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December 29, 1980-March 6, 2007
"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 given Azmacort inhaler- an inhaled corticosteroid- in middle school, but she had such a severe, prolonged case of candida that it had to be discontinued. She took oral prednisone when it was prescribed, which was very rare.) 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, by email, August 10, 2008
Krimson's MedWatch report was filed by her parents and her pharmacist.
It is on page 27 of the Proventil HFA MedWatch PDF, in the Press Room about halfway down the page.
The FDA knew in 1997 that large-scale U.S. postmarketing studies of the replacement HFA asthma inhalers should have been done before CFC asthma inhalers were banned:
DR. JENKINS (FDA): "There is all the other criteria that have to be met (for FDA approval of HFA MDIs), of patient acceptability, serving patient needs... safety data from the large postmarketing experience..." (p.257, 1997 PADAC)
DR. JENKINS (FDA): "you need to remember that the new (HFA MDI) formulations are new drugs, they often have different excipients (inactive ingredients), and different devices, so there are additional needs for more extended studies for those for safety purposes,as well as durability of the efficacy response." (p. 302, 1997 PADAC meeting)
DR. JENKINS (FDA): "I think a point we all need to keep in mind is that normally, when we are approving new drugs, whether it be a new molecular entity, a new formulation of an existing drug, we're approving that thinking that it's going to go into the market and become part of the overall armamentarium for the disease. This (HFA MDIs) is a different paradigm, where these products are being specifically developed to replace existing products (CFC MDIs). So when we approve these non-CFC alternative products, there's an intent through the Montreal Protocol and the Clean Air Act that if those are acceptable to patients, they're (HFA MDIs) going to replace the old products, and part of the question we're trying to get answers from you are, how can we be certain that we're not going to make things worse?"
(p. 172, 1999 FDA PADAC meeting)
And yet, due to opposition from IPAC (the International Pharmaceutical Aerosol Consortium), these critical HFA asthma inhaler U.S. postmarketing studies were never done!
Visit The Campaign Updates Page For 3 Years Of HFA vs. CFC Albuterol MedWatch Data That The FDA Does Not Want You To See...
The Petition To Legalize Chlorofluorocarbon (CFC) Metered-Dose Inhalers (MDIs)
In a dangerous overreaction to the problem of stratospheric ozone layer depletion, the parties to the Montreal Protocol on Substances that Deplete the Ozone Layer (which is enforced in the U.S. by the Clean Air Act Amendments of 1990), have banned chlorofluorocarbon (CFC) metered-dose inhalers (MDIs), which were relied upon by 40 million American asthma and pulmonary patients.
There is substantial evidence to support our position that the replacement 'ozone-friendly' hydrofluoroalkane (HFA) MDIs are not as safe and effective for all patients as CFC MDIs are, due to the HFA-134a propellant itself, or to other INACTIVE INGREDIENTS OR IMPURITIES unique to each HFA MDI. We do not question the safety or efficacy of the active ingredients in HFA MDIs.
Thousands of patients are suffering unnecessarily, and in some cases dying as a result of the ban of CFC MDIs and the forced use of HFA MDIs.
To ensure maximum patient safety, "Clinicians should avoid using new drugs (Ed. like HFA MDIs) when older, similarly efficacious agents (Ed. like CFC MDIs) are available."Journal of the American Medical Association, Vol. 287 No. 17,May 1, 2002.
The FDA is ignoring a strong safety signal about HFA albuterol MDIs in its own MedWatch data, which we have summarized on a chart halfway down the 'Press Room' page of our website.
Stratospheric CFC levels have been falling since the late 1990s, and global ozone has been recovering since the early 1990s, despite the continuous emissions of CFCs from all sources at levels much greater than CFC MDIs ever produced, thereby proving the harmlessness and insignificance of CFC MDI emissions.
Peak global CFC MDI emissions in 1997 accounted for less than .5% of peak global CFC emissions from all sources, the totality of which was never able to produce detectable increases in ground UV-B radiation, proving that THE EPA AND FDA PROPAGANDA CAMPAIGN ABOUT THE ENVIRONMENTAL DANGERS OF CFC MDI EMISSIONS (that they would deplete the ozone layer enough to increase UV-B ground radiation, thereby increasing skin cancer rates) IS ONE OF THE GREATEST SCIENTIFIC FRAUDS IN HISTORY.
Yet based on this non-detectable increase in ground UV-B radiation, 40 million asthma and pulmonary patients have been deprived of their much safer, more effective, non-clogging, lifesaving CFC MDIs.
The ban of CFC MDIs was the first ban of lifesaving drugs in U.S. history without any medical justification, and it has resulted in pain, suffering, decreased quality of life, and death for thousands of innocent men, women, and children.
Therefore, We Demand That
1) The President issue an Executive Order permitting U.S. residents to continue to buy safe, effective, non-clogging CFC MDIs from foreign providers.
2) Congress amend Title VI of the Clean Air Act Amendments of 1990 to allow for the immediate production, sales, and distribution of CFC-11,12 (and the required feedstock carbon tetrachloride) in the United States in amounts determined solely by market demand for orally and nasally inhaled CFC MDIs.
3) FDA Final Rule 21 CFR 2.125 be amended to accommodate the legalization of all orally and nasally inhaled CFC MDIs that meet (or have met) normal standards of FDA approval.
4) 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.
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, extraordinarily misguided treaty.
NOTE: The database of petitioners will be forwarded to the Congress and the Administration when a suitable number has been reached.
PLEASE DONATE TO OUR CAMPAIGN TO PERMANENTLY LEGALIZE CFC MDIs HERE
