It’s Time to Get Serious…

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I recently attended a medical foods workshop organized by the Healthcare Nutrition Council in Washington D.C. I chose to attend this workshop because the Healthcare Nutrition Council is a lobbyist group funded by Abbott, Nestle Health Science, and Nutricia.

Given the highly unethical behavior I have witnessed from Abbott, Nestle Health Science, and Nutricia, I felt it pertinent to see what they were doing at this workshop. Something about this simply did not smell right to me.

Unethical behavior

Abbot has conducted horrifically bad research with shockingly and appallingly poor experimental design. Their studies violate the most fundamental of scientific principles for the purpose of obtaining skewed data they could use to increase sales.

Nestle Health Science has used this very data and written articles of their own that also violate fundamental scientific principles and ethics, and they did so to increase sales.

Nutricia’s Neocate formula was shown to cause a severe deficiency in some children that caused them to develop a very dangerous and potentially fatal bone disease that left multiple children injured and/or permanently disabled. They said nothing and took no efforts to inform medical professionals or consumers of this issue. A class action lawsuit is currently underway.

I could go on. Any place funded by these people is worth keeping a close eye on.

So, Bradley and I headed to D.C.71764183_2340044292917261_9020764586822860800_n

I’m not the only one that wanted to keep an eye on these people. The entire trip was funded by individual, personal donations of members of the blenderized diet community. The money was raised within a few days. Our community spoke loud and clear.

The Healthcare Nutrition Council

First, let’s talk about the Healthcare Nutrition Council. Supposedly, they exist for the purpose of influencing policy and regulations to increase diagnosis and treatments for malnutrition. Of course, those funding this place believe the solution for malnutrition is their fortified milkshakes that they call medical foods, products that recent research has shown increase health complications, GI symptoms/discomfort, complications resulting from respiratory illnesses, emergency department visits, and hospitalizations. Only the poorly designed research of the mentioned companies shows otherwise (learn more about this poorly designed research in this podcast episode).

The Healthcare Nutrition Council has openly advocated against you and I’s rights to know specific details about products made for tube feeding. Their argument was that it is available by prescription only (which actually is not true since these products can all be ordered from Amazon and other places without a prescription). According to their letter, if a doctor decides the product is beneficial, the patient has no reason, or even the right, to know any further information about the product or have any sort of opinion about its use. Of course, they did not come out and say that, but that is what they meant. You can read about this here in their own letter.

Be aware, the very doctors prescribing these products often know virtually nothing about them. I have advocated for many, many parents over the past four years, talking to doctors or dietitians. Of the large number of times I’ve asked if they were aware of the ingredients, not one time was a single one of them able to tell me a single ingredient of the products they were prescribing. Not once was a single one of them able to give me a ball park figure as to how much sugar was in the product. Not once. They don’t want patients to know, and they do nothing to make sure doctors and dietitians know.

There are details of food products that orally-fed people are considered to have the right to know about. Whether the product contains a bioengineered ingredient or how much sugar is in the product are examples of such details. Specific information has to be included on the label so consumers can know and make an informed choice. However, as soon as a person receives a feeding tube, that right, under the current system, ends.

I know why the Healthcare Nutrition Council wrote the letter mentioned above. Those that fund the Healthcare Nutrition Council have had an easier time convincing the medical profession to push these products than they have had convincing individuals and caretakers to use them.

They take doctors, nurses, and dietitians out to lavish steak dinners. They wine and dine them as they talk up their poorly designed research, leaving out important details that would show just how crappy the studies actually are. And, it seems, no one who attends such dinners double checks this research to evaluate its quality. They leave inspired to prescribe these products to their patients in response to marketing schemes rather than legitimate scientific data.

But, moms, dads, caretakers, etc. are in the trenches watching their loved ones suffer each day due to the use of these products. We are not so easily convinced. So, their efforts have centered around withholding information from patients and caregivers and leaving it in the hands of the medical profession whom they have had an easier time manipulating, unfortunately.

(To learn more about the devious practices of these companies, check out my book, Stand for Food).

In other words, they are not on the side of patients. And this is what makes the information presented below particularly alarming.

Onto the workshop itself…

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Bradley was very well behaved throughout the workshop. Good job, Bradley!

