The End of CFC Inhalers

At age two my brother, Greg, sat, hunched and pale on a doctor's exam room table waiting to see a pulmonary specialist. My mom, weary and worried, sat by his side and tried not to think of the past year's struggles. She hoped that this doctor wouldn't brush off Greg's constant coughing, inability to breathe, sunken eyes, and sickness with throw-away diagnoses like "a cold" or "respiratory infection" or "cough." She had tried everything to prevent his recurring winter sicknesses, even bringing a washtub full of snow for him to play with in the kitchen as an alternative to going outside. She knew, even if it was only in her motherly instinct, that there was something more wrong with him than a simple illness. The door opened and the doctor walked in, eyes looking down at Greg's chart. He sat down on a stool, looked up from the chart at my brother, then turned to my mom and said, "So, how long has your son had asthma?" My mom let go tears of relief.

The symptoms of asthma can easily be missed by busy physicians, or by parents who hear nothing but coughing coming from their child's room. But asthma is a chronic disease of inflammation of the lungs, much more than just a cold. When the bronchial tissues are triggered by something - which can be as general as cold air or as specific as cigarette smoke, pet dander, or dust mites - they inflame, constrict and make the everyday act of breathing feel like sucking desperately through a soda straw. Suddenly losing the ability to breathe from an asthma attack is a terrifying event, and if not rectified it can be fatal.

Fortunately for most of the more than 30 million asthma suffers in the U.S., there are medications available to treat the chronic illness, and most asthmatics are able to live normal lives.

Greg uses a rescue inhaler that propels a spray of medication that reduces inflammation in his lungs. He uses it frequently when it is cold outside, or when he is working particularly hard. Fortunately it is small enough to be brought with him wherever he goes. When his inhaler is not enough, he uses a nebulizer, a larger machine that breaks down a stronger medication into a vapor steam that he breathes for several minutes to get relief from an attack. When asthma sufferers go to the emergency room for an asthma attack, the treatment is with a nebulizer. Though very effective, nebulizers are not portable.

Thanks to the availability and effectiveness of these non-steroid inhalers, many people with asthma can be athletes, have physically demanding careers, or in the case of my little brother, do both. He works as a lifeguard and EMT and is healthy enough to run several miles a day. I suspect that his drive to help others was inspired by the amount of time he spent in and out of doctors offices and hospitals while growing up.

Around the same time my brother was diagnosed with asthma, atmospheric scientists became aware of something dramatic happening around the South Pole. In 1985, climate scientists observed that the protective ozone layer of the atmosphere was being eroded by man-made chemicals known as chlorofluorocarbons, or CFCs. The ozone layer is made up of happily bonded triple molecules of oxygen known as ozone. They serve to bounce harmful ultraviolet radiation back into space, and are for the most part non-reactive, and monogamous. They're naturally formed and make up a large portion of our upper atmosphere. CFCs, on the other hand, were developed when my parents were children. They're used for refrigeration, propellant and coolant, and at the time were found in spray cans, manufacturing processes and refrigerators. They're also present in my brother's asthma inhalers.

CFCs degrade the ozone layer chemically. Ultraviolet light from the sun breaks apart the CFC molecule. CFC includes the element chlorine, which, when broken off from the whole acts like a lonely, desperate single. Its desire to pair up can break apart the stable relationship of an ozone molecule. The chlorine insists on pairing with one of the oxygen molecules, leaving the other two to form plain old oxygen. This effectively destroys one of the many millions of molecules making up the ozone layer. But, this chlorine-oxygen bond, like a Hollywood marriage, isn't meant to last. If the pair runs into another lone oxygen, the oxygen will run off with the other oxygen, leaving behind the destructive and angry single chlorine to do it all over again.

