Tobi and the eFlow

Chaggie

New member
Because I hate misinformation, here is the reason why eFlow users can not use TOBI in their nebulizers.

"In a setback for biopharmaceutical company Chiron Corp., a federal judge has ruled that the company's medical-method patent covering a drug-device combination used by cystic fibrosis victims cannot be used to bar use of the treatment in lower concentrations.

The patent at issue in the case, U.S. Patent No. 6,890,907, covers a method of treating lung infections by using certain concentrations of liquid tobramycin with high-efficiency nebulizers."

<a target=_blank class=ftalternatingbarlinklarge href="http://www.cf-dk.org/CFwwwNEWS/cfwwwnews.htm">http://www.cf-dk.org/CFwwwNEWS/cfwwwnews.htm</a>

It has nothing to do with the FDA, once a nebulizer is approved by the FDA drugs to not have to be re-approved for use with it.
 

Chaggie

New member
Because I hate misinformation, here is the reason why eFlow users can not use TOBI in their nebulizers.

"In a setback for biopharmaceutical company Chiron Corp., a federal judge has ruled that the company's medical-method patent covering a drug-device combination used by cystic fibrosis victims cannot be used to bar use of the treatment in lower concentrations.

The patent at issue in the case, U.S. Patent No. 6,890,907, covers a method of treating lung infections by using certain concentrations of liquid tobramycin with high-efficiency nebulizers."

<a target=_blank class=ftalternatingbarlinklarge href="http://www.cf-dk.org/CFwwwNEWS/cfwwwnews.htm">http://www.cf-dk.org/CFwwwNEWS/cfwwwnews.htm</a>

It has nothing to do with the FDA, once a nebulizer is approved by the FDA drugs to not have to be re-approved for use with it.
 

Chaggie

New member
Because I hate misinformation, here is the reason why eFlow users can not use TOBI in their nebulizers.

"In a setback for biopharmaceutical company Chiron Corp., a federal judge has ruled that the company's medical-method patent covering a drug-device combination used by cystic fibrosis victims cannot be used to bar use of the treatment in lower concentrations.

The patent at issue in the case, U.S. Patent No. 6,890,907, covers a method of treating lung infections by using certain concentrations of liquid tobramycin with high-efficiency nebulizers."

<a target=_blank class=ftalternatingbarlinklarge href="http://www.cf-dk.org/CFwwwNEWS/cfwwwnews.htm">http://www.cf-dk.org/CFwwwNEWS/cfwwwnews.htm</a>

It has nothing to do with the FDA, once a nebulizer is approved by the FDA drugs to not have to be re-approved for use with it.
 

gr33nie

New member
forgive me for not knowing the back story.

But can you explain this in simple terms?

Does it mean that you can use the e-flow or any other nebulizer with TOBI?

Thanks
 

gr33nie

New member
forgive me for not knowing the back story.

But can you explain this in simple terms?

Does it mean that you can use the e-flow or any other nebulizer with TOBI?

Thanks
 

gr33nie

New member
forgive me for not knowing the back story.

But can you explain this in simple terms?

Does it mean that you can use the e-flow or any other nebulizer with TOBI?

Thanks
 

Chaggie

New member
yes TOBI can be used in the eFlow, but the dosage needs to be adjusted, and Chiron will not allow TOBI to be distributed in any other dose but the current one. They claim a patent between TOBI and the current nebulizers.
 

Chaggie

New member
yes TOBI can be used in the eFlow, but the dosage needs to be adjusted, and Chiron will not allow TOBI to be distributed in any other dose but the current one. They claim a patent between TOBI and the current nebulizers.
 

Chaggie

New member
yes TOBI can be used in the eFlow, but the dosage needs to be adjusted, and Chiron will not allow TOBI to be distributed in any other dose but the current one. They claim a patent between TOBI and the current nebulizers.
 

NoExcuses

New member
The point was for those who think that the FDA will ever approve a med for a new nebulzier/compressor has their thinking backwards.

Once a device is approved, it can be used with any med. Those who are holding their breath for a certain med to be FDA approved to be used with the eFLow will be waiting until the cows come home. The FDA doesn't work like that.
 

NoExcuses

New member
The point was for those who think that the FDA will ever approve a med for a new nebulzier/compressor has their thinking backwards.

Once a device is approved, it can be used with any med. Those who are holding their breath for a certain med to be FDA approved to be used with the eFLow will be waiting until the cows come home. The FDA doesn't work like that.
 

NoExcuses

New member
The point was for those who think that the FDA will ever approve a med for a new nebulzier/compressor has their thinking backwards.

Once a device is approved, it can be used with any med. Those who are holding their breath for a certain med to be FDA approved to be used with the eFLow will be waiting until the cows come home. The FDA doesn't work like that.
 

Alyssa

New member
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.

My understanding of this is that the eflow nebulizer was originally developed to be used only with Aztreonam (antibiotic). 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. 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.

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.
 

Alyssa

New member
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.

My understanding of this is that the eflow nebulizer was originally developed to be used only with Aztreonam (antibiotic). 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. 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.

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.
 

Alyssa

New member
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.

My understanding of this is that the eflow nebulizer was originally developed to be used only with Aztreonam (antibiotic). 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. 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.

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.
 

Alyssa

New member
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?
 

Alyssa

New member
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?
 

Alyssa

New member
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?
 

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
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.
 
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