Human chorionic gonadotropin (hCG) is a hormone which is
naturally produced in early pregnancy. Commercial
preparations of hCG, which are relatively crude extracts
prepared from the urine of pregnant women, have long been
available as an approved medical treatment for a variety of
conditions, in both women and men. For several years there
has been interest in the possibility that some hCG
preparations might be useful in treating Kaposi's sarcoma.
On October 24, 1996, the results of two small trials (with 36
volunteers total) were published in the New England Journal
of Medicine,1 along with an accompanying editorial.2
These results leave little doubt that this approach to
treatment, which is very different from conventional
chemotherapy, has important potential. But major questions
still remain -- including how to obtain a reliable supply of
the active ingredient (since it is now believed that it is
not hCG itself, but some related substance, which is
affecting KS -- and the commercial hCG preparations vary
greatly from brand to brand and probably even batch to batch
in anti-KS activity). Another critical question is the
possible role of hCG in systemic treatment; these trials were
designed to test treatment of individual lesions by
intralesional injection of hCG, although there was also
evidence of benefit to some lesions which were not injected.
Robert C. Gallo, M.D., one of the authors of theNew England Journal
of Medicine research report, released a press
statement on October 25 urging caution by physicians and
patients until more research is done.,3,But since side
effects are small, and the drug is readily available
(although expensive), and research has been slow due to lack
of commercial interest in this generic treatment for a
limited market, it seems inevitable and appropriate that this
experimental treatment will be tested in clinical practice as
well as in formal trials, especially when conventional
treatments are not satisfactory. Clinical practice, as well
as trials, also produces new knowledge.
The New Results
Here we will briefly summarize the results reported on
October 24; for more information, see the original
article.1
First, because of the great variation in activity of
different preparations of hCG, four different commercial
brands were tested in the laboratory against Kaposi's sarcoma
cell lines. The most active of the four was A.P.L.(R),
produced by Wyeth-Ayerst Laboratories.
Next, a dose-ranging study tested four different doses (250,
500, 1000, and 2000 IU, injected under the skin directly over
a lesion, with a fine needle). In this study, the dose was
administered three times a week for only two weeks. There
were six patients in each dose group, and two lesions were
injected in each patient -- with a third lesion in each
patient injected not with the drug, but with the liquid used
to dilute the drug, as a control. There was one complete
response (a lesion flattened completely, and no evidence of
KS found in biopsy) in one lesion at the lowest dose (of the
12 lesions treated), one complete response and two partial
responses at 500 IU, one complete response and four partial
responses at 1000 IU, and 10 responses at 2000 IU, five of
which were tested by biopsy, with all five showing no
evidence of KS. (The two lesions which did not respond at
2000 IU were in a patient who withdrew from the study after
one dose because of pain at the injection site.)
Also, in the five patients who received more than one dose,
four had their control lesions (which were injected, but
without the active drug) flatten completely, although on
biopsy they did not show KS cell death -- suggesting a
possible limited systemic effect from treatment of two
lesions. (The later controlled study, described below, found
no effect at all from the control injections, in patients who
did not receive any of the active drug.)
As a result of this dose-ranging study, the dose of 2000 IU
intralesionally was chosen for a double-blind randomized
controlled study, which was done next. This study also tested
three injections per week for two weeks. It assigned six
patients to receive hCG, and six to receive the control
injection alone. In each patient, two lesions were injected
(with the active drug, or with the control).
In this study, 10 of the 12 lesions showed responses;
biopsies were done on six lesions, and five of them showed a
complete response. None of the control-injected lesions
responded.
After the two weeks of treatment, the five patients with
complete responses were followed for varying periods no
longer than five months. Two of the five lesions that had
showed a complete response recurred, while the other three
did not, during the followup period.
Also, five of the six who received the control injections
were given open-label treatment later; all had lesions which
flattened completely, although no biopsies were done in this
group. In four of the five patients, none of the lesions
recurred after four to five months (the fifth patient was
lost to followup).
Microscopic examination of the biopsies, by blinded
examiners, found that the treatment was killing the KS cells
by apoptosis (programmed cell death) -- which is different
from cell killing by conventional chemotherapy. Also, there
was no evidence of immune-cell infiltration of the lesions,
suggesting that the treatment was killing the cells directly,
not by stimulating an immune response.
