3 JUNE 2011, VOLUME 12, ISSUE 22

The Health Department has appealed to men who have sex with men and organisations working with this sector to make their voices heard so that their needs are included and addressed in the next National Strategic Plan on HIV and AIDS. Taking an important step in recognising the vulnerabilities of a marginalised group, the Health Department sent a high-ranking official to give the opening address at South Africa's, and probably the continent's, first meeting to focus on the sexual health needs of the MSM community or men who have sex with men.

Giving his address in Cape Town, Deputy Director-General of the Health Department, Dr Yogan Pillay, illustrated how crucial it is not to ignore the health needs of the MSM community. Pillay quoted three well-esteemed world figures. Quoting United Nations' Secretary-General, Ban Ki Moon, he said: 'Not only is it unethical not to protect these groups. It makes no sense from a health perspective and it hurts all of us'. "The second is somebody who knows a bit more about HIV, Peter Piot, who said this: 'Empowering MSMs and other marginalised groups to protect themselves from HIV is one of the world's most urgent health priorities'. "And thirdly, and lastly, the current UNAIDS Executive Director, Michel Sidibe, speaking at the Forum on HIV, Human Rights and Men who have sex with Men in 2009 had this to say and I quote: 'It remains an undeniable fact in all regions of the world that men who have sex with men lack universal access to HIV services'. "It's possible that it's not just HIV services that they lack access to, but a whole range of other services. But he was talking in the context of HIV", said Pillay. While these individuals were not speaking about South Africa in particular, Pillay admitted that their statements equally apply to our country.

Drugs are cheap. There are few drugs that would sell for more than $5-$10 a prescription in a free market. However, many drugs in the United States sell for hundreds of dollars per prescription and, sometimes, several thousand dollars per prescription. There is a simple reason for this fact: government-granted patent monopolies. The government gives patent monopolies to provide an incentive for drug companies to carry through research. This is an incredibly backward and inefficient way to pay for research. It leaves us paying huge amounts of money for cheap drugs. It also often leads to bad medicine.

We can do better -- and Senator Bernie Sanders has proposed a way. He has introduced a bill to create a prize fund that would buy up patents, so that drugs could then be sold at a free market price. Sanders' bill would appropriate 0.55% of GDP (about $80bn a year, with the economy's current size) for buying up patents, which would then be placed in the public domain so that any manufacturer could use them at no cost. This money would come from a tax on public and private insurers. The savings from lower-cost drugs would immediately repay more than 100% of the tax. The country is projected to spend almost $300bn a year on prescription drugs this year. Prices would fall to roughly one-tenth this amount in the absence of patent monopolies, leading to savings of more than $250bn. The savings on lower drug prices should easily exceed the size of the tax, leaving a substantial net reduction in costs to the government and private insurers. The Sanders prize fund bill would go far towards eliminating the problems that pervade the drug industry.

A two-day conference is being hosted by the Vatican on the global fight against AIDS. The meeting was prompted in part by confusion over the pope's recent comments on condom use and HIV prevention. Catholic charities are a major player in the fight against HIV/AIDS -- providing about 25 percent of AIDS care in Africa-- so when Pope Benedict XVI appeared to crack open the door last year for condoms as a prevention method in very limited circumstances, the statement made waves in public health circles. "There may be a basis in the case of some individuals, as perhaps when a male prostitute uses a condom, where this can be a first step in the direction of a moralization, a first assumption of responsibility," the pope said in a book of interviews published in November of 2010.

At first it seemed an oddity: a scattering of reports in the spring and early summer of 1981 that young gay men in New York and California were ill with forms of pneumonia and cancer usually seen only in people with severely weakened immune systems. In hindsight, of course, these announcements were the first official harbingers of AIDS -- the catastrophic pandemic that would infect more than 60 million people (and counting) worldwide, killing at least half that number. But at the time, we had little idea what we were dealing with -- didn't know that AIDS was a distinct disease, what caused it, how it could be contracted, or even what to call it. As AIDS has become entrenched in the United States and elsewhere, a new generation has grown up with little if any knowledge of those dark early days. But they are worth recalling, as a cautionary tale about the effects of the bafflement and fear that can surround an unknown disease and as a reminder of the sweeping changes in medical practice that the epidemic has brought about...

In 1981, drugs against any virus were rare, and none were available for H.I.V. Now, more than 30 licensed drugs widely available in the developed world have turned AIDS from a death sentence to a chronic disease, though not necessarily an easy one to live with... For the patients who died in the early years, the wait for effective treatments -- a decade or so after the first reports of the disease -- was far too long. But that is a relatively short time in the history of medicine to develop treatments and preventions; after all, many incurable cancers and other diseases have been known for centuries. The relative speed with which the therapies were developed owes much to the efforts of cadres of activists who demanded that the Food and Drug Administration loosen the rules for clinical trials and speed its drug approval process. Efforts to develop anti-H.I.V. drugs have paid handsome dividends by leading to development of other drugs to treat other viral infections, like the liver diseases hepatitis B and C and certain types of herpes viruses. Also, AIDS advocacy has spurred leaders of campaigns against breast cancer and other diseases to adopt similar strategies.Soon after the discovery of AIDS, health officials mandated infection-control measures for health care workers -- wearing gloves and sometimes masks, gowns and other gear -- to reduce risks from examining patients and handling blood and other specimens.

