The FDA's concerns center on the IDE (Investigational Device Exemption) along with Medtronic's, Wyeth's and Medicare's data. In all likelihood the significance of this data and the reviewers evaluation will determine whether additional evaluations and analyses will be needed. The panel will have to take a position on whether they believe that there is a statistical significant rate of incidence of overall cancer and pancreatic events in patients treated with Amplify (the test group) as compared to the control group.
In addition, the panel is being asked to consider the difference between Medtronic's and Wyeth's clinical studies, the methodology, the location or placement of Amplify in the body, when the patient was treated, the dosing and concentration, length of follow-up and potential patient co-morbidity. What it comes down to fellow bloggers is that the Federalis are concerned about the number of reported pancreatic cancer events in patients treated with the magic dust. An interpretation of this data will focus on patient demographics, limitations, follow-up and validation of the study.
At this juncture we know that any rhBMP-2 is not recommended for use in women of child-bearing age, yet, the panel will also review secondary procedures due to failure where rhBMP-2 had been used. It will be interesting to see who steps up to the plate on behalf of the evil empire. Will it be the usual suspects? The panel members for the FDA will include three cancer experts and an expert in reproductive biology. Hopefully, the FDA will perform a much better and more thorough proctological examination on Amplify and for that matter Medtronic than they did on Infuse. TSB would like to think that surgeons would take pancreatic cancer a little more seriously, than they did having boney ingrowth into the spinal canal, but what do I know, considering that TSB has no financial interest in these products. TSB wants to know what our readers think?