The intralesional treatment was found to be causing a
systemic decline of two related hormones (FSH and LH). There
were some increases in testosterone, but these were not
statistically significant in this study.
There were also several reports of increased appetite and
weight gain. In one case, chronic diarrhea stopped when the
treatment was started, then started again after the treatment
was ended.
Side effects were described as mild, and affecting only a few
patients.
All of the lesions injected in this study were relatively
small.
Cost
A price of A.P.L., mentioned in the accompanying editorial by
Susan E. Krown, M.D., in the New England Journal
of Medicine2, was $264 per 20,000 IU vial (the drug is also
supplied in 5,000 and 10,000 IU vials). While the editorial
noted that the cost would be "astronomical" if the effect
"requires sustained local concentrations in tumors of the
magnitude achieved after the direct injection of 2000 IU,"
this seems unlikely, since there appeared to be some effect
on untreated lesions when only two lesions in the body were
treated. In the trial, the total amount of drug used at the
2000 dose was 12,000 units per lesion (three times per week
for two weeks), which would prorate to more than $300 for
this two-week therapy for the two lesions. It is not known
how much drug would need to be used systemically, or how
often treatment may need to be repeated.
Highly purified hCG has little anti-KS effect in laboratory
studies; therefore, it is strongly suspected that the active
substance in this treatment is not hCG itself, but probably a
related substance (perhaps a fragment of the hCG molecule).
Eventually, more efficient treatment should be possible. But
the active ingredient will probably be a proprietary drug, so
the price of treatment will likely remain high.
References
1. Gill PS, Lunardi-Iskandar Y, Louie S, Tulpule A, Zheng T,
Espina BM, Besnier JM, Hermans P, Levine AM, Bryant JL, and
Gallo RC. The effects of preparations of human chorionic
gonadotropin on AIDS-related Kaposi's sarcoma. New England Journal
of Medicine. October 24, 1996; volume 335,
number 17, pages 1261-1269.
2. Krown SE. Kaposi's sarcoma -- What's human chorionic
gonadotropin got to do with it? New England Journal
of Medicine. October 24, 1996; volume 335, number 17, pages
1309-1310.
Press Statement of Dr. Robert C. Gallo, Director, The
Institute of Human Virology
Dr. Gallo, listed as senior author on this study, released
the following statement to the press on October 24:
Kaposi's sarcoma continues to be a significant contributor to
AIDS mortality with current therapy options principally
palliative in nature. In addition, the toxicities that arise
from current treatments often interfere with the front-line
antiretroviral agents that are the standard of care
treatments for HIV disease.
The study published in the New England Journal
of Medicine on
the effects of treating dermatological KS with injections of
human chorionic gonadotropin (hCG, a hormone found in early
pregnancy) gives promise of a new treatment with potentially
far less toxicity and no interference with standard of care
antiretroviral therapies. It is clear that some commercial
preparations of hCG induce a local tumor regression response
through the mechanism of inducing cell death; more
investigation is necessary to determine the precise agent
inducing the beneficial effect. Studies are now underway to
evaluate the systemic effects of hCG on KS tumors, which can
include internal organs as well as the skin.
Since hCG is readily available to physicians, several
cautions are in order at the stage of clinical research
[emphasis in original]. While this study confirms that some
preparations of hCG produce a dose-related antitumor
response, it is crucial that the precise biochemical agent be
identified conclusively, and that further clinical studies be
completed before physicians and patients rush into unguided
use of hCG. Currently available commercial preparations of
hCG vary widely in terms of purity and ability to be
effective as intralesional treatment for KS. The method of
injection is also a key variable. It is also likely that hCG
is not the effective molecule, but rather that the effective
agent is an active degradation product. Confirming this must
be a high priority in the next stage of this research.
Dr. Parkash Gill of the University of California School of
Medicine and Dr. Philippe Hermans of the Universite Libre de
Bruxelles in Belgium are to be commended for advancing this
work into human trials. It builds on the work done in 1995 by
Drs. Yanto Lunardi-Iskandar and Joseph Bryant, working with
Dr. Robert Gallo, all presently at the Institute of Human
Virology. These same investigators isolated (in laboratory
tissue culture) the first neoplastic cell line from HIV-1-
associated Kaposi's sarcoma, and subsequently identified
chorionic gonadotropin as the active factor in inhibiting
growth of the cells. (The former is in JOURNAL OF THE
NATIONAL CANCER INSTITUTE 1995;87:974-981, and the latter
study is in NATURE 1995;374:64-68.)
