@jackmallory: "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withdrawn because of safety concerns.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
<quote>"
    @RaekaCeek: "Doesn't anyone read other people's post?
This is the 3RD Time this has been reported here since yesterday.
<email_address> wrote in message 
news:<email_address>
| 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
| >>>
| "
    @none: "news:<email_address>
<quote>
I know my newsreader doesn't update that often. (Sigh) So you have to be
understanding.
Joy"
    @RaekaCeek: "Sorry. Didn't realize that.
Rae
news:<email_address>
|
| news:<email_address>
| > 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
|
|"
    @RaekaCeek: ""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
<email_address> wrote in message 
news:<email_address>
| 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"
| 
<url>
|
| -George
| "
    @kwinkler: "Thank you <email_address> 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 
$151, it seems like a lot.  However, there was undoubtedly a lot of R&D cost 
that went into developing and testing it.  Above all, it works!  Because of 
that, it's worth every penny as far as I'm concerned.  Of course it helps 
that I have insurance!
Keith"
    @Chefchk: "<quote>
Let me tell you something, they will have to pry the Advair out of my 
cold, dead fingers.  That drug has given me a damn life, and if they try 
to take it away from me I will hunt them down like dogs.  I finally, 
finally find something that works and they want to take it away??? I 
dont think so.  They can just forget it.   I will get my asthmatic ass 
down there and make a ruckus the likes of which they have never seen. 
Take my Advair away.  Just let them try it.
Life is uncertain........eat dessert first!
Nancy
8= : )"
    @forum: "<quote>
Those figures are quite reassuring.
The studies that have raised concerns showed that it may be dangerous 
for asthmatics to take Serevent without an inhaled steroid. So pretty 
much asthmatics should be on either Advair or Serevent with another 
inhaled steroid and not just Serevent alone. The fugures you cite seem 
to suggest that this is exactly what is happening the vast majority of 
the time.
You'll note that whenever someone cites a concerning stat claiming 
excess deaths it is alwasy Serevent that is mentioned and never 
Adviar. As far as I have seen the data on Serevent plus a steroid (i.e 
Advair or other combos) has been nothing but good.
All of this has been discussed ad nauseum many times on this board 
before. I would suggest (again - as several others have done on 
several other times) that Rae become aquainted with the archives 
before posting these alarms as if they are new.
00doc "
    @marys: "news:uaZBe.11314$<email_address>
<quote>
<url>
the
anymore.
take
prescribed
a
breathing
the
gets
Well said, Elizabeth. I could not cope without Advair."
    @RaekaCeek: "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!
"Nancy" <email_address> wrote in message 
news:VU%Be.5578$<email_address>
| > 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
| >
| >
| 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 ass
| 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= : ) "
    @RaekaCeek: ""00doc" <email_address> wrote in message 
news:<email_address>
| > "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.
|
| 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
| 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.
uh, excuse me there but I didn't post this. Perhaps you should review the 
posts!
|
|  
| 00doc
|
| "
    @00doc: "<quote>
And you replied:
"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]."
00doc "
    @00doc: "<quote>
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).
Why should this be any different than any other aspect of our society?
00doc "
    @Chefchk: "<quote>
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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