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AIDS TREATMENT NEWS Issue #214, January 6, 1995
   phone 800/TREAT-1-2, or 415/255-0588

CONTENTS:

Oral Ganciclovir Approved

FDA Advisory Committees Meet January 26 on Salk HIV-1 
Immunogen

Women and AIDS -- Unexplained Higher Risk of Death

Some Vitamins Associated with Decreased Risk of AIDS and 
Death

1995: Politics

1995: Business

AIDS-Related Research Meetings, January and February 1995


***** Oral Ganciclovir Approved

On January 5, Syntex (a Palo Alto, California pharmaceutical 
company recently acquired by Hoffmann-La Roche) announced 
that the U.S. Food and Drug Administration had approved oral 
ganciclovir for marketing.

Ganciclovir (Cytovene() has long been an approved drug widely 
used for treating CMV retinitis, which if untreated causes 
blindness in persons with advanced AIDS. A major disadvantage 
of ganciclovir has been that it had to be given intravenously 
every day. In addition to the expense and inconvenience, the 
intravenous administration can increase certain side effects, 
including serious infections.

Treatment with ganciclovir involves two stages: induction 
therapy (usually twice-daily intravenous infusions for two to 
three weeks), followed by maintenance therapy, usually one 
infusion per day. Eventually the maintenance therapy is 
likely to fail; then the induction may be repeated, or the 
patient may be treated with another intravenous drug, 
foscarnet.

The newly-approved oral drug can be used for maintenance in 
some patients; however, intravenous treatment is still 
necessary for induction. 

Maintenance with the oral drug is somewhat less effective 
than with the intravenous; in clinical trials, the average 
time to disease progression was five to twelve days faster 
with the oral drug. Therefore the FDA indicated oral 
ganciclovir only for those "for whom the risk of more rapid 
disease progression is balanced by the benefit associated 
with avoiding daily IV infusions." And many of the side 
effects of intravenous ganciclovir are still present with the 
oral drug, especially hematological toxicities; therefore 
blood tests are necessary with the oral as with the 
intravenous treatment.

Oral ganciclovir is taken either three times a day or six 
times a day, with food.


***** FDA Advisory Committees Meet January 26 on Salk HIV-1 
      Immunogen

On January 26, two advisory committees of the FDA (the 
Antiviral Drugs Advisory Committee, which considers most AIDS 
drugs, and the Vaccines and Related Biological Products 
Advisory Committee) will meet jointly to consider future 
clinical trials of the HIV-1 Immunogen, a potential AIDS 
treatment developed by Jonas Salk, M.D.

The Immune Response Corporation (IRC), of Carlsbad, 
California, has already conducted a number of clinical trials 
of the immunogen; 235 patients have received it in clinical 
trials since 1987, with no drug-related serious adverse 
events and no patients dropping out of trials due to adverse 
events. Now IRC plans to run three larger trials, involving a 
total of almost 5,000 volunteers. These trials, which will 
last from two to four years, will test the treatment in three 
groups of patients: those with T-helper count under 300, 
those with 300-549, and those with 550 and above.

The HIV Immunogen is made with killed HIV, much like killed-
virus vaccines for other diseases. The current and proposed 
trials are not testing it as a preventive vaccine, however, 
but as a treatment for existing HIV infection. Previous 
trials have shown evidence of improvement in various 
immunological and other blood tests; however, they have not 
been large enough to show conclusively that the treatment has 
clinical benefit in delaying disease progression. The new 
studies are intended to determine that, and also to validate 
the use of blood-test "markers" of disease progression for 
studying an immune-based treatment such as the immunogen.

Volunteers in the previous trials have shown much interest in 
continuing their treatment. Those in California have long 
been able to do so (due to California approval by the state's 
Food and Drug Branch), but those in other states have not. 
The FDA has already approved a continuation protocol, which 
applies to volunteers in all states, but supplies of the 
Immunogen have been limited due to manufacturing issues which 
are currently being overcome.

The joint meeting will be held at the Holiday Inn, Bethesda, 
Maryland, Versailles Ballrooms I through III, starting at 8 
a.m. The first session, from 8:00 a.m. to 10:45 a.m. on 
January 26, will be closed to the public, apparently to deal 
with manufacturing issues; the rest of the meeting is 
expected to be open to the public, with a public hearing from 
10:45 to 11:30; persons wishing to speak should make 
arrangements in advance, if possible before January 19. 
[Note: the advisory committee meeting will continue on 
January 27, to deal with other matters.]

For more information, contact Judy Rappaport, Salk Immunogen 
Working Group of ACT UP/Philadelphia, 215/972-1454.


