Using Avandia in Cystic Fibrosis

[saveferris2009]

<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>kitomd21</b></i>

FDA just recommended pulling this drug due to cardiovascular risks...</end quote></div>


I'd like to see this press release. They are investigating but haven't pulled it.

Plus, the FDA doesn't recommend pulling the drug. The just pull it. There's no recommendation.


This is the latest info as of 2/18. Still would love to see support for your statement, kitomd21.

<a target=_blank class=ftalternatingbarlinklarge href="http://www.cnn.com/2010/HEALTH/02/20/avandia.study/index.html?hpt=T2">http://www.cnn.com/2010/HEALTH...tudy/index.html?hpt=T2</a>

 

[saveferris2009]

<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>kitomd21</b></i>

FDA just recommended pulling this drug due to cardiovascular risks...</end quote></div>


I'd like to see this press release. They are investigating but haven't pulled it.

Plus, the FDA doesn't recommend pulling the drug. The just pull it. There's no recommendation.


This is the latest info as of 2/18. Still would love to see support for your statement, kitomd21.

<a target=_blank class=ftalternatingbarlinklarge href="http://www.cnn.com/2010/HEALTH/02/20/avandia.study/index.html?hpt=T2">http://www.cnn.com/2010/HEALTH...tudy/index.html?hpt=T2</a>

 

[saveferris2009]

<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>kitomd21</b></i>

FDA just recommended pulling this drug due to cardiovascular risks...</end quote></div>


I'd like to see this press release. They are investigating but haven't pulled it.

Plus, the FDA doesn't recommend pulling the drug. The just pull it. There's no recommendation.


This is the latest info as of 2/18. Still would love to see support for your statement, kitomd21.

<a target=_blank class=ftalternatingbarlinklarge href="http://www.cnn.com/2010/HEALTH/02/20/avandia.study/index.html?hpt=T2">http://www.cnn.com/2010/HEALTH...tudy/index.html?hpt=T2</a>

 

[saveferris2009]

<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>kitomd21</b></i>

FDA just recommended pulling this drug due to cardiovascular risks...</end quote>


I'd like to see this press release. They are investigating but haven't pulled it.

Plus, the FDA doesn't recommend pulling the drug. The just pull it. There's no recommendation.


This is the latest info as of 2/18. Still would love to see support for your statement, kitomd21.

<a target=_blank class=ftalternatingbarlinklarge href="http://www.cnn.com/2010/HEALTH/02/20/avandia.study/index.html?hpt=T2">http://www.cnn.com/2010/HEALTH...tudy/index.html?hpt=T2</a>

 

[saveferris2009]

<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>kitomd21</b></i>
<br />
<br />FDA just recommended pulling this drug due to cardiovascular risks...</end quote>
<br />
<br />
<br />I'd like to see this press release. They are investigating but haven't pulled it.
<br />
<br />Plus, the FDA doesn't recommend pulling the drug. The just pull it. There's no recommendation.
<br />
<br />
<br />This is the latest info as of 2/18. Still would love to see support for your statement, kitomd21.
<br />
<br /><a target=_blank class=ftalternatingbarlinklarge href="http://www.cnn.com/2010/HEALTH/02/20/avandia.study/index.html?hpt=T2">http://www.cnn.com/2010/HEALTH...tudy/index.html?hpt=T2</a>

 

[saveferris2009]

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

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?

</end quote></div>


Ya sometimes they go through testing, sometimes not. Some have animal models.

Here's the bottomline: CF is an orphan disease and there isn't a lot of money to be made with us.

So this translates into not a lot of money out there to conduct research, even on drugs that are already on the market.

For example, smart docs will tell you you can't compare two drugs against each other for efficacy unless the drugs were compared head to head in a well controlled, randomized, clinical trial.

But for CF drugs, often the best of the best have to compare drugs based on only their PI, not head to head clinical trials, simply because they know studies won't be conducted and/or it could take years to do so due to such a small CF patient population.

So to answer your question - there are many, many reasons as to why this occurs. but it all comes down to $

<div class="FTQUOTE"><begin quote>

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? </end quote></div>

I can't answer as to what happened with Zithro - but I think what happened with Colistin is what happened with Tobramycin before TOBI came out - they know the med works in IV so let's try it in the lungs. No trials / studies to the best of my knowledge.

