EPA Bans CFC-Based Asthma Inhalers

bonch writes "The EPA has banned over-the-counter asthma inhalers as part of an agreement with other nations to avoid using chlorofluorocarbons, a substance once used in aerosol sprays. Alternative albuterol inhalers cost almost three times as much as the $20 epinephrine inhalers sold by online retailers."

Comments

government idiots

[p51d007]

Government, EPA...what a bunch of idiots. Here we have an inexpensive asthma product, that helps MILLIONS of people each day, and now thanks to the government, it will costs those people MORE for a different product. One of the scariest things ever said was... "I'm from the federal government, and I'm here to HELP you".

Re:government idiots

[Anonymous Coward]

Corporations, what a bunch of idiots. Here we have an ozone depleting product, that will affect BILLIONS of people each day, and now thanks to the government, it will save those people MORE by keeping intact the ozone layer. Once of the scariest things ever said was... "I'm from the corporation, and I'm here to SAVE the planet".

Re:government idiots

[Cyberax]

Not really. Right now inhalers are among the most significant remaining sources of CFCs.

The other remaining source is Halon fire suppression systems. Halon is no longer produced, but remaining stocks are still in use.

Re:government idiots

[ravenshrike]

The amount of CFCs pumped into the atmosphere by asthma inhalers is negligible at best. Even if every person on the planet used one, which they don't.

Re:government idiots

[Dunbal]

As a physician I know that endotracheal epinephrine does have its uses in severe asthma and status asthmaticus - it is the ultimate bronchodilator; however I have never prescribed it or recommended it for daily use. The side effects can be quite severe, including cardiac arrhythmias leading to death. I can't imagine that this stuff was allowed to be on sale without a prescription in the US.

Re:government idiots

[0111 1110]

Banning remaining CFC sources will accelerate the healing of ozone layer. And it's not like there are no good replacements available.

Do you have asthma? I do, and I find that the non-CFC HFA inhalers don't work for me. I have resorted to (illegally) ordering CFC inhalers from India and/or using a portable nebulizer, which is both less effective and less portable than the inhalers with propellants.

The problem with the HFA inhalers is that they don't propel the medicine strongly enough and the propellant itself may even be an irritant to some people. I have had times where it has at least seemed to make my asthma worse, not better.

OTOH, I'm not a big fan of primatene mist either. It is dangerous and actually causes pain in my chest. Although in an emergency it is often the only option available other than the ER for someone with asthma.

Re:government idiots

[Miamicanes]

HFA is a weaker propellant, and has a pretty nasty taste & odor to boot.

Primatene's problem is complicated, because the ban isn't entirely motivated by love for Mother Earth(tm). The DEA wants Primatene off the market, because it's basically aerosolized ephedrine ready for meth production.

* If Primatene is reformulated with HFA, it has to be re-approved by the FDA

* Re-approval would be expensive, and the resulting drug would have only limited patent protection due to massive amounts of prior art.

* The DEA wants reformulated Primatene to include additional ingredients that (supposedly) won't affect asthmatic users, but will taint the ephedrine so it can't be used for meth production.

* A new version reformulated to DEA standards WOULD be profitably patentable, but the FDA isn't thrilled about adding chemicals of no benefit to users to a product used by extremely vulnerable people whose breathing is pretty fragile to begin with. They know that somewhere out there are at least a few dozen people likely to die if they use the new formula, and have made it clear that they're going to hold approval of the new version to the highest possible standards and nix it at the *slightest* hint of trouble.

* Primatene's maker is happy about patentability, but worried about lawsuits. Catch-22.

