Studies show that HFA inhalers are as effective as CFC inhalers and have the same rate of side effects. But if they are not used properly, patients will not get adequate doses. There are three critical differences.
HFA inhalers must be pumped four times to prime them -- a number that was not so critical with the more forgiving CFC inhalers, said Dr. Leslie Hendeles, professor of pharmacy and pediatrics at the University of Florida. And each brand of the newer inhaler requires a different frequency of priming.
HFA inhalers have a weaker spray. "It's very soft so people think it's not working," Dr. Stoloff said. Where CFC inhalers deliver a powerful force that feels as if the airway is being pushed open, the newer ones provide a warm, soft mist that also has a distinct taste.
They also require a slower inhale. "You have to take a nice slow, deep breath and hold it," Ms. Sander said. If people worry that it's not working, they may not take the second puff, may fail to wait the necessary 30 seconds between puffs or may take too many puffs. ,And their anxiety may rise, further constricting their airways.
I invite anyone in the audience to take a "nice slow, deep breath and hold it" with a severely constricted airway. Every pulmonary patient I know is reporting the same, completely effing obvious problem: we use these inhalers for emergency relief, when we can't take a slow, deep breath. If we could take a slow, deep breath, we wouldn't need to use our rescue inhalers. And since my rescue inhaler no longer works very well, I may have to go on steroids, with all the fun, fun attendant side effects, for better control.
As a side note, that "distinct taste" made me gag the first time I used my inhaler, which of course makes patients reluctant to turn to their rescue inhalers until they really have to.
It would be one thing if this was necessary to save the ozone. But it's just mindless bureaucratic indifference. The amount of CFCs used for all pulmonary uses peaked at 1% of total peak industrial output in 1999. They were not the culprit behind the hole in the ozone layer. And testing these things on only mild-to-moderate asthmatics for short periods of time, which is all the FDA did before phasing them out, seems borderline criminal.
Finally, saying that the inhalers are just the same except that they require perfect technique is saying that the inhalers are not just the same. In the real world, it's hard to get perfect technique. So substituting an inhaler that requires really very extensive maintenance (it needs to be washed every 3-4 uses, primed if it hasn't been used in a while, and the asthmatic needs to master a fairly complex breathing pattern at a time when, I promise you, you do well just to breathe at all) is the kind of thing that only a non-asthmatic would think was a good trade. Again, if this has to be done to save the ozone layer, fine. But I don't see that it did; I see that we did something stupid and costly to sick people for no good reason.
Update: That was intemperate. But though I regret losing my temper, the point stands. You see this attitude in IT people a lot. There's an acronym for it: PEBKAC (Problem Exists Between Keyboard and Chair), aka an ID10T error. Some of that is fair--I had a very senior executive once tell me that his voice recognition software was malfunctioning because what he'd expected (from a $65 software package) was something much more like the computer on Star Trek: The Next Generation. But it's also a way that developers dismiss crappy UI design. If most of your users have a problem, then it's the software, not the users, at fault.
Similarly, a medical routine that is hard to comply with is a bad routine. Sometimes there's no alternative--what CF patients go through I wouldn't wish on my worst enemy, but that's the only way we know to keep them alive. On the other hand, you don't decide not to give users blood pressure meds because running 10 miles a day would be just as good. A medicine that is easy to use is not the same as a medicine that theoretically gets the same results only if used perfectly every time.
Finally, I think it's worth pointing out what I said yesterday about comparative effectiveness research. I have been repeatedly blythely assured that the FDA "proved" that the medicines are equivalent. But a cursory look at the study shows that they were mostly short, small, and covered only mild-to-moderate asthmatics, which seems guaranteed to put the comparison in the best possible light. Once the FDA had given them the seal of approval, however, they became somehow infallible.
I know that everyone who is assuring me that the new inhalers work just fine does not have respiratory disease. Do you know how I know this?
You don't. This is why it's important to not mistake your own experience for some sort of general "truth.
Touche. Now would you like to concede that yours might not be either? The fact that you're having no trouble using your inhaler, and that a small sample of mild asthma patients studied for 6-8 weeks under intensive conditions did not meet statistical significance on adverse outcomes, doesn't mean that we're all bloody imagining it.
I know that everyone who is assuring me that the new inhalers work just fine does not have respiratory disease. Do you know how I know this?
_______
I had severe pulmonary disease caused by Cystic Fibrosis. Before I received a lung transplant I was using an HFA proventil inhaler in addition to a long acting inhaler and I didn't notice a difference when I switched from the old CFC inhalers. It's possible to use proper technique even when you are only breathing in less than 30% of the air that you are supposed to breathe in.
Possible, sure. But the thing about mass-market items for use in circumstances notable for distraction is, they tend not to be used perfectly anywhere near 100% of the time. It's just like how condoms have 5-10x the failure rates in real life as they do when used perfectly under ideal circumstances. Yeah, some people will use a fancy complicated inhaler properly even in the heat of the moment. Problem is, some people won't, and it's not just a few of them either. Worry about the average user, not the perfect one.
I was wondering why my new inhaler sucked so bad until I saw you mention it. Ridiculous. Also, those "no difference" studies are all arguing for a null effect. A couple crappy measurements or poorly operationalized variable here or there and you can kill any statistical difference.
Also, that picture looks like one of the older, better inhalers - not the newer crappier ones.
My sister has severe asthma, and for most of her life had to use steroids and rescue inhalers especially in the spring. Some years ago she was told by another asthma sufferer about the herbal tincture made from Lobelia, which can be purchased at a good health food store or Whole Foods-type grocery store. She was told to put 15 drops of the tincture in a half-liter bottle of water and sip it when the symptoms are coming on. She found that it works spectacularly, and very fast. I have recommended this for my asthmatic clients, and they have had good results.
My sister says it works for her when she's sitting up at her desk or up and around, but if she has an attack at night when she's lying down, it's not as effective.
Sometimes bad things happen, such as the change in the propellant for the inhalers, and from them you learn new things which would not have interested you before. Maybe this is one of those times.
I don't have asthma generally speaking (thank god!) but I do have very bad allergic reactions to animals, cats being the worst. One of those reactions is an asthmatic one and if there is a worse feeling in the world than not being able to breathe, I don't know what it is. (Perhaps this is what makes water-boarding so awful/effective [depending on your persuasion]?)
Having the ability to quickly relieve that feeling is so key, I am very sorry that environmentalism run-amok has removed that luxury for you, Megan.
I am not at all surprised to see holier-than-thou environmentalists coming in to explain to you that your suffocation is "just in your head" and "if you were doing it right, there wouldn't be a problem". This seems to often be their reaction when any of their favored policies have negative unintended effects.
On the other hand, given the open hostility to humanity evidenced by the nuttier fringe of the environmental movement, perhaps having asthmatics suffocate on their now-useless inhalers isn't "unintended" at all...
I think most people are trying to help you. If you are using your rescue inhaler several times daily, your asthma is poorly controlled due to the inadequacy of your therapeutic regimen or some other intervening issue. Switching back to the old style albuterol is not going to matter if this is the case.
How did everyone decide I was using my rescue inhaler several times daily? I'm not using it daily. I'm using it weekly, which is rare for me, as I am well controlled.
The speed with which everyone jumped to the conclusion that I a) hadn't consulted my doctor b) didn't know how to use the new inhalers and c) was skimping on my control regiment (if indeed I had one) is breathtaking. I'm a well-educated, well controlled asthmatic. However, like many well-controlled asthmatics, sometimes I need a rescue, particularly in the late spring, when whatever it is I'm apparently allergic too acts up.
Does anyone have a link to a calculation of the total effect of this change on the ozone layer? I'm curious whether this has any effect at all. My intuition is that it doesn't, but I'd love to see something more concrete.
I wonder how much of this changeover was driven by the ability to charge way more money for these inhalers, which:
a. Are absolutely necessary for people with asthma (and other stuff like COPD, I think).
b. Were formerly dirt cheap, because they were generic.
I don't doubt at all that you're not getting the same relief, and truly I know what not being able to breath feels like. I was only pointing out that there was significant user error as well as psychosomatic issues with the new inhalers. And I also realize that for you the difference between equally effective and equally effective when used properly is moot. Which is why I think it might be a good idea to talk with a specialist.
If you don't have enough time to use your rescue inhaler before your breathing makes it impossible to use it as intended, albuterol might not be the best fit for you. And truth be told, it doesn't sound like what you should have been on even when the CFC-propellant ones were working for you. But, I am not an MD let alone a specialist, so don't take my word for it. Have you ever been prescribed Advair or Ketotifen?
