59 thoughts on “Albuterol HFA, and Proventil/Ventolin substitutions”

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3. Proventil HFA makes my breathing worse! I cough and can’t breathe right for two days after using it. I can’t be the only one this is happening to. Any suggestions? I just want my plain old generic Albuterol!

4. There is a major action going on to save the Generic Albuterol Inhalers (containing CFC’s). There was also a recent write up in the US News and World report about the huge cost impact to asthmatics.

   Link to online petition:
   http://www.ipetitions.com/petition/saveCFCinhalers/index.html

5. Any current info on this subject.
   My 20 yr old son had to switch to the Proventil HFA inhaler a few months ago. He has complained continually about this inhaler! He says it doesn’t work, doesn’t last as long, and one of the inhalers malfuntioned. The pharmacist said he thought the inhaler was almost out, but my son said it always feels almost out (probably less in there to begin with). The pharmacist said I could just contact the manufacturer??? what?
   Very frustrating and of course, the cost is 4 times greater!
   Is there anything we can do to change this? I am willing.

6. There is half the mass in the HFA containers as there is in the old CFC albuterol. (8.5gm as opposed to 17gm) This is because it takes less HFA to deliver the albuterol where it needs to go.

   Your son needs to get used it. There’s nothing else out there. Whinging like a child isn’t going to bring the CFC albuterol back.

   Sorry, no rush like he’s used to. Time to be a big boy now and move on with his life.

7. RJS,

   The mass may be different, but so is the delivery & its consistency.

   With the old CFC inhalers I got a consistent & forceful puff with every dose. The HFA inhalers seem to lose their power about 1/2 way through. You get the next 15-20 doses with a mere fizzle instead of a puff & usually need to redose to get a decent inhale.

   The biggest sham is that it’s the same damn medication as before yet now they’re able to charge brand name prices for it. Shameful.

8. All of the albuterol HFA inhalers, Proventil HFA, Proair HFA, Ventolin HFA and Xopenex HFA have lower valve pressures and a softer warmer puff. The older CFC or FREON inhalers jetted into the oropharynx so hard that a lot of the albuterol stuck to the throat and was less effective when swallowed than when topically applied within the lung. The warmer softer puff has less chance of Triggering a exacerbation due to the cold spray and give users more time in which to inhale a full puff into the lung. Keep in mind that frequent albuterol use (more than 2x per week) is a sign of poor asthma control and a trip back to your Allergist or Pulmonologists office may save you a trip to the Emergency Room which is common if your lung stay inflamed for a long time.

   Remember, it is not the strength of the puff that gets medicine into the lung, but rather the force of inhalation of the lungs and the subsequent holding of the breath. And poor technique by younger and older users alike lead to an increase in the required medicine to control symptoms. Ask your physician for inhaler technique training with the closed mouth technique. They can actually charge insurance, Medicaid and Medicare for this training so the time is reimbursed and the patient performs better on the medicine which lowers it’s effective cost for patients. (IE. fewer times used, the lower the effective cost.)

   Remember also, that CFC inhalers are notorious for their TAIL OFF. This is where the device still functions, but the medicine has already been used up and all you are inhaling is propellant. All currently marketed asthma inhalers are suspensions and require EXTENSIVE shaking before use, except for QVAR which is a steroid solution that requires no shaking. If you don’t shake alubuterol inhalers before use, it is like a can of spray paint in that the medicine falls out of the propellent and settles by the valve giving more medicine at the beginning of the prescription and less (to none) at the end, even though it will still puff. CFC inhalers are more succeptable than HFA inhalers to this process. (There have been extensive studies of this for the past 9 years despite the previous poster’s comments).

   As For ProAir’s name change, it was mandated by the FDA. In the initial filing of the NDA, the FDA rejected several names including ProAir HFA, Ecobreath HFA, and a couple of others. Rather than waiting 6 months to launch the drug with a FDA approved name, Ivax launched the drug with a blank name and used the generic naming rules of the FDA to call it Albuterol HFA.

   After pharmacists started substituting it for other HFA albuterols due to its 15-20% decrease in cost for the consumer, the FDA came back and granted approval for ProAir HFA. All of the drugs are BX rated meaning that there is no substitution allowed by pharmacies, but at the same time, it is virtually identical to Proventil HFA which is $12-15 more expensive for a 10 year old drug and most pharmacists really want the best product for the best price for their patients.

   I hope this helps clear up some of these issues, and remember in regards to price, your doctor wants to see you frequently to monitor your asthma effectivily and to get you on the lowest dose of medication possible that still maintains your symptoms and they have plenty of Sample Proair Inhalers all over the office (I have been in many offices where 2-3 dozen sit on the shelf at any one time), some Proventil HFA’s, a few Ventolin HFA’s and almost never any Xopenex HFA. On top of the samples, there are 5 month vouchers for Proair HFA available at their website, 2 month vouchers on Proventil HFA, and rebates on Ventolin and Xopenex. Additionally, there are indigent patient programs with Proventil HFA, Proair HFA, and Ventolin HFA, (not sure about Xopenex.)

   One last thought, HFA 134A and HFA 227 which are the new environmentally safe propellants are both made by 3m and there is a virtual monopoly on the gas supply. That is why these inhalers are priced higher than CFC which is made overseas and imported by generic houses. So despite the damage the FREON in the generic inhalers do to the ozone layer(74 million inhalers last year), there is also pollution from transportation from over seas to contend with. And as with most things, the US is the last remaining developed country to allow CFC inhalers, all of the other countries converted with the Montreal Protocol Signing in 1997.

   Hope this helps

9. Thank you for the informative post and to Perril for the follow-up comment. I really miss the old form of albuterol. I feel that I’m intelligent enough to read and follow instructions for the new inhaler. In addition to the info that comes with the inhaler and the pharmacy print-out, I’ve been to the ProAir website as well as several other general inhaler instruction sites, thinking it must be my technique.

   I’ve tried both the closed-mouth and open-mouth inhalation methods; I always shake the heck out of the inhaler; wait the required time between puffs — the whole nine yards. However, I do not feel that ProAir works as well for me as the old abuterol.

   It’s not the decreased sensation of the propellant knocking the stuff into you — I understand fully that the mechanism has changed and that the delivery isn’t going to feel the same. It’s the actual efficacy of the medicine that concerns me. I suppose it could be that my asthma isn’t responding as well as it used to to the albuterol, but it would be a major coincidence for that to have begun immediately upon switching to ProAir.

   It’s so true that you really can’t tell what’s left in the inhaler after a while, either — I’m not sure whether I am getting a full dose but am afraid to take more than the 2 puffs as prescribed. Is it safe to take an extra puff if you feel the first two didn’t quite work?

   As for the comment by RJS, that was really rude. The mother is trying to find help for her son — no need to be hateful to her. I suppose you consider me a whiner as well, but perhaps you’d also “whine” if you couldn’t breathe and your inhaler didn’t help as well as you’re accustomed to albuterol working, despite correct usage.

   Yes, I’m sure there are those who do not understand that the change in propellant = a change in the feel and perceived strength of the delivery, and I’m sure there are those who don’t use proper technique — but surely not every single one of us is doing something “wrong”. Maybe the medicine just plain doesn’t work as well for some of us and for reasons that are not within our control.

   I landed here on a google search, trying to see if I could determine whether one of the other inhalers (Proventil or Ventolin) might be more effective in their delivery than ProAir so that I could call my doctor and ask to switch to one of the others. It appears they’re all about the same, though, and that if they don’t work well for us, we’re just S.O.L.

   I would like to know, if there’s anyone who has tried all three — do either of the others have a less offensive taste than ProAir? I take methotrexate and other meds that make me a bit sick on my tummy anyway, and that nasty Pro-Air taste doesn’t help matters.

   There are so many worse offenders of the environment. Why they’d pick on a medication rather than clamp down on corporate pollution boggles the mind…but that’s government for you, I guess.

   Thanks again for the very helpful information, and good luck to everyone!

   Kindest regards,
   Bunny Johnson

10. All of the Albuterol HFA’s recommend cleaning the device weekly. This means taking the canister out of the device and running hot water over both. The HFA’s can clog, especially after a long period of not being used. Proventil HFA does differ from ProAir in several ways. ProAir HFA is FDA indicated 12 yrs and above where Proventil HFA is FDA indicated 4 yrs and above. This can be a legal issue I don’t wish to deal with. Proventil HFA also has a nonactive thinning ingredient which can help with clogging. ProAir does not. Proventil HFA’s canister is also made entirely of metal where ProAir’s valve is made of plastic. There have been instances where patients have kept pushing down on the ProAir trying to get it to work and broke off the plastic valve without realizing it. These are just some ways the two differ as mentioned above the are not AB rated. Not to mention, the coverage on the the Albuterol HFA’s varies. In my area Proventil HFA is 2nd tier on just about every insurance plan I see and ProAir is 3rd tier.

11. The “inert” thinning agent that Sam is refering too is actually, not so inert. While it is in very low levels, this agent is actually very harmful to the lungs, it is named Oleic Acid. It is found naturally in olives and people with high Mediteranean Diets have had significant lung damage due to this “inert Thinning Agent.” Pull up the Material Data Safety Sheet or one of the many clinical studies on this “inert” ingresdiant and see how safe it is for yourself.

    As for the metal valve vs plastic, the metal or plastic is irrelevant to the clogging issue as is the Oleic Acid. The clogging occurs after the valve on all of these devices and actually on the nozzle of the mouthpiece (the tiny little hole that allows the mist to exit the plastic hand piece. It occurs here due to a variety of reasons. “Tidal Breathing” puts moisture on the nozzle and allows accumulation, Low inspiratory flow rate (pull) through the mouthpiece allows buildup, Not keeping the devices horizontal to the ground while inhaling, (imagine a child inhaling before they blow out birthday candles, they bend over to inhale). Regardless, all of these products clog and all have instructions on how to open them.

    I recently requested and had a conversation with the inventor of the HFA 134A propellant (and also Proventil HFA) and he told me straight up that he likes proventil HFA better, due to some of the valving issues, however, he feels that Schering Plough is raping the population by selling this 10 year old drug at the highest retail price of any Albuterol on the market.

    And I guess that is the bottom line, the change is coming, the EPA and FDA have made their final ruling, and you can get one of 4 inhalers that are out on the market. Any pharmacie that dispenses a generic after December of this year will be fined $27500 per occurance.

    As a consumer, be confident that all 4 inhalers work, proven in preclinical trials, and post marketing studies, and daily clinical experience by nurses, doctors, and respiratory therapists. And now you get to choose either the ProAir at around $31.99 at Walmart, Ventolin 37.99 at Walmart, Proventil $42.95 at Walmart, or levalbuterol (xopenex) for 52.95 at Walmart. Prices checked 4/21/2008.

    If they all are softer, all have cleaning instruction, and all are just as safe (albuterol has been around for over 30 years), why spend more money for one over another?

12. Janet, Natashia, Carol, and Bunny- you are not alone.

    Many patients are unable to tolerate HFA inhalers- see the comments from over 2500 patients on the petition below, which include statements from MDs, nurses, respiratory techs, and PhDs in pharm science. HFA propellants were NEVER tested on pulmonary patients, only on healthy subjects. The clinical trials were a joke- less than 200 patients in the test arms for Proventil and Ventolin, 12 week trials of mild asthmatics (no COPD patients)- 58 patients in the test arm for ProAir’s 6 week trials.(LINKS 5,6,8)

    Schering-Plough ADMITS on its Proventil HFA homepage (LINK 4 of our petition, 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 of our petition).

    Dr. Gene Colice, ‘the father of HFA albuterol’ (Proventil) must be terribly proud. And according to Dr. Colice (assuming perril accurately relayed his conversation with the Great Man) HFA is the BEST of the HFA rescue inhalers!

    All four rescue inhalers (except Ventolin) use ethanol as a co-solvent in amounts of 10-14% by weight- enough to cause BRONCHOCONSTRICTION in a subset of asthma patients (LINK 13 on the petition). BRONCHOCONSTRICTION in a RESCUE INHALER. The ethanol is corn-sourced, which may pose a separate risk to corn-sensitive patients, according to Schering-Plough and Sepracor technical staff.

    perril is wrong about CFC MDI emissions threatening the ozone layer- even HFA proponents like Dr. Leslie Hendeles admits that this is false (LINK 1), as do all credible scientists. CFC MDI emissions at their global peak were too small to do any harm. Cite your reference for CFC MDI emissions harming the ozone layer, perril.

    perril is wrong when he says:

    “So despite the damage the FREON in the generic inhalers do to the ozone layer (74 million inhalers last year)”

    There is no FREON in CFC MDIs. FREON is CFC-113; it is not used in inhalers. CFC-11, 12 are used in MDIs.

