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Post by alcc on Dec 12, 2015 17:38:26 GMT -5
www.newyorker.com/magazine/2015/12/14/tough-medicine"obduracy and closed-mindedness of [the] profession..." First, this mindset acts to block innovation and diffusion of innovation. Then it acts to lock whatever becomes standard of care (RAAs like novolog and humalog) into rigid doctrine of the practice. Deadly one-two punch.
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Post by dreamboatcruise on Dec 12, 2015 18:04:16 GMT -5
Good read.
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Post by slapshot on Dec 12, 2015 19:09:06 GMT -5
WOW
Great find.... i have ordered the book, thanks for sharing.
i would comment, but am literally dumbfounded.
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Post by jpg on Dec 12, 2015 20:50:17 GMT -5
Very interesting article.
To be honest this is how it is in many specialities. In my opinion, and sadly, endocrinology is one of the worst for this type of stuff. It's hard to find a more conservative and slow to embrace innovation speciality. Cardiology and 'modern hemato-oncology' would be at the other end of the spectrum.
His point about protocols and rules is also IMO spot on and one of the major impediments to innovation and discovery. It has a tendency to makes MDs rule/ protocol followers without any clinical nuance. HMO like structures and insurance companies add another layer of difficulty to developing state of the art treatments. But at the same time protocols also tend to get the really backwards MDs to do a bit better.
Sadly Afrezza isn't prescribed by cardiologists (a better lipid/ CAD profile could change that but again there would need to be some trials). Where are these trials? It seems Mannkind didn't think of this conservative nature of endos (even though it took them years to start to understand pumps), the status quo thinking of insurance companies, that pricing as done by their partner could be a problem for not getting insurances on board, not raising capital when the price was high... Such big errors. Retrospectively now we know they had no access to $ what a bunch of dreamers... The desperation of the TASE listing: Sickening. Bunch of dreamers. There are only so many mistakes you can do with even the best of products. As this article demonstrates even an extraordinary drug or treatment can't survive as many errors as Sanofi and Mannkind made/ are making.
Retrospectively I presume Sanofi was the only 'not awful' option or possibly the only option. Mannkind wasn't being picky. They were simply desperate and took the only offer they got. No superiority study as part of the deal. No survival financing if things were slow because of Sanofi loss of focus and a toxic high interest loan package from Sanofi. Sad stuff...
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Post by alcc on Dec 12, 2015 23:43:48 GMT -5
Two "retrospectives" in one post can't be good. Agree with all your points. The TASE maneuver was... pathetic, sad.
I should have learned the best product does not always win. It may not even win more often than not. Still, we here all know Afrezza can be a life-changing, paradigm-shifting med. Let's hope it find success in the end, for the patients' sake.
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Post by Deleted on Dec 13, 2015 8:41:10 GMT -5
Some information about Dr. Bernard Fisher who was a pioneer at UPMC for his work developing the lumpectomy for treating breast cancer. Back in the day, SOP was a mastectomy and for his pioneering work, Dr. Fisher received much scrutiny which was debilitating to him personally and professionally. Ultimately, his foresight was rewarded as his efforts vastly improved treatment for those impacted by breast cancer but his road was long and challenging. I learned about Dr. Fisher this spring at the Jefferies Global Healthcare Conference where Siddhartha Mukherjee, a physician and author of "Emperor of All Maladies: A Biography of Cancer" spoke about Dr. Fishers journey. en.wikipedia.org/wiki/Bernard_Fisher_(scientist)" Fisher faced constant attacks from within medical ranks as he worked to disprove the efficacy of the old status quo treatment, eventually being described as “an iconoclastic figure” who brought about “far reaching changes...in the understanding of cancer and its treatment.”[5] The Atlantic Monthly has called him “a medical hero.”[6] He was awarded the Albert Lasker Award for Clinical Medical Research in 1985 “for his pioneering studies that have led to a dramatic improvement in survival and in the quality of life for women with breast cancer.”[7]" |
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Post by ezrasfund on Dec 13, 2015 10:31:04 GMT -5
www.newyorker.com/magazine/2015/12/14/tough-medicine"obduracy and closed-mindedness of [the] profession..." First, this mindset acts to block innovation and diffusion of innovation. Then it acts to lock whatever becomes standard of care (RAAs like novolog and humalog) into rigid doctrine of the practice. Deadly one-two punch. Bump! LOL This article points out the biggest problems for Afrezza. Note that it is not just practicing physicians but also the FDA that DeVita says is part of the problem. The story of C. diff and fecal transplants is another good example where thousands are dying and many more are suffering while we wait for the standard of care to change. Read more: mnkd.proboards.com/thread/4245/over-sanofi?page=2#ixzz3sAT1dtyS |
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Post by Deleted on Dec 13, 2015 10:34:42 GMT -5