Advair is not dispensed as a rescue inhaler, as is albuterol. I have prescriptions for and use both, as required.
Advair requires a slow, deep breath which is then held as long as possible. That slow, deep breath is every bit as difficult as the one recommended for the new rescue inhalers.
Right, I guess I wasn't being clear. It was my understanding that Advair was sometimes prescribed as a baseline treatment to reduce reliance on rescue inhalers and make attacks less severe (which could enable her to properly use the HFA-propellant albuterol inhaler).
Actually, there's a pretty good way to check the impact of this change, I think. Stats are available on the cause of ER visits for a lot of states. It would be interesting to see some analysis about whether seasonally-adjusted ER visits have tracked upward as the inhalers have switched over.
Hasn't research shown that CFCs aren't so bad for the ozone layer and that the alternatives that replaced them aren't much different in their affect on ozone?
No and not anymore.
CFCs are indeed every bit as destructive to stratospheric ozone as thought when Montreal was signed. HCFCs may be what the second part of your question concerns, as a non-trivial percentage of them were found to be making their way to the stratosphere rather than breaking down in the troposphere as intended. From what I remember, they are being phased out as well. HFCs and PFCs aren't ozone depletors, but they are GHGs and are also being phased out under Montreal.
I don't think there's any serious disagreement over whether the CFCs caused the ozone hole. The alternatives have drawbacks (some are greenhouse gases for example), but they're not ozone-depleting.
You'd be surprised (or maybe not). Just like we've seen with global warming, there was a systematic attempt by industry groups and their right wing media counterparts to deny the science behind CFCs and ozone depletion. I think you can find disinformation about it to this day on Heritage Foundation sites and the like.
Additionally, some HCFCs were initially used as replacements for CFCs and as I mentioned previously contributed to ozone depletion because they made it into the stratosphere.
I think you should go look at the chemical reaction kinetics data that has been developed since the original ozone scare - it turns out that the CFCs really don't react the way the models predicted. The reaction rates that were used were incorrect. And Dupont made a fortune coming up with a replacement refrigerant. They will again, when the green movement gets HCFCs banned.
The problem is that the environmental movement always needs SOMETHING to point to as a hazard, in order to maintain a state of fear in the populace. And the ultimate goal of reducing the population on this planet is well served by having medications become expensive and less effective - after all, you don't want all these useless disabled/poor people sitting around consuming and reproducing, do you?
Sister, I am right there with you. My asthma is not (it sounds) nearly as severe as yours. But when I need it, I NEED it. And the new inhalers are weak sauce.
When I had a recent asthma attack in reaction to a set of allergy shots, I can tell you the nurses station gave me the "real" inhaler, not this new thing. Are doctors holding onto the old ones?
If I may suggest, getting an extender SIGNIFICANTLY improved the quality of my inhaler. Turns out I (shockingly) wasn't getting a deep enough breath. The aerochamber (or whatever the non-brand name is)gives a space so that you can take many, shorter breaths, and get all of the medicine. I got more impact from the same dose, and additionally, don't get the bad taste, either.
It's a little clunky, and makes me look like a drug addict, but I absolutely wouldn't do without it for the world.
...I see that we did something stupid and costly to sick people for no good reason.
No need to repeat yourself, you already mentioned the FDA was involved.
Again, if this has to be done to save the ozone layer, fine. But I don't see that it did; I see that we did something stupid and costly to sick people for no good reason.
I think this shows the limits of what you can expect from treaties/government.
The Montreal Protocol (banning CFCs) was unquestionably a good thing for the world, for humanity, etc. and for everyone except a few chemical companies and, apparently, severe asthmatics.
Would the Protocol have been *better* if it had written in an exception for inhalers for asthmatics? Perhaps. But is it reasonable to expect that a huge international agreement be perfect? Of course not. You, unfortunately, fall into one of the imperfections. There are probably a dozen other minor uses of CFCs where the good outweighs the harm, but once you start sticking in exceptions every country wants to get its own pet clause in, and the agreement collapses/is toothless and we all get skin cancer.
Basically, I find it hard to blame the people involved in the Montreal Protocol for ignoring this issue.
Would the Protocol have been *better* if it had written in an exception for inhalers for asthmatics? Perhaps.
In fact it was written with essential use exceptions, explicitly naming metered dose inhalers. It was only after a sufficient alternative was developed that a move to phase out CFC was undertaken- and although I may be wrong here, I don't think that this was actually done under the aegis of Montreal, but was rather implemented by the medical authorities of individual nations. CFCs might still be legal under Montreal for the time being- I don't know when the essential use exception sunsets for MDIs.
a move to phase out CFC-propellant inhalers was undertaken
There is a preview function. I should take advantage of it.
>and for everyone except a few chemical companies
You got that wrong. It has been a boon to chemical companies. Got them out of the commodity hell of CFS's and into more interesting and more expensive alternatives.
Derek
Would the Protocol have been *better* if it had written in an exception for inhalers for asthmatics? Perhaps. But is it reasonable to expect that a huge international agreement be perfect? Of course not. You, unfortunately, fall into one of the imperfections.
Translation: Gosh, it sucks to be you.
To Megan and other people who loathe HFA inhalers, I'm sorry if I sounded like I was in any way belittling your condition. You're right that I don't have a respiratory disease. I linked to the Times article because, you know, they seemed to have some useful advice on how best to use the new inhalers. I can only imagine the effort of will required to breath slowly when you feel like you're asphyxiating.
That said, allow me to push my luck on this issue by making a kind of a cheap point. I imagine Milton Friedman is quite the hero to any authentic libertarian. Let me quote him (emphasis added):
"The FDA has done enormous harm to the health of the American public by greatly increasing the costs of pharmaceutical research, thereby reducing the supply of new and effective drugs, and by delaying the approval of such drugs as survive the tortuous FDA process."
But Megan said in the post:
And again, upthread:
So libertarians, which is it? Is the FDA delaying the release of potentially life-saving drugs, or not being careful enough in approving them? Do you agree with Freedman that we should shut down the FDA?
By the way, saying "it was government bureaucrats that forbade CFC inhalers in the first place" is true, but beside this particular point. The question about the FDA role/existence remains.
Ummm... unless I'm misreading what you wrote, and what Friedman was saying, I believe the actual logic is...
If the FDA and other agencies, such as the EPA, hadn't forced pharmaceutical companies to change their formulation such that no CFC's were involved, the following would have hapened:
No money would have been spent to re-formulate, thus significantly lowering the cost of healthcare that Obama and everyone else are screaming is too high. No R&D, no clinical trials, no marketing studies, etc. Tens of millions of dollars spent to find a cure for cancer, or something else...
The original, satisfactory (and prefered by Megan) formula would still be available,
If environmentalists and others felt strongly enough that they needed a new, non-CFC formulation, they could have spoken with their wallets and funded it - thus satisfying their preferences without burdening the system with development costs that nobody requested.
And, finally, since the number of inhalers in question generate merely a fraction of the CFC's that any person would consider significant, there would be no measurable harm done.
I believe that is how liberty works, and what Megan was referring to... but I've been wrong before.
But in this case FDA isn't delaying the release of a lifesaving drug. It's simply providing political cover for another bureaucracy to take an existing medical device off the market for non-medical reasons. That's not a point in favor of the FDA's continued existence. And calling a gaping hole at the waterline of your argument "beside this particular point" doesn't make it so.
In Friedman's world the CFC inhalers would still be on the market, so the existence of he FDA would be irrelevant, as nobody with severe asthma would use the new inhalers.
Just to be clear, tsotha and RobM1981, you agree with Friedman and are against the existence of the FDA?
No. But I think in this case the FDA screwed up, so it's not something I'd point to if I were trying to justify the agency's existence.
Right. It screwed up by not applying the "tortuous FDA process" Friedman complained about, so it wouldn't delay the approval of a new drug. The problem here, it seems, was that the process was not quite tortuous enough.
You're being deliberately obtuse. If you're testing a rescue inhaler not including severe asthmatics in your patient population is scientific malpractice independent of any process you might have. I would have included them, and I have no process at all.
Nimed, you seem to be overlooking the difference between approving the new drug and prohibiting the old one.
It is incorrect to characterize the problem as "[The FDA] screwed up by not applying the "tortuous FDA process" Friedman complained about, so it wouldn't delay the approval of a new drug." There is no objection being made to the FDA's decision to approve the new drug. Everyone in this discussion thinks the approval process was sufficiently tortuous.
The problem is that the un-approval process was not sufficiently tortuous. But these are not symmetric procedures; it is perfectly consistent to believe that the FDA should be quick to approve drugs, but slow to un-approve them.
