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glyphosate spraying

Overcoming Glyphosate in 2017

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There have been some massive changes in 2017 and a lot of upheaval. One of the most important being the conversation around glyphosate. The European Union recently voted on the use of this controversial ingredient, and the president of France took to Twitter to express his opinion: he wants this pesticide prohibited in France within three years which is why I am so grateful for brands like MegaFood® who have gone to extra lengths to ensure that their products do not contain it.

macron tweet about glyphosate

So what’s the issue? Glyphosate has been the go-to weed killer for use on genetically engineered, or GMO, crops since the mid-1990s.

Consequently, “Human exposure to glyphosate, a chemical widely found in weed killers, has increased approximately 500 percent since the introduction of genetically modified crops,” according to a report from the University of California San Diego Health.

Since 1974 in the U.S., over three billion, five hundred twenty million pounds of glyphosate active ingredient have been applied. Globally, glyphosate use has risen almost 15-fold since genetically engineered crops were introduced in 1996.

And consumers and government agencies around the world are starting to question it, ever since the World Health Organization declared it a probable carcinogen in 2015.

So, consumers have sent a strong response to this: 8 in 10 households in the U.S. now purchase some organic food (because by law, glyphosate is not allowed to be used on organic crops). But to take this quality assurance a step further, one of my favorite brands has gone even further.

MegaFood is dedicated to improving the lives of others by producing premium whole food supplements for those who care about their health and well-being. It’s a product I have used for years, since first meeting the CEO at a summit for the industry. He could not have been more candid and committed.

And MegaFood reflects that. The company is so committed to quality, safety and purity above all, to provide customers with the most authentic nourishment possible that they are the first supplement brand to have its entire line certified Glyphosate Residue Free by The Detox Project, an independent research and certification organization dedicated to bringing awareness to the public by testing consumer goods and food products for toxic chemicals.

It is because of all of this that I have decided to partner with them to get this news out. I cannot think of anything more important. On top of that, it is a brand that I have used for years, I travel with it, and it literally starts my mornings.

Earning this certification is just one part of MegaFood’s continued commitment toward The Big T Transparency, which is a complete operational transparency between MegaFood employees, suppliers, retailers and customers, as well as its commitment to quality, safety and purity.

It’s a big deal. Glyphosate is the number one herbicide used in the United States, and the World Health Organization (WHO) has classified glyphosate as “probably carcinogenic in humans.” Nearly 75% of all glyphosate was sprayed in the last ten years.

I am really grateful for full transparency on this, for the freedom to opt out of this controversial ingredient. It may take decades for all of the information to come to light. It did with the tobacco industry. In the meantime, I am grateful to know that MegaFood’s Daily Turmeric Booster Powder, one of my favorite products and something that I take every day, is now independently tested to ensure that it does not contain this controversial ingredient.

We have a lot on our plates as moms and as parents. In light of the growing controversy around this ingredient, I don’t think glyphosate should be one of them.

FDA building

How Monsanto’s Man in the FDA Paved the Way for GMOs

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This article was written by Dr. Belinda Martineau on her blog and republished here with her permission.

I have been reading with interest various articles reporting on the trove of internal documents obtained from Monsanto during the discovery phase of a federal multidistrict litigation against that company that is currently pending in the United States. (The documents, and a list of articles from all over the world that have been written about them, can also be found on the website of the NGO US Right to Know.)

Attorneys with Baum, Hedlund, Aristel & Goldman, the firm representing hundreds of plaintiffs across the US in the case, indicate that these so-called “Monsanto Papers” “tell an alarming story of corporate malfeasance. They reveal that Monsanto has been manipulating the science…ghost-writing scientific literature…bullying scientists that publish anything negative…and colluding with regulators to ensure ‘positive’ assessments.”

I was especially intrigued to learn that Henry Miller, who was described in The New York Times as “an academic and a vocal proponent of genetically modified crops,” is implicated in the ghost-writing scandal, albeit in regard to a non-academic journal. As reported in The Times, Dr. Miller “asked Monsanto to draft an article for him that largely mirrored one that appeared under his name on Forbes’s website in 2015.” Forbes has since taken the article in question down from its website and ended its relationship with Dr. Miller.

What was not mentioned in the article in The Times, and the reason for my intrigue, is the fact that Dr. Miller was the founding director of FDA’s Office of Biotechnology from 1989 to 1994. During that timespan, Calgene Inc., was seeking approval from FDA to commercialize what turned out to be the first genetically engineered (GE) whole food to enter the marketplace, the Flavr Savr™ tomato. Back then I was part of a team of scientists at Calgene conducting safety studies, explaining to FDA scientists how the genetic engineering process we were using worked, and participating in a dialogue with those FDA scientists about what possible risks might be associated with crop genetic engineering technology.

I have always felt that the timing of the release of FDA’s policy for dealing with GE food and feed products (not to mention the policy itself) made no sense. And now I am wondering how long the relationship between Dr. Miller and Monsanto, which appears to have included ghost-writing in support of that company, has been going on.

Initial safety data on the first GE whole food had been submitted to FDA, but not yet evaluated by the agency, when the May 1992 FDA policy was established.

