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Malpractice: Fresh from Election, House Republicans Set Vote to Put One Company's Bad Asthma Medicine Back on Shelves

David Doniger

Posted November 11, 2012

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Back for their lame duck session, the House Republican leadership has scheduled a floor vote on the Asthma Inhalers Relief Act of 2012 (H.R. 6190), sponsored by Rep. Michael Burgess (R-TX), a bill designed to put back on the market a 1960’s-vintage over-the-counter product called “Primatene Mist,” which was banned at the end of last year.  

Why was Primatene Mist banned?  Because it contains chemicals that deplete the earth’s ozone layer and a drug that the nation’s top asthma doctors consider ineffective and even dangerous.  

Why do House leaders want to bring it back?  Chalk it up to special-interest lobbying by a drug company and a former Congressman turned lobbyist.

Over the last two years, the House has passed dozens of bills, amendments, and riders to weaken the Clean Air Act and our other environmental laws.  The House majority prefers ideology over science and struggles with basic concepts of physics, medicine, and even arithmetic.  

Now they’re insisting they know better than the nation’s lung doctors how to treat life-threatening asthma attacks. 

H.R. 6190 is a piece of work.  Note that it is the Inhalers, not the Patients, Relief Act.  That’s because the sole purpose of this bill is to put one company’s banned product back on the shelves.  Primatene Mist contains a drug called epinephrine and ozone-destroying chlorofluorocarbons (CFCs).  Both the Food and Drug Association and the Environmental Protection Agency have determined it should come off the market.  Why?  Because epinephrine is no longer considered a safe and effective or essential treatment for asthma, and because CFCs are dangerous to the ozone layer. 

After many years of advance warning, the deadline to stop selling Primatene Mist passed on December 31, 2011.  Primatene’s manufacturer – Amphastar Pharmaceuticals and its Armstrong subsidiary – apparently misjudged the declining market for its product and found itself with stocks of inhalers on its hands after the deadline.  So now, nearly a year after the ban took hold, the company is lobbying Congress to pass a special bill to put those stocks back on the market. 

Meanwhile, other drug companies stepped up to the plate by developing effective asthma inhalers that contain better medicines and no CFCs.  They invested the money for research and testing, got FDA approval, and put their products on the market well before the deadline.  Millions of asthma patients, after seeing their doctors, are relying on them today. 

The nation’s leading lung health doctors oppose this bill because they think it actually would be dangerous for asthma patients to put Primatene Mist back on the shelves.  Here’s what Dr. Monica Kraft, professor of Medicine at Duke University and current president of the American Thoracic Society, said in testimony to an Energy and Commerce subcommittee last summer:

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. 

Amphastar/Armstrong professes concern for the poor, saying they need an over-the-counter medicine that doesn’t require a doctor’s prescription.  In fact, there is another over-the-counter alternative containing no CFCs, though the asthma doctors discourage it.  Here’s the response of Chris Ward, past chairman of the Asthma and Allergy Foundation of America, is his testimony:   

Another false assumption is that low income people need these medications because they are low cost. While the price of Primatene Mist may be lower than the total cost of or co-pay for more effective bronchodilators, the relief from these epinephrine devices does not last as long. Thus, the long term cost is actually higher....

[O]ver-the-counter bronchodilators can promote self-diagnoses, which is particularly unsafe for the symptoms of asthma. With proper diagnoses and treatment, people can control their asthma symptoms, avoiding high-cost interventions like emergency department visits and hospitalizations. Cutting out care by qualified medical practitioners could be dangerous for the patient and costly to the healthcare system.

The bill’s sponsor and Primatene’s staunchest promoter, Rep. Michael Burgess, often notes that he is a doctor.  Yes – he’s an obstetrician and gynecologist.  Do you think America’s asthma sufferers should take an OB/GYN’s advice over the nation’s top lung doctors?

The company hopes to get Democratic support too.  For that they hired former Rep. Bart Stupak, who turned lobbyist after serving in Congress from Michigan.  In reaching out to his former colleagues, Mr. Stupak doesn’t talk about the lung doctors’ warnings on epinephrine, about damage to the ozone layer, or about the business mistake his client made in getting stuck with too much stock when the well-advertised deadline finally came due. 

House leaders have put this bill on the “suspension” calendar meant for non-controversial bills to name post offices and the like.  That means it will take a two-thirds majority to pass the House.  Let’s hope there are enough House members of both parties that respect science, medicine, and asthma sufferers to send this nasty little bill down to defeat right now. 

Update Nov.13:  Politico reports: "House Republicans have for now pulled a bill directing the EPA to allow Amphastar Pharmaceuticals to sell leftover stocks of the asthma inhaler Primatene Mist, which was banned at the end of last year because of an international pact on products containing chlorofluorocarbons.  The bill, initially set for a House vote Monday, will be rescheduled after Thanksgiving, a spokesman for House Majority Leader Eric Cantor emailed.  'We have a scheduling issue,' the spokesman said."

