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on AIDS Wasting Syndrome
When asked to think about the human growth hormone (hGH) and its uses, many would envision an abnormally short man or woman who needs the hormone in order to grow to an average height. And in fact, this is one of the hGHs most vital functions, yet there are many more uses for the hormone, unknown to much of the general public. Human growth hormone is a protein consisting of one hundred and ninety one amino acids and possessing a molecular weight of 21,700 (http://www.eng.rpi.edu/dept/chem-eng/Biotech-Environ/FUNDAMNT/human.htm). It is produced in the pituitary gland of humans, where if functioning normally, it is secreted continuously throughout a persons lifetime. The hormone promotes growth throughout adolescence and has a major role in the metabolism of adults (http://www.novo.dk/backgrou/backgrou/bahghuk.htm). hGH has many uses including the treatment of hypopituitary dwarfism, bone fractures, burns, and bleeding ulcers. In fact, until 1988 hGH was only used to treat those with growth hormone insufficiency, caused by a limited supply of the hormone (http://www.novo.dk/backgrou/backgrou/bahghuk.htm). However, with the widespread infection of the HIV virus, hGH has experimentally and effectively been found to benefit those suffering from AIDS wasting syndrome.
What is AIDS Wasting Syndrome?.
Often nicknamed "slim disease" in parts of Africa, wasting syndrome, in which there is intense loss of lean body mass, is killing people with AIDS. It is now the "second most frequently reported AIDS-related clinical condition in the United States, second only to Pneumocystis carinii pneumonia (Weinroth, 1995). In wasting syndrome, the body begins to burn lean body mass and fat instead of the normal energy, making the body more susceptible to deadly infections. (http://www.critpath.org/newsletter/wtp/0496/growth.htm). The weight loss is very often associated with chronic weakness, constant diarrhea, and/or prolonged, unexplained fever (Weinroth, 1995).AIDS wasting arises in about 15-40% of late-stage AIDS cases (http://www.critpath.org/newsletter/wtp/0496/growth.htm). There is, however, a higher occurrence among women, Hispanics, and intravenous drug users. Once an HIV infected person is diagnosed with wasting syndrome, their classification goes from HIV infected to having AID (Weinroth, 1995). It is now attributed to nine out of ten deaths in AIDS patients (http://www.critpath.org/newsletters/wtp/0496/growth.htm).
Somatotropin is recombinant, biosynthetic, hGH used to treat people with AIDS wasting syndrome. Serostim, marketed by the Serono Laboratories, is the only hGH authorized by the FDA for this treatment (http://www.thebody.com/atn/254.html#HGH). Depending on the patients body weight, treatment is given via subcutaneous injections at doses of 4 to 6mg per day for twelve weeks. The Serostim therapy addresses the metabolic derangement of AIDS wasting and results in the gain of lean body muscle mass. The prevention of the loss, and the acquisition of lean body mass are the keys to improving physical function (http://www.immunet.org/immunet/atn.nsf/page/ZQX20502.html)
Serono Laboratories & Its Trial Studies.
Serono Laboratories, Inc., the company that sponsored this study, manufactures its own hGH originated from mammalian cells, and others from bacteria. Its hGH is now approved in fifty countries including the U.S. (http://www.immunet/atn.nsf/page/ZQX20502.html).
Continuous trial studies have been conducted to prove the validity of the hGHs effects. A placebo-controlled trial sponsored by the Serono Laboratories has showed signs that hGH can "reverse wasting syndrome" (http://www.immunet.org/immunet/atn.nsf/page/ZQX20502.html). Eligibility requirements for the study included the patients having "had to have lost at least ten percent of their pre-illness weight, or to weigh less than 90% of their ideal body weight [and] volunteers had to be able to eat at least seventy-five percent of their estimated caloric requirement"(http://www.immunet.org/immunet/atn.nsf/page/ZQX20502.html). The patients were also advised not to exercise. For three months, ninety patients received 6mg doses per day of the growth hormone, the other eighty-eight took the placebo. The placebo groups patients on average gained one pound, but lost it sometime throughout the three months. In the hGH group the participant gained on average, three and a half or more pounds. The hGH participants gain in lean body mass was more than six pounds, therefore they must have lost at least three pounds of fat to equal the final total weight gain. At the end of the trial, all of the patients "were given open label access to the drug" (http://www.immunet.org/immunet/atn.nsf/page/ZQX20502.html).
In a study conducted at the University of California at San Francisco, affiliated with San Francisco General Hospital, twelve patients, eleven men and one woman gained an average of four pounds over a three months trial period. The participants gained eight pounds of lean body mass, a resulting loss of at least four pounds of fat, without any significant increase in the consumption of overall calories, proteins, fats or carbohydrates. The average increase in calories was actually about 194, from 2647 to 2841. UCSF research dietitian, Viva Tai, R.D., M.P.H., comments that this study gives great reason for the consideration of hGH for those in the wasting syndrome. Because the patients most often have appetite disorders and cannot consume 3000 calories a day, this might be an ideal treatment for them (http://www.onlineworld.com/prohgh/moreinfo/aids.html).