We at Calgene had submitted a large package of data that we hoped demonstrated the safety of our GE tomato to FDA in August of 1991. We had submitted a similarly large package of safety data related to use of a gene conferring resistance to the antibiotic kanamycin, a gene Calgene and most other biotech companies insert(ed) into crops during the genetic engineering process, some 10 months earlier.

But before FDA had responded to these data packages, first by asking questions about their scientific contents and then by asking for more data to support our safety claims—which the agency ended up doing on at least five occasions, FDA came out with its policy for how to “regulate” GE food and feed products in May of 1992. That FDA policy was simple. With only a couple of exceptions, it called for developers of GE food/feed products to voluntarily consult with the agency about them.

The timing of the May 1992 policy just didn’t make sense to me. Why hadn’t the agency waited until it had thoroughly evaluated the safety of (at least) the first GE food product, Calgene’s Flavr Savr™ tomato, before it came out with its policy for “regulating” all GE food/feed products? And, because FDA had not completed evaluation of Calgene’s—or any other developer’s—safety-related data prior to publishing its policy for “regulating” GE foods, how could that policy be based on science?

Thorough evaluation of Calgene’s safety data revealed scientific “surprises” that I feel are relevant to FDA regulation of GE foods.

As it turned out, FDA scientists, and we Calgene scientists as well, continued to discover and deal with scientific issues related to the genetic engineering process in general, and the Flavr Savr™ tomato in particular, for some 18 months after the May 1992 FDA policy was published.

For example, FDA contacted Calgene multiple times between December 1992 and September 1993 about concerns they had with one scientific experiment in which minor gastric lesions developed in the stomachs of 7/20 female rats fed one particular variety of Flavr Savr™ tomato. In response, Calgene conducted multiple, various additional studies on that GE tomato variety until FDA was satisfied as to its safety.

And some six months after the May 1992 FDA policy was published, FDA scientists also asked Calgene to carry out experiments to demonstrate that only the foreign DNA we intended to insert into our tomatoes was, in fact, inserted into them. I, for one, was flabbergasted to find out that in about 20% of our GE tomatoes (and other GE crop plants transformed using the Agrobacterium method), much more foreign DNA—and DNA that was not well characterized at that—had been inserted than we had intended. To my knowledge, this “extra DNA” problem still has not been solved and so crop genetic engineers just have to look for extra DNA in each GE plant and throw out those that contain any.

What might FDA’s policy for regulating GE foods/feeds have looked like had the agency waited until after it had concluded evaluation of Calgene’s safety data to set its policy?

If FDA had waited until after it had reviewed all of Calgene’s data, and until after the scientific issues that surfaced during that review had been resolved to its satisfaction—i.e. until a point at which it could base its policy on some actual science—its policy for regulating GE crops might have been very different. FDA might have required that developers check their GE crops for DNA that was not intended to be inserted into them, for example, and/or required animal-feeding studies of new GE crops as is required in the European Union.

So why didn’t FDA wait until it had evaluated all of (at least) Calgene’s data, and then establish its policy based on that relevant science?

Could FDA’s failure to wait until after it had completed evaluation of the relevant data it had in hand before publishing its policy for “regulating” GE foods have had anything to do with a relationship between Henry Miller, Director of FDA’s Office of Biotechnology at that time, and Monsanto?

Back when Henry Miller was serving as the first director of FDA’s Office of Biotechnology (1989-1994), we at Calgene had heard rumors that Monsanto was not happy that Calgene, a little start-up company, might set regulatory precedence with FDA by being first to commercialize a GE whole food. And we knew that Monsanto employees were also in dialogue with FDA during the years leading up to publication of the FDA policy in May of 1992.

I have read many of Miller’s writings since then and often wondered how much he might have been influenced by Monsanto as the 1992 policy was being set. Especially since, as Monsanto’s Vice President for global strategy, Scott Partridge, told The Nation recently, “the [regulatory] process requires a tremendous amount of contact and interaction with the government.”

Now that it has come to light that Monsanto has apparently ghost-writen for Miller about RoundUp/glyphosate, I am even more curious about what kind of influence that company might have had over Miller back when the FDA policy was being formed.

Monsanto’s influence on EPA

After all, the “Monsanto Papers” suggest that Jess Rowland, a (now former) deputy director of the EPA’s pesticide division, had the kind of relationship with Monsanto that caused Congressman Ted Lieu to ask the Justice Department to investigate the possibility of collusion between Monsanto and EPA employees reviewing glyphosate, the herbicide-active ingredient in RoundUp. (And, as reported in The Nation, the EPA’s Office of the Inspector General has claimed to be looking into that.)

So I wonder: how might Monsanto have influenced Henry Miller, back in the early 1990s when he was director of FDA’s Office of Biotechnology (1989-1994), on the subject of how genetically engineered foods should be regulated by FDA?

1in6

Turning the Titanic: The Sexual Epidemic that Must End

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I first met Frances Fisher when I was invited by Marianne Williamson to speak at one of her campaign events. Marianne was running for Congress in 2014, and like many, she was beyond frustrated that our food system wasn’t part of the health care debate.  After all, true health care is directly tied to the food we put into our mouths. At that event in LA, we spoke on stage together to address it.

