Medical Forum / Diseases and Disorders / Asthma / July 2005
Withdraw Advair?
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jackmallory@webtv.net - 13 Jul 2005 17:48 GMT Fresh from the New York Times
<<< July 13, 2005 Experts to Consider Withdrawal of Asthma Drugs By DENISE GRADY A panel of lung experts is being convened today to advise the government on whether three popular asthma drugs should stay on the market or be withdrawn because of safety concerns. The drugs are Advair and Serevent, made by GlaxoSmithKline, and Foradil, made by Novartis and sold in the United States by Schering Plough. Advair and Serevent contain the same drug, salmeterol; in Serevent, salmeterol is alone, while in Advair it is combined with another medicine. Foradil does not contain salmeterol; its active ingredient is formoterol. The drugs are inhaled to keep the airways open, preventing asthma attacks. Patients are to take them every day even if they are feeling well. The drugs are different from the inhaled medicines used to treat attacks. Concerns have arisen about the three drugs, the Food and Drug Administration said, because in a small number of patients they "have been associated with severe asthma exacerbations." Advair and Serevent already carry warnings about a study that showed a small but significant increase in deaths among people who added the drugs to their usual asthma treatment: 13 deaths in 13,176 patients who took the drugs, versus 3 in 13,179 who took placebos. Foradil was not part of the study and does not carry such a warning. Serevent was one of the drugs singled out by Dr. David Graham, a drug agency reviewer who began speaking out in November about what he called the F.D.A.'s inability to protect the public from unsafe drugs. The meeting today is of an advisory committee of 14 asthma experts who are expected to review the data on the drugs, listen to presentations from the manufacturers and others, and then vote on whether the products should be left as they are, relabeled or taken off the market altogether. Spokeswomen for both companies said they would present data showing that the drugs' benefits far outweighed their risks, and that they should be left on the market. More than 21 million adults and 8 million children in the United States have asthma. Dr. Erwin W. Gelfand, chairman of pediatrics at the National Jewish Medical and Research Center, a hospital for respiratory diseases in Denver, said that he and many other doctors treating asthma thought the drugs helped many patients. "There is no doubt," Dr. Gelfand said. "To my knowledge, when you look at the overall picture from a number of studies there's not really a danger emerging." Advair, sold overseas as Seretide, was the third-best-selling drug in the world in 2004, with sales of more than $4.5 billion. In the past 12 months in the United States, 17.2 million Advair prescriptions were filled. Serevent's sales were $639 million last year, and Foradil's $320 million. Copyright 2005 The New York Times Company
Rae - 13 Jul 2005 19:38 GMT Doesn't anyone read other people's post?
This is the 3RD Time this has been reported here since yesterday.
| Fresh from the New York Times | [quoted text clipped - 49 lines] | million. | Copyright 2005 The New York Times Company TRN - 13 Jul 2005 20:15 GMT > Doesn't anyone read other people's post? > > This is the 3RD Time this has been reported here since yesterday. I know my newsreader doesn't update that often. (Sigh) So you have to be understanding.
Joy
Rae - 13 Jul 2005 21:05 GMT Sorry. Didn't realize that.
Rae
| > Doesn't anyone read other people's post? | > [quoted text clipped - 4 lines] | | Joy gpark@bestofaltoona.com - 15 Jul 2005 06:17 GMT Ok I know a lot has been posted on this but I read another really good article about it on health.dailynewscentral.com, so if you get a chance do check it out. It really enrages me that drug companies will put so many people's lives at risk just for a buck(or many bucks rather!).
"Controversial Asthma Drugs to Remain on Market" http://health.dailynewscentral.com/content/view/1281/31//controversial_asthma_dr ugs_remain_on_market.html
-George
Rae - 15 Jul 2005 15:08 GMT "In 2004, Advair's US sales of $2.4 billion were 10 times that of Serevent's $236 million, Glaxo spokeswoman Lisa Behrens said. Foradil's worldwide sales in 2004 totaled $320 million, Novartis spokesman John Kouten said. "
With figures like that, did anyone really think they'd pull these meds? The FDA is just doing their usual little dance to show they are trying to do their job.
There will have to be a lot more deaths and a lot more public awareness and perhaps even lawsuits before that happens.
