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Post by LosingMyBullishness on Jul 8, 2016 17:08:12 GMT -5
Could MNKD have a section on their website which links to, or provides a library of, peer reviewed third party journal articles about afrezza? Then could reps just tell doctors to see the website for published research literature? It would seem odd if a company website can't inform doctors of published literature, since that could lead to important safety issues being concealed if, say, a paper suggested some risk or side effect. Victoria, are you familiar with rules for websites in the co.uk domain?
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Post by sportsrancho on Jul 8, 2016 17:14:17 GMT -5
I think it was said best by someone already on this board (if true and I understood correctly) that reps can send the literature (with off label results from clamp studiers etc...) to each doctor and then follow up and ask if they have read it allowing the reps a legal entry into the off label conversation with the doctors. If this is true then any rep worth his or her job has already mailed out all the literature to all the doctors on their list and is beginning the follow up. Thats great! And wraps things up:-) Thanks
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Post by Deleted on Jul 8, 2016 18:10:15 GMT -5
If a rep is close to a provider or personally knows them then the worry of legal consequences is out the window.
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Post by rravis1914 on Jul 8, 2016 18:28:18 GMT -5
Something started to happen when I was a rep. 25 years ago. We found out that some Docs were secretly recording presentations for the FDA.
That probably would be illegal today, but if you had a 'bad' doc who wanted to be a horses' hind end he could deliberately
lay a trap for the unsuspecting rep. Sad to say, there are some like that. I know there were some offices that I would 'walk on eggs'
so to speak. On the other hand, there were a lot of Docs that were the salt of the earth. They respected you as much as you respected them,
They are the ones that made the job a "joy".
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Post by victoria on Jul 8, 2016 18:35:50 GMT -5
Could MNKD have a section on their website which links to, or provides a library of, peer reviewed third party journal articles about afrezza? Then could reps just tell doctors to see the website for published research literature? It would seem odd if a company website can't inform doctors of published literature, since that could lead to important safety issues being concealed if, say, a paper suggested some risk or side effect. Victoria, are you familiar with rules for websites in the co.uk domain? Hi, no I'm not unfotunately but in terms of UK medicine promotion I have located these quotes: "This prohibition on advertising unlicensed medicines does not prevent a factual answer to an unsolicited question about an unlicensed medicine, or about use of a licensed medicine outside the terms of its licence (‘off label’ use). Any activity that appeared to be designed to solicit such questions would be likely to be considered promotional and in breach of this prohibition." (ie rather like the US position) and "An advertisement may include statements not included in the SPC provided these can be substantiated and are not inconsistent with the SPC information. A claim that went beyond specific information included in the SPC would be likely to breach this provision. For example, if the SPC makes no mention of any comparative study then a comparative claim would be permitted in advertising, provided it related to the licensed use of the product and was supported by robust evidence. But where the current SPC reports that a comparative study shows non-inferiority and a new study becomes available showing superiority, the SPC would need to be amended before a superiority claim could be made in advertising. " (SPC is Summary of Product Characteristics, and "advertisement" includes a rep. visit). So afrezza would be somewhat hidebound by the non inferiority lable at least as regards say lispro which I beleive is the one mentioned in the label... but query whether "robust" data showing superiority to some other drug not mentioned on the label/SPC would be ok given the above, in the uk. See The Blue Guide at www.gov.uk/government/publications/blue-guide-advertising-and-promoting-medicines
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Post by nylefty on Jul 8, 2016 18:51:14 GMT -5
Something started to happen when I was a rep. 25 years ago. We found out that some Docs were secretly recording presentations for the FDA. That probably would be illegal today, but if you had a 'bad' doc who wanted to be a horses' hind end he could deliberately lay a trap for the unsuspecting rep. Sad to say, there are some like that. I know there were some offices that I would 'walk on eggs' so to speak. On the other hand, there were a lot of Docs that were the salt of the earth. They respected you as much as you respected them, They are the ones that made the job a "joy". In 38 states, including New York, it's perfectly legal to secretly record a conversation without the other party's knowledge or consent. www.dmlp.org/legal-guide/recording-phone-calls-and-conversationsWho must give permission to record a telephone or in-person conversation?
