2/11 Editorial

An advisory panel to the U.S. Food and Drug Administration has recommended that an over-the-counter asthma inhaler sold as Primatene Mist be taken off the market. The stated reason is not that the product has harmed any asthma patients, but that the inhalers are propelled by chlorofluorocarbons (CFCs), the compounds that allegedly destroy the Earth’s ozone layer and have been banned for most other uses.

The notion that the chlorofluorocarbons in asthma inhalers are a threat to the ozone layer is absurd. Before the ban about a million metric tons a year of CFCs were produced. The inhalers produce about 4,000 tons a year.

Even if the science on CFCs and the ozone layer is valid — and it’s less conclusive than most people believe — the chlorofluorocarbons used in asthma inhalers are not enough to be a factor.

It’s more likely, as one doctor suggested, that the panel’s recommendation has more to do with the fact that the active ingredient in Primatene Mist is epinephrine, which comes from a plant and cannot be patented. Since it can’t be patented, it has no hefty constituency to influence the FDA’s decisions, which (given that it is a government body) are more political than scientific.

Taking this product off the market would be a cruel blow to asthma patients, especially those without health insurance or who have lived with the disease long enough to have learned how to handle it.

Epinephrine-based inhalers are called “rescue” inhalers because when somebody feels an asthma attack coming on, a dose can ward it off. Having it available over the counter means somebody can simply go into a drugstore and get it right away without having to get a prescription.

There are other rescue inhalers, made by tweaking epinephrine chemically into something that can be patented, but they require prescriptions. That makes them not only impractical for warding off an immediate attack but more expensive.

According to Wyeth, the largest manufacturer of epinephrine inhalers, about 3 million Americans use Primatene, with two-thirds of them also using prescription inhalers but keeping

Primatene as a backup. Another 700,000 people use them because they don’t have a prescription or lack health insurance.
Wyeth has asked that it be given a couple of years to develop an inhaler that doesn’t use chlorofluorocarbons.

It would be far better if Big Nanny FDA backed off this cruel idea and rejected the proposal to deprive asthma sufferers of a valuable, relatively inexpensive and convenient tool to deal with their condition. Big Pharma’s profits are substantial enough already.