For the last ten days, we have brought attention to the EpiPen pricing issue, as we have heard from parents around the country who are stunned with the new price of a product that has been around for 50 years, especially as they head back to school and find themselves needing to buy multiple sets to keep their children safe. Like the single mom who just shared this image: a $925 price tag for one set of EpiPens with coupon and insurance.
As we began to shine a light on this issue, images flooded in when we asked parents to share pictures of their receipts. As one mom wrote, “I thought I was the only one.” She isn’t, and with the food allergy epidemic in full force, she is joined by millions of parents who share her concern.
Senate Judiciary Committee Chairman Chuck Grassley (R-Iowa) is asking the CEO of Mylan, the maker of EpiPens, to explain sharp increases in the device’s price.
“The substantial price increase has caused significant concern among patients,” Grassley, who is up for reelection this year, wrote in a letter to the company. “I have heard from one father in Iowa who recently purchased a refill of his daughter’s EpiPen prescription. He reported that to fill the prescription, he had to pay over $500 for one EpiPen.”
And while Mylan is saying that their abusive pricing practices are justified because they gifted American schools with some EpiPens, Grassley and millions of Americans aren’t buying it. That’s like an abusive spouse saying their behavior is justified because they gifted the abused.
It’s abusive pricing. Lives are at risk. On top of that, as Senator Grassley mentions, over 40% of American children are on Medicaid, so taxpayers are the ones who are actually shelling out for Mylan’s price-gouging in those cases.
Read Senator Grassley’s letter below. He raises some very important points.
We are sharing this article from Dr Lee Rogers who voiced his concern about the price-gouging of EpiPen consumers and the fact that Mylan’s CEO has a dad in the Senate. Please read on to learn more. At the end, he provides steps of what patients can do.
Anaphylaxis is a deadly reaction to an allergy. After exposure to an allergen, a person breaks out in hives, lips swell, has difficulty breathing, and wheezes, which can eventually lead to shock and death. It has happened to as many as 1 in 50 Americans. Yet, it is one of the simplest emergencies to treat. The initial life-saving treatment is injecting epinephrine (adrenalin) into the fat or muscle, followed by care from a medical professional.
Epinephrine is a hormone produced by the adrenal glands. The body releases it during the “fight-or-flight” response. It increases the heart rate, improves blood flow to muscles, dilates the bronchioles in the lungs (to increase air exchange), and constricts other blood vessels (to shunt blood to vital organs). As a hormone, it a product of nature and cannot be patented.
Seems pretty straight forward, right? Well, not any more. Mylan Pharmaceuticals, the manufacturer of the most commonly used device to deliver epinephrine, called the EpiPen, just jacked up the price of the medication over 400% and there doesn’t seem to be any better reason than… “because they could.”
EpiPen has been around since 1977, but Mylan acquired the product in 2007 when the it cost about $57. Now according to many media outlets and the prescription drug price comparison website www.GoodRx.com, the price has skyrocketed to $640. Fortunately for Mylan, EpiPen has an expiration date of one year, causing the company to bank on an annuity of more than $600 from families who need the life-saving medication, a vast majority of which go unused every year.
The price of epinephrine hasn’t increased in the past 10 years. In fact the epinephrine inside EpiPen costs less than $1. I doubt the price to manufacture EpiPen’s autoinjectors has changed. So what has changed? There are two recent events that help explain. First, EpiPen’s only major competitor, Auvi-Q made by Sanofi, underwent a voluntary recall due to possible dosage miscalabrations. And secondly, this year the FDA rejected an application, which would have been much cheaper, perhaps costing only $10-20, however not auto injected. That opened the door for Mylan to price-gouge consumers into paying outrageous fees for their life-saving medications.
Just in case you might be susceptible to the “poor pharmaceutical company argument,” EpiPen, just one of the products Mylan sells, brings in $1 billion a year and which boosted the company’s 2nd quarter numbers in 2016.
Déjà vu?
If any of this sounds familiar, that’s because it is. We all remember Martin Shkreli, the former CEO of Turing Pharmaceuticals, the sole manufacturer of Darapim, who notoriously raised the price of the generic HIV medication from $14 to $750. Shkreli faced tremendous public scrutiny and was referred to by the media as “the most hated man in America.” Eventually, he was subpoenaed to testify before Congress, charged with securities fraud, and resigned as CEO of Turing.
Who is Shkreli referring to? None other than Mylan CEO Heather Bresch. Bresch isn’t some ordinary greedy pharmaceutical executive. She’s the daughter of US Senator Joe Manchin (D-WV). She finished her BA in political science at West Virginia University (WVU) and was hired by Mylan in 1992 after her powerful father spoke to former CEO Milan Puskar. She rose through the ranks at Mylan, eventually serving at Director of Government Relations from 2002-2005, while her father was WV Secretary of State. In 2008, there was a controversy at WVU after she claimed to have an MBA. The university initially disputed the claim, but then awarded her an MBA despite only completing 22 of 48 credits required. After public embarrassment, WVU rescinded her degree and the university president, a former consultant and lobbyist for Mylan, resigned in disgrace.
In 2011, just after her father was elected to replace the late Robert Byrd as US Senator, she spearheaded the effort in Congress to pass the Generic Drug User Fee Act, making it more difficult for foreign generic drug makers to import into the United States. In 2012, she became CEO of Mylan Pharamceuticals. Fortune Magazine named her as one of the “50 Most Powerful Women in Business in 2012 and 2013.”
Then in 2015, Mylan purchased Abbott’s generic drug division located in the Netherlands. At that point, Bresch led Mylan through complex and controversial corporate tax inversion to base Mylan’s headquarters (domicile) in the Netherlands in an effort to avoid paying US corporate taxes. The corporate executives still live in the US and run the company from the US. The tax inversion is expected to reap the company an additional 10% in profits. The move wasn’t good for everyone. Normally there are no tax implications from a corporate merger for shareholders. But with tax inversions, investors have to pay capital gains tax on the difference between the stock price at their initial investment and what the new company’s stock price would be. Some shareholders were advised to sell their shares at a loss to offset tax capital gains taxes they’d have to pay.
