FDA to make asthmatics suffer

[Danoff]

Decided this one was for the opinion forum rather than current events.

http://www.foxnews.com/story/0,2933,182944,00.html

I'm a little late with this story, but I thought it was interesting. The US FDA in all of its wisdom and glory is teaming up with environmental policies to attempt to murder asthma sufferers by stripping them of their inhalers - get this, because the CFC's in their inhalers contribute to the ozone hole.

The wikipedia entry on the FDA has been attacked

http://en.wikipedia.org/wiki/FDA

But it was a high quality entry prior to that attack as it explained why an organization like the FDA easily results in more death than it saves.

Edit: Thanks for the info flame

 

[Flame-returns]

You most certainly can die from an asthma attack and asthma is one of the main killers in the UK.

Personally I doubt that inhalers have a massive detremental effect on the environment. Looking at mine (the brown one rather than the blue) I see that it contains 100 micrograms of Bechlazone Dipropionate per dose and that it contains 200 doses. No idea how many CFCs that is but at a guess I would say that I bear little responsibility for damaging the ozone layer.

Which looks more damaging;

this

or this

?

 

[FoolKiller]

I saw this and sent it to my brother who is an asthmatic and pharmacy student as well as a tree hugger extraordinaire. I wanted his thoughts. This is what he had to say about it:

From personal experience and as a future pharmacist, I think Primatine Mist should be pulled off the market, but for different reasons. The active ingredient is epinephrine (adrenaline). It's hardly effective at treating asthma; in fact, it's more selective to heart muscle, putting your heart into overdrive, and the cardiovascular side effects outweigh the risks, especially in the U.S. where cardiovascular disease is the #1 killer. Remember that many asthmatics are smokers, obese, or aged... it's just not worth it.

If you have an asthma attack, you should not use Primatine as your rescue inhaler. Back in 1998, long before I went to pharmacy school and knew what I was doing, I tried to self-treat with Primatine. I quickly realized my error and made a doctor's appointment.

Wyeth could reformulate Primatine with a non-CFC propellant, submit an abbreviated new drug application (ANDA), and safely keep Primatine on the market. ANDAs are much, much faster and cheaper than the NDA process for new drugs, because you only demonstrate the reformulation's absorption profile since the drug's safety/effectiveness has already been shown (but in Primatine's case, epinephrine has been around so long that it's "grandfathered" in and doesn't have to show safety/effectiveness... that's a good thing, because it would not be approved by today's FDA standards). Wyeth doesn't want to submit an ANDA because Primatine only brings in a few million in sales; that's because Primatine is a poor treatment for asthma (duh!), and Wyeth knows it's not worth it.

Then later on I talked to a few friends with asthma and none of them used an OTC inhaler. They all tried them but found them useless.

It seems to me that the FDA is not about to harm many people with this. The only ones that will suffer will be people with very minor asthma.

The reasoning being used in this is truly ridiculous but I don't see any true harm being done. This might just mean I need a wider point of view.

All that said, I still think that the FDA should be prevented from this on the grounds that stopping any kind of medication for non-medical grounds is absurd and should be beyond their power. They are over-stepping their bounds and making a bad case in doing it. My brother, a second-year pharmacy student, made a better argument than they did.



The problem with this story is that it is a three-sided case of scare tactics.

1. Steven Milloy (the article's author) is using scare tactics in saying that the FDA wants to take inhalers away. His opening paragraph leaves it hanging like that without saying that it is OTC only. Theen even after he does say it he makes it sound like it is a case of tough luck for the users it does affect. He is guilty of the very thing he accuses environmentalists of weekly.
   
2. The FDA is using environmental scare tactics to pull an ineffective product off the shelves since they can't find any other way to do it. This tactic will allow Wyeth and other companies to replace the product while using the same ineffective active ingredient. They fail in their overall goal.
   
3. Wyeth is scaring their customers by saying it will take years to develop a new version when they are currently making a non-CFC prescription product. All they would have to do is put the old drug in the other inhaler device that they already have.

All in all I think this story smells from all three angles.

 

[Swift]

I have exercised induced asthma. And if the FDA thinks for 2 seconds that they can take my inhaler because of the ozone hole, their are out of there minds!

