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Subject: AIDS Treatment News Issue #224, June 2, 1995

AIDS TREATMENT NEWS Issue #224, JUNE 2, 1995
   phone 800/TREAT-1-2, or 415/255-0588

CONTENTS:

Diarrhea, and the Experimental Treatment Saccharomyces 
boulardii

When Treatments Go Untried

Gallo Starts Major AIDS Research Institute in Baltimore

Lymphoma: New TAG Report

Chinese Medicine: Where Does It Work Best in HIV/AIDS?


***** Diarrhea, and the Experimental Treatment Saccharomyces 
      boulardii

by John S. James

Saccharomyces boulardii is a live yeast widely used in Europe 
and elsewhere to treat diarrhea; millions of doses are sold 
each year. Recently, with increasing interest in using it for 
HIV-related diarrhea, this potential treatment has become one 
of the top sellers at some AIDS buyers' clubs, including 
Healing Alternatives in San Francisco, and the PWA Health 
Group in New York.

A number of published clinical trials (almost all in HIV-
negative persons) have reported apparent usefulness in 
preventing or treating diarrhea resulting from various 
causes. No one knows how S. boulardii may work, however. It 
does NOT seem to kill diarrhea-causing organisms directly; 
instead, it may reduce inflammation in the gut, or increase 
certain immune responses in the blood. (The latter theory 
might explain how one study found S. boulardii may have been 
modestly useful for treating acne, even though the yeast did 
not leave the intestinal tract.)

HIV-Related Research

Little research has been done with S. boulardii in persons 
with HIV. In 1990, French researchers reported on 30 patients 
who had four to eight liters of watery stools per day for at 
least three months. When they were given three grams per day 
of S. boulardii, "fecal output decreased to less than one 
liter per day after 48 hours of treatment, and eight days 
after the onset of the drug, stools were fully formed."(1) 
The following year, the same research team reported on 
improvement in 17 patients with HIV and diarrhea; in 12 of 
them, the cause of the diarrhea could not be diagnosed. The 
average number of stools decreased from 9 to 2.1 per day in 
15 days, and there was an average weight gain of 8 kg (17.7 
lbs).(2) Neither of these reports were from controlled 
trials, however.

In 1992 French researchers reported the results of a placebo-
controlled trial of S. boulardii, in 36 patients with AIDS-
related diarrhea which -- importantly -- was not responsive 
to any attempt to treat any known cause of the diarrhea.(3) 
On entry into the trial, their average age was 34.8 years, 
and their average weight was 58.7 kg (130 lbs). Thirty five 
of the 36 patients completed the study. At the end of the 
trial, 10 of 18 patients who received S. boulardii were 
diarrhea free, vs. only 1 of 17 who received the placebo -- a 
difference which is highly statistically significant. Also, 
the treatment group gained 2.0 kg (4.2 lbs), while the 
placebo group lost 3.1 kg (6.85 lbs); this difference is also 
statistically significant. The length of the trial was not 
stated in the abstract. As far as we know, this is the only 
completed controlled trial of S. boulardii in persons with 
HIV.

The latest medical article anywhere on S. boulardii in HIV-
related diarrhea was published in 1993; it is a case report 
of a successful treatment.(4) (Unfortunately, one major 
computer database mis-translated the German title into 
English as "Saccharomyces boulardii Therapy of HIV Associated 
Failures," instead of "Saccharomyces boulardii Therapy of HIV 
Associated Diarrhea," giving a completely wrong impression of 
the article. But the MEDLINE database generally used in the 
U.S. does have the correct translation of the title.)

Until recently, 26 persons with HIV were being studied in 
controlled clinical trials in Seattle. During the first two 
weeks, some were randomly assigned to receive a placebo. Then 
everyone received the drug in decreasing doses, to help 
define the safest and most effective maintenance dose. 
Unfortunately, this trial was recently stopped -- for 
business reasons, not because of any problem with the 
treatment. (The sponsor decided to focus on another trial, 
testing S. boulardii with antibiotics to prevent recurring 
Clostridium difficile diarrhea; all the persons in that trial 
must be HIV negative. That study may be finished by the end 
of 1995; with luck, S. boulardii could be approved for 
preventing C. difficile recurrences in about two years.)

S. boulardii appears to be quite safe; no serious adverse 
effects have been found in any clinical trial. But one 
theoretical danger is that this yeast could take advantage of 
an immune deficiency and cause a systemic infection. Only two 
cases of this have been reported, out of perhaps more than a 
million people who have used the treatment since it was first 
used for diarrhea in the 1950s. Both were probably HIV-
negative (neither had been tested, but neither was being 
treated for anything HIV related); both previously had 
serious intestinal problems which may have allowed the yeast 
to leave the intestine and enter the bloodstream. Both cases 
were successfully treated with amphotericin B, a powerful 
antifungal.