Indian CRO GVK Biosciences has been named as a preferred provider by a consortium, Product Development Partners (PDP), which is focused on drugs for neglected diseases. Under the collaboration GVK will provide clinical support, logistics, monitoring and project management for trials PDP, a group not-for-profit entities part funded by the Bill and Melinda Gates foundation, is conducting in India and Bangladesh. Illnesses on PDP's target list include tuberculosis, malaria, HIV, pneumonia and diarrhoea which, despite affecting millions of people, are often overlooked by drug companies in favour of conditions that can generate higher revenues. In return for its research efforts Hyderabad-headquartered GVK will receive a fee but only at a concessional rate according to senior vice president of clinical development Shoibal Mukherjee. Dr Mukherjee told Outsourcing-pharma.com that the contract research organisation (CRO) has considerable experience conducting clinical research in this field, which will be important to the success of the project. GVK Biosciences has been working in the area of neglected diseases for several years, and it is this experience that puts the company in a position to participate in the Global Health Product Development Partners Consortium. Mukherjee explained that GVK has been involved in the management and monitoring of six clinical trials with roughly a third of its clinical research workforce directly or indirectly associated with these projects. He added that, although the work is progressing "clinical development of medicines is a lengthy and arduous process. It is typically 2 to 6 years before drugs in clinical trials become marketable and sometimes it is longer."

For his doctors, Timothy Ray Brown was a shot in the dark. An HIV-positive American who was cured by a unique type of bone marrow transplant, the man known as "the Berlin patient" has become an icon of what scientists hope could be the next phase of the AIDS pandemic: its end. Dramatic scientific advances since HIV was first discovered 30 years ago this week mean the virus is no longer a death sentence. Thanks to tests that detect HIV early, new antiretroviral AIDS drugs that can control the virus for decades, and a range of ways to stop it being spread, 33.3 million people around the world are learning to live with HIV... Nonetheless, on the 30th birthday of HIV, the global scientific community is setting out with renewed vigour to try to kill it. The drive is partly about science, and partly about money. Treating HIV patients with lifelong courses of sophisticated drugs is becoming unaffordable. Caring for HIV patients in developing countries alone already costs around $13 billion a year and that could treble over the next 20 years. In tough economic times, the need to find a cure has become even more urgent, says Francoise Barre Sinoussi, who won a Nobel Prize for her work in identifying Human Immunodeficiency Virus (HIV)...

The Berlin patient is proof they could. His case has injected new energy into a field where people for years believed talk of a cure was irresponsible... Most experts say it is inconceivable Brown's treatment could be a way of curing all patients. The procedure was expensive, complex and risky... The International AIDS Society will this month formally add the aim of finding a cure to its HIV strategy of prevention, treatment and care. A group of scientist-activists is also launching a global working group to draw up a scientific plan of attack and persuade governments and research institutions to commit more funds. Money is starting to flow. The U.S. National Institutes of Health is asking for proposals for an $8.5 million collaborative research grant to search for a cure, and the Foundation for AIDS Research, or amfAR, has just announced its first round of four grants to research groups "to develop strategies for eradicating HIV infection." Until recently, people in HIV and AIDS circles feared that to direct funds towards the search for a cure risked detracting from the fight to get HIV-positive people treated. Even today, only just over five million of the 12 million or so people who need the drugs actually get them... In some ways, we have been here before. Early AIDS drugs such as AZT came to market in the late 1980s, but within a decade they were overtaken by powerful cocktail treatments known as HAART, or highly active antiretroviral treatment. HAART had a dramatic effect -- rapidly driving the virus out of patients' blood and prompting some to say a cure was just around the corner.

Experts reviewing Nigeria's new HIV/AIDS prevalence rate have said it called for studies to actually ascertain the country's HIV incidence rate in a bid to know if the various strategies put in place by government was actually reducing new cases of HIV, and to know if the virus is being controlled. In an overview of the HIV/AIDS epidemic in Africa and Nigeria at a training workshop organised by New HIV Vaccine and Microbicide Advocacy Society (NHVMAS) in Sagamu, Dr Morenike Ukpong, said the problem of HIV was better reflected by an incidence study. According to her, Nigeria's HIV prevalence rate among pregnant women attending antenatal care which dropped to 4.1 per cent was a reflection of all HIV/AIDS new and old cases in the population at a given time. Dr Ukpong, who stated that only an incidence survey would give an indication of the rate at which new HIV cases occurred in a specified population, declared, "when a prevalence rate drops like we saw in the Nigeria's HIV case in barely two years, what it portend is that actually more people with HIV had died." According to her, it was a wrong notion to believe that any drop in HIV prevalence meant incidence of new HIV cases were reducing. Dr Ukpong, who remarked that increasing cases of anal sex among youths and homosexualilty, as well as intravenous drug users in the country needed to be taken into consideration, said that the lack of appropriate data on the incidence of HIV would continue to be a challenge in ensuring a control of the virus.

Professor Olusola Olatunji, Head of Haematology and Blood Transfusion, Olabisi Onabanjo University Teaching Hospital (OOUTH), Sagamu, Ogun State said, data on HIV incidence from some health facilities indicated that new cases of HIV might be on the rise. Professor Olatunji said the number of HIV orphans were likely to also increase because the fear of the disease was on the decline and more people now have access to ARVs. He decried the dearth of data for adequate planning of HIV interventions, and called for a more responsive attitude by the government. According to him, tackling the AIDS crisis was a long term task that required sustained effort and planning.

