On December 31, 2011, Primatene Mist, the only over-the-counter asthma inhaler still available, will be taken off the market. The ban is being pointed to as an example of regulatory overreach by the Obama administration. As a physician and asthma specialist, I have been observing the Primatene controversy for — without exaggeration — decades, and have concluded that there’s blame enough to share between both the pro and con government regulation camps, as well as the pharmaceutical and financial industries.
The official reason for the ban is the danger Primatene poses to the environment. I have always thought that extending the ban on chlorofluorocarbon propellants (CFCs) to medication was an example of regulatory overkill, because medication is such a small part of the problem. However, it does help to look at the context. Back in 1987, when Ronald Reagan was President and the Montreal Protocol was written, there was international consensus that we needed to do something about depletion of the ozone layer high in the atmosphere, which was causing problems for us here on earth. For many of the products releasing these gasses into the atmosphere — car air-conditioners, hairspray, and deodorant, for example — alternatives could plausibly be found. I wish we could find a way to relieve asthma attacks with a roll-on, but we can’t.
Medical aerosols were given more time than other products, and, frankly, I don’t think we’ve done a very good job of replacing them. The new inhalers don’t deliver medication as efficiently as Primatene delivers its active ingredient. Still, anyone who looks at the timeline for the upcoming restriction can see that the key decisions were made in 2006 and in 2008. The current administration is following the timetable set by its predecessors.
The charges of over-regulation have been accompanied by newly expressed sympathies for the plight of poor people with asthma. I think the greater disservice was done recently when stronger air-quality regulations were postponed. The best way to treat asthma is to reduce its incidence, and air quality is one of the biggest factors. It's unfair to generalize, but I have a feeling that some of the people looking to demonize Big Government for regulating Primatene were also calling tighter air-quality regulations “job-killers” a few weeks ago.
The best argument against Primatene falls outside of the environmental realm, and that is the medical case. The active agent is epinephrine, which is pharmaceutical adrenaline. This has the ability to relieve the airway tightness produced by an asthma attack, also known as bronchoconstriction. In this, it resembles the action of the preferred asthma-relief medicine known generically as albuterol. However, epinephrine also stimulates the heart. This makes it unsuitable for large numbers of asthmatics who also have heart problems. Most of the people who rely on Primatene are poor, and often overweight and hypertensive. These regular jolts to the heart are not doing them any good.
In addition, it does nothing to control asthmatic inflammation, which is best accomplished with systematic, daily doses of inhaled corticosteroids, a very different kind of drug. Asthmatic lungs are what British doctors called “twitchy,” i.e., they are chronically inflamed and primed for any asthma trigger, such as diesel fumes, airborne allergens, or viruses, to touch off an attack. Primatene treats symptoms, not causes, and I have no doubt that users miss a lot of work or school and are sub-par performers when they do go. Uncontrolled inflammation is remodeling their airways, costing them lung capacity for the long haul.
Many who decry the passing of Primatene believe the ban was contrived to squeeze more money out of those who can least afford it. They probably have a point. I would love to see the FDA memos and transcripts from 2006 when the Primatene decision was made, or from 2008 when the fuse was lit, not to mention those of the current owners when they decided to acquire the drug. Even without access to these secrets, we know that drug makers like to tweak existing medicines and bring them back on the market at higher prices than they command over the counter, and that investors sometimes buy up the rights to older drugs with exactly this in mind.
It doesn’t always work. The next generation drugs are sometimes no improvement over the previous ones. Last year I wrote a post commemorating a landmark: Never before in over 30 years of practice had an entire month passed in which I hadn’t written a prescription for an oral antihistamine. The OTC versions were good, and the new drugs weren’t so much better that they justified prescribing.
When it comes to asthma, I believe in active intervention. The economics of good asthma care have proven themselves again and again. Want to do something for poor people with uncontrolled asthma? Pay for systematic care. Want to lower the nation’s emergency room bills? Help people control inflammation in their airways through daily use of medication and reducing exposure to triggers. Treating asthma symptoms, whether with Primatene or albuterol, is not asthma treatment, any more than a ride in an ambulance is health care.
Dr. Paul Ehrlich is co-author with Dr. Larry Chiaramonte and Henry Ehrlich of Asthma Allergies Children: A Parent's Guide
Photo by eo was taken: Asthma Map
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Report says around the world
Report says around the world almost 70% of populations are suffering from asthma problems; therefore different health organizations are offers several kinds of asthma prevention products such as medicines, inhalers and drops. Most probably FDA bans several asthma drugs and asthma prevention products to deal with asthma problems.
