EPA Attack On Asthmatics Coming To An End?

by Angela Logomasini on August 1, 2012 · 20 comments

in Environment, Features, Precaution & Risk, Regulation

CEI warned policy makers a couple decades ago that an Environmental Protection Agency (EPA) phase out of over-the-counter sales of CFC containing asthma inhalers would threaten public health without providing environmental benefits. These products had been safely used for nearly 50 years, but EPA decided that the public should have limited access because of overblown concerns about their potential to harm the ozone layer. Because of that ban, asthmatics can only access asthma inhalers by prescription.

Congress is considering reversing — albeit only temporarily — this crazy policy thanks to a campaign launched by Amphastar, the makers of Primatene Mist CFC inhalers. Former Congressman Bart Stupak (D-Mich.) — who now represents Amphastar — makes some excellent points on the topic in The Hill‘s Congress Blog. The company has also launched a petition to bring back these inhalers.

According to Amphastar, it has an existing supply of 1 million units, which EPA could allow it to sell or dispose — releasing the CFCs into the environment in both cases. It is likely that some asthmatics stocked up on these inhalers before their complete phase out at the end of 2011. But this supply has an expiration date of August 2013, meaning the company needs approval to make more units if asthmatics are to benefit from them after their existing supplies expire.

The House Energy and Commerce Committee held hearings on July 18 to discuss the Asthma Inhalers Relief Act of 2012 (H.R. 6190), which would allow sale of the existing supply until August 2013. If this legislation passes, consumers will have access for another year, during which Congress could consider a complete repeal of the ban to allow production and sale of these products after August 2013. The Independent Women’s  Forum addressed the hearing on its blog, which you can check out here.

At the hearing, Dr. Edward Kerwin, an Allergy Asthma and Clinical Research Physician, who specializes in the treatment of Asthma and COPD [Chronic obstructive pulmonary disease] patients, testified on why consumers should have access to inhalers:

Asthma, COPD and Acute Bronchitis can occur in the middle of the night, on weekends, during hikes, picnics, excursions, or camps far from cities. Severe Asthma flare-ups and COPD/Bronchitis flare-ups can cause critical, sometimes progressive shortness of breath that can lead to death and very severe distress if untreated. Asthma especially is allergy and exercise triggered. Picnicking near a hay field, visiting relatives with cats, cleaning a moldy basement or dusty carpet can trigger severe life-threatening asthma flare-ups. Exercise also triggers flares. These generally require immediate treatment, usually with 2-4 puffs of a rescue bronchodilator given within minutes of the onset of airway obstruction. Death from asthma can occur within as little as 20 minutes (due to hypoxia, or starving for air) if asthma and bronchospasm are not rapidly treated. … Since Acute Asthma, Acute COPD and Acute Bronchitis are potential medical emergencies requiring immediate treatment, over-the-counter therapies can play a key life-saving role when patients have a flare-up.

Some witnesses argued in favor of the ban because they don’t think consumers are wise enough to use these inhalers judiciously. But the ban was never designed to serve such ill-founded nanny-statist goals. It stems from the U.S. implementation of the the Montreal Protocol on Substances that Deplete the Ozone Layer. The only question for regulators here is whether these inhalers have enough, if any, impact on the depletion of the ozone layer to justify denying consumers access to the life-saving devices. There are plenty reasons to doubt CFC Inhalers have any impact on the ozone layer, as noted in a very interesting piece published in the Tucson Citizen last fall.

The weak case for a ban was apparent at the time EPA imposed the ban. CEI policy analyst Ben Lieberman pointed out:

EPA justifies the [then] proposed ban on the grounds that it will help in “preventing dangerous pollution and protecting the environment.” However, it is not clear whether the old CFC inhalers are bad for the environment, or that the new ones are benign. The amount of CFCs used in MDIs is too small to have an appreciable effect on the ozone layer, according to atmospheric scientists. Current data indicate that the annual CFC contribution from inhalers is approximately one three-thousandth of what is already in the atmosphere. Thus, an additional 5 years of CFC-inhaler use will add only 0.1 to 0.2 percent to the atmospheric burden of this gas. In addition, EPA has neglected to point out that its favorite new inhaler uses a compound called HFC-134a, which it has implicated as a greenhouse gas. Indeed, EPA is already in the process of banning HFC-134a in other uses, because of its “potential to contribute to global warming.” Thus, if the ban on CFC-inhalers succeeds, their replacements could become the next regulatory target, leaving asthmatics with still fewer treatment options.

