Volume 14, II – Autumn 2005

Over the last 30 years India has been a haven for generics but recent laws passed in the Indian Parliament may have dried up this treatment oasis for the developing countries of the world.

It is rare that, when talks on treatment access happen between governments or activists and pharmaceutical companies both parties come out winners, but it can happen.

The EATG position paper on clinical research and drug users provides a valuable opportunity to assess progress and renew advocacy in an area which has received relatively little attention from researchers, industry, and activists alike.

Whoever is aware of the epidemiological situation in Europe, will know that there is an extremely high and increasing number of drug users affected by HIV.

On the general aspects of study design - In an effort to convert to guidelines the ”Points to Consider on the Assessment of anti-HIV medicinal products“ adopted by the EMEA's Committee for Medicinal Products for Human Use (CHMP) in January 1996, last April 2005 the EMEA released a draft document of guidelines on clinical development of HIV drugs.

From the complete letter addressed to Dr. Lee, Dr. Piot, Dr. Feachem and Mr. Costa, which is available at: www.eatg.org, we have selected the following points:

”HIV prevention is for life; therefore, both delivery of existing interventions as well as research and development of new technologies require a long-term and sustained effort.“ – from UNAIDS' seven Principles of Effective HIV Prevention. [1]

Ethics set the line of debate on preventive clinical trials in developing countries ”Science can show us everything except how to think and what to do“.

As more trials with new preventive technologies such as microbicides and AIDS vaccines are starting to be conducted, it is important to look at their characteristics.

The International AIDS Conference has grown to become the largest, most diverse and most visible event in the global response to AIDS.

When I was first asked to summarize the HIV/AIDS situation in Poland for the 9th European Conference on Clinical Aspects and Treatment of HIV Infection in Warsaw in 2003, the request came from Dr. Andrzej Horban, the Director of the Warsaw Hospital for Infectious Diseases.

Analysts of development assistance and observers of the United Nations have grown used to U.S. efforts to turn its particular ideologies into global standards.

Recently, an announcement came from the pharmaceutical company GlaxoSmithKline that they were suspending their Phase II study in treatment naïve people with aplaviroc, a CCR5-inhibitor, due to serious side effects on the liver of some of the participants...

The tipranavir case and the importance of HIV-people's representatives in the defence of their rights - Marketing Authorization (MA), Expanded Access Programs (EAP) or how to see your rights denied when it comes to have access to essential medication.

In the history of the AIDS epidemic, most major gains were made when civil society got a bit ”uncivil“ that is, started demanding their rights to be free from discrimination, for access to clean needles, for access to treatment among other things.