Beginning this year, inhaled beta-agonist asthma medications had to switch to a more environmentally friendly form.
MedPage Today has a special report on the issue, one where most primary care doctors were not well educated on.
Apparently, the new inhalers, which use hydrofluoroalkane (HFA) as a propellant, have been attracting a litany of patient complaints, including that the medicine tastes funny, the propellant isn’t as strong, it’s less effective, and it costs much more.
Some of the patient concerns are valid, and some aren’t. For instance, a study in the NEJM showed that, “patients using the two types of inhalers showed similar bronchodilation and increases in forced expiratory volume,” as well as noting that, “no increase in hospitalization rates for respiratory problems with HFA versus CFC albuterol.”
But, despite the data, doctors are telling patients to take more puffs of the HFA inhaler to combat the myth that these new inhalers “aren’t as strong.”
What’s indisputable is the cost. Old inhalers run between $5 and $10, while the HFA inhalers costs anywhere from $30 to $60. None are generic, with patents expiring in 2012.
Which leads me to wonder if the pharmaceutical lobby abetted the environmentalists in pushing through with the transition.
It’s an interesting piece, and I recommend anyone using these type of asthma inhalers to read it in its entirety.
Related posts:
- A shot of adrenaline, for asthma?
- The controversy surrounding asthma and long acting beta agonists
- The inhaler switch
- Cheap asthma treatment using a homemade spacer
- Clearing the confusion on asthma medications, and why Advair and Symbicort are still safe
- Dying from cervical cancer, and the questions surrounding Jade Goody
- Web 2.0 and asthma management
{ 16 comments }
Kevin, I blogged about this back in May of 2008.
Patient’s perception that the new inhalers don’t work as well is real. Given that studies done seem to indicate they are just as good, it is likely because the “blast” provided by the new inhalers is less forcefull. In reality, this actually may make them better, because the faster the medication comes out, the more likely it is to end up in the back of your throat as opposed to your lungs. It is important for physicians to be aware of this issue and educate their patients.
The other huge issue is co-pays. Each insurance company has a different policy on which of the 4 rescue mediations has the lowest co-pay. Unless your doctor has an electronic medical record with up to date formulary status like we do, there’s almost no way of knowing which inhaler is most affordable. Even worse, retail pharmacies have incentive for certain inhalers over others. If the physician just writes “abuterol MDI”, the pharmacy can dispense three of the 4 available products. Even though one of these inhalers may be substantially less for the patient, the pharmacy is not obligated to look this up and makes a profit on which inhaler is best for them.
If you are a patient that uses a rescue medication, you need to know which medications are at the lowest co-pay on your insurance.
Finally, if you are and asthmatic and uses more than two rescue inhalers a year, your asthma is not under good control and you need to see your doctor to address your daily medications.
I’m a klutz who has always used aerosol MDIs with a spacer. Non-aerosol types like Maxair Autohaler and Advair were easier for me.
Maybe the “not as strong” complaints come from frequent puffers who don’t use spacers – HFA isn’t as forceful as CFC (my observation while priming a Ventolin HFA out of curiosity.) Maybe they don’t get shaky after a couple puffs. Dr Mintz is on target – using that much albuterol (or Maxair in my case)is a lazy, cheap solution.
My PBM copay for Proair HFA or Ventolin HFA is $5, same as generic albuterol HFA would be. I’m inclined to think the US pharmaceutical lobby paid off the generic manufacturers they don’t yet own (like Teva) to keep generic albuterol HFA off the market. I’ve heard rumors of generic Serevent, Flovent, and Advair coming soon, although you can get these outside the US now.
You WONDER if the pharamceutical industry had something to do with the forced transition?
There is no significnt envirionmental impact from the old inhalers. Cost is a huge issue for people who HAVE to have the medication., but cost is the whole point of the transition.
This isn’t some quality of life fun-drug. Cheap delivery mechanisms ought to be available until the patents run out.
Dr. Kevin- this version deletes the “brainwashed MDs” phrase- substitute it for the first one, please.
