## Foundation for the National Institutes of Health — Working Group on Malaria Gene Drive Testing Path

We decided to write about this grant in order to share the rationale for our interest in gene drives. This page is a summary of the reasoning behind our decision to recommend the grant; it was not written by the grant investigator(s).

Foundation for the National Institutes of Health staff reviewed this page prior to publication.

#### 2.3 Case for the grant

Our understanding is that there is not yet consensus on what a pathway for field testing gene drives focused on modifying or suppressing vector mosquito populations should look like. Our guess is that developing such a consensus path might help accelerate the identification and redress of technological, ethical, and regulatory issues, leading to a faster eventual timeline for deployment if it is determined to be appropriate. We also believe that supporting this project is likely to help us better understand the open questions and any disagreements between key parties.

The FNIH seems to us to be well-positioned to lead the process of developing a consensus proposal. Our understanding is that the FNIH (working with funding from BMGF) has been instrumental in supporting gene drive research to date, and that it has experience convening groups of this nature. For instance, it co-organized with WHO a similar report on consensus standards for testing non-gene-drive genetically modified mosquitoes (GMMs) in the past.5 That report was opened for public comment in 2012, and was subsequently incorporated into a WHO guidance framework that was published and adopted in 2014.6 The FNIH also co-sponsored a recent report from the National Academies of Sciences on responsible conduct of gene drive research.7

As mentioned above, the main positive effect we hope this grant could have is reducing deaths from malaria, though we think the grant could also have a smaller positive impact by accelerating a regulatory rejection of gene drive technology (and thereby freeing up research funding and effort for other things) if that turned out to be appropriate. In terms of reducing deaths from malaria, we think a natural comparison point to use is a grant to the Against Malaria Foundation (AMF), the top recommended charity of our sister organization, GiveWell. Roughly speaking, we estimate that this \$1.2 million grant would be more cost-effective than a similarly sized grant to AMF if it relieved two days worth of future malaria burden (more details on this estimate in the footnote).8

Though we see it as a bet worth taking, we think there is a very considerable likelihood that this grant never affects malaria burden at all, for any number of potential reasons, falling into two main buckets:

• The working group doesn’t have any impact on gene drive development:
• The working group fails to develop consensus.
• The consensus recommendations are fairly obvious, and so don’t argue for any changes relative to current plans.
• The consensus recommendations are never adopted by key regulatory bodies, and so projects have to follow the same path they would have had to otherwise.
• Gene drives don’t affect malaria:
• Gene drive technology turns out not to work or to be unsafe to deploy.
• Authorization for gene drive deployment turns out to be impossible to achieve.
• Another technology leads to malaria eradication prior to gene drive having any impact.

Though we think these risks jointly make it quite unlikely that this grant will have any impact on malaria, we see the possibility that it could have a significant impact by leading to faster field testing timelines as sufficient to justify the grant.

We find it plausible that this project could potentially cause an unnecessary delay in the deployment of gene drives to reduce the burden of malaria. If the working group consensus process produces a recommendation that commits researchers working on anti-malaria gene drives to a sub-optimal testing pathway, safe and ethical deployment could take place at a later date than would have been the case in the absence of the working group. We think this is unlikely and that the risk of our grant causing this outcome is mitigated by the likelihood that another funder would have supported it in our absence.

## 3. Plans for learning and follow-up

We do not expect to produce any updates on this grant until after the working group has completed its work, though we are hoping to attend its meetings if scheduling allows. Once the committee has completed its work, we plan on writing a public review of that work and an update about this grant.

Key questions we will follow up on include:

• Did the working group reach a consensus on a plan that seems likely to reduce uncertainty about the field testing path for a malaria gene drive?
• What, if any, disagreements arise during the working group’s convening?
• What do we think about the consensus path recommended by the group?
• Do other organizations (e.g., the WHO) ultimately support the consensus of the group?

## 4. Sources

DOCUMENT SOURCE
Esvelt et al. 2014 Source (archive)