***** Women and AIDS -- Unexplained Higher Risk of Death

A study of 768 women and 3779 men with HIV found that the 
women had a one-third higher risk of death then the men -- 
and yet no higher risk of progressing to AIDS -- after 
statistical adjustment for stage of illness. The cause of the 
difference is unknown.

The study was conducted by the Terry Beirn Community Programs 
for Clinical Research on AIDS (CPCRA), through analysis of 
the records of volunteers already enrolled in existing CPCRA 
studies. In this way, it studied the largest cohort of women 
with HIV yet reported. It did find gender differences in 
opportunistic infections and conditions (for example, about a 
one-third higher risk of bacterial pneumonia in women, and a 
much-lower risk of Kaposi's sarcoma, which occurred in only 
two women). But these differences could not explain the 
overall survival and disease-progression results.

The researchers also found that, "Among patients without a 
history of disease progression at entry, death was the first 
event reported for more women than men (27.5% vs. 12.2%)."

The researchers could not offer a definitive reason for 
poorer survival of women, but suggested looking at 
differences in access to healthcare, and at effects of "lower 
socioeconomic status, homelessness, domestic violence, 
substance abuse, and lack of social support."

The study was published in JAMA (JOURNAL OF THE AMERICAN 
MEDICAL ASSOCIATION), December 28, 1994.

Comment

This important study raises questions it does not answer. Why 
do women have an overall increased risk of death, yet no 
increased risk of progression to AIDS? And why is death more 
often the first AIDS-defining event? These findings suggest 
problems with the 1987 definitions of AIDS-indicating events 
-- based almost entirely on the disease in men -- but that 
was not the conclusion of the study. One difficulty in 
interpreting the data is that the cause of death was often 
unknown.

Another mystery is that women had a considerably higher T-
helper count at entry -- a median of 240, vs. a median of 137 
for the men. This difference was not explained in the 
published paper. We would have expected a difference in the 
opposite direction, since women often receive worse health 
care than men, due to economic reasons, and are often not 
diagnosed with HIV until a later stage of the illness.

AIDS in women has increased more than 20 times since 1981; it 
is now one of the five leading causes of death among women 
aged 25 to 44 nationally, and the leading cause of death in 
that age group in New York City.


***** Some Vitamins Associated with Decreased Risk of AIDS 
      and Death

by John S. James

In December 1993, researchers at Johns Hopkins University 
published results from a study (funded by the U.S. National 
Institutes of Health) of 280 volunteers, who were studied for 
an average followup of 6.8 years, which found that dietary 
intake of certain vitamins was associated with substantially 
reduced risk of progression to AIDS.(1) In the second half of 
1994, they reported on the association of the same 
micronutrients with survival, in posters presented at the 
International Conference on AIDS (Yokohama, August 1994)(2) 
and at the annual meeting of the American Public Health 
Association (Washington, October-November 1994).(3) Both 
results are important because the differences are large; for 
certain micronutrients, persons who used appropriate amounts 
had as little as half the risk of progression to AIDS -- and 
half the risk of dying -- compared to others who used too 
little (or, in some cases, too much).

These results must be interpreted with caution, for several 
reasons:

 (1) First, they are not from clinical trials which randomly 
assign people to take particular treatments or foods. 
Instead, they are from an observational study which asked 
people what they were eating and what supplements they were 
taking, then followed up to see how well they did during the 
following years. This kind of study can only show an 
association -- it cannot prove a cause and effect 
relationship -- between the nutrient and the result.

In particular, the nutrients studied were in large part 
obtained from foods, which also contains many other 
substances which were not looked at in this research. 
Therefore, it is not certain that taking supplements of the 
individual nutrients alone would automatically provide the 
same advantage.

(2) Also, the food questionnaire was given at the beginning 
of the study, in 1984, and that data was used throughout; if 
people changed their dietary habits or use of supplements 
over the years, the change was not considered. (Random 
changes in food intake or supplement use would tend to reduce 
the differences found in this study, however, not to increase 
them. Therefore, we do not think that such changes in food 
usage could be used to argue that the results of the study 
are not real.) Note: the food questionnaire was repeated on 
certain later visits, but the newer food data has not yet 
been analyzed

(3) A third reason for caution is that people might 
misinterpret the results of the Johns Hopkins study and take 
megadoses of certain vitamins. Not only could this be 
dangerous, it is also unnecessary, since the improved 
outcomes seen in this study were associated with modest 
doses.

