Eco-terrorists have struck again.  Not in the dead of night, to be pursued by diligent agents of the FBI, but right out in the open, in a public meeting, under the auspices of the U.S. Food and Drug Administration (FDA). Asthmatics Beware:  The Government May Ban Your Inhaler

Eco-terrorists have struck again.  Not in the dead of night, to be pursued by diligent agents of the FBI, but right out in the open, in a public meeting, under the auspices of the U.S. Food and Drug Administration (FDA).

On January 24, one of those ubiquitous FDA panels of "outside experts" voted, by an 11 to seven margin, to recommend that FDA ban non-prescription, over-the-counter asthma inhalers, used routinely by millions of asthma-sufferers to control the symptoms of their debilitating condition.  As frequently noted in the press, while such recommendations are not binding, they are most often adopted.

The issue for the panel is not drug safety.  It is not drug efficacy.  It is the environment.

The inhalers proposed for extinction are used to treat mild to moderate asthma attacks by opening air passages.  They work by propelling a measured dose of the drug epinephrine (or another bronchodilator) into the lungs.  Unfortunately, the propellant is made up of chlorofluorocarbons, the dreaded CFCs.

Based on the scientific belief that CFCs released into the atmosphere are responsible for ozone layer depletion, they were first banned in consumer aerosol products by the U.S. Environmental Protection Agency (EPA) in 1978.  Then, in 1987, the so-called "Montreal Protocol on Substances That Deplete the Ozone Layer" sought to phase out CFCs on a worldwide basis.  Described, as you might expect, as one of those "landmark" international agreements, the Montreal Protocol has now been signed by more than 180 countries.  Subsequently, the U.S. banned all uses of CFCs as of 1996, except for certain "essential" products - medicines such as asthma inhalers.

Even the EPA, which, typically, has been pushing to extend the ban to asthma inhalers for years now, has estimated that inhaler-produced atmospheric CFC emissions is fractional - no more than 1.5 percent of the total.  While easily accessible data are scant, we have seen one significantly lower estimate, and it is exceptionally difficult to believe that the tiny puffs inhaled by asthmatics produce CFC exhale of sufficient volume to present a real-world (i.e., not some hypothetical computer-modeled) effect.  If such conclusive data, along with transparent methodology by which derived, exist, we'd like to take a look.

Even accepting the most horrific CFC scenarios, we are not talking about 50 million women lacquering big hair with hairspray several times daily or the other consequential uses for CFCs now gone missing except in countries that take a more cavalier (or pragmatic) view of "landmark" international environmental agreements than does the U.S.

We are talking about a medicine that is "essential" to those who use it.  Today, the most prominent of the inhalers that would be banned is Primatene Mist, manufactured by Wyeth Pharmaceuticals, which estimates 3 million American users.

Yes, there are alternatives, including powder formulations that may be sucked into the lungs without propellants and other aerosols that use recently developed propellants currently not deemed to present environmental problems.  But the alternatives are not available without prescription and thus are more expensive, once again posing cost and availability issues for the so-called "little guy," to whose interests some liberal elected officials have recently expressed their undying devotion.

As we understand the Montreal Protocol, it does not absolutely, unequivocally, mandate the ban of CFC products if use is deemed essential and for which there are not available viable alternatives.  Wyeth says it needs until 2009 or 2010 to have a substitute, which itself must be approved by the FDA, for over-the-counter use.

If you are an asthmatic, or have an asthmatic in your family, who depends on an over-the-counter inhaler, you might want to call your congressperson.  Soon.  See how much he or she cares about the "little guy."

January 26, 2006
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