Clinical Trials for Other Diseases

McFarland and Bernasconi(5) reviewed controlled trials 
studying S. boulardii for treatment or prevention of diarrhea 
due to various causes not related to HIV. All the results 
reported below -- from studies they reviewed, and also from 
more recent reports -- are from controlled trials, and are 
statistically significant.

Three large trials studied S. boulardii for prevention of 
antibiotic-associated diarrhea.(6,7,8) This condition can 
occur as a side effect of certain antibiotics, which can kill 
beneficial organisms in the gut and thus allow an overgrowth 
of disease-causing organisms which are normally kept under 
control. In all three of the trials, S. boulardii reduced the 
incidence of diarrhea by at least 50 percent.

Two other controlled studies showed that S. boulardii 
treatment caused about a two-fold or three-fold reduction in 
diarrhea caused by feeding with a nasogastric tube.(9,10)

S. boulardii, used with certain antibiotics, has also been 
studied for treating C. difficile, a serious intestinal 
infection. After several positive case reports and 
uncontrolled studies, a major placebo-controlled trial found 
that S. boulardii plus antibiotics prevented recurrences of 
C. difficile better than the antibiotics alone,(11) but this 
could only be established for patients with a history of 
recurrences; for those with their initial C. difficile 
infection, the difference between the treatment and placebo 
groups was not statistically significant. (This failure to 
reach statistical significance does not mean that S. 
boulardii failed to help in these cases, however; "because of 
the small numbers of patients with initial CDD who failed, 
there was only a 10% power of detecting a significant 
difference; therefore, the result could be a type II 
error."(11))

A study in a few patients with Crohn's disease also found 
statistically significant benefit of S. boulardii in reducing 
diarrhea.(12)

Researchers in Austria tested S. boulardii in 3,000 healthy 
volunteers for prevention of travelers diarrhea. They gave a 
small dose (250 mg per day), a moderate dose (1 gram per day) 
or a placebo to persons about to travel to distant regions. 
Those who received the treatment, especially the higher dose, 
were significantly less likely to get diarrhea.(13)

Studies of S. boulardii for treating ordinary diarrhea in 
children(14,15) have shown significant benefit. And in a 
trial in adults,(16) the treated group did not have a 
significant reduction in the number of stools, but it did 
have a lower proportion of watery stools.

S. boulardii does not remain in the intestine after use is 
stopped, but is eliminated from the body within several 
days.(5)

Research findings differ on whether the yeast needs to be 
alive when taken. Even dead yeast may cause some of the 
effects which have been observed.

Note: A number of laboratory studies, animal studies, and 
uncontrolled human trials, NOT involving HIV in any way, have 
suggested that S. boulardii might be helpful in treating 
specific kinds of diarrhea or other illnesses. In this 
article, we have not reviewed or referenced those studies. 
Instead, we have focused on all HIV studies, and on placebo-
controlled human trials for any condition.

Availability Today

At least two different S. boulardii products are available in 
AIDS buyers' clubs today.

Laboratoires Biocodex, the French company now running 
clinical trials of S. boulardii, markets a lyophilized 
(freeze-dried) form of the yeast in Europe, South America, 
and Africa, but not in the U.S. It is sold under different 
brand names (Ultra-Levure(tm), Thiemann(tm), Perenterol(tm), 
Floratil(tm)) in different countries. This product is 
available from the PWA Health Group, the largest AIDS buyers' 
club in New York (212/255-0520). The three-gram per day dose 
used in trials for AIDS-related diarrhea is moderately 
expensive; at the PWA Health Group, a four-day supply costs 
$36. Biocodex has been selling S. boulardii since 1962.

A competing product sold by Jarrow Formulas is less 
expensive; but whether the two products are equivalent is 
controversial. The PWA Health Group only carries the Biocodex 
version; while Healing Alternatives, the major AIDS buyers' 
club in San Francisco, carries only the Jarrow brand; both 
can ship the product anywhere within the U.S. Some health-
food stores also sell the Jarrow brand.

With the Biocodex product, each 250-mg capsule is formulated 
to contain one billion live yeasts, when tested six months or 
more after manufacture. According to Biocodex, their in-house 
testing, which has not previously been published, has shown 
that there can be as much as a two log (99 percent) drop in 
the number of live yeasts in the month after manufacture. 
According to Jarrow Rogovin, president of Jarrow Formulas, 
this does not happen if the capsules are refrigerated.

With the Jarrow product, each 310-mg capsule is formulated to 
contain at least 500 million live yeasts when manufactured; 
it may contain more.

We believe that what is most important is to find out whether 
or not S. boulardii may be helpful for you -- and that the 
best way to do this is to try a test with the more 
established Biocodex product, starting with three grams a day 
(twelve 250-mg capsules) for at least a week, and preferably 
for two weeks. (You might want to order additional supply, to 
avoid running out if it does seem to work.) After this test, 
if you decide to continue with S. boulardii, you might be 
able to reduce the cost by reducing the dose, and/or 
switching to the Jarrow product, to see if a less expensive 
regimen works as well for you.

