Is the drug companies killing asthmatics? Petition and FACTS!

[Guest guest]

In Memory of Krimson Leah HugheyDecember 29, 1980-March 6, 2007https://www.savecfcinhalers.org/"We are the parents of an Asthmatic. Her symptoms and diagnosis began at age 3. She was very active and was just finishing her BBA. One math class to go. She had already walked with her class waiting for the issuance of her diploma once she finished up that math class. She walked with her class in Dec. of 06. She turned 26 the end of that month. She had a fatal Asthma attack on Feb. 25, 2007. She had filled her prescription for her "new" HFA Proventil inhaler 12 days prior to the attack. My husband was able to do CPR and get back vitals. She was life flighted to a hospital in a larger city 20 miles from us. She remained on life support for 10 days. The oxygen levels were so limited that she sustained brain damage that left her unable to pull out. They could not intubate her because her lungs were so locked down. They bagged her during the squad ride to the local hospital and during the flight. Once she reached the hospital they had to paralyze her in order to put her on the vent."Please understand that our daughter was not taking any other medications other than the HFA Proventil inhaler and her Albuterol for her nebulizer. She was not sick and had been attending her two jobs. In fact she was scheduled to go snowboarding that day but the trip was canceled due to severe weather. She saw our family doctor at least once a year for routine checkups and prescription renewals, and while she was at school in New York she saw another doctor for follow-up whenever necessary. Typically asthmatics get to experience emergency room visits and possible 911 calls to the squad during their early years. Our daughter was no exception. Prior to this incident however, she had only had one previous squad ride and that was 6 years earlier. On that occasion, she immediately responded to treatment and was sitting up and talking to the EMS crew during the ride to the ER. That trip in the fall of 2000 was the last time she had gone to the ER for her asthma, and the only previous time in her life that she had felt the need to call 9-1-1, until the time of her death."We immediately began to suspect that the new HFA Proventil inhaler was a contributing factor to her death. Why would we suspect it? For the simple reason that the inhaler was the only thing that had changed, and that change had taken place just 12 days before this fatal attack. When we mentioned to friends our suspicion, we found that she had expressed a concern to one friend that “my new inhaler doesn’t seem to be helping”. That information reinforced our suspicion so we filed a medwatch report with the manufacturer of the inhaler. "When we read the quote on your website that says “When you can’t breathe, nothing else matters”, it struck a note with us because that is what we experienced that night with our daughter, right here in our home. Her last words were, “Mommy, Mommy, help me, do something, I'm dying.”Phil and Maureen Hughey, Columbus, Ohio, August 10, 2008Krimson's MedWatch report was filed by her parents and her pharmacist. It is on page 27 of the Proventil HFA MedWatch PDF"I support the removal of CFCs in the most expedient and safest way possible. "In 2006 I published an article in the New Zealand Medical Journal (NZMJ 27 Oct 2006, Vol 119, No 1244) comparing a CFC containing asthma inhaler (Ventolin), with a new CFC-free (HFA) inhaler (Salamol). In this study, half of those on the CFC free inhaler developed unstable asthma and 93% of those remaining had demonstrably worse asthma. My clinical observations of Salamol as a CFC-free (HFA) inhaler are that patients don’t like the taste, the device blocks and needs regular cleaning (difficult for arthritic hands), and asthma stability is significantly reduced. My observations are supported by many pharmacists and clinicians and this study has been in the international community for critical review. "I support a policy position that offers CFC free inhalers (HFA inhalers) to patients who successfully complete