Observing the Primatene Mist controversy as an asthma specialist

As the clock ticks away on Primatene Mist, the only over-the-counter asthma inhaler left on the market, it is being ginned up as an argument against regulatory overreach by the Obama administration. I have been observing the Primatene controversy for decades as an asthma specialist. I have to say that there’s blame enough on many sides of this discussion, not just pro and con government regulation, but both the pharmaceutical and financial industries as well.

First, let me state the medical case against Primatene. 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 as albuterol. However, it also stimulates the heart. This makes it unsuitable for large numbers of asthmatics who also have heart problems. Given the fact that 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. Asthmatic lungs are what British doctors called “twitchy.” 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.

Second, I would like to say that I always thought extending the ban on chlorofluorocarbon propellants (CFCs) to medication was an example of regulatory overkill because it was such a small part of the market. However, it does help to look at the context. Back in 1987, when Ronald Reagan was President and the Montreal Protocol was adopted, 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. Many products were releasing these gasses into the atmosphere for which alternatives could plausibly be found—car air-conditioners, hairspray, and deodorant for example. 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, and, frankly, I don’t think we’ve done a very good job of replacing them. The new inhalers don’t deliver albuterol as efficiently as Primatene does with epinephrine. Still, anyone who looks at the decisions for the current change can see that the key ones were made in 2006 and in 2008. The current administration was following the timetable set by its predecessors.

Third, as to suddenly emerging 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. I don’t want 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. I could be wrong.

Fourth, those who believe the ban on Primatene was contrived to squeeze more money out of those who can least afford it 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 the current owners when they acquired the drug. Even without access to 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 investors sometimes buy up the rights to older drugs with exactly this in mind. It doesn’t always work, as I wrote last year in a post observing a landmark in over 30 years of practice; in a whole month I hadn’t written a prescription for an oral antihistamine — the OTC versions were good and the new ones weren’t that much better to justify writing any.

But when it comes to asthma, I still 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 real asthma care. Want to lower the nation’s emergency room bills? Pay for asthma control. Treating asthma symptoms, whether with albuterol or Primatene, is not asthma treatment any more than a ride in an ambulance is health care.

Paul Ehrlich is an allergist and is co-author of Asthma Allergies Children: a parent’s guide.  He blogs at Asthma Allergies Children.

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