Quiz 1: Review of a Journal Article. 2 pages maximum, line spacing 1.5, 12pt font.
Background: You are tasked with reviewing a regulatory submission to the FDA. The applicant (NatuRx) is filing for a new ‘natural’ treatment for cancer derived from highly purified banana extract. NatuRx claims that the attached two papers, taken together, support the safety and efficacy of their proposed treatment. Please review the two papers and address the following questions.
- Are these articles Primary or Secondary sources, or mixed? Please describe why you made your choice by identifying at least 5 examples/pertinent areas of each paper (See: Differences in Biological Response Modifier-like Activities According to the Strain and Maturity of Bananas, Food Sci. Technol. Res., 15 (3), 275 – 282 (2009) and Tumor necrosis factor, tumor necrosis factor inhibition, and cancer risk, Current Medical Research and Opinion, 31:3, 557-574 (2015)).
- Please provide a recommendation regarding the NatuRx application and the potential safety and efficacy of their proposed drug based on the quality of the published pieces. Be sure to identify any data or language red flags/support in the papers; in other words use examples/data within the paper to support your position.
- I would like you to find two additional sources that support your final position; please indicate if they are primary or secondary sources and why you believe they are credible sources.
Because this is not a science class per se, (we are however regulatory scientists for this class) I am providing some hints for you to use as you look at the data:
- No one has been able to repeat the banana experiment, and certainly no one has shown this effect in humans.
- There is not yet a single double-blind clinical trial to show that bananas induce a TNF-alpha response in humans.
- Final note: Good Luck!