ATTW-Rough notes on Technical Assessment panel

13 March 2013

Technical Assessment

Defines with Heideggerian approach

Teston & Graham’s study examines Avastin It passed initial BC clinical trials, but failed the Confirmatory trials that indicate its benefits for breast cancer; produced public outcry; FDA conducted a public hearing (2-day even in 2011)

Graham: “evidence-based medicine is evidence-based policy” Talks about evolution of FDA; the practices become boiled down to “adequate and well-controlled investigations” randomized testing, test claims against empirical evidence; it’s a stat-based discipline

Teston use “charter documents” to make decisions, which include “quantifiable endpoints” 1. Overall Survival 2. Disease-free survival 3. Objective Response rate 4. Complete Response 5. Progression-free survival 6. Symptom endpoints; here’s the focus of the presentation.

Endpoint modeling becomes a key point in the process to deliberate on assessing the claims.

Issues that arise w/ data gathering 1. non-compliance, patient agency 2. reliability of the evidential source, i.e. validity of human responses over long period of time) 3. standards for PRO data collection; how many interviews, how many patients? 4. standardization of assessment criteria 5. discerning noise from data; is it asymptom of disease or symptom of drug toxicity?

Big question to end on How do we resist quantification with endpoint models?

Singapore’s quarantine practices

Examine domestic media coverage of Singapore’s quarantine practices in SARS

Uses Vasek’s 3-generation of human rights policies/protocols, which includes the state’s responsibility to manage the human right to a healthy environment.

Used LexisNexis search and thematic coding 120 articles, 135 pgs of text to code

Lots of appeals to nationalism, community well-being, producing social stigmas, while gov quarantine practices were harsh and framed anyone who did not follow it were conducting criminal activity.