IL-2: Controlled Trial Finds Major CD4 Increases
by John S. James
A controlled trial of IL-2 in 60 patients increased CD4
counts from an average of 428 at baseline, to an average of
916 at month 12 -- while in the control group which was not
given IL-2, the average decreased from 406 at baseline to 349
during that year. All patients entering this trial had a CD4
count over 200, and all were given standard antiretroviral
therapy. This research, at the National Institute of Allergy
and Infectious Diseases, was published October 31 in THE NEW
ENGLAND JOURNAL OF MEDICINE.1
There were no significant differences between the groups in
viral load -- which is good news, since IL-2, which
stimulates the growth of CD4 cells, can also temporarily
increase HIV viral load.
The IL-2 was given for five consecutive days every two
months. Side effects were substantially less than in previous
studies in which higher doses of IL-2 were used. Still, five
of the 30 volunteers assigned to IL-2 had to withdraw due to
side effects.
Five volunteers in the control group either developed a new
AIDS-related condition or died, compared to only two assigned
to the treatment group (during the 14-months study or during
long-term followup after 14 months). These numbers are too
small to be statistically significant, however (meaning that
the difference could easily have happened by chance).
A new trial is being planned to test IL-2 in patients with
CD4 counts below 200 who are using protease inhibitors. In
the past, IL-2 has not worked well in those with counts under
200, probably because the drug stimulated growth of the
virus. Now that better antivirals are available, it is
possible that IL-2 might have usefulness in later disease.
Comment
It has been known for some time that IL-2 can greatly
increase CD4 counts in some patients. But this increase in
the count does not automatically prove that the treatment is
beneficial, since it is possible that some kinds of CD4 cells
are missing, or that for other reasons the new cells will not
work as well as the cells of those who have a high CD4 count
without this treatment. For these reasons, a larger trial is
being planned to confirm that IL-2 treatment does have
clinical benefit.
References
1. Kovacs JA, Vogel S, Albert JM, and others. Controlled
trial of interleukin-2 infusions in patients infected with
the human immunodeficiency virus. THE NEW ENGLAND JOURNAL OF
MEDICINE. October 31, 1996; volume 335, number 18, pages
1350-1356.
NTZ for Cryptosporidiosis: Larger Expanded Access; Buyers' Club/FDA Conflict
by Sally Cooper
[Note by JSJ: The experimental drug nitazoxanide (NTZ)
appears to be the first good treatment for cryptosporidiosis,
an infection which causes severe diarrhea and is responsible
for many deaths (see coverage of NTZ in AIDS Treatment Newsissue #239, January 19, 1996, and #250, July 5, 1996). But
getting pre-approval access for those who need NTZ has been a
continuing struggle, even though there is no manufacturing or
economic reason for a shortage.
The PWA Health Group, New York's oldest and largest AIDS
"buyers' club," has been the central advocate for the AIDS
community in this struggle. It has not only supplied the drug
to individuals (despite Federal seizure of one shipment in
June), but has also created pressure on Unimed
Pharmaceuticals, Inc. and on the FDA to make formal access
arrangements. We asked Sally Cooper, executive director of
the PWA Health Group, to explain the current status of NTZ
access to our readers. Her article follows.]
I. No Numerical Limit on Expanded Access
On October 15, Unimed Pharmaceuticals, Inc., the U.S.
licensee of NTZ, announced that it had received permission
from the FDA to end the numerical limit on the number of
medically qualified persons who could enter its open label
trial for NTZ. Unfortunately, persons who called Unimed in
the few days after the press release were told to call back
the following week, as the person handling enrollment was
away on vacation [see Unimed's reply, below]. She is back
now, and can be reached at 800/864-6330 x3032.
This trial is open to all who qualify. But when a new
government-funded ACTG (AIDS Clinical Trials Group) phase III
trial starts, the Unimed program will be closed to persons
living in cities with ACTG trial sites, unless they cannot
participate in the ACTG trial.
Everyone entering the Unimed program will get NTZ, but will
be randomly assigned to receive either 1000 mg/day or 2000
mg/day for the first month. The dose can be escalated at
monthly intervals, up to 3000 mg/day. Persons who also have
intestinal CMV, MAC, or KS are still excluded, as well as
those taking azithromycin or clarithromycin; but persons with
microsporidiosis in addition to cryptosporidiosis are
allowed. There is no limit to the amount of time people can
receive drug once in this trial.
