A4M Safety Update On Human Growth
Hormone (HGH), January 2003
For over three
decades, children diagnosed with dwarfism (short stature) have been prescribed
Human Growth Hormone (HGH). In these tens of thousands of cases worldwide,
short stature syndrome has been successfully - and safely - treated.
The 1990 study by Dr.
Rudman of the Medical College of Wisconsin ushered in a new and exciting era
for HGH therapy. The improvements seen in lean body mass and associated biological
parameters in the study's healthy, elderly men were unprecedented. Adult men
and women could look forward to living their later years without becoming fat,
flabby, frail, and lethargic. They no longer had to presume that their loss of
sex drive, sleeping difficulties, memory changes, and lack of stamina and
energy were inevitable.
Nearly a decade and
hundreds of clinical studies later, in October 1999 the Johns Hopkins School of
Medicine sponsored a Growth Hormone/Growth Factors Symposium. Some of the
world's leading endocrinologists and scientific researchers convened to discuss HGH therapy. One of the most notable findings reported at this event was that
"GH replacement therapy in adults . is not associated with any increase in
mortality."
In 2002, two studies
caused undue alarm and confusion on the part of the consumer public relating to
HGH for sale safety. Below we bottom-line the outcomes of these studies to clear some of
the common misconceptions about HGH therapy in healthy adults.
Q. In the July 27,
2002 issue of The Lancet, Dr. Swerdlow and colleagues in the United Kingdom
issued a report of a study that tracked 1,800 people who received HGH as
children. Dr. Swerdlow stated that "there were risks about tenfold for
colorectal cancer and Hodgkin's disease." Collectively, these people were
at a three-fold increased risk of dying from cancer overall. Yet, Dr. Swerdlow also
admits that his study was unable to show a direct causative effect between HGH replacement and cancer. What does this all mean?
A. To respond, we
point to the study authored by Dr. David Cook, an endocrinologist at Oregon
Health and Science University. His report appears in the August 6, 2002 issue
of Annals of Internal Medicine, which is the journal of the American College of
Physicians & American Society of Internal Medicine. Published just one week
after Dr. Swerdlow's study appeared in The Lancet, Dr. Cook presents a
compelling scientific argument that counters Dr. Swerdlow's findings.
Dr. Cook explains that epidemiological studies (of which the Swerdlow study
is one) often suggest an increase in cancers in normal persons that corresponds
to elevated levels of circulating (free) IGF-1. (This may be caused by
increased serum concentrations of IGF-1, coupled with reduced levels of the
binding proteins that take up IGF-1, which may result from HGH therapy). Dr.
Cook submits that naturally-occurring situations in which circulating IGF-1
exist (such as in acromegaly) have not been associated with an increase in
cancer. In the words of Dr. Cook, this suggests that "high-normal IGF-1
concentrations may be a marker for cancer but are not causally related to
inducement or growth of cancer."
Dr. Cook continues in
his report to state that "appropriate growth hormone replacement therapy
is associated with normalization, not elevation, of serum IGF-1 concentrations.
In addition, levels of binding proteins are increased with growth hormone
replacement, along with levels of IGF-1, resulting in normal, not elevated,
free IGF-1 concentrations."
Q. In the study by Dr.
Blackman et al published in the November 13, 2002 issue of the Journal of the
American Medical Association (JAMA), the researchers suggested that the side
effects of HGH therapy outweigh potential benefits. The study involved 131
elderly men and women in overall good health, enrolling in a six-month long
study of HGH. At the end of the
study, the researchers reported that 18 of the HGH-therapy participants
experienced carpal tunnel syndrome, joint pain, swollen limbs, diabetes, and
blood sugar dysregulation. Is this cause for alarm?
A. Titering of the HGH
treatment protocol by the administering physician is absolutely critical in
ensuring that neurological and musculoskeletal side effects are avoided. When
patients report unusual joint or limb symptoms while taking HGH, a dosage
reduction is warranted. Within a matter of days, the reported side effects are
eliminated. With regard to the Blackman study, it is important to note that the
total duration of the study was six months, which is a very short timeframe
that may not have allowed for proper titering to take place prior to the final
reporting of both positive and negative effects.
Adult GH replacement
therapy may cause transient blood sugar elevation during the course of
treatment. However, it is important to understand that short-term blood sugar
elevation is not equivalent to diabetic disease. Furthermore, it is a
well-known fact of physiology that HGH antagonizes insulin, and in the short-term, elevated blood sugar levels may
be experienced during HGH therapy. This correlation has existed in published
medical literature for over 30 years. The Blackman study does a disservice to
the public by suggesting that adult GH replacement therapy leads to the
diabetic state and pancreatic damage. Diabetes is a permanent physiological
condition, and a temporary and transient rise in blood sugar as may result from
adult GH replacement therapy does not equate with the clinical disease known as
diabetes. As of this writing, there is no peer-reviewed published scientific
paper implicating adult GH replacement therapy with the onset of a permanent
diabetic state.
The Blackman study
states that "side effects went away after the hormone treatment was
discontinued." This is a testament to the reversible and short-lived
involvement of side effects in HGH therapy. The side effect profile of HGH
therapy is transient and can be managed effectively by a qualified physician.
Finally, it is
important to note that the Blackman study reports a significant benefit to
those in the study who received HGH. The report
explicitly states that the women in the study "gained an average of 2 to 5
pounds of muscle and lost about five pounds of fat. Men on growth hormone had
gained 7 to 10 pounds of muscle and shed about the same amount of fat."
For well over forty
years, HGH therapy has been under controlled and careful surveillance and
research by the US Food and Drug Administration (FDA) and Centers for Disease
Control (CDC). As a result of the monitoring activities of HGH replacement in
adults by the FDA, CDC, medical societies overseas (where adult HGH therapy has
been in-use longer than the US), and the five major pharmaceutical companies
that manufacture HGH, this substance is
one of the most extensively and carefully studied drug in history. Yet, not a
single one of these entities has attributed any death to the use of HGH
replacement when it is administered judiciously by a qualified endocrinologist
or anti-aging physician.
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Of all of the hormones
in-use for adult replacement, HGH has the most extensive history of rigorous
scientific trials and practical clinical application. Confusion and alarm have
been fueled by media reports that proclaim harm while failing to properly
explain the nuances of the study findings. There is a convincing body of
literature demonstrating the safety of HGH therapy in the aggregate, however no
single large-scale study has yet provided unequivocal evidence of improved
health outcomes. As a result, studies involving small populations of adult men
and women in good health who are administered HGH, and demonstrate positive
benefits, are generally dismissed as "anecdotal." Studies that
administered HGH to acutely ill patients fail to provide insight into how HGH therapy
affects healthy men and women. We submit that thorough and objective scientific
data on adult HGH replacement therapy should continue to be collected through
small- and large-scale research studies as well as applied clinical
utilization. (Source world health)