All of this may cause political problems for Bresch’s father, Sen. Manchin. Sen. Bernie Sanders (I-VT) has been very critical of the price hike, taking to Twitter to decry the move. Sen. Amy Klobuchar (D-MN), who was an advocate for getting EpiPens into schools, is now breathing fire over this decision by Mylan. In a recent statement, she said:
“This outrageous increase in the price of EpiPens is occurring at the same time that Mylan Pharmaceutical is exploiting a monopoly market advantage that has fallen into its lap,” said Klobuchar. “Patients all over the U.S. rely on these products, including my own daughter. Not only should the Judiciary Committee hold a hearing, the Federal Trade Commission should investigate these price increases immediately. The Commission should also report to Congress on why these outrageous price increases have become common and propose solutions that will better protect consumers within 90 days.”
Hauling a fellow Senator’s daughter into Congressional Hearings à la Pharma Bro Martin Shkreli would certainly not be good for Senate Democrats, not to mention the embarrassment to Senator Manchin casting light on his daughter’s actions during her tenure as CEO of Mylan.
Additionally, Bresch’s actions may win her a new title, next to Shkreli as the “most hated woman in America.”
What Can Patients Do?
I agree, the EpiPen’s design makes delivering a life-saving drug as simple and as effective as possible. But if you can’t afford to be price-gouged for $600, there are alternatives that are still just as life-saving.
A 1 mL ampule of epinephrine costs less than $5. The dose of epinephrine for anaphylaxis is 0.3 to 0.5 ml delivered subcutaneously (in the fat) or intramuscularly (in the muscle). If patient and family members are comfortable with drawing up their own medication and injecting (no more difficult than using insulin), they can request a prescription from their doctor for the vial and syringes. An example of how the prescription would read is below. This would cost about $10.
Prescription:
Rx: Epinephrine 1:1000, 1 mL ampule
Rx: 1 cc syringe with 25g 1.5 cm needle
Instructions: For severe allergic reaction, break ampule and fill syringe with 0.3 mL of epinephrine, inject under the skin. Call 911 or go to the nearest emergency room.*
*specific instructions will differ, always confer with your doctor.
Owen Mumford makes an auto-injector called Autoject which costs $28. This could be used instead of the syringe if auto injection is desired. It is more complex than the EpiPen and the above method.
Another alternative is the Adrenaclick epinephrine autoinjector which is closest to the EpiPen. It costs approximately $200.
I always recommend patients price shop for their medication. The GoodRx website is a good place to start. A pharmacist can also help find certain coupons or incentives might be available that lower the out-of-pocket costs.
The number of people in the U.S. with food allergies is skyrocketing.
For the last year, we’ve been working to bring an awareness to the risk that the skyrocketing price of EpiPens creates, and the fact that some families are now priced out of this life saving devices due to its jaw-dropping price tag of about $600.
As recently as the 3rd quarter of 2015, the price of one EpiPen was at $300. But that number is misleading, as the product is sold in a two-pack, so the consumer has to pay $600. In some cases, like this week in Colorado, a parent paid over $700 for the exact same device that just six years ago cost $100. No product changes, no device changes, and the key ingredient inside only costs a few dollars.
So what’s going on?
There is very little competition on the market which only makes matters worse. Last year, Auvi-Q, an alternative device designed by twin brothers who wanted an easy-to-carry option was recalled. The New York Times covered their amazing story in 2013 and the sale of their company to Sanofi. It was short-lived.
According to the FDA, “As of October 26, 2015, Sanofi has received 26 reports of suspected device malfunctions in the US and Canada. None of these device malfunction reports have been confirmed.”
So the entire product line was recalled because of 26 unconfirmed reports. 26 unconfirmed reports.
Apparently, a very similar device is also used to deliver other medications and no reports have been mentioned or product recalls announced. According to Kaleo Pharma, “on April 3, 2014, the FDA approved EVZIO, the first and only naloxone auto-injector intended to be available for emergency administration by family members or caregivers in cases of known or suspected opioid overdose. The company’s first product approval, Auvi-Q™ (www.Auvi-Q.com) (Allerject™ in Canada), was licensed to Sanofi US which launched the product in early 2013.”
The Virginia-based company recently regained the rights to the auto-injector from Sanofi US following a full device recall in the fall of 2015. “We now own the product. We are in the process of figuring out when and how best to bring Auvi-Q back to the market,” Spencer Williamson, president and CEO of Kaléo. According to the Richmond Times “earlier this year, Sanofi US and Kaléo terminated a 2009 agreement that called for Sanofi to manufacture and market the Auvi-Q auto injector.
“A Sanofi representative at the time said the company was able to retrieve some of the 26 devices consumers reported not working correctly but was not able to identify a malfunction in the device.”
The entire product line was recalled because of 26 unconfirmed reports that the company itself was not able to identify.
A competitor can’t come on the market soon enough. Stories of needles breaking and failed EpiPen injections riddle social media conversations and private food allergy groups. Consumers have been priced out by a product that Fast Company called a “faulty design,” and lives are at risk.
The rate of people with peanut allergy in the United States more than quadrupled between 1997 and 2010. A life-threatening food allergic reaction now sends someone to the E.R. once every three minutes in the U.S.
The food industry is getting in on it. Mondelez, formerly known as Kraft, recently acquired Enjoy Life Foods, a popular and well-loved brand in the allergy space, free from many of the top eight allergens and also free from genetically modified ingredients.
It was a $40 million company that was acquired for over $80 million.
What does Mondelez plan to do with the acquisition? Grow it into a billion dollar brand.
What are some other billion dollar brands? Cheerios, Lays, Pepsi, Starbucks….
And EpiPen.
According to Bloomberg, “In a 2007 purchase of medicines from Merck, drug maker Mylan picked up a decades-old product, the EpiPen auto injector for food allergy and bee-sting emergencies. Management first thought to divest the aging device, which logged only $200 million in revenue. Today, it’s a $1.2 billion-a-year product that clobbers its rivals and provides about 40 percent of Mylan’s operating profits.”
