Originally published by the Voice of America (www.voanews.com).
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September 10, 2007

Lack of Drug Monitoring Puts Millions at Risk In developing Countries
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http://enews.voanews.com/t?ctl=195ADB7:A6F02AD83191E1601D68E7513FF93C149574F7DCC14957C0 British
Medical Journal article warns of adverse side effects of medicines
More is being done these days to get new medicines to developing
countries. But researchers say little is being done to monitor the
possible adverse side effects. They say millions of people may be put
at risk as a result.

A British Medical Journal article says developing countries bear
almost 90 percent of the world’s disease burden.” So when new drugs
are developed that could fight illnesses, there’s great demand and
pressure to get them to African and other developing countries as soon
as possible.

However, while the side effects of those medicines are monitored
fairly well in developed countries, not so elsewhere. Dr. Munir
Pirmohamed is a physician and professor of clinical pharmacology at
the University of Liverpool.

“Unfortunately, all medicines at the moment come with some degree of
risk. But what we don’t know is what that risk is in the African
population or in other developing countries because they have
different degrees of nutrition. They have different diets and also the
genetic factors may also be important. And so therefore we need
comparable structures in developing countries to be able to monitor
any drug safety issues, which may be occurring there,” he says.

Western nations developed what’s known as “pharmacovigilance” in the
1960’s, after the drug Thalidomide caused disabilities or deformities
in 10,000 babies. The drug had been developed as a remedy for morning
sickness during pregnancy. However, even today, drugs can be on the
market for years before all the side effects are known. So the system
in the West isn’t perfect. But in the developing world, it’s basically
non-existent.

Dr. Pirmohamed tells of a drug developed in the West having an adverse
reaction in Africa.

“For example, there was one drug called Thiacetazone, which is used
for TB (Tuberculosis). In the African population it caused a
horrendous skin reaction in a large percentage (of the patients), up
to 10 percent in some studies. Whereas when it’s been used in other
countries in the Western world and so on, the reaction rate was much
lower. So there are definitely examples,” he says.

Dr. Pirmohamed and the other authors of the British Medical Journal
article say developing nations need to be brought up to speed in drug
monitoring.

“To be able to develop the structures, obviously it’s going to take
decades and enormous amount of expenditure. And we can’t wait decades.
We can’t be exposing drugs, which may be causing harm to the
population there. So we need to develop new ways of thinking and new
ways of working together so that we could try to identify any answers
now. So that we can try to make sure that the patients (are) getting
the drugs they need, but also at the same time we’re maintaining
safety of the drugs,” he says.

In the short term, the researchers recommend setting up programs to
boost local expertise in drug monitoring, possibly through exchange
programs. They say the World Health Organization and the US National
Institutes of Health should take the lead in promoting
pharmacovigilance in the developing world. 





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