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Sitting in her doctor’s office in at the Chiradzulu clinic in the south of ern Malawi, one of Africa's poorest nations, a young woman called Modesta has only one complaint: having to chew swallow 16 pills a day. It seems a minor concern for someone who As an with HIV victim who was close to death four years ago from Aids, the complications caused by the virus, but now looks healthy and expresses hope for the future.
A In theory, a pledge by the leaders of the G8 Group of Eight leading industrial countries at Gleneagles earlier this last month to achieve “as close as possible to universal access to [HIV] treatment for all who need it by 2010” offers fresh optimism to her and millions of other sufferers in the developing world who until recently had little hope of survival. In practice, as AIDS specialists gather in Brazil later this month and. Yet Her story shows how considerable difficulties remain. the challenges in meeting such an ambitious goal. Few politicians, companies or doctors have yet grasped the enormity of the task. “AIDS is a huge problem,” “There is no real strategic approach, no real global leadership, and the policymakers are avoiding every thorny issue,” says Ellen ’t Hoen, head of Médecins sans Frontières’ campaign for access to essential medicines.
Those aiming to translate the promises into reality face the cost and logistical difficulties of providing drugs to patients like such as Modesta, ensuring they take them properly, developing new medicines as they develop resistance to existing treatments, and limiting the chance that they spread the virus to others. But, with political will has already begun to shifting in favour of an ambitious “scale-up” in HIV treatment efforts, international treatment organisations gear up are preparing for a donors’ conference in London next month that will mark their largest ever ever round of fund-raising.
Along before the G8’s latest statement, with governments, and international organisations had been involved in wide-ranging efforts they are seeking to meet goals set by the World Health Organisation in 2003. With its “3 by 5” programme, the WHO sought by 2005 to sharply increase the number of patients receiving antiretroviral treatment to 3m – the same number who die each year from the infections associated with Aids causes, and half of the world's current estimated 6m sufferers. “Priority number one has to be a massive scale-up,” says Richard Feachem, head of the United Nations-backed Global Fund to fight Aids, TB and Malaria, which channels donors’ support to developing countries to tackle the world’s three top killer diseases.We have to beat back Aids and slow down this tide of death, or the future looks extremely bleak.”
With just 1m on treatment in June, the WHO now admits that its initial “3 by 5” goal will not be reached. this year. But there has been progress, towards wide-ranging treatment for HIV, thanks to advances in not only to political commitment and funding but also in science and a shift in the attitudes of pharmaceutical companies. and considerable to make it possible.
Scientifically, recent advances in the understanding of HIV and development of medicines to fight are have been impressive. Diagnostic tests have been established and, from the introduction of a single antiretroviral drug – AZT – in 1987, there are two dozen authorised medicines in use today to limit the spread of the virus in the human body. “We may be able to stay one step ahead of the virus,” says David Reddy, HIV franchise leader for Roche, the Swiss -based group which will unveiled that announced promising new results from treatment with the company’its drug Fuzeon at the International Aids Society conference in Rio de Janeiro last month.
The result of thirty 30 years of the scientific advancement work has been to a sharp ly cut in Aids-related mortality and severe illness for the majority of suffers in Europe and North America, over a number of years, turning what was once a death sentence into a chronic, manageable disease. For a long time, these evolutions left the developing world – where nearly 90 per cent of people with HIV sufferers live – ever further behind. Since the turn of the millennium, However, that situation too has also started to change for the better.
First, the attitude of many governments has evolved, changed: more are seeking to reduce the stigma towards Aids and prejudice towards its sufferers as they see that a the failure to tackle the epidemic risks undermining economic growth and development by draining the workforce, crippling the education sector and imposing an escalating burden on health and social services. Thailand last month pledged free access to HIV treatment. for everyone, for instance. Malawi has set out to do the same. Even President Vladimir Putin of Russia has broken the taboo and begun publicly to discuss the problem of Aids, despite traditional in the face of opposition by displeasure from the Christian Orthodox church.
Second, substantial funding has become available. US President George W. Bush’s Emergency Plan for AIDS Relief (Pepfar), launched in 2003, has pledged to spend $15bn globally over five years. The Global Fund has received $6.5bn in pledges from international donors for spending up to 2008 and the World Bank has lent more than $1bn through its multi-country HIV/Aids programme for Africa alone since 2000.
Finally, medicines have become more affordable. In 2001, the leading multinational drug companies making HIV treatments were seen as a hindrance as they geared up seeking to sue the South African government in a legal battle to defend their patents and prevent generic drugs companies from manufacturing and selling them far more cheaply. Since then, the principal companies have joined the WHO’s Accelerating Access Initiative, adopting policies to make their medicines available at far lower prices to the world's poorest countries. In the past five years, the cost of antiretroviral treatments has fallen from $10,000 per patient per year to as low as $150.
