[Ip-health] Bloomberg: AIDS Drugs, Prices Cut 90%, Out of Reach for Neediest

[Sheila.SHETTLE@geneva.msf.org]

 AIDS Drugs, Prices Cut 90%, Out of Reach for Neediest

Aug. 14 (Bloomberg) -- Ibrahim Umoru, infected with the lethal virus that
causes AIDS, spent four hours a day this year traveling between his home
and a clinic in Lagos, Nigeria, to get the pills that keep him alive.


Umoru, 42, no longer has to make the trip. Since July 28, he's been getting
a new version of medicine that doesn't require the clinic's refrigeration.
Umoru says he knows he's lucky. Just 5 percent of the 200,000 people in
Lagos who need the lifesaving drugs can get them, largely because of high
prices.


Only one in five of the 6.5 million people in impoverished nations who need
medicines to treat HIV, the virus that causes AIDS, get the drugs that can
keep the virus from killing them. Starting in 2000, in response to pressure
from health activists worldwide, drugmakers such as GlaxoSmithKline Plc and
Merck & Co. have repeatedly slashed prices, which started as high as
$10,000 a year. Even with discounts amounting to 90 percent and more, few
poor nations or their residents can afford the lifesaving drugs.


``There's a wide, wide gap between what's needed and what's being
provided,'' says Jens Wenkel, a physician who works with Doctors Without
Borders in Lagos and helps treat Umoru. ``Everyone talks about scaling up
but the process is very slow.''


Health workers in Africa and Asia say prices must drop further and
international aid to the poorest countries must increase if the death rate
from the AIDS epidemic is to be reduced soon. Though drugmakers initially
resisted pleas from the United Nations to lower prices or even give away
the medicines, first introduced in 1996, the companies now say they are
doing all they can to help.


Toronto Meeting


``We've taken profits off the table, we've taken patents out of the room,
and we'll provide manufacturing know-how,'' says Bill Burns, head of
pharmaceuticals at Basel, Switzerland-based Roche Holding AG. ``I'm not
sure there's much more we can do.''


About 24,000 scientists, health officials and company executives are
meeting in Toronto this week at the 16th International AIDS Conference.
Health workers and government officials say they will press the principal
makers of AIDS drugs -- Merck, Glaxo, Roche, and Gilead Sciences Inc. -- to
lower prices further and seek approval for medicines in more countries.
They will also call for additional funding from rich nations to help buy
the drugs.


The AIDS virus has killed more than 25 million people since it was first
recognized in 1981. The World Health Organization set a target in 2003 of
providing drug treatment to 3 million people in developing countries by the
end of 2005. That effort has fallen 1.7 million short. A new goal of 10
million people by 2010 also may be unrealistic unless prices come down and
donations rise, activists say.


Transforming the Disease


About a dozen different anti-AIDS drugs have been developed since the
mid-1990s. Many are used in daily combinations of three or more at a time.
The medicines don't cure AIDS or eradicate the virus from the body. They
can transform the disease from an imminent threat to a chronic condition
and have done so in richer nations where the drugs are covered by insurance
or government plans.


In sub-Saharan Africa, including countries such as South Africa, Zambia,
and Tanzania, the therapy is too expensive, even at reduced prices.


Access to the medicines makes a difference. UNAIDS estimates that the AIDS
death rate is 8.2 percent in sub-Saharan Africa, where about 2 million of
the 24.5 million people infected with the virus died last year. This
compares with a death rate of 1.5 percent in North America, Western and
Central Europe, where about 30,000 of the 2 million people infected with
AIDS died in 2005.


Price Cuts, Licensing


Five AIDS-drug makers, Merck, Glaxo, Roche, Bristol-Myers Squibb Co., and
Boehringer Ingelheim GmbH joined with the UN in 2000 to form the
Accelerating Access Initiative as a way to get more medicines to the needy.
The program, expanded to include Abbott Laboratories in 2001 and Gilead in
2004, has helped to bring down prices for a standard combination treatment
of three medicines to about $130 to $140 a year in the poorest countries.


For some victims, the drugs still remain out of reach. In Nigeria, about 91
percent of households live on less than $2 a day, according to the
International Treatment Preparedness Coalition. The Cape Town, South
Africa-based group says out-of- pocket costs for people getting drug
therapy at public clinics in the country are about $300 annually.


Pressure to cut prices has come from groups such as the New York-based
Clinton Foundation, set up by former U.S. President Bill Clinton. The
charity negotiates bulk-buying deals between poor nations and generic
drugmakers such as Ranbaxy Laboratories Ltd., based in Gurgaon, India.


Avoid Losing Money


As a result of lobbying by such activists and the UN, Whitehouse Station,
New Jersey-based Merck now sells a year's supply of its Stocrin medicine
for $277.40. This is higher than the $240-a-year maximum price for a
generic version negotiated by the Clinton Foundation.


The price is comparable to what the generic makers demand after shipping
charges are factored in, says Jeffrey Sturchio, Merck's president of
external affairs.


Until 2000, drugmakers including Merck said discounting medicines wouldn't
increase access significantly because many poor nations lack health
services required to distribute the treatments. Now, most AIDS drugmakers
offer ``no-profit'' prices. This policy leads to sustainable low prices,
says Jon Pender, director of government affairs at London-based Glaxo.


No `Short-Term' Fix


``We're not looking for short-term fixes, and that's why we don't donate
our medicines,'' he says. ``With no profit and no loss we can continue to
supply these medicines as needed. And they're going to be needed for a long
time.''


Companies also have been selecting corporate partners that may be able to
produce the medicines for local markets at lower prices than the big
drugmakers charge.