Food allergies are not a niche, it is a growing epidemic that is challenging how we think about our food and how it is made. Genetic factors don’t change this quickly, environmental factors do. Are we allergic to food or to what’s been done to it? A lot of families now pay more for free-from food, because we don’t know the answer to that question.
Researchers report that the costs of food allergies, from medical care to food to pharmaceuticals is $4,184 per child per year, costing our economy $25 billion, including lost productivity.
Researchers reporting in the Journal of the American Medical Association states that the costs of food allergies, from medical care to food to pharmaceuticals is $4,184 per child per year, costing our economy $25 billion, including lost productivity.
On top of that, the costs to families with food allergies is skyrocketing. After insurance company discounts, a package of two EpiPens costs about $415. By comparison, in France, where Meda sells the drug, two EpiPens cost about $85. Back in 2007, when the company was purchased, it cost $57. EpiPens wholesale price rose 400% since 2007 and 32% in the last year alone. EpiPen margins were 55 percent in 2014, up from 9 percent in 2008.
According to Bloomberg, the company’s marketing techniques play on the fears of parents and caregivers. There is no incentive here to find a cure or to stop the condition. Sales are explosive.
To discount this condition in any way is irresponsible, but it is just one of the conditions that is triggering a food awakening around the country.
In the last year, Target, Chipotle, Kroger, even General Mills and Cheerios have responded to this growing demand in the marketplace. Free-from foods are showing up in Dollar Tree stores.
These companies aren’t stupid. They see the escalating rates of diseases in their own employees, they feel the financial impact with their own health care costs, and they hear consumers that are saying they want to eat fewer fake, artificial and genetically engineered ingredients.
While the chemical companies selling these new ingredients say there is no evidence of harm, consumers are saying: there is no evidence since these ingredients were never labeled in the United States.
In other words, if you walked into an allergist’s office and asked if you were allergic to soy that has been in the food supply for thousands of years or if you are allergic to Roundup Ready soy, non-GMO soy treated with Roundup or organic soy, there would be no test to give you that answer. Next time, you are at the allergist’s office, ask which soy they are testing for.
With no labels on GMO ingredients in the US to trace their impact and no test to offer definitive answers, the biotech industry is able to claim that there is not a single documented case of these foods ever causing harm.
The explosion in EpiPen sales is significant. It’s significant to the families that use them and delivers significant revenue to the pharmaceutical company selling them, especially here in the United States. EpiPen actually represents 40% of Mylan’s profits.
A study released in the Journal of the American Medical Association, says yes, living in the United States increases your risk of allergic diseases……“significantly.”
“Living in the US raises risk of allergies,” says the headline.
According to the research, living in the United States for a decade or more may raise the risk of some allergies, reports the Journal of the American Medical Association.
“These data indicate that duration of residence in the United States is a previously unrecognized factor in the epidemiology of atopic disease,” it said.
In other words, the longer you live here, the more likely you are to develop some kind of allergy, asthma, eczema or other related condition.
Food allergies have been skyrocketing in the United States in the last fifteen years. Not only has the CDC reported a 265% increase in the rates of hospitalizations related to food allergic reactions in a ten year period, but the sales of EpiPens, a life-saving medical device for those with food allergies, has also seen record sales growth according to the New York Times.
So what’s going on?
The study aimed to find out. Allergies reported in the survey included asthma, eczema, hay fever, and food allergies.
“Children born outside the United States had significantly lower prevalence of any allergic diseases (20.3%) than those born in the United States (34.5%),” said the study led by Jonathan Silverberg of St. Luke’s-Roosevelt Hospital Center in New York.
Let’s restate that:
Children born in the US have more than a 1 in 3 chance of having allergic diseases like food allergies, asthma or eczema, while kids born in other countries around the world had a “significantly lower prevalence” of 1 in 5.
On top of that, “foreign-born Americans develop increased risk for allergic disease with prolonged residence in the United States,” it said.
In other words, if you move here, your chances of developing any one or more of these allergic diseases increase.
The study went so far as to say that children born outside of the US who moved here showed “significantly” higher odds of developing these diseases.
What’s driving this? Is it really Purel and intense handwashing? And the hygiene hypothesis?
And are we allergic to food? Or what’s been done to it?
Because genetics don’t change that quickly, and the environment does.
This presents a risk not only to these children, but also to our economy, as the financial burden of these conditions and their associated health care costs impact not only families but also our country, our military and our productivity.
So what is triggering this escalating, US allergy epidemic?
According to Reuters report on the study and Dr. Ruchi Gupta, who studies allergies at the Northwestern University Feinberg School of Medicine in Chicago but wasn’t involved in the new research, “This is definitely something we see clinically and we’re trying to better understand, what is it in our environment that’s increasing the risk of allergic disease?” said
“Food allergies have increased tremendously,” she told Reuters Health. “We do see people who come from other countries don’t tend to have it.”
Genetically engineered crops are created by inserting a protein from a different organism into the original crop’s genome. This is usually done to create a plant that is more resistant to insects or diseases.
The Food and Agriculture Organization within the World Health Organization has a structured approach to determining whether genetically engineered foods cause allergies, according to Venu Gangur, MSU assistant professor of food science and human nutrition, who also is a faculty member in the National Food Safety and Toxicology Center. “But it has a major flaw. A critical question in that process asks, ‘Does the protein cause an allergic reaction in animals?’ The problem is that there has been no good animal model available to test this.”
It’s food for thought.
The cost of food allergies is burdening more than just the families dealing with them, it’s burdening our schools, our health care system and our economy. It has become a billion dollar business in less than a decade for the company making EpiPens, so they have no reason to stop it.
Until there’s a cure, there’s EpiPen, but there used to be TwinJect and Auvi-Q, too. They are both gone, and consumers are left with a product on the market that was first originally used by the military, whose patent somehow hasn’t expired and whose design has invited countless criticism from both patients and practitioners for its broken needles. It leaves a lot to be desired and a lot of Americans asking the one question: Why 6 price increases in 6 years for a now $600 device?
It reminds us here of another company and their infamous tagline: Ask Why.
That company was Enron. And it’s time for both consumers and members of Congress to “ask why” we are seeing this outrageous increase in the price of EpiPens.