That young people are particularly vulnerable to HIV and AIDS is well established, but a new report reveals for the first time new data on HIV prevalence in this group, which accounts for almost half of new adult infections globally. The Opportunity in Crisis report, released on 1 June by the UN Children's Fund (UNICEF), UNAIDS and other UN agencies, found that an estimated 2,500 young people aged 15-24 become infected with HIV every day, with young women and girls particularly vulnerable. "The picture is grim," said Elhadj As Sy, UNICEF director for eastern and southern Africa, at the launch of the report in Johannesburg. "The faces of young people living with HIV are predominantly African and female. Of the five million HIV-positive young people, close to four million are in sub-Saharan Africa. More than 60 percent are young women and in sub-Saharan Africa, this share jumps to 72 percent." While the report suggest that prevention is working, and some progress has been made, Susan Kasedde, senior specialist in HIV Prevention with UNICEF, warned that countries were falling "far, far short" in their efforts to address HIV among young people and had not invested enough in these programmes. "Strategies and plans are devised, but money is not allocated, or when it is, efforts are not effectively coordinated, and are not at sufficient scale or are not [of] sufficient quality to ensure the greatest impact from the investment," the report found. At the UN General Assembly Special Session (UNGASS) on HIV/AIDS in 2001, countries agreed to cut HIV infection among young people by 25 percent by 2010, but only a 12 percent reduction has been achieved.

As Sy said the greatest barrier was stigma and discrimination, particularly in relation to young people at high risk of infection, such as young men who have sex with men, sex workers and injecting drug users, who have been driven underground by discrimination that often prevents them from accessing HIV services. The report revealed that a young man in the suburbs of Cape Town, South Africa, or Lilongwe, Malawi, who has sex with other men has about a 20 percent chance of becoming HIV-positive by the age of 24, while the risk in the general population of either country is much lower - 4.5 percent in South Africa and 3.1 percent in Malawi. Recommendations included providing young people with information and comprehensive sexual education; increasing the number of adolescents who know their HIV status, establishing laws and policies that respect young people's rights, and strengthening monitoring, evaluation and data reporting on this group. "This [report] should exhort us all to... reflect on commitments made. To prevent HIV, young people must be leadership's priority," urged As Sy.

Around 80 representatives from the pharmaceutical industry, government and academic institutions met for 2 days in April 2011 to discuss repurposing and rescue efforts for old and new drugs. Although drug repositioning is not a new concept, US National Institutes of Health (NIH) officials asserted that the different sectors could better capitalize on advancing science and accumulating clinical data by working together on a systematic approach for screening clinical-stage, abandoned and approved compounds for new uses.

The larger goal of eliminating AIDS globally is being mired in debate over how to best achieve that target, with governments and advocacy groups currently unable to reach consensus ahead of the UN High Level Meeting in New York, June 8-10. Tensions center on what actions the UN will commit to, whether patent rights for AIDS drugs will be honored, and how to best approach high-risk groups. The declaration that is expected to be approved at the meeting had more than quadrupled in size as of May 27, according to a source close to the negotiations. Matters such as how to deal with men who have sex with men have become divisive, for example. AIDS organizations such as the US-based Health GAP are arguing for well-defined programs for gay men. "We need a response to HIV that is tailored to meet the needs of those key populations who are often marginalized and have a hard time accessing services," said Matthew Kavanagh, Health GAP's director of US advocacy. Others disagree with that view. "Many countries are actually being bullied into accepting many of the wrong approaches to the AIDS pandemic, and they're being encouraged to promote the highest-risk behavior," said Sharon Slater, president of the US-based Family Watch International. "Ours is not an anti-homosexual" position, she added. FWI is offering UN delegates talking points and suggesting wording for amendments, including those from "all of the African countries, I believe," Slater said. Sharonann Lynch, a Doctors Without Borders HIV/AIDS policy adviser, said the infighting represents a real threat. "Really, there are so many authors and editors they might make it so we miss the opportunity to get ahead of the wave of infections," she noted.

After a government report confirmed major ethical violations in trials of Human Papilloma Virus (HPV) vaccines on Indian schoolgirls, senior doctors are calling for transparency in clinical trials conducted under private-public partnerships. The report is yet to be placed in the public domain, but its contents were revealed early May by senior doctors who assisted in its preparation, sparking outrage among public health advocates and women's rights groups... Ethical concerns in the HPV trials were first raised by the New Delhi-based Sama Resource Group for Women and Children, a non-governmental organisation (NGO), and Brinda Karat, a member of parliament in April last year. The central health ministry consequently suspended what was officially described as a "demonstration project". The project, conducted by the Programme for Appropriate Technology in Health (PATH), an international NGO, in partnership with the government-run Indian Council of Medical Research, was linked by media reports to the deaths of eight schoolgirls who were given HPV shots. By the time the project was suspended some 14,000 schoolgirls in western Gujarat and southern Andhra Pradesh states had been given the shots manufactured by pharmaceutical trans-nationals Merck and GlaxoSmithKline. "Whether or not the deaths had anything to do with the vaccine, they brought into focus the flouting of many laws governing clinical trials in this country," said Dr. Mira Shiva, a well-known expert on pharmaceutical drugs and member of the influential All-India Drug Action Network. Such was the outcry over the deaths that a week after the suspension of the project the health ministry ordered an inquiry by an expert panel that included S.P. Agarwal, former director-general of health services, and Suneeta Mittal, head of obstetrics and gynaecology at the premier All India Institute of Medical Sciences (AIIMS).

Nonqaba Jacobs, 28, comes from a rural community outside East London; both parents were HIV-positive and she tested positive in 2004. In 2005 she moved to Khayelitsha, near Cape Town, where she found treatment and attitudes towards HIV to be a world away from what she experienced in the Eastern Cape. These days she is doing well, but is worried about her mother, who has gone off her antiretrovirals in favour of "faith healing" at the Christ Embassy church. "I tested in East London. I had come in for another STI, and the nurse suggested the test. I didn't suspect anything, but I knew everything about HIV because my mom and dad were both positive. My dad died in 2004, two months after I found out my status and my mom is still alive and supported me with everything... "I'm okay, but there's one thing that's been upsetting me. My mom attended the healing school in the Christ Embassy and she has stopped her pills since then. She was on second-line. She says it's from Satan that you are positive. She believes she's been healed, so she has nothing more to do with pills. She's just praying when she feels down. Her CD4 is 98, so that's stressing me, because I can't do anything to change her mind. She's the one who first encouraged me to take my pills and do everything right, but now she's turning back. We end up fighting about it, because she says she's saved, and I believe in medicine."

