Using Avandia in Cystic Fibrosis

E

Ender

New member
<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>saveferris2009</b></i>

Fast tracked? You can use the medication NOW.



You don't need FDA approval for use of medication in a different population than what was originally intended.



Zithromax is used in CF even though it's labeling specifically says it shouldn't be used in CF.



Colistin doesn't have a label for nebbed use in CF, but the CF community uses it anyway.



It's called using a medication "off-label." And off-label Avandia use isn't any different.



You could start using it tomorrow.</end quote></div>

I don't get you. You post this info about research on current drugs, toting its benefits. People aren't very sure their docs will prescribe it because it's not labeled for cf. You then say that there are a bunch of drugs that are labelled "off label" that are available for cf...like colistin, and zithromax, fair enough, and that we aren't in the know from reading your blog because there are a bunch of other drugs that are not specifically used for cf that are being tested for it's use...such as zocor and levitra.

However, these drugs are going through clinical phases for cf...and its gonna be a while before they are approved for cf.

We can't use these now, because there is no way in hell doctors will prescribe them to us without them being tested. You should know this, and i know this because i asked my doctor about about these paticular drugs. Basically no one is budging until these tests are done, and the same goes with the drug you mentioned.

You tell people you can do this drug now, but not to run out and get it. I don't understand.

"I was explaining that existing drugs on the market don't need to get re-approved for a different indication to be used in that condition" is what you said. If that's true, then why is zocor and Levitra in different phases of study??
 
E

Ender

New member
<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>saveferris2009</b></i>

Fast tracked? You can use the medication NOW.



You don't need FDA approval for use of medication in a different population than what was originally intended.



Zithromax is used in CF even though it's labeling specifically says it shouldn't be used in CF.



Colistin doesn't have a label for nebbed use in CF, but the CF community uses it anyway.



It's called using a medication "off-label." And off-label Avandia use isn't any different.



You could start using it tomorrow.</end quote></div>

I don't get you. You post this info about research on current drugs, toting its benefits. People aren't very sure their docs will prescribe it because it's not labeled for cf. You then say that there are a bunch of drugs that are labelled "off label" that are available for cf...like colistin, and zithromax, fair enough, and that we aren't in the know from reading your blog because there are a bunch of other drugs that are not specifically used for cf that are being tested for it's use...such as zocor and levitra.

However, these drugs are going through clinical phases for cf...and its gonna be a while before they are approved for cf.

We can't use these now, because there is no way in hell doctors will prescribe them to us without them being tested. You should know this, and i know this because i asked my doctor about about these paticular drugs. Basically no one is budging until these tests are done, and the same goes with the drug you mentioned.

You tell people you can do this drug now, but not to run out and get it. I don't understand.

"I was explaining that existing drugs on the market don't need to get re-approved for a different indication to be used in that condition" is what you said. If that's true, then why is zocor and Levitra in different phases of study??
 
E

Ender

New member
<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>saveferris2009</b></i>

Fast tracked? You can use the medication NOW.



You don't need FDA approval for use of medication in a different population than what was originally intended.



Zithromax is used in CF even though it's labeling specifically says it shouldn't be used in CF.



Colistin doesn't have a label for nebbed use in CF, but the CF community uses it anyway.



It's called using a medication "off-label." And off-label Avandia use isn't any different.



You could start using it tomorrow.</end quote></div>

I don't get you. You post this info about research on current drugs, toting its benefits. People aren't very sure their docs will prescribe it because it's not labeled for cf. You then say that there are a bunch of drugs that are labelled "off label" that are available for cf...like colistin, and zithromax, fair enough, and that we aren't in the know from reading your blog because there are a bunch of other drugs that are not specifically used for cf that are being tested for it's use...such as zocor and levitra.

However, these drugs are going through clinical phases for cf...and its gonna be a while before they are approved for cf.

We can't use these now, because there is no way in hell doctors will prescribe them to us without them being tested. You should know this, and i know this because i asked my doctor about about these paticular drugs. Basically no one is budging until these tests are done, and the same goes with the drug you mentioned.

You tell people you can do this drug now, but not to run out and get it. I don't understand.

"I was explaining that existing drugs on the market don't need to get re-approved for a different indication to be used in that condition" is what you said. If that's true, then why is zocor and Levitra in different phases of study??
 
E

Ender

New member
<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>saveferris2009</b></i>

Fast tracked? You can use the medication NOW.



