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Post by mango on Sept 13, 2018 10:19:01 GMT -5
Yep, all scientific evidence from an FDA approved clinical trial. What will docs say when they see 30% less hypo and superior PPG control? Will it then become a liability to prescribe insulin apart? What happens if a patient is hospitalized from insulin apart and the clinician knew of this data but ignored it? Medical negligence? Unfortunately for us, no that will not be considered medical negligence. I'm not so sure about that..medical negligence becomes medical malpractice when undo injury emerges from negligent treatment and makes the condition worse, causes unreasonable and unexpected complications or requires additional medical treatment, etc...legal causation and damage.
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Post by mango on Sept 13, 2018 10:19:51 GMT -5
Full text is avail now on other site
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Post by joeypotsandpans on Sept 13, 2018 10:21:08 GMT -5
Unfortunately for us, no that will not be considered medical negligence. I'm not so sure about that..medical negligence becomes medical malpractice when undo injury emerges from negligent treatment and makes the condition worse, causes unreasonable and unexpected complications or requires additional medical treatment, etc...legal causation and damage. How about mitigating the damages from denied insurance even after prior authorization???
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Post by mango on Sept 13, 2018 10:24:26 GMT -5
I'm not so sure about that..medical negligence becomes medical malpractice when undo injury emerges from negligent treatment and makes the condition worse, causes unreasonable and unexpected complications or requires additional medical treatment, etc...legal causation and damage. How about mitigating the damages from denied insurance even after prior authorization??? Good point. Health insurance companies have caused a lot of irreversible harm.
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Post by jlaw277 on Sept 13, 2018 12:32:32 GMT -5
I am open to correction, but I believe that Castagna said recently (one of the last two calls) that they had yet to share the STAT results outside of the ADA meeting but that with publication, that the salesforce as well as Kendall would start sharing widely. Also, I believe that the "peer reviewed" component is meaningful in terms of getting the medical community to take this seriously. This comment can be found at the 17:30 minute mark in the HC Wainwright/Rodman Renshaw investor presentation. It sounds like that now that the study has been peer reviewed and published that the salesforce and medical teams can start widely sharing the data. Hopefully this will start to provide a more effective tool box for the salesforce to access. It also suggests that the idea that the salesforce had this data available for use since the ADA conference in June is possibly incorrect.
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Post by xanet on Sept 13, 2018 13:34:01 GMT -5
aged said that this particular journal has a low impact compared to diabetes care. Plus diabetes care is almost entirely freely accessible so it's easy for doctors to read. This was a small study and this journal seems like a good fit. There are likely a couple of other papers that have already been or are close to submission. You can't send them all to the same journal.
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Post by agedhippie on Sept 13, 2018 14:26:49 GMT -5
Plus diabetes care is almost entirely freely accessible so it's easy for doctors to read. This was a small study and this journal seems like a good fit. There are likely a couple of other papers that have already been or are close to submission. You can't send them all to the same journal. If the article is significant enough you can! It's hard to produce articles of that quality in bulk though...
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Post by agedhippie on Sept 13, 2018 14:34:29 GMT -5
Unfortunately for us, no that will not be considered medical negligence. I'm not so sure about that..medical negligence becomes medical malpractice when undo injury emerges from negligent treatment and makes the condition worse, causes unreasonable and unexpected complications or requires additional medical treatment, etc...legal causation and damage. It's not negligent if it's prescribed in compliance with the FDA label. Doctors prescribe previous generations of drugs all the time, think of generics.
