[e-drug] MSF: Drug companies neglect children with AIDS

E-DRUG: MSF: Drug companies neglect children with AIDS
----------------------------------------------------

Please be sure to follow this link
http://www.doctorswithoutborders.org/news/hiv-aids/wad2005/index_wad2005.cfm
in order to:

- See what pharmaceutical companies need to do to develop child-friendly versions of AIDS medicines (there is a useful chart with contact information for companies)
- View the stories of people living with HIV/AIDS enrolled in the MSF program in Kibera slum in Nairobi, Kenya
- View a map of MSF's HIV/AIDS programs
- Watch a video on pediatric HIV/AIDS
- Find additional information about MSF and HIV/AIDS

Thanks,
Rachel

Rachel Cohen, MSF
Rachel COHEN <rachel.cohen@newyork.msf.org>
--

WORLD AIDS DAY 2005 - DECEMBER 1

For Immediate Release
Contact:
New York Kris Torgeson, +1-212-655-3764
Nairobi James Lorenz, ++254-722 51 3981

DRUG COMPANIES LEAVE CHILDREN WITH AIDS TO FEND FOR THEMSELVES:
WITHOUT PROPER TESTS AND DRUGS, MILLIONS OF CHILDREN WILL NOT LIVE TO SEE
THEIR SECOND BIRTHDAY

Nairobi/New York, November 28, 2005 --One of the reasons that half of all
children with HIV/AIDS die before the age of two is that pharmaceutical
companies are not making child-friendly versions of their anti-AIDS drugs.
Today, Doctors Without Borders/Medecins Sans Frontieres (MSF) calls on
companies to make easy-to-use versions for children of all their AIDS
medicines to help prolong and improve the lives of more children with
HIV/AIDS. There is also a desperate need for simple and affordable AIDS
tests for babies in resource-poor settings.

'MSF is giving antiretroviral medicines to nearly 800 children living with
HIV/AIDS here in Kenya,' said Rachel Thomas, MD, medical coordinator of the
MSF project in Kibera, Nairobi. 'The results are very good, but it's an
uphill battle. In the absence of child-strength pills that combine all
needed drugs in one tablet, medical staff and caregivers are often
forced to crush combination pills meant for adults.' In addition to being
less effective, under-dosing may lead to the virus becoming resistant to
the treatment, whereas overdosing can be toxic for these youngest patients.

In addition, the few drugs that do exist in syrup or powder formulations
intended for children are impractical to use: a child must take three
different quantities of three different and often foul-tasting syrups. Some
drugs require refrigeration, others clean water, both of which are often
not available in resource-poor settings.

Based on the encouraging results from treating adults with HIV/AIDS since
2001, MSF is committed to providing even the youngest patients in
developing countries with life-extending treatment. Although 75% of the
1,300 Kenyan children currently receiving antiretrovirals get them through
MSF programs, it is estimated that 17,000 more children in the country need
treatment now.

Existing tests to detect the virus in children are unaffordable or
impractical in resource-poor settings, and the routine test available in
poor countries is useless in babies younger than 18 months because their
blood still contains antibodies from the mother. The test does not indicate
whether the antibodies are the baby's or the mother's.

In western countries, mother-to-child transmission of HIV is avoided in 99%
of the cases, and babies can be tested early on and put on treatment in
time. This is far from the reality in developing countries.

The needs are enormous, and MSF is only touching the tip of the iceberg.
But as long as there is no simple and affordable diagnostic test to detect
the virus in a newborn, and as long as there are limited treatments
specifically made for children, babies will keep dying before they reach
their second birthday. MSF teams have been urging companies to make
child-strength pills, but the response to date has been entirely
inadequate.

Nine out of ten children born with HIV live in Africa. As there is little
profit in researching and developing HIV/AIDS tests and medicines for
children in poor countries, few companies are investing in this area. MSF
is calling for a massive increase in research and development into tests
that can detect the virus in babies, and into simple child-strength pill
combinations. 'We don't yet have a cure, but AIDS is a treatable disease.
Many more young children could lead relatively normal lives with
appropriate tests and medicines, but millions of children are still
waiting' concluded Dr. Thomas.

