Posted on 01/27/2006 3:07:55 PM PST by Tolerance Sucks Rocks
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."
I have had asthma for 67 years
Those over the counter inhalers do nothing for me
I rarely need the prescription for an attack but use it before jogging on cold days as a preventative
I'd be lost without Albuterol. I buy what I have to have, regardless of cost. IMO the lives of many asthmatics, including mine, would be greatly shortened without this drug.
I remember as a kid in the early 50's how it was before the stuff existed.
It's just another step towards national health insurance: 'These poor people can't afford to go to the doctor to get a prescription for their inhalers...'
The Rhinocort AQ (aqueous version) doesn't work for me like the old aerosol did. I no longer bother trying it.
I have a standing prescription for Albuterol. My asthma is quite mild, so, fortunately, I seldom need the inhaler. Even with my insurance, the Primatene Mist is less expensive. And for me, the Primatene works as well as the Albuterol.
My mother (87 years old) is a life-long smoker. (someday those cigarettes will kill her), also has an Albuterol prescription. But she says the Primatene works better for her. Go figure.
Methinks I should stock up on the Primatene. Stupid enviro-wackos.
Wouldn't it be nice if the FDA didn't have a de facto ban of phenylpropanolamine, with the current attempts to get it removed from all products and the recent proposed rule to reclassify it as nonmonograph (Category II) not generally recognized as safe and effective. :-( But like with albuterol, this medication is one for which many people would gladly accept the small added risks of hemorrhagic stroke if they could use it, since not all products are interchangeable.
But I am not a physician.
First, have your doctor write the prescription for three inhalers at once. That's how our doctor writes it. Then my son can have one at home, one at school, and one to carry around with him.
Two, have your doctor also re-assess how your asthma is being managed. You may need some additional meds (like an inhaled corticosteroid, or some of the other new alternatives). You should not be so dependent on the rescue inhaler that you're in danger of running out quickly.
Third, sign up with a different health insurance carrier. This one's protocol stinks.
I, er, meant, uh, three things. (sheepish grin)
I agree with the other poster that if you're burning through albuterol inhalers you may need additional medication. However, the price of a generic albuterol inhaler is about $15, so paying for it out of pocket isn't much worse than buying an over the counter inhaler, and a lot more effective.
Achey day, headache please, go away.
And I'm getting a fever, Oy vey!
Can you tell me how to make, how to make aspirin today?
These you take, when aspirin you make.
Salicylic acid's on the list
And acetic anhydride and an acid catalyst.
Sulfuric to be exact. Mix them all and they react,
And an ester is formed. You esterify. You esterify.
On phenol, acetyl finds its goal.
And from water, white crystals arise.
And to make them pure, from alcohol recrystallize.
by Thomas Ott
Oakland University, Rochester MI
You better stock up! I wrote to Collins and Snowe this evening about this. I am so sick and tired of the FDA I can throw up. They are getting worse, IMHO, instead of better. They sure don't think about the little guy out here.
Good luck. And yes, please stock up. It won't hurt and it can only help. :)
Worth repeating. Thanks!
Not pure socialism but socialism as a way stop to communism.
Let freedom ring, my a$$
Eco-terrorists to beathing impaired: Die! Asthmatic scum!
I don't know exactly what phenylpropanolamine is, but most all drugs do seem to have side effects, it's part of the trade off. In a free society we make our own choices, in an authoritarian society, choices are made by authority, I guess.
Ecoterrorist ping. I guess those of us who would suffocate but for modern medicine, are genetically inferior and deserve to die. Eugenics 101.
For what it's worth, studies have shown that Primatene-type inhalers work as well for the short-term as albuterol and the other prescription ones, but are only effective for an hour or so, versus 4-6 hours for the prescription meds. Also, as posted above, the side effects, especially on heart rate and blood pressure, are much more intense. Primatene has been available over-the-counter only because it was already out before the FDA started regulating over-the-counter drugs. It probably wouldn't be up to safety standards if it were tested now.
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