an appropriate trial AND who are comfortable and competent to use them."Dr Shane Reti (QSM), M.D.Director, International Programs,Division of Clinical Informatics,Beth Israel Deaconess Medical Center,Harvard Medical School Affiliate,330 Brookline Ave,Boston, MA 02215NOTE: The HFA albuterol brand Salamol that Dr. Reti refers to is made by Teva/Ivax and is probably very similar to Teva/Ivax's Proair brand, which dominates the US HFA albuterol market. Dr. Reti is a primary care physician from New Zealand, which has one of the highest asthma rates in the world."Does anyone believe the CFC's from these inhalers poses a harm to the ozone? 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. This policy makes me furious as an asthmatic and a physician." Omar Jassim, MD PhD, MO #2101“If CFC's have not been proven to have had a major effect on ozone production, why are we depriving patients of this therapy?” Kurt Budelmann M.D., SC #2266“As a scientist in Pharmaceutical R & D, and a user of albuterol inhalers, I implore the FDA to rescind this decision. The new HFA inhalers do not function in a manner consistent with the older CFC inhalers, a fact undeniable by all, except by the PMA. People will die from the new HFA formulations. This is an inane quest and was from the outset, with the sole benefit being good public relations for the PMA.” William R. Vincent, Ph.D., NJ #2271Signed without comment, William H. Buck, RRT, RPFT, PA #2157“I have been a Respiratory Therapist for 12 years. I have never seen so many Pulmonary Patients in distress. This is a form of torture. Let Patients have their life-saving medications. HFA inhalers do NOT work for everyone.” Julie, RRT, AZ #2406"I'm a respiratory therapist with asthma and my 18yo son has asthma. He's a football player with a college scholarship and he relies on his albuterol during practice and games. The new albuterol HFA does not give him relief anymore. I had to switch him to a portable nebulizer and now I'm getting Maxair since that hasn't changed yet, but there are plans to ban that too. Asthma medications are supposed to help kids stay active and healthy but we definitely have taken a big step backwards with the "new environmentally safe albuterol" Brenda Lusty, RT, MN #1144"As a nurse I have seen such horrible things with HFC inhalers. They are just awful. I have a friend who is using CFC and may not be with us if not for it." Anonymous, PA #2654"As a health care provider to many patients with COPD, I find this ludicrous and heart-wrenching." Deborah Trendel, RN, CA #2552 "I am an RN and have asthma. I tried the ProAir HFA and found that even with multiple dosing, which is not the way to use an inhaler, I was unable to breathe adequately. During the brief time I used the ProAir HFA, it was necessary to use albuterol nebulizer treatments to actually clear my lungs. My local pharmacy has agreed to provide me with albuterol CFC inhalers whenever possible, but I am truly frightened about what will happen if they are no longer available. I suppose all asthmatics could carry nebulizers with them to work, to concerts, shopping, etc, and use them on an emergency basis to continue breathing. My point is, get real, FDA. The HFA inhalers are NOT as effective, and banning CFC inhalers is dangerous for a significant segment of the population." Nancy Neidt, RN, MN #2296“We must bring back the availability of CFC inhalers. This is a medical crisis. As an asthmatic and health care provider I cannot urge this enough!! In the rush to "Go Green"" we are leaving those with asthma to suffer!” Brandon Wessel, AZ #1293 "If one person dies in the name of political correctness that is too many. This is absolutely ridiculous." Kathy Krizka RRT, IL #1991See more comments at the Quotes from Petitioners page of this site, the Guestbook, and the Original Petition site.The Petition1) CFC-propellant (chlorofluorocarbon) MDIs (metered-dose inhalers), which include a number of different medications used by 40 million U.S. pulmonary patients to help them BREATHE, are being systematically banned by the FDA and the EPA. The ban of all CFC MDIs is politically