It's more complicated than what I wrote above, but that pretty much sums it up. It's the perfect storm of stupid symbolic environmentalism, corporate greed, and the war on drugs. Made worse by the fact that the majority of longterm Primatene users are poor and lack proper health care (people with health insurance use albuterol, unless they have very mild asthma and accidentally go somewhere without their inhaler, at which point they run to Walgreen's and buy Primatene to keep around "just in case"). That's also the main theory of why Advair (combination of a steroid and long-but-slow-acting alpha agonist) has a signficantly higher death rate among poor and minority users with seemingly moderate & controlled asthma -- they get prescriptions for Advair and albuterol, buy the Advair, but skip the albuterol because the new formulation is expensive & they don't need it very often. The problem is, when they DO have an acute attack, all they have on hand is Advair, which isn't suitable as a rescue inhaler, and a small percentage of them end up dying under circumstances where albuterol would have saved them. It's a hard theory to ethically test, but one that explains a bothersome side effect (death) of Advair whose victims are overwhelmingly poor Americans.

Re:government idiots

[Doc Ruby]

Primatene sucks, and barely works. It's cheap because its costs have been paid off for decades, and it's just a brand. But millions of people don't use it, even though it's cheap, because it sucks. The EPA isn't just protecting the health of the rest of us by protecting the Ozone Layer from CFCs - it's flushing this crap product out of the market. The asthma industry has had decades to switch away from CFCs, longer than practically all others. And even this final shutdown has been coming for 3 years, plenty of time to switch.

If you want to be angry at a government agency, be angry at the FDA which requires the non-CFC version, that actually works, to be a prescription. Which drives up its costs, and lets the doctor industry take their cut for peddling it. There's no reason the non-CFC version should cost 50-100% more than the OTC version. It's the doctor/drug cartel that keeps this stuff so profitable and expensive.

What's idiotic is the kneejerk attacks on government agencies that protect us, without knowing anything about what you're talking about. "The government" isn't some monolithic entity. The EPA controls damaging substances to protect us

Re:government idiots

[Doc Ruby]

Ozone regenerates but only accumulates when CFCs aren't destroying it. CFCs in inhalers are just one part of the CFC pollution that we backed away from over several decades. Most of the sources individually are a very small amount, but combined they deplete the ozone layer. Which causes increases in cancer, not just among humans but among other animals around the world. Each small source has its claim to exemption, and some worked those claims for many years while alternatives were developed. This single last brand using CFCs is cheaper because it's generating pollution its competitors don't, which simply externalizes its costs from asthma people to cancer people affected by the ozone depletion.

Re:government idiots

[SuricouRaven]

CFCs function as photocatalysts. More precisely, their breakdown product of free radical chlorine does.

Ozone + Cl ---UV Light---> Oxygen + Cl

So a little CFC can break down thousands of times it's own mass of ozone before the Cl radicals eventually find something else to react with.

CFCs also make very potent greenhouse gas.

Re:government idiots

[Dr_Barnowl]

The pharmaceutical companies probably welcomed this move. The existing CFC laden medication is available over the counter, which means that it's cheaper. By banning it, they get to sell more of their prescription-only substitutes, which cost 1.5 - 3x more.

Although I have to say, you're being screwed anyway. We don't have an over-the-counter equivalent in the UK. The drug in question is an epinephrine inhaler, which is a poor choice as a bronchodilator because it has too many side effects like elevated heart rate. The prescription replacement, albuterol (we call is salbutamol) is a selective beta-2 adrenoceptor agonist - it stimulates the epinephrine receptors in the air passages, but not the ones in your heart, so fewer side effects like dry mouth and palpitations.

You're paying $20 over the internet for a "cheap" epinephrine inhaler (which as we explain, is an inferior medicine for the purpose).
You'll pay a minimum of $30 for a prescribed albuterol inhaler.

Our list price (for our national health service) for a 200 dose albuterol inhaler is £1.50 ( about $2.30 )

Who's screwing you? Ah yes, the evil corporations, the ones who manufacture the fucking medicine.... the HMOs..... etc, etc, etc.

Re:government idiots

[jo_ham]

I'm not the OP, but.... yes. It's just chemistry.

