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New inhalers leave patients breathless
June 13, 2009 3:55 PM   Subscribe

"If we could take deep breaths, we wouldn't need the inhalers." As of the beginning of this year, inhalers used by 40 million asthmatics in the U.S. to deliver life-saving medicines can no longer be powered by chlorofluorocarbon CFCs. The propellants used now are hydroflouroalkane HFAs. The FDA (PDF with Comic Sans!) and doctors insist that the new inhalers are just as effective as the old ones, but many asthma sufferers are adamant that they are not. Oh, and the new inhalers cost three times as much as the old ones.

The change to HFAs was not well-publicized, and many patients and doctors were taken by surprise.
Proper use of the HFA inhalers is also causing problems. The new ones have to be primed first, spraying up to as many as four quick spurts into the air, if they haven’t been used in a couple of weeks. Also, they carry a larger risk of clogging.

“If you don’t clean them regularly, they won’t dispense properly,” Williams said. “I carry one in my purse and in my car for emergencies. If I don’t take them out and clean them, then they won’t give out the right amount.”

Finally, Freudenberger said many patients can’t tell when the new inhalers are actually empty. With the CFC inhaler, patients could get a good feel for when there was still medication in the container.

“If you moved them back and forth, you could hear if any medication remained,” he said. “Also, you could put it in water. If it floated, it was empty.”

You can’t do either with the HFAs. When the medication is spent, there still remains some propellant.
Patients are frustrated, and some are turning to unusual places for answers.
posted by Kirth Gerson (189 comments total) 14 users marked this as a favorite

 
My wife just had to get hers refilled and was pretty shocked at the cost. The pharmacist was able to scrounge up a $15 off coupon for her to use, so you may want to ask about that if cost is an issue.
posted by Rock Steady at 4:02 PM on June 13, 2009


My partner has asthma and uses one of HFA inhalers occasionally. He reports that his inhaler works reasonably well for him, but the cost difference is indeed considerable, and that his insurance does not cover most of the cost increase.
posted by Blazecock Pileon at 4:03 PM on June 13, 2009


Never used anything but Turbohalers, which work perfectly fine for me, but a quick googling indicates that you're supposed to hate them, at least if you live in the US or the UK. Hmm.
posted by effbot at 4:05 PM on June 13, 2009 [1 favorite]


Sucks to their assmar
posted by 7segment at 4:05 PM on June 13, 2009 [20 favorites]


That's not comic sans.
posted by milnak at 4:05 PM on June 13, 2009


You can’t do either with the HFAs. When the medication is spent, there still remains some propellant.

He also says that inhalers have counters on them which indicate how many charges have been dispensed. When he hits 200 charges, he replaces the cylinder.
posted by Blazecock Pileon at 4:06 PM on June 13, 2009


One of the inhalers has a counter.
posted by Kirth Gerson at 4:08 PM on June 13, 2009


Yeah, my eyes about popped out of my head when my usual $5 co-pay for a generic albuterol went to $50 for the HFA name brand. Thankfully I don't have to use it very often since the advent of Advair (also not cheap, but to go from using a rescue inhaler 10X a day to once every few weeks was a godsend).

I also haven't noticed much of a difference in its effect, but that's also probably due to such an infrequent usage.
posted by mr_crash_davis mark II: Jazz Odyssey at 4:08 PM on June 13, 2009


One of the inhalers has a counter.

That could well be true. We're not experts on this. I'm just relating one person's experience with treating his asthma with the new stuff.
posted by Blazecock Pileon at 4:09 PM on June 13, 2009


My little brother has asthma, which he inherited from our mutual grandfather and has suffered from since he was painfully young. I do not.

I would much rather change my lifestyle to a point where it would be painful to me than rely on my brother being constantly aware of the state of his life-saving inhalers and maintaining their efficiency so that when the day comes when they will save his life, they will not only be there, but they will be ready. He's a grownup now in his own right, but it was not that long ago that he was just a kid; my own kid brother who might have an asthma attack if his big sister accidentally made him laugh too hard.

I am pretty sure that my brother and his fellow asthmatics are approximately the least of the problems facing those who would like to protect our environment. Why are we even targeting them?
posted by mayhap at 4:13 PM on June 13, 2009 [1 favorite]


That's not comic sans.

Tekton.
posted by Sys Rq at 4:16 PM on June 13, 2009


Megan McFuckinArdle, really? Keep that shit off the blue.

I had this flashback to three years ago, when it would seem perfectly normal to try to blame environmentalists for their insensitivity to people who just want to take deep breaths.
posted by fleacircus at 4:16 PM on June 13, 2009 [2 favorites]


I wanted to make a joke, something like "suck it up, asthmatics, for the good of the world," but this is really a bad deal. Surely an exception could have been made for this one usage.
posted by moonbiter at 4:29 PM on June 13, 2009 [4 favorites]


Where the environment is concerned, if molecules of CFCs persist for years in the atmosphere, it seems it doesn't really matter how "little" is used for pulmonary treatment. If the reality is that CFCs are not safe in any number, then a rational view of the situation would seem to call for using something else.

Personally, I'd like to see more research into improving the alternatives, as well as Congress stepping in to lift patent restrictions, so as to allow generics to be distributed earlier. Above all, asthma medicine is an attempt to monetize alleviating symptoms, as opposed to treating the cause of the problem. We could also be treating the problem with more stringent environmental laws that help clean our air and reduce asthma incidence rates from the start.

All of these tactics can be applied together to help improve people's lives, without using ozone-destroying chemicals.
posted by Blazecock Pileon at 4:33 PM on June 13, 2009 [7 favorites]


More than 3 times as much- my inhaler used to be 5 dollars with my insurance. Now, with the new propellant, they're 35. I don't get my inhaler filled every month anymore. Instead, I fill it once, and I save it for the worst asthma attacks. Hardly ideal, but I blame insurance companies and pharmaceutical companies, not environmentalists.
posted by headspace at 4:35 PM on June 13, 2009 [8 favorites]


Those old inhalers were also grossly overpriced. An albuterol inhaler that cost $35 in the US could be found for $3.50 in Mexico (the name-brand from a legit pharmacy). So the new ones will produce less spray and more profits for Big Pharma. Yippee.

The Buteyko breathing exercises are very effective for many asthma patients -- in terms of fending off breathing troubles and decreasing dependence on medication. These exercises were developed in a place called the USSR where access to medicines was limited but now, they've gained acceptance as an effective complementary therapy in capitalist countries where access to medicines is limited.

But everyone needs an airway.
posted by grounded at 4:37 PM on June 13, 2009 [4 favorites]


If the reality is that CFCs are not safe in any number, then a rational view of the situation would seem to call for using something else.

I was doing some Q&D research on this in response to this post and apparently the first-world ban on CFCs has had a measurable positive effect, eg. the antarctic o-hole is filling in at around 10% a year rate, with recovery to the 1990 baseline sometime later this century.

Plus the third world still can use CFCs to their heart's content.

The total ban strikes me of zero-tolerance BS but I reserve judgment.
posted by @troy at 4:42 PM on June 13, 2009


Oh, and the new inhalers cost three times as much as the old ones.

No. The cost to future generations of using this dangerous chemical is no longer being passed down to generations in the future. Instead, the actual users of the product have to pay the cost of using the polluting chemical.
posted by Ironmouth at 4:43 PM on June 13, 2009 [12 favorites]


I can't get too angry about this only because I'm so used to the whole, "Sorry, due to govt regs you're stuck with an inferior product and it's gonna cost you 3 or 4 times more" thing.

Considering the mechanics/physics behind using these gases as a delivery mechanism, I'm sure someone will find a fix soon. One would hope that some of that extra cost to the consumers is going into R&D.
posted by snsranch at 4:47 PM on June 13, 2009


"his insurance does not cover most of the cost increase."

That should not be legal - basing reimbursement rates on the price of old, completely different technology that can no-longer be sold.
I imagine it will change in time, but the insurance bureaucracy will no doubt move as slowly as it's able to.
posted by -harlequin- at 4:47 PM on June 13, 2009 [1 favorite]


Had non-CFCs in the UK for years... course with our good old NHS, it's price increase? What price increase?
posted by fearfulsymmetry at 4:50 PM on June 13, 2009 [9 favorites]


Except, Ironmouth, the actual users of the new, more expensive product are not using the polluting chemical, because it's not being used as the propellant anymore. It's more expensive because Pharmaceutical companies can classify it as a "new" drug, get a reboot on the amount of time before a generic can be made, and basically rake in money hand over fist for the same active ingredient with a new propellant.
posted by StrangeTikiGod at 4:50 PM on June 13, 2009 [17 favorites]


This sucks. Asthma and allergies are areas where insurers really stick it to consumers, too.

Yeah, my eyes about popped out of my head when my usual $5 co-pay for a generic albuterol went to $50 for the HFA name brand.

It's really ugly when there are no generic equivalents but the insurer doesn't allow the brand onto their formulary.
posted by Thorzdad at 4:52 PM on June 13, 2009


Aren't there any alternative methods that can use air pressure from a mechanical pump, the way some toy guns work? Pumping the pump may be too difficult for the asthmatic in the course of an attack, but it should be possible to substitute or add in parallel an electric motor. Press button A, wait a few seconds for the motor to compress the air, after which it beeps and flashes a LED; put the outlet to your mouth, start inhaling, and press button B to release a burst of compressed air laden with a dose of mist.
posted by aeschenkarnos at 4:52 PM on June 13, 2009 [3 favorites]


Rant continued: I own the exact inhaler that is pictured in the article! It was prescribed for me, not for asthma, which I do not have, but for the acute bronchitis I was suffering from earlier this cold/flu season.

Based on years of watching my asthmatic little brother coping with his disease, I knew exactly how to use an inhaler: exhale fully, trying to remove every bit of oxygen from your lungs, dispense the appropriate amount of medication from your inhaler, breath in deep and hold that breath for as long as humanly possible, ignoring everything that was going on around you, even if, for whatever reason, your older sister started laughing her head off. (At the time I was ten or eleven, but my six or seven-year-old brother seemed to be able to deal with both his asthma and his dorkass sister).

I had a huge amount of faith, so it didn't matter that my inhaler didn't act as promptly and as effectively as the ones that I'd spent my whole life observing. That's not going to be true for basically anyone who isn't me, and especially not anyone who has a chronic condition, instead of a passing one like I was suffering, where relief of my symptoms was a very good thing for me but not a matter of life or death.

Even with pollutants triggering allergies, is it really necessary to go after the asthmatics to attack global warming?
posted by mayhap at 4:54 PM on June 13, 2009 [1 favorite]


Instead, the actual users of the product have to pay the cost of using the polluting chemical.

dubious how much damage a single charge of CFC can cause in the increment, compared to the historical industrial uses of the agent.
posted by @troy at 4:55 PM on June 13, 2009


Bitch you did NOT just fuck with my Ventolin.

No, but seriously, I'm lucky I live in the 3rd world, or I'd be screwed when it comes to rescue inhalers. I'm happy to pay 3 times the $5 I pay for mine now, but I am not paying $50-60. If I live in the US, they make me buy insurance and pay out the ass just to BREATHE. No thank you.
posted by saysthis at 4:55 PM on June 13, 2009 [4 favorites]


is it really necessary to go after the asthmatics to attack global warming?

CFCs intermix into the atmosphere, eventually breaking down into chlorine and other nasty agents, which then deplete the ozone layer by taking out the free oxygen up there.

This is not a global warming issue but a environmental preservation one, since life on the planet relies on the ozone layer to absorb a lot of the incoming ultraviolet light from the sun.
posted by @troy at 4:59 PM on June 13, 2009


The new inhalers suck! My husband and I have both noticed a difference! These are inferior and they are an insult to patients.
posted by 6:1 at 5:04 PM on June 13, 2009 [1 favorite]


It's unfortunate that asthma sufferers have to be saddled with a new type of inhaler that is substantially more expensive and requires a significant adjustment in routine and implementation. I think there's plenty that could have been done, product design-wise, to make the phase-out easier. But Megan McArdle's analysis is merely vitriolic and ranty, focusing exclusively on her own personal difficulty with the new inhalers.

One point I found especially short-sighted was her complaint that "the amount of CFCs used for all pulmonary uses peaked at 1% of total peak industrial output in 1999" and that the phase-out of CFC-based inhalers is therefore just another example of environmentalism run amok. I was shocked at the 1% figure; given the small scale of inhaler-based CFC production it's actually very high as a percentage of total industrial output.

All of this would be less galling -- after all, it's her blog -- were it not posing under the guise of journalism in The Atlantic.
posted by foxy_hedgehog at 5:05 PM on June 13, 2009


Aren't there any alternative methods

When I was a kid, I had mechanical ones. The medication came in pill-capsules of powder (the powder being the medication). You'd put the the capsule into a slot in the inhaler, twist the inhaler (thus breaking open the capsule), then inhale. Turbulance of the air moving through the inhaler swirled the powder into the air you were breathing.

These inhalers worked just as well as the aerosol inhalers, and were much cheaper (and tasted better :). Their drawback is that you have to take a capsule out of a foil blister strip, and put it in the inhaler, which takes a few seconds longer than the semi-automatic nature of a aerosol inhalers.
posted by -harlequin- at 5:05 PM on June 13, 2009 [2 favorites]


Even with pollutants triggering allergies, is it really necessary to go after the asthmatics to attack global warming?

No one is "going after" asthmatics. This aggravating situation is primarily a product design problem that I strongly suspect could be avoided or improved. The outrageous cost has to do with the reclassification claim StrangeTikiGod mentioned above. Environmentalism is not the problem here.
posted by foxy_hedgehog at 5:10 PM on June 13, 2009


It's amazing how quickly our environmental concern disappears when protecting the environment actually inconveniences us in some way. Fuck the trees, I want my $25.
posted by Justinian at 5:11 PM on June 13, 2009 [2 favorites]


Turbulance of the air moving through the inhaler swirled the powder into the air you were breathing.

Unless I'm completely missing something, that's how the Turbohalers I mentioned earlier work. Instead of inserting a capsule, you just twist the bottom. Exhale, twist, breath in through the Turbohaler, hold your breath a few seconds. Done.
posted by effbot at 5:12 PM on June 13, 2009


Is there a technical reason why CFC-based inhalers couldn't have been replaced with something that doesn't cost more and works just as well, like in every other kind of spray can made since like 1978? If not with HFA then with CO2 or NO or something? I'm wondering whether blame lies not with the government for banning CFCs (these things should not even be manufactured!) but with the pharma companies for making crappy expensive inhalers.
posted by nowonmai at 5:13 PM on June 13, 2009 [2 favorites]


actually inconveniences us in some way

To be fair, this could lead to a number of deaths due to failure to use the device in the new way, clogging, or unexpectedly short device life. It's a bit more than an inconvenience in those cases.
posted by jedicus at 5:17 PM on June 13, 2009 [4 favorites]


which then deplete the ozone layer by taking out the free oxygen up there.

doing more reading I see that Chlorine is quite a bad boy up in the stratosphere. It breaks down the ozone molecule (O3) into an oxygen molecule (O2), and then later as ClO will absorb a free oxygen atom floating around up there to return to pure Chlorine + O2 to start the process over again, so one chlorine atom up in the stratosphere can take out 1000 or more O3 molecules -- Chlorine doesn't just eat ozone, it prevents new ozone from forming by fixing free oxygen atoms into O2, which don't do squat for blocking ultraviolet.
posted by @troy at 5:18 PM on June 13, 2009


It's amazing how quickly our environmental concern disappears when protecting the environment actually inconveniences us in some way. Fuck the trees, I want my $25.

You're caricaturing asthma sufferers who are experiencing legitimate issues with these inhalers, both in terms of their design and their cost, as petty and selfish. That's not fair, and it's not the sentiment I see from the comments here.
posted by foxy_hedgehog at 5:18 PM on June 13, 2009 [19 favorites]


It's amazing how quickly our environmental concern disappears when protecting the environment actually inconveniences us in some way. Fuck the trees, I want my $25.

To me it's a question of proportionality and common sense. If the CFCs released by the small population of inhaler users aren't resulting in measurable harm, then banning them before equivalent technology is available is silly zero-tolerance BS.

The preservation of human health should be the Prime Directive of our socio-economy. Banning such a critical piece of healthcare delivery is a bit different than banning CFCs in industrial use, especially since the healthcare use is apparently so small in comparison.
posted by @troy at 5:22 PM on June 13, 2009 [2 favorites]


I have a hard time taking this ban seriously, from an environmental perspective. This is not in any proportional and rational. The number of asthmatics on the entire planet sucking on CFCs for the entirety of their lives couldn't possibly be one one-millionth, say, all the old air conditioners and refrigerators still operating in the third world.

This smacks of zealotry + careerism + pharma companies more than happy to jack up prices.
posted by Cool Papa Bell at 5:39 PM on June 13, 2009 [2 favorites]


My office manager's daughter goes to a local high school. A couple of weeks ago one of her classmates died.