MSF currently provides antiretroviral treatment (ART) to over 57,000 people
living with HIV/AIDS in 29 countries. Children make up 6% (3,500) of all
patients enrolled in MSF ART programs

E-DRUG: NEJM: Scaling Up Treatment - Why We Can't Wait
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NEJM Volume 353:2392-2394
December 1, 2005 Number 22

Scaling Up Treatment ‹ Why We Can't Wait
Jim Yong Kim, M.D., Ph.D., and Charlie Gilks, D.Phil., F.R.C.P.

[from Nathan Ford <nathan.ford@london.msf.org>
copied as fair use]
   
Many arguments have been raised over the years to justify not moving rapidly
forward with antiretroviral treatment programs for people living with the
human immunodeficiency virus (HIV) and AIDS in settings with limited
resources. The standard litany included the price of therapy as compared
with the poverty of the patient, the complexity of the intervention, the
lack of infrastructure for laboratory monitoring, and the staggering lack of
trained health care providers. Narrow cost-effectiveness arguments have been
commonplace. False dichotomies ‹ prevention or treatment, rather than both ‹
have too often gone unchallenged. Perhaps of greatest concern several years
ago was the ambivalence ‹ if not the silence ‹ of political leaders and
experts in public health. The cumulative effect was to allow the death of
tens of millions of poor people in developing countries who are living with
and becoming ill as a result of HIV infection. Meanwhile, in countries rich
in resources, HIV infection has largely become a manageable, chronic
condition because of the availability of combination-drug antiretroviral
treatment.

The inequity between rich and poor countries in terms of access to HIV
treatment has rightly given rise to widespread moral indignation, and a few
outstanding leaders have been consistent and courageous in their personal
and public stances. The national program in Brazil has long shown what can
be achieved when there is unswerving political commitment and public health
leadership.1 Some innovative projects pioneered by international
nongovernmental organizations in diverse settings have clearly established
that a very simple approach to antiretroviral treatment with intensive
community engagement and support can achieve remarkable results.2,3 In 2000,
the United Nations Accelerating Access Initiative finally brought the
research-based pharmaceutical industry into play and, with the rise in
generic competition, drug prices have since fallen substantially.4 At the
same time, fixed-dose combinations have become more widely available.5

Building on these lessons, the World Health Organization (WHO) has advocated
a public health approach for treating people with HIV and AIDS in
resource-limited settings. This approach proposes the use of standard
first-line treatment regimens based on a simple five-drug formulary, with a
more complex ‹ and so far, much more expensive ‹ set of second-line
options.6 The steps in decision making for patients (the mnemonic is "the
four S's": when to start, substitute for toxicity, switch for failure, or
stop and move to end-of-life care) have been standardized, and
intensive-training packages for health and community workers have been
developed and implemented in many countries.7

These rapid advances in public health have been matched by unprecedented
opportunities and funding through the President's Emergency Plan for AIDS
Relief (PEPFAR) in the United States, The World Bank, and the Global Fund to
Fight AIDS, Tuberculosis and Malaria. In 2003, the lack of access to
treatment was declared a global public health emergency by the WHO and the
Joint United Nations Programme on HIV and AIDS (UNAIDS), and the two
agencies launched the "3 by 5" initiative, with the ambitious, aspirational
target of having 3 million people receiving antiretroviral therapy in
developing countries by the end of 2005.8 Many countries have since set
corresponding national targets and worked gallantly to embed treatment
within their own national AIDS programs and health systems and to harness
the synergistic connections between treatment for HIV and AIDS and
preventive interventions. The recent communiqué from the Group of Eight,
more commonly known as G8, endorsing universal access to HIV treatment by
2010 is another major step forward.

