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Asthma Inhaler Safety and Problems

GlaxoSmithKline recalls Ventolin Diskus inhalers

The inhalers may not deliver the intended dose

GlaxoSmithKline is recalling one lot of Ventolin Diskus inhalers that may not deliver the intended dose.

Ventolin Diskus is a prescription drug used in adults and children 4 years or older to relieve and prevent bronchospasm due to asthma, chronic bronchitis and other chronic lung disorders.

Bronchospasm is a sudden worsening of shortness of breath and wheezing.

Individuals who do not receive the intended dose may not be aware that the dose was not delivered. Their symptom...

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    Last of the aerosol asthma inhalers will soon be gone

    Asthma, COPD patients sacrificed for environmental preservation

    If you use an aerosol inhaler to treat your asthma or chronic obstructive pulmonary disease (COPD) you're going to have to get a new one.

    The last two inhalers used in the United States containing ozone-damaging chloroflurocarbons (CFCs) and are being pulled from the market by the end of this year.

    If you use one of them, you'll have to talk with your doctor about a prescription for an alternative.

    Most people who use inhalers have already made the switch to those that are CFC-free and the U.S Food and Drug Administration (FDA) says that -- in general -- the transition has gone smoothly. 

    Inhaler problems

    The transition may have gone smoothly for the FDA but it hasn't been trouble free for patients.

    An asthma patient in Virginia voiced harsh concerns about the FDA's comments that patients remember to breathe deep with the new inhalers. The new, non-flurocarbon rescue inhalers require the patient to take a deep breath, whereas the older inhalers aggressively shot the medication into the airways. 

    "This is absolutely total ignorance," says Roger M. of Glen Allen, Virginia, in a ConsumerAffairs post. "People having an asthma attack and in a panic state cannot breathe in deeply. People with COPD and limited lung function -- when in need of medication -- cannot breathe in deeply. Recent times have shown the (incompetence-plagued) FDA's inability to properly understand and evaluate these life altering decisions."

    "I may die if I cannot have my CFC inhaler," says Paulette B. of Sacramento, California. "I cannot use hydrofluoroalkanes (HFA) albuterol inhalers as I am allergic to the propellants in all of them. I tried two different ones and they made me cough really badly, and my lungs burned awfully. They gave me an awful headache and caused nausea, too." 

    The phase-out

    But be that as it may, the final two inhalers on the market are going away. 

    Combivent Inhalation Aerosol will no longer be available after July 2013. It contains two medicines -- ipratropium bromide and albuterol sulfate. A bronchodialator intended to open airways, it is approved for patients with COPD. An alternative inhaler -- Combivent Respimat -- contains the same two medicines but does not contain CFCs. It was approved by the FDA in 2011.

    Maxair Autohaler will not be available after Dec. 31, 2013. This inhaler contains pirbuterol, which is also a bronchodilator and is used for the treatment of bronchial spasms in patients with asthma or COPD. Alternative inhalers are available that contain other bronchodilator medicines, such as albuterol or levalbuterol, but do not use CFCs as a propellant to move the medicine from the inhaler.

    CFCs a problem

    CFCs damage the ozone, a thin, outer layer in the stratosphere that acts as Earth's shield against the sun's radiation. The U.S. and most other countries signed the Montreal Protocol in the 1980s to phase out the worldwide production and use of CFCs. In this country, CFCs have been removed from such products as hairsprays, deodorants and air conditioning.

    CFCs have also been used in medical devices, including as propellants to move medicine out of inhalers so that patients can breathe in the medicine. For more than two decades, FDA has coordinated the phase-out of CFCs in inhalers.

    Most inhalers using CFCs have already been phased out. The most widely used -- albuterol CFC inhalers -- were phased out in 2008 and replaced with alternatives that use HFAs. The most recent phase-out was of over-the-counter epinephrine inhalers sold under the brand name Primatene Mist, which were phased out at the end of 2011.

    FDA maintains a list of inhalers for asthma and COPD that do not use CFCs, and adds the names of new non-CFC inhalers as they become available.

    Used by millions

    Millions of people who suffer from asthma, allergies and COPD use inhalers. In the U.S., more than 25 million people suffer from asthma, a disease that affects the airways in the lungs and can cause coughing, trouble breathing, wheezing and tightness or pain in the chest. Attacks can be mild, moderate, severe and even life-threatening.

    Another 15 million U.S residents have been diagnosed with COPD, a serious lung disease that usually causes breathing to get worse over time. It can limit airflow, and may include chronic bronchitis, emphysema or both.

    While all FDA-approved inhalers currently on the market have been shown to be effective, there are some differences between the products. For example, products propelled by HFA may taste and feel different than the spray from CFC-propelled inhalers.

    Although some consumers note that the spray from an HFA inhaler feels less forceful, this does not mean that the medicine is not working. Other alternative medications may use no propellant at all. Your doctor may be able to find the product right for you.

    If you use an inhaler to treat your asthma or chronic obstructive pulmonary disease (COPD) you're going to have to get a new one. The last two inhalers us...

    Victims of Government: Asthma Patients' Lives Shattered by 'Green' Inhalers

    Previously healthy asthma sufferers wind up disabled -- and worse

    On a good day, Victoria O. can walk from her house to the driveway without stopping to catch her breath. But those days are rare for this Florida woman, who has what doctors call severe airflow obstruction.

    I struggle to breathe all the time, she explains, wheezing between her words. Im 43 years old. I should be enjoying my life. I used to have an active life, but I went from a normal person to a very sick person.

    Victoria can pinpoint the moment her health started its downhill spiral -- a rapid decline that has left her unable to work.

    Its the same moment that triggered another, unexpected, battle in her life: one that pits the ailing and financially-strapped woman against her disability insurance company. And in yet another blow to her ongoing battle, Victoria learned just days ago that her employer -- which in May approved her absence under the Family and Medical Leave Act -- will no longer cover her under its health insurance plan.

    As of today, I have no insurance, Victoria told us last Tuesday, choking between breaths. And I have a doctors appointment tomorrow. Here we are in the middle of a national discussion on health care and look what Im going through. I was fine before all this startedI never had a problem with my asthma before.

    But that all changed in April 2008 when Victoria took a puff from her new environmentally friendly rescue inhaler that contains a propellant called hydroflouroalkane (HFA). Victoria hadnt used one of those inhalers before, she says. On the once in a blue moon occasions she needed an inhaler, she used one propelled by chlorofluorocarbons (CFCs).

    And she never had any problems.

    Inhalers banned

    Those albuterol metered-dose CFC inhalers, however, are now banned in the United States under an international agreement called the Montreal Protocol on Substances that Deplete the Ozone Layer.

    That ban went into effect on December 31, 2008, but pharmacies nationwide started switching to HFA inhalers last year in preparation for the mandated change.

    The Food and Drug Administration (FDA) -- and other supporters of the 1987 agreement -- say the CFC propellant in the inhalers damages the ozone.

    Asthma and pulmonary patients must now use the greener and more expensive HFA inhalers, which the FDA acknowledges have a different feel and taste.

    Patients must also breathe in deeply when using the four HFA inhalers now on the market: ProAir, Proventil, Ventolin, and Xopenex.

    FDA officials say these inhalers are a "safe and effective" alternative for the more than 40 million asthma and pulmonary patients nationwide.

    ConsumerAffairs.com, however, has heard from hundreds of scared and angry patients with asthma and other respiratory problems who say the new HFA inhalers dont give them any relief. The inhalers, they say, fail to open their airways and leave them literally gasping for air.

    Some patients also say the HFA inhalers are too costly; theyve jumped in price from about $5 to, in some cases, more than $50.

    Ethanol allergy

    And then there are patients like Victoria, who had an allergic reaction to the ethanol in her HFA inhaler and can no longer work because of her declining health and the constant battle to breathe.

    Compounding those problems, Victoria says, is the recent denial of her short-term disability benefits and last weeks loss of her employer-provided medical insurance.

    Im facing a dilemma that I didnt anticipate, she says, adding her employer had covered her under its plan during her leave. Ive gotten sicker and sicker and I know its solely because of the HFA inhaler.

    ConsumerAffairs.com has learned that other asthma and pulmonary patients are also considering filing for disability, saying theyre unable to work because the HFA inhalers leave them tired and constantly gasping for air.

    Grassley takes an interest

    A few elected officials and public-interest organizations are beginning to take an interest in the asthma victims' plight, however.

    Senator Chuck Grassleys (R-Iowa) office continues its review of the nearly 400 complaints ConsumerAffairs.com has received about HFA inhalers from asthma and pulmonary patients nationwide.

    And an environmental organization in Washington D. C. said it supports efforts to bring CFC inhalers back to the United States.

    The FDA, however, isnt likely to support any efforts to legalize CFC inhalers.

    CFC inhalers damage the ozone," spokesman Christopher Kelly told us. "People will have to get used to the new (HFA) inhalers."

    Asthma and pulmonary patients must also be sure theyre using the HFA inhalers properly -- and keeping them clean to prevent build-up and blockage of the medication, the FDA said.

    What about the increased costs of the HFA inhalers, which do not have a generic alternative?

    The FDA said it expects those prices to drop in the next few years. Until that happens, The Partnership for Prescription Assistance (PPA) and drug companies that make inhalers have special programs and coupons to help consumers cover the higher costs.

    But the salient issue in this debate, the FDA and pulmonary experts say, is for patients to get their asthma under control.

    Someone who uses a 'quick reliever' (rescue) inhaler many times a day does not have well-controlled asthma, says Dr. Norman H. Edelman, chief medical officer for The American Lung Association. "Patients shouldn't need their quick relief inhalers more than two to three to four times a week.

    Asthma is a variable disease and doctors are always readjusting medications and dosages," he added. "If patients are not getting good asthma control, they need to talk to their doctor."

    Problems started with HFA inhaler

    But Victoria and the hundreds of other patients whove contacted ConsumerAffairs.com say their asthma was in control until they used an HFA inhaler.

    In Victorias case, her medical -- and now insurance -- problems started in April 2008 when her doctor prescribed an HFA inhaler for bronchitis and wheezing.

    I hadnt used an asthma pump in years, she recalls. But I couldnt get rid of the bronchitis. The doctor gave me that HFA asthma pump and within a week, I was sicker than Id ever been.

    The moment she took her first puff, Victoria knew something was wrong. A burning sensation instantly blistered the back of her throat. It moved down and burned her windpipe and lungs.

    It felt like liquid acid," the Kissimmee, Fla., woman told us. "I realized I couldn't breatheI thought I was going to die."

    Since that day, she says, her health has deteriorated. I have headaches, throat pain, my immune system is all over the place, my hair has fallen out, and I constantly struggle to breathe.

    Her breathing has become so labored at times that shes had to be rushed to the emergency room and spend days in the intensive care unit.

    In the 30 plus years I've had asthma, I have never had it spiral out of control this quickly or this severely," Victoria says. "I think they've put poison on the market."

    Disability filing

    In May, Victoria heeded her doctors advice and filed for short-term disability.

    My pulmonary tests did not come back very good, she says. I had to file for disability. My doctor said that I have moderate to severe lung obstruction.

    Victoria, however, grappled for months over the decision to apply for those benefits. Ive always worked. Ive always had a job. I like my job and I want to keep working. But how can I work when I cant breathe?

    Despite her health problems -- which she says are documented by two of her doctors -- Victorias insurance company denied her claim.

    Oh my gosh, its been a mess. They keep rejecting, rejecting, rejecting, my claim. They dont believe this asthma issue is a problem.

    I paid into this disability for years, she says. Its very expensive. But I wanted to be sure I had coverage in case something happened. When I sent in my claim, though, they said I wasnt sick enough.

    Victorias short term disability is through a company called Lincoln Financial Group of Omaha, Nebraska. In a letter dated July 27, 2009, the company said it had determined that no benefits are payable.

    After a thorough review of the information currently contained in your claim file, we have determined that you do not meet the definition of Total Disability.

    The company cited the following reasons for its denial of Victorias claim:

    • The date Victoria stopped working. The company said one of her doctors stated she was unable to work back in November 2008, but her employer said she continued working until May 2009;

    • Lack of medical proof that she couldnt perform her sedentary duties as a secretary;

    • Pulmonary tests in April 2008 indicated her lung function had improved, according to the company;

    • Her reluctance to try systemic steroids and controller treatment that might improve her condition.

