There is an article in the British Medical Journal related to international aspects of drug safety in the developing world. “Pharmacovigilance in the Developing World,” written by researchers in England and Ghana (Munir Pirmohamed, Kwame Atuah, Alex Dodoo and Peter Winstanley), points out the inadequacies of the networks for drug safety in much of the impoverished world.

The study notes disadvantaged countries in the world cannot participate in the World Health Organization’s effort in Sweden, the Uppsala Monitoring Center. To quote the article, “less than 27 percent of lower middle income and low income economies have national pharmacovigilance systems registered with the WHO program, compared with 96 percent of the high income countries in the Organization for Economic Co-operation and Development. The main reasons for this are lack of resources, infrastructure and expertise.”

We’re sure no ClinPage readers are surprised by such numbers. The authors of the BMJ advocate the development of a national system for pharmacovigilance in each country, just as countries in the developing world have done. Different living standards and medical practices naturally produce different patterns of adverse events in developing countries.

Data From Africa

Here’s another quote from the article: “The current model for drug development in resource poor settings depends on public-private partnerships, such as the Medicines for Malaria Venture. These partnerships should be encouraged to continue beyond the point of obtaining a drug licence to developing a proactive Phase IV program. Such a program could be designed to show the effectiveness of the drug in a real world situation, and through this obtain safety data in much larger cohorts of patients.”

We’re not sure the BMJ authors were thinking sufficiently big. The reality of the pharmaceutical industry is that it’s global. And we wonder about creating a hodge-podge of systems. We have a funny feeling that some scientist or regulator is going to want to connect all those systems down the road. Why not build one database now and be done with it?

Time For Vision 

Our view is that a single, basic drug safety system for the developing world would be a better idea. This need not be fancy. A simple and unified pharmacovigilance system for poor countries unable to participate in the WHO effort would be a tremendous public relations win.

Such an effort would be painlessly funded by industry associations in Europe and the U.S. In pilot mode, it could be confined to one therapeutic area (antimalarial drugs, for example). Later it could be rolled out to collect small amounts of high quality data directly from hospitals. Such an effort could prevent the recriminations that have already hit selected sponsors attempting to do research in the developing world. This is very doable.

Proactive PR 

As the article in the BMJ points out, there is no way that industrial-strength pharmacovigilance systems in the developed world will be something that the developing world can afford. We get that. But we are not convinced those systems are, at present, anything to write home about. They generate a lot of noise and very little signal. Thinking differently could provide a few insights that could later be applied back in Zurich, London or Atlanta.

With patients in the developed world unlikely to participate in research, the industry’s future is in the rest of the world. So it behooves the industry to make a serious effort to show that it has a pharmacovigilance dashboard for the most needy nations. This dashboard could provide a few early warning signals to public health authorities. The internet’s potential for better pharmacovigilance could be easily and inexpensively tapped to bank some goodwill for the industry prior to its next drug-safety debacle. If the pharmaceutical industry can’t get its act together to do this, it could be a prime opportunity for the technology titans (Accenture, Oracle or IBM) or even the Gates Foundation.

There is another refection on the BMJ article on SciDevNet.

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