Asthmatics take a deep breath, because starting January 1, 2009, the generic albuterol inhaler, a mainstay of both real asthmatics and silver screen geeks, will no longer be legally sold in the U.S. 

Congress is phasing out the inhalers due to the ozone-depleting chlorofluorocarbons (CFCs) they require to propel the medicine into the patient's lungs.  As a result of the pollutant and the corresponding legislation, CFC-driven inhalers are disappearing faster than Lindsay Lohan's brain cells, leaving a heavy supply burden on the estimated 20 million Americans with the condition.

CFCs were initially banned in the U.S. in the late 1980s.  In 1987, Congress ratified the "Montreal Protocol on Substances That Deplete the Ozone Layer," an international agreement to phase out all non-essential uses of CFCs.  That international promise became domestic law in 1990, with the passage of the Clean Air Act.  At the time, albuterol inhalers were deemed "essential" because no other alternative yet existed, and were consequentially exempted from the legislation.

Seeing the need for - or the profit in - creating a non-CFC inhaler, pharmaceutical companies banded together in 1989 to research and develop such an inhaler, eventually succeeding in 1996.  The new inhaler uses a substance called hydrofluoroalkane (HFA), which while still a greenhouse gas does not destroy the ozone layer.

Apart from environmental differences, HFA and CFC inhalers are fairly similar.  They are both the same relative size and shape, are both equally effective, and are both convenient to use.  HFA inhalers do require more stringent cleaning and maintenance, and the mist is slightly warmer and less forceful. 

While on the surface it appears that the HFA inhalers are superior to their polluting cousins, the new inhalers are much more expensive.  The excess cost stems from the patents for the drug still being active, thereby eliminating generic alternatives.  Selections for these alternative propellant inhalers are resultantly very limited.

At the moment, HFA inhalers cost between $30 and $60, while CFC inhalers generally range from $10 to $15. Furthermore, the FDA announcement has made CFC inhalers much scarcer than they once were, driving up the average cost.

Studies have also shown that patients use their anti-asthma medication much less when costs rice; one study noted a 30 percent decrease when the cost of medication doubled.  From a public health perspective, this can be especially troubling, impacting more than shortness of breath. For instance, a pregnant mother with untreated asthma delivers less oxygen to the fetus, increasing the risk of birth defects, premature birth, and other congenital problems.

The FDA declassified the CFC inhalers as essential in 2005 after a second brand of HFA inhaler became available, with the phase-out to be completed by the end of this year. The patent for the first HFA inhaler expires in 2010, at which point generic versions of HFA inhalers will be produced, significantly reducing the cost to the consumer, and correspondingly, the drug companies holding the patents. 

Nicolas J. Gross, a member of the FDA advisory committee and an M.D., Ph.D. expert on lung diseases, has publicly recanted his support of the phase-out, formally requesting that the ban be delayed until the first patent expires and supply of HFA inhalers are more readily available.

It also is increasingly apparent that the move is much more symbolic than environmental.  The CFCs from inhalers contributed less than 0.1 percent of CFCs released at the signing of the treaty, and the simple presence of HFA inhalers has decreased inhaler CFC releases since 1997. 

Given the short timeframe until generics are available, why not wait until 2010 to eliminate the albuterol inhalers? 

"The decision to make the change was political, not medical or scientific," according to University of Florida Professor of Pharmacy and Pediatrics Leslie Hendeles.  It may just be that a politically symbolic action that provides a boon to pharmaceutical companies is too attractive to delay.  

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