required by an international treaty (the Montreal Protocol on Substances that Deplete the Ozone Layer) and legally required by the U.S. Clean Air Act.2) CFC MDIs are being replaced by so-called *'environment-friendly' HFA-propellant (hydrofluoroalkane) MDIs which seem to be safe and effective for most, but unfortunately, not all patients. MANY THOUSANDS OF PATIENTS CAN NOT TOLERATE HFA MDIs AND THESE ADULTS AND CHILDREN WILL NO LONGER HAVE ACCESS TO A SAFE, RELIABLE RESCUE INHALER ONCE CFC ALBUTEROL MDIs ARE BANNED EFFECTIVE DECEMBER 31, 2008. *There is nothing 'environment-friendly' about HFA MDIs. HFA emissions have such severe GLOBAL WARMING POTENTIAL (13 times worse than CFC-12 and 26 times worse than CFC-11) that they have been targeted for reduction by the Kyoto Protocol:Table 1. Relative Ozone Depletion Potential (RODP), Global Warming Potential (GWP), and Atmospheric LifetimesTABLE 2: Greenhouse Gases Trapped Between Treaties 3) The decision to ban CFC MDIs was an ENORMOUS MISTAKE that must be corrected by Congress and the Administration. There are NO other propellants besides CFCs-11,12 that are safe and effective for all patients. 15,000 COMPOUNDS WERE REVIEWED (p.30) AND ONLY HFA-134a AND HFA-227 WERE CONSIDERED TO BE POTENTIALLY SUITABLE ALTERNATIVES TO CFC-11,12. WE NOW KNOW THAT THEY ARE NOT COMPARABLY SAFE TO CFC FORMULATIONS. 4) There is NO benefit to be gained by depriving patients of CFC MDIs. CFC emissions are too trivial to harm the ozone layer and banning them will not reduce UV-B ground radiation. Skin cancer rates and cataract rates can NOT be reduced by banning CFC MDIs, which was the reason given for banning them in the first place. Consider the following: During the period 1957-1984 the annual age-adjusted incidence rate of cutaneous malignant melanoma (CMM) increased by 350% for men and 440% for women in Norway. The annual exposure to carcinogenic sunlight in Norway, calculated by use of measured ozone levels, showed no increasing trend during the same period. Thus, ozone depletion is not a cause of the increasing trend of the incidence rates of skin cancers."The observed trend to increased incidence of melanoma and the common (non-melanomatous) skin cancers (basal and squamous cell carcinomas) during the past two decades is probably due to the popularization of sun bathing rather than depletion of the Earth's protective ozone layer by chlorofluorocarbons (CFC's)." 5) In addition, the deadliest form of skin cancer, malignant melanoma, as well as cataracts, are now thought to be linked to UV-A rather UV-B radiation, and UV-A radiation is NOT absorbed by the ozone layer: "UV-B rays are a shorter wavelength and are absorbed in the top 1mm of the skin, the epidermis, causing sunburn. (UVB = Burning). SPF measures UVB protection.""UV-A rays are a longer wavelength and penetrate more deeply, into the dermis. There, they cause tanning, damage to connective tissue (collagen), damage to the immune system, and the deadliest skin cancer, melanoma. (UVA = Aging and tanning and cancer)" 6) Increasing skin cancer rates are NOT due to ozone layer depletion (which CFC MDI emissions are too trivial to effect, in any event), but rather, to CHANGES IN HUMAN BEHAVIOR OVER THE LAST FEW DECADES, such as tanning, the use of tanning booths, and the widespread use of sunscreens (as opposed to the use of protective clothing), which dangerously inhibit Vitamin D production, among other potential problems:"Worldwide, the countries where chemical sunscreens have been recommended and adopted have experienced the greatest rise in cutaneous malignant melanoma, with a contemporaneous rise in death rates. In the United States, Canada, Australia, and the Scandinavian countries, melanoma rates have risen steeply in recent decades, with the greatest increase occurring after the introduction of sunscreens.13-17 Death rates in the United States from melanoma doubled in women and tripled in men between the 1950s and the 1990s.18 The rise in melanoma has been unusually steep in Queensland, Australia, where sunscreens were earliest and most strongly promoted by the medical community.19 Queensland now has the highest incidence rate of melanoma in the world.20 In contrast, the rise in melanoma rates was notably delayed elsewhere in Australia,20 where sunscreens were not promoted until more recently.""While largely transparent to most of the UV-A spectrum, sunscreens effectively block UV-B. UV-B is the normal stimulus for accommodation of the skin to sun, such as thickening and increased pigmentation. 