Glaxo was the first to do this, in 2001, when it agreed to allow Aspen
Pharmacare Holdings Ltd. of Johannesburg to manufacture its HIV medicines.
Glaxo now has agreements with eight generic-drug makers, including Ranbaxy,
India's biggest pharmaceutical company.


Foster City, California-based Gilead, New York-based Bristol-Myers and
Roche have introduced plans in the past few months to instruct generic-drug
makers how to manufacture their medicines. In February, Bristol-Myers
agreed to let Aspen and Pune, India-based Emcure Pharmaceuticals Ltd. make
generic versions of its Reyataz anti-AIDS medicine.


Manufacturing Partners


Gilead said in May it plans to work with drugmakers in India to produce
versions of its tenofovir medicine, also known as Viread. Roche is in the
process of selecting partners in least- developed countries and sub-Saharan
Africa to make generic versions of its Invirase medicine.


Meanwhile, rising contributions from rich nations also are spurring drug
use. The U.S., through the so-called President's Emergency Plan, aims to
deliver anti-HIV medicines to 2 million people by 2009. As of October 2005,
the program was supporting therapy for about 471,000 people living with
HIV.


As a result of the company price cuts and the higher donations and spending
by some affected countries, such as Botswana, drug therapy was received by
1.3 million people in low- and middle-income countries last year, or five
times more than in 2001, according to the Geneva-based WHO.


Yet, in India, which the UN says may soon have the world's largest
population of people living with HIV, only 7 percent of those who need
treatment are getting it. The UN estimates that about 5.7 million people in
India are infected with the disease.


The drugmakers ``are genuinely trying,'' says Anil Soni, director of
pharmaceutical services for the Clinton Foundation. ``I think they could do
more.''


Stephen Lewis, the United Nations' special envoy for HIV/AIDS said generic
competition rather than efforts by drugmakers was behind the dramatic fall
in prices.


``With all due respect, I don't think the AAI has had much of an impact at
all,'' he said yesterday.


Government Approval


Companies can help further by making it easier for programs like Doctors
Without Borders, an international medical aid organization based in Paris,
to get medicines to programs in poor nations, says Gina Bark, who works at
their Lagos site.


She says she spent six months working with Abbott to get Umoru the new
version of the HIV medicine Kaletra that doesn't need cooling, called
Aluvia, because the Abbott Park, Illinois- based drugmaker hadn't sought
Nigeria's approval.


In March, Marta Darder, who works at a Doctors Without Borders project in
Khayelitsha, South Africa, had to ask patients who had been given Gilead's
Viread to come back so they could share their pills with others. A shipment
delay caused by the need for special importation permission led to short
supplies. Only 60 percent of the patients have any regular access to
telephones, she says.


Abbott and Gilead say they're trying to get the drugs registered in a
number of countries so local facilities can order them more easily.


`Emerging Epidemic'


``We're expediting approval as quickly as we can, but it takes time to get
registered in the developing world,'' says Abbott spokeswoman Jennifer
Smoter.


Abbott said yesterday it will boost manufacturing capacity to get Aluvia to
more patients in poor countries rather than working with generic-drug
makers that often make medicines more cheaply. It also plans to cut the
product's price to $2,200 a year in 45 low and middle income countries.
Previously, the drug was available for $3,000 to $6,000 a year in those
countries.


Price is likely to remain an issue despite the discounts. AIDS is spreading
in countries such as China, which aren't eligible for the lowest prices
negotiated by the UN's access initiative. While the majority of new AIDS
patients are in sub- Saharan Africa, the UN said in November that the
disease is an ``emerging epidemic'' in China.


Classified as lower-middle-income countries by the World Bank, neither
China nor Brazil, which is home to more than one- third of the 1.8 million
people living with HIV in Latin America, qualifies for the lowest prices.
The lower-middle-income designation is given to countries with gross
national income of between $876 and $3,465 per citizen.


Adam Li, 31, became HIV-positive at 18 and now takes a mix of Abbott's
Kaletra and Gilead's Truvada, a pill that combines the company's Viread and
Emtriva medicines.


`Dire, Very Dire'


The drug cocktail costs more than 8,000 yuan ($1,003) a month, equal to an
office worker's wages. Most of China's estimated 650,000 AIDS patients
can't afford this treatment, he says.


Li, who founded the Mangrove Support Group to raise HIV awareness in China,
says his drugs are sponsored by Los Angeles, California-based AIDS
Healthcare Foundation.


``The situation is dire, very dire,'' says Li. ``Chinese AIDS patients
can't afford these U.S. patented drugs.''


The same issue arises in similar countries that are neither the richest nor
poorest. At 60 cents a pill, Roche's Viracept costs about twice as much in
such countries as it does in the poorest nations. The company charges the
equivalent of 29 cents a pill for its 250 milligram dose of Viracept in the
poorest countries while each pill costs about $2.10 in the U.S., according
to Drugstore.com.


Brazil's Costs


Drugmakers say that governments with more money to pay should pick up some
of the costs of providing more access. The Brazilian government does pay
for drugs for everyone infected with HIV, yet the costs are so high that
money is being drained from important educational and economic programs,
the Clinton Foundation's Soni says.

``It's not like they're not putting up their own money,'' Soni says.
``They're not asking for charity. Sixty-six percent of Brazil's health-care
budget goes to paying for three drugs: Kaletra, Viread and Stocrin.''

+++++++++++++++++++++
at Toronto AIDS Conference:  +1.416.455.7916
+++++++++++++++++++++
Sheila Shettle
Communications Officer
M=E9decins Sans Fronti=E8res
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