By Sal Marinello

Human growth hormone (HGH) research has been conducted thanks to the Orphan Drug Act (ODA) passed by Congress back in 1983. Here’s a brief overview of the ODA and the current state of HGH research.

The Orphan Drug Act was passed to encourage the research and subsequent development of pharmaceuticals for the use in treatment of rare diseases that affect fewer than 200,000 Americans or in cases where more than 200,000 are affected but for which there’s no reasonable expectation that costs of bringing a drug to market can be recouped. The ODA is responsible for bringing over 100 drugs and other biological products to the market over the past 25 years.

The most well known member of the ODA club is the family of drugs commonly known as human growth hormones. HGH was developed to treat children with short-stature due to low levels of this hormone and HGH treatment is also prescribed for individuals with AIDS-related wasting syndrome and adults who have growth hormone deficiency (GHD).

Drugs that are developed under this program – granted “orphan status” – and pharmaceutical companies who invest in these products are given marketing exclusivity, tax incentives and offered grants to reward them in their efforts to develop drugs that have a low-likelihood of being profitable. Recent statistics indicate that there are approximately 50,000 adults with GHD, with 6,000 new cases each year. However, looking at the sales figures it’s hard to conclude that HGH is being used for just those people who qualify for treatment under the very narrow diagnosis criteria established by the Food and Drug Administration.

IMS Health, an independent pharmaceutical industry research company, has compiled data that indicates over 212,000 new and refill growth hormone prescriptions were filled by retail and mail order/Internet pharmacies in 2004. All of these prescriptions accounted for $622 million in sales, which is 89% for the total of all drugs classified as “anabolic steroids.” (This data was included in the article “Provision of Distribution of Growth Hormone for Anti-aging,” that appeared in the 1/14/08 edition of the Journal of the American Medical Association.)

There have been estimates that the worldwide sales figures for HGH approached the $3 billion mark in 2007. Given the very narrow scope of HGH’s use, these figures indicate that a whole lot of people are using HGH for more than it’s approved purposes.

Despite the restrictions that govern the use of HGH, and the fact that the marketable drugs have been developed to be used by an infinitely small group of people, there is no question that it won’t be long before HGH is approved for a wide range of treatments. Visit www.ClinicalTrials.gov and search the data base for studies being done with HGH and you’ll find studies are being conducted to see if HGH can be used to combat aging, diabetes, broken bones, juvenile arthritis, obesity, heart failure and polycystic ovary syndrome among other conditions.

There is overwhelming evidence that the drug companies are actively looking for other applications for HGH, and that there is reason to believe that in the near future there will approvals for HGH to be marketed for off-label purposes, in addition to HGH being approved for other specific uses. Too much money is being spent on research to think that this orphan drug is just going to languish on the periphery of medical treatments. There have been too many promising results from these efforts to think otherwise.

The fact that all of this research is being done makes it hard to take seriously the claims put forth by the anti-HGH folks that the use of this hormone poses a grave health risk. When you consider that HGH has already been shown to be safe for kids, a huge hurdle has been cleared in the efforts of pharmaceutical companies to gain approval for HGH for other uses in the rest of the population, especially since the reported adverse affects of HGH are relatively benign.

As a matter of fact, the drug companies must love all of the attention that HGH is getting from the media as they cover the performance-enhancing drugs in baseball story. I think it’s safe to say that the coverage given to HGH over the past year or so has most likely increase demand for this hormone. And understanding the economic dynamic in play, getting HGH approval for a wide range of treatments will serve as a windfall for pharmaceutical companies.

It will be interesting to see how the feds actually treat the anti-aging clinics that are involved with dispensing both HGH and testosterone for anti-aging or age-management purposes. The high-profile clinics that engage in this course of treatment now produce marketing materials that toe the line with regard to statements that deal with how HGH and testosterone are prescribed. Rather than make the drugs the centerpiece of the treatment regimen, age-management clinics are careful to say that HGH is prescribed only after evidence-based medical data and private consultations with physicians indicate that hormone therapy is warranted.

The reality is that there aren’t any over-the-counter supplements or exercise and diet regimens that can add pounds of lean muscle to the frame of a 60-year old man. But for now, these clinics and the feds will continue the dance to make it look as if everything is being done by the book.

But the inevitable is already here. HGH is being used for anti-aging purposes. Men of all ages are taking HGH legitimately and illegitimately and will continue to do so. The only change to this situation will be when the FDA changes the rules and allows HGH to be prescribed for anti-aging and/or allows the hormone to be subjected to off-label marketing. It’s a matter of when, and not if, this will happen. There’s too much money at stake for HGH therapy to be relegated to obscurity.

Right or wrong, good or bad, Pandora’s Box has been opened and there is a great deal of interest from a large segment of the population to gain access to HGH therapy. All of the regulation that our government can muster will not quell the tide or reduce the demand for greater HGH access, and the biotech and pharmaceutical companies have too much at stake to not let hormone therapy be available to the masses.

In the next installment of this series looking at HGH, I’ll tell you why over-the-counter HGH supplements don’t and can’t work. In the meantime, trust me and stop spending your money on this junk.

Please visit Sal’s website: Health and Fitness Advice