Despite these cautions, the findings on micronutrients and 
AIDS progression urgently need more attention. We may not 
have fundamentally better information for many years, since 
conclusive proof might require clinical trials with survival 
or AIDS-progression endpoints, which would take years to run; 
it is possible that such trials will never be conducted, due 
to increasing uncertainty of government financial support, 
and lack of pharmaceutical interest in research which does 
not sell a product. Meanwhile, failure to consider safe, 
simple strategies which might reduce the risk of AIDS and of 
death by 40 to 50 percent or more would be tragic.

The Johns Hopkins study is similar in some ways to a major 
San Francisco study of micronutrients and AIDS,(4) which was 
reported in 1993 (see summary in AIDS TREATMENT NEWS #181, 
August 20, 1993). This study also reported that higher intake 
of certain nutrients may delay the development of AIDS.

The Zinc Controversy

There is much disagreement and confusion among experts as to 
whether zinc supplements may be harmful or helpful for 
persons with HIV (or possibly harmful in some cases and 
helpful in others). The Johns Hopkins data suggests that even 
small amounts of zinc -- close to the U.S. Recommended Daily 
Allowance of 15 mg -- might be harmful. The researchers did 
not suggest a possible mechanism.

But many other nutrition experts are skeptical. They cite 
other studies which found different results -- or which found 
widespread zinc deficiencies in people with HIV, deficiencies 
which might interfere with immune functioning.

In this article on the Johns Hopkins results, we will report 
the findings for zinc along with the other findings, but 
leave our analysis for later. We may report about zinc in a 
separate article, based on interviews with experts. However, 
we suspect that clinical trials might be necessary for 
resolving this important issue and making an appropriate 
nutritional recommendation -- trials which may never be done. 
(One trial we would like to see, which could be run quickly 
and inexpensively, would be to see if viral load changes when 
people with HIV start using zinc supplements.)

In any event, the confusion about zinc should not distract 
from the other study results.

Background: The Study Methodology

The Johns Hopkins data on micronutrients and AIDS progression 
came from about 280 patients who enrolled in a major, ongoing 
national study -- the Multicenter AIDS Cohort Study (MACS), 
funded by the National Institute of Allergy and Infectious 
Diseases (NIAID). This study enrolled about 5,000 gay men 
(both HIV positive and HIV negative) by early 1985, and 
conducts followup visits every six months for blood tests, 
physical examinations, and interviews. The 5,000 volunteers 
are in four cohorts, in Baltimore, Chicago, Los Angeles, and 
Pittsburgh.

The Baltimore cohort has over 1,000 men, but only those who 
were HIV positive at their first (baseline) visit, and 
completed an extensive food questionnaire on their second 
visit, were included. (Also, anyone who had AIDS by their 
third visit -- a year after they entered the study -- was 
excluded. The reason for this is that the researchers wanted 
to learn how diet influenced the progression of early HIV 
disease. They did not want their results to be complicated by 
changes in diet that people may have made as a result of 
their illness.)

Micronutrient data was obtained by asking the men what 
supplements (vitamin pills, etc.) they used, and also by a 
food questionnaire. The questionnaire listed 116 foods, and 
asked participants to rate how often they ate each (choosing 
one of nine categories from "Never, or less than once per 
month" to "6+ per day") on the average over the last year. 
Then special software developed for use with this 
questionnaire estimated the total amount of each nutrient in 
the diet, based on those answers.

For each nutrient, data was analyzed by grouping the 
volunteers into four equal groups based on their total intake 
of that nutrient (both from foods and from supplements). 
Usually the top "quartile" (the 25 percent of the volunteers 
who used the most of the particular nutrient) was compared 
with the other three quartiles averaged together. But vitamin 
A/beta carotene was handled differently, because it has shown 
a U-shaped curve in other studies, with those taking moderate 
amounts doing better than those taking either too much or too 
little; for vitamin A, therefore, the two middle quartiles 
were compared with the two extreme ones. And zinc was also 
handled differently, with each quartile being compared to the 
lowest, in order to show the dose response.

The differences in progression to AIDS, or in death, between 
high and low users of particular supplements was given as 
"relative hazard." For example, a relative hazard of 0.60 
means that one group had only 60 percent of the risk of the 
other group of progressing to AIDS (or death) within the time 
frame of the study (6.8 years or more).

All the results given below are statistically significant, 
unless otherwise stated. This means that it is unlikely that 
they would have occurred by chance alone.

We report the results in two separate sections, one on the 
risk of AIDS prevention, the other on survival.

