Posted by: CMdeux
« on: January 24, 2014, 01:49:08 PM »
And let me just add that the image that created in my head made me smile.
News:
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And let me just add that the image that created in my head made me smile.
Posted by: twinturbo
« on: January 24, 2014, 01:10:16 PM »Forceful correction documented in the public eye treated with equal weight as any other medical consumer protection is far, FAR more valuable than any monetary amount but that it did include a slight damage amount as it would for virtually any other breach is important in the sense it wasn't treated any more or any less. Just saying what I appreciated about it. It makes me want to hug kittens and throw daisies in the air.
Posted by: CMdeux
« on: January 24, 2014, 01:00:13 PM »Oh, I doubt it too-- and the amount of the monetary award actually paid out seems WAY excessive to me...
but the publicity is a very good thing in the wake of the ad, and that's the ultimate benefit there. That is, neither state could really afford to mount a national campaign that would have the visibility to debunk the original ad, but the media picking up the settlement-- and esp. AG Rosenblum's statements-- accomplishes almost as much in the end.
but the publicity is a very good thing in the wake of the ad, and that's the ultimate benefit there. That is, neither state could really afford to mount a national campaign that would have the visibility to debunk the original ad, but the media picking up the settlement-- and esp. AG Rosenblum's statements-- accomplishes almost as much in the end.
Posted by: LinksEtc
« on: January 24, 2014, 12:55:10 PM »Well, except that probably they can argue that the stress on public-health services from people following the (seeming) advice in this ad...
well, you see where I'm going with that one, right?
Sure it sells devices, but is also promoting their USE, basically, by advocating poor management. Which means emergency room use, too.
Yeah, sure, I can see the argument ... I personally would have left it alone once the lesson was learned (as provided by FDA & the allergy community) ... but that's just me. I can't say for sure, but I doubt the ad directly caused an increase in reactions. Just my opinion <shrug>.
Posted by: twinturbo
« on: January 24, 2014, 12:32:09 PM »Here's the release from state DOJ. AG Rosenblum understands avoidance and epinephrine well. Almost a little too well to not have some personal background in it.
Quote
MISLEADING EPIPEN ADVERTISEMENTS LEAD TO SETTLEMENT
November 7, 2013
Attorney General Ellen F. Rosenblum announced today that pharmaceutical company Mylan Specialty L.P. has agreed to submit any new television commercials for EpiPen and EpiPen Jr. to the Food and Drug Administration before airing them to consumers. Mylan further agrees to address any material FDA comments about the submitted advertisements, and to provide notice to the Oregon Department of Justice if FDA does not comment on the materials.
Today’s agreement also requires Mylan to pay $250,000 to the State of Oregon. Mylan denies wrongdoing.
The settlement concludes DOJ actions taken in response to a national television advertisement that promoted EpiPen products. Attorney General Rosenblum alleges that the commercial wrongly suggested that parents who were “prepared with EpiPen” did not need to worry about letting their allergic children eat food with unknown ingredients.
“Severe food allergies are a potentially fatal health risk,” said Attorney General Rosenblum. “Epinephrine injections can save lives in emergencies, but Mylan was extremely irresponsible to suggest to parents that EpiPen is a substitute for vigilantly avoiding their children’s allergens. Our resolution of this case ensures that consumers will understand the limitations of EpiPen as well as its approved uses.”
In December of 2012, Pfizer, Inc. agreed to pay Oregon $1 million over Pfizer’s role in the same advertising campaign. Although Pfizer and Mylan had marketed EpiPen jointly, Mylan subsequently obtained Pfizer’s interests in EpiPen products in the United States.
Following the Pfizer settlement, Oregon DOJ learned that the office of Massachusetts Attorney General Martha Coakley was conducting a related investigation regarding Mylan. Attorney General Rosenblum thanks Assistant AG David Hart for coordinating with his colleagues in Massachusetts to achieve this excellent result for Oregonians.
Quote
Pfizer Inc. and Mylan Specialty LP reached settlements with the State Attorney General of Massachusetts related to a 60-second TV commercial that ran in April 2012 for EpiPen. The state alleged that the commercial violated a 2008 consumer protection settlement because it misled consumers into believing that carrying the self-administered epinephrine injector alone was sufficient to protect against life-threatening reactions. Pfizer as the EpiPen manufacturer agreed to pay $375,000 and Mylan as the exclusive licensee agreed to pay $250,000. Pfizer also agreed to extend the term of its consumer protection settlement an additional 18 months for ads that run in Massachusetts.
