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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)
Is it really that hard to believe that inevitably, out of 35 million pulmonary patients, there will, in fact, be many asthma patients, including children, with hypersensitive, inflamed airways and severe allergies, who will suffer horribly and possibly die from asthma attacks that are caused by these 'ozone-friendly' rescue MDIs, WHICH HAVE A KNOWN BRONCHOCONSTRICTOR IN THEM?
Could this be one of the reasons why SO MANY patients complain that the HFA MDIs DO NOT RELIEVE THEIR ASTHMA, OR MAKE THEIR ASTHMA WORSE? WHY MUST WE EXPOSE SICK ASTHMATIC CHILDREN TO THESE DEADLY HFA RESCUE INHALERS?
ATTENTION MEMBERS OF THE NATURAL RESOURCES DEFENSE COUNCIL: Are you very proud of what your organization is doing to sick asthmatic children by its illogical, irrational drive to rid the planet of lifesaving CFC metered-dose inhalers (MDIs) with YOUR tax-deductible contributions?
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 Congress to immediately amend Title VI of the Clean Air Act 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.
We call upon the Administration to immediately draft 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.
These actions are necessary to ensure that America's 35 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.
Pulmonary patients did not create this disaster, they are the victims of it. 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.
FINALLY, WE BELIEVE THAT IT IS IMPERATIVE that extremely qualified executives from outside of the FDA with sufficient experience and authority to overcome decades of organizational inertia be appointed to oversee the entire re-introduction process of CFC MDIs into the marketplace.
The FDA must focus all of its resources on improving its atrocious track record with new drug safety and postmarketing surveillance, and immediately quit its participation in the Montreal Protocol and all other similar adventures. The FDA has yet to prove that it is capable of protecting patient health and safety- it needs to prove that it can consistently accomplish this primary mission before it tries to save the world from the horrors of man-made stratospheric ozone depletion and/or man-made global warming.
COMMENTS FROM PETITIONERS:
"This is so wrong. As a patient and a doctor, I just cant believe that the FDA can turn such a blnd eye." Dr. Edna Hirsch, MD #2102
It's one thing when I have to suffer, but I can't take seeing my son suffer. Bill Conrad, DE #591
The new HFA inhalers make my son cough until he vomits. Amy Prater, OH #1304
It is 2:00 am and I can't sleep because of the persistent cough and pounding heartbeat brought on by this inhaler. My resting heart rate is 97 at the moment, and I am still wheezing. I am very afraid of what my future will be like now. Please don't do this to me. I am a mother of 3. My youngest is only 5. My husband is on dialysis and he needs me to take care of him. I am supposed to donate a kidney to him in a couple of months. I don't want to go back to the old days when my asthma went uncontrolled and HE was taking care of ME. I have nearly died several times from asthma but have had a brief period of respite for the last few years as I seemed to be growing out of the worst of my problems...until they introduced THIS. I have so much to live for. I am going to school right now at University of California. I am entering my senior year as a psychology major. After that I would like to become a doctor...if I can live that long. I have so much to offer the world, I am not ready to die. Please don't take away the one medicine that has kept me alive for the past 20 years. I only started using this new medicine for about 2 months now as I ran out of my other inhalers and they won't sell me the CFC ones anymore. I have a nonstop cough. I am very sick, and getting sicker every day. I could probably drag on for a couple more years like this, but I will have no quality of life anymore, and I will eventually have a fatal asthma attack. Maybe I will be able to save my husband's life first, but will you save mine? Debbie Tharp, CA #2170
1. Too costly. The investment drug companies made to comply is trivial compared to the $ spent on a NEW drug. Yet they get essentially a new patent period? This is criminal. 2. Waste of resources. Does anyone believe the CFC's from these inhalers poses a harm to the ozone? How about compared to other emissions in the US. What would happen if all the wasted resources on this ridiculous project were invested on the environment. 3. This will kill people. I am sure this will make it unaffordable to people without insurance and even some people with insurance. We all know asthma can kill. 4. Why don't we go after other drugs that may harm the environment? I'm sure the production of Botox, fillers, viagra, etc involve the production of greenhouse gases, solid/liquid waste. This policy makes me furious as an asthmatic and a physician. Omar Jassim, MD PhD, MO #2101
"Please do not ban CFC inhalers! My husband's life depends on it!!!" Melissa Filtz, WI #257
"I did not realize until today (May 13, 2008) that CFC inhalers were being banned. The asthma suffering public has received virtually no notice regarding this ban. The new HFA inhalers DO NOT WORK! I had thought that my asthma symptoms had worsened, and thought it odd that old, past expiration date inhalers were alleviating my symptoms while brand new ones did not. I now realize why this is happening and that it was not my imagination. This ban is a medical disaster in the making for illusory environmental benefits. This ban must be reversed. Make no mistake, asthma inhalers are nothing less than miracle workers for asthma sufferers. These devices enable asthma sufferers to travel far from home free of the concern that they will be require hospitalization in an unfamiliar place. Inhalers allow asthmatics to lead active, full lives. Inhalers also limit required hospitalizations, reducing medical costs and life disruptions. Asthma sufferers are careful to carry inhalers with them wherever they go, and keep multiple inhalers in useful locations. This medicine matters! If federal regulators are going to alter a medication that has literally transformed the lives of millions of their fellow citizens, they had better do so carefully with an eye to cost and medical effectiveness above all other aspects. There are lives at stake. It is clear that the decision to ban CFC inhalers was made without regard to cost or medical effectiveness. It is long past the time for zealotry to take a backseat to common sense. There are millions of Americans who are and are going to be profoundly harmed by this regulatory action. I urge anyone with the power to make a change to reverse this ban. It is a well-intentioned mistake." Eric Wigginton, NJ #2132
"My doctor told me straight out that these new inhalers are not as good. The American Lung Assoc. sides with the enviro-terrorists and offers no support except to tell me I am not using the product correctly. Tell me, how does an inhaler user for 20 years suddenly become dumb? Please do not insult my intelligence. My health is suffering. If one person dies from this crappy product, their blood is on your hands." Mitchell Ivey, TX #1406
"MY DAUGHTER IS 18 AND HAS ASTHMA. HER PUFFER WAS CHANGED TWO YEARS AGO TO PROVENTIL HFA AND NOW SHE IS WORSE. NOW SHE HAS TO TAKE ADVAIR 500, SINGULAR, PREVICID, AND NOW WE ARE ON A NEBULIZER. SHE IS IN COLLEGE AND IS CONSTANTLY HAVING ASTHMA ATTACKS. USING THE PROVENTIL SEVERAL TIMES PER DAY ALONG WITH THE NEBULIZER. I WANT TO HELP SAVE HER LUNGS." Teresa Kaylor, TN #122
"I used the Serevent inhaler along with my Proventil inhaler for two years. I felt great for the first time in years I could breath. I can no longer get Serevent (only in powder which is useless same as Advair) and now my Proventil is no longer available. Between the powder Serevent and Proventil HFA I have zero energy, I can't catch my breath. What is the plan? We need these inhalers to LIVE. Or maybe that is the plan." Faith Wiest, MN #154
"My girlfriend has nearly died trying to use these new non CFC inhalers they do not work. Wake up and bring back the old ones!" Milo Alltop, OH #220
"I HATE THE "NEW INHALERS" BRING BACK THE CFC PROPELLANT ALBUTEROL INHALERS!!!" Linda Rust, NJ #256