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Post by matt on Sept 13, 2018 14:36:17 GMT -5
Do I understand this correctly? Now, our sales reps can tell this info to doctors. In the past, our reps were restricted to the label, and they could not talk about superiority. Now they can. So, this would indeed be a big deal. Per Dr. Kendall: "The completion of this proof-of-concept trial and peer-reviewed publication allows for broad sharing of these data with diabetes healthcare professionals.” Yep, all scientific evidence from an FDA approved clinical trial. What will docs say when they see 30% less hypo and superior PPG control? Will it then become a liability to prescribe insulin apart? What happens if a patient is hospitalized from insulin apart and the clinician knew of this data but ignored it? Medical negligence? This was not a particularly well-designed trial which is why it will not create any physician liability. The protocol required both injectable and Afrezza patients to take their prandial dose and monitor with a CGM, but only the Afrezza patients were allowed to adjust dosing, twice, in response to the CGM reading while injectable patients could not adjust their dose. Should it be a surprise to anybody that patients who have the ability to act multiple times on an out-of-bounds reading on their CGM get better results than those who don't? Wouldn't a better comparison be insulin aspart vs Afrezza where both groups had a chance to adjust dosing. Heck, you could even do it with insulin aspart adjusted with Afrezza puffs. The point is that when you tie the hands of the comparator arm in a trial, physicians are not going to embrace the results. And no, this was not an FDA approved trial. Medical case studies using already approved medications within the scope of their label don't need further regulatory approval. Most hospitals will have an ethics committee / IRB approval the trial, but that is not an FDA requirement.
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Post by joeypotsandpans on Sept 13, 2018 14:46:21 GMT -5
Yep, all scientific evidence from an FDA approved clinical trial. What will docs say when they see 30% less hypo and superior PPG control? Will it then become a liability to prescribe insulin apart? What happens if a patient is hospitalized from insulin apart and the clinician knew of this data but ignored it? Medical negligence? This was not a particularly well-designed trial which is why it will not create any physician liability. The protocol required both injectable and Afrezza patients to take their prandial dose and monitor with a CGM, but only the Afrezza patients were allowed to adjust dosing, twice, in response to the CGM reading while injectable patients could not adjust their dose. Should it be a surprise to anybody that patients who have the ability to act multiple times on an out-of-bounds reading on their CGM get better results than those who don't? Wouldn't a better comparison be insulin aspart vs Afrezza where both groups had a chance to adjust dosing. Heck, you could even do it with insulin aspart adjusted with Afrezza puffs. The point is that when you tie the hands of the comparator arm in a trial, physicians are not going to embrace the results. And no, this was not an FDA approved trial. Medical case studies using already approved medications within the scope of their label don't need further regulatory approval. Most hospitals will have an ethics committee / IRB approval the trial, but that is not an FDA requirement. Perhaps you just fell off the boat, but if you "OD"/hypo on aspart from a trial it would be akin to manslaughter, that's the whole point, you can't get correction with aspart as quickly without putting the participant in jeopardy. Afrezza allows you to take those corrective doses to achieve and maintain TIR much quicker and more accurately in a comparative study highlighting/comparing the pharmacokinetic advantages of subject compared to aspart phar·ma·co·ki·net·ics ˌfärməkōkəˈnediks/Submit noun the branch of pharmacology concerned with the MOVEMENT of drugs within the body.
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Post by mnkdfann on Sept 13, 2018 15:04:11 GMT -5
Yep, all scientific evidence from an FDA approved clinical trial. What will docs say when they see 30% less hypo and superior PPG control? Will it then become a liability to prescribe insulin apart? What happens if a patient is hospitalized from insulin apart and the clinician knew of this data but ignored it? Medical negligence? This was not a particularly well-designed trial which is why it will not create any physician liability. The protocol required both injectable and Afrezza patients to take their prandial dose and monitor with a CGM, but only the Afrezza patients were allowed to adjust dosing, twice, in response to the CGM reading while injectable patients could not adjust their dose. Should it be a surprise to anybody that patients who have the ability to act multiple times on an out-of-bounds reading on their CGM get better results than those who don't? Wouldn't a better comparison be insulin aspart vs Afrezza where both groups had a chance to adjust dosing. Heck, you could even do it with insulin aspart adjusted with Afrezza puffs. The point is that when you tie the hands of the comparator arm in a trial, physicians are not going to embrace the results. The paper itself also says: "Conclusions: We conclude that using TI appropriately at mealtimes with supplemental dosing improves prandial glucose (TIR and 1–4 h) control without any increase in time in hypoglycemia or weight gain in patients with T1DM on MDI. The study results support a larger study using a treat-to-target design to confirm these findings." Many physicians may well wait for this confirmation.