You don't need FDA approval for use of medication in a different population than what was originally intended.



Zithromax is used in CF even though it's labeling specifically says it shouldn't be used in CF.



Colistin doesn't have a label for nebbed use in CF, but the CF community uses it anyway.



It's called using a medication "off-label." And off-label Avandia use isn't any different.



You could start using it tomorrow.</end quote>

I don't get you. You post this info about research on current drugs, toting its benefits. People aren't very sure their docs will prescribe it because it's not labeled for cf. You then say that there are a bunch of drugs that are labelled "off label" that are available for cf...like colistin, and zithromax, fair enough, and that we aren't in the know from reading your blog because there are a bunch of other drugs that are not specifically used for cf that are being tested for it's use...such as zocor and levitra.

However, these drugs are going through clinical phases for cf...and its gonna be a while before they are approved for cf.

We can't use these now, because there is no way in hell doctors will prescribe them to us without them being tested. You should know this, and i know this because i asked my doctor about about these paticular drugs. Basically no one is budging until these tests are done, and the same goes with the drug you mentioned.

You tell people you can do this drug now, but not to run out and get it. I don't understand.

"I was explaining that existing drugs on the market don't need to get re-approved for a different indication to be used in that condition" is what you said. If that's true, then why is zocor and Levitra in different phases of study??
 
E

Ender

New member
<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>saveferris2009</b></i>
<br />
<br />Fast tracked? You can use the medication NOW.
<br />
<br />
<br />
<br />You don't need FDA approval for use of medication in a different population than what was originally intended.
<br />
<br />
<br />
<br />Zithromax is used in CF even though it's labeling specifically says it shouldn't be used in CF.
<br />
<br />
<br />
<br />Colistin doesn't have a label for nebbed use in CF, but the CF community uses it anyway.
<br />
<br />
<br />
<br />It's called using a medication "off-label." And off-label Avandia use isn't any different.
<br />
<br />
<br />
<br />You could start using it tomorrow.</end quote>
<br />
<br />I don't get you. You post this info about research on current drugs, toting its benefits. People aren't very sure their docs will prescribe it because it's not labeled for cf. You then say that there are a bunch of drugs that are labelled "off label" that are available for cf...like colistin, and zithromax, fair enough, and that we aren't in the know from reading your blog because there are a bunch of other drugs that are not specifically used for cf that are being tested for it's use...such as zocor and levitra.
<br />
<br />However, these drugs are going through clinical phases for cf...and its gonna be a while before they are approved for cf.
<br />
<br />We can't use these now, because there is no way in hell doctors will prescribe them to us without them being tested. You should know this, and i know this because i asked my doctor about about these paticular drugs. Basically no one is budging until these tests are done, and the same goes with the drug you mentioned.
<br />
<br />You tell people you can do this drug now, but not to run out and get it. I don't understand.
<br />
<br />"I was explaining that existing drugs on the market don't need to get re-approved for a different indication to be used in that condition" is what you said. If that's true, then why is zocor and Levitra in different phases of study??
 
S

saveferris2009

New member
OK the issue might be that many don't understand the FDA approval process (and it might be different in Canada).



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




You then say that there are a bunch of drugs that are labelled "off label" that are available for cf...like colistin, and zithromax, fair enough </end quote></div>

Yes


<div class="FTQUOTE"><begin quote>
there are a bunch of other drugs that are not specifically used for cf that are being tested for it's use...such as zocor and levitra.
</end quote></div>

That info is from the CFF website, yes.

<div class="FTQUOTE"><begin quote>
However, these drugs are going through clinical phases for cf...and its gonna be a while before they are approved for cf.

</end quote></div>

OK so here is where I think you might not understand the FDA process. These drugs - zithromax, colistin ia neb, and maybe in the future Zocor, Levitra and Avandia - won't ever get "approval" for CF use.

The US FDA has given approval to these drugs for another use and therefore the drugs can be used in the US for any condition that a doctor deems appropriate.

The tests that these drugs are going through are to give CF docs data as to whether or not to prescribe. But the tests aren't part of an approval process. The bottomline is any doc can prescribe these meds for any condition right now.

