Comments on: Avandia And Actos Get A Black Box http://www.pharmalot.com/2007/08/avandia-and-actos-get-a-black-box/ News, Comment and Conversation Mon, 22 Mar 2010 06:06:44 +0000 http://wordpress.org/?v=2.6.2 By: BOB FIDDAMAN http://www.pharmalot.com/2007/08/avandia-and-actos-get-a-black-box/#comment-17561 BOB FIDDAMAN Thu, 23 Aug 2007 18:13:34 +0000 http://www.pharmalot.com/2007/08/avandia-and-actos-get-a-black-box/#comment-17561 Okay, we all know who he is, we all know his stance on Seroxat 'I think patients have nothing to fear taking Seroxat' but did you know he is now defending the diabetes drug, Avandia? Read more here: http://fiddaman.blogspot.com/2007/08/is-alistair-benbow-deranged.html Fid Okay, we all know who he is, we all know his stance on Seroxat ‘I think patients have nothing to fear taking Seroxat’ but did you know he is now defending the diabetes drug, Avandia?

Read more here:

http://fiddaman.blogspot.com/2007/08/is-alistair-benbow-deranged.html

Fid

]]> By: Ed Silverman http://www.pharmalot.com/2007/08/avandia-and-actos-get-a-black-box/#comment-17010 Ed Silverman Wed, 15 Aug 2007 22:49:29 +0000 http://www.pharmalot.com/2007/08/avandia-and-actos-get-a-black-box/#comment-17010 Hi BJ, I appreciate the clarification and that you're not being argumentative, just trying to keep everything - and everyone - in line. And that's good. I see your point. For whatever reason, although the panel was asked to address Avandia, there was an expectation that warnings would also be extended to Actos, for various reasons. I was referring to that point, although I agree I could have been more eloquent in my previous comment to you. As an aside, I did write on July 30 that David Graham made a contrast between Avandia and Actos heart attack risks - a lot and none, or words to that effect. I've been aware of the distinction you're making and, I believe, I got it right previously. In the end, though, they both did receive the same warning anyway, for CHF. I'm not trying to be argumentative either. I simply thought I was clear. If not, apologies. But I'm trying. Regards ed Hi BJ,

I appreciate the clarification and that you’re not being argumentative, just trying to keep everything - and everyone - in line. And that’s good.

I see your point. For whatever reason, although the panel was asked to address Avandia, there was an expectation that warnings would also be extended to Actos, for various reasons. I was referring to that point, although I agree I could have been more eloquent in my previous comment to you.

As an aside, I did write on July 30 that David Graham made a contrast between Avandia and Actos heart attack risks - a lot and none, or words to that effect. I’ve been aware of the distinction you’re making and, I believe, I got it right previously. In the end, though, they both did receive the same warning anyway, for CHF.

I’m not trying to be argumentative either. I simply thought I was clear. If not, apologies. But I’m trying.

Regards
ed

]]> By: BJ http://www.pharmalot.com/2007/08/avandia-and-actos-get-a-black-box/#comment-17007 BJ Wed, 15 Aug 2007 22:30:47 +0000 http://www.pharmalot.com/2007/08/avandia-and-actos-get-a-black-box/#comment-17007 Yes, you did refer to heart failure in the original post, however, you are not correct regarding whatever happens to Avandia will probably happen to Actos. Actos is the only TZD with a "completed" cardiovasular outcomes study. This study shows a decrease in risk with a hazard ratio of .84, which is a 16% risk reduction for heart attack. In the 7/30 meeting, panelists said themselves that Actos did not appear to be the same. The recommendations for stronger labeling were only directed at GSK and Avandia due to increase in risk of heart attack. They may be in the same class, but they act differently in the body. Actos decreases trigs, Avandia raises them. Actos increases LDL particle size more than Avandia. Each of these creates a scenerio that would lessen the risk of heart attack. I am not arguing, just trying to clear the mud that seems to always get in the water by media folks. I just get tired of hearing half truths and comments that are so easily taken out of context. Yes, you did refer to heart failure in the original post, however, you are not correct regarding whatever happens to Avandia will probably happen to Actos. Actos is the only TZD with a “completed” cardiovasular outcomes study. This study shows a decrease in risk with a hazard ratio of .84, which is a 16% risk reduction for heart attack. In the 7/30 meeting, panelists said themselves that Actos did not appear to be the same. The recommendations for stronger labeling were only directed at GSK and Avandia due to increase in risk of heart attack. They may be in the same class, but they act differently in the body. Actos decreases trigs, Avandia raises them. Actos increases LDL particle size more than Avandia. Each of these creates a scenerio that would lessen the risk of heart attack. I am not arguing, just trying to clear the mud that seems to always get in the water by media folks. I just get tired of hearing half truths and comments that are so easily taken out of context.