    Generic inhaler sales in the US are about 52 million- please provide your reference for 74 million generic inhalers last year, perril.

    perrill is wrong when he says:

    “The “inert” thinning agent that Sam is refering too is actually, not so inert. While it is in very low levels, this agent is actually very harmful to the lungs, it is named Oleic Acid. It is found naturally in olives and people with high Mediteranean Diets have had significant lung damage due to this “inert Thinning Agent.” Pull up the Material Data Safety Sheet or one of the many clinical studies on this “inert” ingresdiant and see how safe it is for yourself.”

    Olec acid is a well tolerated, extremely safe excipient used for many years in CFC MDIs.

    Compare the Material Data Safety Sheets perril cites to support his ignorant statement about Oleic Acid with the same safety sheet for Ethanol and you will see that Oleic Acid is much safer. THAT is the relevant comparison for the purpose of CFC MDI vs HFA MDI safety- oleic acid vs. ethanol- and there is NO CONTEST. Oleic acid is MUCH SAFER.

    Cite your reference for the dangers of oleic acid in inhalers as I’ve done for ethanol, perril.

    Google: ‘Mediteranean Diet oleic acid lung damage’ just to keep perril honest. You’ll find a lot of listings like these:

    “Mediterranean diet cuts the risk of lung disease. Eating a Mediterranean diet rich in fruit and …. The key is oleic acid, the main component of olive oil. …”

    “Sep 18, 2007 … Mediterranean Diet Halves Risk Of Progressive Lung Disease – A large …. Breast cancer (thanks to the Olive oil that contains Oleic Acid) …”

    In conclusion, perril once again gets it backwards- oleic acid DECREASES the risk of lung disease. Where do you get your information, perril?

    Drug company reps like perril and RJS (beneath contempt- a real pig, as evidenced by his replies on this thread) will say anything to convince patients that HFA MDIs are as safe and effective for all patients as CFC MDIs are. Ignore them. They post anonymously for a reason. Do not be intimidated by them. They have no idea what they’re talking about. Trust YOUR OWN reactions to HFA MDIs, not what these fools say.

    To get the facts and join our campaign to save CFC MDIs, go here:

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

    Arthur Abramson
    The National Campaign to Save CFC Asthma Inhalers

13. Correction- try this link:

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

    If it doesn’t work, google: ‘save cfc’ or click on my name below.

    Arthur Abramson
    The National Campaign to Save CFC Asthma Inhalers

14. Artie Boy is evidently a very arrogant prick and beyond contemp. Firstly I am no Pharma Rep, just happened to be related to a practitioner who uses these products and someone who has 2 family members (wife and Son) who have been impacted by this ordeal and have researched this topic extensively.

    Firstly, I never claimed that the rational behind the Ban of CFC was accurate and in fact, feel that the whole global warming and impact on CFC and CO2 in the atmosphere is overblown, however CFC and FREON damage to atmospheric Ozone is the REASON given by President Reagan and the Socialist Co-president Clinton’s for signing and ratifying the Montreal Protocal in 1986 and 1996. So ask them to cite their claims for why they are causing me to pay 4 times more for the albuterol for my wife and son.

    Secondly, I too could have cited the chemical composition and structure of the actual propellant causing the damage, or simply put FREON as being the culprit to make the issue more understandable to the common person who is probably very familiar with the ban on FREON 12 and 22 in their cars and Home AC units for this very same reason. CFC-12 or Automotive FREON (A/C Refrigerent)was actually cited by “Artie Boy” as being used in inhalers.

    From Artie’s response:

    “There is no FREON in CFC MDIs. FREON is CFC-113; it is not used in inhalers. CFC-11, 12 are used in MDIs.”

    Anyone who fixes their own vehicle knows that until 1993, CFC-12 was used in automotive refrigeration. (And many vending machines.)

    As for Dr. Colice: a very well educated and respected physician who I have also met, and whom I was NOT referencing, I was referencing the Gentleman who created HFA 134a and HFA 227 and started using them in PRECLINICAL work (Animal Studies and Toxicology Work) before Dr. Colice was even involved. And I could cite his name, but I am sure that “ARTIE BOY” in his “know it all manner” can tell me who this VERY well respected Researcher with a major NOT FOR PROFIT Respiratory Research Center is, in his arrogant response to this message. This person I am referencing started work on the Proventil HFA drug and Mometasone HFA (HFA 227)drug ,(which was changed to dry powder mometasone in the late 90’s”,in the Mid 1980’s before Reagan signed the initial Montral Protocol.

    And since “Artie” evidently cannot even quote my previous post accuratly when I stated that this practitioner feels that since all of the HFA’s are basically the same as all of the others HFA’s, that ProAir HFA would be the best choice since it costs less. IE all HFA’s have same safety, and efficacy so lower costs are better.

    “I recently requested and had a conversation with the inventor of the HFA 134A propellant (and also Proventil HFA) and he told me straight up that he likes Proventil HFA better, due to some of the valving issues, however, he feels that Schering Plough is raping the population by selling this 10 year old drug at the highest retail price of any Albuterol on the market.”

    Nextly, Artie was actually correct on the number of Albuterol inhalers that are sold each year, however when you also add the number of “other CFC’s” used by actual patients and not grandstanding assholes like Mr. Abramson, IE Combivent, Atrovent, Tilade, Etc which were very helpful for patients with COPD and Emphasyma, the total of inhalers impacted is just about the 74 million figure I quoted. Or I could just say 74 million inhalers impacted which is simpler for most people who may not understand the depth of this issue.

    Nextly regarding Oleic Acid,

    I was responding to a post that stated that this chemical is inert and used to thin the medication, and since “Artie” evidently thinks I was attacking the incredient, I must clarify this as well, I really couldn’t give a shit one way or another if the puff has oleic acid or ethanol in it, NEITHER of these chemicals are “inert” as a previous poster stated and I felt that this issue needed clarification.

    But since, the “Big Prick” needs a citation, I will provide one regarding the lung damage caused by high levels of Oleic Acid in “Mediteranean Diets”

    Oleic Acid Damages Ion Transport and Promotes Alveolar Edema
    The Dark Side of Healthy Living
    Sadis Matalon, Ph.D. and Hong-Long Ji, M.D.
    Department of Anesthesiology University of Alabama at Birmingham Birmingham, Alabama

    And I will also include the definition of the word “INERT” to help him better his knowledge base so that he does not make a mistake when he uses “INERT” as his word of the day.

    inert
    adj 1: unable to move or resist motion
    2: (chemistry) having only a limited ability to react
    chemically; not active

    Which I believe means that any ingredient that has any activity, Positive OR Negative can hardly be called INERT.

    And lastly regarding this petition. “Artie” is probably not aware that the FDA has already made the final ruling regarding this issue based on guidance by the EPA. No amount of petitions are going to change the fact that the CFC’s are gone in this country probably by November since the last Manfuacturer, Armstrong, has recently produced that last batch based on their yearly allocation of the CFC gas and that the EPA prohibits the importation fo the gas after this year.

    Also, Artie probably does not understand that the gas HFA 134A has over 25 years in HUMAN testing with thousands of patients across the world and when the drugs he cites went for approval, the FDA only required the drugs to prove they worked relieving bronchoconstriction in their trials since the propellant was already proven safe.

    “Artie” is also probably unaware that in clinical testing, side effects must be recorded regardless of if they were caused by the drug or other reasons, IE. If a patient in the accepted human trial has menstral cramps or dies in a bus accident cramping and death are recorded on the PI as if the drug played a role in the side effect. What should be looked at is the standard deviation from the placebo for that side effect.

    And I am sure that “Artie Boy” could have explained all of this except that his purpose is not to educate anyone on this board, but rather to get everyone up in arms and worried about this event and get them to sign up for this petition, where I am confident, at some point a “donation” link or banner advertising for a Law Firm will be provided to “Help win the fight to save CFC’s” As with most arrogant asses like Mr. Arthur Anderson, follow the money and you will see what the real agenda is. It would not surprise me if he has a financial interest in the manufacture of CFC inhalers and that is the real reason he is trying to get an angry mob behind this dead issue.

    So remember in your response ARTIE, you started the name calling, and you need a lot more information regarding this issue, not just Internet and Web Page Excerpts. There is nothing worse or more unethical than someone who cannot discuss the disease state, trying to prove a medical point through anecdotal evidence.

15. Perrill,

    I know for a fact that you are 100% wrong about Mr. Art Abramson. He truly CARES about those that are suffering because the HFA propelled inhalers are not working for them. I am one of those people, and I work personally Art for this cause. And there are NOT dollar signs in our eyes. He cares, I care, and we care about PEOPLE, not $$$ SIGNS!!! I’m completely offended by your comments about Art.

    Cheri Modrow

16. Thanks for your thoughtful reply, perrill.

    The oleic acid reference was interesting. I looked through some of the associated references and didn’t find anything that suggested that oleic acid in the amounts used in CFC-MDIs would cause alveolar edema or any other pulmonary problems (and I know that you did not suggest that). If there was any evidence of this, you can be sure that the HFA propaganda machine would include it in their daily press releases.

    I DID provide a reference in my previous post that showed that ethanol in HFA-MDIs DOES cause bronchoconstriction in a subset of asthma patients- information that is, of course, suppressed by the HFA propagandists (the FDA, the drug companies, the conflicted doctors, the conflicted non-profits, etc.).

    I repeat:

    All four rescue inhalers (except Ventolin) use ethanol as a co-solvent in amounts of 10-14% by weight- enough to cause BRONCHOCONSTRICTION in a subset of asthma patients (LINK 13 on the petition, below). The ethanol is corn-sourced, which may pose a separate risk to corn-sensitive patients, according to Schering-Plough and Sepracor technical staff.

    The company line from the HFA proponents is: the only difference between HFA albuterol and CFC albuterol is the cost, the taste, the warmth and speed of the plume, and the priming and cleaning requirements. The safety and efficacy of the CFC and HFA MDI inhalers is equal according to them, based on all of the clinical studies.

    This is FALSE.

    I will repeat for your benefit, perrill, what Schering-Plough says about Proventil HFA:

    Schering-Plough says on its Proventil HFA homepage (LINK 4 of our petition, 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 of our petition).

    Most people who read this will NOT agree that Proventil HFA and CFC albuterol are equally safe- you may feel differently.

    I repeat:

    Many patients are unable to tolerate HFA inhalers- see the comments from over 2500 patients on the petition below, which include statements from MDs, nurses, respiratory techs, and PhDs in pharm science. HFA propellants were NEVER tested on pulmonary patients, only on healthy subjects. The clinical trials were a joke- about 200 patients in the test arms for Proventil and Ventolin, 12 week trials of mild asthmatics (no COPD patients) only 58 patients in the test arm for ProAir’s 6 week trials. (LINKS 5,6,8)

    Why were such small trials used? A) Probably because the drug companies persuaded the FDA into using an unprecedented “bridging” technique to speed up the regulatory process for pre-clinical AND clinical trials of HFA MDIs (they “bridged” the safety and efficacy of CFC MDIs over to HFA MDIs!). According to the FDA’s Dr. John Jenkins (LINK 30)- “this “bridging” approach significantly reduces the regulatory burden for clinical testing of new non-CFC formulations… ” (such as the HFA inhalers many pulmonary patients are now suffering with- and in some cases, undoubtedly dying from) and B) as FDA whistleblower Dr. David Graham points out: “The classic approach of industry and FDA has been to do studies that are too small to conclusively identify that a risk is real,” he added. “They can conclude, therefore, that there is no risk.” FDA Safety Officer David Graham, MD,MPH (LINK 37)

    You don’t have much respect for anecdotal data, perrill- you only trust the drug-company sponsored PR pieces posing as objective research, written by financially incentivized doctors (or sometimes written by the drug companies themselves and only signed by paid-off doctors). That’s fine.

    You write:

    “There is nothing worse or more unethical than someone who cannot discuss the disease state, trying to prove a medical point through anecdotal evidence.”

    The biggest drug disasters in US history all started with drug-company sponsored peer-reviewed clinical trials required for their FDA approvals- and it was ANECDOTAL EVIDENCE that initially signaled that these drugs were dangerous. Had the FDA listened to this substantial anecdotal evidence with drugs like Trasylol, Vioxx, Tambucor, etc., many tens of thousands of lives (closer to hundreds of thousands) in this country alone would have been saved. This is the rationale behind the FDA’a MedWatch program (they call it the ‘early warning’ system for
    dangerous drugs) – that anecdotal evidence DOES have value and should be listened to.

    Do some research yourself, perrill, on the subject of drug company suppression/distortion of unfavorable data in clinical trials, FDA complicity over the years with drug company data manipulation, doctors- often the so called ‘thought leaders’- who are incentivized to say the right things or come up with just the right, superficial trial design to get ‘acceptable’ results- we’re seeing a lot of that right now with the HFA transition.

