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Abstracts (PDF file, 1.8MB) - Society for Risk Analysis

Abstracts (PDF file, 1.8MB) - Society for Risk Analysis

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SRA 2013 Annual Meeting <strong>Abstracts</strong><br />

T4-J.4 Sertkaya, A*; Jessup, A; Wong, H; Eastern Research<br />

Group; HHS Assistant Secretary <strong>for</strong> Planning and Evaluation;<br />

Aylin.sertkaya@erg.com<br />

Modeling Incentives <strong>for</strong> the Development of New<br />

Antibacterial Drugs<br />

We per<strong>for</strong>m an economic analysis of possible incentives <strong>for</strong> the<br />

development of new antibacterial drugs <strong>for</strong> 6 different<br />

indications, including acute bacterial otitis media (ABOM),<br />

acute skin and skin structure infections (ABSSSI), community<br />

acquired pneumonia (CABP), complicated intra-abdominal<br />

Infections (CIAI), complicated urinary tract infections (CUTI),<br />

and hospital acquired bacterial pneumonia (HABP). To assess<br />

the current state of investment in antibacterial research and<br />

development (R&D) <strong>for</strong> areas of unmet medical need, we<br />

develop an economic model to calculate the expected net<br />

present value (ENPV) <strong>for</strong> prospective new drugs <strong>for</strong> each<br />

indication under various market conditions. The model is based<br />

on a multi-stage decision tree framework, in which there are a<br />

series of decision nodes. At each node there is an expected<br />

probability of success and marginal expected NPV. The ENPV<br />

uses the private opportunity cost of capital (also referred to as<br />

the private rate of discount) to account <strong>for</strong> changes in the value<br />

of money over time. Using the model, we then examine<br />

different types of incentives designed to stimulate antibacterial<br />

drug development. The incentive analysis involve solving <strong>for</strong> the<br />

level of each type of incentive to meet a set private ENPV target<br />

by indication using the decision-tree model developed.<br />

W4-H.1 Severtson, DJ; University of Wisconsin-Madison;<br />

djsevert@wisc.edu<br />

How do maps influence perceived accuracy and validity<br />

and how do these perceptions influence risk beliefs?<br />

It is important to convey the uncertainty of modeled risk<br />

estimates depicted on maps. Findings from an earlier study<br />

indicated how 3 map features selected to depict the uncertainty<br />

of estimated cancer risk from air pollution influenced beliefs<br />

about risk that are predictive of decisions and the ambiguity of<br />

these beliefs. Viewers’ perceptions of the validity and accuracy<br />

of the mapped in<strong>for</strong>mation may have a role in explaining how<br />

mapped risk influences risk beliefs and ambiguity. This study<br />

used previously unanalyzed data to assess how map features<br />

influenced (a) perceived accuracy and validity of the mapped<br />

in<strong>for</strong>mation and (b) how these perceptions influenced risk<br />

beliefs and the ambiguity of risk beliefs. The full factorial 2 x 2<br />

x 2 x 4 study used 32 maps that varied by the 3 features at 4<br />

risk levels. Map features (uncertain vs certain) were: number of<br />

colors (1 vs 3), appearance of map contours (unfocused vs<br />

focused), and how risk was expressed in the legend (verbal and<br />

relative with no safety benchmark vs numeric natural<br />

frequencies with a safety benchmark). Each study map depicted<br />

an assigned “You live here” location within 1 of the 4 risk level<br />

areas. Maps were grouped into 8 blocks. Undergraduate<br />

participants (n=826), randomly assigned to a block of 4 maps,<br />

answered survey items assessing beliefs and ambiguity <strong>for</strong> each<br />

map and perceived accuracy and validity <strong>for</strong> each of the first<br />

two maps. Structural equation modeling was used to assess<br />

proposed relationships controlling <strong>for</strong> prior risk beliefs and<br />