"PLEASE BRING BACK THE ATROVENT CFC ,,,I AM UNABLE TO TAKE THE HFA ,,ATROVENT CFC WAS THE ONLY MEDICINE I COULD USE,,,,PLEASE FOR MY LIFE BRING IT BACK AND BAN THE HFA ,,THIS ISNT RIGHT TO ALLOW US TO SUFFER WHEN THERE IS MEDICINE THAT COULD BE AVAILABLE......THINK OF CHILDREN AND ALL PEOPLE WHO NEED THESE LIFE SAVING MEDICATIONS,,ITS NOT JUST THE ALBUTEROL ,,ITS ATROVENT AND ALL OTHERS THAT CONTAINED THE CFC..THE HFA'S ARE NOT GOOD" Pamela Burnley, FL #147
"Please stop the madness and stop attacking those of us with asthma! Who cares if we shoot CFC's into our lungs so we can stay alive? This environmentalism has run amok and is hurting WORKING PEOPLE & PEOPLE WITH A SERIOUS CHRONIC ILLNESS. Where is the Democratic Party that used to stand up for the working class in OUR COUNTRY?" Nevenka Crnojevich, WI #272
"I have Asthma and the new change in Inhalers does not work for me.I have been to the Emergency Room because I cannot get my breath.I did not have this problem before.Please bring our old Inhalers back.Its a matter of Life and Death!" Betty Kosegi, OH #292
"My sister needs this medicine to breathe and live. Please don't take it away from her." Robin Corsino, PA #321
"My son has had asthma since birth. 14 years. It is terrifying for him, and gives me a feeling of total helplessness knowing i can't do anything to help him breathe. Please do not take these inhalers away. They keep my son alive." Kelly Denham, MI #370
"The HFA Albuterol inhaler is not working for me like the CFC Albuterol inhaler did. I can no longer run, and I have trouble sleeping because I can't breathe despite using the HFA multiple times!!" Laura A. Weiland, PA #371
"I fully support CFC inhalers remaining on the market. I tried these HFA inhalers in the late 90's when they first came out and they tasted terrible, gave me mouth and throat sores and did not work nearly as well. I quickly switched back to my trusty CFC inhaler." Carly Kidd, MN #374
"my daughter will be 21 in 2 weeks and has had asthma since she was 2 months old. Over the past 2 months she was in the ER 2 times and received this replacement inhaler as well. UNFORTUNATELY, IT IS NOT THE SAME!! We need to save lives first!! The environment is not being effected by this medication by the asthmatics in this country are!" Jacy, MD #393
"I have had asthma for 24 yrs. I have been through slobid and the use of Albuterol since it was introduced. I have been able to play sports with no incidents and live a normal life. Now I am dependent on my inhalers, 3-4 times a day, I am unable to do the activities I once did and enjoyed. Please reinstate the CFC Inhalers." Jason, TX #367
"My son's HFA inhaler is so ineffective, it's only proper place is in the trash recepticle! I feel lied and betrayed by my own government. When the FDA is touting it being as effective, why are most of the people I know with asthma complaining about their HFA inhaler's ineffectiveness (the nurse at the dr's office even complained about it and she's a professional!)." Katherine Mitchell, IN #406
"Please reinstate the use of CFC's in medical inhalers! The new HFA does not work as well as the previous inhalers and I use my inhaler twice as much...IT HAS BEEN A NIGHTMARE! They are not as effective and I have had asthma for 20 years...PLEASE hear our request to return to CFC inhalers!" Kim Litvinow, NJ #523
"I want to take up the cause to ban ProAir immediately and that the FDA reinstate the generic Albuterol that has helped me and millions of people suffering from asthma." Craig Kessel, WA #1405
"The new inhalers are very ineffective especially in cold weather." Richard J Vance, MI #1407
"Please don't take this much needed item of the market. Not using the old inhaler alomost killed my friend and now she has permanent damage to her heart, becasue of a resulting heart attack. Her health has been in continual decline since she changed inhalers." D Ette, NM #1420
"I tried proAir HFA ,the new asthma inhaler, it made my asthma worse, deeper congestion, more shallow breathing. What do I do now? I have had manageable asthma with albuterol inhaler and now I don't." Carla Travis, GA #1423
"Are they really serious? that this inhaler works as well as the cfc one? Do any of these urls posted on here give us an opportunity to reply to their smug attitudes? NO... This is a disgrace.. and no one will listen to us until deaths occur..Thanks Bill Clinton.. one more or your mistakes we are paying for." Carla Travis, IA #1426
"DOCTORS SAY THAT HFA INHALERS ARE AS EFFECTIVE BUT YOU NEED TO BREATHE IN A LITTLE HARDER, IT IS EXTREMELY DIFFICULT TO DO THAT WHEN YOU ARE HAVING AN ASTHMA ATTACK AND CAN HARDLY BREATH AT ALL. BRING BACK THE CFC INHALERS AND SAVE LITERALLY MILLIONS FROM SUFFERING." CARLOS BIELMA, CA #1433
"I have used Proventil CFC inhalers successfully for many years. When I ordered a refill, I could only get Proventil HFA. When I used it, I experienced bronchial spasms, chest pain, high heart rate, and extreme nausea. I cannot afford to vomit as I have a tracheotomy (on a ventilator) and I could aspirate. I cannot tolerate alcohol... in the HFA inhaler. Not only are people suffering from asthma put in great danger by this change to HFA inhalers; there are many people like myself who have been able to enjoy a quality of life using CFC inhalers. Now I have become a hostage in my home with NO alternative but to stay by the nebulizer. I was shocked to read that the Clinton Presidency pressured and succeeded to include the banning of CFC inhalers in the Montreal Protocol in 1997, when they had been excluded. HFA inhalers are a serious health threat to me and to many others. I hope that the time has come for our government to realize just how really horrifying and unbelievable it is find out, in our Country, this health risk is not important. I find it hard to believe that CFC inhalers cause such drastic harm to our environment. We should at least have the alternative to get CFC inhalers if the HFA inhaler presents serious medical problems." J. Nelson MN #1436
"As a Cystic Fibrosis patient, I feel that the inhalers lacking CFC's (Pro-air, Proventil) are more than 75% less effective. I am coughing more, wheezing, and out of breath constantly. I believe when it comes down to human health issues, it's a miniscule price to pay." Kim Kreidler, FL #1437
"Signed ~ If we can't breath, and the new inhalers don't work.. what are we to do? Nebulizers make you a bit dizzy after each use.. and some people need to use their normal inhaler at least once every 4 hours.. some people more. You can't use a nebulizer that much. And the effects of a nebulizer won't last as long as we would like. Wanna help the environment? Make more electric cars damn it." Matt Modrow, WI #1444
"I experienced an acute asthma attack 12/30.07, which sent me to an urgent care facility when my HFA inhaler did NOTHING to relieve my symptoms and allow me to breathe. PLEASE BRING BACK CFC INHALERS. A country of asthma sufferers is counting on this happening so we can breathe again." Christina Ansley, FL #1445
"My daughter and husband are asthmatics and needs these inhalers....the new replacements are not effective. Please consider the facts and allow these inhalers back on the market" Beatrice Johnson, TX #1454
"I had the pleasure of taking my roommate to 2 urgent care facilities for an asthma attack. The first would not see her because it was pediatrics only. by the time we got to the 2nd she was in respiratory distress and required an ambulance ride( which came to $995). all because her rescue inhaler wouldn't work. it was the small HFA ( red one.) if she had the large CFC inhaler ( white one), this would have precluded a costly hospital visit and ambulance ride." Pete Hornung, CO #1463
"I don't like it when my own country threatens to take my life away when I never did anything wrong. Please help us." Jennifer Dukovich, MI #1467
"am a life long chronic asthma sufferer and am very concerned about the changeover from CFC to HFA inhalers. I received a HFA inhaler from my local pharmacy about six months ago and noticed straight away that inhalations of this medicine did not relieve my breathing. I subsequently requested that I only bought CFC inhalers as long as they lasted. Now it seems the only CFC inhalers available are manufactured by Armstrong - and THESE INHALERS DO NOT WORK!!!! IN FACT THEY SEEM TO HAVE MADE MY ASTHMA SYMPTOMS WORSE!!! I have been to the emergency room five times since November 2007, it is now February 2008, am on my fifth dose of prednisone - the only way I seem to be able to relieve my breathing is to use my nebulizer. I am signing this petition because I believe that many people are going to die, including myself, because of this change in medicine" karen roberts, CT #1483