Generic drug producers companies – notably Cipla and Ranbaxy in India – with low-cost, high-volume production and no traditional need to fund innovation have helped drive these price reductions. They have “reverse engineered” their rivals’ patented drugs and earned endorsement by the WHO, the Global Fund and lately Pepfar as acceptable alternatives to the branded medicines on which they are based. The generics groups companies have also produced the standard triple medicine “cocktails” prescribed as single “fixed-dose combination” pills, making them far easier for patients to take. That, alongside pilot programmes to train non-medical specialists to diagnose and treat Aids, has helped spread access well beyond expectations remedies into poor rural areas.
“For years and years there was real opposition from donors to antiretroviral treatment in the developing world,” says Peter Piot, executive director of UNAids, which co-ordinates the UN ’s nited Nation'co-ordinating body for action on the disease. “When I proposed it in the 1990s, some said I was irresponsible, that it was too expensive or complex. We’ve come a long way since then.”
Despite the progress to date, however, the challenges ahead remain even more daunting. With some justification, the Large pharmaceutical companies maintain that, while believe that they have received the brunt of criticism in recent years, while other aspects hindrances to ing the scale-up of treatment have been underplayed. are being overlooked. These factors include the need to tackle the brain drain of medical specialists from low-income countries, to establish better the inadequacy of medical infrastructure to ensure that effective diagnosis and treatment – and to tackle the sheer poverty including and malnutrition which that hinders compliance with prescription regimes for HIV drugs. Political will, regulation and corruption also remain barriers.significant hurdles.
“The infrastructure requirements are much more formidable than people thought, and one of the biggest impediments is bureaucracy,” says Joe Steele, a vice-president at Gilead, which makes the drug tenofovir. “We have no infrastructure in Africa but have to devote extensive resources to it. There are 54 countries with 51 different [regulatory] systems.”
Despite Although Gilead ’s policy of supplies ying to sub-Saharan Africa at cost and makes supplemented with donations, by the company, he says Nigeria has still not authorised an application the group made in December 2003 to distribute tenofovir. In South Africa, official approval is required before each patient gets a drug in each clinic and the regulator imposes a fee that can be higher than the local price of the drug itself.
Another important ce hindrance to scale-up is simply the volume of funding that will be required. and the accompanying political commitment. UNAids estimates that there is currently projects a funding gap between pledged funds and real needs of totalling more than $18bn over the next three years and says that annual spending should increase of $22bn will be needed by 2008. While some of these costs may reduce in subsequent years once health facilities have been built, the continuing expenditure represents a much larger future such commitment by international donors than at any period???? ever before.
“Scale-up brings the world to a phase of long-term very substantial morally binding commitments,” says Mr Feachem from the Global Fund, which is seeking a further $7bn for 2006-07 alone, to channel to projects around the world. “For the first time in the business of development finance, you can’t have fashions to move money elsewhere. We have to live with millions of people who will stay on antiretrovirals for the rest of their life. To turn off funding would lead to their death in a few weeks or months.”
Furthermore, once scale-up has taken place, any subsequent fall-off in funding would trigger a vicious spiral: many more people would be carrying strains of HIV that had mutated under the influence of the drugs they had been taking, as incomplete compliance with Aids medicines leads to the accelerating the spread of drug-resistant HIV that could spread more quickly around the world. With no medicines yet available to cure HIV, and the prospect of a vaccine still many years away, bodily resistance to available treatments may threaten to might overtake scientific advances.
While South Africa has been widely criticised for its official ambivalence towards Aids and a slow uptake in HIV treatment, its government is not alone in questioning whether financing to tackle the disease is draining too many of its own and donors’ resources away from greater prevention efforts, let alone other important health and development goals.
Others say detection needs greater emphasis. “The most urgent long-term task is to prevent the spread of the disease, [and] the only way to stop that is by testing,” Richard Holbrooke, president of the Global Business Coalition on HIV/Aids and the former US ambassador to the UN, argued recently.
A final brake on scale-up remains the pharmaceutical companies. While most have established policies on fairer and more affordable access to HIV drugs, an analysis last month by Médecins sans Frontières argued that says their approaches and implementation both vary ied widely. A study by the UK-based Ethical Investment Research Service concluded that only half of the 12 largest drugs companies producing antiretrovirals extended preferential prices beyond the poorest countries and just five had made licensed ces available to local manufacturers to produce drugs more cheaply.
Most companies now agree that “tiered pricing” based on a population's ability to pay makes commercial as well as ethical sense, although they remain concerned about discounted drugs being diverted to richer markets where they are sold at higher prices by corrupt intermediaries. Also, Another risk for the companies is that as they agree to provide no- free or low-cost HIV drugs to the world's poorest nations, they experience fear pressure to do more in middle income countries as well as among the uninsured in developed nations.