The two compounds in Primatente Mist are CFC-12 and CFC-114, or dichlorodifluoromethane and 1,2-dichlorotetrafluoroethane respectively. These are well studied in stratospheric ozone chemistry and are responsible for the catalytic loss cycle by breaking down in the presence of UV light and giving halogen radicals that attack ozone. The atomic chlorine (it usually appears as a chlorine radical) catalytically destroys ozone:

O3 + Cl. > ClO. + O2
O + ClO. > Cl. + O2

The mono-atomic oxygen there is a simplification of other processes that form it, but it's a good simplification of what happens overall - the chlorine is long-lived in the stratosphere, so very small amounts destroy a large amount of ozone.

It's not the only loss cycle of course - there are natural and man-made processes going on up there, but it is one of the ones that has had such a huge effect.

Re:wrong calculation

[Anonymous Coward]

That's utter bullshit. The amount of compressed gas in asthma inhalers is minuscule. Even when you multiply that by thousands, the amount would be extremely modest. Besides, negative health outcomes by people who don't have inhalers they need (because they can't afford the 'green' ones) would far, far exceed any damage to the ozone layer.

God damn hippies.

Very Old News

[nbetcher]

This is actually extremely old news. A treaty was signed over a decade ago to ban various uses of CFCs in phases. The OTC epinephrine inhalers were pulled off of the market by the manufacturer some time ago due to a different reason (which I forget), then they decided to not restart production on it because CFC inhalers would be banned as of 1/1/2010.

Anyone that has asthma will tell you that things dramatically changed for them in 2010 when their old albuterol (fast-acting, for emergencies) inhalers were reformulated to not include CFCs (dubbed HFA, aka Hydrofluoroalkane) . Most HFA-using patients state that they cannot "feel" the aerosol or that it doesn't work nearly as well as the CFC-based ones.*

Point being, CFC inhalers haven't been around for a couple of years and we knew they were going away over a decade ago!

(*From my professional experience.)

Re:wrong calculation

[nbetcher]

I recommend not going to Walgreens or CVS - go to an independent pharmacy, you'll get better care there anyways and cheaper prices. Then, don't get Proventil or Proair, get Ventolin! Ventolin is the cheapest and Glaskosmith-Kline has $15 rebate checks they give to pharmacies sometimes (and no, I don't work for ANY Pharmas). You also may want to check their website because they have programs you can enroll in to get your meds for cheap/free, plus they may even have some coupons you can use there.

Re:Reducing competition through regulation

[geekoid]

Since this has been the plan for YEARS NOW, I don't think you're correct.

The lobbying was in delaying the change.

But hey, don't let facts and common sense stop you from using a pop culture fad belief as an excuse to rant.

My costs went up substantially, and less effective

[assemblerex]

The new inhaler with no insurance? $60. Before? $30
Less pressure, not as effective in getting the meds to my lungs.
I now order them from mexico, same old good stuff that works.

OK that article is a canned article

[geekoid]

being propagated through the media. Probably written by some anti regulation type; or it's plain shoddy 'reporting'.

a) There is a non- CFC primatine mist coming out.

http://www.empr.com/update-on-primatene-mist-discontinuation/article/208381/

b) this has been a phased roll out since 2008

c) albuterol was the first to be regulated to be CFC free.

d) The corporation the make CFC products stalled in making a replacement in order to maximize there profits, and probably to make regulation seem bad.

e) the only impact CFC inhalers, not over the cuonter inhalers. So you will see OTC inhalers, probably soon.

Whoever wrote that article should be slapped up side the head for sowing discontent in the populace with factual lies.

Re:Cost falls with mass production, life improves

[causality]

The important thing is that the mean blood lead level in 1975 was 15.5 g/dl. The mean blood lead level today is less than 2g/dl.

That can't be right. That would be what, about a third of a kilogram of lead in the average person's body?

The average adult has about 5 pints of blood in their body. A pint is a little more than half a liter. So that's approximately 2.5 liters * 10 * 15.5, which works out to about 387 grams of lead. I think that's enough to kill a blue whale.

From reading the Wikipedia article on lead poisoning, I assume you meant micrograms.

