FDA Approves
Lilly's Growth Hormone for Healthy Children
Mon, 28 Jul 2003
The FDA has approved Eli Lilly's injectable human growth
hormone (hGH) therapy, Humatrope, for healthy children who are
short but have no hormonal deficiency. Lilly claims that its
trials in 300 healthy short children resulted in an increase
in height of 1.5 to 2.8 inches.
Growth hormone therapy (hGH) has had a tragic history:
children suffered the pain of multiple injections and
unintended, severe--even fatal--consequences. The National
Institute of Child and Human Development (NICHD) conducted a
sweeping 22 year experiment from 1963 to 1985 in which world
wide, 27,000 healthy children were injected with growth
hormone to boost their growth--of these, 7,700 were American
children. Growth hormone was obtained from the pituitary
glands from cadavers--some of the glands were tainted.
In 1984, Mavis Lay, a 22 year old British woman who had
been injected with growth hormone in that experiment developed
the deadly Creutzfeldt-Jakob disease (CJD)--which has a long
incubation period. She died before she reached her 23
birthday. CJD is rare, in young people it is extremely rare.
Since then a new NIH report (2003) states that the number
of CJD casualties among those who were injected with hGH has
increased since its 1999 report:
26 Americans died............. out of 7,700,
89 French died .................out of 1,700
38 British died ................out of 1,848
Another 9 died of CJD in New Zealand (5); Holland (2); Brazil
(1) and Australia (1).
Additionally, NIH reports:
"More hGH recipients have died from adrenal crisis than from
CJD."
See NIH report:
http://www.niddk.nih.gov/health/endo/pubs/creutz/update.htm#1
David Davis, a journalist, was one of the subjects of that
government approved experiment. His riveting first person
accounts are online: Growing Pains. LA Weekly, March 21, 1997,
http://www.mad-cow.org/dec_early_news.html and,
Cut Short. Mother Jones, March 23, 2000
http://www.motherjones.com/news_wire/short.html and
When Good Medicine Goes Wrong. Atlanta Magazine, Aug. 2001
An excellent investigative report in the Los Angeles Times
(2000) relied on documented evidence unearthed during a 1996
British class action lawsuit. A British court ruled against
the government and awarded $7.5 million in damages. None of
the surviving American families whose children or parents died
of CJD have been compensated. Indeed, the American families
can't even get answers from NIH, which has refused to release
the names of participants who want to connect with one
another. NIH refuses to disclose the data pertaining to this
experiment, claiming "sovereign privilege." See: EMILY GREEN.
A Wonder Drug That Carried the Seeds of Death. The Los Angeles
Times, May 21, 2000. pg. 1
In the 1980s and 1990s, a growth hormone experiment was
conducted on 20 babies and children with Down syndrome. They
were 1 to 4.5 years old. The experiment used synthetic hGH was
conducted at the Institute for Basic Research for
Developmental Disabilities (IBR), a New York State facility of
the Office of Mental Retardation. It is doubtful that children
with Down Syndrome could benefit from growth hormone therapy.
Without a scientific justification for subjecting the children
to pain and discomfort, the experimental treatment is
unethical.
Indeed, a letter critical of the IBR experiment following
publication of the investigators' report, is as relevant today
as it was in 1992: "Before patients are treated with this or
any other therapy, a clearly defined benefit should be seen to
outweigh the risks of therapy, including those risks that
cannot be foreseen at present." by Nancy Binder, MD, PhD
(Oregon Health Sciences University) Journal of Pediatrics, May
1992, Vol 120, p. 832
Genentech was the supplier of hGH in the IBR experiment. It
is estimated that the cost per child, per year was $20,000 to
$30,000.
British endocrinologists appear to have learned a lesson:
experimental treatments involve risks and unintended
consequences. Therefore the precautionary principle--"First,
do no harm"--should be followed-- especially when children are
involved. BBC reports (below) that today, "UK endocrinologists
treat growth hormone deficient patients very conservatively,
with only the most severely deficient patients receiving
ongoing treatment." FDA officials seem to throw caution to the
wind, approving medically unjustifiable treatments whose risks
are not fully known.
The New York Times reports (below) that "Lilly pledged
tight restrictions on Humatrope's availability. It will be
prescribed only by certain specialists and shipped by special
drug stores to patients who undergo tests."
Who are they kidding? Growth hormone injections are big
business. Websites such as, American Pharmacy (a discount drug
supplier) offer direct shipments of Humatrope.
http://www.mexicohgh.com/chart.html
Humatrope is being marketed much as snake oil was:
"...clinical trials demonstrated that somatropin human growth
hormone (hGH) replacement therapy resulted in an increase of
lean muscle mass, a decrease in body fat, an increase in
exercise capacity and an increase in quality of life among
adults with somatropin human growth hormone (hgh) deficiency."
