HIV 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) showed that no muscle was gained. I underline that all the studies
on GH and HIV have documented changes in lean body mass, but never tell us which
part of the LBM tissue is gained. No details are given that would actually tell
us whether GH increases muscle tissue. And before now the studies have never
used sophisticated 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 released in the details of the studies
it 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 ~$19,000 - my note.)
The injustice 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 are primarily anabolic to muscle
tissue, and testosterone has been shown to significantly increase muscle growth
(5) at a far lower cost than GH. Because of this deception many HIV(+) people
who have needed anabolic steroids to build their bodies and their health have
been given Serostim GH by well-intentioned physicians.
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. 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 does appear
to have value for treating some symptoms of lipodystrophy, but I caution that
the 4, 5, and 6 mg Serono doses are overdoses, and lower doses between 0.5 mg
and 3 mg per day should be considered by the physician. Additionally, Serostim's
price is predatory and out of reach of most HIV(+) people.
Bovine 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. 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 HIV(+) people with lipodystrophy have a better chance
of accessing Serostim.
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,
22():285-312 1994.
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.
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