|
|
Post by peppy on Jan 6, 2019 12:02:55 GMT -5
This is very interesting. Someone with A1C of 14 is already having all sorts of microvascular problems.The problem is that if you have been running high levels for a while your body adapts and sees that as the new normal. If you reduce your average value markedly as in this case you get apparent hypos because your body is trying to maintain that higher level. The trick is to bring it down over a period rather than with a big bang so your body adjusts. Given that we are talking about an A1c of 14 to 7 and A1c tests cover the last 3 months I would think this was probably done over a period of weeks. The flip side to this is that if you consistently get hypos your body thinks that is where it should be and you end up losing hypo-awareness which is dangerous. The advice then is to run higher than normal for a few weeks. An A1c of 14. sounds sticky. Like a floor that has had coca-cola or Kool-aide spilled on it. A HbA1c of 14 is off the chart. Looks like 375 mg/dl. The hemoglobin is sticky, it loses it shape. Now, eat some fat. A McDonald's breakfast meal deal. I love those hash browns. My blood is now sluggish. it takes more pressure to move this around.  |
|
|
|
Post by vdexdiabetes on Jan 6, 2019 15:34:48 GMT -5
I have to disagree with the posts in opposition to bringing HbA1c down quickly. Let me admit that I'm not a doctor, but as the Founder of Vdex along with my very close physician friend, I get medical input on all aspects of Vdex, all the time. I have 3-4 different physicians that I can access quickly. All are in favor of attacking HbA1c levels aggressively. It is true when you bring someone from an A1c of 14 to 7 there is an adjustment period for their body, but that is brief. There can be some "symptoms" of hypoglycemia, but theses are transitory and not dangerous. It's just the body adapting to the new normal. However, the salutary benefits of a more rapid drop in HbA1c are huge. Some, such as much better sleep, really help reinforce the change and keep the patient motivated to improve. I think that in part explains the high compliance among Vdex patients.
A subtle point is the issue of Afrezza's mode of action in reducing HbA1c. Because Afrezza attacks the post prandial excursions, or more accurately stated, preempts them, Vdex gets more bang for the buck with less danger. Here's why: the post prandial excursions where blood sugar levels skyrocket into the 300-400s and more for many patients, are what really drive up the HbA1c values. Since HbA1c is an average of lots of data points, if one eliminates the worst data one gets a bigger effect on the average than if one brought all data points down a small amount. In statistical terms, we're eliminating outlier data. Even if we don't address the basal data we still see a large effect on A1c. But, here's a key point: since we don't initially address the basal data, we haven't so dramatically changed the existing blood sugar state of the patient. I apologize for not making this clearer, but what I'm trying to explain is that there is a statistical effect that is not necessarily indicative of a physiologic effect.
I've never seen this issue addressed in the literature but that may be because never had a product before that could do it. Just one more way Afrezza is ground-breaking
|
|
|
|
Post by mnholdem on Jan 6, 2019 15:40:37 GMT -5
I have commented in another post on another thread that I think the sales of Afrezza will struggle. I said that in Jan of 2018 and I reiterated it for 2019. Sayhey is right in much of what he writes. We at Vdex have encountered loads of resistance to Afrezza and in particular our use of Afrezza, from those most immersed in the diabetes communities. Yes, the endos will be the most resistant. They know it all, they think. Consider this story that happened in our Espanola, NM office: We had a patient come in with an HbA1c of 14+ (our in-office meter only goes that high - with CGM you can actually get higher readings). We put the patient through our protocol and in a little more than a month had her down to an HbA1c of 7. The patient was thrilled. She went back to her endo and that endo took her off Afrezza, said what we were doing was irresponsible, and forbade her coming back to us. Yes, forbade her. The patient called us and told us all this. Remarkably, that patient wouldn't return because she was afraid of her doctor. I naively thought the doctor might be happy to see his patient drop 7+ points in HbA1c with no hypos, sleeping and feeling better. I thought that endo might call us asking how we were doing it. He might ask us to see others of his patients. He might refer us to others. I couldn't have been more wrong. The doc never reached out to us and in fact, bad mouthed us to other physicians in the community. Espanola's small so we eventually heard all about it. Its heart-breaking to be witness to stories like this, but its out there. There is just so much resistance to Afrezza. This is why I'm skeptical about more TV advertising suddenly causing script numbers to soar. Frankly, I'm surprised that you haven't approached the local/regional press with this. I bet they'd publish the story and both VDex proprietary treatment protocol and Afrezza Inhaled Insulin would get some much needed press, not to mention a rebuttal against any HCP allegedly bad-mouthing your clinic. Seriously! Take it to the press. Names can be redacted to legally protect yourself (i.e. HIPAA Privacy Rules) but you have specific names should you be intimidated by threats of legal action by an endo who sees VDex as stealing sheep and cutting into their business above the health of their patients. |
|
|
|
Post by vdexdiabetes on Jan 6, 2019 15:53:38 GMT -5
I like how you think mnholdem. We've thought about things like this. We're holding back a little longer before we "go nuclear," but I believe you're right.
