Remember Martin Shkreli? He was the hedge fund manager who bought a life-saving AIDS drug and then raised its price overnight by more than 5,500 percent. Yeah, that dude. Well he’s not the only one giving Big Pharma a bad name. Mylan CEO Heather Bresch is the newest pharmaceutical exec to face similar criticism after she struggled to justify hiking the price of the EpiPen by more than 400 percent in the past decade.

Mylan CEO Heather Bresch is in the hot seat over EpiPen price hikes https://t.co/HuKPlKO2G5 pic.twitter.com/fnLFFZU7C6

— Fortune (@FortuneMagazine) August 24, 2016

“No one is more frustrated than me,” Bresch told CNBC “Squawk Box” on Thursday when asked to explain the exorbitant price increase and why Mylan can’t cut the price of the drug. Bresch tried to argue that the problem isn’t with Mylan and other pharmaceutical companies, but rather a broken health-care system that often forces consumers to pay the full retail price for prescription medications.

Bresch explained in a press release,

We recognize the significant burden on patients from continued, rising insurance premiums and being forced increasingly to pay the full list price for medicines at the pharmacy counter. Patients deserve increased price transparency and affordable care, particularly as the system shifts significant costs to them.

A standard two-pack of EpiPens now costs about $600, but in 2009 the cost was only $100. Mylan announced Thursday plans to cover up to $300 of out-of-pocket pharmacy cost through the use of a savings card, reducing patient cost by 50 percent.  Previously, the savings card covered $100. The decision to increase the rebate comes a day after Hillary Clinton called out Mylan to immediately  reduce the price of EpiPens.

While this new increased rebate sounds like a step in the right direction, the drug could still cost hundreds of dollars for patients and their families who are required to replace the allergy medication each year when it expires. And as patients still pay more money, Bresch’s paycheck still continues to increase. Her salary went form roughly $2.5 million in 2007, the year of the EpiPen acquisition, to $19 million in 2015.

Bersch acknowledged that high retail prices of EpiPens in the U.S. effectively subsidize the cost of the devices when they are sold in Europe, at just $100 or $150. CNBC notes that many of the countries there have government-run health-care systems that limit drug prices charged by manufacturers, unlike the U.S.

She also repeated several times throughout the interview that Mylan is taking immediate action to help ensure that everyone who needs an EpiPen gets one. “I am hoping that this is an inflection point for this country,” Bresch said. “Our health care is in crisis. It’s no different than the mortgage financial crisis back in 2007.”

Alexis Evans

Alexis Evans is an Assistant Editor at Law Street and a Buckeye State native. She has a Bachelor’s Degree in Journalism and a minor in Business from Ohio University. Contact Alexis at aevans@LawStreetMedia.com.

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A Massachusetts family is suing Panera after their daughter was served a grilled cheese sandwich that contained peanut butter. The parents, John and Elissa Russo, aren’t suing because the sandwich was a curious and gross gourmet choice; rather their six-year-old daughter is highly allergic to peanuts. The unfortunate incident led to an overnight hospital stay for the child.

The lawsuit states that the Russos placed an order online at their local Panera in Natick, Massachusetts in January. Elissa, who completed the form, wrote in two separate places that her daughter has a peanut allergy. To people who don’t have a food allergy, that may seem strange–after all, why would you warn about a peanut allergy on an order for a grilled cheese sandwich? But it’s a pretty automatic step for someone with a food allergy (or the parent of a child with a food allergy)–it helps avoid “cross-contamination”–which happens when someone preparing the food uses tools or surfaces that have touched nuts on a nut-free meal. Essentially the Russos were asking that the Panera worker making the sandwich take simple steps like changing his gloves, or wiping down the counter before preparing the food.

But in a strange turn of events, when the Russos’ daughter bit into her grilled cheese, there was a large dollop of peanut butter in it. After she began vomiting, they brought her to the hospital where she developed other symptoms and had to stay the night.

It’s unclear exactly how the peanut butter ended up on the sandwich. When John Russo called the Panera, it was explained as a “language” issue. According to the Boston Globe:

Conceivably, an employee with limited English could have seen the notation of ‘peanut’ as an instruction to add it to the grilled cheese rather than to keep it out of the sandwich.

But Russo said that explanation was ‘no excuse’ and didn’t even strike him as plausible. Since the online order twice said ‘peanut allergy,’ he asked, ‘Did they just see ‘peanut’ and not the ‘allergy’ part?’