Posted by: CMdeux
« on: January 24, 2014, 12:04:07 PM »Well, except that probably they can argue that the stress on public-health services from people following the (seeming) advice in this ad...
well, you see where I'm going with that one, right?
Sure it sells devices, but is also promoting their USE, basically, by advocating poor management. Which means emergency room use, too.
well, you see where I'm going with that one, right?
Sure it sells devices, but is also promoting their USE, basically, by advocating poor management. Which means emergency room use, too.
Posted by: LinksEtc
« on: January 24, 2014, 12:00:40 PM »I don't know ... they already got slapped on the wrist by FDA (which I think was good)... but states getting this much $ out of this thing (which probably wasn't even intentional) seems a bit overboard ... just my opinion.
Posted by: Macabre
« on: January 24, 2014, 10:25:21 AM »You may wand to make that
[url=http://blah blah
[url=http://blah blah
Posted by: twinturbo
« on: January 24, 2014, 09:56:22 AM »Mylan settles deceptive ad charges involving EpiPen
So.
Where's my money? And
state AG you rock and you know it.
Quote
"Mylan was extremely irresponsible to suggest to parents that EpiPen is a substitute for vigilantly avoiding their children's allergens," said Attorney General Ellen Rosenblum of Oregon, which also will get $250,000.
Mylan denied any wrongdoing, the Oregon attorney general's office said.
Mylan did not respond to an email Friday seeking comment.
New York City-based Pfizer, which received a warning letter about the ad campaign from the FDA, agreed to pay $375,000 to Massachusetts to settle the deceptive ad charges. Last year, it agreed to pay Oregon $1 million.
So.
Where's my money? And
state AG you rock and you know it.Posted by: rainbow
« on: April 23, 2012, 08:11:45 PM »x
Posted by: rainbow
« on: April 23, 2012, 08:07:54 PM »Wow...I didn't see the ad and just caught up on this. The link doesn't work now that the ad is pulled - anyone know how to see it?
Totally irresponsible...and in my years dealing with anaphylactic food allergies, I've had many people say to me, "But the Epipen will just work right!". They don't seem to understand that if it is at that point, it is extremely serious and in fact, it doesn't always work! So, no, it is NOT safe to just eat that Birthday Cake with "who knows what" in it!! (although, they are right that many allergy kids do, and w/out Epipens, but the tone of their ad was encouraging it as long as the child had the Epipen).
FYI, to those not understanding the Type I diabetes situation...kids (and adults) with the most severe form are often on an insulin pump 24x7. The pump (which controls insulin flow directly into veins thru a catheter - a needle in the vein all the time just like an IV) when the child eats extra carbs (e.g., a cupcake or candy bar, or extra piece of fruit, or extra bread - all high carb foods). If the child goes without insulin, the child will go into insulin shock and die if the insulin is not given in time. It IS extremely serious. And, they are dealing with constantly watching intake and adjusting a constant flow of medication (insulin), day in and day out. My friend's child was on the pump since he was THREE when his body suddenly stopped producing insulin and he went into shock and almost died (he is 6 now). These kids go to the school nurse constantly for help in adjusting insulin, checking blood sugar (which they must do several times a day by pricking their finger), etc. Others not on the pump likely require a shot from the school nurse after lunch. These kids do not have it easy -- it affects daily quality of life and carries risk of death if not properly managed -- and we need to be compassionate toward that community too.
Totally irresponsible...and in my years dealing with anaphylactic food allergies, I've had many people say to me, "But the Epipen will just work right!". They don't seem to understand that if it is at that point, it is extremely serious and in fact, it doesn't always work! So, no, it is NOT safe to just eat that Birthday Cake with "who knows what" in it!! (although, they are right that many allergy kids do, and w/out Epipens, but the tone of their ad was encouraging it as long as the child had the Epipen).
FYI, to those not understanding the Type I diabetes situation...kids (and adults) with the most severe form are often on an insulin pump 24x7. The pump (which controls insulin flow directly into veins thru a catheter - a needle in the vein all the time just like an IV) when the child eats extra carbs (e.g., a cupcake or candy bar, or extra piece of fruit, or extra bread - all high carb foods). If the child goes without insulin, the child will go into insulin shock and die if the insulin is not given in time. It IS extremely serious. And, they are dealing with constantly watching intake and adjusting a constant flow of medication (insulin), day in and day out. My friend's child was on the pump since he was THREE when his body suddenly stopped producing insulin and he went into shock and almost died (he is 6 now). These kids go to the school nurse constantly for help in adjusting insulin, checking blood sugar (which they must do several times a day by pricking their finger), etc. Others not on the pump likely require a shot from the school nurse after lunch. These kids do not have it easy -- it affects daily quality of life and carries risk of death if not properly managed -- and we need to be compassionate toward that community too.