    Victoria balks at those reasons for denying her claim.

    I needed the insurance, she says, adding her family was covered under her employers health care plan until she went on leave in May. I have a 12-year-old son. And like I said, Ive always worked and I like to work.

    Victoria says she was finally forced to stop working in May when her portable nebulizer broke down. I couldnt work without that machine. And I couldnt afford to fix it or rent another one.

    What about her sedentary job duties?

    First of all, I was running all over the place at my job, Victoria says, adding the company used a Department of Labor (DOL) description for her secretarial duties. In a letter she sent to Lincolns president and CEO, Victoria criticized the company for using that job description in her case.

    I dont see how DOL job descriptions apply to my realistic situation or my health, she wrote. My breathing became critical at times because of the undue stress on my lungs at work.

    Victoria also counters the companys claims that her lungs improved and she didnt want to try new treatment methods.

    I have documentation from two doctors who placed me on disability, she says. One said as far as he was concerned I would never go back to work. The other one said maybe I would go back to work. But we dont know all the effects the HFA inhaler (and the ethanol) will have on me. I may clear up. I hope thats the case."

    'Ruined my life'

    She adds: I cant tell you how much HFA inhalers have ruined my life. Im sick all the time and Im not getting better. Some days I feel okay in the morning, but by the afternoon, I feel like a three-week wilted rose.

    Victoria told us shes shocked and disappointed that Lincoln Financial ignored her doctors opinions.

    My doctors have given them everything -- all the analysis and the blood tests. Theyve told them that I have difficulty breathing.

    Their (Lincoln Financial) doctors have never even met me or talked to me, she says. If they did, theyd hear me wheezing and choking. But yet, they said Im fine. Its almost a mockery of how the system is supposed to work.

    ConsumerAffairs.com obtained a copy of July 26, 2009, letter from Victorias pulmonologist, who said shes been disabled since April.

    (She) is under my care for moderate to severe persistent asthma, wrote Dr. James Lucio of Kissimmee, Fla.

    Dr. Lucio said he evaluated Victoria in April 2009 and again in Mid-July and did not see signs of improvement. She continues to manifest persistent and disabling respiratory symptoms, including persistent wheezing, shortness of breath, and cough. She has had only a modest response to therapy.

    Dr. Lucio also confirmed that Victoria has been unable to work due to the recalcitrant nature of her symptoms. He wrote: Therefore, in my medical opinion, she has been temporary (sic) disabled as of 4/21/09.

    Victoria is now appealing Lincoln Financial Groups denial of her disability benefits and has included Dr. Lucios July 2009 letter to back her claim. She has also consulted an attorney regarding the companys decision.

    ConsumerAffairs.com contacted Lincoln Financial about Victorias case. The company's Assistant Vice President of Risk Services did not respond to our inquiries.

    More disability filings

    New inhalers, like this Proventil model, are powered by non-aerosol propellants

    During our investigation, we also discovered that other asthma and pulmonary patients -- who say the HFA inhalers dont give them any relief or made their conditions worse -- are now considering filing for disability.

    Their problems may signal a new and troubling trend in the ongoing debate over the governments decision to ban what hundreds of asthma patients call their life-saving CFC inhalers.

    Consider:

    The new inhalers dont work for me, says Roberta W. of New York. After the CFC inhalers were banned, I developed a severe respiratory infection. I nearly died and now I can barely shop for necessities or run the vacuum in the living room.

    This legislation could very well end my life decades sooner and it has disabled me completely, she adds. I cannot live independently or care for my disabled husband.

    An asthma patient in Louisiana worried that should couldnt continue working because the HFA inhalers leave her constantly out of breath.

    I would like to know what procedures I need to take to become considered fully disabled as an asthmatic since I can barely function on an everyday basis because of my asthma, says Kimberly W. of Maurepas, La. The government wants this change that affects my quality of living as a normal person. I have to rest after everything I do; Im constantly out of breath.

    Kimberly, however, recently found a job and hopes she can keep working in spite of her asthma. She also hopes the extra income will cover the increased costs of the HFA inhalers.

    I cannot afford the new inhalers, she says. (They are) $80 more ($126 plus tax) than the one I've used since I was 12 years old.

    Early warnings ignored

    In Washington, D.C., the head of an environmental organization said he isnt surprised that so many asthma and pulmonary patients have experienced physical -- and now financial -- problems because of their HFA inhalers.

    He warned the public about these issues before the ban on CFC inhalers went into effect.

    "The breath of life for asthmatics is being seriously threatened by the elimination of CFCs in asthma inhalers, wrote Norris McDonald, president of the African American Environmentalist Association and Center for Environment, Commerce & Energy. We need to immediately amend the Clean Air Act to fix this well intended, but woefully misguided, effort to protect the ozone layer. Asthmatics unite.

    The HFA inhalers are not as effective (as the CFCs), said McDonald, who suffers from asthma, in a ConsumerAffairs.com interview. And thats the scary part. The old CFC inhalers gave you a nice boost.

    I much prefer the old inhalers with the CFC propellant, which had an insignificant effect on the ozone layer.

    McDonald says his organization supports legislative efforts to legalize CFC inhalers in the United States -- and would even lobby Congress to make that happen.

    Theres a lot on their (Congress) plate and were a little bitty group, he says. It takes a groundswell to get things moving and this is not on top of the radar screen. But as more and more people start having problems with these (HFA inhalers), that might move Congress to do something.

    He added: Your call has refocused my attention to this issuemaybe its now time put out more publicity on this.

    One group that is already spearheading efforts to bring back CFC inhalers is The National Campaign to Save CFC Inhalers.

    The California-based organization -- which says the FDA and other supporters of the ban duped the public about the need for the action and the safety of HFA inhalers -- is lobbying Congressional leaders to amend the Clean Air Act and make CFC inhalers permanently legal in the United States.

    We are the last hope for asthma and pulmonary patients, says the organization's founder, Arthur Abramson. And we will fight this state by state."

    Asked if his organization has heard from asthma and pulmonary patients who are considering filing for disability because of HFA-inhaler related problems, Abramson said: Yes, several. His group, however, doesnt track whether patients have received those benefits.

    Neither does McDonalds environmental organization. But he empathizes with patients whove encountered problems with their insurance companies because of asthma and problems related to their HFA-inhalers.

    I cant get insurance because of my asthma and so I have to pay (cash) for the HFA inhalers, he says. And its a $10 to $15 increase over the CFC inhalers. Its a vicious cycle. I cant get insurance because of my asthma and Im paying more for my asthma medication.

    Back in Florida, Victoria says she can no longer afford her medications or medical treatments.

    Last week, her employer dropped her from its insurance plan.

    It is my understanding that you were turned down by Lincoln Financial Group for your short-term disability claim, her employer wrote in an e-mail. Unfortunately, it is our policy that once a claimant is denied benefits, that individual may no longer remain on our health insurance plan.

    Therefore, regrettably, your coverage will end at the end of business today.

    The only way Victorias employer will put her back on its insurance plan is if Lincoln Financial approves her appeal. But that process could take weeks or months, Victoria says. And she needs medical coverage now.

    This is obviously another upset in this dilemma since I now am not able to seek medical care unless I get Medicaid, which is a very long and difficult process, she says, adding she cant file for long-term disability through the state until her appeal process is over. I just applied online tonight since I know that this could take months in the state of Florida.

    In spite of these setbacks, Victoria refuses to give up her fight. Or change her surprisingly optimistic outlook on life.

    I have emotionally accepted this the best I can, she says. I dont like it and it makes me angry, but I have a strong faith. I believe there must be a reason Im going through this. And I thank God that Im alive.

    Shes also thankful that her husband recently found a job. But hes had to move to New York for that position and he doesnt have medical coverage yet.

    Victims of government

    As she struggles to catch her breath, Victoria says she isnt waging this battle just for herself. Shes fighting for all asthma and pulmonary patients whove experienced similar problems.

    I'm sure I'm not the only HFA victim who became disabled, she told us. I think that asthmatics are still having major reactions to this medication and many (people) should know what life looks like after using HFA inhalers.

    Congressional leaders, she says, need to pay closer attention to this issue and those suffering in its wake. They also need to legalize CFC inhalers in the United States. Unfortunately, the powers that be in Congress are not interested in listening.

    We need somebody to advocate that there are sick people out there, she says. There are people who are so sick (because of their HFA inhalers) and theyre not getting better. They used what was out there (for their asthma or respiratory problems), but that is whats creating their disability.

    And now there are people like me who are not getting their disability benefits. My insurance company isnt there when I need them. I now stand alone.

    Read consumers' comments about the new inhalers.

     



    Victims of Government: Asthma Patients' Lives Shattered by 'Green' Inhalers...

    Jackie Joyner-Kersee: FDA "Insensitive" to Asthma Patients' Problems

    Sen. Grassley investigating federally-mandated "death machine" inhalers

     

    Jackie Joyner-Kersee

    A ConsumerAffairs.com investigation that exposed what asthma patients nationwide call a life-threatening ban on medication that gave them instant relief — their chlorofluorocarbon (CFC) albuterol inhalers — has triggered action and support from Sen. Chuck Grassley (R-IA) and four-time Olympic track and field star Jackie Joyner-Kersee.

    Grassleys office is reviewing the more than 200 complaints ConsumerAffairs.com has received from asthma and pulmonary patients nationwide who are outraged by the recent ban on CFC rescue inhalers and say the hydroflouroalkane (HFA) alternatives they must now use under federal law leave them gasping for air.

    Staffers in California Senator Barbara Boxers office and Connecticut Congresswoman Rosa L. DeLauros office also said they would review our investigations findings. But Emilia DiSanto, chief investigative counsel in Grassleys office, decided to take a deeper look and review all the complaints ConsumerAffairs.com has received about the problems and concerns asthma patients have with HFA inhalers.

    Our review continues, DiSanto told us earlier this week.

    Meanwhile, among the growing number of asthma patients worried about the ineffectiveness of HFA inhalers is three-time Olympic gold medalist Joyner-Kersee, who said federal bureaucrats are being "insensitive" to the life-threatening problems asthma patients are experiencing.

    Ive had problems with HFA inhalers, she said during an exclusive interview this week with ConsumerAffairs.com. I didnt feel like I was getting the same rescue effect that I was before with my (CFC) inhaler. Im telling you, I thought they made a mistake when they gave me that (HFA inhaler). To me, it was differentand I was getting lightheaded. It doesnt have the same effect as my CFC inhaler. Im not feeling it.

    The woman many consider the greatest female athlete in history said our investigation had shed light on a problem that could impact the more than 40 million asthma patients across the country.

    Im glad you brought this to my attention, said Joyner-Kersee, an advocate for asthma awareness. We need someone fighting for us on thisasthma is a silent killer.

    Silent killer

    Im concerned about the lives of others with asthma, she added. Like the person who is not on top of their medication or taking their asthma seriously. Or some young child who might reach for an HFA inhaler and find out it doesnt work for them.

    As ConsumerAffair.com has reported, CFC inhalers are banned in the United States — as of December 31, 2008 — under an international agreement called the Montreal Protocol on Substances that Deplete the Ozone Layer.

    According to the Food and Drug Administration (FDA) — and other supporters of this 1987 agreement — the CFC propellant in the inhalers damages the ozone.

    CFCs reduce the amount of ozone in the ozone layer that surrounds the earth and protects the earth against the sun's harmful rays, the FDA said in a written statement. The loss of ozone can increase the risk of skin cancer, cataracts, and other health problems.

    Asthma and other pulmonary patients must now use environmentally friendly — and expensive — inhalers that contain the propellant hydroflouroalkane (HFA).

    The FDA, pharmaceutical companies, and pulmonologists say the HFA inhalers have a different feel and taste — and asthma patients need to take deep breaths when using them.

    But they say the four HFA inhalers now on the market — ProAir, Proventil, Ventolin, and Xopenex — — are just as effective as CFC inhalers when properly used.

    The more than 200 asthma and pulmonary patients whove contacted ConsumerAffairs.com, however, disagree.

