December 9, 2016 – The American Journal of Tropical Medicine and Hygiene published a systematic evaluation of potential risks associated with the use of mosquitoes genetically modified through gene drive technology to reduce the burden of malaria in Africa. The National Academies of Science, Engineering and Medicine recently recognized that gene drive technology holds promise for addressing difficult challenges, such as the eradication of insect-borne infectious diseases. The report also advised researchers to consider the potential for unintended consequences. The Problem Formulation for Use of Gene Drive Technology in Mosquitoes workshop, hosted by the Foundation for the National Institutes of Health (FNIH) in May 2016, took the first step in exploring these consequences by bringing together global experts to identify, discuss and develop consensus that will inform the design of gene drive research, and future guidelines and regulations on the use of the technology.
Malaria continues to be a priority public health issue, with more than three billion people remaining at risk for infection and more than 200 million cases and 400,000 deaths attributed to the disease in 2015, according to the World Health Organization. This burden falls disproportionately on Sub-Saharan Africa, where the deadliest malaria parasite and the most efficient malaria vectors exist. New gene drive technologies, including those employing CRISPR/Cas9, reduce the ability of mosquitoes to transmit parasites and could play an important role in reducing the burden of malaria.
The workshop featured a diverse group of international participants from academic, government and not-for-profit organizations. During the workshop, participants applied a problem formulation approach, focusing on gene drive methods for control of the malaria vector Anopheles gambiae in Sub-Saharan Africa. Normally the first step in risk assessment—known as problem formulation—is a process for identifying plausible risks that warrant further analysis while removing other potential, but negligible, risks from consideration. Participants agreed that relevant interactions for future risk assessments of specific gene drive approaches would include human and animal health related to disease transmission. Harmful effects to biodiversity were considered unlikely, but participants agreed on certain important ecological interactions that should be examined. Participants also recognized the importance of placing the use of gene drives in the context of existing malaria mitigation strategies. Gene drive strategies hold promise as a strong complement to other methods and participants noted that they should not be considered a single solution. Read the full article and consensus points here.
“Before gene drive technologies are field tested it is necessary to consider possible risks, as well as their benefits,” said Stephanie James, Ph.D., FNIH Director of Science. “The report provides a scientifically-based examination of possible adverse effects of the technology on widely-recognized protection goals including, but not limited to, human health, animal health and biodiversity. The expert consensus derived from the Problem Formulation workshop was a critical step to help inform the ongoing dialogue about the use of gene drive strategies against malaria vectors and to guide future risk assessments of specific technologies.”
For more information about the Problem Formulation workshop click here. The workshop was made possible through support by the Bill & Melinda Gates Foundation to the FNIH for the Vector-based Control of Transmission: Discovery Research program.