"It seems ludicrous to put ethanol, a bronchial restricting toxin, in an inhaler for people who are having trouble breathing. Imagine opening your mouth and not being able to get any air. It is like drowning. I have had asthma all my life and all I can say is if this thing goes through, I hope the class action lawsuit(s) make the decision makers feel as if they cannot get any air!" Robin Cook, CT #1493
"My husband is the one that has to use the inhaler... Often enough to keep one handy. I cannot imagine why something like this could harm the environment when there are more pressing things that need to be regulated. Why someones' health needs to be hurt. We are in our 80's and live on a small pension and ss...have you tried that lately?" Lucile Gates, TX #1494
"People come first!" Frank Clyburn, AK, #1496
"I have almost no- relief from my asthma attacks with these new inhalers, these were supposed to be emergency inhalers but now when i feel an attack coming and I use these new ones that don't work I begin to panic and that makes the attacks even worse. I belief I my die because of this and something needs to be done" Samuel M. Johnson, IL #1500
"What do we have to do? File a class action lawsuit-- leave the country? I'm allergic to these new HFA inhalers (probably the ethanol corn based crap in them-- they actually induce an asthma attack. What a greedy country we live in. I will be fighting for my life."Marla Del Collins, NY #2099
"THE HFA INHALERS DON'T WORK FOR ME! IT SEEMS LIKE THE HFA MANUFACTURER IS TRYING TO CUT A FAT HOG. PLEASE HELP THE ASTHMA SUFFERERS, OR OUR EMERGENCY ROOMS WILL BE OVERRUN WHEN THE BAN BEGINS" GARY LEIFESTE, WA #1400
"This ProAir HFA does NOT work well for me. Instead of using the CFC Inhaler.. 2 puffs .. 4 times daily, I use the HFA inhaler 3 puffs (at least) 6 times a day. Therefore I am running out after 2 1/2 weeks and have to wait another 1 1/2 weeks before my insurance will pay for another. I end up having to use an over the counter inhaler, which works about the same as the HFA. Who does my husband sue if I have an Asthma Attack and die because this 'crap' they are giving us does NOT work ???? " Gloria Frasier, MI #1399
"If you don't do this peoples quality of life will drastically decrease or worse they will die." Marcus Contonikolas, NJ #1398
"Since using the new medicines I'm having attacks all the time. Before, I would have attacks for 1 week in April and 1 week in September like clockwork for the for the past 9 years. I've had multiple attacks EVERYDAY for the months of Aug, Sept and October. It's January and since mid December I'm having between 4 and 10 attacks weekly. I cannot imagine this sudden onslaught of attacks is a coincidence that suddenly my asthma has just gotten worse. I actually called the pharmacy to tell them that I must have gotten a faulty inhaler when he explained I was one of hundreds he had talked to. This is outrageous." K Kirkilas, IL #1396
"Plz reinstate CFC meds (albuterol)" Rosario Hermann, WI, #1395
"I can barely breathe without the old ones by Warrick. An inhaler that used to last forever now lasts maybe 4 weeks. They just aren't good enough." Josh Pasqualini, CA #1984
"They can tell me the medicine is the same but, if I don't have enough air to inhale as deeply for it to be effective what good is it. I'm sick of people making laws so I can't breathe but they still manufacturer cigarettes. It's insane." sharon orozco, IL #1986
"I have asthma and I have tons of allergies, one of them being corn. Any inhaler using ethenol is a death notice for someone like me, I really believe that the do gooders in this world don't give a hoot about the 3 million of us who rely on our inhalers." Joan Grimm, IL #1988
"If one person dies in the name of Political Correctness that is too many. This is absolutely ridiculous." Kathy Krizka RRT, IL #1991
"My daughter is a soccer player with sports induced asthma. She uses her albuterol inhaler prior to games and practice and never has a problem. When I put her new inhaler in her bag, Pro air, she said she could not breathe during the game. she did not even know that I had given her a different inhaler. I was able to obtain some Albuterol inhalers, but she will be in big trouble when they discontinue them altogether." diane johnson, IL #1992
"the new inhalers do not work i am so afraid everyday that i'll have a severe attack and not get enough relief from my inhaler" irene diericks, IL #1994
"I need Primatene to live!!!!!!!!" Bryan peterson, MN #2001
"HFA inhalers absolutely do not work for my asthma symptoms! Bring back the CFC inhaler!" Nora Walsh, IL #2025
"I am not being served equivently with ProAir HFA as I was with the generic CFC albuterol. I must now use 4-10 puffs and do not always get relief. I am therefore now using albuterol nebulizer treatments as a rescue method with no backup. I can no longer exercise as I used to, which causes other problems." Mary L Nelson, MN #2028
"I find the new inhalers totally useless. There is nothing more fightening than being able to breathe and trying to use the new inhaler. It takes so many puffs I am afraid I will fall over before I get some relief." Barbara Malik, IL #2029
"it didn't help me like the old inhalers." David Rodriguez, IL #2031
"This is going to kill alot of people!.. Myself included." Tracie Lemmon, MI #2037
"I MUST HAVE the old CFC Inhaler!!!!!" Benjamin Partlow, MD #2040
"This is totally absurd - I am an environmentalist but I understand that this has a negligible effect on the ozone layer. With all of the trespasses being made against our resources and environment, why pick on people who can't breathe?" Annie Cotten, NY #2043
"Albuturol CFC inhalers allow me to live a normal life. Without this inhaler, I am truly handicapped. This ban is inhumane to athmatics!!! I thought the function of government was to protect not cripple its citizens." Christine Adams, PA #2047
"the new inhalers are not effective" Gerald Pfefer, CA #2053
"My daughter needs the resue relief the current albuterol inhalers give her!" Susan, PA #2054
"Restore CFC Albuterol inhalers!!! My asthma has gotten worse on ProAir inhaler and I have not been able to breathe properly." Julie Carrasco, TX #2055
"My daughter suffers from asthma and the new inhalers are in effective. Please reinstate the "old" inhalers. People are suffering and we can't afford to worry about the environment while people are dying from asthma. Lets get our priorities straight." Adrienne Erickson, FL #2061
"The new inhalers make my condition worse!!" Billy Tomlinson, GA #2062
"Pro Air inhalers really suck! They don't help my asthma and they don't even last as long as the Warrick Albuterol inhlaers which work so much better. It's like we're being ripped off!! Please save Warrick Albuterol CFC inhalers!!" Mike Buffardi, NY #2065
"Knock off the political BS. Who is getting their pocket lined? Stop making our lives worse. I can't afford my medication as it is! Why are you doing this to your citizens?" Neal Alders, FL #2070
"The environment is very important. However, people are even more important! This makes absolutely no sense. Keep Warrick inhalers on the market!" C. McQuade, NY #2072
"As a copd patient I need these inhalers. So please do not ban them" Elsie Jones, NC #2075
"Everyone who sees this please sign my husband needs this bad. These last two weeks would have been unbearable if he didn't have his inhaler. He has been an asthmatic all his life and this is the only thing that helps him. If he didn't have his inhaler he would have been in the ER. The other crap don't work and they know it they just want us to keep going back to the doctor to waste more money! I believe the worst feeling you can have is suffocation but he has to go through it almost everyday.And he would actually suffocate if it was not for his inhaler so please sign this and pray that god listens so my soulmate and everyone else out there suffering like him can breathe a little easier!" Crystal Leslie, IN #2082
"This type of inhaler is the only kind that works for me. Please reconsider your ban on the CFC propellant inhaler. I need it for my survival" Matthew Flatley, WI #2083
"The new CFC free HFA inhalers do not work for my asthma." Davin Noto, AZ #2085
"I've used the Warrick "CFC" albuterol inhaler for seasonal allergies with accompanying asthma with great results. One puff, once a day and I'm fine. Recently I have been prescribed ProAir which I tried last night and it made my symptoms worse and I almost had to go to the ER. Please bring back the CFC inhalers so everyone who suffers from asthma can breath easier. These new HFA inhalers do not work." Aaron Diemel, CA #2086