<b>The reason I made the statement that the drugs were available right now is because someone asked if the drug would be fast tracked for FDA approval. I was simply explaining that you don't have to apply for FDA approval for a new indication - physicians can already use the drug. THAT was the reason I brought up the whole topic of being able to use the drug now. I wasn't suggesting you should - I was simply shedding light on the US FDA process as it pertains to new uses of the drug in new populations. </b>



<div class="FTQUOTE"><begin quote>
We can't use these now, because there is no way in hell doctors will prescribe them to us without them being tested. You should know this </end quote></div>


YES! I do know this... which is why I've stated I only brought up the point that the drug could be used now to explain the FDA approval process. I never suggested that you should use it now.

<div class="FTQUOTE"><begin quote> Basically no one is budging until these tests are done, and the same goes with the drug you mentioned.
</end quote></div>

I agree 100%

<div class="FTQUOTE"><begin quote>
You tell people you can do this drug now, but not to run out and get it. I don't understand.

</end quote></div>

Yes, I was explaining that you can get the drug now as part of understanding the US FDA process for new indications. I never suggested that someone should.

<div class="FTQUOTE"><begin quote>
"I was explaining that existing drugs on the market don't need to get re-approved for a different indication to be used in that condition" is what you said. </end quote></div>

YES! Because Futant3 said "What kind of impact would the fact that it's an existing medication have on it being used for a new purpose? Seems like it could be fast tracked if it's results continue to pan out."

Fast tracked in the US means faster FDA approval for a drug - mostly used for orphan drugs - than normal approval for drugs submitted to the FDA.

So, as you'll see in my reply, I am explaining that Avandia doesn't need to be re-reviewed by the FDA for a CF indication - this was a response to Futant3's misundestanding that the drug needs to be FDA reviewed to be used for CF. The drug can be used NOW for any indication.


<div class="FTQUOTE"><begin quote>
If that's true, then why is zocor and Levitra in different phases of study??</end quote></div>

Because CF docs want an understanding of how drugs will play out in CF bodies. Levitra and Zocor could be used in CF patients now, today, in the US if they wanted to. Because Levitra and Zocor are already on the US market so US docs can use those meds for any indication in any patient they want.

But as you said -and I agree - CF docs want research to understand how those drugs impact CF people. But these CF docs don't have to have these study results to prescribe the drugs to CF patients - per FDA rules. That is the only reason I brought up the fact that the drugs could be used now - to shed light on FDA rules. Not to endorse use without studies. It's a matter of "could" versus "should."

I really think you question was due to a misunderstanding of why I was saying what I was saying as well as the nuances of the US FDA approval system. I hope my responses clear up the confusion.
 
S

saveferris2009

New member
OK the issue might be that many don't understand the FDA approval process (and it might be different in Canada).



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




You then say that there are a bunch of drugs that are labelled "off label" that are available for cf...like colistin, and zithromax, fair enough </end quote></div>

Yes


<div class="FTQUOTE"><begin quote>
there are a bunch of other drugs that are not specifically used for cf that are being tested for it's use...such as zocor and levitra.
</end quote></div>

That info is from the CFF website, yes.

<div class="FTQUOTE"><begin quote>
However, these drugs are going through clinical phases for cf...and its gonna be a while before they are approved for cf.

</end quote></div>

OK so here is where I think you might not understand the FDA process. These drugs - zithromax, colistin ia neb, and maybe in the future Zocor, Levitra and Avandia - won't ever get "approval" for CF use.

The US FDA has given approval to these drugs for another use and therefore the drugs can be used in the US for any condition that a doctor deems appropriate.

The tests that these drugs are going through are to give CF docs data as to whether or not to prescribe. But the tests aren't part of an approval process. The bottomline is any doc can prescribe these meds for any condition right now.

<b>The reason I made the statement that the drugs were available right now is because someone asked if the drug would be fast tracked for FDA approval. I was simply explaining that you don't have to apply for FDA approval for a new indication - physicians can already use the drug. THAT was the reason I brought up the whole topic of being able to use the drug now. I wasn't suggesting you should - I was simply shedding light on the US FDA process as it pertains to new uses of the drug in new populations. </b>



<div class="FTQUOTE"><begin quote>
We can't use these now, because there is no way in hell doctors will prescribe them to us without them being tested. You should know this </end quote></div>


YES! I do know this... which is why I've stated I only brought up the point that the drug could be used now to explain the FDA approval process. I never suggested that you should use it now.