27 Sunscreens also inhlbit the skin's production of vitamin D, which is similarly dependent on UV-B.28 Laboratory findings indicate that vitamin D metabolites suppress growth of melanoma cells,29 suggesting the possibility that vitamin D deficiency in the skin may have a role in the etiology of melanoma.""There may be no such thing as a ‘safe’ tan based on ultraviolet (UV) radiation, according to a series of papers published in the October issue of Pigment Cell & Melanoma Research, the official journal of The International Federation of Pigment Cell Societies (IFPCS) and the Society for Melanoma Research. Reviewing published data in the field, the authors report that both tanning and skin cancer seem to begin with the same event – DNA damage caused by UV exposure. This leads them to suggest that a ‘safe’ tan with UV may be a physical impossibility.""The complex relation between sunscreens and skin cancer is further illustrated by reports of an increased risk of malignant melanoma in sunscreen users.""People 35 or younger who used the (tanning) beds regularly had a melanoma risk eight-fold higher than people who never used tanning beds. Even occasional use among that age group almost tripled the chances of developing melanoma.""Women who use tanning beds more than once a month are 55 percent more likely to develop malignant melanoma, the most deadly form of skin cancer." 7) The FDA acknowledges that it has no evidence whatsoever that the ban of CFC MDIs will yield any human health or environmental benefits, no evidence that it will result in any reductions in skin cancer or cataract rates:"... we (the FDA) are unable to quantify the environmental and human health benefits of reduced CFC emissions from this regulation (banning CFC MDIs.)"(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)."(p.75)Our three year review of FDA MedWatch data shows that HFA rescue inhalers are significantly more dangerous than CFC rescue inhalers. Clinical trials show that HFA albuterol inhalers are significantly more dangerous than CFC albuterol inhalers. Schering-Plough, one of the three marketers of HFA albuterol discloses on its homepage that "RAPID HEART BEAT, VOMITING, CHEST PAIN and PALPITATION OCCURS MORE FREQUENTLY WITH PROVENTIL HFA (than with CFC albuterol)." There is a large United Kingdom postmarketing study that shows that HFA albuterol is more dangerous than CFC albuterol. There is a New Zealand clinical trial that shows that HFA albuterol is more dangerous than CFC albuterol- so much more dangerous, in fact, that the physician who conducted the study believes that HFA inhalers should only be prescribed for "patients who successfully complete an appropriate trial AND who are comfortable and competent to use them." Ethanol, a toxic substance according to the EPA and a Class 3 Residual Solvent according to the FDA, is used in amounts of between ten to fourteen percent by weight in three of the four HFA rescue inhalers (and many HFA control inhalers) and ethanol in MDIs is a PROVEN BRONCHOCONSTRICTOR for some pulmonary patients. This might explain the GREATER DEATH RATE and GREATER ADVERSE REACTION rate for HFA inhalers that shows up in the FDA MedWatch database over a three year period. 