The Russos’ lawsuit alleges that the franchise was “unfair and deceptive” when it put the peanut butter in the sandwich. They also are claiming “intentional or reckless infliction of emotional distress and assault and battery.”

It’s tough to eat out when you have dietary restrictions–from nut allergies to celiac, food concerns are growing in the U.S. It’s important that restaurants put safeguards in place to ensure that allergens don’t make it into their customers’ orders–for some, it can be a fatal error.

Anneliese Mahoney

Anneliese Mahoney is Managing Editor at Law Street and a Connecticut transplant to Washington D.C. She has a Bachelor’s degree in International Affairs from the George Washington University, and a passion for law, politics, and social issues. Contact Anneliese at amahoney@LawStreetMedia.com.

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Imagine ripping into a warm baguette with your bare hands. You owe its intoxicating fluffiness and delectable chewiness to gluten. A water insoluble protein found in wheat, gluten and its compounds bring us everything we expect from bread. It helps dough rise and hold its shape while also lending elasticity, making bread deliciously chewy.

Yes, we’re talking about the same gluten that has become a modern villain, misunderstood and widely hated. Popular books like “Wheat Belly and Grain Brain: The Surprising Truth About Wheat, Carbs” and “Sugar—Your Brain’s Silent Killers” turned gluten into poison in the public eye. Testimonials extolling the virtues of a gluten-free diet crusade the internet, converting many a faithful bread eater. In short, few foods have gained as much notoriety as gluten and many people think it equals anything bad in food.

Far from evil, gluten just presents a digestive challenge. When you digest wheat, the proteins break down into peptides with compact and complicated structures that cause adverse reactions in people with conditions like Celiac Disease, wheat allergies, or IBS. Unfortunately, in the past 60 years these conditions have become more common, stumping manufacturers and regulators who struggle to satisfy growing market demand for safe, gluten-free products. Read on to find out what they’ve done about gluten, and what they still have to figure out.

The anti-gluten craze: trend or reality?

Is gluten-hatred just a viral trend that people flock to like lemmings? Or is there some truth behind the gluten hate?

Scientifically, aspects of gluten-hatred hold water. Celiac Disease has quadrupled in the last 60 years. Celiac Disease is a disorder triggered by gluten that causes intestinal problems and poor absorption of vitamins and minerals.

Unfortunately, these statistics don’t point to an explanation, leaving scientists to toss around possible theories like darts. Some point the finger at wheat-breeding practices, others insist modern processing plays a part. At this point, only more well-controlled studies on the subject will lead to a consensus.

One study ruled out the possibility that the statistical growth in Celiac Disease results from better detection and diagnosis. A researcher at the Mayo Clinic analyzed existing blood samples from Air Force recruits taken between 1948-1954. He searched for the presence of transglutaminase, an enzyme that indicates Celiac Disease, and compared the percentage he found in the retro sample to the percentage he found in a modern sample of similar subjects. The percentage in the retro sample was significantly lower than what he found in the modern sample, leading him to conclude that something has happened since the 1950s to increase the overall rate of the disease–and it has nothing to do with diagnostics and detection.

The increase in Celiac Disease, combined with the increased demand for gluten-free products, even among people without diagnosed conditions, put pressure on regulators and producers. They responded first with better labeling.

Put a Label on it

In August 2013, the Federal Drug Administration (FDA) issued a final rule on gluten-free labeling that became enforceable the following year. The rule took nine years to develop and stems from the Food Allergen Labeling and Consumer Protection Act of 2004. It set a uniform protocol for companies wishing to market their products as gluten-free that established the acceptable gluten threshold at 20 parts per million (ppm). Why not zero ppm? Some processing techniques can remove most gluten from wheat-derived ingredients. The rule ensures these ingredients can’t add up to pass the safe threshold for people with gluten sensitivity. Furthermore, any food bearing a gluten-free label that lists wheat as an ingredient must also provide an explanation of how the wheat has been processed to remove the gluten.

The rule doesn’t expressly require testing and monitoring of gluten levels in ingredients to ensure compliance, but that would certainly be a safe bet for manufacturers. With the substantial list of ingredients from different sources going into processed foods, only diligent testing and monitoring can guarantee a gluten-free product. Even foods that don’t contain gluten can be cross-contaminated at some point in the long supply chain.