<div class="FTQUOTE"><begin quote> Basically no one is budging until these tests are done, and the same goes with the drug you mentioned.
</end quote></div>

I agree 100%

<div class="FTQUOTE"><begin quote>
You tell people you can do this drug now, but not to run out and get it. I don't understand.

</end quote></div>

Yes, I was explaining that you can get the drug now as part of understanding the US FDA process for new indications. I never suggested that someone should.

<div class="FTQUOTE"><begin quote>
"I was explaining that existing drugs on the market don't need to get re-approved for a different indication to be used in that condition" is what you said. </end quote></div>

YES! Because Futant3 said "What kind of impact would the fact that it's an existing medication have on it being used for a new purpose? Seems like it could be fast tracked if it's results continue to pan out."

Fast tracked in the US means faster FDA approval for a drug - mostly used for orphan drugs - than normal approval for drugs submitted to the FDA.

So, as you'll see in my reply, I am explaining that Avandia doesn't need to be re-reviewed by the FDA for a CF indication - this was a response to Futant3's misundestanding that the drug needs to be FDA reviewed to be used for CF. The drug can be used NOW for any indication.


<div class="FTQUOTE"><begin quote>
If that's true, then why is zocor and Levitra in different phases of study??</end quote></div>

Because CF docs want an understanding of how drugs will play out in CF bodies. Levitra and Zocor could be used in CF patients now, today, in the US if they wanted to. Because Levitra and Zocor are already on the US market so US docs can use those meds for any indication in any patient they want.

But as you said -and I agree - CF docs want research to understand how those drugs impact CF people. But these CF docs don't have to have these study results to prescribe the drugs to CF patients - per FDA rules. That is the only reason I brought up the fact that the drugs could be used now - to shed light on FDA rules. Not to endorse use without studies. It's a matter of "could" versus "should."

I really think you question was due to a misunderstanding of why I was saying what I was saying as well as the nuances of the US FDA approval system. I hope my responses clear up the confusion.
 
S

saveferris2009

New member
OK the issue might be that many don't understand the FDA approval process (and it might be different in Canada).



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




You then say that there are a bunch of drugs that are labelled "off label" that are available for cf...like colistin, and zithromax, fair enough </end quote></div>

Yes


<div class="FTQUOTE"><begin quote>
there are a bunch of other drugs that are not specifically used for cf that are being tested for it's use...such as zocor and levitra.
</end quote></div>

That info is from the CFF website, yes.

<div class="FTQUOTE"><begin quote>
However, these drugs are going through clinical phases for cf...and its gonna be a while before they are approved for cf.

</end quote></div>

OK so here is where I think you might not understand the FDA process. These drugs - zithromax, colistin ia neb, and maybe in the future Zocor, Levitra and Avandia - won't ever get "approval" for CF use.

The US FDA has given approval to these drugs for another use and therefore the drugs can be used in the US for any condition that a doctor deems appropriate.

The tests that these drugs are going through are to give CF docs data as to whether or not to prescribe. But the tests aren't part of an approval process. The bottomline is any doc can prescribe these meds for any condition right now.

<b>The reason I made the statement that the drugs were available right now is because someone asked if the drug would be fast tracked for FDA approval. I was simply explaining that you don't have to apply for FDA approval for a new indication - physicians can already use the drug. THAT was the reason I brought up the whole topic of being able to use the drug now. I wasn't suggesting you should - I was simply shedding light on the US FDA process as it pertains to new uses of the drug in new populations. </b>



<div class="FTQUOTE"><begin quote>
We can't use these now, because there is no way in hell doctors will prescribe them to us without them being tested. You should know this </end quote></div>


YES! I do know this... which is why I've stated I only brought up the point that the drug could be used now to explain the FDA approval process. I never suggested that you should use it now.

<div class="FTQUOTE"><begin quote> Basically no one is budging until these tests are done, and the same goes with the drug you mentioned.
</end quote></div>

I agree 100%

<div class="FTQUOTE"><begin quote>
You tell people you can do this drug now, but not to run out and get it. I don't understand.

</end quote></div>

Yes, I was explaining that you can get the drug now as part of understanding the US FDA process for new indications. I never suggested that someone should.

<div class="FTQUOTE"><begin quote>
"I was explaining that existing drugs on the market don't need to get re-approved for a different indication to be used in that condition" is what you said. </end quote></div>

YES! Because Futant3 said "What kind of impact would the fact that it's an existing medication have on it being used for a new purpose? Seems like it could be fast tracked if it's results continue to pan out."