    It’s fine if you want to ignore the anecdotal complaints from thousands of patients, perrill. Stick to the clinical trials- but at least READ THE ADVERSE REACTIONS CHARTS for Proventil and Ventolin (LINKS 5,6 on our petition, link below) before you decide that the safety of HFA and CFC albuterol is equal- even the clinical trials refute this. And don’t complain that the trial samples are too small- that was the decision of the drug companies. Let them run larger trials if they dispute the safety results of their smaller trials, which are deliberately kept small as a subterfuge, as described by Dr. Graham above (25 year FDA whistleblower).

    Thanks for telling me about 21 CFR 2.125(g)(3), perrill, the final rule banning CFC albuterol. Our position is that it is ILLEGAL, because the FDA failed, in our opinion, to meet either/both of these legal requirements:

    A) The FDA was legally required to find that there was “adequate U.S. (not foreign) postmarketing data” on Proventil HFA and Ventolin HFA (sufficient to show that patients were “adequately served” by these inhalers)- but they gave an inadequate, superficial response to one of the pulmonologists at the June 10, 2004 Pulmonary Allergy Drug Advisory Committee meeting who asked them to review this data (Link 22, p.243-244). They have NEVER produced this data. We believe that this data contradicts the FDA’s position that HFA MDIs “adequately serve” patients.

    B) The FDA was legally required to find that Proventil HFA and Ventolin HFA “adequately served” patients. We believe that there is INADEQUATE U.S. postmarketing data to SUPPORT this finding. We believe that there is ADEQUATE U.S. postmarketing data to REFUTE this finding.

    As for your assertion, perrill, that the campaign to save CFC inhalers is a financial scam intended to benefit me personally, that is a lie. It is defamatory. It is libel. I really wouldn’t repeat it if I were you. I have not received a dime in compensation from anyone or any organization, neither has anyone else that is involved in this “dead issue”. Our intention is to work with Congress and the Administration to make CFC inhalers available for the patients that need them, and then leave this behind. I have no interest in making a career out of this. We never have, we are not now, and we will not work with law firms to pursue class action lawsuits (or any other litigation). We will pursue a political solution only, and I’ll repeat, we have never been compensated for this work, we are not now being compensated, nor will we be compensated for this work in the future.

    Perrill, one last point you made needs clarification:

    “… the gas HFA 134A has over 25 years in HUMAN testing with thousands of patients across the world… ”

    Yes, but everything I’ve read indicates that these were HEALTHY subjects that were tested with HFA-134a. They did NOT have asthma or other pulmonary disease. Healthy subjects do not have hypersensitive, inflamed airways and/or severe allergies and/or otherwise compromised respiratory systems. The only time PATIENTS were tested (and COPD or severe asthmatics were never tested) was in the clinical trials- the small clinical trials discussed above and similar small, short term drug company sponsored PR/marketing ‘research’.

    A number of specialists have advised some of our petitioners that they are probably allergic to or otherwise unable to tolerate HFA-134a. It is NOT as safe as CFC-11 and CFC-12 for all patients. And ethanol is NOT as safe as oleic acid is, in the amounts used in MDIs.

    You’re NOT suggesting that you have evidence that large numbers of PULMONARY patients were tested with HFA-134a by itself, are you, perrill? If so, I’d seriously appreciate seeing the reference. I never pretended to ‘know it all’ as you suggested- far from it. I just don’t put the FDA and drug company-sponsored clinical trials on a pedestal like you do, and I DO have a lot more respect for the complaints that we get daily from patients all over the country, and the world- the ‘anecdotal evidence’ that you dismiss.

    To join our campaign to save CFC MDIs and stay updated on future events, go here:

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

    If it doesn’t work, google: ‘save cfc’ or click on my name below.

    Arthur Abramson
    The National Campaign to Save CFC Asthma Inhalers

17. I’ve been on both sides of this issue. I have Asthma/COPD. I have tried all 4 of the HFA inhalers. Not one of them worked. How many Pulmonary Patients have to suffer/die before tha FDA steps forward and takes full responsibility for this nightmare that they allowed to happen? Perrill, instead of name calling good people and making false accusations, why don’t you look at some of the big name Org. that are on the take from the Drug Companies that make these canisters full of toxic gas?
    Get a grip Perrill-not all asthmatics can tolerate the HFA inhalers. End of story. Dr. Meyers from the FDA and everyone involved in this horrible decision should be held accountable.

18. I have no dog in this hunt other than family members who are also impacted by the switch. Arthur while you, once again, may have taken my post regarding donate buttons and web banners out of context (which is exactly the way I intended it to sound), I do feel that there is an agenda here, when rather than try to help these patients who feel that they cannot tolerate this propellant to:

    A) Understand that it is not harmful as proven out in every other industrialized nation on earth
    B) Understand that it feels different, tastes difference, and yet has the same efficacy as proven out by every placebo controlled trial published in regards to the HFA Albuterol Products.
    C) Understand that their disease is treatable by more than just Albuterol and that by getting appropriate treatment, their use of these albuterol products would be significantly reducd.
    D) Understand that there are other forms of this product such as Maxair CFC, Forodil DPI, SEREVENT DPI, ADVAIR DPI, Spiriva MDI that all have data to show some Albuterol Sparing benefit.
    E) Understand that tablet and nebulized albuterol is available to augment the MDI therapy.

    You would rather have them waste time signing petitions regarding a dead issue than getting informed of the facts. Your development and promotion of this effort will embolden some patients who have tried the HFA inhalers once or twice and didn’t like the taste, or puff, or feel of the device to believe that the product itself is defective and therefore not be as complient with their physicians instructions and rational for prescribing what they do (IE patients my not trust that their doctor has their best interest in mind and feel as you do that it is a conspiracy with Big Pharma). This in itself could cause increased deaths in the patients you claim to care about.

    For example: A physician precribes a long acting B2 agonist for a COPD patient (Foradil or Serevent) and rather than use their HFA rescue medicine because they think as you do that it is “toxic”, they take additional doses of their LABA throughout the day. Due to the very narrow therapeutic window of these drugs, a few extra puffs per day may lead to downregulation of B2 receptors and possible cardiac arrythmia and arrest, and death.

    This is why I stated that someone with limited knowledge of the disease state working up a mob into a frenzy and denying them the ability to understand that they wont die next month when the CFC supply runs out was unethical.

    Now back to the issue at hand:

    This is an international treaty that was signed in 1987 and ratified by the Clintons in 1997, This treaty banned CFCs from all sources, Air Conditioners, Spray Cans, Military applications, and on and on and on with 2 major exceptions for the United States spelled out in the treaty:

    Medical exceptions (MDI’s Being one of them)and the space shuttle program.

    I also know for a fact that all but one current manufacturer of CFC albuterol has left the market in regards to these products in the US and that remaining manufacturer is out or running out of CFC gas as we speak. There will be no more, regardless of the hype, fear mongering, petitions, whatever, whether based on 2500 or 25,000,000 signers of the petitions.

    The financial and trade penalties of not meeting the treaty guidelines spelled out in the montreol protocol supercedes all of the concerns listed in your petitions, even though that is not what you want to hear.

    An example would be if we chose to ignore this treaty and then France backs out of some other treaty using our failure to comply as precedent and that treaty may impact 150 million Americans rather than the 27 million people or so that have used CFC MDIs in the US last year.

    Now some facts that are readily researchable:

    The US is the last industrialized, modern country in the world that still utilizes this propellant in MDI’s and will in some cases till 2010 or 2013. HFA gas has been through animal trials, human trials with both healthy and diseased lung because no-one was excluded from the trials based on underlying diseases. (This information was given to me by the lead preclinical investigator) So if you had 100 patients in the trial of the gas, before there was ever an active drug added to the mix, the statistics of around 20% of these patients having been smokers, asthmatics, or having reactive airways means that 20 or so were included.

    These studies were effective enough to convince regulators in Australia (socialized medicine with patient follow up) , New Zealand (socialized medicine with patient follow up), England (socialized medicine with patient follow up), Germany (socialized medicine with patient follow up), France (socialized medicine with patient follow up) , Norway (socialized medicine with patient follow up), Japan (who happens to have some of the strictest regulations out there for drug approval).

    Much of this same data was used in the approval of HFA 134A Gas for use in human trials in the US for Proventil HFA, Beclomethasone HFA, Flovent HFA, Flunisolide HFA, Ciclesonide HFA, Ventolin HFA, Xopenex HFA, Triamcinilone HFA and all of these drugs that went for approval or are currently under consideration included damaged airways on top of the randomized controlled trials of the plain gas in humans. If they did not perform an active comparison between HFA Placebo and the HFA drug and in many cases to the CFC Active drug, they would NEVER even be reviewed.

    A great product to look at is QVAR (Beclomethasone HFA), it is available both in the US and in Europe and was an old drug (35 years on the market in the CFC Form) that was changed to HFA about 10 years ago. Literally thousands of patients with Asthma and COPD in both Pediatric and Adults studies were evaluated HEAD to HEAD between the HFA and CFC products and between active HFA drug and Placebo HFA and there is no difference in the side effects even if you take into account a dosage adjustment due to INCREASED penetration in the lung.

    Meaning less active drug was needed to treat the damamged airways because the HFA’s softer engineered puff along with a smaller particle size increased lung deposition.

    The developer of the HFA technology explained why this is the case, and once again, you won’t like to hear this:

    The majority of the propellant does not make it into the lung. It “boils” off once the device is actuated and falls out of the “puff” and into the mouth as a solid particle where it is swallowed and eliminated through the gut. (Ever notice the stronger taste of HFA over CFC?) Ever wonder how you would taste propellant that is inhaled into the lung? And yes Arthur I am trying to hold my temper and use simpler terms that most people reading this will understand so forgive me for not explaining out the science about the liquid to gas change, release of energy and solidification of the popellant particles when used.

    These are the facts about HFA. The puff was engineered by 3M to be softer as a way of increasing the efficacy of inhaled medicine by decreasing oropharengeal deposition (throat) and removal through the gut.

    In some cases, the HFA technology increased getting the active drug into the lung by 5 to 6 times what is possible with CFC gas. Additionally, cold air is one of the major triggers of many asthmatics and CFC’s liquid to gas change, cools the puff of CFC inhalers by 60+ degrees. The more forcefull puff hitting the back of the throat combined with the “cold” air hitting the lungs is why most people “feel” the CFC works better. (Even though there is no change in lung function due to either of these facts as proven out by spirometry, plethysmography, or nitrogen washout tests)

    When you take off the force and warm the puff to close to the same as ambient air, people don’t feel it and in many cases the placebo effect takes hold and in SOME patients anxiety of not being able to breath (Broncho Constriction) combined with not feeling the medicine makes them think it doesn’t work and therefore it doesn’t (Placebo Effect). A good friend of mine and I were discussing this issue a few days of mine. This person is a pulmonologist. He had a pteint who complained that the Proventil HFA did not work, so gave her a breathing test (spirometry),he had her take 2 puffs as directed, waited 15 minutes, repeated the test and showed her the slip of paper that showed a 12% improvement in her FEV1, she argued that the machine was broken because it didn’t work, she still could not breath. He asked her if she would rather try a different HFA inhaler or switch to a nebulizer and she then asked if there was one that was cheaper than Proventil HFA. She finally admitted that the cost of her old inhaler was around $30 for 3 months supply and this new inhaler was twice the price and tasted bad and that was the reason she didn’t like it.

    So the question rises Authur, where are all of the deaths attributed to this “toxic” gas as you put it. It has been used for decades in other countries with healthy and diseased lung, in our country for over 10 years in both healthy and diseased lungs in both albuterol HFA and inhaled steroids and since it seems that you are the supporter of anecdotal evidence, not me, why do you only focus on FDA approval studies simply designed to show safety and efficacy of already approved propellants (HFA) and active drugs in Asthma and COPD patients as the only data that is out there. When in fact, hundreds if not thousands of studies have been performed in this and other countries regarding this propellant, and in many of those other countries, lifetime health records are kept as part of their socialized medicine structure and yet this “toxic” gas is still being used.

    Don’t you think if there was any substance to your concerns it would have shown up by now and taken off the market in other countries? Don’t you think that these other countries would have used the medicial exception clause to get CFC’s for their patients ? After all, isn’t socialized medicine the model that we as Americans are begging Obama to take us due to the quality of care?

    I am sorry some of you who may have real issues with this product are being impacted by this change. I honestly got onto this board to help simplify this issue with facts and not some speculation about conspiracy theories with “Big Pharma” and doctors involved.

    I urge you to move on and not base you hopes on this dead issue of a petition and schedule an appointment with your doctor, if you can afford it, see a specialist if possible (Pulmonologist or Allergist), or go to your ER next time your chest tightens (they have to see you and prioritize your visit due to breathing trouble regardless if you can afford the visit) And be confident that any of the products I listed above have been using this propellant for over 10 years and as far as I can reasearch no deaths attributed to the product. Google any of the product names and look at the clinical studies on “MEDLINE” to see for yourself. Don’t rely on anonymous people who may or may not have a financial interest one way or the other.