For the last ten days, we have brought attention to the EpiPen pricing issue, as we have heard from parents around the country who are stunned with the new price of a product that has been around for 50 years, especially as they head back to school and find themselves needing to buy multiple sets to keep their children safe. Like the single mom who just shared this image: a $925 price tag for one set of EpiPens with coupon and insurance.
As we began to shine a light on this issue, images flooded in when we asked parents to share pictures of their receipts. As one mom wrote, “I thought I was the only one.” She isn’t, and with the food allergy epidemic in full force, she is joined by millions of parents who share her concern.
How can a parent keep a child safe if they can no longer afford this life saving device? What cost-benefit analysis is being done by the company to justify the skyrocketing price tags – an almost 500% increase in just 6 years? And what value are they putting on the lives of Americans when they run their models, testing the price elasticity of their signature product that accounts for 40% of their revenue?
We have countless stories now, but here are two real-life stories of families impacted dramatically by the price-gouging and profiteering practices of Mylan Pharmaceuticals. Their pricing practices are placing the life-saving EpiPen out of reach of many families. Lives are in danger for the sake of share price and executive compensation. Perhaps the most trying issue in all of this is that the U.S. is the only country in the world where this price-gouging is happening. We also have one of the highest rates of food allergies.
The issue has taken on such concern that EpiPen Canada recently issued a statement on their Facebook page:
“IMPORTANT: Please note that recent news of EpiPen® price increases announced by Mylan, the US distributor of EpiPen®, apply to the US market only. They do not impact Canada (where EpiPen® is distributed by Pfizer Canada). In Canada, medicine prices are regulated and price increases are strictly controlled. As such, the price Canadians pay for EpiPen® has remained fairly consistent for several years.”
The company in the U.S. will argue that insurance covers these jaw-dropping costs, as well as a coupon that they offer. This statement is incomplete at best, as families with high deductibles find themselves paying the full price of between $600-800 while families around the world pay anywhere between $58 and $98. Families that don’t have insurance are simply out of luck, and many are praying that their child or loved one does not encounter a hidden ingredient in a meal that could end a life.
Read these stories and use this link to contact your representatives in Washington. It is time to put and end to pharma price gouging and profiteering.
See the gallery of images at the end of this article for more evidence of Mylan’s deplorable greed.
Elizabeth Bostic’s Story
I am the mother of a 9 year old with peanut and tree-nut allergies, a history of anaphylaxis, and asthma. We are a single income family with a high deductible insurance, and have watched the price of EpiPens rise for years. We need a set for home and a set for school. The last time I went to pick up my daughter’s EpiPenJR I was shocked when the price had shot up once again in less than a year. The price went up about $200 from the last time I had purchased them. At well over $700 a box at my local Publix pharmacy, I declined to purchase the Epipens. Even with the Mylan coupon the price was still over $600 a pack. I searched for a cheaper option and found that the only other option was the generic version of Adrenaclick. Only one local pharmacy would order one, and it was still expensive at over $500.
There have been times where a purse, belt, or bag with the EpiPens in it has been left accidentally in a hot car, and at over $600 a pack to replace the EpiPens, I hate to admit that I have chosen to forgo replacing the EpiPens. If the cost of the EpiPens were more affordable, I would have replaced them right away to be 100% certain of their effectiveness. My daughter is learning to be responsible and self carry her medications while out and about, a simple mistake, a little purse left in a hot car after a day out, or a lost Epi belt, is a very costly mistake, and discourages me from allowing her to carry her medications when I should be encouraging it at her age.
Jennifer DiMercurio’s Story
My husband left his job of seven years in October 2014. His father had to undergo Chemotherapy for his Leukemia and his job was preparing the next big wave of lay-offs. We decided it would be best for him to resign and for our family to take a trip to San Diego to see his parents. Once we returned, knowing my father-in-law was stable, my husband began a new job search. We had utilized Cobra insurance for several months and were looking to get our own policy.
We began the new policy in March 2016. We were paying more per month and our deductible was very high. Our son, Liam is 7 and has severe food allergies to the top 8 (- fish + sesame) as well as severe eczema. We have had to administer his Epi Pen on 8 different occasions. The medicine has saved his life and turned around some extremely severe reactions.
In May 2015 we had to administer epinephrine due to a reaction to a generic Benedryl. At the time we purchased 2 more Epi Pens. They used to let us replace the used one, but now they required a purchase of a 2 pack every time. We had to pay around $250.00 with the discount (the $0 Co-pay card). We had never paid that amount before but we knew our new insurance policy was different. My husband had just started a new job and wasn’t receiving insurance.
In October 2015 Liam had an exposure to an unknown allergen and had to receive another EpiPen. This time the Epi Pens were closer to $400. We still had one of his recent refills, plus another pen from his pack before. We decided we didn’t need to get more at that time. I homeschool my kids so they are with me all the time and we could manage safely with 2 EpiPens. My concern would be purchasing more when the old one expired in a few months, especially at the current price.
My daughter Sofia is 9, while without any allergies, has to receive a daily injection (6 days a week) for Growth Hormone Deficiency. Her levels are so low; we have never had any trouble getting her medication. The treatment is necessary for her health and strength. Thankfully despite the high cost of her medication they send it, never making us pay upfront. The doctors are always looking for ways to help, knowing how important it is. We have been fortunate to receive assistance from CVS/Caremark as well.
On Halloween I experienced my first severe reaction. I had previous allergic reactions to latex and have suffered seasonal environmental allergies my whole life. This time a washable paint from Crayola (later I noticed the disclaimer of the possible latex gloves worn during manufacturing). I went to the ER and received a prescription for my own EpiPens. The price for 2 Epi Pens was now up to $465. My husband had taken on another job with insurance, in addition to his current job. Unfortunately, the probationary period was lengthy, so we were still on our own personal medical insurance policy. We would be until May 2016. The increase also seemed to coincide with the recent recall of Auvi-Q. The insurance company didn’t care if we needed the EpiPens. Deductibles had to be fulfilled first. Even if that meant not getting your medication.
The weekend before Christmas 2015 I had another severe reaction. I had to self-administer my EpiPen. I felt instant relief. My throat was closing and I was getting ready to pass out. We had creatively pull the money together for the first 2 Epi Pens. Our savings was depleted and we now had growing medical bills for the ER visits, in addition to our usual specialist visits.
