increase of about 5 cm or 2 inches), might not be worth it given the new data suggesting possible health risks.

The SAGhE Cohort Study

For reasons unknown to me, Ms. Brody did not even mention what is arguably the most important study on growth hormone side-effects in children. I am referring to the Safety and Appropriateness of Growth Hormone Treatments in Europe Consortium (SAGhE). This study started about 10 years ago, and and I think is now completed. Investigators in 8 European countries (Belgium, France, Germany, Italy, Netherlands, Sweden, Switzerland, and the UK participated). Preliminary data suggested increased death rates in young adults who had ben treated with growth hormone injections during childhood. But, now after analyzing data from 24,232 patients, including greater than 400,000 patient-years of follow-up, the investigators have concluded that patients with isolated growth hormone deficiency and those with ISS did not show any adverse health outcomes compared to individuals not treated with growth hormone. The investigators did find a slight increase in adverse health outcomes in patients treated with growth hormone injections, if the indication for growth hormone injections was children born small for gestational age (Savenduhl, L et al: The Lancet 2020;8:683-698).

The Bottom Line

In my opinion, it comes down to risk versus benefit when one considers treating a child with growth hormone injections (the same for any medical intervention). Growth hormone deficiency is a disease, and in most cases treatment is appropriate. But, ISS is a made-up term to describe children who are not known to be short from any specific medical condition. It is certainly reassuring from the SAGhE data that prescribing growth hormone injections in children with ISS (those who meet the FDA criteria for use of growth hormone injections in ISS) is very likely safe in the long run. It is, however, still unclear if such treatment is appropriate, So I do agree with Ms. Brody’s conclusion, but for different reasons.

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