Fast tracked in the US means faster FDA approval for a drug - mostly used for orphan drugs - than normal approval for drugs submitted to the FDA.

So, as you'll see in my reply, I am explaining that Avandia doesn't need to be re-reviewed by the FDA for a CF indication - this was a response to Futant3's misundestanding that the drug needs to be FDA reviewed to be used for CF. The drug can be used NOW for any indication.


<div class="FTQUOTE"><begin quote>
If that's true, then why is zocor and Levitra in different phases of study??</end quote></div>

Because CF docs want an understanding of how drugs will play out in CF bodies. Levitra and Zocor could be used in CF patients now, today, in the US if they wanted to. Because Levitra and Zocor are already on the US market so US docs can use those meds for any indication in any patient they want.

But as you said -and I agree - CF docs want research to understand how those drugs impact CF people. But these CF docs don't have to have these study results to prescribe the drugs to CF patients - per FDA rules. That is the only reason I brought up the fact that the drugs could be used now - to shed light on FDA rules. Not to endorse use without studies. It's a matter of "could" versus "should."

I really think you question was due to a misunderstanding of why I was saying what I was saying as well as the nuances of the US FDA approval system. I hope my responses clear up the confusion.
 
S

saveferris2009

New member
OK the issue might be that many don't understand the FDA approval process (and it might be different in Canada).



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




You then say that there are a bunch of drugs that are labelled "off label" that are available for cf...like colistin, and zithromax, fair enough </end quote>

Yes


<div class="FTQUOTE"><begin quote>
there are a bunch of other drugs that are not specifically used for cf that are being tested for it's use...such as zocor and levitra.
</end quote>

That info is from the CFF website, yes.

<div class="FTQUOTE"><begin quote>
However, these drugs are going through clinical phases for cf...and its gonna be a while before they are approved for cf.

</end quote>

OK so here is where I think you might not understand the FDA process. These drugs - zithromax, colistin ia neb, and maybe in the future Zocor, Levitra and Avandia - won't ever get "approval" for CF use.

The US FDA has given approval to these drugs for another use and therefore the drugs can be used in the US for any condition that a doctor deems appropriate.

The tests that these drugs are going through are to give CF docs data as to whether or not to prescribe. But the tests aren't part of an approval process. The bottomline is any doc can prescribe these meds for any condition right now.

<b>The reason I made the statement that the drugs were available right now is because someone asked if the drug would be fast tracked for FDA approval. I was simply explaining that you don't have to apply for FDA approval for a new indication - physicians can already use the drug. THAT was the reason I brought up the whole topic of being able to use the drug now. I wasn't suggesting you should - I was simply shedding light on the US FDA process as it pertains to new uses of the drug in new populations. </b>



<div class="FTQUOTE"><begin quote>
We can't use these now, because there is no way in hell doctors will prescribe them to us without them being tested. You should know this </end quote>


YES! I do know this... which is why I've stated I only brought up the point that the drug could be used now to explain the FDA approval process. I never suggested that you should use it now.

<div class="FTQUOTE"><begin quote> Basically no one is budging until these tests are done, and the same goes with the drug you mentioned.
</end quote>

I agree 100%

<div class="FTQUOTE"><begin quote>
You tell people you can do this drug now, but not to run out and get it. I don't understand.

</end quote>

Yes, I was explaining that you can get the drug now as part of understanding the US FDA process for new indications. I never suggested that someone should.

<div class="FTQUOTE"><begin quote>
"I was explaining that existing drugs on the market don't need to get re-approved for a different indication to be used in that condition" is what you said. </end quote>

YES! Because Futant3 said "What kind of impact would the fact that it's an existing medication have on it being used for a new purpose? Seems like it could be fast tracked if it's results continue to pan out."

Fast tracked in the US means faster FDA approval for a drug - mostly used for orphan drugs - than normal approval for drugs submitted to the FDA.

So, as you'll see in my reply, I am explaining that Avandia doesn't need to be re-reviewed by the FDA for a CF indication - this was a response to Futant3's misundestanding that the drug needs to be FDA reviewed to be used for CF. The drug can be used NOW for any indication.


<div class="FTQUOTE"><begin quote>
If that's true, then why is zocor and Levitra in different phases of study??</end quote>

Because CF docs want an understanding of how drugs will play out in CF bodies. Levitra and Zocor could be used in CF patients now, today, in the US if they wanted to. Because Levitra and Zocor are already on the US market so US docs can use those meds for any indication in any patient they want.

