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Post by cm5 on Apr 30, 2016 11:01:28 GMT -5
Please, that's rude.
Without a Wiley subscription, one cannot read article.
Second, your comment about physicians' financial incentive to treat is a personal editorial comment, and not clarified as such.
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Post by agedhippie on Apr 30, 2016 11:07:55 GMT -5
While we are at it the Conflict of Interest section caught my eye, in particular this gem:
All authors were involved in the decision to submit the article for publication. Novo Nordisk sponsored data analysis, medical writing and editorial/submission support, contributed to study design, analysis and interpretation of data, and was also responsible for obtaining data from the CPRD.
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Post by centralcoastinvestor on Apr 30, 2016 11:19:11 GMT -5
Al Mann and others often referred to "the lost decade" in diabetes treatment. Because so many people fear needles and there is such a stigma of using insulin in general, people wait, on average, ten years before they begin using insulin. Imagine the damage inflicted on a person's body if they should have been using insulin for ten years. It's no wonder there are so many preventable diabetic complications like amputations, heart disease, blindness etc, etc, etc. MannKind now has a tremendous opportunity and dare I say responsibility to shake the entire diabetic treatment esablishment. I believe it is possible that we all are witnessing what a revolution looks like in its infancy. MannKind has been counted out, mocked, berated, beat up, starved of financing....I could go on. If Afrezza gets any kind of foothold ..... Watch out!!!!
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Post by agedhippie on Apr 30, 2016 11:22:45 GMT -5
Please, that's rude. Without a Wiley subscription, one cannot read article. Second, your comment about physicians' financial incentive to treat is a personal editorial comment, and not clarified as such. I tested the link is a couple of browsers and it opens fine for me. I definitely don't have an account! As to the financial incentive - my mother was a practice manager with an NHS group and as a diabetic I have an interest in this sort of thing! Doctors in the UK are self-employed and their revenue is partial based on hitting NHS targets, one of the targets is diabetes. Here you go though - a link to a journal for NHS primary care physicians. |
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Post by peppy on Apr 30, 2016 11:23:03 GMT -5
Please, that's rude. Without a Wiley subscription, one cannot read article. Second, your comment about physicians' financial incentive to treat is a personal editorial comment, and not clarified as such. Doctors Use These Toxins on You, But Not On Their Own Family Members! www.youtube.com/watch?v=Mt6vzqMAZjk
Why Does This Doctor Say 'Stay Away from the Oncologist'? www.youtube.com/watch?v=7ymdy91zynA
After almost a year on this board, I finally figured out, agedhippee doesn't miss much. Peppy <---- not the brightest bulb on the tree.
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Post by cm5 on Apr 30, 2016 11:23:34 GMT -5
Re: "conflict of interest", see complete acknowledgements and conflict of interest.
Acknowledgements
The authors acknowledge medical writing support from Paul Tisdale, PhD and editorial/submission support from Daria Renshaw, both of Watermeadow Medical Limited, UK (an Ashfield company). This support was funded by Novo Nordisk. K. K. and M. J. D. would like to acknowledge support for this work from the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care East Midlands, and the NIHR Leicester-Loughborough Diet, Lifestyle and Physical Activity Biomedical Research Unit, University of Leicester. S. K. P. acknowledges infrastructure research support from the Australian Government's National Collaborative Research Infrastructure Strategy initiative through Therapeutic Innovation Australia.
Conflict of Interest
K. K. has acted as a consultant and speaker for Novartis, Novo Nordisk, Sanofi-Aventis, Lilly, Merck Sharp & Dohme, Janssen, Astra Zeneca and Boehringer Ingelheim. He has received grants in support of investigator and investigator-initiated trials from Novartis, Novo Nordisk, Sanofi-Aventis, Lilly, Pfizer, Boehringer Ingelheim, Merck Sharp & Dohme, Janssen and Roche. K. K. has received funds for research, honoraria for speaking at meetings and has served on advisory boards for Lilly, Sanofi-Aventis, Merck Sharp & Dohme and Novo Nordisk, Boehringer Ingelheim, Janssen and Astra Zeneca. M. J. D. has acted as consultant, advisory board member and speaker for Novo Nordisk, Sanofi-Aventis, Eli Lilly, Merck Sharp & Dohme, Boehringer Ingelheim, Astra Zeneca and Janssen, and as a speaker for Mitsubishi Tanabe Pharma Corporation. She has received grants in support of investigator and investigator-initiated trials from Novo Nordisk, Sanofi-Aventis and Eli Lilly. M. A. has acted as a consultant for Novo Nordisk. A. N. and B. L. T. are employees and shareholders of Novo Nordisk A/S. S. K. P. has acted as a consultant and/or speaker for Novartis, GI Dynamics, Roche, AstraZeneca, Guangzhou Zhongyi Pharmaceutical and Amylin Pharmaceuticals LLC. He has received grants in support of investigator and investigator-initiated clinical studies from Merck, Novo Nordisk, Astra Zeneca, Hospira, Amylin Pharmaceuticals, Sanofi-Aventis and Pfizer.