Posted by: rainbow
« on: April 23, 2012, 07:56:24 PM »
I do not think all these people are uneducated. I do not think they are all in denial. I do not think all their kids have only had mild reactions. There are just some moms who are unmotivated by fear, or who are motivated by social concerns that are stronger than the fear.
I think they are playing the odds. Yes, kids can die from food allergies but very few do. Thank God! But that's the reality. They can almost always not carry an Epi-Pen and their kid will either have a mild reaction that requires only Benedryl OR the ambulance will get there in time.
There's a social cost and a stigma from allergies. Allergic kids are not cool. Allergic moms have a not-great reputation of sometimes being over the top. Allergies lead to teasing and exclusion. If a mother could avoid all that and the risk of death was very low (and it is), I can see why she might want to. Apparently a good percentage of them want to.
The mom in the commercial was very cool. Young. Skinny. Nice make-up, clothes, jewelry. Looked like an SUV. Max/Jake popular boys names. All the cool trappings were there.
Yep. All this exactly!!
(and welcome back boo!)
Posted by: CMdeux
« on: April 23, 2012, 05:05:05 PM »I do think that a first step is to more honestly address the questions about risk-benefit in a way that doesn't dismiss the value of normalcy in contributing greatly to quality of life.
There are some people who really can live nearly normally-- and maybe they should. Maybe those of us with greater sensitivity or more ubiquitous allergens need to live a more restrictive kind of lifestyle, but maybe it also isn't for us to say that everyone has to manage food allergies that way, YK?
I think this point is particularly important in light of recent research developments that suggest rather strongly that strict avoidance (beyond that needed to avoid major reactions, I mean) is probably more harmful than beneficial in terms of kids outgrowing or having diminishing sensitivity.
An honest acknowlegement that risk profiles differ substantially between individuals is probably a great first step to making room for everyone to live openly with food allergies. If we remove the "crazy" stigma associated with those epipens, maybe more COOL moms would be okay with keeping one around, YK?
This ad in particular was a pretty ham-fisted attempt in that direction, I think. But the ideas behind that aren't necessarily a bad thing. I don't mind at all if someone ASKS me just what "food allergies" means in my particular circumstances. I'm guessing that CoolMom wouldn't mind that either.
There are some people who really can live nearly normally-- and maybe they should. Maybe those of us with greater sensitivity or more ubiquitous allergens need to live a more restrictive kind of lifestyle, but maybe it also isn't for us to say that everyone has to manage food allergies that way, YK?
I think this point is particularly important in light of recent research developments that suggest rather strongly that strict avoidance (beyond that needed to avoid major reactions, I mean) is probably more harmful than beneficial in terms of kids outgrowing or having diminishing sensitivity.
An honest acknowlegement that risk profiles differ substantially between individuals is probably a great first step to making room for everyone to live openly with food allergies. If we remove the "crazy" stigma associated with those epipens, maybe more COOL moms would be okay with keeping one around, YK?
This ad in particular was a pretty ham-fisted attempt in that direction, I think. But the ideas behind that aren't necessarily a bad thing. I don't mind at all if someone ASKS me just what "food allergies" means in my particular circumstances. I'm guessing that CoolMom wouldn't mind that either.
Posted by: CMdeux
« on: April 23, 2012, 04:57:49 PM »Right-- their brains automatically go to "Oh, that is for those people. Not me."
It's a weird diversionary loop in their thinking. I've seen it happen with my own two eyes, and it's really an amazing thing to see in action.
It's this strange thing that is the opposite of catastrophizing, which is what the over-the-top (okay, probably borderline mentally-ill) parents do on the other end of the spectrum. Those are the parents who have never seen their child have a reaction-- ANY reaction-- to anything-- but "just to be sure" have them blood-tested with a "panel" of allergens... and carry autoinjectors (multiples) for those "found" allergies, call every manufacturer, make it their mission to have all of the child's putative allergens removed from play-groups, daycare, preschool, etc...
I'm not sure which of those two groups is in more need of intervention, nevermind which one is more resistant to it.
Both are cognitive distortions in some respects, but both will always result in anecdotal evidence to support the beliefs, as well. In the first group, the odds are in their favor anyway for never having it happen to them, and in the second, well, minimizing risk may be a game of diminishing returns, but by golly, they. are. SAFE-SAFE-SAFE.