Rae
| Ok I know a lot has been posted on this but I read another really good | article about it on health.dailynewscentral.com, so if you get a chance | do check it out. It really enrages me that drug companies will put | so many people's lives at risk just for a buck(or many bucks rather!). | | "Controversial Asthma Drugs to Remain on Market" http://health.dailynewscentral.com/content/view/1281/31//controversial_asthma_dr ugs_remain_on_market.html
| -George 00doc - 16 Jul 2005 16:53 GMT > "In 2004, Advair's US sales of $2.4 billion were 10 times that of > Serevent's $236 million, Glaxo spokeswoman Lisa Behrens said. [quoted text clipped - 8 lines] > There will have to be a lot more deaths and a lot more public > awareness and perhaps even lawsuits before that happens. Those figures are quite reassuring.
The studies that have raised concerns showed that it may be dangerous for asthmatics to take Serevent without an inhaled steroid. So pretty much asthmatics should be on either Advair or Serevent with another inhaled steroid and not just Serevent alone. The fugures you cite seem to suggest that this is exactly what is happening the vast majority of the time.
You'll note that whenever someone cites a concerning stat claiming excess deaths it is alwasy Serevent that is mentioned and never Adviar. As far as I have seen the data on Serevent plus a steroid (i.e Advair or other combos) has been nothing but good.
All of this has been discussed ad nauseum many times on this board before. I would suggest (again - as several others have done on several other times) that Rae become aquainted with the archives before posting these alarms as if they are new.
 Signature 00doc
Rae - 19 Jul 2005 05:05 GMT | > "In 2004, Advair's US sales of $2.4 billion were 10 times that of | > Serevent's $236 million, Glaxo spokeswoman Lisa Behrens said. [quoted text clipped - 10 lines] | | Those figures are quite reassuring. Yeah, figures you would view it that way.
| The studies that have raised concerns showed that it may be dangerous | for asthmatics to take Serevent without an inhaled steroid. So pretty [quoted text clipped - 12 lines] | several other times) that Rae become aquainted with the archives | before posting these alarms as if they are new. uh, excuse me there but I didn't post this. Perhaps you should review the posts!
00doc - 20 Jul 2005 02:54 GMT Ummm let's see. I said:
>> You'll note that whenever someone cites a concerning stat claiming >> excess deaths it is always Serevent that is mentioned and never >> Adviar. And you replied:
> uh, excuse me there but I didn't post this. Perhaps you should > review > the posts! But apparently you forgot that in just the post prior you had said:
"There will have to be a lot more deaths and a lot more public awareness and perhaps even lawsuits before that happens [Advair gets pulled from the market]."
 Signature 00doc
00doc - 20 Jul 2005 02:57 GMT >> Those figures are quite reassuring. > > Yeah, figures you would view it that way. I notice that you don't have any arguement as to why I am wrong.
 Signature 00doc
Elizabeth Blake - 16 Jul 2005 02:12 GMT > Ok I know a lot has been posted on this but I read another really good > article about it on health.dailynewscentral.com, so if you get a chance [quoted text clipped - 5 lines] > > -George I've been using Advair for the past 2 1/2 years. I was diagnosed with asthma when I was 2 years old. My childhood was hell because of it. By the time I reached high school/teen years, it almost seemed to disappear. It would flare up at times but it wasn't a constant, everyday problem anymore. That continues through my 20's. 8-9 years ago I started to have a lot of breathing problems again. Went to one doctor who was a complete idiot and refused to prescribe anything but an albuterol inhaler. He told me to take 4-6 puffs at a time if 2 didn't help. Went to another doctor who prescribed Azmacort. After a couple fo months it was obvious that it didn't do much, and he presribed a pill (forget which) and then sent me to a specialist. The specialist took me off whatever pill my PCP had prescribed and gave me a script for Singulair instead. I spent the next 5 years on those, breathing only slightly better than I had before. My current PCP told me to stop the Azmacort and gave me a script for Advair 2 1/2 years ago. Within a few days, I could breathe freely again. I wasn't able to walk more than two blocks before Advair, and I found myself not needing the albuterol/rescue inhaler anymore. Since starting Advair, I've used the rescue inhaler 6-8 times.
Every medication has risks, but for me the benefits of Advair FAR outweigh the risks. I am obviously not one of the people whose symptoms/asthma gets worse from it. If Advair is taken off the market, I'll be back to looking for something else to help me breathe and whatever I choose will also have side effects and people saying it should be taken off the market.
