-------------------------------------------
The pivotal person in this re-approval was Bengt Wiholm,
head of the adverse reactions division of the Swedish
drug agency (Medical Products Agency) in Uppsala who was
at the time a member of the IAAAS team ("Boston trial"),
and has always staunchly defended the point of view and
the statistical data of this trial. In retrospect - and
in view of the commercial goals of the IAAAS - one could
have some doubts whether it was wise decision for a civil
servant to play such an active role, but that is for others
to judge. At the time Barbro Westerholm still maintained
that her own data mirrored the truth.
Bengt Wiholm is therefore probably in the best position to
defend Hoechst's point of view and explain why the MPA
approved dipyrone again.
Leo Offerhaus MD PhD
Koedijklaan 1a 1406 KW Bussum The Netherlands
Tel 0031-35-6923288 Fax 0031-35-6923290
E-mail: LO@EURONET.NL, CompuServe 71530,15
Eur J Clin Pharmacol ONLY: POB 75552, 1070 AN Amsterdam
-------------------------------------------
I would be fascinated to know the reasons for Sweden
reapproving dipyrone. It is registered in South Africa and
widely used in combination with hyoscine butyl bromide.
Many clinicians feel that the SA Regulatory Authority (MCC)
would have withdrawn dipyrone if the evidence against it was conclusive. Colleagues who have reviewed the literature also
feel that there is not enough conclusive evidence against
dipyrone, and the risk of serious adverse effects is not
great.
The use of a NSAID related agent in combination with a
belladonna alkaloid (theSA product) is not rational,
particularly where the indication is antispasmodic. However,
a balanced review of the data for and against its use will
ultimately decide the fate of dipyrone.
Can anyone, particularly Sweden comment from this aspect.
With thanks
Leesette Turner
Moderator, INDICES
South Africa
Email: hamis@iafrica.com
Note from the moderator:
------------------------
I am copying the above messages and the original to
Dr. Beje Wiholm of Swedish with a request for feed-
back. Thanks.
Syed Rizwanuddin Ahmad
Email: srahmad@essential.org
--
Send mail for the `E-Drug' conference to `e-drug@usa.healthnet.org'.
Mail administrative requests to `majordomo@usa.healthnet.org'.
For additional assistance, send mail to: `owner-e-drug@usa.healthnet.org'.