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oh, I wasnt sure if they did or not. More popular with school because of the non exposed needle etc?
Wow. Speechless.
Well then, I should head to Red Lobster tomorrow for lunch and just down some fried shrimp.
Not.
Ugh.
"Wow, honey, I'm 58 years old, 90 pounds overweight, and have a history of heart problems. Are you sure I should run this marathon?"
"Don't be silly, dear. With the new MedAssist Portable Defibrillator, we'll be prepared!"
Complain to the FDA, folks!
[url]http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/DrugMarketingAdvertisingandCommunications/ucm209384.htm#RecognizeReport[/url]
Email: BadAd@fda.gov
Tell them that this ad overstates the effectiveness of EpiPen.
I sent DH the link to this thread and here's what he wrote me back:Quote"Wow, honey, I'm 58 years old, 90 pounds overweight, and have a history of heart problems. Are you sure I should run this marathon?"
"Don't be silly, dear. With the new MedAssist Portable Defibrillator, we'll be prepared!"
I do love his sense of humor.
I suspect, since it is a marketing campaign, they are targeting people who might need epipens, but do not bother. They will not be selling any more epipens to people like us here. We already buy as many as we can. So, if you are the person who thinks, I won't ever need that, and Iknow a few, maybe they are trying to reach those folks. Make them recinsider. "Hmmm, maybe I shoud get one."Well, maybe they have something there-- since I'm not sure just how many epipens it would take for me to live as though I didn't have any food allergies. But I'm pretty sure it's more than a pair of refills every 18 months.
Education? Right. It is all about money and trying to sell more epipens, right?
Really misleading ad for the general public to see.
Remember, Maria Acebal is a former Dey exec. I'm not terribly surprised if there is a partnership between FAAN and Dey/Mylan such that the PR is a well-oiled machine and FAAN is controlling their message on the subject for the sake of that partnership.
we were distinctly persona non grata.
Thanks, everyone, for thinking about this and expressing your thoughts to Dey, to the FDA, and/or to others.These are very good points. The commercial like so much marketing/outreach about food allergies only focuses on peanut allergy. It's as if that were the only allergy that existed.
One thing that DD pointed out was (and this was ENTIRELY uncoached, I just showed her the ad-- no titling, no preface, no nothing); "Wow. Way to make it seem as though this doesn't interfere with ANYTHING in a person's life. It makes us look like total WHINERS if we don't live like <hand gestures> THAT."
She also had some choice things to say about the obvious extensions to gun safety... auto insurance, health insurance, etc. Yes, she went on for quite some time, once she stopped that initial speechless spluttering in inchoate fury.
This pathologically cheery "this is NO! BIG! DEAL!" attitude is fairly classic in the context of FAAN rhetoric, too, though, and it's a prime reason why we dropped our membership when DD was but a tiny tot.
They clearly weren't interested in OUR experiences with food allergies. Our experiences were so profoundly COUNTER to that cheery, Stepford-esque worldview of how to manage allergies that we were distinctly persona non grata.
SO what if they alienate kids who can't GO to the party with a cake made from "who knows what"? It's not like anyone with a reaction history like THAT is ever going to stop carrying epinephrine anyway. Why try harder, YK?
Which on the one hand, I understand as an outreach thing. I get that they want to reach the people (as becca pointed out) who don't think that they NEED to be carrying epi because they are determined to "live their lives" in spite of FA.
I just don't think it is necessary to take a giant crap on those of us who don't ever have that luxury by virtue of our (or our child's) unfortunate circumstances (being much more sensitive than average, being inconveniently allergic to a non-top-8 allergen, and/or not "outgrowing" those pesky ubiquitous allergens like wheat, soy, or milk). Way to make life even harder for the subset of people whose lives are ALREADY HARDER THAN MOST people with the condition. Way to make them have to work that much harder to gain the cooperation of those around them.
Yeah. Too bad we choose to be such a bunch of PITA's. We should just... lighten up and carry MORE epinephrine. Idiocy. :rant: <fuming>
Mylan Chief Executive Officer Heather Bresch commented, "We are pleased with this settlement, and are confident that the EpiPen® Auto-Injector will continue to be a market leader, given the proud, 20-year heritage of this important treatment for anaphylaxis. Anaphylaxis poses a life-threatening risk for many, and yet there continues to be low awareness of the signs, symptoms or steps that can be taken to be prepared to respond when anaphylaxis occurs - including ensuring immediate access to epinephrine auto-injectors. That is why we believe that, in addition to our significant efforts in this area, people with life-threatening allergic reactions will benefit from more voices in the fight to raise anaphylaxis awareness, preparedness and access to treatment."
