Enzymedica's GlutenEase - an enzyme to assist digestion of gluten?

[CarolM]

A friend of mine picked up an Enzymedica Product Pamphlet in the doctor's office and passed it along to me.  It lists a product called "GlutenEase" that purports to allow a person with a gluten intolerance to safely digest gluten if the product is taken with the meal.

The page on the website doesn't specifically list Celiac Disease, but the Handout Sheet for it does.

I'm concerned about the fact that this company may be grossly misleading people into thinking that this product protects them from the damage Celiac Disease may cause.  My first thought was, "If this product can truly do what it claims, why haven't I heard about it??"  I'm pretty sure the reason I haven't heard about it is because it's a load of baloney.  I think this company is incredibly irresponsible in making these claims.

I'm interested to hear your thoughts on this product.

   Carol
----------------------------------------------------

I found another discussion about this product on another board here:
http://glutenfreeforum.com/lofiversion/index.php/t19281.html

Here is the webpage for the product:
http://www.enzymedica.com/products/GlutenEase


Below is the text from the Handout (mostly similar to the webpage content):

GlutenEase contains a modified Protease Thera-blend and a new enzyme called DPP-IV. This new formula supports people suffering with gluten or casein intolerance.*

Cause of Gluten Intolerance
For many individuals who consume wheat or dairy products, the particular proteins gluten and/or casein are difficult to digest and can lead to intestinal inflammation and a number of disorders including Celiac disease, Leaky Gut or other syndromes.

Gluten exhibits a unique amino acid sequence which creates inflammation and a flattening of the villi of our intestinal tract. The villi provide the intestine with the ability to absorb nutrients from the foods we eat, thus damaged villi can lead to responses such as malabsorption, nutrient deficiencies or other digestive disorders.

What Can Be Done?
The main treatment for gluten or casein intolerance has been to remove offending foods from a person’s diet, also known as the GFCF (gluten-free, casein-free) diet. Though effective in the short term, removing foods does not provide an ultimate solution. Once those foods are reintroduced to the diet, the symptoms return. GlutenEase offers those suffering with such intolerances assistance in digestion and assimilation of the offending proteins. DPP-IV, is able to break down an exorphin peptide (a protein) believed to be a contributing factor in gluten and casein intolerance. This proactively heals the gut, reduces inflammation, allows proteins to be properly absorbed in their digested state and broadens the amount of potential food groups a person may eat. GlutenEase may also be used by those who wish to remain on the GFCF diet to ensure complete breakdown of proteins safe and effectively.

Added Benefits
GlutenEase addresses a related issue that also stems from gluten intolerance, problems digesting the carbohydrates of offending foods. For this reason, Enzymedica adds Amylase Thera-Blend™ and Glucoamylase to this formula. Amylase Thera-Blend™ has proven highly effective for those who suffer with an amylase deficiency or have difficulty digesting sugars and starches. Glucoamylase is necessary to finish the digestion of those sugar and starch molecules to glucose, the simplest sugar used by the body for energy.

Recommended Usage: Take 1 capsule with any meal containing gluten or casein. More may be taken if needed. This product works best when used in combination with Digest or Digest Gold.

Each capsule of GlutenEase provides:
DPP IV Protease Thera-blend™ . . . . . . . . . . . . . . . . .60,000 HUT
Amylase Thera-blend™ . . . . . . . . . . . . . . . . . . . . . . . . .15,000 DU
Glucoamylase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15 AGU

60 servings per bottle. No fillers.
Enzymedica uses an exclusive Thera-blend process for its protease, lipase, amylase and cellulase. Each of these enzymes actually represents multiple strains which are blended for their ability to break down numerous bonds in varying pH levels.

* These statements have not been evaluated by the Food and Drug Administration.  This product is not intended to diagnose, treat, cure or prevent any disease.

[the sensible celiac]

I've seen this product advertised on several different domains using the same claims.  They use Google Ads that are clearly targeted at pages about celiac disease. I've had to ban these ads from my websites.