II. Federal Action against PWA Health Group
During the same week in October, the U.S. Customs Service
notified the PWA Health Group in New York that they were
fining the group $1000 for a shipment of NTZ seized by
Customs late in June. The NTZ was released to the group on
October 25, with a Customs escort for re-importation back
into Mexico. Attempts to negotiate with the FDA to bring the
drug back into the United States failed, despite appropriate
personal use documentation and prescriptions, since this case
was being used as "an example to buyers' clubs." Meanwhile
the PWA Health Group has other NTZ in stock for persons with
prescriptions who are waiting to get it, or who are unable to
get into Unimed's open-label trial.
Comment
by Sally Cooper
There were many myths this summer about the U.S. Customs
seizure of our NTZ. One was that the NTZ was in a car without
license plates (sorry, Mexican rental cars do have license
plates). Many people asked us why the product had not been
declared (an uncalculated mistake on our part), but as Tom
Gardine, of FDA Regulatory Affairs, said, "we would have
seized it anyway." In other words, that was never the real
question, just a smokescreen to divert attention from the
central issue: that this is an approved medication in Mexico,
and was brought in with legal prescriptions -- something that
AIDS buyers clubs have done for years to help persons with
AIDS who cannot get to Mexico on their own. Emphasizing the
failure to declare also ignores another key aspect of
underground access: it provides fantastic leverage to push
laggard companies who are dragging their feet about
compassionate use and effective trials.
Unimed is a case in point. All last year, they refused to
expand their open label trial, or allow people to stay in who
had responded [see reply by Unimed, below]. One reason the
PWA Health Group decided to import NTZ was the frantic calls
from persons unable to get back into the trial, when their
diarrhea recurred after a month or two. Asked by Customs in
September for an advisory opinion about the seizure, the FDA
found itself stuck, as there were no trials open, and only a
handful of available slots in Unimed's open label trial. A
month passed with no response, and then a solution was
announced: penalize the PWA Health Group, but open up the
company trial. Which, on the balance, is good, as more people
with AIDS will have access to free drug.
It could have been much better if Unimed had decided to run a
compassionate use program instead of a trial [see reply by
Unimed, below]. Compassionate use programs are not trials.
They stem from a hodgepodge of regulations allowing the FDA
to permit access for emergency care, and offer an excellent
mechanism for widespread early access and concurrent
collection of safety data. With compassionate access,
patients are able to work with their physicians and the
sponsoring company to start treatment quickly, and change
doses as needed. A major advantage of NTZ is that patients
often respond within days; therefore the dose can be quickly
adjusted if necessary. But Unimed's open label trial remains
inflexible, offering no dose escalation for four weeks, no
combination therapy, and no access for persons with
concurrent gastrointestinal infections.
Several critical NTZ research questions remain. Earlier this
year, Unimed expressed interest in running a dose-escalating
study, as recent trial results suggest that higher doses (up
to 4,000 mg/day in a Mexican study) may be needed for some
people with AIDS to clear cryptosporidiosis in the stool. But
since the ACTG agreed to run a large phase III placebo-
controlled trial offering 2000 mg/day [now expanded to 3,000,
according to Unimed], Unimed has put this plan on hold. The
result will probably be marketing approval with insufficient
dose information for treating cryptosporidiosis, no
information on treating children with AIDS-related diarrhea
[see reply by Unimed, below], and no information on how NTZ
works against microsporidiosis, giardia, cyclospora, amoebas,
etc. Such FDA marketing carte blanche is a huge problem,
especially with promising therapies for opportunistic
infections, because relatively fewer people are affected,
reducing community pressure to safeguard the interests of
individual patients and of the public at large.
Reply by Sandy Faulkner Unimed Pharmaceutical, Inc.
1. Unimed has always had and currently has several personnel
working on the NTZ free expanded access program. The very
nature of our work in clinical trials requires travel away
from the office, but every effort has been made to respond to
calls for NTZ from both patients and physicians in a timely
manner.
Unimed will not refuse to provide NTZ to persons in need.
2. The FDA limited the duration of NTZ therapy to 60 days;
however, Unimed has always been very responsive to patients
responding to NTZ and requesting additional treatment beyond
the 60 days provided in the early version of the protocol.