David Doniger August 1, 2012 at 1:01 pm

C’mon guys, this is one of the most incredibly dishonest posts I’ve ever seen from my friends at CEI. No mention of the testimony of the American Thoracic Society, the associationof the nation’s lung doctors. Here’s what ATS president Dr. Monica Kraft,(Professor of Medicine at Duke University) testified ( http://republicans.energycommerce.house.gov/Media/file/Hearings/Energy/20120718/HHRG-112-IF03-WState-KraftM-20120718.pdf):

“It is my strongly held view and the view of the American Thoracic Society, that returning epinephrine inhalers to the U.S. market, even for a limited time, would be ill advised.

“This view is shared by several other physician organizations including, the American Academy of Allergy Asthma and Immunology, the American College of Asthma Allergy and Immunology, the American Association of Respiratory Care and the National Association for the Medical Direction of Respiratory Care. …

“The take away message is that in the majority of cases, asthma can be successfully treated by working with health care professionals to find the right combination of safe and effective medications.

“Epinephrine is NOT one of the medications that is considered safe for the treatment of asthma. …

“For years the medical community has recognized the dangerous side effects of epinephrine for the treatment of asthma and has recommended against it use for asthma. In 1999 the American Medical Association 1) urged that warning labels on over the counter epinephrine inhalers be strengthened to warn patients about the dangers of epinephrine use, 2) encouraged FDA to consider removing inhaled epinephrine from the market and 3) requested studies to determine whether the availability of inhaled epinephrine is a risk factor in asthma morbidity and mortality. The American Medical Association again reaffirmed this position in 2009. …

“The American Thoracic Society strongly encourages any patient who is using over the counter medications–like Primatene Mist CFC–to treat their asthma to see a healthcare provider who can help the patient develop an asthma management plan and recommend more effective and safer medications to manage the asthma. …

“If the intent of the legislation is to restore a safe and effective asthma drug to the market place, then this legislative effort is mis-informed. Inhaled epinephrine is not a safe drug for the treatment of asthma. The adverse side effects of epinephrine are serious and well documented. No current clinical practice guideline for the diagnosis and treatment of asthma recommends the use of epinephrine. In fact, asthma guidelines specifically recommend against inhaled epinephrine for treating asthma.”

Don’t be a shill for a company trying to sell a banned, and dangerous, medicine to poor people.

Rob August 1, 2012 at 6:48 pm

Did you even read the article? Primatene was NOT banned because of any health concerns. For MILLIONS of Asthma sufferers, prescription inhalers are out of reach. An OTC inhaler allows people who have no insurance and/or can’t afford the costly prescription inhalers access to a medicine they desperately need. For the record, for many asthma patients, Primatene works better than an albuterol (Proventil, ProAir) inhaler. David, don’t be a shill for the Big Pharma companies that would prefer the cheaper, more effective (for many people) OTC Primate never returns to the market as it would put a dent in their profits.

Jesse Brown August 1, 2012 at 7:08 pm

The difference between the people and the Doctors who perpetuate their own brand of economics is the doctors have more money to push. On the flip side the people outnumber YOU

Dayna Kent August 2, 2012 at 8:28 am

Dangerous…. Not being able to breath is dangerous.. Don’t be mad because they have the only product that works for the poor and the richest of the RICH… So don’t say they are taking advantage of the poor. There are side effects to EVERYTHING… Oh so let’s trust the great we know what’s best for you doctors… I have taken care of my dad foe 13 years… He passed away 7/27/12… He suffered from asthma, COPD,Emphysema… He was on 4lts of oxygen at rest an 6 if he was up… He served 3 tours in Vietnam and was exposed to agent orange. In his last year of life the great doctors our him on Prednisone, (steroids) to help him breath. The side effects was massive swelling including his face and neck witch then the great doctors had to add lasix,to reduce the fluids and then Potassium to put back what the lasix was causing him to lose. And so you say Primatine is dangerous.. the great doctors push and I mean PUSH bad meds in peoples mouths daily. And because these great know everything that is best for you doctors do not read patients files they write prescriptions that often cause immediate death.. my grandfather used primatine for more than 30 years and passed away only had the hands of a DOCTOR with a needle full of blood thinner. The only cases where people have died from epinephrine have been at the hands of the great doctors with a needle of pure epinephrine in the ER while trying to treat an asthma attack. I to have asthma and had used primatine for 22 yrs. And want it back on the shelves for everyone. Poor and Rich.

dan August 22, 2012 at 11:55 pm


Some medicine for poor people is better than NO medicine for poor people.

dianne August 23, 2012 at 7:32 pm

You are probably not even an asthmatic – and likely never had to suffer through a night of suffocation. Never had to experience the feeling in your parent or child. And blessed with ample insurance to cover prescription and doctor care. And I’m also sure a deep analysis of your life would reveal some glaring unhealthy practices – you are no one to tell me what is safe for me and my family. Like the woman and her friends who’s SUV’s cause more harm to the environment – than hundred’s of Primatine users (and perpetuate even more use) … Frankly sir – you don’t have a clue what you are talking about.