These encouraging advances mean that there can be no more excuses for not
expanding global access to antiretroviral treatment. Solid progress has been
made ‹ with approximately 1 million people estimated to have been in
treatment by June 2005 ‹ although not at the desired pace.9

Certainly, significant challenges remain. Some skeptics doubt that a high
standard of care can be provided by nurses and community health workers
(rather than scarce highly trained physicians10), although this approach is
now being used successfully in many countries. But we who have worked in
developing countries know that in many settings that are poor in resources,
adoption of a decentralized model of care is essential if health systems are
to overcome serious human-resource constraints and move toward the goal of
monitoring and supporting patients for life. Innovative strategies to
support adherence may be required, but so far, adherence rates in even the
most impoverished settings compare favorably with those of patients in the
United States.11 Drug-supply links are fragile in many countries, but
concerted efforts are now being made to strengthen them, with potentially
great benefits for the provision of other essential medicines. It is now
clear that responding aggressively to HIV and AIDS is critical to
reinforcing health systems as a whole and to achieving broader development
objectives in the coming decade.12

The article by Severe et al. from the Groupe Haïtien d'Etude du Sarcome de
Kaposi et des Infections Opportunistes (GHESKIO) project in this issue of
the Journal13 is particularly important for the contribution it makes to the
still-limited published literature on the scale-up of access to
antiretroviral therapy in settings with limited resources. Port-au-Prince,
Haiti, is one of the most challenging urban centers in the world in which to
implement a major public health intervention. The results, as compared with
those from settings in the United States, are truly remarkable. In a setting
with only limited infrastructure and few staff members, over 1000 patients
are now being treated. After one year of therapy, 87 percent of adults and
98 percent of children were still alive. Dropout rates were less than 8
percent, an outcome that vindicates the decision to link the treatment
program with nutritional supplementation and existing social programs. Of
particular note is the estimated cost per patient in treatment per year:
about $1,600 with (largely generic) antiretroviral medications accounting
for 35 to 40 percent of the total.

What are the tasks ahead for those of us working in these programs? In most
countries where there is a high prevalence of infection with HIV and AIDS,
the number of people in need of treatment still exceeds the capacity to
provide it. Enrollment must be accelerated in both urban and rural settings,
and sufficient quantities of good-quality, affordable antiretroviral
medicines must be guaranteed. In the years ahead, keeping patients on
treatment will be by far the greatest challenge, and information about
evidence-based approaches and best-practice protocols for the management of
chronic diseases in settings with limited resources is sorely needed.
Adherence support, rather than regimen potency, may be the single most
critical determinant of long-term success. Our overall efforts to combat the
epidemic of HIV and AIDS must build on the pace and rhythm that countries
have achieved already in their responses to the concrete treatment goals set
first by PEPFAR and then by the WHO with the 3 by 5 initiative. Most
important, we must bring a rapidly accelerated pace to our prevention
efforts. We must move beyond pilot projects, set clear prevention targets
that are time-limited, and dramatically accelerate our efforts in testing
and counseling. The recent commitment from the minister of health in Lesotho
to offer an HIV test to every person in his country in short order could
build much-needed momentum and provide an example that should be replicated
in other high HIV-burden settings.

It has often been said that our generation will be judged by our response to
the HIV and AIDS pandemic. Although there is much more to do, the GHESKIO
project and the responses from many other developing countries give us hope
that the final judgment may be less harsh than we had feared.

Source Information

From the HIV/AIDS Department, World Health Organization, Geneva.

References

Levi GC, Vitória MA. Fighting against AIDS: the Brazilian experience. AIDS 2002;16:2373-2383. [CrossRef][ISI][Medline]
Coetzee D, Hildebrand K, Boulle A, et al. Outcomes after two years of providing antiretroviral treatment in Khayelitsha, South Africa. AIDS 2004;18:887-895. [CrossRef][ISI][Medline]
Mukhurjee J, Colas M, Farmer P, et al. Access to antiretroviral treatment and care: the experience of the HIV Equity Initiative, Cange, Haiti: case study. Geneva: World Health Organization, 2003.
Accelerating Access Initiative: widening access to care and support for people living with HIV/AIDS: progress report. Geneva: World Health Organization/UNAIDS, June 2002.
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