Update Dec. 11:  The Primatene Mist bill is baaaack!, scheduled for a House floor vote tonight.  Check back here later to see what happens.

Update Dec. 12:  The Primatine Mist bill failed in the House today.  It fell far short of the 2/3rds majority needed for a bill on the "suspension" calendar, which is usually reserved for non-controversial bills.  The vote was 229-182, with 29 Republicans voting against, and 31 Democrats voting for.

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Asthma suffererNov 11 2012 12:28 PM

I don't care what doctors say... this inhaler is the best medicine for my allergy-induced asthma symptoms! Since the ban, I have been stuck with the only option available, albuterol, which, in my case, causes heart palpitations; something I never experienced with primentene.

Paul MayNov 11 2012 03:15 PM

I have used Primatene Mist for asthma since the age of 8 and found it to be the only effective aid. I am now 77. I believe it's removal from the market to be a money-making gimmick by the pharmaceutical industry. My lungs are quite healthy, thank you. I am a tuba player in a major orchestra.
The only problems I have were created out of thin air - the air supposedly being protected by substitutes.

Robert KisselNov 11 2012 04:30 PM

Who the heck asked you?

Like many others, Primatene Mist was a GOD-SEND, and worked VERY effectively, with NO side-effects for most of my life (I am approaching 60). My doctor, who has cared for me attentively for well over thirty years, has offered me alternatives to try, and when I've said I felt as if I was getting better relief from Primatene Mist, he was perfectly all right with me using it to keep my handicap from interfering with my life.

The gratuitous ban has been a terrifying and pointless interference by people who have no business interfering. The CFC's in the formulation have NO measurable effect on the environment whatsoever, and the ban served only to drive the costs of asthmatics up astronomically and inconvenience and endanger us no end.

It is WE--the patients--who have been begging our legislators to take pity on our plight and save us--not drug companies. We've been telegramming, writing letters, trying to figure out, desperately, how to make Washington recognize what it's doing to us, a tiny minority who desperately needs to have this over-the-counter, convenient aid, in order to live in peace.

You, who have never felt the terror of being unable to gasp for air, should really keep your mouth shut--it infuriates me and other asthmatics to hear PRECISELY the sort of know-it-all thinking to led to this catastrophe in the first place.

Look for yourself at the desperation on the groups that sprung up on facebook--all of us have doctors, all of us can spend five times as much on medicines that don't work as well for us . . . and then someone like you comes along, just as we FINALLY get congress to pay some attention to our suffering, after months of calling and writing letters, only to come across a column like this, trying to make political hay and throw mud at the manufacturers--who aren't really making any sort of sensible profit from keeping us alive.


June GiaconaNov 11 2012 04:31 PM

I have asthma and having depended on Primatene Mist for years ... I will only pray that the bill is passed and the remaining safe and effective inhalers are returned to the shelves where they should be .. Epinephrine is a life saver for asthmatics . I would suggest that you do a little homework before you post negative about epinephrine a 50 + year old medication that has saved millions of lives and is over the counter as I type. Millions really need this inhaler , it works better than any other available . Please pass our bill

Juliet YanklowitzNov 11 2012 04:34 PM

Doninger, it's pretty obvious that you haven't got the slightest clue about reality. Primatene Mist has been the most effective and safe medication OTC for the last half a century and even the ozone experts state repeatedly that the CFC it uses as a propellant is so miniscule that it has zero effect on the depletion of the ozone hole. To think and publish, for the world to see, that this is a "drug that the nation’s top asthma doctors consider ineffective and even dangerous" is downright fraudulent. Do your research, instead of kissing the ass of Big Pharma so you can get your free government grant money. The petition to Bring Back My Primatene MIst has 7,500 signatures on it now and counting. That many Asthmatics are not lying about how this MDI inhaler, Primatene Mist is the best medication they have ever used

Robert KisselNov 11 2012 04:35 PM

And let me add that I used Asthma-nephrin both BEFORE Primatine Mist became available, and it was still an atomizer with a rubber bulb, and I purchased it AFTER the ban to see if I could use it.

It's DIFFICULT, it's BULKY, and it takes daily fussing and attention. Primatene mist fit easily in ones trouser pockets, was easily portable, simple to use, and cost about 1/3 of the price.

YOU try playing with tiny ampules, individually sealed in packaging material that cannot possibly be any better for the environment than the minuscule puff of CFC's released by every asthmatic in the U.S.!

My gosh, the arrogance of your column is just ASTOUNDING--it comes straight out of a world in which medicine is run by insurance companies instead of sensible, compassionate doctors.

Juliet YanklowitzNov 11 2012 04:49 PM

Also, Mr. Doninger, while we are on the subject, please tell us why it is that, the only OTC inhaler containing CFC was banned, but there are still 2 less effective, PRESCRIPTION ONLY, CFC containing asthma inhalers still available until Decmber 2013. You forgot to mention that in your article. Gee, it's certainly not hard to tell who's lining the pockets of NRDC.ORG. Could it be Big Pharma???

