Obama Administration Set to Ban Asthma Inhalers Over Environmental Concerns

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    Sep 26, 2011 2:54 PM GMT
    Knowing a number of asthma sufferers, this seems like the height of idiocy. Making sufferers pay even more money for a product that has limited environmental impact to begin with.

    http://today.msnbc.msn.com/id/44627081/ns/today-today_health/t/otc-inhalers-be-phased-out-protect-ozone-layer/#

    WASHINGTON — Asthma patients who rely on over-the-counter inhalers will need to switch to prescription-only alternatives as part of the federal government's latest attempt to protect the Earth's atmosphere.

    The Food and Drug Administration said Thursday patients who use the epinephrine inhalers to treat mild asthma will need to switch by Dec. 31 to other types that do not contain chlorofluorocarbons, an aerosol substance once found in a variety of spray products.

    The action is part of an agreement signed by the U.S. and other nations to stop using substances that deplete the ozone layer, a region in the atmosphere that helps block harmful ultraviolet rays from the Sun.

    But the switch to a greener inhaler will cost consumers more. Epinephrine inhalers are available via online retailers for around $20, whereas the alternatives, which contain the drug albuterol, range from $30 to $60.

    The FDA finalized plans to phase out the products in 2008 and currently only Armstrong Pharmaceutical's Primatene mist is available in the U.S. Other manufacturers have switched to an environmentally-friendly propellant called hydrofluoroalkane. Both types of inhalers offer quick-relief to symptoms like shortness of breath and chest tightness, but the environmentally-friendly inhalers are only available via prescription.
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    Sep 26, 2011 7:16 PM GMT
    Same old tired conservative talking point.

    Where were you when cheap albuterol MDIs with CFCs were phased out? That was in the Bush administration. That's the real reason why albuterol and ipratropium MDIs are expensive now because there are no generics yet.

    expensive now.
    http://mediamatters.org/blog/201109230025
    Moreover, the FDA stated in a September 22, 2011, press release that it began "public discussions about the use of CFCs" for inhalers as early as January 2006 and that it had "finalized the phase-out date for using CFCs in these inhalers and notified the public in November 2008." From the FDA press release:

    The FDA began public discussions about the use of CFCs in epinephrine inhalers in January 2006. The FDA finalized the phase-out date for using CFCs in these inhalers and notified the public in November 2008. Many manufacturers have changed their inhalers to replace CFCs with an environmentally-friendly propellant called hydrofluoroalkane (HFA).


    Your "limited environmental impact" is not very limited at all.
    http://en.wikipedia.org/wiki/Ozone_hole#Consequences_of_ozone_layer_depletion

    For the first time in recent history, the ozone hole hasn't grown, thanks to the efforts in the 1980's and 1990's. Even then, it's going to take till 2060 to reach pre-1980's levels.
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    Sep 26, 2011 7:22 PM GMT
    q1w2e3 saidSame old tired conservative talking point.

    Where were you when cheap albuterol MDIs with CFCs were phased out? That was in the Bush administration. That's the real reason why albuterol and ipratropium MDIs are expensive now because there are no generics yet.

    expensive now.
    http://mediamatters.org/blog/201109230025
    Moreover, the FDA stated in a September 22, 2011, press release that it began "public discussions about the use of CFCs" for inhalers as early as January 2006 and that it had "finalized the phase-out date for using CFCs in these inhalers and notified the public in November 2008." From the FDA press release:

    The FDA began public discussions about the use of CFCs in epinephrine inhalers in January 2006. The FDA finalized the phase-out date for using CFCs in these inhalers and notified the public in November 2008. Many manufacturers have changed their inhalers to replace CFCs with an environmentally-friendly propellant called hydrofluoroalkane (HFA).


    Your "limited environmental impact" is not very limited at all.
    http://en.wikipedia.org/wiki/Ozone_hole#Consequences_of_ozone_layer_depletion

    For the first time in recent history, the ozone hole hasn't grown, thanks to the efforts in the 1980's and 1990's. Even then, it's going to take till 2060 to reach pre-1980's levels.


    Same old liberal viewpoint that there are no costs or unindended consequences to policies. As for the environmental impact - I was referring specifically to that of inhalers.
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    Sep 26, 2011 7:39 PM GMT
    There you go again putting words in my mouth. There are ALWAYS consequences to every action. The FDA has planned ahead so that people have time to switch to other non-CFC containing meds.

    You do know your basic ozone layer chemistry, right?

    http://en.wikipedia.org/wiki/Ozone_holeCFCl3 + electromagnetic radiation → CFCl2 + Cl
    Cl + O3 → ClO + O2
    ClO + O3 → Cl + 2 O2
    A single chlorine atom would keep on destroying ozone (thus a catalyst) for up to two years (the time scale for transport back down to the troposphere) were it not for reactions that remove them from this cycle by forming reservoir species such as hydrogen chloride (HCl) and chlorine nitrate (ClONO2)...the amount of chlorine released into the atmosphere by chlorofluorocarbons (CFCs) yearly demonstrates how dangerous CFCs are to the environment.

