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  • Originally posted by nephron

    I listened to the podcast. I understand the theory of wanting the fda to review primary data that the drug company submits, but they are literally just duplicating what the drug company's scientist have already done. If I were running the show, I would review the data in paper format (ie whatever they end up submitting to nejm), and decide to approve or disapprove the vaccine based upon the abstract. I might look at table 1 and one or two of the results tables. I know that the data will be incomplete and may end up being refuted by future studies, but I can't see how having government scientist pore over and re-examine primary data collected by drug companies come to a much different conclusion then whatever will be published (will they note 2 patients in the 30,000 checked off nausea but the drug company did not report it as a side effect?). It seems like the idea that recounting the votes may change an election result. They are dependent on what the drug company did or did not do. I just think that with thousands of patients dying on a daily basis, if you have a vaccine which has a purported 95% efficacy, you can't sit on it for several weeks looking over primary data. It's not like they are collecting new data so I don't see them coming to a drastically different conclusion. It's typical government bureaucracy having hours of meetings going over work someone else completed. You can always review the work post distribution and penalize the companies if they falsified data.
    sure sounds like we can read it after we pass it to me

    Sounds very sketchy to just trust the pharma companies. Just because they say its 95 % doesn't mean it's 95 %, we have huge agencies with tons of people that can examine the data before our entire country and all associated entities essentially force everyone to get the vaccines, why don't we take a step back and actually confirm their claims?

    Comment


    • “why don't we take a step back and actually confirm their claims?”
      I hear your objections. What are you suggesting?
      What is your suggestion?

      Comment


      • that its normal to examine what the companies are claiming. what they're doing.

        Comment


        • Originally posted by Panscan
          that its normal to examine what the companies are claiming. what they're doing.
          And that is what FDA is doing from the podcast.
          They have the plan, the data and the company’s analysis and conclusions. Free to run FDA data analysis and verify the company’s representation.
          The step that is missing is verifying the data collection. I still do not see what additional steps FDA is suggested.

          Comment


          • For those in inpatient medicine, how are your hospitals holding up? Mine is stretched nearly to breaking at this point. Surgeries are not cancelled but will need to be throttled soon because ICU overflow has taken 1/3 of the PACU beds. The ED is full of admission holds; administration says ICU holds will go to the ED next but I don't know where. We ran out of oxygen cannulas yesterday. We only have enough vents because the NICU closed to transfers so we got some of their vents. We are trying and failing to transfer patients in from critical access hospitals in our system because EMTALA transfer requests are coming in from 500 miles away. We have already pulled every nurse who has ever (even if it was 20 years ago) worked ICU to do shifts, and our staffing ratios are still approaching 4:1. Every metro hospital is the same as us, or worse off and it's getting worse every day.

            Comment


            • SD is doing okay still. Southern county hosp have continued to be hammered since March with periods of calmer staters. Currently not on divert but they are getting close.

              Our system is fine. Uptick on admissions over the past two weeks, but still not at surge status. Thanksgiving may bring us further though -- daily #s passing 1000 twice now and up to 5% 7day moving average, which is highest we've been

              luckily we're a bit more seasoned on the triage and have a few better regimens ongoing. Handful of monoclonal available too.

              Comment


              • Originally posted by Tim

                And that is what FDA is doing from the podcast.
                They have the plan, the data and the company’s analysis and conclusions. Free to run FDA data analysis and verify the company’s representation.
                The step that is missing is verifying the data collection. I still do not see what additional steps FDA is suggested.
                Right. And a poster didn't see the point of that. Which is what I was addressing.

                Comment


                • Originally posted by pulmdoc
                  For those in inpatient medicine, how are your hospitals holding up? Mine is stretched nearly to breaking at this point. Surgeries are not cancelled but will need to be throttled soon because ICU overflow has taken 1/3 of the PACU beds. The ED is full of admission holds; administration says ICU holds will go to the ED next but I don't know where. We ran out of oxygen cannulas yesterday. We only have enough vents because the NICU closed to transfers so we got some of their vents. We are trying and failing to transfer patients in from critical access hospitals in our system because EMTALA transfer requests are coming in from 500 miles away. We have already pulled every nurse who has ever (even if it was 20 years ago) worked ICU to do shifts, and our staffing ratios are still approaching 4:1. Every metro hospital is the same as us, or worse off and it's getting worse every day.
                  Where are you, if I may ask?