But understand there is a difference between using an antibiotic via IV (FDA approved) or using it in a neb (off label but for the same purpose).

Something like Avandia is FDA approved for diabetes treatment. But an off label use for CF inflammation is very different - nothing like the off label use for Colistin. Make sense?

 

[saveferris2009]

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

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?

</end quote></div>


Ya sometimes they go through testing, sometimes not. Some have animal models.

Here's the bottomline: CF is an orphan disease and there isn't a lot of money to be made with us.

So this translates into not a lot of money out there to conduct research, even on drugs that are already on the market.

For example, smart docs will tell you you can't compare two drugs against each other for efficacy unless the drugs were compared head to head in a well controlled, randomized, clinical trial.

But for CF drugs, often the best of the best have to compare drugs based on only their PI, not head to head clinical trials, simply because they know studies won't be conducted and/or it could take years to do so due to such a small CF patient population.

So to answer your question - there are many, many reasons as to why this occurs. but it all comes down to $

<div class="FTQUOTE"><begin quote>

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? </end quote></div>

I can't answer as to what happened with Zithro - but I think what happened with Colistin is what happened with Tobramycin before TOBI came out - they know the med works in IV so let's try it in the lungs. No trials / studies to the best of my knowledge.

But understand there is a difference between using an antibiotic via IV (FDA approved) or using it in a neb (off label but for the same purpose).

Something like Avandia is FDA approved for diabetes treatment. But an off label use for CF inflammation is very different - nothing like the off label use for Colistin. Make sense?

 

[saveferris2009]

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

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?

</end quote></div>


Ya sometimes they go through testing, sometimes not. Some have animal models.

Here's the bottomline: CF is an orphan disease and there isn't a lot of money to be made with us.

So this translates into not a lot of money out there to conduct research, even on drugs that are already on the market.

For example, smart docs will tell you you can't compare two drugs against each other for efficacy unless the drugs were compared head to head in a well controlled, randomized, clinical trial.

But for CF drugs, often the best of the best have to compare drugs based on only their PI, not head to head clinical trials, simply because they know studies won't be conducted and/or it could take years to do so due to such a small CF patient population.

So to answer your question - there are many, many reasons as to why this occurs. but it all comes down to $

<div class="FTQUOTE"><begin quote>

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? </end quote></div>

I can't answer as to what happened with Zithro - but I think what happened with Colistin is what happened with Tobramycin before TOBI came out - they know the med works in IV so let's try it in the lungs. No trials / studies to the best of my knowledge.

But understand there is a difference between using an antibiotic via IV (FDA approved) or using it in a neb (off label but for the same purpose).

Something like Avandia is FDA approved for diabetes treatment. But an off label use for CF inflammation is very different - nothing like the off label use for Colistin. Make sense?

 

[saveferris2009]

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

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?

</end quote>


Ya sometimes they go through testing, sometimes not. Some have animal models.

Here's the bottomline: CF is an orphan disease and there isn't a lot of money to be made with us.

So this translates into not a lot of money out there to conduct research, even on drugs that are already on the market.

For example, smart docs will tell you you can't compare two drugs against each other for efficacy unless the drugs were compared head to head in a well controlled, randomized, clinical trial.

But for CF drugs, often the best of the best have to compare drugs based on only their PI, not head to head clinical trials, simply because they know studies won't be conducted and/or it could take years to do so due to such a small CF patient population.

So to answer your question - there are many, many reasons as to why this occurs. but it all comes down to $

<div class="FTQUOTE"><begin quote>

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? </end quote>

I can't answer as to what happened with Zithro - but I think what happened with Colistin is what happened with Tobramycin before TOBI came out - they know the med works in IV so let's try it in the lungs. No trials / studies to the best of my knowledge.

But understand there is a difference between using an antibiotic via IV (FDA approved) or using it in a neb (off label but for the same purpose).

Something like Avandia is FDA approved for diabetes treatment. But an off label use for CF inflammation is very different - nothing like the off label use for Colistin. Make sense?