Let me expand on that a bit. I believe you ought to be able to buy drugs which have not been approved by the FDA. I believe you ought to be able to walk into a pharmacy and buy anything in the inventory without a doctor's prescription (including addictive drugs like oxycodone and codeine).
But I think the FDA generally does a good job of determining if a drug is safe and if it works. I'd like to keep it around so doctors and patients have a relatively unbiased information source.
They could then be used for non-medical purposes. I take it you're consistently in favor of banning all drug restrictions.
Yep. As far as I'm concerned you ought to be able to put whatever you want into your body, and I don't see any reason for anyone else to second-guess your choices. On the other hand, if you get in over your head I don't feel any obligation to help you straighten out.
If the government has a role there it's to make sure good information is available so you can make informed choices.
Even anti-biotics? I'm pretty libertarian, but I think a FDA-like something or other should provide information about risk factors and let people make their own choices (i.e. not make one size fits all risk decisions for us).
I definitely think you should need a prescription for anti-biotics at least. I'm more worried about those than opioids.
Antibiotics are a little bit of a closer call, because you're creating supergerms if you use them incorrectly. My feeling is it probably doesn't matter that much, in the end, because they're so heavily used in agriculture and also because they're so available in other countries.
Also, the drug manufacturer doesn't have to make its products available without restriction. If your product's raison d'etre is efficacy after everything else has failed (like Ciprofloxacin or Vancomycin) you don't need the FDA to set up contractual arrangements limiting its availability.
To be clear:
I am against the existince of the FDA as currently formed.
I am not against an FDA that sets basic regulations, such as truth in labeling, and can then acts as a policing force.
I *am* against the FDA's drug and device approval function. Why?
We can demonstrate that FDA approval:
Dramatically delays the release of critical pharmaceuticals and devices,
Dramatically increases the cost of bringing those pharmaceuticals and devices to market, and
Dramatically shortens any patent-protection window that a company has for their drug or device, further driving up the cost to the consumer.
And what do we get in return?
Partial assurances that the pharmaceuticals and devices that we are taking are effective and safe.
Not full assurances, by any means, but just partial.
The ocean of drug-based lawsuits is witness to just how partial the FDA's assurance is. Moreover, drugs and devices manufactured overseas - a trend that continues to grow - are produced at plants that are not FDA inspected.
Thus, on top of everything else, the FDA also drives jobs offshore.
It's the classic liberal nirvana: the illusion of equity and safety, at the expense of actual prosperity. What more could you ask for?
Megan isn't complaining about the FDA approving non-CFC inhalers. She's complaining about the FDA deciding, without evidence, that non-CFC inhalers were just as good, for everyone, as CFC inhalers.
Friedman's point isn't that the FDA is slow, and instead it should just make all decisions quickly. It's that the FDA is slow about the wrong things: the FDA is slow about letting treatments become available, but it's fast about making them unavailable again. In other words, the FDA's bias is consistently towards fewer available treatments.
Friedman, and libertarians in general, want the exact opposite: more treatments, both because we allow potentially life-saving treatments to be made available quickly, and because we don't turn around an disallow them without, at minimum, very strong evidence that they have no redeeming value.
Megan's complaint was also that the FDA released the new inhalers on the market without proper testing, "only mild-to-moderate asthmatics for short periods of time". So the FDA was not slow about letting treatments become available. It was too fast. The CFC inhalers, of course, were taken out of the market for reasons not related to their efficacy. We can discuss the merits of these decision, but this should be clear.
I don't think you should place the burden of evidence on having just any redeeming value. Health benefits should outweigh the costs, and patient choice on potentially harmful drugs, if not very well informed, can lead to disaster.
No, that wasn't Megan's complaint, as I and others have pointed out more than once now. Please reread what she said: "And testing these things on only mild-to-moderate asthmatics for short periods of time, which is all the FDA did before phasing them out, seems borderline criminal." (emphasis added).
Once again, Megan's complain is not that the FDA was "slow about letting treatments become available." Megan did not object to the FDA making non-CFC inhalers available.
While the motivation for removing CFC inhalers was not related to their effectiveness, it requires a decision, by the FDA, that the new inhalers were sufficiently effective by comparison. It is this decision that Megan objects to.
Apparently we disagree. I think it's an interesting (and very difficult) issue, but probably a bit far afield from the topic of Megan's post.Marinol is probably just as good at suppressing nausea as pot, but for some reason the jerk cancer patients kept puking up the pills. It's almost as if delivery mechanisms matter. Thank G-d we live in a modern, civilized society where the enlightened can tell those who selfishly wish to breathe where they can get off.
LOL... bravo.
Those damn cancer patients shouldn't be engaging in interstate commerce like that.
Win.
I know that everyone who is assuring me that the new inhalers work just fine does not have respiratory disease. Do you know how I know this? Because they point to things like this:
My wife seems to manage just fine, and I've seen her in the middle of some pretty bad attacks. Her friends also manage just fine without any complaints. It's almost if anecdotal data and "asking your friends" isn't a scientific study.
So, how many people have to suffer before Megan's point is valid?
So, how many people have to suffer before Megan's point is valid?.
You need to conduct a clinical study with the minimum of scientific rigor. There will be some people who "get worse" due to the medicine, but it could be coincidence that the worsening symptoms happened at that time. Making scientific decisions based on anecdotal data is not the way to do it.
Just to show, I have some friends that claim generic medicines "don't work" Even though they deliver the same active ingredient, only name brand Tylenol works on them. This does not convince me that I should spend more money on Tylenol.
If they didn't include severe asthmatics in the original studies I would say the minimum scientific rigor standard hasn't been reached.
And herein lies the nut at another of health-care reform issues:
what works for a large percentage of the population in question may not work for all of the population.
Which leads to the second conundrum, just because something doesn't work for an individual, does not always mean it's a patient error.
That's why prescription drugs come with warnings of all those side effects that are statistical anamalies.
If you're wife filled out her prescription a while ago and got extra inhalers, she may not even have the new crappy one yet. I just got my first a month ago, since my asthma is pretty mild.
In fact it was written with essential use exceptions, explicitly naming metered dose inhalers.
It's always kind of nifty to discover that a process worked more or less as well as you would want it to.
Now if only it happened more often.
The Ozone hole is actually expanding again. The reason they got away with it the first time is that there was no effective internet presence to check the data. They had another round of it against C02, except this time they've run into some problems making sure there is no debate.
I knew if this stayed alive long enough an Ozone Truther would show up...
Do tell the class about The Great Ozone Hoax.
Are there really so many asthmatics huffing away on rescue inhalers they have a measurable effect on the ozone layer? It's hard to believe.
Health benefits should outweigh the costs
That's the rub, isn't it? If the benefit is not feeling the constant urge to move your leg, and the cost is an urge to gamble (by far my favorite side effect), how do we know when the benefit outweighs the cost? They can't even be measured on the same axis. So...might it be better to let the patient and doctor do the weighing, rather than a central planner?
Or, as in the case of drugs like Seldane and Vioxx, we have highly effective treatments that cause serious problems in a tiny number of cases. Who should decide if a 1.5% risk of serious complication instead of 1% (A shocking 50% increase!!!!) is worth the relief they provide? Me or the FDA? (Numbers made up, BTW; but IIRC, Vioxx was associated with a large-percentage-but-small-overall increase in something serious).
(My second-favorite side effect is death, which is apparently associated with certain asthma treatments. See, doc, I have a frightening medical condition that might kill me. Do you have anything that will make it less frightening, but increase the risk that it will kill me?)
Funny you should mention that. For awhile my doctor suspected I might have asthma, but he was reluctant to prescribe anything for it. When I asked him why he said the medication kills more people than the asthma does. I'd still chance it if I was having trouble breathing - there's a quality of life issue here.
Heh, that reminds me, I read once that prescription medicines taken as prescribed were in the top ten causes of death.
My theory is that it's best to avoid non-diagnostic medicine to the extent possible consonant with reasonably good health, and one must exercise all due diligence before accepting a medical treatment recommendation.
Speaking as someone in medical school now, I could not agree with you more. I have slightly elevated blood pressure and will put off taking medication for as long as possible. All drugs have some sort of side effect, even if it's dose dependent.
Megan, how dare you value your own health over an infinitesimal effect on the well-being of our sacred Earth? Don't you realize you are no more important than a blade of grass or a tree?
May Gaia strike you down for your selfishness.
Well, if it isn't ellipsis man.
Looks like he's mending his ways. He now stays away from data and sticks to what he does best - bad jokes.
Nimed,
You should go back and read the response before embarassing youself further.
TallDave, the whole thing is really too barefaced for you to weasel your way out. But I can't say I'm surprised you're trying.