But as you said -and I agree - CF docs want research to understand how those drugs impact CF people. But these CF docs don't have to have these study results to prescribe the drugs to CF patients - per FDA rules. That is the only reason I brought up the fact that the drugs could be used now - to shed light on FDA rules. Not to endorse use without studies. It's a matter of "could" versus "should."

I really think you question was due to a misunderstanding of why I was saying what I was saying as well as the nuances of the US FDA approval system. I hope my responses clear up the confusion.
 
S

saveferris2009

New member
OK the issue might be that many don't understand the FDA approval process (and it might be different in Canada).
<br />
<br />
<br />
<br /><div class="FTQUOTE"><begin quote><i>Originally posted by: <b>Ender</b></i>
<br />
<br />
<br />
<br />
<br /> You then say that there are a bunch of drugs that are labelled "off label" that are available for cf...like colistin, and zithromax, fair enough </end quote>
<br />
<br />Yes
<br />
<br />
<br /><div class="FTQUOTE"><begin quote>
<br />there are a bunch of other drugs that are not specifically used for cf that are being tested for it's use...such as zocor and levitra.
<br /></end quote>
<br />
<br />That info is from the CFF website, yes.
<br />
<br /><div class="FTQUOTE"><begin quote>
<br />However, these drugs are going through clinical phases for cf...and its gonna be a while before they are approved for cf.
<br />
<br /></end quote>
<br />
<br />OK so here is where I think you might not understand the FDA process. These drugs - zithromax, colistin ia neb, and maybe in the future Zocor, Levitra and Avandia - won't ever get "approval" for CF use.
<br />
<br />The US FDA has given approval to these drugs for another use and therefore the drugs can be used in the US for any condition that a doctor deems appropriate.
<br />
<br />The tests that these drugs are going through are to give CF docs data as to whether or not to prescribe. But the tests aren't part of an approval process. The bottomline is any doc can prescribe these meds for any condition right now.
<br />
<br /><b>The reason I made the statement that the drugs were available right now is because someone asked if the drug would be fast tracked for FDA approval. I was simply explaining that you don't have to apply for FDA approval for a new indication - physicians can already use the drug. THAT was the reason I brought up the whole topic of being able to use the drug now. I wasn't suggesting you should - I was simply shedding light on the US FDA process as it pertains to new uses of the drug in new populations. </b>
<br />
<br />
<br />
<br /><div class="FTQUOTE"><begin quote>
<br />We can't use these now, because there is no way in hell doctors will prescribe them to us without them being tested. You should know this </end quote>
<br />
<br />
<br />YES! I do know this... which is why I've stated I only brought up the point that the drug could be used now to explain the FDA approval process. I never suggested that you should use it now.
<br />
<br /><div class="FTQUOTE"><begin quote> Basically no one is budging until these tests are done, and the same goes with the drug you mentioned.
<br /></end quote>
<br />
<br />I agree 100%
<br />
<br /><div class="FTQUOTE"><begin quote>
<br />You tell people you can do this drug now, but not to run out and get it. I don't understand.
<br />
<br /></end quote>
<br />
<br />Yes, I was explaining that you can get the drug now as part of understanding the US FDA process for new indications. I never suggested that someone should.
<br />
<br /><div class="FTQUOTE"><begin quote>
<br />"I was explaining that existing drugs on the market don't need to get re-approved for a different indication to be used in that condition" is what you said. </end quote>
<br />
<br />YES! Because Futant3 said "What kind of impact would the fact that it's an existing medication have on it being used for a new purpose? Seems like it could be fast tracked if it's results continue to pan out."
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<br />Fast tracked in the US means faster FDA approval for a drug - mostly used for orphan drugs - than normal approval for drugs submitted to the FDA.
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<br />So, as you'll see in my reply, I am explaining that Avandia doesn't need to be re-reviewed by the FDA for a CF indication - this was a response to Futant3's misundestanding that the drug needs to be FDA reviewed to be used for CF. The drug can be used NOW for any indication.
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<br />
<br /><div class="FTQUOTE"><begin quote>
<br /> If that's true, then why is zocor and Levitra in different phases of study??</end quote>
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<br />Because CF docs want an understanding of how drugs will play out in CF bodies. Levitra and Zocor could be used in CF patients now, today, in the US if they wanted to. Because Levitra and Zocor are already on the US market so US docs can use those meds for any indication in any patient they want.
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<br />But as you said -and I agree - CF docs want research to understand how those drugs impact CF people. But these CF docs don't have to have these study results to prescribe the drugs to CF patients - per FDA rules. That is the only reason I brought up the fact that the drugs could be used now - to shed light on FDA rules. Not to endorse use without studies. It's a matter of "could" versus "should."
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<br />I really think you question was due to a misunderstanding of why I was saying what I was saying as well as the nuances of the US FDA approval system. I hope my responses clear up the confusion.
 