Thanks,
Arthur Abramson
The new HFA inhalers AREN’T as strong as CFC albuterol. According to GlaxoWellcome’s (now GlaxoSmithKline) New Drug Application to the FDA for Ventolin HFA:
•”In the multiple dose adolescent and adult studies, albuterol HFA showed a numerically smaller improvement in FEV1 (forced expiratory volume in 1 second) than was seen with albuterol CFC” (page 4)
•”We note that in the two 12 week clinical trials in adolescents and adults, Ventolin HFA Inhalation Aerosol consistently showed a smaller effect size than Ventolin CFC Inhalation Aerosol” (page 4)
•”There was other evidence that the HFA formulation delivers a lower/less effective dose on a per acutation basis than the CFC product. In the single dose, dose ranging study in adults, and in the single dose methacholine challenge study in adults one and two acutations of albuterol CFC were statistically indistinguishable in terms of effect, whereas significant differences were seen between one and two acutations of albuterol HFA. Finally, the combined adolescent/adult studies showed that the HFA formulation had a longer median time to onset of effect(4.2-9.6 minutes versus 3.6-4.2 minutes), had a shorter duration of effect(1.55-3.30 hours versus 2.29 – 3.69 hours), and was associated with more albuterol ‘back up’ use than the CFC formulation.” (page 3)
This is on the ‘Press Room’ page of our website at SaveCFCinhalers.org
In addition, many patients can’t tolerate the inactive ingredients (such as ethanol, which causes bronchoconstriction in many patients, corn residue in the ethanol, and the HFA-134a propellant itself- which was never tested by itself on asthmatics- only on normal patients- who don’t have inflamed, hyperreactive airways and serious allergies.
We have substantial peer-reviewed clinical data on the Press Room page of our website showing the much greater danger of HFA MDIs vs. CFC MDIs, including THREE YEARS OF FDA MEDWATCH DATA.
Patients are also probably reacting to the unique impurities of HFA MDIs (such as the extractables and leachables). These HFA MDIs were only tested on small numbers of mild/moderate asthmatics- large-scale, real world studies on ALL types of patients were never done in the US until NOW- which is why these problems are now coming to light.
To get the FACTS- read the ‘Press Room’ page and the ‘HFA MDIs: Poorly Tested’ page at SaveCFCinhalers.org Also read the ‘Doctors Speak Out’ page to hear from some MDs who KNOW that HFA MDIs are NOT as safe and effective as CFC MDIs for all patients (they do exist- many of them are patients themselves).
Arthur Abramson
The National Campaign to save CFC Asthma Inhalers
CORRECTION- SHOULD READ:
In addition, many patients can’t tolerate the inactive ingredients (such as ethanol, which causes bronchoconstriction in many patients, corn residue in the ethanol, and the HFA-134a propellant itself- which was never tested by itself on asthmatics- only on normal SUBJECTS (NOT patients)- who don’t have inflamed, hyperreactive airways and serious allergies.
Thanks,
Arthur Abramson
The National Campaign to Save CFC Asthma Inhalers
SaveCFCinhalers.org
I was a late adopter of the HFA inhalers since I’m a very infrequent rescue inhaler user, which may have influenced my experience. Still, I was very impressed with my primary care doctor’s manner in handling the transition. He explained the differences from the CFC inhalers (both official differences and thinks like “my patients tell me that priming it for a couple puffs before using it is really critical”), and let me know that some patients had shown preferences among the available inhalers. He also briefly reviewed inhaler usage and maintenance.
@Dr. Mintz: I have you beat. Kevin, I blogged this over two years ago, back in February 2007.
Comments made then indicated that people would have to die before someone paid attention. I don’t disagree.
Some folks are having some major problems with the new HFA inhalers.
The most compelling story is at consumer affairs:
http://www.consumeraffairs.com/news04/2009/02/asthma_hfa02.html
Read the thousands of complaints at this petition:
http://www.ipetitions.com/petition/saveCFCinhalers/signatures.html
More complaints:
https://www.savecfcinhalers.org/Guestbook.php
http://www.askapatient.com/viewrating.asp?drug=20503&name=PROVENTIL-HFA
http://www.opednews.com/populum/diarypage.php?did=11627
If you are unhappy with the new HFA inhalers, kindly sign the petition to save CFC inhalers.
http://www.savecfcinhalers.org
Also worth mentioning from the FDA website is the following:
http://www.fda.gov/cder/foi/nda/2001/20-983_Ventolin-HFA_medr_P1.pdf
These quotes taken directly from the new drug application for Ventolin HFA.
