Human Pituitary-Derived Growth Hormone (11/25/87)

DATE:     November 25, 1987

FROM:     Director, Office of Biologics Research and Review

SUBJECT:  Deferral of Donors Who Have Received Human
          Pituitary-Derived Growth Hormone

  TO:     All Registered Blood Establishments

In April 1985, it was recognized that three young adults who had
received human pituitary-derived growth hormone (pit-hGH) during
childhood died of an extremely rare neurological disease called
Creutzfeldt-Jakob disease (CJD).  Since that time, there have
been four more CJD deaths associated with pit-hGH, two in the
U.S. and two in other countries.  The likelihood of young adults
developing CJD is so remote that it has been concluded that pit-
hGH must have been inadvertently contaminated with the
transmissible agent that causes CJD.  The pit-hGH was distributed
free of charge in the U.S. through a government program, now
called the National Hormone and Pituitary Program.  Approximately
7,000 U.S. children received therapeutic pit-hGH between 1963
through early 1985.  Pit-hGH was also available from 1978 through
early 1985 from two commercial sources, Serono (Asellacrin) and
KabiVitrum (Crescormon).  Also, there are unknown numbers of
persons who may have used this drug non-therapeutically, e.g.,
during rigorous physical training.  Distribution of pit-hGH was
halted in the U.S. in 1985, but pit-hGH is till in use in some
foreign countries.

Transmission of CJD is known to occur in direct tissue-to-tissue
contact following transplantation but not by sexual means nor
from mother to child across the placenta.  Experimental evidence
from animal studies does suggest that it may be possible to
transmit CJD by blood transfusions from a person who has been
infected with CJD but who is asymptomatic.  Because there is a
remote, but finite, chance that CJD may be transmitted through
the blood of pit-hGH recipients who are asymptomatic yet
harboring the agent, and because there exists no means of testing
to detect such infected persons, prudence dictates that all
persons who have received injections of pit-hGH should be
permanently deferred from blood donation.

Blood establishments should develop and implement specific
screening procedures to defer permanently recipients of pit-hGH
from donating blood or plasma products.  Such deferral is not
necessary for recipients who have received only recombinant
growth hormone available as an investigational new drug from
several companies, or commercially since 1985 from Genentech,
Inc. (Protropin), or since March 1987 from Eli Lilly and Company
(Humatrope).

The National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK) has prepared and distributed a fact sheet on
"Human Growth Hormone and Creutzfeldt-Jakob Disease" to human
growth hormone recipients and pediatric endocrinologists who
treated these persons.  This fact sheet provides telephone
numbers and names of persons who can answer additional questions. 
A copy of the latest revision, which includes an update about
limitations on donations of tissues and organs as well as blood,
is enclosed.  This fact sheet should be retained in the donor
screening area for ready reference.

                          Elaine C. Esber, M.D.