BTW, the "new" OTC asthma product from Nephron called Asthmanefrin, which Big Pharma has tried to pawn off as an alternative to PM, is now offering the same medication, epinephrine OTC that was in Primatene, in a box with small vials for anyone to buy. Oops! I guess that epinephrine isn't so dangerous after all, is it? The EZ Breathe atomizer delivery system is so faulty and expensive, $60-70 dollars, the failure rate so far is about 99%, even with manufacturer replacement. Not a lot of folks who have tried this new stuff are happy about that, although getting the epinephrine has provided some relief from the desperation of not having the favored PRimatene MIst inhaler.

June GiaconaNov 11 2012 04:56 PM

My question for you David , is why would you be against the return of the Primatiene Mist inhalers in storage , I believe this blog is under handed on your part and at least one other person .. These inhalers do not hurt the Ozone Layer , we could aim each one available at the sky and there would still be NO harm done .. David are you in with big Pharma ?, Or did you get more information from the Ozone Hole than came from suffering Asthmatics .. Since this bill passing should not personally effect you it tells me the kind of person you are . I hate to wish Asthma on anyone , but you really deserve to have an attach to realize the full picture and real suffering .. I would hate to think that someone took money and spent it only to have a tree huger make a blog to under mind the passing of a bill that will bring relief to so many Americans .. You and yours have truly turned out to be pieces of work .. Once again the Rx inhalers available do not give Asthmatics the quality of life they deserve .. There are numerous documents that prove the CFC inhalers have no negative on the ozone . More important they are necessary for humans to live , breathe ... The nerve of you stuck up with inhalers that cost 200 dollars plus and do not work .. Karma will come to those that have deprived us from our choice to breathe ...

Kris ShofnerNov 11 2012 05:17 PM

PRIMATENE MIST is the ONLY ASTHMA RELIEF that was available to me!! now I HAVE NOTHING!! I had tried a Prescription Inhaler that made my HAIR FALL OUT!! I Do Not have Medical Insurance and have used PRIMATENE MIST for YEARS! It has kept me from going to the Emergency Room NUMEROUS TIMES!! There certainly is not enough Ozone Depletion due to Primatene Mist!!I I is RIDICULOUS to believe that the CFC's in an ASTHMA INHALER causes Ozone Depletion but a Can of COVER MY BALD HEAD SPRAY has No Affect!!?? PLEASE PASS Asthma Inhalers Relief Act of 2012 (H.R. 6190)!!!!!!!!!!!

Kristin GraefNov 11 2012 05:30 PM

I see hair products on the market and consumed in obscenely large quantities which are a thousandfold more harmful to the ozone layer (and, ironically, packed fully of asthma attack triggers and allergens), than our life-saving Primatene Mist.

Jeanie N Randy Russell-CausinNov 11 2012 05:32 PM

Please bring back our Primatene Mist. Nothing is as safe and affordable as PM. I have used this medicine as a rescue inhaler since I was young with NO side effects. When allergy season hits, it is a lifesaver and NOTHING compares to it. There are so many hair sprays, bug sprays and other pollutants out there that I do not believe us using PM will cause more damage to our environment. PLEASE, Bring Back My Primatene Mist! Thank you!

Rick WilliamsNov 11 2012 05:36 PM

Doninger, you have obviously never experienced an asthmatic have an attack or you wouldn't be against bringing back Primatene Mist, or have never watch a man or woman having an attack try to open medication and mix it so they can prolong life just a little longer. I want you to visualize this scenario: I have my hands around your neck, choking the life out of you, and right before you pass out you try to remove my hands from you neck, darn near impossible. Now, same situation, but right before you lose consciousness, someone else removes my hands from you. That, Mr. Doninger, is the difference between your medication (albuteral), and our medication ( Primatene Mist). Our medication has actually saved lives in panic situations, yours has cost lives in panic situations. So get off your high horse and think about the people you are trying to kill and give them their lives, and mine, back. Rick Williams, Western North Carolina

Bruce WardNov 11 2012 08:24 PM

Comment removed. We welcome all opinions on Switchboard, but incivility in any form will be removed. – Switchboard editors

David DonigerNov 12 2012 10:39 AM

I respect the passion of the commenters on this post. I want to respond to several points.

First, I do know something about what it's like. My daughter suffered from asthma as a child, with inhalers, nebulizers, and trips to the ER. My mother depended on an inhaler the last 20 years of her life. And I have had episodes where I needed one too.

Second, NRDC gets no money from pharmaceutical companies or any other industry. We have occasionally received very small government grants but only on wholly separate subjects.

Third, I reject the implication that the lung doctors are in cahoots with the pharmaceutical companies. I believe Dr. Craft and the other leaders of the American Thoracic Society care above all about the health and well-being of their patients and all who suffer with asthma.

Comments are closed for this post.


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