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I'm paying for your ozone. You're welcome!

Nov 29, 2012#1

strawman

tldr: Green air act raised the cost of asthma inhalers by 1,200%.

Prescription asthma inhalers had cheap generic brands available for over a decade, but they used CFCs, which have been banned by the clean air act. They were allowed to continue to be sold with CFCs as an essential medical need until someone came out with an alternative.

A drug company released a CFC free inhaler in 2004, leading to the complete ban of CFCs in albuteral based asthma inhalers as of 2008. Due to the FDA testing process, even though the active drug is the same, the whole thing is still protected under patent and by the FDA as though it were a completely new drug, meanwhile all the generics were taken off the market since there is now a CFC free alternative.

So green air legislation is costing me to the tune of $60 inhalers for each refill rather than the old $5 per refill inhalers, and this will persist until all the applicable patents run out, and the competitors start producing a sufficient supply of CFC free generics. It's also lining the pockets of the pharmaceutical company that happens to have been first to push their product through FDA testing. The patents ran out in 2009, but three years later there are still only two companies producing it, they are not doing so in a competitive manner, and it still costs $60 per inhaler.

While my insurance doesn't cover it, many insurances do cover some of this cost, which means this is one of the many reasons your premiums have gone up in the last decade. You also no longer have to wonder why untreated asthma is so prevalent among the poor - even if they can use a free clinic no one's going to pay for the medicine.

Approximately 250,000 people die prematurely each year from asthma (3,300 in the US alone). Almost all of these deaths are avoidable. I'm not saying this to suggest that these deaths are due to the increased cost of the medication, but to assert that this is not a minor disease (1 in 9 have it generally, some minority populations are 1 in 6) and access to this medication can prevent many of these deaths.

Yay for the ozone though - that's a pretty big win right there.

Nov 29, 2012#2

MindDetective

Well, it seems like multiple parties might have had an incentive to ban the old CFC inhalers then. Who instigated the ban? The environmental folks or the drug companies?

Nov 29, 2012#3

strawman

This was a big deal in the 80's and early 90's when everyone started phasing CFCs out of hair spray, refrigeration systems, etc. Definitely environmental - the pharmacy companies probably didn't participate in the debate back then- and if they did it was probably to argue to allow them to continue to use CFCs so they didn't have to do human trials of the drugs all over again since they still held the patents.

Check out http://www.epa.gov/ozone/science/sc_fact.html for detail, but here are a few snippets:

The ozone layer absorbs a portion of the radiation from the sun, preventing it from reaching the planet's surface. Most importantly, it absorbs the portion of ultraviolet light called UVB. UVB has been linked to many harmful effects, including various types of skin cancer, cataracts, and harm to some crops, certain materials, and some forms of marine life.

...

For over 50 years, chlorofluorocarbons (CFCs) were thought of as miracle substances. They are stable, nonflammable, low in toxicity, and inexpensive to produce. Over time, CFCs found uses as refrigerants, solvents, foam blowing agents, and in other smaller applications. Other chlorine-containing compounds include methyl chloroform, a solvent, and carbon tetrachloride, an industrial chemical. Halons, extremely effective fire extinguishing agents, and methyl bromide, an effective produce and soil fumigant, contain bromine. All of these compounds have atmospheric lifetimes long enough to allow them to be transported by winds into the stratosphere. Because they release chlorine or bromine when they break down, they damage the protective ozone layer.

...

...numerous experiments have shown that CFCs and other widely-used chemicals produce roughly 84% of the chlorine in the stratosphere, while natural sources contribute only 16%.

...

The initial concern about the ozone layer in the 1970s led to a ban on the use of CFCs as aerosol propellants in several countries, including the U.S. However, production of CFCs and other ozone-depleting substances grew rapidly afterward as new uses were discovered.

Through the 1980s, other uses expanded and the world's nations became increasingly concerned that these chemicals would further harm the ozone layer. In 1985, the Vienna Convention was adopted to formalize international cooperation on this issue. Additional efforts resulted in the signing of the Montreal Protocol in 1987. The original protocol would have reduced the production of CFCs by half by 1998.

