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."
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."
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.
"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."
"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...