Of an asthma attack.


Just sayin'.
posted by St. Alia of the Bunnies at 5:49 PM on June 13, 2009


No one is "going after" asthmatics.

No one who isn't an asthmatic uses these inhalers as a essential life-saving device. I used one for a short period of time after I was prescribed it as a method of alleviating my symptoms as I recovered from bronchitis over a couple of weeks. It wasn't something I needed to keep by my side and functional for the rest of my life lest I die of an acute asthma attack when it struck me. A change in the device which would affect whether or not it was prepared to save my life would make a big difference to me, if I were asthmatic.
posted by mayhap at 5:53 PM on June 13, 2009 [1 favorite]


Keep in mind if you need a rescue inhaler like albuterol/Proair, etc. on any kind or regular basis then you are not controlling your asthma. Rapid acting bronchodilator therapy is an emergency measure, not part of the maintenance plan of asthma. The irony of all this is that we may finally get patients to give up their addictions to beta-agonists and start using their steroid inhalers as they were designed.

I would also guess that some of the cost is just proprietary malarky and that within a short time someone at Barr or another generic powerhouse will make these for a lot less.
posted by docpops at 5:59 PM on June 13, 2009 [3 favorites]


My office manager's daughter goes to a local high school. A couple of weeks ago one of her classmates died.

Of an asthma attack.


And the leading cause of these deaths is over-reliance on albuterol. Right up to when it doesn't work.
posted by docpops at 6:01 PM on June 13, 2009 [2 favorites]


Rapid acting bronchodilator therapy is an emergency measure, not part of the maintenance plan of asthma

You've got to be fucking kidding me. I'm glad the way you envision your life and your health doesn't involve "emergency measures", but I'm still going to call the ambulance if you need it.
posted by mayhap at 6:06 PM on June 13, 2009 [1 favorite]


The total ban strikes me of zero-tolerance BS but I reserve judgment.

don't. it is bullshit. the amount of cfc propellant in athsma inhalers and it's impact on the environment is negligible to nonexistant. the amount it took to rip the ozone a hole was: gallons of freon in every home and car air conditioner, every refrigerator, and every spray can on the planet. (plus god knows what other industrial uses in, undoubtedly, huge quantities). the idea that even 40 million 1/2 ounces compares in any way to that is insane.
and i say this as the kind of hippie who's doing everything in his power to reduce his carbon footprint. there's 'good for the environment' and there's 'just plain stupid'. this is the latter. people are going to die. the cfc boogieman killed the space shuttle columbia astronauts already (the foam that fell of the tank and damaged the tiles was a non-cfc replacement that was not even required by nasa's and the federal government's environmental impact teams...the original foam was fine, used minimal amounts of cfc, and was replaced for purely p.r. reasons...disgusting.) and now they're going for the athsma sufferers as well? grate.
posted by sexyrobot at 6:09 PM on June 13, 2009 [4 favorites]


And the leading cause of these deaths is over-reliance on albuterol. Right up to when it doesn't work.

Cite please.
posted by mayhap at 6:09 PM on June 13, 2009 [2 favorites]


Mayhap, please educate yourself on the treatment goals and guidelines for asthma, and don't take things so personally.

docpops is right.
posted by herrdoktor at 6:10 PM on June 13, 2009


I've lived with asthma for my entire life (41 years) and remember before there were 'rescue' inhalers and how severe attacks required a trip to the hospital for an adrenalin shot.

I've used the various versions over the years and am now using the HFA versions.

Here are my experiences:

The puff is much less forceful and at first seems like it's not delivering a proper dose.
The nozzle tends to clog and requires cleaning fairly often.
The taste is different than the old kind.
If there were no adverse effects to the ozone, I'd love to go back to the CFC inhalers.

Personally, I don't doubt their effectiveness. I'm pretty focused when it comes to getting a clean inhale and holding my breath.

My best guess is that the problem involves two things. First, people don't like change, and they really don't like change to important things in their life. Someone with chronic asthma considers an inhaler pretty damn important. Change is often regarding with fear, suspicion and loathing. Second, some people don't inhalers right. I watch how other people use them. Sometimes they aren't inhaling when the puff occurs and do a 'puff then inhale' method. Or sometimes they don't hold their breath as long as possible. I'm not saying that explains everything, but I bet it covers a lot.

You can also take abuterol via a nebulizer or as a liquid. The nebulizer works great, but it complicated. The liquid/syrup is prescribed for children/infant, but works great for adults too. I have used the liquid when my lungs are overly congest from a cold or other chest infection. So there are options for people with severe asthma not getting help from the HFA inhalers.

As far as death, from what I know, the main cause is that people are not on a course of treatment to prevent the attacks themselves. I take Accolate & Allegra to prevent wheezing, and only use an inhaler on occasion. The sad thing is seeing people that ONLY use an inhaler to stop an attack after it has occurred rather than trying to stop an attack before it occurs. Like with many other ailments, preventive care is the best, most effective care.

There is no conspiracy at work here. Sadly, this is a case of a drug delivery method that was extremely effective begin replaced with a method that is simply effective.
posted by Argyle at 6:24 PM on June 13, 2009 [2 favorites]


Mayhap, please educate yourself on the treatment goals and guidelines for asthma, and don't take things so personally.

Every single time a new (and exciting!) asthma treatment is proposed, promising to dramatically, profoundly reduce the number of asthma attacks an asthmatic will suffer, it still warns that whatever drug it is does not take the place of emergency inhalers.

Emergency inhalers need to be functional at the very second that an asthmatic is suffering an emergency, to increase the likelihood that oxygen will get into their lungs long enough for them to be not dead long enough for any treatment, whatever it may be, to be administered.

If emergency inhalers are less likely to be effective if they are not regularly used, that is much, much worse in conjunction with other drugs that make them less likely to be regularly used. If my brother is used to his old inhaler, which sat there until he had a serious asthma attack, and he now has a new inhaler which will do just as good a job of sitting there but will not actually save him from a serious asthma attack when he has one, that is a major problem. He would be better off having asthma on a regular basis, if he could trust that it would never, ever result on him suffocating because of an inadequate device.

And it is a much more serious problem than anyone who doesn't have asthma faces. I do not know what I would need to change to compensate for everyone who has asthma to have an effective inhaler, but I would certainly cooperate. I can't even imagine why anyone would not. I really can't help but feel that you're attacking my brother, unless you're generally unconcerned about how what you do affects the next generation.
posted by mayhap at 6:27 PM on June 13, 2009 [3 favorites]


I'm a lifetime asthmatic (am 40, got diagnosed at 5, didn't grow out of it).

For the past couple of years I have been taking Advair, which is a breath-powered (by inhale) combination of serevent and flovent in a casein matrix. I was really skeptical because I remembered when I was a kid that there was a similar delivery method of an entirely different drug that did. not. work. (can't remember the name, sorry.)

Anyway, I am aware that my lung function is really good (my PEF average is usually 620 l/min, but last quick test at the doctor's office was 700 l/min), so take this with a grain of salt, but I'm cool with the change from CFC to other propellants in propelled inhalers like albuterol. I'd rather not rely too heavily on the stuff. When I was younger I had a couple of near misses with the problems docpops and herrdoktor talk about above.

Back when I was on CFC-propelled inhalers exclusively, I always wondered what they were doing to my lungs. Maybe I get time to heal from that stuff now. That would be good.
posted by kalessin at 6:27 PM on June 13, 2009 [2 favorites]


Mayhap, I can't find a direct link, but work done at National Jewish Health, pointed this out in in some of their newsletters over the years. I have contributed to their research and am on their mailing list.

As some who considers an inhaler something I must "keep by my side and functional for the rest of my life" I have to agree that the inhaler should be the 'last line of defense' before heading to the hospital. Taking my preventative medicine is KEY to my treatment.

Also, I'm prepared for not having an inhaler by also having over-the-counter pills like Bronkaid that will stop an attack but have some nasty side-effects.

I understand the empathy for those that are hurt by the change in inhalers, I feel it too when I read of people traveling to Mexico to buy them because of the cost or of anyone that dies from asthma, but there has been a spectacular improvement in preventive care in the last 30 years that needs to be utilized more.
posted by Argyle at 6:34 PM on June 13, 2009


what

I've been a severe asthmatic for decades now. Recently weaned myself off Advair (which is a non-propellant medication and almost certainly the best treatment out there right now, but also physically addictive) to pure Flovent/HFA and generic Albuterol/HFA for emergencies.

I've noticed almost zero difference in the HFA inhalers, other than the meters which are super-handy. Never even occurred to me that they were qualitatively different. But then again I was trained rigidly by my allergist's nurse when I was 12 on how to use an inhaler properly.

I think Argyle has it dead on, in that the problem is a combination of perception, improper use, and the fact that we're so dependent on our inhalers that even a minor change is enough to cause emotional distress.
posted by xthlc at 6:36 PM on June 13, 2009 [1 favorite]


Long-time asthmatic, first-time caller...

I was changed over to a non-CFC inhaler (Pro-Air from Teva Pharmaceuticals... I just noticed the label says "Mfd in Ireland") at the beginning of 2007, with its category changed from $10 co-pay to $29 co-pay. That sucked, but I do have the option of a 90-day-supply via mail order, which is 4 inhalers for less than the price of 3. (Because 200 doses taken 8 a day max is 25 days - but I'm not supposed to NEED 8 doses a day) Near the end of last year, my doctor had coupons to get two single refills of the more expensive Proventil free and I've gone back to single refills of the Pro-Air. It has worked very well for me for over two years until just the last two refills have been getting clogged and needed cleaning a lot more often. Odd.

At one point in my long history with albuterol, I was overusing it, but that was when I was having other pulmonary problems that it couldn't help anyway. Right now, my costliest problem with the inhalers is misplacing them (no, Mr. Pharmacist, I didn't use it up in 16 days, it fell out of my pocket when I was visiting L.A.), which is another story.
posted by wendell at 6:37 PM on June 13, 2009 [1 favorite]


I was diagnosed about three weeks ago with asthma, though I've apparently had a low-grade form of it all my life. My doctor gave me a sample of Symbicort and wrote me a prescription for it. When the sample started running low, I went to the pharmacy and filled the prescription. One month's supply of Symbicort costs me $60 (I have insurance - this is my portion of the cost.) I am faced with deciding whether to treat an illness I didn't know I had for 37 years, or to just ignore it.

My area has terrible air quality (a combination of huge amounts of decaying biomass - Reagan's 'polluting trees' - and a large number of upwind coal-fired power plants) so I know that untreated asthma is likely to get worse, but I just can't justify spending $60/month on it.

I was unaware of the switch to ozone-friendly propellants; I just assumed these blasted things had always been this expensive.
posted by workerant at 6:45 PM on June 13, 2009


I have a hard time taking this ban seriously, from an environmental perspective. This is not in any proportional and rational. The number of asthmatics on the entire planet sucking on CFCs for the entirety of their lives couldn't possibly be one one-millionth, say, all the old air conditioners and refrigerators still operating in the third world.

Several people have said something along these lines. It's a fair argument. It's also a fair argument against virtually every step we as individuals take to be more environmentally friendly. The biggest contributors to environmental damage are always going to be things beyond the control of you and I. But we still switch to new lightbulbs. We still mandate new cars be more fuel efficient and produce fewer emissions. We still encourage recycling. We still encourage the use of reusable grocery bags.

And yet each of those contributions is as nothing compared to the pollution put out in a single airplane trip. Have you ever ridden on an airplane? If so, you might as well leave all your lights on all the time, drive around in an SUV, throw out all your recyclables, and always use plastic grocery bags. Because your other steps are but a tiny feel-good measure as compared to your planet-damaging actions in flying and driving even new, more energy efficient cars.

The argument that any individual action makes only a tiny, tiny difference is an argument for doing nothing. It's what has gotten us to this point in the first place.

(The other argument that the new inhalers don't work as well and could lead to deaths is legitimate. I'd like to see controlled studies to compare their efficacy before I made a judgment there).
posted by Justinian at 7:00 PM on June 13, 2009 [1 favorite]


I've used HFA inhalers - one kind had a counter, the other did not. The maker of the counter-less one expects users to keep track of the number of puffs they've used, up to 120 (or 200, I forget). The likelihood of even the most fastidious record keeper getting this right approaches zero.
posted by zippy at 7:02 PM on June 13, 2009


New formulation = new patent protection = new premium. I've worked for Big Pharma. They make ExxonMobil look like boy scouts. And ExxonMobile does some seriously evil shit (I know, since they are a client again.) Alas.

From personal experience as an asthmatic smoker (yeah, yeah..I fucking know ok?) let me tell you in no uncertain terms; these new inhalers suck, and not in the $50 well-spent at Hunts Point way either.

They clog. After like three uses. I'm constantly poking the damn thing aperture with a pen or a pin to get it to open up. You absolutely cannot tell when it's near empty. Piece of shit all around.

Look, I recycle every damn thing I can in New York. I eat free range organic seasonal everything. I use only phosphate free cleaners. I never ever smoke around my kids or spouse. I only own one, very fuel efficient care and *still* take only public transportation to work.

For fuck's sake, let me fucking have a hit when it's 4:00 am and I've got nothing else to keep me from a night of sitting up, panic attack time when I've got to be up at 6:00 to work the job I hate to feed my two kids. Medical patents - the way they are handled now, are pure, unadulterated evil, and I've helped more than a few companies get them through CBER/CDER.

It's all about profit in a multibillion dollar catagory, and that's really the end of the story. The fuckers.
posted by digitalprimate at 7:03 PM on June 13, 2009 [12 favorites]


Are CFCs really the only acceptable propellant? No other gases that could be compressed?
posted by ook at 7:22 PM on June 13, 2009


Another vote for "not much difference" between the new and old inhalers, along with "worth it to not use CFCs." Posted an AskMe about it a few months back where the general feeling in most answers was the same.
posted by mediareport at 7:34 PM on June 13, 2009 [1 favorite]


I don't mind giving up the other propellant. I understand why it happened, and I'm good with that. But what I'm not good with is the fact that because they had to change the propellants, my inhaler went from 5 bucks a month to 35 bucks a month.

Because Singulair is now being used to treat allergies, my insurance company hiked my premium on that from 25 to 45 bucks a month. Put that on top of the Q-Var steroid I'm supposed to be taking, which is 60 dollars a month. I asked my doctor for generics, for equivalents, for anything he could possibly give me that would fall into the normal 15 dollar copay on my insurance, and he couldn't find anything on their formulary that would. I cried during that visit, and I haven't been back since.

With the state of my insurance and my finances, I can't *afford* the daily, maintenance medication for my asthma, which means I really, really need my emergency inhaler. But now, because the propellant- not the medicine, just the propellant changed, the pharmaceutical company gets to say it's not generic anymore and jacked that price up, too.

It just seems to me like somebody along the line could have looked out for the interests of everybody- the environment, and the chronically ill- and, I dunno, put their foot down and said "This isn't a new drug, you're just complying with new government standards." But I guess that would require federal employees, who have excellent government-funded healthcare to actually give a flip about people who have to make do with crappy private insurers. Like that's ever going to happen.
posted by headspace at 7:40 PM on June 13, 2009 [13 favorites]


CFCs are not related to global warming, but rather the depletion of the ozone layer, which protects of from ultraviolet light, which causes skin cancer.
posted by delmoi at 7:43 PM on June 13, 2009


"the amount of CFCs used for all pulmonary uses peaked at 1% of total peak industrial output in 1999"

She misquotes.

The actual quote is that the global amount of CFCs for pulmonary uses peaked, in 1997, at an amount that was 1% of the peak global production of CFCs (which was in 1987).

The figures on this are awfully disconnected, but the amount of CFCs used in inhalers in 1997 was about 10%, of the CFCs produced worldwide in 2000 (though the CFCs themselves weren't necessarily produced in that year).

That's a huge amount. It's especially a huge amount when it's all, by design, being released directly into the atmosphere on the first exhale instead of sitting quietly in refrigerators and air conditioning units.
posted by ROU_Xenophobe at 7:58 PM on June 13, 2009 [3 favorites]


Instead, the actual users of the product have to pay the cost of using the polluting chemical.

Obvious Troll is Obvious. Nevertheless, I will take the time to correctly direct the outrage.

Instead of figuring out how to dispense economical and effective generic albuterol without CFCs, the drug companies convinced the Bush administration to allow them fuck over asthma patients with patented drugs that do less and cost more.

That make it clearer?

Of course, nowadays, Advair makes rescue inhalers less of a monthly expense, but Advair is two hundred and fifty bucks for a month's worth if you don't have insurance, plus Singulair, plus rescue inhaler, plus Claritin/Xyrtec (no longer covered under prescription plans now they're over-the-counter). Put together, that's a pretty steep "tax on living" Big Pharma exacts. If you can't pay it, you suffer, incredibly, and perhaps die. Or at least rack up a few thousand in ER bills you have no hope of repaying once every other month.

