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."
No inhalers, no sudafed and coming soon no asprin.
BTTT
They wish to ban an over the counter product in favor of a much more expensive prescription-only product. Sure sounds like some of the healthcare monstrosity that Hillary has been working for since she was President a decade ago.
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.
Duh, Wyeth, have you ever heard of Albuterol?
My husband has Asthma and -- thank goodness -- we control it with Singulair and homeopathics, but during monsoon season he does have to use the occasional inhaler and these people evidentally don't understand that asthma is a life-threatening disease and people -- children included -- die from asthma attacks.
I haven't seen the request for them to review over the counter inhalers so I don't know the question they were asked. I question if it is the responsibility of the FDA advisory panel to judge CFCs. Where does FDA get statuatory authority to ban a product because of CFCs?
I don't agree with banning aerosol epinepherine, but to be fair, albuterol is generic, and not terribly expensive.
What annoyed me was that they banned the aerosol Serevent, and it was replaced with that awful powder version.
At least the HFA replacement for the old Flovent is not so bad.
If someone has severe enough asthma for it to be life-threatening, they shouldn't be using OTC inhalers anyways. It's a lousy way to control moderate or severe asthma.
The product would not be used for a moderate or severe problem. Asthma can kill. But the inhaler seems to be enough to take care of an occasional light touch of asthma. By all means, if the problem is severe get to the doctor.
Okay, I say all those who want to do this can have their suggestions seriously considered AFTER they have their air supplies restricted to about 10% for 120 consecutive minutes. Then maybe they'll have a slight idea of what asthma feels like.
The environs are probably the most successful mass murderers on the planet. They have killed literally millions with the successful banning of DDT. They are probably more dangerous overall that any terrorists we face.
My daughter learned to make aspirin recently at a seventh grade physical sciences/biological sciences seminar for "gifted" kids. She brought it home for us to see. They did not have time to press the stuff into pills. She thought it was pretty cool.
What's the problem?
So you're OK with this ban? Does the little bit of CFCs in these inhalers actually get under your skin?
"No aspirin?"........THIS MEANS WAR!
Albuterol requires a prescription.
HOW did THEY make aspirin? At school?
For the first time in over 10 years, I had to break down and go to the drug store to get one of these inhalers, because I could not stop wheezing after a brisk, two mile hike on Wednesday.
I rarely buy these things, but it made the difference for me of wheezing, staying up all night and calling my doctor, or getting a good nights rest (and oxygen.)
CFC's, the FDA, and these environazi's be damned.
The pharma lobby, acting through Jack Abramoff as usual, is lobbying to have everything we ingest put on prescription. Coming soon: prescription requirements on aspirin, water, and air.
propane could be used as a propellant
I have an Albuterol inhaler but it is by prescription. Albuterol is a controlled drug.
The problem is that albuterol can only be purchased by prescription. Basically, insurance companies make it so you can only buy one inhaler at a time within an arbitrary period. If you happen to: (a) run out, or (b) misplace your inhaler, and (c) its too soon to buy another one feel, yet you an attack coming on, Primatine (or its equivalent) is an excellent fall-back choice.
This has happened to me on occasion, and I have been very grateful to be able to get Primatine easily.
Epinepherine does increase heart rate and raise blood pressure, however, so it is best used sparingly by people with hypertension.
We told em so PING
These people are stark raving bonkers. How the H do asthma inhalers post the slightest risk to the environment? It's not like people with inhalers are squirting them up into the air, for crying out loud. You breathe the entire dose into your lungs. That's why they're called "inhalers".
What a bunch of idiots.
These are the same people that will be jumping on the idiotic California crapola that SHS causes asthma bandwagon.........tough luck.
In addition, many asthmatics WITH health insurance occasionally find themselves having an asthma attack while they don't have an inhaler (left it home, are on vacation, don't usually carry one but need one momentarily, etc.). It's a comforting feeling for ANY asthmatic to know they can pop into any drugstore, plop down $8-12 and get those invisible hands from around their throat. I speak from personal experience
I heard this on Fox News yesterday. I can't believe it.
Millions of people depend on Primatene Mist. I guess the ozone is more important then people's lives.
What a crock the FDA is. I'm sick of them!
your doctor can shorten that period by the way he writes the prescription because insurance companies cannot tell a doctor how to write a prescription....yet.
;No inhalers, no sudafed and coming soon no asprin.
No aspirin. Well the active ingredient in aspirin can be extracted by boiling willow bark. In fact that is how aspirin got started.
So they can't ban aspirin unless they ban willow trees. And since they've already made several other plants illegal who knows..............
I can only assume that most of these folks have never had the feeling that pallet of bricks was parked over their chest. Drugs have come a long way since my first memory of an asthma attack in 1956. Here's hoping the same tx can be packaged without CFCs.
And, of course, don't submit it for insurance coverage.
Right. Have you noticed how these people never exhale? All those CFCs are just absorbed into the bloodstream, I guess. </sarc>
You might want to hesitate before casting that "idiot" stone. :-)
I have encountered the problem of having to use the albuterol inhaler a bit more often than normal during a given month. I've gone to the pharmacy to buy another, and was told the insurance company would not pay for it because they said I should only use a certain number of puffs in a certain number of days.
Yeppers...all the Big Nanny Government types, Republicans and Democrats alike, are loving how we slap prescription requirements on these things. Except for public health risks (such as overuse of antibiotics), there shouldn't be a prescription requirement. As supportive as I am of physicians, there's no reason people should have to shell out the cash to see a doc to get a prescription for many medications.
They can either ban the plant, or try to stop people from extracting it. I think the DEA and FDA (and let's not forget Treasury!) would love to knock on a few doors to go after home-grown "aspirin labs"... :-(
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.
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