E-DRUG: Unethical drug promotion in India (2)
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Dear E-druggers,
It is always a surprise seeing a MIMS editor protesting against unethical
promotion;
the problem must therefore be quite serious, or there is a commercial
problem in the
country (competitors protesting?). But, anyhow, the main problem is that
Western
regulators are not actively removing old drugs unless there is a serious
safety
problem. Appeal procedures are ponderous and clumsy and extremely time-
consuming. That means that if a drug is of some commercial interest the
manufacturer will do his best to keep it on the market, and even inventing
indications
to obtain that goal.
Piracetam is a good example: I remember that the head of the drug agency of
the
German Medical Society called the word "nootropics" the invention of a
medical
representative with a classical education. It is still being manufactured by
the orginal
manufacturer, UCB (Union Chimique Belge - on international terms a minor
player in
the field) and by a host of generic producers, mainly in Germany. It is
actually quite
funny to look at the indication claimed in different countries - every
country has its
own indication, all very vague if not non-existing: "Cortical myoclonus"
(GB); "Age-
related diseases and general weakness (D); "Age-related loss of memory";
"Vertigo
of central origin" (NL). The most damning opinion was given by the German
drug
bulletin "Arznei-Telegramm". It is the classical example of a "drug looking
for a
disease". It might have some anti-epileptic acivity, and an isomer is now
being
marketed as an adjunct in anti-epileptic treatment.
Buclizine is only marketed as an adjunct to some anti-migraine mixtures
because of
its weak anti-emetic (and sedative) action. It also has some antihistaminic
activity
and there is some (weak) evidence that some antihistaminics improve
appetite.
Many years ago Merck made similar claims in Asia for their own drug, but
these
claims have long been dropped.
The only measure one can take is information, and I hesitate to say that the
Pakistani Network has given a very good example on how this can be done.
Good luck and best wishes,
Dr Leo Offerhaus
Netherlands
lo@euronet.nl
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