Results: Risk of AIDS Progression

The work on micronutrients and AIDS progression was reported 
in a 14-page paper published a year ago.(1) The last 
paragraph summarized the findings:

"In summary, we have found that high intake of several 
nutrients (niacin, vitamin C, and vitamin B1) were associated 
with slower progression to AIDS, after adjustment for 
confounding variables. Vitamin A may have a U-shaped relation 
with risk of AIDS, and increasing zinc intake was associated 
with more rapid disease progression. These results need to be 
replicated before any firm conclusions can be drawn about 
their relevance to the natural history of HIV-1 infection."

We discuss some of the numbers below. Note that the nutrient 
amounts given in this article are NOT recommendations, for 
many reasons. One is that these figures for nutrient intake 
include both food and supplements, not supplements alone. 
Also, there is no adjustment for body weight, or for 
individual medical conditions. And the situation with vitamin 
A is more complex, because the amounts are given in 
international units of vitamin A, while in fact, the relation 
found was between beta carotene intake and AIDS (beta 
carotene is converted to vitamin A in the body, and is safer 
to take than vitamin A itself); no relation was found between 
vitamin A intake and AIDS. Professional assistance will be 
required to develop recommendations for individuals, or to 
prepare general guidelines, based on this micronutrient study 
and other information.

For vitamin C, the volunteers in the highest quartile had a 
relative hazard of 0.55 of progression to AIDS -- meaning 
that they were scarcely more than half as likely as those who 
used less vitamin C to progress during the study. Those in 
this upper quartile took 715 mg (0.715 grams) or more of 
vitamin C per day, in food and supplements combined.

For vitamin B1, those in the highest quartile had a relative 
hazard of 0.60 of progression to AIDS, compared to those who 
took less. Those in this quartile took greater than 4.9 mg of 
vitamin B1 per day, in food and supplements combined.

For niacin, those in the highest quartile had a relative 
hazard of 0.52. Those in this quartile took greater than 61 
mg of niacin per day total (in their food and supplements 
combined).

For vitamin A, those who did best were in the two middle 
quartiles, with total intake (mostly from beta carotene) from 
food and supplements combined being equivalent to between 
9,062 IU (international units) and 20,268 IU. Their relative 
hazard of progression to AIDS was 0.55, compared to the those 
in the lower quartile (who consumed less than 9,062 IU per 
day). The upper quartile (who consumed a total of more than 
20,268 IU) had a relative hazard of 0.94 (not statistically 
significant), compared to the lower quartile -- meaning that 
the risk of progression for these two groups was about equal.

For zinc, those in the highest quartile (consuming more than 
20.2 mg per day in food and supplements combined) had a 
relative hazard of 2.06 of progression to AIDS, compared to 
those in the lowest quartile (less than 11.7 mg per day). 
[This is a cause for concern in that the U.S. RDA is only 15 
mg per day -- and many, probably most, of the 
multivitamin/mineral pills in common use contain the 15 mg 
RDA. Yet taking only 20.2 mg of zinc per day, from food and 
supplements combined, was found to be associated with double 
the risk of progression to AIDS, compared to those who used 
less zinc.]

These particular numbers depended on how the statistics were 
analyzed. The numbers above were from the analysis which the 
researchers chose to use in their abstract. These numbers (a 
"single nutrient model") look at each nutrient alone, 
statistically adjusted for age, symptoms, T-helper count, 
lymphocyte count, energy intake, use of antiretrovirals, and 
use of pneumocystis prophylaxis. A different analysis -- 
which statistically adjusted with some of the nutrients 
together, not alone -- did not change the relative hazards 
much, except for zinc, where the relative hazard increased, 
from 2.06 to 2.97 for the highest quartile (those consuming 
over 20.2 mg per day).

Two other nutrients barely missed being statistically 
significant for risk of AIDS progression. They are vitamin B2 
(relative hazard 0.61, for those consuming more than 5.9 mg 
in food and supplements together, vs. those consuming less), 
vitamin B6 (relative hazard 0.60 for those consuming greater 
than 5.7 mg per day, vs. those consuming less then 2.0 mg). 
However, both of these were significant in the analysis of 
relative hazard of death, below.

Results: Survival

The full results on micronutrient intake and probability of 
survival have not yet been published. The most complete data 
made public so far was presented at a poster at the annual 
meeting of the American Public Health Association, October-
November 1994 in Washington. D.C.(3)

For beta carotene, the third quartile of intake was 
associated with increased survival (relative hazard of death, 
0.58), and increasing amounts of zinc were associated with 
poorer survival. After the data was statistically adjusted 
for beta carotene and zinc (as well as for age, symptoms, T-
helper count, lymphocyte count, energy intake, and 
treatment), the following were statistically significant: 
vitamin B1 (relative hazard 0.62), vitamin B2 (relative 
hazard 0.61), vitamin B6 (relative hazard 0.47), and niacin 
(relative hazard 0.59).

