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Post by mango on Feb 19, 2017 3:31:52 GMT -5
SANOFI-AVENTIS U.S. LLC (2015) Total General Payments —$27,167,823.08 Total Research Payments —$16,173,338.41 openpaymentsdata.cms.gov/company/100000000076/summarySANOFI PASTEUR BIOLOGICS LLC (2015) Total General Payments —$2,568.97 Total Research Payments —$325,366.64 openpaymentsdata.cms.gov/company/100000010771/summarySANOFI PASTEUR INC. (2015) Total General Payments —$2,586,753.51 Total Research Payments —$14,719,584.32 openpaymentsdata.cms.gov/company/100000000299/summarySANOFI US SERVICES INC. (2015) Total General Payments —$2,266,080.70 Total Research Payments —$90,122,106.59 openpaymentsdata.cms.gov/company/100000000067/summary
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Post by mango on Feb 19, 2017 3:36:01 GMT -5
Open your eyes and quit your bitching about script counts, what management shoulda/woulda/coulda and realize you are not invested in a company that is a corrupt parasite full of unethical practices.
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Post by rockstarrick on Feb 19, 2017 4:24:38 GMT -5
Open your eyes and quit your bitching about script counts, what management shoulda/woulda/coulda and realize you are not invested in a company that is a corrupt parasite full of unethical practices. I rest my case, Mango adds a different flavor to this forum with the information he/she continues to share. Cheers Mango
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Post by boca1girl on Feb 19, 2017 7:32:57 GMT -5
Wow. Afrezza has a steep uphill battle.
$$$$$ is the great motivator in our health care system.
My questions to Mango:
1. Have you shared this information with MNKD management so there is NO DOUBT that they are aware?
2. If so, what was their response and action plan to combat this "recommendation" (publication) to the practitioners?
I appreciate all the informative information you post. Too bad a investigative news show, like 60 Minutes, can't expose how $$$$$ is influencing our medical care givers. You would think they would jump on a story like this, especially since drug pricing has been in news lately.
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Post by mango on Feb 19, 2017 9:40:26 GMT -5
Wow. Afrezza has a steep uphill battle. $$$$$ is the great motivator in our health care system. My questions to Mango: 1. Have you shared this information with MNKD management so there is NO DOUBT that they are aware? 2. If so, what was their response and action plan to combat this "recommendation" (publication) to the practitioners? I appreciate all the informative information you post. Too bad a investigative news show, like 60 Minutes, can't expose how $$$$$ is influencing our medical care givers. You would think they would jump on a story like this, especially since drug pricing has been in news lately. 1. Have you shared this information with MNKD management so there is NO DOUBT that they are aware?No. I honestly do not know how to convey all this information in a precise and condensed way, and for it to be informative and slap the point across that an executive would take the time to read and understand. I hope someone else can take the task of doing so. If not, someone can just tweet Mike to read the thread. 2. If so, what was their response and action plan to combat this "recommendation" (publication) to the practitioners?Who knows if MannKind will even share the same views.
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Post by mnkdfann on Feb 19, 2017 10:21:36 GMT -5
I'm not so sure they are even thinking of Afrezza when they comment on 'inhaled insulin'. The 2017 statement references a 2005 paper where it mentions 'inhaled insulin', and that 2005 paper in turn references a 2001 Lancet study, which I suspect is about Exubera. Sorry, but Dr. Janet B. McGill is apart of this official 2017 concensus statement and Dr. Janet B. Mcgill represented MannKind during the 2014 FDA Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) Meeting for Afrezza. She was also an Afrezza Clinical Trial Investigator. www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM392909.pdfYes, thanks, I saw this mentioned in one of your posts made subsequently to my own. Based on your first post, though, that McGill knew about Afrezza was not clear to me at the time. So it appears McGill was an early vocal proponent for Afrezza and now apparently treats it as an afterthought. Not encouraging to say the least. What changed? She was bought off? She had an evidence based change of heart? She was just never really as enthusiastic as she once was?
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Post by agedhippie on Feb 19, 2017 10:51:37 GMT -5
It's a consensus paper and consensus changes slowly - get over it.
I love this in particular: —
It is difficult not to cite that paper, it's the standard paper on the topic! Is there a rule that you cannot cite a highly cited paper (877 other papers cited it) if you were an author? If so that's a rule that's been ignored forever. There is no ethical duty breach regardless of what you might think.
