here's a list of liraglutide adverse events reported to FDA:
only 13 cases listed
& clinical trials with maps
Well got tied of waiting for the FDA approval of Liraglutide so I am giving Byetta a try, despite health risks. Found two cons of byetta, needs to be kept refrigerated (Liraglutide doesn't) and the byetta injection pen isn't dose adjustible, but Liraglutide was IN THE STUDY. Not sure once released. Still anxious to get a script for Liraglutide and compare costs/results.
We can meet to discuss the 5 items you have listed, although it does not appear to me that those 5 items are the best solution to the issues brought out in this e-mail thread.
First issue, the problem that Janetta observed. I looked into ClinDesk and into IMPAC and in both places I see physician notes for both 3/31 (the note in which Dr. Bolger states his intention to perform the bone marrow). I also see in ClinDesk, on 4/25, another physician note in which Dr. Bolger discusses the laboratory and pathology results of said 3/31 bone marrow, however, this particular document not did not get scanned into IMPAC. So, as I understand the first issue, it appears that someone missed scanning the 4/25 document in IMPAC.
Second issue, reported by Terri Eichelmann, "...there must be a post procedure note w/ the required JCAHO elements. Immediately pretty much means if you don't have a system like GI Lab where they create and send it to the record electronically then it is not immediately. In other words, if they dictate it is not immediate and requires a post procedure note." The MultiACCESS product at MBMC does have a system like the GI Lab, in which physician notation can be performed immediately and w/ the required JCAHO elements. eSCRIBE (together with Dragon Naturally Speaking) and the Structured Noting software, PhAST Note were purchased sometime ago as were the supporting interfaces to pass this information from MultiACCESS into ClinDesk , however, MBMC has made the decision to not implement this software at this time. If you'd like to discuss of resources and a timeline for the implementation of these readily available and already purchased product, just let me know.
I will not speak to the investment community shenanigans by Novo Nordisk, but it is borderline fraud. As Amylins data reported shows .......results today of HbA1c reductions of 1.8 and 1.5 for Byetta LAR and Byetta twice daily, respectively. These numbers are better than the 1.1 percentage point reduction seen with Novo Nordisk's GLP-1 in a similar trial population. Yet Novo did not say theirs was a marketing study, nor that it was unblinded, and that the Company then compared it with a 4 year old Exenatide study blinded and approved by the FDA ..by a different design ........in unblinded trials, recipients of a new drug are more compliant than controls, due to higher expectations. Here GLP-1 would be presented to trial patients as the new drug and Byetta as the control.....and Novo Nordisk also claimed their fake difference was statistically significant. It's meaningless to talk about statistics if a real comparison can't be made in the first place.
I LOVED it. The trial is over and would love to get my hands on more. Can't wait til FDA approves it. Not only did it drop my HGA1C from 7.5 to 6.4, I lost 20 lbs in 3 months, while actually eating worse than normal. All this while taking less than study suggested. To me, it is a miracle drug. Not only for diabetics, but for weight loss (Phase II I believe) also.
Disclaimer for the investors, yes I do own stock in the NVO. I bought soon after I started the trial.