E-DRUG: MSF on tenofovir: false promises by Gilead?
---------------------------------------------------
[Press release by MSF on tenofovir; WB]
Gileads Tenofovir Access Program For Developing Countries:
A Case of False Promises ?
Denver, CO-February 7, 2006 As AIDS experts gather this week in Denver to
discuss advances in treatment at the 13th Conference on Retroviruses and
Opportunistic Infections (CROI), Doctors Without Borders/Médecins Sans
Frontières (MSF) is concerned that innovations from years ago are still not
reaching people in developing countries. More than three years after Gilead
Sciences first announced its Access Program for tenofovir, this key
antiretroviral medicine remains largely unavailable in developing
countries.
Marketed as Viread® (tenofovir disoproxil fumarate) in the United States,
tenofovir was approved by the US Food and Drug Administration more than
four years ago and is now an important option for antiretroviral treatment
for both AIDS patients starting therapy for the first time, and those that
require access to newer drugs a few years down the line, particularly
because it has fewer side effects than older antiretrovirals.
As Gilead is the sole producer of tenofovir (no generic versions have been
internationally validated), MSF and others are dependent on the willingness
of the company to make this urgently needed drug widely available. In
December 2002, Gilead announced that tenofovir would be available at a
reduced price initially to 68, and then to 97 developing countries through
its Viread Access Program. Over three years later, tenofovir is registered
for use in only six of these countries the Bahamas, Gambia, Kenya,
Rwanda, Uganda, and Zambia. The company has failed to request marketing
clearance or otherwise make their drugs available in most developing
countries.
Gilead is proud to show physicians and shareholders how effective
tenofovir is in treating AIDS, but other than issuing press releases and
empty promises, the company has done little to ensure that the medicine is
available to those who need it most in developing countries, said Dr.
Alexandra Calmy, AIDS specialist with MSFs Campaign for Access to
Essential Medicines, attending CROI in Denver this week.
In South Africa, Gilead only completed its registration application in
November 2005, three years after it announced the price reduction for
selected developing countries. Considering the average time between filing
and approval of a drug registration application in South Africa, this means
the drug is unlikely to reach patients before 2007. Thats a five-year gap
between Gileads announcement and availability in the country.
To obtain the drug for patients in South Africa today, MSF physicians
running AIDS treatment programs are forced to go through a series of
burdensome procedures, like providing the name of each patient needing the
drug, in order to import tenofovir directly from Gilead in California under
a special authorization of South African law.
The complicated application process and in particular the difficulties and
added expense of shipping from California means that the vast majority of
physicians in South Africa will not have access to tenofovir. And if
shipments get delayed, we will also be faced with the painful reality of
needing to ration the drug. said Dr. Eric Goemaere, head of mission for
MSFs HIV/AIDS treatment project in Khayelitsha, outside of Cape Town.
Gilead does not consider Thailand as an Access Country and has, to date,
not marketed the drug there. When MSF met with the Gilead representatives
at the International AIDS Conference here in Bangkok back in July of 2004,
they assured us they would register the drug right away, said Dr. David
Wilson, medical coordinator for MSFs AIDS treatment programs in Thailand.
18 months later, we are still waiting.
If Gilead waits to register tenofovir in Thailand until after the
US-Thailand Free Trade Agreement is signed, the company could have five
years of exclusivity on the drug. One cant help but wonder if this is
motivating the delay, Wilson concluded.
MSF is urging Gilead to turn its promises on paper into pills for patients
and make good on its promises.
MSF and HIV/AIDS Treatment:
MSF began providing HIV/AIDS prevention and care services in the 1990s. In
2000, MSF introduced antiretroviral therapy in its projects in Thailand,
South Africa, and Cameroon. Currently, MSF provides antiretroviral therapy
to nearly 60,000 patients in 50 projects in 29 countries.
Contact: Kris Torgeson, +1-917-913-0183 or +1-212-655-3764
---
Sheila Shettle
Communications Officer
Médecins Sans Frontières
Campaign for Access to Essential Medicines
Rue de Lausanne 78
1211 Geneva
Switzerland
+ 41.22.849.8403
sheila.shettle@geneva.msf.org
www.accessmed-msf.org