[e-med] (2)Appel à signature: lettre ouverte au coordinateur américain

[remed@remed.org]

E-MED:(2)Appel à signature: lettre ouverte au coordinateur américain
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[Modérateur: vous pouvez renvoyer la lettre précédente en français signée à
pdavis@healthgap.org Il s'agissait en fait d'une traduction de la lettre
ci-dessous qui a été publiée sur Ip-Health. Vous trouverez après la lettre
de MSF. Mes excuses pour avoir confondu les deux lettres.CB]

26 March 2004

Ambassador Randall Tobias
Global AIDS Coordinator
U.S. Department of State
Washington, D.C.

Dear Ambassador Randall Tobias,

We, the undersigned organizations, are writing to express our serious
concerns about efforts by the Bush administration and by your office
to block the use of affordable generic HIV/AIDS medicines in U.S.-financed
programs in poor countries. In order to mount a rapid and successful
response to the growing AIDS pandemic, we call upon you to ensure that
programs use the most affordable medicines available, and accept the
current drug quality standards of World Health Organization's drug
prequalification program.

We are particularly concerned about the U.S.-initiated "Conference on
Fixed-Dose Combination (FDC) Drug Products: Scientific and Technical
Issues related to Safety, Quality, and Effectiveness," 29-30 March 2004
in Gaborone, Botswana. This meeting needlessly casts doubt upon the
clinically proven quality of generic AIDS medicines, and disregards the
WHO's internationally recognized Drug Prequalification Program. The
meeting is intended to create a justification to use only expensive, less
effective branded drugs in international assistance programs, and will be
used by the US to justify its efforts to use bilateral assistance
programs to lock generics out of developing countries. Of particular
concern is your attempts to discredit the use of urgently needed fixed-
dose combinations (FDCs) of antiretroviral AIDS medications.

Single-pill combinations promote adherence, decrease the risk of
resistance, and facilitate stock and procurement management, and are
widely recognized as a core element in efforts to scale up ARV treatment
in developing countries. FDCs are strongly preferred over blister packs
and other multi-pill regimens. In addition to ease of use and other
advantages, FDCs, which are taken in the form of one pill twice a day,
are also by far the least expensive option: today, triple FDCs from
generic manufacturers are available for as little as $140 per person
per year. The same combination from brand-name companies costs a minimum
of $562 per person per year and must be taken in the form of six pills
a day. Forcing people with HIV/AIDS to accept higher pill burdens,
wasting limited taxpayer resources on brand name products, and, most
importantly, using scarce resources to treat one person when the
same amount of money could treat four is unacceptable.

If the ambitious goals of the President=B4s Emergency Plan for AIDS
Relief (PEPFAR), and the WHO's "3 by 5" initiative are to be met,
triple combination FDCs pre-qualified by WHO must be made widely
available.

FDCs are recommended in WHO treatment guidelines, and several generic
FDCs have been certified by WHO as meeting stringent international
standards for drug quality, safety and efficacy through its
Prequalification Project. The WHO's standards for prequalification
are supported by UNICEF, the World Bank, the Global Fund to Fight
AIDS. TB, and Malaria, Columbia University's MTCT-Plus program, many
national governments in developing countries, international
humanitarian organizations such as M=E9decins Sans Fronti=E8res (MSF),
and other programs with experience treating people living with HIV.
Clinicians in resource poor settings are already using triple combination
generics with tens of thousands of patients, with efficacy and adherence
rates equal-to-or-better than treatment success and adherence rates in
the United States.

Rather than disregarding the drug procurement policies of developing
nations to creating expensive new barriers that benefit US drug companies,
your office should accept the WHO's internationally recognized drug
quality standards and promote access to affordable medications.
We object to any and all efforts by the Bush Administration and your
office to block the use of WHO prequalified generic medications, and
any efforts to discredit the standards of WHO's prequalification
project that would impose new barriers to generics entering the
global market.