How S. boulardii Is Used

Because of the lack of scientific studies of S. boulardii for 
persons with HIV, information on how to use this treatment is 
highly anecdotal and imprecise, and sometimes contradictory.

According to at least one of the buyers' clubs, most people 
using S. boulardii for HIV-related diarrhea start with 3 
grams a day, and then work down to 1 gram a day if that is 
sufficient to keep the diarrhea controlled. Most people 
divide the dose into two or three portions, and take the 
capsules with a glass of water after eating. (One 
recommendation we have seen says two hours after meals; 
another just says after eating.) Some people take a gram a 
day or less "for gut regulation or stomach aches," even 
without diarrhea. According to the PWA Health Group, there 
are no known drug incompatibilities, although it has been 
suggested that if fluconazole maintenance is being used, the 
two treatments should not be taken at the same time, so that 
the fluconazole will be less likely to kill the yeast.

How many people have used S. boulardii for HIV-related 
diarrhea? No one knows; the PWA Health Group estimates that 
maybe a few hundred people have tried it; and they have 
received only one report of a suspected side effect, a rash. 
Healing Alternatives was selling about 90 bottles a month 
before a recent article in a gay newspaper in San Francisco 
increased demand. It has only heard one anecdotal report that 
the treatment did not work; all the other reports have been 
positive, even with severe diarrhea. (Readers should keep in 
mind, however, that negative results are usually the least 
likely to be reported; the treatment is probably not working 
as well as the existence of so few negative reports might 
suggest.)

Perhaps the most serious safety concern with S. boulardii is 
that appropriate medical care could be delayed, if people 
treat themselves for diarrhea without first getting medical 
attention so that the underlying cause of the problem can be 
diagnosed and treated, when possible. People should remember 
that the HIV-related medical studies cited above were done 
with patients whose diarrhea either could not be diagnosed, 
or could not be treated by standard means. In many cases, 
standard medical care cannot help; this is why new treatments 
are needed. But failure to use available therapy for a 
treatable condition, such as CMV infection, could lead to 
serious harm.

The Future

So far there has been very little study of use of S. 
boulardii for treating AIDS-related diarrheas. We have heard 
that a trial is being conducted in Germany; as far as we 
know, this is the only study anywhere of S. boulardii in 
persons with HIV. Biocodex may study it again for HIV 
diarrhea sometime in the future, but probably not until the 
development for C. difficile is complete. It would be very 
difficult for anyone to conduct a legal, U.S. study of S. 
boulardii independently of Biocodex, either using its 
product, or any other; collaboration might be possible, 
however.

Sally Cooper, executive director of the PWA Health Group in 
New York, informally outlined some research directions she 
would like to see, in a private communication to AIDS 
TREATMENT NEWS on May 30, 1995:

"Things I'd like to see followed up: use in kids with HIV -- 
what a great thing to have a safe intervention for kids, who 
have wicked diarrhea all the time, and there have been at 
least two studies in non-HIV kids; amoebas (also a small 
number of promising abstracts, much gentler than Flagyl and 
even tinidazole, again safe for kids); various stomach 
ailments; thrush and preventing the spread of thrush (as per 
animal studies). 80% of the lymph is in the gut, so things 
that work specifically in the gut, like S. boulardii and 
ketotifen, seem especially interesting. Both are theorized 
(and shown in people with ketotifen, but only in animals with 
S. boulardii) to improve and maintain mucosal membrane health 
in the gut. And people gain weight -- seems like more than 
just stopping up the system. I suspect it might be an 
excellent maintenance therapy for PWAs with low CD4 counts, 
or anyone starting a major course of antibiotics, especially 
clindamycin." [Note: tinidazole and ketotifen are drugs which 
are approved in some countries but not in the U.S., and are 
used by people with AIDS.]

The bad news is that none of this research is likely to start 
for years; who would pay for it? But the good news is that a 
great many people have used S. boulardii, and some people 
have used it for AIDS-related diarrhea over the last several 
years; from all we know at this time, the treatment appears 
to be exceptionally safe.

The other good news is that if S. boulardii is going to work, 
it works quickly, usually greatly reducing diarrhea within a 
week or two. A short test should be enough to see if it is 
going to work for you. If not, little has been lost. And if 
the treatment does work, then the financial cost, and the 
small, largely theoretical risk of serious side effects, may 
be worth accepting.

References

1. Saint-Marc T, Sellem C, Rosello L, and Touraine JL. 
Treatment of chronic diarrhea with Saccharomyces boulardii. 
Sixth International Conference on AIDS, San Francisco, June 
20-24, 1990 [abstract #Th.B.363].

2. Saint-Marc T, Rossello-Prats L, and Touraine JL. 
Efficacite de Saccharomyces boulardii dans le traitement des 
diarrhees du SIDA. ANNALES DE MEDECINE INTERNE. 1991; volume 
142, number 1, pages 64-65.

