and patients with GHD, either alone or along with multiple hormone deficiencies, as a result of disease of the pituitary, hypothalamic disease, surgery, radiation therapy or trauma or patients who were deficient of growth hormone as children. That’s pretty specific. And the inclusion of the “and” in the diagnosis criteria is pretty significant. The statistics show that there is only 1 case per 10,000 adults per year that meet the diagnosis criteria of GHD. There is estimated to be about 50,000 adults with GHD in the US and there are about 6000 new cases each year and, according to the North American Biotechnology Industry and Suppliers’ Guide, a large portion of these adults are not being treated with HGH. A legal, or scientific, diagnosis of GHD cannot be made by simply comparing the levels of older adults with the levels of younger adults, and prescribing drug therapy on the basis of the lower levels found in older adults. You might have heard of something called “off-label marketing,” which is when researchers and physicians find new uses for already approved drugs. This method is legal and legitimate. For example over 62% of cancer patients use off-label drugs in their treatments. Pharmaceutical companies are able to educate physicians on potential off-label uses for their drugs. However, doctors do not have this off-label discretion when it comes to HGH. Off-label distribution or marketing of HGH to treat aging or aging related conditions is illegal. The Secretary of Health and Human Services determines the indications for which HGH can be distributed, and anti-aging treatments are not on the Secretary’s list. Recently the FDA has issued some pretty stern warnings with regard to the illegality of distributing HGH as an anti-aging treatment, and has imposed severe penalties for those who have gotten caught distributing HGH for his purpose. The fines and prison terms are pretty serious for those who breech the rules. Companies or individuals who distribute HGH via the Internet are also breaking the law, as HGH must be prescribed by a doctor who, “based upon an individualized determination of a proper course of treatment, authorizes the drug’s distribution to a patient under his supervision.” This is per the regulations set by the Federal Food, Drug and Cosmetic Act. There is no doubt that the position of the regulatory apparatus of the US Government is that, as of now, HGH is not a legal or valid therapy for anti-aging purposes. And furthermore, that there is a very precise and specific criteria for diagnosing GHD in adults. What all of this means is that clinics and physicians engaged in “anti-aging therapy,” “age management medicine,” or any other endeavor that is involved with prescribing HGH to combat growth hormone deficiency in adults should be very careful. With the current climate of heightened sensitivity to HGH use outside the very specific parameters set-up by the government, doctors engaged in this practice could find themselves in the crosshairs. In the next article I’ll tell you about the “Orphan Drug Program” and show you what researchers have been up to in their hunt for new uses for human growth hormone.