Microbicides 2004 Microbicides 200428-31 March 2004, Hilton London MetropoleThe conference42 million men, women and children worldwide were living with HIV by the end of December 2002 (source: UNAIDS), including five million newly-infected during that year alone. Another 45 million people will become infected between 2002 and 2010, unless the current transmission rates can be vastly reduced. Of the 42 million, 29.4 million live in sub-Saharan Africa and 58% of them are women. Not only are women more susceptible to HIV infection, many are powerless to insist on the use of condoms or other methods of protecting themselves. In this context, and with the knowledge that an effective HIV vaccine is unlikely to be available for several years, the need for an effective topical microbicide grows ever more urgent. 2004 should prove to be a landmark year in the field of microbicide development as the first Phase III trials of novel products are due to start – the next step along the road to making a microbicide available to the millions worldwide in desperate need of protection.The aims of the Microbicides 2004 conference are to:Report novel or innovative work in the microbicides fieldProvide updates on recent microbicides research, divided into three tracks: basic science, clinical science, and behavioural science (including public health and the microbicide marketplace)Provide a forum for the discussion of new developments in microbicide research including ethical, clinical, behavioural and methodological issuesPresent opportunities for knowledge-sharing between microbicide researchers, public-health workers and advocacy organisations.There will be an opening ceremony on the evening of Sunday 28 March at which politicians, policy makers and the international media are expected. The conference will run for a full three days, each of which will contain:Scientific overviews and presentations with plenary sessions, invited lecturers and presentations of original researchWorkshops to review issues unique to microbicides such as trial design and outcome measures, and ethical issues in the clinical trials of microbicidesPoster sessions. Focus on LondonFollowing the successful Microbicides conferences in Washington in 2000 and Antwerp in 2002, March 2004 sees the focus move to London.The venue is the Hilton Metropole Hotel, two minutes by taxi from Paddington station and the Heathrow Express, with a journey time from the airport of 15 minutes. The hotel is in walking distance of Hyde Park and London’s main shopping streets, and close to Imperial College. Accommodation will be available at the venue and other hotels in the vicinity.London in March offers a variety of diversions for out-of-conference relaxation, including sight-seeing and shopping; the arts and the theatre; and pubs, clubs and restaurants to suit every taste. Conference staff will be on hand to help delegates plan their spare time.To book your place or find out more information, e-mail info@microbicides2004.org.uk or telephone the Event Office on +44 (0) 20 7720 4411
Oral: invited speaker Oral: Track A Oral: Track B Oral: Track C Poster: Track A Poster: Track B Poster: Track C Abstract only Authors

SC-02 THE “STANDARDS OF CARE DEBATE”: SOME PERSPECTIVES FROM THE DEVELOPING WORLD

Professor Zulfiqar A. Bhutta
The Aga Khan University, Karachi, Pakistan

The issue of a universal standard of care for research subjects in developing countries was brought to the fore by the controversy surrounding the HIV using ACTG 076 triple therapy versus placebo. This resulted in an acrimonious global debate and a review of exiting ethical review guidelines on the issue. While it can be argued that the principle of beneficence dictates that all research subjects must maximally benefit from planned interventions, the most pervasive arguments supporting the continued use of placebos are based on efficiency and economics. Also the “tyranny” of the randomized controlled trial precludes any learning from alternative methods of evaluation such as quasi-experimental designs.

The standard of care may be seen as the global rather than local standard of care, although others have questioned this. What constitutes a standard therapy in one health system with profligate expenditure on medical practice based on defensive medicine, may be totally inappropriate in another system with limited resources. Thus a reasonable compromise may be seeking the highest attainable local standard rather than an impossible alien and unsustainable alternative. Nevertheless there is a legitimate debate as to what constitutes an acceptable standard? Is it a prevalent local standard or one that is ideal in any given circumstance i.e. a local de-facto versus de-jure standard? Thus the standard of care does not necessarily relate to the most expensive or sophisticated treatment regimen but those that perform best given the local conditions and health systems. Another important issue around the standard of care argument is that it is frequently interpreted in the narrow context of medications or dugs used in trials alone rather than the overall care within the health system.

It must be emphasized that the current safeguards and guidelines were largely devised to prevent undue exploitation of vulnerable populations and developing countries. The need is to develop pragmatic and flexible approaches that marry the fundamental principles of beneficence with a public health approach that allows the possibility of incremental benefits.

Professor Zulfiqar A. Bhutta
The Aga Khan University, Stadium Road, P. O. Box 3500, Karachi 74800, Pakistan
(Telephone) 92-21-4930051 (Fax) 92-21-4934294 (E-mail) zulfiqar.bhutta@aku.edu