Study Shows No Muscle Growth From Serostim Growth Hormone
by Michael Mooney (July, 1999)
Serostim growth hormone
(GH) may have value in therapy for lipodystrophy because of its potential for
improving lipid oxidation (fat burning) in HIV, and while data from several
studies by Mulligan and others show that GH can increase lean body mass (LBM),
note that LBM does not always mean muscle tissue. The tissue compartments that
make up LBM include muscle, bone, connective tissue, organs, and water. Several
studies on HIV(-) subjects have shown that GH does not increase muscle tissue.
(1-4) For details see the article called Serostim Growth
Hormone: How Much Muscle Does It Really Build?
Does GH have a different
effect in HIV(+) wasting subjects? Is there muscle growth in wasting HIV(+)
subjects? This remains to be known conclusively, but the first study that actually
analyzed what tissue was gained in HIV(+) subjects using MRI (magnetic resonance
imaging), which is a much more critical method of analysis than bioelectric
impedance analysis (BIA), showed that no muscle tissue was gained.
I underline that all the
studies on GH used with HIV(+) people have documented changes in LBM, but none
of these studies have actually told us which part of the LBM tissue is gained.
So until now we have not had any confirmation that GH really increases muscle
And until now the studies
have never used sophisticated measuring techniques like MRI to ascertain what
is actually happening to the different tissues in the body.
This may have been purposeful
on Serono's part; because they know that Serostim is inferior to anabolic steroids
as an anabolic (muscle-building) agent to address wasting in HIV, it appears
that Serono has kept this information from being uncovered in the details of
the studies it creates and funds. But now the lack of a significant effect on
muscle tissue begins to leak out.
Here is some of the relevant
text of the report:
At the Cannes Conference
data from a study by Donald P. Kotler, MD reported the results of an interim analysis
of a 6-month open-label trial of the safety and efficacy of recombinant human
growth hormone (rhGH) upon visceral adipose tissue, as determined by whole body
MRI scanning, in HIV-infected men and women with documented changes in body fat
distribution by clinical criteria. Therapy with 6mg of Serostim
rhGH did not promote a significant change in skeletal muscle during the first
12 weeks of therapy in the 8 subjects for whom repeat MRI data were available.
(Cost for 12 weeks was approximately $19,000 - my note.)
The political problem here
is that Serostim GH has been promoted as an anabolic agent with claims by Serono
sales people that GH builds muscle better than testosterone or anabolic steroids.
Note that testosterone and anabolic steroids have been proven to be anabolic
to muscle tissue, and testosterone has been shown to significantly increase
muscle growth (5) at a far lower cost than GH. Testosterone costs between $100
and $200 per month for high dose injectable versions. Various anabolic steroids
also cost much less than Serostim.
Because of the deception
of Serono's sales people many HIV(+) people who have needed anabolic steroids
to build their bodies and their health have been given Serostim GH by well-intentioned,
but misinformed physicians.
Anabolic Steroids Safer Than Serostim Growth Hormone?
Additionally, while Serono sales people continue to say that GH is safer than
anabolic steroids, this is not what the published data indicates so far.
While none of the studies
on testosterone or anabolic steroids used for HIV have documented any significant
health problems associated with their proper therapeutic use, Dr. Gabe Torres'
data on his patients who experienced a reduction in symptoms of HIV-related
lipodystrophy with Serostim growth hormone showed that at the standard 5 and
6 mg doses, 80 percent of his HIV patients experienced significant side effects,
including elevated glucose, elevated pancreatic enzymes, or carpal tunnel syndrome.
(It should be noted though, that anabolic steroids and testosterone decrease
the body's own production of testosterone while they are being used, which can
temporarily result in atrophied testicles in HIV(-) subjects. No one knows if
testicular atrophy can become permanent in HIV(+) subjects, though.)
Elevated blood glucose can
lead to diabetes and the problems that can result, including cardiovascular
problems, eye damage, and neuropathy; elevated pancreatic enzymes can lead to
pancreatitis; and carpal tunnel syndrome may require surgery. So far, Serostim
growth hormone does not appear to be significantly safer than testosterone or
anabolic steroids used for HIV therapy.
Serostim GH certainly does
appear to have value for treating some of the symptoms of lipodystrophy, but
I caution that the 4, 5, and 6 mg Serono doses are overdoses for many HIV(+)
people, and lower doses between 0.5 mg and 3 mg per day should be considered
by the physician.
price is out of reach of most HIV(+) people, if insurance will not cover it.
Human Growth Hormone Costs 300 Times More Than Cow GH
Bovine (cow) growth hormone (BGH), which is a very similar molecule and costs
about the same to manufacture as human GH, costs farmers about $20 per month,
while Serostim costs humans over $6000 per month at 6 mg per day. This indicates
that Serono has an outrageous profit margin, and this is why insurance companies
resist paying for Serostim.
Serono should lower their
prices so that all HIV(+) people with lipodystrophy have a better chance of
On several occasions we
have tested Serono's patient assistance programs for people who do not have
insurance, and found
that while some of the other companies that make anabolic agents, like Biotechnology
General (Oxandrin), and UNIMED (Anadrol) have very user-friendly patient assistance
programs, Serono's program
is one of the biggest
hoop-jumping contests in AIDS, which means that very few HIV(+) people are provided
with assistance from Serono.
For other related details
see: Cost Comparison Of Anabolic Agents Available
In The United States: Weight Gained Versus Time Versus Cost Per Month
1. Yarasheski KE, et al. Effect of
growth hormone and resistance exercise on muscle growth in young men. Am J Physiol,
262(3 Pt 1):E261-7 1992 Mar.
2. Yarasheski KE, et al. Effect of resistance exercise and growth hormone on
bone density in older men. Am J Physiol, 268(2 Pt 1):E268-76 1995 Feb.
3. Zachwieja JJ, et al. Does growth hormone therapy in conjunction with resistance
exercise increase muscle force production and muscle mass in men and women aged
60 years or older? Source Phys Ther, 79(1):76-82 1999 Jan.
4. Yarasheski KE. Growth hormone effects on metabolism, body composition, muscle
mass, and strength. Exerc Sport Sci Rev, 22():285-312 1994.Exerc Sport Sci Rev,
5. Bhasin S, et al. The effects of supraphysiologic doses of testosterone on
muscle size and strength in normal men [see comments] N Engl J Med, 335(1):1-7
1996 Jul 4.
6. Torres RA, et al. Treatment of dorsocervical fat pads (buffalo hump) and
truncal obesity with Serostim (recombinant human growth hormone) in patients
with AIDS maintained on HAART. XII International AIDS Conference, Geneva (1998)
June 28-July 3. Abstract No. 32164.