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THE PETITION

In a dangerous overreaction to the problem of stratospheric ozone depletion, the Parties to the Montreal Protocol and The United States (through the Clean Air Act, the EPA, and the FDA) have decided to ban lifesaving chlorofluorocarbon (CFC) propellant metered-dose inhalers (MDIs) that are relied upon by 40 million U.S. pulmonary patients, even though the trivial amount of CFC emissions from MDIs does not threaten the ozone layer.

We applaud the Parties to the Montreal Protocol for their historic accomplishment of reducing global CFC emissions from peak levels of 1.2 million tons/year in 1987 to less than 50,000 tons/year today. It is encouraging to see that atmospheric concentrations of CFCs have been in a clear downward trend since 1994, at a time when global CFC emissions were considerably higher than they are today (LINK 31, p.8). It is also reassuring to know that ozone concentrations in a key region of the stratosphere have held steady since 1997, after years of decline, according to two independent studies. (LINK 33).

The amount of CFCs required for the world's pulmonary patients peaked at less than 10,000 tons (including U.S. use) per year in 1997 (less than 1% of the peak global 1987 CFC emissions for all industrial uses). U.S. CFC MDI use peaked at 2,645 tons/year in 1999. (LINK 33, p.36) These amounts are trivial and harmless.

However, rather than simply creating a permanent medical exemption for this tiny amount of CFC for the world's pulmonary patients, the Parties to the Montreal Protocol just assumed that an alternative 'ozone-friendly' medical propellant equal in safety to CFCs would one day emerge, and so they decided to completely eliminate CFC MDIs once the new propellant, HFA, was settled on, and HFA MDIs became available.

Unfortunately, HFA MDIs have turned out to be grossly inferior in safety and efficacy to CFC MDIs for many pulmonary patients, FDA propaganda to the contrary notwithstanding.

There are two simple reasons why Congress and the Administration must permanently save CFC MDIs. First, because they are safer and more effective than HFA MDIs for many pulmonary patients, and second, because CFC MDIs do not harm the ozone layer, and banning them will not yield any health or environmental benefits whatsoever; on the contrary, banning them will result in massive increases in pain, suffering, deterioration of health, decrease in quality of life, and death, for many pulmonary patients.

1) HFA MDIs ARE NOT AS SAFE AND EFFECTIVE AS CFC MDIs FOR ALL PULMONARY PATIENTS

Schering-Plough ITSELF admits on its Proventil HFA homepage (LINK 4, 4th paragraph from the bottom, last sentence): "RAPID HEART BEAT, VOMITING, CHEST PAIN and PALPITATION OCCURS MORE FREQUENTLY WITH PROVENTIL HFA (than with CFC albuterol) ."

Their adverse reactions chart also shows that RESPIRATORY DISORDER, FEVER, BACK PAIN, and ALLERGIC REACTIONS occur more frequently with Proventil HFA than with Albuterol CFC. (LINK 5)

The clinical trial data CLEARLY indicate that there are more serious side effects with Proventil HFA and Ventolin HFA MDIs than with CFC MDIs controls. (LINKS 4,5,6)

The above-mentioned clinical trial results agree with the results of a large postmarketing surveillance study done in the United Kingdom in 1998 comparing the UK version of Proventil HFA (manufactured by 3M, called Airomir HFA) with CFC salbutamol (what the rest of the world calls albuterol).

The study included 6,614 patients, and followed them for three months. Some patients were given CFC salbutamol , some patients were given HFA salbutamol. (LINK 35)

"General practitioners attributed more adverse events to hydrofluoroalkane (HFA) inhalers (3.1%) than to chlorofluorocarbon (CFC) inhalers (0.7%)." (LINK 35)

"More patients using the hydrofluoroalkane (HFA) inhaler stopped taking study medication because of adverse events (3.8% compared with 0.2% in the chlorofluorocarbon (CFC) inhaler group)." (LINK 35)

"However, more patients using the hydrofluoroalkane (HFA) inhaler than the chlorofluorocarbon (CFC) inhaler withdrew because of adverse events (3.8% and 0.9% respectively)." LINK 35)

Ethanol (a toxic, Class 3 Residual Solvent) is used in three of the four HFA rescue MDIs in amounts between ten and fourteen percent by weight (it is not needed in any CFC MDIs). And while the FDA assures us that the ethanol is used in amounts too small to cause any danger, they are contradicted by investigators who have concluded that "In a subset of asthmatic patients ETHANOL CAN TRIGGER BRONCHOCONSTRICTION..." (LINK 13)

In addition, the ethanol is derived from corn, and there are many asthmatic patients with serious corn allergies. The corn residue remaining with the corn-sourced ethanol can not be ruled out as a POTENTIAL SERIOUS RISK to corn-allergic patients, according to technical staff at Schering-Plough (Proventil HFA) and Sepracor (Xopenex HFA).