"Both my parents have COPD and use their inhalers daily. Please don't ban something that is helping them so much." Linda Davis, TN #2090
"I THINK THAT WHEN OUR POLITICIANS LISTEN TO NO GOOD LOBBYISTS REGARDING MILLIONS OF PEOPLES MEDICINE, MEDICINE THAT SAVES LIVES ON A DAILY BASIS, I THINK THAT THOSE POLITICIANS SHOULD BE OUSTED AND NEVER ALLOWED BACK IN ANY PUBLIC OFFICE AGAIN. THE HFA INHALERS DO NOT ADMINISTER THE MEDICINE EFFECTIVELY. THE MEDICINE SITS IN MY THROAT AND NEVER GETS TO MY LUNGS. APPARENTLY MY LIFE MEANS NOTHING TO THESE POLITICIANS" CANDICE HOLLINGER, CA #2091
"Please Hear US! I am allergic to the HFA inhaler - almost immediately my scalp itches, then feels like someone left a hot iron on my scalp & my hair proceeds to fall out. The reaction happens after just ONE DOSE! Also it stings my lungs! You can't carry a nebulizer with you when you suddenly can't breathe! I have COPD but DON'T WANT TO DIE" Susan Hooper, OH #2094
"I have asthma. I cannot tolerate the HFA albuterol inhalers. I am allergic to them. I can only use the CFC albuterol inhalers, which I can still get. But when they are banned, I will have to switch to a nebulizer, which I don't know if I can handle. If that doesn't work I WILL DIE. That isn't fair. Please fix this problem so I can continue to breath and not die before my time." Paulette Brady, CA #1983
"COPD patient, and the new ones DON'T work. Help us, please." Vicki W Huehner, NC #1978
"i have had asthma since the day i was born, i am 20 years old. i have never been to the hospital because of asthma before the pharmacy started giving me proair hfa. since then ive been to the hospital 5 times, had tubes stuffed down my throat, passed out because of lack of oxygen, and wrecked a car because my breathing was so bad." John William Beever IV, MD #1973
"For fourteen years I have had asthma that was completely controlled under my CFC Inhaler. I used to be extremely active in various activities including swimming, running, horseback riding and now I can barely get up a flight of stairs. I am a teacher and all of my absences are affecting my children's performance. I have tried "acceptable alternatives" for CFC Inhalers but have only ended up more sick due to their side effects. I know my case isnt the worst and I know I'm not alone. They cannot do this to us!" Jeannette Glime FL, #1958
"My son, who is 14 years old now has been using the Warrick inhaler for 14 years with good success. For the FDA to insist that we change to this ineffective HFA inhaler is medieval. He now has asthma that turns into pneumonia on occasion and I pray to God that nothing happens to him. We need to bring a class action suit against this policy." Laura Harris, MD #1957
"I was rushed to the hospital er in late 2007 for a severe asthma attack. well needless to say 7 breathing treatments,a tank of oxygen,and a shot I started to breath better. The er doctor said that his er has had a record in cases since our LIFE LINE has been taken from us. Please help us and let us decide if it's bad for us or not. I would like to bike ride with my children again but I can't because there is no FAST acting relief for me. Please give us back our life saving CFC's. My children and other children as well as adults are suffering and when is enough, enough already? Please help us who are suffering everyday because of this." Stephanie Brown, MO #1956
"These NEW HFA inhalers DO NOT WORK they make my asthma worse. Please don't let me suffer all I ask is that I can breathe" Janice Crotzer, CA #1940
"This is having a significant effect on my life-- I've had to reduce exercise in the winter months to almost nothing because my new rescue inhalers simply do not work." Kevin J. Causgrove, MI #1939
"I have used these inhalers about 8 times and have not had good results. There is no worse feeling than not being able to breath and now I have no confidence these new inhalers will ever work. Please leave rescue type meds alone!!" james ciccolo, MA #1930
"Please leave the cfc inhalers in the market." Rabbi Moishe Mayir Vogel, UT #1921
"ProAir sucks and people will die from this change." Shannon Smith, SC #1910
"HFA inhalers are dangerously ineffective. Thank you for the opportunity to sign this petition." Bruce Parker, NJ #1900
"you suck you sonofabitches!!!!!" Amy Wood, IN #1899
"I have to tell you.. My heart rate increases with use of this product, I had a very scary episode a week ago that made me wish for a minute that my asthma got the best of me. I had an alergic reaction to something, and it took 5 puffs of this stupid inhaler (proair hfa) and a nebulizer treatment for my breathing to be restored. My lung function has decreased with use of this thing. Remember politicians can be voted out just as easy as they can be voted in. Safe a few lifes washington. it may justify everything else you do... bring back the cfc inhaler/" Michael Land, CT #1880
"I have had severe chronic asthma for over 25 years, along with severe allergies, and sinus. Until the FDA mandated a change from CFC to HFA inhalers, combining prescription medications with a very regimented lifestyle (that included restrictions on environment, food, some medications, and sundry other items) enabled Me to live a life that was about 80% normal. The new HFA propellants (Qvar & Proventil HFA) each gave me an extremely severe asthma attack. The control of my asthma has declined dramatically! And I have NO EMERGENCY INHALER! Friends with asthma tell me that the HFA inhalers just dont deliver the medicine. My insurance company has mailed me a notice that the HFA propellants require much more force to inhale! This would be ironically funny if it were not a matter of life and breath. Restore CFC inhalers!" P Johnson, NJ #1870
"I can't breathe, the new inhalers suck, how much money was it worth to someone to kill people?" Ashley Kay, TX #1869
"Oh please, please bring back my old albuterol inhaler. With the pro-air, I just can't inhale. Selfish me, I care more about being able to breath than political correctness." Connie Jewell Byerley, MO #1857
"bring back my old inhaler,so I can breathe" sallie freeman, IA #1851
"My son needs CFC inhalers for his asthma. Do NOT take these off the market!" Eileen Sullivan, NC #1846
"Want the old inhaler BACK" Rosanne Robinson, FL #1840
"PLEASE keep these inhalers on the market. The new ones DO NOT work as well and are causing health concerns for many people including myself and my daughter." Sandy Sanders, IL #1839
"HFA inhalers do NOT work as well as the CFC...making this switch is screwing with people lives!" Christy Grasmick, CO #1834
"Please help me breath again!!!!!!!!!!!!!!!!!!!! I just want my old med. back. As if it's not bad enough not to be able to breath and now you can't get the ONLY med. which helped." Melody Schmitz, MO #1824
"The new HFA inhalers are a direct threat to people's health. They do *NOT* work like the old inhalers did and should be taken off the market immediately and the old inhalers brought back!" David Rheault, MD #1817
"I almost died one month after beginning use of this inhaler. I have never been hospitalized for asthma, untill use of PROair HFA. I have no clue why but it just does not work. I want my life back." Christopher S Cantrell, NM #1815
"I wouldn't wish the agonizing death from anoxia on anyone. Why is my government forcing it on me?" Marc A. Pozza, OH #1813
"Since age 2 I have relied on inhalers. The new ones do not work and made my breathing much worse. I am currently getting the old ones from Mexico." mary earhart, CA #1812
"I hate the new inhalers. I would like to have the old Warwick CFC back The HFA does not relieve symptoms. Thanks" Adolphine Slattery, FL #1810
"I have a life threatening corn allergy, which make the use of ethanol (corn alcohol) in inhalers deadly for me. Please help save my life." Christine Robinson, CO #1804
"Please Please Please bring them back. I want to breathe again!" Paul Bandur, IL #1866
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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)
Is it really that hard to believe that inevitably, out of 35 million pulmonary patients, there will, in fact, be many asthma patients, including children, with hypersensitive, inflamed airways and severe allergies, who will suffer horribly and possibly die from asthma attacks that are caused by these 'ozone-friendly' rescue MDIs, WHICH HAVE A KNOWN BRONCHOCONSTRICTOR IN THEM?
