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A ConsumerAffairs.com Investigation

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

Previously healthy asthma sufferers wind up disabled -- and worse

By Lisa Wade McCormick
ConsumerAffairs.com
Copyright © 2009 All Rights Reserved

September 8, 2009

Asthma • Special Report: Asthma Sufferers Live in Fear of New Inhalers • Asthma Patients Outraged at Indifference to Problems with New Inhalers • Jackie Joyner-Kersee: FDA "Insensitive" to Asthma Patients' Problems • Victims of Government: Asthma Patients' Lives Shattered by 'Green' Inhalers • Consumer Complaints --- • Physicians Question Asthma Treatment • Asthma May Be Overdiagnosed • FDA Studies Asthma Drug's Potential Suicide Link • Indoor Allergens Torment Asthma Sufferers • Patients Balk at New Asthma Inhalers • Study: Farm Kids Have Lower Risk of Asthma • Researchers Link Spray Cleaners With Asthma • National Study Links Asthma to Allergies • Study Finds High Rate of Asthma in College Athletes • Can an Apple a Day Keep Asthma Away? • Survey Shows Asthma Not Controlled in Majority of Patients • Asthma Patients Pay the Price for Ozone Protection • Asthma Linked to Obesity in Women • Researchers Say "Killer" Asthma Inhalers Should Be Recalled • Asthmatic Kids Need No-Smoking Rules • Study: Asthma Patients Think It's Temporary • Female Hormones May Affect Allergies, Asthma • Home-Based Clean-Ups Help Childhood Asthma, Study Finds • Asthma and Obesity: Is There A Connection? • Bacteria in Household Dust May Trigger Asthma Symptoms • Air Pollution, Asthma May Be Linked • Americans Lack Vital Asthma Info: EPA • Researchers Find Ties Between Asthma and Emotion • A Good Laugh Can Trigger Asthma Attack

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. “I’m 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.

It’s 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 doctor’s appointment tomorrow. “Here we are in the middle of a national discussion on health care and look what I’m going through. I was fine before all this started…I 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 hadn’t 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 don’t 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; they’ve 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 week’s loss of her employer-provided medical insurance.

“I’m facing a dilemma that I didn’t anticipate,” she says, adding her employer had covered her under its plan during her leave. “I’ve gotten sicker and sicker and I know it’s solely because of the HFA inhaler.”

ConsumerAffairs.com has learned that other asthma and pulmonary patients are also considering filing for disability, saying they’re 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 Grassley’s (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, isn’t 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 they’re 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 who’ve contacted ConsumerAffairs.com say their asthma was in control until they used an HFA inhaler.

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

“I hadn’t used an asthma pump in years,” she recalls. “But I couldn’t get rid of the bronchitis. The doctor gave me that HFA asthma pump and within a week, I was sicker than I’d 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 breathe…I 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 she’s 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. “I’ve always worked. I’ve always had a job. I like my job and I want to keep working. But how can I work when I can’t breathe?”

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

“Oh my gosh, it’s been a mess. They keep rejecting, rejecting, rejecting, my claim. They don’t believe this asthma issue is a problem.

“I paid into this disability for years,” she says. “It’s 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 wasn’t sick enough.”

Victoria’s 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 Victoria’s 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 couldn’t 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 employer’s health care plan until she went on leave in May. “I have a 12-year-old son. And like I said, I’ve 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 couldn’t work without that machine. And I couldn’t 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 Lincoln’s president and CEO, Victoria criticized the company for using that job description in her case.

“I don’t 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 company’s claims that her lungs improved and she didn’t 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 don’t know all the effects the HFA inhaler (and the ethanol) will have on me. I may clear up. I hope that’s the case."

'Ruined my life'

She adds: “I can’t tell you how much HFA inhalers have ruined my life. I’m sick all the time and I’m 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 she’s shocked and disappointed that Lincoln Financial ignored her doctors’ opinions.

“My doctors have given them everything -- all the analysis and the blood tests. They’ve 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, they’d hear me wheezing and choking. But yet, they said I’m fine. It’s almost a mockery of how the system is supposed to work.”

ConsumerAffairs.com obtained a copy of July 26, 2009, letter from Victoria’s pulmonologist, who said she’s 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 Group’s denial of her disability benefits – and has included Dr. Lucio’s July 2009 letter to back her claim. She has also consulted an attorney regarding the company’s decision.

ConsumerAffairs.com contacted Lincoln Financial about Victoria’s 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 don’t 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 government’s decision to ban what hundreds of asthma patients call their “life-saving” CFC inhalers.

Consider:

“The new inhalers don’t 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 couldn’t 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; I’m 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 isn’t 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 that’s 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.

“There’s a lot on their (Congress) plate and we’re 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 issue…maybe it’s 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, doesn’t track whether patients have received those benefits.

Neither does McDonald’s environmental organization. But he empathizes with patients who’ve encountered problems with their insurance companies because of asthma and problems related to their HFA-inhalers.

“I can’t get insurance because of my asthma and so I have to pay (cash) for the HFA inhalers,” he says. “And it’s a $10 to $15 increase over the CFC inhalers. “It’s a vicious cycle. I can’t get insurance because of my asthma and I’m 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 Victoria’s 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 can’t 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 don’t like it and it makes me angry, but I have a strong faith. I believe there must be a reason I’m going through this. And I thank God that I’m alive.”

She’s also thankful that her husband recently found a job. “But he’s had to move to New York for that position and he doesn’t have medical coverage yet.”

Victims of government

As she struggles to catch her breath, Victoria says she isn’t waging this battle just for herself. She’s fighting for all asthma and pulmonary patients who’ve 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 they’re not getting better. They used what was out there (for their asthma or respiratory problems), but that is what’s creating their disability.

“And now there are people like me who are not getting their disability benefits. My insurance company isn’t there when I need them. I now stand alone.”

Read consumers' comments about the new inhalers.

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