    That is why it's taking so long for ozone destroying chemicals' levels to decrease:
    517px-Ozone_cfc_trends.png
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    Sep 26, 2011 7:43 PM GMT
    The EPA has taken into account the impact of CFC MDIs. That's why they were the last to go among all CFC-containing products.
    http://www.epa.gov/ozone/title6/exemptions/inhalers.html
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    Sep 26, 2011 7:50 PM GMT
    And, as a doctor, I cannot tell you the last time I know of a patient who used an epinephrine inhaler for asthma. Albuterol has been the gold standard for many years.

    Ask your asthma friends what they use for their asthma. Chances are 50 to 1 it's albuterol.
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    Sep 26, 2011 7:52 PM GMT
    And finally, will you PLEASE correct your title? It's not the Obama administration who's banning CFCs--the policy was set back in the Bush administration as part of compliance with the Montreal Protocol. I refer you to my second post in this thread.
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    Sep 26, 2011 8:46 PM GMT
    q1w2e3 saidAnd, as a doctor, I cannot tell you the last time I know of a patient who used an epinephrine inhaler for asthma. Albuterol has been the gold standard for many years.

    Ask your asthma friends what they use for their asthma. Chances are 50 to 1 it's albuterol.


    Sorry, what kind of doctor are you? Are you saying that the market data is wrong?

    http://www.foxnews.com/health/2011/09/26/popular-asthma-inhaler-to-be-pulled-off-market/

    Approximately 3 million people in the United States rely on Primatene Mist, according to the latest statistics from Amphastar Pharmaceuticals, the company that produces the drug.


    Not only are you banning something that has relatively limited impact compared to other CFC uses (ie cheap refrigerants in developing countries) - which incidentally was my point - and doubling the cost of something that is both effective, in use, and significantly cheaper.

    Incidentally, the science itself has been changing - but apparently in your arrogance at attempting to explain the chemistry, you missed a mountain of evidence in the intervening years that call into question the interaction specifically at the ozone layer:
    http://www.nature.com/news/2007/070924/full/449382a.html

    It is however this Administration that is going ahead with the ban. The title is in fact correct and true - why would I change it?
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    Sep 26, 2011 8:49 PM GMT
    bla bla charts graphs bla

    Shouldn't have been using them in the first place.
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    Sep 26, 2011 9:19 PM GMT
    Emphasis mine:
    riddler78 said
    Approximately 3 million people in the United States rely on Primatene Mist, according to the latest statistics from Amphastar Pharmaceuticals, the company that produces the drug.



    I'm sorry, but you're clearly not a doctor. I happen to be a nephrologist. But it doesn't even matter. Ask any doctor of whatever specialty in the US what their first drug of choice is for treating asthma.

    I just asked my pulmonologist friend and he's has never, ever suggested epinephrine inhalers for asthma to his patients.

    I said "basic" ozone hole chemistry. I didn't mention ALL the advances in chemistry with ozone. I'm not a chemist, are you?
    And your article says this about CFCs.
    nature articleThe new measurements raise “intriguing questions”, but don't compromise the Montreal Protocol as such, says John Pyle, an atmosphere researcher at the University of Cambridge. “We're starting to see the benefits of the protocol, but we need to keep the pressure on.” He says that he finds it “extremely hard to believe” that an unknown mechanism accounts for the bulk of observed ozone losses.

    Nothing currently suggests that the role of CFCs must be called into question, Rex stresses. “Overwhelming evidence still suggests that anthropogenic emissions of CFCs and halons are the reason for the ozone loss. But we would be on much firmer ground if we could write down the correct chemical reactions.”


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    Sep 26, 2011 9:22 PM GMT
    As for your title, I'm not going to bother quoting my 2nd post again. The finalized date for the phase out was set in 2008 by the FDA.
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    Sep 26, 2011 9:28 PM GMT
    And may I remind you that there's still terbutaline (much cheaper than albuterol currently) which is equally effective for mild asthma (the majority of these OTC epinephrine inhaler users). Nonselective beta agonist agents (i.e., epinephrine, isoproterenol, metaproterenol) are not recommended due to their potential for excessive cardiac stimulation, especially in high doses.

    My point is that such a minor specialized issue has been elevated by conservative outlets into a major talking point that it boggles the mind. I talk to my colleagues and this "news" was the first time they have even considered epinephrine as an OTC med for asthma, because they already have trouble getting their patients to use their prescribed inhalers paid for by their insurance. (Racemic epi is still frequently used for croup, and also in codes when you can't get epi in an IV, but I digress.)

    Bravo to the marketing department of Primatene's manufacturer and to the anti-regulation cabal at Fox News, from hence I'm sure the other news outlets picked this piece of medical esoteric factoid up. Oh, sorry, it's some reporter from AP who recognized the inevitable notoriety for reporting such a juicy story, sure to be picked up by all the major outlets because the anti-regulation tone is de facto in this toxic environment.icon_lol.gif
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    Sep 26, 2011 11:30 PM GMT
    q1w2e3 saidAnd may I remind you that there's still terbutaline (much cheaper than albuterol currently) which is equally effective for mild asthma (the majority of these OTC epinephrine inhaler users). Nonselective beta agonist agents (i.e., epinephrine, isoproterenol, metaproterenol) are not recommended due to their potential for excessive cardiac stimulation, especially in high doses.