    So do the hundreds of asthma and pulmonary patients whove contacted The National Campaign to Save CFC Asthma Inhalers . The California-based group is lobbying Congressional leaders to amend the Clean Air Act and make CFC inhalers permanently legal in the United States.

    No relief

    New inhalers, like this Proventil model, are powered by non-aerosol propellants

    ConsumerAffairs.com receives complaints almost daily about HFA inhalers from asthma patients across the county. Most say the inhalers do not give them quick relief and sometimes make their asthma worse.

    Unfortunately for me, the HFA inhalers do not relieve my asthma, Star R. of Whitethorn, Calif., wrote us. Since November 2008 to the present I have had increased, terrifying asthma attacks that the HFA inhalers have done little to control. I have found that in an emergency the HFAs are worthless and, therefore, quite dangerous.

    I was never informed that my inhaler formulation had been changed to a different propellant, she added. The way I found out was in the middle of the night, during an asthma attack, when my new HFA inhaler didn't work.

    Some asthma patients have experienced allergic reactions to the ethanol or other ingredients in the HFA rescue inhalers.

    I cannot use HFA albuterol inhalers as I am allergic to the propellants in all of them, says Paulette B. of Sacramento, Calif. I tried two different ones and they made me cough really badly and my lungs burned awfully. They gave me an awful headache and caused nausea, too. I fortunately still have a few CFC albuterol inhalers and then will have to go to a nebulizer only. I may die if I cannot have my CFC inhaler.

    Many asthma patients also say theyre not convinced the CFCs in their old inhalers harm the ozone.

    They all say theyre environmentalists. What asthma patient doesnt want clean air? many have asked us. But they believe the government picked the wrong product to ban.

    I found out that the effect that the CFCs in the old inhalers were actually proven to only show negligible effects on the ozone, if any at all, Heather C. of Abilene, Texas, told us. Shame on the FDA and everyone else involved in making this come aboutI wonder if this will lead to any deaths or hospitalizations in regard to not getting the relief you must get from these (rescue) inhalers.

    The increased cost of the HFA inhalers is another concern many asthma patients have repeatedly expressed. HFA inhalers do not have a generic version and can be five to ten times more expensive than their $5 CFC albuterol counterparts.

    The new inhaler is about $40, say Suzanne G. of Jackson, Wyoming. Apparently, I will need three a month for a total of $120. My CFC inhaler cost me around $12 and lasted over a month. So I'm out $108 a month.

    (But) the cost is not as burdensome as the loss of a normal athletic and basic life for a young woman and mother, she adds. The HFA inhalers do not work as effectively as the CFC inhalers in rescue situations. I have to take twice as much medicine with the HFA inhalers, and the HFA inhaler clogs causing medicine to go up in the air instead of into the mouthpiece and lungs. This is really scary for me. I cannot exercise at the gym like before, and I dare not go for a run. I cannot play with my 4-year-old daughter like I used to do for fear of a complete bronchial shut down.

    The skyrocketing costs of HFA inhalers are also worrisome to Joyner-Kersee, founder of a non-profit organization that helps children in her hometown of East St. Louis, Illinois.

    Cost has always been a concern with me, Joyner-Kersee said. With there not being a generic of this (HFA inhaler).its very expensive. I dont want to see some of my asthmatic counterparts dropping and drying (because they cant afford their medicine).

    FDA won't budge

    Despite asthma patients concerns, ConsumerAffairs.com has learned the FDA is not likely to change its position on CFC inhalers.

    CFC inhalers damage the ozone, spokesman Christopher Kelly told us. People will have to get used to the new (HFA) inhalers. Kelly said his agency researched its decision to phase-out CFC inhalers for several years.

    He referred us to pages of documentation on the FDAs Web site about the ban and the safe and effective alternatives for CFC inhalers.

    There are three albuterol HFA inhalers and one levalbuterol HFA inhaler that are alternatives to albuterol CFC inhalers, one posting states. Each of the HFA inhalers is different. It is important to remember that it is the deep breath that gets the medication into a patient's lungs, not the force of the spray. The spray from an albuterol HFA inhaler may feel softer than the spray from an albuterol CFC inhaler, but this will not affect the amount of drug that a patient breathes into their lungs.

    The posting adds: If patients have problems with the albuterol HFA inhaler, they should talk to their healthcare provider as a different product may work better for them.

    Kelly said the FDA knows many consumers are upset about the ban on CFC inhalers.

    More than 300 consumers, he said, filed complaints with FDA last year about this action 295 by phone and 39 by e-mail. The complaints concerned the cost increase and patients getting used to the new formulation," Kelly said. But I don't think our position is going to change on this."

    Kelly and other proponents of the ban say a generic alternative should be available in a few years, which will reduce the cost of HFA inhalers. Some pharmaceutical companies and the The Partnership for Prescription Assistance now offer programs and coupons to help consumers cover the increased costs of HFA inhalers.

    "Advocates" sit it out

    During our investigation, weve also talked to The American Lung Association and supposed advocates of asthma patients whove emphasized the salient issue for patients is to get their disease under control.

    Someone who uses a 'quick reliever' inhaler many times a day does not have well-controlled asthma, said Dr. Norman H. Edelman, chief medical officer for the American Lung Association. Patients shouldn't need their quick relief inhalers more than two to three to four times a week. Asthma is a variable disease and doctors are always readjusting medications and dosages. If patients are not getting good asthma control, they need to talk to their doctor.

    Edelman said asthma patients will notice a difference when using an HFA inhaler. It's a softer feel. The particles are more finely disbursed and people don't feel that same blast.

    Patients must also prime the HFA inhalers and keep them clean to prevent build-up and blockage of the medication.

    But as far as we know, the studies done on these (HFA inhalers) show that when they are used properly, they are as effective as the old (CFC) inhalers, Edelman said.

    A clinical professor at the University of Florida — and the co-author of a 2007 paper in the New England Journal of Medicine about the transition to HFA inhalers — agrees the four HFA-albuterol inhalers now are the market are safe and effective alternatives for asthma and pulmonary patients.

    There was a wide range of studies done on these (HFA inhalers), pharmacist Leslie Hendeles told us. These were double-blind, random, placebo studies. The FDA was careful to require studies (on HFA inhalers) to detect any differences and make sure they were equivalent (to CFC inhalers.").

    Proper technique

    Hendeles said he reviewed all the HFA inhalers now on the market for his article in the New England Journal of Medicine.

    We analyzed the data. There isn't a hint that any one of those drugs doesn't work as well as CFCs. The difference is everyone in those studies was trained to use the HFA inhalers correctly.

    That's why Hendeles suggests patients work on the technique" they use with these new inhalers.

    What I tell our patients is 'let me see how you use (the HFA inhaler) and maybe I can make some suggestions to get an increase of the medicine in your lung.' Studies that have examined how people use inhalers have shown many dont use them correctly.

    He added: I'm also going to throw out the possibility that the HFA inhaler is less forgiving (to bad technique) than the CFC inhalers. If you didn't have good technique with a CFC inhaler it may be magnified with the HFA inhaler.

    Hendeles said he's had excellent results with patients who've improved their technique. I've rarely had anyone come back (with complaints) who is using the correct technique. It's uncommon.

    Some patients also respond differently to the various HFA inhalers, he said. We've had a lot of patients say the ProAir (which has ethanol) doesn't work for them and we've switched them to Ventolin, (which doesn't have excipients other than the propellant) and they say they're okay.

    Other patients, he said, have trouble with the HFA inhalers because they don't clean them as often as their CFC devices.

    Unlike the CFC inhalers, the HFA propellant plugs the opening if patients don't follow the directions, Hendeles said. What we have found is people are — after using them a few times — may not be washing them. That makes them clog and they don't get a full dose. Or some patients may not prime the (HFA) inhaler when it comes out of the package or if they haven't used in a few weeks.

    If people say they're having trouble with these inhalers, Hendeles added, ask them how often they're washing them.

    Decision was political

    Hendeles also told us the decision to ban CFC inhalers had nothing to do with protecting the environment. The motivation, he said, was political.

    Why was it political? asked Hendeles. "Some years ago, the United States, along with other countries, signed an agreement to phase out all CFCs. Thats political. Secondly, Congress amended the Clean Air Act to include this (ban). Thats political.

    He disagrees with political and environmental officials who say CFC inhalers harm the ozone.

    The science is not there that these (CFC inhalers) were damaging the ozone, he told us. A majority of the damage (from CFCs) came from refrigerators and air conditioners.

    A medical exemption allowing CFC inhalers to remain on the market was included in the Montreal Protocol when it was signed in 1987. At the time, there weren't viable alternative propellants for CFCs. But that exemption was removed when HFA-albuterol inhalers became available. In 2005, the FDA determined CFC inhalers were no longer "essential" and said they must be phased out by December 31, 2009.

    Longtime asthma patients say their CFC inhalers are medically essential because the HFA alternatives do not relieve their breathing problems during an attack.

    Ive had it with these HFA-metered-dose inhalers, says Wendy W. of Springfield, Illinois. They dont work. I have had to resort to using an electric nebulizer machine to dispense my fast-acting relief medicine.

    Wendy and other asthma patients also take issue with those who suggested they arent using their inhalers correctly — or cleaning them according to the directions. They say they know how to use the HFA inhalers — and they clean them regularly. And nearly every patient whos contacted us says their asthma was in control until they used an HFA inhaler.

    I am 43 year old and have (had) asthma since for the past 31 years, says Kathleen Ann F. of Fresno, California. I have always had my asthma under control and have never had to use any kind of inhaler until 2003. The reason for my use of an inhaler is the fact that I am allergic to many chemicals that were and are used at my place of employment. I have used albuterol, which was the most effective treatment I have used. Since the ban on CFCs and the change in inhalers allowed to be prescribed it is almost unbearable to continue working.

    Kathleen and scores of other pulmonary patients also say anyone who suggests they need to take deep breaths when using an HFA inhaler has never had an asthma attack.

    How are asthmatics who are suffering an asthma attack supposed to inhale deeply when they are having trouble breathing in the first place? she asks.

    "Insensitive"

    Joyner-Kersee echoes those sentiments.

    I think those comments about breathing deep and cleaning your inhaler are insensitive and come from people who are not asthmatics.

    She added: I do have my asthma under control and I noticed a difference with these HFA inhalers.

    During our interview, Joyner-Kersee offered to lend her voice to help asthma patients who are struggling with HFA inhalers and want their trusty and affordable CFC devices back on the market.

    I would support 100 percent changes in the law (to bring back CFC inhalers), she said. We need a voice (on Capitol Hill) to take a serious look at this and not let us asthmatic die by the wayside.

    The founder of The National Campaign To Save CFC Asthma Inhalers said hed like Joyner-Kersee to join his team, which has launched a grassroots effort to convince lawmakers in Washington D.C. to change the Clean Air Act.

    We are very pleased to hear that a world-class athlete of Jackie Joyner-Kersees stature supports our campaign to permanently legalize CFC inhalers, and that she agrees with us that the problems that many patients have with HFA inhalers cant be solved by improved inhaler technique, said Arthur Abramson. We greatly appreciate her support, and wed love to have her join our campaign.

    Abramson is also grateful that Sen. Grassleys office is taking a closer look at this issue.

    Sen. Grassley has had a reputation for many years as the leading defender of patient health and safety in Congress several others in Congress like to talk a good game when it comes to patient safety, but most of them are owned by drug companies and/or environmental extremist groups, Democrats and Republicans alike.

    He added: We are confident that when Senator Grassley understands the magnitude of this problem, and reviews the substantial clinical and anecdotal evidence that we have (including three years worth of FDA MedWatch data) that proves that the replacement HFA MDIs (metered-dose inhalers) are not nearly as safe and effective for all patients as CFC MDIs are, he will work with us to permanently legalize CFC inhalers, even though it will require us to abrogate certain provisions of the Montreal Protocol, amend the Clean Air Act, and upset a handful of drug companies.

    Asthma patients like Leonard S. of Wisconsin hope something is done soon to get CFC inhalers back on the market.

    The HFA alternatives, he says, are death machines.