|
|
|
|
Post by sayhey24 on Jan 6, 2019 17:02:22 GMT -5
I like how you think mnholdem. We've thought about things like this. We're holding back a little longer before we "go nuclear," but I believe you're right. Bill - I think the time has come to take off the gloves. I think Mike and Dr. Kendall need to get down to your place and vet your 200 pilot asap. It looks like you have done an amazing job.
As I have been saying since listening to the Endo as the Adcom, Endos are not our friends. In as many words he said afrezza would put him out of business. It seems you have come to learn this through your experiences. I am not sure Mike has yet learned this based on Friday's call.
The next step for VDex is proper funding and a working relationship with MNKD. Mike says he is willing to sell direct, thats a start. IMO, its time to take this to the next level assuming the vetting works out as well as I expect.
There is no reason each clinic should not be doing 50 new PWDs per week. If Mike wants to buy TV time advertising clinics would be a better spend with a serious message by a well spoken person than hamburgers flying through the air. We can put that commercial together for $10k instead of the $1M.
|
|
|
|
Post by sayhey24 on Jan 6, 2019 17:17:23 GMT -5
sayhey, I highly regard your input…. What do you think about HMOs and Afrezza? Less Endos, less cost - less hypos, less cost - less diabetic complications, less cost - etc. If Afrezza can save them money, will they ever see the light? and how? I tried working with a large company whose insurance is self-funded but managed through Aetna. I actually made some progress or so I thought. I don't know all of what happened but I can tell you the "wellness" company which was also contracted and started understanding the benefits of afrezza got fired.
Why they got fired I am not really sure. I am sure there were other issues. What I do know is they had been tasked with ways to reduce costs and they told me diabetes was the biggest health cost driver. I was able to leverage some of the earlier VDex success stories plus a simple tag line; if you don't believe what VDex has in their white paper, try it yourself.
IMO, doctors are not going to change. They will add some new "exotic" drug like a GLP1 or SGLT2 which requires the PWD to ask more questions and have more reliance on the doctor and make the doctor feel more important and pay more money. Having them use afrezza and getting near non-diabetic results provides no value for the doctor. Its not a value proposition. Getting some free hand-outs from their old BP sales friends is.
The only thing which will get their attention is if you can hit them in the pocket. HMOs don't write the scripts the doctors do.
|
|
|
|
Post by peppy on Jan 6, 2019 17:33:38 GMT -5
sayhey, I highly regard your input…. What do you think about HMOs and Afrezza? Less Endos, less cost - less hypos, less cost - less diabetic complications, less cost - etc. If Afrezza can save them money, will they ever see the light? and how? I tried working with a large company whose insurance is self-funded but managed through Aetna. I actually made some progress or so I thought. I don't know all of what happened but I can tell you the "wellness" company which was also contracted and started understanding the benefits of afrezza got fired.
