How is hGH manufactured, and why is it so expensive?
It’s hard to synthesize this hormone. Its large and complex molecular structure involves 191 amino acids. Since 1985 it has been made through recombinant DNA technology in which bacteria or animal cells are given a gene that directs them to make hGH. The cells are then grown in a tissue culture that synthesizes a pure hormone identical to that produced by the human pituitary. We can’t copy this substance using the growth hormones of animals and plants, and molecules of this size can’t be absorbed through skin or mucous membranes. If taken in pill form, hGH will be deactivated by stomach acid and enzymes, so it has to be given as a shot under the skin.

What are the FDA approved indications for use of hGH?
According to the FDA, it should only be prescribed for adults by physicians for the treatment of disease (the wasting syndrome of AIDS) and/or growth hormone deficiency. They generally consider the latter as one that is due to an absolute lack of hGH as a result of pituitary disease, surgery, radiation or trauma. Growth Hormone Deficiency (GHD) also includes grownups that were GH deficient during childhood (children of very short stature and certain genetic syndromes).

In order to make the diagnosis of growth hormone deficiency, an endocrinologist has to give an injection to stimulate production of growth hormone and measure the response. According to the FDA and the American Association of Clinical Endocrinologists, measuring IGF-1 level and stating that this is lower than that of a young adult does not constitute a valid scientific diagnosis of GHD.

Is the prescribing of growth hormones for other reasons (i.e. muscle building, sports enhancement or in individuals who don’t have a deficiency) legal?

NO!  According to the FDA, and the penalties chapter of the FDCA (The Food, Drug and Cosmetic Act), “whoever knowingly distributes or possesses with intent to distribute human growth hormone for any use in humans other than the treatment of a disease or other recognized medical condition where such use has been authorized by the Secretary of Health and Human Services under Section 505, is guilty of an offense punishable by not more than five years in prison.” This section also permits courts to impose fines of up to $250,000 for an individual or $500,000 for an organization as well as forfeiture of property used in or derived in violation of the hGH law. 

The Federal Trade Commission has filed cases against the “supplement” industry.  In one case, two Florida businesses were named in a complaint, along with two individuals involved in the businesses, including one who was a physician. The defendants agreed to a federal court order requiring them to pay up to $20 million in consumer regress (that’s the largest monetary judgment ever obtained in a FTC health fraud case) — to settle charges that “they deceptively claimed that their pills and sprays would increase consumers’ human growth hormone levels and provide anti-aging benefits.”

Obviously, baby boomers have to be advised about anti-aging products.
Yes, if a doctor, clinic or Web site promises you that they have a non-injectable product that will restore your growth hormone level to that which you had when you were young, beware. Products available without prescription are imposters and have no effect.  Those that are prescribed and injected are expensive, and we don’t have the long-term studies that give conclusive proof that they work. Know that hGH use for “anti-aging” per se is not FDA approved. If you consult with a physician who prescribes it because the marker for growth hormone (IGA-1) is low, you (and the physician) are entering a world of “off-label” use and you are in essence experimenting with your body and health. In centers where it is prescribed and patient claims are made that it does indeed work (they feel better, lost weight, have more energy etc.), the shots are frequently combined with nutritional counseling, exercise and other forms of hormone therapy (estrogen and/or testosterone). Many doctors who do prescribe this hormone admit that hGH therapy alone is not a “fountain of youth.”

Only on TODAY.MSNBc.com! Dr. Judith Reichman addresses your questions about women's health. LAST WEEK: Will removing my ovaries prevent cancer? GO TO ALL HEALTH TUESDAY COLUMNS

In my opinion, if you want to invest in methods to maintain your health and body and achieve “well-gevity”, you should invest your time, money and energy in attaining appropriate weight control, lipid and sugar control. Exercise and eat properly; don’t smoke and get the testing you need for early disease detection. Most importantly, start any necessary treatment without delay. We baby boomers worked hard to redefine our lives; most of us have learned that there are no simple (albeit how expensive) shortcuts.

Dr. Judith Reichman, the “Today” show's medical contributor on women's health, has practiced obstetrics and gynecology for more than 20 years. You will find many answers to your questions in her latest book, "Slow Your Clock Down: The Complete Guide to a Healthy, Younger You," which is now available in paperback. It is published by William Morrow, a division of HarperCollins.

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