Wasting Syndrome -- Affordable Treatments


The May issue of Treatment Issues, published by GMHC (the
Gay Men's Health Crisis, in New York), includes several excellent
articles on treatment of wasting syndrome -- severe loss of lean
body mass not due to obvious causes such as nutritional
deficiency or intestinal infection -- in AIDS. The bottom line
is that there are inexpensive potential treatments, and some
early experience suggests that most patients can be successfully
treated by using one or another of them. This may mean that only
a few patients will need the extremely expensive treatments,
which are out of reach economically for most people -- human
growth hormone, which costs about $1000 per week, or total
parenteral nutrition (TPN), which usually costs even more.

[Note: While human growth hormone costs about $1000 per
week, the growth hormone for cows (which will not work in humans)
costs $3 per week. Both are made by similar recombinant
technology; we have been told that the amino acid sequences are
two-thirds identical. But for people the commercial price is $42
per milligram (somewhat less for "cost recovery" for a special
AIDS program, where the drug has not been fully approved). For
the closely related agricultural product, however, the price to
dairy farmers, we have heard, is less than 2 cents per milligram.
Someone should investigate how the price of human growth hormone
has remained so disproportionate to the cost of production for
many years. A number of companies sell this drug throughout the
world -- at the identical price of $42 per mg. The substance
itself is produced by the body and cannot be effectively
patented; processes for manufacturing it are patented, and there
has been considerable patent litigation.]

[Persons who need human growth hormone and cannot pay for it
should realize that there is an indigent program, sponsored by
Serono Laboratories, Inc., the company which researched the use
of human growth hormone for AIDS-related wasting. Serono provides
the hormone without charge to a small number of patients who need
it and have no way to pay.]

An example of an affordable treatment for AIDS-related
weight loss (when not too severe) is testosterone enanthate, used
with an appropriate exercise program. In some cases nandrolone,
an anabolic steroid, is added as part of the regimen. While this
treatment has not been proven in clinical trials, some leading
AIDS physicians are using it and finding good results; Treatment
Issues mentioned Marcus Conant in San Francisco.

"We are frequently using testosterone to treat people with
AIDS-related weight loss," Dr. Conant told AIDS TREATMENT NEWS.
"And in some cases we are also using nandrolone when these people
have shown some promise of weight gain." Dr. Conant explained
that the nandrolone generally worked well only in those who had
already responded successfully to the testosterone.

What about people with true wasting -- who have lost more
than ten percent of their body weight, and continue to lose
weight despite testosterone, exercise, and nandrolone? Dr.
Conant's team has found that these people respond very well to
human growth hormone; 14 of the 16 severely wasting patients they
have treated have gained weight with the hormone, according to
Gordon Sanford, PA-C, a physician's assistant in Dr. Conant's
office. And they have not found any other treatment which worked
for those patients -- the FDA-approved wasting treatments Megace
or Marinol did not work. [However, Conant's experience cannot
rule out thalidomide, or ketotifen (see below). Thalidomide has
seemed to work for severe AIDS-related wasting in small studies;
larger trials are needed to confirm this finding. Ketotifen has
led to striking weight gain in a few cases; it needs a formal
study.]

Your physician can call Dr. Conant's office in San
Francisco, and talk to Dr. Conant, or to Gordon Sanford, to learn
the doses, and other critical details and important information
on how to use testosterone treatment most effectively.

[Note that this discussion of testosterone, and the other
potential wasting treatments below, assumes that the patient has
already had a complete workup to look for any obvious causes of
weight loss, such as parasites or other intestinal disease, MAC
or certain other infections, lymphoma, inadequate food intake,
etc. These specific causes need to be considered first. The
potential weight loss/wasting treatments mentioned here are tried
when such specific causes cannot be found.]

Another affordable possibility for treating wasting syndrome
is ketotifen, believed to be a very safe drug, which is widely
used in Europe for asthma and allergies, but not approved in the
U.S. You can get ketotifen through the PWA Health Group in New
York (phone 212/255-0520). The main drawback is that not much
research has been done yet on using it for AIDS-related wasting;
also, since the drug is not regularly used in the U.S., most
doctors here will not know anything about it. The main advantage
is that there seems to be little risk, cost, or other "down side"
to trying it.

A third affordable possibility is thalidomide, which is now
available under a special, tightly controlled "underground
compassionate access" program through the PWA Health Group, or
through Healing Alternatives, a similar buyers' club in San
Francisco. (Thalidomide is also available through an official,
FDA-approved compassionate access program for people with AIDS,
but at this date that is only for treatment of aphthous ulcers,
not for treatment of wasting.) The main danger, of course, is
birth defects if this drug is taken in pregnancy. In addition,
larger doses of thalidomide can cause neuropathy or other adverse
effects.

Two treatment are FDA-approved for AIDS-related wasting
syndrome: megestrol acetate (Megace), and also dronabinol
(Marinol), which uses the active ingredient of marijuana as an
appetite stimulant. Both of these are expensive; and it is
controversial how effective they are for increasing lean body
mass, which is what a wasting-syndrome treatment must do. The
May Treatment Issues mentions these treatments, but does not
discuss them in depth. (We have been told by others that persons
who use Megace should have their testosterone levels monitored.)

[Note: on July 4 we talked to Dave Gilden, editor of
Treatment Issues and author of an article on human growth hormone
in the May 1995 issue. He said that if he were publishing that
issue today, it would have more information on exercise, and more
coverage of Megace and Marinol. Also, he would urge activists to
campaign to get the FDA-approved compassionate access program for
thalidomide expanded to allow persons with wasting syndrome --
not only those with aphthous ulcers, as is the case today -- to
receive the drug. And he would emphasize the great need for more
research in AIDS-related wasting.]

We strongly recommend that anyone interested in wasting
syndrome get the May 1995 Treatment Issues; it includes
background and details which we only summarized above. Better
yet, anyone interested in AIDS treatment can get a complete set
of the back issues of this very useful publication for a
suggested donation of $25. To order, send $3 for the May issue
only, or $25 for a reprint of all the back issues, to: GMHC,
Treatment Education, 129 West 20th St., New York, NY 10011. We
also recommend subscribing to Treatment Issues, suggested
donation $35/year (11 issues) for individuals, $70/year for
physicians, institutions, or international subscriptions.

[Note: For additional information on wasting and its
treatments, also see "Turning the Corner on Wasting? A Symposium
on Wasting Disorders," by Jeff Getty, in BETA (Bulletin of
Experimental Treatments for AIDS), June 1995; BETA is published
by the San Francisco AIDS Foundation. And see Notes from the
Underground, April/May 1995, available without charge from the
PWA Health Group, 212/255-0520.]