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 (Third Avenue Books), available only from Amazon.com and from Barnes & Noble. He is co-founder of the website www.asthmaallergieschildren.com, and president of the New York Allergy and Asthma Society. He has been featured as one of the top pediatric allergy and immunology specialists in New York Magazine for the last 10 years.
Photo by eo was taken: Asthma Map