Kevin August 24, 2012 at 8:40 am

You are a F***ing idiot. At this time I am suffering froma week long asthma attack that could have been avoided with Primatene Mist. I have used almost all other asthma meds and they are not even close to being as effective as PM. I have been using PM for over 30 years without any problems. So unless you have an close relative that has died or otherwise from the use of PM (which I highly doubt), shut up. And let me recommend 1 more thing… try breathing thru a cocktail straw for one day and u will see what its like to have a severe asthma attack!!! The come and post your4 BS!!!

June Giacona August 1, 2012 at 7:29 pm

This is the best news I’ve heard in months , I totally agree with this article . I would like to Thank anyone who spoke in favor of the return of Primatene Mist . I have used epinephrine – Primatene Mist since I was a very young child , I have also seen Doctors and have been given prescriptions , taken steriods etc to control my asthma , so its not that people aren’t being seen by professionals , not in my case or many others that I know of, it just that Primatene works best for me as a fast acting inhaler, and I thank God it has been available to me , don’t know if I would be here today if I couldn’t have gotten my hands on one of those inhalers , on many occasions .. This article stated correctly the ban of this product started because it was said to be destroying the ozone layer , and has now turned into a much bigger issue with its safety being called in to question . I can speak from experience , or you can read the prescription inhaler inserts for yourself , there are very dangerous side effects with most all the prescription inhalers ….. I have had some horrible side effects with a couple of these, and some just do not work at all .. I have never had a problem with Primatene Mist , if there is something long term that I’m not aware of , well I choose to Breathe , If I can’t breathe I can’t do anything else .. Please let the people that suffer make their own choice on which inhaler works best for them .. Please Bring Back Primatene Mist to the shelves , make this available for the millions that suffer , as we now suffer and wait ..
Thanks so much Again to all that understand the millions of Asthmatic’s

John August 6, 2012 at 2:27 pm

Does anybody care this company is using the ‘poor patients’ to lobby congress so they can dump one million canisters of banned inhalers they knew couldn’t be sold after December 31st, 2011? They say they will give charity their profits….well right now they must be out a bunch of money from manufacturing all those inhalers and they’ve already had to get rid of their CFC albuterol inhalers so they must have some idea how much it costs to dispose of the Primatene Mist inhalers so the only charity will be them….and they’ll probably get a tax break to boot all the while claiming they are doing this for the good of the poor patient.

Whew….I feel for anyone who swears adrenaline is the only thing that works for them but let’s not forget this is about a pharmaceutical company and their bottom line is their goal….

Forge August 22, 2012 at 8:50 pm

I have news for you, not all of us are poor and not all of us believe the lies our doctors tell us. OTC drugs are HATED by doctors because it means WE DONT NEED to RUN to the doctors. I feel for anyone who was not smart enough to buy them in bulk (and no, they do not magically expire after a date stamped on them) as I have a lifetime supply of them that will keep “Polluting” your environment for the next 80 or so years.

dan August 22, 2012 at 11:52 pm


As a poor patient, I don’t have any care in the world. The fact is, while there may be side effects to this drug, the manufacturers and pharmaceutical companies of the “correct” stuff is causing most of us to suffer. As it has been said in previous post, we are aware of the side effect and like Primatene Mist, there are side effects to every drug. Some of those side effects include DEATH. Well guess what, for the hundreds of thousands of people who can’t breathe without Primatene Mist and can’t afford a doctor or prescription, our death rate INCREASES. So if you’re asking if we are willing to risk a few side effects to prevent death, then you bet your sweet bottom that I will take Primatene Mist anytime.

If this was really about the environment, then we would be outlawing trucks, factories, cars, and all the other dangerous things that are helping causing my breathing problems. If this was about getting us asthma sufferers the correct medicine so we could breath and not suffer the “dangers” of Primatene Mist, then the medicine would be available to everyone who used Primatene Mist and be priced accordingly.

Sadly, this has always been about one thing… and that is money. Anyone who thinks otherwise is incredibly dense.
In fact, I think Primatene Mist is looking out for us small folk (while making a profit) which is ok, because they could price this at 30 or 40 dollars and we’d still eat it up.

