Tobi and the eFlow

Chaggie

New member
This is the kind of misinformation i am talking about.

<div class="FTQUOTE"><begin quote>I actually just learned a little bit about this today at a Parent Education Day put on by our clinic for Children's in Seattle.</end quote></div>





The eFlow was not developed for Aztreonam. Aztreonam is the first drug that has gone through clinical trials with eFlow as the delivery system.




<div class="FTQUOTE"><begin quote>The problem with using the eflow with other medications is that it delivers things at a different rate and/or particle size than what was tested in the trials -- so this presents a problem for Tobi because it is most likely delivers more of the drug into the lungs than the Pari LC does -- this could cause toxicity problem for the liver and such.</end quote></div>




This is correct, the respirable of medications is much higher with eFlow, this means that more optimal particle sizes are created for inhalation and less medicine is needed. Pharmacies that are providing the eFlow medicines have adjusted the antibiotic doses accordingly.




<div class="FTQUOTE"><begin quote>Other concerns for other meds such as Pulmozyme.... they are not sure with all the shaking that the eflow does (again a totally different type of delivery system) that damage to the enzyme in Pulmozyme might be occurring, and with saline that too much won't be delivered, (not really all that harmful) but may cause more irritation that with the Pari delivery.</end quote></div>



That may be a concern of your clinic, mine as well, which by the way isn't prescribing it either. studies were done prior to FDA approval that show these things don't happen.



<div class="FTQUOTE"><begin quote>So basically what our docs & nurses were saying is -- until there have been studies done on the safety of the meds being run through this new delivery system, they will not be recommending it, but if we requested it they would write out our prescriptions to be filled by the pharmacy that is "reformulating" the medications when they fill the Rx for you and send it with the e-flow.</end quote></div>

I'm glad your clinic is at least willing to prescribe if asked, mine won't at all. These are the same concerns my clinic has and they are warrentless, there have been countless in-vitro studies done for the FDA to determine the safety and effectiveness of the device. In-vivo(human) studies aren't going to happen unless they are done independently by clinics. For a drug company to do studies on drugs is very expensive and pointless since they have already been approved. Per the FDA drugs do not need to be approved for use with particular nebulizers.

This all goes back to, What will for for some will not for everyone. This device may not be good for some people, it may cause more irritation or reactive airway problems for some, but should that keep the others from being able to use it. This disease is all about trial and error in finding out what works us. This is a new tool we should be given to see it does help. If it doesn't help me, I won't use it but I shouldn't be kept from it because my clininc doesn't want to take the relponsibilty to learn about it.

The information for these studies is out there all you need to do is look for it. would get it for you but there is just too much to post.
 

Chaggie

New member
<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>Alyssa</b></i>

I didn't read the link until after I posted -- I was surprised to see Children's in Seattle specifically referenced in the article (how ironic!) ....relating to a generic equivalent for TOBI (not the e-flow stuff) -- but if I understand what that link said correctly... Chiron & Children's together brought a law suit against another company who had planned on marketing a generic TOBI.....I can understand why Chiron would do this, but why would Children's be involved in this? Anyone know?</end quote></div>

Not quite right, Childrens was involved in another suit brought by Chiron. against Roxanne for trying to make a generic version of TOBI. I'm assuming because they have some of the patent rights.
 

Chaggie

New member
<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>Alyssa</b></i>

I didn't read the link until after I posted -- I was surprised to see Children's in Seattle specifically referenced in the article (how ironic!) ....relating to a generic equivalent for TOBI (not the e-flow stuff) -- but if I understand what that link said correctly... Chiron & Children's together brought a law suit against another company who had planned on marketing a generic TOBI.....I can understand why Chiron would do this, but why would Children's be involved in this? Anyone know?</end quote></div>

Not quite right, Childrens was involved in another suit brought by Chiron. against Roxanne for trying to make a generic version of TOBI. I'm assuming because they have some of the patent rights.
 

Chaggie

New member
<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>Alyssa</b></i>

I didn't read the link until after I posted -- I was surprised to see Children's in Seattle specifically referenced in the article (how ironic!) ....relating to a generic equivalent for TOBI (not the e-flow stuff) -- but if I understand what that link said correctly... Chiron & Children's together brought a law suit against another company who had planned on marketing a generic TOBI.....I can understand why Chiron would do this, but why would Children's be involved in this? Anyone know?</end quote></div>

Not quite right, Childrens was involved in another suit brought by Chiron. against Roxanne for trying to make a generic version of TOBI. I'm assuming because they have some of the patent rights.
 