After the original Protocol was signed, new measurements showed worse damage to the ozone layer than was originally expected. In 1992, reacting to the latest scientific assessment of the ozone layer, the Parties to the Protocol decided to completely end production of halons by the beginning of 1994 and of CFCs by the beginning of 1996 in developed countries. More information on the phaseout of ozone depleting substances is found here.

Because of measures taken under the Montreal Protocol, emissions of ozone-depleting substances are already falling. Levels of total inorganic chlorine in the stratosphere peaked in 1997 and 1998. The good news is that the natural ozone production process will heal the ozone layer in about 50 years. More information on the current state of the ozone layer is found here.

So CFCs and other ozone depleting substances are causing a significant problem, and it's right to phase them out, but the asthma inhalers have mere grams of propellant per refill, and they should have allowed them to continue to have the CFC based generics for 10 years after the release of the brand name cfc-free versions.

Nov 29, 2012#4

MindDetective

I know all of that. I'm talking about the push to phase them out in 2008. The movement to phase out CFCs from consumer products and the more recent banning are separated by almsot 20 years! It makes me think there is more to the story than a simple continuation of a 20 year old movement.

Nov 29, 2012#5

Shakey

Yeah, this is stupid. You can't get any non-prescription inhalers anymore because of this too. I have a prescription, but it was nice to be able to grab these to keep in different places just in case. Just the other month I wanted to spend the night at the girlfriends place, but forgot my inhaler. I used to be able to just run to the grocery store and pick one of these up. I ended up just going home that night instead. It's an hour drive from my place to hers, so I didn't bother going back to my place and then going back to hers.

As useless as they are, there is an online petition. The title is specific to Primatene, but it's about repealing the CFC ban on inhalers.
https://www.change.org/petitions/environmental-protection-agency-bring-back-my-primatene-mist

Nov 29, 2012#6

strawman

MindDetective said:
I know all of that. I'm talking about the push to phase them out in 2008. The movement to phase out CFCs from consumer products and the more recent banning are separated by almsot 20 years! It makes me think there is more to the story than a simple continuation of a 20 year old movement.

The Montreal agreement allows for essential use cases to be petitioned by companies who can demonstrate their use of the CFC was necessary. The EPA and FDA work together to determine when CFC metered dose inhalers can be banned:

EPA coordinates with the United States Food and Drug Administration (FDA) to determine which CFC MDIs continue to be essential for public health as alternatives penetrate the market. In 2005, FDA removed the essential use designation for albuterol used in oral pressurized MDIs as of December 31, 2008. As of December 31, 2008, CFC-albuterol MDIs cannot be sold, distributed or offered for sale or distribution in interstate commerce pursuant to Section 610 of the Clean Air Act

There are actually three brand versions of CFC free albuteral inhalers now, and no generics. There are supposed to be programs intended to help out low income users to help offset the increase in cost. My doctor didn't bring this up (though I specifically asked whether she specified generic drugs or not), perhaps it's a more frequent topic of conversation in lower income areas.

CFC and ODS phaseout: http://www.epa.gov/ozone/title6/phaseout/index.html
Essential use exemptions: http://www.epa.gov/ozone/title6/exemptions/essential.html
Metered dose inhaler exemptions: http://www.epa.gov/ozone/title6/exemptions/inhalers.html

Nov 29, 2012#7

MindDetective

In 2005, FDA removed the essential use designation for albuterol used in oral pressurized MDIs as of December 31, 2008.

My question is why? Some person or committee of persons was involved in that decision. "EPA coordinates" is hardly descriptive of their input level. It also doesn't eliminate the possibility that other interested groups provided input either. Companies have requested FDA action in the past to implement bans: http://www.nytimes.com/2012/07/18/science/fda-bans-bpa-from-baby-bottles-and-sippy-cups.html?_r=0

Nov 29, 2012#8

strawman

It wouldn't surprise me if there was an amount of lobbying by the three producers of the newly approved cfc free inhalers suggesting that since there's at least three of them, they could no longer claim the cfc options were "essential."

