[e-drug] Open letter to Tobias & Thompson re FDC Meeting

[Kate Evans <KateEvans@newyork.msf.org>]

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