Cheap asthma inhalers banned

As usual, it was initially reported as unmitigated "happy news."

"Your Metered-Dose Inhaler is Changing to Help Improve the Environment," is how the U.S. Food and Drug Administration chose to present word that the inhalers used by those who suffer from asthma and other respiratory ailments are being pulled from the shelves as of Wednesday.

Back in 1987, U.S. representatives signed the "Montreal Protocol," in which 27 major industrialized nations agreed to halve their use of chlorofluorocarbon gases, which some believe could damage the earth's ozone layer.

Real-world experiments to prove the theory have been in short supply -- it would first have to be shown how chlorofluorocarbons, which tend to be heavier than air, could reach the ozone layer, in the first place.

Nor did the Montreal deal actually call for banning the propellant from the inhalers, since that use represents only about 1.5 percent of all CFC uses (it was less than 1.0 percent at the time), and signatory nations get to choose what uses to change. (The Environmental Protection Agency saw no immediate need to go after foam insulation for coaxial cable, or CFC-based fire extinguishers.)

But the U.S. Food and Drug Administration ruled the inhaler switch would be mandatory as soon as a viable replacement could be marketed.

So 22.9 million American asthma sufferers now face a changeover to more expensive brand-name alternatives that use the "environmentally friendlier" propellant hydrofluoralkane -- which can be three times as expensive, raising the cost to about $40 per inhaler.

Why not wait till after generic alternatives become available? Skeptics point out that changing now could mean billions more dollars for the three drug companies that hold patents on the replacement HFA-albuterol inhalers, according to Emily Harrison, writing in the August issue of Scientific American.

At least one member of the FDA advisory committee, Nicholas J. Gross of the Stritch-Loyola School of Medicine, has publicly recanted his support and requested that the ban be pushed back until 2010, when the first patent expires, Ms. Harrison wrote.

Meantime, multiple studies have shown that raising costs leads to poorer adherence to treatment; one study found that patients took 30 percent less anti-asthma medication, for instance, when their co-pay doubled.

There are also concerns about patients getting proper instruction on use of the new inhalers, which need to be primed more often, and which also tend to clog and thus need to be cleaned more often.

Considering that asthma and other respiratory diseases disproportionately strike the poor, is it possible that what seemed a responsible environmental decision might in the end exact an unexpected human toll -- more asthma deaths? How should that risk be weighed against the risk of the chlorofluorocarbons to the ozone layer?

To answer that question, we'd need to know whether CFCs really damage the ozone layer, and by how much -- the kind of real-world scientific evidence that the radical greens show little patience for gathering, prone as they are to shout: "The debate is over! No time to dilly-dally! By the time we know, it'll be too late!"

Funny how that always works out.