3. Blehaut H, Saint-Marc T, and Touraine JL. Double blind 
trial of Saccharomyces boulardii in AIDS related diarrhea. 
Submitted to the Eighth International Conference on AIDS, 
Amsterdam, 1992, but not published in the conference 
abstracts.

4. Born P, Lersch C, Zimmerhackl B, and Classen M. 
Saccharomyces-boulardii therapie HIV-assoziierter durchfalle. 
DTSCH. MED. WOCHENSCHR. 1993; volume 118, number 20, page 
765.

5. McFarland LV and Bernasconi P. Saccharomyces boulardii: A 
Review of an Innovative Biotherapeutic Agent. MICROBIAL 
ECOLOGY IN HEALTH AND DISEASE. 1993; volume 6, pages 157-171.

6. Adam J, Barret A, Barret-Bellet C, and others. Essais 
cliniques controles en double insu de l'ultra-levure 
lyophilisee. Etude multicentrique par 25 medecins de 388 cas. 
GAZETTE MEDICALE DE FRANCE. 1977; volume 84, pages 2072-2078.

7. Surawicz CM, Elmer GW, Speelman P, McFarland LV, Chinn J, 
and Van Belle G. Prevention of antibiotic-associated diarrhea 
by Saccharomyces boulardii: a prospective study. 
GASTROENTEROLOGY. 1989; volume 96, pages 981-988.

8. McFarland LV, Surawicz CM, Greenberg RN, and others. 
Prevention of beta-lactam-associated diarrhea by 
Saccharomyces boulardii compared with placebo. THE AMERICAN 
JOURNAL OF GASTROENTEROLOGY. 1995; volume 90, number 3, pages 
439-448.

9. Tempe JD, Steidel AL, Blehaut H, Hasselmann M, Lutun PH, 
and Maurier F. Prevention par Saccharomyces boulardii des 
diarrhees de l'alimentation enterale a debit continu. LA 
SEMAINE DES HOPITAUX DE PARIS. 1983; volume 59, pages 1409-
1412.

10. Schlotterer M, Bernasconi P, Lebreton F, and Wassermann 
D. Interet de Saccharomyces boulardii dans la tolerance 
digestive de la nutrition enteral a debit continu chez le 
brule. NUTRITION CLINIQUE ET METABOLISME. 1987; volume 1, 
pages 31-34.

11. McFarland LV, Surawicz CM, Greenberg RN, and others. A 
randomized placebo-controlled trial of Saccharomyces 
boulardii in combination with standard antibiotics for 
Clostridium difficile disease. JAMA. 1994; volume 271, number 
24, pages 1913-1918.

12. Plein K, and Holtz J. Therapeutic effects of 
Saccharomyces boulardii on mild residual symptoms in a stable 
phase of Crohn's disease with special respect to chronic 
diarrhea -- a pilot study. Z. GASTROENTEROL. (Germany). 1993; 
volume 31, number 2, pages 129-134.

13. Kollaritsch H, Holst H, Grobara P, and Wiedermann G. 
Prevention of traveler's diarrhea with Saccharomyces 
boulardii. Results of a placebo controlled double-blind 
study. [English translation of the title.] FORTSCHR MED. 
1993; volume 111, number 9, pages 152-156.

14. Chapoy P. Traitement des diarrhees aigues infantiles: 
essai controle de Saccharomyces boulardii. ANNALES DE 
PEDIATRIE 1985; volume 32, pages 561-563.

15. Cetina-Sauri G and Basto GS. Evaluacion terapeutica de 
Saccharomyces boulardii en ninos con diarrea aguda. TRIBUNA 
MEDICA. 1989; volume 56, pages 111-115.

16. Hochter W, Chase D, and Hagenhoff G. Saccharomyces 
boulardii bei akuter erwachsenendiarrhoe. MUNCHENER 
MEDIZINISCHE WOCHENSCHRIFT. 1990; volume 132, pages 188-192.


***** When Treatments Go Untried

by Denny Smith

The HIV pandemic is fourteen years along, affecting at least 
that many millions of lives, with no certain end in sight. 
New treatments are winding their way through laboratory 
studies and clinical trials, but not at a pace that reassures 
people who now have AIDS. For many, it is a situation defined 
by anxiety.

Yet long-time observers have seen some true progress in HIV 
research and clinical care. Four antiretrovirals are 
available in developed countries. Though certainly inadequate 
in the long run, they can at the least delay HIV progression 
for many people, especially when used in combinations. And 
almost every opportunistic illness can be controlled to some 
degree with one or more treatments. Moreover, significant 
progress has been made in the treatment of wasting, and 
dementia is finally receiving the sort of attention that 
could make a difference in outcome.

But we are concerned that potential treatments often lie idle 
on pharmacy shelves, that useful treatment strategies are 
languishing on the printed page, and that for many people the 
hard-won progress in research and care generally is being 
squandered. This impression grows out of years of 
conversations with readers of AIDS TREATMENT NEWS, with 
activists and physician friends, and with people who care for 
someone with HIV.