 

[Danoff]

I have exercised induced asthma. And if the FDA thinks for 2 seconds that they can take my inhaler because of the ozone hole, their are out of there minds!

If you use an OTC inhaler you just might be out of luck.

The FDA is using environmental scare tactics to pull an ineffective product off the shelves since they can't find any other way to do it. This tactic will allow Wyeth and other companies to replace the product while using the same ineffective active ingredient. They fail in their overall goal.

The FDA isn't pulling the product off the shelf. This actually isn't really totally the FDA's fault. Environmental policies would have pulled this product years ago were it not for the FDA stepping in and calling inhalers "essential medication". But they're about to revoke that label, which leaves it at the mercy of environmentalists.

But I hate the FDA so any opportunity to smear them is one I'm going to pounce on, and they're well aware that removing that label will mean that asthmatics will not have access to inhalers OTC for a couple of years. Keep in mind that the FDA has to approve the replacement product that won't use CFCs.

 

[FoolKiller]

Keep in mind that the FDA has to approve the replacement product that won't use CFCs.

According to RegFactSheet:

ANDAs are filed with the Office of Generic Drugs at the FDA. The review time for approval of an ANDA ranges from 12-24 months with an average approval time of approximately 16 months.

If Wyeth were to file now they could be approved before this would take effect. This is just a recommendation panel and not a final decision at this point. It will be a year or two before it would take effect, if it were approved. Wyeth could get around this and not lose money if this appears to be a definite outcome.

Or the FDA could quit being jerks and just let it go.

 

[Danoff]

If Wyeth were to file now they could be approved before this would take effect.

When will this take effect? I did a quick scan of the article and it didn't mention when this would take effect (maybe I missed it), only that replacements probably wouldn't be available until 2009-2010.

 

[Swift]

If you use an OTC inhaler you just might be out of luck.

It's a prescription.

 

[Danoff]

It's a prescription.

Then I think you're still protected under the "essential" safety blanket for now.

 

[FoolKiller]

Then I think you're still protected under the "essential" safety blanket for now.

Most prescriptions don't use CFCs anyway. Very few prescription inhalers will be affected.

 

[Danoff]

Most prescriptions don't use CFCs anyway. Very few prescription inhalers will be affected.

...and most serious sufferers of asthma aren't going to rely on OTC inhalers anyway. So what are you trying to say? Are you trying to tell me that my title for this thread is a little over-the-top and that I should back it off?

ok... fine...

 

[FoolKiller]

...and most serious sufferers of asthma aren't going to rely on OTC inhalers anyway. So what are you trying to say? Are you trying to tell me that my title for this thread is a little over-the-top and that I should back it off?

ok... fine...

I'm saying that prescription inhalers don't fall under the essential safety blanket anyway. You used the words for now making it sound as if they were attacking prescription inhalers next.

I could care less about the title.

 

[Danoff]

I'm saying that prescription inhalers don't fall under the essential safety blanket anyway. You used the words for now making it sound as if they were attacking prescription inhalers next.

I could care less about the title.

What percentage of prescription inhalers use CFCs?

 

[FoolKiller]

What percentage of prescription inhalers use CFCs?

I don't have a percentage but Hydrofluoroalkane (HFA) is an "ozone-friendly" propellant used in many prescription inhalers such as Albuterol HFA and Flovent HFA. Those are the two most popular.

I am sure some prescription inhalers use CFCs still but according to this Seattle Times article it is a phase out period through 2008 and Wyeth seems to just be trying to make trouble. I am sure if it were an issue with anyone else they would be in the complaint with Wyeth.

It seems to me like this will be an across the board thing with a multiple year-long deadline.

Maybe this is just Wyeth trying to stand up against the FDA for making bad policy based on reasoning that should be outside their reach. If they are purposely harassing the FDA I must say I applaud them. 👍

 

[Canadian Speed]

I'm sure it was the inhalers and not this that caused all the problems we're having today... http://www.athropolis.com/arctic-facts/fact-bomb.htm

 

[Sage]

Woah, I didn’t even know OTC inhalers existed – every single asthmatic I’ve ever known (myself included) has used Albuterol.