Why they got fired I am not really sure. I am sure there were other issues. What I do know is they had been tasked with ways to reduce costs and they told me diabetes was the biggest health cost driver. I was able to leverage some of the earlier VDex success stories plus a simple tag line; if you don't believe what VDex has in their white paper, try it yourself.
IMO, doctors are not going to change. They will add some new "exotic" drug like a GLP1 or SGLT2 which requires the PWD to ask more questions and have more reliance on the doctor and make the doctor feel more important and pay more money. Having them use afrezza and getting near non-diabetic results provides no value for the doctor. Its not a value proposition. Getting some free hand-outs from their old BP sales friends is.
The only thing which will get their attention is if you can hit them in the pocket. HMOs don't write the scripts the doctors do.
from matt; Rebates generally have a performance trigger, like 80% of all prandial insulin dispensed must be a particular brand to earn that brand's rebate, but you cannot compute and pay the final rebate until after year end. Typically a pharmacy will pay the full wholesale price during the year and get a lump sum rebate after the year is over. If you look at the difference between the AWP and NADAC prices, and multiply that by the total number of diabetic covered lives in an insurance plan, you will understand why formulary adherence and rebates are such a compelling economic incentive. Christmas scripts.  one more thing as far as I can tell HMO are gone. HMO's were a government bill, a program. correct me if I am wrong please. |
|
|
|
Post by sellhighdrinklow on Jan 6, 2019 17:34:50 GMT -5
I have commented in another post on another thread that I think the sales of Afrezza will struggle. I said that in Jan of 2018 and I reiterated it for 2019. Sayhey is right in much of what he writes. We at Vdex have encountered loads of resistance to Afrezza and in particular our use of Afrezza, from those most immersed in the diabetes communities. Yes, the endos will be the most resistant. They know it all, they think. Consider this story that happened in our Espanola, NM office: We had a patient come in with an HbA1c of 14+ (our in-office meter only goes that high - with CGM you can actually get higher readings). We put the patient through our protocol and in a little more than a month had her down to an HbA1c of 7. The patient was thrilled. She went back to her endo and that endo took her off Afrezza, said what we were doing was irresponsible, and forbade her coming back to us. Yes, forbade her. The patient called us and told us all this. Remarkably, that patient wouldn't return because she was afraid of her doctor. I naively thought the doctor might be happy to see his patient drop 7+ points in HbA1c with no hypos, sleeping and feeling better. I thought that endo might call us asking how we were doing it. He might ask us to see others of his patients. He might refer us to others. I couldn't have been more wrong. The doc never reached out to us and in fact, bad mouthed us to other physicians in the community. Espanola's small so we eventually heard all about it. Its heart-breaking to be witness to stories like this, but its out there. There is just so much resistance to Afrezza. This is why I'm skeptical about more TV advertising suddenly causing script numbers to soar. This is nothing short of CRIMINAL activity. Unreal!! |
|
|
|
Post by lennymnkd on Jan 6, 2019 17:39:51 GMT -5
Great part of our 60 minutes story ,
|
|
|
|
Post by peppy on Jan 6, 2019 17:44:27 GMT -5
I have commented in another post on another thread that I think the sales of Afrezza will struggle. I said that in Jan of 2018 and I reiterated it for 2019. Sayhey is right in much of what he writes. We at Vdex have encountered loads of resistance to Afrezza and in particular our use of Afrezza, from those most immersed in the diabetes communities. Yes, the endos will be the most resistant. They know it all, they think. Consider this story that happened in our Espanola, NM office: We had a patient come in with an HbA1c of 14+ (our in-office meter only goes that high - with CGM you can actually get higher readings). We put the patient through our protocol and in a little more than a month had her down to an HbA1c of 7. The patient was thrilled. She went back