Paper #3: The Limits of Discourse

Introduction: Your first paper examined the peer review process, and your second paper explored the FDA approval process as a variant of peer review. These are fundamental to the insights you will develop in this third assignment. Here, you will use the development, approval, and failure of Vioxx as a heuristic device for describing the power and limitations of your discipline's discourse. Your task is not to judge Vioxx, but to use it as a tool for exploring how a discourse community makes, sustains, revises, and overturns its knowledge.

Preliminary steps:

1. Three frameworks: In order to write the paper, we have established two schematics of the processes by which Vioxx (or any drug) comes into use. The first of these schematics is from the FDA, and it describes the linear flow of processes that control the ultimate (non)use of a drug. The second of these was the class' schematic that places Vioxx within the corporate mechanism of research, product development, and marketing. We need to recognize that each of these schematics is a “narrative” that places a particular institution at the center of the Vioxx story. Further, the relation between these two representations remains to be clarified. A third issue for which we do not have a schematic is embodied in the experimental techniques, sampling strategies, statistical tests, etc. that confirm or deny a hypothesis. [see note below]
   
   
2. Tentative list of sub-group topics:
   • [Scientific History] The discovery, recognition, and development of Cox-2 inhibitors represents a substantial scientific discovery. How/where does the initial research emerge, and how does it become directed toward the development of a new drug?
     
     
   • [Research Methods: credibility and bias] What is the network of corporate research, academic research, and various forms of review? Where do these intersect? Are there conflicts of interest that might lead to bias? How do researchers both within Merck and within the academy control for such bias?
     
     
   • [Cultural values and the idea of acceptable risk] How does the riskiness of Vioxx expose how we think about risk? Where do cultural values enter into our definition of risk and benefit?
     
     
   • [Marketing and the Social Network] The discourse of pharmacy includes pharmacists, pharmacologists, doctors, drug companies, academic researchers, insurers, and others. Does Merck's marketing reveal the structure of the discourse community?

---

NOTE: Today, JAMA published two articles and an editorial about Merck's use of “ghost authors,” and its release and manipulation of data. Your work for this assignment will be shaped by these documents, and I expect that you will read them carefully. They are available HERE

1. Peer Review: discourse
2. FDA Approval Processes
3. The Limits of Discourse
4. Patient Education

1. Writing Resources
   
   
2. Content Tools
   

1. Instructor Email hugh@culik.com
   
   
2. Peer Assistance [list serve]