Why do potentially valuable treatments go untried? Lack of 
availability is the simple answer for millions of people, 
especially in developing countries. Where availability is not 
the problem, however, lack of motivation often is. Following 
are the most common problems, in our view, and some potential 
remedies. Some of the problems are nearly solved simply by 
being acknowledged.

* Insufficient information

An enormous percentage of treatment decisions seem to be made 
with only a limited number of options on the table.

For example, one reader told us that his doctor had no 
treatment for a KS lesion on his eyelid that had grown so 
much that his vision was impaired. Other lesions had 
responded well to radiation, but his doctor said that 
radiation would be dangerous focused directly toward the eye. 
However, we had heard that a small lead shield could be 
placed between the eye and the lid during radiotherapy. He 
brought that information to his doctor and was successfully 
treated within a few weeks.

Only coincidence and timing brought that information from an 
unrelated treatment setting to AIDS TREATMENT NEWS and 
through the patient back to his doctor. How could the process 
be more dependable?

When faced with an apparent treatment dead-end, the physician 
and the patient should consider whether all options have been 
uncovered. The first resort could be a literature search 
which calls up all relevant journal abstracts for the last 
several years. Next, community news sources should be 
surveyed, because a lot of potential treatments are tried in 
the community before they attract well-funded research 
backing. At some point, a specialist with HIV experience 
should be consulted. Our friend's doctor had effectively 
treated KS before, but only a radiation oncologist would be 
likely to know about seldom-used techniques like the lead 
shield.

* Acceptance of the "terminal" prognosis

Many people, including some who should know better, continue 
to regard HIV infection as a terminal condition, rather than 
a chronic, life-threatening disease. The distinction is 
important for shaping public policy. But there are also 
scientific reasons for dumping the word "terminal."

(1) According to data from the San Francisco Clinic Study, 
which has tracked long-term HIV infection in hundreds of gay 
men, among people who have been infected for ten to 16 years, 
6.9% continue to have CD4 counts above 500; another 8.7% have 
counts below 500 but above 200. No one can dismiss the 
possibility that many of them will fulfill their natural life 
expectancy. (2) For people with declining CD4 counts, the 
antiretroviral drugs now on the market can delay the 
progression to opportunistic illnesses for months or years. 
(3) New treatments for opportunistic illnesses can extend 
lives well beyond the first symptoms of AIDS. 

Beyond inaccuracy, the "terminal" label can itself be life-
threatening, since a choice of words implies a choice of 
action. The word "terminal" fosters a sense of resignation 
for both the patient and provider, such that when a health 
crisis presents itself, neither party is motivated to pursue 
more than the minimal, most conservative diagnostic work-up 
and treatment. It is an approach that certainly simplifies 
life but, almost as certainly, shortens it. One does not get 
more than what one settles for.

* Disinterested health care providers

Too many people with HIV are finding themselves under the 
care of physicians who are simply unenthused about HIV 
medicine. Sometimes there is little choice in the matter for 
the patient; for reasons of geography, or health-care 
coverage, they cannot easily switch doctors. Nor is it a 
choice of every physician to assume the responsibility of 
managing an unpredictable, complex disease for which 
treatment recommendations are constantly changing.

Yet that is the situation faced half-willingly by physicians 
and patients who meet each other in one of two contexts: 
health-maintenance organizations (HMOs) and teaching 
institutions.

HMO subscribers are limited to seeing only physicians who 
participate in that health plan. Within this limit, 
fortunately, it is often possible to find a good, 
collaborative "match."

But people who do not have private insurance in the U.S. 
often get their care in teaching institutions, where they are 
followed by young interns who rotate through various clinical 
situations as part of an extended residency program. Such 
teaching programs are an important vehicle for taking medical 
students from school into the real world of patients. But 
they are also a great money-saver for large institutions, 
which would otherwise have to pay enormous salaries to more 
experienced physicians.

The interns can be caring and attentive and are sometimes 
more willing than older, established physicians to try 
innovative treatment approaches. But they are just as often 
exhausted and hurried and prone to inappropriate assessments. 
It is a system that can only guarantee minimal HIV training 
to a new doctor and minimal health care to their patients. 

Moreover, many people who get their care in teaching 
institutions come from trying or troubled social settings, 
and they tend to delay health care until the need is acute. 
And so, in many instances, individuals with the most urgent 
personal concern are tracked into a health-care setting with 
the least eager professional concern.

One solution would be to exempt interns and residents from 
patient care that they truly are unprepared for. Another, 
parallel, solution is the HIV-focused clinic, where the care 
is largely provided by experienced physicians, with some 
uncomplicated patients managed by residents genuinely 
interested in HIV medicine. 

