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 also use a nebulizer and I have to haul it everywhere I go and I would have liked the smaller version but my insurance company doesn't want to pay for it. I checked on it a couple of years ago and it was expensive at that time.
Yep.... and it is in a number of the prescription products. This looks more like an issue of just reformulating the non-presctiption stuff to me.
You let out where a poor suffocating asthmatic kills a few environmentalists before he or she drops dead from lack of oxygen.
I'm writing my Congresscritters NOW! My daughter is an asthmatic dependent on these inhalers.
There's a big controversy over that right now. Apparently most of the "mixed to order" hormones end up having the same dosage proportions as you could get by buying the correct bulk-manufactured one. So, that's why insurers are reluctant to pay for them.
Anybody who's dealt with drugs and drug interactions can't help but marvel over the large variety of responses individuals get. I have a doctor who no longer even questions people who report something's not working for them, he just prescribes something else. He's come to the conclusion that if it works best for you, then it works best, period. It doesn't matter if there's a cheaper alternative that's exactly the same chemically. That theory has led him to better outcomes and happier patients, but it drives insurance companies nuts.
Hi there - sorry I just saw your message.
I Googled "portable nebulizer" and there were some choices there - they are between $60-115 for the purchase, and the little bottles aren't very expensive. I think they give better delivery too than the atomizers..more relaxing.
Have a look see - I didn't think I should put the links up here because of the "spam factor".... but google has quite a selection of ads.
Happy breathing!!!
He sounds like a good doctor.
Thank you for your confidence in my genius, but I really don't need to repeat the detailed analyses that have been completed and peer reviewed by others. In fact, you can go back even before the 1978 rule EIS to Midgely's American Chemical Society candle demonstration (I think that was dichlorodifluoromethane and I think MDIs use other CFCs, but research has been done on all), which made the very point was that these new "FreonTM" products were considered inert, harmless and odorless. [DISCLOSURE NOTE: I am employed by a firm on a consulting contract with E. I. du Pont de Nemours and Company (DuPont), but I am not a physician nor involved in this business segment, and everything herein is my own opinion, not DuPont's and not to be taken as professional opinion. All standard disclaimers apply. :-)]
And look at all the medical studies that demonstrate the overall breakdown and/or transfer to body tissues and bloodstream are negligible. Even the amounts that are not immediately exhaled are unchanged when they are excreted/exhaled later (recall that CFCs have a molecular weight 120+, so some of the heavy gas can settle in the lungs for a while).
The burden of proof is on you that inhalation somehow removes the compounds from the system, since it doesn't do it via immobilization or destruction.
More than all the death camps combined from Hitler.
I did. :-)
FoFortunately my Doc does the same thing. I have found some meds (even though they say they are the same stuff) do not work or make matters worse in some cases.
One of them stopped me from being able to taste anything except a charcoal like taste for about three days. Ever eat charcoal ice-cream or macs&cheese? LOL! Drove me nuts. Also no matter where I was, I smelled smoke like the place was on fire. Very odd feeling.
Did you see this one yet? Talk about nanny state.
http://www.daytondailynews.com/money/content/shared-gen/ap/Finance_General/Insect_Red.html
Did you see this one yet? Talk about nanny state.
http://www.daytondailynews.com/money/content/shared-gen/ap/Finance_General/Insect_Red.html
The FDA plans to tackle the labeling of prescription drugs that include the colorings in a separate rule.
Well, Sudefed will fall under this then. If it isn't taken off the market from the meth makers. heh!
When you read those prescribing instructions and they cite the studies done that show only three percent of patients had a negative response... just call me "three".
I can have no reaction whatsoever to a whole multitude of reasonably high side-effect drugs, and then proceed to light up like a Christmas tree on one low-problem drug. So your charcoal-taste experience doesn't sound at all odd to me.
That one doesn't bother me very much. At least they aren't banning the crap, and they aren't caving in to CSPI, who, for all we know, may just want to gross out people.
I am most upset.
Do the math: An asthmatic has trouble breathing. He/she takes a hit off a $20. inhaler....or incurs an $800. ambulance ride to the emergency room.
God bless you! They used to cost alot of money and I didn't know that the price had come down. I am going to buy one!
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