“In the multiple dose adolescent and adult studies, albuterol HFA showed a numerically smaller improvement in FEV1 than was seen with albuterol CFC”
“There was other evidence that the HFA formulation delivers a lower/less effective dose on a per acutation basis than the CFC product. In the single dose, dose ranging study in adults, and in the single dose methacholine challenge study in adults one and two acutations of albuterol CFC were statistically indistinguishable in terms of effect, whereas significant differences were seen between one and two acutations of albuterol HFA. Finally, the combined adolescent/adult studies showed that the HFA formulation had a longer median time to onset of effect(4.2-9.6 minutes versus 3.6-4.2 minutes), had a shorter duration of effect(1.55-3.30 hours versus 2.29 – 3.69 hours), and was associated with more albuterol ‘back up’ use than the CFC formulation.”
“We note that in the two 12 week clinical trials in adolescents and adults, Ventolin HFA Inhalation Aerosol consistently showed a smaller effect size than Ventolin CFC Inhalation Aerosol”
“Because it is expected that many physicians will prescribe Ventolin HFA Inhalation Aerosol for patients who have previously used the CFC formulation, it would be appropriate to include some description of the relative effectiveness of these two formulations in the product label.”
“Unfavorable changes in physical examinations were observed in the ears, nose, and throat category as follows: 8% placebo HFA; 13% albuterol HFA; and 5% albuterol CFC.”
I have to say, I’m relieved to read that the new inhalers are less effective. The last time I used my inhaler (during a respiratory infection) I wondered if the return of symptoms so quickly was a sign that my lungs were somehow getting worse. I was concerned that I would start finding myself hospitalized due to minor respiratory infections within a few years rather than many decades from now. Not a fun thought for a healthy active person who usually doesn’t even have to think about asthma.
This will end up costing me and my insurance more money. At least now I know that it probably isn’t because my lungs are falling apart.
Interesting that the decreased efficacy is being blamed in part on a weaker plume. How then, again, do spacers help? Albuterol is not passively “blasted” into the lungs, it’s actively inhaled.
This is not a huge pharmaceutical conspiracy and yes, it does require some education and adjustment on the part of prescribers and patients. As a pharmacist, I'm continually in the middle of this, providing explanations & education.
First – educate yourself!! The switch of CFC to HFA inhalers was done secondary the The Montreal Protocol which was signed by 50 industrialized countries in 1987 & amended several times since.
The Montreal Protocol dealt with all substances which depletes the ozone layer: halons, carbon tetrachloride, methyl chloroform, methyl bromide and othes. There were 2 timelines, one for developed countries and the other for developing countries. There were some specific exceptions to the timeline – albuterol being one of them.
At the time, it was deemed to be of such medical necessity, particularly in developing and underdeveloped countries and it was so inexpensive (due to it being out of patent for so long) that it would affect the health of patients. In addition, drug approval in most developed countries takes significant amount of time. Even though the drug is the same, the delivery is different so it requires an NDA – new drug approval.
Within 3 years of the albuterol exception was to run out – about the time it takes for an NDA to get approved – all manufacturers left the albuterol business with the exception of Schering-Plough (Proventil HFA), GSK (Ventolin HFA), and Teva (ProAir). It is expensive to process an NDA, particularly when the drug is so cheap. They all have patents now (not on the drug, on their delivery systems), so those will last 17 years from patent approval, so we have about 12 years left.
In December of 2007, all pharmacists and prescribers (you probably threw that letter out) were warned that manufactur of CFC albuterol inhalers would be discontinued and their sale would be prohibited in December of 2008. During those two years, we had significant shortages because manufacturers chose to leave the market.
Now, we have 3 manufacturers of albuterol HFA (not 4 as the poster above mentioned). We also have Xopenex HFA (levalbuterol – the R-enantiomer of albuterol). All manufacturers provide discount cards which are available to physicians, pharmacists and patients by going online. The pharmacist does not make anymore money off one product or another. The patients insurance company determines which one will be on their formulary. If the pt is paying out of pocket, the ProAir is less expensive if no manufacturer coupons are involved.