Sigh.
Let's recap: I said there are differences in how countries record infant mortality. You replied with obscenities claiming otherwise. What does the data say?
I've both a USNEWS story and the source OECD paper which clearly states there are comparability problems with infant mortality because of how preemies are recorded. I've also supplied the Japan/Hong Kong study which clearly shows those countries are fudging their stillbirth numbers. Finally, I've noted there are scenarios in which, even if WHO standards were followed strictly, difference in infant mortality could arise having nothing to do with quality of care (e.g. differences in propensity to abort children with birth defects).
You've raised, with a torrent of abuse, the irrelevant point that there is a WHO standard (which OECD has openly stated is not being applied evenly), and claimed some personal malfeasance on my part for omitting a Wikipedia notation about the WHO standard, the ignoring of which is the point of all the above data.
I won't ask for an apology (though I'm clearly owed one), but would like to see you try to be a bit more rational in your criticisms.
People, let's be grown ups, shall we?
TallDave, when you quoted that wikipedia entry, you decided to skip the precise sentence that stated the comparability issues you were defending ceased to exist, and the countries in question changed their child mortality rules. Even if you disagree with the sentence, I find it difficult to swallow that somebody wouldn't find it relevant. And the fact that you're not addressing this specific omission in your replies is not helping.
Nimed, the place to discuss this is in the original thread. Even if you're justified to be pissed, what you're doing now is hijacking this thread and cluttering it. We get it, you caught TallDave with his pants down. Now that you made you point, maybe you should move on and stop the trolling.
Jaspel,
Sorry, but I have to point out again it is in fact not relevant. The 2006 USNEWS article stated various countries are not using the same criteria for infant mortality. The fact those countries adopted WHO in the 1980s and 1990s doesn't make a whit of difference. The whole point of the 2006 article is that they aren't following the WHO standard, or any other universal standard.
But maybe I'm wrong. In that case please explain how the dates when they adopted the standard they aren't following is relevant?
I omitted it precisely because this irrelevancy creates confusion. From the structure of the paragraph, one might wrongly assume (as Nimed did) that in the 1970s, USNEWS reported some problems with infant mortality comparison, which were then fixed in the 1980s and 1990s. But in fact the USNEWS article is from 2006, as is the OECD link. All the omisssion tells us is that some countries are not good at following the standards they adopt.
Ah, I see you made the same assumption:
Again, this is not what happened, though it is understandable someone could read it that way (hence my omission, in a vain attempt to avoid this confusion). The problems were identified in 2006/2007, the WHO standards were adopted in the 1980s/1990s. The latter did not solve the former.
Uh... I don't want to be dragged too much into this. I actually find the comparability discussion in the other thread quite interesting and instructive, so I'm enjoying the back and forth. Let me give you my take on the wikipedia thing:
The USNews article and the scientific article referenced in the omitted sentence are mutually contradictory. Either those European countries officially adopted the WHO definition in the 80s and 90s and now all use the same criteria - in which case the USNews article was wrong - or they didn't, and the Social and Preventive Medicine article is wrong. There is no adopting the definition without following it, as you say. It's a classification system, after all: to adopt it is to follow it, except apparently in Hong Kong/Japan's case, where they may be doing it unofficially. But if they were doing it unofficially it wouldn't show up in the USNews piece anyway.
So one of the sources is definitely wrong, but both are undoubtedly relevant to the discussion, and your omission of the one who happened to be against your position is understandably suspect. So I get where Nimed is coming from in this. You say the omission was motivated by an attempt to avoid confusion about dates. Well, ok. All I can say is, I'd probably be pretty pissed if I was in Nimed's position and noticed the omission. The interpretation that you were not arguing in good faith is hard to avoid.
But this is a question about your intentions, and it's not like if anybody is going to read your mind on this, so I'll accept it. And I would definitely not bring it up in other threads. At least I hope I wouldn't.
Jaspel,
Either those European countries officially adopted the WHO definition in the 80s and 90s and now all use the same criteria - in which case the USNews article was wrong -
Which is why I linked the OECD report, which clearly states different standards are being used.
or they didn't, and the Social and Preventive Medicine article is wrong.
Or, they officially adopted it, but aren't doing a very good job of actually applying it at the everyday level. This happens all the time (see Kyoto).
But this is a question about your intentions, and it's not like if anybody is going to read your mind on this, so I'll accept it.
Thank you.
There is no adopting the definition without following it, as you say. It's a classification system, after all: to adopt it is to follow it, except apparently in Hong Kong/Japan's case, where they may be doing it unofficially. But if they were doing it unofficially it wouldn't show up in the USNews piece anyway.
Sure there is. It's one thing for a country to sign a paper saying they'll adopt a standard and another for them to actually start applying it at every hospital. There could be all sorts of internal wrangling going on. Hospital administrators are naturally going to resist moving to a standard that makes them look worse.
So, what does the evidencve say is happening? We have a 2006 USNEWS article which says they are not following the standard (there are numerous ways USNEWS could find out about this, e.g. surveying doctors, checking standards actually in use at local hospitals, etc). We have a 2007 OECD paper which says some countries are not following the standard. We have a study from Japan/Hong Kong that says the standard is not being followed there either. Clearly, all the available evidence says countries are not following the WHO standard, even if they adopted it.
On the other side, we have a Wikipedia link that no one can actually follow which claims they adopted the standard... but even if this unreadable link is accurate it's irrelevant because countries aren't following it.
Clearly, IM/LE is not comparable across countries.
Jaspel
What? No hijacking? Oh, come on, live a little.
Jaspel
Ahah, so you are going to thread hijack yourself. I knew it.
Jostel
You said it perfectly. It's a classification system, not a disarmament treaty. Unless there's weird off-the-books stuff, like maybe what's happing in Japan, how could you adopt it without following it? It makes no sense. And if there's off-the-books stuff, USNews wouldn't know about it.
But let me give you some context on how all this started:
TallDave
TallDave solves the mistery of high child mortality in the U.S. - the sole reason the U.S. is behind this indicator is that countries with bad socialist doctors abort problem pregnancies. But which countries are those? Well, we can eliminate the former communist countries, like Russia, Poland, etc. They have high rates of abortion, but concomitant rates of infant mortality. He's talking about someone else...
TallDave
I find out in this passage that I'm a venomous socialist, so we may deduce the definition of "socialism" employed is not be very strict. Western Europe countries, of course, fit the definition like a glove.
These two passages sum TallDave's initial theory: infant mortality rates are lower in Western Europe because problem pregnancies are much more frequent, and they are more frequent because "government bureaucrats make life and death decisions for you".
Furthermore, this is just one of the faults of the likes of Austria, France, Italy, Switzerland, Germany, Sweden and other Western European societies. For instance, you can't really rely on their data, not due to different mortality criteria (that was still to come up) but because "undiagnosed illness deaths never make it into their numbers" and they "spend far less in diagnostic data". Oh, and the "plain old-fashioned bureaucratic number-jiggling". These countries are shit-holes!
Naturally. TallDave never provides evidence for these amazing claims. But he insists on one point:
And, as proof, he links to this article. This is an article that reports on abortions performed on fetuses with minor disabilities, not life-threatening conditions: club feet, webbed toes, cleft lips and palates. A Reverend protests against the possibility, not obligation, of performing these abortions after 24 weeks. Naturally, nowhere in the article it is said that abortions are done "without telling the parents birth is possible". There are no government bureaucrats making decisions for you. This remains a figment of TellDave's imagination. Indeed, the theme of the piece is the abuse of the "seriously handicapped" term in The Abortion Act by mothers and doctors to perform late-term pregnancies of children with minor disabilities. If you are shocked by this, you should be shocked with the mothers first, and the doctors who assist them in this second.
This is a recurring topic:
TellDave
What TallDave doesn't tell you is that he dreamed up a Western European country X. I would consider an argument like "religious couples, which are relatively more numerous in the U.S., are more inclined to carry through a pregnancy of a child with birth defects". This sounds more reasonable, although I would still call for evidence.
We now reach the infamous post with the Wikipedia quote, largely discussed in the other thread. About the omission, Phlinn said
And Jaspel says
Thanks guys. I was wondering how transparent this was. Given the record of the particular discussion, is it unfair to attribute bad faith to TallDave's omission? I definitely think so. The irrelevance and date confusion are definitely very unconvincing. TallDave left it out because it was too confusing and I could assume the USNews article was from the 70s? Please.
But I suppose I'll take your advice, Jaspel. It's definitely not fruitful to speculate on commenter's intentions. And I was a bit of a troll.