Now we were faced with the dilemma, risk having only 1 EpiPen for me or borrowing money from someone to get another set of 2. Thankfully someone was kind enough to help us out and I had 3 EpiPens. This turned out to be a great decision because two weeks later I needed to give myself another EpiPen. I had no idea what we were going to do if we needed any more. We were out of resources. I had begged my primary care doctor to help. He was in disbelief when he saw the rabidly increasing epinephrine prices. However, he could do nothing. I asked my new allergist if she knew she could provide any help. She gave me an EpiPen $0 Co-Pay card. This was not much help and I certainly didn’t get my Epi Pens for free. In fact, the assistant at the pharmacist counter thought there was a price mistake and went to talk to the pharmacist. No one could do anything. I began hearing about prices reaching even higher for some folks.
I have seen the medication save my son’s life numerous times and experienced the lifesaving medication myself, twice. It’s not an option. Thankfully we don’t need more than 2 EpiPens per person because I homeschool. I cannot imagine with school quickly approaching what some families are going to do. Especially if there is more than one person that needs the epinephrine in a household. When my daughter needs her medication we receive it and people bend over backwards to make it available. With severe food and other allergies this is not the case. Something has to be done. We need at least 2 EpiPens at all times. I shudder to think of children and adults walking around unequipped for a severe reaction.
The number of people in the U.S. with food allergies is skyrocketing. 15 million Americans, 6 million of which are children now have food allergies. A life-threatening food allergic reaction now sends someone to the E.R. once every three minutes in the U.S.
For someone with a food allergy or who is allergic to insect bites as well, an EpiPen can mean the difference between life and death. An EpiPen is an injectable form of epinephrine which is the ONLY lifesaving medication available at this time that can quickly reverse an allergic reaction.
The price of this lifesaving medication has been skyrocketing in the past few years leaving many worrying how or if they will be able to even carry something that is their only form of life support if there was to be an allergic reaction. I have heard story after story of parents who went to pick up their Epipens and how drastically the price had changed from the last refill from approximately $50 to now over $700. That is with insurance. That is outrageous. Some families have more than one person with allergies and need to get several sets. How can anyone be expected to be able to afford this?
No one should have to decide between whether they can afford to have a lifesaving medication, feeding their family or paying their rent/mortgage. I’m a mother who lost their child to a food allergy. I cannot tell anyone enough how very important is it to be able to have epinephrine with you everywhere, you need Epipens everywhere you go. You are supposed to carry TWO with you at all times. You need them for school, childcare, grandparents, etc.
Epinephrine is the only LIFESAVING medication available and it is criminal that a company knowing that one needs this to stay alive can make it completely inaccessible to so many because of greed. When Mylan is paying out BILLIONS in salaries to their top executives and leaving us breaking piggy banks to help kids alive
Something needs to be done. They need to be stopped. How can a life be measured in $$$? How can they not care? What can we do? It is time we all do what we can now!!!
Ten years ago this week, I launched AllergyKids. Our goal was to provide free information about this condition to families that were dealing with it. Little did we know what this work would become or how quickly this condition would escalate.
Today, the numbers are jaw-dropping, and this condition is changing the food industry. Families around the country are reading labels like never before, and with that comes a food awakening and a demand to #dumpthejunk.
Food allergy is an immune disease that causes the body to have an allergic reaction to food. This allergic reaction can manifest as a range of symptoms. These symptoms can include hives and itching or more systemic symptoms (anaphylaxis) including difficulty breathing, low blood pressure and ultimately, death. A recent study shows this disease has increased by about 50% in children over the past 20 years and continues to increase. There are now at least 6 million children in the U.S. with food allergy and about 9 million adults. A life threatening allergic reaction sends someone to the emergency room once every three minutes.
These individuals are most likely to be allergic to one or more of the top eight most common food allergens, which include cow’s milk, egg, wheat, soy, peanut, tree nuts, fish and shellfish. But we are quickly learning about an increasing number of Americans who are allergic to corn, beef, chicken and even things like lettuce.
Many of us know someone who has a life-threatening food allergy so it is important for us to learn more about what foods are most likely to cause reactions and what symptoms to look for when reactions happen. It is also helpful to know how to keep those with food allergy safe. When severe reactions do happen, it is important to give injectable epinephrine immediately and to call for emergency medical help.
The infographic below explains what you need to know about protecting kids with food allergies. You can also visit the Bunning Food Allergy Institute to learn about how we care for kids with food allergies.
Today, a life threatening allergic reaction to food sends someone to the emergency room in the United States once every six minutes. EpiPen is now a $1 billion brand.
Today, one in eleven children struggle with asthma, and one in four are affected by allergies. The incidence of allergy has increased significantly over the past two decades, and allergy to peanuts has more than quadrupled from 1997 to 2010. Approximately 30 million children – more than 1/3 of our kids – are affected by one of these four new childhood epidemics. This is not something we can just accept.
An official statistic held that allergies affect some 7 million Americans, including about 6 percent of children below the age of three. That information came courtesy of U.S. Food and Drug Administration Deputy Commissioner Lester M. Crawford, J., D.V.M., Ph.D., speaking before the Consumer Federation of America on April 22, 2002. But that data is now over ten years old.
Today, it is now estimated that up to 15 million Americans have food allergies, 1 in every 13 children. That’s roughly two in every classroom.
The Centers for Disease Control also issued a report in 2008 that said that there has been a 265% increase in the rate of hospitalizations related to food allergic reactions over the prior ten year period.
This begs explanation
An allergy is basically an overreaction by your immune system to a protein that it perceives as a threat—for example, the proteins in particular types of food, the dust mite protein, or pollen. For people without allergies, these proteins are harmless. But if you’ve got an allergy, your immune system sees these proteins as dangerous invaders.
To drive the invader out, your immune system mobilizes all its resources: mucous, to flush out the intruder; vomiting, to force it out; diarrhea, to expel it quickly. Such conditions may make you feel sick, but they’re actually evidence of your body’s attempts to get well.
