Petition to save CFC inhalers (New ozone-friendly asthma medications don't work)

ipetitions.com & FDA ^ | 5/30/08 | AngieGal

[AngieGal]

The following petition has 2,200 signatures. Also please file any complaints with the FDA (Medwatch Reporting Form). Here is the link.

https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm
Find the blue Begin button to the right to start.

Text of petition:

The FDA, in compliance with the Montreal Protocol, has banned the use of life-saving CFC propellant albuterol asthma rescue inhalers in order to help restore the ozone layer, even though it has been widely acknowledged that these CFC inhaler emissions are too trivial to harm the ozone layer:

Leslie Hendeles, University of Florida Professor of Pharmacy and Pediatrics, has noted that CFC inhalers release negligible amounts of the propellant and DO NOT POSE A THREAT TO OZONE DEPLETION. (LINK 1)

"The amount of CFCs in inhalers is minute, so BANNING THEM WON'T MAKE ANY IMPROVEMENT (in the ozone layer)." says Sallie Baliunas, an astrophysicist at Harvard University and the George Marshall Institute (LINK 2)

CFC rescue inhalers have proven their safety, effectiveness, and reliability to tens of millions of asthma, COPD, cystic fibrosis, lung cancer, and other pulmonary patients for almost thirty years.

Therefore, before the FDA could ban CFC rescue inhalers (by removing their "essential use" exemption from the U.S. Clean Air Act's Ozone Depleting Substances ban [ODS]), it was LEGALLY REQUIRED TO FIND that:

A) PATIENTS WERE "ADEQUATELY SERVED" by Proventil HFA and Ventolin HFA replacement inhalers, and

B) THERE WAS (as of March 31, 2005) or there would be, by December 31, 2008, "ADEQUATE U.S. POSTMARKETING DATA" on Proventil HFA and Ventolin HFA (sufficient to find that patients were "ADEQUATELY SERVED" with these HFA replacement inhalers). (LINK 25, p.14)

The FDA found that the above two requirements were fully satisfied on March 31, 2005, despite the fact that at that time, almost none of the nation's 35 million pulmonary patients were regularly using HFA inhalers.

We consider the FDA's findings on these two legal requirements to be completely without merit, for the following reasons:

1) Based on several FDA quotes referenced below from their June 10, 2004 PADAC (Pulmonary-Allergy Drug Advisory Committee) meeting, it is obvious that the FDA never seriously analyzed questions (A) and (B) (above) before this PADAC meeting. And based on what they published later as their Final Rule on March 31, 2005 (LINK 25) it is equally obvious that the FDA never seriously analyzed questions (A) and (B) (above), AT ALL. These findings were a COMPLETE TRAVESTY, there was NO EVIDENCE PRESENTED to support them, and the CFC inhaler ban is, therefore, we believe, CLEARLY ILLEGAL.

For example, Dr. Robert J. Meyer (FDA) disclosed that as of the time of the PADAC meeting, the FDA had never bothered considering whether or not Proventil HFA and Ventolin HFA were safe and effective based on U.S. postmarketing data: (LINK 22, p.243-244)

DR. SWENSON (University of Washington, Seattle): "... we really didn't see any data regarding the safety and the track record (of Proventil HFA and Ventolin HFA). Can you give us a brief synopsis? I suspect, because they have been out as long as they have, they are probably safe. But can you tell us so from your data monitoring?"

DR. MEYER (FDA): "I THINK FOR THE PURPOSES OF THE PROPOSED RULE (to ban CFC albuterol) WE REALLY DIDN'T CONTEST THAT THIS WAS NOT THE CASE... " They just assumed, without doing any serious analysis, that the U.S. postmarketing data on Proventil HFA and Ventolin HFA (A) was "ADEQUATE" and (B) showed that these HFA inhalers could "ADEQUATELY SERVE" tens of millions of pulmonary patients.

In addition, this Advisory Committee was treated very differently than other Advisory Committees in another interesting way, as well. Not only was critical data about the main agenda topic withheld from the committee, but in addition, THE COMMITTEE WAS FORBIDDEN TO VOTE ON THE KEY QUESTION: 'SHOULD CFC ALBUTEROL LOSE ITS "ESSENTIAL USE" EXEMPTION?'

DR. CHINCHILLI (FDA): "Now, we are not really voting; okay? We are really just discussing and making recommendations to the FDA. So, unlike other advisory-committee meetings, we really are not taking person-by-person votes today." (LINK 22, p.217)

Based on these comments, and the large amount of anecdotal evidence that is rapidly accumulating about the gross inferiority of HFA inhalers for MANY (not all) patients, and the points discussed below, we believe that:

"ADEQUATE U.S. POSTMARKETING DATA" ("ADEQUATE" for the purpose of finding that these two HFA rescue inhalers can safely, effectively and reliably REPLACE CFC rescue inhalers for 35 million Americans- many with SEVERE disease) DOES NOT EXIST AND WILL NOT EXIST by the December 31, 2008 deadline, and

Proventil HFA and Ventolin HFA DO NOT "ADEQUATELY SERVE" PATIENTS.