This is like the golfer that shrugs at weather warnings and says (rightly) "I've been playing through thunderstorms for YEARS and I've never been struck by lightning. Why WORRY??"
as compared to most golfers who say; "It's a low risk, but it's not worth taking."
Then there is an admittedly tiny group that avoids golf courses entirely and refuses to wear anything containinig metal as a means of avoiding being struck by lightning. Rational? Well, probably not. But they can certainly claim that they are keeping themselves safe from harm, and the evidence speaks for itself. They haven't been struck by lightning, right?
The real question to ask ourselves is...
where do we PERSONALLY fall on that spectrum? I'm pretty confident in saying that I'm not so risk averse that I'm playing golf with wooden golf clubs, YK? But I'm also not playing in FL during severe weather and congratulating myself on the great tee time availability. LOL. Okay, probably not the most awesome analogy at some point, here, but you get the idea.
It's a weird diversionary loop in their thinking. I've seen it happen with my own two eyes, and it's really an amazing thing to see in action.
It's this strange thing that is the opposite of catastrophizing, which is what the over-the-top (okay, probably borderline mentally-ill) parents do on the other end of the spectrum. Those are the parents who have never seen their child have a reaction-- ANY reaction-- to anything-- but "just to be sure" have them blood-tested with a "panel" of allergens... and carry autoinjectors (multiples) for those "found" allergies, call every manufacturer, make it their mission to have all of the child's putative allergens removed from play-groups, daycare, preschool, etc...
I'm not sure which of those two groups is in more need of intervention, nevermind which one is more resistant to it.
Both are cognitive distortions in some respects, but both will always result in anecdotal evidence to support the beliefs, as well. In the first group, the odds are in their favor anyway for never having it happen to them, and in the second, well, minimizing risk may be a game of diminishing returns, but by golly, they. are. SAFE-SAFE-SAFE.
This is like the golfer that shrugs at weather warnings and says (rightly) "I've been playing through thunderstorms for YEARS and I've never been struck by lightning. Why WORRY??"
as compared to most golfers who say; "It's a low risk, but it's not worth taking."
Then there is an admittedly tiny group that avoids golf courses entirely and refuses to wear anything containinig metal as a means of avoiding being struck by lightning. Rational? Well, probably not. But they can certainly claim that they are keeping themselves safe from harm, and the evidence speaks for itself. They haven't been struck by lightning, right?
The real question to ask ourselves is...
where do we PERSONALLY fall on that spectrum? I'm pretty confident in saying that I'm not so risk averse that I'm playing golf with wooden golf clubs, YK? But I'm also not playing in FL during severe weather and congratulating myself on the great tee time availability. LOL. Okay, probably not the most awesome analogy at some point, here, but you get the idea.
Posted by: booandbrimom
« on: April 23, 2012, 03:42:09 PM »Boo's posts and blog are very interesting. I think it is maybe the best blog I have seen so far on FAs.
Oh man! High praise indeed.
(Seriously...thank you.)I do not think all these people are uneducated. I do not think they are all in denial. I do not think all their kids have only had mild reactions. There are just some moms who are unmotivated by fear, or who are motivated by social concerns that are stronger than the fear.
I think they are playing the odds. Yes, kids can die from food allergies but very few do. Thank God! But that's the reality. They can almost always not carry an Epi-Pen and their kid will either have a mild reaction that requires only Benedryl OR the ambulance will get there in time.
There's a social cost and a stigma from allergies. Allergic kids are not cool. Allergic moms have a not-great reputation of sometimes being over the top. Allergies lead to teasing and exclusion. If a mother could avoid all that and the risk of death was very low (and it is), I can see why she might want to. Apparently a good percentage of them want to.
The mom in the commercial was very cool. Young. Skinny. Nice make-up, clothes, jewelry. Looked like an SUV. Max/Jake popular boys names. All the cool trappings were there.
Remember how many people refused to wear seat belts? For some of us, the fear of accidents was great and wearing a seat belt was always a no-brainer. For others, it was uncool and they probably weren't going to be in an accident anyway, right? It took a law to get (mostly) compliance.
There are always glass-half-full people and glass-half-empty people when it comes to risk. You have to market completely differently to the two groups. It's unfortunate that there are virtually no other marketing efforts to this other group because, as long as the percentage of them is so high, people will continue to believe we overreact, rather than that they under-react. Showing them the news stories of dead kids would make no difference. The news channel does that every night. They're aren't wired to personalize it.