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.