Unimed consulted with the FDA for each patient who requested
additional therapy and, without exception, the FDA granted
the request and medication was provided to the patient.
Many patients in the expanded access program have been
restarted on NTZ following relapse. Only patients who are
non-responders following six months of NTZ are not re-
enrolled.
Once we provided the FDA with sufficient safety data, the
protocol was amended to increase enrollment and the duration
of therapy.
3. Unimed has provided NTZ through an open-label trial that
is authorized by the FDA. The objective was and is to gather
safety and efficacy data to allow for the fastest possible
submission to the FDA seeking approval to market NTZ. Because
of this proactive planning, the data regarding NTZ's safety
and effectiveness is substantial and Unimed's efforts to
collect key data in the expanded access program may result in
the saving of several months in the "approval process,"
thereby making NTZ available to all patients with the least
paperwork hassles.
4. Additionally, we have data on several children from the
expanded access program and are working on a pediatric study
with the ACTG.
Comment by John S. James
In 1989 the FDA published regulations allowing importation
for personal use of medicines approved abroad but not in the
U.S. But often when someone needs treatment, there is no
time, credit card, fax access, etc. to place an international
order and wait for the government paperwork required. In such
cases, buyers' clubs have sought to keep a supply on the
shelf for immediate prescription use, then later use those
prescriptions to document a bulk order from abroad, to
replace the supply as it is used. This stretches the
regulations, which describe the placement of a separate
international order by each patient.
The FDA has always been unhappy with such arrangements, but
usually was willing to tolerate them. (And the FDA became
particularly unhappy when health-food promoters started
arguing in court that people with AIDS were getting special
treatment, and prosecution of the promoters' commercial
ventures was therefore unequal application of the law.) Under
Commissioner David Kessler, the FDA has tried hard to set up
sanctioned channels to allow physicians to get the drugs they
need. These efforts have often been successful, but many
people in urgent need still fall through the cracks.
The programs do not cover everyone who needs treatment, for
many reasons. Often, the company with the monopoly refuses to
offer expanded access. Often, an expanded access program
needs to pretend to be a trial (a trial which no one would
propose for scientific or medical reasons), greatly
increasing paperwork -- and excluding most patients in public
clinics, whose doctors have neither the staff nor the time to
fill out massive forms. Often companies want to test their
drug alone until it is approved (after which they have little
incentive for further testing), excluding patients who need
combination treatment. Often they want uniform patients in
order to get clean data, excluding patients with
complications. There are many other problems as well, such as
access to IRB (institutional review board) approval.
Conflicts arise between the FDA and buyers' clubs because the
regulations and procedures best suited for routine use are
not those best suited for an emergency. In past years, when
AIDS activism was stronger than it is today, the FDA would
back off in these cases. Today activism is weaker, so the FDA
pushes further.
NTZ could provide a textbook case of how institutions cannot
be trusted to govern in the best interests of those they
rule, and why those directly affected need their own power
and their own voice. Without the PWA Health Group, the
patients who obtained the drug from them would be without
effective treatment. And the official expanded-access program
would probably have happened much later, and been much more
limited, if it existed at all.
International Treatment Access and Research, How You Can Help: Interview with Dr. Peter Piot of UNAIDS
by John S. James
The recent International Conference on AIDS in Vancouver
demonstrated a greatly increased interest of U.S. AIDS
activists in access to medical treatment for people
throughout the world. At stake is not only the life and
health of the 90% of persons with HIV who now cannot get
modern medicines, but also the best possible care for those
who do have access. This is because effective treatment in
the developing world will require scientific testing of
traditional and accidentally discovered treatments; and if
any of them are found to be effective (as has happened
frequently in the history of medicine) they would become
available for use together with pharmaceutical-industry
drugs.
On September 30 AIDS Treatment News interviewed Peter Piot,
M.D., executive director of the Joint United Nations
Programme on HIV/AIDS (UNAIDS), which brings together six UN
agencies in a common effort against the epidemic, on what can
be done to improve treatment access throughout the world, and
improve research on natural and traditional medicines.
AIDS Treatment News: What is UNAIDS doing to make AIDS
treatments more accessible?