 

[saveferris2009]

<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>Ender</b></i>
<br />
<br /> 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 /></end quote>
<br />
<br />
<br />Ya sometimes they go through testing, sometimes not. Some have animal models.
<br />
<br />Here's the bottomline: CF is an orphan disease and there isn't a lot of money to be made with us.
<br />
<br />So this translates into not a lot of money out there to conduct research, even on drugs that are already on the market.
<br />
<br />For example, smart docs will tell you you can't compare two drugs against each other for efficacy unless the drugs were compared head to head in a well controlled, randomized, clinical trial.
<br />
<br />But for CF drugs, often the best of the best have to compare drugs based on only their PI, not head to head clinical trials, simply because they know studies won't be conducted and/or it could take years to do so due to such a small CF patient population.
<br />
<br />So to answer your question - there are many, many reasons as to why this occurs. but it all comes down to $
<br />
<br /><div class="FTQUOTE"><begin quote>
<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? </end quote>
<br />
<br />I can't answer as to what happened with Zithro - but I think what happened with Colistin is what happened with Tobramycin before TOBI came out - they know the med works in IV so let's try it in the lungs. No trials / studies to the best of my knowledge.
<br />
<br />But understand there is a difference between using an antibiotic via IV (FDA approved) or using it in a neb (off label but for the same purpose).
<br />
<br />Something like Avandia is FDA approved for diabetes treatment. But an off label use for CF inflammation is very different - nothing like the off label use for Colistin. Make sense?

 

[theLostMiler]

I heard the same thing on my yahoo homepage the other day (2/19) about it being the diabetes drug report being "leaked"...

I am only supplying one source of information for where the person said the FDA was "recommending" it to be removed... and I didnt read all of it... b/c I am not really "involved" (as in not interested in this right now) just wanted to post this because I saw it and just now read that saveferris wanted a link and it might even be like the cnn link you provided saveferris...

<a target=_blank class=ftalternatingbarlinklarge href="http://www.nytimes.com/2010/02/20/health/policy/20avandia.html?no_interstitial">NY Times Article "Leaked report on Diabetes Drug" </a>

Edited: Just checked the CNN articfle... they arent the same but the article on top says 2/20 and saveferris you said it was as of 2/18?

 

[theLostMiler]

I heard the same thing on my yahoo homepage the other day (2/19) about it being the diabetes drug report being "leaked"...

I am only supplying one source of information for where the person said the FDA was "recommending" it to be removed... and I didnt read all of it... b/c I am not really "involved" (as in not interested in this right now) just wanted to post this because I saw it and just now read that saveferris wanted a link and it might even be like the cnn link you provided saveferris...

<a target=_blank class=ftalternatingbarlinklarge href="http://www.nytimes.com/2010/02/20/health/policy/20avandia.html?no_interstitial">NY Times Article "Leaked report on Diabetes Drug" </a>

Edited: Just checked the CNN articfle... they arent the same but the article on top says 2/20 and saveferris you said it was as of 2/18?

 

[theLostMiler]

I heard the same thing on my yahoo homepage the other day (2/19) about it being the diabetes drug report being "leaked"...

I am only supplying one source of information for where the person said the FDA was "recommending" it to be removed... and I didnt read all of it... b/c I am not really "involved" (as in not interested in this right now) just wanted to post this because I saw it and just now read that saveferris wanted a link and it might even be like the cnn link you provided saveferris...

<a target=_blank class=ftalternatingbarlinklarge href="http://www.nytimes.com/2010/02/20/health/policy/20avandia.html?no_interstitial">NY Times Article "Leaked report on Diabetes Drug" </a>

Edited: Just checked the CNN articfle... they arent the same but the article on top says 2/20 and saveferris you said it was as of 2/18?

 

[theLostMiler]

I heard the same thing on my yahoo homepage the other day (2/19) about it being the diabetes drug report being "leaked"...

I am only supplying one source of information for where the person said the FDA was "recommending" it to be removed... and I didnt read all of it... b/c I am not really "involved" (as in not interested in this right now) just wanted to post this because I saw it and just now read that saveferris wanted a link and it might even be like the cnn link you provided saveferris...

