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Solution-Focused Risk/Benefit Assessment (RBA) for

Gain-of-Function Experiments
Adam M. Finkel, Sc.D., CIH
Second NAS Symposium on Gain-of-Function Research
Washington, DC
March 10, 2016
University of Pennsylvania Law School and University of Michigan School of Public Health

afinkel@law.upenn.edu

Five Themes for These Brief Remarks:


1. Risk and benefit estimates should be balanced, quantitative, humble, explicit
about value judgments, and channeled in service of a thoughtful decision rule.
2. Benefit estimates can be made commensurable with risk estimates, and
should be communicated with equal care.
3. Purely riskbased prioritization is inferior to netbenefit prioritization.
4. Transparency in public engagement is important, but not as important as
apparency.
5. Solutionfocused analysis of GOF and public choice may require wholly new
institutional arrangements, not just incorporated into existing policy
frameworks.

The Two Common (and Useless) Risk-Like Kinds of Pronouncements:

1. Exactly this outcome can happen (but with what probability??)


2. With exactly this probability, something bad will happen

Risk equals (and only equals) f (probability and severity-as-experienced)

A hierarchy of decision rules (w/o symbols or equations):


1. Tolerate no risk from something or tolerate no cost of controlling it.
2. Make as many people as possible safe, somehow moderated by cost.
3. Pretend to estimate total net benefit (TNB), but botch the calculation completely.
4. Derive a reasonable estimate of the expected value of TNB.
5. Derive a pdf for TNB, and present it fully, or choose an estimator from it transparently.
6. Ditto, but take account of offsetting risks and offsetting costs (net net benefit).
7. Estimate, for 1 or more subpopulations or paradigm individuals, the net net benefit to them.
8. Derive (pdf for) TNB as the unweighted sum of individual NB, taking into account
interindividual differences in exposure, susceptibility, and preference
9. Derive (pdf for) TNB as the weighted sum of individual NB.

(from A. Finkel, Environmental Health Perspectives, 1995)

Risk in the Name of Benefit

[If society allowed IVF to proceed, some enormous concepts


were at stake: the idea of the humanness of our human life
and the meaning of our embodiment, our sexual being, and
our relation to ancestors and descendants.]
--Leon Kass, after the birth of Louise Brown in 1978

The Impoverished (Vapid) Question is Is It Safe?: Increasingly


Useful and Ambitious Questions Include
Does the application have positive net benefit? That is, does its risk-reduction potential
exceed its propensity to create additional risks?
Compared to other ways to produce the same or a similar material, does the SynBio
application have greater marginal net benefit * than the alternative(s)?
Compared to other ways to fulfill the same human need, does the SynBio application
have greater marginal net benefit than the alternative(s)?
Does the existing dominant means of fulfilling a particular human need have a
particularly poor risk profile, such that society might look to an unmet application of
SynBio to displace it?
* This could reflect a case where a conventional way to produce a material has positive net benefit (reduces risks more strongly than it
imposes them), but a SynBio application has even greater net risk-reducing potential. Similarly, the SynBio application could have
negative net benefit, but could replace a conventional application whose net benefit profile is even more strongly negative (a lesser of
two evils case).

Traditional risk assessment asks a narrow kind of question: What


allowable concentrations of each of 5 different chemicals should we
allow in our plastic water bottles? Solution-Focused Risk
Assessment (SFRA), in contrast, poses a more ambitious question:
How might we provide ready access to cold drinking water, perhaps
with 29 billion FEWER bottles of any kind bought and promptly thrown
away each year? (Finkel, A.M. (2011). Solution-Focused Risk Assessment: A
Proposal for the Fusion of Environmental Analysis and Action. Human and Ecological Risk
Assessment, 17(4):754-787)

Two Examples of Risky Technologies/Products that


Lack SynBio Alternatives:
1. Palm Oil

Desirable trans-fat-free oil;

Several million hectares of tropical forest converted annually to oil


palm monoculture;

Use of child labor;

Threatened extinction of wild orangutan population

2. Methane Production in Cows

If the 22 million cows in Europe could produce 25% less methane, this

would yield the CO2 reduction equivalent to powering 5 million homes


for a year.

Could researchers working on SynBio microflora in humans turn to this


question?

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