Adam F from "The Street" redefines the term "clinically significant" for FEV1 reduction in his article titled:
"MannKind's Mysterious Lung-Safety Study Is Open But Shhh...Don't Talk About It"
http://www.thestreet.com/story/11897731/2/mannkinds-mysterious-lung-safety-study-is-open-but-shhhdont-talk-about-it.html
Adam makes the statement:
"The chart above is reprinted from the lung-safety study results published in Diabetes, Obesity & Metabolism. It shows a statistically significant, 34 ml relative decrease in forced vital capacity for Afrezza compared to usual care after 24 months."
The Problem:
Adam's definition of "clinically significant" does not:is not aligned with:
1. Definition of "statistically significant" within this trial:
Non-inferiority = annualized change is no greater than 50 mL/year.
The 34 and 37 mL decrease was below this number, thus the P value being less than 0.05.
2. Definition of "statistically significant" from the American Thoracic Society:
The American Thoracic Society (ATS)
recommends a 15% year-to-year FEV1
decline for clinical significance.
With a baseline of 3.24 and 3.29, the 34 mL reduction equates to:
10%
He defends this term vigorously in the comments section, and is a blatant misrepresentation of facts to mislead investors, as I'm fairly confident Adam understands statistics, or I hope so, as his mantra is "Data Are".
Well, "Data Are" was misrepresented.
I'm mad as hell, and I'm not going to take it any more!