The above relative hazards relate to total intake of the 
nutrient, from both foods and supplements. If one looks at 
supplements alone, the results are sometimes different. Those 
who took vitamin B6 in supplements at more than twice the RDA 
had improved survival (relative hazard of death, 0.63). Any 
intake of zinc supplements was associated with poorer 
survival (relative hazard, 1.52, meaning that those who took 
zinc supplements had a .52 greater chance of dying; the 
median amount of zinc supplement taken was 15 mg per day, 
which is the same amount as the RDA). Use of vitamins B1 and 
B2 at five times the RDA or more was associated with better 
survival, but this result was not statistically significant. 
Information on niacin from supplements alone is not 
available, because the software did not break out this 
number. And while total vitamin C may have been associated 
with increased survival, no relationship was found between 
vitamin C from supplements alone and survival.

Comment

This observational study cannot prove that the supplements 
are causing the changes in progression to AIDS and in 
survival. To get definitive proof will require clinical 
trials -- a different large trial for each nutrient -- which, 
as we pointed out before, will take a long time, if they are 
done at all.

It might be possible to get some insights into what is 
happening by doing small, short, exploratory trials, which 
randomize patients to nutritional supplements and look at 
changes in viral load, T-cell subsets, tests of immune 
functioning, and other markers. If the results of these 
trials parallel the results of the observational study -- for 
example, if the optimal amount of vitamin A leads to 
improvement in the markers, while too much leads to worsening 
-- this would help to confirm the observational results, and 
open doors to further rapid testing of combinations of 
nutrients, and to the use of nutrients to enhance drug 
therapy. But no one knows in advance which markers, if any, 
would be appropriate, since we do not know the possible 
mechanisms of action of the various nutrients.

Still, the fact remains that certain safe, inexpensive 
nutrients may be associated with a greater long-term reduced 
progression of HIV disease, and improved survival, than that 
of any known anti-HIV drug. The key question, of course, is 
whether there is cause and effect -- whether improving 
nutrient level will improve disease outcome.

Or could it be that persons with HIV who tend to take certain 
levels of nutrients also tend to do better, for other 
reasons? Perhaps those who eat well and use reasonable levels 
of supplements also tend to have better access to health 
care, or take better care of their health in other ways. Or 
maybe those who are healthier anyway are more likely to eat 
well. If theories like these account for the associations 
found in the micronutrient study, then changing one's 
nutrient intakes to match those associated with favorable 
outcome might not be of any benefit.

But it seems unlikely that these theories could explain the 
results observed. How would they explain why some nutrients 
were associated with improvement in the study, while zinc was 
consistently and unexpectedly associated with worse outcome? 
How would they explain the U-shaped curve of the response to 
vitamin A/ beta carotene (also seen in other studies), where 
a moderate amount seemed to be better than either too much or 
too little?

We will be living with uncertainty about micronutrients and 
HIV disease for years to come. We need to make the best 
decisions possible now and at each future time, instead of 
waiting for perfect information. What we know now strongly 
suggests that rational strategies for improving micronutrient 
intake can improve disease outcome. And since the strategies 
suggested are generally quite safe, the cost of adopting them 
in error is far less than the cost of ignoring the strategies 
if, in fact, they do work.

For too long the micronutrient work outlined in this article 
has received little attention, partly because people are 
afraid to make nutritional recommendations, due to the 
possibility that they might be wrong. What we need now is for 
medical and scientific experts to examine all the information 
available, and develop guidelines (by consensus when 
possible) for use by physicians and patients.

For More Information on HIV and Nutrition

IMMUNE POWER, A COMPREHENSIVE TREATMENT PROGRAM FOR HIV: 
COMBINING HOLISTIC AND STANDARD MEDICAL THERAPIES INTO THE 
OPTIMAL TREATMENT PROGRAM OR HIV, by Jon D. Kaiser, M.D. 
(Saint Martin's Press, New York, 1993) It costs $18.95 in 
bookstores.

A new book which should be out this Spring is POSITIVELY 
WELL: LIVING WITH HIV AS A CHRONIC, MANAGEABLE, SURVIVABLE 
DISEASE, by Lark Lands (Irvington Publishers Inc., New York, 
1995). Copies can be ordered by calling 800/542-8102, 9-5 
Eastern time, to be shipped when the book is available.