That's the American healthcare tradition!
posted by Slap*Happy at 7:59 PM on June 13, 2009 [4 favorites]


It's also a fair argument against virtually every step we as individuals take to be more environmentally friendly

No, CFCs are in a different class of pollution, since the the UV shield they eventually decimate is a rather critical public if not planetary good. The jury's still out on carbon footprints and the like.

Carbon footprints and general ecology is just the practice of economizing and making tradeoffs where it makes sense to be less wasteful and less polluting. Every little bit of individual effort helps when looking at the aggregate of 1B first-world citizens producing the bulk of environmental hazards.

If we all were carrying inhalers for non-critical health needs then restricting them would make sense, but the anti-hippie pro-business argument of reducing restrictions because they are worthless is not something I buy when looking at the numbers and the risk involved.

A passenger on an jet aircraft is having burned for his benefit, what, $300 worth of JP-8, max? This is equivalent to 150 gallons of gasoline which can in fact be offset by buying a 35MPG car rather than a 20MPG car in about a year of average driving.

I think carbon offsets are probably feel-good BS but I also feel reducing and economizing where possible is prudent insurance, either in case CO2-driven climate change it isn't BS or for ancilliary benefits of a less wasteful, more economically-wise first world.
posted by @troy at 8:03 PM on June 13, 2009


Following @troy, CFCs are so catastrophically horrible that governments headed by those noted environmentalists Ronald Reagan and Maggie Thatcher stand up and say "HOLY SHIT WE'VE GOT TO STOP DOING THIS RIGHT NOW."
posted by ROU_Xenophobe at 8:21 PM on June 13, 2009 [7 favorites]


"dubious how much damage a single charge of CFC can cause in the increment, compared to the historical industrial uses of the agent."

But it's not a single charge now is it? 40 million Americans (somewhere in this thread) times even an ounce annually (seems reasonable) is 2.5 million pounds of CFC. Even if you shift that down an order of magnitude, 250,000 lbs of CFC is a shit tonne of ozone depletion.
posted by Mitheral at 8:21 PM on June 13, 2009


I don't have a dog in this race, but here's a link that talks a little about change in mortality possibly related to albuterol (only one I could find quickly not behind a paywall).
posted by BrotherCaine at 8:26 PM on June 13, 2009


The argument that any individual action makes only a tiny, tiny difference is an argument for doing nothing.

Nice combination of a cognitive distortion and a false dilemma. I'm impressed. What did the French judge give you?

The problem with "let's all take individual actions in spite of their being an elephant in the room" is that ... well ... there's an elephant in the room.

Any time or effort spent patting yourself on the back for saving a little is time you could have spent saving a lot.

You're right -- this isn't an all-or-nothing problem. But it is a bang-for-the-buck problem. Proportionality and prioritization are how adults handle things. Ninnies think they're saving the world by tackling the little things first.
posted by Cool Papa Bell at 8:43 PM on June 13, 2009 [2 favorites]


Ninnies think they're saving the world by tackling the little things first.

And assholes use that as an excuse to do nothing.
posted by wendell at 8:47 PM on June 13, 2009 [8 favorites]


Ooo, burn!
posted by Cool Papa Bell at 8:49 PM on June 13, 2009 [1 favorite]


250,000 lbs

compared to the historical production is insignificant.

In the first analysis it would seem seeing what the effect of continued allowance of pharmaceutical exception was having wouldn't be measurably harmful when compared to the immense releases of CFCs already up there.

The immediate consumer cost rises of this move is rather bogus for the marginal if not insignificant gain in environmental health, and the FDA saying the Montreal agreement required phasing out CFCs now is bogus since the price differential is significant.

As perm the norm, healthcare consumers are getting bent over by Big Pharma; one of the previous admin's last goodbye presents to the people, though to be fair this was started under Clinton.
posted by @troy at 9:03 PM on June 13, 2009


When the medication is spent, there still remains some propellant.

If all else fails, you can still get in a few last-minute whip-its before brain damage sets in.
posted by dr_dank at 9:13 PM on June 13, 2009


The cost is definitely more of an issue than the effectiveness. I've got chronic asthma (diagnosed at 5, as seems to be common around here) and I'm on Allegra and Asmanax (which is similar to Advair in that you crush the tab and inhale the powder) as well as having my emergency inhaler. Even so I tend to need it a few times a month on average (like, two months with nothing and then every day for a week when something particularly pernicious is pollinating or shedding or whatever it is mold does).

Let me be the first to say that the new inhalers taste like a strawberry's asshole. The old one was all bitter and medicine-y, which I didn't mind as much. I haven't noticed much decrease in effectiveness, personally, though I would agree that this propellant doesn't propel nearly as well. I'm unnerved to read that it might not work if I don't use it regularly; I've had some close calls.

I really hate that it costs me somewhere between sixty and a hundred dollars a month to breathe. It's like a tax on crap genetics.
posted by Scattercat at 9:28 PM on June 13, 2009 [1 favorite]


I really hate that it costs me somewhere between sixty and a hundred dollars a month to breathe.

But Hannity told me privatized medicine is the best system in the world. Surely he's not full of shit!
posted by Mikey-San at 9:59 PM on June 13, 2009 [1 favorite]


"compared to the historical production is insignificant."

So? It's still very damaging.
posted by Mitheral at 10:06 PM on June 13, 2009


I really hate that it costs me somewhere between sixty and a hundred dollars a month to breathe. It's like a tax on crap genetics.

I'm definitely sympathetic, but this is true of all chronic conditions. My Zyrtec (cetirizine) used to cost a ton every month before it went over the counter. For some reason Claritin doesn't seem to work as well.
posted by Justinian at 10:35 PM on June 13, 2009


So THAT'S why it got expensive! I had no clue, but honestly, the demand curve for breathing is perfectly inelastic, so I don't really ask them questions when they are giving me the medicine that I need to be able to breathe. They charge me money and I have to pay it - whatever it is.

In other asthma-related tales: Back when I conducted the high school marching band, the Director made me promise never to use my inhaler before I conducted because it ruined my concept of tempo. I would take pieces far too fast, leaving the band gasping and trying to keep up. Once, I used my inhaler before performing Tartini's Concertino for clarinet and left my poor accompanist in the dust. She occasionally managed a well placed downbeat.
posted by greekphilosophy at 10:37 PM on June 13, 2009 [1 favorite]


HFA albuterol MDIs are not as EFFECTIVE as CFC albuterol MDIs, according to the research summarized by Glaxo Wellcome itself (now GlaxoSmith Kline) in its New Drug Application to the FDA for Ventolin HFA, the only HFA rescue MDI, by the way, that does NOT include ethanol as a solvent (ethanol is a proven bronchoconstrictor in amounts used in MDIs for a subset of asthmatic patients.) We link to all of the above in the top half of the Press Room Page of our website.

HFA albuterol MDIs are not as SAFE as CFC albuterol MDIs, according to the clinical trials for Proventil HFA and Ventolin HFA, a New Zealand study, a large UK postmarketing study, three years of FDA MedWatch data, and Schering Plough itself (manufacturer of Proventil HFA) which says:

"Rapid heart beat, vomiting, chest pain and palpitation occurs more frequently with Proventil HFA (than with CFC albuterol) ."

We link to all of the above in the top half of the Press Room page and the bottom of the Stakeholders page of our website.

The idea that CFC MDI emissions deplete the ozone layer enough to increase UVB ground radiation sufficiently to increase skin cancer rates is one of the greatest scientific frauds in history. It is a lie. Research that supports this conclusion (from the World Meteorological Organization's 2006 Ozone Assessment) is linked to at the bottom half of the Press Room page of our site.

It is not the active ingredients in HFA MDIs that cause the problems for so many patients, it is the inactive ingredients and unique impurities that are causing the reduced efficacy and increased, serious adverse reactions in many (not all) patients. HFA MDIs were never properly tested in real world, large scale U.S. postmarketing studies, as we show in the HFA MDIs: Poorly Tested page of our website.

CFC MDIs should never have been banned. Then-Vice President Al Gore and EPA Administrator Carol Browner forced this (Decision IX/19 Part 5) through the Ninth Meeting of the Parties of the Montreal Protocol in September 1997 for reasons of political expediency- NOT because CFC MDI damaged the ozone layer. We have EPA quotes that show this on the top half of the Stakeholders page of our site. Their partners in crime were the members of IPAC (the International Pharmaceutical Aerosol Consortium) which grabbed the opportunity given to them by these pseudo-environmentalists to get new patents on their old drugs due to HFA reformulation.

This scam will be repeated, now that HFA emissions are now known to be severe global warmers: IPAC is working to find a NEW propellant to replace HFA-134a; they want to get the Copenhagen Accord to ban HFA MDIs and "force" them to reformulate their old drugs with this new propellant (and get new patents, again, on these old blockbuster drugs,such as albuterol) when their HFA MDI patents start to expire in a few years.

We have thousands of comments on our site from patients, including patients who are MDs, pharm/chem PhDs, RNs, RRTs, RN anaesthesiologists (see the Doctors Speak Out page of our website), who KNOW how to clean and use their inhalers. They KNOW what many of the uninformed posters on this thread do not know, which is that for many patients (not all), HFA MDIs are NOT as safe and effective as CFC MDIs, and for that reason, Congress MUST amend the Clean Air Act of 1990 to permanently legalize harmless, lifesaving CFC MDIs.

Congress has created a permanent exemption for ozone-depleter methyl bromide (for its QPS Quarantine/Pre-Shipment application) due to the power of Big Ag.

They've created a permanent exemption for ozone depleting chemicals injected directly into the stratosphere for commercial and military rockets and the space shuttle due to the political power of this lobby. See the Updates page of our site.

Once asthma and pulmonary patients get organized, they will create an exemption for CFC MDIs as well.

Arthur Abramson
The National Campaign to Save CFC Asthma Inhalers
www.SaveCFCinhalers.org
posted by Arthur Abramson at 10:40 PM on June 13, 2009 [4 favorites]


So? It's still very damaging.

But compared to the damage being caused by the post-Montreal 1988-1996 widescale use of CFCs vanishingly small, if the bar chart in my link above is anything to go by.

So small that stopping the pharmaceutical use won't result in any measurable difference in ozone layer regeneration rates. Asthmatics are being required to pay more for inferior treatments for nothing since the scale of their use of CFCs is/was so small.
posted by @troy at 11:27 PM on June 13, 2009 [1 favorite]


I'd like some smart sciencey-type of person explain to me why it would make any difference at all what propellent is used.
posted by five fresh fish at 11:28 PM on June 13, 2009


(in case you're wondering, "MDI" in Mr Abramson's post above stands for "metered dose inhaler")
posted by @troy at 11:30 PM on June 13, 2009


Is there a technical reason why CFC-based inhalers couldn't have been replaced with something that doesn't cost more and works just as well, like in every other kind of spray can made since like 1978? If not with HFA then with CO2 or NO or something?

and

Back when I was on CFC-propelled inhalers exclusively, I always wondered what they were doing to my lungs. Maybe I get time to heal from that stuff now. That would be good.

The big deal about CFCs is that most of them, and of course the ones used in medicine, are totally non-toxic. Freon, everybody's favorite CFC, and which absorbs oxygen very easily, was actually used in some experimental protocols as a way of providing oxygen to people. As in, you can circulate oxygenated freon into, say, collapsed lungs or for people who fight ventilation.

In fact, their non-toxicity is one of the reasons CFCs became so popular. They were studied to death before they went into widespread use. And every test came back a-okay. Of course, we didn't bother to test their effect on ozone at extremely low pressure with high radiation exposure. Literally the only place CFCs are harmful is in the upper atmosphere.

But, CO2 or N2 (you didn't mean NO, and I assume you didn't mean N2O, which is laughing gas) are not replacements for CFCs or HFAs.

The problem is one of density. Using a gas, you couldn't possibly pack in enough propellant to make an inhaler worthwhile. With a half-ounce volume, and a really good regulator, you'd get a dozen sprays. This is why we use CFCs and HFAs. They sit in the can as a liquid with some vapor pressure above them. That vapor is used to propel a dose, and is then immediately replenished as more of the liquid boils off. So, you can pack in a lot of propellant in a very small volume. Likewise, they're self-regulating, meaning that the vapor pressure in the can is always at approximately the right pressure, which also happens to be nice and low--you don't need a mechanical regulator.

At room temperature, CO2 becomes a liquid at about 800psi. I don't know the number for nitrogen, but my paintball airtank gets compressed to 3000psi, and scuba tanks do 4500psi; neither of those liquefy the air. So, in order to get a liquid out of those gases, you'd need a really heavy duty inhaler. Made of steel. Plus, if you didn't want the blast of medicine being literally injected into your tongue via pressure, you need a regulator. A multi-stage regulator, in fact, because you probably don't need more than about 50psi and it's pretty hard to go from 800psi to 50psi in one step.

Not to mention that CO2 venting is very cold. Cold enough that I've frostbitten my hands on my paintball gear. Oh, and also, our bodies trigger the breathing reflex based on the level of CO2 in our lungs. Adding CO2 to an asthmatic's lungs during an attack is going to increase anxiety levels, as well as making it physiologically far more difficult to hold his breath.

The propellants used in spray cans these days are usually hyrdrocarbons, with butane and propane being especially popular. These are not things one would want to spray down one's lungs.

I agree that better engineering should be possible. But, the old CFCs were actually perfect in every way except the ozone. And inert gases just aren't the answer.
posted by Netzapper at 11:42 PM on June 13, 2009 [13 favorites]


Arthur Abramson writes "Congress MUST amend the Clean Air Act of 1990 to permanently legalize harmless, lifesaving CFC MDIs."

Arthur Abramson CFCs are known not to be harmless. You may think they represent an acceptable trade off but to state they are harmless in that trade off is hyperbole at best and fraudulently misleading at worst. Your web site says:
Stratospheric CFC levels have been falling since the late 1990s, and global ozone has been recovering since the early 1990s, despite the continuous emissions of CFCs from all sources at levels much greater than CFC MDIs ever produced, thereby proving the harmlessness and insignificance of CFC MDI emissions.
The conclusion does not follow from the premise in that statement. Also the size of the ozone hole did not start to decline until 1997, after the implementation of the Protocol. And because there is great variablity in size due to weather the decline hasn't been steady and some years has even reversed. Your press room seems to (I admit the formatting makes it very hard to read so I just skimmed; you need to back off on the yelling) concentrate solely on the ozone hole's effects on humans. Humans for the most part were not in direct danger from the ozone hole, it was the effect on plants and ocean life that was the mind blowing concern. I encourage anyone who isn't familiar with this issue to browse NASA's ozone site.

Also your website states:
Nor are 'environment-friendly' HFA-134a MDIs environment-friendly. Their Global Warming Potential is much worse than that of CFC-11,12 MDIs
The Montreal protocol had nothing to do with global warming. This is a red herring in your campaign and is sure to confuse people. Not sure if that was what you are trying to do but if not you might want to at least rephrase these bits of your website.

As a data point CFC inhalers were discontinued in Canada years ago and we have no love of big Pharma (nor they of us). People suffering from asthma have not been dropping like flies despite the change over. Your web site states:
There were no large-scale, *real world, multi-year, U.S. postmarketing studies done on HFA MDIs (metered-dose inhalers) in the U.S. to ensure product safety
While true in the strictest sense non-cfc inhalers have been used successfully in Canada, Australia, Japan and Europe for years. Concentrating so much web space on the quasi-conspiracy theory of profits for big Pharma being the reason for the phase out is hurting your cause as many people associate those kinds of statements with discredited movements like vaccines cause autism. Your case for an exeption for CFC inhalers would be much stronger if you could find significant accepted research from some of these other jurisdictions showing that HFAs are more dangerous than CFCs.

"Congress has created a permanent exemption for ozone-depleter methyl bromide (for its QPS Quarantine/Pre-Shipment application) due to the power of Big Ag."

Again you are being misleading. The exemption for Mythyl Bromide is authorized by the Montreal Protocol and agreed to by the 191 signing countries. The EPA agreed to the Montreal Protocol's definitions of quarantine and preshipment, as described in Decisions VI/11 and VII/5.

PS: we don't "sign" our posts here as the system automatically adds a byline with each post.
posted by Mitheral at 11:52 PM on June 13, 2009 [5 favorites]


And on non-preview: What netzapper wrote about the awesomeness of CFCs is true. As a family their usefulness is unbelievable. They were used everywhere in literally tens of thousands of applications from deodorant through blowing foam and fire suppression to refrigeration. The fact that not only was the world able to come agreement on the Montreal Protocol but also that there was such a consensus (East Timor is the only hold out to not sign the original Protocol) speaks strongly to how seriously the world governments took the issue. Are there any other agreements with such far reaching effect that have near unanimous levels of agreement? Even such obvious treaties as the land mine ban fall short of this kind of consensus (-37).

