E-DRUG: two generic ARVs back on WHO Prequalification list (2)
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Dear friends:
Yesterday, WHO made public the re-listing of two ARV from CIPLA. New
bioequivalence tests fulfilled the Prequalification system' criteria. They
were delisted for 6 months, so one can assume that we are talking about same
formulations of same products. 6 months seems to be short enough just to
find new bio-studies enterprise and conduct the new bioequivalence study.
During these 6 months, following the WHO recommendations, some countries
could ban the products canceling its registration (fortunately, as far as we
know there is no report of any case), some others cancelled purchases,
cancelled shipments, cancelled distribution and switch patients to other
options. Some others simply didn't do anything (and we hope, it was the vast
majority). All of these choices -if you remember- are consistent with the
broad scope of WHO recommendations.
It did not avoid that -as far as we can confirm- in Colombia, one
research-based pharmaceutical industry distributed copies of the WHO press
releases as an evidence of the bad quality of generic antiretrovirals in
particular, and generics in general. That in Latin America, organizations of
people living with HIV-AIDS reject the use of generic ARV arguing its not
proved quality. In Venezuela it was presented a constitutional sue against
MOH because of the use of generic ARVs which quality was under suspect. And
specially, an international efficient but underground campaign to undermine
the image of generics by using bioequivalence tests.
It is important to point out that we never ever though or suggest that WHO,
and particularly the prequalification system have had the intention to
support someone or undermine other one. But, by the very first press release
we warned about the risk to manage the information in the way it was, to
take the kind of decisions that were took, and to include bioequivalence
tests as quality criteria for generic ARV. The fact is that decisions and
communications were used, and still being used to discredit generics.
The technical discussion about bioequivalence tests for ARVs is still
unsolved. And it is important to point out that costs of tests are not a
major issue. For a generic manufacturer a biotest means just another
production cost to add to the final price of the product. One can distribute
the more or less US $ 50.000 of these studies in the millions and millions
of pills commercialized with only one test. Even in products destined only
for national markets. The price of studies is not the problem.
The risk of increasing resistance with non bioequivalent ARV is other
argument. But it is a circular argument, meaning that you need the
consequence as a cause. In other words one is assuming that without
bioequivalence there is no therapeutic equivalence. But the question, the
primary question is if you need Bioequivalence to prove therapeutic
equivalence, or if it can be proved with other -not in vivo- tests. We want
to stress again the experience of Brazilian AIDS program. Until we find
technical arguments to justify these tests, there are technical -and
ethical- reasons to reject this tests and its generalization.
Anyway, it seems to be necessary to have strong statements rejecting the
misuse of bioequivalence in general, and particularly the results of the
prequalification systems, to undermine the image of generics by the research
based industry in developing countries.
Claudia Vacca
Francisco A. Rossi. B.
francisco_rossi@hotmail.com