E-drug: Request for information
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Dear E-druggers,
As a final year student in University College Cork, Ireland, I am
carrying out research on the pharmaceutical industry's unethical
promotion of inappropriate drugs, particularly in developing countries.
For this reason I subscribed to e-drug am I am now looking for help.
One of the cases I am focussing on is the controversy over G.D.
Searle's antidiarrhoeal drug Lomotil in the early 1980's. I have read
Social Audit's report with interest but I am having trouble finding
updated information on the present situation and the regulatory status
of the drug. Searle does not list it as one of its drugs currently on
the market, but other sources say it is still on market, but
recommended for extreme cases only.
My question is therefore: What is the situation at present? Is Lomotil
still on the market in developed and developing countries? Is it still
widely marketed, recommended and used in developing countries in
particular?
I would really appreciate any information subscribers have on this
subject, especially from those who have spent some time in developing
countries and seen Lomotil being prescribed or bought over the
counter, and the effect it has had on the user.
Thanks in advance,
Aoife Collins,
Dept of Sociology
University College Cork
Cork, Ireland
e-mail: a.p.collins@student.ucc.ie
[Note from the moderator: The WHO publication "The Rational Use of
Drugs in the Management of Acute Diarrhoea in Children" (WHO 1990)
reviewed all known literature on the most commonly used antidiarrhoel
agents in the world (including diphenoxylate, or Lomotil). As far as
diphenoxylate is concerned, the publication stressed that
"diphenoxylate cannot be recommended for the management of diarrhoea
in children, and there is thus no rationale for the production and sale
of liquid and syrup formulations for peadiatric use". WHO distributed
this publication widely (some 15,000 copies worldwide).
Having been closely involved in these efforts, I conducted research
into the regulatory response of the world's countries to the publication
and distribution of this book. In a resulting article I evaluated the
actions against antidiarrheal drugs taken by national drug regulators
during and after these events (Haak H, Claeson ME. Regulatory actions
to enhance appropriate drug use: the case of antidiarrheal drugs.
Social Science and Medicine 1996: 42(7); 1011-1019).
Sixteen countries reported regulatory actions on 21 occasions during
the period of study. The majority of actions concerned antimotility
drugs; few were against adsorbents, antidiarrhoeal drugs containing
antimicrobials, or adult formulae. Most actions occurred in the two-year
period immediately after the distribution of the WHO review and the
attention in the media. Diphenoxylate per se was deregistered in 9
countries. Although the results were encouraging, it is likely that
antidiarrhoeal drugs remained registered in a great number of
countries. How many countries remain with diphenoxylate and other
antidiarroeal drugs registered, is difficult to say, since regulatory
systems are generally not open to researchers.
Deregistration of profitable drugs is very difficult and drug regulators
may have chosen to delay regulatory action until the end of a drug's
registration cycle (the so-called "passive deregistration"). If true,
many more antidiarrheal drugs may loose their registration in the
future through a passive deregistration process. But we may not easily
know about it.
Hilbrand Haak
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