The National Campaign to Save CFC Asthma Inhalers attempts to discount the severity of the effect of ozone deleting chemicals
MOST AMERICANS ARE GETTING TOO LITTLE UV-RADIATION, RESULTING IN VITAMIN D ('THE SUNSHINE VITAMIN') DEFICIENCY!
Americans Need More Vitamin D
1
is disappointing.

[1] Sorry for no direct link (no anchors on that massive page); the quote is about 4/5ths of the way down.
posted by Mitheral at 12:14 AM on June 14, 2009 [2 favorites]


Well, we probably don't get enough vitamin D, but geez. that argument is just wrong.
posted by caddis at 12:22 AM on June 14, 2009


So? It's still very damaging.

Can you quantify that, or is that just your opinion?
posted by TungstenChef at 12:35 AM on June 14, 2009 [1 favorite]


Every time an asthmatic snorts a CFC inhaler, an Australian gets a melanoma.

It is remarkable that the entire frakin' world agreed to quit using this cheap and miraculous cure-all for issues refrigerant and propellent. That tells me it was one helluva humongous threat, because we sure as heck haven't achieved global agreement on anything else.

Rather than snorting down inhalers like there's no tomorrow, maybe we should be focusing on cleaning up our environment. I find it pretty much impossible to believe asthma was a big problem a hundred years ago. I think we've done something to our environment that is killing the susceptible among us. That's surely a bad sign.
posted by five fresh fish at 1:00 AM on June 14, 2009


"Can you quantify that, or is that just your opinion?"

I can't give exact numbers because i can't seem to find which CFC is being used in these inhalers. The exact impact depends on how many chlorine atoms reach the stratosphere. The specific composition of the CFC determines what percentage reaches the stratosphere (some compositions are susceptible to destruction at lower altitudes) and how much chlorine is then released (not all CFCs contain the same number of chlorine atoms per molecule).

However generally speaking each chlorine atom that reaches the stratosphere is able to react with and destroy upwards of 100,000 ozone molecules. The ratio is so high because the chlorine acts as a catalyst rather than being consumed by the reactions. Once the chlorine reaches the stratosphere it basically munches away at ozone until it reacts with another free radical. Even if we posit a CFC molecule with a single chlorine atom of which only 1 in 100 molecules reach the straoshpere (a very low ratio for chemicals of concern) and an average of 50,000 molecules destroyed per that's still 500 molecules of ozone destroyed for every molecule of CFC released.
posted by Mitheral at 1:43 AM on June 14, 2009


Here's some quantification.

In 1998, EPA allocated 4,365 metric tons, and in 2007, allocated 167.0 metric tons.[1]

3136 metric tons in 2000
3099 metric tons in 2001
3388 metric tons in 2002
3270 metric tons in 2003
2077 metric tons in 2004
1820 metric tons in 2005
1002 metric tons in 2006
167 metric tons in 2007
27 metric tons in 2008
63 metric tons in 2009

For ~20,000 metric tons of CFCs for MDIs this decade.

In the 1980s ~9 million metric tons of the stuff was produced, so the medical use of CFCs this decade was 0.2% of the total use of the 1980s.

At an annual run rate of (say) 3,000 metric tons it would take over 300 years of medical use to equal the amount produced during the peak year of 1988 (1,000,000 metric tons).

Looking over the EPA documents it does appear a bureaucratic pissing match took place.
posted by @troy at 1:51 AM on June 14, 2009 [3 favorites]


"The HFA inhalers cost more than the CFC inhalers. What can I do if it’s hard for me to pay for my HFA inhaler?

- Talk to your health care professional about programs to help patients get medicines they need.
- Some drug companies have patient assistance programs that make medicines available to patients at no cost, or at a lower cost.
- Some patients may be able to get help paying for medicines from the Centers for Medicare & Medicaid Services."

In other words, if you're already working two jobs and barely getting by and you have sick kids, not our problem. The programs they cite mostly don't work and are more time and trouble than they are worth, and I personally know two asthmatic kids (not mine) who are at serious risk of DYING if they have a bad enough asthma attack.

I took one of them to the ER a couple of months ago when we were out at a show an hour away from her home, and she had forgotten to replace her ONE inhaler in her bag before we left. She would not have survived without emergency treatment, which, by the way, cost $1,500 which the hospital, county and state will now absorb since Kaiser is refusing to pay since we went to the nearest ER instead of a Kaiser ER. If the health-care industry (Kaiser and the State of California, I'm looking at you) were not so penny-wise and pound-foolish, she would have plenty of asthma prevention medicine and be able to afford more than one inhaler at a time.

Asthma already disproportionally affects low-income families.

The costs here are being pushed onto these low income-families to benefit the entire rest of the world. Saving the ozone is a worthwhile goal and all, but could we please make sure we aren't doing it at the expense of the powerless?

FDA, GO HOME!
posted by Hello Dad, I'm in Jail at 2:44 AM on June 14, 2009 [2 favorites]


Comparing current production to the peak year, which no one few would argue was an unmitigated disaster of pollution strikes me as misleading in an attempt to minimize the perceived impact. It's like describing an oil spill of 82,000 litres in Prince William Sound as only 0.2% of the peak year emission. I'm not saying it isn't important but it is attempting to put the best possible light on the subject through pretty heavy spin via statistics.

A better metric would be what percentage of 2007's production was used in CFC inhalers?

At 167 metric tons (~367,000 pounds) allocated to inhalers I see my WAG of 2.5 million pounds was an order of magnitude to high. I wonder if it's because the 40 million figure is too high or if it was the one ounce per user figure that was out of whack.

Hello Dad, I'm in Jail I don't it would come as a surprise to most of the people here that the US health care system is seriously under performing. Why should the entire world pay for the externalized cost of that though?
posted by Mitheral at 2:50 AM on June 14, 2009


From @troy's link I gleaned that the propellant being used is CFC-114 DICHLOROTETRAFLUOROETHANE which has an ozone depletion potential rating of 1 (IE: equal to the base CFC-11) and a lifetime of 300 years. Stuff we produce today will still be destroying Ozone three centuries from now.
posted by Mitheral at 3:06 AM on June 14, 2009


Because the ozone layer was replenishing without banning CFC's for medical use?

The problem with CFCs was not that they were used at all, but that they were used in massive quantities. Every refrigerator, A/C unit and pressurized product from oven cleaner to hair spray used the stuff, and it showed up in strange places like the production of fast-food containers. Paring down use to only where it was absolutely essential has shown to be a winning strategy that works without removing medical-grade CFCs

Condemning the poor to misery and death because you don't understand the scale and nature of the environmental impact strikes me as both callous and stupid. You're not "saving the world" at this level, and you're undermining the case for future actions which may actually be essential, yet difficult to sell to the public.

The attitude of "Too bad, so sad, hurry up and die so the world gets saved" needs to be changed. In a hurry. May I suggest "make Big Pharma accountable for its role in spreading the use of CFCs by offering replacement generics."
posted by Slap*Happy at 3:22 AM on June 14, 2009 [1 favorite]


The UK switched to CFC-free inhalers in 1998-9.

Yeah. A decade ago. To my knowledge, asthma morbidity and mortality has not been affected by this, and we've had, oooh, a whole decade to look at this. The change was so long ago that I've never used anything but a CFC-free inhaler.

The NHS price for a generic CFC-free salbutamol inhaler? About £3 (note that we pay standard prescription charges, so to the patient that's either free or £7.20 in England or £5 in Scotland). Yes, the NHS gets a discount. But this is one of the reasons that US healthcare scares me.
posted by Coobeastie at 3:31 AM on June 14, 2009 [3 favorites]


I find it pretty much impossible to believe asthma was a big problem a hundred years ago. I think we've done something to our environment that is killing the susceptible among us. That's surely a bad sign.

fff, don't be stupid. Look at the life expectancies from a century ago, or the infant mortality rates - that's due partly to things like clean water, access to food and nutrition, and shelter from the elements; but a huge part of it is modern medicine, including inhalers.

It seems two major objections are being raised in this thread to HFA inhalers: their efficacy, and their cost. The former, I'd like to see more than anecdotal evidence about, especially since the UK seems to have done okay with them (which I only know about anecdotally, so that's totally reliable either). The latter is definitely a huge problem, though. Until you've had a chronic medical condition, or a family member with one, it can be difficult to understand just how badly the US healthcare system can screw you over.
posted by spaceman_spiff at 3:42 AM on June 14, 2009


I find it pretty much impossible to believe asthma was a big problem a hundred years ago. I think we've done something to our environment that is killing the susceptible among us.

TUBERCULOSIS! Really. Tuberculosis and asthma seem to have a 'see-saw' relationship; when one's high, the other's low. One hundred years ago the predominant respiratory complaint was TB, which killed massive number of people (probably the biggest killer in Victorian Britain). The numbers dying of asthma today are miniscule compared to deaths from TB.

Asthma is not fun. But TB is really, really, really not fun.

Sorry for the caps. This 'modern life is rubbish' ahistorical bullshit gets me angry.
posted by Coobeastie at 3:53 AM on June 14, 2009 [1 favorite]


I'm not saying it isn't important but it is attempting to put the best possible light on the subject through pretty heavy spin via statistics.

What I'm demonstrating with that is that medical exceptions are statistical noise compared to the damage that's already been done and still will be done by the other uses of the 20th century.

If the ozone couldn't replenish itself then continued exceptions for medical "necessity" would be more dubious since further medical use would be causing more cumulative, irreparable harm.

But the science is implying that the cutbacks of the 90s have succeeded in halting the damage and the ozone is beginning to recover even with the heavy load of CFCs still making its way into the stratosphere.

Stuff we produce today will still be destroying Ozone three centuries from now

True, but the ozone does have a natural rate of recovery and the relatively small amount formerly allowed for medical applications won't overwhelm this recovery. Scientists are predicting a full recovery of the ozone holes sometime mid-century, and I don't think the ~3000 metric tons per year medical allowance would materially alter this process given the other industrial pollutants still being produced and released, eg. halon.

Zero-tolerance results in governments going stupid; cf kids getting expelled for bringing butter knifes and advils to school.

This entire issue looks to be a remarkable failure of government and a typical success of free market corporato-capitalism in screwing the little guy for the longest possible time.
posted by @troy at 4:02 AM on June 14, 2009 [2 favorites]


"make Big Pharma accountable for its role in spreading the use of CFCs by offering replacement generics."

That's orthogonal to the patent protection they get for trivial reformulations. They play these packaging games all the time without the international treaty involvement of the present case.

At any rate, if Big Pharma was only consuming 4000 metric tons of the stuff per year they were responsible for just 4% of the problem, and since the safe delivery of medicine into the lungs is a pretty good prioritizing factor in the global allocation of environmentally-balanced quotas, I'd say they really weren't part of the problem at all since the stratosphere can safely handle that level of pollution.
posted by @troy at 4:09 AM on June 14, 2009 [1 favorite]


Sorry, "0.4% of the problem" above.
posted by @troy at 4:12 AM on June 14, 2009


Here in Belgium, we also have HFC based ventolin and have had for a long time (I cannot remember not having them)... The cost (for GSK's ventolin-100): a mere €5, of which the state's obligatory insurance pays €4.75...

This appears to be another example of US companies ripping off the consumer and redirecting criticism away from themselves with an "It's the FDA's fault - we have to charge more because it costs more" - thank goodness I live in a country with a heavily regulated 'socialist' medical system (which does have it's own probelms, admittedly).
posted by nielm at 6:24 AM on June 14, 2009 [1 favorite]


Rather than snorting down inhalers like there's no tomorrow, maybe we should be focusing on cleaning up our environment. I find it pretty much impossible to believe asthma was a big problem a hundred years ago. I think we've done something to our environment that is killing the susceptible among us. That's surely a bad sign.

Actually, perhaps we are too clean, not too dirty.
posted by caddis at 6:55 AM on June 14, 2009


I find it pretty much impossible to believe asthma was a big problem a hundred years ago.

Yes, because in houses and metropolises full of soot and coal dust, among other contaminants, there must have been far higher air quality.
Particulate concentrations show a peak at the end of the 19th century.
Or maybe the air quality didn't make a difference.
posted by elfgirl at 7:38 AM on June 14, 2009


The cost difference is likely all because of the sudden requirement lack of supply and lack of a generic alternative. That should all settle down shortly and the generics will enter the market and the name brands will drop in price to compete. People in other countries have been using these. US doctors and patients will learn the technique over time. This all seems like much to do over nothing.
posted by caddis at 7:48 AM on June 14, 2009 [1 favorite]


My wife has asthma, and fortunately, her insurance approved her for an expensive medication called Xolair, that is administered in biweekly shots. She still has to carry an epi-pen everywhere she goes, so this discussion is close to home for us.

I don't have asthma myself, but I do have allergic rhinitis, and take meds for that.

We felt a similar budgetary pinch several years ago when Loratadine (Claritin) went OTC. At that point, the insurance company decided "You can just take Claritin" and jacked up the copays for all our allergy meds to the top bracket. At the time I was on 3 meds with $20 copays, and my wife was too. The new copay was $40. So our monthly prescription costs went from $120 to $240, just because the insurance companies are rotten bastards and bent us over because they can.

Something desperately needs to be done about this, but the insurance companies and Big Pharma are lining so many pockets that change will be slow to come, if ever.
posted by Fleebnork at 8:26 AM on June 14, 2009 [1 favorite]


I just looked up the likely chemical structure of HFA versus CFC (I've got a background in Chemistry/Biochemistry).

I have to say that HFA don't look that much safer as propellants than CFCs overall. HFA is likely either hexa-fluoro ethane or possibly 1,2,3,6,7,8-hexa-fluoro propane, but I haven't been able to determine specifically.

In contrast, CFCs are usually 1, 2 or 3 chlorine atoms and 3, 2, or 1 fluorine atoms all surrounding a carbon atom (technically a methane derivative).

What it means chemically is that the CFC is thermodynamically/kinetically more likely to cleave off a halogen (chlorine or fluorine) radical which would be highly reactive and probably destroy an atom in your lung cell lining. But honestly, the hexafluoro alkane is not that much safer. It is more stable because there are more carbon atoms (ethane has 2 and propane has 3) in the molecule, but the likelihood is that if something does cleave off, it's still going to be a halogen radical and it's still going to be nuking some molecules in your tissues.

That said, radicals cleaving off of alkanes in general (methane, ethane, propane, butane, etc.) is not particularly frequent. It just gets riskier with halogens because they're so reactive and if they do cleave, it's so much more destructive (than, say, if hydrogen cleaved off instead).
posted by kalessin at 8:34 AM on June 14, 2009


> But, CO2 or N2 (you didn't mean NO, and I assume you didn't mean N2O, which is laughing gas) are not replacements for CFCs or HFAs.

Thanks for the info! I did indeed mean N2O, because Wikipedia told me it was a food-safe aerosol propellant used for whipped cream and the like, but I wasn't wed to any particular solution. Temperature issues obviously depend on pressure difference and quantity, so I think comparison to paintball equipment is a bit off. In light of subsequent information in this thread, my question probably boils down to "why can't American asthmatics get the CFC-free inhalers that people have been using for years in Europe at a reasonable price" and I think we all know the answer to that one.
posted by nowonmai at 8:59 AM on June 14, 2009


elfgirl, how do you draw that conclusion? I read that page and what I see are endless studies demonstrating that the higher the pollution levels, the more likely children are to develop asthma.

We have done amazingly stupid things with our air. Things like leaded gas, asbestos brake pads, low-quality diesel. And the over-use of "air fresheners" and other stinky products in homes — nothing says lovin' like evaporating toxic VOCs, phthalates, glycol ethers, formaldyhydes, etc into one's home. Especially when put into a new home that has carpets, paints, and other things also outgassing their poisons.

Over 5% and possibly up to 15% of the population has asthma. Does it really make sense to think this is natural? To my mind, it seems very counter-evolutionary. Seems to me very likely that we've got such high rates because something outside our bodies is causing it.

IANAD and IANAA, so it's very possible I'm full of shit. But that list of studies to which you linked, elfgirl, tends to indicate that pollution is playing a big role.
posted by five fresh fish at 9:00 AM on June 14, 2009


kalessin there are three things (well four technically) that affect a compounds Ozone Depletion Potential:
  1. The nature of the halogen (bromine-containing halocarbons usually have much higher ODPs than chlorocarbons, because atom for atom Br is a more effective ozone-destruction catalyst than Cl.)
  2. The number of chlorine or bromine atoms in a molecule.
  3. Atmospheric lifetime (CH3CCl3 has a lower ODP than CFC-11, because much of the CH3CCl3 is destroyed in the troposphere.)
As far as I know (IANAC) HFA doesn't contain any Chlorine or Bromide and therefor doesn't attack the ozone layer (or at least not in the magnitudes that halogenated compounds do).
posted by Mitheral at 9:20 AM on June 14, 2009


But that list of studies to which you linked, elfgirl, tends to indicate that pollution is playing a big role.

