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Post by mannmade on Sept 12, 2015 17:52:44 GMT -5
Looks like I'm misinformed. I could swear that I read that data revealed many trial patients inhaled Afrezza too soon. It appears that wasn't the case. Good detective work. I read it as well. I had to look. I am glad we have it in print now. We know.
Additionally, Mannkind submitted Afrezza with the black box warning. Did I say that correctly.
No I was told by Matt that they purposely asked for the warnings against smokers and asthma to prevent potential law suits initially until there was more history etc... |
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Post by peppy on Sept 12, 2015 17:57:09 GMT -5
I read it as well. I had to look. I am glad we have it in print now. We know.
Additionally, Mannkind submitted Afrezza with the black box warning. Did I say that correctly.
No I was told by Matt that they purposely asked for the warnings against smokers and asthma to prevent potential law suits initially until there was more history etc... You said it well. I said it poorly. Yes, what you said, is what I read. |
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Post by mannmade on Sept 12, 2015 18:01:44 GMT -5
What I meant to say in my haste was no you said it well...  |
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Post by spiro on Sept 12, 2015 18:58:11 GMT -5
Savzak, it's the weekend, Spiro is venting a little. Too many Endo's are happy with an A1c of 8.
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Post by mannmade on Sept 12, 2015 19:33:17 GMT -5
Spiro, perhaps we should have you do a video with Sam and get it on the internet... Just a thought... And then send you to Australia to do one with Matt B and on your way home a stop in England for a video with Brendan. |
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Post by od on Sept 12, 2015 21:27:16 GMT -5
No I was told by Matt that they purposely asked for the warnings against smokers and asthma to prevent potential law suits initially until there was more history etc... You said it well. I said it poorly. Yes, what you said, is what I read. What am I missing here? MNKD requested a boxed warning? I can't imagine a company requesting a black box, or any warning, except as part of an approval or labeling negotiation with the agency. |
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Post by Deleted on Sept 12, 2015 22:19:34 GMT -5
You said it well. I said it poorly. Yes, what you said, is what I read. What am I missing here? MNKD requested a boxed warning? I can't imagine a company requesting a black box, or any warning, except as part of an approval or labeling negotiation with the agency. You would say that now but would have said why wasn't the risk put on the label when bad reviews pop up and fda warnings all over the news |
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Post by lynn on Sept 12, 2015 22:33:07 GMT -5
I also recall that the black box label was requested my Mannkind , not the FDA .At least as far as it not being recommended for smokers , People with COPD ect .
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Post by mannmade on Sept 12, 2015 23:35:46 GMT -5
It was and for good reason... Why would you risk a lawsuit or bad publicity, especially at launch, on what is really a very small percentage of the patient population? You can always expand later when you have history on this area. Risk evaluation is always an important factor in a business plan. It is good "prophylactic" management and shows great forsight in my opinion.
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Post by ezrasfund on Sept 13, 2015 9:01:53 GMT -5
Savzak, it's the weekend, Spiro is venting a little. Too many Endo's are happy with an A1c of 8. Sorry to re-post this link but I think it is important to realize what the protocols for T2 are. Spiro is right. Endos seem content to let their patients die a slow death from diabetes. Look especially at the change in treatment protocols if the patient is considered less treatment compliant or just older. www.accurateinsulin.org/for-doctors/deciding-whether-to-transition-your-patient-to-mealtime-insulin/ |
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Post by agedhippie on Sept 13, 2015 9:18:06 GMT -5
Totally agree,,,, "less hypo's" (arguably should be NO hypo's) AND less weight gain are big concerns.... My wife, 38 yrs old, was diagnosed type 1, 10 years ago. She's put on 25 lbs (she was 5' 8" 130 lbs) that she can't get rid of and struggles with hypo's in the middle of the night, a couple time a week..... Solving only those two issues would change her life. Her appt to DEMAND Afrezza is in 3 weeks. I am a Type 1 and while I have no weight problems with Lantus I have several friends who do. For the most part changing to Levemir fixed their problems so that might be worth a try. I don't think that changing to Afrezza will fix her night time hypo problem unless it is the bed time correction that is causing it. In that case she may want to change her correction factor as people are often more insulin sensitive at night. Apologies if I am telling you things you have already tried. |
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Post by liane on Sept 13, 2015 9:23:12 GMT -5
ezra,
I don't think that it's so much the endos allowing their patients to slowly die. Rather, it points to how complicated it is to manage diabetes in the pre-Afrezza era. It's complicated under the best of circumstances. Then you throw in poverty, homelessness, needlephobia, general disregard for one's health, and any number of other factors. There is only so much that your typical overworked physician can do. So they come up with these algorithms - OK, we can't get perfect compliance, here's the next best thing, and the next best thing after that...
Afrezza will change all that; it just will take time to shift the paradigm.
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Post by spiro on Sept 13, 2015 9:44:40 GMT -5
Do some Endo's really care about their patients? Spiro, since starting Afrezza 6 month's ago, has not had one episode of small fiber neuropathy pain in his hands or feet. Before Afrezza his average BG was 157, now it is around 125. Truthfully, until someone mentioned high blood glucose levels and neuropathy on this board month's ago, Spiro had not connected neuropathy pain to his diabetes. Well, Spiro's Diabetes is still present, but his small fiber neuropathy is damn sure gone. New Research on High Glucose Levels September 12, 2012 by David Spero Print Text Size: A A A American Diabetes Association (ADA) guidelines advise “lowering A1C to below or around 7%” and postprandial (after-meal) glucose levels to 180 mg/dl or below. But new research shows that these glucose levels damage blood vessels, nerves, organs, and beta cells. An article by diabetes blogger Jenny Ruhl analyzes at what blood glucose level organ damage starts. According to Ruhl, research shows that glucose can do harm at much lower levels than doctors had thought. This news could be discouraging or even terrifying. If it’s hard to meet your current glucose goals, how will you reach tighter goals? Such news might make some people give up. But remember, a high postprandial or fasting reading won’t kill you. All we know is that higher numbers correlate with higher chances of complications. You have time to react. In fact, we could choose to look at this as good news. We all know of people who developed complications despite “good control.” But complications are not inevitable; it’s just that so-called “good control” wasn’t really all that good. First, the numbers. “Post-meal blood sugars of 140 mg/dl [milligrams per deciliter] and higher, and fasting blood sugars over 100 mg/dl [can] cause permanent organ damage and cause diabetes to progress,” Ruhl writes.
