FDA May Make Breathing Difficult for Asthmatics

The government may tell asthmatics to “take a hit” for the environment. But that “hit” won't be from their inhalers, which might be taken away.<?xml:namespace prefix = o ns = “urn:schemas-microsoft-com:office:office” />

A Food and Drug Administration advisory panel voted this week to recommend removing the “essential use” status that permits inexpensive, nonprescription asthma inhalers, like Primatene Mist, to remain on sale.

Powered by chlorofluorcarbon (CFC) propellants, the inhalers shoot epinephrine into the lungs of asthmatics, allowing them to breathe during potentially life-threatening asthma attacks. But environmentalists labeled CFCs a threat to the ozone layer in the 1980s, leading to an international phase-out of CFCs under the 1987 Montreal Protocol.

Nonprescription inhalers–and millions of asthmatics–have so far survived the Montreal Protocol because CFC use in inhalers is deemed to be “essential” and, therefore, exempt from the ban. Wyeth Consumer Healthcare estimates that 3 million Americans use its Primatene for mild or intermittent asthma and about 700,000 use Primatene alone because they can't get prescriptions or lack health insurance, according to the Seattle Times (Jan. 25). Wyeth says that substitute non-CFC inhalers won't be ready until 2009 or 2010–and probably at a much higher cost.

But the FDA panel was apparently swayed by arguments that CFC-inhaler use threatens the ozone layer and public health. The hypothesis-of-hysteria is that CFCs thin the stratospheric ozone layer which, in turn, allows more solar ultraviolet (UV) radiation to reach the Earth's surface which, in turn, increases the risk of skin cancer, cataracts and other health problems.

But asthmatics should not have to gasp for air because of this guesswork.

First, accepting for argument's sake that ozone depletion alarmism is justified, only a trivial amount of CFCs would be released into the atmosphere due to inhaler use. No detectable damage to the ozone layer would likely result.

Global CFC production peaked pre-ban at over 1 million metric tons. But in 1999, for example, the U.S. requested an “essential use” exemption of only about 4,000 metric tons for inhalers–hardly a return to the old days when CFCs were used in a wide range of consumer and industrial products.

Back to the real world, however, the ozone depletion hypothesis has a great big hole of its own.

No one disputes the basic chemistry of ozone depletion–chlorine atoms from CFCs released into the environment can find their way into the stratosphere where they can chemically react with and “destroy” ozone.

It should be noted, however, that CFCs aren't the only source of chlorine atoms in the stratosphere–Mother Nature, in fact, may supply most of them. Also, ozone is also continually being created so we won't ever run out of ozone.

In any event, none of the alleged environmental and public health horrors of CFC-induced ozone “destruction” have ever been observed despite extensive study–one of the best kept secrets of environmentalism.

While overexposure to UV is a risk factor for some types of skin cancer and cataracts, no scientific study has ever demonstrated a link between ozone depletion and such overexposure or any health effects.

A December 2003 article in the journal Photochemical & Photobiological Sciences, for example, would only go so far as to say that “The potential health effects of elevated levels of ambient UV-B radiation are diverse, and it is difficult to quantify the risks.” [Emphasis added]

The absence of evidence linking ozone layer thinning with health effects isn't surprising because the phenomenon was never thought (by experts, anyway) to lead to more than a trivial (10 percent) increase in UV radiation reaching the Earth's surface.

As there is about a 5000 percent increase in UV radiation moving from the poles to the equator, a 10 percent increase in the mid-latitudes equates to a move 60 miles to the south–”hardly a source for health concerns,” says physicist Dr. S. Fred Singer of the Science and Environmental Policy Project.

It's not even clear that ozone depletion, in its pre-phaseout heyday, ever increased the amount of UV radiation hitting the Earth's surface. “There has been, of course, a determined search for a secular increase in [UV radiation] to match the presumed depletion of ozone. But no such trends had been observed,” says Dr. Singer.

And a little common sense about UV radiation goes a long way. Life flourishes in the tropics where UV radiation levels are far higher than in the quite inhospitable polar regions.

Yes, there is an “ozone hole,” but that label is more appropriately applied to the Montreal Protocol than the ever-changing thickness of the ozone layer over the Antarctic polar region.

Former Vice President “Ozone Al” Gore acknowledged in a recent presentation I attended that the real value of the Montreal Protocol was that it demonstrated the global political power of the environmental movement.

But while getting a junk science-fueled international treaty signed may have been a valuable political exercise for environmentalists, the Montreal Protocol can hardly be considered a success if it winds up needlessly depriving asthmatics of available, affordable and effective medication.