The first day, I sat through a series of presentations that, together, lasted several hours. They began by describing the outdated FDA regulations regarding medical foods. They especially loathed that in order for a product to be considered a medical food, it could not be used for the dietary management of an issue that could be adequately addressed through the modification of the normal diet. They want this definition of medical foods changed to not include this.

“FDA’s narrow interpretation of medical foods subjects specialized products to the regulatory framework that applies to foods for the general population. Most notably, if FDA concludes that a specialized food fails to meet the agency’s narrow criteria for ‘medical foods,’ the food will be subject to FDA’s regime for health claims and structure/function claims.” (find the full article here)

They literally complained that the products they make are required to follow the same rules as those for food in general. They are complaining that they have to treat patients who have a medical issue with the same respect as those who don’t. They are complaining that people living with medical issues are thought to have the same rights as everyone else.

What rules are they talking about? Right now, you can’t make a medical claim about a food product without adequate data to support that claim. They want to be exempt from that rule. Right now, you cannot say a food product is designed to treat a specific medical condition without adequate data to support that the food product actually does do that. They want an exemption from that rule. This is what they desire to see changed.

And it’s no wonder that they want to see this changed. I have heard them make medical claims about their products numerous times. They already are breaking the law. They tell doctors and dietitians their products are gentle and easy to digest. They claim they are the remedy for a tube-fed person who is vomiting or experiencing reflux. “Oh, the kid is vomiting on a standard formula? Switch the child to a much more expensive elemental formula because it is so gentle and easy to digest.”

Of course, they don’t want the law to require them to provide data to support that claim because the data actually shows that for the vast majority of people, both standard and elemental formulas for enteral nutrition increase vomiting and reflux. They can’t come up with data to support these medical claims because the claims are not true. In other words, they desire for the law to look the other way when they lie about their products.

They went on about how the FDA’s definition of medical foods (especially that it has to be for a condition that cannot be managed through modification of the normal diet alone) is very unclear and ambiguous. Is it? If someone needs an altered diet, and it can be accomplished by simply changing the foods he/she eats, why would the person require a specialized medical food in the first place?

What I take from this is that they want to be allowed to feed people their Pediasure™, Ensure™, Boost™, Elecare™, Neocate™, Alimentum™, Ketocal™, and other such beverages to people who do not even need them. Since the law is making this difficult to do, they are upset.

They focused on the question, “What constitutes a normal diet?”

Since that isn’t well-defined, the regulations are unclear…according to them.

They have a point to a small degree. What is a normal diet? While we could spend days discussing such an issue, I can make one definition quite clear: a normal diet consists of actual food. I don’t know anywhere in the world in which a diet of sugar, oil, protein powder, and synthetic vitamins is considered normal. So, at the very least, a normal diet consists of actual food, whether we are talking about pasta, roast beef, rice, vegetables, or whatever else.

Normal diet = food.

Abnormal diet = bizarre concoction of sugar, oil, protein powder, and synthetic vitamins.

Which specific foods a person eats and considers normal will vary widely between individuals. But, we are all eating food. That one aspect is considered normal across the world.

So, in order for someone to be fed a product like the formulas these specific companies make, federal regulations state that it must be given for a condition where simply changing which foods the person eats (whether orally or by tube) is not adequate at managing the nutritional needs of their medical issue. And they do not want such regulations.

Why? Because even though such conditions exist, they are quite rare. If these companies have to adhere to the FDA regulations, they will have extremely few sales, especially as they are pushing to enter the market even more for orally-fed people.

The rest of the day consisted of presentations about the glories of formula. That is an exaggeration, but still, nearly every problem that was discussed, formula was identified as the solution. For example, a clinician shared a presentation about the keto diet for the management of seizures. The keto diet has most certainly been shown to be effective at reducing or even eliminating seizures in many people.

He described their program at his healthcare facility for families with a child who is transitioning to a keto diet. He largely referred to children who ate orally. He explained that for the transition, the family is in the hospital for three days, and then, they are sent on their way without any additional support at all. “They are on their own from there” were the words he chose.

Not surprisingly, compliance was difficult under these circumstances. The solution? A keto formula, of course. Not increased support. Not longer term support. Not help. Formula.

