On July 23rd, Roche met various HIV community groups, including Act
Up-Paris, at the International AIDS Conference in Sydney. During the
meeting, Roche made certain specific commitments with regard to remedying
the Viracept® recall debacle. Activists require that Roche make these
commitments official.
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.