Now, regarding the comparability of infant mortality rates between the U.S. and Western Europe, both TallDave and Phlinn linked a number of good sources (we are all freaking experts on the subject by now).
Two concepts are useful here:
Infant Mortality Rate = Deaths from birth to up to one year of life per 1000 live births
Perinatal Mortality Rate = Deaths from 22 weeks of gestation up to 1 month of age = fetal mortality + neonatal mortality
First, what do we know about uniformity of criteria on infant mortality in Western Europe and the U.S.?
Wikipedia gives us the 2 conflicting sources already discussed. Unfortunately, one of the sources referenced in the Wikipedia entry, note [6], is not available online (except for the first page). So, in the name of good faith, let's take the USNews article at face value and say there are relevant differences in the measure of infant mortality rate. According to the article, the U.S. has the most lax criteria: all births with any sign of life count as a live birth. Other countries have, in addition to signs of life, either weight, age or length requirements to be considered a live birth. How much these more stringent criteria affect statistics in the first year? We don't know. The more stringent European requirements are quite modest, though: weight of 500 grams (the normal in a new born is 3 kg), or 6 months and 2 weeks of pregnancy, or a length of 30 cm. One must wonder the percentage of babies in the U.S. that are born below these criteria and still show signs of life
Recent data on infant mortality:
http://www.oecd.org/dataoecd/4/36/40321504.pdf
The study has a disclaimer:
"In several countries, such as in the United States, Canada, Japan and the Nordic countries, very premature babies with relatively low odds of survival are registered as live births. This increases mortality rates compared with other countries that register them as fetal deaths instead of live births. "
Let's exclude cheating Japan. Notice that, in the study, the countries with the U.S. mortality criteria still have lower mortality rates than the U.S.. That includes Canada and the Nordic countries. How do you know which are the Nordic countries? You don't. But you know that they aren't Mexico, Turkey or the Slovak Republic, which are the only countries with higher mortality rates than the U.S. So this is a strong clue that stringent IM criteria are probably not at least not completely responsible for the lower mortality rates in Western Europe (besides the Nordic countries are themselves certainly European).
Furthermore, Iceland, the only European Country with the same requirements as the U.S., has less than half the infant mortality rate. USNews looks like an article made to enumerate reasons for the gaps with Western Europe countries, and so they give a bunch of non-medical reasons for the gap with Iceland. They are pretty plausible.
Anyway, comparing infant mortality with all these cautionary facts in mind, we find that U.S. as a mortality rate about 40-50% higher than the average Western European country.
That's it for infant mortality. Phlimm then proposed we use the perinatal mortality rate as a comparison proxy. TallDave linked an article with 1994 data warning that perinatal data among European countries is also not comparable. But, in fact, it is. When comparability adjustments were made, the maximum adjustment was of 17%. The average adjustment was less than 5%. In sum, the different criteria change the final numbers very little.
You can check it here (table 4, indirect adjustment method). Remember these are 1994 numbers, so the absolute values are higher than in the present day. This article serves to establish comparability.
http://www3.interscience.wiley.com/cgi-bin/fulltext/119025613/HTMLSTART
Contrary to infant mortality, there is no source that tells us that the U.S. has a more stringent criteria than Western Europe. So much for that excuse. So what are the values for perinatal mortality?
I'm citing them from here
http://www.who.int/making_pregnancy_safer/documents/9789241596145/en/index.html
deaths per 1000 live births:
U.S. - 7
Western Europe
I'm setting the islands appart for reasons I'll explain latter:
Ireland - 9
U.K. - 8
Continental Western Europe:
Sweden - 5
Switzerland - 5
Spain - 4
Portugal - 5
Norway - 4
Netherlands - 7
Italy - 5
Iceland - 4
Germany - 6
Finland - 4
Denmark - 5
France - 6
Belgium - 5
A couple of observations:
1- the gap with the U.S. is reduced in relation to the infant mortality rate, which is consistent with stricter criteria for this measure in the U.S.
2- the countries that are above the U.S., the U.K and Ireland, are also the ones which were closer to the U.S. on infant mortality. So the 2 measures are coherent. This is also consistent with the low reputation of health services in English-speaking Europe (the U.S. better not choose U.K. model of universal health care)
3- Finally, except for Netherlands, Western Europe maintains lower indices of perinatal mortality than the U.S. across the board.
In sum, natal health care indicators are consistently better in Western Europe, whatever the measure used. Perinatal deaths are about 30% higher in the U.S. Remember that average consistency of perinatal criteria is in average, about 5%
Finally, I'm repeating myself, but let's remember what started the whole discussion in the first place:
TallDave
I have prolonged this discussion because it's not the first time that I hear people state these and other profoundly ignorant statements. I want to stress that only someone who has absolutely no idea of how life is like in Western Europe could paint such a distorted picture.
We get it, you caught TallDave with his pants down. Thanks guys. I was wondering how transparent this was.
No, actually, you just misread the article and embarassed yourself by bringing up your misinterpration as some evidence of personal malfeasance on my part, while calling me all sorts of names. Your interpretation of the omitted sentence requires some sort of time travel to be involved, as it would mean problems identified in 2006 were fixed in the 1980s and 1990s.
I find out in this passage that I'm a venomous socialist
Given that you've referred to me personally with about a dozen different obscenities, I'd say the evidence is clearly on my side here when I characterize your reaction as "venomous."
So what are the values for perinatal mortality?
And what does the WHO say about comparing those values?
So, values in the same order of magnitude can be considered identical, given the known issues with the data. That is to say, there is NO DIFFERENCE, I repeat NO DIFFERENCE, in perinatal mortality between the U.S. and any European country, as they all fall in the same order of magnitude.
So, we can further say that the oft-repeated assertion from socialists that infant mortality and life expectancy (which is heavily based in IM) are gerater in socialist countries is suspect at best.
Sorry, should read:
So, we can further say that the oft-repeated assertion from socialists that infant mortality and life expectancy (which is heavily based in IM) are better in socialist countries is suspect at best.
Of course, much of the socialist argument collapses if socialized medicine countries do not, in fact, have better IM/LE, and the data clearly do not support them.
The IM/LE comparability problem is a nontrivial point, because the Soros-backed Commonwealth reports actually explicitly make this claim, and lefty policymakers here in the U.S. are citing those reports.
Finally, it's worth noting two of the three "profoundly ignorant" quoted statements by me were supported by multiple links. The other (regarding doctors not notifying parents birth was possible) is (iirc) from a recent survey of Swedish doctors, though I don't have a link. I note this not so much in my defense (debating how awful I am or am not is not particularly interesting even to me, let alone Megan's readers) but as another example of how poorly argued the socialist position is.
Again with this? You are now, of course, being deliberately idiot, as opposed to your usual naturally idiot. Jaspel answered this nonsense for me, so it's clear these ridiculous attempts to pin an erroneous interpretation on me aren't obviously pretty futile.
Ah, but, you see, there's a difference. You have proved yourself to be a dishonest steaming pile of s*** with selective quoting and omission of inconvenient sentences. I, on the other hand, was "venemous" from message 2. Not that I mind, I see it more as a sign of paranoia. You obviously see socialists everywhere. By the way, "a dozen different obscenities"? You're getting a little hysterical now.
Ah ah, this is the new cop-out. You can't compare anything! The WHO study is only accurate up to an order of magnitude, so there is no discernible difference between the U.S. and Western Europe, even though every single indicator shows 20-40% higher mortalities in the U.S., and perinatal data is pretty consistent with IM data.
But, as is his habit, TallDave omits the inconvenient. Throughout the report you read that underdeveloped and developing nations show severe underreporting and do not have reliable data. These are mainly African and Latin American countries. Many of their figures thus require adjustments and a high number of statistical assumptions. Of course, with all of this, precise comparability suffers.
What does this have to do with comparisons between U.S. and Western European countries on perinatal data? Nothing. Obviously they don't have this problem. The funny thing is, TallDave himself linked a study showing that perinatal measures among European Western countries have been consistent at least since 94, with adjustments showing difference of less than 5% on average.
Notice also that TallDave didn't say a peep about the OECD study he also linked himself, in which all countries with the same criteria as the U.S. in IM show lower infant mortality rates.
Where Don Quixote saw windmills, TallDave sees socialists. And his mission in life is very clear: to desperately convince himself and others that health care is extremely bad outside the U.S., where the socialists are. Well, in some countries it is. In Western European countries it isn't. Western European countries have consistently better statistics in all natal measures, and most of them perform fewer abortions than the U.S.
By the way, even if the Western European countries had only the same results as the U.S., which they don't, the defense of their "socialist health care" would have been accomplished, because their health care systems are by far than the U.S. system is.