to her endo and that endo took her off Afrezza, said what we were doing was irresponsible, and forbade her coming back to us. Yes, forbade her. The patient called us and told us all this. Remarkably, that patient wouldn't return because she was afraid of her doctor. I naively thought the doctor might be happy to see his patient drop 7+ points in HbA1c with no hypos, sleeping and feeling better. I thought that endo might call us asking how we were doing it. He might ask us to see others of his patients. He might refer us to others. I couldn't have been more wrong. The doc never reached out to us and in fact, bad mouthed us to other physicians in the community. Espanola's small so we eventually heard all about it. Its heart-breaking to be witness to stories like this, but its out there. There is just so much resistance to Afrezza. This is why I'm skeptical about more TV advertising suddenly causing script numbers to soar. Quote: " We had a patient come in with an HbA1c of 14+ (our in-office meter only goes that high - with CGM you can actually get higher readings). We put the patient through our protocol and in a little more than a month had her down to an HbA1c of 7. The patient was thrilled. She went back to her endo and that endo took her off Afrezza, said what we were doing was irresponsible, and forbade her coming back to us. Yes, forbade her." Reply: This physician, doesn't know that with afrezza the patient gets the first phase? He thinks it was hypoglycemia that brought her down? I think I get it now.  |
|
|
|
Post by ltta on Jan 6, 2019 18:33:22 GMT -5
Thank you sayhey! When asking about HMOs, I was thinking Kaiser Permanente and other key payers. If Mankind could get them onboard would the dominoes likely start to fall?  Mike C said in the last call: “The third topic here I want address is payers/patient access. We are continuing to see positive payer coverage as we start out 2019 as evidenced by our recent signing of the contract with Kaiser [ph] and ongoing discussions with other key payers.” From the Kaiser website: Founded in 1945, Kaiser Permanente is one of the nation’s largest not-for-profit health plans, serving 12.2 million members, with headquarters in Oakland, California. It comprises: • Kaiser Foundation Hospitals and its subsidiaries • Kaiser Foundation Health Plan, Inc. • The Permanente Medical Groups Health Plan Membership, by Region Northern California: 4,288,153 Southern California: 4,530,385 Colorado: 655,437 Georgia: 356,744 Hawaii: 252,977 Mid-Atlantic States (Va., Md., D.C.): 772,340 Northwest (Ore./Wash.): 606,159 Washington: 705,267 Medical Facilities and Physicians Hospitals: 39 Medical Offices: 690 Physicians: Approximate as of June 30, 2018, representing all specialties 22,013 Nurses: Approximate as of December 31, 2017, representing all specialties 58,345 Employees: Approximate, representing technical, administrative and clerical employees and caregivers 217,173 Data as of September 2018, unless otherwise noted. |
|
|
|
Post by liane on Jan 6, 2019 19:21:38 GMT -5
If many of the endos are having the response that vdexdiabetes describes, then MNKD should be targeting the PCPs. With Afrezza and a little coaching, any PCP could keep his/her diabetes care in house (and bill for it). For the PCP, prescribing Afrezza will not decrease business; the patient will continue to see the PCP for their primary health issues - same as before. |
|
|
|
Post by mango on Jan 6, 2019 19:39:25 GMT -5
. Terrible shame. Maybe someone can call the medical board that oversees Espinola, and report the doctor. The allegation may not be as obvious a violation as in a wrongful death malpractice but it could light a fire under this dr. Unfortunately another doctor playing God, and we know how that usually turns out. I'm not a medical doctor, but some quick googling turns up reasons why a doctor could be upset with a one month drop in HbA1c from 14+ to 7. E.g., on a page at forum.diabetes.org.uk, there are comments that going "totally over the top and reduc[ing] your HbA1c too quickly" may be very bad "as the sudden changes can cause problems particularly in the microvascular area (i.e. things like retinopathy or nephropathy, even neuropathy". What I think (remember, I'm not a medical doctor) are related journal references are given below. If the above is accepted medical wisdom in the U.S. (IDK, is it?), then a complaint might backfire. www.ncbi.nlm.nih.gov/pubmed/29217386bmcendocrdisord.biomedcentral.com/articles/10.1186/s12902-017-0213-3This may suggest that a gradual lowering would be better received by the medical community. That is a systematic review of PubMed references there and a paper about a hypothesis. ° The Diabetes Control and Complications Trial was a multicenter, randomized trial designed to compare intensive insulin therapy with conventional diabetes therapy and their effects on the development and progression early vascular and neurologic complications in insulin-dependent diabetes patients. 