Frances and I then worked together on food labeling and social justice campaigns with our friends at the Environmental Media Association.  She is a strong, graceful and powerful advocate.

But as I watched her social media feed over the last week, I knew that she had more to say than ever. The truth she was speaking was crystal clear, and she was saying it as an actress, a mother, and friend.  She is also building a platform and stage for young women.  In the past, I’d seen her stand shoulder to shoulder with Shailene Woodley at Standing Rock, but this was different – her calls to action were so unbelievably strong, a very clear voice, speaking out against horrific accusations.

Her social media feed was flooded with Hollywood stories of #metoo.

According to CBS News, more than 12 million “Me Too” Facebook posts, comments and reactions were made in 24 hours.The hashtag was tweeted nearly a million times in 48 hours, according to Twitter.  Before this outpouring of stories of heart ache and terror,Tarana Burke started a “Me Too” campaign in 2007 to help sex abuse survivors know they are not alone.

So I reached out to Frances to see if she’d come on our podcast.  Her daughter, Francesca Eastwood, is starring in the newly released M.F.A., a film about college campus rape.  Just this week, the University of Colorado had conducted its own survey: 28% of female undergrads were sexually assaulted while in college. And what about the ones too afraid to speak, to say #metoo?

So Frances spoke.  As Ashley Koff and I begin the interview, she shares with complete candor her exhaustion.  The #metoo campaign triggers emotions for  anyone, male and female –  the experiences and memories are too close, the fact that it has happened to so many friends, family members, loved ones, of both sexes, too many times to even count, suffocates your heart. And it has to stop.  And so in our interview, we discuss what it takes to advocate, the emotional and physical toll it can take, how self-care is so critical, and what we can do for each other.

My friend, Aviva Romm, MD, and another podcast guest says we must give ourselves “permission to pause.”

I hope that you will pause for a moment and listen to Frances.  She is an extraordinary advocate, as well as being an incredible actress.  She will be remembered for so many of her roles, especially Titanic, but in my heart, she is a true friend, a sister in this work and an incredible ally for all working towards justice in the world.

And while any one of these issues may feel like an impossible task, we have to participate, for the sake of our children and the future that they are inheriting.  #Metoo is an epidemic. It is one that has to end with our generation.

And as Frances shares, it’s the words from Bob Dylan’s song, The Times They Are A-Changing, that we need to hear.

You can listen to our interview with Frances Fisher in the link below and on our iTunes podcast here.

To learn more about the #metoo survivors march on November 12, 2017, please click here.

 

GMAban

Courage, Campbell’s and Comfort Zones

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About seven years ago, I was invited to a think tank meeting in DC. The organizer was trying to fix the food system. He had a strong network, a strong reputation for negotiation and knew a lot of the stakeholders in the food industry.

Several attendees were from the Grocery Manufacturers Association, and they decided that I shouldn’t be there.

So I was uninvited.

I pushed the organizer, promising that I would listen and that he didn’t have to worry. He hesitantly agreed.

I paid my own way.

I walked into the first day of the meeting. Someone from the industry said, “Robyn, we finally meet” in the most condescending voice possible.

I thought, “What the hell am I doing here? Why did I leave my family at home for this?”

And I spent two days listening and quietly speaking with attendees in the hallways.

On the first day, someone from the Food Marketing Institute pulled me aside and shared that she had cancer. She asked about food. Someone from Safeway’s leadership team had a child with autism.

But it was a senior executive from Campbell’s that made that meeting worth the trip. He was respectful. He was willing to sit at the table and have the hard conversations, despite the fact that we didn’t see eye to eye on everything. We stayed in touch ever since.

So when Campbell’s announced that they supported mandatory GMO labeling last year, he was the first person that I emailed. He was also the first that I emailed when I saw Campbell’s announcement that they are leaving the Grocery Manufacturers Association.

It takes courage to create change.

It is those quiet conversations, out in the hallways or at the end of a day, when no one else was listening, that proved that there was more that unites us than divides us in this work. Whether at that DC meeting or when the CEO of Nestle’s Frozen Food division called and said, “You can say things that I can’t say.” It is the candid and shared concerns, especially as they relate to the health of our families, that give so many hope that we can fix this.

We have our work cut out for us. Less than 1% of our farmland is organic here in the U.S. while Germany just announced a record that 7.5% of their farmland is now organic. We are late to this game on the global playing field and don’t have a supply chain to keep up with demand. Other countries are benefiting from our inaction.

There is a deep and real need to move beyond commodity-based agriculture if we are going to fix our food system, farm economy and the health of our families. There are new regulatory needs in light of the growing demand for organic and the skyrocketing rates of food allergies, diabetes and cancer in America.

And there are consumers who are serving as a compass, telling the industry exactly what they must do to meet the needs of all stakeholders and shareholders and ensure profitability.

Some companies like Campbell’s are listening. Some like Kashi are working to transition farmers to organic, while other processed food companies are so entrenched in a 20th century way of thinking that all you can do is to get out of their way as they take themselves out.