A key aspect of the immune response is known as inflammation, characterized by one or more of four classic symptoms: redness, heat, swelling, and pain. Inflammation doesn’t occur only in allergic reactions; it flares up whenever your body feels threatened, in response to a bruise, cut, bacteria, or virus as well as to otherwise harmless pollen, dust, or food. Scientists now believe that much of our immune system is found in our digestive tracts, where many of these inflammatory reactions occur in the form of stomachaches, cramping, nausea, bloating, and vomiting.
Ironically, the immune system’s inflammatory reaction—meant to heal and protect the body—often causes more problems than the initial “invader” in the cases when allergic reactions become life-threatening.
Common Symptoms of Food Allergy: Immediate Reactions
rash or hives
nausea
stomach pain
diarrhea
itchy skin
eczema
shortness of breath
chest pain
swelling of the airways to the lungs
anaphylaxis
Food Allergies and Food Sensitivity: Our Immune System Overreacts Again
At first glance, the distinction between “allergies” and “sensitivity” may seem like a meaningless word game. But understanding the relationship between these two conditions is crucial to grasping the true nature of the allergy epidemic—and to seeing how even the supposedly healthy foods in our kitchens may be harmful to our health.
As we’ve seen, allergies are an overreaction of our immune system, a kind of exaggerated response to a perceived danger. When a child comes in contact with these proteins (peanut, egg, wheat, etc.) her immune system “recognizes” the protein as dangerous, just as it would have seen the danger in the bacterium that causes pneumonia or the virus that causes mumps. In response, her immune system creates special “fighter” proteins called antibodies designed to identify and neutralize the “invader.”
These fighter proteins are known as immunoglobulin E, or IgE for short. When they’re released into the bloodstream, their purpose is to “seek and destroy” the invader, which they do by creating one or more of the classic food allergy symptoms, such as the hives, or the diarrhea with which other children respond, or, in more extreme cases, the anaphylactic shock that can kill a child within minutes.
The classic IgE response occurs within minutes or even seconds, because IgE proteins are some of the most aggressive antibodies we know. That immediate IgE response is the defining characteristic of an allergic reaction.
Food sensitivities start out in a similar way. If a “sensitive” child is exposed to a protein that his system perceives as a threat, he’ll manufacture another type of fighter protein, known as Immunglobulin G, or IgG. Although IgE and IgG antibodies play similar roles, they produce somewhat different—though often overlapping—symptoms.
A crucial difference between the two, though, is their reaction time. The less aggressive IgG antibodies typically produce a delayed response that might not appear for hours or even days after the child has consumed the offending food.
So even though food sensitivities and food allergies both produce painful, inflammatory, and potentially dangerous responses, this delayed reaction time has led many doctors to give food sensitivities second-class status. Partly that’s because they don’t present an immediate and obvious threat to children’s lives: only the IgE proteins trigger anaphylactic shock, for example, and in that sense, only the IgE proteins can kill (though the IgG reaction can have serious long-term consequences). I also think that traditional doctors tend to downplay the importance of nutrition, frequently dismissing the idea that such symptoms as earache, eczema, crankiness, brain fog, and sleep problems might be related to a child’s diet.
However, an article in The Lancet, Britain’s most respected medical journal, casts another light on the subject. The article referred to doctors who use elimination diets—diets that begin with a very limited, “safe” array of food choices and then add potentially problematic foods back into the diet, one by one.
The reason to do an elimination diet is to identify which foods in your diet might be triggering symptoms like skin rashes, fatigue, or stomach ache. Often, some foods affect us without our realizing it and we live with the symptoms, taking medicine to alleviate the suffering. But if you eliminate these foods from your diet, you may find that your symptoms disappear. What becomes even more interesting is that when you reintroduce the offending food, you may suddenly suffer drastic symptoms which make it clear that the food was indeed triggering one or more problems. An elimination diet can sometimes reveal with dramatic speed that a particular food you’ve always believed was harmless is actually causing such chronic symptoms as headache, digestive problems, and even more serious complaints. Masked by your daily diet and by the slowness of the food-sensitivity reaction, the offending food does its dirty work without ever realizing that it is the culprit behind your—or your child’s—disorders.
When you take a break from eating that problem food, however, and then add it back into your diet, you see how powerful its effects are and how responsible it may be for a seemingly unrelated problem. Foods that you thought were safe for you turn out to be highly problematic, indicating the presence of a previous undiagnosed food sensitivity. As a result, the authors of the Lancet article conclude that the prevalence of food sensitivity (referred to in the article as “food intolerance”) has been seriously underestimated.
Certainly, food allergies are far more dramatic. Whenever you read about a kid who died within minutes of eating at a fast-food joint or after breathing in the peanut dust from a friend’s candy wrapper, that’s an “IgE-mediated” food allergy. They’re fast, they can be deadly, and I’m glad doctors want to give them the attention they deserve.
But I also think doctors should be looking at delayed reactions, too, the “IgG-mediated” responses to food sensitivities. And some doctors do look seriously at both. Most conventional doctors, though, tend to focus on IgE immediate reactions. I think there are lots of reasons why they should view the two types of reactions as part of a larger, single problem.
First, both reactions have the same ultimate cause: the immune system’s overreaction to apparently harmless food. According to internationally acclaimed author and physician Kenneth Bock, M.D., there’s also quite a bit of overlap between IgE and IgG symptoms. Both can contribute to inflammatory responses in multiple body systems.
True, the delayed IgG reactions are less likely to cause hives and are more likely to produce a host of apparently vague symptoms, such as headache, brain fog, sleep problems, joint pain, fatigue, and muscle aches. But both the immediate and the delayed responses are immune system problems triggered by a supposedly “harmless” food.
Conventional doctors’ tendency to separate “IgE-mediated” food allergies and “IgG-mediated” food sensitivities into two separate problems has the effect of minimizing the allergy epidemic. Remember, IgE allergies, IgG sensitivities, and asthma—three similar ways that our immune systems can overreact—are all on the rise. It makes sense to find a doctor who is willing to address all three as symptoms of a greater underlying issue.