 

[BuzzOrHowl]

I have pretty serious asthma, and I use two different kinds of inhaler (Flovent and Albuterol) . When they switched to ozone friendly propellants, I wouldn't have even noticed except for my pharmacist mentioning it regarding the Flovent... So this alleged attempt to "take away our inhalers" had so little impact that as a double inhaler using athsmatic I didn't even notice... in the meantime, laws like the clean air act have reduced particulate matter in the air I breathe and reduced my athsma...That I have noticed, and it makes a big difference... My point is that people who are out to paint environmentalists as asthmatic killers are forcing an ideological agenda that has no basis in reality. Thanks to the efforts of environmentalists, my athsma is triggered less often and my quality of life is improved... Funny how Fox just left out the experiences of asthmatics like me in their inflamatory story...

Fox News: We distort, You don't know any better...

 

[High-Test]

My Athsma used to be so bad that I had 3 inhalers and an albuterol nebulizer back in 3rd grade -all of them I used almost regularly.

After years of Ventolin, Serevent, Tilade, and later Flovent, they finaly switched me over to Advair. It's so much easier to use and keep track of. Since Advair is a powder that is inhaled from a little packet, isn't Advair CFC proof?


Primatene Mist sucks, by the way. I've used it twice in my life, once before I knew I had Athsma (kindergarten-ish) and once last year on a sunday when Osco's pharmacy was closed. Didn't do hardly diddly, and it made me feel really odd inside.

 

[Anderton Prime]

Call me crazy, but doesn't whatever is in the asthma inhaler go into your lungs, not the outside air? And if it's true that this stuff is depleting the ozone layer, what is it doing to asthmatics' bronchi?

 

[High-Test]

Call me crazy, but doesn't whatever is in the asthma inhaler go into your lungs, not the outside air? And if it's true that this stuff is depleting the ozone layer, what is it doing to asthmatics' bronchi?

Uh... 💡








Redecorating our alveoli?

 

[FoolKiller]

I'm sure it was the inhalers and not this that caused all the problems we're having today... http://www.athropolis.com/arctic-facts/fact-bomb.htm

Except that the hole in the ozone layer is on the opposite side of the globe.

Funny how Fox just left out the experiences of asthmatics like me in their inflamatory story...

Fox News: We distort, You don't know any better...

Funny how you missed that Junk Science is an independent website that is syndicated by Fox News, or the fact that the author does make a point that the FDA is passing a ruling that shouldn't be within their power based on bad science.

Maybe you also missed that the article was in the Views section. This is the same section that also has articles from ifeminists.com and Martin Frost, former chairman of the House Democratic Caucus.

Call me crazy, but doesn't whatever is in the asthma inhaler go into your lungs, not the outside air? And if it's true that this stuff is depleting the ozone layer, what is it doing to asthmatics' bronchi?

Good question. According to this CDC article It causes heart problems and lung depressions with long-term high level exposure. In test cases it required 10,000 ppm for more than five minutes to have an effect. Dogs developed arrhythmias and fibrillation with 5,000 ppm over time.

That said, legal limits are no more than 1,000 ppm over an 8 hour period for workers and no more than 1,250 ppm over a 15 minute period. I am guessing that inhalers are putting out much less than that and it is for a split second.

So, like all poisons the secret is in the size of the dose.

 

[Danoff]

I have pretty serious asthma, and I use two different kinds of inhaler (Flovent and Albuterol) . When they switched to ozone friendly propellants, I wouldn't have even noticed except for my pharmacist mentioning it regarding the Flovent... So this alleged attempt to "take away our inhalers" had so little impact that as a double inhaler using athsmatic I didn't even notice... in the meantime, laws like the clean air act have reduced particulate matter in the air I breathe and reduced my athsma...That I have noticed, and it makes a big difference... My point is that people who are out to paint environmentalists as asthmatic killers are forcing an ideological agenda that has no basis in reality. Thanks to the efforts of environmentalists, my athsma is triggered less often and my quality of life is improved... Funny how Fox just left out the experiences of asthmatics like me in their inflamatory story...

Fox News: We distort, You don't know any better...

Iteresting how self-centered this post is. I don't have asthma, and I don't really know anyone with serious asthma. I brought this thread up out of concern over what our laws are doing to people I don't even know. You respond by saying "well it doesn't affect me, so what do I care?" typical liberal response - not caring about the people these laws are screwing over (ie: asthma sufferers that use OTC inhalers).