    How many of us will wind up in the morgue thanks to these HCA inhalers? Leonard asks. This is quack medicine at its best. Death comes to those who cannot deliver sufficient albuterol to the lung. The pressure required to push the inhalant must be able to overcome the opposing pressure of an inflamed lung. An HFA (inhaler) fails all the way. It's a death machine.

    Read consumers' comments about the new inhalers.

     



    Jackie Joyner-Kersee: FDA Insensitive to Asthma Patients' Problems...

    Asthma Patients Get Scant Response to Problems with New Inhalers

    Government agencies "sympathize" but offer little more than that

    New inhalers, like this Proventil model, are powered by non-aerosol propellants

    Asthma patients nationwide are getting little more than sympathy — and not much of that — from government agencies and health officials in response to their complaints about the new ban on chlorofluorocarbon (CFC) albuterol inhalers and the life-threatening problems many say they are having with the environmentally-friendly hydroflouroalkane (HFA) rescue inhalers.

    In just the last few days, ConsumerAffairs.com has heard from more than 125 asthma and pulmonary patients who are outraged and frightened by the government's "life-threatening" ban on CFC inhalers —which took effect on December 31, 2008 —and the ineffectiveness of the new HFA alternative inhalers.

    So far, Congressional leaders have not responded to our inquiries about patients' concerns.

    At the Environmental Protection Agency (EPA), a spokeswoman said she empathizes with patients' concerns, but said it would be more appropriate for the Food and Drug Administration (FDA) to comment.

    Meanwhile, a clinical pharmacist at the University of Florida called the ban on CFC inhalers "political," and said he has also heard reports that asthma and pulmonary patients are having trouble adjusting to the new HFA inhalers.

    He suggested patients work on their "technique" to get more relief because studies have shown many people don't use the "emergency" HFA inhalers correctly. He also downplayed efforts to bring back CFC inhalers, saying there's a "tremendous" shortage of the Freon propellant.

    But the founder of a California-based organization trying to get CFCs inhalers back on the market disagrees with that supply assessment.

    While politicians stall and agencies stonewall, ConsumerAffairs.com continues to hear from angry and scared asthma and pulmonary patients. Not one of them has expressed support for the ban on the CFC "rescue" inhalers or told us the HFA-models are an effective alternative.

    Making matters worse

    In fact, most told us the HFA inhalers made their asthmas worse.

    Many also said they're shocked by what they call the FDA's "lack of concern" and "ignorance" about this issue especially its position that pulmonary patients will just have to get used to the HFA inhalers and remember to take deep breaths when using the devices.

    "The thing the FDA doesn't realize is that to say we need to take a deeper breath to make the new HFA inhalers work is almost an oxymoron," an asthma patient in Litchfield Park, Arizona, told us. "If we could take deep breaths, we wouldn't need the inhalers. We need medicine that opens the passages quickly ... with little effort ... so that we can breathe deeply and function as normal people do."

    Another asthma patient in Virginia voiced harsher concerns about the FDA's comments that patients remember to breathe deep with the HFA inhalers.

    "This is absolutely total ignorance," says Roger M. of Glen Allen, Virginia. "People having an asthma attack and in a panic state cannot breathe in deeply. People with COPD and limited lung function —when in need of medication —cannot breathe in deeply. This decision needs to be reversed, but it may be too late because the drug companies most probably will not resume production on these old products."

    He added: "Recent times have shown the (incompetence-plagued) FDA's inability to properly understand and evaluate these life altering decisions. If allowed to stand, these bureaucrats and their abettors will have successfully reduced the quality of life for millions of lung disease sufferers throughout the world."

    Breathe through a straw

    Another consumer who responded to our investigation suggested FDA officials try to "breathe through a straw for a week" so they could understand the fears pulmonary patients have when they're gasping for air.

    "I contacted the FDA, which replied saying I should speak to my doctor," says Rose Anne S. of Las Vegas. "What can the doctor do but prescribe another HFA inhaler that will do the same thing. It appears that the FDA really doesn't care. With all my heart I hope someone on the President's staff is monitoring this situation.

    "Believe me I want these HFAs to work," she added, "but they don't. As soon as I puff on them, my breathing gets worse. I'm allergic to alcohol so all it does it make it worse."

    As we've reported, metered-dose CFC inhalers are —as of December 31, 2008 —banned in the United States under an international agreement called the Montreal Protocol on Substances that Deplete the Ozone Layer.

    The FDA and other supporters of this 1987 agreement say the CFC propellant in the inhalers damages the ozone.

    "CFCs reduce the amount of ozone in the ozone layer that surrounds the earth and protects the earth against the sun's harmful rays," the agency wrote. "The loss of ozone can increase the risk of skin cancer, cataracts, and other harmful rays."

    Asthma and other pulmonary patients must now use an environmentally friendly —and more costly —type of inhaler that contains a propellant called hydroflouroalkane (HFA).

    The FDA and other health organizations say HFA inhalers have a different feel and taste — and patients need to take deep breaths when using them.

    The HFA "emergency" inhalers give patients the same dose of albuterol as CFC inhalers and are a "safe and effective" alternative for the more than 40 million asthma and pulmonary patients nationwide, according to the FDA.

    A Florida pharmacist and a spokesman for The American Lung Association and also told us the HFA inhalers now on the market — ProAir, Proventil, Ventolin, and Xopenex — are just as effective as the CFC inhalers when properly used.

    But the key issue, ey said, is for patients to get their asthma under control

    The scores of patients who contacted us say their asthma was in control until they tried the new HFA inhalers.

    They also told us:

    • The HFA inhalers don't give them quick relief;

    • In some cases, the HFA inhalers made their asthma worse. Some say they're allergic to the ethanol in the HFA inhalers;

    • HFA inhalers are more expensive than CFC inhalers. The price has skyrocketed from about $5 for a CFC inhaler to around $50 for an HFA inhaler. That's because there is no generic alternative for HFA inhalers;

    • Many are not convinced CFC inhalers harm the ozone. They also say they're environmentalists, but believe the government picked the wrong product to ban;

    • Many wonder why people can't choose which type of inhaler to use. They understand some patients don't have problems with the HFA inhalers. But what about those who do? Why can't they use their old CFC inhalers?

    The comments we've heard from asthma and pulmonary patients in the past two days mirror those concerns. Consider:

    • "I may die if I cannot have my CFC inhaler," says Paulette B. of Sacramento, California. "I cannot use HFA albuterol inhalers as I am allergic to the propellants in all of them. I tried two different ones and they made me cough really badly, and my lungs burned awfully. They gave me an awful headache and caused nausea, too;"

    • "I have been using CFC inhalers for years with very effective results in controlling my asthma," says Kori L. of Queen Creek, Arizona. "As soon as the CFC inhaler ban was complete, I was forced to use the new HFA inhaler. Not only did the HFA inhaler not work as well controlling my symptoms, but I went from using 1 CFC inhaler a month (a cost of $10/month) to using at least 2-3 HFA inhalers a month and insurance only covers 1 Rx (prescription) a month (at $20) so I was stuck having to pay for the full cost of the additional inhalers or just suffer through my asthma symptoms;"

    • "I have tried all the new inhalers meant to replace the CFC and had no good results," says Dana of Greenwood Village, Colorado. "My asthma is on the side of severe and next to impossible to keep under control. I take a preventive medication, but also need a fast acting inhaler when exposed to any of my many triggers. These new inhalers are completely ineffective and give side effects unable to conquer. This new ban makes my quality and quantity of life a disgrace. I am unable to work, leave my house, or exert energy to play with my children;"

    • "During an attack, I used the new inhaler and my attack became worse," says Jessi Rose F. Fredericksburg, Virginia. "The lack of function of my inhaler frightens me, and I feel unheard and uncared for (because) I was not given a choice in the system I use. I find the switch to be not just careless, but dangerous. At the very least, I feel that we should be given a choice;"

    • "The CFC inhalers would usually give me relief, even if I was having a bad attack, or at the very least, enable me get to the ER without an ambulance ride," says Mary M. of Edgewater, Florida. "I don't care what the doctors, pharmacists, or the FDA say. The HFA inhalers are not the same and they don't work as well, if at all. It has absolutely nothing at all to do with us not using the inhaler 'correctly'. How could so many people have used CFC inhalers fine, but not know how to use an HFA inhaler to get relief? HFA inhalers are dangerous and will cause many preventable deaths. Maybe some of these people from the FDA who won't budge on this will even get to watch a family member or loved one struggle for their last breath because of a defective and unsafe inhaler that replaced one that worked;"

    • "I just read your article on the new HFA inhalers and reading the comment by the FDA representative about not changing (its) position on these new HFA inhalers is short sighted and a disservice to asthmatic patients," says Kim C. of Mebane, North Carolina. "These new inhalers are inferior, case closed! I was sick for many months after using these products: coughing, burning chest, worsening asthma symptoms and body aches. It was horrible. Peoples' health should have never been subjected to political correctness, and that's what this is all about politics."

    Change was "political"

    A clinical professor at the University of Florida —and the co-author of a 2007 paper in the New England Journal of Medicine about the transition to HFA inhalers —agrees the switch was political.

    "Why was it political?" asks pharmacist Leslie Hendeles. "Some years ago, the United States, along with other countries, signed an agreement to phase out all CFCs. That's political. Secondly, Congress amended the Clean Air Act to include this (ban). That's political."

    He disagrees with political and environmental officials who say CFC inhalers harm the ozone.

    "The science is not there that these (CFC inhalers) were damaging the ozone," he told us. "A majority of the damage (from CFCs) came from refrigerators and air conditioners."

    A medical exemption allowing CFC inhalers to remain on the market was included in the Montreal Protocol when it was signed in 1987. At the time, there weren't viable alternative propellants for CFCs.

    But that exemption was removed when HFA-albuterol inhalers became available. In 2005, the FDA determined CFC inhalers were no longer "essential" and said they must be phased out by December 31, 2009.

    The four HFA-albuterol inhalers now on the market, Hendeles says, are safe and effective alternatives. And he takes issue with those who question the validity of the FDA's studies on these new inhalers.

    "There was a wide range of studies done on these (HFA inhalers)," he told us. "These were double-blind, random, placebo studies. I've been studying asthma studies for 35 years. I've served on the FDA's advisory committee ... you're talking to someone who is knowledgeable about this. The FDA was careful to require studies (on HFA inhalers) to detect any differences and make sure they were equivalent (to CFC inhalers.").

    Hendeles said he reviewed all the HFA inhalers now on the market for his article in the New England Journal of Medicine.

    Good technique needed

    "We analyzed the data. There isn't a hint that any one of those drugs doesn't work as well as CFCs. The difference is everyone in those studies was trained to use the HFA inhalers correctly."

    That's why Hendeles suggests patients work on the "technique" they use with these new inhalers.

    "What I tell our patients is 'let me see how you use (the HFA inhaler) and maybe I can make some suggestions to get an increase of the medicine in your lung.' Studies that have examined how people use inhalers have shown many don't use them correctly."

    He added: "I'm also going to throw out the possibility that the HFA inhaler is less forgiving (to bad technique) than the CFC inhalers. If you didn't have good technique with a CFC inhaler it may be magnified with the HFA inhaler."

    Hendeles said he's had excellent results with patients who've improved their technique. "I've rarely had anyone come back (with complaints) who is using the correct technique. It's uncommon."

    Some patients, he told us, also respond differently to the various HFA inhalers. "We've had a lot of patients say the ProAir (which has ethanol) doesn't work for them and we've switched them to Ventolin, (which doesn't have excipients other than the propellant) and they say they're okay."

    Other patients, he said, have trouble with the HFA inhalers because they don't clean them as often as their CFC devices.

    "Unlike the CFC inhalers, the HFA propellant plugs the opening if patients don't follow the directions," Hendeles said. "What we have found is people are —after using them a few times --maybe not be washing them. That makes them clogs and they don't get a full dose. Or some patients may not prime the (HFA) inhaler when it comes out of the package or if they haven't used in a few weeks.

    "If people say they're having trouble with these inhalers," Hendeles added, "ask them how often they're washing them."

    Hendeles echoed other medical professionals who say the key issue is for asthma and pulmonary patients to get their disease under control. "The guidelines say you shouldn't use your rescue inhaler more than twice a week."