HIV infection should not, in our opinion, be considered just 
another responsibility of general internal medicine. It 
presents too many complexities that cross over many medical 
disciplines, including immunology, hematology, dermatology, 
infectious disease, gastroenterology, oncology, psychiatry 
and neurology. HIV medicine warrants a distinct setting of 
expertise, where each patient receives individualized care.

* Hyper-cautious providers

There are other health care providers who are both informed 
about HIV and interested in treating it, but who adhere to an 
oppressively conservative clinical approach.

What may be a well-worn strategy in some disease models can 
be ill-applied to HIV. Diabetes, hypertension, heart disease 
or liver disease usually have well-understood causes and 
prognoses. They may best be managed with behavioral changes 
and cautious observation. But other health crises, like 
cancer and HIV disease, are fundamentally different. Caution 
and behavioral counseling may prevent them but will not treat 
them. Exam room philosophies like "watchful waiting," "if it 
ain't broke...," and "do no harm" can have a legitimate 
place, but miss the mark in contexts where progress has been 
achieved with innovative, aggressive intervention.

One example of excessive caution is the unwillingness to 
prescribe drugs off-label. Off-label refers to the use of an 
FDA-approved drug for a purpose that was not part of the 
original treatment indication, or "labeling." All physicians 
have the professional discretion to prescribe any drug off-
label, and many drugs have been found to be invaluable for 
new uses, such as mexiletine for neuropathy. To adhere 
arbitrarily to the original labeling can deprive patients of 
the treatment they need. This is an ethical, not a 
regulatory, problem.

Another example of misplaced caution is the avoidance of 
anecdotal or empirical evidence of treatments. A number of 
indispensable HIV therapies started out as anecdotal reports 
from physicians and patients who pioneered new treatment 
approaches out of necessity. In many HIV-related situations, 
there is no established treatment or the established 
treatment just does not work for everyone. Today's anecdotal 
report may be tomorrow's treatment.

* The artificial polarity between "conventional" and 
"alternative" treatments

The U.S. has a large and vital alternative health culture. 
Depending on how the word 'alternative' is defined, this 
culture may encompass holistic or naturopathic medicine, 
Chinese medicine and acupuncture, nutritional 
supplementation, homeopathy, herbal medicine, chiropractic, 
and other forms of treatment.

Unfortunately, alternative therapies are not taken very 
seriously by many traditional physicians; and allopathic, or 
conventional, "Western" medicine is often posed in the 
community as the "other," a mercenary devil, the problem for 
which alternatives exist. There is on both sides a propensity 
toward unreasonable exclusion of the other.

The most productive approach would probably integrate 
everything that works, with an eye toward dropping the 
distinctions of alternative vs. conventional. If a treatment 
works when nothing else has, what about it is "alternative"? 
This idea was well presented in the following excerpt from a 
manifesto by the New York activist Jon Greenberg, who died of 
AIDS in 1993.

"The AIDS community tends to fall into two separate camps 
regarding alternative therapies. Some dismiss all alternative 
treatments, regardless of evidence demonstrating efficacy, 
and others defend all alternative treatments, regardless of 
evidence demonstrating toxicity or lack of efficacy. The 
reality of most alternative therapies probably lies somewhere 
between these two extremes . . . The goal of alternative 
treatment activists is to advocate for controlled clinical 
trials of alternative treatments, so that approval and 
acceptance can be gained for those treatments which are found 
to be effective. Our goal is to make the term 'alternative' 
obsolete."

* Over-eager concerns about expense

We have met physicians who hesitate to use a potentially 
valuable treatment if they think it is very expensive or will 
not be reimbursed by the insurer. This is partly a symptom of 
the inefficient, commerce-driven system of healthcare in the 
United States. Doctors are forced to spend inordinate amounts 
of time worrying about money instead of medicine.

At least some of the concern, however, may be inflated. We 
know of instances in which a treatment was avoided by 
physicians who assumed the cost could not be covered by the 
insurance company, when in fact the same treatment had been 
covered by that insurer when prescribed with convincing 
documentation by other physicians.

Furthermore, many pharmaceutical companies have assistance 
programs for patients who are underinsured. No treatment 
should be automatically considered out of reach.

* The culture of rumor consumers

Many people will not take the approved antiretrovirals-AZT, 
ddI, ddC, and d4T-because they heard the drugs do not work, 
or even that they are "poison." The truth, less dramatic but 
widely accepted, is that these drugs can inhibit HIV 
progression to some limited degree, and also can cause some 
side effects. But ever since it became clear the drugs were 
not the final answer, and that not everyone has the same 
experience with each drug, a subculture of misinformation has 
been simmering.

This subculture is characterized by inconsistency. Some 
people who absolutely refuse to try AZT are inexplicably open 
to the other nucleosides (some of which have potentially more 
serious toxicities). Others will not use any nucleoside 
analog whatsoever but are famous for tying up community 
hotlines each time the words 'AIDS' and 'treatment' appear in 
a television newscast.