For nerve damage, University of Utah researchers studied people with painful sensory neuropathy, or nerve damage. They found that participants who did not have diabetes but who had impaired glucose tolerance on an oral glucose tolerance test, or OGTT, (meaning that their glucose levels rose to between 140 mg/dl and 200 mg/dl in response to drinking a glucose-rich drink) were much more likely to have a diabetic form of neuropathy than those with lower blood glucose levels.
The higher these OGTT numbers go, the more nerve damage is found, according to Johns Hopkins Hospital researchers. The OGTT gives a good idea of how high after-meal blood glucose levels are likely to be.
Glucose can also start killing beta cells at levels below 140. One study found that people with fasting blood glucose from 110–125 (within the official “prediabetic” range) had already lost up to 40% of their beta cell mass.
Italian researchers found that even with glucose levels in the supposedly “normal” range, beta cells started to fail. Ruhl says that researchers “found that with every small increase in the 2-hour glucose tolerance test result, there was a corresponding increase in…beta cell failure. The higher a person’s blood sugar rose within ‘normal’ range, the more beta cells were failing.” Failing beta cells will lead to worsening diabetes, a truly vicious cycle. Slightly elevated glucose has also been shown to cause eye damage (“retinopathy”) and increased rates of heart disease, kidney damage, and stroke. Where Does High Start? Studies like the ones Ruhl quotes and others indicate that damage occurs with even slightly elevated blood glucose. But what can you do about that? Is it reasonable to try to keep glucose at normal levels all the time? It seems for some people, that course would lead to frustration and burnout. In fact, ADA says that older, sicker people should have even less strict goals. How do you set reasonable goals for yourself? Keeping normal numbers may require extraordinary effort. It may require very low carbohydrate intake. It may not be possible for you. If you’re taking insulin or drugs in the sulfonylurea or meglitinide classes, aiming too low can put you at risk of hypoglycemia (low blood glucose). The whole thing can make you crazy, because sometimes numbers will go up for no apparent reason. As a result, most people set less-demanding goals for themselves. If they can keep their postprandial glucose under 180 and their fasting below 120, they’re OK, and the ADA agrees. There’s nothing wrong with that. People can trade off how low they want their blood glucose against how much work they are willing to do and how many foods they’re willing to cut back or give up. They are adding to their risk, but, to me, quality of life is the most important thing. Important note: Bringing blood glucose down by means of multiple drugs has NOT been shown to decrease complications much. Two huge studies, the ACCORD and ADVANCE trials showed this. But people who manage to keep normal or near-normal numbers through healthy eating and living and intelligent use of medicines seem to live long, relatively healthy lives. They can even reverse type 2 or the complications of Type 1, even if they have spent years with elevated blood glucose before getting them under control. It’s almost never too late to get on track. So my question is what are your target numbers? How high is too high for you? Does it make sense to aim for normal, non-diabetic levels, or is that just too demanding and unrealistic? If you had a newly diagnosed friend or relative, what would you tell him or her about glucose goals? www.diabetesselfmanagement.com/blog/new-research-on-high-glucose-levels/ |
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Post by curiousdoc on Sept 13, 2015 10:17:00 GMT -5
ezra, I don't think that it's so much the endos allowing their patients to slowly die. Rather, it points to how complicated it is to manage diabetes in the pre-Afrezza era. It's complicated under the best of circumstances. Then you throw in poverty, homelessness, needlephobia, general disregard for one's health, and any number of other factors. There is only so much that your typical overworked physician can do. So they come up with these algorithms - OK, we can't get perfect compliance, here's the next best thing, and the next best thing after that. Afrezza will change all that; it just will take time to shift the paradigm. Great point. Docs would love their patients to have A1Cs under 7. But for the vast majority of their patients, this is unrealistic due to lack of treatment compliance, social limitations or the very real risk of significant hypoglycemic events with aggressive therapy using current drugs. Not to mention, you cant find many patients suffering ONLY from type 2 diabetes. They are likely on many other meds including anti-hypertensives, statins, etc; all of which add to the patient's treatment burden and drug interactions. |
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Post by od on Sept 13, 2015 10:28:20 GMT -5
ezra, I don't think that it's so much the endos allowing their patients to slowly die. Rather, it points to how complicated it is to manage diabetes in the pre-Afrezza era. It's complicated under the best of circumstances. Then you throw in poverty, homelessness, needlephobia, general disregard for one's health, and any number of other factors. There is only so much that your typical overworked physician can do. So they come up with these algorithms - OK, we can't get perfect compliance, here's the next best thing, and the next best thing after that. Afrezza will change all that; it just will take time to shift the paradigm. liane, thank you for the most important post on the MNKD board (at least to od). I hope I don't have to suspend disbelief when I share that I am sure everyone on the board would like to see an end to the ravages of diabetes. But money and ego are not friends to objectivity. |
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