When Campbell’s announced in 2016 that they were breaking with the Grocery Manufacturers Association and going with mandatory GMO labeling, other companies quickly followed. Why? The Grocery Manufacturers Association no longer served the needs of its members. It spent millions telling consumers that their concerns were not valid, that thei voice had no merit, that the customer was not right. And the Grocery Manufacturers Association was wrong. Consumers, driven by growing concerns for the health of their families, are driving a massive change in the food industry.

And just as Campbell’s led and others followed in 2016, it will be interesting to see who moves next here, too.

Change does not happen in our comfort zones, and change at its core can seem hypocritical. But if you want change to happen, you have to lean into it and into any fear or butterflies. A friend once shared that those butterflies are your internal applause cheering you on.

It’s a good thing to remember as we rethink food for the 21st century. Less than 1% of our farmland is organic. Not a single food company in the United States benefits from that, not one. The economics don’t work.

Now more than ever, it’s time to build out a supply chain that allows American food companies to compete in the 21st century and meet the changing needs of 21st century families.

Let’s lean into it, dump the junk, and cheer it on.

Mylan's boardroom

Investors Rip Mylan’s Board, Calling for the Removal of Chairman & Others

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We’ve addressed the skyrocketing prices of EpiPens here since October 2015. We’ve been on the frontline of #epigate for over a year and half.

A few weeks ago, in an interview on Fox Business, I was asked about the jaw dropping paycheck given to Mylan’s chairman, Robert Coury. He received total compensation of almost $160 million in 2016.

My statement? “I think investors would be smart to do what Wells Fargo did, clean out that board and start over.”

This week, four pension funds that hold about 4.3 million shares of Mylan, the maker of Epipen, shares valued at $170 million, called for just that, an overhaul of 6 board members including the chairman. They also revealed something else:

“This controversy also caused investors – including several of us – to urge the Board to strengthen its oversight of Mylan’s drug‐pricing strategy and risks, requests that have been largely ignored.”

The letter itself is jaw dropping in that it suggests that Myan’s chairman relocated the company’s headquarters overseas, structured what is known as a poison pill, with the intent to avoid being acquired by Teva Pharmaceuticals. In the letter, the shareholders suggest that this was perhaps done with the intent of keeping himself on the payroll.

It begins:

“As long‐term Mylan shareowners, collectively holding about 4.3 million shares valued at $170 million, we believe the time has come to hold Mylan’s Board accountable for its costly record of compensation, risk and compliance failures….

Mylan’s Board reached new lows in corporate stewardship in 2016, when it agreed to make extraordinary and egregious payments in 2016 and over the next five years to Chairman and former CEO Coury. His compensation totaled $97.6 million in 2016 according to the Company’s Summary Compensation Table, which in some ways understates his total pay. Including vesting and payments triggered in part by inconsistent Board determinations, Mr. Coury received more than $160 million in 2016 (see Appendix). The added payments related in part to his third new compensation arrangement since he stepped down as CEO on January 1, 2012, while still remaining Chairman and – through 2016 – a Named Executive Officer (“NEO”).”

It turns out the company has 3 named executive officers (NEOs). Out of the 20 companies in their peer group, 15 only have one. The investors go on to state:

“In a year in which Mylan suffered significant reputational and financial harm as a result of its EpiPen pricing controversy and its shareowners suffered a negative 29.4% total shareowner return (“TSR”), CEO Heather Bresch and President Rajiv Malik felt no comparable financial pain.”

In a year in which more children lost their lives to a life-threatening allergic reaction, where families could no longer afford this life-saving device, many American families felt pain beyond anything that money can measure.

Please take a minute to read and share the letter. Mylan’s annual shareholder meeting is June 22. Please post your comments below the article or contact us directly, so that these shareholders know how many millions of Americans are impacted by this egregious behavior.

The letter is in its entirety below.

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Food-for-Thought

Watch and Share: Food for Thought Webinar with Dr. Frank Lipman and EWG

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I was asked by my dear friend, Dr Frank Lipman to moderate this month’s Be Well Workshop. It featured Dr. Lipman, a NYC-based physician and the founder of Be Well and Ken Cook, founder of Environmental Working Group (EWG).

It was a very important conversation, in which we talked about the correlation between our food supply, the rise of chronic disease and conditions, and the influence that money has had on the science. All experts shared their mutual viewpoint on the issue and encouraged consumers to take action.

“What we are realizing is that the food system from the 20th century cannot feed 21st century families. We are too allergic, we are too diabetic, we are battling too many autoimmune conditions and too many diseases—and we need food that’s free from a lot of the ingredients we’ve been using the 20th century.”  —Robyn O’Brien

“I always suggest to eat as close to nature as possible. I have this motto: if it’s made by god, it’s probably good; if it’s made by man, be careful. So I encourage patients and readers to know the source of their food, know your farmer, shop at farmer’s markets, speak to your farmers and encourage them to know their clients’ needs.”
—Dr. Frank Lipman

“Do something that’s going to make you feel successful; make you feel like you are on a winning streak and that might mean just making some slight changes in the produce aisle; more and more choices available in large grocery stores are now organic than before, like potatoes, carrots, spinach, fresh lettuce—all of these are a significant portion of the organic produce supply because of what consumers have done and how farmers have responded.” —Ken Cook

Mylan epic greed

Another Class-Action: Mylan Sued for Violations of Anti-Trust Laws

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Another class-action lawsuit against Mylan has been filed for scheming to eliminate meaningful competition, evergreening the EpiPen patents and forestalling education initiatives for novel devides, using illegal exclusive dealing agreement to shut out competitors.