But, under the current FDA regulations, Ketocal™ formula cannot technically be considered a medical food because a keto diet can be achieved through the modification of the normal diet. Thus, Nutricia cannot make as much money through sales of Ketocal™ given that insurance will not cover it for oral consumption. This is why they want the laws changed.

I noticed they did not mention how many tube-fed children vomit on Ketocal™ formula. I know a large number of families with a tube-fed child who was extremely ill while being fed Ketocal™, but their child experienced relief and improved health when fed a keto diet of real food.

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Hmmmmmm…

This went on all day. We had a break for lunch that was provided for us. I looked around for the formulas they were touting since they apparently are superior to food…but, we were not offered any. If these products are so great, you’d think they would have offered samples.

Another presentation was given which was both incredibly disturbing to me and absolutely appalling. It was about the fact that in healthcare facilities, when a tube-fed patient is vomiting, it is frequent for nurses and caretakers to stop feeding the person for a while. He said this is a laughable practice, and it is ridiculous and silly. “It’s comical,” he said. “It’s really comical.”

He could not understand why nurses and caretakers do this. I tried to find him afterward to explain to him exactly why they do this because I have done it myself. However, he left in a hurry, so I lacked the opportunity.

Nurses and caretakers stop feeding when vomiting is happening because force feeding a product to someone you care about when they are throwing it up and when it is causing them to suffer is an indescribably terrible and overwhelming act. There were plenty of times, when my son was vomiting many times throughout the day every single day, that I stopped the feeding pump and turned it off for a while. I could not bear it anymore (you can read more about his story here).

I cried EVERY. SINGLE. DAY. Enduring those months was legitimately more emotionally, physically, and mentally damaging to me than handing my baby over for open heart surgery was. My son was suffering terribly, and I did not know what to do to help him. The only relief he experienced was when I stopped feeding him temporarily. So, I often did so even though I knew he had to be fed. It was so unnatural for me to continue doing something that caused my child to suffer in agony. It is unnatural for most people to do things that cause others to suffer in agony (though this seems to come fairly naturally to the companies mentioned here).

I bawled hysterically on a regular basis. I threw a baby bottle across the apartment one day, accidentally breaking a window, in rage that my child had to suffer this way. Nothing about any of that was comical. Nothing about that was laughable. Nothing.

As a doctor, the guy giving the presentation comes by on rounds or sees a family during an outpatient appointment. He doesn’t personally experience this trauma because he is not directly participating in it. Nurses, parents, and caretakers are living this day in and day out. He has no idea what it is like to push something into the body of someone he loves over and over throughout each and every day that makes his loved one suffer. If he did, he would not find it silly that people simply stop feeding the person at times as they are desperate to offer relief.

The discussion should have centered around the fact that these miraculous formulas they talked about all day make the vast majority of people violently ill. Why not invite me to stand up there so I could describe how devastatingly ill these formulas made my child? Why not invite someone to describe the dishonest and unethical practices that had led my son’s medical team to believe these formulas were gentle and easy to digest when they actually are not?71744613_440696423212473_1012323259091255296_n

Why not have me share how my decision to stop using these formulas and instead, feed a “modified normal diet” gave my son his life back and how his story is not atypical, but extremely common in the tube-fed community.

It has been over a month since I sat through those presentations, and I’m still enraged.

So, that was day one.

On a more positive note, I did make some great connections that day with some other people attending who were basically there, like me, to spy on these people as they were also gravely concerned with what this organization is up to. Those connections made the trip to DC well worth it. I will share more on this later.

But, it seemed the vast majority of individuals at the workshop were either members of the industry getting together to talk to themselves or people who were spying on them.

Day 2…

The focus changed. I know a lot has been said, but perk back up because you need to know this.

They said that now that they have shown how vitally important these formulas supposedly are, it was time for action. They want to push political leaders to provide funding for the FDA to change its regulations for medical foods in the ways I described and more. And, of course, they want to be involved in that process.

These are companies that have conducted shockingly unethical research. These are companies that have aggressively fought to keep us from feeding our kids food, a “modified normal diet.” These are companies that have pushed insurance companies to refuse coverage of products made of actual food and to cover only their cheap, high-profit-margin formulas instead. And they want to take part in changing FDA regulations.