Calls for lower prices for other types of drugs among such patient groups will follow.
Threats to A third further concern is that their intellectual property will come under threat, would remove ing the incentive to continue invest ing in the developing ment of new medicines. Jean-Pierre Garnier, chief executive of GlaxoSmithKline, one of the world's largest producers of antiretrovirals, says: “For GSK, there is no going back. But a biotechnology company might be a bit shy when thinking about whether to go into HIV research, knowing it’s a political hot potato.”
Brazil this month forced price reductions after coming close to overriding the patents of three drug companies’ antiretroviral medicines that were consuming 70 per cent of the national Aids drugs budget. Drugs makers They are far more divided on whether to attempt to substantially increase their own production to meet greater demand, delegate to a preferred sub-contractor or allow generic companies to manufacture their patented drugs in exchange for modest royalties. But For now, however, the trend is moving in the opposite direction. India’s new patent laws, approved this year, will curtail the scope for ability of generic groups to make copies of a newer HIV drugs. That suggests there will be little scope for a reduction in prices of second-generation medicines already six to twelve 12 times higher than first-line older existing treatments.
“I’m not against patents but I'm against monopolies in countries that can’t afford them,” says Dr Yusuf Hamied, head of the Indian generics group Cipla, who is gearing up plans a court to a court challenge to to his country’s recent legal shift. in court.
The issue cost of newer more expensive drugs is likely to prove the most an explosive issue of all, as patients in poorer countries develop resistance to older drugs. After just four years on such treatments, Modesta in Malawi has had to make the switch – and the baby on her back is a reminder that she remains sexually active, potentially spreading resistant HIV virus to others.
While the debate continues over the donors work out how best model to scale up treatment, countries such as Malawi – which alone currently has more cases of HIV infection than the total number currently being treated around the world – are running simply to stand still.
‘We need privacy but not secrecy’
Anock Kapira, a worker at Manet, an organisation for Aids sufferers in Malawi, tells a story about his HIVpositive cousin to show why better treatment alone will not stop the world’s Aids pandemic.
Mr Kapira’s cousin is putting at least two people’s lives at risk with his reaction to the results of his HIV test: he has not disclosed the fact to his wife and he does not want antiretroviral therapy himself because she would then find out.
In Malawi, where 15 per cent of the adult population is infected, that sort of attitude convinces officials and health workers that stronger measures – which in some cases would test the boundaries of accepted medical ethics – are needed to limit the spread of the virus.
“Treatment is important but we must also support prevention or this epidemic will become unmanageable,” says Roger Teck, head of Médecins sans Frontières-Belgium’s Malawi operations. “Sometimes there is a conflict with human rights.”
Concerned about patients’ ability to stick to prescribed drug regimes, and with its funds limited, MSF, like Malawi’s government, has had to make choices about who to treat and how to go about doing so.
One decision has been to limit the idea of patient confidentiality by insisting that each person given access to MSF’s programmes must agree to reveal their HIV status to a “guardian” – a relative or friend who can support them and make sure they take all the drugs prescribed them. The aim is to ensure high levels of compliance, reducing the risk of creating drug resistance.
The most lively debate over medical ethics in Malawi has been generated by efforts to increase diagnosis of Aids, with a growing shift by state and non-governmental organisations to change the emphasis from “opting in” to “opting out” of Aids testing. That includes encouragement to take an Aids test for all pregnant women, blood donors and anyone being treated for tuberculosis or a sexually transmitted disease – infections frequently found in patients with Aids.
“We’re shifting strategies to something very new,” says Erasmus Morah, UNAids co-ordinator in Malawi. “If you seek consent [to test], you continue to put up roadblocks. If a doctor gives the choice over testing, you ask whether it is the right thing. It’s a form of intimidation.”
Not everyone is convinced. Tiwonge Loga, head of the National Association for People with HIV/Aids in Malawi, which has opposed routine testing, says: “I don’t think we need it. There is a risk of coercion, especially in rural areas.”
Most controversially, in June the health ministry went as far as calling for “beneficial disclosure”, raising the prospect that a doctor may have the power to inform the partner of someone who has been tested HIV positive. Such moves are seen as particularly important given that up to half of all couples in the country are “discordant”, with one HIV positive and the other not. Insufficient testing, or a refusal to disclose the results and take necessary precautions, risks sending the infection out of control.
“What people were doing wrongly was protecting patients’ right to protect their HIV status,” says Dr Morah. “If you know, you have a right to confidentiality but your partner also has a right to know.”
Victor Kamanga, Mr Kapira’s colleague at Manet, says: “Human rights includes duties and obligations for patients to protect their spouses. If you are HIV positive and don’t take precautions, it’s a violation of the rights of the other person. We need privacy, but not secrecy that endangers the life of others.”