    One study of COPD PATIENTS from France that addresses this issue directly:

    Comparison of the safety of drug delivery via HFA- and CFC-metered dose inhalers in CAO
    G Huchon, P Hofbauer, G Cannizzaro, P Iacono, and F Wald

    The objective of this study was to compare the long-term safety of a fixed combination of fenoterol hydrobromide (50 microg) and ipratropium bromide (20 microg) delivered using a metered dose inhaler (MDI) formulated with a non-chlorinated propellant, hydrofluoroalkanel34a (HFA-MDI), with delivery using the conventional chlorofluorocarbon propellant (CFC-MDI, Berodual/Bronchodual). The study was designed according to Safety Assessment of Marketed Medicines (SAMM) guidelines, to reflect as far as possible the use of MDls under normal prescribing conditions. Two thousand and twenty-seven patients with chronic airways obstruction (CAO) were enrolled from 99 centres in France, 95 centres in Germany and 24 centres in Italy. Following a 2-week run-in period, patients were randomized on a 2:1 basis (1,348 patients to HFA-MDI, 679 patients to CFC-MDI) to receive a flexible dose regimen of the combination (2 puffs, 2-4 times a day, as prescribed by the investigator) during a 12-week open label phase. The overall incidence of adverse events was comparable between both groups. In addition, the incidence of respiratory side effects was also similar, with CAO exacerbations or bronchitis the most frequently recorded events. The safety profile of the HFA formulation was comparable to those of the marketed CFC-MDIs used in Germany and France/Italy. No clinically significant differences were detected between HFA134a or CFC driven inhalers on the switch from CFC- to HFA-MDI (2 weeks before randomisation versus 2 weeks after randomization). There was a trend for taste complaints to be reported more frequently by patients in the HFA-MDI group (0.7% before randomization versus 3.4% after randomization). This, however, was an expected finding as the HFA134a formulation does have a different taste to the CFC formulation. No difference between formulations was observed in the incidences of coughing or paradoxical bronchospasm. The incidence of falls in FEV1 >15% within 15 min following inhalation at each of the clinic visits was 1.2% for both CFC- and HFA-MDIs. In conclusion, administration of a fenoterol/ipratropium bromide combination via hydrofluoroalkane-metered dose inhaler is as safe as delivery by the currently available chlorofluorocarbon-metered dose inhaler, in an extended population of patients with CAO under normal prescribing conditions.

    Here is a study of 2024 patients with COPD where HFA gas was evaluated for safety versus identical active drug in CFC.

    This one study has 2024 patients with diseased lungs that had the same side effects from CFC, HFA and placebos versus Arthur’s 2500 strong petition of people with issues regarding the switch. Can you begin to see why it is pointless and time to move on, there are thousands of these studies out there.

    Now I will bow out of this fight and wish you all the best, but keep in mind I am not asking you to do anything. I am not trying to scare anyone to action, only reassure, I was not the one who came on and used google search excerpts of science to try to motivate a sick population to stress themselves over an issue that is already over with.

    All I have done so far is to prove HFA’s safety from sources all over the world, provided information on which products are most cost effective, provide options for other therapies that may help some of you and urged you to visit a physician to ask them, trained medical professionals, about the real risks/benefits of these products. I have also tried to explain proper use of the inhalers that leads to the best efficacy and tried to inform you of the true risks of some of the “Inert” ingredients, and what did I get out of it?

    Called a drug rep and have my credibility attacked from a person who does not understand that HFA is not a new issue and one who is trying to scare eveyone that comes onto the page into a panic. Believe it or not, there is plenty more to drugs, drug safety, and drug development that the FDA and their actions.

    For real information, if you don’t know whom to believe, go to your local medical school and ask for a meeting with a clinical pharmacologist or toxicologist and get them to explain the safety of HFA to you. I have done that and the person I found happened to have invented the molecule HFA 134A.

    And Arthur, I know you have put a lot of time into your fight, and I can respect your tenacity, but this is not a HFA and CFC albuterol issue, it is much larger than that and I would encourage you to be part of helping some of these people rather than scaring them half to death. Try expanding your research to include all of the HFA 134A that is in use in the many different theraopies for damaged lungs before you cite 3 studies regarding HFA albuterol and call the FDA’s decision illegal. I do understand that anyone who undermines your doomsday scenario takes away a lot of the impetous you feel regarding your petition and web site, but the facts don’t lie.

    CFC’s are gone this year, HFA’s are safe for the VAST majority of patients, and America will finally conform to what every other developed country has done years ago.

19. Perril, thank you so much for taking the time to compose that most informative post! In my case, I wasn’t afraid of any “toxic” properties or such — I just felt that, while the Pro-Air did work, it didn’t seem to clear my breathing as quickly or as well as the CFC albuterol.

    Since my original post, I’ve seen my doctor. It turns out my asthmatic bronchitis has worsened, and she felt sure that was a factor in my feeling the Pro-Air didn’t work as well for me. She upped the dosage of Advair, and since then the Pro-Air seems to work much better when I use it. It seems the key is to get extremely good control with the baseline med, and then when you do use the rescue inhaler, it works better (since your lungs aren’t as wheezy and gunky to begin with).

    I gotta say, though, I still hate the taste. If it weren’t for the nauseau issue I have, that wouldn’t be a factor. Because I frequently feel queasy anyway, though, anything that tastes or smells “off” to me can trigger a cookie-tossing. ;-)

    It’s something I can live with, though I do wish they could do something to disguise the taste — override it with a very strong minty fresh or cinnamon flavor or something. Maybe that’ll happen eventually.

    I hope my earlier comment didn’t set off the arguing…that wasn’t my intent. Thanks to everyone for offering your perspectives and a special thanks to Perril for that last post — it was superb. I really appreciate your taking the time, Perril.

    Kindest regards to all,

    Bunny Johnson

20. So, if every asthmatic needs to go on a steroid inhaler to tolerate the HFA inhalers? Someone is going to be very rich(the drug companies) and some will be very poor(the asthmatics). Ok, cost aside-why is it so hard for many in the medical profession to just believe that some of us are unable to tolerate the HFA134a formulation? We know, prime, clean, softer flume, inhale deeper, use a spacer, etc….. We followed the instructions, we primed, we cleaned, we accepted the softer flume-the results were-increased bronco-spasm, severe nausea, rashes, chest pain! If we continue use we will be dead-end of story.

21. Lynn,

    I told myself I would not respond to this board anymore, but I have repeatedly heard comments such as yours all over. Let me make it very clear:

    If you need Albuterol to help you breath, you have a disease that needs to be treated. Albuterol does not treat anything other than the SYMPTOMS of the DISEASE, not the disease itself.

    If the DISEASE is not treated, you will lose significantly more lung function every day due to underlying inflamation, mucus plugging, gas trapping, etc. Every disease that requires the use of albuterol (Exception being possibly Excercised Induced Asthma) worsens over time. Asthma has been shown to go away after Puberty in many cases, only to come back with a vengence later in life.

    And as for therapy choices, steroid inhalers are one, leucotriene modifyers, anticolinergics, Long Acting B2/Combos, Antihistimines, Theophylene, Mast Cell Stabalizers all have important roles in helping you function without dragging an oxygen tank around behind you for the last 5 years of your life. This is why I recommended to go see ya PHYSICIAN to see what medicine works best for YOUR disease and not listen to generalities posted on some board.

    As for the big pharma conspiracy theory that you think lurks in the background, you need to understand that steroids have nothing to do with tolerating albuterol, however, they can lower the amount of albuterol you use, which would reduce the number of inhalers needed over the year and lower the money these greedy drug companies make.

    You can screw their whole big plan by seeing your doctor!

    Finally, if you have ASTHMA, and are using more than 3-6 prescriptions of albuterol per year, your disease is not in control, you are losing lung function that you will never get back, and you will most probably end up in the ER at least once in the next 12 months, which costs way more than 12 steroid inhalers over the course of the year.

    COPD and Emphasyma are different diseases and may require daily albuterol use.

    So, the change is coming, doctors have no say in it, blame President Clinton for ratifying the Montreol Protocol Treaty in 96. That is what is forcing the change over and more expensive drugs.

22. Perril,
    Eventhough, some of us are on preventive meds we still need our rescue inhalers periodically-we just need one that works. I see the Drs., actually I was introduced to asthma meds after a severe adverse reaction to anesthesia and a stay in ICU-I coded twice and came home on Slo-bid and a rescue inhaler, then switched to preventive inhaler and along with the rescue inhaler-all worked well until the recent changes. I experience increased bronco spasm, severe nausea, rashes that look like chemical burns and chest pain-had numerous tests done following the use of the HFA inhalers-conclusion I am unable to tolerate the HFA formulation as others are. My child has EIA and the HFA inhalers did not relieve her symptoms-an emergency trip to the school with the CFC inhaler was made. I listened to the Drs, I listened to the pharmacists, we sufferered the consequences! Some will be able to tolerate HFA inhalers, while others will not be able to, no matter what anyone says.

23. Lynn,

    I am not unsympathetic to your cause. As I have repeatedly stated, The Vast majority of patients will not have an issue with HFA. I have never said that none will have issues. Once again, My wife hates the HFA inhalers due to taste and she claimed she did not feel relief, my son, who was never on a cfc never complains about the taste. Both get great relief from the HFA inhalers as proven by their Allergist with spirometry. I would suggest you go back to your doctor and take 2 tests one before and one after taking the HFA if you think it does not work.

    My debate with Arthur has to do with his lack of knowledge of the history of HFA as well as the vast majority of people who use it daily and never have an issue vs his message of doom and gloom and you are all going to die(yes, an exageration of his point, but none the less) if you use HFA which is just a false statement. Additionally, he would rather patients be afraid of their rescue medicine and not take it, but sign up for his Petition even though it is a decided issue already and he has to have the knowledge that the change has already occured in regards to these inhalers.

    I would suggest you go back to your doctor and ask about other options to just steroid inhalers such as Antihistimines, Cromylin sodium (Tilade) may help if it is reactive airways that trigger your exacerbations, Forodil or Serevent may help give you a little more open nature and help you prevent using some albuterol (works great in EIB for your child as well), Maxiar is not albuterol, but works almost as well and is still available with cfc, Theophylline is an older medicine that may help keep your airways open (however, blood levels need to be monitored).

    Lynn, keep in mind that there are some older medicines available, not just Advair, Symbicort or Asmanex that have been proven to treat different areas of the lungs, but because they don’t spend all of the advertising dollars and have the same number of sales reps out there, are often overlooked by physicians. It is proven that sometimes, treating a different area of the lung such as the distal areas, patients have much greater relief from their symptoms and can cut back significantly on their mediciation. I have a friend (pulmonologist) who has seen this very thing with a version of 35 year old beclomthasone which costs 1/3 of what some of the other medicines cost only he cannot get samples because no rep out there.

    I would also suggest that you see an immunologist about getting tested for allergies to hfa by using a placebo inhaler and allow your reactions to be documented and submitted to the FDA.

    No drug works 100%, no drug is 100% clean, and no person can take all drugs, it’s just a fact of life.

    Another avenue to try is a pocket RF nebulizer with albuterol solution and an Epi-pen. The Epi-pen should be a staple for all who suffer from Chronic Lung Disorders no matter what you try in case you close up and can get no rescue medicine.

    If you have Allergic Asthma, Zolair, or anti IgE may be a solution as well, except it is very cost prohibitive.

    It’s not a perfect answer, however, it is THE answer that is available. CFC’s have been banned and are going away. All of the manufacturers have stopped making it or are out of propellant to make it and the EPA and FDA have issued the final ruling regarding this issue.

    I hope some or at least one of these ideas may help you, but the main thing is find a doctor that is responsive to you and your concern of HFA sensitivity and have them test you in a blinded manner so that you will not have to guess as to if there is an issue with the gas, the preperation, the brand, or possible one of the additives. Don’t wait till you have an attack to find out if one of these issues is the problem, be proactive.

    I wish you good luck and good health.

    P.S. get an Epi-pen for you and your child at school.

24. perrill,

    I don’t have the time to reply to all of the mistakes in your posts- it’s hard to know where to begin (and I don’t deny that you have some good information)- but I do need to clear up your mischaraterization of my position:

    “My debate with Arthur has to do with his lack of knowledge of the history of HFA as well as the vast majority of people who use it daily and never have an issue vs his message of doom and gloom and you are all going to die(yes, an exageration of his point, but none the less) if you use HFA which is just a false statement.”

    You exaggerate my position to the point of absurdity and then attack this idiotic exaggeration as an example of a “false statement” on my part! This is very dishonest of you, perril.

