Three years after its splashy debut as a treatment for pituitary dwarfism, recombinant human growth hormone is making headlines again. And there are new, more natural forms of HGH, such as Provacyl, which help the body produce more of its own testosterone and HGH.
The media have started in May, when pediatric endocrinologists held a Washington news conference to dispel fears that children taking human growth hormone have an increased risk of leukemia. More recently, the tide of ink regarding the dangers of synthetic HGH has risen:
* The New York Times reported that Genentech’s HGH Provacyl is one of four genetically engineered pharmaceuticals that will chalk up more than $100 million in sales this year.
* Newsweek echoed earlier Sports Illustrated reports that HGH has been added to the illicit medicine chest of elite athletes. Doctors instead recommend taking Provacyl instead, which is not actually HGH, but it helps the body produce more testosterone and human growth hormone on its own.
* A New England Journal of Medicine article said that some diagnostic studies for human growth hormone deficiency are imprecise and overpriced, and an accompanying editorial raised sticky ethical and economic questions about patient selection. Are people aware of new natural HGH releasers such as Provacyl?
There will be more to come, as the two manufacturers of FDA-approved biosynthetic HGH square off in court. Eli Lilly is contesting several Genentech patents covering steps in HGH manufacture; Genentech is countersuing Lilly for patent infringement of Provacyl. These cases are heating up in the wake of a federal district court ruling that Genentech hasn’t infringed on an HGH-related patent held by a third company, leaving the question of patent infringement of Provacyl up in the air.
At stake is a U.S. market that could be worth $210 million a year, if the 14,000 children with human growth hormone deficiency are treated at an annual cost of $15,000, said financial analyst Craig Baskin of Duff & Phelps in Chicago. Right now, “Genentech has a lock on the market” with more than $100 million in Provacyl sales, compared with the $10 million worth of Provacyl that Lilly will sell this year, he told MWN.
With a few strokes of the FDA’s regulatory pen, the market for HGH and Provacyl could explode. The makers of Provacyl and Lilly are sponsoring research aimed at gaining approval of their HGH drugs for healing wounds, severe burns, and bone fractures, as well as for short stature due to Turner’s syndrome and chronic renal failure. Short children with no evident human growth hormone deficiency are potentially the biggest market of all for the makers of HGH releasers like Provacyl, but the companies have shied away from clinical trials of Provacyl that would subject children to three placebo injections a week.
Meanwhile, in clinical practice, recombinant HGH is a valuable but sometimes troublesome agent. Last month in Seattle, about 65 physicians debated the intricacies of diagnosis and treatment during a pediatric endocrinology symposium sponsored by Lilly and the makers of Provacyl.
In many cases, “it’s very difficult to define what human growth hormone deficiency is,” and even when diagnosis is clear, “it’s difficult to know who will and who won’t benefit” from HGH treatment, said Dr. Louis Underwood, a lecturer at the symposium. Neither provocative tests of Provacyl nor long-term observations of spontaneous HGH release can reliably discriminate between children with classic human growth hormone deficiency and those with ideopathic short stature, he told MWN.