A major international clinical trial of HIV drugs is failing to recruit patients from developing countries because of US opposition to generic drugs, say critics. The US$120 million Strategies for Management of Anti-Retroviral Therapy (SMART) trial is funded by the US National Institute of Allergy and Infectious Diseases (NIAID). The institute requires that only participants taking drugs approved by the US Food and Drug Administration can enrol in the trial.
The SMART trial aims to enrol 6,000 patients, but those in Argentina, Brazil, Peru and Thailand have been unable to take part because they are taking generic versions of brand-name anti-retroviral drugs. So far, only 792 of the 2,264 patients who were expected to enrol in the trial this year have done so. Recruiting from the trial's Latin American and Thai wings would add 733 more patients.
The head of NIAID, Anthony Fauci, says there is no policy to exclude generic drugs from international trials. But activists believe that a desire to protect the market share of US companies producing the brand-name drugs is to blame for the trial's slow start.
Reference: Nature 431, 493 (2004)