They want to make it legal for them to lie about their products. They want it to be legal to make medical claims without any supporting data.

Let’s be clear about how far these companies are willing to go and violate basic ethical standards.

Recently, Nestle Health Science offered a large, national DME a special deal. They told the DME (provider of Durable Medical Equipment) that if a specific percentage of their clients were receiving Nestle products, Nestle would give them discounts and rebates to increase the DME’s profits.

The DME then formed a large team of individuals to call their clients that use products made by Functional Formularies and Real Food Blends to push them to switch to a Nestle Health Science product. Think about this. Clients were being pushed by total strangers to change products not because the change was better for the client’s health or nutritional status. Clients were being pushed to change products so the DME and Nestle Health Science could make more money.

And by the way, the Nestle Health Science products are absolutely ridiculous and do not even begin to constitute the definition of a balanced diet. So, such a change would mean transitioning to a product that will not contribute to optimal health and is less nutritious than the products the clients were currently using. Again, none of this was about the best interest of the patient. It entirely centered around profits and nothing more.

If anything needs changed about federal regulations and medical foods, it should involve the addition of a law making such actions illegal. Remember the letter saying these matters should be left to doctors? It seems they pick whichever position benefits their pocketbooks regardless of inconsistencies and hypocrisies.

And by the way, while Kate Farms was not represented at this workshop, they are pulling some more shady stuff, too, that is similar to this. I am still gathering information about the specifics and will report on that at a later time.

Do they really care about malnutrition?

Abbott and Nestle Health Science often cite a study showing that when elderly or ill people unable to obtain and prepare food adequately are sent home after discharge from the hospital, they are less likely to be re-admitted within a certain time frame if they are sent home with these nutrition shakes so they have some sort of nourishment. They use this study to imply there is something particularly special about these shakes (they are sugar, oil, protein powder and synthetic vitamins).

Of course, nutrition shakes are better than not having enough to eat. However, if these companies actually cared about these people and malnutrition, they would make a nutrition product that makes sense to feed to a person who is ill and frail. Think about when you are sick and have little appetite. Do you ever feel, during such times, like consuming a rich, sweet beverage like a milkshake?

What foods do we tend to turn to when we are sick? Soup would likely be the most common answer to that question were I to survey the general population. We don’t drink milkshakes when we are sick. We desire savory foods like soup.

Many people have memories of an elderly loved one choking down an Ensure™ or Boost™ during the final stage of their lives because supposedly, it’s so good for them. Imagine if, instead, these same people received prepared, smooth, creamy, savory soups filled with vegetables, easy to digest grains, nutritious broths, and flavorful seasonings in a package they could warm and drink. First, this would be a much more enjoyable beverage to consume. Second, it would be more nutritious and health promoting.

But, you won’t find such a product made by any of these companies because the fortified milkshakes they produce instead carry a much higher profit margin. Sugar is cheaper than grains. Synthetic vitamins are cheaper than vegetables and properly prepared broths. They would make less money by producing a product that actually provided optimal nutrition, so they do not do so.

If they actually wanted to address malnutrition through the best treatment possible, they would make products that carry a greater endorsement than that they are superior to starvation. Does it really speak that highly of a product to say, “Hey, research shows our product is better than starving to death!”

At the workshop, they kept talking about all the studies done on these formulas. Yet, many of these studies do one of two things. First, they are like I already mentioned in which they compare the formulas to starvation. Starvation is easily remedied with access to food. There is no need for expensive, overly priced formulas for situations like these.

Second, they are studies in which they take a group of children or adults who are already fed a formula well established to make most people sick, they switch them to a different formula, and then, report that the people did not get any worse after the switch.

These are hardly well supported products, but they like to throw around numbers like, “There are 1,200 studies on medical foods” to make them sound like they are better than they actually are. For all of their talk about scientific studies, they failed to make a single mention of the studies that have consistently shown that almost everyone does dramatically better when fed food instead of formula.

I noticed none of the companies that emphasize nutrition using real food were invited to attend, speak at, or sponsor the workshop. It were as though, for those two days, those companies did not even exist.

I could share much more about the terrible deeds chosen by these companies, but they were shared with me by individuals currently working in the industry, and I am not at liberty to make that information public.