Orphans and vulnerable children in 10 of Zimbabwe's poorest districts will start benefiting from a government scheme to help them go to school, have enough to eat and access medical care. There are about 100,000 child-headed households in Zimbabwe and a quarter of all children in the country, about 1.6 million, have lost one or both parents to HIV and other causes. HIV prevalence in Zimbabwe is one of the world's highest, at 13 percent. The government has started rolling out a cash transfer programme with the UN Children's Fund (UNICEF), under the National Action Plan (NAP) for Orphans and Vulnerable Children (2011-2015). The implementation of the plan is supported by the Child Protection Fund, a multi-donor-pooled funding mechanism managed by UNICEF. Under the cash transfer programme, extremely poor households will receive an average of US$20 a month. The payout will vary depending on the size of the family. A pilot programme is under way in Goromonzi, about 100km outside the capital Harare, where about 105 households are receiving payments. This pilot programme is intended to assist the government in designing a national scheme by December 2013. Sydney Mhishi, director of social services in the Ministry of Labour and Social Services, said the full roll-out was expected to begin in July 2011 to an estimated 23,166 households in the first year...

A recent UNICEF report on the status of women and children in Zimbabwe found that worrying levels of poverty and vulnerability were limiting women's and children's access to education, medical care and social protection. The report highlights that endemic poverty and HIV/AIDS are the major contributors to high levels of vulnerability. "We know that many orphaned children in child-headed households are poor and struggle to even access the most basic social services. As a result, they are sometimes forced to work to meet their daily needs. In the process they miss out on school and fail to access life-saving health services," said UNICEF country representative Peter Salama. "We have introduced the cash transfer programme with this in mind. Our intention is to reduce poverty and vulnerability levels in these households and to ensure that these orphaned children are not disadvantaged or end up engaging in risky behaviours to survive," he added.

Poor-performing donors were lambasted by UK Prime Minister David Cameron at this year's G8 leaders' meeting for failing to move towards meeting 0.7 percent [of gross national income] aid targets; but most major donors are to blame for tying aid to donor-based contractors, say aid watchdogs, and for reporting money spent at home as aid. AidWatch, a group of European aid experts representing 1,600 NGOs, estimates European Union members reported US$7.4 billion (EU5.2 billion) in inflated aid in 2010 - that is, the money was actually spent on debt cancellation, on foreign students, and on refugees in donor countries. This is equivalent to almost 10 percent of the total aid provided that year. Donors may report the first year of housing costs for refugees, and costs spent on foreign students, as part of official development aid (ODA)...

A significant proportion of the rest is tied - that is, spent on consultants and contractors from donor countries, said Karin Christiansen, director of NGO Publish What You Fund. Much progress has been made to untie aid [but]... even when aid-tying is banned, contracts can still easily end up in the coffers of companies from donor countries, according to Christiansen... In the end, aid figures vary wildly depending on who is reporting them and how. In the pre-G8 accountability report, leaders claim to have fallen short of 2005 Gleneagles aid commitments by just $1 billion per year; while the OECD DAC estimates they were $22 billion short... Spending aid at home, and aid-tying are unlikely to disappear soon, said Christiansen, but more open reporting of aid figures would at least enable a more honest debate, and less quibbling over numbers."This is why we need transparency - so we can have a genuine conversation about the numbers. We can't influence decision-making around spending, if all the information is based on hunch and rhetoric." ...G8 leaders stressed aid transparency and accountability at this year's summit, stating in a communique: "We will improve transparency of our aid information. In particular, we will make further efforts on publishing information on allocations, expenditure and results." ONE and Publish What You Fund welcome these commitments. But Luca De Fraia, global governance expert and NGO ActionAid's deputy director in Italy, stresses donor accountability must focus as much on recipients as on taxpayers at home.

The US global AIDS coordinator is leading discussions within the government about the ramifications of recent landmark research showing the public health benefits of early antiretroviral therapy for people with HIV. This month, the federal government announced that a large clinical trial proved early HIV treatment, given before the immune system faltered, reduced transmission of the virus to heterosexual partners by 96 percent. "This is a study that needs to challenge the way we've been doing business," said Dr. Eric Goosby. "We need to ask ourselves if this indeed presents an opportunity for us to be more effective in preventing new [HIV] infections. What I'm now committed to doing is shepherding the dialogue within the US government - to go quickly, but I want to do it consciously." Goosby leads the President's Emergency Plan for AIDS Relief, which spends about $7 billion annually. US-funded programs will soon be treating nearly 4 million people in 88 countries. Putting an early-treatment model into practice, however, could result in a nine-fold increase in the number of people receiving medications. "How do we deal with ... prioritizing who gets on antiretroviral drugs first?" Goosby asked. "Should it still remain patients with late-stage disease, pregnant women, patients with pulmonary TB, children diagnosed at birth? Or should anybody, regardless of the stage of disease, get treated?" he asked, noting issues involved with lifetime use of the powerful drugs.

