National Physicians Group Debunks Human Growth Hormone

JACKSONVILLE, Florida, October 1998 --The American Association of Clinical Endocrinologists (AACE), representing the nation’s physicians who specialize in the endocrine system, has issued a health alert calling for ‘responsible use” of human growth hormone in light of news reports that some people may be taking the hormone for anti-aging or athletic fitness purposes.

“Responsible use means consulting a physician who can determine whether such therapy is indicated by appropriate diagnostic testing and scientifically proving a growth hormone deficiency,” Dr. Helena W, Rodbard, president of AACE, said at a recent news conference.

“In too many cases, those who truly do not need human growth hormone are getting it, and those who truly do need human growth hormone are not getting it,” added Dr. Stanley Feld, a former president of AACE.

Recent news reports have focused national attention on the growing use of human growth hormone by vitality clinics who charge thousands of dollars a year to baby boomers and senior citizens seeking to feel younger, and athletes who hope to enhance their performance.

To promote responsible use of the hormone, AACE has published ‘Clinical Practice Guidelines for Growth Hormone Use in Adults and Children,” the first comprehensive guidelines on the subject issued by the medical profession for both children and adults

“It is estimated that about 75,000 out of 265 million Americans currently have a true growth hormone deficiency indicating the need for replacement therapy. That is why we are sending our guidelines to physicians across the country, and that is why we are issuing a health alert to discourage use that is not indicated on the basis of science or FDA (Food and Drug Administration) approval,” said Dr. Hossein Gharib, who chaired the AACE task force that developed the guidelines.

“Human growth hormone is not the fountain of youth, a formula to create super athletes, or a magic cure for short kids, but it is highly effective in the limited number of adults and children who have actual human growth hormone deficiency,” said Dr. Feld.

“Growth hormone deficiency in children is well established as a disease where therapy in the care of a trained physician should probably be continued throughout the patient’s growing period. Then the patient should be retested and, if he or she is still deficient, therapy should be continued for life,” noted Dr. Paul H. Saenger, who co chaired the task force.

“In cases where growth hormone replacement therapy is used to restore vitality, there might be an underlying disease other than growth hormone deficiency that has decreased the vitality, and that disease should be diagnosed and treated by the physician instead of using the replacement therapy,” explained Dr. Gharib.

AACE has launched a national public awareness campaign to draw public and physician attention to the problem. Those seeking a copy of the Guidelines or other information may visit AACE’s website (www.aace.com).

Human growth hormone, made by the pituitary gland, promotes the normal development and maintenance of tissues and organs by triggering the release of insulin-like growth factors (IGF’s) and inducing other beneficial physiological and metabolic effects.

Synthetic human growth hormone made through genetic engineering became widely available after 1985, creating a virtually unlimited supply for approved uses.

According to the new AACE Guidelines, human growth hormone replacement therapy is indicated for children and adults with scientifically proven growth hormone deficiency whose bodies produce insufficient or ineffective levels of the hormone.

‘The gold standard for the diagnosis of growth hormone deficiency is dynamic stimulation testing of the patient’s ability to release growth hormone, and not a single static test,” said Dr. Saenger. “Normal people can have borderline low levels of IGF I but have an absolutely normal stimulatory test. These people do not have growth hormone deficiency.”

Symptoms for human growth hormone deficiency include fatigue, lack of energy, poor sleep, decreased exercise capacity and psychological problems. Signs include decreased lean body mass, increased visceral fat, decreased muscle strength and bone density, and increased lipids.

“The non-specific nature of these signs and symptoms is believed to have contributed to the use of growth hormone therapy in some people who do not have a scientifically proven deficiency,” added Dr. Gharib.

Adults who may have growth hormone deficiency include those with pituitary tumors, those who have had radiation or surgery for such tumors, and those with hypothalamic disease.

Reported side effects associated with human growth hormone therapy include fluid retention, carpal tunnel syndrome, joint pain, headaches and other discomfort usually occurring at the onset of therapy and resolving in one to two months.

The FDA also has approved HGH therapy for children who have short stature as a result of chronic renal insufficiency. It is also approved for girls with a proven HGH deficiency who have Turner syndrome, a chromosomal abnormality that occurs in one of every 2,000 live born girls.

Clinical studies are under way to determine whether human growth hormone therapy can help strengthen the aging body or help counteract wasting in patients with burns or chronic diseases. However, to date, the FDA has approved the hormone’s use for patients suffering from wasting only due to HIV or AIDS.

“Responsible HGH use promises many benefits for those for whom it is indicated. It would be unwise to act on the basis of promises which exceed scientific evidence,” said Dr. Rodbard.

According to the National Institute on Aging of the National Institutes of Health (NIH), “Despite what advertisements or stories in the media may claim, hormone supplements have not been proven to prevent aging. Some harmful side effects already have been discovered, and further research may uncover others.”

“We want to thank Genentech, Inc., and Pharmacia & Upjohn Company for providing AACE with unrestricted educational grants to promote the responsible use of growth hormone therapy and to alert the public to this issue,’ said Dr. Rodbard.