Actually, they have very different systems and it's profoundly stupid to lump them together. Switzerland, for instance, has good results with all health insurance companies and hospitals in private hands, and the U.K. has not so good results with everything in the hands of the government. But to clueless TallDave, they are all part of homogeneous socialist Europe. Oh, well...
This is now D. Quixote winning battles against the windmills. On the laughable assertions TallDave thinks he proved, he didn't produce a shred of what you and I call "evidence" in their support. Not a single one. The most he could do was completely misread an article from an U.K paper.
A reminder of what TallDave "proved":
- "child mortality is lower in most socialist countries because doctors in those countries are far more likely to abort problem pregnancies" - notice the causal relationship. No link ever produced.
- "in Western Europe abortions are sometimes done without even telling the parents birth is possible" - TallDave says he lost a link from a survey of Swedish doctors. But, in his original post, he provided the U.K. paper link to support this idiotic assertion. Now he probably re-read the article, saw how completely unfounded his assertion is, and is now changing his story. Nothing new about this.
- "socialist rationing means expensive babies get the axe. But that's reality. It's ugly but it's rational, and it's what happens when government bureaucrats make life and death healthcare decisions for you." - no single link supporting this supposed government bureaucrat decision making.
Again, that I'm even discussing these last 3 sentences is itself telling. Pretty much any citizen from a Western European society would react to them with either outrage or perplexed amusement.
If Oprah were an econ blogger it would probably look a lot like this one.
Laugh of the day.
I'm just glad we have progressed beyond steam vaporizers, cool mist vaporizers, eucalyptus oil, oil of camphor, Vicks VapoRub under the nose and on the chest, sleeping in a recliner, adrenalin shots, aminophilin suppositories, prednisone and small oxygen cylinders. (I'm a lot older than Megan, who probably missed out on some of those wonders.)
welcome to the collective, where decisions of the collective (mini effect of inhalers trumps use of the more effective inhalers because there is more noise and interest on our side of the line and you are alone). Individual rights can look good in comparison to group right ,right?
I have to say HFA inhalers are working for me too. But I didn't have a major crisis since I've switched, so the jury is still out.
I agree with McArdle's larger point, though: if CFC inhalers are not responsible for a significant portion of emissions, they could keep it available in the market. They could, at the most, make them relatively more expensive by taxing them.
if CFC inhalers are not responsible for a significant portion of emissions
That is tautologically based on Megan getting to arbitrarily define what constitutes "significant", isn't it?
The larger point is that Montreal didn't ban the CFC-propellant MDIs and in fact made an explicit exception for them until a suitable alternative was developed. Megan is the exception to the general finding that the HFA inhalers are equally effective. Based on this we are to somehow conclude that the move away from a CFC-based propellant inhaler is doing nothing to help ozone depletion recovery and is generally a fuckup by the government, the intergovernmental signatories of Montreal, or environmentalists depending on who is doing the blaming.
Megan made at least three fairly bold claims that require equally bold support to take seriously:
1) That the move to HFA inhalers was "costing" "sick people" for "no good reason".
2) That CFC-propellant inhalers were not "noticeably depleting the ozone layer".
and lastly and already demonstrably false:
3) "I know that everyone who is assuring me that the new inhalers work just fine does not have respiratory disease."
Based on this we are to somehow conclude that the move away from a CFC-based propellant inhaler is doing nothing to help ozone depletion recovery and is generally a fuckup by the government, the intergovernmental signatories of Montreal, or environmentalists depending on who is doing the blaming.
Oh, I think she's being very specific regarding who she thinks deserves blame. Where does she blame international bureaucrats or environmentalists? If you're going to criticize Megan why don't you stick with the arguments she's made.
Megan is the exception to the general finding that the HFA inhalers are equally effective.
Perhaps. But if what she says is true - that they didn't test severe asthmatics to arrive at these findings - the "general finding" is junk science of the worst kind. Did it occur to you it's possible a high percentage of severe asthmatics are an exception to that general finding?
And again, it's very, very hard for me to believe there are so many people huffing on rescue inhalers the ozone layer is affected. When I was a contractor with the navy I remember the AC guys on our base opening the valves on large tanks of refrigerant because they had too many and the trash people wouldn't take pressurized tanks. How many inhalers could you charge with 150 gallons of Freon?
" That is tautologically based on Megan getting to arbitrarily define what constitutes "significant", isn't it?
The larger point is that Montreal didn't ban the CFC-propellant MDIs and in fact made an explicit exception for them until a suitable alternative was developed. "
So who gets to "arbitrarily" define what constitues "suitable alternative"? Agenda-driven Gaiacrats?
Okay, so back to the original point... why not keep the CFC inhalers on the market and just encourage people to try the HFA ones and voluntarily switch?
Because the needs of the many out way the needs of the few. At least according to our leaders.
Seeing as the new inhalers are massively more expensive and appear to be harder to use, I doubt anyone other than real devoted enviros would ever use the new inhalers.
Thanks so much for writing this Megan. My daughter uses an inhaler and I hate the new ones. They are outrageously expensive so we no longer are able to keep an inhaler for her in various locations (home, car, school, Grandma's, etc.) but instead we just have a couple and we have to make sure we have one of them with us at all times. The last time I went to my pediatrician I told her the last inhaler we got was $50 and she gave us a card from the manufacturer that gives us a $15 discount. Not much help, but better than nothing.
The spray is much weaker. My daughter uses a spacer with hers, which helps, but is a pain to have to take everywhere because it is bulky. My daughter uses the nebulizer now when we are home and only uses the inhaler when away from the house. When we go anywhere overnight we take the nebulizer since I don't trust the new inhaler.
So, you apologize for being intemperate toward the drug companies and the FDA by slagging on IT developers? Nice. Thanks.
C'mon. I spent four years in IT. You KNOW this happens. Everyone hates UI, and they tend to criticize the users when they don't master it.
I deny it completely. The staff here are all sympathetic to the needs of our end users and conduct themselves with courtesy and humility at all times.
And yes, my boss does read this blog occasionally.
IT would be so easy if not for those darned users.
It's time to inject a few facts into the HFA MDI discussion for the benefit of the arrogant fools on this thread who insist that the complaints of thousands of asthma and pulmonary patients (including patients who are MDs, pharm/chemistry PhDs, RNs, RRTs, and nurse anaesthesiologists) are "psychomatic".
1. HFA rescue MDIs ARE less effective than CFC rescue MDIs- GlaxoWellcome (now GlaxoSmithKline) admitted this in their own New Drug Application for Ventolin HFA (and Ventolin HFA is the only HFA rescue MDI that DOESN'T use the PROVEN BRONCHOSTRICTOR ethanol as a solvent).
2. HFA rescue MDIs ARE more dangerous than CFC rescue MDIs. Schering-Plough itself says this about its product, Proventil HFA:
"RAPID HEART BEAT, VOMITING, CHEST PAIN and PALPITATION OCCURS MORE FREQUENTLY WITH PROVENTIL HFA (than with CFC albuterol)."
3. We have links to the safety comparison charts on the Press Room page of our website at SaveCFCinhalers.org for Proventil HFA and Ventolin HFA clinical trials (only these two ran against active CFC albuterol controls, and only these two were used by the FDA to determine that CFC albuterol could be banned per FDA Final Rule 21 CFE 2.125). We also link to the NEJM chart which includes ProAir safety data. A bright 10 year old can review these charts in a few minutes and intelligently decide that CFC albuterol is MUCH SAFER than the HFA formulations.
4. Non-racemic levalbuterol tartrate (Xopenex HFA) is, in my personal opinion, better than the racemic HFA albuterol formulations, but it does have some very nasty side effects and we have many patients who can't tolerate it. Again, we link to its safety data, which is not reassuring, even when compared to an active HFA control, despite its great 'story'.
5. We have three years of FDA MedWatch DATA which is posted on our site which STRONGLY supports our position.
6. We have DATA from a large UK study by Ayres, which supports our position.
7. We have New Zealand DATA which supports our position.
8. The problem with HFA MDIs is NOT with the active ingredients, the problem is with the INACTIVE ingredients and the UNIQUE IMPURITIES in each MDI (CFC or HFA). Some people (not all) are allergic to/intolerant of these excipients and impurities and better inhaler technique will only cause them to inhale MORE of these toxic substances (for THEM) which will harm, not help them.
