Is Treatment with Human Growth Hormone (HGH) Safe?
Last week, a brief news clip about HGH was published in the NYT. The article was entitled: “Growth hormone treatment for children may increase stroke risk,” and was written by Nicholas Bakalar. The article cited a newly published study in the journal Neurology, that showed young adults treated with growth hormone as children had a 7-fold increased risk for the development of stroke. The study was conducted in France and included almost 7000 young adults treated with HGH in the 1990s. I had already known about the study; a week earlier, I received an e-mail from the Pediatric Endocrine Society (PES) that mentioned the study. Several days ago, I received another e-mail from the PES that provided a detailed critique of the study. Based on my review of the study data, I would agree with the PES assessment that the data, while of concern, cannot at this point be considered “conclusive,” and that there is no justification for changing current HGH prescribing practices. Regardless, it is a bit scary that these data follow preliminary results reported in 2010 from another French study that suggested an increased risk of death in young adults who were treated with HGH as children (the Sante Adulte GH Enfant study or “SAGhE” study). With respect to that study, the U.S. Food and Drug Administration (FDA) concluded at the time that the evidence suggesting a link between HGH and an increased risk of death was inconclusive. The SAGhE study is still ongoing.
I would add that these data should serve to remind us what we should already know: all medications and procedures have potential risks and benefits. The risks can be proven, uncertain, or unknown. We pediatric endocrinologists already know quite a bit about unknown risks from past experience with medications whose devastating side effects were discovered only years after the medications were in use (e.g., cadaveric HGH and diethylstilbesterol or DES). The known risks of a medication or a procedure are far easier to deal with than the uncertain and unknown risks. In my opinion, we as physicians and other care givers must inform patients as best we can about the potential benefits and risks from any proposed treatment. In my experience, pediatric endocrinologists do a pretty good job at that task. If the potential benefit is great, even large risks might be worth taking, while if the potential benefit is trivial, even small risks may not be worth taking. Of course, in the end it is up to the patient and family to decide.
FYI: If you are interested in the issues discussed above, you can read more about risks vs. benefits by checking out my blog archive; on March 14, 2912, I wrote an entry about the SAGhE study and on September 18, 2011, I wrote an entry about the DES story.
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