September 15, 2016

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September 15 2016

Scientist: Claims that GMO Safety Is Settled Are Nonsense

Biotech proponents’ claims that the debate over the safety of genetically modified foods is settled is wrong, according to Sheldon Krimsky, co-editor of the new book, The GMO Deception: What You Need to Know about the Food, Corporations, and Government Agencies Putting Our Families and Our Environment at Risk.

As its title suggests, the book takes a very critical look at GM foods with articles written by leading scientists, educators, and environmentalists. Articles cover the whole range of the GMO debate from human and environmental health, labeling, and corporate control of agriculture to regulation, sustainability, and ethics.

Krimsky has sounded warnings about the risks of GM foods since the 1980s. He has written or edited 13 books that provide a critical examination of breaking issues in science and technology. He is also chairman of the Council for Responsible Genetics, which fosters public debate about the social, ethical, and environmental implications of genetic technologies.

Krimsky is the Carol Zicklin Visiting Professor of Philosophy at Brooklyn College, the Lenore Stern Professor of Humanities and Social Sciences at Tufts University, and adjunct professor in the Department of Public Health and Community Medicine at the School of Medicine at Tufts University.

What led to the publishing of the GMO Deception?

Sheldon Krimsky: Claims were being made that the health effects of genetically modified foods were resolved. The only issue was public perception.

But when I investigated the scientific literature, I found more than a dozen studies showing negative health impacts, and these have to be addressed. You can’t just throw them away.

When dealing with risks, it’s not about having more studies showing no harm than ones showing harm. One negative outcome is worth 99 positive outcomes because many positive outcomes are funded by industry.

When you want to prove something is safe, you have to set conditions that are most likely to find effects. When developing a new airplane, you don’t just fly at normal conditions; you fly at extreme conditions. In the same way, you have to test GMOs under more extreme conditions in order to have confidence that they are safe.

Unfortunately, every time a scientist shows an adverse effect (from GMOs), that scientist is vilified. We saw this most recently with (Professor Gilles-Eric) Séralini (who published a study showing negative impacts to rats fed GM corn and Roundup herbicide). The things that have been done to him are unprecedented in the history of science. Retracting a paper after a year when the editors initially supported the reviewers and retracting it because “the results are not definitive” is not really valid in the ethics of science. Based on that criterion a great amount of published work would also be retracted.

How did you gather the material for the book? What were your criteria for inclusion in the book?

SK: We tried to piece together good articles from the past with good recent articles.

The articles are written by well-respected scientists and environmental activists. There is a preface by Ralph Nader, and an introduction to the science of genetic engineering by John Fagan.

There are segments in the book that deal with environmental impacts. I published a book in 1996, Agricultural Biotechnology and the Environment, when the biotechnology industry was just starting. We raised the issue of herbicide resistant weeds; that if glyphosate were used ubiquitously, then weeds would become resistant to it. That is what has happened.

Readers of the book can see what scientists are saying and raising questions that aren’t raised in the media.

What are you trying to achieve with the book?

SK: I hope that readers of the book develop their own skepticism when they read articles from mainstream press, such as the Wall Street Journal, that have been persistent in calling skeptics luddites and don’t know what they are talking about.

The agricultural biotech business has tried to construct the science for its commercial interests. There is a lack of recognition of studies that don’t conform to their point of view and a vilification of scientists who produce results they don’t like.

Chapter three is a conversation with Árpád Pusztai (who conducted research showing negative impacts to rats fed GM potatoes), an internationally respected scientist and expert on lectins. He was literally driven out of the United Kingdom and lost his job. The things said about him were unconscionable. That story needs to be told.

What concerns do you have about genetically modified foods?

SK: The fact that we have been eating GM corn and soy for 15 years doesn’t convince me that they are safe. We had lead and PCBs in our environment for 40 to 50 years. You don’t determine something is safe by forcing it in the consumer market and then waiting a number of years to say it’s safe.

It is true that people aren’t keeling over. That’s all we’ve shown with the introduction of GM corn and soy.

But there are many ways that GMOs can affect consumers other than an immediate effect. They can produce chronic effects on the immune system and reduce or increase nutrients in food products. We need to know if we are getting the same nutrients from GM corn as from conventional or organic corn. We need to have transparency.