9. The doctors who say that 'the studies all show that HFA rescue MDIs are just as safe and effective as CFC rescue MDIs' either NEVER READ THE STUDIES, or they are LYING. It is common to find (in drug company-sponsored clinical trials- which were a JOKE in this case because they were so small) that THE DATA CONTRADICT THE PAID 'INVESTIGATOR'S' self-serving, biased CONCLUSIONS. Doctors who only read the CONCLUSIONS have NO IDEA what they are talking about, so they tend to dismiss their patient's complaints and step them up (in this case) to more dangerous drugs (black box warnings, only to be used as a LAST RESORT) containing Long Acting Beta Agonists like Advair and Symbicort- which their patients would NEVER HAVE NEEDED (in many cases) IF THEY STILL HAD ACCESS TO CFC MDIs.
10. 'Environment-friendly' HFA-134a propellant was NEVER TESTED on asthma/pulmonary patients. It was only tested on normal, healthy volunteers, who, as a rule, do NOT have severe allergies, or hyperreactive, inflamed airways.
11. HFA MDIs SHOULD have undergone large scale, REAL WORLD ('real world' testing is done on older, sicker patients- including COPD, cystic fibrosos, lung cancer, severe asthmatics- unlike the pre-approval clinical trials, which tested only a handful of mild/moderate asthmatics) US postmarketing studies- we have FDA quotes to this effect- but IPAC (HFA MDI drug companies) said 'NO' and so these large tests WERE NEVER DONE. Until NOW. And the results for many thousands of patients are disastrous.
12. Hate to disappoint the enviro-freaks on board, but 'environment-friendly' HFA-134a is such an intense global warmer- MUCH more so than CFC-11,12- that it TOO will eventually be banned, at Copenhagen. IPAC is already hard at work coming up with a NEW 'environment-friendly' propellant, which should be ready by the time the HFA MDI patents start to expire in a few years. The 'environment-friendly' medical propellant du jour cash cow is the gift that keeps on giving- to the drug companies.
The CFC MDI ban is a story of junk science and drug company greed gone wild. It should never have happened. It is medically, scientifically, and morally UNJUSTIFIABLE.
13. 'The Literature' about clinical drug trials is mostly drug compony sponsored, and drug company sponsored studies are a
cesspool of LIES and MANIPULATION. Most doctors grew up from Day 1 of medical school in this cesspool and they are hopelessly
brainwashed. They don't know (or care) that many studies have repeatedly proven that drug sponsored drug trials ARE FIVE
TIMES MORE LIKELY to conclude that the drug being 'studied' is as safe and effective as the current market leader, compared to NON drug-company-sponsored trials of the same drug.
14. Look around this link to get an idea of how serious this problem is: http://www.ahrp.org Most people have an idea that this problem exists, but they have no idea about how pervasive it is.
15. Regarding the 'danger' of CFC MDI emissions- THERE ARE NONE. There is NO EVIDENCE that these trivial emissions threatened the ozone layer (even some honest HFA MDI proponents admit this is nonsense), increase ground-level UVB, or increase skin cancer prevalence, which, by the way, IS NOT CAUSED BY OZONE DEPLETION in any event.
All of this is documented in the Press Room page and HFA MDIs: Poorly Tested page at www.SaveCFCinhalers.org
We invite anyone who wants to join our campaign to have Congress amend the Clean Air Act to allow for the permanent legalization of CFC MDIs to sign up at our website.
Arthur Abramson
The National Campaign to Save CFC Asthma Inhalers
#1 should read 'BRONCHOCONSTRICTOR', and we have the link (Press Room page) proving that ethanol in MDIs ARE BRONCHOCONSTRICTORS for some patients. That's right- unlike CFC MDIs, all HFA RESCUE MDIs (except Ventolin HFA) use a known BRONCHOCONSTRICTOR as a solvent.
SaveCFCinhalers.org
Actually, this has been brought up before, on threads TallDave has participated in, iirc. I've posted this four or five times now, I think: the WHO Life Tables.
Go to say, Canada, and you will see that life expectancy is given not just once, but for a range of ages, from less than one to 100+. Clicking on the life expectancy for someone aged one to four years in Canada, we find that it is 80.0 years. Clicking on the same age for the U.S. gives us 77.5 years. Somehow, I don't think that different ways of counting live births figures much into this statistic ;-) [1] Note, btw, that looking at older ages gives us more information. For someone aged 65-69, their average life expectancy is something like 19.7 years in Canada, vs 17.3 years in the U.S.
Are we all agreed then that TallDave has seen this data, that he knows where to find it, and that if he keeps repeating his debunked talking points that he will indeed be operating in extreme bad faith?
[1]Granting that different countries record live births differently, the numerically proficient person might perhaps ask what the difference in percentages amount to. If the stillborn vs live birth is one in one hundred - an absurdly high figure - then that can only influence life expectancy by an equally small weighted amount. For some figures, take 99 people who live to be 80 and one person who dies aged one; the average age then is 79.2 years instead of 80. Since the differences in life expectancy are usually greater than one year, this objection, even if true, lacks force.
Turn this around: why aren't 'the drug companies' fighting this one? If there is indeed any fighting; it seems that an at least equally plausible hypothesis is that it is simply not worth while to keep these alternatives in stock. Googling, I find that:
Well, you know, according to Megan, these companies deserve every cent of profit they make, because of all the R & D they do to bring new palliatives to the market :-)
SoV... true, new drugs SHOULD cost more. And that's fine. But in this case, the FDA BANNED an alternative drug that worked better, thus forcing patients to buy the new, more expensive drug. The FDA should have left the old one on the market and the new drug would have had to compete... then market forces would have been able to work.
It's wrong to force drug companies to lower their prices until they lose money. It's ALSO wrong to ban alternatives so that patients are forced to pay higher prices.
The more I read about how WHO gets their mortality and life expectancy data, the more skeptical I become. A lot of estimation and modification of the raw data goes on to account for many different factors... I'm not sure how they can go back and verify their modifications since they clearly don't have good data to start with (or they wouldn't have to modify it). Unfortunately, each country is different to some degree, so it's hard to know if data massaging that is appropriate for one is also appropriate for another.
If the 'alternative drug' works better, why didn't the pharmaceutical companies present evidence to the contrary? Why didn't they fight this decision? Isn't there a profit to be made from the 'superior alternative'? Assuming they fought it at all, as opposed to actively lobbying for it . . .
Notice, btw, that the drug isn't new; it's the propellant that's been changed. So why is the price higher? Surely you have some great free-markets-based explanation as to why this is so?
ScentOfViolets, the drug companies which made CFC MDIs SUPPORTED the CFC MDI ban because their CFC MDI patents were expiring, and they were given a unique opportunity to reformulate their old, blockbuster drugs (such as albuterol) with the new 'environment-friendly' HFA propellant (a very expensive process, but NOWHERE NEAR as expensive and challenging as coming up with a new drug). This allowed them to call their reformulated HFA MDIs 'Brand' drugs (with the FDA's blessing), and charge over 300% MORE than the soon-to-be generic CFC MDIs. Hope this helps.
SaveCFCinhalkers.org
Should read: SaveCFCinhalers.org
SoV... why would the pharmaceutical companies fight an FDA decision that generates more money for them?
Why would there be a free market explanation for something that is happening in a HEAVILY regulated environment?
By banning the alternative, the FDA made the market even less like a free market than it already was. The existence of a cheaper alternative would have put pressure on the drug compnaies to lower the price of the new one. Without it, there is no such pressure.
I'm in tentative agreement. Imho, Megan should be railing at the corporate types, and not the FDA (and guess on whose watch this happened on, and what their philosophy was about the companies they were supposed to provide regulatory oversight for?)
So in your view, if the FDA makes a decision that screws over patients but is good for the pharmaceutical companies, and those companies sneakily say nothing and let the FDA do it, the blame should fall on the pharmaceutical companies for, what, failing to spend time and money lobbying on behalf of third parties?
elseif, I would doubt that the role of pharmaceuticals in this was just to "sneakily say nothing". Cases like these are the reason why lobbies are created.
Our campaign is equally is critical of the drug companies (IPAC-the International Pharmaceutical Aerosol Consortium, in particular) AND Clinton/Gore's EPA Administrator (and current Global Warming Czar) Carol Browner. EPA was lead agency to the Montreal Protocol, which hammered the FDA to speed up the ban of CFC MDIs starting the year after Proventil HFA hit the streets (1997) without 'wasting time' on doing thorough postmarketing studies of HFA MDIs, even though they would SUDDENLY REPLACE CFC MDIs which 40 million Americans relied on for 30 years.
An honest, tough-minded FDA (an oxymoron) would have MANDATED that rigorous U.S. postmarketing studies of HFA MDIs be done BEFORE banning CFC MDIs. Not only did they fail to do so due to IPAC's, but they greased the skids for IPAC by using a watered-down, sweetheart 'bridging' regulatory scheme (at IPAC's suggestion) for the preclinical and clinical pre-approval trials. These clinical trials were a JOKE. The FDA deserves every ounce of criticism it gets, as does the EPA. IPAC could NEVER have pulled this off without Browner's decision to force through Decision IX/19 Part 5 at the Ninth Meeting of the Parties to the Montreal Protocol in 1997.