Although you and others find this to be a huge conspiracy, its not. Its part of a larger multinational agreement to improve the health of the world. You may have moaned when you lost your spray on Right Guard and had to change to roll on or you may have grumped when you no longer could buy your VO5 hair spray and had to change to a pump spray. You may feel that none of this including the inhalers makes a significant difference – particularly when you read the list of chemicals and their uses – in airline manufacturer, gasoline, laboratories – the list is huge.
But, a worldwide consensus feels otherwise. Since we are part of the world ecology and economy (other countries have phased in the HFA inhalers faster than we have) we must go along with an agreement which was signed 20 years ago.
Complain if you wish – thats alwasy a choice, although unproductive.
However, you might want to educate yourself a bit more. Read up on the Montreal Protocol. Learn about the HFA inhalers (they must be primed and cleaned more frequently). They also work much much better with a spacer – difficult for athletes, but everything is workable.
This is not about “education”. This is about what works best as a life saving medication for people that desperately need it. Perhaps it would be best for the powers that be to educate themselves and admit that they have made a massive mistake. Did you read the info straight from Glaxo about Ventolin HFA? It’s plain and simple. HFA is not as safe and it is also not as effective. Let me post again:
“In the multiple dose adolescent and adult studies, albuterol HFA showed a numerically smaller improvement in FEV1 than was seen with albuterol CFC“
“There was other evidence that the HFA formulation delivers a lower/less effective dose on a per acutation basis than the CFC product. In the single dose, dose ranging study in adults, and in the single dose methacholine challenge study in adults one and two acutations of albuterol CFC were statistically indistinguishable in terms of effect, whereas significant differences were seen between one and two acutations of albuterol HFA. Finally, the combined adolescent/adult studies showed that the HFA formulation had a longer median time to onset of effect(4.2-9.6 minutes versus 3.6-4.2 minutes), had a shorter duration of effect(1.55-3.30 hours versus 2.29 – 3.69 hours), and was associated with more albuterol ‘back up’ use than the CFC formulation.”
“We note that in the two 12 week clinical trials in adolescents and adults, Ventolin HFA Inhalation Aerosol consistently showed a smaller effect size than Ventolin CFC Inhalation Aerosol”
“Because it is expected that many physicians will prescribe Ventolin HFA Inhalation Aerosol for patients who have previously used the CFC formulation, it would be appropriate to include some description of the relative effectiveness of these two formulations in the product label.”
“Unfavorable changes in physical examinations were observed in the ears, nose, and throat category as follows: 8% placebo HFA; 13% albuterol HFA; and 5% albuterol CFC.”
What is so difficult about that to understand? Is your position that, yes these new formulations are less safe and less effective but pulmonary patients must learn to deal with it and/or possibly die because of the political will of a few?
Asthma Patients Outraged at Indifference to Problems with New Inhalers:
http://www.consumeraffairs.com/news04/2009/02/asthma_hfa02.html
Olympian Jackie Joyner-Kersee: FDA “Insensitive” to Asthma Patients’ Problems:
http://www.consumeraffairs.com/news04/2009/03/asthma_hfa04.html
The number of patient complaints is skyrocketing:
http://www.consumeraffairs.com/health/hfa_inhalers.html
Read the thousands of complaints at this petition:
http://www.ipetitions.com/petition/saveCFCinhalers/signatures.html
Patients at askapatient.com are reporting HFA inhalers as “useless” with a rating of 1.2 on
a scale of 1 to 5 with 5 being the best and 1 being the worst:
http://www.askapatient.com/viewrating.asp?drug=20503&name=PROVENTIL-HFA
To fellow Anonymous 6:41 – yes, i've read all the studies on HFA albuterol & yes, when compared head to head, the HFA "delivers" less drug than the CFC. This is due to the difference in propellant – the delivery system.