We further believe that the FDA's actions throughout this process border on malfeasance in office, and that their March 31, 2005 Final Rule banning CFC albuterol rescue inhalers is, therefore, ILLEGAL.

2) As of May 2008, U.S. pulmonary patients had only been starting to use these HFA inhalers in significant numbers for about a year or two (before this, these HFA inhalers were almost never regularly used, due to the availability of safe, effective, reliable, and much less expensive CFC inhalers). Many patients who did try HFA inhalers quickly switched back to CFC inhalers.

"The safety of new agents cannot be known with certainty until a drug has been on the market for many years." (Journal of the American Medical Association, May 1, 2002) (LINK 11). Despite Proventil HFA's approval in 1996 and Ventolin HFA's approval in 2002, these are, for all practical purposes, virtually new drugs without any significant U.S. postmarketing data, and it will take many years of use by large numbers of patients before their safety and efficacy can be established.

IT IS GROSSLY UNFAIR TO FORCE 35 million pulmonary patients, many of them extremely ill, to participate in what are essentially enormous postmarketing clinical trials, but in this unique situation, the traditional drug of choice alternative (CFC albuterol) has been BANNED FROM THE MARKET WITHOUT MEDICAL JUSTIFICATION. This disaster (for many, not all, patients) was easily anticipated and could easily have been avoided by having the FDA mandate that the drug companies conduct PROPER postmarketing clinical trials over the last twelve years.

3) Clinical trial data indicate that there are MORE SERIOUS SIDE EFFECTS WITH Proventil HFA and Ventolin HFA inhalers than with CFC inhalers. (LINKS 4,5,6) And it is extremely important to point out that the clinical trials for each HFA inhaler brand (Proventil and Ventolin) only tested about 200 or so MILD ASTHMATICS with the HFA inhaler. NO COPD or seriously ill subjects were tested; WE HAVE MANY SERIOUS COMPLAINTS FROM COPD PATIENTS. These clinical trials were very short term- usually they lasted only 12 weeks.

To use such small, short term clinical trials as the basis for determining that these HFA inhalers are TRULY CAPABLE OF ADEQUATELY REPLACING CFC RESCUE INHALERS for ALL types of pulmonary patients (including many with very severe disease) is extremely thoughtless, even for the FDA.

SCHERING-PLOUGH states on its Proventil HFA homepage (LINK 4): "RAPID HEART BEAT, VOMITING, CHEST PAIN and PALPITATION OCCURS MORE FREQUENTLY WITH PROVENTIL HFA (than with Albuterol CFC) ." The same Adverse Reactions chart also shows that RESPIRATORY DISORDER, FEVER, BACK PAIN, and ALLERGIC REACTIONS occur more frequently with Proventil HFA than with Albuterol CFC. THIS REPLACEMENT INHALER IS NOT GOOD ENOUGH, in our opinion. (But ProAir HFA (Teva/Ivax) is THE WORST RESCUE INHALER ON THE MARKET, in our opinion.)

Ethanol (a toxic, class 3 residual solvent) is used in three of the four HFA rescue inhalers (it is not used in CFC inhalers) in amounts between ten and fourteen percent by weight, and ETHANOL IS A KNOWN BRONCHOCONSTRICTOR for many asthma patients. (LINK 13). This may explain why so many patients complain that the HFA RESCUE INHALERS are either INEFFECTIVE, or actually make their asthma symptoms WORSE.

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. Fifteen thousand compounds were considered to find suitable alternative propellants to CFC-11 and CFC-12, and only two out of the fifteen thousand were found to be suitable. (LINK 19) Notice the greater percentage of several serious side effects with HFA placebo compared to albuterol CFC 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.

It is astonishing to consider the amount of UNNECESSARY PATIENT SUFFERING AND UNNECESSARY INCREASED PATIENT DRUG COSTS (and MANY asthma patients are poor, or working poor) that the FDA HAS ALREADY CAUSED with this CFC inhaler ban IN ORDER TO SOLVE A PROBLEM THAT DOES NOT EXIST, except in the overheated imaginations of INCREDIBLY BRAINWASHED FDA and EPA senior officials. They have never offered one iota of evidence to justify this CFC ban BECAUSE THERE IS NO JUSTIFICATION FOR IT. The increased skin cancer rates that they FALSELY ATTRIBUTE to ODS-CAUSED OZONE DEPLETION have been repeatedly shown to be CAUSED BY HUMAN BEHAVIOR- (including the dramatic increase in the use of tanning beds over the last few decades)- NOT BY INCREASED GROUND LEVEL UVB RADIATION SECONDARY TO OZONE DEPLETION.

"In "The Relationship between Skin Cancers, Solar Radiation and Ozone Depletion," Moan and Dahlback (1992) contend... that the dramatic increases in the annual age-adjusted incidence rate of malignant melanoma from 1957 to 1984 were not accompanied by increases in exposure to ultraviolet radiation, based on measured ozone levels. They conclude that OZONE DEPLETION COULD NOT BE RESPONSIBLE FOR INCREASES IN SKIN CANCER RATES.