The HFA-134a PROPELLANT ITSELF WAS NEVER TESTED ON PULMONARY PATIENTS, only on healthy subjects. (Healthy subjects typically do not have hypersensitive, inflamed airways and/or severe allergies.) Fifteen thousand compounds were considered to find alternative propellants to CFC-11 and CFC-12, and only two propellants out of the fifteen thousand were thought to be suitable. (LINK 19) Apparently, they were not suitable, either.

Notice the greater percentage of several serious side effects with HFA-134a alone AND HFA Albuterol compared to CFC ALBUTEROL in the clinical trial adverse events charts (LINKS 5,6). FOR MANY PATIENTS, HFA-134a IS SIMPLY NOT AS SAFE AS CFC-11 and CFC-12.

We have read many reports from asthma patients ALL OVER THE WORLD who cannot tolerate HFA MDIs (here are two recent examples):

"Good luck with it all. Asthma that is unable to be controlled is terrifying. I wish they hadn't changed the meds in Australia. My doctor told me that it wouldn't make a difference but it has. Sometimes I can barely walk up a flight of stairs (and I am reasonably fit.)..." Selma O'Sullivan, 42, Sydney, Australia, October 19, 2007 (LINK 16)

CFC-Free inhalers do not work! Since using the HFA inhalers my asthma has got increasingly worse I have had to have a course of steroids to get my asthma under control. Since switching to the new inhaler my asthma has deteriorated. I am not the only one; millions around the world are having the same problem. Are you one of them? Kirsty Manchester, UK Tuesday May 20, 2008

2) CFC INHALER EMISSIONS ARE TOO TRIVIAL TO HARM THE OZONE LAYER AND THERE IS NO EVIDENCE THAT BANNING THEM WILL YIELD ANY HEALTH OR ENVIRONMENTAL BENEFITS WHATSOEVER

Former Surgeon General C. Everett Koop wrote that there is no comparison between the infinitesimal improvement in ozone depletion that would result from the FDA's ban and the direct impact of forced elimination of medications on American asthmatics. (LINK 17)

Leslie Hendeles, University of Florida Professor of Pharmacy and Pediatrics (and a proponent of HFA MDIs, by the way) has "noted that CFC inhalers release negligible amounts of the propellant and do not pose a threat to ozone depletion." (LINK 1)

"... we (the FDA) are unable to quantify the environmental and human health benefits of reduced CFC emissions from this regulation (banning CFC MDIs.)" (LINK 25, p.74)

"... we (the FDA) are unable to assess or quantify specific reductions in future skin cancers and cataracts associated with these reduced CFC emissions (achieved by banning CFC MDIs)." (LINK 25, p.75)

We believe that the FDA's argument that a permanent humanitarian exemption for CFC medical inhalers would destroy the Montreal Protocol (because other Parties would use this as a justification to carve out their own special CFC exemptions) is utter nonsense. A simple review of the diplomatic history of the Montreal Protocol (LINK 28) leaves no room for such pessimism, provided, of course, that we added some world-class diplomats to the U.S. delegation. The amount of CFC that would be required for all of the world's pulmonary patients is too insignificant, and the benefit is too universal and powerful, for such a unique exemption to destroy the Montreal Protocol, as the alarmists at the FDA would have us believe.

THIS IS THE FIRST TIME IN HISTORY THAT SAFE, EFFECTIVE DRUGS HAVE BEEN BANNED BY THE FDA FOR POLITICAL RATHER THAN FOR MEDICAL REASONS.

Furthermore, this ban violates the prudent medical convention of using older, widely used prescription drugs (such as CFC MDIs) rather than newer, less widely used drugs (such as HFA MDIs).

The reason for this is simple: it takes many years, and large numbers of patients, to reveal all of the serious side effects of newer drugs. (LINK 11)

"BASED ON OUR RESULTS AND THOSE OF OTHERS*, CLINICIANS SHOULD AVOID USING NEW DRUGS WHEN OLDER, SIMILARLY EFFICACIOUS AGENTS ARE AVAILABLE."(LINK 11)

*US General Accounting Office. FDA Drug Review: Post approval Risks, 1976-1985. Washington, DC: US General Accounting Office; 1990. Publication GAO/PEMD-90-15.

Therefore, we call upon the Administartion to IMMEDIATELY issue any Executive Order necessary to allow U.S. citizens to continue to import CFC MDIs from legitimate foreign sources.