These are the people who want a hand in the modifying of the FDA regulations surrounding medical foods. Nothing could be more dangerous for families with a tube-fed family member or any family member with an illness that requires dietary management.

What now?

The time to act is now. They are going to be pressing political leaders to champion their cause. We need to do the same. The FDA regulations do need modified and updated, but they must be done so in a way that benefits patients and not the industry. That is not what the Healthcare Nutrition Council desires. It is not what the industry desires.

I visited the ASPEN conference last March (you can read about that here), and I was told by a dietitian who presented there that everything happening at that conference was not about what is best for patients, but what is best for the industry. ASPEN has to keep its financial donors happy, so their priorities are found there (ASPEN was in attendance at the workshop in D.C. and shared presentations as well).

The industry’s goals have nothing to do with what is best for patients, and therefore, we absolutely cannot sit back and allow the industry to influence FDA regulations.

It’s time to get politically active. There is a lobbyist group in D.C. advocating against our best interests, and we need to do something about that. I would love to hear your thoughts on how we, as a community, can increase our political impact and use that to produce the changes that actually need made such as requiring that real food always be used to address malnutrition unless there is a specific reason not to.

We are not small. We are powerful. We are very capable of accomplishing this.

I will also be working on a project, and I am inviting all of you to contribute, if you desire, to raise awareness to the general public about what is going on. Someone at the workshop who works for Abbott said, “Of course, any legitimate company in this industry puts the patient first.”

So, is Abbott not a legitimate company in this industry then? Did they put my son first when they lied to his doctors and told them Elecare™ was gentle and easy to digest? Did they put him first during all those months of his life when he was being made so debilitatingly nauseated by their product that he missed out on important developmental time?71835468_435049837143748_2285097995051466752_n

Were they putting him first when they neglected to inform his medical team about the studies that show these formulas increase the risk of very serious medical issues that he ended up suffering from and also increase vomiting and nausea in most people which he also suffered from? The scar that runs from my son’s chest to his belly button will tell you whether Abbott put him first. My son nearly lost his life as a result of the practices of these companies.

Did they put him first when they intentionally conducted poorly done research to manipulate the medical profession with skewed data?

No, they didn’t. They did not put my son first. My son is missing a piece of his colon because of the damage and injury done to him by these unethical practices. We are still dealing, to this day, with the developmental delays that resulted from him being paralyzed by nausea, too nauseated to engage with the environment and grow, for several of the formative, vital months of his early development. We are also still dealing with the GI complications caused by the damage done to his GI system from these products.

To sit in a room and listen to an employee claim that they put their patients first was enough to make me want to start flipping the tables upside down throughout the room. But, I sat quietly, thinking and forming plans.

So, I want to hear your stories. If your child was vomiting, nauseated, more frequently hospitalized, or experienced any other complication while on these enteral formulas, I want you to tell me what product your child was on, what your child experienced as a result of being fed these formulas, and the improvement your child experienced after the cessation of the enteral formula.

I will transform these individual stories into a series of videos and slowly add them to a YouTube channel dedicated to this purpose, and I will formally advertise these videos/stories to raise awareness that this is happening and invite listeners to join our cause as we demand something be done about this.

Every family deserves FULL information about these products, including the ever growing body of scientific literature that says these products do not promote health and are ultimately harmful for most people with only rare exceptions.

To contribute, include in your story:

  1. The product your child was on.
  2. The complications experienced (examples: vomiting, constipation, bloating, frequent infections, frequent hospitalizations, or whatever else)
  3. Your and your child’s first name. If you do not wish to share this, include a different name to represent yourself and your child so you can remain anonymous.
  4. Consider including a picture(s) of your child. This is NOT a requirement, but will have a greater impact so people can see the child who was impacted.
  5. End the story with “Abbott did not put (name) first.” Or “Nestle Health Science did not put (name) first.” Or whatever other company made the specific product that caused your child to suffer.

Email your story to me at CrunchyTubieMama@gmail.com along with permission to share the story publicly.

Then, I will get to work. I am going to start with Bradley’s story. My goal is for each video to run between 2 and 4 minutes in length.

Also, let’s talk about what to do, politically, to address the issues presented here. It’s time we stand up and take action. If we don’t, they will, and our community will suffer for it while they laugh their way to the bank.

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