QuoteMylan Chief Executive Officer Heather Bresch commented, "We are pleased with this settlement, and are confident that the EpiPen® Auto-Injector will continue to be a market leader, given the proud, 20-year heritage of this important treatment for anaphylaxis. Anaphylaxis poses a life-threatening risk for many, and yet there continues to be low awareness of the signs, symptoms or steps that can be taken to be prepared to respond when anaphylaxis occurs - including ensuring immediate access to epinephrine auto-injectors. That is why we believe that, in addition to our significant efforts in this area, people with life-threatening allergic reactions will benefit from more voices in the fight to raise anaphylaxis awareness, preparedness and access to treatment."
Maybe they should think about what the CEO said here when they are making their next ad.
boo ~
:bye:
:heart:
:grouphug:
Oh, he's fine! A fail in this context is a good thing - it means he's in the study. If he passed the peanut challenge, he would not have been eligible (or would need to qualify with one of his other allergies, and only hazelnuts are on their list, something to which he's never had a real reaction). He's sleeping off the Benedryl now, but it was more boring than scary, other than the 20 minutes of acute reaction.
I actually learned quite a lot today. I'll have to write a whole blog post to get it all in, but one interesting note: they consider a lowering of peak flow to be an objective symptom of a food allergy. He didn't need to get to all-out wheezing. There was no Epi - only Benedryl. (And incidently, CM, all 4 clinicians in the room had the same take on Benedryl short-circuiting reactions that you do.)
And thanks for the blog feedback. I've had haters coming out of the woodwork lately, so I appreciate it a great deal. We've become a sorry community if there's only room for one official opinion on issues and anyone who doesn't conform is shunned or harassed. Just another way I'm feeling Amish, I guess. :)
"Mylan Specialty recognizes that allergen avoidance is a critical first step to all anaphylaxis management plans and would never intentionally suggest otherwise."
Um. Except they did in a commercial. :dunce:
Doesn't really sound like taking responsibility to me.
"Mylan Specialty recognizes that allergen avoidance is a critical first step to all anaphylaxis management plans and would never intentionally suggest otherwise."
Um. Except they did in a commercial. :dunce:
Doesn't really sound like taking responsibility to me.
I'm glad that the ad has been pulled. I think FAAN should give more credit to the little people who demanded that they sit up and pay attention!
I'm glad that the ad has been pulled. I think FAAN should give more credit to the little people who demanded that they sit up and pay attention!
QFT! I love how they always pat themselves on the back, but they probably didn't even know about the ad until lots of other people in the community pointed it out.
Confirming ad has been pulled. :yes:
From Elizabeth Goldenberg-onespot Allergy: Update via Dr. John James CO Allergy Asthma:
"I just heard from the FAAN office and they said that Mylan will be pulling the commercial on EpiPen today. Apparently, they are going to extensively modify the commercial and said that FAAN may review the content before launching again later this summer. This will be a good thing!!! You can pass this information along…" Dr. John James WAY TO GO Lisa Horne, Arizona Food Allergy Alliance, and Team Anaphylaxis for spearheading the effort to get this dangerous ad off the air! Thank you to everyone who tweeted, posted, emailed, and called Dey Pharma/Mylan and the FDA. Victory!!
I'm glad that the ad has been pulled. I think FAAN should give more credit to the little people who demanded that they sit up and pay attention!
You guys are really, really sweet. Ok...I'm officially registered. But I really need to limit my time here! (Who's laughing right now, knowing how that's gone for me over the last 13 years...)
Carefulmom, I've thought of your daughter often. We started baked milk last summer. Frankly, it's been hard to get geared up for it, since my son still had mild reactions if we cross a magical threshold. He cannot tolerate baked cheese at all. However, we were up to half milk/butter in a cinnamon roll recipe before stopping for this trial. Unfortunately, we can't do both, at least at first. They want to know the changes are the results of the medication, not mild dosing.
How is your daughter doing?
I'm glad that the ad has been pulled. I think FAAN should give more credit to the little people who demanded that they sit up and pay attention!
Carefulmom, I assumed that that's what they meant. But it is hardly clear from the commercial (unless it was in the fine print at the bottom that I couldn't read), and not the conclusion that 99% of the viewers would come to. Very, very damaging, IMHO.
Seriously, I think it's good that the commercial got pulled but I really don't feel like cheering about it. This might have actually helped moms who don't have Epi-Pens get Epi-Pens. Now they won't.
Kids without Epi-Pens. Yay.
It's a complicated issue. I hate how our community always makes it so black and white. You're either with "us" or you're not worth saving. I really don't see advocates stepping in and trying to reach these mothers and, as Mylan pointed out in their letter, there are a ton of them.
Boo's posts and blog are very interesting. I think it is maybe the best blog I have seen so far on FAs. :)
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.
"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.
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.
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.
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.