Uli

New member
As far as I know, the european version of the eflow is used for all medications, including tobi.

Uli,44,Germany
 

Uli

New member
As far as I know, the european version of the eflow is used for all medications, including tobi.

Uli,44,Germany
 

Uli

New member
As far as I know, the european version of the eflow is used for all medications, including tobi.

Uli,44,Germany
 

Jem

New member
I find this thread very informative...thank you to all who have contributed. I will be asking about acquiring the eFlow at my next clinic visit in April.
 

Jem

New member
I find this thread very informative...thank you to all who have contributed. I will be asking about acquiring the eFlow at my next clinic visit in April.
 

Jem

New member
I find this thread very informative...thank you to all who have contributed. I will be asking about acquiring the eFlow at my next clinic visit in April.
 

NoExcuses

New member
<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>Uli</b></i>

As far as I know, the european version of the eflow is used for all medications, including tobi.



Uli,44,Germany</end quote></div>

the device is identical in the US as in Europe.

the problem, as Chris pointed out so well, is enormous amounts of misinformation.

docs think doses haven't been worked out, which isn't true. or studies haven't been done, which also isn't true. <img src="i/expressions/face-icon-small-smile.gif" border="0">
 

NoExcuses

New member
<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>Uli</b></i>

As far as I know, the european version of the eflow is used for all medications, including tobi.



Uli,44,Germany</end quote></div>

the device is identical in the US as in Europe.

the problem, as Chris pointed out so well, is enormous amounts of misinformation.

docs think doses haven't been worked out, which isn't true. or studies haven't been done, which also isn't true. <img src="i/expressions/face-icon-small-smile.gif" border="0">
 

NoExcuses

New member
<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>Uli</b></i>

As far as I know, the european version of the eflow is used for all medications, including tobi.



Uli,44,Germany</end quote></div>

the device is identical in the US as in Europe.

the problem, as Chris pointed out so well, is enormous amounts of misinformation.

docs think doses haven't been worked out, which isn't true. or studies haven't been done, which also isn't true. <img src="i/expressions/face-icon-small-smile.gif" border="0">
 

Alyssa

New member
Chris,

I was still curious about why Children's would be involved in the previous law suit against Roxane.... I just didn't understand how a hospital could be involved in drug development and/or drug patent...... but I found an article that stated, in part:

Chiron Corporation (Emeryville, CA) and Children's Hospital and Regional Medical Center of Seattle (Seattle, WA) have settled a patent infringement suit against Roxane Laboratories, a subsidiary of Boehringer-Ingelheim Corporation, regarding Roxane's plans to market a generic equivalent of TOBI tobramycin solution for inhalation. The suit was brought to enforce United States Patent 5,508,269 (the '269 patent), <u>which is co-owned by Chiron and Children's Hospital.</u>

Ah ha! <b>The patent is co-owned by Chiron & Children's </b>!!!!! This is pretty interesting !!! Who knew ! That probably explains why so many of the events at Children's that I attend are sponsored by Chiron..... I guess they are "partners" in more ways that one huh.

On the other hand, this is disturbing to learn too, because in a way it seems like a bit of a conflict of interest for the hospital - I always assumed the hospital was in no way connected to the drug companies (as far as a financial connection anyway) But if they hold patent rights together then (I'm assuming) the hospital has a financial benefit every time they prescribe TOBI at $3300.00 per month. This would explain why they did not want anyone to market the generic before 2014.
 

Alyssa

New member
Chris,

I was still curious about why Children's would be involved in the previous law suit against Roxane.... I just didn't understand how a hospital could be involved in drug development and/or drug patent...... but I found an article that stated, in part:

Chiron Corporation (Emeryville, CA) and Children's Hospital and Regional Medical Center of Seattle (Seattle, WA) have settled a patent infringement suit against Roxane Laboratories, a subsidiary of Boehringer-Ingelheim Corporation, regarding Roxane's plans to market a generic equivalent of TOBI tobramycin solution for inhalation. The suit was brought to enforce United States Patent 5,508,269 (the '269 patent), <u>which is co-owned by Chiron and Children's Hospital.</u>

Ah ha! <b>The patent is co-owned by Chiron & Children's </b>!!!!! This is pretty interesting !!! Who knew ! That probably explains why so many of the events at Children's that I attend are sponsored by Chiron..... I guess they are "partners" in more ways that one huh.