On Wednesday, the Los Angeles City Council voted 10-0 in favor of requesting state legislation that would allow the city to require condom use on adult-film sets as a condition of issuing a film permit. AIDS Healthcare Foundation has been calling for the city to take action. "The industry has refused to implement common-sense protection," said Brian Chase, AHF's assistant general counsel. "If it was required in the permits issued by the city, it would go a long way in preventing [STDs]." Mandatory condom use has been debated in the adult-film business for some time, said Tom Hymes, a senior editor at the industry's AVN Media Network. "Clearly, the industry is not for this move and the result of it would be that more productions would go underground to the extent they are able to do that," he said. "It is my understanding that the inspectors could come in only if there is a complaint," he added. Council member Paul Koretz noted that he introduced a similar measure when he served in the state Assembly. Council member Richard Alarcon, chair of the Jobs and Business Development Committee, said he wants to develop an overall policy on condom use in adult films. But Diane Duke, executive director of the industry's Free Speech Coalition, said the issue of mandatory condom use in porn "has come before the state Legislature a number of times and has failed."

More Hong Kong residents in their 20s are contracting HIV than people in their 30s, government physicians reported Thursday. A lack of awareness of safer sex among the young may be to blame, said Dr. Wong Ka-hing of the Department of Health's Center for Health Protection. Hong Kong logged 103 new HIV infections and 13 new AIDS cases in the first quarter of 2011. It has seen a total of 4,935 HIV infections since 1984 and 1,198 AIDS cases since 1985.

On June 5th 1981 America's Centres for Disease Control and Prevention reported the outbreak of an unusual form of pneumonia in Los Angeles. When, a few weeks later, its scientists noticed a similar cluster of a rare cancer called Kaposi's sarcoma in San Francisco, they suspected that something strange and serious was afoot. That something was AIDS. Since then, 25m people have died from AIDS and another 34m are infected. The 30th anniversary of the disease's discovery has been taken by many as an occasion for hand-wringing. Yet the war on AIDS is going far better than anyone dared hope...

If AIDS is defeated, it will be thanks to an alliance of science, activism and altruism. The science has come from the world's pharmaceutical companies, which leapt on the problem. In 1996 a batch of similar drugs, all of them inhibiting the activity of one of the AIDS virus's crucial enzymes, appeared almost simultaneously. Much of the activism came from rich-world gays. Having badgered drug companies into creating the new medicines, the activists bullied them into dropping the price... The altruism was aroused as it became clear by the mid-1990s that AIDS was not just a rich-world disease...

The result is patchy. Not enough people--some 6.6m of the 16m who would most quickly benefit--are getting the drugs. And the pills are not a cure. Stop taking them, and the virus bounces back. But it is a huge step forward from ten years ago. What can science offer now? A few people's immune systems control the disease naturally (which suggests a vaccine might be possible) and antibodies have been discovered that neutralise the virus (and might thus form the basis of AIDS-clearing drugs). But a cure still seems a long way off. Prevention is, for the moment, the better bet... In the early days scientists were often attacked by activists for being more concerned with trying to prevent the epidemic spreading than treating the affected. Now it seems that treatment and prevention will come in the same pill. If you can stop the virus reproducing in someone's body, you not only save his life, you also reduce the number of viruses for him to pass on. Get enough people on drugs and it would be like vaccinating them: the chain of transmission would be broken. That is a huge task.

It was not quite a birthday present, but it was pretty close. On May 12th the HIV Prevention Trials Network (HPTN), an international research collaboration, announced that its most important project [HPTN Trial 052)] was being terminated--not because it had failed, but because it had succeeded... On June 5th, a little over three weeks after HPTN's announcement, AIDS will be 30 years old--or, more accurately, it will be 30 years since America's Centres for Disease Control and Prevention reported a cluster of unusual infections in Los Angeles that were the first medically recognised cases. On June 8th a meeting of the United Nations' General Assembly, expected to be attended by 40 heads of state and government, will discuss progress in fighting the pandemic and wrestle with the question of what to do next. HPTN052, as the trial in question is known, points the way...

The first UN meeting on AIDS, held ten years ago near the 20th anniversary, catalysed the formation of the Global Fund (which also has tuberculosis and malaria in its remit) and that, in turn, led to the United States President's Emergency Plan for AIDS Relief (PEPFAR) created by George Bush junior. No one likes to be seen as mean and so, in a decade of rising prosperity, politicians put their hands in their taxpayers' pockets and donated generously to the cause. This time, the atmosphere is different. It is still the case that no one wants to be seen as mean, but the game of chicken is now the other way round. Then, each act of generosity made it harder for others to refuse. Now, each withdrawal from the fray makes another's easier... There is also dark talk of several countries trying to water down the language of the declaration that the UN meeting is expected to issue, so that it no longer has numerical targets with specific dates. In a time of austerity, then, value for money is even more important than it might otherwise be. A group of researchers led by Bernhard Schwartlaender, director of evidence, strategy and results at UNAIDS, have therefore put their minds to how to spend what is available most wisely.

Anniversaries are times for reflection, and this one should be no exception, for the 30-year history of AIDS is a mirror in which humanity can examine itself. From questionable scientists to philanthropic billionaires, people's actions against AIDS, and reactions to it, have shown up the best and worst that humans have to offer. Such dualism was there from the beginning, in the question of who discovered the AIDS--causing virus. There were two claimants. One, Robert Gallo, is American. The other, Luc Montagnier, is French. Dr Gallo called his discovery HTLV-3. Dr Montagnier called his LAV. They were in fact the same thing. It turned out, however, that Dr Gallo's virus had come from Dr Montagnier's laboratory. It was never conclusively proved how, though a contaminated sample may have been to blame. And Dr Gallo was exonerated of any wrongdoing by an official investigation and is universally recognised to have done important work on AIDS. But only Dr Montagnier won the Nobel prize--eloquent testimony to some people's opinion of the whole affair.

