PHM-Exch> Malaria drug-makers ignore WHO ban

[Claudio Schuftan]

From: Vern Weitzel <vern.weitzel at gmail.com>
crossposted from: "[health-vn discussion group]" health-vn at anu.edu.au


Malaria drug-makers ignore WHO ban

Health agency calls for clampdown on artemisinin monotherapy.

Declan Butler

There is a growing risk that malaria parasites will develop resistance to
artemisinin because almost half of both its manufacturers and
malaria-affected
countries are failing to comply with World Health Organization (WHO) demands
to
sell it only in combination with other drugs. Artemisinin and its
derivatives
are the leading treatments for the disease, being the only antimalarials
that
have not yet seen widespread resistance in malaria parasites.

The full scale of the problem is revealed in a soon-to-be-published WHO
briefing
seen by Nature, "Stop the marketing of oral artemisinin monotherapies",
which
calls for governments to empower national drug-regulatory authorities to
clamp
down on offending companies.

Treatments that use only artemisinin need to be taken for seven days to kill
all
parasites, but patients often stop treatment after a few days when they
begin to
feel much better. This leaves the remaining parasites in contact with low
levels
of the drug — a recipe for resistance. The WHO recommended in January 2006
that
artemisinin should always be given in combination with other drugs for at
least
three days, because a cocktail reduces the chances of resistance. The need
to
move away from monotherapies has become all the more urgent with recent
reports
of resistance arising in Cambodia.

Although artemisinin-based combination therapies (ACTs) have become the
treatment of choice for malaria, with a three-day programme curing more than
95%
of patients, monotherapies are cheaper to produce and sell.


Of the 69 manufacturers of artemisinin monotherapies that the WHO has
identified, 21 have withdrawn monotherapies, and 14 say they intend to
comply
with the WHO's recommendations. But the remaining 34 have not yet disclosed
their intentions. Many have not even replied to multiple WHO e-mail and fax
requests for information, says Andrea Bosman, an official at the WHO's
Global
Malaria Programme (see http://tinyurl.com/m4gqmn).

Regulatory authorities in just 39 of the 76 countries using malaria drugs
have
so far complied or said they intend to comply with the WHO's recommendations
(see http://tinyurl.com/m94wqk). National regulatory authorities could help
by
banning monotherapies, says Bosman, but many are weak, understaffed and lack
expertise.

"It's terrible," says Bosman, adding that every country where malaria is
endemic
is affected by the problem. "Who says there is no profit to be made in
malaria?
When you see the number of companies operating in Africa, and the diversity
of
products, you'd just be amazed."
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