<a target=_blank class=ftalternatingbarlinklarge href="http://www.nytimes.com/2010/02/20/health/policy/20avandia.html?no_interstitial">NY Times Article "Leaked report on Diabetes Drug" </a>

Edited: Just checked the CNN articfle... they arent the same but the article on top says 2/20 and saveferris you said it was as of 2/18?

 

[theLostMiler]

I heard the same thing on my yahoo homepage the other day (2/19) about it being the diabetes drug report being "leaked"...
<br />
<br />I am only supplying one source of information for where the person said the FDA was "recommending" it to be removed... and I didnt read all of it... b/c I am not really "involved" (as in not interested in this right now) just wanted to post this because I saw it and just now read that saveferris wanted a link and it might even be like the cnn link you provided saveferris...
<br />
<br /><a target=_blank class=ftalternatingbarlinklarge href="http://www.nytimes.com/2010/02/20/health/policy/20avandia.html?no_interstitial">NY Times Article "Leaked report on Diabetes Drug" </a>
<br />
<br />Edited: Just checked the CNN articfle... they arent the same but the article on top says 2/20 and saveferris you said it was as of 2/18?

 

[saveferris2009]

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

just wanted to post this because I saw it and just now read that saveferris wanted a link and it might even be like the cnn link you provided saveferris...



<a target=_blank class=ftalternatingbarlinklarge href="http://www.nytimes.com/2010/02/20/health/policy/20avandia.html?no_interstitial">NY Times Article "Leaked report on Diabetes Drug" </a>

</end quote></div>

So I think the confusion may be this: the FDA is comprised of many individuals. And these individuals right now have conflicting ideas about what to do with Avandia.

So when individuals from the FDA make statements or recommendations, that isn't the FDA talking - it's these individuals.

As I said earlier, the FDA doesn't "recommend" for the removal of a drug. If the FDA wants a drug removed from the market, the drug is simply removed. There is no "recommendation." It's an order and the law.

FDA members can make recommendations - but this is just their opinion and by no means law or frankly of any consequence.

To add another layer, there is what's called an FDA Advisory Panel. This panel is comprised of physicians or other experts (pharmacists, biologists, etc) that don't comprise the FDA per-say, but simply meet to make scientific recommendations to the FDA. Most of the time the FDA follows the commendations of the Advisory Panel.

But in the case of Avandia, the FDA Advisory Panel has not made a recommendation but will most likely in the future.

So to the original point, the FDA hasn't made a recommendation, and never will. The FDA Advisory Panel has not made a recommendation, but probably will in the future.

It may seem like a matter of semantics but the differences are huge and have very different consequences.

To quote from your article, TheLostMiller:

"In a December 2009 internal memorandum, Dr. Janet Woodcock, director of the F.D.A.'s drug center, wrote that "there are multiple conflicting opinions" about Avandia within the agency, and she ordered officials to assemble another advisory committee, expected this summer, to reconsider whether the drug should be sold.

"I await the recommendations of the advisory committee," the agency's commissioner, Dr. Margaret Hamburg, said Friday night."

<div class="FTQUOTE"><begin quote>

Edited: Just checked the CNN articfle... they arent the same but the article on top says 2/20 and saveferris you said it was as of 2/18?</end quote></div>

You are absolutely right. I went all day today thinking it was the 18th today. The article was posted and dated Feb 20. Sorry for the confusion.

 

[saveferris2009]

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

just wanted to post this because I saw it and just now read that saveferris wanted a link and it might even be like the cnn link you provided saveferris...



<a target=_blank class=ftalternatingbarlinklarge href="http://www.nytimes.com/2010/02/20/health/policy/20avandia.html?no_interstitial">NY Times Article "Leaked report on Diabetes Drug" </a>

</end quote></div>

So I think the confusion may be this: the FDA is comprised of many individuals. And these individuals right now have conflicting ideas about what to do with Avandia.

So when individuals from the FDA make statements or recommendations, that isn't the FDA talking - it's these individuals.

As I said earlier, the FDA doesn't "recommend" for the removal of a drug. If the FDA wants a drug removed from the market, the drug is simply removed. There is no "recommendation." It's an order and the law.