References

1. Tang AM, Graham NMH, Kirby AJ, McCall LD, Willett WC, and 
Saah, AJ. Dietary micronutrient intake and risk of 
progression to acquired immunodeficiency syndrome (AIDS) in 
human immunodeficiency virus type 1 (HIV-1)-infected 
homosexual men. AMERICAN JOURNAL OF EPIDEMIOLOGY December 
1993; volume 138, number 11, pages 937-951.

2. Tang AM, Graham NMH, and Saah AJ. The effect of 
micronutrient intake on survival in HIV-1 Infection. Tenth 
International Conference on AIDS, Yokohama, August 7-12, 1994 
[abstract PB0894].

3. Tang AM, Graham NMH, and Saah AJ. The effect of 
micronutrient intake on survival time in HIV-infected gay and 
bisexual men. American Public Health Association 122nd Annual 
Meeting, Washington, DC, October 30 - November 3 [abstract 
book, page 2082].

4. Abrams B, Duncan D, and Hertz-Picciotto I. A prospective 
study of dietary intake and acquired immune deficiency 
syndrome in HIV-seropositive homosexual men. JOURNAL OF 
ACQUIRED IMMUNE DEFICIENCY SYNDROMES August 1993; volume 6, 
number 8, pages 949-958.


***** 1995: Politics

by John S. James

[Note: Each year AIDS TREATMENT NEWS publishes a list of 
treatments to watch during the coming year. Our list for 1995 
was not ready for this issue; it will probably appear in 
issue #215.]

As of this writing (January 6), it is too early to know what 
threats to AIDS research, care, and prevention will come from 
the new Republican-controlled Congress. A serious but little-
noticed concern is that Congress will spend the next six 
months debating and passing tax cuts, without telling people 
what programs will be cut to pay for them. Then, starting 
around July, programs will suddenly and hastily be cut before 
the new fiscal year which begins in October. Military 
programs, social security, and Medicare -- which are the most 
expensive -- will be spared because they have powerful 
constituencies, resulting in huge cuts elsewhere (including 
Medicaid, which unlike Medicare is only for persons with 
financial difficulties). Exactly where the cuts occur will 
depend on the strength of political constituencies, not on 
the national interest.

Under this scenario, the reauthorization of the Ryan White 
CARE Act -- a major priority of AIDS organizations -- could 
be relatively easy. But reauthorization is only one step in 
funding; money must also be appropriated later. We will need 
grassroots public support for both steps.

 On AIDS prevention, another concern is that funding from the 
U.S. Centers for Disease Control may be put into block grants 
to states; then states with conservative administrations may 
defund AIDS prevention because it is controversial. With 
block grants, state bureaucrats controlled by the governor 
and the legislature will make the decisions, eliminating the 
community involvement which has developed in Federal 
programs.

AIDS should be bipartisan, and there is talk that Washington 
AIDS organizations over the years have worked mainly with a 
few Democrats, and not built working relationships with other 
Democrats, or with moderate Republicans, and their staffs. 
(The new Congress could be helpful in some ways, such as 
reducing the vast, legally-required inefficiencies in drug 
development, allowing small companies to participate 
effectively.)

Both parties should remember a nationwide survey, published 
by the BOSTON GLOBE on June 17, 1990, page 1, which found 
that one American in five personally knew someone who had 
AIDS or was HIV positive; the survey questioned 1,000 adults 
chosen to be representative of the U.S. population. As far as 
we know, no similar survey has been done since, so we do not 
have more recent data. But the percentage is probably higher 
by now, because there are more cases, and also because there 
is more openness about AIDS, so the illness is less likely to 
be concealed.

[Incidentally, the same poll which showed that mass 
organizing in AIDS is possible also showed why it is 
necessary --the huge "compassion gap" depending on how people 
were infected. About 88 percent strongly agreed that people 
who got AIDS from a blood transfusion should be treated with 
compassion. But the figure fell to about 43 percent for those 
who got AIDS through a homosexual act, about 42 percent if 
through IV drug use, and about 45 percent if through sex with 
a drug user.]

Of these 50 million or more people who have a personal 
connection with the epidemic, a relative, friend, or 
acquaintance whose life is at risk, probably far fewer than 
one percent have ever contacted their representatives in 
Congress, or any other public officials, to let them know of 
their concern. Many members of Congress -- probably most -- 
never hear from their constituents that AIDS is important to 
them. Unless this changes, we are in serious trouble.

A central reason for the silence is that AIDS organizations, 
with very few exceptions, have failed to ask the public (in 
ways that make sense to those not already heavily involved) 
to contact their representatives. Most AIDS "action alerts" 
have been written for AIDS professionals; they take many 
shared assumptions for granted, and do not explain the 
rationale of the issue to the general public. Many of the 
largest AIDS political organizations do not even offer 
individual memberships, or any other way for non-specialists 
to be involved.