    The Asthma and Allergy Foundation of America (AAFA), which told us it's keeping this issue on its radar, concurs."The bottom line is that asthma patients need to make sure they're getting their asthma under control," said Charlotte Collins, the foundation's director of public policy and advocacy. "If they're having trouble with these (HFA) inhalers, they need to get with a specialist to find alternatives."

    One alternative the FDA isn't likely to consider is letting CFC inhalers back on the market.

    "CFC inhalers damage the ozone," spokesman Christopher Kelly told us. "People will have to get used to the new (HFA) inhalers."

    Kelly said his agency researched its decision to phase-out CFC inhalers for several years. He referred us to pages of documentation on the agency's Web site about the ban and the "safe and effective" alternatives for CFC inhalers.

    One FDA posting said: "There are three albuterol HFA inhalers and one levalbuterol HFA inhaler that are alternatives to albuterol CFC inhalers. Each of the HFA inhalers is different. It is important to remember that it is the deep breath that gets the medication into a patient's lungs, not the force of the spray. The spray from an albuterol HFA inhaler may feel softer than the spray from an albuterol CFC inhaler, but this will not affect the amount of drug that a patient breathes into their lungs.

    The posting adds: "The spray from an albuterol CFC inhaler often hits the back of the mouth. The spray from an HFA inhaler is a fine mist that may actually be easier to breathe into the lungs compared to a CFC inhaler. If patients have problems with the albuterol HFA inhaler, they should talk to their healthcare provider as a different product may work better for them."

    Kelly said his agency knows many consumers are upset about the ban on CFC inhalers.

    More than 300 consumers, he said, filed complaints with FDA last year about this action: 295 by phone and 39 by e-mail.

    "The complaints concerned the cost increase and patients getting used to the new formulation," Kelly said. "But I don't think our position is going to change on this."

    He and other proponents of the HFA inhalers also say the costs should come down in the next few years.

    Until that happens, The Partnership for Prescription Assistance (PPA) and drug companies that make HFA inhalers say special programs and money-saving coupons are available to help consumers cover the higher prices.

    Hendeles and others also told us Wal-Mart now sells a smaller Ventolin inhaler for $9.99.

    Congressional action

    But many asthma patients don't like those options. They want their trusty —and more affordable —affordable CFC inhalers.

    The National Campaign to Save CFC Asthma Inhalers is trying to help those patients get what it argues is much-needed medication.

    The California-based organization encourages asthma and pulmonary patients to join its grassroots campaign to convince Congress to amend the Clean Air Act.

    "Congressional action is the answer," says the organization's founder, Arthur Abramson. But first, Abramson wants President Barack Obama to issue an emergency order to allow CFC inhalers in the country.

    "We're the lead organization on this. If we are silent about this then there is no hope for people. We are the last hope for asthma and pulmonary patients. And we will fight this state by state."

    "Not realistic"

    Hendeles, however, doesn't consider either of those viable options.

    "Neither is realistic," he told us. "No one is making CFC inhalers. And an emergency order would not bring about change. There's a tremendous shortage of Freon propellant.

    "The reality is there isn't enough CFC to supply the companies (making the inhalers)."

    Not true, says Abramson, who said he has researched this issue for two years. "That's nonsense to say that you can't get CFCs anymore. It's absolutely untrue."

    Abramson said he's been in contact with a lab in New York that could make CFC — MDI inhalers. He also told us that Honeywell has publicly said it would "be happy to make" CFC inhalers again.

    A Honeywell spokesman said on Friday that she would research the issue and have a response later this week.

    We've also contacted various Congressional leaders about patients' concerns regarding the ban, including California Senator Barbara Boxer, chairwoman of the U.S. Senate's Committee on Environment and Public Works (EPW) and Michigan Congressman Bart Stupak, who serves on the Committee for Energy and Commerce that has oversight over the FDA.

    We're waiting for comments from these elected officials.

    EPA is "sympathetic"

    A spokeswoman for the EPA told us her agency is sympathetic to asthma patients' concerns. "But it would be more appropriate for the FDA to comment," said Catherine C. Milbourn, the agency's senior press officer. "I am reluctant to step on another agency's turf. It sounds like they (FDA) have extensive information on their Web site."

    She added: "We regulate the propellant (CFC) itself. And under the Montreal Protocol, CFCs were phased out. The only thing we would have is the responsibility for phasing out the CFCs."

    Meanwhile, Abramson said he will continue his grassroots campaign to bring back CFC inhalers and educate consumers about what he calls the "false and misleading" information the FDA and others have made about this ban and HFA inhalers.

    That false information, he claims, includes:

    • CFC inhalers harm the ozone. There's no evidence to support this claim, Abramson says. "The trivial amount of CFC emissions from MDIs (metered-dose albuterol inhalers) does not threaten the ozone layer," Abramson states in his group's petition to save CFC inhalers. "The amount of CFCs required for the world's pulmonary patients peaked at less than 10,000 tons (including U.S. use) per year in 1997 (less than 1% of the peak global 1987 CFC emissions for all industrial uses). U.S. CFC MDI use peaked at 2,645 tons/year in 1999. These amounts are trivial and harmless;"

    • HFA inhalers are safe. "There's no way HFA inhalers are safe or effective for all patients who were doing well with CFC MDIs," Abramson told us. "They have ethanol, corn, leachables, HFA-134a Propellant, which was untested in asthma and other pulmonary patients, and many and other potentially dangerous impurities in them."

    • HFA inhalers were thoroughly tested before they went on the market: The tests done of the HFA inhalers were flawed, Abramson says. "The group was too small, the duration was too short, and the population in the clinical tests was a carefully groomed group. These are not real world tests."

    The organization's petition reiterates those concerns.

    "The FDA's false and misleading PR campaign is primarily based on twelve week drug company bought-and-paid-for 'clinical trials' of a couple of hundred mild/moderate asthmatics each — no severely ill patients are included, and black patients (who often have severe asthma), older patients (who often have complex medical problems), and COPD, cystic fibrosis and other important patient populations are frequently under-represented/not represented in these virtually worthless 'clinical trails,' which are nothing more than drug company advertising/PR sales pieces."

    Abramson says he initially launched the campaign because he opposed the ban on CFC inhalers. "I've had asthma since birth —it's not severe —but the new HFA inhalers are not nearly as effective for me as my CFC inhaler."

    The scores of asthma patients who've contacted us hope Abramson's campaign is successful.

    Many, like April T. of Murrieta, California, say this is a mater of life and death.

    "Please, please, please. I am begging whoever can make this change happen to allow people like me who cannot take the new (HFA) medications have an alternative and bring back the life saving CFC inhalers."

    Read consumers' comments about the new inhalers.

     



    Asthma Patients Get Scant Response to Problems with New Inhalers...

    Asthma Patients Outraged at Indifference to Problems with New Inhalers

    Lack of concern by government agencies "criminal," say patients who fear the new inhalers will kill them

     

    New inhalers, like this Proventil model, are powered by non-aerosol propellants

    A ConsumerAffairs.com investigation about the new ban on chlorofluorocarbon (CFC) albuterol inhalers — and the problems many consumers are experiencing with the environmentally-friendly hydroflouroalkane (HFA) inhalers — has generated an outpouring of response from asthma patients nationwide.

    There have been no expressions of concern from the government officials who imposed the switch and no hint that anyone plans to do anything to provide relief to frightened asthma patients. And organizations that supposedly represent the interests of asthma victims say patients need to get used to the new inhalers.

    Since Part 1 of this series appeared on Sunday, we've heard from scores of asthma patients who are outraged by the government's decision to ban the "rescue" inhalers they rely on and force them to use a new type of inhaler they say doesn't give them any relief.

    One woman even told us her daughter died after using an HFA inhaler.

    "She was not sick and was not doing any activities that were not a part of her regular routine," says Maureen H. of Marengo, Ohio. "She was 26 years old and had been diagnosed (with asthma) when she was three. She was not a rookie at managing her asthma. She had an attack on Feb. 25, 2007, and died. We know without a doubt that the HFA inhaler contributed to her death. Someone must help the folks who are suffering ill effects from these new inhalers."

    Many patients now fear they may die without their CFC "rescue" inhalers.

    "I am very worried about not having CFC inhalers available, dying and leaving my two sweet young children motherless," Melissa L. of New York City, told us. "Within three weeks of starting the new HFA inhaler, my normally well-controlled asthma became scarily severe. The FDA has clearly made a mistake in its safety assessment of HFA propellant."

    Another asthma sufferer who read our investigation called the ban on CFC inhalers "criminal."

    "A travesty"

    "This is a travesty of untold proportions," says Kathleen W. of Scottsdale, Arizona. "To take away viable effective medication that is vital for saving the lives of pulmonary patients is insane, inhumane, and criminal."

    As we reported, metered-dose CFC inhalers are — as of December 31, 2008 — banned in the United States under an international agreement, the Montreal Protocol on Substances that Deplete the Ozone Layer.

    The Food and Drug Administration (FDA) — and other agencies supporting the 1987 agreement — say the CFC propellant in the inhalers damages the earth's ozone layer.

    "CFCs reduce the amount of ozone in the ozone layer that surrounds the earth and protects the earth against the sun's harmful rays," the agency wrote. "The loss of ozone can increase the risk of skin cancer, cataracts, and other harmful rays."

    Asthma and other pulmonary patients must now use an environmentally friendly — and more costly — type of inhaler that contains a propellant called hydroflouroalkane (HFA).

    The FDA says HFA inhalers have a different feel and taste — and patients need to take deep breaths when using them.

    But the HFA "emergency" inhalers give patients the same dose of albuterol as CFC inhalers and are a "safe and effective" alternative for the more than 40 million asthma and pulmonary patients nationwide, according to the FDA.

    Lung Association's stance

    A spokesman for The American Lung Association also told us the HFA inhalers now on the market — ProAir, Proventil, Ventolin, and Xopenex — are just as effective as the CFC inhalers when properly used.

    But the key issue, he said, is for patients to get their asthma under control

    But the more than 100 patients who have contacted us say their asthma was under control until they tried the new HFA inhalers.

    They also told us:

    • The HFA inhalers don't give them quick relief;

    • In some cases, the HFA inhalers made their asthma worse. Some say they're allergic to the ethanol in the HFA inhalers;

    • HFA inhalers are more expensive than CFC inhalers. The price has skyrocketed from about $5 for a CFC inhaler to around $50 for an HFA inhaler. That's because there is no generic alternative for HFA inhalers;

    • Many are not convinced CFC inhalers harm the ozone. They also say they're environmentalists, but believe the government picked the wrong product to ban;

    • Many wonder why people can't choose which type of inhaler to use. They understand some patients don't have problems with the HFA inhalers. But what about those who do? Why can't they use their old CFC inhalers?

    A pharmacist in the Midwest told us his patients have raised similar concerns. "My customers are not happy," says Pete Spalitto, owner of Spalitto Pharmacy in Kansas City, Missouri. "I don't anyone who is happy with these (HFA inhalers). They just flat out don't want them — young, old, middle-age. Moms don't like them for their kids. Our customers can't stand them."

    He adds: "The albuterol (CFC) inhalers immediately opened up the lungs for people who had asthma, emphysema, and bronchitis. When you're gasping for air, you like to feel that inhalation going in. But people don't feel that with this new (HFA) inhaler."

    Since our story ran, we've received an overwhelming response from asthma patients who echo those sentiments. In fact, we haven't heard from a single patient who supports the ban on CFC inhalers or says the new HFA emergency inhalers are an effective alternative.