Common Symptoms of Food Sensitivity: Delayed Reactions
fatigue
gastrointestinal problems, including bloating and gas
itchy skin and skin rashes like eczema
brain fog
muscle or joint aches
headache
sleeplessness and sleep disorders
chronic rhinitis (runny nose), congestion, and post-nasal drip
Five Take-Aways:
1. Even if your kids can’t talk, their skin speaks volumes! Did you know that the skin is a person’s largest organ? Even when your kid is too young to tell you how he feels or too used to her symptoms to identify them (when kids hurt all the time, they don’t know they hurt!), you can often read your child’s condition in his or her skin.
Does your kid have eczema? Does he get rashes around the mouth, especially after he eats a certain food or swallows a certain beverage? Rashes around the knees, elbows, or armpits? Does he have “allergic shiners”—that is, dark circles under the eyes?
These are all inflammatory reactions, signs that the body is trying to rid itself of what it perceives as “toxic invader.” In your child’s case, that “toxic invader” might be an apparently harmless food, to which your kid is either allergic or “sensitive.” Keeping that invader away from your kid may bring relief from symptoms—and it may clear up other problems, such as brain fog, crankiness, sleep problems, inattention, acne, and mood swings.
2. Look below. Your kids’ bowel movements, not to be too delicate here, also speak volumes. Runny poops are a sign that a person isn’t properly digesting his food. And indeed, as we got the allergens out of some children’s diets, poops tend to firm up.
3. Chronic ear infections are often a sign of dairy allergies. In some cases, milk may have ill effects like eczema, upset stomachs or chronic ear infections for children who are allergic or sensitive to it.
4. Find a doctor who is willing to work with you, test for both IgE and IgG allergies and sensitivities and to address the important role that elimination diets can play in managing allergic symptoms like eczema, ear infections and chronic mucous.
5. More research is needed. Food allergies are impacting a growing number of Americans. It is impacting everything from how schools feed children to what snacks airlines choose to carry on planes. Napster co-founder, Sean Parker, recently donated $24 million to Stanford to conduct research to get to the bottom of this condition, what is triggering it and how to cure it.
6. Find a friend. Find an ally to help you get safe snacks in the classroom or meet with your Congressman to discuss this epidemic. The landscape of childhood is changing. It is changing families and changing the food industry. None of us can do everything, but all of us can do something.
Always discuss individual health inquiries and medical issues with a qualified personal physician and/or specialist.
The Allergy Solution: Unlock the Surprising, Hidden Truth about Why You Are Sick and How to Get Well by Leo Galland, M.D., and Jonathan Galland, J.D. is going to be published on May 10, 2016.
I can’t wait for this book.
An epidemic of allergies is spreading around the world. One billion people suffer from allergic diseases such as asthma, hay fever, eczema, and food allergies. But this is just the tip of the iceberg. In this groundbreaking book, award-winning doctor Leo Galland, M.D., reveals the shocking rise of hidden allergies that lead to weight gain, fatigue, brain fog, depression, joint pain, headaches, ADHD, digestive problems, and much more. Astonishing new research shows how each of these is linked to the immune imbalance that is at the root of allergy.
A brilliant clinician, Dr. Galland has unlocked the power of this breakthrough science to help thousands of patients who have struggled with mysterious symptoms answer the question: “Doctor, what’s wrong with me?” Here, he is joined by his son, Jonathan Galland, J.D., a passionate health writer and environmental advocate, in exposing the truth that just as the earth’s environment is out of balance, our bodies are out of balance. The modern world, with pollution, unhealthy eating habits, lack of exercise, and excessive exposure to antibiotics, is fueling the rise in allergies.
The Allergy Solution takes an in-depth look at how we can balance immunity through nutrition and lifestyle to reverse allergies without drugs. It offers an easy nutritional program, starting with a Three-Day Power Wash designed to “clear the tracks,” to help us take back control. Do you suffer from asthma, eczema, or sinusitis? Are you sick of pain, fatigue, brain fog, weight gain, depression, anxiety, or wondering what is behind your mysterious symptoms? Let Dr. Galland’s clinical experience and unique insights into cutting-edge science guide you back to health.
Key Messages:
An epidemic of allergies is sweeping the world.
Over a billion people in the world have allergies, making allergic disorders among the most prevalent condition in the world. What makes that so astonishing is that allergies were originally considered to be exceptional and uncommon. The frequency of allergic rhinitis (nasal allergies) for example, has increased in the US from 10 % of the population to 30 % over the past 40 years.
Allergies like disguises and are great mimics.
Although most people think of allergies in terms of symptoms like itching, swelling, and sneezing, allergic reactions can cause a huge variety of symptoms that are not usually considered to be allergic. The science shows there is a role for allergy in causing weight gain, headaches, joint and muscle pain, a range of digestive symptoms, mood problems, poor mental focus, ADD, insomnia and more.
The allergy epidemic is fueled by 3 factors:
Eating fast food or processed food, environmental toxicity—indoor and outdoor— and depletion of beneficial intestinal bacteria. Environmental toxins create vicious cycles that drive the allergy epidemic. In each of these, an environmental toxin, either synthetic or natural, damages a surface of the body (the respiratory lining or the skin or the intestinal lining).
The damaged lining tissue becomes a site where allergy develops. Good nutrition can stop the cycle from snowballing. Yet the standard American diet increases the snowball effect.
Examples: (a) Automotive and industrial emissions damage the lining of our respiratory tracts and increase the inflammation you experience when exposed to pollen. They also make allergenic plants produce more pollen, and it’s a pollen that is more allergenic than normal pollen.
(b) Dust mites are major indoor allergens. But they’re not just allergens, they’re toxic. They secrete an enzyme that damages the lining of your respiratory tract, producing inflammation there that makes allergic sensitization more likely. Chemical toxins run interference for dust mites, preventing our bodies from resisting the dust mite enzyme.
Allergies can be reversed, not just suppressed with drugs
By drilling down into the science of allergy, The Allergy Solution reveals hundreds of new ideas that will change the way the world views allergy and health. It is a scientifically validated approach backed by hundreds of references to research from around the world.