Also, most people will not phone or write public officials 
alone by themselves, just on the basis of a written document; 
they also want to hear about the issue from other people. 
AIDS organizations need to support grassroots groups 
throughout the country, which could meet frequently and make 
their concerns known to their representatives.

Our representatives must hear from us no matter what their 
position -- even if they already seem to be committed 
enemies, or committed friends. They need to know their 
constituents care. And we will need to include political 
communication as a regular part of our everyday lives, not 
only at elections or when AIDS is in the headlines, but at 
all times.

The "AIDS Coffee Klatch," described in the last issue of AIDS 
TREATMENT NEWS, is one model for small, local groups. We had 
to start independently, as national AIDS organizations are 
not doing this work. And we had to write our own action 
alerts, because most of the existing ones proved unusable. 
Small citizens' groups should not need to do this.

The AIDS community is facing disaster if it does not do a 
better job of grassroots organizing. It must bring together 
the organizers who can do the work with those who can fund 
them. And it must support local groups with policy 
recommendations and action alerts which both activists and 
the public can fully endorse. And it must develop a 
"corporate culture" of day-in, day-out mass mobilization of 
support.


***** 1995: Business

Biotechnology investors had a terrible year in 1994. This is 
bad for people with AIDS, because it makes it hard for 
companies to raise money to develop new treatments and test 
them.

BioCentury, a weekly fax newsletter which reports on the 
business of biotechnology, found that only the largest 
companies, with market capitalization over $500 million, held 
their own in stock prices during 1994. The 190 smaller 
companies which BioCentury follows lost an average of 37 
percent in shareholder value; the "infectious diseases and 
AIDS" group of companies lost 42 percent. This is on top of 
other losses in 1993.

BioCentury's analysis showed that the actual performance of 
the industry was not bad in 1994; the success rate for new 
drugs was about what would be expected in the pharmaceutical 
industry. The problem, some experts suggested, may have been 
the great unpredictability of which drugs will work. Some 
were expected to do well, but instead failed in clinical 
trials.

Comment

In this business climate, advocates for people with AIDS, 
cancer, and other serious diseases should think carefully 
before pushing for price-control laws or other mechanisms to 
hold down the prices of newly-developed pharmaceuticals. The 
few drugs which do work must pay not only for their own 
research and development, but also for the many more research 
and development projects which fail. Otherwise, investors 
will keep losing money until they stop putting more money in 
to this high-risk area, and new treatments will not be 
produced.

The impossibility of predicting which new drugs will actually 
work in people also reinforces the need for many small, 
screening trials, to see which potential treatments do seem 
to be working, and to learn more about them as a basis for 
further development. The danger, in both corporate and 
government research, is that too much of the available money 
and other resources will be diverted to a few large projects, 
because they have more political influence than small ones.

[Note: For information about BioCentury, call 415/595-5333.]


***** AIDS-Related Research Meetings, January and February 
      1995

This incomplete list is in order by starting date. Note that 
most of these meetings are intended for research specialists 
(including AIDS treatment activists), or for other healthcare 
professionals.

** Retroviral Integrase: Molecular Biology and Pharmacology, 
A Novel Target for the Treatment of AIDS, January 19-20, 
Lister Hill Auditorium, National Institutes of Health.

This meeting, "to bring together academic and industry 
groups," is sponsored by several institutes/offices at NIH. 
For a copy of the brochure, call Technical Resources, Inc., 
301/770-0610.

** National Task Force on AIDS Drug Development, January 19, 
Holiday Inn, Bethesda, Maryland.

The mission of the National Task Force "is to insure that all 
aspects of AIDS drug development are rapidly taking place in 
a creative, coordinated manner, free of unnecessary 
barriers." So far the group has not done much, but that could 
change. Note additional listing for the meeting starting 
February 23, below.

The January 19 meeting will review the recommendations made 
to this point.

** CPCRA (Terry Beirn Community Programs for Clinical 
Research on AIDS) 16th group meeting, January 25-27, Hyatt 
Regency Washington, Washington, D.C.

The first day is an orientation session for new groups; the 
regular meeting begins January 26. For more information, call 
Rii Conference Department, Silver Spring, Maryland, 301/565-
4020.

** FDA advisory committees meeting on Salk Immunogen, January 
26.

See separate article in this issue of AIDS TREATMENT NEWS, 
page 1.

** Third International Congress on Biological Response 
Modifiers, January 26-29, Cancun, Mexico.

This meeting is organized by the Inter-American Society for 
Chemotherapy. For registration information, contact Meetings 
Manager, CME, Inc., Princeton Junction, New Jersey, 609/799-
2300, fax 609/275-8745.