Bill Thorne, a member of the San Francisco group ACT UP Golden Gate, wants increased admittance to the hGH. He testifies to the success of the treatment through the progress of his lover, Ronald Nemeth. After six months of experimental treatment with Seronos growth hormone, Nemeth, before "bedridden and paralyzed was able to go to the Mediterranean and walk through Pompeii" (http://www.critpath.org/newsletters/wtp/0496/growth.htm).
Yet, researchers note that even with the drug, some people who show "phenomenal success" while others "have showed no benefit" (http://www.critpath.org/newsletters/wtp/0496/growth.htm).
Other Methods of Treatment.
The FDA has approved megestrol acetate (a synthetic progestational agent that stimulates appetite and promotes weight gain in cancer patients. It has several side effects, including: alopecia, hyperglycemia, and carpal tunnel syndrome)and dronabinol (Also called tetrahydrocannabinol, is one of the major ingredients in marijuana). It has been approved by the FDA for use of patients with HIV) both to stimulate appetite (http://www.thebody.com/atn/234.html). The stimulus could then result in the gain of weight, though more-than-likely a fat gain, in wasting patients. Lower cost options come from the use of anabolic steroids and testosterone or thalidomide(Clears ulcerative lesions in HIV patients with nonspecific aphthous stomatisis)(Weinroth, 1995). The AIDS buyer club, for persons with wasting syndrome had obtained thalidomide. In a placebo-controlled trial eight out of nine patients gained weight as opposed to the two out of nine who gained weight the placebo group. In a test of AIDS sufferers with tuberculosis similar results occurred. Yet, further studies into the benefits of thalidomide are hindered by the lack of participants in the studies. Because the study is placebo-controlled, patients with wasting syndrome severe enough to qualify for the trial are unwilling to risk being in the group receiving the placebo, rather than taking other useful drugs. Thalidomide is also plagued with a history of causing birth defects in pregnant women (http://www.thebody.com/atn/234.html).
Hence, when other treatments have failed, some of the best results have come from hGH. This prompted the FDA to sponsor a special program intended to "allow compassionate use" of the drug in extreme cases of need by the patient. It also allowed companies to charge for cost recovery in the supplying of the drugs (http://www.thebody.com/atn/234.html). hGH is an extremely expensive treatment, which might be its greatest hindrance.
hGH can cost up to one hundred and fifty dollars a day or one thousand dollars a week. The prescription version of the drug is even more expensive. "The substance itself is produced by the body and cannot be effectively patented" (http://www.immunet.org/immunet/atn.nsf/page/ZQX22601.html). However, manufacturing process has been patented. Yet, the price of the hormone is still extremely disproportionate to the cost of production. For this reason many patients opt to be treated by using a less expensive treatment. Thalidomide is one of the lowest cost options. However, for those whose only option is the hGH, and they cannot afford it, there are indigent programs available. For example, ones sponsored by Serono Laboratories, Inc., and also through state programs like Californias Medi-Cal, which will reimburse on average up to 85% of the drugs cost(http://www.thebody.com/atn/234.html).
More Trial Studies.
Two additional studies to test the effects of recombinant human growth hormone have produced opposing results.
The first study performed, with the association of the Serostim Study Group, wanted to observe the effects of long-term treatment with the human growth hormone on weight, functional performance, body composition, and quality of life in patients suffering from wasting syndrome. Through randomized, double-blind, placebo-controlled multicenter trial, one hundred seventy-eight patients participated. The patients were either give 0.1 mg/kg of body weight of recombinant human growth hormone per day or placebo, for twelve weeks. The patients were measured by "weight; body fat, lean body mass, and mineral content (measured by dual-energy x-ray absorptiometry); total body water (by sodium bromide dilution); work output (by treadmill exercise); quality of life; and safety of treatment." The treatment with the recombinant growth hormone resulted in a significant and sustained increase in weight and lean body mass. In addition, there was a decrease in overall body fat in a large percent of the patients. "Side effects that may have been related to the growth hormone were mild, did not negatively affect quality of life, and generally responded to reductions in dose." From these results the researchers concluded that the growth hormone appears to be a "safe and potentially effective therapy" for those suffering from AIDS related wasting syndrome.(Schambelan, 1996)
Weinroth, S., Parenti, D., Simon, G. (1995). Wasting Syndrome in AIDS: Pathophysiologic Mechanisms and Therapeutic Approaches. Infectious Agents and Disease. 76-89.
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