This MSNBC interview took place February 18th, 2011. Morris Waxler, PhD, former Chief of the FDA branch responsible for reviewing LASIK clinical trials, filed a petition with the FDA calling for immediate withdrawal of LASIK devices and asking for a LASIK public health advisory. In this interview Dr Waxler explains why. He also intends “to submit CONFIDENTIAL information on these matters [1] separately to FDA’s Office of Criminal Investigation.”
Qutotes:
“...the adverse event rate is 20%, twenty folder higher than the adverse event rate that was expected and approved under....”
“...Essentially the LASIK community lied and withheld data from the agency with regard to these events and distorted that information...” [2]
Footnotes
| [1] | these matters — see the first three paragraphs of II. Factual Grounds for the full explanation. |
| [2] | events — meaning the aforementioned adverse events such as dry eye, distorted vision, night driving difficulties, etc. See 2. Manufacturers Pressured FDA to Not Count Certain Adverse Events.. |