    Consider some of their comments:

    • "I suffered a serious allergic reaction to the HFA Albuterol Sulfate inhalers (two different brands)," Judy F. of Broomfield, Colorado, told us. "The inhalers were also ineffective in relieving my asthma;"

    • "Like the people in your article, I have COPD and asthma," says 52-year-old Bob D. of Wyandotte, Michigan. "I did manage to stock up on a couple of CFC inhalers before the ban, but I am having to try to stretch them out and am using the HFA inhalers as much as possible. I echo the sentiments that they do not work. I have heard and tried all the explanations and helpful tips, but they do not work. My doctor, who has asthma, agrees with me. But he feels as helpless as I do. I can no longer go about my routines like I used to.I worry that I will soon have a heart attack or cardiac arrest;"

    • "The HFA inhaler fails as a rescue device, which is after all the only use of albuterol consistent with good asthma management," says Roger D. of Chicago, Illinois. "This new inhaler is going to kill somebody - hopefully not me;"

    • "My son needed a new inhaler for his asthma," says Cindy Crockett of Raleigh, North Carolina. "We tried three different HFA inhalers--each at $20 co-pay instead of $10. They simply do not work as well. He has had asthma for 15 years and the problem is not because he doesn't know how to use the inhaler. It just doesn't work as well. I worry that if he has a really bad attack, he will end up in the hospital. (The damage) from this is several extra and more expensive co-pays;"

    • "I have had asthma for about 30 years and COPD for the last 15," says Amanda Otero of Lincoln, California. "My asthma has always been well controlled with medications and inhalers, including CFC albuterol inhalers. I lead a very active life. A few months ago my doctor switched me to ProAir HFA inhaler. My asthma immediately became worse I could not breathe. I went back to the CFC inhalers and have had no problems since. I have a supply on hand, but live in fear of what will happen once they are gone. How can the FDA condemn so many asthmatics to this fate? Why is there not a mercy clause in this law that allows those for whom the HFA inhalers do not work to continue using the CFC's, especially when the FDA has stated that the damage done to the ozone layer by inhalers is negligible? Something has to be done to right this wrong;"

    • "The HFA inhalers do not work for me," says Jen of Enfield, New Hampshire. "They have made my asthma 100 times worse than it has ever been. This is such a helpless feeling that our government would take away a life-saving medication for the label of going green. It feels like genocide. I am only 35 and I have a 2-year-old son and a 3-year-old daughter. I live in constant fear that one of them could develop asthma and have no effective medication available for them. I don't know how the FDA or the American Lung Association can turn a blind eye and keep saying the HFA inhalers are just as effective as the CFC ones. It is absolutely disgusting and unforgivable. They are killing people, and the government is watching it happen;"

    • "These new HFA Inhalers do not work," wrote Ryan W. of Burbank, California. "We need our Old CFC inhalers back. I almost died."

    "On the radar"

    The Asthma and Allergy Foundation of America (AAFA) told us today that it's heard similar concerns from patients. And it's keeping this issue on its radar.

    "We continue to hear from patients and review the information we are getting," said Charlotte Collins, the foundation's director of public policy and advocacy. "We have not done a stand-alone survey (on this). That's not outside the realm of responsibility, but that really is the place of the FDA. We've advocated for (the FDA) to do some surveying to make sure what's going on with patients as a result of this transition."

    How is the foundation helping patients cope with this change?

    It says it's using a three-prong approach: listening to patients' concerns, reminding them to keep their asthma under control, and educating them through its Web site about the mandatory switch to HFA inhalers and the different types of options available.

    "The bottom line is that asthma patients need to make sure they're getting their asthma under control," Collins said. "If they're having trouble with these (HFA) inhalers, they need to get with a specialist to find alternatives."

    AAFA officials also applauded our investigation for bringing this issue to the public's attention.

    "We need to hear these things," said spokeswoman Angel Waldron. "I'm glad you're educating readers about this so there can be more discussion. This transition is happening and we're trying to learn how we can help patients cope with this change. For now, we have to figure out a way to make this (ban) work so people get the relief they need."

    She added: "This is a hard issue. We, as a society, are trying to go green and make our air, our planet, safer for our kids and grandkids. The important thing for patients (who are having problems) to remember is none of the medication has changed. The only thing that is different is the way in which it is propelled. We understand patients' concerns with this, but our hands are tied. We've got to comply with this legislation."

    FDA won't budge

    As we reported, the governmental agency in charge of enforcing the ban on CFC inhalers — the FDA — has adopted a take-it-or-leave-it attitude.

    "CFC inhalers damage the ozone," spokesman Christopher Kelly told us. "People will have to get used to the new (HFA) inhalers."

    Kelly said his agency researched its decision to phase-out CFC inhalers for several years. He referred us to pages of documentation on the agency's Web site about the ban and the "safe and effective" alternatives for CFC inhalers.

    One FDA posting said: "There are three albuterol HFA inhalers and one levalbuterol HFA inhalers that are alternatives to albuterol CFC inhalers. Each of the HFA inhalers is different. It is important to remember that it is the deep breath that gets the medication into a patient's lungs, not the force of the spray. The spray from an albuterol HFA inhaler may feel softer than the spray from an albuterol CFC inhaler, but this will not affect the amount of drug that a patient breathes into their lungs.

    The posting adds: "The spray from an albuterol CFC inhaler often hits the back of the mouth. The spray from an HFA inhaler is a fine mist that may actually be easier to breathe into the lungs compared to a CFC inhaler. If patients have problems with the albuterol HFA inhaler, they should talk to their healthcare provider as a different product may work better for them."

    Kelly said his agency knows many consumers are upset about the ban on CFC inhalers. More than 300 consumers, he said, filed complaints with FDA last year about this action: 295 by phone and 39 by e-mail.

    "The complaints concerned the cost increase and patients getting used to the new formulation," Kelly said. "But I don't think our position is going to change on this."

    He and other proponents of the HFA inhalers claim the costs "should" come down in the next few years.

    Until that happens, The Partnership for Prescription Assistance (PPA) and drug companies that make HFA inhalers say special programs and money-saving coupons are available to help consumers cover the higher prices.

    Whose job is it?

    ConsumerAffairs.com also learned the American Lung Association has received complaints from asthma patients about the ban and the switch to HFA inhalers.

    "Patients tell us the HFA inhalers are not working as well as their CFC inhalers," said Dr. Norman H. Edelman, the association's chief medical officer. "I have no idea how prevalent this is, but we know there are some people who feel this way.

    "There is such a thing as post-marketing surveillance," he added. "It is the responsibility of the FDA to ask doctors to collect these reports and make a determination if there is a problem. Right now, I can't tell if it's a problem or if people feel antsy."

    But according to its many fund-raising publications and its Web site, it is the job of the Lung Association to be an advocate for patients.

    "The American Lung Association is the leading organization working to save lives, improve lung health and prevent lung disease. With your generous support, the American Lung Association is 'Fighting for Air' through research, education and advocacy," boasts the organization's Web site.

    Edelman says patients will "notice a difference" when using HFA inhalers. "It's a softer feel. The particles are more finely disbursed and people don't feel that same blast."

    Patients must also prime the HFA inhalers — and keep them clean to prevent build-up and blockage of the medication.

    "But as far as we know, the studies done on these (HFA inhalers) show that when they are used properly, that are as effective as the old (CFC) inhalers," Edelman said.

    As a pulmonologist, though, Edelman said his focus is making sure patients get their asthma under control.

    "Someone who uses a 'quick reliever' inhaler many times a day does not have well-controlled asthma," he said. "Patients shouldn't need their quick relief inhalers more than two to three to four times a week.

    "Asthma is a variable disease and doctors are always readjusting medications and dosages," he added. "If patients are not getting good asthma control, they need to talk to their doctor."

    Many asthma patients, however, told us what they really need are their trusty and affordable CFC inhalers.

    Brute political force

    The National Campaign to Save CFC Asthma Inhalers is trying to help those patients get what it agrees is much needed medication. And the California-based organization encourages asthma and pulmonary patients to join its grassroots campaign.

    "We're the only game in town and our strategy is simple: brute political force to get Congress to amend the Clear Air Act amendments of 1990," says the organization's founder, Arthur Abramson. "Congressional action is the answer."

    But first, Abramson wants President Barack Obama to issue an emergency order to allow CFC inhalers in the country.

    "We're the lead organization on this. If we are silent about this then there is no hope for people. We are the last hope for asthma and pulmonary patients. And we will fight this state by state."

    Abramson has spent the past two years researching this issue. During that time, he says, he uncovered documents that reveal the FDA and other proponents of the ban duped consumers about the need for this action and the safety of the HFA inhalers.

    The FDA, he claims, has spread such false and misleading information as:

    • CFC inhalers harm the ozone. There's no evidence to support this claim, Abramson says. "The trivial amount of CFC emissions from MDIs (metered-dose albuterol inhalers) does not threaten the ozone layer," Abramson states in his group's petition to save CFC inhalers. "The amount of CFCs required for the world's pulmonary patients peaked at less than 10,000 tons (including U.S. use) per year in 1997 (less than 1% of the peak global 1987 CFC emissions for all industrial uses). U.S. CFC MDI use peaked at 2,645 tons/year in 1999. These amounts are trivial and harmless;"

    • HFA inhalers are safe. "There's no way HFA inhalers are safe or effective for all patients who were doing well with CFC MDIs," Abramson told us. "They have ethanol, corn, leachables, HFA-134a Propellant, which was untested in asthma and other pulmonary patients, and many and other potentially dangerous impurities in them."

    • HFA inhalers were thoroughly tested before they went on the market: The tests done of the HFA inhalers were flawed, Abramson says. "The group was too small, the duration was too short, and the population in the clinical tests was a carefully groomed group. These are not real world tests."

    The organization's petition reiterates those concerns.

    "The FDA's false and misleading PR campaign is primarily based on twelve week drug company bought-and-paid-for 'clinical trials' of a couple of hundred mild/moderate asthmatics each no severely ill patients are included, and black patients (who often have severe asthma), older patients (who often have complex medical problems), and COPD, cystic fibrosis and other important patient populations are frequently under-represented/not represented in these virtually worthless 'clinical trails,' which are nothing more than drug company advertising/PR sales pieces."

    Abramson says he initially launched the campaign because he opposed the ban on CFC inhalers. "I've had asthma since birth -- it's not severe -- but the new HFA inhalers are not nearly as effective for me as my CFC inhaler."

    Now he's fighting for pulmonary patients around the world, especially the moms who've sent him heartbreaking letters about HFA inhalers making their kids "cough until they vomit."

    "Two years later, after uncovering the incredible betrayal of patients, including kids I decided to try to do something — with a small group of others — to permanently legalize CFC (inhalers) for those who are suffering terribly and who currently have no voice," he told us. "And, yes, I'm confident that we will prevail."

    Back in Washington, the Asthma and Allergy Foundation of America didn't rule out the possibility of — someday — backing Abramson's effort.

    "Any issue that effects patients' right, access to health care, and improves patients' quality of life might be something we'd be active in," spokeswoman Waldron told us. "If he (Abramson) gains ground on this, we might try to be involved with it in some way and try to offer our support. We advocate for patients."

    Tough odds

    What are the odds of getting the Clean Air Act amended?

    "It would be pretty unprecedented," said Collins, the foundation's public policy and advocacy director. "The FDA has spent years on this and it has gone through the normal regulatory process.

    "But," she added, "it's not outside the realm of possibility."

    Until the law is changed, however, Collins said the best strategy for asthma patients to follow is to get their disease under control.

    "And even if a law went into effect tomorrow (allowing CFC inhalers back on the market), that doesn't mean there will be a supply available for everyone. Those meter-dose CFC inhalers are not going to be available overnight. They are no longer available as of January 1st.

    "What we're advocating patients do right now," she said, "is make the transition (to HFA inhalers) sooner than later so they can find out if they have any issues."

    But the scores of patients who've contacted ConsumerAffairs.com are adamantly opposed to making that transition.

    "It is completely shocking and disturbing that this (ban on CFC inhalers) is now a law considering the fact that it was millions of peoples' everyday medication for years and years," says Jamie L. of San Diego, California. "I'm 22. I've had asthma for 10 years. The HFA inhalers do not work. I am not able to breathe with them. This is horrifying. Please bring my inhalers back."

    Read consumers' comments about the new inhalers.

     


     

    Asthma Patients Outraged at Indifference to Problems with New Inhalers...

    Asthma Sufferers Live in Fear of New Inhalers

    Do new rules pit human life against the ozone layer?

     

    New inhalers, like this Proventil model, are powered by non-aerosol propellants

    Something was wrong.

    Victoria O. knew it the moment she took the first puff of her new inhaler. A burning sensation blistered the back of her throat. It moved down to her windpipe and into her lungs.

    "It felt like liquid acid," the Kissimmee, Florida, woman says. "I realized I couldn't breatheI thought I was going to die."

