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), 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 tissue.

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.

Are 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.

Additionally, Serostim's price is out of reach of most HIV(+) people, if insurance will not cover it.

Serostim 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 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.