ambiguity, perceived numeracy, and sex. Findings indicate<br />

perceptions of accuracy and validity are differentially<br />

influenced by map features and these perceptions differentially<br />

influence outcomes of beliefs and ambiguity. Numeracy<br />

moderated some of these relationships. Some perceptions<br />

mediated the influence of map features on outcomes,<br />

suggesting perceived trust and validity may have important<br />

roles in explaining how maps influence decisions.<br />

T1-E.1 Shao, K*; Gift, JS; NCEA, USEPA; shao.kan@epa.gov<br />

The importance of within dose-group variance in BMD<br />

analyses <strong>for</strong> continuous response data<br />

Continuous data (e.g., body weight, relative liver weight) have<br />

been widely used <strong>for</strong> benchmark dose analysis (Crump 1984) in<br />

health risk assessments. The BMD estimation method <strong>for</strong><br />

continuous data published in the literature (Crump 1995, Slob<br />

2002) and used by the US EPA’s BMD software (USEPA BMDS<br />

2013) essentially models continuous responses at each dose<br />

level as a certain distribution (e.g., normal distribution or<br />

log-normal distribution). However, the default method<br />

employed by regulatory agencies (USEPA BMDS 2013,<br />

European Food Safety Authority 2009) <strong>for</strong> BMD calculation<br />

defines the benchmark response (BMR) as a certain change<br />

relative to the mean response at background dose level. By this<br />

definition, the BMD calculation is based solely on the central<br />

tendency, which is just a part of the in<strong>for</strong>mation of the response<br />

distribution. As EPA and other organizations move towards<br />

unifying the approaches <strong>for</strong> cancer and non-cancer<br />

dose-response assessment and defining risk-specific reference<br />

doses as suggested by the NAS (NRC 2009), a full consideration<br />

of the response distribution rather than just the mean value will<br />

play a more and more important role in dose-response analysis.<br />

This can be done by accounting <strong>for</strong> within dose-group variance<br />

using methods such as the “Hybrid” approach (Crump 1995).<br />

This study focuses on demonstrating the importance of<br />

considering within dose-group variance in BMD estimation <strong>for</strong><br />

continuous data through a number of examples.<br />

T1-J.1 Shapiro, S*; Carrigan, C; Carrigan - George Washington<br />

University, Shapiro -- Rutgers University; stuartsh@rutgers.edu<br />

What’s Wrong with the Back of the Envelope? A Call <strong>for</strong><br />

Simple (and Timely) Cost-Benefit <strong>Analysis</strong><br />

Cost-benefit analysis has been a part of the regulatory process<br />

<strong>for</strong> more than three decades. Over this period, it has been the<br />

subject of criticism across the ideological spectrum. Solutions<br />

to the perceived ineffectiveness of cost-benefit analysis tend<br />

toward one of two extremes. Opponents of analysis, not<br />

surprisingly, want to see it eliminated. Supporters of analysis<br />

often call <strong>for</strong> “deeper and wider cost-benefit analysis” We argue<br />

that cost-benefit analysis has evolved into a complex tool that<br />

does little to in<strong>for</strong>m decisions on regulatory policy. Analyses<br />

either omit consideration of meaningful alternatives or are so<br />

detailed that they become practically indecipherable. And in<br />

either case they are often completed after a policy alternative is<br />

selected. Adding complexity or judicial review may eliminate<br />

the naive studies but will also increase incentives <strong>for</strong> agencies<br />

to make them even more opaque. Yet, eliminating analysis<br />

abandons all hope that an analytical perspective can in<strong>for</strong>m<br />

critical policy decisions. We believe that a noticeably simpler<br />

analysis conducted much earlier in the regulatory process can<br />

play a critical role in regulatory decisions. Such an analysis<br />

would have to be completed well be<strong>for</strong>e a proposed rule and be<br />

subject to public comment. However, to ensure that it does not<br />

cripple the regulatory process, the examination could eschew<br />

the monetization and complex quantification that bedevils most<br />

current regulatory impact analyses. The more timely and<br />

modest analysis would be required to detail several policy<br />

alternatives being considered by the agency. The agency would<br />

list the likely benefits <strong>for</strong> each alternative in terms of gains to<br />

public health or welfare and be required to do the same with<br />

the probable costs. Public and political overseers would then be<br />

in a position to provide meaningful feedback be<strong>for</strong>e the agency<br />

has already decided on its course of action.<br />

December 8-11, 2013 - Baltimore, MD

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