    My point is that such a minor specialized issue has been elevated by conservative outlets into a major talking point that it boggles the mind. I talk to my colleagues and this "news" was the first time they have even considered epinephrine as an OTC med for asthma, because they already have trouble getting their patients to use their prescribed inhalers paid for by their insurance. (Racemic epi is still frequently used for croup, and also in codes when you can't get epi in an IV, but I digress.)

    Bravo to the marketing department of Primatene's manufacturer and to the anti-regulation cabal at Fox News, from hence I'm sure the other news outlets picked this piece of medical esoteric factoid up. Oh, sorry, it's some reporter from AP who recognized the inevitable notoriety for reporting such a juicy story, sure to be picked up by all the major outlets because the anti-regulation tone is de facto in this toxic environment.icon_lol.gif


    Boggles the mind? That an environmental policy means that the Obama Administration is banning a medical product being used by 3 Million people against cheaper alternatives? A statistic you term "esoteric"? Whatever happened to "do no harm"? That's irrelevant if it suits your personal preferences? 3 Million people esoteric? Really?
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    Sep 26, 2011 11:46 PM GMT
    It's useless to explain to you how esoteric this is, unless you actually practise medicine.
    And again, it's the FDA in 2008 (before Obama was president) who set the date for the phase out. I can't say this again. The phase-out date of an OTC medicine is not part of daily presidential concern.
    There are far better alternatives to Primatene even for intermittent asthma, which is the only possible use for this OTC medicine. None of the guidelines, and I emphasize, NONE of the guidelines recommend use of Primatene for control of asthma.
    This phaseout has been around for THREE years at least. Where were your concerns in 2008? Why now?
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    Sep 26, 2011 11:56 PM GMT
    FDA Panel Calls for Banning OTC Asthma Inhalers
    Published: January 25, 2006
    http://www.medpagetoday.com/Pulmonology/Asthma/2554
    ROCKVILLE, Md., Jan. 25 - FDA advisers have recommended that the agency ban nonprescription asthma inhalers because they contain a propellant that endangers the ozone layer.

    By an 11-7 vote, the members of the Pulmonary-Allergy Drugs Advisory Committee were swayed by arguments that the inhalers, including the popular Primatene Mist, made by Wyeth Consumer Healthcare, represent a public health threat.
    ...
    The EPA said it expects 295 million fewer cases of non-melanoma skin cancers over the next century as a result of the phase out. The EPA cited data suggesting that a 1% decrease in stratospheric ozone would lead to a 2% increase in non-melanoma skin cancer.

    Wyeth estimated that approximately three million Americans use Primatene Mist for the treatment of mild asthma. The drug generated $43 million sales in 2005, the company said. OTC inhalers are also an option for those who lack insurance.

    Yet, physicians have questioned the sale of OTC inhalers because of concerns that patients will self-medicate and not get the appropriate treatment for their asthma symptoms. Many physicians prescribe albuterol inhalers.

    Pramod Kelkar, M.D., of Minneapolis, a member of the American Academy of Allergy, Asthma, and Immunology said, "Given a choice, I would like to have this particular inhaler not on the market because of the concern that some patients may misuse it. It's better that patients get the right diagnosis and the right treatment, and that particular path is harder when such inhalers are available over-the counter."
  • nanidesukedo

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    Sep 27, 2011 12:24 AM GMT
    Points to Q here. Primatene mist? Really? Really? I may not have my MD yet, but I see crap tons of clinic patients every day (finish up my MD later this year...not like it matters...but I know what I'm talking about).

    I have never seen a patient on primatene mist...and I, nor anyone that I work with in my hospital, have ever suggested that a patient take Primatene. As Q has stated, this phasing out of products over environmental concerns is status quo. It happened to the actual, effective, gold-standard medicine for immediate symptomatic relief for asthma (albuterol).

    So...let's summarize:

    A. CFCs have been phased out in other inhalers (albuterol, ipratropium..etc). This isn't anything new. This isn't an Obama policy.

    B. Primatene mist? Get over it money grubbing company. The only time I'm giving epinephrine mist is if I'm giving racemic epinephrine for a kid with croup. I would NEVER...and I repeat...NEVER EVER suggest that anyone with asthma rely on it for symptomatic treatment of symptoms. Albuterol is a far better drug.

    PS - I hope this epinephrine shit does leave the market. Epinephrine inhalers and tablets meant for "asthma relief (BS)" are used as study aids for kids who can't get their hands on stimulants. They've also been used (mainly the tabs, but sometimes the inhalers...less bioavailability for necessary receptors that way, though) for people trying to lose weight.


    Bottom line: Tough cookies. Ineffective medicine is going the way that other inhalers have. No big loss. Frankly, it's probably better this way.