    Let me make this clear to you. It is a FACT that there IS a percentage of patients who have serious problems with HFA albuterol inhalers- the clinical trials (LINKS 5,6 on the petition, under Adverse Reactions in the package inserts- the BEST data the companies have) show MUCH greater safety of CFC albuterol relative to Proventil HFA and Ventolin HFA, DESPITE the fact that the STATED CONCLUSIONS in the package inserts (about “comparability”) CONTRADICT the RESULTS (this happens in much of the drug company sponsored research I’ve read- but you’d actually need to READ the papers to see this).

    These patients were fine with their CFC rescue inalers and they are being denied their rescue inhalers for no good reason. This is extremely offensive to me as a citizen of a free country, and I will do what I can to change it.

    At the end of the day, when these patients use whatever other control Rx drugs they need to use, they STILL need a rescue inhaler that SAFELY AND RELIABLY WORKS FOR THEM.

    Now I don’t know if it’s the HFA-134a or the ethanol or the corn residue or the leachables and extractables in these HFA MDIs that’s causing the problem, I’m sure it varies with the patient, but I’ve read enough (and experienced enough- I’ve tried all of them- and I think I’m ok with Xopenex, although I still primarily use Warrick CFC) over the last sixteen months to know that MANY pulmonary patients can’t handle this stuff, and I don’t think we should TORTURE THEM by depriving them of the medicine that they need to ease their suffering, or prevent their premature death.

    As for your continuous references to so-called “conspiracy theories” in the drug industry- for the last time- google David Graham, MD, MPH, a 25 year vet of the FDA- the only medical officer promoted to the rank of master medical reviewer (sounds like a real quack, right, Einstein?) and see what HE’S said on the subject- read his Congressional testimony, READ about Ketek, READ about Trasylol, you could read what former FDA employees say, respected MDs say, for DAYS- and THEN tell me there’s no manipulation/suppression of data by drug companies ENABLED by FDA management. I feel like I’m telling a five year old that there’s no such thing as Santa Claus. Sorry to disturb your blissful ignorance with the FACTS, perril.

    Since you imply that your knowledge of the history of HFA is much superior to mine, I CHALLENGE YOU TO POST A LINK to back up your position that HFA-134a tests were conducted on other than normal, healthy subjects. I don’t believe the IPACT-I or IPACT-II tests used pulmonary patients, and forgive me, but I don’t give a damn what the “lead preclinical investigator” told you, personally. Everything I’ve read, as well as common sense, tells me that ONLY normal subjects were tested with the propellants.

    MORE dishonesty from perril:

    “Additionally, he would rather patients be afraid of their rescue medicine and not take it, but sign up for his Petition even though it is a decided issue already and he has to have the knowledge that the change has already occured in regards to these inhalers.”

    I have ALWAYS encouraged people to choose the best HFA rescue inhaler they can find for themselves now, and watch carefully for side effects, for weeks. I have NEVER told anyone NOT to use their rescue inhalers. I have invited anyone who wants to join our effort to save CFC MDIs to do so.

    I could go on and reply to some of the other nonsense you’ve posted, but I have to prioritize my time.

    One more history lesson from perril:

    “So, the change is coming, doctors have no say in it, blame President Clinton for ratifying the Montreol Protocol Treaty in 96. That is what is forcing the change over and more expensive drugs.”

    Actually, in this country, The President doesn’t ratify treaties, perril, Congress, does, and Congress ratified the Montreal Protocol in 1988.

    I DO blame Clinton/Gore for their role at the Ninth Meeting of the Parties in September, 1997, for forcing through a REQUIREMENT that all Parties come back in a year with a national plan for CFC MDIs to transition to non-ODS MDIs. Without this effort, the CFC MDI transition would have just coasted- no other Parties really cared that much about it (except IPAC- the MDI drug companies’ consortium- which worked with the EPA to hammer the FDA into submission on the issue. The drug companies organized IPACT-1 and IPACT-II around 1990, and CONSTANTLY pressured the FDA to move faster to comply with the Montreal Protocol. Clinton/Gore/Browner(EPA), the ‘environmentalists’ (the Natural Resources Defense Council, mainly), and IPAC (the MDI drug companies’ consortium) formed an unholy trinity to force the Montreal Protocol to deliver the HFA MDI disaster to many, many patients, ALL OVER the world.)

    CFC MDI emissions are too trivial to harm the ozone layer. Many innocent adults and children are suffering BADLY because they CAN NOT TOLERATE HFA MDIs- THIS IS A FACT. To help us overturn this dangerous, foolish ban, google “save cfc” or go here:

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

    Arthur Abramson
    The National Campaign to Save CFC Asthma Inhalers

25. I agreed with you

26. Arthur,

    Once again, In regards to Clinton, I was simplifying the issue in that without his action the CFC ban would have been ignored in regards to MDI’s rather than give a civics lesson to the board.

    In regards to the use of HFA 134A in Sick patients, I posted one actual study for all to see, not the link, over 2000 patients, over 30 clinical sites in over 3 countries with realistic daily prescribing and there was no difference between CFC and HFA in safety and side effects.

    The mediciation being looked at has different names than what is found in the US, but I think it was Combivent, and ALL of these patients suffered from COPD. So they were ALL sick patients with chronic lung diseases. But here it is again.

    One study of COPD PATIENTS from France that addresses this issue directly:

    Comparison of the safety of drug delivery via HFA- and CFC-metered dose inhalers in CAO
    G Huchon, P Hofbauer, G Cannizzaro, P Iacono, and F Wald

    The objective of this study was to compare the long-term safety of a fixed combination of fenoterol hydrobromide (50 microg) and ipratropium bromide (20 microg) delivered using a metered dose inhaler (MDI) formulated with a non-chlorinated propellant, hydrofluoroalkanel34a (HFA-MDI), with delivery using the conventional chlorofluorocarbon propellant (CFC-MDI, Berodual/Bronchodual). The study was designed according to Safety Assessment of Marketed Medicines (SAMM) guidelines, to reflect as far as possible the use of MDls under normal prescribing conditions. Two thousand and twenty-seven patients with chronic airways obstruction (CAO) were enrolled from 99 centres in France, 95 centres in Germany and 24 centres in Italy. Following a 2-week run-in period, patients were randomized on a 2:1 basis (1,348 patients to HFA-MDI, 679 patients to CFC-MDI) to receive a flexible dose regimen of the combination (2 puffs, 2-4 times a day, as prescribed by the investigator) during a 12-week open label phase. The overall incidence of adverse events was comparable between both groups. In addition, the incidence of respiratory side effects was also similar, with CAO exacerbations or bronchitis the most frequently recorded events. The safety profile of the HFA formulation was comparable to those of the marketed CFC-MDIs used in Germany and France/Italy. No clinically significant differences were detected between HFA134a or CFC driven inhalers on the switch from CFC- to HFA-MDI (2 weeks before randomisation versus 2 weeks after randomization). There was a trend for taste complaints to be reported more frequently by patients in the HFA-MDI group (0.7% before randomization versus 3.4% after randomization). This, however, was an expected finding as the HFA134a formulation does have a different taste to the CFC formulation. No difference between formulations was observed in the incidences of coughing or paradoxical bronchospasm. The incidence of falls in FEV1 >15% within 15 min following inhalation at each of the clinic visits was 1.2% for both CFC- and HFA-MDIs. In conclusion, administration of a fenoterol/ipratropium bromide combination via hydrofluoroalkane-metered dose inhaler is as safe as delivery by the currently available chlorofluorocarbon-metered dose inhaler, in an extended population of patients with CAO under normal prescribing conditions.

    The interesting this about this study is that it was open labeled, meaning that patients were told which medicine they were taken, and still there were no differences in the side effect profile. If I were to take 10 visitors from this site and give 6 of them HFA and 4 CFC do your think that there would be similar outcome in regards to side effects. You see, in Europe, there isn’t this pressure and false information out there about imaginary dangers of this propellant, so in their minds, it was just a new propellant and they knew it was different so they did not expect it to taste or feel the same, and when Spirometry was performed, FEV change was the same in both drugs with only 1.2% having a decrease in FEV1 (bronchoconstriction) So CFC and HFA had the same number of non-responders, so I guess that by Arthur’s standards, the CFC drug did not work 1.2% of the time and the gas was probably at fault and the Drug companies pressured the regulators to ignore this HUGE failure of the drug.

    As for the “False Statement”, I was referring to my exageration of your claim, I am sorry if you took that the wrong way. But keep in mind YOU used the word TOXIC in regards to HFA 134A in your prior post and that is what I was referencing.

    As for a single unhappy ex-member of the FDA, I give very little credence to one anecdotal statement by some government burnout. Believe me, there is HUGE money in litigation with Pharmaceutical Companies, over 20 billion dollars that I am aware of have been paid by US pharma Companies to State and Federal government for all sorts of issues, and I TRUST the TRIAL LAWYERS in that if anything untoward was going on regarding undue pressure from Big Pharma, it would have been in the courts, remember, several generic companies have gone out of business because their main drug was Albuterol CFC and they could no longer import the gas, and I suppose none of them have lawyers that are willing to take on BIG Pharma and the FDA? They sue big pharma every day in regards to patents, etc. The reason there are no suits regarding this topic is that there is no issue here.

    It’s that simple.

    If you think you cannot tolerate the inhalers, go see your doctor, take the spiromotry challenge have testing prior to taking and after taking HFA and try to prove me wrong, my wife had similar complaints, tried and she failed to prove me wrong because the HFA worked at least as well as her CFC ihaler.

27. perril,

    The problem with posting an ABSTRACT instead of a LINK that let’s you read the DATA is that the reader is forced to accept the author’s CONCLUSIONS, which, as I’ve shown you several times, OFTEN CONTRADICT THE RESULTS in drug company sponsored clinical trials.

    So while YOU may be impressed with the following CONCLUSIONS from this abstract, I am NOT, because I’ve SEEN the same PHONY CONCLUSIONS in PETITION LINKS 5,6 (the Proventil HFA and Ventolin HFA clinical trials used in their NDAs and summarized in the package inserts) and numerous OTHER trials that are CONTRADICTED by the RESULTS:

    “The overall incidence of adverse events was comparable between both groups. ”

    “In addition, the incidence of respiratory side effects was also similar,… ”

    “The safety profile of the HFA formulation was comparable to those of the marketed CFC-MDIs used in Germany and France/Italy.”

    “No clinically significant differences were detected between HFA134a or CFC driven inhalers on the switch from CFC- to HFA-MDI (2 weeks before randomisation versus 2 weeks after randomization).”

    “In conclusion, administration of a fenoterol/ipratropium bromide combination via hydrofluoroalkane-metered dose inhaler is as safe as delivery by the currently available chlorofluorocarbon-metered dose inhaler, in an extended population of patients with CAO under normal prescribing conditions.”

    Without seeing the DATA we have no way to evaluate the CREDIBILITY of these CONCLUSIONS.

    Since you can’t be bothered to read the results on the LINKS I’ve provided, I’ll bring the results to you:

    First, a couple of definitions:

    COMPARABLE means similar or equivalent.

    INCIDENCE means the FREQUENCY with which something appears in a particular population.

    Schering-Plough says (LINK 5 in our petition):”Overall, the INCIDENCE and nature of the adverse reactions reported for PROVENTIL HFA Inhalation Aerosol and a CFC 11/12 propelled albuterol inhaler were COMPARABLE.”

    But they also say (LINK 4 of our petition, 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) .”

    How much more frequently do Proventil HFA’s adverse reactions occur?

    The incidence of TACHYCARDIA (rapid heart beat) during the 12 week clinical trials was over 200% greater for Proventil HFA than it was for CFC albuterol (7% vs. 2%),

    the incidence of VOMITING during the 12 week clinical trials was over 200% greater for Proventil HFA than it was for CFC albuterol (7% vs. 2%),

    the incidence of FEVER during the 12 week clinical trials was over 200% greater for Proventil HFA than it was for CFC albuterol (6% vs. 2%),

    the incidence of BACK PAIN during the 12 week clinical trials was 100% greater for Proventil HFA than it was for CFC albuterol (4% vs. 2%),

    the incidence of ALLERGIC REACTIONS during the 12 week clinical trials was 50% greater for Proventil HFA than it was for CFC albuterol (6% vs. 4%),

    and the incidence of RESPIRATORY DISORDERS during the 12 week clinical trials was 50% greater for Proventil HFA than it was for CFC albuterol (6% vs. 4%).

    In my opinion, the INCIDENCE of the adverse reactions reported for Proventil HFA and CFC albuterol ARE NOT COMPARABLE, so I REJECT Schering-Plough’s CONCLUSION.

    The numbers of patients tested in drug trials, according to whistleblower David Graham MD, MPH, the FDA’s 25 year AND CURRENT top medical reviewer/safety officer (and as of 12/11/05 at least, the ONLY FDA medical officer ever to be promoted to the rank of master medical reviewer) are deliberately kept low (only about 200 patients each for 12 weeks were tested with Proventil HFA and Ventolin HFA)- not because the drug companies can’t afford larger trials, and not by accident- they are kept low so that if someone points out the above lousy adverse reaction results (for example), the drug companies can deflect the criticism by saying that the sample size is too small to draw such a conclusion:

    “The classic approach of industry and FDA has been to do studies that are too small to conclusively identify that a risk is real,” he added. “They can conclude, therefore, that there is no risk.” FDA Safety Officer David Graham, MD, MPH (LINK 37).

