In 2007, the United States Food & Drug Administration began a push to clarify the legitimate uses for human growth hormone. U.S. law had made it illegal to prescribe recombinant human growth hormone (hGH) for off-label purposes. The FDA emphasized that in adults, approved uses were limited to AIDS wasting syndrome, short bowel syndrome, and Adult Growth Hormone Deficiency Syndrome (AGHD). By AGHD, the FDA was not referring to the normal decline in GH levels with age. Instead, they defined AGHD as a condition where pituitary output of GH is reduced due to a specific clinical cause. They explained that physicians should only prescribe hGH if there is a subnormal response to the standard growth hormone stimulation test, and some relative clinical history such as pituitary disease, hypothalamic disease, surgery, radiation therapy, trauma, or childhood-onset GH deficiency.
According to recent figures by the Connecticut medical research firm IMS Health, this action may have stalled the U.S. growth hormone market. While testosterone prescriptions (another cornerstone of anti-aging medicine) have continued to rise every year since, hGH use hit its peak in 2007, when approximately 454,000 prescriptions were written. Over the next three years, it was estimated that 424K, 431K, and 428K prescriptions were written for the drug, respectively. This represents a slight but still clear drop in use. Money spent on the drug increased over the same time, however, which likely reflects the loss of cheaper compounded rHGH medications over the same time. The report did not address the effect the price of therapy may have had on the number of prescriptions written.
While a drop of approximately 25,000 prescriptions per year is substantial, the domestic market for hGH remains fairly strong. This presumably reflects the continued use of this medication in many age management clinics. While most physicians are no longer prescribing hGH based simply on blood level testing, many are administering GH stimulation tests on their patients and approving the drug when their response and medical history are deemed appropriate. The FDA has been relatively quiet about such use. Note that these figures also do not account for GH stimulating drugs such as sermorelin, GHRP2, and GHRP-6, which have been replacing recombinant human growth hormone in many anti-aging practices. A broader assessment of “total growth hormone therapies” over the same time has not been made.