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If you can’t pay, you’ll die

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Expensive drugs and a lack of funds complicate the fight against AIDS – By Corinna Arndt

More HIV-positive Africans have been developing resistance to classic drug regimens and are unable to afford more effective medication. But the pharmaceutical companies are refusing to give in.

Thembisa Mkhosana, 36, looks like a woman who is, to use a well-worn cliché, in the prime of life. Self-confident with laughing eyes, she has a way of walking that turns men’s heads. It is impossible to see that she’s HIV positive – thanks to anti-retroviral drugs.

Mkhosana is living proof that HIV does not mean that people measure their lives in weeks instead of years. She herself has passed this message on to others, in her work as an activist in the clinics in her hometown of Khayelitsha, the largest of the townships outside Cape Town. But she stopped going to work a few weeks ago. “My blood test results have worsened dramatically,” she said, nervously kneading her hands. “And now I suddenly have fever and am in pain. I’m really worried.”

The mother of two children has more than just fever. She has full-blown AIDS because the drugs she had been taking no longer work. Her doctors know that she will die and so does she. “They say I should just keep on taking my pills. There are no others to be had.”

Since 2004, South Africa – which has the world’s largest HIV-positive population – has provided its people with free AIDS drugs. If patients become resistant to the drugs, they receive a second-line treatment. “Any further resistance means the end,” Gilles van Cutsem, the program director of Doctors Without Borders (MSF), said. The humanitarian organization runs one of Africa’s oldest AIDS programs in Khayelitsha. That puts it at the forefront of the battle against the disease, a battle that is far from won while funds have been running low recently.

The Global Fund, the UN-backed public-private partnership that battles AIDS, faces a more than €2-billion funding shortfall. “We’re heading straight for a disaster,” van Cutsem said. “And the only reason is because the rich countries are not keeping their promises – they’re not paying enough money.” He is referring to the internationally agreed-upon target of the UN Millennium Development Goals, which stipulates that everyone in the world with AIDS will by 2010 have access to treatment and drugs. This is a goal that G-8 nations – including Germany – had committed to.

Even though substantial sums have been paid into the fund so far, demand has been growing faster than available cash. And donor countries have been rather reluctant to respond to calls to significantly increase their contributions – in part because of the financial crisis.

Doctors Without Borders, meanwhile, has already documented the consequences of the gap in funding for six African countries. In 2009, Tanzania received 25 percent less money to combat AIDS than it did in 2008. Many clinics in Uganda are no longer accepting any patients. And in many places in Malawi, pills are running out. Worldwide, about seven million people remain without access to AIDS drugs.

Cutting back programs at this point would be an “unprecedented” step backward, van Cutsem said: “In Europe, people may lose their jobs because of the economic crisis. In Africa, they lose their lives.” From his modest office on the second floor of a building in Khayelitsha, he looks out at a small market square with flimsy shacks of wood and cardboard. Every third person there carries the HIV virus, he says.

The program in Khayelitsha serves as a model for Doctors Without Borders and offers a glimpse into Africa’s potential future. The organization has just carried out a new study. Mkhosana is a part of this statistic, since 16 percent of all patients develop resistance against their first course of treatment. A quarter of these patients then no longer react to the second regimen. While an effective third course of treatment exists, it is not part of South Africa’s public health system. “The drugs aren’t officially registered here and they are incredibly expensive,” van Cutsem said. These drugs cost about €2,000 a year per patient compared to about €55 for the first course of treatment.

The rest of the continent now faces the same threat as what is occurring in Khayelitsha, where an increasing number of AIDS patients have developed resistance and died – a tragically ironic consequence of well-run AIDS programs. The situation mirrors that of a decade ago when the first AIDS drugs cost a small fortune, and when even experts thought it was utopian to develop a comprehensive treatment plan for Africa.

The basic issue has not changed. Drug companies have patented new drugs and generally sell them for the highest-possible price. Africa, a poor continent, is not viewed as a good customer, said van Cutsem. So the companies are asked time and again to lower their prices and are in no hurry to push through licensing for their drugs in developing countries. This not only leads to more deaths, it also drives up the costs for AIDS programs, he added. In the end the international community ends up paying more for programs it is largely funding in the first place.