Allergy starts in the gut
The gut is the largest part of the immune system, which is the source of allergies. Proper functioning of the gut protects against toxins and allergens in your digestive system. It contains trillions of bacteria, which play an important role in allergies, and in supporting health, or allowing illness to happen. These aspects of the gut work together to determine your immunity, allergies, metabolism, and mood.
Leo Galland, M.D., a board-certified internist, is recognized as a world leader in integrated medicine. Educated at Harvard University and NYU School of Medicine, he won the Linus Pauling Award for his trailblazing vision that created a new way to practice medicine for thousands of doctors. Dr. Galland has been featured in The New York Times, The Wall Street Journal, Self, and Men’s Fitness and has appeared on the TODAY show, Good Morning America, the Dr. Oz Show, PBS, CNN, and Fox. He is the author of The Fat Resistance Diet, Power Healing, and Superimmunity for Kids and the director of the Foundation for Integrated Medicine. Join his natural health community at drgalland.com and on facebook.com/leogallandmd and twitter @LeoGallandMD
Jonathan Galland, J.D., a leader in integrated health education, is a health writer for the Huffington Post and MindBodyGreen. He holds a degree in Law, which supports his research and presentation of the environmental health aspects for The Allergy Solution, expanding the book to include a strong environmental message. He is founder of pilladvised.com, which brings together integrated medicine and environmental health. Jonathan created the recipes and meal plans for The Fat Resistance Diet, featured in Fitness, Woman’s World, on The Dr. Oz Show, and in The Washington Post. He has appeared on Martha Stewart Living Radio and given dozens of radio interviews. In addition to his degree in Law, he holds a degree in Asian Studies, speaks Chinese, Japanese and Italian and brings an international understanding of the worldwide nature of health and environmental and issues. To help educate the public on the impact of allergies in their lives, Jonathan co-wrote the script for the upcoming public TV special on The Allergy Solution. Join the movement to save your health and protect nature on facebook.com/jonathangallandjd and twitter @JonathanGalland
Our youngest turn 11 today. I can’t think about it without my eyes watering, as she so completely changed our lives.
We’d had three kids in less than three years, and we were wrecked. We’d always talked about having four children, but at that point, it seemed unfathomable.
So we waited. A few years later, our youngest child arrived. I remember the night before she was born. We had pork chops for dinner. There was a Texas beer called Shiner Bock in the fridge.
But nothing could have prepared us for how that child would change our lives. Just before her first birthday, she had an allergic reaction that changed everything.
We aren’t the first parents to have this happen, and unfortunately, we won’t be the last. A life threatening allergic reaction to a food now sends someone to the emergency room once every six minutes in the U.S. EpiPen is now a $1 billion brand. Classrooms, preschools, playgrounds, Sunday schools, families and holidays are forever changed. The number of Americans with peanut allergy has more than quadrupled since 1997. And it’s not getting any better.
But there is a silver lining, and I think it is a big one: Food allergies force you to #rethinkfood. They move you away from processed foods which can often have hidden ingredients, and they move you towards a simpler way of eating. They break your dependencies on fast food, and they teach you how to create a food independence, to grow your own, to learn to cook.
A few years after our fourth child’s diagnosis, one of the older children turned to me and said, “Mom, her food allergies were a blessing. They helped all of us eat better.” And she was right. We ate better, we had to dump the junk, we ate less processed foods because we were never sure if production had changed. We looked out for her, we looked out for each other, and as we learned about food as a family, we learned that others wanted to learn, too.
None of us can do everything, but all of us can do something.
And today, doing nothing is no longer an option. 1 in 5 children has eczema, 1 in 10 has asthma, 1 in 13 has food allergies, 1 in 68 has autism and ADHD seems to be everywhere. Together, these conditions are known as the 4As and earned our kids the title of Generation Rx. It’s not OK, not when you add these on top of the escalating rates of pediatric cancer, diabetes and obesity.
I could not turn my back on this. I could not unlearn what I learned about our food system, about the double standard and how we allow ingredients into our foods like artificial growth hormones (rbGH), artificial dyes, additives and genetically modified ingredients (GMOs) that other countries do not allow. I could not turn my back.
Genetics don’t change this quickly, but in the last twenty years, our food has. Correlation is not causation, but a correlation of this magnitude merits investigation and precaution. Labels matter. Labels on allergens, on sugar, on fat and on GMOs.
Our children are not a science experiment. American families can not take personal responsibility for their health if they are not informed about what is in their food or how it is made. It is a fundamental freedom that exists around the world, enjoyed by all of our key trading partners. But here in the United States, that freedom is not ours because it is one that is lobbied against by the agrochemical industry, the chemical companies making these GMOs and the ones selling the weedkiller that the World Health Organization declared a “probable carcinogen.”
Why?
Look around. How many people do you know with cancer? It’s expected to impact 1 in 2 men in the U.S. and 1 in 3 women. Cancer is the leading cause of death by disease in American children. It took 50 years for #tobaccoscience to be exposed, we can’t afford to wait that long.
Americans deserve to know how their food is made. We know if milk is pasteurized and if orange juice comes from concentrate. We should know if our food has been genetically engineered to withstand additional applications of weedkillers like Roundup.
Anything else is un-American. It is not the American way. It is not how we protect the health of our country, our families and our economy.
And this is not the way that it will always be. In the last ten years, since our youngest child’s allergic reaction, I learned what it means to be brave. I learned how to lead and I learned how to ask why. Why are so many American so sick? Why do we spend more on healthcare and disease management than any other country on the planet? And what can we do to protect our health?
We’ve come together, with teams of scientists, farmers and pediatric specialists. We have stood up for our rights, our children, our health, our families. We have stood up for our country. And every time that we do, we inspire someone beside us to do the same.
Courage is so contagious.
And love is a rocket fuel. Look into the eyes of your children, your parents, someone you love, and know that 30 years from now, when they ask what we did to create change when we learned our food system was so full of so much artificial junk, we will be able to say: We fixed it.
We fixed it as families, parents inside of big food companies and entrepreneurs starting new ones, and we did it as Americans to protect ourselves, our economy and our standing in the global marketplace.
So let’s #dumpthejunk and change the name of this generation of kids from Generation Rx to Generation Strong.
