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A ConsumerAffairs.com Investigation

Asthma Patients Get Scant Response to Problems with New Inhalers

Government agencies "sympathize" but offer little more than that

By Lisa Wade McCormick
ConsumerAffairs.com

February 23, 2009

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

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 --- • California Wins $21 Million Settlement Over Albuterol Price Hikes • 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

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.

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