Research On Recombinant DNA Human Growth Hormone
Research on recombinant DNA human growth hormone (rhGH) began in the late 1970s as a way to circumvent the problems of expense and disease contamination that had plagued conventional hGH therapies using cadaver-based material. Central participants included several of the same research scientists and companies also involved in the development of human insulin. Howard Goodman helped develop methods that resulted in the successful cloning of the rhGH gene in bacteria in 1979. In 1985, Genentech began to market rhGH for children with pituitary deficiencies, as did Eli Lilly in 1987. The rhGH story also has its own lawsuit drama. In 1999, the University of California won a $200 million settlement from Genentech for patent infringement related to Protropin, the company's own costly rhGH drug. Microbe-produced rhGH drugs now on the market, including orally administered forms, are free of CJD, essentially unlimited in supply, and come at a price that more people can afford. They have helped many children with hypopituitarism grow up to lead more normal lives. In 1996, the Food and Drug Administration (FDA) also approved the drugs for adults with brain tumors or other factors causing pituitary disease and hGH deficiency. Notwithstanding the medical and commercial success of rhGH, some troubling ethical questions have arisen. First, should societies permit rhGH use by children of short stature but without serious hypopituitarism? Many parents seek growth-enhancing drugs in the belief that their children thereby might gain higher social standing or economic opportunities in life (lifetime income is correlated with physical stature, some studies suggest). Second, since rhGH helps build muscle mass, should it be used by athletes or others to enhance physical performance? At the 1998 Olympic Games in Sydney , Australia , for example, and in professional baseball in the United States , the wide use of somatotropinlike steroids was suspected and has been verified. Finally, what are the long-term health risks and benefits of high supplemental dosages of GH? Because the market drugs have been available to a large audience for less than 20 years, no one fully knows.” 3
The first use of supplemental human growth hormone took place in the mid-20 th century when quantities of this important protein were obtained from human cadavers during autopsy procedures. Numerous pharmaceutical companies undertook this task and it became more routine after the 1950’s when this method was used in Sweden and the United States as a method for treating dwarfism.
During this time, due to the way in which it was harvested, human growth hormone could only be obtained in limited quantities and it was quite expensive. This created limited treatment options and only those who were wealthy enough to afford the treatment were able to access it.
As early as the 1970’s, researchers were searching for a way to produce simulated versions of the human growth hormone to replace the expensive limited quantities obtained through autopsies. The matter became even more pressing when, in 1985, the FDA as well as other foreign governments ordered that the ‘natural’ forms of the human growth hormone be taken out of use. The order was given following the deaths of multiple patients from a rare viral disease which doctors and researchers believed may have been obtained from the autopsy derived human growth hormone they had been given many years prior.