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AIDS Drugs, Prices Cut 90%, Out of Reach for Neediest (Update1)

By Carey Sargent and Marni Leff Kottle

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.''

To contact the reporter on this story: Carey Sargent in Geneva at csargent3@bloomberg.net.

Last Updated: August 14, 2006 10:21 EDT

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