    (CONTINUED)

28. I hate when that happens-

    I apologize to everyone for the triple posting- I thought it didn’t go through.

    Moderator- please remove the redundant posts.

    Thank you,

    Arthur Abramson

29. Arthur,

    Use medline and look up the title and authors for the clinical. I am not going to pay the “use fee” to prove my point when the authors point out the most important issue in the abstract that demonstrates the topic you are interested in, that the side effect profile and non-responsiveness are identicle with the two propellants.

    Additionally, I don’t always beleive what drug makers put out on the market in regards to data. If you want to accept their negative data that they have in their filing, why do you reject their positive data even though all of the data was funded by the drug maker, not an independent non-profit or government organization? That is quite the double standard.

    Once again, let me reinforce that you are singling out Proventil HFA and other rescue medicine, you need to expand your research to the approval trials for the HFA gas which is the data you “don’t give a care about” in regards to the inventor of the molecule and preclinical investigator that I spoke in regards to a former post. I understand that this data refutes your claims and that is why you ignore it.

    Additionally, the data from overseas in at least 3 therapeutic classes where the safety and tolerability of HFA gas has been proven out and is used exclusively today and for the past 8 years in their MDI type products (with no exceptions allowed by their governments) once again is ignored in your cherry picking of the data you wish to speak about.

    I understand your methodology, only point out the points that reinforce what you want to prove rather than the entire body of evidence that has been researched and published everywhere. And for the average person out there looking for the truth behind why they are forced to change their trusted lifesaving medicine to a medicine that they don’t really care for, your bullet point and cherry picking of data which even the pharmaceutical industry is not allowed to do (they must provide fair balance to all evidence provided the general public) influences the more naive patients who are actually impacted by this change and their disease.

    For those of us who actually take the time to look into the issue, the sensationalization of this issue would be laughable except that it could dramatically influence those same patients who now may feel that no-one cares about them due to those greedy drug companies and the corrupt FDA.

    To reinforce my point, I will paraphrase what I have seen as I have visited several boards on this topic and demonstrate my favorite quote from a patient was posted:

    “I don’t trust my doctor, he tried to get me to use a more expensive medicine that he said would better treat my asthma. He actually wanted me to believe that my asthma can change over time.”

    This was posted in a thread that hit the same points YOU make that this is all a profitability scam, that drug comapnies run the FDA and that Doctors are complacent in the profit making of drug companies.

    Now back to reality, if it was not for HFA, the only Lung medications available next year would be nebulized at 15 minutes per treatment and less than 50% compliance with medication, or pills(Proventil Repitabs, Theophyline, Volspar, Accolate, and Singulair), or DPI’s (Which have been proven to increase side effects like thrush, parodoxical cough, and even increased death (SMART study Glaxo Welcome and subsequent Black Box Warning.)

    I now that in your ind you are trying to give patients a choice in their medicine, even though that issue has already been decided, however, the approach you are using is pointing out nothing but the thing that YOU perceive as negatives.

    Why not provide the patients with fair data like the percentage of patients on CFC that suffered from Paradoxical Bronchospasms due to the cold puff that get great relief from HFA. Or what about those asthmatics that got less than 50% of their targeted dose of medicine from CFC inhalers when the Ambient temperature dropped below Freezing (for those of you who live in the north and keep their inhalers in their car or who are active outdoors in the winter) Or what about the patients who cut their medicine bill by 50% by useing HFA versions of Steroid inhalers and are able to get off of expensive combo therapies and maintain their quality of life?

    I have no vested interest in HFA, I have no vested interest in CFC. I do have a vested interest in the health and wealfare of at least 2 asthmatics(my family) and if I can help bring balance to this discussion by being a sounding board to your cherry picking and negativity, I will continue to do so.

    Warmest Regards

30. Perril,

    Post some DATA (NOT CONCLUSIONS) to back up your arguments as I have done, or take satisfaction in having the last word, because I won’t waste any more time arguing against your unsupported assertions.

    We are facing a BAN of CFC ALBUTEROL on 12/31/08- which is why I am using the ONLY DATA AVAILABLE (aside from the FDA MEDWATCH data- which is just BRUTAL for you HFA proponents, perril, PARTICULARLY in the context of HFA’s much lower market share during the three years covered- just REALLY ugly data for your team, perril) to prove that the ban will replace SAFER CFC ALBUTEROL with MUCH more DANGEROUS HFA ALBUTEROL. YOU CAN’T ARGUE AGAINST THIS DATA, PERRIL, SO HAVE THE CLASS AND DECENCY TO ADMIT THAT YOU WERE WRONG ABOUT THIS. CFC ALBUTEROL IS MUCH SAFER, as I’ve shown below- even with the weak, trivial data favorable to HFA included. Nothing changes. BE HONEST AND ADMIT YOU WERE WRONG ABOUT HFA ALBUTEROL BEING JUST AS SAFE AS CFC ALBUTEROL, PERRIL, OR LOSE ALL CREDIBILITY ON THIS FORUM.

    I will not be drawn into a sideshow on other therapeutic classes when CFC ALBUTEROL ALONE is being banned now and our immediate goal is to save CFC rescue inhalers.

    I DO UNDERSTAND THAT you would LIKE to distract us with another pointless discussion of other therapeutic classes and other papers WITHOUT DATA from around the world because MY DATA on the SUPERIOR SAFETY of CFC ALBUTEROL vs. HFA ALBUTEROL IS IMPOSSIBLE FOR YOU TO ARGUE AGAINST, SO IT’S TIME TO GET OUT OF DODGE.

    BUT AS USUAL, you DIDN’T DO YOUR HOMEWORK SO NATURALLY YOU WANT TO REFUSE TO ACKNOWLEDGE THE DATA THAT CRUSHES YOUR HFA ALBUTEROL MDIs AND THROW ALL SORTS OF ‘STUFF’ AGAINST THE WALL TO SEE IF ANY OF IT STICKS, like this:

    “Why not provide the patients with fair data like the percentage of patients on CFC that suffered from Paradoxical Bronchospasms due to the cold puff that get great relief from HFA. Or what about those asthmatics that got less than 50% of their targeted dose of medicine from CFC inhalers when the Ambient temperature dropped below Freezing (for those of you who live in the north and keep their inhalers in their car or who are active outdoors in the winter) Or what about the patients who cut their medicine bill by 50% by useing HFA versions of Steroid inhalers and are able to get off of expensive combo therapies and maintain their quality of life?”

    Have you SEEN ANY OF THE ABOVE DATA, perril? I HAVEN’T.

    POST THE LINKS THAT GIVE US THE DATA.

    YOU CAN’T, WE KNOW.

    This is TRIVIAL GARBAGE or OTHERWISE SEVERELY FLAWED. I don’t believe a word of it.

    FOCUS ON THE SAFETY DATA I GAVE YOU- ADMIT THAT YOU ARE WRONG AND THAT CFC ALBUTEROL IS MUCH SAFER THAN HFA ALBUTEROL- DON’T RUN AWAY FROM IT.

    We have real live HUMAN BEINGS WHO SAY THAT HFA ALBUTEROL is MUCH LESS EFFECTIVE IN COLD WEATHER!

    CITE YOUR REFERENCE TO THE CONTRARY- I WANT DATA- NOT YOUR TYPICAL BS CONCLUSIONS FROM PAID HACKS IN WHITE COATS.

    YOU CAN’T YOU FIND ONE LOUSY PAPER THAT PROVES ANYTHING YOU SAY ABOVE, PERRIL? WITH ACTUAL DATA, RESULTS? No. Of course you can’t.

    You are playing EGGHEAD ACADEMIC GAMES, perril. EVEN THE FDA ADMITS THAT THE HFA TRANSITION WILL HURT PATIENTS FINANCIALLY- your arguments are trivial and bizarre.

    I HAVE COMPLAINTS FROM 2600 PATIENTS WHO CAN NOT TOLERATE HFA MDIs. I provided IRREFUTABLE DATA TO PROVE MY ARGUMENT ABOUT CFC ALBUTEROL’S MUCH GREATER SAFETY vs HFA ALBUTEROL.

    You accuse me of ignoring the POSITIVE DATA, of cherry-picking my data? No problem.

    I’ll re-post the DATA that supports the greater safety of CFC albuterol, followed by the DATA that favors HFA- and readers can decide for themselves which formulation is safer, and whether I am guilty of ‘cherry-picking’ my data or just leaving out trivial data (on BOTH SIDES- I’ve included ALL DATA BELOW for your benefit):

    A) DATA SHOWING CFC ALBUTEROL SAFETY:

    The incidence of TACHYCARDIA (rapid heart beat) during the 12 week clinical trials was over 200% greater for Proventil HFA than it was for CFC albuterol (7% vs. 2%),

    the incidence of VOMITING during the 12 week clinical trials was over 200% greater for Proventil HFA than it was for CFC albuterol (7% vs. 2%),

    the incidence of FEVER during the 12 week clinical trials was over 200% greater for Proventil HFA than it was for CFC albuterol (6% vs. 2%),

    the incidence of BACK PAIN during the 12 week clinical trials was 100% greater for Proventil HFA than it was for CFC albuterol (4% vs. 2%),

    the incidence of ALLERGIC REACTIONS during the 12 week clinical trials was 50% greater for Proventil HFA than it was for CFC albuterol (6% vs. 4%),

    and the incidence of RESPIRATORY DISORDERS during the 12 week clinical trials was 50% greater for Proventil HFA than it was for CFC albuterol (6% vs. 4%).

    B) MORE DATA SHOWING CFC ALBUTEROL SAFETY THAT I DIDN’T BOTHER MENTIONING BEFORE:

    the incidence of INHALATION TASTE SENSATION (this is what NAUSEATED BUNNY, and MANY OTHERS) during the 12 week clinical trials was 33% greater for Proventil HFA than it was for CFC albuterol (4% vs. 3%),

    the incidence of NAUSEA during the 12 week clinical trials was 11% greater for Proventil HFA than it was for CFC albuterol (10% vs. 9%),

    the incidence of UPPER RESPIRATORY INFECTION during the 12 week clinical trials was 5% greater for Proventil HFA than it was for CFC albuterol (21% vs. 20%),

    C) DATA SHOWING PROVENTIL HFA SAFETY:

    The incidence of INHALATION SITE SENSATION (COOLNESS of the spray which MANY patients PREFER and should NOT even be considered an ADVERSE REACTION- this is an ABSOLUTE GARBAGE metric in my opinion- and not a WORD about greater paradoxical bronchospasm secondary to the cool spray that you ASSERTED ABOVE WITHOUT PROOF, AS USUAL, PERRIL) during the 12 week clinical trials was 50% greater for CFC Albuterol than it was for Proventil HFA (9% vs. 6%),

    The incidence of TREMOR during the 12 week clinical trials was 14% greater for CFC albuterol than it was for Proventil HFA (8% vs. 7%),

    The incidence of NERVOUSNESS during the 12 week clinical trials was 29% greater for CFC albuterol than it was for Proventil HFA (9% vs. 7%),

    The incidence of RHINITIS during the 12 week clinical trials was 38% greater for CFC albuterol than it was for Proventil HFA (22% vs. 16%),

    The incidence of URINARY TRACT INFECTION during the 12 week clinical trials was 33% greater for CFC albuterol than it was for Proventil HFA (4% vs. 3%),

    THERE IS NO CONTEST. NOTHING CHANGES. THE INCIDENCE (AND SEVERITY) OF ADVERSE REACTIONS BETWEEN THE TWO ARE NOT AT ALL COMPARABLE AS THE CONCLUSION FALSELY STATES. CFC ALBUTEROL IS CLEARLY MUCH SAFER THAN PROVENTIL HFA.

    NOW FOR VENTOLIN HFA:

    I POSTED THIS DATA SHOWING CFC ALBUTEROL SAFETY:

    D) the incidence of THROAT IRRITATION was 66% greater for Ventolin HFA than for CFC-albuterol (10% vs. 6%),

    the incidence of VIRAL RESPIRATORY INFECTION was 75% greater for Ventolin HFA than for CFC albuterol (7% vs. 4%),

    and the incidence of COUGH was 150% greater for Ventolin HFA than for CFC albuterol (5% vs. 2%).

    D) THERE WAS NO DATA (ZIP, ZERO, NADA) SHOWING VENTOLIN HFA SAFETY.

    E) BOTH FORMULATIONS SHOWED 5% INCIDENCE OF UPPER RESPIRATORY INFLAMMATION AND MUSCULOSKELETAL PAIN.

