SciDev.Net

This article, written by scientists from Canada, China, Egypt and India, examines the spread of alliances in health biotechnology and the extent of collaboration in this sector between the South and the North.

The authors surveyed 288 firms on South–North health biotech collaborations and use the results to map the extent and geography of partnerships. They analyse the international collaborations of firms in Brazil, China, Cuba, Egypt, India and South Africa and compare them to South–South collaborations.

The authors conclude that developing countries' firms are closely tied to northern health biotech networks and that South–North collaborations are common practice in health biotech. More than half the firms surveyed actively collaborate with countries in the North — compared to just a quarter working with other developing countries. Egypt is the only country where South–South collaborations outnumber South–North ones.

This paper proposes a model to provide better access to fairly priced antiretroviral (ARV) drugs for HIV-infected people in poor countries, while also safeguarding the interests of ARV manufacturers.

The authors explain what governments and brand and generic companies are doing to increase the availability of ARVs in developing countries, taking examples from Brazil, Canada, China, India, the United States and Thailand. They also discuss the implications of creating more South–South partnerships to produce and market ARVs; and the impact that the UNTAID–Clinton Foundation coalition has had on lowering ARV prices in developing countries.

The authors recommend an incentive-based strategy that includes international donors bulk-purchasing generic ARVs, individual governments providing financial relief packages for generic companies, and the WHO brokering negotiations between brand and generic companies.

Vaccination for infectious diseases is a vital method of prophylaxis, and has transformed modern medicine. By contrast, research into vaccines against chronic diseases has been less successful, in part because of the increased complexity involved.

In this opinion piece, the authors outline the prospects for the development of chronic disease vaccines. These might not need to rely on the traditional method of inducing the body to produce antibodies, but rather on introducing monoclonal antibodies against specific proteins — this has so far worked well against Crohn's disease and rheumatoid arthritis.

The authors outline key hurdles in developing a successful therapeutic vaccine. Safety and efficacy are two obvious ones, but there is a third that is unique to vaccines for chronic diseases. Because these vaccines would block bodily chemicals — such as cytokines or hormones — it would not be acceptable for a vaccine to induce a life-long block (unlike a malaria vaccine, for example, where a lifelong block would be ideal).

These might be particularly useful in developing countries, say the authors. Because prophylaxis with vaccines is already a familiar concept, there should be no problem with patients' compliance, and judicious partnerships between public and private organisations could mean the vaccines are produced cheaply.

This series of five articles outlines new challenges and unsolved problems since the journal's last series in 2005. The first article ([189kB]) predicts the disease burden and economic losses that developing countries would face from chronic diseases such as cardiovascular disease, cancer, chronic respiratory disease, and diabetes. In the 23 countries that the authors incorporated into a model, chronic disease was responsible for 50% of the disease burden in 2005. If no action is taken, they say, about US$84 billion of economic production will be lost from heart disease, stroke, and diabetes alone in these 23 countries between 2006 and 2015. The second article ([105kB]) looks at how to scale-up strategies to fight chronic diseases in developing countries. The authors review evidence to identify which methods are cost-effective and financially feasible, and therefore ready to be scaled-up.

Tobacco control, salt reduction (both of which are detailed in the series' third paper ([177kB])), and a multidrug strategy to treat individuals with high-risk cardiovascular disease (see an in-depth look in paper four ([220kB])) are prime candidates for scaling-up. What effect improving health systems has on the level of chronic diseases should be properly evaluated, say the authors. For some health interventions, such as preventing or controlling diabetes, there is little cost-effectiveness data for low or middle-income countries, but their scientific effectiveness is so compelling that countries should consider how best to incorporate them. The final paper ([92kB]) is a call to action to incorporate existing interventions into healthcare programmes, which in 2005 was costed at US$5.8 billion.

Launched to coincide with the 2004 International AIDS Conference in Bangkok, in this strategy document, the IAVI outlines plans to strengthen and expand the research and development pipeline of candidate HIV vaccines, and engage as partners those countries most affected by HIV/AIDS. Future scientific strategy includes focusing on vaccines that trigger neutralising antibodies, and understanding how live weakened vaccines work in animal models for clues to what is needed in a vaccine for protecting people.