In particular, higher levels of particulate matter in the air--dust, fecal material, animal dander--increase the incidence of childhood asthma. The first study showed that in London, at least (and I'm presuming other industrialized cities), the levels of particulate matter in the air peaked at the end of the 19th century. If greater levels of particulate matter in the air causes a higher incidence of childhood asthma, it follows that asthma would have been more prevalent 100 years ago than it is today.

Therefore, the statement, "I find it pretty much impossible to believe asthma was a big problem a hundred years ago," ignores the fact that the causes of asthma were more prevalent a century ago, which makes it likely that asthma and other reperatory illnesses were more of a problem then, not less.
posted by elfgirl at 9:24 AM on June 14, 2009


^respiratory, not reperatory. Gah.
posted by elfgirl at 9:25 AM on June 14, 2009


"A hundred years ago" is a figure of speech: make it a couple hundred years, if that makes you happier. And of course the mega-cities are always going to have more problems: they're always more polluted. London and Los Angeles both have had amazingly unhealthy pea-soup smog, to the point that people up and die from it.
posted by five fresh fish at 9:29 AM on June 14, 2009


Asthma history
At the beginning of the 20th century asthma was seen as a psychosomatic disease - an approach that probably undermined any medical breakthroughs at the time. During the 1930s to 1950s, asthma was known as one of the holy seven psychosomatic illnesses.

Asthma was described as psychological, with treatment often involving, as its primary component, psychoanalysis and other 'talking cures'. A child's wheeze was seen as a suppressed cry for his or her mother. Psychoanalysts thought that patients with asthma should be treated for depression. This psychiatric theory was eventually refuted and asthma became known as a physical condition.

Asthma, as an inflammatory disease, was not really recognized until the 1960s when anti-inflammatory medications started being used.
posted by Kirth Gerson at 10:00 AM on June 14, 2009 [2 favorites]


True enough. However, wood burning stoves (for heat and cooking) and organic dust were pretty well universal in the 19th century, going back to the dawn of time. So, two major causes of asthma have been present pretty much forever.

That said, as coobeastie mentioned, there is an inverse relationship between the incidence of Tuberculosis and asthma in a population. Considering the high rates of TB in the past, it may be that there was a lower rate of asthma 100/200/300 years ago because TB was giving the general population an immunity to it.
posted by elfgirl at 10:03 AM on June 14, 2009


And, just for the record, if my options for asthma control are $50 inhalers or TB exposure? I'll take the inhaler.
posted by elfgirl at 10:06 AM on June 14, 2009 [1 favorite]


The increased cost of HFA MDIs is a temporary problem and it is not our main concern, as important as it is. Our main concern is the inferior safety and efficacy of HFA MDIs, which is strongly supported by both the clinical studies, FDA MedWatch data, and other anecdotal data from thousands of patients all over the world (many of whom are getting 'stepped-up' to more dangerous drugs containing long-acting beta agonists, such as Advair and Symbicort, that they would not otherwise need if they had access to CFC MDIs). HFA MDIs are making many patients very sick.

For those patients who do well with HFA MDIs, congratulations. Unfortunately, many patients get minimal or no relief from them, and/or suffer terrible side effects from them, whether you like it or not, whether you believe it or not. The clinical data is at the top half of the Press Room page, the anecdotal data is on the Doctors Speak Out Page, the Patients Speak Out page, with additional links on the Updates page. It is more than sufficient to convince all but the willfully blind.

TungstenChef asked mitheral the key question, which is whether or not he could quantify his unsubstantiated assertion that "So? It's (CFC MDI emissions) still very damaging."

Mitheral responded with the mother of all red herrings in this debate, which is to discuss the number of ozone molecules destroyed per chlorine atom. This is totally irrelevant, although it is a very effective distraction from the real question, which is this: how much increased ground level UVB radiation can be attributed to CFC MDI emissions. The ONLY reason we care about ozone layer depletion is because it was supposed to cause increased rates of carcinogenic ground level UVB, and this has NEVER been observed. (The fact that there is now growing evidence that UVA, rather than UVB, is the carcinigenic wavelength (and the ozone layer, like most sunscreen, does not protect us from UVA radiation) makes the ban of CFC MDIs even more idiotic than it already is, if that is possible.)

We know that according to the WMO 2006 Ozone Assessment, there has never been any detected increase in ground level UVB.

Therefore, the amount of increased ground level UVB attributable to CFC MDIs is zero, and this is the honest answer to TunstenChef's question.

The FDA (in close consultation with the EPA) admits that they have no evidence to support the BIG LIE that CFC MDI emissions are harmful (bottom of Press Room page):

"... we are unable to quantify the environmental and human health benefits of reduced CFC emissions from this regulation (banning CFC MDIs.)"(p.74)

"... we are unable to assess or quantify specific reductions in future skin cancers and cataracts associated with these reduced CFC emissions (achieved by banning CFC MDIs)."(p.75)


Mitheral is correct when he says that "Humans for the most part were not in direct danger from the ozone hole," (there is substantial evidence at the bottom of the Press Room page that shows that the increased rate of skin cancer we've seen over the last few decades was caused not by increased ground UVB secondary to ozone depletion, but rather, to simple changes in human behavior).

However, his assertion that "it was the effect on plants and ocean life that was the mind blowing concern." is revisionist history at its finest. The Montreal Protocol was convened due to the widespread hysteria that the ozone hole would lead to massive increases in skin cancer rates. The EPA testified in front of Congress (based on their computer models) that the US would experience an additional 6.7 million additional skin cancer deaths between 1990 and 2165 unless CFCs were banned. This was always the main concern of the Montreal Protocol. We see this hysteria today in comments such as this, by five fresh fish: "Every time an asthmatic snorts a CFC inhaler, an Australian gets a melanoma." A very powerful argument, except that CFC MDI emissions (in fact, the TOTALITY of global CFC emissions from all sources), have not resulted in detectable increases in UVB ground radiation.

This thread is very interesting, but unfortunately, real men, women and children all over the world are suffering unnecessarily due to their inability to tolerate (or get adequate relief from) HFA MDIs, and since we know that neither CFC MDI emissions (nor the totality of CFC emissions) cause Australians, or anyone else to get melanoma, the only humane, logical solution is to create an exemption for CFC MDIs for the thousands of patients who need them.

We encourage anyone who is interested in joining our campaign to legalize CFC MDIs to join us at SaveCFCinhalers.org
posted by Arthur Abramson at 10:45 AM on June 14, 2009 [2 favorites]


Zero-tolerance results in governments going stupid; cf kids getting expelled strip-searched for bringing butter knifes and advils to school.
posted by oaf at 10:53 AM on June 14, 2009 [1 favorite]


I don't mean to be contrary, but I would like to respond to the above mention of the "Buteyko method" of treating asthma. I'm an asthmatic and have been aggressively interested in any possible pharmaceutical, surgical or complementary treatments. Sadly, the Buteyko method is not legitimate, except for its placebo effect.

The only random, double-blind experiment that has ever been conducted on the Buteyko method is the one that is often referenced by its adherents as evidence of its efficacy. In fact, this study allowed the UK to say that the method could be suggested to patients. But the study itself is deeply flawed.

First, when tested against another breathing method, there was zero sign of any change in CO2 levels in the bloodstream. That's counter to the actual claim made by the Buteyko adherents. Second, the study DID show a reduction in medicine use and a reported higher quality of life, BUT it was later discovered that the Buteyko researchers were exclusively contacting the Buteyko test patients during the trial, which alone could account for a placebo effect on perceptions of wellness (and thus a reduction in medication use).

Not only is the key study thus flawed, but there is absolutely no evidence that the underlying Buteyko theory has any basis in fact. The hypothesis is essentially that by employing the method, one increases the CO2 level in the bloodstream and essentially forces the Krebs Cycle to run in reverse. Again, the one study generally cited actually shows there is no significant impact on the CO2 levels. Nor have there been any studies to suggest that the Krebs Cycle could be induced to reverse itself even if CO2 levels were increased.

Sadly (and it is sad, because I would love it to be true) Buteyko ranks right up there with homeopathic remedies, aura balancing and crystal therapy as a complementary treatment for asthma. It "works" only to the degree the patient can convince himself or herself that it does.
posted by darkstar at 11:00 AM on June 14, 2009 [2 favorites]


>Keith Gerson, thanks for that bit of history. I remember being in the doctor's office when my parents were told that my asthma was psychosomatic (I was young, but not so young as to not know what psychosomatic meant). Being told at 6 or 7 that your suffocating, inexplicable physical condition is due to being crazy is not something I would wish on anyone.
posted by jokeefe at 11:21 AM on June 14, 2009 [1 favorite]


@Mitheral, if you look at the periodic table at the halogen column (usually column VII), you will see a stack of symbols.

Bromine, Chlorine and Fluorine are all in the halogen column. So are Iodine and Astatine.

Fluorine is a nasty chemical to work with. In its elemental form, it's a gas (two Fluorine atoms together make a molecule of fluorine gas) and it's colorless, so you only know that it's leaking from your experimental setup when you can smell it (smells like cut grass). Unfortunately, if you can smell it, it's eating away at your lungs/mucosal tissues.

Now, the fluorine radical, if it's just come off of a halocarbon (a molecule that has carbon and various halogens in it), is a radical or ion that is free floating (this would be one of those nasty free radicals we sometimes hear about) and just looking for something to bond to (so it can get or share a missing electron). The bad news is that when it bonds to something it usually changes its nature so extremely that it kills it or changes it so it's not bochemically useful to your body any more.

Your source is not mentioning fluorine in ozone production, but in principle Encyclopedia Brittanica agrees that it is extremely reactive. It looks like that's because Fluorine's extreme reactivity that actually makes it a poor cleaver-from-molecules - perhaps once it's stuck it's hard to get it off again. (Yes, I think that's it. Go here and search for "HF", which is a sort of proto CF4 or C2F6.)

Anyway, I wanted to underline that I was looking at the hexafluoroalkanes (HFAs) from the point of view of "do I want that stuff in my lung more than I want the CFCs in there?" and I think that I am still going to say that I don't see a lot of difference from that standpoint (largely because of all the energy and enzymes and catalysis going on in the biochemical organism, I am skeptical that the HFAs are all that stable in the lungs - though I haven't seen or looked for any studies for or against that suspicion), though I think you are right in saying that the HFAs seem not to be something to worry about from the point of view of ozone generation in the atmosphere.
posted by kalessin at 11:32 AM on June 14, 2009


I understand the this issue as : (1) HFAs are non-obvious and patentable, but that patent has expired, and pharma companies didn't own it. (2) Our moronic patent office allows the pharma company to get a new patent for using the propellant HFA for a propellent of an existing medication. Duh! obvious! wrong, illegal, etc.

You can fix this several ways : (1-6) A class action lawsuit or a lawsuit by a generics manufacturer against the patent office and/or the company. (7) Lobby Obama until he makes the patent office fight the patent for you.
posted by jeffburdges at 11:41 AM on June 14, 2009 [2 favorites]


The fact that the ozone layer is regenerating is simple proof that there is a certain amount of punishment it can take, and if the major industrial sources are removed it should no longer be a problem.

Because the amount of CFCs generated by asthma sufferers is *substantially less* than the amount the ozone layer can naturally handle, it seems pointless and cruel to inflict less effective solutions on people with a terrifying medical problem.

I strongly suspect that the vast majority of those arguing against the existence of CFC-based inhalers have not woken up at 3AM clawing at their throat and gasping, lurching semi-blind and semi-conscious toward their nightstand for a small plastic device that is their only hope of surviving the next ten minutes. This happens to me once every month or so. I otherwise have no signs of asthma.

I still have a couple functioning CFC-based inhalers that are starting to run low. I'm terrified as to how things are going to play out for me over the next year.

Those of you arguing against ANY CFC usage because it will return the ozone layer to pre-industrial levels at BEST a few months sooner than otherwise ought to be deeply ashamed.
posted by Ryvar at 11:51 AM on June 14, 2009 [3 favorites]


Oh, and I personally couldn't care less about the cost of the new inhalers. This is a straight survival vs. ozone regeneration rate question for me, and there just isn't enough benefit to the latter to compromise on the former.
posted by Ryvar at 11:55 AM on June 14, 2009 [1 favorite]


Asthma already disproportionally affects low-income families.

So does, well, pretty much everything. That's sort of the problem with a Capitalist society with the largest rich/poor disparity combined to an exponential degree with categorizing health care as a luxury commodity. Poor families also eat worse because they have to buy less healthy food and get generally sicker in all aspects because of a lack of basic health coverage. Asthma, tragically, isn't exactly a special exception in the perfection that is The Best Health Care System In The World.™

Those of you arguing against ANY CFC usage because it will return the ozone layer to pre-industrial levels at BEST a few months sooner than otherwise ought to be deeply ashamed.

I'm not, and it's sad that once again anger is directed at those who have been aware of this problem and in general have noted the ample opportunity to address it for an excessive amount of time. This country has been aware of the dangers, and worked to ban, CFCs for probably as long as I've been alive now. As many have already noted in this thread, European nations have had effective, functional non-CFC inhaler devices for over a decade at this point. The very rule that ordered the eventual removal of CFC-using inhalers in the U.S. was created twenty-two years ago.

Clearly am neither happy nor hopeful for the injury and death of asthma sufferers because of this, but exactly how many times do I have to watch this amazing dance of stubborn capitalism and consumer apathy- be it the auto company CEOs who whine that it's simply impossible to make a car in fifteen years that gets 6 MPG more, the television viewers being shocked- shocked to discover that their TV antennas don't work after only two years of warnings about it, or the banks furious- furious- that the thousands of people they lied to in unregulated mortgage offers had the audacity to end up not having the money to pay the money back, before I don't have to be the one yelled at for someone else's self-motivated greed?

As a progressive I guess I'm used to the idea of political martyrdom but when this is yet another example of business failing to put any effort into planning ahead at the expense of immediate profit and instead of outrageous fury at said industries and politicians who allowed it to happen it's told, preemptively, that I'm an asshole for the idea that not only do I not care, but haven't been caring for the last decade, then I am not the one who should feel any shame.
posted by XQUZYPHYR at 12:35 PM on June 14, 2009 [2 favorites]


"As many have already noted in this thread, European nations have had effective, functional non-CFC inhaler devices for over a decade at this point."

This is not true for large numbers of patients all over the world, who get minimal or inadequate relief and/or suffer serious adverse reactions from HFA MDIs, and anyone who would deprive them of the CFC MDIs that work safely and effectively for them (in the name of some non-existent environmental 'benefit') should be deeply ashamed of themselves, as the poster above said. But unfortunately, pseudo-environmentalists such as yourself are completely shameless.
posted by Arthur Abramson at 12:52 PM on June 14, 2009


since we know that neither CFC MDI emissions (nor the totality of CFC emissions) cause Australians, or anyone else to get melanoma

The above statement is irrational and wrong.
posted by Blazecock Pileon at 12:52 PM on June 14, 2009


Why do I feel like we're being astroturfed?
posted by Blazecock Pileon at 12:53 PM on June 14, 2009


"since we know that neither CFC MDI emissions (nor the totality of CFC emissions) cause Australians, or anyone else to get melanoma"

"The above statement is irrational and wrong."


No, it is rational and true.

If you have any evidence showing detectable increases in ground level UVB sufficient to cause melanoma, why don't you share it with the World Meteorological Organization. They could use the help.

"Why do I feel like we're being astroturfed?"

Because your phony arguments about the dangers of CFC MDIs are being exposed as the garbage that they are.
posted by Arthur Abramson at 1:04 PM on June 14, 2009


You're caricaturing asthma sufferers who are experiencing legitimate issues with these inhalers, both in terms of their design and their cost, as petty and selfish. That's not fair, and it's not the sentiment I see from the comments here.

It's not that asthma sufferers in particular are "selfish" but just that all human beings tend to put their own interests far above a general and almost abstract interest like the environment. If it's true that the impact on the environment is so small as to be negligible, this could just be dumb decision-making by the gov't, but when it's framed as terrible to have to pay $35, even though the cheaper meds cause ozone holes, it's easy to see why it doesn't reflect well on the individual.

This is nothing against people who have been saddled with difficult medical issues. It's just pointing out the obvious - people don't like to die or suffer, and when it comes down to the wire, are often willing to do things that might be harmful in broad or long-term ways if it will save us or someone we love right now.

