On June 6 2007, news came out that Viracept®, an HIV protease inhibitor marketed by Roche outside North America, has been contaminated at high levels (1) by a well-known genotoxic substance : ethyl mesylate (EMS).

While there is no data for the specific toxicity of EMS in humans, the substance is considered carcinogenic and teratogenic (i.e. it can cause both cancer and birth defects). Marketing authorization for Viracept has been suspended by the EMEA (2), and outstanding Viracept® stock has been recalled from the market. Health authorities have recommended that all patients previously using Viracept® switch to another antiretrovira.

Accused by many groups to be lacking in transparency and communication in its management of the recall, Roche organized today a “clarification meeting“ at the IAS Conference in Sydney, Australia. Act Up-Paris was one of the community groups attending this meeting, where Roche made the following commitments:
 To pay for costs associated with recall (transport, medical advice, tests) and switching to alternative regimens or to nelfinavir manufactured by another company
 To pay for epidemiological studies, establishment of registries, and follow up, of victims of the Viracept recall
 To pay the cost of the independent studies and batch analysis needed to determinate potential and actual EMS toxicity in humans
 To reimburse National Drug Regulation Authorities for all additional costs associated with expert advice to deal with the Viracept recall
 where needed, to provide monetary compensation to patients who suffered toxic events from Viracept EMS
 To show absolute transparency about the extent of the contamination, the share of batches that were contaminated, their degree of EMS content, and the process of manufacturing
 To provide opportunities for public hearings with independent experts

Act Up-Paris requires Roche to confirm publicly these commitments before the end of the IAS Conference, for example at the occasion of a press conference.

(1) Contamination of some of the 2007 batches has been measured at 2,000 ppm, while toxicologists recommend less than 1 ppm.

(2) EMEA : European Medicines Agency.