Rx Targets

[cm5]

Please understand that pharma reps can/do provide printouts/summaries/original articles, etc of results of studies/surveys not specifically approved for label of a medication.

In other words, dedicated physicians read/think/consider/hear/collect/discuss valid information provided not only in printed information/but presentations/patients' experiences---and on and on.

And, please review these posts about what is allowed/restricted, per recent opinions, and court decisions----there is more leeway in what is discussed/understood. And, it is about time---

Mannkind: A Growing Threat To The Status Quo 
Post by cm5 on Apr 30, 2016 at 3:16pm

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.

Read more: mnkd.proboards.com/user/1756/recent#ixzz4EbIBrXhG

Mannkind: A Growing Threat To The Status Quo 
Post by cm5 on Apr 30, 2016 at 2:32pm

Off-Label Use of Approved Drugs, quoted below from FDA site:
Read more: mnkd.proboards.com/user/1756/recent#ixzz4EbIPpWS

Mannkind: A Growing Threat To The Status Quo 
Post by cm5 on Apr 30, 2016 at 3:08pm

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


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

Read more: mnkd.proboards.com/user/1756/recent#ixzz4EbIvAEDq

OF COURSE, Mannkind does not presently have the resources for participating in a lawsuit as the above case (see NYT link).

OF COURSE, the roll out does not begin until the 25th! So, why are naysayers posting so negatively about Mannkind? One wonders!

OF COURSE, pharmacy benefit managers have to make changes----Mike is working on this, has terrific experience/knowledge/drive/motivation. This does not happen instantaneously!

OF COURSE, there are providers who are not in the top tier, or highly dedicated, or knowledgeable, etc etc etc---but the vast majority work very hard to do the right thing for those they care for. We take it seriously, and are driven to take it seriously. All that is required to start the avalanche is good, focused support which is in the works. Please stop trashing corporate leadership of Mannkind. 

Transformational change is coming----the cascade of dominoes is beginning. 

[Deleted]

Jul 16, 2016 14:26:14 GMT -5 cm5 said:

Please understand that pharma reps can/do provide printouts/summaries/original articles, etc of results of studies/surveys not specifically approved for label of a medication.

In other words, dedicated physicians read/think/consider/hear/collect/discuss valid information provided not only in printed information/but presentations/patients' experiences---and on and on.

And, please review these posts about what is allowed/restricted, per recent opinions, and court decisions----there is more leeway in what is discussed/understood. And, it is about time---

great to hear from a doc..
Are you an internist? or deal with PWD's ?

[cyn]

Agreed, launch dynamics are very different and should not be compared with Sanofi script numbers.  I would expect quick recovery of former scripts and refill rates.  I hope the company was continually reaching out to former patients and Endos with information updates during their transition...and are being targeted right out the gate by the Field Reps.  

[cm5]

In response to iam2sekc4u2002

Subspecialist, who constantly sees problems arising from/pathology/medical issues continually arising from Obesity, Pre-diabetes, Diabetes Types I, II, III--- 

It's frustrating, it's sad, it's infuriating, it's exhausting. We deal not only with not only how hard it can be to help people make changes in their own best interest, but how hard it is to see all the problems/misery. At times, it is emotionally exhausting, but we do not give up. It's what we planned to do/worked hard to become/etc--and generally most of the time, we love what we do. We have the opportunity to speak to truth, and to do the best possible with what is available.

It's also frustrating, but not surprising, the hierarchical resistance to change----on any level. But it's a fact, and we don't give up.

Also, be aware that the recently cited information that diabetes consumes 12% of world wide health care costs, is only considering the DIRECT costs of diabetes.

[Deleted]

Jul 16, 2016 14:39:08 GMT -5 cm5 said:

In response to iam2sekc4u2002

Subspecialist, who constantly sees problems arising from/pathology/medical issues continually arising from Obesity, Pre-diabetes, Diabetes Types I, II, III--- 

It's frustrating, it's sad, it's infuriating, it's exhausting. We deal not only with not only how hard it can be to help people make changes in their own best interest, but how hard it is to see all the problems/misery. At times, it is emotionally exhausting, but we do not give up. It's what we planned to do/worked hard to become/etc--and generally most of the time, we love what we do. We have the opportunity to speak to truth, and to do the best possible with what is available.

It's also frustrating, but not surprising, the hierarchical resistance to change----on any level. But it's a fact, and we don't give up.

Also, be aware that the recently cited information that diabetes consumes 12% of world wide health care costs, is only considering the DIRECT costs of diabetes.

so looking at the amazing results of Afrezza, I understand your frustration and hoping you are advocating Afrezza for those patients even though you cant rx one...

May be you can recommend / introduce your acquaintances to Mike's team.

[cm5]

In response to iam2sekc4u2002

I have constantly/will continue to do so----bring up the discussion/talk about Afrezza to patients, other providers, friends, and in the casual wonderful random conversations that enrich our lives. From the moment it was approved.

I would need to be a primary, an internist, an endocrinologist to have the appointment space/time/other practical skills, staff, etc to prescribe Afrezza at the current time.

Another field that will take Afrezza and run with it are the concierge total care practices, including the concierge practices focused on health rather than disease. 

And, once governments and politicians figure out the cost savings----those decisions are essentially made on a cost/benefit basis---the wall of resistance will come crashing down. And, that's not even considering what Technosphere can do!

[mnkdfann]

Jul 16, 2016 10:52:53 GMT -5 daduke38 said:

Been reading a lot on here about what can be said and what can't.  If sales reps can only say what is on the label, how do drugs get used for off label needs?
For example, my daughter had Post-concussion Syndrome a few years back.  It was a scary period in our lives. After taking her to a top neurologist at Duke, I was kind of surprised he put her on Cymbalta.  And it wasn't due to any depression.  And guess what, it worked.
So, how does this happen?  I am sure it was accidentally found to work and word spread.  But I bet it isn't on the label for Concussion treatment.

This may help:

www.ncbi.nlm.nih.gov/pmc/articles/PMC3538391/

But note Question 9 "Can Drug Companies Promote OLDU?" and its answer.