Another source of conflict was whether HIV, as the virus eventually came to be known, was truly the cause of AIDS. At the beginning of the epidemic, that might have been debatable. Perhaps HIV was merely a passenger that took advantage of an immune system weakened by another cause? One once-respected scientist, Peter Duesberg, who did early research on viral causes of cancer, would not drop the idea. He insisted--and still insists--that the weakening of the immune system characteristic of AIDS is caused by drug-taking (he blames both recreational drugs and AZT, one of the early anti-AIDS drugs), and that HIV is, indeed, a passenger. This theory would not have mattered much except that Thabo Mbeki, a former president of South Africa, latched on to it. Since South Africa has the world's largest number of AIDS cases, and one of its highest infection rates, this was bad news, as was Mr Mbeki's health minister, Manto Tshabalala-Msimang, who was appointed mainly because she agreed with him, and recommended beetroot and garlic as treatment for the disease. Only with the election of Jacob Zuma, who has himself been publicly tested for HIV (he did not have it), did South Africa return to sensible anti-AIDS policies.

Among the heroes, Bill Gates looms large. The foundation into which he poured much of his Microsoft fortune took AIDS seriously from the beginning, forming a particularly fruitful partnership with the government of Botswana, one of the worst-affected countries. And Nelson Mandela, the heroes' hero, also cleaved eventually to the path of righteousness, even while admitting he had not done enough to combat AIDS during his own presidency of South Africa. Mr Gates and Mr Mandela are easy to admire. One hero that many AIDS activists have difficulty accepting, though, is George Bush junior. Activists do not much like born-again Christians, who take a dim view of the sort of sex lives that help to spread HIV. But Mr Bush was responsible for setting up the President's Emergency Plan For AIDS Relief (PEPFAR) and for making sure it had plenty of money. PEPFAR is one of the two main organisations, along with the Global Fund, that dish out the cash that rich countries give poor ones to combat AIDS. Last year, it spent almost $7 billion on AIDS and the tuberculosis that often accompanies it, and it is responsible for helping half of the 6.6m people now on anti-retroviral drugs. Many activists may be reluctant to give Mr Bush credit. But handsome is as handsome does.

As the third decade since AIDS was first recognized comes to an end, extraordinary advances have occurred in the understanding, treatment, and prevention of HIV infection and AIDS. As a result of these successes, it is now time to focus on future challenges. Paramount among these is reaching the goal of truly controlling and ultimately ending the HIV and AIDS pandemic. To that end, AIDS researchers and public health personnel worldwide are aggressively pursuing 3 key areas of scientific research. Given the availability of highly effective therapeutic regimens for HIV infection, the first challenge is efficiently identifying a maximum number of HIV-infected persons through voluntary HIV testing and initiating antiretroviral therapy (ART). Second, scientists are trying to develop a cure for HIV infection, which would alleviate the need for lifelong ART. Finally, preventing new cases of HIV infection, which currently number approximately 2.6 million per year globally, is critical to any attempt to end this pandemic. This article addresses each of these challenges and provides

Today, approximately 1.4 billion people in the world live in extreme poverty, with incomes so low that they cannot fill their basic needs. In 2000, when eight Millennium Development Goals (MDGs) were set to guide efforts to combat various dimensions of extreme poverty, a specific call was made in the sixth MDG "to combat HIV/AIDS, malaria, and other diseases." In response, new financing and delivery mechanisms for disease control were introduced through the Global Fund to Fight AIDS, Tuberculosis, and Malaria, as well as the U.S. President's Malaria Initiative (PMI) and the President's Emergency Plan for AIDS Relief (PEPFAR).

Daily pre-exposure prophylaxis (PrEP) with Truvada (FTC and TDF) is a novel HIV prevention strategy recently found to reduce HIV incidence among men who have sex with men. We used a macaque model of HIV transmission to investigate if Truvada maintains prophylactic efficacy against an FTC-resistant isolate containing the M184V mutation. Five macaques received a dose of Truvada 3 days before exposing them rectally to SHIV162p3M184V followed by a second dose 2h afterwards. Five untreated animals were used as controls. Virus exposures were done weekly for up to 14 weeks. Despite the high (>100-fold) level of FTC resistance conferred by M184V, all five treated animals were protected from infection while the five untreated macaques were infected (p=0.0008). Our results show that Truvada maintains high prophylactic efficacy against an FTC-resistant isolate. Increased susceptibility to tenofovir due to M184V and other factors including residual antiviral activity by FTC and/or reduced virus fitness due to M184V may have all contributed to the observed protection.

Abstract
Background: Long-term effects of abacavir (ABC)-lamivudine (3TC), compared with tenofovir (TDF)-emtricitabine (FTC) with efavirenz (EFV) or atazanavir plus ritonavir (ATV/r), on bone mineral density (BMD) have not been analyzed.

Methods: A5224s was a substudy of A5202, in which HIV-infected treatment-naive participants were randomized and blinded to receive ABC-3TC or TDF-FTC with open-label EFV or ATV/r. Primary bone end points included dual-emission X-ray absorbtiometry (DXA)-measured percent changes in spine and hip BMD at week 96. Primary analyses were intent to-treat. Statistical tests used the factorial design and included linear regression, 2-sample t, log-rank, and Fisher's exact tests.

Results: Two hundred sixty-nine persons randomized to 4 arms of ABC-3TC or TDF-FTC with EFV or ATV/r. At baseline, 85% were male, and 47% were white non-Hispanic; the median HIV-1 RNA load was 4.6 log10 copies/mL, the median age was 38 years, the median weight was 76 kg, and the median CD4 cell count was 233 cells/lL. At week 96, the mean percentage changes from baseline in spine and hip BMD for ABC-3TC versus TDF-FTC were -1.3% and -3.3% (P 5 .004) and -2.6% and -4.0% (P 5 .024), respectively; and for EFV versus ATV/r were -1.7% and -3.1% (P 5 .035) and -3.1% and -3.4% (P 5 .61), respectively. Bone fracture was observed in 5.6% of participants. The probability of bone fractures and time to first fracture were not different across components.