"In their Lancet commentary "Skin Cancer and the Ozone Shield," Staehelin et al. (1990) also maintain that the INCREASING INCIDENCE OF SKIN CANCER in Switzerland MUST BE ATTRIBUTED PRIMARILY TO HUMAN BEHAVIORAL CHANGES RATHER THAN OZONE DEPLETION." (LINK 26)

And while the summary quoted above, which apparently was written in the early 1990's, refers to the agreement of a number of authors that "current and future increases in ultraviolet radiation exposure due to ozone depletion will exacerbate the trend toward higher incidence of melanoma" IT IS IMPORTANT TO REPEAT, for the benefit of the FDA and EPA senior officials who apparently have not kept up with the literature, that the hysterical speculation from the 1980's and the 1990's about depletion of the ozone layer causing increases in ground level UVB radiation that will result in massive increases in skin cancer deaths has turned out to be just that: HYSTERICAL SPECULATION.

FURTHERMORE, there is NO RESEARCH to suggest that the trivial amounts of CFC emissions from life-saving CFC inhalers pose ANY threat to the ozone layer or play even the slightest indirect role in increasing rates of human skin cancer. This simple fact was never forcefully communicated by our delegates to the Montreal Protocol, UNEP, TEAP, and the UN Aerosols Technical Options Committee.

THEREFORE, WE THE UNDERSIGNED, DEMAND THAT THIS RECKLESS AND DANGEROUS BAN OF CFC INHALERS BE RESCINDED IMMEDIATELY BY PRESIDENTIAL EXECUTIVE ORDER, and that the relevant provisions of the U.S. Clean Air Act be amended by Congress as well, and that the Montreal Protocol be amended by the Parties to permanently allow for the small allotments of CFCs needed for all present and future CFC inhaler drug applications. Ideally, all Parties to the Montreal Protocol should be able to have an adequate supply of CFCs FOR MEDICAL PURPOSES ONLY.

PULMONARY PATIENTS DID NOT CREATE THIS DISASTER. This disaster was created by the failure of the Parties to the Montreal Protocol to make a PERMANENT humanitarian exemption for CFC inhaler patients in the first place. THE FACT OF THE MATTER IS THAT THERE IS NO SATISFACTORY ALTERNATIVE TO CFC INHALERS FOR ALL PULMONARY PATIENTS, AND WE DEMAND THAT OUR CONGRESS AND ADMINISTRATION PLACE THE HEALTH AND SAFETY OF THESE PATIENTS AHEAD OF THE REQUIREMENTS OF THE SEVERELY FLAWED MONTREAL PROTOCOL AND THE EQUALLY FLAWED U.S. CLEAN AIR ACT.

FURTHERMORE, if the Parties to the Montreal Protocol fail to adopt this amendment creating a PERMANENT MEDICAL EXEMPTION from the ODS ban on an emergency, expedited basis, WE DEMAND that Congress UNILATERALLY ABROGATE the relevant provisions of this severely flawed treaty and work on an emergency, expedited basis with the Administration to get high quality, inexpensive generic CFC albuterol rescue inhalers back into the marketplace as soon as possible to prevent as much unnecessary pain, suffering and death as possible.

FINALLY, WE BELIEVE THAT IT IS IMPERATIVE that extremely qualified executives from outside of the FDA, THE EPA, and the State Department, with sufficient experience and authority to overcome decades of organizational inertia be appointed to oversee the entire re-introduction process of CFC inhalers into the marketplace, and to carefully select, reject, monitor and supervise ALL U.S. DELEGATES TO ALL FUTURE MEETINGS OF THE MONTREAL PROTOCOL, UNEP, TEAP, UN AEROSOLS TECHNICAL OPTIONS COMMITTEE, AND ANY AND ALL RELATED MEETINGS OR WORKING GROUPS that impact on U.S. decisions as to which medications it chooses to make available to its citizens.

[AngieGal]

God bless you. I hope you can find something to get your asthma under control again.

[precisionshootist]

So where is the multi-billion dollar class action suit against the FDA and who ever else has anything to do with this?

[saveCFCinhalers]

Thanks for posting the petition, AngieGal.

We just revised it yesterday (6/15/08), I just thought I’d mention it.

We’re dealing with a glitch at the new website- our first email to petitioners will go out shortly- hopefully today.

Thanks,

Art
sponsor@savecfcinhalers.org

[saveCFCinhalers]

The petition link is:

http://www.ipetitions.com/petition/saveCFCinhalers/

It has been revised.

Our website will be up shortly, and we will contact all petitioners by mid-July. We apologize for the delay.

Thanks,
Art
The National Campaign to Save CFC Asthma Inhalers
sponsor@saveCFCinhalers.org

[NonValueAdded]

Good news, short of a lifting of the ban: Wal-Mart To Sell Cheaper Inhaler