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Post by liane on Sept 13, 2018 15:06:44 GMT -5
joeypotsandpans - Right on! The study pits the standard usage of insulin aspart against the usual usage of TI. You generally do not give corrective doses of aspart due to the risk of a hypo.
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Post by comnkd on Sept 13, 2018 15:07:00 GMT -5
Yep, all scientific evidence from an FDA approved clinical trial. What will docs say when they see 30% less hypo and superior PPG control? Will it then become a liability to prescribe insulin apart? What happens if a patient is hospitalized from insulin apart and the clinician knew of this data but ignored it? Medical negligence? This was not a particularly well-designed trial which is why it will not create any physician liability. The protocol required both injectable and Afrezza patients to take their prandial dose and monitor with a CGM, but only the Afrezza patients were allowed to adjust dosing, twice, in response to the CGM reading while injectable patients could not adjust their dose. Should it be a surprise to anybody that patients who have the ability to act multiple times on an out-of-bounds reading on their CGM get better results than those who don't? Wouldn't a better comparison be insulin aspart vs Afrezza where both groups had a chance to adjust dosing. Heck, you could even do it with insulin aspart adjusted with Afrezza puffs. The point is that when you tie the hands of the comparator arm in a trial, physicians are not going to embrace the results.And no, this was not an FDA approved trial. Medical case studies using already approved medications within the scope of their label don't need further regulatory approval. Most hospitals will have an ethics committee / IRB approval the trial, but that is not an FDA requirement. You say tomato, I say tomatoe. Joey sums it up nicely. This trial allowed Afrezza to be used how it was intended versus the FDA approved Afrezza trial which...wait for it...”tied the hands of [the comparator] MannKind”.
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Post by goyocafe on Sept 13, 2018 15:16:38 GMT -5
Yep, all scientific evidence from an FDA approved clinical trial. What will docs say when they see 30% less hypo and superior PPG control? Will it then become a liability to prescribe insulin apart? What happens if a patient is hospitalized from insulin apart and the clinician knew of this data but ignored it? Medical negligence? This was not a particularly well-designed trial which is why it will not create any physician liability. The protocol required both injectable and Afrezza patients to take their prandial dose and monitor with a CGM, but only the Afrezza patients were allowed to adjust dosing, twice, in response to the CGM reading while injectable patients could not adjust their dose. Should it be a surprise to anybody that patients who have the ability to act multiple times on an out-of-bounds reading on their CGM get better results than those who don't? Wouldn't a better comparison be insulin aspart vs Afrezza where both groups had a chance to adjust dosing. Heck, you could even do it with insulin aspart adjusted with Afrezza puffs. The point is that when you tie the hands of the comparator arm in a trial, physicians are not going to embrace the results. And no, this was not an FDA approved trial. Medical case studies using already approved medications within the scope of their label don't need further regulatory approval. Most hospitals will have an ethics committee / IRB approval the trial, but that is not an FDA requirement. How did they get anyone to pier reiview this study? With such a poor design, I’d certainly have reservations about its validity. On the other hand, a treat to target trial with a second arm doing follow up dosing of another RAA may be very difficult to fulfill recruiting. Will they be allowed to dose with glucagon? If so, let’s be sure to include all the incidents of severe hypoglycemia and hospitalizations. But heck, let’s do it. While at it, I think the next trial should change the target limits to 80-140.
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Post by agedhippie on Sept 13, 2018 17:39:43 GMT -5
Perhaps you just fell off the boat, but if you "OD"/hypo on aspart from a trial it would be akin to manslaughter, that's the whole point, you can't get correction with aspart as quickly without putting the participant in jeopardy. Afrezza allows you to take those corrective doses to achieve and maintain TIR much quicker and more accurately in a comparative study highlighting/comparing the pharmacokinetic advantages of subject compared to aspart This is nonsense. First everyone gets hypos on trials, both Afrezza and RAA arms - look at the Phase 3 trial. Second you are taught to use correction doses with RAA - it's expected. You must know this, it's why you need to know your correction factor. If anyone wants to learn more feel free to google correction factor. Minimally your bed time shot is a correction since there is no food involved.
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