    So did a woman thousands of miles away, who used the same type of inhaler for her asthma.

    "I used to go hiking a lot, but I'm afraid to after I had a severe asthma attack while I was hiking," says 20-year-old Marissa M. of West Hills, California. "My new inhaler did not work and I was fearful of dying on a trail."

    An asthma sufferer in New York experienced similar fears when she used that same type of inhaler.

    "I thought I was going to die on the way to hospital," says Danielle A. of Brentwood, New York. "I had to pull over and call an ambulance. I can't rely on these new inhalers. I can't breathe with them. That's like having your throat close. It's a very real feeling that you're going to die."

    These asthma sufferers are not alone.

    In the past few months, ConsumerAffairs.com has heard from more than 55 people nationwide with various pulmonary conditions who are scared, outraged, and often literally gasping for breath because they can no longer use the medication that gives them instant relief: their chlorofluorocarbon (CFC) albuterol inhalers.

    That's because metered-dose CFC inhalers are — as of December 31, 2008 — banned in the United States under an international agreement called the Montreal Protocol on Substances that Deplete the Ozone Layer.

    According to the Food and Drug Administration (FDA) — and other supporters of this 1987 agreement — the CFC propellant in the inhalers damages the ozone.

    "CFCs reduce the amount of ozone in the ozone layer that surrounds the earth and protects the earth against the sun's harmful rays," the FDA said in a written statement. "The loss of ozone can increase the risk of skin cancer, cataracts, and other health problems."

    Asthma and other pulmonary patients must now use an environmentally friendly — and more expensive — type of inhaler that contains a propellant called hydroflouroalkane (HFA).

    "A different feel"

    New inhalers are safe and effective, FDA insists.

    The FDA says HFA inhalers have a different feel and taste — and patients need to take deep breaths when using them. But the HFA inhalers, the agency says, give the same dose of albuterol as CFC inhalers and are a "safe and effective" alternative for the more than 40 million asthma and pulmonary patients nationwide.

    Those who've relied on their CFC "rescue inhalers" for years disagree.

    For the past several weeks, ConsumerAffairs.com has talked to scores of asthma and pulmonary patients nationwide about what many call a "life-threatening" ban on CFC inhalers and how they're adjusting to the new generation of rescue inhalers.

    Here are the patients' concerns:

    • The HFA inhalers don't give them quick relief;

    • In some cases, the HFA inhalers made their asthma worse. Some say they're allergic to the ethanol in the HFA inhalers;

    • HFA inhalers are more expensive than CFC inhalers. The price has skyrocketed from about $5 for a CFC inhaler to around $50 for an HFA inhaler. That's because there is no generic alternative for HFA inhalers;

    • Many are not convinced CFC inhalers harm the ozone. They also say they're environmentalists, but believe the government picked the wrong product to ban;

    • Many wonder why people can't choose which type of inhaler to use. They understand some patients don't have problems with the HFA inhalers. But what about those who do? Why can't they use their old CFC inhalers?

    A pharmacist in the Midwest isn't surprised by our findings. None of his clients are happy about the ban or their HFA inhalers, he says.

    Neither are the hundreds of asthma and pulmonary patients who have contacted the National Campaign to Save CFC Asthma Inhalers. The California-based group is lobbying Congressional leaders to amend the Clean Air Act and make CFC inhalers permanently legal in the United States.

    But our investigation reveals the government isn't likely to change its position on this issue.

    An FDA spokesman told ConsumerAffairs.com the agency thoroughly researched this topic and stands by its decisions.

    The FDA also said a generic alternative should be available in a few years, which will reduce the cost of HFA inhalers.

    Until then, some pharmaceutical companies and The Partnership for Prescription Assistance have programs to help consumers cover the increased costs of HFA inhalers.

    "Just as effective"

    During our investigation, we also talked to The American Lung Association.

    A spokesman told us the HFA inhalers now on the market — ProAir, Proventil, Ventolin, and Xopenex — are just as effective as the CFC inhalers when properly used.

    But the key issue, he said, is for patients to get their asthma under control.

    Asthma sufferers like Victoria in Florida say their disease was under control until they used an HFA inhaler.

    "In the 30 plus years I've had asthma, I have never had it spiral out of control this quickly or this severely," Victoria says. "I think they've put poison on the market."

    Victoria's health problems started last fall when she developed bronchitis. Her doctor gave her a prescription for a ProAir inhaler.

    "Upon initial use I realized I was in respiratory distress," she says. "And as I administered the second treatment, I felt a burning sensation in my lungs. Thank God I have a nebulizer. I was able to clear myself that day. But within a week, I felt like I was dying. I had a high fever, couldn't breathe, and I haven't been better since."

    Victoria's doctor gave her antibiotics "over and over again."

    "But my health continued to decline," she says, adding her doctors suspect she had an allergic reaction to the ethanol in the HFC inhaler. "Eventually, I was up all night because of a constant choking sensation, shivering, temple headaches, nausea, throat pain, heart palpitations, general body pain, and severe asthma. My hair started to fall out. I was rushed to the emergency room twice and was in the hospital from Christmas to New Years."

    The ripple effects from using a HFA inhaler, Victoria says, have damaged nearly every aspect of her life.

    "This is killing me. I'm at a point where my boss is ready to fire me (because she's missed so much work). My credit score has gone down because of my medical bills. I gave up my New York apartment and asked my husband to come to Florida. He had to quit his job in New York City and came to Florida to care for me."

    She adds: "My asthma was extremely controlled. But I've gone from someone with controlled asthma to someone who has to be careful where I go. I even have a handicap sticker now."

    Remember Marissa in California? She says the HFA inhalers also wreaked havoc on her active lifestyle.

    "There are a lot of things I can't do anymore. I was into hiking and rock climbing. But I'm terrified to do those anymore. I'm scared because my (HFA) inhaler doesn't work. I'm waiting and waiting for relief. I've had people have to carry me to my nebulizer.

    "Not being able to do the things I love — and not being able to get the relief for my asthma — is sheer torture," says Marissa, who has kept her disease in control for the past 12 years. "I'm always out of breath and I have more severe asthma attacks than ever before."

    Marissa, who calls herself an environmentalist, says the government chose the wrong product to pull off the market.

    "It's amazing to me that you still have Hummers and NASCAR racing and yet you have to get rid of a life-saving medicine. Why ban a medicine that is saving peoples' lives? I just can't see how something like this (CFC inhaler) makes a big impact on the environment.

    "I think that something that can save lives should be made available to the people who need it," she says. "HFA inhalers do not work for everyone. Take the SUV's and Hummers off the road before you take away my CFC inhaler. It is my breath and my independence."

    One problem Marissa hasn't faced with the HFA inhalers is the higher cost. "I'm lucky and have very good insurance. I still pay $5. But I have friends who are not doing well in this economy and they have asked to use my inhaler."

    Higher cost

    Many asthma patients who contacted ConsumerAffairs.com told us they can't afford the pricier HFA inhalers.

    "I called to see how much my inhaler would cost — $32 at Wal-Mart," says Mary Kathleen D. of Tamaqua, Pennsylvania. "The ProAir inhalers are half the size of the albuterol ones, which only cost $22. My husband is on workman's compensation for a knee injury and will be having a lung reduction surgery soon. I can't afford $32 for one inhaler that I need."

    Heather of West Virginia can't, either.

    "They're too expensive," she says of the HFA inhalers. "I have two kids to take care ofand there is a big difference between paying $20 and paying $50 for an inhaler."

    During our investigation, we learned some consumers stocked up on CFC inhalers before the ban went into effect in December.

    "I went to Target and paid out of pocket for four CFC inhalers and then went on some India company's Web site and had four more shipped to me," says Dean D. of Boca Raton, Florida. "So I have my stash or I couldn't continue to work out as aggressively as I do.

    "My asthma is exercise-induced," he adds. "I went for a run and I couldn't breathe (with the HFA inhalers.). In fact, it made my breathing worse. The feeling is like always needing to yawn and not getting a complete and satisfying amount of air in my lungs. It's very scary. I was afraid to push and complete the workout."

    Dean says his stash of eight CFC inhalers should last him about a year and a half.

    "After that, I guess I will try the HFA inhalers again. Maybe there will be a new product on the market. Or I may look at India, China, or Canada. What else can I do? Stop working out? "

    Another worried consumer stocked up on CFC inhalers because she couldn't breathe with the HFA-propelled ones.

    "I paid hundreds of dollars out of pocket and got 37 (CFC) inhalers," says Danielle A. of Brentwood, New York. "Those should last me about two years. Even an expired albuterol (CFC) inhaler is more effective than the ProAir."

    Danielle doesn't want to think about what will happen when her CFC inhalers are gone. It's too frightening for this 29-year-old, who says she's kept her asthma in check since she was four.

    "I'm ready to burst into tears knowing that I may die sooner than later from an asthma attack because a medication that works better than any other (my CFC inhaler) is being discontinued. I'm going to keep my fingers crossed that something changes or rely on my nebulizer more. I can't rely on these new inhalers. They simply don't work. Whatever the thrust isthat's the part that's missing. The medicine doesn't reach my lungs."

    A pulmonary patient in North Carolina is also fearful — and angry — about facing the future without his CFC inhalers.

    "I'm outraged," says Paul E. of Pilot Mountain. "I'm fighting a cold as we speak. I have COPD and asthma and I go through one of these new inhalers in half a day. They don't work. They're about 15 percent as effective as the CFC inhalers. I don't think I'm getting as much medicine. If I am, it's not in a form that gets in my lungs. I'm seriously concerned for my health."

    The ban on CFC inhalers may force Paul to give up his favorite pastime — spending time at the ball park with his kids.

    "I don't think I can coach baseball anymore," he says, adding his CFC inhaler has given him instant relief for the past 20 years. "I may be doing batting practice with the kids and need my rescue inhaler.

    "I've had asthma attacks where if I didn't have my (CFC) inhaler I wouldn't be here. If I have to rely on this red (HFA) inhaler I'm in bad shape."

    Paul's new game plan is to order CFC inhalers online — from other countries.

    "I also travel overseas in my work, so every time I go, I will bring another suitcase that I can fill full of CFC inhalers."

    Hundreds of miles away in Missouri, pharmacist Pete Spalitto is hearing similar concerns about the ban on CFC inhalers.

    "My customers are not happy," says Spalitto, owner of Spalitto Pharmacy in Kansas City. "I don't anyone who is happy with these (HFA inhalers). They just flat out don't want them — young, old, middle-age. Moms don't like them for their kids. Our customers can't stand them."

    He adds: "The albuterol (CFC) inhalers immediately opened up the lungs for people who had asthma, emphysema, and bronchitis. When you're gasping for air, you like to feel that inhalation going in. But people don't feel that with this new (HFA) inhaler."

    What's Spalitto telling his worried and upset customers?

    "We try to be sympathetic and tell them they're not alone. We also tell them we can't purchase the albuterol inhalers anymore — these are the alternatives. If they don't work, we suggest they contact their doctor or get albuterol through a breathing machine."

    The National Campaign to Save CFC Asthma Inhalers has another suggestion for asthma and pulmonary patients who are upset about the ban: join its grassroots campaign.

    "We're the only game in town and our strategy is simple: brute political force to get Congress to amend the Clear Air Act amendments of 1990," says the organization's founder, Arthur Abramson. "Congressional action is the answer."

    Presidential action

    But first, Abramson wants President Barack Obama to issue an emergency order to allow CFC inhalers in the country.

    "We're the lead organization on this. If we are silent about this then there is no hope for people. We are the last hope for asthma and pulmonary patients. And we will fight this state by state."

    Abramson has spent the past two years researching this issue. During that time, he says, he uncovered documents that reveal the FDA and other proponents of the ban duped consumers about the need for this action and the safety of the HFA inhalers.