    THERE IS NO CONTEST. AGAIN, NOTHING CHANGES. THE INCIDENCE (AND SEVERITY) OF ADVERSE REACTIONS BETWEEN THE TWO ARE NOT AT ALL COMPARABLE AS THE CONCLUSION FALSELY STATES. CFC ALBUTEROL IS CLEARLY MUCH SAFER THAN PROVENTIL HFA.

    You write:

    “Once again, let me reinforce that you are singling out Proventil HFA and other rescue medicine,…”

    YES, since the RESCUE INHALER BAN IS WHAT WE ARE FACING IN 5 MONTHS, I PREFER TO MAKE MY CASE AGAINST IT BY PROVING MY POINT WITH TARGETED DATA.

    YOU PREFER TO MAKE YOUR POINT WITH WILDLY UNSUBSTANTIATED CLAIMS FLYING ALL OVER THE PLACE TO TRY TO DISTRACT US FROM THE IRREFTABLE FACTS THAT DESTROY YOUR ARGUMENT THAT HFA ALBUTEROL IS JUST AS SAFE AS CFC ALBUTEROL.

    You write:

    ” you need to expand your research to the approval trials for the HFA gas which is the data you “don’t give a care about” in regards to the inventor of the molecule and preclinical investigator that I spoke in regards to a former post. I understand that this data refutes your claims and that is why you ignore it. ”

    BEEN THERE, DONE THAT, provided a reference on a previous post showing ONLY NORMAL HEALTHY SUBJECTS WERE USED.

    YOU NEED TO PROVE YOUR POINT THAT HFA WAS TESTED ON PULMONARY PATIENTS.

    YOU CAN’T.

    IPACT-I and IPACT-II NEVER TESTED HFA ON PULMONARY PATIENTS.

    Ask Dr. Leech (I’m guessing this is who you are talking about) to give you SOME LINK, SOME PROOF, or have him email it to me at sponsor@saveCFCinhalers.org If I am wrong, I’ll ADMIT IT. I want to see the ADVERSE REACTIONS DATA not just his CONCLUSIONS- the ADVERSE REACTION RESULTS on PULMONARY PATIENTS TESTED with HFA-134a vs CFC-11,12. I DON’T BELIEVE IT WAS DONE. SHOW ME I’M WRONG. PLEASE TELL DR. LEECH (or whoever it is) that I would SINCERELY APPRECIATE THE OPPORTUNITY TO TALK TO HIM ASAP- please send me his email/phone- if there’s any truth to this- I want to know it and if I’m wrong I WILL ADMIT IT. You might consider doing the same.

    Good Night, perril,

    Arthur Abramson

31. Aurthur,

    If a pharmaceutical rep were to provide the information you just provided to a physician, the company that hired him would be fined by the FDA for illegal promotion and the representative would be fired. The groups of patients used in the studies you cited were not the same patients and did not have the same diseases, co-morbidities, and everyday aches and pains, infections and colds so the FDA does not recognize validity in head to head PI comparisons.

    If this is some of the data you are basing your claims on in your petition, NOW I understand your frustration and the reason you are being ignored by the powers that be.

    If you have experience with Scientific study design and protocol, which is recognized and adopted by every major medical journal around the world and the FDA, you would understand that if you took the same lets say 100 patients and enrolled them in a clinical study during March, April and May (Spring) and then again in October, November, and December (Cold and Flu season) with the same drug and the same dosing regimen, that the side effects reported in each study will be dramatically different. And it would be unfair to use data from these two different time points and different stages of their disease to show a distinction in safety based on isolated and random complaints such as Back pain, or respiratory infections, or Rhinitis (Runny Nose) or Urinary Tract Infections. ESPECIALLY with diseases of the lung that temperature, pollution, pollen, indoor activities (Fall/Winter) verses Outdoor activities (Spring/Summer) impact dramatically.

    And again, I understand your passion in regards to this issue, however, you are beating a dead drum if this is the data you are focusing on. I will be sure to forward your post to a practicing physician (Pulmonologist) and to the investigator in which I am referencing and let them decide if they feel your information is valid enough to contact you. From the conversations I have had with them regarding this issue, they think that you have an agenda that is outside of simple concern and that you lack understanding of valid study design and protocol. I would be happy to give you their contact information, however, they gave it to me in confidence, but to be fair I will give them the chance to respond to you if they wish.

    You are attempting to move a mountain with a garden spade if this is the majority of the data that you are basing your claims on. To help you convince the FDA to delay this action (which they won’t) look for the studies that include active drug, placebo of same drug, active comparator, vs CFC. These studies are out there, I have found 3 this morning, and unfortunately, they really don’t give you the tools you would need to prove your points. These types of studies would be needed to remove seasonal variability, variability in sex, race, age, disease severity, co-morbidities, etc in order to be accepted by the FDA.

    In regards to FAIR BALANCE here is the FULL statement for Proventil HFA that is allowed for publication by the company:

    Important Safety Information

    PROVENTIL® HFA Inhalation Aerosol or Albuterol (CFC) Inhalation Aerosol can produce paradoxical bronchospasm,

    which may be life threatening. Paradoxical bronchospasm, when associated with inhaled formulations, frequently

    occurs with the first use of a new canister.

    Please consult Prescribing Information regarding drug interactions between PROVENTIL® HFA or Albuterol (CFC)

    Inhalation Aerosol and oral sympathomimetics,beta-blockers,monoamine oxidase inhibitors,or tricyclic antidepressants.

    In a clinical study, total adverse events reported with PROVENTIL® HFA were comparable to traditional CFC containing

    inhaled albuterol (upper respiratory tract infection 21% vs 20%, rhinitis 16% vs 22%, nausea 10% vs

    9%, tremor 7% vs 8%, nervousness 7% vs 9%), respectively.Tachycardia (7% vs 2%), vomiting (7% vs 2%), chest pain

    (<3%), and palpitation (<3%) occurred more frequently with PROVENTIL® HFA

    You will notice as you pointed out that there was less rhinitis and tremors and nervousness( the largest side effects reported with albuterol use) with HFA versus CFC, but more tachacardia, vomiting and chest pain, however the drug companies cannot just report the good to the FDA or to the public, they must include the bad as well.

    In regards to HFA vs CFC in SICK PATIENTS please look at the following:

    Safety of Long-term Treatment With

    HFA Albuterol*

    Joe W. Ramsdell, MD; Nancy M. Klinger, BS; Bruce P. Ekholm, MS; and

    Gene L. Colice, MD, FCCP

    I tried to post the relevant sections from the study, however the format did not hold up and I don’t feel like re-typing the entire 12 pages to give balance.

    As for your statistical analysis of side effect differences between cfc and hfa, that is really dishonest. A 2% incident of a side effect versus a 1% incident may be a 100% change or increase in a given side effect, it is actually only the difference between 99 patients out of a hundred not having an issue and 98 patients out of a hundred not having an issue. And by using a head to head comparison and actually dividing out by the percentages skews the data in a dishonest way that only serves to scare patients and of course try to make your position look accurate.

    It would be similar to having 3 people from Mississippi (a red state) in a room and asking them who they support for president. 2 say McCain and 1 says Obama and then publish the results as 2/3rds of Americans polled support McCain. Or you could correctly say that 100% more of polled Americans support McCain than Obama. While it may be true, it is not accurate. Until you get the demographic data and verify that all respondents are about the same (IE same income, sex, political party, age, etc) the results have no meaning. And in regards to the medical data you are comparing, it is the same thing, when was the study performed, how were the results measured (patients survey, or clinical examination)? What medicines were the patients on, what was their sex, race, age, co-morbidity. Were any of the patients athletes (cramping and sore backs)? Were any of the patients sick or infected with the flu or a cold? And finally, what were the numbers of each type of these patients in each study. Since there is no way to prove randomization of all of these factors between the two separate non-concurrent studies, there is no fair way to compare them. This is universal across the globe, no medical journal in the US or other country would publish, and no medical researcher would base any conclusion on the data you provide in regards to this issue because it is not credible since it has no context.

    While you may dismiss other therapeutic classes as irrelevant, there is much more money to be made by drug companies in those areas (Notice how ADVAIR 500/50 is over $200 and Asmanex over $160 while rescue meds are $2-$60 per script), so they study the other drugs more than albuterol. That is why you should look for safety data there, rather than with a rescue medicine. It is not an attempt to distract you from a focus on albuterol, however I thought your issue was with the safety of HFA gas, if you simply hate Proventil HFA or Ventolin HFA and want options to those drugs, then the overall safety of HFA IS irrelevant and I apologize.

    However, if the safety of the HFA propellant is the issue, logically the same safety issues would be an issue in those therapy classes as well, and all of the horrible side effects like abdominal cramping and muscle aches and common colds would show up there as well, with a much larger sample size of sick patients, (which is kinda what you were asking for in your earlier post)

    By the way, I loved CFC albuterol for my wife and son,($5 copay) versus HFA ($35) copay (I now pay cash $31.99 at Walmart which is cheaper than my co-pay). And remember, I think this whole global warming and ozone issue is a crock of crap, I am also Republican and support supply and demand in which this ruling interferes. But, they are gone, and it is not going to change. You are focused on the next 5 months when in fact, the transition has already occurred in that the last maker of Albuterol (Armstrong)is out or close to out of CFC gas, there is no domestic maker of the gas, and the EPA will not allow any more CFC gas to be imported and if they did allow it to be imported, it would take around 4-6 months to start production on a new batch of inhalers and that would mean no inhalers on the market till next summer. The EPA is not going to relent.

    So I would rather be part of the solution to help some of these patients who are impacted rather than be a distracter from the help they need in order to gather support for a personal agenda. And after looking at the design of HFA when it was developed and trial and error with my own family in regards to the same complaints posted by many of the patients here (no chemical burns yet), I have learned the real facts regarding the HFA and I feel that it offers real advantages to the vast majority of patients at UNFORTUNATELY a higher price.

    By the way, I noticed that after posting the data on sick patients on COPD therapy that shows almost identical safety between propellants that your tone turned increasingly hostile (similar to a schoolyard bully who starts to shout when someone crosses them, and not like someone who is truly interested in completely researching the issue to make the best argument possible).

    Just an observation

    Warmest Regards

32. testing

33. Sorry, perril- I can’t copy/paste my reply for some reason- it’s not the first time I’ve had that problem with this site. My reply is not longer than others that have posted, so I don’t know what the problem is, but I’ve lost patience with this site.

    Best Regards,

    Arthur Abramson
    sponsor@saveCFCinhalers.org
    The National Campaign to Save CFC Asthma Inhalers

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

    or google: ‘save CFC’

    P.S. I’m really not interested in talking to your pulmonologist friend, I’ve talked to plenty of doctors, including FDA PADAC doctors, but if you could arrange for me to talk to the IPACT-I investigator specifically about the adverse reaction DATA among pulmonary patients tested with HFA and CFC, I’d really appreciate it. I still find it almost impossible to believe that IPACT-I tested pulmonary patients, but I’ve been wrong before.

34. Arthur, you need to stop using sponsor@savecfcinhalers.org as your email address. Because you are subscribed to get email updates from this thread, I get a “Thank you, your message has been received” autoreply from you each time someone posts a comment. (Posting this comment will trigger it.)

    Consider it a warning. If it happens again, I’m going to delete your subscription, and all of your posts. I’m tired of it. I’ve gotten 15-20 of these stupid auto-reply emails since the first time you posted a message here.

    It’s also considered extremely bad email etiquette. If it’s annoying me, it’s probably annoying other people that you haven’t considered when you set up that particular nuisance.

35. Arthur,

    I am not sure he is with the group that you think he may be. He is just a practicing Pulmonologist that is on about 5 different speaker bureaus for pharma companies and has been involved in clinical trials for inhalers for about 25 years. He still uses CFC Maxair to this day for patients who feel as though many of patients that are looking for help on this board feel. (Maxair’s exception has been extended a few more years which may be another reason why the FDA has closed off the options on the other inhalers I.E. patients still have access to nebulized therapy and Maxair CFC.)

    I forwarded your information and am waiting to hear back, but with all of his obligations, sometimes he is out of pocket for several weeks. The clinical researcher I mentioned is also an adrenaline junkie who will be out of the country trying some insane stunt until after October. So I know I won’t have access to him until then.

    As for the testing, I am not saying there was or not, I have not personally seen the papers with my own eyes, I just know that when I brought up the adverse events listed on THIS board and expressed concern as to if they were seen in trials of just the gas and no active drug, the developer laughed and told me that there was no statistical difference in any measure other than taste sensation and in fact most patients could not even tell there was a difference in the gas at all. This lack of sensation was deemed a successful answer all of the criticisms of CFC MDI’s up until that point. HFA increased lung deposition, decreased paradoxical bronchospasm caused by cold, ans decreased oropharangeal deposition in the throat which was what the technology was meant to do.