In response to controversy over a trial in Cambodia that was halted earlier this year, this document, written for a broad audience, addresses a range of issues regarding tests of the antiretroviral drug tenofovir in healthy uninfected individuals. The clinical trials, taking place in Africa, Asia and the Americas, aim to see whether Tenofovir can protect against HIV infection in those who are at high risk of exposure to the virus — so-called Pre-Exposure Prophylaxis, or PREP. But its use raises a whole set of concerns regarding its potential impact on trial volunteers and their communities, including the prospects for encouraging drug-resistant strains of HIV to emerge and higher risk sexual behaviour.

This collection of 43 essays is by people involved in HIV/AIDS research, community education, clinical trials and advocacy, and aims to both inform and encourage global action. Written in an easy-to-read style, it introduces many of the major scientific, policy, social, ethical and economic challenges of developing an AIDS vaccine, with chapters covering issues such as HIV vaccine science, vaccine safety, ethics of clinical trials, informed consent, community action to encourage HIV vaccine development, and sources of information and help. Notable contributions from developing country authors include the personal experiences of a vaccine scientist involved in establishing the first HIV vaccine trials in Uganda, the vulnerability of women to HIV/AIDS in India , and the challenges of recruiting women to participate in clinical trials in Kenya. Illustrations include photographic accounts of the HIV virus and its life cycle, and clinical and laboratory tests on clinical trial volunteers.

This news feature aimed at a broad scientific audience likens the perplexing task of trying to develop an HIV vaccine to “flying without a compass”. HIV poses unique challenges, including its infinite variability and protective coating that masks it from antibodies, yet researchers have evidence from both human and animal studies suggesting that it may one day be possible to trigger an immune response that protects against infection.

A policy working paper concerning the demand for an HIV vaccine usefully compares studies conducted globally and nationally, concerning both public and private sectors, in order to help inform future healthcare strategies and financial planning, and investment from industry in HIV vaccine research and development.

This policy brief highlights key issues in assessing the demand for an HIV vaccine, including what factors influence demand, such as efficacy and cost of vaccine candidates and acceptability among target populations, and differences between public and private sectors in their willingness to pay for a vaccine and political commitment.

This is a useful policy paper that assesses the total level of spending needed for AIDS vaccine research and development in the near future and the gap between current and projected spending. It considers the main stumbling blocks in vaccine research and development that could be significantly overcome with sufficient increase in spending: identification of high-quality candidate vaccines, increasing the number of such candidates entering clinical trials, and speeding up the establishment of clinical trials with faster recruitment of volunteers and regulatory approval.

This report from a workshop on “Promoting R&D in Preventive Health Technologies,” held in India in December 2004 outlines the potential role that the biotechnology sector in India could have in HIV vaccine research and development. India, as other “innovative developing countries” such as Brazil and China, has the research and manufacturing capacity to take a significant role in HIV vaccine research and development. The report strongly advocate’s IAVI’s strategy of promoting public-private partnerships in order to finance such developments.

In this commentary article, HIV vaccine researcher Ron Desrosiers presents his view that the main reason we do not yet have a vaccine for HIV is due to unsolved scientific questions rather than a bottleneck in conducting clinical trials. Accordingly, he advocates a "renewed, coordinated and focused effort" on basic research rather than clinical trials for "feeble" candidates that "stand little chance of being effective".

Desrosiers is well known and respected in the HIV research field for his contribution to the scientific debate, and presents five lines of evidence for his contentions. These include the failure of immune responses elicited by current vaccines in HIV-infected individuals to control the virus; the failure of the animal models much favoured by researchers to fully represent HIV infection in humans; and the ability of new strains of HIV to 'super-infect' individuals already infected with another strain, even if their immune system appears to be controlling the first infection. He also disagrees with the aim of the recently formed "Global Vaccine Research Enterprise" of placing more candidates in clinical trials more quickly. 

The article is written for general readers with a scientific background, and assumes knowledge of how the immune system works and relevant technical terms. Nonetheless, it is a well-argued piece that provides much food for thought for the vaccine community and policymakers alike.