I could compare kinetic profiles of the same drug via different delivery systems & see the same end results. This is why you seek out a physician to prescribe and a pharmacist to dispense. If you weere to read about any drug on the internet, you might find information which is old and outdated. Physicians have been informed of this since 2007. Pharmacists have been informed of this since 2003 since many of our topical products used to be CFC propellant driven. In fact, some inhalants previously contained CFC & were switched to HFAs without issue (Atrovent is a good example). Since this was still under patent, no one noticed nor complained – particularly since we educated our patients on the switch.
However, this is where education comes in. A prescriber will not give the same dosing instructions to a patient receiving metoprolol vs metoprolol extended release or even albuterol inhaler vs albuterol liquid.
But, if the patient is not receiving the same therapeutic endpoint the prescriber wants, there are alternatives availabe – use a spacer for more adequate delivery, increase the dose (which drives up side effects) or switch to Xopenex which is the active R-enantiomer that is actually doing the work of the racemic mixture which is albuterol.
I still hold – education is the key. Additionally, this is not the result of the political actions of a "few". This was a world-wide consensus. Somehow most countries have adapated. I'm confident we will too.
To TEN OUT OF TEN, you are correct. Albuterol is actively inhaled, and spacers may be effective for SOME patients who are unable to deeply inhale the weaker HFA plume.
However, TEN, spacers will NOT help patients who are allergic to or intolerant of the INACTIVE INGREDIENTS of the formulation (i.e., the HFA-134a propellant itself, the ethanol, the corn residue in the ethanol, or any of the DOZENS of other NEW inactive ingredients in HFA inhalers that most doctors and pharmacists are unaware of) or the UNIQUE NEW IMPURITIES of the HFA formulations (including, but not limited to, the various extractables and leachables that form as a result of the new ingredients, elastomers, coatings, oils, etc.)
ANONYMOUS #2, it’s a shame that you don’t have the courage to identify yourself, since you pose as an expert pharmacist, but I understand your reason for hiding behind your anonymity. YOU ARE THE ONE WHO NEEDS TO BE EDUCATED.
IPAC orchestrated the ban of CFC MDIs. They saw the unprecedented opportunity to reformulate old drugs in an ‘ozone-friendly’ propellant and began to exploit this opportunity one year after the Montreal Protocol was convened. (For all of the technical difficulties involved in the HFA reformulation efforts, this was still a MUCH EASIER, LESS EXPENSIVE WAY to win NEW PATENTS, as opposed to designing new drugs from scratch).
NOW they are going to try to do the same thing AGAIN in Copenhagen this December, because, as it turns out, HFAs are much worse GLOBAL WARMERS than CFCs ever were, and so now HFA MDIs will need to be eventually replaced (according to ‘The Masters of the Universe’- see our website) with a NEW propellant currently under development by IPAC, that will be ready just about when the HFA MDI patents run out. But of course, professor, there was (and is) no IPAC conspiracy to exploit this junk science as a way to get new drug patents on old drugs.
Not incidentally, professor, there was NO NEED for CFC MDIs to be banned in the first place- they do NOT harm the ozone layer, increase ground UV-B radiation (there has never BEEN any increased UV-B ground radiation detected, according to the World Meteorological Organization’s 2006 Ozone Assessment) and of course, they do not increase skin cancer rates.
EXTREMIST, RADICAL ENVIRONMENTALISTS such as GORE/BROWNER ADMITTED that CFC MDIs were banned SOLEY FOR POLITICAL EXPEDIENCY and happily greased the skids for IPAC (by forcing through Decision IX/19 Part 5 at the 9th Meeting of the Parties in 1997), and asthma and pulmonary patients have paid for this scam with their LIVES AND HEALTH.
We have complaints from all over the world. Other countries may have “adapted”, professor, but MANY OF THEIR PATIENTS HAVE NOT “ADAPTED” AND NEVER WILL. And we DO get Advair HFA and QVAR HFA complaints from patients. It is not just the rescue inhalers that are causing problems for many patients (and we do recognize that many patients seem to have no problems with HFA formulations.)
The other problem you have, professor, and you share this problem with many MDs and pharmacists- is that you are unaware (or you pretend to be unaware) of the major problems with drug company-sponsored clinical trials, and as a result, you put too much faith in the “The Literature” (all bow), and too little faith in what your patients are telling you- or even in what the RESULTS of said “Literature” clearly indicate.
