Fwd: RE: Generic Drugs

Jeffrey Jon Shaw jeffreyj at usp.br
Thu Aug 16 11:14:55 BRT 2001


>Delivered-To: jeffreyj at usp.br
>From: "Davidson, Robert N" <r.n.davidson at ic.ac.uk>
>To: 'Jeffrey Jon Shaw ' <jeffreyj at usp.br>
>Subject: RE: Generic Drugs
>Date: Tue, 14 Aug 2001 23:12:31 +0100
>X-Mailer: Internet Mail Service (5.5.2653.19)
>
>Dear Dr Shaw and other leishmaniacs,
>
>as one of the authors of the paper Jeffrey cites, and as the technical
>adviser on kala azar for Medecins Sans Frontieres - Holland, let me make a
>few comments about generic drugs for leishmaniasis.
>
>1. Generic sodium stibogluconate (SSG) can be obtained cheaply, easily,  and
>in large quantities from the International Dispensary Association in
>Amsterdam. IDA is a non-profit generic drug supplier which will be well
>known to many who work in poor countries. IDA sources generic SSG from a
>manufacturer in India, and IDA independently verifies all aspects of the
>quality control according to (and beyond) British Pharmacopoeia standards.
>Because SSG from other sources has been regularly reported to be of variable
>quality, and because anecdotes of "toxic batches of SSG" have abounded for
>decades, MSF endorses only the IDA product, and not generic SSG from other
>sources. We hope that the documentation of the independent quality control
>by IDA can allow national governments to import this SSG.MSF uses IDA
>generic SSG product in its kala azar programmes, having done large-scale
>evaluations of the product in the field.
>MSF-H has treated about 45,000 cases of kala azar in the east African region
>since 1989. Our shift to IDA's high-quality generic SSG has been the result
>of 7 years of work by MSF-H - there have been many who have opposed us.
>
>2. MSF-H is very aware that wider availability of SSG at an affordable price
>in Africa could lead to increasing drug resistance, as has occurred in
>India. Thus we are doing all we can to support WHO/TDR in completing the
>final steps in the re-licencing of paromomycin (also known as aminosidine)
>as an alternative (2nd line) drug for leishmaniasis. This product is
>manufactured by IDA. It is already available on a compassionate basis, and
>when licenced will be available as a generic drug - at low cost.
>
>If anyone would like to read the field evaluations MSF has conducted on
>generic SSG I can provide the references; and if anyone needs a contact
>email for IDA, I shall be happy to assist.
>
>yours, Robert Davidson



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