Because of its runaway nature, there was a worldwide summit held in 1987 on the the use of CFCs that led to a treaty known as the Montreal Protocol. The protocol called for drastic reduction and eventual complete cessation of CFC production. In 1990, when my brother entered kindergarten, international diplomats voted to eliminate all CFCs by the year 2010. Most of the treaty's effects took place early as CFC refrigeration was replaced by other chemicals. Companies manufacturing aerosols made the slow and costly switch over to non-CFC units. My brother's asthma inhalers, however, were never switched over to a different propellant, because there was no other substitute that was both effective as a propellant and safe enough for patients to inhale. But with the 2010 deadline looming, the makers of asthma medications had to find a solution.

After a brief period of tests on non-asthmatics to look for harmful side effects, an alternative known as hydrofluoroalkane, or HFA was developed for use in the inhalers 5-7 years ago. It carried with it a final blow for the CFC propelled medications. Per the FDA and in compliance with the Montreal Protocol, on January 1^st of 2009 the CFC inhalers will no longer be available to pharmacists in the United States. Though physicians have been urged to change patients over to the new inhalers for some time, there is still a significant hold out of patients who have not yet made the switch, or haven't seen their doctor recently enough to know about the change.

For some asthmatics who have already switched, the change to the new prescription came with no side effects. They found the difference between the inhalers to be minimal and nothing they couldn't adapt to. But, the propellant in the new inhalers is at a warmer temperature than the CFC inhalers, is stickier and more prone to clogging, and some users may not think that they're getting the same amount of medicine in each puff. According to the new medication's instructions, the proper use of the new inhalers is something that patients can be educated about by their doctors, and pose no real concern. But not everyone agrees.

"I hate environmentalists," my brother told me when I answered my phone earlier this year. "You're all killing me." Greg received his first HFA inhaler and found himself unable to run or stay outside when it was cold without having to stop to gasp and wheeze. Greg, along with a growing number of asthmatics, noticed that the inhalers were not doing their job as well as they should, or that they even seemed to make their asthma attacks worse. When he begged his pharmacist for the old CFC inhalers, he was told that he'd have to "get used to it".

Some asthmatics also felt brushed off when they reported these symptoms to doctors and were told that they had no alternative to the new inhalers. After all, published research showed that there was no difference in effectiveness or side effects between the two inhaler versions, so physicians have no reason to believe that the differences are due to anything but lack of patient competency with the new inhalers. It has been suggested, however, that one of the problems may be with the delivery of the medication itself. To properly take the medicine from this inhaler, it is necessary to take a long, slow, controlled breath which is nearly impossible to do during an asthma attack.

When reporting symptoms and problems to doctors and pharmacists failed, many turned to consumer complaints. Reports began to pour into MedWatch, a consumer watchdog group for medications. Some patients reported that their asthma suddenly became uncontrolled after a lifetime of stability. Some even reported having to return to their nebulizer in order to get through a single day, making them feel like prisoners of their own houses. In an extreme case, having uncontrolled asthma has lead to the death of at least one person. Krimson Leah Hughey, a twenty-six year old with well-controlled asthma is reported to have died twelve days after starting the new inhaler. She used the inhaler to respond to an attack, but it did not improve her breathing. Krimson suffered brain damage from lack of oxygen and died several days later on a ventilator.

On the National Campaign to Save CFC Inhalers website (www.savecfcinhalers.com), desperate asthmatics are signing a petition that asks lawmakers to exempt the inhalers from the CFC ban because of their medical necessity, until a better alternative to HFA can be found. Quotes from asthma sufferers and practitioners fill the site with their pleas.

Julie, a respiratory therapist says, "I have been a Respiratory Therapist for 12 years. I have never seen so many pulmonary patients in distress. This is a form of torture. Let patients have their life-saving medications. HFA inhalers do NOT work for everyone."

"I am truly frightened about what will happen if they are no longer available," says Nancy, a RN in Michigan, "I suppose all asthmatics could carry nebulizers with them to work, to concerts, shopping, etc, and use them on an emergency basis to continue breathing."

In addition to the physical concerns, there is also a major difference between the two inhalers that wasn't mentioned in any clinical trial that could have a large impact on the health care community. A sick child nearly always has a significant effect on a family's finances including trips to the doctor, prescriptions, and missed days of work. In the U.S., the growing ranks of the uninsured make this burden even heavier for families to bear.