Per the rule, if a food labeled gluten-free actually contains gluten, it would be deemed misbranded by the FDA and subject to regulatory action. Depending on the nature of the offense, that could mean anything from a little warning letter to criminal prosecution.

Gluten Outlaws

Gluten labeling has lead to criminal prosecution before, and it happened when no FDA rule existed to break. In 2011, several customers of the Great Specialty Bread Co. in North Carolina found their Celiac symptoms became mysteriously aggravated after eating bread labeled “gluten-free.” These angry customers took their complaints to the North Carolina Department of Agriculture and Consumer Services, which passed it on to the Wake County District Attorney.

During the trial that followed, testimonies from injured customers forged a strong case against the company. One of them was a new mother whose Celiac reaction to the mislabeled bread caused her to prematurely deliver her baby. Other complaints included severe abdominal pain and rashes.

The owner of the company was ultimately found guilty of 23 counts of fraud and sentenced to nine to 11 years in prison.

Gluten: It’s Complicated

So we have an enforceable labeling policy and some criminal precedent for labeling abuse. What we lack to advance policies is a complete understanding of why gluten sensitivity is growing in the first place and how to control it.

Negative reactivity to gluten changes depending on the specific condition a person has and the variety of wheat that they eat, making gluten sensitivity hard to study as an overall subject. Gluten-sensitive conditions like Celiac Disease, wheat allergies, and other wheat sensitivities are also irritated by different compounds in wheat. Furthermore, separate varieties of wheat contain different amounts of gluten compounds and these amounts can fluctuate among the same variety depending on growing techniques and processing methods.

Growing Techniques

Studies have shown that reactivity of a wheat variety can change based on its growing location. Some compounds in wheat even increase with fertilization and in certain weather conditions. We don’t track gluten content from farm to table, so at present it’s impossible to isolate these factors to produce less reactive products.

Processing Techniques

Processing methods influence the reactivity of wheat products and stand as the prime suspect in explaining why wheat-related sensitivity has increased over the last 60 years. Of all the factors affecting the wheat industry, processing methods have changed the most. Today we favor refined white flour, we extract wheat proteins to use as additives, and we shorten the natural fermentation process using fast-acting yeast.

All of these complex factors complicate the study of gluten sensitivity and keep us from determining why conditions are growing. Any and all of these factors could be contributing to the problem. Costs and the complexity of food processing deter researchers and producers from tackling the issue, but only further testing can provide food manufacturers with the guidance they need to improve their growing and processing methods to lessen negative reactivity among their gluten-sensitive customers. While the process would be tedious, it could indicate what wheat varieties and techniques to favor in order to cater to the growing culture of wheat sensitivity.

Gluten, Still a Hot Topic

While many people mock the anti-gluten trend, a growing segment of our population needs to avoid gluten for medical purposes. Even so, a gluten-free lifestyle remains persistently trendy outside of that population. In the National Restaurant Association’s What’s Hot in 2014 survey, gluten-free took the #5 spot.

The trend ultimately helps people with diagnosed conditions as manufacturers and restaurants race to innovate tasty new products. If demand holds steady, it won’t be long until a perfect, gluten-free iteration of an exquisite baguette is within reach.

Resources

Primary

FDA: FDA Defines “Gluten-Free” for Food Labeling

FDA: Food Allergen Labeling and Consumer Protection Act of 2004 Questions and Answers

Federal Register: Food Labeling; Gluten-Free Labeling of Foods

Additional

Food Politics: Good News: FDA Issues Rules for a Gluten-Free Claim on Food Packages

New Yorker: Against the Grain

Comprehensive Reviews: A Grounded Guide to Gluten: How Modern Genotypes and Processing Impact Wheat Sensitivity

Food Liability Law: FDA Issues Gluten Free Labeling Compliance Guide

WRAL: Durham Bread Company Owner Sentenced For Fraud

Institute of Food Technologists: Testing for Gluten in Foods

National Restaurant Association: 2014 Culinary Forecast

Ashley Bell

Ashley Bell communicates about health and wellness every day as a non-profit Program Manager. She has a Bachelor’s degree in Business and Economics from the College of William and Mary, and loves to investigate what changes in healthy policy and research might mean for the future. Contact Ashley at staff@LawStreetMedia.com.

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