Could this be one of the reasons why SO MANY patients complain that the HFA MDIs DO NOT RELIEVE THEIR ASTHMA, OR MAKE THEIR ASTHMA WORSE? WHY MUST WE EXPOSE SICK ASTHMATIC CHILDREN TO THESE DEADLY HFA RESCUE INHALERS?
ATTENTION MEMBERS OF THE NATURAL RESOURCES DEFENSE COUNCIL: Are you very proud of what your organization is doing to sick asthmatic children by its illogical, irrational drive to rid the planet of lifesaving CFC metered-dose inhalers (MDIs) with YOUR tax-deductible contributions?
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 Congress to immediately amend Title VI of the Clean Air Act 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.
We call upon the Administration to immediately draft 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.
These actions are necessary to ensure that America's 35 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.
Pulmonary patients did not create this disaster, they are the victims of it. 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.
FINALLY, WE BELIEVE THAT IT IS IMPERATIVE that extremely qualified executives from outside of the FDA with sufficient experience and authority to overcome decades of organizational inertia be appointed to oversee the entire re-introduction process of CFC MDIs into the marketplace.
The FDA must focus all of its resources on improving its atrocious track record with new drug safety and postmarketing surveillance, and immediately quit its participation in the Montreal Protocol and all other similar adventures. The FDA has yet to prove that it is capable of protecting patient health and safety- it needs to prove that it can consistently accomplish this primary mission before it tries to save the world from the horrors of man-made stratospheric ozone depletion and/or man-made global warming.
COMMENTS FROM PETITIONERS:
"This is so wrong. As a patient and a doctor, I just cant believe that the FDA can turn such a blnd eye." Dr. Edna Hirsch, MD #2102
It's one thing when I have to suffer, but I can't take seeing my son suffer. Bill Conrad, DE #591
The new HFA inhalers make my son cough until he vomits. Amy Prater, OH #1304
It is 2:00 am and I can't sleep because of the persistent cough and pounding heartbeat brought on by this inhaler. My resting heart rate is 97 at the moment, and I am still wheezing. I am very afraid of what my future will be like now. Please don't do this to me. I am a mother of 3. My youngest is only 5. My husband is on dialysis and he needs me to take care of him. I am supposed to donate a kidney to him in a couple of months. I don't want to go back to the old days when my asthma went uncontrolled and HE was taking care of ME. I have nearly died several times from asthma but have had a brief period of respite for the last few years as I seemed to be growing out of the worst of my problems...until they introduced THIS. I have so much to live for. I am going to school right now at University of California. I am entering my senior year as a psychology major. After that I would like to become a doctor...if I can live that long. I have so much to offer the world, I am not ready to die. Please don't take away the one medicine that has kept me alive for the past 20 years. I only started using this new medicine for about 2 months now as I ran out of my other inhalers and they won't sell me the CFC ones anymore. I have a nonstop cough. I am very sick, and getting sicker every day. I could probably drag on for a couple more years like this, but I will have no quality of life anymore, and I will eventually have a fatal asthma attack. Maybe I will be able to save my husband's life first, but will you save mine? Debbie Tharp, CA #2170
1. Too costly. The investment drug companies made to comply is trivial compared to the $ spent on a NEW drug. Yet they get essentially a new patent period? This is criminal. 2. Waste of resources. Does anyone believe the CFC's from these inhalers poses a harm to the ozone? How about compared to other emissions in the US. What would happen if all the wasted resources on this ridiculous project were invested on the environment. 3. This will kill people. I am sure this will make it unaffordable to people without insurance and even some people with insurance. We all know asthma can kill. 4. Why don't we go after other drugs that may harm the environment? I'm sure the production of Botox, fillers, viagra, etc involve the production of greenhouse gases, solid/liquid waste. This policy makes me furious as an asthmatic and a physician. Omar Jassim, MD PhD, MO #2101
"Please do not ban CFC inhalers! My husband's life depends on it!!!" Melissa Filtz, WI #257
"I did not realize until today (May 13, 2008) that CFC inhalers were being banned. The asthma suffering public has received virtually no notice regarding this ban. The new HFA inhalers DO NOT WORK! I had thought that my asthma symptoms had worsened, and thought it odd that old, past expiration date inhalers were alleviating my symptoms while brand new ones did not. I now realize why this is happening and that it was not my imagination. This ban is a medical disaster in the making for illusory environmental benefits. This ban must be reversed. Make no mistake, asthma inhalers are nothing less than miracle workers for asthma sufferers. These devices enable asthma sufferers to travel far from home free of the concern that they will be require hospitalization in an unfamiliar place. Inhalers allow asthmatics to lead active, full lives. Inhalers also limit required hospitalizations, reducing medical costs and life disruptions. Asthma sufferers are careful to carry inhalers with them wherever they go, and keep multiple inhalers in useful locations. This medicine matters! If federal regulators are going to alter a medication that has literally transformed the lives of millions of their fellow citizens, they had better do so carefully with an eye to cost and medical effectiveness above all other aspects. There are lives at stake. It is clear that the decision to ban CFC inhalers was made without regard to cost or medical effectiveness. It is long past the time for zealotry to take a backseat to common sense. There are millions of Americans who are and are going to be profoundly harmed by this regulatory action. I urge anyone with the power to make a change to reverse this ban. It is a well-intentioned mistake." Eric Wigginton, NJ #2132
"My doctor told me straight out that these new inhalers are not as good. The American Lung Assoc. sides with the enviro-terrorists and offers no support except to tell me I am not using the product correctly. Tell me, how does an inhaler user for 20 years suddenly become dumb? Please do not insult my intelligence. My health is suffering. If one person dies from this crappy product, their blood is on your hands." Mitchell Ivey, TX #1406
"MY DAUGHTER IS 18 AND HAS ASTHMA. HER PUFFER WAS CHANGED TWO YEARS AGO TO PROVENTIL HFA AND NOW SHE IS WORSE. NOW SHE HAS TO TAKE ADVAIR 500, SINGULAR, PREVICID, AND NOW WE ARE ON A NEBULIZER. SHE IS IN COLLEGE AND IS CONSTANTLY HAVING ASTHMA ATTACKS. USING THE PROVENTIL SEVERAL TIMES PER DAY ALONG WITH THE NEBULIZER. I WANT TO HELP SAVE HER LUNGS." Teresa Kaylor, TN #122
"I used the Serevent inhaler along with my Proventil inhaler for two years. I felt great for the first time in years I could breath. I can no longer get Serevent (only in powder which is useless same as Advair) and now my Proventil is no longer available. Between the powder Serevent and Proventil HFA I have zero energy, I can't catch my breath. What is the plan? We need these inhalers to LIVE. Or maybe that is the plan." Faith Wiest, MN #154
"My girlfriend has nearly died trying to use these new non CFC inhalers they do not work. Wake up and bring back the old ones!" Milo Alltop, OH #220
"I HATE THE "NEW INHALERS" BRING BACK THE CFC PROPELLANT ALBUTEROL INHALERS!!!" Linda Rust, NJ #256
"PLEASE BRING BACK THE ATROVENT CFC ,,,I AM UNABLE TO TAKE THE HFA ,,ATROVENT CFC WAS THE ONLY MEDICINE I COULD USE,,,,PLEASE FOR MY LIFE BRING IT BACK AND BAN THE HFA ,,THIS ISNT RIGHT TO ALLOW US TO SUFFER WHEN THERE IS MEDICINE THAT COULD BE AVAILABLE......THINK OF CHILDREN AND ALL PEOPLE WHO NEED THESE LIFE SAVING MEDICATIONS,,ITS NOT JUST THE ALBUTEROL ,,ITS ATROVENT AND ALL OTHERS THAT CONTAINED THE CFC..THE HFA'S ARE NOT GOOD" Pamela Burnley, FL #147