www.newyorker.com/magazine/2015/12/14/tough-medicine"obduracy and closed-mindedness of [the] profession..." First, this mindset acts to block innovation and diffusion of innovation. Then it acts to lock whatever becomes standard of care (RAAs like novolog and humalog) into rigid doctrine of the practice. Deadly one-two punch. Bump! LOL This article points out the biggest problems for Afrezza. Note that it is not just practicing physicians but also the FDA that DeVita says is part of the problem. The story of C. diff and fecal transplants is another good example where thousands are dying and many more are suffering while we wait for the standard of care to change. So will global competition to deliver healthcare allow another country without all the constraints we face here to lead the way in delivering innovative solutions and therapies to difficult diseases? Here is Morgan Spurlock (Supersize Me) in Thailand getting healthcare: www.cnn.com/videos/tv/2015/01/23/exp-n-spurlock-inside-man-medical-tourism-1-29.cnn-promos |
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Post by nylefty on Dec 13, 2015 10:48:22 GMT -5
www.newyorker.com/magazine/2015/12/14/tough-medicine"obduracy and closed-mindedness of [the] profession..." First, this mindset acts to block innovation and diffusion of innovation. Then it acts to lock whatever becomes standard of care (RAAs like novolog and humalog) into rigid doctrine of the practice. Deadly one-two punch. Bump! LOL You laughed out loud? Really? I sure didn't. |
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Post by ezrasfund on Dec 13, 2015 10:52:20 GMT -5
Just LOL about "bumping" this most important point back to the top of the list. YMB tricks are usually frowned upon here. I have been making this point for some time now, that is that the "first, do no harm" conservative nature of the medical profession is one of Afrezza's main obstacles.
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Post by mnholdem on Dec 13, 2015 11:07:37 GMT -5
Ironic that the "do no harm" aspect of the Hippocratic oath, in this instance, involves providing the body with something it should produce naturally but cannot - human insulin. All because it's delivered through what is probably the toughest organ in the human body, second only to skin. Men and women can smoke their entire lives, and/or breath in pollution day after day yet the idea of inhaling a "powder" into the lungs raises a red flag for many. It's no mystery why MannKind called it Technosphere Insulin and why Sanofi calls Afrezza a "dry formulation". The idea that inhaling an insulin "powder" (FDA's official description) might be bad for you is another misconception that must be corrected by educating physicians and patients alike.
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Post by ezrasfund on Dec 13, 2015 11:16:26 GMT -5
Yes, see also my "smoking doesn't cause cancer...tobacco does" rant.
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Post by mssciguy on Dec 13, 2015 11:27:00 GMT -5
Ironic that the "do no harm" aspect of the Hippocratic oath, in this instance, involves providing the body with something it should produce naturally but cannot - human insulin. All because it's delivered through what is probably the toughest organ in the human body. Men and women can smoke their entire lives, and/or breath in pollution day after day yet the idea of inhaling a "powder" into the lungs raises a red flag for many. It's no mystery why MannKind called it Technosphere Insulin and why Sanofi calls Afrezza a "dry formulation". The idea that inhaling a powdered insulin (FDA's official description) is bad for you is another misconception that must be corrected by educating physicians and patients alike. In courses covering atmospheric chemistry and physics, very small particles (below a couple microns) are characterized as behaving like gases. The TS particles not only behave as gases for penetration, but also dissolve upon impact with moisture in the lung tissue. |
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Post by kball on Dec 13, 2015 14:03:56 GMT -5
Love Malcolm. One of my favorite talk show guests too.
I'm actually more optimistic (in the long run) about Afrezza adoption after reading.
I vote Malcolm write Al's biography.
And a few afrezza articles right now
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Post by stevil on Dec 13, 2015 14:54:08 GMT -5
Ironic that the "do no harm" aspect of the Hippocratic oath, in this instance, involves providing the body with something it should produce naturally but cannot - human insulin. All because it's delivered through what is probably the toughest organ in the human body. Men and women can smoke their entire lives, and/or breath in pollution day after day yet the idea of inhaling a "powder" into the lungs raises a red flag for many. It's no mystery why MannKind called it Technosphere Insulin and why Sanofi calls Afrezza a "dry formulation". The idea that inhaling a powdered insulin (FDA's official description) is bad for you is another misconception that must be corrected by educating physicians and patients alike. In courses covering atmospheric chemistry and physics, very small particles (below a couple microns) are characterized as behaving like gases. The TS particles not only behave as gases for penetration, but also dissolve upon impact with moisture in the lung tissue. They dissolve, but leave residue. However, the studies I read showed virtually 100% clearance of FDKP, meaning TS won't be causing any lung complications, but whatever medication attached to FDKP may. However, insulin is a small enough protein to get absorbed in alveoli. This shouldn't be an issue. I need to check before making this statement, but I wonder if insulin is any larger than other inhaled steroids that are commonly prescribed for asthma. I can understand some hesitation but there should be enough docs that can be convinced to try it to build a strong base for momentum. |
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