I remember being in the doctor's office when my parents were told that my asthma was psychosomatic (I was young, but not so young as to not know what psychosomatic meant). Being told at 6 or 7 that your suffocating, inexplicable physical condition is due to being crazy

That is not what psychosomatic means. The mind is powerful and you are not always controlling it. Very serious and very difficult medical issues can be the result of stress, trauma, anxiety or other psychological beginnings. Asthma is very commonly at least related to one's mental state. Obviously that is not the only aspect to be aware of, but it shouldn't be dismissed as nonsense either.
posted by mdn at 1:23 PM on June 14, 2009


"However, his assertion that 'it was the effect on plants and ocean life that was the mind blowing concern.' is revisionist history at its finest. "

This is not revisionist history, I was heavily involved with this at the time of the Montreal Protocol; I hold one of the first 50 CFC Refrigeration Certification tickets issued in my province. The company I worked for had been reclaiming and reusing R-12, 22 and 501 for decades when industry practise was to vent it to the air. Now maybe they were handing out the Flavour-Aid back then too. And maybe the media who bring us shark attack and missing white girl hyped up the human danger. But concern for oceans has always been a front and centre concern.

"I wanted to underline that I was looking at the hexafluoroalkanes (HFAs) from the point of view of 'do I want that stuff in my lung more than I want the CFCs in there?' and I think that I am still going to say that I don't see a lot of difference from that standpoint (largely because of all the energy and enzymes and catalysis going on in the biochemical organism, I am skeptical that the HFAs are all that stable in the lungs"

From that point of view, ya, a CFC of some sort is probably better. It's the whole wonder chemical thing again.
posted by Mitheral at 1:34 PM on June 14, 2009


but when it's framed as terrible to have to pay $35, even though the cheaper meds cause ozone holes, it's easy to see why it doesn't reflect well on the individual.

the core issue is that this is an incorrect framing, ie a lie.

The cheaper meds (those that lacked patent protection) were not used in sufficient quantity by asthma sufferers to measurably affect ozone levels.

While we can say the same about any arbitrarily small class of CFC user, medical users *had* an exception to the CFC ban, and AFAICT the EPA and FDA revoked the exception too early.

Since inhalants of some form are a medical necessity, requiring their users to pay more to substitute non-CFC technology in the effort of eco purity was and is an unfair burden on these users.
posted by @troy at 1:52 PM on June 14, 2009 [1 favorite]


Yeah, but when it seems to get right down to it, if the new HFA meds were the same or nearly the same price as the old CFC meds, there doesn't seem like there would be much argument. And the pricing is entirely within governmental regulatory control - if it's not simply a matter of the old generic producers being slow to switch their plants over, and thus that this problem will resolve itself soon enough. So holler at your elected officials, point out that the regulatory switch from CFC propellant to HFA propellants raised prices on asthma drugs by $x, and get them working on your side for a change.

I mean, it just seems like the CFC issue is something of a red herring here, the real issue is that the feds regulated pharma away from CFC propellants, and pharma is taking advantage of the switch to reset their patents. Users in other countries (total anecdata, I know) seem to be reporting that when the price concern isn't an issue (due to their governments having slightly more sane health insurance programs), HFA works well enough to be negligibly different from the old CFCs.
posted by Kyol at 2:09 PM on June 14, 2009


but when it's framed as terrible to have to pay $35, even though the cheaper meds cause ozone holes, it's easy to see why it doesn't reflect well on the individual.

the core issue is that this is an incorrect framing, ie a lie.


I didn't mean "the individual" as in, that particular individual, to be clear - I meant "the individual" as opposed to "the group"... I'm just saying, it isn't about who is saying what, because I'm sure anyone in a situation where they need something for their health is going to be annoyed at it being harder to get, costing more, or not working as well. It's classically difficult to deal with the conflict between immediate personal needs and vague, long-term group interests, and the latter usually lose out even when they're really important.

Anyway, I already agreed that in this instance there are more complications, but the original post and the initial responses did not bring that up.
posted by mdn at 2:22 PM on June 14, 2009


"Yeah, but when it seems to get right down to it, if the new HFA meds were the same or nearly the same price as the old CFC meds, there doesn't seem like there would be much argument."

This is false. For large numbers of patients in the US and around the world, the issue is not the temporary, higher cost of HFA MDIs, it is the inferior safety and/or efficacy of HFA MDIs.
posted by Arthur Abramson at 2:30 PM on June 14, 2009


the issue is not the temporary, higher cost of HFA MDIs, it is the inferior safety and/or efficacy of HFA MDIs.

This claim appears to be incorrect:

"Clinical trials in children and adults with asthma have demonstrated that when these HFA albuterol products are administered at the FDA-approved dose, their efficacy and safety profiles are similar to those of the CFC albuterol products they are intended to replace [emph. added]." - NEJM 356(13):1344-51.
posted by Blazecock Pileon at 2:50 PM on June 14, 2009


"This claim appears to be incorrect:"

"Clinical trials in children and adults with asthma have demonstrated that when these HFA albuterol products are administered at the FDA-approved dose, their efficacy and safety profiles are similar to those of the CFC albuterol products they are intended to replace [emph. added]." - NEJM 356(13):1344-51.
posted by Blazecock Pileon at 2:50 PM on June 14 [+] [!]"


Wrong, the claim from thousands of patients about the inferior safety and efficacy of HFA MDIs is correct.

As is often the case with drug-company sponsored clinical trials, the self-serving conclusion written by the paid, conflicted investigators is often contradicted by the study results, as is the case in this paper.

If you look at the adverse reactions chart (Table 3, p. 1349) you can see for yourself that in terms of virtually all of the significant adverse reactions listed (Allergic reactions or symptoms, Back pain, Fever, Dizziness, Headache, Vomiting, Tachycardia, Ear, nose, and throat irritation, Lower respiratory tract infection. Cough (a major asthma symptom), and Pharyngitis) CFC albuterol is much safer than HFA albuterol.
posted by Arthur Abramson at 3:14 PM on June 14, 2009


To repeat my comment from earlier in this thread, which quotes Schering Plough itself:

HFA albuterol MDIs are not as SAFE as CFC albuterol MDIs, according to the clinical trials for Proventil HFA and Ventolin HFA, a New Zealand study, a large UK postmarketing study, three years of FDA MedWatch data, and Schering Plough itself (manufacturer of Proventil HFA) which says:

"Rapid heart beat, vomiting, chest pain and palpitation occurs more frequently with Proventil HFA (than with CFC albuterol) ."

We link to all of the above in the top half of the Press Room page and the bottom of the Stakeholders page of our website.

posted by Arthur Abramson at 3:34 PM on June 14, 2009


Wrong, the claim from thousands of patients about the inferior safety and efficacy of HFA MDIs is correct

Your assertion is anecdotal. Further, your assertion is dubious, given the wealth of clinical trials conducted across the world that suggest the opposite.

As is often the case with drug-company sponsored clinical trials, the self-serving conclusion written by the paid, conflicted investigators is often contradicted by the study results, as is the case in this paper.

You have provided no evidence whatsoever that the investigators involved in the 21 clinical trials listed in the paper I cited have competing financial interests that would call the trial results into question.

For the sake of their own health and well-being, I suspect that people here at MetaFilter and elsewhere would do well to take your very passionate assertions with an equally large grain of salt.
posted by Blazecock Pileon at 3:39 PM on June 14, 2009


In any case, it appears some patents on HFA inhalers will be lifted in 2010, thus reducing their cost as generics come online. I'll wager that some of the opposition to the use of HFA-based medication will reduce once the cost is as manageable as older CFC products.
posted by Blazecock Pileon at 3:45 PM on June 14, 2009


Wrong, the claim from thousands of patients about the inferior safety and efficacy of HFA MDIs is correct

Your assertion is anecdotal.

Yes, the above is anecdotal. I remind you that anecdotal does not mean worthless.

But this is not anecdotal- it is a summary of 3 (not 21) clinical trials (for Proventil HFA, Ventolin HFA and Proair HFA):

If you look at the adverse reactions chart (Table 3, p. 1349) you can see for yourself that in terms of virtually all of the significant adverse reactions listed (Allergic reactions or symptoms, Back pain, Fever, Dizziness, Headache, Vomiting, Tachycardia, Ear, nose, and throat irritation, Lower respiratory tract infection. Cough (a major asthma symptom), and Pharyngitis) CFC albuterol is much safer than HFA albuterol.

The clinical safety results reported in the paper you cited clearly supports the large amount of anecdotal we (and others, such as ConsumerAffairs.org, which we link to on the Updates page of our site) have posted on our linked sites.

Further, your assertion is dubious, given the wealth of clinical trials conducted across the world that suggest the opposite.

Show me the "wealth" of clinical RESULTS (as opposed to self-serving CONCLUSIONS) you refer to that show the equal safety of HFA albuterol- I've never seen them, and I've been looking for over two years.

I am sorry that the clinical results and the anecdotal complaints from thousands of patients (including MDs, pharm/chem PhDs, RNs, RRTs, etc.) and Schering Plough itself, displeases you.

The paper clearly discloses the following- you missed it:

"Dr. Colice reports receiving lecture fees from GlaxoSmith-Kline and consulting fees from IVAX/Teva and Schering-Plough. Dr. Hendeles reports receiving a research grant from
GlaxoSmithKline and consulting fees from AstraZeneca. No other potential conflict of interest relevant to this article was reported. Dr. Meyer’s participation in this article represents his personal views and does not necessarily represent the views of
the FDA."

Note: Dr. Meyer ran the FDA's CFC ban project since the late 1990's, so while he was never paid by the drug cos., he was certainly not a disinterested investigator.
posted by Arthur Abramson at 4:02 PM on June 14, 2009


WHAT THE HELL! I think you are being lied to!

I'm looking at an inhaler - a GOOD one - never clogs, can always tell how much is in it, etc etc, and this particular one I have in my hand is so old that it expired in December 2002, and it states that the propellant is HFA134a! WTF?!?

This CFC-free inhaler is starting to sound like an American scam!

This inhaler was not obtained in the USA. The manufacturer is Glaxo Wellcome, a UK company. Is is a 200 dose 100mcg albuterol inhaler (though it uses the international naming (INN) Salbutamol, which is albuterol in the USA (USAN))


So the rest of the world has had CFC-free inhalers THAT WORK and we've had them FOR YEARS. You're being sold a bridge.

A google search for HFA134a beings up plenty, including "HFA134a (1,1,1,2-tetrafluoroethane) is a nonozone-depleting candidate to replace the chlorofluorocarbons used as propellants in metered-dose inhalers (MDIs) for pharmaceuticals that are widely used in the treatment of respiratory tract disease." Other studies I could find likewise indicated that the stuff was good to go.


Incidentally, this CFC-free inhaler that is so old that it expired SEVEN YEARS AGO - it's STILL IN PERFECT WORKING ORDER and as far as can be determined from first hand testing, it's just as effective as it always was.

The rest of the world has had CFC-free inhalors that really work for years now. Don't settle for second best.
posted by -harlequin- at 4:02 PM on June 14, 2009


As is often the case with drug-company sponsored clinical trials, the self-serving conclusion written by the paid, conflicted investigators is often contradicted by the study results, as is the case in this paper.

Oh for fuck's sake. Don't be absurd.
posted by ook at 4:11 PM on June 14, 2009


You are referring to Glaxo's UK version of Ventolin HFA salbutamol (the brand name is Evohaler, I think), which was available in the UK a couple of years or so before Ventolin HFA was first marketed in the US in 2002. Proventil HFA was first marketed in the US in 1996.

It works well for you, that's great. Unfortunately, HFA MDIs are not as safe and/or effective as CFC MDIs for all patients. Patients should have the ability to choose the products that work best for THEM, especially since there is no environmental benefit to be gained by the ban of CFC MDIs, as evidenced by the lack of detectable increase in UVB ground radiation, even when ozone layer depletion was at its peak, in the early 1990's.
posted by Arthur Abramson at 4:20 PM on June 14, 2009 [1 favorite]


As is often the case with drug-company sponsored clinical trials, the self-serving conclusion written by the paid, conflicted investigators is often contradicted by the study results, as is the case in this paper.

Oh for fuck's sake. Don't be absurd.


Brilliant comment.

You obviously know nothing about the cesspool of conflict and corruption that permeates drug-company sponsored clinical trials. Do some research, or remain ignorant, it doesn't matter.

According to David Graham MD, MPH (28 year FDA safety officer and well-known whistleblower- he testified in front of Congress about the massive number of unnecessary deaths due to Vioxx), the conclusions about the safety/efficacy of any given drug that is studied in drug company-sponsored clinical trials are FIVE TIMES MORE LIKELY to be favorable as the studies of the same drug done by organizations other than the sponsoring drug company. He said that numerous studies have confirmed these results, and he has no axe to grind.
posted by Arthur Abramson at 4:31 PM on June 14, 2009 [1 favorite]


Unfortunately, HFA MDIs are not as safe and/or effective as CFC MDIs for all patients.

No drug is 100% effective. Nonetheless, numerous clinical studies exist that contradict your anedotal assertion.

Patients should have the ability to choose the products that work best for THEM

Were that an option, I suspect (American) patients would once again quickly press their legislators for government regulation in the form of FDA approval, or its equivalent, once people get hurt by snake oil salesmen.

there is no environmental benefit to be gained by the ban of CFC MDIs

That is not obvious, either. Further, there is a documented increase in skin cancer and other UV-related pathologies in regions of the southern hemisphere affected by the regress in ozone protection.
posted by Blazecock Pileon at 4:35 PM on June 14, 2009


Nonetheless, numerous clinical studies exist that contradict your anedotal assertion.

As I've already told you, twice, the SAFETY RESULTS I pointed out to you in Table 3, p.1349, of the paper YOU cited, is not anecdotal, it is clinical trial data. I don't think you know what anecdotal or clinical trial data means.

And as I've told you, and as others have noted, the self-serving CONCLUSIONS in drug-company sponsored clinical trials are frequently contradicted by the RESULTS in those same studies. I've already PROVEN THIS in the paper YOU CITED.

You are being willfully blind. You keep parroting the same thing, you are not able to understand or refute my argument. I am posting not for your benefit, but for the benefit of others on this thread who are willing to face the facts about the inferior safety/efficacy of HFA MDIs for many (not all) patients.

there is a documented increase in skin cancer and other UV-related pathologies in regions of the southern hemisphere affected by the regress in ozone protection.

Wonderful. There is increased skin cancer in areas close to the ozone hole. There have also been several decades of increased skin cancer in the mid-latitudes, where ozone depletion has been much less of an issue, if not totally absent.

Now all you need to do is find some evidence that the increase in skin cancer over the last few decades has been caused by ozone depletion (as opposed to changes in human behavior, of which there is ample evidence), as evidenced by increases in ground level UVB (which the WMO says they've never observed) and you get a gold star.

Good luck with that.
posted by Arthur Abramson at 4:56 PM on June 14, 2009


As I've already told you, twice, the SAFETY RESULTS I pointed out to you in Table 3, p.1349, of the paper YOU cited, is not anecdotal, it is clinical trial data. I don't think you know what anecdotal or clinical trial data means.

And as I've told you, and as others have noted, the self-serving CONCLUSIONS in drug-company sponsored clinical trials are frequently contradicted by the RESULTS in those same studies. I've already PROVEN THIS in the paper YOU CITED.


Please see table B of the Supplementary Materials, which lists the clinical trials cited in the NEJM summary paper. No significant difference in safety or efficacy was concluded.

If there are conflicting financial interests on behalf of the investigators involved in the clinical trials, it is not discussed in the paper, and conclusions drawn from multiple trials on behalf of pharmaceutical companies would seem (to my eyes) to require a larger than usual conspiratorial effort. Which is not impossible, but makes, in light of the other issues with your comments, this possibility seems less likely.

Now all you need to do is find some evidence that the increase in skin cancer over the last few decades has been caused by ozone depletion (as opposed to changes in human behavior, of which there is ample evidence), as evidenced by increases in ground level UVB (which the WMO says they've never observed) and you get a gold star.

Here is some research which suggests a connection between increased UV exposure due to ozone depletion and skin injuries and cancers:

Punta Arenas, Chile, the southernmost city in the world (53°S), with a population of 154 000, is located near the Antarctic ozone hole (AOH) and has been regularly affected by high levels of ultraviolet-B (UV-B) radiation each spring for the last 20 years. Large increases in UV-B associated with the AOH have been measured with increases in UV-B at 297 nm of up to 38 times those of similar days with normal ozone. Recently we reported significant increases in sunburns during the spring of 1999 on days with low ozone because of the AOH...

For the 14-year period – from 1987 to 2000 – 173 cases of skin cancer were diagnosed, 65 during the first 7 years, 108 during the second, an increase of 66% [emph. added]. Cutaneous malignant melanoma (CMM), 19% of the cases, increased by 56%, raising the rate from 1.22 to 1.91 per 100 000. Non-melanoma skin cancer (NMSC), 81% of the total, increased the rate from 5.43 to 7.94 per 100 000 (P <>a 46% increase. Patients with CMM and NMSC had skin phototypes I–II in 59% and 54% of cases, respectively. Days with more than 25% ozone loss occurred in 143 days during the last 20 springs. Significant increases of UV-B were observed under ozone hole conditions, especially around 300 nm, the most carcinogenic wavelengths.