"Please stop the madness and stop attacking those of us with asthma! Who cares if we shoot CFC's into our lungs so we can stay alive? This environmentalism has run amok and is hurting WORKING PEOPLE & PEOPLE WITH A SERIOUS CHRONIC ILLNESS. Where is the Democratic Party that used to stand up for the working class in OUR COUNTRY?" Nevenka Crnojevich, WI #272
"I have Asthma and the new change in Inhalers does not work for me.I have been to the Emergency Room because I cannot get my breath.I did not have this problem before.Please bring our old Inhalers back.Its a matter of Life and Death!" Betty Kosegi, OH #292
"My sister needs this medicine to breathe and live. Please don't take it away from her." Robin Corsino, PA #321
"My son has had asthma since birth. 14 years. It is terrifying for him, and gives me a feeling of total helplessness knowing i can't do anything to help him breathe. Please do not take these inhalers away. They keep my son alive." Kelly Denham, MI #370
"The HFA Albuterol inhaler is not working for me like the CFC Albuterol inhaler did. I can no longer run, and I have trouble sleeping because I can't breathe despite using the HFA multiple times!!" Laura A. Weiland, PA #371
"I fully support CFC inhalers remaining on the market. I tried these HFA inhalers in the late 90's when they first came out and they tasted terrible, gave me mouth and throat sores and did not work nearly as well. I quickly switched back to my trusty CFC inhaler." Carly Kidd, MN #374
"my daughter will be 21 in 2 weeks and has had asthma since she was 2 months old. Over the past 2 months she was in the ER 2 times and received this replacement inhaler as well. UNFORTUNATELY, IT IS NOT THE SAME!! We need to save lives first!! The environment is not being effected by this medication by the asthmatics in this country are!" Jacy, MD #393
"I have had asthma for 24 yrs. I have been through slobid and the use of Albuterol since it was introduced. I have been able to play sports with no incidents and live a normal life. Now I am dependent on my inhalers, 3-4 times a day, I am unable to do the activities I once did and enjoyed. Please reinstate the CFC Inhalers." Jason, TX #367
"My son's HFA inhaler is so ineffective, it's only proper place is in the trash recepticle! I feel lied and betrayed by my own government. When the FDA is touting it being as effective, why are most of the people I know with asthma complaining about their HFA inhaler's ineffectiveness (the nurse at the dr's office even complained about it and she's a professional!)." Katherine Mitchell, IN #406
"Please reinstate the use of CFC's in medical inhalers! The new HFA does not work as well as the previous inhalers and I use my inhaler twice as much...IT HAS BEEN A NIGHTMARE! They are not as effective and I have had asthma for 20 years...PLEASE hear our request to return to CFC inhalers!" Kim Litvinow, NJ #523
"I want to take up the cause to ban ProAir immediately and that the FDA reinstate the generic Albuterol that has helped me and millions of people suffering from asthma." Craig Kessel, WA #1405
"The new inhalers are very ineffective especially in cold weather." Richard J Vance, MI #1407
"Please don't take this much needed item of the market. Not using the old inhaler alomost killed my friend and now she has permanent damage to her heart, becasue of a resulting heart attack. Her health has been in continual decline since she changed inhalers." D Ette, NM #1420
"I tried proAir HFA ,the new asthma inhaler, it made my asthma worse, deeper congestion, more shallow breathing. What do I do now? I have had manageable asthma with albuterol inhaler and now I don't." Carla Travis, GA #1423
"Are they really serious? that this inhaler works as well as the cfc one? Do any of these urls posted on here give us an opportunity to reply to their smug attitudes? NO... This is a disgrace.. and no one will listen to us until deaths occur..Thanks Bill Clinton.. one more or your mistakes we are paying for." Carla Travis, IA #1426
"DOCTORS SAY THAT HFA INHALERS ARE AS EFFECTIVE BUT YOU NEED TO BREATHE IN A LITTLE HARDER, IT IS EXTREMELY DIFFICULT TO DO THAT WHEN YOU ARE HAVING AN ASTHMA ATTACK AND CAN HARDLY BREATH AT ALL. BRING BACK THE CFC INHALERS AND SAVE LITERALLY MILLIONS FROM SUFFERING." CARLOS BIELMA, CA #1433
"I have used Proventil CFC inhalers successfully for many years. When I ordered a refill, I could only get Proventil HFA. When I used it, I experienced bronchial spasms, chest pain, high heart rate, and extreme nausea. I cannot afford to vomit as I have a tracheotomy (on a ventilator) and I could aspirate. I cannot tolerate alcohol... in the HFA inhaler. Not only are people suffering from asthma put in great danger by this change to HFA inhalers; there are many people like myself who have been able to enjoy a quality of life using CFC inhalers. Now I have become a hostage in my home with NO alternative but to stay by the nebulizer. I was shocked to read that the Clinton Presidency pressured and succeeded to include the banning of CFC inhalers in the Montreal Protocol in 1997, when they had been excluded. HFA inhalers are a serious health threat to me and to many others. I hope that the time has come for our government to realize just how really horrifying and unbelievable it is find out, in our Country, this health risk is not important. I find it hard to believe that CFC inhalers cause such drastic harm to our environment. We should at least have the alternative to get CFC inhalers if the HFA inhaler presents serious medical problems." J. Nelson MN #1436
"As a Cystic Fibrosis patient, I feel that the inhalers lacking CFC's (Pro-air, Proventil) are more than 75% less effective. I am coughing more, wheezing, and out of breath constantly. I believe when it comes down to human health issues, it's a miniscule price to pay." Kim Kreidler, FL #1437
"Signed ~ If we can't breath, and the new inhalers don't work.. what are we to do? Nebulizers make you a bit dizzy after each use.. and some people need to use their normal inhaler at least once every 4 hours.. some people more. You can't use a nebulizer that much. And the effects of a nebulizer won't last as long as we would like. Wanna help the environment? Make more electric cars damn it." Matt Modrow, WI #1444
"I experienced an acute asthma attack 12/30.07, which sent me to an urgent care facility when my HFA inhaler did NOTHING to relieve my symptoms and allow me to breathe. PLEASE BRING BACK CFC INHALERS. A country of asthma sufferers is counting on this happening so we can breathe again." Christina Ansley, FL #1445
"My daughter and husband are asthmatics and needs these inhalers....the new replacements are not effective. Please consider the facts and allow these inhalers back on the market" Beatrice Johnson, TX #1454
"I had the pleasure of taking my roommate to 2 urgent care facilities for an asthma attack. The first would not see her because it was pediatrics only. by the time we got to the 2nd she was in respiratory distress and required an ambulance ride( which came to $995). all because her rescue inhaler wouldn't work. it was the small HFA ( red one.) if she had the large CFC inhaler ( white one), this would have precluded a costly hospital visit and ambulance ride." Pete Hornung, CO #1463
"I don't like it when my own country threatens to take my life away when I never did anything wrong. Please help us." Jennifer Dukovich, MI #1467
"am a life long chronic asthma sufferer and am very concerned about the changeover from CFC to HFA inhalers. I received a HFA inhaler from my local pharmacy about six months ago and noticed straight away that inhalations of this medicine did not relieve my breathing. I subsequently requested that I only bought CFC inhalers as long as they lasted. Now it seems the only CFC inhalers available are manufactured by Armstrong - and THESE INHALERS DO NOT WORK!!!! IN FACT THEY SEEM TO HAVE MADE MY ASTHMA SYMPTOMS WORSE!!! I have been to the emergency room five times since November 2007, it is now February 2008, am on my fifth dose of prednisone - the only way I seem to be able to relieve my breathing is to use my nebulizer. I am signing this petition because I believe that many people are going to die, including myself, because of this change in medicine" karen roberts, CT #1483