In this article, Simon Noble, editor of IAVI Report, explores the prospects for a kind of HIV vaccine that aims to boost the immune response in people already infected with the virus, rather than what most vaccine researchers are working on, namely to protect against infection in the first place.

The article is written for scientifically educated readers who already have a basic knowledge about vaccines, and lay readers may therefoer find it somewhat technical. Nonetheless, it is a useful account of what many researchers feel is a worthwhile goal. The article reviews the different approaches in designing and testing therapeutic vaccines, and presents the views of different experts in the field.

It also features some of the scepticism around the concept of a therapeutic vaccine, including the concern that the immune system is so impaired by HIV infection, and the virus already so diverse after multiplying millions of times in the body, that it may not be possible to mount a stronger and more effective immune response against the virus.

This freely-available online medical textbook is written by expert clinicians in Europe and the United States in clear language that will have broad appeal to non-medical readers. Updated every year, it contains searchable information about the clinical manifestations of HIV/AIDS and its treatment, including acute infection, antiretroviral drugs, and drug resistance testing. Rather than going into detail about scientific or medical research, the textbook concentrates on the facts and explanations around HIV/AIDS signs and symptoms.

This report - the result of a one-year literature review and consultation with experts - provides the case for developing microbicides, and contains a useful account of the recent history of the field. The report notes that although the previous five years had seen a dramatic increase in the number of researchers working on microbicides, progress remains slow.

While there is some overlap with the 2002 reports of the Microbicide Initiative, this document also suggests priorities for stimulating industry investment into research and development of microbicides. These include the need to provide proof of concept (evidence that microbicides can be effective against HIV and other sexually transmitted diseases), and the importance of exploring new sources of investment such as venture capital.

This short report summarises five different sets of priorities for action on microbicides: development, marketing, public health, consumer access and advocacy. These are the key points of reports from five Working Groups of experts, assembled by the Microbicide Initiative, an umbrella organisation dedicated to the production and global use of microbicides. The full report of the Scientific Working Group is recommended reading, which represents a scientific roadmap for understanding microbicides and accelerating their development.

The key points listed in this summary include the need for further research into preventing the HIV virus from crosssing the mucous membranes of the female genital tract, and the roles of other sexually transmitted diseases. It also outlines the complexities and challenges of pre-clinical and clinical testing, and features a table listing products in clinical trials, as of February 2002.

This 94-page document is an extensive state-of-the-art report by the Science Working Group of the Microbicide Initiative. With individual chapters authored by different scientific experts, it provides a scientific road map for the development of a safe effective vaginal microbicide against infection with HIV and other sexually transmitted diseases.

A microbicide is viewed as "a critical adjunct to condoms, as well as complementing current efforts to develop a therapeutic or prophylactic HIV vaccine", with the added advantage that an effective microbicide is likely to be produced more widely and more rapidly than a vaccine.

The report covers topics ranging from basic research, through the challenges of pre-clinical and clinical testing, to key issues in manufacturing, formulation, acceptability and end use. Highlights of the basic science section includes diagrams showing how HIV infection takes place, the HIV life cycle within an infected cell, and steps where microbicides may act. Also included are tables of microbicides in development, and their many sponsors and developers. Final chapters include a section on the global epidemiology of HIV and other sexually transmitted diseases.

This review - which includes a moderate level of technical detail - covers both the progress of microbicides through laboratory and clinical testing, and the social science and market research that supports microbicides as an HIV prevention option.

Particularly useful is the brief information it provides on which companies are developing each product, and the locations of clinical trials. However, it lacks the illustrations and graphic design of other reviews of microbicide development.

In this article, leading vaccine researchers and advocates join forces to call for a global strategy for developing an effective HIV vaccine. The goal, they say, would be to unite teams of researchers in a series of coordinated global HIV vaccine centres, each with the critical mass, focus and scientific expertise for a more rapid and systematic approach to vaccine development.

The authors point to the recent success of the Human Genome Project in achieving the full sequencing of the human genome within a shorter than predicted timeframe. They say this provides an encouraging model, which highlights the need for a common vision among funders and major stakeholders, including those from developing countries.