But that's not something that is going to be easy to discover. In theory the generics should be coming online any year now, but it'll still take awhile to get down to the price the cfc versions were.[DOUBLEPOST=1354210877][/DOUBLEPOST]Ah, here's more detail on how they determined it:

Under 21 CFR 2.125, several criteria must be met for a listed product to be considered no longer essential. These criteria are the following:

Sufficient non-ODS alternatives are available with the same indications and approximate level of convenience;

There is adequate post-marketing data for the alternative products.

Supplies are adequate to meet the demand;

Patients who require the product are adequately served; and

HHS/FDA initiated notice and comment rulemaking in June of 2004 to allow public input into the determination. The agency received over 75 comments. After thoroughly reviewing and evaluating the comments received, and in consultation with other federal agencies, HHS/FDA has determined these conditions will be met by December 31, 2008, which will render the use of CFCs in albuterol MDIs no longer essential.

So it could have been objectively determined even if the drug companies didn't submit their own comments (which I'm sure they did).

Nov 29, 2012#9

Chad Sexington

I just came to say thanks for the ozone.

(But seriously that's not cool.)

Nov 29, 2012#10

GasBandit

I came in to make a numa numa joke.

Mai ya HEE... mai ya HOO... mai ya HAAA... mai ya HA-HA...

Nov 29, 2012#11

PatrThom

The current practice of patent-it-and-then-raise-the-price-obscenely is not limited to inhalers.

--Patrick
(I was trying to find a story I read about a company which was awarded a patent, sued to shut everyone else down, then raised the price several thousand percent, but I could not find it. So I offer the above linked story instead)

Nov 29, 2012#12

GasBandit

PatrThom said:
The current practice of patent-it-and-then-raise-the-price-obscenely is not limited to inhalers.

--Patrick
(I was trying to find a story I read about a company which was awarded a patent, sued to shut everyone else down, then raised the price several thousand percent, but I could not find it. So I offer the above linked story instead)

Apple V Samsung?

Nov 29, 2012#13

PatrThom

GasBandit said:
Apple V Samsung?

Neither Apple nor Samsung raised the price of their product(s) several thousand percent and basically told people "Either pay the new price for your life-saving meds or else die, we don't care about anything but your money" after securing their monopoly. That's something that seems to be confined to the pharmaceutical industry.

--Patrick

Nov 30, 2012#14

GasBandit

PatrThom said:
Neither Apple nor Samsung raised the price of their product(s) several thousand percent

and basically told people "Either pay the new price for your life-saving meds or else die,

Ok, life-saving, I'll grant you. Change it to life-eating, maybe.

we don't care about anything but your money"

after securing their monopoly.

Well, thankfully, they haven't come that far yet... but they're trying, hard. And they've made more progress than I can believe a sane judge would allow.

Nov 30, 2012#15

Bowielee

GasBandit said:
Well, thankfully, they haven't come that far yet... but they're trying, hard. And they've made more progress than I can believe a sane judge would allow.

How so? They're still not even close to the dominant computer company. The iPad/iPhone still have plenty of competitors out there. I'm not really seeing your point here.

Nov 30, 2012#16

GasBandit

Bowielee said:
How so? They're still not even close to the dominant computer company. The iPad/iPhone still have plenty of competitors out there. I'm not really seeing your point here.

They have a patent on rectangles with rounded corners.

A patent. On something being rectangular.

This is as stupid as having a patent on "a box with wires coming out of it."

And a judge upheld it.

That's asinine. Other things they think they own (exclusively): Pinch zooming, sliding to unlock, the screen "bouncing back" after scrolling to the end. Apple sued their way to an injunction against the galaxy tab 10.1's release in california.

Granted, the competition hasn't been put out of business, but this is already father than it should have been allowed to go, by far.

