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.
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.
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.").
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.
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...