Conclusions: Compared with ABC-3TC, TDF-FTC-treated participants had significantly greater decreases in spine and hip BMD, whereas ATV/r led to more significant losses in spine, but not hip, BMD than EFV.

Abstract
Background: There is considerable debate as to the relative merits of using randomised controlled trial (RCT) data as opposed to observational data in systematic reviews of adverse effects. This meta-analysis of meta-analyses aimed to assess the level of agreement or disagreement in the estimates of harm derived from meta-analysis of RCTs as compared to meta-analysis of observational studies.

Methods and Findings: Searches were carried out in ten databases in addition to reference checking, contacting experts, citation searches, and hand-searching key journals, conference proceedings, and Web sites. Studies were included where a pooled relative measure of an adverse effect (odds ratio or risk ratio) from RCTs could be directly compared, using the ratio of odds ratios, with the pooled estimate for the same adverse effect arising from observational studies. Nineteen studies, yielding 58 meta-analyses, were identified for inclusion. The pooled ratio of odds ratios of RCTs compared to observational studies was estimated to be 1.03 (95% confidence interval 0.93-1.15). There was less discrepancy with larger studies. The symmetric funnel plot suggests that there is no consistent difference between risk estimates from meta-analysis of RCT data and those from meta-analysis of observational studies. In almost all instances, the estimates of harm from meta-analyses of the different study designs had 95% confidence intervals that overlapped (54/58, 93%). In terms of statistical significance, in nearly two-thirds (37/58, 64%), the results agreed (both studies showing a significant increase or significant decrease or both showing no significant difference). In only one meta-analysis about one adverse effect was there opposing statistical significance.

Conclusions: Empirical evidence from this overview indicates that there is no difference on average in the risk estimate of adverse effects of an intervention derived from meta-analyses of RCTs and meta-analyses of observational studies. This suggests that systematic reviews of adverse effects should not be restricted to specific study types.

A comprehensive and collaborative strategy to enable the investigation of new uses of approved and abandoned drug compounds could advance translational research. Discoveries about the molecular basis of disease are providing unprecedented opportunities to translate research into clinically useful products. However, the translational process is fraught with frustration: failure rates can be as high as 95%, the average time from target selection to approval is ~13 years and, when failures are accounted for, the cost of bringing a new drug to market exceeds US$1 billion. So, strategies to reduce the time frame, decrease costs and improve success rates are urgently needed. Drug rescue and repurposing can be one of those strategies, and it offers the key advantage of harnessing previous research and development (R&D) efforts. Approved drugs and many abandoned compounds have already been tested in humans, and so detailed information is available on their pharmacology, formulation, dosing and potential toxicity. This can enable the rapid testing of new clinical hypotheses, leading to remarkable health outcomes. For example, in the early days of the HIV epidemic, investigators at the US National Institutes of Health (NIH) collaborated with academic and industry experts to rescue AZT -- a compound that was originally investigated for use in cancer but abandoned owing to lack of efficacy -- and it became the first drug to treat patients with HIV.

Looking to the future, much could be gained by wider application of comprehensive collaborative approaches to drug rescue and repurposing. However, there are scientific, economic and administrative challenges that need to be addressed, including the collection and organization of compounds and data, incentives for further development and commercialization, safety issues and intellectual property considerations. The private sector holds a substantial proportion of the assets, data and knowledge needed for drug rescue and repurposing, but the ideas and wherewithal to advance new applications, especially for rare diseases, may come from different companies, the non-profit sector or academia. To explore ways to approach drug rescue and repurposing more strategically and comprehensively, the NIH held a round-table meeting with leading representatives of academia, government and private sector R&D on 21-22 April 2011. Acknowledging the value of drug rescue and repurposing, participants at the meeting discussed ways to make the process more practical and less burdensome. Furthermore, it was agreed to establish a round table as a standing forum for fostering cross-sector efforts in translational science to tackle challenges for which such collaboration is critical for success. Informed by these discussions and in close collaboration with industry, academia and non-profit organizations, the NIH will be launching a comprehensive effort to identify appropriate abandoned compounds, establish master agreements, match partners, make data and resources available, and provide a central access point to relevant resources and expertise.

The US National Institutes of Health (NIH) has launched a freely available drug database, which is designed to definitively and comprehensively list approved drug molecular entities and active pharmaceutical ingredients.

Practical support and psychosocial interventions are desperately needed to help those dealing with the fallout of AIDS, says Lucie Cluver.

Medical advances cannot help those who deny they are at risk of HIV and avoid HIV tests. Salim S. Abdool Karim describes how such attitudes may be overcome.

There has been substantial investment in the past decade to provide academic institutions with the capabilities for early-stage drug discovery, such as high-throughput screening of large compound libraries and medicinal chemistry for hit optimization. However, so far, analysis of the rationale for and impact of this investment has relied on expert opinions rather than on data. To address this lack of data, we conducted a survey of academic and non-profit drug discovery entities in the United States...