]]> By: Ed Silverman http://www.pharmalot.com/2007/08/avandia-and-actos-get-a-black-box/#comment-16971 Ed Silverman Wed, 15 Aug 2007 11:31:30 +0000 http://www.pharmalot.com/2007/08/avandia-and-actos-get-a-black-box/#comment-16971 Dear BJ, The facts are correct. I wrote the warnings came 'after' the July 30 meeting, not a result of the meeting. But the agency asked its panel for a recommendation to act on, did it not? And while the meeting focused on Avandia, there was wide expectation in and out of the agency that any warning would also apply to Actos. This was widely reported. In addition, this post refers to heart failure only. We try to get our facts straight, and when we don't, we gladly correct mistakes. In this instance, however, we believe the post is correct. Nonetheless, your comments are appreciated and we thank you for stopping by. ed Dear BJ,

The facts are correct. I wrote the warnings came ‘after’ the July 30 meeting, not a result of the meeting. But the agency asked its panel for a recommendation to act on, did it not?

And while the meeting focused on Avandia, there was wide expectation in and out of the agency that any warning would also apply to Actos. This was widely reported. In addition, this post refers to heart failure only.

We try to get our facts straight, and when we don’t, we gladly correct mistakes. In this instance, however, we believe the post is correct.

Nonetheless, your comments are appreciated and we thank you for stopping by.

ed

]]> By: BJ http://www.pharmalot.com/2007/08/avandia-and-actos-get-a-black-box/#comment-16968 BJ Wed, 15 Aug 2007 11:06:54 +0000 http://www.pharmalot.com/2007/08/avandia-and-actos-get-a-black-box/#comment-16968 First of all, this boxed warning ws not a result of the July 30th meeting. This was asked to be done for both drugs in Feb. of this year. The recommendations from July 30th were strictly for Avandia and an increase risk of heart attacks. Make sure that you get the facts straight before you put these type of things up here. Actos has no data to show any increased risk of heart attack or any macrovasular events. The only issue is risk of CHF. With that being said, proper prescribing is essential. The high rates of CHF come from giving the drugs to class 3 and 4 heart failure pts, which by the way, neither drug have ever been indicated for that. So...thank your doctors for this warning as they are the ones with bad rxing habits that caused the rate to be as high as it is. First of all, this boxed warning ws not a result of the July 30th meeting. This was asked to be done for both drugs in Feb. of this year. The recommendations from July 30th were strictly for Avandia and an increase risk of heart attacks. Make sure that you get the facts straight before you put these type of things up here. Actos has no data to show any increased risk of heart attack or any macrovasular events. The only issue is risk of CHF. With that being said, proper prescribing is essential. The high rates of CHF come from giving the drugs to class 3 and 4 heart failure pts, which by the way, neither drug have ever been indicated for that. So…thank your doctors for this warning as they are the ones with bad rxing habits that caused the rate to be as high as it is.

]]> By: Neil http://www.pharmalot.com/2007/08/avandia-and-actos-get-a-black-box/#comment-16965 Neil Wed, 15 Aug 2007 08:35:07 +0000 http://www.pharmalot.com/2007/08/avandia-and-actos-get-a-black-box/#comment-16965 Shocked no it only took 7 plus years and countless deaths and disabilities. Had the Ceo's of these companies been the lab rats I bet safety would well override profit margin. However that was not the case with this class of drugs. All they did was gain fat bonuses and happy stock holders. However hundreds or even trhousands paid the price. Much like my father who had no idea nor we his family. We had no idea the drug he took carried such a risk. His blodd sugar was under control he even passed a full physical exactly 3 weeks prior to a no warning sign massive and fatal heart attack. Nothing now will bring him back nor replace or repair the hardship this placed on my mother. Lets face it if a car made today had a brake failure rate of 1:50 like these drugs do I know it would not take 7 plus years for someone to notice. Of course seems the very ones approving todays drug have or had ties to the companies begging approval. I often wonder what type perks go along with a thumbs up approval. I wonder how many lives have been turned upside down while this debate on what do we do to save the stock prices of the mega drug empires. Maybe someone will wake up and put safety first instead of planning that next dream vacation. Shocked no it only took 7 plus years and countless deaths and disabilities. Had the Ceo’s of these companies been the lab rats I bet safety would well override profit margin. However that was not the case with this class of drugs. All they did was gain fat bonuses and happy stock holders. However hundreds or even trhousands paid the price. Much like my father who had no idea nor we his family. We had no idea the drug he took carried such a risk. His blodd sugar was under control he even passed a full physical exactly 3 weeks prior to a no warning sign massive and fatal heart attack. Nothing now will bring him back nor replace or repair the hardship this placed on my mother. Lets face it if a car made today had a brake failure rate of 1:50 like these drugs do I know it would not take 7 plus years for someone to notice. Of course seems the very ones approving todays drug have or had ties to the companies begging approval. I often wonder what type perks go along with a thumbs up approval. I wonder how many lives have been turned upside down while this debate on what do we do to save the stock prices of the mega drug empires. Maybe someone will wake up and put safety first instead of planning that next dream vacation.

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