K. K. and S. K. P. contributed equally to the study design, statistical analysis plan, data interpretation and writing of this manuscript. A. N. and B. L. T. contributed to the study design, analysis and interpretation of data, and review of the manuscript. M. J. D. contributed to the research idea, and the interpretation of the data and results, and commented on the manuscript. M. A. contributed to the study design, statistical analysis and review of the manuscript.
K. K. is the guarantor of this work and, as such, had full access to the study data and takes responsibility for the integrity of the data and the accuracy of the data analysis.
All authors were involved in the decision to submit the article for publication. Novo Nordisk sponsored data analysis, medical writing and editorial/submission support, contributed to study design, analysis and interpretation of data, and was also responsible for obtaining data from the CPRD.
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Post by cm5 on Apr 30, 2016 11:47:48 GMT -5
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Post by cm5 on Apr 30, 2016 12:27:45 GMT -5
Alzheimer's disease and Diabetes - the common pathogenesis----
More evidence that Afrezza, inhaled monomeric human insulin, will cause a cataclysm in health care. See quotation below and link to PubMed.
"Epidemiological studies presented evidence that Alzheimer's disease and type 2 diabetes share common features in their pathophysiology and clinical patterns. Insulin resistance is a characteristic feature of both diseases. According to the pathomechanism, inflammatory, metabolic, and an atypical form based on the deficiency of zinc ions can be distinguished. Glucose metabolic disorders, related to Alzheimer's disease, are type 2 diabetes, and prediabetes/metabolic syndrome. Based on the common pathophysiological patterns of these two diseases, Alzheimer's disease is customary (sic) called type 3 diabetes. In the research on dementias, insulin resistance stands in the highlight for its documented harmful effects on cognitive function and causes dementia." Neuropsychopharmacol Hung. 2016 Mar;18(1):5-19 www.ncbi.nlm.nih.gov/pubmed/27038867
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Post by peppy on Apr 30, 2016 13:15:29 GMT -5
Alzheimer's disease and Diabetes - the common pathogenesis----
More evidence that Afrezza, inhaled monomeric human insulin, will cause a cataclysm in health care. See quotation below and link to PubMed.
"Epidemiological studies presented evidence that Alzheimer's disease and type 2 diabetes share common features in their pathophysiology and clinical patterns. Insulin resistance is a characteristic feature of both diseases. According to the pathomechanism, inflammatory, metabolic, and an atypical form based on the deficiency of zinc ions can be distinguished. Glucose metabolic disorders, related to Alzheimer's disease, are type 2 diabetes, and prediabetes/metabolic syndrome. Based on the common pathophysiological patterns of these two diseases, Alzheimer's disease is customary (sic) called type 3 diabetes. In the research on dementias, insulin resistance stands in the highlight for its documented harmful effects on cognitive function and causes dementia." Neuropsychopharmacol Hung. 2016 Mar;18(1):5-19 www.ncbi.nlm.nih.gov/pubmed/27038867 I learned the only thing that can be said about Afrezza is what the FDA approval states. Is there any fast acting insulin that is allowed by the government regulatory bodies to make this claim (may help Alzheimer's) ? Just asking...
Pharma has been a learning process for me. I would think people could use their eye sight, but no. No claims about afrezza can be made because we have eyeballs. screencast.com/t/BQ2WnilGfm screencast.com/t/RS1fU7qR
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Post by cm5 on Apr 30, 2016 13:32:31 GMT -5
Off-Label Use of Approved Drugs, quoted below from FDA site:
"Off-Label Use of Approved Drugs
The drug label of FDA-approved drugs gives information about the drug, including the approved doses and how it's to be given to treat the medical condition for which it was approved. When a drug is used in a way that is different from that described in the FDA-approved drug label, it is said to be an "off-label" use. This can mean that the drug is:
Used for a different disease or medical condition.
