Monday, September 26, 2011

More Tales From the Over Regulated State - A Series

Wherein tonight's episode can be called, "I hope you don't have asthma". 

I do.  Relatively mild - my main symptom is a tendency to get chest congestion - but I know asthma can be a killer.  Every year, about 5000 people die of asthma, and that number is growing despite the improved long range treatments.  There are two main treatment approaches for asthma symptoms: a fast-acting "rescue inhaler", and daily administered corticosteroids, which help reduce the need for the rescue inhaler.   Most of these are administered by an inhaler, as well.  The "gold standard" propellant for those inhalers has been freon: a light, extremely inert propellant. 

Enter the EPA and the Montreal protocol, a treaty to reduce the use of so-called ozone damaging chlorofluorocarbons, or CFCs, like freon.  Although medical uses were not specifically banned in the treaty, the FDA decided to ban CFCs in those asthma inhalers.  In the place of freon, HFA, hydrofluoroalkane is used - but some inhalers included small amounts of ethanol (the kind of alcohol we drink).
“Whereas the direct contact of ethanol with the bronchial mucous caused bronchospasm, the consumption of alcohol had never caused the patient’s asthma to worsen. Various effects on the bronchial tone after the ingestion of ethanol have been documented and approximately 30% of asthmatics report an exacerbation in their symptoms (5). In an animal model, it has been shown that ethanol can trigger bronchoconstriction through TRPV1 (transient receptor potential vanilloid-1) activation of the airway sensory neurons in the brochi (6). Our findings suggest that bronchospasm is caused by ethanol-induced TRPV1 activation [in humans].” (Bronchospasm induced by inhalant corticosteroids: the role of ethanol).

This was big news in 2008, (at least among asthma patients_ and I sent some money to a group that was trying to stop the removal of CFCs from prescription inhalers.  The problem was that side effects from the new propellants were far more common, and people died because of their "rescue inhaler"!  While the chart shown on this page shows that HFA inhalers held about 1/3 of the market, almost 1/2 of the asthma deaths were HFA users.  This could be statistical noise and it could be a warning shot. 

The "Doctors Speak Out" page I just linked to is full of comments by physicians and respiratory therapists saying that the new inhalers are not working.  This one is representative:
“My daughter has stopped using HFA albuterol inhalers because she ended up in the ER several times (always at 3 am) after they exacerbated the problem. My daughter and I have tried all four HFA inhalers (we cleaned them every day) and we think they are dreadful! They are not effective at all. They make the asthma problem worse. Right now we are using CFC albuterol inhalers from India, and my daughter will be forced to use her nebulizer for emergency relief when these run out.”  Robin Levinson, MD, Hematologist, Florida, by email, July 20, 2009
You might think that patient care and improved outcomes would be the most important aspect in a medication - and I'm sure that's what every doctor I've ever known is interested in - but then you would not have been a good observer of the FDA, whose regulations are all written in the blood of those they didn't protect until it was too late.  Or a good observer of an environmental movement who thinks the world needs about 95% fewer people. 

This all took place in 2008, so why is it a topic tonight?  There is one remaining over the counter treatment for asthma, Primatene Mist, and it is being banned from the market because it has retained its CFC propellant.  The FDA has told them to be off the market by January 1.  Primatene is epinephrine - adrenaline - and is very safe and effective.  Perhaps 2 million people have a Primatene inhaler in their home, their purse, or other place where it's always at hand.  As Twitter user @jimgeraghty said
Think of how much smaller the U.S. carbon footprint will be without all of those asthma sufferers around.
So people who get relief from a Primatene inhaler will, at least temporarily, not be able to get an over the counter inhaler (in this press release, they say they're working on an HFA version).  Their cost will go up from about $20 to perhaps $60.  And until an OTC asthma inhaler is available again, they'll need to see their doctor to get a prescription, and probably go back once a year for a follow up. 

Will they be able to get a product onto market soon enough? Don't hold your breath.  In the mean time get some spares.  Hoard.  And if you don't have asthma, you might consider getting one or two.  Epinephrine is also therapy for bee stings and other severe allergic reactions. 

4 comments:

Tango Juliet said...

The Earth is more important than people. Junk science says so.

LeverAction said...

The other aspect of this change (and I remember when it happened because my wife and several of my children use them) was new patents on the "new" inhalers - which meant no generics - that drove prices through the roof. What used to be a $10 inhaler all of a sudden cost $40 or more. I'm pretty sure that a lot of the reason for the change was because the drug companies saw a way to squeeze new profits out of old products. Typical crony capitalism - using foolish, imbecile ideologues in the .gov to force new markets. I don't know who to be more disgusted with, the drug companies or the FDA.

Graybeard said...

There's a rumor that the reason for outlawing freon as propellant is that the patents on freon expired, while HFA is still under patent. That patent is said to be why HFA inhalers are so much more expensive. It has been rumored that the freon industry was behind Montreal, so that they could get more money for new refrigerants and propellants.

Me, I don't know.

Reg T said...

Many years ago (early seventies) I worked in an ER in Connecticut. When I had asthma issues - especially bronchospasm in the winter - the head ER doc would give me an epi injection (to keep from sending me home, I think ;-) It worked pretty well. Perhaps folks who want some back-up until this is sorted out (if it ever is) might want to see about getting a 'script from their doctor, the way people allergic to bee stings do. I don't know if the Epi-pens would be the correct dosage or not, but your doctor should.

For those who prep, it used to be legal to buy epinephrine from vet supply companies without a 'script (although it looks like you need an RX now). I did when I had draft horses and other livestock. A supply of epi and some syringes from a pharmacy or vet supply company would be a good thing to have on hand. Perhaps you can still get epinephrine from an overseas pharmacy, like you can get some other meds?