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Medical Forum / Diseases and Disorders / Asthma / July 2005

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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withdrawn because of safety concerns.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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