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 an additional potential serious risk to corn-allergic patients, according to technical staff at Schering-Plough (marketer of Proventil HFA) and Sepracor (marketer of Xopenex HFA). Potentially dangerous impurities known as "extractables" and "leachables" which are caused by the interaction of the propellant with the complex materials inside the inhaler canister are only now starting to be researched and analyzed. It seems very likely that this will prove to be a contributing factor to the GREATER DEATH RATE and GREATER ADVERSE REACTION RATE that we see in HFA inhalers.'ENVIRONMENT-FRIENDLY' HFA-134a was NEVER tested on pulmonary patients- it was only tested on normal, healthy subjects. (Normal, healthy subjects do not have INFLAMED and HYPER-REACTIVE AIRWAYS and SEVERE ALLERGIES.) HFA albuterol inhalers were NEVER thoroughly tested in the U.S. The FDA ignored the strong advice of its own PADAC (Pulmonary Allergy Drug Advisory Committee) Physician Advisors over several years to conduct rigorous, long-term, real world postmarketing studies, phase IV clinical trials, and/or large-scale database analyses BEFORE banning CFC albuterol inhalers. Instead, the FDA took the advice of the drug companies (IPAC, the International Pharmaceutical Aerosols Consortium) and decided that large-scale, thorough, long term testing of these critical medications (which are relied upon by 40 million patients) was not necessary.At the suggestion of the drug companies, the FDA adopted watered-down standards for the pre-clinical and clinical trials of HFA MDIs. They "bridged" the remarkable safety record of CFC MDIs over to HFA MDIs because the active ingredient of CFC MDIs was virtually the same as the active ingredient of the HFA re-formulated version. HOWEVER, VIRTUALLY EVERYTHING ELSE ABOUT THE RE-FORMULATED VERSIONS WAS DIFFERENT: THE CO-SOLVENTS (ETHANOL), THE PROPELLANT (NEVER TESTED ON PATIENTS, ONLY ON NORMAL, HEALTHY SUBJECTS) THE USE OF CORN RESIDUE (IN THE ETHANOL), THE ELASTOMERS AND OTHER HI-TECH MATERIALS THAT WOULD INTERACT TO PRODUCE A BRAND NEW GROUP OF POTENTIALLY DANGEROUS EXTRACTABLES AND LEACHABLES. This is all you need to know about the FDA's committment to the health and safety of patients and the quality of their clinical judgment. The FDA was unable or unwilling to produce the U.S. postmarketing data that it was legally required to rely on (per FDA Final Rule 21 CFR 2.125) to determine whether or not HFA albuterol inhalers "adequately served" patients at its June 10, 2004 PADAC meeting. It has never produced this data. THEREFORE, WE DEMAND THATThe Clean Air Act be AMENDED to allow for the immediate production of CFC-11,12 and carbon tetrachloride in the United States in amounts determined solely by market demand for CFC MDIs.FDA Rule 21 CFR 2.125 be COMPLETELY ABOLISHED.The Parties to the Montreal Protocol be STRONGLY ENCOURAGED to create a permanent MEDICAL EXEMPTION for CFCs, but the U.S. MUST NOT DELAY RESUMPTION of CFC MDI production pending the Montreal Protocol's consideration of this amendment.World-class executive talent with a proven track record of commitment to patient safety be APPOINTED to lead the FDA, in order to quickly reverse decades of organizational inertia and rapidly execute the new policy of emergency approval, production and distribution of all previously approved CFC MDIs. We STRONGLY RECOMMEND that the next President of the United States look for such talent within the FDA's Office of Surveillance and Epidemiology.While it is unfortunate that these emergency actions will require that the U.S. at least temporarily ABROGATE certain provisions of the Montreal Protocol, this is a necessary evil. The health and safety of America's citizens must take precedence over the U.S.'s political commitments to this severely flawed treaty.NOTE: The list of petitioners will be forwarded to Congress and the Administration when a sufficient number of signatures has been collected.However, this is only a formality. The petition in and of itself is meaningless. If a sufficient number of people call their five political targets, we will prevail; if not, we will lose.PHYSICIANSFor your patients who complain about HFA inhalers, why not have them try Warrick CFC albuterol inhalers and see if they don't feel better almost immediately? WARRICK CFC ALBUTEROL MDIs MAY BE ORDERED UNTIL DECEMBER 31, 2008, WHILE SUPPLIES LAST, FROM: GILLESPIE'S DRUGS44523 Marietta RoadCaldwell, Ohio 43724PHONE: 1-740-732-2356FAX: 1-740-732-7381HOURS: Monday-Friday, 8:30 am to 6:00 pm, Saturday 8:30 am to 