“It is high time that pharmaceutical companies possessing patents for urgently needed AIDS drugs drastically lowered their prices in Africa and allowed their drugs to be registered in countries where they have yet to be registered,” van Cutsem said. According to MSF spokesman Stephan Grosserüschkamp, this applies in particular to drugs whose patents are held by companies such as Gilead (Tenofovir), Merck (Raltegravir, Efavirenz), Bristol-Myers Squibb (Atazanavir), Abbott (Lopinavir, Ritonavir), Tibotec (Darunavir) and Johnson & Johnson (Etravirine).

Taking the example of Tenofovir: The World Health Organization recommends the drug as a first-line treatment. But even in countries where a generic version of the drug is available, the tablets cost at least twice as much as an $80 (€56) American alternative considered obsolete and with serious side effects. And yet this cheaper drug is still considered standard in many African countries. In countries where the patented original is the only drug available, the costs rise to more than €700 per person annually.

Cheaper and better access to Tenofovir would not only sharply reduce the costs of AIDS programs – and spare poor patients the severe side effects of obsolete medications – it would also mean that fewer people would later develop drug resistance, according to van Cutsem.

The pharmaceutical firm Gilead – the patent holder for Tenofovir – points out that it has been offering discounted prices to developing countries since 2005 and that it is cooperating in some countries with the producers of generic drugs. More than 500,000 patients in poorer nations are currently being supplied with Tenofovir. “That’s about 13 percent of all people who need the pills,” Gilead spokeswoman Polly Ruettgers said.

Given the company’s tough stance, MSF was relieved when India followed in Brazil’s footsteps and refused to grant a patent to Tenofovir. Patients can now hope for lower prices in these markets because generic drugs will now go into production.

Abbott (which produces Lopinavir and Ritonavir) and Merck – with its newly developed and important drug called Raltegravir – reacted in a similar fashion. They said they were willing to help the poorest AIDS patients but refused to comment on potential future price cuts for their products in Africa. And they also drew attention to existing discounts for developing nations.

Van Cutsem says he welcomes each of these steps in the right direction but that they are far from enough. Besides, the problem is not just limited to the few companies mentioned here. MSF, for instance, has called for all AIDS drugs currently recommended by the WHO, as well as all newly developed medicines, to be collected in an international patent pool by the UN-supported organization UNITAID. This would allow companies around the world to make their own version of the drugs. Major companies would have to give up their lucrative patent rights – instead having to be content with smaller but fairer profits from licensing fees.

Gilead and Merck have expressed cautious support for the project, while Abbott said any participation would have to be voluntary. None of the three companies have been willing to make a firm commitment, however. But Van Cutsem thinks the patent pool is absolutely necessary: “If we don’t succeed then I’m afraid we’ll have to protest again next year to make another company take another little step. The same thing will happen in five years, and in 10 years.”

But his patients cannot wait such a long time. Those like Mkhosana,  lack the money to buy the pills that would help them survive. Mkhosana recently attended an international conference in Cape Town where AIDS activists accused the pharmaceutical industry of price gouging. Industry employees, whose supposed aim is to work for the benefit of all of humanity, remained silent. Some even quietly slipped behind big advertising billboards – until the protesters had left the area.


Easier access to AIDS medication

Starting mid-2010, a so-called “patent pool” is to help poorer countries get easier access to new and more effective AIDS medication, announced UNITAID in Geneva. The pool will make 19 patented medications from nine different pharmaceutical companies available to generic manufacturers after they pay a licensing fee. Up till now, only first generation AIDS medication cocktails are available in developing countries. Newer medicines, which have been available in developed countries for some time, are patented and therefore more expensive and not available everywhere. This becomes an issue once the virus becomes resistant to the older medications. UNITAID estimates that €700 million each year can be saved through the pool. Founded in 2006 through the initiative of France and Brazil, UNITAID focuses on making medications for HIV/AIDS, malaria and tuberculosis available at lower prices. One of the ways it finances itself is through a solidarity fee put on plane tickets in eight nations, including France and South Korea.