Given in a different way (such as by a different route).
Given in a different dose.
For example, when a chemotherapy drug is approved for treating one type of cancer, but is used to treat a different cancer, it is off-label use.
Off-label is also called "non-approved" or "unapproved" use of a drug. New uses for these drugs may have been found, and often medical evidence supports the new use. But the makers of the drugs have not put them through the formal, lengthy, and often costly studies required by FDA to officially approve the drug for new uses."
In other words, the provider is not restricted to the "approved" use(s) of a pharmaceutical agent. Many, many pharmaceutical agents are widely prescribed "off label", according to current, accepted medical practice.
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Post by victoria on Apr 30, 2016 13:43:57 GMT -5
Please, that's rude. Without a Wiley subscription, one cannot read article. Second, your comment about physicians' financial incentive to treat is a personal editorial comment, and not clarified as such. I tested the link is a couple of browsers and it opens fine for me. I definitely don't have an account! As to the financial incentive - my mother was a practice manager with an NHS group and as a diabetic I have an interest in this sort of thing! Doctors in the UK are self-employed and their revenue is partial based on hitting NHS targets, one of the targets is diabetes. Here you go though - a link to a journal for NHS primary care physicians. Hi- Just (if I may) to make a minor observation: in the UK, General Practitioners (GPs), ie 'primary care physicians' in your system, are essentially self employed but not doctors and surgeons etc outside of primary care such as in hospitals (unless we are talking about private medicine outside the NHS of course where they might be self employed or work for a company or whatever). The merits or otherwise of paying doctors to hit targets for healthcare standards are interesting. I think its hard to see a better option than this sort of target based incentive to encourage good care but (as a bit of an NHS sceptic) one has to avoid incentivising doctors to over treat. Targets sometimes have strange unintended consequences. A classic one is that the NHS had (or has?) a requirement for a GP practice to offer an appointment to a patient within a certain number of days of the request for an appointment. Unintended side effect: GP practices started ONLY offering appointments within a certain number of days, so as to ensure they hit targets, even if the patient wanted or needed a later appointment! (I think that one was fixed but its odd how things pop up like that). |
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Post by peppy on Apr 30, 2016 14:03:17 GMT -5
Off-Label Use of Approved Drugs, quoted below from FDA site:"Off-Label Use of Approved Drugs The drug label of FDA-approved drugs gives information about the drug, including the approved doses and how it's to be given to treat the medical condition for which it was approved. When a drug is used in a way that is different from that described in the FDA-approved drug label, it is said to be an "off-label" use. This can mean that the drug is:
Used for a different disease or medical condition.
Given in a different way (such as by a different route).
Given in a different dose.For example, when a chemotherapy drug is approved for treating one type of cancer, but is used to treat a different cancer, it is off-label use. Off-label is also called "non-approved" or "unapproved" use of a drug. New uses for these drugs may have been found, and often medical evidence supports the new use. But the makers of the drugs have not put them through the formal, lengthy, and often costly studies required by FDA to officially approve the drug for new uses." In other words, the provider is not restricted to the "approved" use(s) of a pharmaceutical agent. Many, many pharmaceutical agents are widely prescribed "off label", according to current, accepted medical practice.
I think Matt down under is considered off label as well, as he lives in Australia. Off label is possible, yes. I am not sure what you are saying. My understanding is in the USA, the pharma reps may only discuss what is on the label with physicians.
If the physicians here are not prescribing afrezza on label, hard to believe off label would be a revenue stream. Just saying. I have gone over this in my head with the help of this board. I see you also are working through it.
