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Thursday, June 12, 2008

Help for the environment is on the way but maybe not for asthma patients

Fears of ozone depletion and the purported health effects of that should be soothed somewhat with knowledge that the CFC containing bronchodilator inhalers will be outlawed in December 2008. See here for The FDA message concerning the impending prohibition.

The new non-CFC inhalers (some contain HFA) will taste different, need regular priming and cleaning to prevent them from plugging and blocking delivery of medication to the lungs but that is the least asthmatics can do to help the environment. Additionally there are no generics for the non-CFC units so cost will increase. I wonder if we will see black market old fashion type albuterol inhalers.Again it is the least asthma patients can do to prevent sunburn and skin cancer in Australia.

Judging from how hard it may be to instruct someone to properly use an inhaler, I'll bet there will be more than a little trouble in switching over to the new units. There are 4 brand names and apparently the priming and cleaning directions vary by brand.Further, different pharmacy management companies may well favor one unit or another based on deals they make with the manufacturers .

Dr. Mintz in his medical blog does an excellent job of explaining the new inhalers here
Several of his readers replies are also instructive and I think a harbinger of the problems to come.I believe the confusion about them will lead to problems for asthma patients, in some- just inconvenience but for others- poorer control and more visits to the ER before everything is sorted out.

A huge number of skin cancers are alleged to be prevented by the CFC ban ( see here for a old CDC request for comments regarding CFC in asthma inhalers).Here is a link to an entirely different view on the issue which raises issues of the lack of proven safety of the new inhalers and other potential problems they may present and several presumed experts who maintain that any contribution of the CFC from the asthma inhalers is basically too small to have any effect on ozone depletion. The new HFA units have only been used for a relatively short time and recent events involving side effects that became evident long after all the clinical trials leading to approval were completed might give the FDA pause.

At least two questions are raised by the banning action of the FDA.Will the ozone zone recover faster when the CFC ban is completed or will it have any effect and it there any way anyone will even know. I claim no expertise in that area but my basic cynicism leads to think that the stratosphere will not really change much one way or the other long after asthma patients and others with obstructive lung diseases pay more for their medication.

The other interesting aspect is that I think this is the first time that the FDA bans a medication or group of medications not because they are thought or proven to be harmful to those who use but because they are thought to possibly harm folks who do not use it. (OK, the purported skin carcinogenic effect of increased sun rays from the purported decrease in ozone layer thickness would affect everyone- even asthmatics.) Since the task of determining harm to medication users has proven much harder that the FDA or anyone ever thought, it is admirable that the FDA will take on an even more difficult task.


John A said...

Hmm... A week or so back, I read that the [in]famous "hole in the ozone" of the southern hemisphere was "healing" - and that it was feared this would lead to rising temperatures for Antarctica. Since concern about this was actually begun, and CFCs banned, during the Sixties-Seventies fooforaw about Global Cooling...

Anonymous said...

This is an updated version of the petition Dr. Gaulte refers to above in his blog:


or google 'save cfc'

Dr. William Happer (former #2 at DOE, currently a Physics Professor at Princeton) and Dr. Leslie Hendeles, PharmD, University of Florida and an HFA proponent, by the way) both agree that CFC inhaler emissions are too trivial to threaten the ozone layer. Former Surgeon General Koop agreed in 1997- we have these quotes on the petition- as well as others- including FDA quotes- we have not seen anyone state that CFC MDI emissions threaten the ozone layer- this is EPA/FDA propaganda. It is a lie, one of many that these disreputable, politicized agencies have cultivated over the years on this issue.

Atmospheric CFC concentrations have been falling steadily since 1994, and this was happening while CFC emissions were much greater than they are now- and much greater than peak CFC MDI emissions globally. Ozone concentrations in key regions of the stratosphere have held steady since 1997 after years of decline, acccording to two recent studies.

We can 'restore the ozone layer' without torturing and murdering pulmonary patients by forcing many of them to use HFA MDIs that they can not tolerate. CFC MDIs should never have been banned. This is nothing more than a case of environmental extremists hijacking an international treaty and running amok without adult supervision. We will fight this, and if we can enlist even a fraction of 1% of the US pulmonary patient population of 35 million, based on conversations we've had with key staff of the Senate Environment Committee- which oversees the Clean Air Act (which authorized the CFC MDI ban) we believe we will prevail within 1-2 years.

Arthur Abramson
The National Campaign to Save CFC Asthma Inhalers

Anonymous said...

As a pulmonologist, after seeing at least hundreds, if not thousands, of asthmatics and their families suffer from asthma, can you state that is "the least" asthmatics can do for the environment?
As a physician, I find your comments at the least disconcerting,
especial in view of the fact, that the CFC inhalers were banned because an exemption to small producers would set a precedent for other small producers.
Now that is really a rational for eliminating a medication for a life-threatening disease. When someone is more worried about the environment than someone's health there is something wrong. But then when WHO banned DDT and some 50 million sub-Sahara men,women, and children died from malaria, why should we be surprised?

james gaulte said...

I'm afraid sometimes my sarcasm is not perceived as such.I hope you did not read my comments to mean that I really thought that asthma patients deserved to sacrifice anything for some alleged common good.Sorry if I was misunderstood,I thought the ban was far worse than just a bad idea. Thanks for your comments.