E-drug: Re: Essential antimalarials for paediatric use
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Dear E-druggers,
Dr Ojoo makes a good point when he stresses the need for
paediatric formulations. As far as we know a paediatric formulation
of Co-artem does not exist. For children we need syrups or oral
suspensions or suppositories or appropriate injectables. None of
these formulations of Co-artem do exist.
Is it not surprising that in spite of this tremendous deficiency WHO
has added this drug Co-artem (a co-formulation of artemether and
benflumetol in tablets) to the essential drug list. At the same time
they consider to withdraw the "monotherapy" drugs Artemether
injectable and Artesunate tablets (see e-drug correspondence of the
last few days). Indeed: what a child need is an acceptable
formulation as Dr Ojoo points out. But co-formulated suppositories
do not exist, the same applies to the injectables of artemether. The
non existence is, at least in part, the result of pharmaceutical
legislation. It should be mentioned that it is not easy to make a
co-formulation of artemether in suppositories or in oily injections
and co-formulations will many times create problems of chemical
and/or pharmaceutical incompatibility. This makes the decision of
the WHO's expert committee even more bizarre since it is unlikely
that such co-formulation drugs will come. It should not be forgotten
that Co-artem is a product protected by patent, exclusively in
favour of Novartis and that WHO is recommending all governments
to go for this drug in case resistance problems occur in their
country, which is the case nearly everywhere. After Novartis failed
to introduce Co-artem successfully in the private market in selected
African countries over the last few years, they offered it with a lot
of media publicity "at cost price" to WHO which would then make
the drug available to countries and governments needing such a
drug. And, indeed, officials of WHO have been pushing hard over
the past months to have this idea accepted. At several occasions I
was a witness at such meetings. Now, 11 months after this special
"donation" of Novartis to the WHO, the experts suddenly decide to
add this Co-artem drug to the essential drug list. What a remarkable
surprise? Whereas in the past none of the officials ever were
concerned about the possibility of creating drug resistance for the
malaria parasites, not for Chloroquine or Amodiaquine, not for
Fansidar, not even for Quinine when used in monotherapy, they
suddenly become extremely concerned that if the use of Artemether
and Artesunates is not protected a malaria disaster will threaten
Africa. And this all coincides with the period of the introduction of
Co-artem by Novartis. In Europe this Co-artem is very expensive but
in Africa it is still expensive in spite of the transfer at the so called
cost price. We believe that at the selling price of 2.30 US dollar for
a Co-artem pack there still is considerable profit for the company
concerned. Is this all coincidence? I do not think so. This should be
investigated in detail. Nevertheless good formulations for children
are available from Dafra Pharmaceuticals, a Belgian pharmaceutical
company. Those will satisfy the wishes of Dr Ojoo. Apart from
formulations for adults, Dafra brings GMP paediatric formulations in
monotherapy (tablets for elder children, powder for oral
suspensions, artemether for i.m. injection at adequate concentration
and suppositories with artemether for emergency treatment of very
sick babies and children. The company advises that combination
therapy can be installed by the responsible physician if he wishes to
do so. They also have a combination preparation of Artesunate with
SP which will soon become available for prescribing physicians in
the various malaria countries.
Yours sincerely,
Dr. F.H. Jansen
30 Witte Bremlaan
B-2360 Oud-Turnhout
Belgium
e-mail: fhjansen@skynet.be
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