Because existing asthma medications have been around long enough there are generics containing CFC as a propellant available at a lower price, but they will also be eliminated at the end of the year. Because the HFA inhalers are technically a new product, there will not be a generic equivalent for years, leaving little help for struggling families.

At the prescription counter, this means that a non-CFC inhaler can cost up to three times more than the CFC version. Add to that the fact that some patients were not even notified of the switch, because it is the "same medication" and you have a recipe for a risky situation. As a parent struggling to make ends meet, a trip to the pharmacy to pick up the usual round of inhalers for your child could leave you staring at total cost of up to triple what you paid last month. For some, that's a cost that they are unable to afford.

There is some concern in the medical community that the cost of the new HFA inhalers alone (aside from supplementary medications they may need to control their asthma) will drive people to switch to over the counter, less effective treatments, or no treatments at all. This could further increase yearly emergency room visits, and put children in danger of fatal attacks. Some, like my brother, are so desperate that they're seeking to order the CFC inhalers from other countries such as India and Canada, even without the guarantee of safety.

The cost is only a small piece of an issue that is really one of environmental justice. The tricky thing about asthma is that it can be triggered by things in the environment, and there is some evidence that children can be more prone to asthma in more polluted areas, which are often the most economically depressed. There are significantly more children with asthma who are living under the poverty line than those that aren't. So in the end, those most affected by asthma will likely be the ones most likely to feel the brunt of the increased financial burden, and may have to make the terrible choice between paying for their child's medications or other daily needs.

As an environmentalist, making choices about environmental regulation is always challenging, but more often than not, the choice that is better for the environment happens to have a positive impact on human health. The matter becomes more complex when the two are in opposition. By helping the planet maintain its ozone, we're unwittingly discriminating against those with a disease that they have no choice about; a disease we may have made worse by allowing the kind of pollution that set children up for a life of respiratory challenges in the first place. I can't argue that the CFC ban hasn't been beneficial to the planet's overall health, nor am I leaping to fight for the destructive chemical to be reinstated. But once a violation is recognized, I wonder if we should continue on despite the unintended effects solely because it's good for the planet? And once the whispers of those gasping for breath reach the ears of doctors should patients continue to be dismissed as anomalies, as the few outliers?

The decision to switch away from the CFC inhalers was a landmark decision in that it was the first time that an environmental/political reason has justified a change in a medication, instead of one only for the benefit of the people using it. Because of this, there are no protocols in place for how to handle such a change. I would hope in the future that environmentalists can more closely consider the complexities of environmental regulation when it concerns environmental justice or human rights. The costs of any environmental policy should be weighed not only on the environment, but on the effects to humans as well. Families affected by changes like this should have a voice or weight when the issue is so crucial to their survival. By making the switch away from CFC inhalers without investigating the consequences, developing alternatives, or by simply by not planning ahead and anticipating cost and social justice, we have failed to live up to our good intentions.

Doctors, too, should examine this situation closely. It may be easier to assume that a patient is resisting a change by complaining about it, but the complaints can be grounded in real symptoms and problems that deserve attention. Patients like my brother should be required to be notified any time a prescription is changing, even if the change is only in the binding agent, propellant spray, or food coloring being used in it and not the medication itself. A changed drug should also be tested by the FDA as rigorously as a new one. And if the cost difference between the old drug and new one is substantial, some kind of assistance should be available to grandfather in those who can no longer afford the "same" medication.

As the deadline of the first of the year looms closer, many asthmatics are not seeing the new year as a time of hope, but wonder if they'll be able to continue to live the same lives they had before a decision was made far away, for far away reasons. After Greg visited his doctor several times to complain of his worsening asthma, he was prescribed a second type of inhaler and a daily oral medication, costing him a total of three hundred dollars a month to fill. It is too soon to tell if he'll be able to continue running into burning buildings to save lives, or venture out into a cold winter's night to rescue someone having respiratory distress. His only consolation is that the few puffs left in his old CFC inhaler are keeping him running, for now.