No one should be faulted for having legitimate qualms about 
drug toxicities, or a legitimate interest in new research 
developments. But mainstream news sources rarely get a story 
straight, and someone who will not consider a reasoned 
treatment approach from their doctor is ill-prepared to 
interpret a patchwork story from an evening newsmagazine.

The community-generated news media, where the stakes are more 
personal than mercantile, can be a more dependable source of 
HIV news, but can also display more subjectivity than 
objectivity. Some community news sources have allowed very 
irresponsible opinions to be set forth as newsworthy. These 
include the discredited idea that HIV is harmless, the claims 
that AZT is a prohibitively toxic drug with no redeeming 
benefit, and the advice that everyone can or should manage 
AIDS exclusively through non-medical therapies.

There is a disingenuous approach to medical news throughout 
the larger culture that is fueled by a contemporary anti-
science trend in America and that has unfortunately found 
some friends in HIV treatment circles. Mostly this trend just 
obstructs a presentation of the news in its entirety. But at 
its worst, anti-science thrives on promotions which tug 
selectively at people's cynicism: HIV is the product of a 
government plot and pharmaceutical drugs are an extension of 
this plot, or AIDS is simply an imbalance of oxygen or energy 
in the body, or the U.S. research establishment can't be 
trusted but a clinic in Switzerland or Kenya or Mexico has a 
cure. Promotions, or evasions, like these are not always 
mistruths so much as manipulated bits of the larger truth.

Anti-science often shares company with the superstitions of 
right-wing ideology, including creationism, anti-
environmentalism, and the demonization of homosexuals. All 
anti-science ideology endangers the fight against AIDS in one 
way or another. Not the least of these are the paranoias 
keeping some people from medical therapies that could extend 
the length and quality of their lives.

* * *

Running through all of these problems is the lack of a 
widely-accepted, coherent treatment strategy for HIV. Piece-
meal management by conflicting agendas does not serve the 
AIDS community well. The problems above should be solved with 
long-term strategies that anticipate and not merely react to 
crises, strategies that are generated together by people with 
HIV and the health professions.


***** Gallo Starts Major AIDS Research Institute in Baltimore

by John S. James

Leading AIDS scientist Robert Gallo, M.D. is leaving 
government service after 30 years at the U.S. National Cancer 
Institute, to start the Institute of Human Virology, which 
will be part of the University of Maryland system. The new 
Institute will focus on AIDS, but will also do research in 
other human viral diseases, and in cancer.

The Institute is being started with over $16 million in 
funding from the state of Maryland, the University of 
Maryland, the city of Baltimore, and other sources. It will 
begin operations this fall with a staff of 50; Dr. Gallo 
hopes it will eventually grow to have a staff of about 250 
and an annual budget of $30 million.

Dr. Gallo told AIDS TREATMENT NEWS that the Institute will 
focus on basic research, primarily to develop better 
therapies. Specific areas include gene therapy, antisense, 
looking for treatments which target cellular factors which do 
not mutate as rapidly as the virus (e.g. hydroxyurea), and 
hormonal control (e.g. HCG, the hormone found at high levels 
in pregnant women which may help to control Kaposi's 
sarcoma). Other research will involve manipulation of 
cytokines to treat HIV. An immediate goal is to "hit the 
ground running" with a focus on KS.

Dr. Gallo noted the calls for virology research centers near 
rain forests, to watch for emerging viruses. He said we also 
need centers elsewhere which are immediately ready to study 
viruses which break through, as AIDS did.

Dr. Gallo will be program director for basic research. He 
will share leadership with two other program directors, 
William Blattner, M.D., in epidemiology, and Robert Redfield, 
M.D. in clinical research. Dr. Gallo believes this is the 
first AIDS research institute to combine basic research, 
clinical research, and epidemiology -- which will allow, for 
example, the development of a cohort of well-studied patients 
who can volunteer for trials of new therapies which are 
particularly appropriate for them. Gallo also hopes to start 
a biotechnology company, to be called Virex, which will allow 
new discoveries to move immediately into drug development, 
without waiting until business executives elsewhere get 
interested.

The Institute is also beginning collaborations with leading 
private and government research centers in the U.S., in 
Europe, and in Asia. It is setting up an ultra-modern 
telecommunications system, with the help of one of the 
founders of CSPAN.

Dr. Gallo praised Parris N. Glendening, Governor of Maryland, 
whose brother died of AIDS last year. Governor Glendening, 
who formerly taught at the University of Maryland, has been 
personally involved in negotiations for the Institute for the 
last six months.

Comment

Dr. Gallo has been one of the most productive AIDS 
scientists. At the National Cancer Institute he was hampered 
by lack of a clinical partner, problems with technology 
transfer, government rules which are becoming increasingly 
burdensome despite activists' work, and repeated 
investigations resulting from years'-long demonization by the 
CHICAGO TRIBUNE and by the office of Congressman John Dingell 
(Democrat, Michigan). The new Institute should allow more 
effective focus on the task at hand of finding better 
treatments for AIDS.


