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HISTORY
Prior
to the advent of recombinant DNA technology, the only source of
growth hormone was from human cadavers. More than 27,000 children
worldwide were treated with growth hormone of this source (pit-hGH).
Due to short supply, children were treated with low doses and interrupted
regimens. As a result, their response and ultimate height was mitigated.
Distribution of pit-hGH was stopped in the United States and most
of Europe in 1985, with the emergence of Creutzfeldt-Jakob Disease.
This is a rare and fatal spongiform encephalopathy, caused by a
small pathogen called a prion. This is the same pathogen that causes
"Mad Cow Disease" recently seen in Europe from infected cattle.
It is impossible to catch Creutzfeldt-Jakob Disease or any other
infection from recombinant human growth hormone because it is not
derived from a human or animal source, but from a purified tissue
culture. For purposes of this discussion, the term growth hormone,
GH or hGH will mean growth hormone made by recombinant DNA technology.
The
bio-potency of commercially available growth hormone is typically
represented by either milligrams or units. To put it simply, 1 milligram
of growth hormone is equivalent to 3 units. The international units
were developed by the World Health Organization in order to standardize
growth hormone preparations because of the various production techniques
used early on in the manufacturing process.
By now, the manufacturing process has been streamlined and largely
perfected so the bio-equivalency of the various brands of growth
hormone (at least those manufactured and approved by the FDA for
sale in the United States) are identical. Therefore, a typical 15-unit
vial of growth hormone contains 5 mg, and a 4-unit vial contains
1.33 mg.
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