While creation of intellectual property is acknowledged as an important part of their mission, most centres are also focused on fulfilling the academic objectives of their institutions while creating new medicines. The innovative outlook of the centres is demonstrated by the relative lack of clinical validation data on the targets being pursued, a major focus on neglected and orphan diseases.... Of the respondents who answered our open-ended question about obstacles, 68% identified some aspect of funding (such as amount and stability) as an obstacle. A lack of expertise in medicinal chemistry, a lack of understanding of drug discovery in academia or a poor fit between the more individually oriented conventional academic career paths and the team efforts required for drug discovery were also identified as obstacles.... Although concerns over funding are not surprising, the expense of lead optimization and preclinical studies needed for filing of investigational new drug applications are daunting in the face of flat government funding and extreme competition for grants. Unless public and private funders create mechanisms to progress projects through this phase, much of the value may be lost. Unfortunately, the venture capital investments that drove the past decade of innovation4 have largely retreated from preclinical opportunities. Creative models for public-private partnerships to share the costs, risks and rewards are needed to sustain the current efforts in these centres, combine complementary skills, and address the key challenge of translation from a lead compound to a potential drug.

Abstract
Background: Overpopulation, poor hygiene and disease prevention conditions in prisons are major structural determinants of increased infectious risk within prison settings but evidence-based national and WHO guidelines provide clear indications on how to reduce this risk. We sought to estimate the level of infectious risk by measuring how French prisons adhere to national and WHO guidelines.

Methods: A nationwide survey targeting the heads of medical (all French prisons) and psychiatric (26 French prisons) units was conducted using a postal questionnaire and a phone interview mainly focusing on access to prevention interventions, i.e. bleach, opioid substitution treatment (OST), HBV vaccination and post-exposure prophylaxis (PEP) for French prisoners. Two scores were built reflecting adherence to national and WHO international guidelines, ranging from 0 (no adherence) to 10 (maximum adherence) and 0 to 9 respectively.

Results: A majority (N=113 (66%)) of the 171 prisons answered the questionnaires, representing 74% coverage (46,786 prisoners) of the French prison population: 108 were medical units and 12 were psychiatric units. Inmate access to prevention was poor. The median[IQR] score measuring adherence to national guidelines was quite low (4.5[2.5; 5.5]) but adherence to WHO guidelines was even lower 2.5[1.5; 3.5]; PEP was absent despite reported risky practices. Unsuitable OST delivery practices were frequently observed.

Conclusions: A wide gap exists between HIV prevention policies and their application in prisons. Similar assessments in other countries may be needed to guide a global policy reform in prison settings. Adequate funding together with innovative interventions able to remove structural and ideological barriers to HIV prevention are now needed to motivate those in charge of prison health, to improve their working environment and to relieve French prisoners from their currently debilitating conditions.

Substantial changes are needed to achieve a more targeted and strategic approach to investment in the response to the HIV/AIDS epidemic that will yield long-term dividends. Until now, advocacy for resources has been done on the basis of a commodity approach that encouraged scaling up of numerous strategies in parallel, irrespective of their relative effects. We propose a strategic investment framework that is intended to support better management of national and international HIV/AIDS responses than exists with the present system. Our framework incorporates major efficiency gains through community mobilisation, synergies between programme elements, and benefits of the extension of antiretroviral therapy for prevention of HIV transmission. It proposes three categories of investment, consisting of six basic programmatic activities, interventions that create an enabling environment to achieve maximum effectiveness, and programmatic efforts in other health and development sectors related to HIV/AIDS. The yearly cost of achievement of universal access to HIV prevention, treatment, care, and support by 2015 is estimated at no less than US$22 billion. Implementation of the new investment framework would avert 12·2 million new HIV infections and 7·4 million deaths from AIDS between 2011 and 2020 compared with continuation of present approaches, and result in 29·4 million life-years gained. The framework is cost effective at $1060 per life-year gained, and the additional investment proposed would be largely offset from savings in treatment costs alone.

Dates: 11/02/2011 - 11/05/2011
Location: New Delhi, India
Abstract submission deadline: June 15, 2011.
Early registration deadline: July 15, 2011.

Description: The theme of the conference, "Promoting Sexual Health: Basic Science to Best Practices," will optimize the implementation of the latest scientific discoveries and best practices regarding prevention, diagnosis, and treatment of STIs/HIV, through integrated programmatic approaches to achieve sexual health. The organizers will be collaborating with global and local faculty to bring a diverse and rewarding scientific program that encompasses basic science, epidemiology, clinical science, vaccine research, and the programs that assimilate these into best practices.

Date: 06/27/2011
Location: London, United Kingdom

Description: The agenda items for this conference include: HIV stigma: what is the impact for HIV-positive adolescents; A report from the 2010 Children's HIV Association summer camp; Challenging adolescents? Towards a developmental understanding of adolescence; the CHIVA Africa project - empowering clinicians in KwaZuluNatal, South Africa about work with HIV-positive adolescents; Pregnancy, STIs and adherence to ARVs; Pre-Exposure Prophylaxis(PrEP), Post-Exposure Prophylaxis (PEP) and male circumcision; Successfully managing the HIV-positive adolescent's journey from paediatric to adult services.

Funder's Fund ID: PA-11-218 Mechanistic Studies of HIV-Exposed Seronegative Individuals (HESN) (R01)
Companion FOA: PA-11-217, R21 Exploratory/Developmental Grant.

Purpose: To support mechanistic studies of individuals who are repeatedly exposed to HIV but remain seronegative (HESN), or demonstrate resistance to infection. Projects supported under this FOA could involve cellular, structural and systems biology; host and viral genetics; immunology, or virology. Applicants are encouraged to show how proposed studies will explore the mechanisms underlying HIV seronegativity or resistance.

Sponsor(s): US Department of Health and Human Services
First Application Due Date: 09/07/2011
First Project Start Date: 04/01/2012
Duration: Up to 5 years.

Web Page: grants.nih.gov/grants/guide/pa-files/PA-11-217.html
Web Page: grants.nih.gov/grants/guide/pa-files/PA-11-218.html

Number of Awards: 1
Total Award: $6.3 million
Minimum Award: $5.5 million