So go ahead with your plight, but I hope you never have a breathing issue when you can’t afford insurance

RD August 6, 2012 at 9:51 pm

I want and need my Primatene inhaler now. Luckily, I had one in early July. One of the stray kittens I was taken care of was hit by a car. I was so upset when I saw it dead by the side of the road that I literally lost my breath. It happened like that!!!!! I made it back to my apartment and my inhaler. Two puffs and my breathing was restored. It saved my life- literally. I did not have time to get to an ER. Bring back Primatene. Time to abolish the EPA and FDA.. Idiots. I am a democrat. But if they block primatene being allowed back on the market, I will NOT vote for any DEM…..this is that important to me.

Tracy August 8, 2012 at 2:05 pm

I have been an asthma sufferer my entire life (40+ years). I have health insurance and I currently take multiple prescription medications to manage my asthma (which even with insurance still cost me almost $200 per month – Advair, Singulair, Albuterol). HOWEVER, if I am having a severe attack (which often happens when I am sick with a cold or flu, or if I am around horses or cats) – the ONLY thing that breaks the attack is Primatene or going to the ER for an IV of steroids. I have been told one doctor how dangerous Primatene is – but I have had another doctor tell me that it is more important to use whatever means necessary to break the attack so you can breathe and then get to an ER for further treatment – even if it means using Primatene. My dad who is unemployed and not yet old enough for medicare – also has asthma and struggles on a daily basis because he cannot afford the monthly $150 for Advair and $75 for Albuterol, not to mention the $200 office visit to the doctor. The removal of Primatene has been devastating for both of us. The EPA needs to go worry about the damn raping oil and natural gas companies and leave asthmatics alone.

Elizabeth August 12, 2012 at 10:15 am

Thank you everyone for this great post. I’m 27 yrs old, I’ve suffered with asthma my whole life.. I was 4 when playing in the cold and caused an attack. My memory is still so clear of that day. I was in preschool and nobody new what to do. luckily my mother (who also as asthma and now COPD) was off that day and close by showed up with her inhaler. She understood…. But yes at that point I have asthma. Didn’t need a doc to tell me that, but none the less they put me on all kinds of craziness..(Mom said) She didn’t give it to me. THANKS MOM!! At that age giving me steroids..? I grew up very active and played sports through school. I did this because of primatene mist! It was ALWAYS in my backpack. I believe it saved my life more than I can count. My attacks were (and still are) so sudden my coach new where I kept my relief inhaler. I’ve been using primatene mist for over 20 yrs now… I’m a working, single woman without any children. So needless to say, I can’t afford heath care. It’s all I can do to pay my rent and buy food at the end of the week. It’s crazy what our government forces us to do. I HAVE TO BREATHE!! so…what are asthmatics suppose to do? Buy other peoples scripts? see a DR and get an Albuterol prescription? Okay sure, What do we do with the piece of paper with chicken scratch on it? That chicken scratch is a golden ticket to me…but means nothing when I can’t afford to cash it! Honestly…. what do we do??? I guess speaking on this page is a step!
Thanks, *Short of breath in east USA*

Forge August 22, 2012 at 8:44 pm

ANY post by ANY doctor or “asthma study group” should be discounted as fraudulent from the start. These people are in the business of keeping YOU in THEIR office.

Its not about “deaths” or any “Danger” from the OTC inhaler, its about keeping you coming back again and again for expensive inhalers and expensive doctor visits. After all, Phama reps and Doctors have to keep those big payments rolling in for their BMWs and houses. We don’t matter. Our safety does not matter, its all about stealing our money by flat out lying to us and fear mongering which is almost ALL modern medicine is anymore.

Jeff Pehrson August 22, 2012 at 9:01 pm

Does anyone know when this legislation may come up for a vote?

laura August 22, 2012 at 10:40 pm

mateneWhat has happened to this country? I have used Primatene inhaler since I was 12 yrs old and now I’m 50 and the only inhaler that ever worked for me is taken off the market because of the “ozone layer”? Has anyone in the EPA ever had an asthma attack……..if you have ever had one you are afraid you may not recover because YOU CAN’T BREATH! Let me decide whether or not epinephrine is my choice of inhaler-note that word “MY” choice not your choice. My health is more important, and the ozone will be there tomorrow and 100 years after that. Bring Primatene back immediately!!!!!!

laura August 22, 2012 at 10:42 pm

Bring back Primatene!!!!!!!!!!!!

darlene mcclelland August 27, 2012 at 11:32 am

I’ve used primatene mist for over 25 years its been my hero its saved my life for years pleas don’t take it away for good please put it back on the shelf I can’t live without it if u don’t put it back on the shelf thete will be 100s of people dieing includeing my self I don’t want to die please …this is my hero we the people have the right to use this for our health I’m scared I need u to bring it back please let me live a few more years unfilled its my time to go. Please I beg u to put primatene mist back on the shelf…thank u ….

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