Specifically, it has been well documented that clinical trials paid for by drug companies are FIVE TIMES MORE LIKELY to draw favorable conclusions about a new drug’s safety/efficacy compared to studies that are NOT paid for by drug companies. WHY IS THAT, PROFESSOR?
Even worse, it is VERY COMMON to find that these favorable CONCLUSIONS are often DIRECTLY CONTRADICTED by the reported RESULTS in these studies, but many doctors are either too busy to read the papers, so they just read the conclusions, or, they are too BRAINWASHED too grasp these GLARING contradictions, which is why we post these studies on our site.
THERE IS MASSIVE CLINICAL TRIAL DATA THAT PROVES THAT HFA MDIs ARE MUCH MORE DANGEROUS AND MUCH LESS EFFECTIVE THAN CFC MDIs.
Schering-Plough and GlaxoSmithKline THEMSELVES admit this.
TO GET THE FACTS, go to http://www.saveCFCinhalers.org and read the ‘Press Room’ page and the ‘HFA MDIs:Poorly Tested’ page.
Professor- YOU need to read the ‘IPAC’ page (quoted verbatim from a PR text as a brilliant PR case study- you’ll need to read between the lines, professor, but you’ll get the point) to see how the IPAC PR campaign to ban CFC MDIs made the planning for the invasion of Normandy on D-Day look like child’s play.
To my fellow patients, don’t lose hope. EVERY DAY, more and more REAL DOCTORS see through the lies they’ve been fed for years by the FDA, IPAC, and the ‘Gang of Nine’ (aka the U.S. Stakeholders Group on MDI Transition, all of whom were HEAVILY FUNDED by IPAC, to help pave the way for THE GREATEST BETRAYAL OF PATIENTS IN U.S. HISTORY). Some of them are quoted on our ‘Doctors Speak Out’ page- more will soon be posted. THE TIDE IS TURNING.
There ARE good doctors out there who KNOW about the drug company-sponsored lies and half-truths routinely published with dishonest conclusions in the glitzy sales/advertising pieces referred to as ‘peer-reviewed clinical trials’. If your doctor denies these IRREFUTABLE FACTS, or if he puts more faith in what these misleading ’studies’ CONCLUDE as opposed to the RESULTS they report, or the problems that thousands of patients experience, GET ANOTHER DOCTOR, before he or she automatically assumes that your underlying disease has gotten worse (since they KNOW for a FACT that the HFA MDI ITSELF can’t POSSIBLY be what’s making you sick; after all, ‘The Literature’ says so) and ’steps you up’ to potentially more dangerous drugs.
Arthur Abramson
The National Campaign to Save CFC Asthma Inhalers
http://www.SaveCFCinhalers.org
CORRECTION: should read:
“And we DO get serious Atrovent (not Advair) HFA and QVAR HFA complaints from patients. We have also received serious Pulmicort HFA complaints in the past, although I don’t think that’s sold here anymore.
“Many patients stop complaining when they see the U.S. and international political forces aligned against them, and they are overwhelmed by the constant barrage of FDA lies and half-truths, so they suffer and die quietly. You are confusing this with patient “adaptation”, professor. I will be posting a lengthy email from an obviously well-educated patient from Russia this weekend (we have several patients from Russia), which more clearly explains this concept of “adaptation”.
To be clear, many patients seem do to well with HFA MDIs, and others can apparently be helped with better inhaler technique, cleaning, or the use of spacers. But some patients ARE ALLERGIC TO/INTOLERANT OF either the inactive ingredients or the impurities of HFA MDIs, and these problems are only now starting to come to light because HFA MDIs NEVER UNDERWENT REAL WORLD U.S. POSTMARKETING STUDIES, thanks to the high-pressure tactics of IPAC, the EPA, and THE GANG OF NINE.
Arthur Abramson
The National Campaign to Save CFC Asthma Inhalers
http://www.SaveCFCinhalers.org
Hello Pharmacist,
It looks like your train of thought is getting some more bad press:
Ozone-friendly inhalers could face early demise
http://www.journalgazette.net/article/20090330/BIZ/303309942/1031/BIZ
Benefits vague, problems clear in inhaler ban
http://www.journalgazette.net/article/20090330/BIZ/303309941
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