"It seems ludicrous to put ethanol, a bronchial restricting toxin, in an inhaler for people who are having trouble breathing. Imagine opening your mouth and not being able to get any air. It is like drowning. I have had asthma all my life and all I can say is if this thing goes through, I hope the class action lawsuit(s) make the decision makers feel as if they cannot get any air!" Robin Cook, CT #1493
"My husband is the one that has to use the inhaler... Often enough to keep one handy. I cannot imagine why something like this could harm the environment when there are more pressing things that need to be regulated. Why someones' health needs to be hurt. We are in our 80's and live on a small pension and ss...have you tried that lately?" Lucile Gates, TX #1494
"People come first!" Frank Clyburn, AK, #1496
"I have almost no- relief from my asthma attacks with these new inhalers, these were supposed to be emergency inhalers but now when i feel an attack coming and I use these new ones that don't work I begin to panic and that makes the attacks even worse. I belief I my die because of this and something needs to be done" Samuel M. Johnson, IL #1500
"What do we have to do? File a class action lawsuit-- leave the country? I'm allergic to these new HFA inhalers (probably the ethanol corn based crap in them-- they actually induce an asthma attack. What a greedy country we live in. I will be fighting for my life."Marla Del Collins, NY #2099
"THE HFA INHALERS DON'T WORK FOR ME! IT SEEMS LIKE THE HFA MANUFACTURER IS TRYING TO CUT A FAT HOG. PLEASE HELP THE ASTHMA SUFFERERS, OR OUR EMERGENCY ROOMS WILL BE OVERRUN WHEN THE BAN BEGINS" GARY LEIFESTE, WA #1400
"This ProAir HFA does NOT work well for me. Instead of using the CFC Inhaler.. 2 puffs .. 4 times daily, I use the HFA inhaler 3 puffs (at least) 6 times a day. Therefore I am running out after 2 1/2 weeks and have to wait another 1 1/2 weeks before my insurance will pay for another. I end up having to use an over the counter inhaler, which works about the same as the HFA. Who does my husband sue if I have an Asthma Attack and die because this 'crap' they are giving us does NOT work ???? " Gloria Frasier, MI #1399
"If you don't do this peoples quality of life will drastically decrease or worse they will die." Marcus Contonikolas, NJ #1398
"Since using the new medicines I'm having attacks all the time. Before, I would have attacks for 1 week in April and 1 week in September like clockwork for the for the past 9 years. I've had multiple attacks EVERYDAY for the months of Aug, Sept and October. It's January and since mid December I'm having between 4 and 10 attacks weekly. I cannot imagine this sudden onslaught of attacks is a coincidence that suddenly my asthma has just gotten worse. I actually called the pharmacy to tell them that I must have gotten a faulty inhaler when he explained I was one of hundreds he had talked to. This is outrageous." K Kirkilas, IL #1396
"Plz reinstate CFC meds (albuterol)" Rosario Hermann, WI, #1395
"I can barely breathe without the old ones by Warrick. An inhaler that used to last forever now lasts maybe 4 weeks. They just aren't good enough." Josh Pasqualini, CA #1984
"They can tell me the medicine is the same but, if I don't have enough air to inhale as deeply for it to be effective what good is it. I'm sick of people making laws so I can't breathe but they still manufacturer cigarettes. It's insane." sharon orozco, IL #1986
"I have asthma and I have tons of allergies, one of them being corn. Any inhaler using ethenol is a death notice for someone like me, I really believe that the do gooders in this world don't give a hoot about the 3 million of us who rely on our inhalers." Joan Grimm, IL #1988
"If one person dies in the name of Political Correctness that is too many. This is absolutely ridiculous." Kathy Krizka RRT, IL #1991
"My daughter is a soccer player with sports induced asthma. She uses her albuterol inhaler prior to games and practice and never has a problem. When I put her new inhaler in her bag, Pro air, she said she could not breathe during the game. she did not even know that I had given her a different inhaler. I was able to obtain some Albuterol inhalers, but she will be in big trouble when they discontinue them altogether." diane johnson, IL #1992
"the new inhalers do not work i am so afraid everyday that i'll have a severe attack and not get enough relief from my inhaler" irene diericks, IL #1994
"I need Primatene to live!!!!!!!!" Bryan peterson, MN #2001
"HFA inhalers absolutely do not work for my asthma symptoms! Bring back the CFC inhaler!" Nora Walsh, IL #2025
"I am not being served equivently with ProAir HFA as I was with the generic CFC albuterol. I must now use 4-10 puffs and do not always get relief. I am therefore now using albuterol nebulizer treatments as a rescue method with no backup. I can no longer exercise as I used to, which causes other problems." Mary L Nelson, MN #2028
"I find the new inhalers totally useless. There is nothing more fightening than being able to breathe and trying to use the new inhaler. It takes so many puffs I am afraid I will fall over before I get some relief." Barbara Malik, IL #2029
"it didn't help me like the old inhalers." David Rodriguez, IL #2031
"This is going to kill alot of people!.. Myself included." Tracie Lemmon, MI #2037
"I MUST HAVE the old CFC Inhaler!!!!!" Benjamin Partlow, MD #2040
"This is totally absurd - I am an environmentalist but I understand that this has a negligible effect on the ozone layer. With all of the trespasses being made against our resources and environment, why pick on people who can't breathe?" Annie Cotten, NY #2043
"Albuturol CFC inhalers allow me to live a normal life. Without this inhaler, I am truly handicapped. This ban is inhumane to athmatics!!! I thought the function of government was to protect not cripple its citizens." Christine Adams, PA #2047
"the new inhalers are not effective" Gerald Pfefer, CA #2053
"My daughter needs the resue relief the current albuterol inhalers give her!" Susan, PA #2054
"Restore CFC Albuterol inhalers!!! My asthma has gotten worse on ProAir inhaler and I have not been able to breathe properly." Julie Carrasco, TX #2055
"My daughter suffers from asthma and the new inhalers are in effective. Please reinstate the "old" inhalers. People are suffering and we can't afford to worry about the environment while people are dying from asthma. Lets get our priorities straight." Adrienne Erickson, FL #2061
"The new inhalers make my condition worse!!" Billy Tomlinson, GA #2062
"Pro Air inhalers really suck! They don't help my asthma and they don't even last as long as the Warrick Albuterol inhlaers which work so much better. It's like we're being ripped off!! Please save Warrick Albuterol CFC inhalers!!" Mike Buffardi, NY #2065
"Knock off the political BS. Who is getting their pocket lined? Stop making our lives worse. I can't afford my medication as it is! Why are you doing this to your citizens?" Neal Alders, FL #2070
"The environment is very important. However, people are even more important! This makes absolutely no sense. Keep Warrick inhalers on the market!" C. McQuade, NY #2072
"As a copd patient I need these inhalers. So please do not ban them" Elsie Jones, NC #2075
"Everyone who sees this please sign my husband needs this bad. These last two weeks would have been unbearable if he didn't have his inhaler. He has been an asthmatic all his life and this is the only thing that helps him. If he didn't have his inhaler he would have been in the ER. The other crap don't work and they know it they just want us to keep going back to the doctor to waste more money! I believe the worst feeling you can have is suffocation but he has to go through it almost everyday.And he would actually suffocate if it was not for his inhaler so please sign this and pray that god listens so my soulmate and everyone else out there suffering like him can breathe a little easier!" Crystal Leslie, IN #2082
"This type of inhaler is the only kind that works for me. Please reconsider your ban on the CFC propellant inhaler. I need it for my survival" Matthew Flatley, WI #2083
"The new CFC free HFA inhalers do not work for my asthma." Davin Noto, AZ #2085