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Post by matt on Feb 19, 2017 11:04:14 GMT -5
• The name of the inhaled insulin, Afrezza, is not stated. A passive gesture was merely used in the two instances that mentioned 'inhaled insulin'. The author(s) clearly, and by clearly I actually mean deliberately, mentioned inhaled insulin as an afterthought that is easily overlooked/read-over. It is common for medical societies and scientific papers to refer to all drugs by their generic names. If you look at the package insert the description is "Afrezza ® (insulin human) Inhalation Powder". Inhaled insulin is a valid generic description. Don't expect that a position paper like this is going to mention a brand name specifically, regardless of the brand, unless the brand itself has become a generic term (Bayer, for example, lost the trademark on the word "aspirin"). It is not up to the endos to advertise Afrezza. As for payments to thought leaders, is that really surprising? Pharmaceutical companies always seek out physicians with good reputations and deep experience in a field to advise them on their drugs, and frankly that is a far better practice then using uninformed physicians. A lot of times those advisory sessions take an entire day, and there are 8-10 outside advisors involved in a committee, so that involves paying them for their lost work time plus travel expenses. A top consultant can charge $5-6K for a meeting, especially if travel and several hours of preparation time are included. That may sound like a lot, but it is on the low side of the market when compared with hourly billing rates for top consultants, auditors, lawyers, and other skilled professionals, some of whom bill $1,000 / hour. Given the number of advisors involves it is easy to drop $100K on a single meeting, and if the advisors meet quarterly, the price tag is $400K per year for the panel. Large companies with multiple therapeutic categories will have multiple advisory panels and those aggregate costs run into the millions. So long as a single physician is not making more than about $20-30K in consulting fees per year, plus reimbursement of expenses, from a particular firm that is not out of line. Research support is generally paid directly to the affiliated university or hospital system, just like it is for NIH grants or any other grant support, and that money is not paid onward to the physician; it supports R&D expenses and graduate student stipends. You may not like the fact that pharma pays so much into the research world, but if the pharma companies don't do it then a lot of useful science would never get done. Both the industry and the medical world would love a workable alternative, but so far that hasn't happened. It is unfair to call it corrupt unless you have a better, and more practical, solution.
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Post by mango on Feb 19, 2017 12:09:33 GMT -5
It's a consensus paper and consensus changes slowly - get over it. I love this in particular: — It is difficult not to cite that paper, it's the standard paper on the topic! Is there a rule that you cannot cite a highly cited paper (877 other papers cited it) if you were an author? If so that's a rule that's been ignored forever. There is no ethical duty breach regardless of what you might think. How is a paper over a decade old "the standard" paper on the topic when it does not even include the most advanced modern day prandial insulin, Afrezza? Hello? Waiting for that answer. In the meantime while you try to think of a clever rebuttal, yes, there is an ethical breach as is evidenced by the disclosures and if you want to argue on that point then you will be aguing with yourself. Again, how is that paper even relevant and considered as the CURRENT standard when it is OUTDATED and does not have CURRENT and RELEVANT information?!?!? Also, WHERE IS THE REFERENCE TO INHALED INSULIN AKA AFREZZA???
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Post by uvula on Feb 19, 2017 12:24:05 GMT -5
Mango, agedhippie has a good point. It isn't his fault that it takes a long time for standards of care to change. I think we are all on the same side here.
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Post by cm5 on Feb 19, 2017 12:59:18 GMT -5
It's been said many times to young physicians:
"Want to become an expert on a certain disease topic? Sign up to give a talk at a meeting. Over time, as you give more talks, you will be invited to present at more and more meetings. You'll be able to travel to great locations, travel/lodging/meal costs are covered, plus you will receive a stipend. At some point, if you are a minimally effective speaker, you will be invited by industry to be a 'spokes person' and even more opportunities will arise."
I wanted to see if this was really so, so I hopped on the train very a very short period of time. It is true. It was lucrative. I also had to attend private sessions held/directed by a pharmaceutical giant so that I would be "informed". I was provided with Power Point presentation, coaching on what queries to be expect/to be prepared for, what to say, what not to say---
I donated the payment for this one presentation to a responsible medical charity, and sent a letter stating that I was not interested to doing any similar activities in the future.
As an aside, I also volunteered to sit in on health care organization committee meetings for determining which new medications would be added, and most significantly, what would the organization gain from rebates from the major pharmacy benefit managers--------
Absolutely we need new and better ways to promote health and to help those who have become ill. I am not opposed to valid research and development by ethical companies, better ways of approval for medication, and helping people living better lives.
I learned all I needed from these two experiences.
