The History of Human Growth Hormone

HGH (human growth hormone) was discovered in the 1920's. It was first used in children in 1958 where it helped those with stunted growth due to pituitary deficiency to grow more normally.

Up until 1985 it came from the brains of cadavers, mostly from Africa. It would take thousands of dead brain cells to obtain a few drops of growth hormone to treat the children who suffered with pituitary insufficiency.

Although many children were benefiting from the HGH injections, in the 1980's it was found to cause "Creutzfeld-Jakob" disease (CJD) and so it was removed from the market. Once removed there was no source for the children who needed it, so human growth hormone had to be reproduced synthetically. Since HGH is a protein which is made up of 191 amino acids it would be a very difficult task since every amino acid had to first be identified.

The Source of Today's HGH

In 1985 Congress passed the "Orphan Drug Act" as a financial incentive for pharmaceutical companies to develop drugs that would be needed by fewer than 200,000 persons. If a company would agree to develop a certain drug they would be given exclusivity for 7 years and so no one else would be allowed to compete in their market.

Around this time genetic engineering with its gene splicing was invented. This new technology allowed scientists to clone the proteins that make up the human body. Scientists could now more easily identify the exact DNA sequence for a particular protein. Once cloned, the bacteria E. coli could be used to turn out an endless supply of the drug.

Genentech's Protropin

In 1985 Genentech introduced the 2nd recombinant DNA drug ever produced, called Protropin. It was almost identical to the DNA chain of HGH, except its code sequence was off by one amino acid. This slight variation in code did not affect the performance of Protropin but it left the doorway open for other companies to compete.

Eli Lily's Humatrope

In 1986 Eli Lily, a company based in Indianapolis succeeded in making a human growth hormone product that contained all 191 amino acids and was 100% identical to the growth hormone made by the pituitary gland of the human body.

Eli Lily called their product Humatrope. They also sought protection for their new product with the Orphan Drug Act. A court battle then ensued between the two companies. In the end Genentech agreed to license its process patents to Eli Lily for about $145 million. After the battle the decision was that both companies would be able to produce and distribute their drug and all other companies would be kept out of the US market.

Legal Battles Over HGH

Once the court battle between Genentech and Eli Lily had ended each company began to distribute their products for use in children. Although it was not in writing, these companies and the FDA seemed to have an understanding that the products would only be used in children to treat growth hormone deficiency.

With one year's supply of their product costing each patient $14,000 to $30,000 per year, Genentech and Eli Lily soon made about $175 million just by selling their products for use in children. This was an enormous amount of money but with the clinical studies that were being done on adults it soon became clear that the real potential of human growth hormone lay in what it could do to fight aging and how it could help various health conditions in adults.

By 1995 their time of exclusivity under the Orphan Drug Act had run out, and in 1996 the FDA approved the use of human growth hormone in adults. Several European companies were ready and waiting to enter the U.S. market, and so the battle was on.

Lisa Wells, RN