Treatment Issues; Vol. 9, No. 5 - May 1995
Dave Gilden

Not surprisingly, enrollment has been slow, but is picking up. In the first week of May, Serono counted 70 people receiving HGH, as against 58 the week before. Another 190 individuals have applied for HGH but have not yet received the drug. The cost seems to be a major obstacle. Except for some companies in California, few insurance companies will compensate their subscribers for the cost of HGH, and no state Medicaid or AIDS Drug Assistance Program (which subsidizes people of moderate income) has agreed to cover the compound. Serono has hired a company, HMI of Charleston, South Carolina, to advocate with third party payers on the behalf of TIND applicants. Most of the 190 people on line for HGH are awaiting the negotiations between HMI and their third-party payers.

Serono also is operating a very modest "indigent program" that provides free or discount HGH for people who cannot purchase the drug any other way. There are the equivalent of only 25 slots in this program, which now has a waiting list. Thirty-five individuals were receiving at least some discount in the price of HGH as of May 1.

One applicant who is still waiting for HGH is GMHC client Nick Iacobazzi. He has had Pneumocystis carinii pneumonia three times, and each time, he says, "My weight didn't quite come back. If growth hormone would help me come back from OIs, it would be cost effective. Hospital stays cost $1,000 a day, but dealing with Blue Cross over HGH has been so frustrating. I'm sure a lot of people just give up." Iacobazzi notes that he is experiencing similar frustration getting on Serono's indigent program waiting list.

Serono officials rather perversely deny that cost has been the key issue behind slow enrollment. Rather, they point to doctors' confusion about how to proceed with a TIND. If the doctors would only apply for their patients, the company supposedly could set a precedent of reimbursing for HGH with all the insurance carriers and then enrollment in the TIND would be simple.

Physicians' concerns go far beyond ignorance about TINDs, though. Donald Abrams, M.D., who is assistant director of the AIDS Clinic at the public San Francisco General Hospital and a member of the advisory panel for California's AIDS Drug Assistance Program, wonders, "Should we start paying for TIND drugs? Is the quality of life increase [from HGH] worth $55,000 a year? I'm working in a health care system that's broke."

Scant Available Data

The real problem is not just the price -- some approved drugs with AIDS applications sell for amounts comparable to the HGH TIND cost recovery price. Neupogen (G-CSF), for example, costs $158 per day wholesale to combat drug-induced bone marrow suppression. The price issue is compounded by uncertainty over how and when to use the drug. Doctors are not even sure how long to prescribe HGH.

At present, most of the public data on using growth hormone comes from a single twelve-week placebo-controlled study involving 178 participants (of which only six were women). These individuals were losing one-half to one kilogram of lean tissue (as opposed to fat -- see Treatment Issues, September 1994, pages 3-12 for more details about the wasting phenomenon). After twelve weeks in the trial, volunteers on HGH gained an average of three kilograms of lean body mass (those on placebo gained nothing). Treadmill performance among those on HGH was much better after twelve weeks in the HGH arm compared to the placebo arm, as was self-reported quality of life.

Serono plans to file a licensing application (NDA) with the FDA in June, at which time results of the open-label follow- up from this study will be available. More data now undergoing analysis come from a second study that looked primarily at overall weight gain and quality of life. This information will give further indication of HGH's immediate value and long-term usefulness. Serono also is currently conducting a trial in children and considering a study on "maintenance" regimes to be used after the first twelve weeks.

The scant available data notwithstanding, HGH certainly has its fans among people with AIDS. Jeff Getty of Oakland, California, who has been receiving HGH for a year as part of the long-term follow-up study, claims that he experienced a dramatic turnaround in his physical condition as a result of growth hormone therapy. Getty says, "I really believe in this drug, and it's really horrendous to see people denied because of the price."

Some Alternatives to HGH

Fortunately, most people with wasting may have alternatives to HGH. A considerable number of doctors are now prescribing an extremely inexpensive regimen of testosterone plus synthetic anabolic steroids to men, at least, with wasting syndrome and reporting very good results on an anecdotal basis. One such practice is that of Marcus Conant, M.D., in San Francisco, which has 2200 patients with AIDS or HIV infection. Gordon Sanford, a physician assistant there, reports that a "huge" number of these patients are receiving testosterone and the anabolic steroid nandrolone. Sanford, who administers the HGH TIND in the Conant office, says that he now has ten patients accepted into the TIND, ten on the indigent program waiting list and only ten more who would "fare well" on HGH.

Asked to explain who is a good candidate for HGH rather than steroids, Sanford replied, "If we had ten patients on steroids and a vigorous exercise program, nine of ten would gain weight. But people who are truly wasting -- taking in 100 percent of caloric intake and exercising but not gaining muscle mass -- those are people who will benefit from HGH." Wasting syndrome, as opposed to malnutrition caused by a digestive problem, springs from a metabolic change occurring during chronic HIV infection. This disruption causes the body to break down protein to meet its energy requirements rather than first using its stores of fat. During intermittent periods of relative health, the body may restore some of its weight, but this takes the form of new fat, not restored protein or lean tissue mass.

Human growth hormone does not reverse the underlying metabolic defect; high doses of HGH just overwhelm it through other hormonal channels. Possible contributors to wasting include low testosterone levels, which is where testosterone replacement supplemented by anabolic steroids comes in, or excessive production of such inflammatory compounds as tumor necrosis factor alpha (TNF), which could be reversed with anti-inflammatory drugs such as thalidomide.

We review a number of these alternative therapies in the following pages. They all cost a small fraction of growth hormone (whose price will probably increase when it is officially approved -- Genentech and Eli Lily both charge around $40 per milligram for their versions of HGH, which are licensed for use in short-stature children). It is possible that the most effective regimens combine several approaches, with or without some HGH. Logic would dictate that the alternatives be given a try before relying on HGH, the Cadillac of the group. Unfortunately, research on all these alternatives is slow, and none are close to FDA approval.

Tightening the Economic Screws

As an indication of what economic pressure can do, we note in closing that bovine growth hormone (otherwise known as bovine somatotropin or BST) only costs three dollars per week when it is administered to cows to increase milk output (a BST dose is six times the HGH wasting dose). The compound is synthesized using the same basic genetic engineering processes as HGH production utilizes.

Granted there are differences in standards for veterinary and human medications that would make BST cheaper than HGH, and BST is made in much larger quantities, thus benefiting from economies of scale. For the price difference to be so astronomical, a different type of economics must be at work, though: The price of BST has to be justifiable in terms of the extra milk it yields. For the price of HGH, the sky is the limit -- but only as long as there is no viable competition, and for that see below.

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