When scientists face controversy, they go to the literature review. I did this. I looked at articles on GMOs and health effects. I found seven from 2008 to 2014. I found that there was disagreement in the review articles. Reviewers arrived at different conclusions. One review article said that animals fed GM crops died. One or two said there were no problems, and several said there were problems.

To argue that there is no controversy left in this field is nonsense. That is what I found by going deep in the literature. You can’t just write it away.

The tobacco industry used to say that cancer is not caused from smoking; that it must be something else.

Skepticism is a really important part of being scientist. To say there is no controversy left and use a preexisting notion of what is safe and apply that to every product is not the way we do science.

Biotech proponents claim the technology is precise. Do you agree with that claim?

SK: When you put a gene into a plant genome you don’t know where it will go. It could cause gene expression of one part to rise or to diminish.

There are circumstances when you don’t want gene expression to rise. There are toxic effects in a plant that you don’t want to rise, but it could happen with GMOs.

We eat certain plants for their nutrient value. An inserted gene could cause gene expression for a nutrient to go down.

It’s a lot more complex than saying I fed it to the mouse and it survived. It’s a very simplistic view of what’s safe and not safe.

Originally published at the Organic and Non-GMO Report.

September 15 2016

U.S. of Allergies: How EpiPen Became a Billion-Dollar Brand

Robyn O'Brien Food Allergies, Food Financials 0

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.”

Kaléo, the developer of the Auvi-Q epinephrine auto-injector appears to be planning the return of its “talking” device to market.

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.”

According to Science Daily:

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.

Lives are at risk.

September 15 2016

A Pediatric Emergency MD Sounds the Alarm on EpiPen Safety

Robyn O'Brien Food Allergies, Health 0

I’ve recently spent some time connecting with Dr. Julie Brown, a Pediatric Emergency Medicine Physician and Associate Professor at the University of Washington. For the last several years, she has been sounding the alarm on injuries sustained after patients use the EpiPen. Her research is startling.

She uses social media to get the word out, both her Pinterest page and Facebook, but as she tried to bring awareness to larger organizations and platforms, her concerns were often met with silence.

Her story, in her own words, is below:

This is my story. I am a Pediatric Emergency Medicine Physician, working in a children’s hospital. While on shift one day, I received an ambulance delivering a 4-year-old boy who had suffered an anaphylactic reaction while at daycare. His daycare providers had appropriately decided to inject him with his EpiPen. Two of them together attempted to restrain him and hold the device in place for the required 10 seconds. He, not surprisingly, struggled, and the needle tore down his leg, resulting in a long leg laceration, and then dislodged. The daycare provider, believing it took the full 10 seconds to deliver the medication, instinctively tried to reinsert the needle, resulting in a second laceration. This poor young man thus not only required treatment for his anaphylaxis, he now also had two large wounds that required repair.

After this shift, I realized I didn’t know enough about EpiPens and how they worked. It seemed strange to me that such a small dose of epinephrine would take such a long time to eject from the device. And I couldn’t think of another situation in medicine where we would hold a needle in a child’s muscle for 10 seconds and expect that to happen without issue. So I decided to do a little investigating. First, I asked a colleague for a used EpiPen, which I fired off in a small light box I bought online, while videotaping. I ended up firing off many EpiPens, and you can watch one of these videos here: https://www.youtube.com/watch?v=r6ZkAx7djyk. What struck me was that the medication was always fully ejected in less than a second. Now I was even more puzzled. The more I researched, the more I realized there was little evidence to support holding the device for 10 seconds, and compelling evidence that 3 seconds was more than enough (I can share all this information in greater detail if you are interested). It seemed that the reason for the 10 second hold was historical, and related to the use of atropine injectors by the military as a nerve gas antidote. There were really no facts to support it as good practice for epinephrine devices. And yet, we were routinely subjecting parents and children to this 10-second hold.

Furthermore, I also discovered that nowhere in the instructions for use did it mention restraining a child while administering the medication, even in the pediatric formulations of the device, like EpiPen Jr. So these poor parents were being placed in a position of administering the device, holding a needle in their child’s thigh for 10 seconds, without even being given the simple advice to restrain their child. This seemed to me like an injury just waiting to happen. I thought I had better at least share with my colleagues what I had learned.