1:00 pm ESTWeb: http://gillespiesdrugs.com/Email: staff If your patients do better with Warrick CFC Albuterol MDIs please email us at sponsor Thank you.NOTE: We receive no compensation for this referral. We receive no compensation from any vendor mentioned on this website. We receive no funding from any government, for-profit or non-profit agency or organization. The National Campaign to Save CFC Asthma Inhalers is 100% financed by non-deductible contributions made by concerned citizens. PETITIONERS1) Sign-up on this new petition is mandatory for all old and new petitioners if you want to receive emailed updates from us.2) We need volunteers who are willing to talk to local newspaper reporters about their (or their family member's) problems with HFA inhalers. If you are willing to do this, tell us in the sign-up form below and PLEASE include your telephone number with area code since reporters often call us at the last minute. We’ll prepare you first, by phone. Everyone who’s done this has felt very satisfied afterwards; when you see the signatures spike in your state the day the story runs, you'll know that YOU have helped hundreds of people.3) Please make sure to update your contact information whenever necessary by clicking on the "manage your subscription" link on every email you get from us. 4) Visit the old petition to see incoming comments. 5) Please continue to post your comments and questions in the 'Guestbook' page of this site.Here's how to find your CONGRESSIONAL DISTRICT NUMBER for the sign-up form below, as well as the PHONE NUMBERS FOR THREE OF YOUR FIVE POLITICAL TARGETS:1) Go to this link: http://www.visi.com/juan/congress/2) Scroll down a bit and enter your full address (ignore their directions- you may live in a ‘split’ Congressional District and our directions will save you time.)3) Click on the “Submit it” button 4) You will be brought to the next screen, scroll down to find your two senators and one representative. It will be very similar to the example below: (The names of your Senators and Representative will be different, of course, based on your own address) Member Name DC Phone DC FAXSenator Herb Kohl (D- WI) 202-224-5653 202-224-9787Senator Russell D. Feingold (D- WI) 202-224-5323 202-224-2725Representative Paul Ryan (R - 01) 202-225-3031 202-225-33935) Your Congressional District Number is located immediately to the right of your Representative’s name. As in the example above, R-01 would be your Congressional District Number. Please enter this number on the sign up form.PLEASE: If you want help finding your correct Congressional District Number, just email us your name, street address, city, state and zip code to sponsor and we will do this for you and email you the phone numbers for your FIVE POLITICAL TARGETS. PLEASE do not guess.6) Save the above three phone numbers for YOUR THREE POLITICAL TARGETS- you'll be calling them for different reasons in the future. AND ADD THESE TWO TO COMPLETE YOUR FIVE POLITICAL TARGETS:THE McCAIN CAMPAIGN: (703) 418-2008or: http://www.johnmccain.com/Contact/THE OBAMA CAMPAIGN: (866) 675-2008 option 6or: barackobama.com/page/s/contact2URGENT: PLEASE ADD US ( savecfcinhalers.org ) TO YOUR 'SAFE SENDERS' LIST OR WHITELIST SO OUR EMAILS DO NOT END UP IN YOUR SPAM/JUNK/BULK MAIL FOLDERS. If you don't know how to do this, please ask your email provider or ISP. Email deliverability is TERRIBLE unless you do this.Please sign the petition To Visitors From Foreign Countries: If you, or someone you know, is having medical problems or not getting the relief they need from any type of HFA inhaler, PLEASE describe the complaint in as much detail as possible in the 'GUESTBOOK' page of this website, and try to include the BRAND of the drug, if possible, and what it is used for, and your NAME, CITY, and COUNTRY.The FDA wants the U.S. public to believe that patients in other countries are completely satisfied with HFA inhalers, when we know for a fact that many patients all over the world can NOT tolerate HFA inhalers and want to be able to use CFC inhalers again. Please post your comments and help us expose this FDA 'myth'.