FDA members can make recommendations - but this is just their opinion and by no means law or frankly of any consequence.

To add another layer, there is what's called an FDA Advisory Panel. This panel is comprised of physicians or other experts (pharmacists, biologists, etc) that don't comprise the FDA per-say, but simply meet to make scientific recommendations to the FDA. Most of the time the FDA follows the commendations of the Advisory Panel.

But in the case of Avandia, the FDA Advisory Panel has not made a recommendation but will most likely in the future.

So to the original point, the FDA hasn't made a recommendation, and never will. The FDA Advisory Panel has not made a recommendation, but probably will in the future.

It may seem like a matter of semantics but the differences are huge and have very different consequences.

To quote from your article, TheLostMiller:

"In a December 2009 internal memorandum, Dr. Janet Woodcock, director of the F.D.A.'s drug center, wrote that "there are multiple conflicting opinions" about Avandia within the agency, and she ordered officials to assemble another advisory committee, expected this summer, to reconsider whether the drug should be sold.

"I await the recommendations of the advisory committee," the agency's commissioner, Dr. Margaret Hamburg, said Friday night."

<div class="FTQUOTE"><begin quote>

Edited: Just checked the CNN articfle... they arent the same but the article on top says 2/20 and saveferris you said it was as of 2/18?</end quote></div>

You are absolutely right. I went all day today thinking it was the 18th today. The article was posted and dated Feb 20. Sorry for the confusion.

 

[saveferris2009]

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

just wanted to post this because I saw it and just now read that saveferris wanted a link and it might even be like the cnn link you provided saveferris...



<a target=_blank class=ftalternatingbarlinklarge href="http://www.nytimes.com/2010/02/20/health/policy/20avandia.html?no_interstitial">NY Times Article "Leaked report on Diabetes Drug" </a>

</end quote></div>

So I think the confusion may be this: the FDA is comprised of many individuals. And these individuals right now have conflicting ideas about what to do with Avandia.

So when individuals from the FDA make statements or recommendations, that isn't the FDA talking - it's these individuals.

As I said earlier, the FDA doesn't "recommend" for the removal of a drug. If the FDA wants a drug removed from the market, the drug is simply removed. There is no "recommendation." It's an order and the law.

FDA members can make recommendations - but this is just their opinion and by no means law or frankly of any consequence.

To add another layer, there is what's called an FDA Advisory Panel. This panel is comprised of physicians or other experts (pharmacists, biologists, etc) that don't comprise the FDA per-say, but simply meet to make scientific recommendations to the FDA. Most of the time the FDA follows the commendations of the Advisory Panel.

But in the case of Avandia, the FDA Advisory Panel has not made a recommendation but will most likely in the future.

So to the original point, the FDA hasn't made a recommendation, and never will. The FDA Advisory Panel has not made a recommendation, but probably will in the future.

It may seem like a matter of semantics but the differences are huge and have very different consequences.

To quote from your article, TheLostMiller:

"In a December 2009 internal memorandum, Dr. Janet Woodcock, director of the F.D.A.'s drug center, wrote that "there are multiple conflicting opinions" about Avandia within the agency, and she ordered officials to assemble another advisory committee, expected this summer, to reconsider whether the drug should be sold.

"I await the recommendations of the advisory committee," the agency's commissioner, Dr. Margaret Hamburg, said Friday night."

<div class="FTQUOTE"><begin quote>

Edited: Just checked the CNN articfle... they arent the same but the article on top says 2/20 and saveferris you said it was as of 2/18?</end quote></div>

You are absolutely right. I went all day today thinking it was the 18th today. The article was posted and dated Feb 20. Sorry for the confusion.

 

[saveferris2009]

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

just wanted to post this because I saw it and just now read that saveferris wanted a link and it might even be like the cnn link you provided saveferris...



<a target=_blank class=ftalternatingbarlinklarge href="http://www.nytimes.com/2010/02/20/health/policy/20avandia.html?no_interstitial">NY Times Article "Leaked report on Diabetes Drug" </a>

</end quote>

So I think the confusion may be this: the FDA is comprised of many individuals. And these individuals right now have conflicting ideas about what to do with Avandia.

