E-DRUG: Spate of FDCs in India (2)
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Dear E-druggers,
Mr Vaidya has raised a very important issue.
Surprisingly and sadly we still get this despite all
the talk (and action) about RUD.
I would talk about something similar and be interested
to know the reaction from the members (and perhaps a
word of advice too.
I sit on several Ethics Committees. One (in which I am
the Chairman)is an Independent Ethics Committee for
the research centre of a big and reputed
pharmaceutical company. It seems they are doing a
plenty of work as we have to meet at least twice a
month and each time an average of four protocols are
discussed. Most of this work is either in the form of
bioequivalence studies (to meet the national
regulations or that of a foreign country where the
product will be exported) or the clinical trials of
usually known drugs (? to get patent/permission etc).
However, products tested in both the groups are hardly
single and usually they are combinations. Commonly
tested combinations are antihypertensives,
antidiabetics, antihypertensive + antihyperlipidemic,
anti-ulcer + medications for GERD etc. Unfortunately, we
can hardly ever find anything unethical in these tests
and as expected barring one or two projects all have
been given approvals so far. Although most of the time
rationale is explained by the investigators (quoting
published work), the usual arguments for a combination
therapy are ease of administration, reduction in pill
load particularly in chronic diseases and a reduction
in cost sooner or later.
I am obviously feeling suffocated and helpless.
Leaving these Committees would not be an appropriate
answer (as they can always find someonelse). In some
situations argument like look we first introduced this
combination here (I think it is
atorvastatin + amlodipine, if my memory goes right) and
later on it was permitted even by FDA in US is also
given. To my horror I sometime start thinking if we
are not being unnecessarily rational and whether our
rationality is also not irrational ?
Dr Ram K Dikshit
Professor & Head
Department of Pharmacology
B J Medical College,
Ahmedabad 380 016
Gujarat
INDIA
ramdixit@yahoo.com
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