Dr. Piot: There is now a major shift in international AIDS
work. Until very recently, the programs have focused
exclusively on prevention, with hardly anything being done on
care. Some programs still maintain this policy. We are trying
to change it; we advocate with governments, and with AIDS
programs in the countries we work with, that they not deal
only with prevention. That is the first step. With over 22
million people infected today, it would be obscene not to pay
any attention to care. And successful prevention programs
have been linked with care and support for people living with
HIV and patients with AIDS.
Our staff is now covering 80 countries in the developing
world, and that is part of their priorities, to put AIDS care
and access to drugs higher on the agenda.
We must be realistic in what we can achieve. In the least
developed countries, the newest antiretrovirals will not be a
feasible option, if they have sometimes only ten dollars per
year per person for health care in general.
There are other countries -- such as Brazil, Thailand, South
Africa -- that are near the top of the income distribution of
developing countries; there, access to the latest new
antiretrovirals and other drugs is not a naive dream. We are
working with the governments to try to negotiate lower
prices, by bulk procurement for example. Also, we are
supporting some local initiatives with non-governmental
groups, community organizations, to set up a buyers' club,
for instance.
Most of what we are doing is to promote wider access to
generic drugs, to many drugs that are affordable for
prevention or treatment of opportunistic infections, or
palliative care. Even this is not being done; I believe that
about 90% of people with AIDS in the world do not even have
access to this kind of standard of care. We learned that
preventive therapy for tuberculosis, the number one killer of
AIDS patients in Africa, costs about $15 per year. It is
affordable to people either if they have to pay themselves,
or if the government or some organization budgets for it.
How to we improve this kind of access? We work with the
governments, the ministers of health, pushing them to put it
on their budgets. Also we work with the private sector, the
non-governmental sector, which is becoming a bigger part of
the healthcare system.
One of the biggest obstacles to good care is inadequate
training of the doctors. They are overwhelmed, they have to
deal with so many other major problems; therefore we need to
invest more in their training, to help them with very simple
ways of diagnosing opportunistic infections, and alerting
them, for example, that patients should be on TB prophylaxis.
This educational effort with healthcare personnel has not
happened in most countries.
ATN: What can be done to develop less expensive treatments by
improving research on traditional and natural medicines?
People call and write us about proposed herbal remedies which
might be antiviral; it would be easy to test them in a few
people and see if their viral load went down. How could such
research be organized?
Piot: Such treatments are often country-specific; they are
being used in one country but not elsewhere, or nobody has
heard of the treatment outside of a country. Our
representatives first check what it's all about, because a
lot of this is not in good faith. If the interest does look
serious, if it is not just someone trying to make money out
of the misery of others, we try to bring them in contact with
individuals who could do some preliminary assessment. You do
not need to start with big trials. But we have not done much
in this difficult and diverse field. India or China, for
example, have a very long tradition with these medicines. We
hope to work with institutions like the Chinese Academy of
Traditional Medicine.
To move treatment access forward, one has to work with a
number of stakeholders. For example, in July we made plans
for what UNAIDS would do in improving access to drugs,
working with persons from government, from community groups,
groups of people living with HIV, to get a better sense of
what is possible. How can we learn from AIDS activism in the
Western world? How can some of its approaches be used in some
developing countries, especially where a very high proportion
of the adult population is infected? The political issues in
this work are as difficult as the technical problems.
ATN: Where do we go from here in developing worldwide AIDS
activism? What could activist organizations do in the U.S.
and other countries? What can individuals here do to help?
Piot: The first issue is awareness that there is a very
important international impact of this epidemic. Activists in
North America or Western Europe often have an agenda that is
purely domestic or local; this is understandable as there are
many problems. But also there is much to offer to our
colleagues in developing countries. So raising the awareness
among the domestic activist community that AIDS has a global
dimension, that there is a role to be played for local
activists in the whole international arena, is really
important. That can only come from within. People like Eric
Sawyer from Housing Works in New York, Paul Boneberg and GAAN
(Global AIDS Action Network), and the National Council for
International Health are trying to do this; much more has to
be done.
AIDES in France, the very big AIDS service and support
organization, has developed partnerships with AIDS activist
groups and NGOs (non-governmental organizations) in
neighboring countries, mainly Algeria and Morocco, but also
in Poland. There are many migrants from North Africa living
in France. Perhaps you could do something similar in the
U.S., linking up with groups in Mexico, the Caribbean, where
a large proportion of the population is coming from, and
support them. Not necessarily with money, but also lessons
learned; shortening the learning curve on how to be effective
in activism is very important. I'm not sure that enough is
happening at that level in the U.S. We in UNAIDS would be
very open to working with such initiatives. Linking up with
colleagues in other countries makes it concrete, not limited
to theoretical discussions about international AIDS work.