It is possible that behaviors have changed dramatically that cause Chileans in Punta Arenas to stay outdoors longer, but this news article suggests that the Chilean government has in fact taken steps to recommend that Chileans keep themselves and their children indoors during daylight hours, which would seem to point to the same or less time spent outdoors, or at least awareness that existing behaviors may increase the risk of damaging one's health.

An argument might be possible that the amount of CFCs from pulmonary use is minimal enough that the ozone hole will change size or shape independent of this usage, even though I don't think the evidence even suggests that, at least with what we know would be used at the current time.

What doesn't seem in dispute, to me, is that environmental ozone depletion does in fact lead to increased UV transmission, which in turn appears to have increased skin burns and cancers in people living in affected areas.
posted by Blazecock Pileon at 5:27 PM on June 14, 2009


Anyway, I don't intend to do much further back-and-forth on this. I only wanted to point out that the body of research out there seems to contradict a large number of your claims, and that it might serve others well to do a little of their own research before signing your petition.
posted by Blazecock Pileon at 5:38 PM on June 14, 2009


An argument might be possible that the amount of CFCs from pulmonary use is minimal enough that the ozone hole will change size or shape independent of this usage, even though I don't think the evidence even suggests that, at least with what we know would be used at the current time.

Just what are you basing that conclusion on?
posted by TungstenChef at 5:45 PM on June 14, 2009


Just what are you basing that conclusion on?

That the ozone hole continues to both increase and decrease in size. While the hope is that ozone depletion will reverse, that's not a given. Perhaps another decade of recovery would confirm that we're on the right track. So I don't agree that, at this point, adding more molecules of CFC to the equation (however few) is a good idea, when there are technical solutions to the problems presented that do not require CFCs.
posted by Blazecock Pileon at 5:55 PM on June 14, 2009


That the ozone hole continues to both increase and decrease in size. While the hope is that ozone depletion will reverse, that's not a given.

What you're actually saying then is that the level of CFCs used in inhalers hasn't been proven harmless to the ozone layer.
posted by TungstenChef at 6:15 PM on June 14, 2009


Please see table B of the Supplementary Materials, which lists the clinical trials cited in the NEJM summary paper. No significant difference in safety or efficacy was concluded.

What are you talking about?

I'm sorry. I have no idea what you are talking about when you refer to "table B of the Supplementary Materials", which shows "no significant difference in safety or efficacy was concluded. What page is it on? The only 'B' I see in the NEJM paper you cited is a graph on page 1348, which clearly shows the much greater tachycardia with HFA albuterol vs. CFC albuterol, so I doubt that's what you are referring to.

There are 49 papers mentioned in the bibliography. I've looked up all that I can access, and posted quotes from Ayres (#49) the UK postmarketing study, in the Press Room. This is another perfect example of the conflicted investigator's CONCLUSION being contradicted by his own RESULTS.

If there are conflicting financial interests on behalf of the investigators involved in the clinical trials, it is not discussed in the paper,...

I've already pointed out the conflicts of two of the three investigators in the NEJM paper; Here it is again:

Dr. Colice reports receiving lecture fees from GlaxoSmith-Kline and consulting fees from IVAX/Teva and Schering-Plough. Dr. Hendeles reports receiving a research grant from GlaxoSmithKline and consulting fees from AstraZeneca. No other potential conf lict of interest relevant to this article was reported. Dr. Meyer’s participation in this article represents his personal views and does not necessarily represent the views of the FDA.(Meyer ran the FDA's CFC ban project for over 10 years until he left the FDA for his new job at Merck, a year ago).

Dr. Colice was at 3M when he did the Proventil HFA trials. Feel free to look up any trial you want to, if you find one where a) the SAFETY RESULTS, NOT THE CONCLUSION, show equivalent safety between HFA albuterol and CFC albuterol, and b) there is no disclosed conflict by the author, please post the link.

I'm glad you brought up Punta Arena, that's the only refuge of the ozone depletion alarmists, but unfortunately, that dog won't hunt.

To quote from our website (bottom half of the Press Room, forgive the caps, I'll de-cap this):

OZONE DEPLETION HYSTERICS WILL BE DISAPPOINTED TO LEARN THAT A SEARCH FOR THEIR BELOVED PUNTE ARENAS, CHILE DATA IN THE 2006 WORLD METEOROLOGICAL ORGANIZATION SCIENTIFIC ASSESSMENT OF OZONE DEPLETION (IMMEDIATELY ABOVE) TURNED UP NOTHING.

THE CONCLUSION IN THIS PAPER (IMMEDIATELY BELOW) PUBLISHED IN THE JOURNAL OF GEOPHYSICAL RESEARCH MAY HELP EXPLAIN WHY THE AUTHORS OF THE WORLD METEOROLOGICAL ORGANIZATION'S 2006 OZONE ASSESSMENT DECIDED NOT TO MENTION PUNTE ARENAS:

"THE MAXIMUM INTEGRATED/WEIGHTED INTENSITIES (OF UV-B RADIATION) IN OCTOBER, DURING (OZONE) HOLE EVENTS INCREASED OVER BACKGROUND VALUES BETWEEN 2 AND 3 TIMES, WHICH REPRESENT VALUES NEAR THE LOCAL SUMMER MAXIMUM BUT NOT YET BEYOND LEVELS NORMALLY OBSERVED AT LOW-LATITUDE STATIONS."

In other words, there is no evidence of increased UV-B ground radiation during ozone hole events beyond what is normally seen at this latitude during the summer maximum. If there was, the WMO would have been all over it, rather than completely ignoring it.
posted by Arthur Abramson at 6:16 PM on June 14, 2009


What are you talking about?

If you open the electronic article from NEJM's site you will be able to access the Supplementary Materials link. There are two tables in this PDF file, the second of which documents the clinical trials that the paper cites in reaching its conclusion.

The "Results" column of this document appears to show that, for those trials related to efficacy and safety, HFA and CFC medicines demonstrated equal efficacy and safety, and greater efficacy of both, compared with placebo.

The only 'B' I see in the NEJM paper you cited is a graph on page 1348, which clearly shows the much greater tachycardia with HFA albuterol vs. CFC albuterol, so I doubt that's what you are referring to.

Perhaps I'm not reading the figure on pg. 1348 correctly, but it appears to say the opposite:

Figure 2. Mean (±SE) Changes in FEV1 and Heart Rate after Cumulative Doses of Albuterol Delivered by HFA and CFC Inhalers.

Data are from a randomized, modified blinded, two-period crossover, cumulative dose–response study involving 19 subjects with stable, moderately severe asthma. Before the study, the mean FEV1 was 2.2±0.7 liters (60±12% of the predicted value), and the subjects were using only an inhaled -agonist for symptom control. Doses of HFA albuterol and CFC albuterol (Proventil HFA and Proventil, respectively; Schering-Plough) were administered at 30-minute intervals, and measurements were obtained 12 to 18 minutes after each dose. No significant differences in bronchodilation or heart rate were detected with use of the HFA or CFC formulations. [emph. added] Data are reproduced from Ramsdell et al.,35 with the permission of the publisher.

posted by Blazecock Pileon at 6:42 PM on June 14, 2009


Ok, I just have the paper itself in pdf, which does not have the supplementary link you are referring to.

The only 'B' I see in the NEJM paper you cited is a graph on page 1348, which clearly shows the much greater tachycardia with HFA albuterol vs. CFC albuterol, so I doubt that's what you are referring to.

Perhaps I'm not reading the figure on pg. 1348 correctly, but it appears to say the opposite:

No, in 'B' (mean change from predose heart rate (bpm) the top blue line is HFA albuterol and the bottom red line is CFC albuterol and so the HFA has the greater increase in heart rate. Ramsdell says it's not significant.

But when you look at the composite side effects table for the three inhaler clinical trials (Table 3, p. 1349) it shows that 3-7% of the HFA patients experienced tachycardia compared to 2% of the CFC patients. And Schering-Plough (Proventil HFA) confirms the greater frequency of rapid heart rate with Proventil HFA vs CFC Albuterol.
posted by Arthur Abramson at 6:59 PM on June 14, 2009


Ramsdell says it's not significant.

In other words, HFA and CFC treatments are not found to have a statistically different effect wrt to heart rate.
posted by Blazecock Pileon at 7:34 PM on June 14, 2009


"There have also been several decades of increased skin cancer in the mid-latitudes, where ozone depletion has been much less of an issue, if not totally absent."

Thinning of the ozone layer is significant over Canada. For example in 1993 average ozone levels over Canada were 14% below normal. During the late 90s the thinning averaged ~6%.

Since 1979, the annual average amount of stratospheric ozone has dropped globally by 3-6% per decade at midlatitudes [sic]
This link starts with a nice graphic showing ozone levels over Canada and over the world. Do you have any data showing places that have not experienced below average ozone levels over head in the last 20 years?
posted by Mitheral at 7:36 PM on June 14, 2009


Do you have any data showing places that have not experienced below average ozone levels over head in the last 20 years?

I don't think there's ever been any ozone depletion in a fairly wide band centered over the equator. Ozone depletion requires extremely cold air, although I understand that there is a certain amount of circulation.

Your second link shows a graph through 2001 which says "stratospheric ozone layers not yet recovering". This strongly contradicts the WMO 2006 Ozone Assessment which shows global ozone recovering since it's low in 1991 (after the Mt. Pinatuba eruption), at which time global ozone was 6% below pre-1980 levels. In 2006 it was up to 4% below pre-1980 levels. You can see these charts for yourself at the bottom of the Press Room page.
posted by Arthur Abramson at 7:57 PM on June 14, 2009


Ramsdell says it's not significant.

In other words, HFA and CFC treatments are not found to have a statistically different effect wrt to heart rate.


All I see is the abstract of this 22 patient trial, from authors, including Colice, who I know are conflicted, and without any NUMBERS (at least in the abstract).

We are expected to take their word for it that the differences are not significant, and it's clear that these patients had only mild/moderate asthma.

Here's the abstract:

Cumulative dose response study comparing HFA-134a albuterol sulfate and conventional CFC albuterol in patients with asthma
Authors: J W Ramsdell, G L Colice, B P Ekholm, N M Klinger
BACKGROUND: As a result of the pending ban on chlorofluorocarbon production, the non-chlorofluorocarbon propellant 1,1,1,2-tetrafluoroethane (HFA-134a) is being evaluated as a replacement for CFCs in metered-dose inhalers. OBJECTIVES: This cumulative dose response study compared the safety and bronchodilator efficacy of 16 cumulative inhalations of albuterol sulfate in an HFA-134a, CFC-free propellant system (108 microg of albuterol sulfate, equivalent to 90 microg of albuterol base) with that of equivalent doses of albuterol in a conventional CFC propellant system. METHODS: Twenty-two patients with at least a 12-month history of stable asthma, who were currently taken an inhaled beta-adrenergic bronchodilator, and who had a FEV1 between 40% and 80% of predicted, were enrolled in this randomized, modified-blind, two-period crossover study. One, 1, 2, 4, and 8 inhalations of study drug were self-administered at 30-minute intervals, resulting in 16 cumulative inhalations. Pulmonary function and safety measures were assessed after each dosing interval. RESULTS: A significant dose response was found for HFA-134a albuterol sulfate and CFC albuterol with regard to changes in FEV1, serum potassium, heart rate, and blood pressure after 16 cumulative inhalations. No significant differences were demonstrated between HFA-134a albuterol sulfate and CFC albuterol for any FEV1 or safety parameter at any cumulative dose level. No clinically meaningful laboratory or physical examination abnormalities were found with administration of either HFA-134a albuterol sulfate or CFC albuterol. CONCLUSIONS: HFA-134a albuterol sulfate provides bronchodilation comparable to CFC albuterol and has a similar safety profile.
Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology. 01/01/199901/1999; 81(6):593-9.
ISSN: 1081-1206

In conclusion, this study is very weak, in my opinion. Hardly conclusive.
posted by Arthur Abramson at 8:11 PM on June 14, 2009


All I see

I couldn't possibly convince you otherwise, obviously! All you see, indeed.
posted by Blazecock Pileon at 8:14 PM on June 14, 2009


All I see

I couldn't possibly convince you otherwise, obviously! All you see, indeed.


Sorry about that. It's a very weak study.
posted by Arthur Abramson at 8:25 PM on June 14, 2009


It's a very weak study.

I'm not sure that you have the credentials, knowledge or honesty to make that determination. Sorry.
posted by Blazecock Pileon at 9:55 PM on June 14, 2009


Now all you need to do is find some evidence...
....as evidenced by increases in ground level UVB (which the WMO says they've never observed) and you get a gold star.

Good luck with that.


Firstly, researchers expect to not observe an increase because they didn't start measuring until after noticing the hole - and it's just silly to suggest that this lack of evidence is somehow evidence that the estimated increase hasn't occurred. You're referring to studies that try to extrapolate something from seasonal variations. Good luck with that. Your standard of evidence has already been thrown out as unlikely to exist regardless of whether the effect is there or not.

Secondly, look at the plants! It sounds like you haven't been to New Zealand and taken a good look. The more vulnerable flora is visibly burning - and this is a recent change in the last decades. Patterns of plant life are changing, and that changing is due to an increase in UV damage. The locals blame ozone thinning for the increase in UV damage (but what would they know).

Lastly, and I know this means less than nothing, because it's just one of countless anecdotes, and there are other factors (like pollution) that influence UV, but when you're close to the hole, you can feel the difference on your skin. You can observe firsthand. In the USA, the sun feels weak. I took an American down once. We were going to spend 2-3 hours outdoors in the sun, so we made sure she put on a lot of sunscreen (even though she was a sunbather). After an hour or so, we knew to slather on more, but didn't realise that she didn't. She was shocked at how badly she burned, and how quickly. Through her hair too. You just can't find UV like that in the USA. The pollution in the USA certainly plays it's role, but the shrivelled plants point out that that's not the only player in the story.
posted by -harlequin- at 9:57 PM on June 14, 2009 [2 favorites]


It works well for you, that's great. Unfortunately, HFA MDIs are not as safe and/or effective as CFC MDIs for all patients.

None of the listed complaints about HFA inhalers seem to be true of the British-designed HFA inhalers. So I don't think it's HFA MDI's that are the problem at all, I think it's whatever worthless design is being foistered on US patients that is the problem (and from the sound of it, the reason for this is more to do with patent games and profits than with delivering medicine properly and effectively)

If the goal is something other than delivering medicine effectively, then it's no surprise tthat the new inhalers are shit.
posted by -harlequin- at 10:23 PM on June 14, 2009


It's a very weak study.

I'm not sure that you have the credentials, knowledge or honesty to make that determination. Sorry.


And you do?

Thanks for the laugh.
posted by Arthur Abramson at 10:28 PM on June 14, 2009


And you do?

I know enough about how to read journal articles to know where their supplementary materials are to be found, and how to interpret the statements they make.

Further, when I took the time and effort to point out the contradictions in your statements with reported research — being exceedingly polite and patient with you, despite you patting me on the head with promises of a "gold star" — you then dissembled and changed the topic, arguing either from incredulity using CAPITAL LETTERS, or by ascribing wrongdoing on the part of any and all investigators who reported results that did not agree with your preformed conclusions.

The financial wrongdoing of every investigator of every one of these numerous clinical trials is still a matter for which you have failed to establish with any hard evidence. I look forward to you presenting it, even though I shan't be holding my breath.

So far, it appears a wide body of research contradicts most of your claims. But you know better and will not acknowledge any of it. So to the extent that I regret having wasted my time, I feel truly awful for any asthma sufferer foolish enough to sign your ridiculous petition or otherwise sponsor your dishonest campaign.
posted by Blazecock Pileon at 10:47 PM on June 14, 2009 [3 favorites]


But Blazecock, you fail to acknowledge that you are educated stupid by the FDA. WAKE UP SHEEPLE!
posted by ROU_Xenophobe at 11:21 PM on June 14, 2009 [4 favorites]


(google ron paul)
posted by Justinian at 11:30 PM on June 14, 2009 [1 favorite]


I know enough about how to read journal articles to know where their supplementary materials are to be found, and how to interpret the statements they make.

As I told you (I have to repeat everything two-three times for you), I have the pdf of the article that does not have the link you referred to. And you were unable to tell which formulation (HFA or CFC) had the greater increase in tachycardia in an extremely simple chart (B) in the NEJM, so it's not clear what you are able to interpret.

you then dissembled and changed the topic, arguing either from incredulity using CAPITAL LETTERS, ...

I never dissembled about anything. You are unable to understand very simple concepts. I stand by all of my comments to you.

The financial wrongdoing of every investigator of every one of these numerous clinical trials is still a matter for which you have failed to establish with any hard evidence. I look forward to you presenting it, even though I shan't be holding my breath.