Republicans were largely owned by the drug companies, now Democrats get most drug company money. We know who the *radical, junk-science-based enviro-freaks support (as opposed to more rational groups such as the Environmental Investigation Agency, which NEVER advocated the ban of CFC MDIs). But turning this into a Republican/Democrat, Clinton/Bush debate is pointless- there is plenty of blame to go around for both parties and administrations.
SaveCFCinhalers.org
Should read: "Not only did they fail to do so due to IPAC's objection,... "
Megan, you are completely correct that the new inhalers do not work as effectively. As someone who got a great deal of relief from my old inhaler, I can attest to this.
Part of the problem with the conclusion that the inhalers are equally as effective is that medical professionals tend to disregard more generalized complaints from patients such as you describe from your personal experience. This happens both in studies and in physician practice.
It isn't malicious. It's just very hard to quantify such complaints and medical professionals just stop hearing them after awhile. In fact, it spurs them to rely on more empirical data that sometimes flies in the face of anecdotal feedback from patients.
That being said, the best doctors listen to their patients. If you say you can't breathe as well, then... you probably can't breathe as well.
I think the similar thing happened with insulin. The manufacture changed from animal based to a chemical manufacture. Or something similar. Most had no issue, but some had quite strong reactions.
Derek
I really hate to wish sickness or poor health on anyone. But if these people had to go what I go through with my asthma, they might have a little bit of understanding. I'm sure that one Chinese coal-fired generating plant negates the effects of this stupid-ass decision. I hope these people don't ever wake up choking, trying to breathe. Well yes I do. This stuff is garbage. It doesn't work like the old Albuterol. Jerks.
I know just enough about chemistry to know CFC's are much heavier than air. Can someone tell me how the hell they get up to the ozone layer from sea level? I've wondered for years and never heard a good explanation. I also found it interesting that one of the main supporters of a CFC ban was Dupont, who has the patent on the "new" coolants, which like the new inhalers don't work nearly as well.
In my view, the new formulation, which is more expensive, doesn't work nearly as well.
Megan, I don't know anything about your asthma other than what you've posted, and I know you say you have it well controlled. I think you should talk to your doctor about a steroid treatment for the spring season. I've used Advair and have heard good things about Symbicort. Advair is truly a miracle drug. Yes, there's a black box warning. So what? The freedom to move without any concerns at all about my asthma is worth something. (If you try Advair, obviously you should try the discus and probably avoid the new HFA formulation.)
Symbicort is an HFA inhaler, and I don't think it has a dry powder diskus version. I tried it and hated it, for the taste if nothing else. It was like using Bitter Apple as a mouthwash. Advair's much less offensive (unless you happen to be pregnant and have severe morning sickness, at least).
Think of it this way: oxygen is heavier than nitrogen, and carbon dioxide is heavier than oxygen. So why isn't there a layer of CO2 a few hundred feet thick at the bottom of the atmosphere, with a layer of O2 on top of that and above the 02 zone a layer of N2? Why do we find carbon dioxide and oxygen in the upper layers of the atmosphere?
I feel compelled to add my two cents to this argument since I seem to be the only physician here to have actually treated these patients on not on the pharma industry payroll (work in an academic center and not in any industry sponsored trial).
1. As far as the science behind the phaseout, the active ingredients are the same but the delivery mechanism has been altered. I work in an academic center taking care of a lot of patients with Medicaid or no insurance. I have been told by a significant number of them that although Medicaid gives the HFA inhaler for free (they can get three free prescriptions a month) they actually pay cash on the blackmarket to get the old inhalers. This more than anything speaks volumes out the actual user experience with CFC versus HFA. If poor people living month to month would actauly pay hard cash to get the CFC during the transition period its not just a question of getting used to it.
2. Now about the underlying motivation and incentives for the involved people. The active ingredients are the same but the delivery mechanism has been altered. This by itself should not really result in granting new patents and much higher costs but unfortunately that is not how the current healthcare system works. Most of the new drugs and top sellers on the market are just trivial modifications of prior generics but are sold at many multiples of generic prices . So there is a significant amount of money involved here. The FDA is funded by user fees and so their financial well being is related to the financial well being of the pharmaceutical industry . (the actual consumer or his health really does not matter to either the FDA or the pharmaceutical industry).
3. FDA: About its existence. Nimed, you do not seem the understand the inherent contradiction in your own logic (doublespeak in other words). So singlespeak will have to spell it out for you. The FDA banned one delivery method of a drug and brought another in its place without any data. The argument here is about banning the old formulation in the absence of any evidence of harm and not about approval of a new formulation. As far as the libertarian position goes, there should be no FDA and you should be able to get your medications at a pharmacy without a prescription.
About abuse of medications, a recent article in the New England journal of Medicine reported data from a nationwide health survey and found that a significant number of people under 30 use prescriptions drugs for abuse instead of the illegal ones like cocaine. The libertarian position would be to make everything legal.
Dear Doctor (singlespeak),
You are one of the growing number of honest, tough-minded MDs who sees through the FDA disinformation campaign on the supposed equivalent safety and efficacy of HFA MDIs.
We need strong quotes from physicians like you to post on the 'Doctors Speak Out' page at www.saveCFCinhalers.org.
We are also looking to increase the number of physicians who we can call upon when we are contacted by the media for quotes, if you are interested, but the quote for our website is most important.
Please contact me at sponsor@saveCFCinhalers.org if you are willing to provide us with a quote about your opinion of the relative safety and efficacy of HFA rescue MDIs vs CFC rescue MDIs- or your opinion of the CFC ban in general (your point #1 buy itself would be great, as is).
We would need you to use your name and city or state (your specialty and/or academic center affiliation would be optional).
Quotes such as yours are critically important to counter the lies of the FDA and the US Stakeholders Group on MDI Transition (aka The Gang of Nine):
The American Lung Association (ALA)
The Asthma and Allergy Foundation of America (AAFA)
The Allergy and Asthma Network Mothers of Asthmatics (AANMA)
The American Academy of Allergy, Asthma and Immunology (AAAAI)
The American Academy of Pediatrics
The American Association for Respiratory Care (AARC)
The American College of Allergy, Asthma and Immunology (ACAAI)
The American College of Chest Physicians (ACCP)
The American Thoracic Society (ATS)
Please help us.
Sincerely,
Arthur Abramson
The National Campaign to Save CFC Asthma Inhalers
sponsor@SaveCFCinhalers.org
I live in an area where a great deal of asthma research and testing is done, and I have been a research subject in a number of studies, including those conducted by the EPA which are specifically studying environmental factors. No one likes the HFA inhalers. The respiratory therapists don't like them. Asthma patients don't like them. Pulmonologists don't like them. As Megan said, even if they did work as well, they are considerably more difficult to use with the cleaning, priming, and types of breath required. The only advocates I've ever personally encountered for HFA inhalers 1) don't have asthma and 2) don't regularly work with people who have asthma.
Another quick footnote to add: there's a reason that most studies use mild to moderate asthmatics. Most asthma studies require numerous methacholine challenges, bronchoscopies, exposure to environmental triggers, etc. These can be dangerous for a severe asthmatic. Yes, researchers want to learn more about causes and treatments of asthma, but they don't want their test subjects hospitalized or dead.
Maretha2,
I'd really like to talk to you to hear more about your feedback from patients, pulmonologists and RRTs- I'd also love to get a quote from you for our site. (Your first paragraph above would be great- if we could have your name, and state with it, for credibility).
I'm going to disagree with you a little regarding the reason mild/moderate asthmatics were used in the clinical trials for the New Drug Applications, at least (the EPA studies you refer to may be very different from the FDA NDA clinical trials I've seen- which were watered-down 'bridging' trials. This is another thing I'd like to talk to you about.) These (NDA clinical trials) did not involve metacholine challenges, bronchoscopies, etc. They would not have endangered severe asthmatics, COPD, cystic fibrosis patients (except to the extent that the HFA MDI itself would have harmed them).
Please contact me at sponsor@saveCFCinhalers.org- we need quotes from people with your level of experience. Your feedback from MDs in particular would be invaluable. Thank you.
Lots of asthma patients find the new HFA inhalers as worse than CFC inhalers and even harmful. It is outrageous that the governments of the US, Japan, Australia, and in Europe have all banned CFC inhalers when the environmental damage from them is so small and the medical need is so large.