Paul Davis
Health GAP (Global Access Project)
e: pdavis@healthgap.org
t: +1 215.833.4102 (mobile)
f: +1 215.474.4793
w: www.healthgap.org

on déjà signé
Signed,

International Organizations
Act Up-Paris, France
Action for Southern Africa (ACTSA), UK
Agua Buena Human Rights Association, Costa Rica
AIDS ACCESS Foundation, Thailand
Australian People for Health, Education and Development Abroad
(international humanitarian agency of the Australian Council of Trade
AVERT - Averting HIV and AIDS Worldwide, UK
Canadian African Partnership on AIDS (CAP-AIDS), Canada
Canadian HIV/AIDS Legal Network, Canada
Canadian Union of Public Employees (CUPE), Canada
CARE Raks Thai Foundation, Thailand
Center for Information and Advisory Services in Health, Nicaragua
Centers of Excellence- Substance Abuse & HIV/AIDS, India
Centre for International Health (CIH) of the Macfarlane Burnet institute fo=
r
Medical Research and Public Health, Australia
Difaem - German Institute for Medical Mission. Germany
Discipline of Clinical Pharmacology, Faculty of Health, University of
Newcastle, Australia
Freedom Foundation-India
Health Issues Centre, Australia
Ipas Mexico A.C., Mexico
Kenya Treatment Access Movement, Kenya
McGill International Health Initiative, Canada
People Living With HIV/AIDS New South Wales, Australia
Regional Committee for the Promotion of Community Health, Nicaragua
RESULTS, Canada
Social Welfare Association for Men (SWAM), India
Spiritia Foundation (Indonesian Peer Support Network for PLHAs), Indonesia
Unions), Australia
Women's Dignity Project, Tanzania

International organizations, multi-country
International Planned Parenthood Federation, Western Hemisphere Region,
Int=B9l - USA/NY
AIDSETI - AIDS empowerment & Treatment International, Int=B9l =AD USA/DC
Sisters of Maryknoll AIDS Task Force, USA/DC
Artists for a New South Africa, Int=B9l/USA-CA
Health Alliance International, Int=B9l =AD USA/WA
Australasian Society for HIV Medicine, Int=B9l/Australia
The River Fund, Int=B9l =AD USA/FL
INTERSECT Worldwide, Int=B9l-USA
WE-ACT - Women's Equity in Access to Care & Treatment, Int=B9l =AD USA/CA
Interact Worldwide, Int=B9l =AD UK
International Peoples Health Council, Int=B9l

Nationwide US Organizations
50 Years Is Enough: U.S. Network for Global Economic Justice, USA
ActionAid International USA
Africa Action, USA
Africa Faith and Justice Network, USA
AIDS Treatment Data Network, USA
American Jewish World Service, USA
American Medical Students Association, USA
Center for Health and Gender Equity (CHANGE), USA
CHAMP, USA
Corporate Responsibility Program, Province of St. Joseph of the Capuchin
Order, WI, USA
Essential Action, USA
Global AIDS Alliance, USA
Health GAP (Global Access Project), USA
Health Professional Student AIDS Advocacy Network, USA
Maryknoll Office for Global Concerns, USA
Medical Mission Sisters' Alliance for Justice, USA
National Association for Victims of Transfusion-Acquired AIDS (NAVTA), USA
National Minority AIDS Council (NMAC), USA
Operation USA
Student Global AIDS Campagn, USA
Treatment Action Group, USA
Washington Office on Africa, USA
Women's International League for Peace and Freedom, United States Section

US Local and Regional Organizations:
ACT UP East Bay, CA
African Services Committee, NY
AIDS Action Baltimore, MD
AIDS Policy Project, PA
Gay Men's Health Crisis (GMHC), NY
HIV Law Project, Inc, NY
Migration & Refugee Services, Diocese of Trenton, NJ
NCATA (NW Coalition for AIDS Treatment in Africa), WA
Office for Religious Diocese of Scranton, PA
Pediatric HIV/AIDS program at The Children's Hospital of Philadelphia, PA
Philadelphia International Action Center, PA
Planet Poz, NM
New Mexico POZ Coalition, NM
RESULTS Seattle, WA
Sisters of St. Joseph of Carondelet, St.  Louis Province, MO
Survive AIDS, CA

********************

-----Message d'origine-----
De : Kate Evans [mailto:KateEvans@newyork.msf.org]
Envoyé : mardi 23 mars 2004 16:12
À : e-drug@usa.healthnet.org
Objet : [e-drug] Open letter to Tobias & Thompson re FDC Meeting


<OFCDC57CBF.D5963067-ON85256E5F.0080C757-85256E5F.00812A04@msf.org>
Sender: owner-e-drug@usa.healthnet.org
Precedence: bulk
Reply-To: e-drug@usa.healthnet.org