So when individuals from the FDA make statements or recommendations, that isn't the FDA talking - it's these individuals.

As I said earlier, the FDA doesn't "recommend" for the removal of a drug. If the FDA wants a drug removed from the market, the drug is simply removed. There is no "recommendation." It's an order and the law.

FDA members can make recommendations - but this is just their opinion and by no means law or frankly of any consequence.

To add another layer, there is what's called an FDA Advisory Panel. This panel is comprised of physicians or other experts (pharmacists, biologists, etc) that don't comprise the FDA per-say, but simply meet to make scientific recommendations to the FDA. Most of the time the FDA follows the commendations of the Advisory Panel.

But in the case of Avandia, the FDA Advisory Panel has not made a recommendation but will most likely in the future.

So to the original point, the FDA hasn't made a recommendation, and never will. The FDA Advisory Panel has not made a recommendation, but probably will in the future.

It may seem like a matter of semantics but the differences are huge and have very different consequences.

To quote from your article, TheLostMiller:

"In a December 2009 internal memorandum, Dr. Janet Woodcock, director of the F.D.A.'s drug center, wrote that "there are multiple conflicting opinions" about Avandia within the agency, and she ordered officials to assemble another advisory committee, expected this summer, to reconsider whether the drug should be sold.

"I await the recommendations of the advisory committee," the agency's commissioner, Dr. Margaret Hamburg, said Friday night."

<div class="FTQUOTE"><begin quote>

Edited: Just checked the CNN articfle... they arent the same but the article on top says 2/20 and saveferris you said it was as of 2/18?</end quote>

You are absolutely right. I went all day today thinking it was the 18th today. The article was posted and dated Feb 20. Sorry for the confusion.

 

[saveferris2009]

<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>theLostMiler</b></i>
<br />
<br /> just wanted to post this because I saw it and just now read that saveferris wanted a link and it might even be like the cnn link you provided saveferris...
<br />
<br />
<br />
<br /><a target=_blank class=ftalternatingbarlinklarge href="http://www.nytimes.com/2010/02/20/health/policy/20avandia.html?no_interstitial">NY Times Article "Leaked report on Diabetes Drug" </a>
<br />
<br /></end quote>
<br />
<br />So I think the confusion may be this: the FDA is comprised of many individuals. And these individuals right now have conflicting ideas about what to do with Avandia.
<br />
<br />So when individuals from the FDA make statements or recommendations, that isn't the FDA talking - it's these individuals.
<br />
<br />As I said earlier, the FDA doesn't "recommend" for the removal of a drug. If the FDA wants a drug removed from the market, the drug is simply removed. There is no "recommendation." It's an order and the law.
<br />
<br />FDA members can make recommendations - but this is just their opinion and by no means law or frankly of any consequence.
<br />
<br />To add another layer, there is what's called an FDA Advisory Panel. This panel is comprised of physicians or other experts (pharmacists, biologists, etc) that don't comprise the FDA per-say, but simply meet to make scientific recommendations to the FDA. Most of the time the FDA follows the commendations of the Advisory Panel.
<br />
<br />But in the case of Avandia, the FDA Advisory Panel has not made a recommendation but will most likely in the future.
<br />
<br />So to the original point, the FDA hasn't made a recommendation, and never will. The FDA Advisory Panel has not made a recommendation, but probably will in the future.
<br />
<br />It may seem like a matter of semantics but the differences are huge and have very different consequences.
<br />
<br />To quote from your article, TheLostMiller:
<br />
<br />"In a December 2009 internal memorandum, Dr. Janet Woodcock, director of the F.D.A.'s drug center, wrote that "there are multiple conflicting opinions" about Avandia within the agency, and she ordered officials to assemble another advisory committee, expected this summer, to reconsider whether the drug should be sold.
<br />
<br />"I await the recommendations of the advisory committee," the agency's commissioner, Dr. Margaret Hamburg, said Friday night."
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<br />Edited: Just checked the CNN articfle... they arent the same but the article on top says 2/20 and saveferris you said it was as of 2/18?</end quote>
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<br />You are absolutely right. I went all day today thinking it was the 18th today. The article was posted and dated Feb 20. Sorry for the confusion.