A bridge too far

Are the antiretrovirals (ARV) produced in Indonesia equal to the imported ones? This question is often asked in the various forums and during meetings with people with HIV here. I have usually answered that the generic drugs industry in Indonesia is said to have a good reputation, that the Indonesian Food and Drug Administration (BPOM) is said to do a good job of monitoring the industry, and anyway, 'the proof of the pudding is in the eating': my friend Yuni has been on locally-produced ARVs for almost seven years now, with a CD4 rise from 17 to more than 800, and a consistently undetectable viral load. In addition, it seems that all of the ingredients are imported from standard sources (in China?), and are only assembled and packaged here.

But now I'm not so sure. The headline in today's Jakarta Post says it all: "Consumers warned of ‘substandard’ generic drugs." The article even specifically refers to Kimia Farma (KF, the producer of the generic ARVs here) - although it is not clear that there is any specific concern with that company.

Actually. a presentation "Generics: access, efficacy and quality" by Andrew Hill from Liverpool University at the recent HIVNAT Symposium in Bangkok has already raised worries in my mind. Andrew raised the concept of "PK bridging", which is used to "prove" that generics are in every way equivalent to the original drug. There is a 'gold standard PK bridge' (picture of the Golden Gate), that is employed by reputable companies. There are 'other forms of PK bridging" (picture of rickety footbridge) that are 'much less stable." Several elements of this bridge should raise red flags. For example, unpublished trials - I have yet to see any data about trials by KF. And why are they not WHO approved - do KF practices meet the standards? Where can we get answers to these questions?

Sometimes I'm scared to dig too deep...

Babé