Nov 30, 2012#17

strawman

The patent system needs reform, sure, but what is available that doesn't trample on apple's patents is still amazing. If apple's products didn't exist, but we still had everything else everyone else came up with, we'd still be quite happy.

Even the stupid patents run out eventually, and for the most part companies license patents to each other so while apple may have patents on pinch to zoom, they allows others to use it because they also want to use Stupid Patent X that the other company came up with.

It's not ideal, but it's not so bad that competitors products are trash.

Nov 30, 2012#18

GasBandit

Yet.

Nov 30, 2012#19

strawman

GasBandit said:
Yet.

Pessimist.

Apple does not own the future, and there are a ton of exciting and intriguing ideas out there yet to be patented and implemented. Besides which, Apple has missed the boat a few times and had to play catch up when they realized the market wasn't obeying their commands - the ipad mini, for example, should have come out last year. Even now it's inferior to many other 7" tablets and apple has to rely more on marketing to push it into users hands than simply providing a toy people want and will buy.

Automotive manufacturers in the US used to never provide luxury options on the lower end vehicles. Buying a ford focus? You couldn't get a built in GPS or sync with it - you had to go to the pricier and larger vehicles for that.

But in Europe you can get these cheap tiny cars with all the bells and whistles.

When Kia and other competitors started offering cheaper cars with bells and whistles, the big three ignored it, assuming people who wanted the advanced electronics would rather have the bigger cars as well - they were wrong, and now you can get many, if not most, of the bells and whistles on the lower end vehicles for all the manufacturers.

Apple is selling luxury at a high price, but there's a huge gap they've force themselves into between the phones/ipods and the big tablets, and while they've pretended to fill that gap with a smaller version of the ipad two, they're finding that only apple adherents are biting. People who are locked into the system due to app store purchases or similar.

But the mini doesn't have the HD resolution of even the $160 Kindle fire - that's a year old. It's half as much, and is a better tablet, save for missing cameras, and a few other things.

So yes, the patents are stifling movement in many directions, but there are huge gaps that people are running through, and the patents aren't going to stop innovation in this area. Competition is still very strong, despite Google's many missteps with android.

Nov 30, 2012#20

PatrThom

TIL that GasBandit is not an Apple Fanboi.

--Patrick

Nov 30, 2012#21

GasBandit

TODAY you learned that?

Anyway, my first foray down this line of conversation was made with tongue in cheek, but once pushback developed over it.... you know I can't leave it alone.[DOUBLEPOST=1354302091][/DOUBLEPOST]

stienman said:
Pessimist.

Why thank you.

Nov 30, 2012#22

PatrThom

GasBandit said:
TODAY you learned that? Anyway, my first foray down this line of conversation was made with tongue in cheek, but once pushback developed over it..

Pushback? Neither vendor has ever raised their prices several thousand percent. If anything, Apple has gotten into more trouble by lowering their prices (IIvx, original iPhone). Dunno about Samsung.

--Patrick

Nov 30, 2012#23

strawman

PatrThom said:
Pushback?

We responded seriously to his joking:

GasBandit said:
Apple V Samsung?

So he ran with it, though it really wasn't something he actually cared about.

He just likes to argue.

A lot.

Nov 30, 2012#24

PatrThom

stienman said:
He just likes to argue.

A lot.

That's what I thought, but it looks like what he really likes to do is bicker.

--Patrick

Nov 30, 2012#25

GasBandit

PatrThom said:
That's what I thought, but it looks like what he really likes to do is bicker.

--Patrick

People, People! This is supposed to be a 'appy occasion! Let's not bicker and argue about who's arguing and who's bickering...

Nov 30, 2012#26

strawman

GasBandit said:
View attachment 9124

People, People! This is supposed to be a 'appy occasion! Let's not bicker and argue about who's arguing and who's bickering...

Bickering is just a form of arguing. So you can argue and bicker, and you can just argue, but you can't bicker without arguing.

Nov 30, 2012#27

GasBandit

Nov 30, 2012#28

strawman

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