"I've used the Warrick "CFC" albuterol inhaler for seasonal allergies with accompanying asthma with great results. One puff, once a day and I'm fine. Recently I have been prescribed ProAir which I tried last night and it made my symptoms worse and I almost had to go to the ER. Please bring back the CFC inhalers so everyone who suffers from asthma can breath easier. These new HFA inhalers do not work." Aaron Diemel, CA #2086
"Both my parents have COPD and use their inhalers daily. Please don't ban something that is helping them so much." Linda Davis, TN #2090
"I THINK THAT WHEN OUR POLITICIANS LISTEN TO NO GOOD LOBBYISTS REGARDING MILLIONS OF PEOPLES MEDICINE, MEDICINE THAT SAVES LIVES ON A DAILY BASIS, I THINK THAT THOSE POLITICIANS SHOULD BE OUSTED AND NEVER ALLOWED BACK IN ANY PUBLIC OFFICE AGAIN. THE HFA INHALERS DO NOT ADMINISTER THE MEDICINE EFFECTIVELY. THE MEDICINE SITS IN MY THROAT AND NEVER GETS TO MY LUNGS. APPARENTLY MY LIFE MEANS NOTHING TO THESE POLITICIANS" CANDICE HOLLINGER, CA #2091
"Please Hear US! I am allergic to the HFA inhaler - almost immediately my scalp itches, then feels like someone left a hot iron on my scalp & my hair proceeds to fall out. The reaction happens after just ONE DOSE! Also it stings my lungs! You can't carry a nebulizer with you when you suddenly can't breathe! I have COPD but DON'T WANT TO DIE" Susan Hooper, OH #2094
"I have asthma. I cannot tolerate the HFA albuterol inhalers. I am allergic to them. I can only use the CFC albuterol inhalers, which I can still get. But when they are banned, I will have to switch to a nebulizer, which I don't know if I can handle. If that doesn't work I WILL DIE. That isn't fair. Please fix this problem so I can continue to breath and not die before my time." Paulette Brady, CA #1983
"COPD patient, and the new ones DON'T work. Help us, please." Vicki W Huehner, NC #1978
"i have had asthma since the day i was born, i am 20 years old. i have never been to the hospital because of asthma before the pharmacy started giving me proair hfa. since then ive been to the hospital 5 times, had tubes stuffed down my throat, passed out because of lack of oxygen, and wrecked a car because my breathing was so bad." John William Beever IV, MD #1973
"For fourteen years I have had asthma that was completely controlled under my CFC Inhaler. I used to be extremely active in various activities including swimming, running, horseback riding and now I can barely get up a flight of stairs. I am a teacher and all of my absences are affecting my children's performance. I have tried "acceptable alternatives" for CFC Inhalers but have only ended up more sick due to their side effects. I know my case isnt the worst and I know I'm not alone. They cannot do this to us!" Jeannette Glime FL, #1958
"My son, who is 14 years old now has been using the Warrick inhaler for 14 years with good success. For the FDA to insist that we change to this ineffective HFA inhaler is medieval. He now has asthma that turns into pneumonia on occasion and I pray to God that nothing happens to him. We need to bring a class action suit against this policy." Laura Harris, MD #1957
"I was rushed to the hospital er in late 2007 for a severe asthma attack. well needless to say 7 breathing treatments,a tank of oxygen,and a shot I started to breath better. The er doctor said that his er has had a record in cases since our LIFE LINE has been taken from us. Please help us and let us decide if it's bad for us or not. I would like to bike ride with my children again but I can't because there is no FAST acting relief for me. Please give us back our life saving CFC's. My children and other children as well as adults are suffering and when is enough, enough already? Please help us who are suffering everyday because of this." Stephanie Brown, MO #1956
"These NEW HFA inhalers DO NOT WORK they make my asthma worse. Please don't let me suffer all I ask is that I can breathe" Janice Crotzer, CA #1940
"This is having a significant effect on my life-- I've had to reduce exercise in the winter months to almost nothing because my new rescue inhalers simply do not work." Kevin J. Causgrove, MI #1939
"I have used these inhalers about 8 times and have not had good results. There is no worse feeling than not being able to breath and now I have no confidence these new inhalers will ever work. Please leave rescue type meds alone!!" james ciccolo, MA #1930
"Please leave the cfc inhalers in the market." Rabbi Moishe Mayir Vogel, UT #1921
"ProAir sucks and people will die from this change." Shannon Smith, SC #1910
"HFA inhalers are dangerously ineffective. Thank you for the opportunity to sign this petition." Bruce Parker, NJ #1900
"you suck you sonofabitches!!!!!" Amy Wood, IN #1899
"I have to tell you.. My heart rate increases with use of this product, I had a very scary episode a week ago that made me wish for a minute that my asthma got the best of me. I had an alergic reaction to something, and it took 5 puffs of this stupid inhaler (proair hfa) and a nebulizer treatment for my breathing to be restored. My lung function has decreased with use of this thing. Remember politicians can be voted out just as easy as they can be voted in. Safe a few lifes washington. it may justify everything else you do... bring back the cfc inhaler/" Michael Land, CT #1880
"I have had severe chronic asthma for over 25 years, along with severe allergies, and sinus. Until the FDA mandated a change from CFC to HFA inhalers, combining prescription medications with a very regimented lifestyle (that included restrictions on environment, food, some medications, and sundry other items) enabled Me to live a life that was about 80% normal. The new HFA propellants (Qvar & Proventil HFA) each gave me an extremely severe asthma attack. The control of my asthma has declined dramatically! And I have NO EMERGENCY INHALER! Friends with asthma tell me that the HFA inhalers just dont deliver the medicine. My insurance company has mailed me a notice that the HFA propellants require much more force to inhale! This would be ironically funny if it were not a matter of life and breath. Restore CFC inhalers!" P Johnson, NJ #1870
"I can't breathe, the new inhalers suck, how much money was it worth to someone to kill people?" Ashley Kay, TX #1869
"Oh please, please bring back my old albuterol inhaler. With the pro-air, I just can't inhale. Selfish me, I care more about being able to breath than political correctness." Connie Jewell Byerley, MO #1857
"bring back my old inhaler,so I can breathe" sallie freeman, IA #1851
"My son needs CFC inhalers for his asthma. Do NOT take these off the market!" Eileen Sullivan, NC #1846
"Want the old inhaler BACK" Rosanne Robinson, FL #1840
"PLEASE keep these inhalers on the market. The new ones DO NOT work as well and are causing health concerns for many people including myself and my daughter." Sandy Sanders, IL #1839
"HFA inhalers do NOT work as well as the CFC...making this switch is screwing with people lives!" Christy Grasmick, CO #1834
"Please help me breath again!!!!!!!!!!!!!!!!!!!! I just want my old med. back. As if it's not bad enough not to be able to breath and now you can't get the ONLY med. which helped." Melody Schmitz, MO #1824
"The new HFA inhalers are a direct threat to people's health. They do *NOT* work like the old inhalers did and should be taken off the market immediately and the old inhalers brought back!" David Rheault, MD #1817
"I almost died one month after beginning use of this inhaler. I have never been hospitalized for asthma, untill use of PROair HFA. I have no clue why but it just does not work. I want my life back." Christopher S Cantrell, NM #1815
"I wouldn't wish the agonizing death from anoxia on anyone. Why is my government forcing it on me?" Marc A. Pozza, OH #1813
"Since age 2 I have relied on inhalers. The new ones do not work and made my breathing much worse. I am currently getting the old ones from Mexico." mary earhart, CA #1812
"I hate the new inhalers. I would like to have the old Warwick CFC back The HFA does not relieve symptoms. Thanks" Adolphine Slattery, FL #1810
"I have a life threatening corn allergy, which make the use of ethanol (corn alcohol) in inhalers deadly for me. Please help save my life." Christine Robinson, CO #1804
"Please Please Please bring them back. I want to breathe again!" Paul Bandur, IL #1866
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