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Asthma Inhalers
For nighttime asthma attacks, lung function and symptoms improved just as fast, improved the same average amount, and the improvement lasted just as long after patients took several puffs of Primatene Mist as when they took several puffs of albuterol on a different night. Unexpectedly, average pulse rates went down after Primatene Mist, but up after albuterol. Blood potassium levels fell lower after albuterol than after Primatene Mist, further evidence that the adrenaline inhalers were safer than the albuterol inhalers. Similar studies have not been done in children or older adults, but should be.
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Primatene is not for systematic care anyway!
While it may be true that systematic care is the best thing to do in the case of asthma, using that argument as an excuse for banning Primatene is disingenuous at best.
The purpose of Primatene is to give fast relief WHEN YOU ARE HAVING AN ASTHMA ATTACK. Systematic care is totally irrelevant in that instance. You are having an attack NOW, not two or three weeks from now when "systematic care" has had a chance to take hold. And for those who cannot afford the systematic care, taking Primatene off the shelves is very likely to cost many of them their lives.
NOTHING relieves asthmatic symptoms as quickly and clearly as epinephrine. Nothing in this world. Take it from me: albuterol is good, but not AS good. It might be more highly recommended for safety reasons, but tends to be more expensive, and it is simply not as effective as epinephrine in an emergency.
So in his particular instance, "systematic care" is nothing but a straw-man argument. It has no bearing on immediate needs that can the the critical difference between life and death.
Very occasional user here
I had bad asthma as a child but as an adult I barely ever have use for an inhaler. It doesn't make sense for me to take daily medication, nor to have to visit a doctor and keep a prescription current. For many, many years I have relied on having a Primatene inhaler in my purse for the VERY occasional asthma attack brought on by something unforeseen such as being exposed to strong harsh chemicals. I have used my inhaler once or at most twice a year. I am not a fan of the medical e$stablishment, and resent that I now have the choice between either coming under their control or not having my peace of mind for that "just in case" situation. It seems ridiculous that I will have to spend hundreds of dollars for medical appointments and prescriptions, rather than being able to simply pick up a $25 inhaler at the drug store once every few years. I absolutely do not buy the environmental "reason" for the withdrawal of this product. It is a money and power grab from the doctors and pharmacies, period. I'd love to compare the cumulative effects of all the CFC's released by Primatene users in a year vs the pollution put out by any ONE large industrial plant in a DAY--I'm sure Primatene doesn't even make a dent in the ozone comparatively.
Primatene
I'm So relieved to see another asthmatics' comments about the effectiveness of Primatene and how HFA inhalers don't work as well, because I felt completely alone considering how many times I've been told by the pharmacist and my doctors that I'm imagining that Proventil HFA & Ventolin etc. just DOESN'T DO anything for an asthma attack like they did when they were aeresol..I Just keep hearing the same thing over and over from them.... " It works, it's the SAMEeeee medicine as before etc etc", as if to suggest that the HFA's DO work but that I MUST be using it wrong etc etc.
Up until a few years ago I was constantly in the ER for asthma because depending on how serious the asthma attack was, albuterol is useless.
It was sheer luck that one day after having to pay cash for refills on my albuterol inhalers ( which are over $60 ) and didn't work very well anymore now that they were HFA, I didn't have the $$ for another refill and so I bought Primatene until I could get enough cash to buy the doctor recommended inhaler, but after trying Primatene and FINALLY being able to BREATHE freely for the 1st time in ages after just 2 puffs, I threw out all my other asthma meds and for the FIRST time in my entire life ..for $20.00 I was feeling so great that I haven't been to the hospital OR the lung specialist in 5 years, as opposed to having to go by ambulance at LEAST TWICE a year, not to mention that every damn day it was a struggle to breathe because the HFA inhalers ( and albuterol in general) did absolutely nothing, and with Primatene I was able to finally travel, exercise, you name it !!..In fact I had forgotten what it was like even to have an asthma attack after so many years of Primatene use, until 2 mos ago when even BEFORE the dec 31, 2011 no sale deadline, the stores stopped selling Primatene.
And NOW I remember what it was like not to be able to breathe even after using albuterol !!!...I was lucky enough to stock up on Primatene a few mos ago hoping to try to wean myself off Primatene and get used to using Proventil again, but the albuterol DOESN'T work now that it's HFA and I refuse to struggle to breathe so now the Primatene inhalers are almost gone and I have only 1 left and I KNOW that after that is gone , I'll drop dead, because I TRIED using Proventil just a little over a mos ago and twice was grateful I had a Primatene, otherwise I would've collapsed.
It is hysterical that doctors and pharmacists REALLY believe that ONE albuterol inhalers should last a few mos to a YEAR !! ahaha...that's INSANE!!...it also makes for great business..they TELL you it should last that long and insurance wont cover refills in under a month, BUT..if you tell the pharacist you'll pay CASH...all fo a sudden the druggist doesn't care that you're taking it too much, they WILL refill it for you if you pay out of pocket, all of a suddent they dont care, which leads me to believe that this is ban on Primatene is a money thing.