    The FDA, he claims, has spread such false and misleading information as:

    • CFC inhalers harm the ozone: There's no evidence to support this claim, Abramson says. "The trivial amount of CFC emissions from MDIs (metered-dose albuterol inhalers) does not threaten the ozone layer," Abramson states in his group's petition to save CFC inhalers. "The amount of CFCs required for the world's pulmonary patients peaked at less than 10,000 tons (including U.S. use) per year in 1997 (less than 1% of the peak global 1987 CFC emissions for all industrial uses). U.S. CFC MDI use peaked at 2,645 tons/year in 1999. These amounts are trivial and harmless;"

    • HFA inhalers are safe: "There's no way HFA inhalers are safe or effective for all patients who were doing well with CFC MDIs," he said. "They have ethanol, corn, leachables, HFA-134a Propellant, which was untested in asthma and other pulmonary patients, and many and other potentially dangerous impurities in them;"

    • HFA inhalers were thoroughly tested before they went on the market: The tests done of the HFA inhalers were flawed, Abramson says. "The group was too small, the duration was too short, and the population in the clinical tests was a carefully groomed group. These are not real-world tests."

    The organization's petition reiterates those concerns.

    "The FDA's false and misleading PR campaign is primarily based on twelve week drug company bought-and-paid-for 'clinical trials' of a couple of hundred mild/moderate asthmatics each — no severely ill patients are included, and black patients (who often have severe asthma), older patients (who often have complex medical problems), and COPD, cystic fibrosis and other important patient populations are frequently under-represented/not represented in these virtually worthless 'clinical trails,' which are nothing more than drug company advertising/PR sales pieces."

    Abramson says he initially launched this campaign because he opposed the ban on CFC inhalers. "I've had asthma since birth — it's not severe — but the new HFA inhalers are not nearly as effective for me as my CFC inhaler."

    Now he's fighting for pulmonary patients around the world, especially the moms who've sent him heartbreaking letters about HFA inhalers making their kids "cough until they vomit."

    "Two years later, after uncovering the incredible betrayal of patients, including kidsI decided to try to do something — with a small group of others — to permanently legalize CFC (inhalers) for those who are suffering terribly and who currently have no voice," he told us. "And, yes, I'm confident that we will prevail."

    FDA won't budge

    In an asthma attack, the airways become inflamed and swollen.

    The FDA, however, isn't likely to change its position on the ban.

    Why?

    "CFC inhalers damage the ozone," spokesman Christopher Kelly told us. "People will have to get used to the new (HFA) inhalers."

    Kelly said his agency researched its decision to phase-out CFC inhalers for several years.

    He referred us to pages of documentation on the agency's Web site about the ban and the "safe and effective" alternatives for CFC inhalers.

    One FDA posting said: "There are three albuterol HFA inhalers and one levalbuterol HFA inhaler that are alternatives to albuterol CFC inhalers. Each of the HFA inhalers is different. It is important to remember that it is the deep breath that gets the medication into a patient's lungs, not the force of the spray. The spray from an albuterol HFA inhaler may feel softer than the spray from an albuterol CFC inhaler, but this will not affect the amount of drug that a patient breathes into their lungs."

    The posting adds: "The spray from an albuterol CFC inhaler often hits the back of the mouth. The spray from an HFA inhaler is a fine mist that may actually be easier to breathe into the lungs compared to a CFC inhaler. If patients have problems with the albuterol HFA inhaler, they should talk to their healthcare provider as a different product may work better for them."

    Kelly said his agency knows many consumers are upset about the ban on CFC inhalers.

    More than 300 consumers, he said, filed complaints with FDA last year about this action — 295 by phone and 39 by e-mail. "The complaints concerned the cost increase and patients getting used to the new formulation," Kelly said. "But I don't think our position is going to change on this."

    When asked about buying CFC inhalers from countries oversea, Kelly said: "Buying the CFC albuterol from other countries, outside the closed U.S. supply system, (either prior to or after 12/31/08) is not legal and the safety and efficacy of the product is unknown."

    Kelly and other proponents of the HFA inhalers say the costs should come down in the next few years.

    In the meantime, The Partnership for Prescription Assistance (PPA) and drug companies that make HFA inhalers say special programs and money-saving coupons are available to help consumers cover the higher prices.

    Another organization that's hearing complaints about the ban on CFC inhalers is The American Lung Association.

    "Patients tell us the HFA inhalers are not working as well as their CFC inhalers," said Dr. Norman H. Edelman, the association's chief medical officer. "I have no idea how prevalent this is, but we know there are some people who feel this way.

    "There is such a thing as post-marketing surveillance," he added. "It is the responsibility of the FDA to ask doctors to collect these reports and make a determination if there is a problem. Right now, I can't tell if it's a problem or if people feel antsy."

    Patients, he said, will notice a difference when using HFA inhalers. "It's a softer feel. The particles are more finely disbursed and people don't feel that same blast."

    Patients must also prime the HFA inhalers — and keep them clean to prevent build-up and blockage of the medication.

    "But as far as we know, the studies done on these (HFA inhalers) show that when they are used properly, that are as effective as the old (CFC) inhalers," Edelman said.

    As a pulmonologist, though, Edelman's focus is making sure patients get their asthma under control.

    "Someone who uses a 'quick reliever' inhaler many times a day does not have well-controlled asthma," he said. "Patients shouldn't need their quick relief inhalers more than two to three to four times a week. Asthma is a variable disease and doctors are always readjusting medications and dosages," he added. "If patients are not getting good asthma control, they need to talk to their doctor."

    Back in Florida, Victoria's doctors are still trying to find out why her asthma suddenly spun out of control. The key suspect, she says, is her HFA inhaler.

    "I've seen a pulmonologist, who is pretty much boggled about how someone can go from no asthma to severe in a couple months. And my immunologist is trying to figure out if I had a really bad (allergic) reaction and that's why my hair is falling out. I also have to see a cardiologist because of the choking sensations at night."

    Victoria — who still receives nebulizer treatments every four to six hours — doesn't want other asthma patients to experience similar problems with an HFA inhaler.

    Neither do the scores of other asthma-sufferers who've contacted ConsumerAffairs.com.

    The only solution, they say, is to bring back CFA inhalers. And let patients decide which type of inhaler works best for them.

    "Obviously, the HFA inhalers work for some people," says Ivy G. of Van Nuys, California. "But for those of us that they don't work for, give us the option of having our old (CFC) inhalers. No one has a problem if they (HFA inhalers) work, but they don't work for everyone. They don't work for me. I can't breathe when I use them."

    Victoria agrees.

    "I cannot believe the FDA has allowed these HFA Inhalers to be forced upon an unsuspecting public. They've put a dangerous drug on the market that is causing people to suffer. The FDA has to reconsider this ban."

    Read consumers' comments about the new inhalers.

     



    Asthma Sufferers Live in Fear of New Inhalers...

    Asthma Patients Pay the Price for Ozone Protection

    Polluters Can Pollute Away but Asthma Victims Must Pay Up

    No one's putting any restrictions on Hummers, backyard grills, coal-fired power plants or other pollutants but those who are already victims of air pollution -- asthma victims -- will be paying up to three times as much for their live-saving inhalers, all in the name of protecting the ozone layer.

    A study in the March 29 New England Journal of Medicine finds the new inhalers effective, but expensive.

    Conducted by two university professors and a director for the Food and Drug Administration, the review examines the consequences of switching to hydrofluoroalkane, which is replacing chlorofluorocarbon, or CFC, as a key ingredient in albuterol inhalers designed to relieve asthma. The FDA has ruled that U.S. sales of CFC albuterol inhalers be prohibited after 2008.

    About 52 million prescriptions are filled for albuterol each year in the United States, with most containing a generic version of CFC. But because of rising global concerns about CFC's ozone-depleting effects, "medically essential" inhalers are finally joining a list of banned products that started in 1978.

    The researchers say their analyses show that inhalers with CFC and the new brands that contain hydrofluoroalkane, or HFA, are equally effective at treating asthma.

    "Hopefully, by communicating with health-care professionals, we'll be able to reassure patients," said Leslie Hendeles, the University of Florida professor of pharmacy and pediatrics who spearheaded the review.

    Albuterol, one of the medicines that relieve asthma attacks, is the seventh most commonly prescribed drug in the United States. Because it's so widely used, the report predicts Americans will spend an additional $1.2 billion a year on three patented inhaler brands containing the new propellant (Ventolin, ProAir and Proventil) until generic versions reach pharmacies, probably after 2012.

    Patients who pay for their own medications will probably be hit hardest by new costs -- paying on average $26 more per prescription, or $312 more per year -- but people with prescription benefit plans will likely face higher co-pays as well, according to the review.

    Additionally, while the new inhalers are just as effective as their traditional CFC counterparts, a few differences have been reported. One brand, for example, comes sealed in a protective pouch. After that pouch is opened, the drug carries a shelf life of just two months, while most inhalers can typically be stored for 15 to 24 months, Hendeles said.

    Consumers will also notice that only the Ventolin brand of HFA inhaler comes with a counter to track how much medicine is left. For that reason, Hendeles suggests keeping a backup inhaler handy if physicians prescribe a device without a counter.

    "There isn't any reliable way of estimating when they're going to run out," said Hendeles, who also serves as a consultant to the FDA.

    The review also reports that some HFA inhalers tend to clog more easily. To prevent clogging in HFA inhalers, Hendeles advised patients to remove the devices' metal canister once a week and clean the plastic actuators with warm water.

    Not all of the new HFA inhaler products are ideal for everyone and health-care providers and their patients should be aware of important differences.

    Two brands of HFA inhalers contain ethanol. It may not be an appropriate therapy choice depending on the patient's religious beliefs, and can temporarily cause a false reading on breath alcohol tests performed by law enforcement agencies, Hendeles said.

    Hendeles noted that CFC inhalers release negligible amounts of the propellant, and do not pose a threat to ozone depletion. However, the United States joined more than 185 other countries in signing the Montreal Protocol, an international treaty requiring complete withdrawal of all CFC products. The inhaler, deemed medically necessary, was exempt until new market replacements using HFA became available.

    Hendeles said he hopes the review will dispel myths about HFA for doctors and patients. Still, even though HFA inhalers are safe for the environment and effective at treating asthma, some people may feel uncomfortable when making the switch. HFA inhalers spew slower and warmer plumes of medicine than their CFC counterparts, so asthma patients may fear their new inhalers aren't strong enough.

    "There undoubtedly will be some people who are absolutely certain it doesn't work as well," Hendeles said, adding that patient education is the key to proper care.

    Dr. Rachel L. Miller, an assistant professor of clinical medicine and public health at Columbia University, said she would urge asthma patients to consult their pharmacist or health-care provider if they're nervous about using the new inhalers.

    "It's really the same drug," said Miller, who has worked with both CFC and HFA inhalers. "I have found both of them, in my personal experience, seem to work fine."

     



    Asthma Patients Pay the Price for Ozone Protection...

    Recalled Asthma Inhalers May Be Linked to Deaths

    WASHINGTON, August 10, 2001 -- A consumer watchdog group says asthma inhalers recalled by Schering-Plough Corp. are the "primary suspect" in the deaths of 17 asthma patients that occured from late 1998 through early 2001.

    Schering-Plough has recalled albuterol inhalers distributed during that time period because of a manufacturing problem that could have caused some of the inhalers to contain no active ingredient. The manufacturer insists that possibility is "remote."

    The Public Citizens Health Research Group said that at least 10 of those who died were attempting to use the inhalers that were later recalled. Albuterol is used in "emergency" inhalers which asthma patients use when they are having an attack. Other inhalers are used on a preventive basis.

    Public Citizen said its study of Food and Drug Administration (FDA) records indicated that asthma deaths spiked during the time that the recalled inhalers were being distributed and called for a criminal investigation to determine whether Schering-Plough knowingly shipped defective inhalers.

    In a letter to Tommy Thompson, Secretary of Health and Human Services, Public Citizen said remarks in FDA reports clearly indicate there were problems with albuterol inhalers during the time the recalled units were in use.

    The remarks included those of a 21-year-old, shortly before his death, who complained on several occasions that his albuterol inhaler did not seem to treat his asthma attacks as usual. A ten-year-old boy who had an asthmatic attack reached for his inhaler and obtained no relief and died shortly thereafter.

    "Both of these people were using inhalers from the recalled lots. Of those who died whose ages were known, six were under the age of 30 including three who were less than 20 (10, 12, and 16)," said Sidney M. Wolfe, MD, Director, Public Citizens Health Research Group.

    Recalled Asthma Inhalers May Be Linked to Deaths...

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