On April 7, 2017, a group of EpiPen purchasers filed a nationwide class-action lawsuit against Mylan and others over their unlawful scheme to monopolize the market for EpiPens, systematically raise prices without justification, and reap massive, inflated profits at customers’ expense.

According to the suit (attached below), “First, by “evergreening” the EpiPen device patents (a tactic by which patent holders make minor or insignificant changes in their devices or drugs, and then reintroduce them as new products with new and extended patent life) and by aggressive misuse of legal and regulatory systems, defendants have foreclosed the market to generic competition.

Second, to forestall education initiatives for novel devices, Mylan has used illegal exclusive dealing agreements to shut competitors out of public schools, and keep new auto-injectors from schools nurses, parents, students, administrators or others that might become familiar with them. Aside from safety concerns, insurance coverage is another important factor in choosing an auto-injector, yet defendants have used their monopoly power to manipulate coverage for competitor devices as well.”

After remaining relatively stable around $75 to $100 per dosage from 2001 through the end of 2008, beginning in and around 2009, in conjunction with the defendants’ successful efforts to effectively curtail any meaningful epinephrine auto-injector competition then and since, Mylan has raised the price of EpiPen at a rapid pace to over $600 per dosage in 2016 – an increase from its $99 December 2007 price of more than 514%, as illustrated below.

The lawsuit claims that Mylan has been able to maintain their epinephrine auto-injector market dominance for nearly a decade – they have illegally thwarted competition.

Since Mylan’s acquisition of EpiPen, the class-action suit claims that Mylan has engaged in specific conduct designed to exclude rivals and harm the competitive process in the epinephrine auto- injector market. Defendants’ anticompetitive and illegal exclusionary conspiracy to maintain Mylan’s monopoly has made them billions of dollars at the expense of consumers and third-party payors, with EpiPen annual sales recently exceeding $1 billion, up from $200 million in revenue when Mylan first acquired EpiPen.

Those who have purchased an EpiPen out-of-pocket or with a high deductible plan may contact the attorneys below to become involved in the case or learn more.  Boies, Schiller Flexner LLP is a global powerhouse in litigation.

According to Law360.com, “throughout its 19-year history, Boies Schiller & Flexner LLP has garnered a reputation as a firm that excels at taking complicated cases to trial and has locked down major litigation victories for clients including Barclays and Oracle, earning it a place among Law360’s Litigation Powerhouses. With 260 attorneys — 115 of whom are partners — in its litigation practice, Boies Schiller takes pride in its ability to win difficult cases in creative ways for its diverse group of clients.”

Contact information is provided below for any questions or to learn more:

Duane Loft

BOIES SCHILLER FLEXNER LLP

(212) 909-7606

[email protected]

Brian Penny

Goldman│Scarlato│Penny  p.c.

(484) 342-0700

[email protected]

de1 1 - Complaint - 17-2401 DNJ
Daniel Lubetzky - Founder of Kind Snacks

Kind Snacks Founder Creates Organization to Promote Public Health by Countering Food Industry Propaganda

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Daniel Lubetzky, the Founder and CEO of KIND Healthy Snacks (KIND), recently announced the launch of Feed the Truth. Established as an independent organization, Feed the Truth will seek to improve public health by making truth, transparency and integrity the foremost values in today’s food system.

Given what we’ve learned about Coca Cola’s hand in obesity studies and Monsanto’s hand in food allergy research, it is well past time to shine a brighter light on the conflicts of interest in science.

To ensure Feed the Truth’s independence from KIND, Lubetzky will remove himself entirely from all activities and governance of the new organization. He has assembled three unaffiliated public health advocates whose sole role is to nominate Feed the Truth’s Board of Directors. The advisors, all of whom have offered their expertise voluntarily and are not being paid for their involvement, include:

  • Deb Eschmeyer, former Executive Director of Let’s Move! and Senior Policy Advisor for Nutrition Policy at The White House
  • Michael Jacobson, PhD, Co-Founder and President of the Center for Science in the Public Interest
  • Marion Nestle, PhD, MPH, Professor of Nutrition, Food Studies, and Public Health at New York University

Feed the Truth will ensure science overrules special interests by revealing and counteracting the food industry’s undue influence in shaping nutrition policy and ability to disseminate biased science, among other activities that are detrimental to public health. While specific programming will be decided by an Executive Director that will be appointed by the Board of Directors, activities could potentially include grants to support investigative journalism, consumer education campaigns and educational briefings to policymakers and influencers.