ATN: How did AIDES get started in this?
Piot: I believe that it is the vision of Arnaud Marty-
Lavauzelle, the chairman of AIDES and also a member of the
governing board of UNAIDS, that made this possible. In the
last two years they developed more and more international
work. It is not their primary mandate, of course. But because
they are confronted with people living in France who are from
various other countries, they started working in the
countries of origin of these people. That is a concrete link,
and very helpful in doing a better job, since there is a big
service component; it is not only an activist group, it has
counseling centers, and provides home care and other
services. That has been a very successful program. For those
working in New York and Miami, it is clear that linking up
with the Caribbean would be an obvious thing to do.
ATN: Few if any U.S. organizations have made it part of their
mission to work with NGOs in the countries of origin of their
clients. It would be a natural step to take.
Piot: It's concrete, and it would be very helpful for people
in these countries -- working with community organizations
for prevention, and also for access to care and drugs. The
U.S. is surrounded by countries where standards of care for
people with HIV are not where they should be.
From UNAIDS headquarters in Geneva, we are supporting
networks of groups -- GNP+ (the Global Network of People
Living with HIV), ICASO (International Council of AIDS
Service Organizations), ICW (the International Community of
Women Living with HIV/AIDS) and others; and within countries,
we are pushing that activist groups, NGOs, community groups,
be involved in development of national policies. This is not
now the case in most countries, although it is in a few, like
Brazil.
Today the gap is immense between people with HIV who are rich
or living in a rich country, and the overwhelming majority
who can only dream of the new treatments. There is a need for
a strong strategic alliance -- even more, I believe, after
the Vancouver conference and the recent breakthroughs with
protease inhibitors and other drugs.
Retroviruses Conference -- Some Scholarships Available
The 4th Conference on Retroviruses and Opportunistic
Infections, January 22-26 at the Sheraton Washington Hotel in
Washington, D.C., will probably be the most important AIDS
conference in the U.S. in 1997. The number of scholarships
available is not known at this time. AIDS Treatment News
received the following notice on September 25:
Community Scholarship Program
A limited number of scholarships are available to attend the
4th Conference on Retroviruses and Opportunistic Infections.
Eligibility Criteria:
The program is designed to provide travel support for AIDS
treatment community activists and people with and affected by
AIDS to attend the conference. The eligibility criteria are:
Must be affiliated with a local AIDS treatment
organization;
Must be involved in community outreach activities and have
a commitment to share with your community what you learn from
the conference;
Prefer individuals representing diverse and under-
represented populations who may not have access to community-
based newsletters (community-based press are ineligible for
this program).
Financial Support:
Transportation to Washington, D.C. (airfare, trainfare, or
reimbursed mileage);
Complimentary registration;
A $400 stipend (for hotel and incidental expenses).
Application Process:
Submit a letter of application outlining your eligibility and
include a resume. Applications will be peer reviewed by the
Community Liaison Subcommittee.
Application Deadline: December 2, 1996
Applicants will be notified of the disposition of their
application by December 20.
Submit Application To:
Scholarship Program - 4th Retroviruses Conference, c/o
Conference Secretariat, IDSA, 11 Canal Center Plaza, Suite
104, Alexandria, VA 22314. 703/299-0200 (phone),
703/299-0204 (fax).
Starting and Changing HIV Treatment: Conference Call Nov. 5, Recording Later
A free interactive telephone call, "New Guidelines for
Starting or Changing Treatment for HIV Infection," will be
presented by the San Francisco AIDS Foundation on Tuesday,
November 5, at noon Pacific Time, 1:00 Mountain, 2:00
Central, 3:00 Eastern Time. To join the conference (allowing
you to ask questions of the experts), you need to register in
advance, by calling 800/707-BETA. But no registration is
required to listen to a recording of the call afterwards;
call 800/847-8912 and follow the voicemail prompts.
Guest experts will be Michael Saag, M.D., Roy Gulick, M.D.,
and Kathleen Squires, M.D. The call is moderated by Ron
Baker, Ph.D., editor of BETA, the treatment newsletter of the
San Francisco AIDS Foundation. It is supported by an
educational grant from Hoffmann-La Roche.