E-DRUG: Open letter to Tobias & Thompson re FDC Meeting
-------------------------------------------------------

                     OPEN LETTER TO THE US ORGANIZERS OF
       THE Conference on Fixed-Dose Combination (FDC) Drug Products
                  Gaborone, botswana on March 29-30, 2004


March 22, 2004

To: Ambassador Randall Tobias and Secretary Tommy Thompson,

We are writing on behalf of Doctors Without Borders/Médecins Sans
Frontières (MSF) to seek clarification on the objectives of the Conference
on Fixed-Dose Combination (FDC) Drug Products, which you initiated, that
will take place on March 29-30, 2004, in Gaborone, Botswana, and to request
that there be space added to the agenda for the presentation of actual
field experience using FDCs, including clinical outcomes, and the
identification of concrete strategies for increasing access to affordable
FDCs.  Space for such presentations must not be limited to the period for
â??general commentsâ?? and should include representatives of
non-governmental
organizations and associations of people living with HIV/AIDS from the
region for whom the registration fee must be waived.

We would also like to see space on the agenda for promoting the development
of future FDCs that are urgently needed from a medical point of view,
including, for example, FDCs that can be used in both women of
child-bearing age and patients co-infected with TB, as well as pediatric
FDCs.

The availability of FDCs of antiretrovirals (ARVs)â??pills containing two or
three AIDS drugs in one tabletâ?? is a reality and has dramatically improved
the ability of treatment programs in poor countries to scale up access to
ARVs and to reach people in remote settings. MSF is currently providing
antiretroviral therapy (ART) to more than 11,000 people living with
HIV/AIDS in over 20 countries in Africa, Asia, Latin America, and Eastern
Europe, and expects the total number of patients on ARVs to reach 25,000 in
25 countries by the end of 2004.  Over 50% of our current patients and over
70% of those newly enrolled are starting treatment using WHO-recommended
triple FDCs.

Because FDCs promote adherence, decrease the risk of resistance, and
facilitate stock and procurement management, they are widely recognized as
being a key element in efforts to scale up ARV treatment in developing
countries.  They are also significantly less expensive than originator
companies´ products, which are not available in fixed-doses.  The
above-mentioned advantages of FDCs are also valid for the treatment of
other diseases such as malaria and TB.

FDCs are recommended in WHO treatment guidelines and several FDCs,
including those from generic producers, have been certified by WHO as
meeting stringent international standards for drug quality, safety and
efficacy through its Prequalification Project.  A recent meeting on FDCs
held on December 16-18, 2003 organized by WHO, which documented some of the
field experience with FDCs to date, came out in strong support of the use
of FDCs and endorsed the WHO-managed UN Prequalification Project to help
support the procurement of effective and safe medicines of quality.

The most affordable ARVs produced today, including FDCs, are produced by
generic companies based in developing countries. However recent public
statements by the US administration, the initiator of this conference,
regarding generic medicines seem to indicate a troubling lack of support
for WHO prequalified generics, including FDCs. The U.S. Global AIDS
Coordinator has made several public remarks, which question the quality of
generic ARVs, undermine international quality standards set by the WHO, and
infer that providers of ARV treatment in developing countries who use
generics may be endangering their patientsâ?? lives.

In light of the above, we question what this meeting will add to the
processes that are already underway and whether it will in any way
contribute to the urgent task of expanding access to affordable essential
medicines for HIV/AIDS and other illnesses.

We request a response to this letter by no later than Wednesday, March 24,
at 5:00pm EST.  Thank you in advance for your response.

Sincerely,

Ellen ´t Hoen, Director, MSF Campaign for Access to Essential Medicines
Eric Goemaere, MD, Head of Mission, MSF South Africa
Kris Torgeson, Acting Executive Director, MSF-USA

cc:   UNAIDS
        WHO
        SADC
_____________________________________________________________________
Kate Evans
Program Associate, Campaign for Access to Essential Medicines
Doctors Without Borders/Medecins Sans Frontieres (MSF)
333 7th Ave, 2nd Floor *New York, NY *10001-5004*USA
Tel: +1-212-655-3773
Fax: +1-212-679-7016
E-mail: kate.evans@newyork.msf.org

http://www.doctorswithoutborders.org
http://www.accessmed-msf.org

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