On the other hand, this is disturbing to learn too, because in a way it seems like a bit of a conflict of interest for the hospital - I always assumed the hospital was in no way connected to the drug companies (as far as a financial connection anyway) But if they hold patent rights together then (I'm assuming) the hospital has a financial benefit every time they prescribe TOBI at $3300.00 per month. This would explain why they did not want anyone to market the generic before 2014.
 

Alyssa

New member
Chris,

I was still curious about why Children's would be involved in the previous law suit against Roxane.... I just didn't understand how a hospital could be involved in drug development and/or drug patent...... but I found an article that stated, in part:

Chiron Corporation (Emeryville, CA) and Children's Hospital and Regional Medical Center of Seattle (Seattle, WA) have settled a patent infringement suit against Roxane Laboratories, a subsidiary of Boehringer-Ingelheim Corporation, regarding Roxane's plans to market a generic equivalent of TOBI tobramycin solution for inhalation. The suit was brought to enforce United States Patent 5,508,269 (the '269 patent), <u>which is co-owned by Chiron and Children's Hospital.</u>

Ah ha! <b>The patent is co-owned by Chiron & Children's </b>!!!!! This is pretty interesting !!! Who knew ! That probably explains why so many of the events at Children's that I attend are sponsored by Chiron..... I guess they are "partners" in more ways that one huh.

On the other hand, this is disturbing to learn too, because in a way it seems like a bit of a conflict of interest for the hospital - I always assumed the hospital was in no way connected to the drug companies (as far as a financial connection anyway) But if they hold patent rights together then (I'm assuming) the hospital has a financial benefit every time they prescribe TOBI at $3300.00 per month. This would explain why they did not want anyone to market the generic before 2014.
 

NoExcuses

New member
Before you jump down your hospital's throat (which it sounds like you want to), understand that the hospital probably had a great deal of effort including research, clinical studies and money to bring TOBI to the market.

The FDA requires such strict studies to be conducted that it costs millions upon millions of dollars to conduct those studies. So the fact that your hospital decided to recoup those costs is just business - hospitals aren't charity organizations. They have to make money to be able to run their operation.

You must be thrilled that your hospital is proactive in the CF community for bringing drugs to market. That is something to be proud of.
 

NoExcuses

New member
Before you jump down your hospital's throat (which it sounds like you want to), understand that the hospital probably had a great deal of effort including research, clinical studies and money to bring TOBI to the market.

The FDA requires such strict studies to be conducted that it costs millions upon millions of dollars to conduct those studies. So the fact that your hospital decided to recoup those costs is just business - hospitals aren't charity organizations. They have to make money to be able to run their operation.

You must be thrilled that your hospital is proactive in the CF community for bringing drugs to market. That is something to be proud of.
 

NoExcuses

New member
Before you jump down your hospital's throat (which it sounds like you want to), understand that the hospital probably had a great deal of effort including research, clinical studies and money to bring TOBI to the market.

The FDA requires such strict studies to be conducted that it costs millions upon millions of dollars to conduct those studies. So the fact that your hospital decided to recoup those costs is just business - hospitals aren't charity organizations. They have to make money to be able to run their operation.

You must be thrilled that your hospital is proactive in the CF community for bringing drugs to market. That is something to be proud of.
 

Alyssa

New member
<b>No, in no way did I want to jump down their throats</b> -- and I just returned to the computer to clarify what I had said (hopefully before anyone saw it) because it swirled in my head more after I walked away to do something else.....

<u>The connection I was having a hard time making was why would a hospital have anything to do with a patent</u>.... then it dawned on me how much research Children's does -- my brain was focused on the treatment & care we received at Children's, not the research they participate in. I had always envisioned when a patent was issued for a drug it was owned solely by the drug manufacturers. I now have a better understanding.

You are correct - I'm sure it was their involvement in the research and development of the drug years ago and I don't dispute the fact they deserve or are entitled to recoup their expenses -- I just never thought of them as being involved in patents before -- but it's not like I've ever really looked into it before - so it's probably very common for a research hospital... I'm just saying I never really thought about it before.
 
Top