TREATMENT ISSUES Article on New Therapies After Protease Inhibitors
The cover article in the October TREATMENT ISSUES, the
newsletter of the Gay Men's Health Crisis, looks at new
therapeutic approaches which may be useful for patients who
have failed protease inhibitors (as well as in other
therapeutic situations). "When HAART Is Not Enough,"; by
editor Dave Gilden, looks at approaches for "establishing an
immune environment hostile to HIV." (The title word "HAART"
is an acronym for "highly active antiretroviral therapy" --
referring primarily although not only to combination therapy
with protease inhibitors.) This article focuses on research
approaches for future therapies, not on treatment options
widely available now.
To obtain a copy, call Chuck Sock, 212/337-3613, or contact
Dave Gilden, GMHC Treatment Education and Advocacy, 129 West
20th St., New York, NY 10011, fax 212/337-3656, email
DAVE_G@gmhc.org.
AIDSACT, New Email List for Activists
AIDSACT, a new electronic mailing list for AIDS activists,
"provides a means of communication for AIDS activists who
address AIDS as a political crisis." Persons who subscribe to
the list will receive all email later sent to the list.
Subscribers can send email to the list; but to prevent
irrelevant communications, messages need to be approved by
the list manager before they go out.
AIDSACT grew out of an earlier list, which ACT UP chapters
and other organizations and activists used to plan actions at
the Eleventh International Conference on AIDS in Vancouver.
To subscribe to AIDSACT, send a message to:
listproc@critpath.org
with no subject and a one-line message body in the form
subscribe AIDSACT First Last
where "First" and "Last" are your first and last names.
If you just want to get more information about AIDSACT,
without subscribing at this time, send email to the same
address, but instead of the "subscribe" line, say
info AIDSACT
Hepatitis C: Protease Structure of Virus Published
Two companies, Agouron Pharmaceuticals Inc. and Vertex
Pharmaceuticals Inc., have determined the chemical structure
of the protease enzyme of the hepatitis C virus. Both
published papers about their work in the October 18, 1996
issue of CELL. Both companies used X-ray crystallography to
determine the structure of the enzyme.
This discovery could lead to a new class of protease
inhibitor drugs which target the hepatitis C virus -- similar
to the development of protease inhibitors which now target
HIV.
Bioethics: Major Meetings in San Francisco, November 20-25
by John S. James
The International Association of Bioethics will hold its
III World Congress of Bioethics in San Francisco, November
22-24, 1996. This meeting occurs every two years. It is
presented by the Pacific Center for Health Policy and Ethics
(at the Law Center at University of Southern California), on
behalf of the International Association of Bioethics and the
American Association of Bioethics.
Several other bioethics meetings are also happening in San
Francisco around that time:
American Association of Bioethics Annual Meeting, November
20-22;
The International Bioethics Summit of National Bioethics
Advisory Bodies, November 21, 1996;
First International Conference on Feminist Approaches to
Bioethics, November 24-25;
Studying Human Genetic Diversity: Can We Do It Right?,
November 25;
The Globalization of Bioethics: International Human Rights
and the Health Professions, November 25;
Second International Meeting of the Network on Defining
Death: A Cross-National Perspective, November 25.
The headquarters for the Congress and related meetings is the
Crowne Plaza Parc Fifty Five Hotel in San Francisco.
Detailed programs and other information are available at
http://www.usc.edu/dept/law-lib/bioethics/world-congress.html .
For a brochure of the Bioethics Congress, call the Pacific
Center at 213/740-2541.
Comment: There are few AIDS-related sessions (there are
sessions on gay issues), and few AIDS activists in San
Francisco know about these meetings. Somehow the two
communities of AIDS and bioethics are surprisingly separate.
At the least, this situation represents lost opportunities,
as there are many issues (around access to treatment, for
example, or clinical trials, or the press and
medical/scientific journals) which could use more ethical
review. At worst, this apparent disconnect could be
dangerous, as there are efforts to roll back patient
empowerment in favor of more authoritarian approaches to
public health.
Copyright 1996 by John S. James. Permission granted for
noncommercial reproduction, provided that our address
and phone number are included if more than short
quotations are used.
This article was provided by AIDS Treatment News. It is a part of the publication AIDS Treatment News.