-- Liz
Keith Winkler - 16 Jul 2005 03:20 GMT Thank you gpark@bestofaltoona.com for posting that link. I was worried that we would lose Advair. It has done a lot of good for me. Prior to starting it, I was barely able to function. Just like Liz, I could barely walk two blocks. Now I can walk for miles with no problem.
What people tend to forget is that prescription drugs can be dangerous and have adverse side effects. That's why they are prescription drugs to be taken only under a physician's supervision. Sure GlaxoSmithKline makes a lot of money from Advair. When I look at this plastic thing that costs $151, it seems like a lot. However, there was undoubtedly a lot of R&D cost that went into developing and testing it. Above all, it works! Because of that, it's worth every penny as far as I'm concerned. Of course it helps that I have insurance!
Keith
Mary - 17 Jul 2005 07:46 GMT > > Ok I know a lot has been posted on this but I read another really good > > article about it on health.dailynewscentral.com, so if you get a chance > > do check it out. It really enrages me that drug companies will put > > so many people's lives at risk just for a buck(or many bucks rather!). > > > > "Controversial Asthma Drugs to Remain on Market" http://health.dailynewscentral.com/content/view/1281/31//controversial_asthma_dr ugs_remain_on_market.html
> > -George > [quoted text clipped - 24 lines] > > -- Well said, Elizabeth. I could not cope without Advair.
Donald Link - 16 Jul 2005 05:39 GMT Did you ever think that for every bad reaction there might be hundreds that it helps. Of course drugs have side effects, but most problems do arise because most people do not research and have no idea what reaction with other drugs. The dumb sh.t that try such things as viagra with a heart condition deserves to take the blame not the drug. All I know is that when I was a kid 60 years ago the treatment for asthma did not exist and many died an early death, probably thousands than the few that do now.
>Ok I know a lot has been posted on this but I read another really good >article about it on health.dailynewscentral.com, so if you get a chance [quoted text clipped - 5 lines] > >-George Nancy - 16 Jul 2005 05:17 GMT > Fresh from the New York Times > [quoted text clipped - 49 lines] > million. > Copyright 2005 The New York Times Company Let me tell you something, they will have to pry the Advair out of my cold, dead fingers. That drug has given me a damn life, and if they try to take it away from me I will hunt them down like dogs. I finally, finally find something that works and they want to take it away??? I dont think so. They can just forget it. I will get my asthmatic a.s down there and make a ruckus the likes of which they have never seen. Take my Advair away. Just let them try it.
Life is uncertain........eat dessert first!
Nancy 8= : )
Rae - 19 Jul 2005 05:03 GMT I'm glad all you guys have found something to give you relief. Truy I am. ASthma is horrible. I've been there. But as long as you give Advair such glowing accolades, don't expect the drug company to rush any improvements to market. You should instead be DEMANDING a safer alternative from them!
You have the money....you have the power!
| > Fresh from the New York Times | > [quoted text clipped - 62 lines] | Nancy | 8= : ) 00doc - 20 Jul 2005 02:56 GMT > I'm glad all you guys have found something to give you relief. Truy > I > am. ASthma is horrible. I've been there. But as long as you give > Advair such glowing accolades, don't expect the drug company to rush > any improvements to market. You should instead be DEMANDING a safer > alternative from them! What on earth makes you think that drug companies have no interest in making safer and more effective meds?
Sure when they can't they'll try other methods of maintaining profts, some of which range from shady to downright despicable. But the best way to make lots of money will always be to make a better product (and then charge an arm and a leg for it).
> You have the money....you have the power! Why should this be any different than any other aspect of our society?
 Signature 00doc
Nancy - 20 Jul 2005 05:07 GMT > I'm glad all you guys have found something to give you relief. Truy I am. > ASthma is horrible. I've been there. But as long as you give Advair such [quoted text clipped - 69 lines] > | Nancy > | 8= : ) What exactly do they need to improve? Advair works wonderfully. I am just about totally off oral steroids, and for me that is a majorly big deal, I've been taking the oral steroids for the last 8 years. It's fine just the way it is, and they better not mess around with it.
Life is uncertain........eat dessert first!
Nancy 8=: )
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