“In establishing Feed the Truth, my intent is to elevate reputable science, bolster the voices of the nutrition community, and improve the guidance and information offered to Americans,” Lubetzky said. “As a business owner, I understand the importance of prioritizing your bottom line, but it’s equally as important to consider how you can succeed while also thinking about the long-term impact on the community.”

Lubetzky’s journey to create Feed the Truth began in 2004 when his frustration with a lack of wholesome, nutritious snacks in the marketplace led him to launch KIND. What began as a line of whole nut & fruit bars sparked the creation of an entirely new healthy snacking category and gave Lubetzky a window into long-held industry operating procedures that often benefited companies financially at the expense of public health.

In May 2015, KIND faced a public confrontation with the U.S. Food & Drug Administration (FDA) over the company’s usage of the term “healthy” as a nutrient content claim on its packaging. The FDA’s guidance – which was established over 20 years ago – limited total fat intake, regardless of source or type, and prevented demonstrably nutritious foods like nuts, salmon and avocado from being labeled as “healthy.” After months of exploration and discovery, KIND filed a Citizen Petition, with the support of leading nutrition and public health experts, requesting the agency update the regulation to be consistent with modern nutrition science.

By September 2016, the FDA announced it would begin the process of revising this regulation and offered a sensible interim solution – both of which incorporated KIND’s recommendations. That same month, a JAMA Internal Medicine report found that in the 1960s the Sugar Association funded scientific studies to diminish findings that linked sugar consumption to poor heart health. Instead, the Association used industry-funded research to vilify fats – an act that would go on to directly inform the government’s dietary guidance, spur a surge of low-fat, high-sugar products, and ultimately, distort consumer perception of all dietary fat.

“We’re eager for Feed the Truth to step in and hold all of us in the food community accountable for what we say and claim,” said Lubetzky. “While this ‘Big Sugar’ revelation underscored the need to provide more tools to public advocates, it doesn’t mean that ‘fat’ or ‘protein’ should now be evangelized. Feed the Truth’s independent Board of Directors, once established, will seek to ensure consumers have access to unbiased nutrition information.”

“This commitment could have a salutary effect on educating the public about nutrition and cleaning up deceitful marketing practices,” said Michael Jacobson.

Lubetzky’s donor advised fund has made an initial contribution of $5 million to Feed the Truth. Lubetzky intends to fund an additional $20 million over the next ten years.

To learn more and get involved visit FeedtheTruth.org.

 

ronkids

Save the Garden: Ron Finley Needs Help!

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The first time I met Ron Finley was in LA. I was speaking at an event, and there he was. There was an instance recognition between us, two unlikely candidates fighting for better food, and a friendship that started immediately.

He has many titles: Fashion Designer, The Renegade Gardener, Guerilla Gardener, Gangsta Gardener, Head Trouble Maker but most importantly Revolutionary.

He’s been a true friend in this work for a long time.

In 2010, he decided to take his health and the health of his community into his own hands and “Plant Some Shit,” turning a strip of city-owned land into a food oasis. After a citation, fine and eventual warrant for Finley’s arrest over the grass that he transformed into a food forest for his community, word spread quickly about the “Gangsta Gardener.”

With the help of his powerful 2013 Ted Talk and 2015 film “Can You Dig This,” his message that gardens are solutions to inner city health problems, gang violence and poverty has echoed around the world. The ringing of his words has given birth to urban communities across the globe coming together to grow their own food in areas that have none.

People from all walks of life have shown their support for Finley’s efforts: Alice Waters, Rainn Wilson, Penny Marshall, Carson Daley, Rachel Hunter and Robert Horry have reached out in solidarity, as well as statewide dignitaries including Mayors Aja Brown, Kevin Johnson and Councilman Herb Wesson.

Over the years, the Gangsta Garden has evolved into more than a symbol of healthy change for urban communities including an educational site, a propagation station for more edible landscapes and the formal headquarters for The Ron Finley Project (RFP). Furthermore, it has become the focus of study for local K-12 classrooms and universities worldwide including the renown institutions of MIT, Harvard and University of Southern California.

Currently, RFP is fighting for their headquarters; the very same location that ignited a good food revolution when Finley took back city land and planted the seeds to cultivate happy and healthy communities. After numerous attempts by the property owner for a loan modification with no avail, the land was sold to Strategic Acquisitions, Inc. in a foreclosure.

This company, Strategic Acquisitions Inc., has made their business out of buying up distressed assets, putting the squeeze on, then flipping them. They don’t care about the underlying assets or the children that are benefiting. They simply saw what Ron was doing, moved in in the most predatory way, and are now driving a stake through the heart of his work.

RFP has requested that Strategic Acquisitions allow them to continue operating from the location as to sustain the important work they are doing in the community. The only solution they have been offered is to purchase the property for $500,000, otherwise… they face eviction.

Finley took on city lawmakers in 2010 sparking a worldwide food justice revolution. Now the world needs to rally behind him!

If you have been touched by RFP or support access to healthy food for ALL communities please donate what you can and share widely.