I've already mentioned the conflicts and contradiction between the RESULTS and CONCLUSIONS of the NEJM paper you cited- you are unable to grasp this simple concept. I listed all of the side effects in Table 3 which clearly showed the greater safety of CFC. You are unable to understand this, it's another chart. The numbers tell the story. I don't know why you don't understand it but you don't. It's really very simple. I've also given you a second example, the Ayres study (#49 in the NEJM biblography), which we have quoted from in the Press Room, but you didn't bother to read it, or it went over your head as well.

I didn't say that every author with a conflict is dishonest, but I've seen it enough to want to see the numbers (RESULTS) for myself.

Read some of the patient quotes on the Doctors Speak Out page. The Patients Speak Out page. The ConsumerAfairs.org Readers Comments. You are quick to dismiss all of their complaints, as if they are all lying, crazy or stupid. And you have too much faith in 'The Literature', you are willing to accept all of it at face value (do some reading on this site to learn something about this http://www.ahrp.org ). You have no appreciation of the numerous cases of conflicts and corruption in much of the drug company sponsored-clinical studies, despite all of the evidence about it (from the FDA's David Graham, and many other reputable physicians). This alone makes your opinion on this subject, and on the merits of our campaign, absolutely worthless.
posted by Arthur Abramson at 11:39 PM on June 14, 2009


BP, do you have a link for the full article that isn't behind a paywall?
posted by BrotherCaine at 12:23 AM on June 15, 2009


BP, do you have a link for the full article that isn't behind a paywall?

The NEJM article?

http://wisemanstudios.net/NEJMWithdrawalofAlbuterolInhalersContainingChloroflu.pdf
posted by Arthur Abramson at 12:37 AM on June 15, 2009


I suspect I might as well try to help a trained parrot, but:

Really, has nobody explained the concept of statistical significance to you?

The basic idea is that when you're trying to figure out what's going on with a whole population but can only get information about a random sample, your figures might be off. The bigger your sample, the smaller your errors will tend to be. This is the same force that drives the "margins of error" that polls report.

So you know that your sample had 6% with some reaction. What does that mean for the population? What percent of the population would you expect to have that reaction? If you had 100 people, what emerges from the math is a confidence interval of 1.5-10.5%. That is, the best that your sample 6% can tell you with 95% confidence is "Somewhere between about one and ten percent." If you had 1000 people in your sample, your 95%CI would be down to 4.5--7.5%.

Now, the stuff in table 3 of that NEJM article is assembled out of a whole host of actual studies, and figuring out what the really proper confidence intervals would require the information from the studies, and be more work than I care to do right now.

But treating it sloppily, as single samples of 450 each in HFA/CFC/placebo, the differences you keep harping about range between the marginal and undiscernible or "statistically insignificant." For instance, look at tachycardia. The sloppy confidence interval for CFC inhalers would be about 0--4%. For HFA inhalers, 3-7. The important thing is that these intervals overlap -- this means that if we care about the numbers, as you claim to, we can't be very confident that the rate of tachycardia in HFA users is actually higher than in CFC users, and if there is a difference it's slight.

Obviously you care a lot about the issue.

But when you shout about LOOK AT THE NUMBERS, and I do, and they don't say that HFA inhalers are clearly much less safe as you assert (except that HFA users puke slightly more), you just look like an ignoramus to anybody that's taken even a basic statistics class. I mean, this is really basic stuff. In a narrow tactical sense, you really should go learn about these issues and/or stop shoving forward information that doesn't support the claims you're making.

I suppose it's possible that you'll come back with something that indicates that you actually have some understanding of sampling error, confidence intervals, and statistical significance. But if this were the case, all you'd be doing is revealing yourself as arguing dishonestly.
posted by ROU_Xenophobe at 12:38 AM on June 15, 2009 [3 favorites]


For what it's worth, that Chart B you go on about shows a difference only at 8 inhalations. See the little bars that stick up and down from the circles? Those are error bars. When the error bars overlap, that means roughly that you can't tell the two points apart. The only point where the error bars don't overlap is for 8 inhalations, but they go back to overlapping at the next data point.

Put differently, what that chart actually shows is that either HFA and CFC inhalers cause the same increase in heart rate, or that, at most, HFA inhalers cause a marginally larger increase under very limited conditions.

Again, this really is pretty basic stuff, and your apparent ignorance of these issues really hurts your credibility about, well, everything else you say.
posted by ROU_Xenophobe at 12:53 AM on June 15, 2009 [1 favorite]


I understand that these numbers may be statistically insignificant, and I do not consider them to be the sole basis of our argument that HFA inhalers are not as safe as CFC inhalers.

They are part of a pattern of studies presented on the Press Room page, which includes the New Zealand study, the Ayres UK postmarketing study, and three years of FDA MedWatch data, all of which point in the same direction.

These studies are smaller than normal clinical trials (we link to the FDA's unique 'bridging approach' to the HFA MDI pre-clinical and clinical trials, suggested by IPAC), which allowed these studies to be conducted on as few as 200 mild/moderate asthma patients in the test arms, in trials that generally only ran 6-12 weeks. These tiny studies were all that the FDA relied on to decide that CFC MDIs could be safely banned, even though 40 million patients had relied on them for decades.

We state in the Press Room:

According to twenty-seven year FDA veteran safety officer, whistleblower, and master medical reviewer David Graham M.D., MPH, the use of small clinical trials (we assume he would agree with us that this would include the clinical trials bulleted above) is a deliberate strategy employed by the FDA and drug companies specifically intended to deflect any criticism of drug safety:

"The classic approach of industry and FDA has been to do studies that are too small to conclusively identify that a risk is real," he added. "They can conclude, therefore, that there is no risk." FDA Safety Officer David Graham, MD,MPH

Graham charged that "FDA standards of evidence give drugs and drug companies a free pass on safety."


He's seen this repeatedly, and he has no reason to lie.

These data are not presented as conclusive proof. But they consistently show that CFC inhalers are safer when compared to HFA inhalers, and they are supported by many MDs who treat asthma, CF, and other pulmonary patients.

The MedWatch data which covers three years is definitely statistically significant.

The New Zealand study is definitely statistically significant.

HFA MDIs should have undergone large scale, real world, US postmarketing studies- the FDA acknowledges this in their Advisory Committee meetings, posted on the HFA MDIs: Poorly Tested page.

These tests were never mandated due to the objection of IPAC, and the tests that we've posted are admittedly too small to reach a conclusion, but the results are all consistent with the anecdotal complaints of thousands of patients.

We have the link that proves that ethanol in MDIs (which is used as a solvent in 3 of the 4 rescue inhalers) causes bronchoconstriction in a subset of asthmatics.

And HFA-134a itself was tested only on normal subjects, not on asthmatic or pulmonary patients. Normal subjects do not have hyperreactive, inflamed airways and severe allergies.

Taken together, we think this data strongly suggests that HFA MDIs are not as safe as CFC MDIs.
posted by Arthur Abramson at 1:32 AM on June 15, 2009


And again, Schering Plough itself (Proventil HFA)- one of the three clinical trials included in the NEJM composite chart, says the following:

"Rapid heart beat, vomiting, chest pain and palpitation occurs more frequently with Proventil HFA (than with CFC albuterol) ."

I don't think they'd make this statement if these findings were not statistically significant.

And you can be glib about vomiting during an asthma attack, but we have quotes from two mothers who both said that their kids coughed until they vomited with HFA MDIs.
posted by Arthur Abramson at 1:41 AM on June 15, 2009


Arthur Abramson, I think you lose this argument by simple fact that other nations have been successfully using CFC-free inhalers for ages now.

Instead of arguing that CFCs should be brought back, maybe you should be fighting to have the apparently superior, cheap technology used in other countries brought to the USA.
posted by five fresh fish at 9:10 AM on June 15, 2009


I understand that these numbers may be statistically insignificant

If you really understood what "statistically insignificant" means, you would quit trying to use those numbers to support your argument. You markedly reduce your credibility when you fail at statistics.

which allowed these studies to be conducted on as few as 200 mild/moderate asthma patients… even though 40 million patients had relied on them for decades.

Again, you demonstrate a lack of understanding of basic statistics. A sample size of 200 can very well be a perfectly good number of subjects from which to draw a conclusion regarding the general population.

I think we now need to know whether you have any qualifications for judging the validity of the studies. Have you take post-secondary studies in statistics at a reputable college? Did you take any coursework beyond the basic 101-level?
posted by five fresh fish at 9:34 AM on June 15, 2009 [1 favorite]


Respectfully, I find Adamson's argument unconvincing. It may have some truth in it, but the data don't seem to lead to a high degree of confidence in his conclusion.

Furthermore, the somewhat limited understanding of statistical significance, coupled with the variable weight given to the conclusions based, seemingly, only on whether they agree with the premise, leads one to view the presentation as a highly charged soapbox oratory rather than a scientific argument.

Finally, the rather loose ad hominems undermine what credibility it might muster. When investigators with contradictory conclusions are summarily dismissed as having putatuve (though unproven) ulterior and disqualifying motives, yet an FDA researcher with a supporting conclusion is assumed to have "no reason to lie", something doesn't smell right.
posted by darkstar at 9:43 AM on June 15, 2009 [1 favorite]


Of course, a UK study just showed that less than half of respondents could actually locate their heart on a human anatomy diagram. With no particular reason to believe that US respondents would fare any better, it seems that a large swathe of the public can be demonstrably ignorant of even the most fundamental medical facts about their own bodies. So internet petitions, by their nature, are likely to receive quite a bit of support, regardless of how soundly they are argued.
posted by darkstar at 9:50 AM on June 15, 2009 [1 favorite]


The patent situation is somewhat interesting. The manufacturers appear to have been able to get some broad patents to inhalers using these alternative propellants. A broad study is too time consuming for someone not interested in launching a generic. Nevertheless, let's look at some of the patents covering Proventil. US Patent No. 5,605,674 broadly covers a medicament for aerosol administration to a lung using 1,1,1,2-tetrafluoroethane as a propellant. This patent expires 2014. However, they also have US Patent No. 5,225,183 which claims the same thing but adds the limitations of a surface active agent and certain polar solvents. That patent provides narrower coverage and expires in 2010. One could easily see that the broader claims are obvious in view of the narrower claims. That usually triggers an obviousness-type double-patenting rejection which is cured by essentially linking the life span and ownership of the two patents together. They both must expire on the same day, the earliest day, sometime in 2010. That didn't occur here. I am sure some wily generic manufacturer has already identified this problem and may well be set to trigger suit in 2010. Their US Patent No. 5,766,573 has similar broad claims, expires in 2015 and will likely also be subject to attack come 2010. The rush to the FDA begins July 10 next year. I wonder if the other products have similarly issues in their patent protection?
posted by caddis at 9:50 AM on June 15, 2009


*swath
posted by darkstar at 9:51 AM on June 15, 2009


BP, do you have a link for the full article that isn't behind a paywall?

The legal manner to access the NEJM article and associated materials is through a school proxy, a subscription, or by paying for a copy of the article. If none of these are appealing, you can also sign up for a free trial account with NEJM and then cancel it after accessing the information.
posted by Blazecock Pileon at 9:53 AM on June 15, 2009 [1 favorite]


A sample size of 200 can very well be a perfectly good number of subjects from which to draw a conclusion regarding the general population.

Yes, but more to the point, except for very small populations, population size is almost completely irrelevant to population inferences.

A sample of 200 out of 10000 is the same as a sample of 200 out of 100000 is the same as a sample of 200 out of a million billion trillion zillion. For convenience confidence intervals, margins of error, statistical significance and the like are usually calculated as if the population were infinite.
posted by ROU_Xenophobe at 11:08 AM on June 15, 2009


The only problem I see with the stated "side-effects" of HFA-MDI's is pretty much the same effects of straight Albuterol, no matter what method you are introducing it to the body. I've used a CFC inhaler, an HFA inhaler, and a nebulizer to get albuterol during asthma attacks, and each time, if I take too much (you know, because I'm not able to breathe, so I hit the inhaler twice instead of once, etc), I get the jiters, a headache, cough, racing heartbeat, nausea (usually because my heart is trying to jump out of my chest). I don't think it's the propellant that's causing these symptoms, it's the drug itself.

And yes, I get the same symptoms with a nebulizer as well, and the only propellant that is using is distilled water and an air compressor. So, yeah. The "safety" concerns are more with the side-effects of albuterol than the propellant, methinks.
posted by daq at 1:32 PM on June 15, 2009


I don't know the mechanics of using inhalers, but is it possible that HFA MDI's are more likely to cause the user to take too many puffs because they think they didn't get an adequate delivery? There are definitely difficulties involved in procedures you only use in an emergency.
posted by BrotherCaine at 2:56 PM on June 15, 2009


A sample size of 200 can very well be a perfectly good number of subjects from which to draw a conclusion regarding the general population.

Yes, but more to the point, except for very small populations, population size is almost completely irrelevant to population inferences.


Unless... you want to more thoroughly identify adverse reactions in the replacement HFA MDI (before you completely ban the CFC MDIs that were used by 40 million patients) that are rare enough so that they don't get picked up in your 200 patient test arm. Everything quoted below comes from FDA PADAC (Pulmonary Allergy Drug Advisory Committee) meeting transcripts:

DR. MEYER (FDA): "I think clinical trials, well-controlled (pre-approval) clinical trials tell you a lot, but they don't tell you certainly everything, and particularly they're very well-groomed (younger, healthier) patient populations that are taken into them. They're the only the patient populations for which the drug is indicated, and I think we're very much interested in the post-marketing period about what happens in the patients who are using it for other indications off-label or more severe patients than were the clinical trials or younger or older, so on. And then, finally, just due to some of your statistical limitations, if you have a database of a thousand patients, you're not likely to pick up a very rare event. So if there was some rare reaction to the formulation, we wouldn't pick that up in clinical trials, unless we were quite lucky, either. So." (p. 140, 1999 FDA PADAC meeting)

DR. JENKINS (FDA): "I think a point we all need to keep in mind is that normally, when we are approving new drugs, whether it be a new molecular entity, a new formulation of an existing drug, we're approving that thinking that it's going to go into the market and become part of the overall armamentarium for the disease. This (HFA MDIs) is a different paradigm, where these products are being specifically developed to replace existing products (CFC MDIs). So when we approve these non-CFC alternative products, there's an intent through the Montreal Protocol and the Clean Air Act that if those are acceptable to patients, they're (HFA MDIs) going to replace the old products, and part of the question we're trying to get answers from you are, how can we be certain that we're not going to make things worse? We certainly may not be able to address some of the concerns that are out there now, but I don't think we want to make things worse by making a determination that the alternative product (the HFA MDI) meets patient needs, and you declare the CFC product as no longer essential, and the CFC product goes off the market, and then you find out that maybe it (the HFA MDI) really didn't meet patient needs. So it's a very different paradigm, and that's why we're asking these difficult questions." (p. 172, 1999 FDA PADAC meeting)
posted by Arthur Abramson at 8:55 PM on June 15, 2009


I don't know the mechanics of using inhalers, but is it possible that HFA MDI's are more likely to cause the user to take too many puffs because they think they didn't get an adequate delivery? There are definitely difficulties involved in procedures you only use in an emergency.

Yes, this happens frequently. As Glaxo showed in their New Drug Application for Ventolin HFA, it has a longer onset of action, a shorter duration of action, and lower FEV1 than CFC albuterol. They are less effective than CFC MDIs according to the Ventolin NDA, at least.

This, combined with the softer, slower plume of the HFA MDIs often causes new users of HFA MDIs, especially, to over-medicate.

The "safety" concerns are more with the side-effects of albuterol than the propellant, methinks.

The safety concerns really are not limited to the albuterol sulfate itself.

We know that some patients can and do have their asthma aggravated by the ethanol solvent in three of the four HFA MDIs (CFC MDIs used no ethanol). We link to the medical letter that shows the bronchoconstriction that ethanol in MDIs can cause. And according to technical staff at Schering Plough (Proventil HFA) and Sepracor (Xopenex HFA), the corn residue in the ethanol (it is all corn-sourced) can definitely not be excluded as a potentially serious risk for corn-sensitive patients.
posted by Arthur Abramson at 9:18 PM on June 15, 2009


At an annual run rate of (say) 3,000 metric tons it would take over 300 years of medical use to equal the amount produced during the peak year of 1988 (1,000,000 metric tons).

Since none of the people commenting on this post will be alive in 300 years, this is clearly none of our concern.
posted by Ironmouth at 9:54 AM on June 17, 2009


So would this be a good time to mention that I like the HFA inhaler better? The CFC one was too effective at getting the albuterol into me (I think) and I got too much sometimes.
posted by dilettante at 6:41 PM on June 18, 2009 [1 favorite]


Homeopathic Hospital Emergency Room. Arnica for a broken arm, 1:10000000 dosage, plus flower therapy.
posted by five fresh fish at 10:09 AM on July 4, 2009 [2 favorites]


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