** HIV Immune-Based Therapies Workshop, January 27-29, 
Stouffer Harborplace Hotel, Baltimore, Maryland.

For information, call Clinical Immunology Society, Thorofare, 
New Jersey, 609/848-1000 ext. 213.

** The Second National Conference on Human Retroviruses and 
Related Infections, January 29 - February 2, 1995, Sheraton 
Washington Hotel, Washington, D.C.

This meeting is especially important this year, since there 
will be no International Conference on AIDS in 1995. 
Unfortunately it is also expensive (on-site registration 
$425), and as far as we know there are no scholarships for 
people with AIDS or HIV. AIDS TREATMENT NEWS and many other 
AIDS publications will be there and will publish reports.

Note: A satellite round-table meeting on protease inhibitors 
and drug resistance, organized too late to be on the program, 
is scheduled Feb. 2 at the conference hotel. The working 
title is, Protease: Resistance, Cross-Resistance, 
Implications for Monotherapy and Combination use, and 
Clinical Studies for 1995 and Beyond. Time and location will 
be announced on bulletin boards at the conference.

The Human Retroviruses conference is sponsored by the 
American Society for Microbiology, in Washington, D.C. For 
information, call their meeting hotline at 202/942-9356 (24 
hours voicemail).

[Comment: A philosophical issue about the fight against AIDS 
in the current era is highlighted by the following, from the 
preliminary program of the Human Retroviruses conference: "It 
is hoped that this second conference, conducted in an 
atmosphere of scientific inquiry and collegiality, will 
catalyze free exchange of information and ideas and spawn new 
data and collaborative studies to hasten the understanding of 
these relatively new agents and their diseases." In other 
words, a meeting unchallenged by people with AIDS will spawn 
data and studies, it is hoped.]

** HIV 7th National AIDS Update Conference, January 31 - 
February 3, Moscone Convention Center, San Francisco.

This is not primarily a research meeting, but a major 
continuing-education meeting for healthcare professionals. 
For more information, contact Krebs Convention Management 
Services, San Francisco, phone 415/255-1297, fax 415/255-
2244.

** Gene Therapy & Nucleic Acid Vaccine Strategies, February 
16 and17, Hyatt Regency, Bethesda, Maryland.

Expensive and highly technical meeting on DNA vaccines, etc. 
for cancer, AIDS, other viruses. For information, contact IBC 
USA Conferences Inc., Southborough, Massachusetts, phone 
508/481-6400, fax 508/481-7911.

** ACTG (AIDS Clinical Trials Group) 19th meeting, February 
18-22, Washington Renaissance Hotel, Washington, D.C.

This technical meeting of researchers participating in the 
largest AIDS clinical-trials network happens twice per year. 
For more information, call Rii Conference Department, Silver 
Spring, Maryland, 301/565-4020.

** HIV Infection in Women: Setting a New Agenda, February 22-
24, Sheraton Washington Hotel, Washington, D.C.

About 1500 experts are expected for this major conference, 
which will focus solely on adult and adolescent women with 
HIV. Sponsors include the U.S. National Institutes of Health, 
the Centers for Disease Control, the Food and Drug 
Administration, the Health Resources Services Administration, 
the Substance Abuse and Mental Health Services 
Administration, the Agency for Health Care Policy and 
Research, and the Public Health Service Office on Women's 
Health.

For registration forms and additional information, contact 
the conference secretariat, phone 703/356-8376, fax 703/790-
7237.

** National Task Force on AIDS Drug Development, February 23-
24, Holiday Inn, Bethesda, Maryland.

This meeting of the National Task Force will focus on 
protease inhibitors. Persons wishing to make a formal 
presentation should notify Jean H. McKay or Kimberley M. 
Miles, FDA Office of AIDS and Special Health Issues, 301/443-
0104, by February 9, "and submit a brief statement of the 
general nature of the evidence or arguments they wish to 
present, the names and addresses of proposed participants, 
and an indication of the approximate time required to make 
their comments." A transcript will be available approximately 
15 working days after the meeting.

** Wasting Disorders: Molecular and Clinical Aspects, 
February 23-26, Bonaventure Resort and Spa, Fort Lauderdale, 
Florida.

For information, contact Serono Symposia, USA, Norwell, 
Massachusetts, phone 800/283-8088 or 617/982-9000, fax 
617/982-9481.



***** AIDS TREATMENT NEWS
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AIDS TREATMENT NEWS reports on experimental and 
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collect information from meetings and conferences, 
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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 
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