RFP needs to raise $500,000 to #savethegangstagarden. More than that, he also needs help bringing attention to this real estate company, because they won’t stop here.  They’ll move on to the next guy changing the world and milk him for another half million.

Please share this post. You can support and save the garden here.

Mylan-Increases-Paid-Search-Ad-Spend-in-April-May-2016-AdGooroo

Mylan Responds with a Press Release that Dodges Concerns and Questions

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On January 20th, 2017, almost exactly eleven years to the day since I was thrown into this work in the food allergy world, I heard from from Mylan’s communication’s department for the first time. They wanted to discuss points made in a recent FOX interview. I was grateful. After a decade of working in this space, they finally wanted to talk.

So I turned to our community for feedback, prior to the call.

But the call didn’t happen. Instead, the communications team responded with a press release.

When I first saw it, I sent an email suggesting that we get on a call, as the press release fails to address so many of the concerns that our community has.

But I haven’t heard back.

Since Mylan continues to follow what is written here, we have decided to post the concerns from our community, along with their press release. Thank you so much to all of you who have written, responded and called.

  1. Mylan refers to EpiPen users as “patients.” Referring to our children and loved ones as “patients” suggests that we are sick. While that may be how the company recognizes EpiPens recurring revenue model, many food allergy consumers are healthy, read labels, and many avoid additives, artificial ingredients, GMOs and other synthetic ingredients. Countless times, the community have said that food allergies are a blessing in disguise, as it taught them how to make smarter and healthier food choices. Perhaps rather than using the word “patient” as they do below, Mylan can stick with consumer or even “user” (a term used by Coca Cola).
  2. Our community is composed of pediatricians, allergists, TV producers, journalists, attorneys, MDs, parents, teachers, nurses, investment bankers, Congressmen and women and so many more. Again, “patient” minimizes the incredible diversity of the food allergy world.
  3. The press release below fails to answer a question asked by many allergists: how did Mylan secure exclusivity with the pharmacy benefit managers? Was a deal cut? Did money change hands to secure that EpiPen was the only device offered? Under what terms was Mylan able to secure the exclusivity? Was something done to ensure market foreclosure? Contracts between Mylan and the PBMs could answer that.
  4. Mylan suggests that they “invested over $1 billion in raising awareness and increasing education about the risks of anaphylaxis.”“Mylan increased its branded ad spending on the EpiPen by 357% over five years. During the same time the drugmaker hiked the price of the allergy auto-injector by 179%.Mylan spent $43 million on branded ad spending for the EpiPen in 2015, down slightly from $48.9 million in 2014 and up significantly from $9.4 million in 2011, according to data from Kantar Media. At the same time, the drugmaker has steadily increased the wholesale acquisition price, which excludes rebates and discounts, twice a year since 2011, according to Elsevier Clinical Solutions’ Gold Standard Drug Database. In May 2011 the EpiPen was priced at $164.98, and that price rose to $461 by May 2015. It now costs $608.61.”
  5. Given that the United States and New Zealand are the only two countries in the world that allow pharmaceutical advertising directed at the consumer, is the skyrocketing advertising budget the reason that Mylan jacked up the price of the EpiPen twice a year since 2011?
  6. How did the search ad spending drive pricing decisions? Mylan didn’t just shell out for TV ads as EpiPen prices soared. Search spending was way up, too. According to FiercePharma, “the company shelled out and worked hard to build EpiPen’s profile in the marketplace. Coupled with the company’s repeated price increases, its EpiPen marketing program built the epinephrine injector into a blockbuster product accounting for 20% of the company’s revenue. The thinking goes like this: Potential customers see an ad on TV, go to their smartphones and type a word or brand into Google search to find out more. Why not place an ad linked to allergy keywords?” EpiPen.com increased paid search ad spend by 1,800% as the price of the device hits an all time high in May 2016.
  7. In the fall of 2016, Mylan’s CEO was questioned by Congress in a Congressional hearing about Mylan’s market share. She acknowledged what has also been acknowledged that EpiPen had a 95% market share (Athenahealth states that EpiPen’s market share was 95.7% in August 2016). How was Mylan able to secure that monopoly? Was that exclusivity ensured through the product donations to schools?
  8. The release below does nothing to address consumer concerns that Mylan misrepresented its drug classification to Medicare and Medicaid. The drugmaker reached a $465 million settlement with the U.S. Justice Department and other government agencies to resolve questions over rebates required by the Medicaid program.
  9. And lastly, consumers have been asking for refunds since the price drop. As an anti-trust probe is launched, many are lining up for more answers.

Below is Mylan’s press release:

We appreciate the work that you do for the community and your role in continuing this important conversation. We reached out to you to address some of the concerns that have been raised. We value the comments we read from the community on your social media outlets, and given their engagement and interest in our discussion, we feel it is most appropriate to respond where the broader group can read it. While this post is lengthy, we wanted to address the many topics that were raised.

First and foremost, we were saddened to read about the boy who passed away on Thanksgiving after experiencing anaphylaxis, and we share our condolences with this family. While the collective severe allergy community has made progress over the years in raising awareness and increasing education, tragedies such as this demonstrate there’s more work to be done.

