As a professional participant in pharmaceutical product development, I learned to evaluate its many non-technical aspects: e.g., patient and prescriber acceptance, adoption rates, competition, effect of regulation and politics, manufacturing, distribution, marketing. As a potential participant in product development and innovation in global health, I’ve noticed that often a technology’s developers are fixated on the technology as the solution to a problem, without considering the problem fully, the context of the solution, and alternative solutions. Their focus on achieving what they think is a quick fix to a problem can result in a long, expensive development of a product that doesn’t solve the problem and may even perpetuate the problem’s underlying conditions.
This meander is prompted by my reading about the development of vaccine vial monitors (VVMs) in the recently published Case Studies for Global Health (GH Case Studies). This compendium is written by the Alliance for Case Studies for Global Health, a Gates-funded effort whose members are prominent not-for-profits with the acronyms, AUTM, GHP, IAVI, and TDR, and has as its goal “illustrating” how organizations have worked together to solve a global health problem. At 200+ pages and almost 40 studies, it is comprehensive and illustrative of the many facets of global health solutions, but, like many compendia, it is light on integration and analysis. About a quarter of the cases involve developing new technologies, but only a few, like the VVM case, describe the introduction and use of a new technology, that is, innovation.
VVMs are tiny stickers on vaccine vials that change color with exposure to heat and therefore can indicate that the vial has been in conditions that may have adversely effected its contents. The problem of assuring vaccine quality through the long route from developed world manufacture to developing world use was apparently generally known in public health circles prior to 1979 when, according to the case report, WHO promoted the idea of VVMs, specifically for the measles vaccine. The pre-Gates PATH (Program in Appropriate Technologies for Health) then developed a VVM for the measles vaccine using a licensed chemical and possibly the experience of companies developing such monitors for food products. It worked, but not well enough to be used on all global public health vaccines.
At this point, someone or entity (my guess is a committee of academicians and public health experts) decided to advocate for the development of a universal VVM. Starting around 1990, USAID, though its Healthtech program (USAID Healthtech), funded PATH and a commercial partner, and by 1996 they had a field-tested product. During this time, PATH also worked with vaccine manufacturers to implement the use of VVMs and with UNICEF’s vaccine purchasing group to get them to pay for (about a cent more per dose) and require VVMs. PATH and WHO also tried to get five other companies to develop VVMs, but the companies could not develop a product less costly than the original, whose development and production costs were subsidized (not a surprise). The author of the study does not mention the total investment made in developing the VVM.
Currently, despite endorsements by WHO and UNICEF and the requirement of VVMs on all vaccines purchased by GAVI after 2004 (the primary agency for global immunization), “the consistent use of the product has been difficult to ensure.” The reasons? Vaccine manufacturers in developing countries producing vaccines for local markets don’t use them and the Pan American Health Organization (PAHO) doesn’t see the need and can’t justify the increased cost. The study author states that WHO estimated cost savings of $5 million per year and PATH estimates VVMs will enable the annual delivery 1.4 billion more doses, but apparently no actual measurements have been made. So is the VVM a technology fix or did it become a fixation of its promoters?
I realize my post- and ad-hoc analysis is simple-minded, but I have to wonder if, at some point over the 20 years of development and use of VVMs, someone or some entity should have done a comprehensive analysis of the problem and possible solutions, of which VVMs may have been one. Other approaches may be to:
-encourage manufacturers to find temperature-stable vaccines and formulations;
-find cheap solutions for ensuring thermal protection for vaccines during the final miles of delivery;
-use of point-of-care QA to weed out unusable doses;
-encourage local, inexpensive manufacture so that the losses are acceptable; and
-improve overall the distribution and delivery system.
For-profit entities, at least the successful ones, do comprehensive analyses before committing to a development of a product, and I hope the professionals in global health, in government, NGOs, foundations, and academia, do so also.