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[e-med] Nouvelle stratégie SIDA de l'OMS

E-MED: Nouvelle stratégie SIDA de l'OMS
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Cet article du Washington Post annonce que l'OMS s'apprête à lancer sa
stratégie globale de lutte contre le SIDA qui permettrait l'accès à des
associations médicamenteuses 3-en-1 à bas prix à 3 millions de malades. Ces
associations pourraient être fabriquées par des génériqueurs indiens. Mais
évidemment ces génériques risquent fort de se heurter aux brevets toujours
valables de chaque constituant de l'association. On parle de 3TC
(lamivudine), d4T (stavudine) et névirapine que Cipla fabrique déjà pour le
marché indien. On sait déjà que l'administration Bush se heurtera à un
puissant front du refus alors qu'elle lancera son programme de cinq ans de
lutte contre le SIDA en Afrique et ailleurs. On sait aussi que l'industrie
pense que cette association n'a pas été suffisamment testée. Bien sûr l'OMS
mettra en avant la facilité du traitement et la baisse de prix qui
s'établit entre $132 et $240 par patient par an en Afrique du Sud.
[Résumé par Chharles Rambert. Merci]


E-DRUG: new WHO AIDS strategy
-----------------------------
[From the Washington Post, a good write-up of WHO's AIDS policy.
The 3-in-1 fixed dose combination is now the centre of attention.
Copied as fair use. WB
http://www.washingtonpost.com/wp-dyn/articles/A14310-2003Oct24.html]

AIDS Plan Would Cut Drug Costs for Poor
WHO Would Provide 3-in-1 Pill to Nations
By Shankar Vedantam
Washington Post Staff Writer
Saturday, October 25, 2003; Page A01

GENEVA, Oct. 24 -- The World Health Organization will disclose next week
the first details of a global AIDS strategy to bring low-cost drugs to 3
million people in poor countries, a plan that top officials said will
eventually include endorsement of pills that combine three HIV drugs in a
single tablet.

The endorsement of the three-in-one pills is expected to be controversial
because they could violate a variety of patents. Only about 300,000 people
are receiving AIDS medicine in the regions targeted by WHO.

The strategy is also expected to call for treating patients at the first
sign of symptoms, rather than waiting for tests to confirm infection by
HIV, the virus that causes AIDS, and to allow nurses and community
organizations to dispense the medicines. As a first step, WHO will issue a
list next week of the "first line" medicines to be used in poor countries.
One "fixed-dose" combination already is being sold by a generic-drug
manufacturer in India, and several others are in the pipeline.

Health experts here said the single-pill combinations would offer huge
benefits by providing medication that would work for about 80 percent of
patients in an easy-to-use and low-cost form. If the pills proved popular
and effective, the Bush administration could face a politically difficult
choice between high-priced patented drugs and low-cost combination generics
as it implements its own five-year program to fight AIDS in Africa and
elsewhere. Unlike generic AIDS medicines that copy a single drug's formula,
each of the new combination pills could infringe on several patents in one
stroke, taking the conflict between providing lifesaving medicines and
protecting intellectual property rights into uncharted waters.

"If we have this regimen in fixed-dose combinations, it will be the best,"
Paulo Teixeira, director of WHO's HIV/AIDS Department, said in an
interview. "I hope very soon we will have more and more fixed-dose
combinations."

The combination pills are expected to be part of a broad strategy that the
health agency will soon outline to reach its "3 by 5" target. Teixeira and
others said the effort could press ahead without the all-in-one pills, but
such medicines would be the best way to rapidly increase the number of
people receiving lifesaving therapies.

Of the 3 million patients targeted worldwide, nearly 2 million are in
Africa; the rest are scattered across Asia and Latin America. Activist
groups have championed the "fixed-dose" approach. The International
Federation of Pharmaceutical Manufacturers Associations opposes the
approach, however, contending that combination pills have not been
rigorously tested and would make it easier for counterfeit drugs to enter
the market.

The pending WHO announcement will mark the second important development in
days in the effort to increase access to AIDS medicines. On Thursday, the
William J. Clinton Presidential Foundation, founded by former president
Bill Clinton, announced agreements with three generic-drug manufacturers in
India and one in South Africa to dramatically lower the price of AIDS
drugs. Ira Magaziner, chairman of the foundation's HIV/AIDS Initiative,
said three fixed-dose combination pills were covered by the agreement, at
an annual cost of $132 to $240 per patient.

Meeting WHO's goal of providing treatment to an additional 2.7 million AIDS
patients by the end of 2005 means 100,000 people would need to be started
on medication every month. Several officials here privately conceded that
the target is unrealistic, but all said it will spur a long-overdue
international effort. More than 5 million people in poor countries need
AIDS medication but are not receiving it, health specialists estimate.
Teixeira said the ultimate goal is to radically expand access to AIDS
treatment in poor countries.

"We will say, you don't need to get care only from doctors; let's train
nurses, community organizations and families," he said. "We're changing the
paradigm of AIDS treatment." Teixeira is credited for having rapidly
increased access to HIV treatment in his native Brazil. Half of all
patients in poor countries now being treated for AIDS are Brazilians.

The fixed-dose approach has several advantages, as well as a few drawbacks.
Peter Graaff, an AIDS medicine policy expert at WHO, said the biggest
advantage may be in getting people to take the medicine on the right
schedule. Taking combinations of separate pills can be difficult, and
supply problems with any one medicine can upset the entire regimen, he
said. That could make it more likely that patients would develop and pass
along resistant strains of the virus. However, some patients on fixed-dose
medicines may experience side effects caused by just one of the medicines
in the combination, Graaff said, and packaging the drugs in a combination
tablet would limit the flexibility to switch patients to a different drug
combination.

One combination medicine, called Triomune, developed by the Indian
pharmaceutical company Cipla, is being used in Africa. It combines the
medicines 3TC (lamivudine), d4T (stavudine) and nevirapine. India is not
part of the global system on intellectual property rights, but is expected
to sign on by 2005. Under recently negotiated exceptions to the patent
system, poor countries can allow local manufacturers to duplicate
lifesaving generic medicines, and to export them after completing
arrangements that carve out limited exceptions to patents.

Negotiating those "compulsory licensing" arrangements is expected to be
much more complicated for the fixed-drug combinations. Thomas Kanyok, who
works in a WHO program that develops medicines for poor countries, said the
threat of compulsory licensing could prompt multinational pharmaceutical
companies to develop their own fixed-dose combination medicines or license
other manufacturers to make them.

The other large variable in the equation is the U.S. government, which has
pledged $15 billion to fight AIDS in Africa and the Caribbean over five
years.

"Will that be used to buy generics, or will there be stipulations to buy
from a U.S. manufacturer?" Kanyok asked. Harvey Bale, director general of
the international pharmaceutical federation, said that generic fixed-dose
combination drugs have not being thoroughly tested and that WHO's
endorsement would encourage counterfeit drugs.

"We're going to start treating 3 million by 2005," he said. "The question
is, are we going to help 3 million by 2005?" But Ellen 't Hoen, spokeswoman
for the Campaign for Access to Essential Medicines of the nonprofit group
Doctors Without Borders, said combination pills are essential to fight AIDS
in poor countries. "WHO would have to say that this is the way to go," she
said. "That implicitly says that patents shouldn't stand in the way."

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