Last year, the World Health Organization removed some HIV/AIDS drugs made in India from its list of approved therapies.
It did this not because the drugs were found to be ineffective, but because the institutions contracted to test the drugs had not followed the organisation's laboratory and data-handling procedures (see Two generic HIV drugs removed from UN approved list).
This incident was one of a few that fuelled arguments that generic drugs should not be used because they are not as rigorously regulated as brand-name drugs.
In this article in The Lancet, Kevin Robert Frost of the American Foundation for AIDS Research argues that the lack of independent review of generic drugs has worrying implications for the HIV-infected people in the developing world who need to access them.
Some funders of aid programmes — such as the US President's Emergency Plan for AIDS Relief (PEPFAR) — have refused to buy generic HIV/AIDS drugs. Moreover, says Frost, it is only a matter of time before news emerges of patients being given sugar pills instead of HIV drugs. He predicts that when this happens, programmes that do use generics might withdraw their support for them.
Better testing might also prove that PEPFAR's insistence on using brand-name drugs has been "a monumental waste of resources", says Frost.
Ultimately, he concludes, we need to do all we can to get effective treatment to the estimated six million people for whom access to HIV/AIDS drugs is a matter of life and death.
Link to full article in The Lancet*
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