1441 patients were recruited at 29 centers from 1983 - 1989. "Intensive therapy of patients with IDDM delays the onset and slows the progression of clinically important retinopathy, including vision-threatening lesions, nephropathy, and neuropathy, by a range of 35 to more than 70 percent." CONCLUSIONS Intensive therapy effectively delays the onset and slows the progression of diabetic retinopathy, nephropathy, and neuropathy in patients with IDDM. Bill said the patient had no hypos. We already know Afrezza dramatically reduces overall and severe rates of hypoglycemia and really flattens the curves. The risks are associated with subcutaneous insulin formulations. RAAs have erratic, poor absorption and cannot adequately address post-prandial glucose, and it's late persistence causes a mess. ° In that trial, intensive insulin therapy patients had increase of 33 % in the mean adjusted risk of becoming overweight. At five years, patients receiving intensive therapy had gained a mean of 4.6 kg more than patients receiving conventional therapy. ° In the intensive-therapy group, there were 62 hypoglycemic episodes per 100 patient-years in which assistance was required in the provision of treatment, as compared with 19 such episodes per 100 patient-years in the conventional-therapy group. This included 16 and 5 episodes of coma or seizure per 100 patient-years in the respective groups. ° There were 54 hospitalizations, usually brief, to treat severe hypoglycemia in 40 patients in the intensive-therapy group, as compared with 36 hospitalizations in 27 patients in the conventional-therapy group, including 7 and 4 hospitalizations, respectively, to treat hypoglycemia-related injuries. ° From five years onward, the cumulative incidence of retinopathy in the intensive-therapy group was approximately 50% less than in the conventional-therapy group. During a mean of six years of follow-up, retinopathy as defined above developed in 23 patients in the intensive-therapy group and 91 patients in the conventional-therapy group. Intensive therapy reduced the adjusted mean risk of retinopathy by 76% Intensive insulin therapy also carries increased risk of acquiring localized insulin-derived amyloidosis. Something that is not associated with Afrezza. www.nejm.org/doi/full/10.1056/NEJM199309303291401 |
|
|
|
Post by mnholdem on Jan 6, 2019 20:27:23 GMT -5
Thank you sayhey! When asking about HMOs, I was thinking Kaiser Permanente and other key payers. If Mankind could get them onboard would the dominoes likely start to fall? Mike C said in the last call: “The third topic here I want address is payers/patient access. We are continuing to see positive payer coverage as we start out 2019 as evidenced by our recent signing of the contract with Kaiser [ph] and ongoing discussions with other key payers.” [remainder clipped] Then it sure would have been nice for MannKind's Marketing and IR departments to have put out a PR to that effect. "MannKind Announces Agreement with Kaiser for Coverage of Afrezza Inhaled Insulin."
|
|
|
|
Post by goyocafe on Jan 6, 2019 20:34:38 GMT -5
Thank you sayhey! When asking about HMOs, I was thinking Kaiser Permanente and other key payers. If Mankind could get them onboard would the dominoes likely start to fall? Mike C said in the last call: “The third topic here I want address is payers/patient access. We are continuing to see positive payer coverage as we start out 2019 as evidenced by our recent signing of the contract with Kaiser [ph] and ongoing discussions with other key payers.” [remainder clipped] Then it sure would have been nice for MannKind's Marketing and IR departments to have put out a PR to that effect. "MannKind Announces Agreement with Kaiser for Coverage of Afrezza Inhaled Insulin."
|
|