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Post by mango on Feb 19, 2017 13:07:32 GMT -5
• The name of the inhaled insulin, Afrezza, is not stated. A passive gesture was merely used in the two instances that mentioned 'inhaled insulin'. The author(s) clearly, and by clearly I actually mean deliberately, mentioned inhaled insulin as an afterthought that is easily overlooked/read-over. It is common for medical societies and scientific papers to refer to all drugs by their generic names. If you look at the package insert the description is "Afrezza ® (insulin human) Inhalation Powder". Inhaled insulin is a valid generic description. Don't expect that a position paper like this is going to mention a brand name specifically, regardless of the brand, unless the brand itself has become a generic term (Bayer, for example, lost the trademark on the word "aspirin"). It is not up to the endos to advertise Afrezza. As for payments to thought leaders, is that really surprising? Pharmaceutical companies always seek out physicians with good reputations and deep experience in a field to advise them on their drugs, and frankly that is a far better practice then using uninformed physicians. A lot of times those advisory sessions take an entire day, and there are 8-10 outside advisors involved in a committee, so that involves paying them for their lost work time plus travel expenses. A top consultant can charge $5-6K for a meeting, especially if travel and several hours of preparation time are included. That may sound like a lot, but it is on the low side of the market when compared with hourly billing rates for top consultants, auditors, lawyers, and other skilled professionals, some of whom bill $1,000 / hour. Given the number of advisors involves it is easy to drop $100K on a single meeting, and if the advisors meet quarterly, the price tag is $400K per year for the panel. Large companies with multiple therapeutic categories will have multiple advisory panels and those aggregate costs run into the millions. So long as a single physician is not making more than about $20-30K in consulting fees per year, plus reimbursement of expenses, from a particular firm that is not out of line. Research support is generally paid directly to the affiliated university or hospital system, just like it is for NIH grants or any other grant support, and that money is not paid onward to the physician; it supports R&D expenses and graduate student stipends. You may not like the fact that pharma pays so much into the research world, but if the pharma companies don't do it then a lot of useful science would never get done. Both the industry and the medical world would love a workable alternative, but so far that hasn't happened. It is unfair to call it corrupt unless you have a better, and more practical, solution. You are someone that defends the FDA and refuses to come to terms with the fact that not only has and is the FDA been involved in corruption, but what I posted is literally a very tiny snippet of another form of corruption. Nothing you say will ever change my mind on that. There is WAY too much evidence. What evidence do YOU have to defend your claims?
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Post by mango on Feb 19, 2017 13:16:54 GMT -5
Mango, agedhippie has a good point. It isn't his fault that it takes a long time for standards of care to change. I think we are all on the same side here. No comment.
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Post by cm5 on Feb 19, 2017 14:18:01 GMT -5
BTW----the point of my post above is that once a physician, who gives the "canned" talks, receives just average review from attendees, said physician now on the g train for as long as one wants. Decades, if one wants. Vacation/dinner schedules are set for years to come.
So, a physician with a license and board certification and seeing patients in a certain field is really the only requirement.
And then one will have built a track record, is invited to more and more conferences. Then one is invited to give presentations at specialty meetings, which give valid Category 1 Continuing Medical Education Credits (aka CME, so many hours of such category required for maintenance of licensure, varying from state to state).
So, then one will have many CME talks to give at great venues----Hawaii, Aspen, Boston, etc etc-----and without having done a lick of ongoing real clinical or lab research.
And, the industry sponsored speaker sessions with generous stipends for non-CME dinners and such continue, as well.
Some of us weary of spending excessive dollars to go to these meetings to obtain such required CME HOURS, as we call it------hearing same ole, same ole, same ole, for the most part-----at these national and regional meetings. There is good material at these meetings----but not enough to meet the required hours.
And Standards of Care have been promulgated by above said experts.
I absolutely would do this if I really was an expert, and what I was teaching/explaining was a pharmaceutical that improves the qualities of lives on a logarithmic, if not exponential scale.
But I am neither an expert nor doing real research.
But I do know enough to post on Mannkind Proboards in support of a disruptive technology (Technosphere) and human insulin (Afrezza), and the multitude of patents, including diketopiperazine which, for instance human insulin, to pass into the alveolar capillary without damage/disruption to cellular membranes--------
Diketopiperazine is the transporter--------of targeted chemotherapy, vaccines, hormones, pain relief, on and on and on------
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Post by babaoriley on Feb 19, 2017 14:52:33 GMT -5
One thing is proven beyond doubt: An agitated Mango can type copious amounts of materials at supersonic speed. And do it correctly.
Agree or not with Mango, he did a heck of a job in getting his point across!! Excellent work, Mango!!
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