Federal law permits recording telephone calls and in-person conversations with the consent of at least one of the parties. See 18 U.S.C. 2511(2)(d). This is called a "one-party consent" law. Under a one-party consent law, you can record a phone call or conversation so long as you are a party to the conversation. Furthermore, if you are not a party to the conversation, a "one-party consent" law will allow you to record the conversation or phone call so long as your source consents and has full knowledge that the communication will be recorded.
In addition to federal law, thirty-eight states and the District of Columbia have adopted "one-party consent" laws and permit individuals to record phone calls and conversations to which they are a party or when one party to the communication consents. See the State Law: Recording section of this legal guide for information on state wiretapping laws.
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Post by agedhippie on Jul 8, 2016 19:30:19 GMT -5
I think it was said best by someone already on this board (if true and I understood correctly) that reps can send the literature (with off label results from clamp studiers etc...) to each doctor and then follow up and ask if they have read it allowing the reps a legal entry into the off label conversation with the doctors. If this is true then any rep worth his or her job has already mailed out all the literature to all the doctors on their list and is beginning the follow up. They cannot do that. The doctor has to specifically request the literature. This is where raising awareness like the ADA event matters because it lets the doctor know what is out there and they can then ask the rep for the literature.
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Post by uvula on Jul 8, 2016 21:50:07 GMT -5
Instead of spending time on these msg boards maybe our time would be better spent mailing articles to doctors. Could be an interesting grass roots effort.
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Post by mnkdfann on Jul 8, 2016 23:11:37 GMT -5
Instead of spending time on these msg boards maybe our time would be better spent mailing articles to doctors. Could be an interesting grass roots effort. Care is needed. How does the average person respond to unsolicited mail?
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Post by kball on Jul 9, 2016 8:37:40 GMT -5
Instead of spending time on these msg boards maybe our time would be better spent mailing articles to doctors. Could be an interesting grass roots effort. Bad idea imo. Very bad. Dear Doctor, you don't know me but let me state upfront that i'm sending you these articles not because i've lost a lot of money investing in this company, but rather i'm only trying to help you, your practice, and your patients.
Just the worst idea ever
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Post by sportsrancho on Jul 9, 2016 8:57:01 GMT -5
Instead of spending time on these msg boards maybe our time would be better spent mailing articles to doctors. Could be an interesting grass roots effort. Bad idea imo. Very bad. Dear Doctor, you don't know me but let me state upfront that i'm sending you these articles not because i've lost a lot of money investing in this company, but rather i'm only trying to help you, your practice, and your patients.
Just the worst idea ever I think the point is to do something other than bitching! Tell your own doctor. Wear a T-shirt! #Reachout
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Post by Deleted on Jul 9, 2016 10:51:23 GMT -5
It is a terrible idea for investors to mail Dr's about a drug they are losing money on. Some investors are straight up stalkers on social media now we are going to upgrade to mail harassment. I have started to put something together to send to VICE. They are the least unbiased media outlet there is nowadays and they always put the FDA on blast.
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Post by kball on Jul 9, 2016 11:06:02 GMT -5
Love VICE. Find myself almost always wishing the segments were longer than 15 minutes.
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Post by Deleted on Jul 9, 2016 12:34:25 GMT -5
Love VICE. Find myself almost always wishing the segments were longer than 15 minutes. HBO Vice segments are only 15 minutes but they have their own channel now. Its called Viceland. I am in NYC and they are head quartered here so I am not sure if its just a local or national channel. Check to see if you have the channel.
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Post by prvs on Jul 9, 2016 13:57:32 GMT -5
Thinking about the Nurse Educators and this topic. As they educate the Drs and patients, they must have to help them decide when to take Afrezza and how to interpret the CGM readings after Afrezza is taken. I can imagine the patients following the advice and saying this works great! Why does it say on the label that it's not better than Lispro? I think it's MUCH better, I'm getting better A1Cs and I'm always in range. The nurse might say "I'm not allowed to tell you that because of what's written on the box, but discuss it with the DR". So in a round about way, the nurse educator is able to tell the doctor (and demonstrate at the same time) that Afrezza is superior.
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