***** Lymphoma: New TAG Report

The Treatment Action Group (TAG) has published a 64-page 
booklet on the current status of AIDS-related lymphoma. THE 
LYMPHOMA PROJECT REPORT: CURRENT ISSUES IN RESEARCH AND 
TREATMENT OF AIDS-ASSOCIATED LYMPHOMA, by Michael Marco, with 
an introduction by Lawrence D. Kaplan, M.D., is based on 
interviews with dozens of experts.

Lymphoma, of which there are several kinds, is a cancer of 
the lymphatic system which occurs in HIV-negative as well as 
HIV-positive persons; it is much more common in persons with 
immune deficiency (whether caused by HIV, by drugs to prevent 
rejection of organ transplants, or by other causes) than in 
the general population. Lymphoma occurs in about five to ten 
percent of persons with HIV, often after AIDS has been 
diagnosed (although it is the first AIDS-defining illness in 
about three percent of persons with AIDS). While it can occur 
at any CD4 (T-helper) count, the risk is greater when the 
count is low. However, the length of time one is HIV infected 
may be a more important risk factor than the degree of immune 
suppression; for this reason, the number of cases of lymphoma 
is increasing since people with HIV are now living longer 
than before. Unlike Kaposi's sarcoma, which occurs mainly in 
gay men, lymphoma occurs about equally in all HIV risk 
groups; for unknown reasons, white men are at a slightly 
higher risk than others.

Sometimes lymphoma is found in a single rapidly-swelling 
lymph node; in other cases there is no specific sign, and the 
disease is difficult to diagnose.

Lymphoma can be cured in many cases, with chemotherapy, 
radiation, or other treatments. But it still remains a major 
life-threatening condition, with many people living less than 
a year after diagnosis.

The TAG booklet, first released May 1995 at the 31st Annual 
Meeting of the American Society of Clinical Oncology, looks 
at all aspects of AIDS-related lymphoma, including 
conventional and experimental treatments. It includes 23 
recommendations, mainly for improving future research. The 
writing is fairly technical, about at a medical-student 
reading level.

THE LYMPHOMA PROJECT REPORT is available for $10 from 
Treatment Action Group, 200 East 10th Street #601, New York, 
NY 10003. It is available free of charge to people living 
with HIV disease who cannot afford to pay: call TAG at 
212/873-9044.


***** Chinese Medicine: Where Does It Work Best in HIV/AIDS?

In San Francisco, where Chinese medical treatment has been 
funded for three years by the Ryan White CARE Act, the 
American College of Traditional Chinese Medicine has treated 
over 300 symptomatic HIV-positive patients in long-term care. 
A study of the medical records of these patients, and of 
quarterly health surveys, has identified seven HIV-related 
conditions which appear to be most responsive to Chinese 
medicine.

These seven conditions are: weight loss; diarrhea/loose 
stools; abdominal pain; nausea; headaches; enlarged lymph 
nodes; and neuropathy.

Note: The American College of Traditional and Chinese 
Medicine can be reached at 415/282-9603.

Reimbursement Issues

After many years of refusing to pay for "alternative" care 
such as traditional Chinese medicine, the trend today is 
toward coverage by insurers and other third-party payers. The 
reason is that alternative care usually costs much less than 
Western medicine, and companies can save money by paying for 
it.

In San Francisco, acupuncture was covered under the health 
plan for city employees for several years, but was 
discontinued last year due to a budget shortage. It has now 
been restored effective July 1. But the San Francisco plan 
has only covered acupuncture; other parts of traditional 
Chinese medicine, such as herbal treatment, have had to be 
paid by the individual. There is now a movement to expand 
coverage for San Francisco employees, and for others; San 
Francisco supervisor Angela Alioto has been very supportive.

The state of California has licensed acupuncturists for many 
years. (The law also allows medical doctors to practice 
acupuncture, regardless of whether they have been licensed or 
trained to do so.) California law requires health insurance 
companies which have their home office in California, and 
which are not HMOs or PPOs, to cover acupuncture treatment. 
Many of these companies, however, have ignored the law and 
refused to do so.

For information on how you can help to expand health-care 
coverage for traditional Chinese medicine in San Francisco 
and in California, call George Wedemeyer at 415/661-2080.



***** AIDS TREATMENT NEWS
      Published twice monthly

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Editor and Publisher:
   John S. James
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Statement of Purpose:
AIDS TREATMENT NEWS reports on experimental and 
standard treatments, especially those available now. We 
interview physicians, scientists, other health 
professionals, and persons with AIDS or HIV; we also 
collect information from meetings and conferences, 
medical journals, and computer databases. Long-term 
survivors have usually tried many different treatments, 
and found combinations which work for them. AIDS 
Treatment News does not recommend particular 
therapies, but seeks to increase the options available.

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ISSN # 1052-4207 

Copyright 1995 by John S. James.  Permission granted for 
noncommercial reproduction, provided that our address 
and phone number are included if more than short 
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