We also call upon the Administration to IMMEDIATELY issue any Executive Orders necessary to facilitate the emergency production of sufficient amounts of carbon tetrachloride, CFC-11 and CFC-12 for CFC MDIs for U.S. (and hopefully, foreign) pulmonary patients, and to strongly encourage and facilitate in every possible way the production of all previously marketed CFC MDIs by generic drug manufacturers, as well as by patent owners.

We call upon the Congress to immediately amend Title VI of the Clean Air Act Amendments of 1990 to explicitly allow for the permanent production of sufficient carbon tetrachloride (which is needed to make CFC, and which is also being banned), CFC-11 and CFC-12, for adequate supplies of CFC MDIs for U.S. (and hopefully, foreign) pulmonary patients. Similarly, all EPA and FDA rules and regulations dealing with carbon tetrachloride and CFC MDIs must be immediately repealed.

The most favorable tax treatment possible must be applied to carbon tetrachloride and CFCs for MDIs, in order to keep CFC MDIs as inexpensive and therefore as accessible as possible.

These actions are necessary to ensure that America's 40 million pulmonary patients once again have unfettered access to the safest and most effective medications possible. Hopefully, the U.S. delegates to the Montreal Protocol can persuade all Parties to the Montreal Protocol to adopt a permanent medical exemption for CFCs, since all countries, presumably, would want their citizens to have access to the safest and most effective medications possible, and since CFC MDIs do not harm the ozone layer.

However, any diplomatic efforts to create a medical exemption for CFCs within the Montreal Protocol MUST NOT DELAY U.S. CONGRESSIONAL AND PRESIDENTIAL EMERGENCY ACTION THAT IS URGENTLY NEEDED TO GET CFC MDIs PRODUCED AND MADE AVAILABLE TO U.S. PULMONARY PATIENTS AS SOON AS POSSIBLE, TO MINIMIZE PAIN, SUFFERING AND DEATH OF U.S. CITIZENS. This will require the U.S. to ignore certain provisions of the Montreal Protocol while it acts to protect its citizens. It is unfortunate that the U.S. must unilaterally abrogate certain provisions of the Montreal Protocol, but the health and safety of U.S. citizens MUST TAKE PRECEDENCE over U.S. compliance with this badly flawed treaty.

This disaster was created by the failure of the Parties to the Montreal Protocol to apply simple common sense and create a permanent humanitarian exemption for CFC MDIs over twenty years ago. The fact of the matter is that there is NO satisfactory alternative to CFC MDIs for all pulmonary patients, and WE DEMAND THAT OUR CONGRESS AND ADMINISTRATION PLACE THE HEALTH AND SAFETY OF THESE PATIENTS AHEAD OF THE DECISIONS OF THE FLAWED MONTREAL PROTOCOL AND THE EQUALLY FLAWED U.S. CLEAN AIR ACT.




PLEASE DONATE $5 or $10 to help us get this campaign out to 40 million asthma and pulmonary patients. We are 100% petitioner-financed. WE WILL ONLY BE ABLE TO REACH THE MASSES OF PEOPLE WE NEED TO REACH TO PERSUADE CONGRESS TO AMEND THE CLEAN AIR ACT AND LEGALIZE CFC INHALERS WITH YOUR FINANCIAL SUPPORT.

Please click here to donate by credit card, debit card, echeck, or PayPal:

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If you have any questions, comments or suggestions, please email us at sponsor@saveCFCinhalers.org or call us at 1-800-284-4619 or 415-295-4509

We need your ideas and feedback as well as your financial support!

THANK YOU!
THE NATIONAL CAMPAIGN TO SAVE CFC ASTHMA INHALERS




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Petition sponsor


THE NATIONAL CAMPAIGN TO SAVE CFC ASTHMA INHALERS

Contact us at:
sponsor@saveCFCinhalers.org

WELCOME TO OUR BRAVE, NEW WORLD WHERE JUNK SCIENCE ROBS PATIENTS OF THEIR LIFESAVING MEDICATIONS!! CFC ALBUTEROL MDIs ARE NOW BANNED IN THE U.S.! GO TO OUR WEBSITE AT:

https://www.savecfcinhalers.org/

URGENT!

Have You filed YOUR HFA inhaler online MEDWATCH Complaint(s)?

THIS IS IMPORTANT. It takes 3 minutes. Your complaint does not have to be complete. Just do the best you can, and explain your medical problem(s) with the HFA inhaler(s)- one complaint per brand- (Ventolin HFA, Xopenex HFA, Proventil HFA, ProAir HFA, Atrovent HFA, Flovent HFA, etc.) as clearly as possible. It is never too late to do this. Your name and email address is required but YOUR ANONYMITY IS GUARANTEED.

PLEASE FILE YOUR MEDWATCH COMPLAINT RIGHT HERE:

https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm

Links


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