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Post by cm5 on Apr 30, 2016 14:08:31 GMT -5
Regarding "Off-Label Use" and "Freedom of Speech Issues", see the following quotes and links: In other words, off label use prohibitions/restrictions are in a state of flux for manufacturers/pharmaceutical corporations, but physicians continue to have freedom of speech to be truthful about the uses/doses of pharmaceutical agents, with a nod toward current, accepted medical standards. University of Pennsylvania Law Review Online [Vol. 162: 239
scholarship.law.upenn.edu/cgi/viewcontent.cgi?article=1120&context=penn_law_review_online"The FDA can look to statements by pharmaceutical representatives as evidence of a drug’s intended use, thereby placing manufacturers that promote off-label in a Catch-22: the drug will be subject to the FDCA’s misbranding provisions if manufacturers add labeling instructions for that intended use, but also if they fail to add those instructions. To legally promote a new intended use, pharmaceutical companies must satisfy the FDA’s rigorous approval process. In United States v. Caronia, the Second Circuit Court of Appeals ruled
that the FDCA could not be interpreted to prohibit truthful, off-label promotion." See NYT, Court Forbids F.D.A. From Blocking Truthful Promotion of Drug AUG. 7, 2015
www.nytimes.com/2015/08/11/business/dealbook/fdas-off-label-drug-policy-leads-to-free-speech-fight.html
" It certainly seems odd that speaking the truth can violate the law. Yet the Food and Drug Administration takes the position that when it approves a drug for a particular treatment, the manufacturer of that drug cannot promote it for other uses even if those statements are true.
But that policy has been called into question in a decision by Judge Paul A. Engelmayer of the Federal District Court in Manhattan, who found that the First Amendment protects drug companies that want to make truthful statements about their drugs, even if it is for an unapproved use. His decision sets up a likely appeal to determine just how far the government can go to punish speech that is truthful. ---- Amarin Pharma, a small drug manufacturer, challenged the F.D.A. when it sought to promote the off-label use of its cardiovascular health drug, Vascepa, for patients with a different condition. An F.D.A.-approved study showed that the use of the drug was effective, but the agency had denied approval for use by those patients. The company and four doctors sued the F.D.A. after it threatened to bring civil charges against them if they used the study to help sell off-label use of Vascepa. They claim that the agency’s rule on off-label promotion violates their First Amendment right to free speech, asking the district court to block any enforcement action. Judge Engelmayer sided with the company, pointing out the many incongruities in the F.D.A.’s approach to off-label marketing. The agency does not prohibit doctors from prescribing medications for nonapproved uses because it does not have direct authority over them. The judge pointed out that “the therapeutic — indeed, sometimes lifesaving — value of off-label uses of F.D.A.-approved drugs has been widely recognized.” For some conditions “off-label prescription is the norm rather than the exception,” a fact the F.D.A. is aware of and even encourages on occasion.
""That appeal would go to the United States Court of Appeals for the Second Circuit, however, and the conclusion in the Caronia case that the First Amendment protects truthful statements about off-label drug use will be difficult to overcome, especially when there is no evidence of fraud or other deception by Amarin. Pursuing the issue to the Supreme Court may also present substantial hurdles for the F.D.A.’s regulation of off-label marketing. The justices have been receptive in the last few years to First Amendment claims by corporations, as the decision in Citizens United v. Federal Election Commission shows, so they may well side with companies that want to make truthful statements about their products."
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Post by cm5 on Apr 30, 2016 14:16:51 GMT -5
Here's the summary and the link to a lengthy article about Off Label Drug Use ( OLDU), Mayo Clin Proc. 2012 Oct; 87(10): 982–990 www.ncbi.nlm.nih.gov/pmc/articles/PMC3538391/. Please note this was published prior to the cases cited in the above post. "Off-label drug use involves prescribing medications for an indication, or using a dosage or dosage form, that has not been approved by the FDA. Since the FDA does not regulate the practice of medicine, OLDU has become common. It occurs in every specialty of medicine, but it may be more common in areas of medicine in which the patient population is less likely to be included in clinical trials (eg, pediatric, pregnant, or psychiatric patients). Pharmaceutical companies are not allowed to promote their medications for an off-label use, which has lead to several large settlements for illegal marketing. To limit liability, physicians should prescribe medications only for indications that they believe are in the best interest of the patient on the basis of the most credible available evidence. In an era of global exchange of medical information, this approach to physician prescribing practices may have greater utility than restricting practices solely to indications approved by a US-based pharmaceutical labeling system. Health care professionals should continually educate themselves about OLDU to weigh the risks and benefits and provide the best possible care for their patients." |
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Post by sportsrancho on Apr 30, 2016 14:29:05 GMT -5
Just a aside, there are parents on Twitter every week asking, how do I get my T1 kids on Afrezza? I tell them to get a script off label. It has to come from awareness, not the reps. Once the doc's know Afrezza is here to stay and we get some advertising the demand should come from the parents. It makes their life SO much easier! And parents are much more demanding it seems to me. Much more willing to put their foot down for their kids than themselves!
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