Here is where my journey really began. I emailed my colleagues and told them if they were prescribing an EpiPen, they should advise their caregivers to hold the child well, because I had cared for a child with leg lacerations, and the instructions for use said nothing about patient restraint. To my surprise, one of my colleagues replied that SHE had recently had a child with a leg laceration from an EpiPen. Now I knew I was on to something. I decided I had better explore the issue further. So I wrote an email and posted it on a Pediatric Emergency Medicine list-serve called PEM-L. And lo and behold, I heard about another 11 cases, plus a few other injuries. And what’s more, one of the physicians said the mother of his patient told her that she had seen photos of similar injuries on a Facebook allergy group called No Nuts Moms.

What happened next changed me and my career forever. I naively joined the closed group ‘No Nuts Moms’ to ask about leg lacerations from EpiPens. And I learned about many more, from some of the most amazing allergy moms I could ever hope to know, who selflessly shared their stories of the most traumatic days of their lives. But they and other allergy parents also opened my eyes to how much more I needed to understand about food allergies and anaphylaxis, the poor state of anaphylaxis care across the country, and the need for more research and education in the area of emergency care. I heard stories that literally made me feel ill, of children being placed at terrible risk by providers who knew less about anaphylaxis than the patient’s parents. These parents have educated me, and asked fantastic questions that have led me down paths of inquiry, so that I in turn could educate them. I have since made dozens of YouTube videos, and have Pinterest pages specific to auto-injectors, based largely on work I have done dissecting and examining these devices: https://www.pinterest.com/Donteatmagnets/epinephrine-auto-injectors-eais-epipen-auvi-qtm-al/. My understanding of these devices has been driven by the questions of these allergy moms, and I couldn’t have produced anything like the same quality of educational materials or research without the give-and-take relationship that two years of almost daily interacting on this Facebook group allowed. I am now considered an honorary allergy mom, a title I wear proudly. I am committed to focusing on anaphylaxis research for the rest of my medical career, which makes me fairly unique amongst emergency medicine colleagues. But emergency providers are needed in this field, as they are the ones who are responsible for providing the first response in the event of allergic reactions, and need the training and tools do that job well.

Ultimately, we ended up to with 26 cases of EpiPen-associated injuries, which we published, along with a review of the literature supporting a rapid release of epinephrine from the Epipen device, and recommendations for reducing the Epipen hold time. We also recommended adding restraint recommendations to the patient instructions for all epinephrine devices. A succinct summary of our research can be seen here: https://www.aaaai.org/global/latest-research-summaries/New-Research-from-JACI-In-Practice/epinephrine-autoinjectors-(1) and the full original article (which is quite graphic) is here: http://www.annemergmed.com/article/S0196-0644(15)00588-0/fulltext.

Two FDA officers, one in charge of safety and one in charge of labeling, recently emailed me to say that it was our research that was the primary driving force behind recent FDA changes, which include reducing the EpiPen hold time to 3 seconds, and adding restraint instructions to all auto-injector patient instruction materials: http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019430s061lbl.pdf#Patient. I am proud that our research was instrumental in making this change, and in making the use of EpiPens and other auto-injectors safer for children.

This study, and these FDA changes, are only the beginning for me. Driven by a passion to improve the lives of people with food allergies, and fueled by the many unanswered questions that have stacked up over the past two years, I have many other projects in progress. Our current work involves understanding the challenges around auto-injector use, and emergency preparedness. We recently published a systematic review of epinephrine stability at extreme temperatures, which is a first step in working towards expanding allowed temperature ranges for auto-injectors. We are also nearing completion of a systematic review of the stability of epinephrine when drawn up into a syringe. While this is never a good solution for anyone, the reality is that some patients are currently going without ANY epinephrine due to the high costs of auto-injectors, so a better understanding of the alternatives is important. It is also relevant to emergency care, where syringes and ampules are often used, and can result in delays to care while doses are calculated and drawn up.

In the future, I hope to do pharmacokinetic research—evaluating epinephrine levels in children in anaphylaxis, which has never been done (even in adults). I also have many ideas for education and research to improve emergency anaphylaxis care, including an anaphylaxis rap that I wrote and am trying to figure out how to get produced.

The largest barrier to accomplishing all these research goals is funding. I am frustrated by the time wasted trying to secure dwindling sources of funding that could be spent doing the research and improving the lives of children with allergies. I have a fundraising site: http://giveto.seattlechildrens.org/anaphylaxis. Please help if you can.