E

Ender

New member
Thanks Amy, it all makes a lot more sense to me. It's always hard trying to figure out context in type...

The big thing that confused me was why would they go along the whole process of testing drugs (phase 1, 2 etc) if they can just start using them now for the disease...but i guess obviously they want to make sure that isn't harmful to us...

which kinda brings me to another point. There are a bunch of drugs out there that have off label uses, do you think that a lot of those went through testing as well, or did they realize that they could be used for a certain condition and just started prescribing it?

I only ask because i wasn't sure that they did any testing with zithromax, or colistin. It wasn't until after doctors started using it that they started doing some clinical trials? Or am i wrong?

I wish doctors let us try some of these experimental drugs on our own....i hate waiting for stuff.
 
E

Ender

New member
Thanks Amy, it all makes a lot more sense to me. It's always hard trying to figure out context in type...

The big thing that confused me was why would they go along the whole process of testing drugs (phase 1, 2 etc) if they can just start using them now for the disease...but i guess obviously they want to make sure that isn't harmful to us...

which kinda brings me to another point. There are a bunch of drugs out there that have off label uses, do you think that a lot of those went through testing as well, or did they realize that they could be used for a certain condition and just started prescribing it?

I only ask because i wasn't sure that they did any testing with zithromax, or colistin. It wasn't until after doctors started using it that they started doing some clinical trials? Or am i wrong?

I wish doctors let us try some of these experimental drugs on our own....i hate waiting for stuff.
 
E

Ender

New member
Thanks Amy, it all makes a lot more sense to me. It's always hard trying to figure out context in type...

The big thing that confused me was why would they go along the whole process of testing drugs (phase 1, 2 etc) if they can just start using them now for the disease...but i guess obviously they want to make sure that isn't harmful to us...

which kinda brings me to another point. There are a bunch of drugs out there that have off label uses, do you think that a lot of those went through testing as well, or did they realize that they could be used for a certain condition and just started prescribing it?

I only ask because i wasn't sure that they did any testing with zithromax, or colistin. It wasn't until after doctors started using it that they started doing some clinical trials? Or am i wrong?

I wish doctors let us try some of these experimental drugs on our own....i hate waiting for stuff.
 
E

Ender

New member
Thanks Amy, it all makes a lot more sense to me. It's always hard trying to figure out context in type...

The big thing that confused me was why would they go along the whole process of testing drugs (phase 1, 2 etc) if they can just start using them now for the disease...but i guess obviously they want to make sure that isn't harmful to us...

which kinda brings me to another point. There are a bunch of drugs out there that have off label uses, do you think that a lot of those went through testing as well, or did they realize that they could be used for a certain condition and just started prescribing it?

I only ask because i wasn't sure that they did any testing with zithromax, or colistin. It wasn't until after doctors started using it that they started doing some clinical trials? Or am i wrong?

I wish doctors let us try some of these experimental drugs on our own....i hate waiting for stuff.
 
E

Ender

New member
Thanks Amy, it all makes a lot more sense to me. It's always hard trying to figure out context in type...
<br />
<br />The big thing that confused me was why would they go along the whole process of testing drugs (phase 1, 2 etc) if they can just start using them now for the disease...but i guess obviously they want to make sure that isn't harmful to us...
<br />
<br />which kinda brings me to another point. There are a bunch of drugs out there that have off label uses, do you think that a lot of those went through testing as well, or did they realize that they could be used for a certain condition and just started prescribing it?
<br />
<br />I only ask because i wasn't sure that they did any testing with zithromax, or colistin. It wasn't until after doctors started using it that they started doing some clinical trials? Or am i wrong?
<br />
<br />I wish doctors let us try some of these experimental drugs on our own....i hate waiting for stuff.
 
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