Re:primatiene mist if having an attack

[ColdWetDog]

Or you could just see your doctor, maybe manage your asthma better. Maybe have a prescription available in your wallet if you really need it. If you're running to the 24 hour pharmacy in the middle of the night chances are you're doing it wrong.

Get a peak flow meter, learn how to use it. Works great for most people and gives them a 12-24 hour window of alert time before you really get symptomatic.

Speaking as an asthmatic

[raddan]

/.'ers are being characteristically reactionist. I use the new inhalers, and have done so for several years now. This story should be modded anti-government flamebait.

Furthermore, epinephrine inhalers are less effective than salabuterol inhalers, with more side effects (epinephrine can be very unpleasant). That's the real reason they're going away-- reformulating them for a new propellant is not worth the cost.

Quantitative? I'll take a shot at it.

[Guppy]

Quantitative proof or GTFO.

Well, I'll take a shot at it. Please excuse me if I miss a decimal point somewhere, corrections are welcome.

About 14g of material in a Primatene Mist Inhaler. Non-propellant mass is ascorbic acid, dehydrated alcohol (34%), hydrochloric acid, nitric acid, purified water (actual mass of drug is negligible). Don't know the breakdown, but guesstimating about 4g of CFC-12 and CFC-114 propellant per inhaler, since alcohol is ~1/3 mass, and ascorbic acid is listed before the alcohol (ingredients should be listed in order of descending weight, so at least 1/3 ascorbic acid).

In one of the recent news interviews about this, FDA spokesman estimated 1-2 million Primatene Mist users out there. Let's say 12 vials per year * 2mil users (I don't really know how many vials an asthmatic goes through), and call it 20 million vials. That would be 24,000kg of CFCs per year, or 24 metric tons.

For reference, reported peak production of CFC-12 was reached in 1988, at 421,002 metric tons (1000kg in a metric ton), and 8,938 metric tons in 2004 (last reported year). So total usage is not tiny, but still a small fraction of the overall CFC usage.

Re:Quantitative? I'll take a shot at it.

[Nethemas the Great]

Actually, engineers resolved the notion of the user powered pump quite some time ago. It's really cool, you just squeeze or depress the mechanism and out comes the product. For the lazy though they've come up with the ingenious notion of replacing the aerosol with carbon dioxide or nitrous oxide when used in human consumables. Either way there are alternatives to CFCs and most cost no different or even less than CFC propellant. The problem isn't the propellant it's the drug manufacturers that feel like charging more.

Re:Quantitative? I'll take a shot at it.

[MakinBacon]

I take it you've never used any of the environmentally friendly inhalers before, because they are fucking terrible. I've been using them for a few years (The EPA went apeshit insane on albuterol a few years ago, and I had no idea that there was an OTC alternative), and they get routinely clogged up by both dust and even dried medicine, and I can ensure you that this was never a problem with the old inhalers. Thankfully, my asthma is really mild and I rarely need these, but if I ever have a real emergency, I'm fucked.

Re:Quantitative? I'll take a shot at it.

[gmack]

I have used those along with several forms of liquid and several forms in pill. One day I mentioned to my specialist that the compressed air version of my medication worked better than the same chemical in powered form (also inhaled) and he replied that I was correct: the most effective way to get something into the blood stream is through the lungs and the most effective way to do that with with the compressed air versions.

Any doctor pushing a bronchodilator for anything other than the rare emergency use is simply incompetent . Lifestyle changes don't work in all cases although they do help depending on what the triggers are and I have found that relaxation techniques are a great way to avoid a panic attack and passing out but aren't entirely effective. In my case the magic treatment that finally got me off daily Ventolin, along with making sure my house is clean and avoiding smokers (even when they aren't smoking), was Alvesco and that is compressed air inhaled.

As an aside, I really worry about the US when I find out that an Albuterol inhaler there costs $20. My CFC free version of Ventolin cost me $12 in Canada and in Spain I pay less than 10 Euros. The Americans are getting ripped off.