In addition to muscle strength and size, claims are made
that GHT improves: energy level; healing powers; sexual
function; emotional stability; memory; skin texture and
elasticity and makes wrinkles disappear. See;
http://www.hgh-humangrowthhormone.com/hgh_growth_hormone_research.htm
The likelihood, therefore, that Lilly will keep its
"pledge" and maintain "tight restrictions on Humatrope's
availability" is less than credible.
~~~~~~~~~~~~~~~~~~~~~~~~~
http://www.nytimes.com/2003/07/27/science/27HORM.html?pagewanted=print&position=
July 27, 2003
A Hormone to Help Youths Grow Is Approved by F.D.A.
By THE ASSOCIATED PRESS
WASHINGTON, July 26 (AP) - Children who are healthy but
abnormally short will be able to have injections of growth
hormone in hope of gaining one to three more inches of height,
the Food and Drug Administration said Friday, deciding an
emotionally charged issue.
The drug, Humatrope, is not for normal children yearning
for a few extra inches, the agency cautioned. It is for the
shortest 1.2 percent.
The drug's maker, Eli Lilly & Company, counts about 400,000
such children ages 7 to 15, but predicts that only 10 percent
will receive growth hormone because of eligibility
restrictions and because six shots a week are required for
years.
"This is not cosmetic use," said Dr. David Orloff, the
agency's chief of endocrinology.
Growth hormone has been used for 16 years to treat children
who are extremely short because their bodies do not produce
the substance or because of diseases. Some 200,000 children
worldwide have taken it.
Lilly sought federal approval to market its brand of growth
hormone for children who do not have those medical conditions
but are still abnormally short: boys predicted to be shorter
than 5-foot-3 as adults, and girls shorter than 4-foot-11.
Lilly's studies of about 300 children with no known causes
of abnormal shortness found injections added an average of 1.5
inches to 2.8 inches of height by adulthood.
Lilly pledged tight restrictions on Humatrope's
availability. It will be prescribed only by certain
specialists and shipped by special drug stores to patients who
undergo tests.
Copyright 2003 The New York Times Company |
http://news.bbc.co.uk/2/hi/health/2150953.stm
BBC
Friday, 26 July, 2002, 00:43 GMT 01:43 UK
Hormone therapy linked to cancer
Growth hormone has been used for decades
People who take human growth hormone treatment may be at
increased risk of developing bowel and colon cancer, research
suggests. Scientists say the finding is far from conclusive,
and that more work is needed to confirm their suspicions.
Our data do suggest the need for increased awareness of the
possibility of cancer risks Professor Anthony Swerdlow
They also stress that no such link has been made with the
modern synthetic form of growth hormone that is now used in
treatment - although it is possible that it would have the
same effect.
Their finding centres on the use of growth hormone taken
directly from the pituitary glands of cadavers.
This was widely used until the mid-1980s as a treatment for
children and young adults whose growth was impaired.
The researchers from the Institute of Cancer Research and
Institute of Child Health, UK, studied data on 1,848 people in
the UK who were treated with human growth hormone between 1959
and 1985.
They found that these people were almost three times more
likely to die from cancer overall.
But their risk of dying from colorectal cancer was 11 times
higher.
Greater vigilance
Writing in The Lancet medical journal, lead researcher
Professor Anthony Swerdlow said: "Our data do not show
conclusively whether cancer incidence is increased by growth
hormone treatment, but they do suggest the need for increased
awareness of the possibility of cancer risks, and for
surveillance of growth hormone-treated patients.
"At the moment this is a possibility that needs further
investigation, rather than a certain relationship that is a
cause for immediate concern."
It is possible that use of human growth hormone increases
the risk of cancer by boosting levels of a chemical in the
body called IGF-1, which has been shown to stimulate the
division of cancer cells.
However, it is also possible that people who are deficient
in growth hormone might naturally be more predisposed to
colorectal cancer, and that the treatment itself has no
effect.
In an accompanying commentary, Dr Edward Giovannucci, of
the Harvard School of Public Health, Boston, said it was
important to stress that growth hormone treatment had health
benefits.
However, he said: "While the data reported by Professor
Swerdlow and colleagues should not discourage appropriate
treatment of growth hormone deficiency, they should provoke
reassessment of the risks and benefits of growth hormone
therapy for more controversial indications that are unrelated
to growth hormone deficiency, particularly if such treatment
is prescribed for long periods."
Muscle bulk
Growth hormone, as well as helping to promote growth, can
be used to build muscle bulk, and improve cardiac performance.
It has been used by bodybuilders as an alternative to
steroids.
However, it is not officially licensed for such use in the
UK.
The Society for Endocrinology and the British Society for
Paediatric Endocrinology and Diabetes issued a joint statement
welcoming the study.
However, it stressed that artificial growth hormone was of
greater purity than the natural version, and that doses were
more tightly controlled than they once were.
The statement went on: "We believe replacing the missing
growth hormone in severely growth hormone deficient patients
can dramatically improve the quality of life of affected adult
patients, and allow growth hormone deficient children to grow
to a normal adult height.
"UK endocrinologists treat growth hormone deficient
patients very conservatively, with only the most severely
deficient patients receiving ongoing treatment."
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