This is the primary reason why we have invested over $1 billion in raising awareness and increasing education about the risks of anaphylaxis. We worked to change laws to allow access to epinephrine in schools so it is readily available for any child who has an anaphylactic event. We have given away nearly 800,000 EpiPen Auto-Injectors to schools across America. These free devices have been used hundreds of times. We don’t want to go back to a time – not that long ago – when awareness of anaphylaxis was much lower and epinephrine auto injectors were only available in schools with a prescription for an individual child. Achieving this level of expansion of awareness requires a significant commitment.
Mylan takes its role within this community seriously and has been – and continues to be – committed to increasing awareness, preparedness and access to treatment.

  • In regards to price, patients are rightfully concerned about rising drug prices. Mylan has felt the full weight of these concerns in relation to the price of EpiPen® (epinephrine injection, USP) Auto -Injector. However, it is important to understand that the way consumers pay for their healthcare has changed dramatically over the past few years. The stark reality is that a sharp rise in high deductible health plans has exposed more consumers to higher out-of-pocket costs for their medications. And working families will continue to face sticker shock at the pharmacy counter for medications and be forced to make difficult choices until the process of pricing pharmaceuticals is reformed to recognize the increasing shift of costs directly to consumers.
  • As it relates to EpiPen Auto-Injector, last summer approximately 85% of consumers prescribed EpiPen had an out-of-pocket cost of less than $100 and a majority paid less than $50. However, as a result of the rise in high deductible plans, about 15% of EpiPen purchasers were exposed to a wholesale acquisition cost (WAC), or list price, of $600 or more. While some competitors have recently suggested that patients do not pay the WAC price, you and many in this community know firsthand that this is not always the case in today’s environment. This is why we took immediate and decisive action to cut the price of EpiPen Auto-Injector in half through the launch of our authorized generic and to adjust our enhanced patient programs and resources to help increase access for this patient population. This was the most direct way to reduce the cost for patients. Media coverage has noted how the recent Auvi-Q® announcement reflects the challenges facing our system Mylan offers the lowest WAC* price ($300 for the authorized generic for EpiPen Auto-Injector and $608 for EpiPen Auto-Injector) and cash cost/direct ship cost ($300) to all patients, not just those visiting a select retailer.
  • There was some confusion from your readers about our resources; let us clarify.
    • For all patients, the authorized generic for EpiPen Auto-Injector is now widely available at pharmacies across the U.S. at half the wholesale acquisition cost ($300) of EpiPen Auto-Injector.
  • A savings card and relevant terms and conditions are available online
  • If you are being charged a cost that significantly exceeds $300 for either dose of product, this is an error. Please contact Mylan Customer Relations at 1-800-395-3376 or [email protected].
  • Mylan also provides a direct ship option that offers the authorized generic for EpiPen Auto-Injector at a cash price of $300, the lowest direct to patient cost.
    • For commercially insured patients purchasing EpiPen Auto-Injector, we expanded our My EpiPen Savings Card® program.
  • This savings card and relevant terms and conditions are available online
    • For uninsured and underinsured patients, we doubled the eligibility for our patient assistance program to support those earning up to 400% of the Federal Poverty Level. This means an uninsured or underinsured family of four making up to $97,200 pays $0.
      Information about all of these resources can be found on Mylan.com/EpiPenAccess.
  • Many have questioned why we did not just lower the cost of the branded product. It would not have ensured that EpiPen Auto-Injector would be made more affordable for patients, especially for the uninsured, underinsured and those with high deductible health plans. Because we cannot control the costs charged by additional parties involved in the pharmaceutical supply chain and reimbursement system in which we operate, and given contractual arrangements with customers, cutting the list price of the branded product woul d not have guaranteed that patients would pay a lower price at the pharmacy. Therefore, we introduced the authorized generic for EpiPen Auto-Injector, which is identical to the branded product, at 50% of the WAC price, and expanded our savings card and assistance programs to reach more patients.
  • Contrary to what appears to be a popular misperception, patients at risk for anaphylaxis, a life-threatening allergic reaction, have – and always have had – various alternatives when it comes to epinephrine. For more than 10 years, the market has been a competitive one, providing consumers and healthcare professionals with numerous options for their prescribed epinephrine auto-injector.
  • Recent media attention about the various epinephrine auto-injectors on the market has generated confusion about patient options. There are important differences between products in terms of the functionality and administration process. We suggest that all patients work with a healthcare professional to determine the option that’s best for them. All patients should receive training on proper administration of a prescribed epinephrine auto-injector in a physician’s office and practice between doctor office visits.
    Mylan remains dedicated to meeting the needs of those at risk for anaphylaxis, and we are committed to providing access to EpiPen Au to-Injector. We understand the frustration of anyone facing barriers to access. We respect the opinions that have been shared and welcome continued feedback and dialogue. Our hope is that the conversation surrounding EpiPen Auto-Injector serves as a catalyst for reform and real transparency in pharmaceutical pricing.

*The final retail cost to the patient for EpiPen Auto-Injector and the authorized generic will be dependent upon their insurance and any mark-ups within the supply chain.

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