                  Comment


                  • Originally posted by Bmac

                    Where are you, if I may ask?
                    I'd like to preserve a semblence of anonymity on the internet, so I'll just say central US-part of the huge swath of red on all the COVID maps.

                    Comment


                    • Originally posted by pulmdoc
                      For those in inpatient medicine, how are your hospitals holding up? Mine is stretched nearly to breaking at this point. Surgeries are not cancelled but will need to be throttled soon because ICU overflow has taken 1/3 of the PACU beds. The ED is full of admission holds; administration says ICU holds will go to the ED next but I don't know where. We ran out of oxygen cannulas yesterday. We only have enough vents because the NICU closed to transfers so we got some of their vents. We are trying and failing to transfer patients in from critical access hospitals in our system because EMTALA transfer requests are coming in from 500 miles away. We have already pulled every nurse who has ever (even if it was 20 years ago) worked ICU to do shifts, and our staffing ratios are still approaching 4:1. Every metro hospital is the same as us, or worse off and it's getting worse every day.
                      I'm psychiatry, not medicine but we are about to get crushed here in UT. ICUs are 90% full in the state and our numbers have skyrocketed in the past 2 weeks. Currently at nearly 24% positive rate, most schools still in session and governor not even bothering to tell people not to gather for Thanksgiving. I fear what is going to happen 2 weeks from now, truly.

                      Comment


                      • Originally posted by wideopenspaces

                        I'm psychiatry, not medicine but we are about to get crushed here in UT. ICUs are 90% full in the state and our numbers have skyrocketed in the past 2 weeks. Currently at nearly 24% positive rate, most schools still in session and governor not even bothering to tell people not to gather for Thanksgiving. I fear what is going to happen 2 weeks from now, truly.
                        So the school issue. I just deleted a lengthy diatribe because I recognize I have a pony in the race (I have a kid that I want back in the class and we are a family without comorbidities). We did not see an uptick in cases when class resumed. I understand that the deck has changed--as perhaps the aces have already been dealt--but is keeping kids home the right answer? I mean, the nail salons, bars, art galleries are all still open....

                        Comment


                        • Originally posted by G

                          So the school issue. I just deleted a lengthy diatribe because I recognize I have a pony in the race (I have a kid that I want back in the class and we are a family without comorbidities). We did not see an uptick in cases when class resumed. I understand that the deck has changed--as perhaps the aces have already been dealt--but is keeping kids home the right answer? I mean, the nail salons, bars, art galleries are all still open....
                          I’m not sure about schools, but it is certainly ridiculous to close schools without restrictions on bars, restaurants, gyms, theaters, etc. What NYC did last week when positives went over 3% made no sense. Most schools in Western Washington have been remote all fall with more recent halting of inside dining, etc. as case numbers have risen. More defensible it seems.

                          Comment


                          • Originally posted by wideopenspaces

                            I'm psychiatry, not medicine but we are about to get crushed here in UT. ICUs are 90% full in the state and our numbers have skyrocketed in the past 2 weeks. Currently at nearly 24% positive rate, most schools still in session and governor not even bothering to tell people not to gather for Thanksgiving. I fear what is going to happen 2 weeks from now, truly.
                            Presumably demographics, but I find Utah’s Covid experience very interesting. Cases per capita are 6th in the US whilst deaths per capita are 46th. I believe it’s the biggest differential. Wyoming fairly similar.

                            Comment


                            • Originally posted by Bmac

                              I’m not sure about schools, but it is certainly ridiculous to close schools without restrictions on bars, restaurants, gyms, theaters, etc. What NYC did last week when positives went over 3% made no sense. Most schools in Western Washington have been remote all fall with more recent halting of inside dining, etc. as case numbers have risen. More defensible it seems.
                              nah, there are restrictions. I'm just hung up on the fact I can get a mani/pedi and have a drink at the bar--although at reduced capacity--but my kid can only see the teacher in 2D.

                              Comment


                              • WCICON24 EarlyBird
                                Originally posted by G

                                nah, there are restrictions. I'm just hung up on the fact I can get a mani/pedi and have a drink at the bar--although at reduced capacity--but my kid can only see the teacher in 2D.
                                Kids don’t vote, so I honestly think politicians don’t care.

                                Comment

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