    He is also the person who mentioned the foreign data that I passed on to you in order to help you understand the depth of knowledge and safety data that is out there regarding this gas in all patient types.

    As I am sure you have seen, the FDA approval process is a game in that they expect to see certain data in every submission, but whole worlds of data exists that the drug companies never publish in order to protect its use as building blocks for future drugs. If they submit or publish much of this data, other companies will have the data results and not have to perform the same research and cut corners and time for their own drug approvals and increase their profitability.

    I want you to know that I am not against you on this, I just feel that your approach could be potentially harmful to some of the more naive patients who don’t understand the real issues. I honestly feel that 999 out of every thousand patients who take HFA albuteral will never see a negative issue, and for the others, ethanol content may cause some nausea, Some patients may be overly sensitive to chemicals and need to use spacers or chambers to keep it off of their skin, some may have high levels of oleic acid in their diet and the little bit extra that is in some of the inhalers may push them over the top in an additive manner to having decreased lung function. But in all honesty, I have reviewed dozens of studies that encompassed hundreds of patients with diseased lungs and healthy lungs, and one thing is very clear, there is vertual no difference in response rates to hfa propelled drug and cfc propelled drugs and statistically (I know, I already demonstrated how statistics can be skewed) the side effect profile is almost identical. And this similarity proven to a 95% confidence interval or p>.05 is the litmus test for the FDA.

    Also, you should know that WARRICK inhalers are a Schering Plough product (Marketer of Proventil HFA) and they have invested way too much money in this conversion to ever get back into the cfc business, and with the way the FDA has cracked down on safety issues for inhalers in the late 90’s ($500 million dollar fine for bad manufacturing processes), for a new generic maker to enter the inhaler market would be so cost preventative, that they could never recoup their investment.

    As an example of this, the FDA actually delayed the ProAir HFA product from hitting the market for over a year due to swirling amd color inconsistancy in the plastic part of the device.

    I hope you understand the direction from where I come. It is not personal, and I have way to many irons in the fire to perform the research you are asking for me do in order to “Prove” it on this board, but I have pointed you in many areas where you, or someone else at your organization, can get access to very relevent data on the gas and its safety profile in all patient types.

    Warmest Regards!

36. Sorry, RJS. I wish you told me sooner.

37. perril,

    Thanks for the reply.

    We may only be talking about 1-3% of the population of 40 million US CFC MDI users (I thought it was 35 million- I saw this number on a credible site last night- the number is in this area) who can’t handle HFA MDIs, who were doing fine with CFC MDIs (primarily albuterol complaints, but a lot of COPD complaints about Atrovent also, we get others as well, and we are really just getting started. COPD patients were NEVER tested with HFA MDIs as far as Hendeles, Colice and Myers know- March 2007 NEJM- and a lot of them are are in a world of hurt).

    We just got a complaint from a young paraplegic- she is in trouble with HFA- no pulmonary disease but she needs albuterol when she needs it and the HFA doesn’t do it- cystic fibrosis patients, lung cancer- it goes on and on- there ARE a LOT of people who are being BADLY HURT FOR NO REASON, all of your studies/papers notwithstanding. Studies and papers DO NOT tell the whole story- they never did and never will. Any REAL doctor knows this.

    You want to talk about agendas? We have a top level official of the allergy/immunology college- their past rep to the ‘US Stakeholders to the MDI Transition’- Dr. Finegold- telling Forbes in July that the CFC MDI ban will prevent a large number of skin cancer deaths, ok? I have the reference. And as bad as your temper is, I guess mine is worse. We have the American Lung Association, Allergy Asthma Foundation of America, and Allergy Asthma Network Mothers of Asthmatics- all making a cottage industry out of this ‘transition’, all paid off big-time by the drug companies- petitioning the FDA to ACCELERATE the CFC MDI BAN in 2004 on behalf of ASTHMA patients- not because CFCs weren’t great products, but because it was MUCH more profitable to get on the CFC MDI/ozone depletion bandwagon. They ALL need to lose their tax-exempt status yesterday.

    One day, take some time and read our complaints from MDs, PhDs, RRTs, RNs, intelligent civilians who ARE using the MDIs correctly, and keep telling yourself that the papers and studies invalidate their comments. I gave up a huge amount of time I should have spent on my business since I first got into this 17 months ago when I was given my first Proair and found out what this was all about. I pay all expenses. We accept no funding/compensation from anyone. So people are welcome to speculate about my ‘agenda’ all they want- it doesn’t bother me a bit- unless/until it becomes slander or libel.

    Re logistics- gas manufacturer, CFC MDI componenents manufacturer, outstanding MDI manufacturer all ready willing and able to produce if they get the green light- this is NOT an issue.

    Re harming naive patients- naive patients listen to their doctors, not to me. I’ve never told anyone NOT to take their meds, and I won’t accept responsibility for what fools do- nor will I lose sleep over it. I am focused on REAL people in REAL distress. Either there are a massive number of people who agree that this needs to be changed and are willing to lobby Congress and the Administration, looking towards the 2010 elections as a deadline- or there are not. If there are- we’ll change it- no matter who likes it or doesn’t like it. If there are not enough people willing to fight this- at least I’ll know I did my best. Doing nothing, laying down for this collection of lying, greedy (expletives deleted), for me, is not an option.

    Take care, perril,

    Arthur Abramson
    The National Campaign to Save CFC Asthma Inhalers
    http://www.ipetitions.com/petition/saveCFCinhalers/

    or google: ‘save cfc’

38. I would like for this thread to get back to the isuue at hand. We are just normal people. I feel like I am back in my College Science Class. It does not matter how or why this happened. Knowing the Chemical Compound information and ratios,etc. does not help us breathe any better. We should be told good solid information that we can use now not in 2010. A woman helped myself and my family and many others with the transition. She showed us the way and how to get the correct iformation. All of us had rough spots but we had a successful transition, as have many. Get the facts you can use. The ALA and AANMA have easy to follow steps. The FDA website is also very educational. Help is out there. This will not be changed. HFA inhalers do work.

39. I just love these Allergy and Asthma Network MOTHERS of Asthmatics (AANMA) cheerleaders- most of these posts are written by their founder and president, Nancy Sander- under her various aliases (TangoLou, etc, etc, etc)- or one of her staff. A very mature group of individuals. They’ve posted virtually identical emails on various blogs to drum up business for her paid membership, tax-exempt, ‘non-profit’ for as long as I can remember. Now she’s asking Congress to spend millions of dollars for ‘patient education’ on the ‘transition’- which, coincidentally, is what her ‘non-profit’ does. She takes a lot of money from the drug companies for ‘patient education’ as well. This is what I meant when I said they’ve turned ‘the transition’ into a cottage industry.

    If anyone needs to deal with one of these non-profits for ‘patient education’ because your doctor can’t tell you how to clean and use your inhaler, go to the Asthma and Allergy Foundation of America- they are the least obnoxious of the three.

    And Nancy- you never took a “College Science Class”- that’s part of your problem. What post talked about “Chemical Compound information and ratios”? And I’ll tell you one more thing, Nancy- our paths will cross much more frequently in the media now. If I EVER read a quote from you or your organization like this: “HFA inhalers do work.” without qualifying that statement by acknowledging the FACT (which I know you are well aware of) that there ARE some people who did well on CFC MDIs who do NOT do well on HFA MDIs, you will regret it. I give you my word on that.

    Have a nice day, Nancy,

    Arthur Abramson
    The National Campaign to Save CFC Asthma Inhalers
    http://www.ipetitions.com/petition/saveCFCinhalers/

    or google: “save CFC”

40. Why does everyone get off the subject? I know Lewis. Nice, kind man. Not Nancy Sander. The main concern is about CFC/HFA inhalers. What does any of this petty finger-pointing solve? There are websites all over the net for good information.

41. Sorry, RJS. I wish you told me sooner.

    No worries. :)

42. HFA inhalers don’t work and are an obvious ploy of the medical profession to drum up more business in increased office and hospital visits and more money for pharmacies, many of which are owned by doctors. It is another example of the shameless greed operating in this country at the expense of its citizens. People have died from HFA inhalers, and more will, especially people who can’t afford insurance. These people, like myself, just found out that their rescue inhaler has been eliminated and no replacement is in place. What are we supposed to do? Die?

43. People like you are what’s wrong with this country, stephanie. Morons who open their mouth and spout off about something they know nothing about. (And who obviously haven’t bothered to try to educate themselves before mouthing off.)

    It’s really a pity your vote counts as much as mine.

    But back on topic:

    The medical profession has NOTHING to do with the decision to go HFA-only. In fact, most of the medical profession (myself included) think it’s a waste of time and money.

    Blame the fools chasing after CFC pollution and the hole in the ozone. (That would be the EPA, since it’s obvious you’re too ignorant to figure this out without someone spoon-feeding it to you.)

    I don’t know why I’m bothering to try to educate you, but pharmacies make more money on generic medications than on brand-name medications. That means we make more money filling your beloved CFC inhaler than the HFA inhalers you apparently so detest.

    So take your misplaced vitriol and stuff it up your ass.

44. you are a rude, crude, vulgar bastard. You medical people are all blatant liars. The Montreal Protocol, by name, exempted CFC inhalers from the CFC ban. Doctors pushed to get them banned. I don’t believe pharmacies make more on a $10 generic than a $70 brand. I don’t have insurance. I pay full price.

    http://www.breatherville.org/MDITransitionTEAM/?gclid=CPDWsbrp2JUCFQukHgodCF4qXg

    Here is the website with all the medical associations supporting this.

45. Yes I am rude, crude, and far more vulgar in person than here on my blog. I’m also a bastard, because I don’t know my father. So you’re right on all counts, there.

    And since we’re in a pissing match, we’re both wrong. CFC inhalers were banned by the FDA, not the EPA, because of the Montreal Protocal. Take it up with them. Every pharmacist and doctor in America will stand up and applaud if the ban on CFC inhalers is reversed.

    http://www.fda.gov/bbs/topics/ANSWERS/2005/ANS01349.html

    I don’t believe pharmacies make more on a $10 generic than a $70 brand. I don’t have insurance. I pay full price.

    Your belief is not required to make it so, but this fact is quite well known. If you pay $70 for something like Proair HFA, the pharmacy is probably only keeping ~$1.50. If you pay $30 for a generic CFC formulation, the pharmacy is keeping about $10.

    Actual numbers may vary, but relative percentages are ballpark.

    If you want to start conspiracy theories about who’s influencing who, you might want to blame the drug companies, because they’re the only ones profiting from this.

    And lest you think I am a completely insensitive bastard, you might want to read these:

    http://rianjs.net/2007/12/how-much-does-nexium-cost

    http://rianjs.net/2007/09/generic-carvedilol

    http://rianjs.net/2007/12/keep-up-if-you-can-jay-parkinson

46. Thanks for the information. I’ll amend what I was going to say on the voice for the uninsured website.

    Since every doctor & pharmacist will applaud if the ban on CFC inhalers is reversed, maybe you could all get behind something to help make it happen.

47. I think them banning albuterol is just outrageous! I personally remember a few years back that they changed these inhalers because of the cfc’s now they go and ban them which is just stupid. In the 80’s with all the cfc’s that were used in the hair spray had more effect on the enviroment then the cfc’s in an inhaler. They are worried about the enviroment now when they have already polluted the whole planet! Makes no sense to me. To breath or not to breath. I cant afford the $56.00 they want for the new inhaler they say i have to get. So i get to sit here and not hardly breath because they get rid of the albuterol.

48. Elizabeth,

    It *is* crazy. The hole in the ozone layer doesn’t exist anymore. There is no need to ban ALL use of CFC products. In this case, the economic harm done by banning CFC products entirely is far greater than the marginal environmental harm done by keeping them on the market.

    I think it’s ridiculous, but it’s unlikely to be reversed anytime soon.

49. I read all of the postings in favor of or against hfa inhalers.I had been using the generic Albuterol for about 5 years before being FORCED to switch to HFA pro-air. From the start, the PRO-AIR was terrible, the taste and puffs so weak that I felt no relief. It also caused a severe rash on my leg.A few months ago, I found that CVS drug stores still had some generic Albuterol left. All I was able to get before Dec.31,08 was two. Using the generic for 7 days, my rash dissapeared and I felt much more in control of my shortness of breath.I have severe COPD=Emphysema with 20% lung capacity.They can post all of the stats in favor of the HFA,but the real truth is they are dangerous.I hope that the pushers of this product someday need an inhaler, because only then will they realize the truth !!!

50. My doctor prescribed Ventolin HFA on an as needed basis to supplement combivent which he prescribed to be taken on a daily basis(2 puffs in the AM and 2 puffs in the PM). Ventolin costs almost twice as much as proventil and pro-air.

    I don’t really know, if there are differences in efficacy among the three. Naturally, I would go for the least costly, if there are none. My pharmacist says Ventolin not being in the formula list is the reason why it is more expensive.

    So, Ventolin or Proventil?