The push to expand access to life-saving drugs and vaccines in low-income countries is threatened by the lack of drug safety monitoring.
How so? Well, the standard approach to getting drugs out to the developing world has been for the pharmaceutical industry to first make a product it can sell to the rich world and, as costs go down over time, eventually distribute it to the poor. The problem with that approach is that the costs don’t always go down enough and many drugs or vaccines needed solely in poor communities simply don’t get developed.
It was this fundamental problem – which Bill Gates in the early days of his philanthropy identified as one of the world’s most deadly kinds of market failure – that helped launch the movement (and/or industry) we now call global health.
The problem now, with a flood of new vaccines and drugs in the R&D pipeline specifically developed to deal with diseases of poverty such as tuberculosis or malaria, is that the poor countries will be getting products the rich world marketplace won’t have vetted first.
We’re not talking about the lengthy and extensive vetting process known as clinical trials research. What we’re talking about is what happens after the Phase 3 studies are done, the drug is approved and introduced into wide use – monitoring for safety known variously as ‘post-market surveillance’ or Phase 4.
Poor countries usually don’t have anything close to the FDA or CDC or some other kind of regulatory framework aimed at monitoring and identifying adverse drug reactions or worse – unsafe or ineffective drugs.
Trying to figure out what to do about the lack of drug safety surveillance in poor countries is the point of a new report sponsored by the Bill & Melinda Gates Foundation and co-authored by Thomas Bollyky, at the Council on Foreign Relations, and Andy Stergachis, director of the Global Medicines Program at the University of Washington. Below is a ‘heat map’ from the report showing the risk posed by planned introductions of new drugs or vaccines in countries lacking adequate systems of drug safety surveillance:
“This is a global problem, and it’s not getting any better,” said Stergachis.
Even in the highly regulated marketplace in the U.S. and Europe, he noted, pharmaceutical products can get approved that only later, when in wide use, turn out to be ineffective or even harmful. The Vioxx episode, Stergachis said, in which an approved anti-arthritis drug was found to be causing high rates of heart attacks in users was just the most high-profile example of this.
“I think we have a better system of post-market surveillance today because of that,” Stergachis said. Both he and Bollyky served on a blue-ribbon panel convened nearly a decade ago by the Institute of Medicine that led to improved monitoring of drug safety after FDA approval. But in much of the rest of the developing world, there is little or no such monitoring going on.
“The coming decade will be vital for improving drug and vaccine safety surveillance,” said Bollyky in a statement accompanying the report’s release.
“Given the expanding access to treatment and immunization but limited resources in many of these countries, we must prioritize our capacity building efforts,” he said.”Investments made in support of new vaccine and drug introduction should be done in a manner that builds functioning safety surveillance systems and leaves something behind to support future product introductions.”
The 65-page report compiled over a year’s time and with the assistance of some 40 experts does a good job of describing the looming challenge posed by the anticipated introduction of these drugs or vaccines tailored to benefit the developing world. What it does not answer is how to pay for creating something like an FDA watchdog for poor countries.
“We explore some options, but that remains an open question,” said Stergachis.
Also not addressed in the report are concerns sometimes raised by the generic drug industry in India and advocacy groups such as MSF (Médecins Sans Frontières, or Doctors without Borders) or Oxfam who see the fight against fake or counterfeit medications as a disguised effort by Western drug makers, or Big Pharma, to undermine the competition from generic manufacturers in middle- or low-income emerging economies. Said Rohit Malpani, then with Oxfam, in this 2011 Guardian story:
The European Union and the United States continue to focus almost exclusively on eliminating counterfeit medicines which form only a small part of this public health problem – but which are a serious concern for their multinational companies. They have used the crisis in medicine quality in developing countries as an excuse to push for new intellectual property rules that will boost the profits of pharmaceutical giants at the expense of affordable medicines for the poor.
Some may see that as a legitimate concern, Stergachis said. But the main focus of this report, he said, was to identify the need and how to best fill this dangerous gap created by the lack of drug surveillance in poor countries.
(Editor’s note: Nobody from the Gates Foundation who worked on this initiative was available today to comment. But here’s the philanthropy’s global health chief Trevor Mundel blogging about it….)