Target: President Barak Obama and The Congress
of the United States of America
From: We the People of the United States of America
Subject: The scientifically, medically and morally
unjustifiable ban of CFC (chlorofluorocarbon) Asthma, COPD
and Cystic Fibrosis inhalers by the FDA, pursuant to the Montreal
Protocol and the U.S. Clean Air Act
Whereas: There is no evidence that the small amounts of CFC inhaler emissions (even at their global peak usage) were capable of perceptibly depleting the ozone layer, increasing ground-level UV-B radiation levels, or causing an increase in the incidence of skin cancer;
Whereas: The EPA itself admitted that CFC inhalers were banned not because they themselves posed any threat to the environment, but only for political expediency;
Whereas: Just four space shuttle flights do more damage to the ozone layer than all of the CFC inhaler emissions generated by U.S.patients during an entire year (at peak usage), and there has been no attempt to ban or minimize any military or civilian rocket launches due to concerns about ozone-depletion;
Whereas: The FDA's own MedWatch data clearly shows that CFC inhalers are much safer than the replacement HFA (hydrofluoroalkane) inhalers;
Whereas: The FDA never provided the legally required U.S. postmarketing data for Proventil HFA and Ventolin HFA (pursuant to 21 CFR 2.125(g)(3)(iii) and 21 CFR 2.125(g)(3)(iv)) establishing the safety and effectiveness of these HFA replacement inhalers prior to the ban of CFC albuterol inhalers, rendering their decision to ban CFC albuterol inhalers fraudulent and illegal;
Whereas: The HFA-134a propellant gas was never tested by itself in asthma and pulmonary patients. (It was only tested in animals and healthy volunteers. Healthy volunteers do not have inflamed, hyperreactive airways and severe allergies. Many physicians believe that their asthma, COPD and cystic fibrosis patients are allergic to the HFA propellant gas itself.);
Whereas: The HFA inhalers usually contain corn-sourced ethanol as a solvent, and it has been clearly established that inhaled ethanol and/or corn residue can actually cause bronchoconstriction. These inactive ingredients should never have been included in an emergency medical device intended to prevent bronchoconstriction;
Whereas: Some of the many inactive ingredients and impurities in HFA inhalers are responsible for the decreased safety and effectiveness of these replacement inhalers, since the active ingredients are virtually identical in CFC and HFA inhalers;
Whereas: It is clearly established that the replacement HFA inhalers tend to clog easily, even when they are meticulously cleaned, and they clog when wet or damp. (It is not always possible for asthmatics to schedule their asthma attacks for dry weather; nor is it always possible for them to schedule their asthma attacks for those times when the HFA replacement inhalers have finished air-drying after their frequently-required cleaning.);
Whereas: Many physicians, nurses and other medical professionals agree with us that HFA inhalers are not nearly as safe and effective as the banned CFC inhalers;
Whereas: It has been clearly established that the leading allergy and pulmonology medical associations and non-profit asthma and COPD 'patient advocate' organizations have severe conflicts of interest on the subject of CFC vs. HFA inhaler safety and effectiveness (due to their enormous, on-going funding by IPAC members (the International Pharmaceutical Aerosol Consortium)), which renders their assurances about the relative safety and effectiveness of HFA replacement inhalers virtually worthless;
Whereas: The FDA approved the ban of CFC inhalers without mandating that the replacement HFA inhalers undergo large scale, long-term 'real world' U.S. postmarketing studies to ensure the safety of 40 million Americans who rely on these inhalers, despite their own admissions that such studies were needed to ensure patient safety;
Whereas: It is clearly established from numerous clinical trials that CFC inhalers are much safer and more effective than HFA inhalers;
Whereas: Some HFA inhaler manufacturers themselves admit that CFC inhalers are safer and more effective than HFA inhalers;
Whereas: Thousands of adults and children all over the world know that CFC inhalers are safer and more effective than HFA inhalers, because they suffer (and in many cases, die) as a result of having to use the inferior HFA inhalers;
Therefore, We The Undersigned, demand that the U.S. Government amend the Clean Air Act to provide for the immediate and permanent legalization of all previously approved CFC inhalers;
Further, we demand that the President of the United States issue any executive orders necessary to provide for the fastest possible manufacture and distribution of CFC inhalers in this country on an emergency basis, in order to minimize patient death, disability and suffering;
Finally, we demand that the President issue an executive order that would provide for the legal importation of foreign CFC inhalers until domestic production is re-established.
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