Because WHO can afford the now $75 it costs for ONE Proventil inhaler???!..but now that people can't buy OTC, it forces people to HAVE to got to the ER, AND buy albuterol with cash AND you have no choice but to go to the doctor at least 2X a year so that u can get refills ahaha...it's a DAMN JOKE !!
I have NO idea what I'm going to do when this last Primatene runs out, I'm pretty sure that if this was REALLY about the "enviroment" that spray paint, hair spray, furniture polish etc etc would be removed from shelves FIRST..instead of life saving medications !!
But NOPE, what fun would THAT be?!..afterall...people don't NEED spray paint, hair spray etc etc, so making money over the loss of sales from THOSE types of aerosols would be hard to do, but it's REALLY easy to make $$ for everyone involved in this ban when that aerosol is necessary for people who need it , buy it to LIVE and that they have no choice now but to scramble to find a doctor now and insurance and so on...
And as far as epinephrine being "bad" ..that's funny too, haha, because most people with asthma get rushed to the ER and are administered a shot of what?..yes, adrenaline ( same thing) ..I would rather be able to breathe my last breath and have a heart attack rather than have a healthy heart and not be able to breathe, because what's the point?
Primatene and the War on (Asthma) Drugs
As an asthmatic, I applaud that an asthma specialist takes the time to weigh in on this issue. However this article paints asthmatics with the same broad brush that resulted in the 2006 and 2008 decisions referenced in Paul's well-written but flawed article. I am neither "poor" in the financial sense, nor do I want anyone's sympathy. I am a CPA, CFA, a Wall Street analyst and I have used Primatene Mist for over 30 years. To assume that the average Primatene user does not take his/her disease seriously and/or is not competent enough to understand the risks/side effects of epinephrine is simply preposterous. I can choose to take calculated risks such as flying a plane, riding a motorcycle, hang-gliding, scuba diving etc, but the medical community apparently does not feel I am competent to make the decision to use a potentially life-saving, life-style preserving medication. If medical professionals/politicians insist on framing this issue in a medical context (which is NOT the basis for the ban), then the views expressed in public forums should be balanced against the side effects and risks associated with the full monty of risky/dangerous drugs and/or procedures on the market today. At the end of the day it is up to the physicians to explain these risks and for the patients to decide. Yes, all asthmatics (who are insured and can afford it) should focus on maintenance rather than treating the symptoms. Most of us do. I comply with my maintenance prescriptions religiously (Symbacort, Singulair, Allegra, Patanase is the latest cocktail) and I have been visiting the best and the brightest "asthma specialists" for 30 years. I have yet to meet the medical professional with the hubris to suggest that he/she could prescribe a solution that would obviate the need for a rescue inhaler. I consider my asthma to be relatively well controlled. Nevertheless I need a rescue inhaler daily, often 2-3 times daily. And here is the rub - for whatever reason, rescue inhalers using HFA propellants simply do not relieve my asthma, whereas those using CFCs, and in particular Primatene, do. I am not unique by any stretch of the imagination, as a simple perusal of the tens of thousands of petitioners on the web will demonstrate. Moreover, the availability of an effective OTC rescue inhaler is critical to the quality of an asthmatics life. Regardless of how diligent an asthmatic may be, if one is rationed only 1 rescue inhaler per month, and only allowed to purchase said life saving medication through prescription, there will inevitable come a time when one finds oneself with an empty inhaler, or without an inhaler at all - on a plane, a camping trip, at the beach, in a foreign country, even at the office. This is less likely when rescue inhalers are available OTC because we can carry multiple backups, and find them at the nearest 7-11. Paul makes a good point - clean air initiatives will lower the incidence of asthmatics 50 years from now, and for those of us who already have it, perhaps our frequency of attacks will diminish, although for an asthma specialist it is surprising that he would ignore the fact that asthma can be triggered not just by allergens and irritants, but by excercise and stress. Nevertheless, for asthmatics today, who live active and productive lives, and fear that this lifestyle may be threatened as the last effective rescue inhaler is being taken off the market will take cold comfort in the knowledge that the "asthma specialists" to whom we have intrusted our health and welfare have turned their attention to future generations.
Agreed...
I have had asthma all my life and when I have had an attack or wheezing badly (very frequent in my childhood) Primatene Mist was the only thing that worked--and prob saved my life a few times.
As an asthmatic, I have seen
As an asthmatic, I have seen this effect since the 90's. Many of the prescription drugs that change to eliminate CFCs in them, because God forbid that I should damage the environment and trying to breathe. The result is that prescription inhalers have become more expensive. The ban on free sale is only a straw.