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