If there was a scientific basis for these claims of medical benefit, then these ads would surely mention that basis. The fact that no reference is made to any controlled studies or FDA approval makes it clearly evident to me that these are snake oil salesmen preying upon the huge frustration of people with celiac disease.

I'm strongly opposed to this company, I consider their advertising to be intentionally deceptive.  I would not be surprised if their claims were in violation of federal law in the US.

Close attention should be paid to their own disclaimer that is clearly intended to keep these persons out of jail:

This product is not intended to diagnose, treat, cure or prevent any disease.

Therefore, by their own admission, this product DOES NOT TREAT CELIAC DISEASE.

[CarolM]

Even more disturbing is I also found a discussion on AutismWeb.com about it.  Apparently, some people give it to their kids.

http://www.autismweb.com/forum/viewtopic.php?p=71901&sid=ad0cea05caeea43f113bb6c1e9486ff0

I agree with you, their claims are deceptive and dangerous.

Carol

[DaveBarton]

[SYSTEM OPERATORS NOTE: Read with extreme caution, please see the reply below]
This message has been modified by the System Operator.  The disclaimer used by Enzymedica to avoid prosecution has been inserted in a few places
This product is not intended to diagnose, treat, cure or prevent disease.
Hello,

My name is David Barton, and I'm a technical adviser at Enzymedica. I came across this discussion, and I wanted to address some of the concerns you have shared about GlutenEase and clarify its use and intent.
  This product is not intended to diagnose, treat, cure or prevent disease.
At Enzymedica, we have positioned GlutenEase as a digestive supplement that's supportive of those with gluten intolerance, not as a cure for celiac disease. GlutenEase was formulated as both a "safety net" of sorts for events when people do not control the preparation of their foods, and thus the possibility of gluten contamination exists; as well as a product to help those just with gluten intolerance (but are not diagnosed as having a specific disease). GlutenEase was launched as a component to addressing  gluten intolerance, in conjunction with good judgment and a thorough knowledge of one's own digestive and bodily limits.
  This product is not intended to diagnose, treat, cure or prevent disease.
Many people suffer from gluten intolerance symptoms that range from mild to severe. Obviously, most of these people do not have celiac disease, but may often have a sensitivity to gluten. For these people, GlutenEase has  been very helpful.
  This product is not intended to diagnose, treat, cure or prevent disease.
GlutenEase's primary role is to break down gluten into its individual amino acids, ideally resulting in no damage to the gut or food sensitivity issues. A key component to the product is a protease enzyme with a high amount of DDP-IV, along with amylase and Glucoamylase, to break down carbohydrates, and thus we would recommend GlutenEase in conjunction with gluten-free, casein-free diets. A digestion supplements such as GlutenEase has been shown to help those who simultaneously incorporate the supplement along with their diet.
This product is not intended to diagnose, treat, cure or prevent disease.
Please accept our apology for any confusion about GlutenEase being used to “cure” celiac disease  or other gluten intolerance conditions. I welcome the  continuation of an open discussion about our products, and I along with Enzymedica's team, will continue to monitor our messaging to avoid potential health issues that arise from considering our product a cure for any disease.
  This product is not intended to diagnose, treat, cure or prevent disease.
We have an active educational process where we work to inform retailers that carry our products about what they can and cannot do. This very topic was the focus of a lengthy interview I just conducted with a top  health industry retail publication, Vitamin Retailer (Nov. 2007). In that interview I discussed how  GlutenEase is to be used, the fact it is not a cure for diseases such as celiac, as well as how and why it works. Understanding how difficult health conditions like celiac disease can make everyday life, it’s exciting to see that at some point, enzymes may have a role in improving symptoms. I would encourage you to read the Journal of the American Medical Association Aug. 14, 2006 issue that included the article “Enzymes Might Cut Celiac Symptoms.” The article discusses how Stanford University  doctors “presented evidence that suggests that a cocktail of enzymes might be a useful therapy for celiac disease.”
  This product is not intended to diagnose, treat, cure or prevent disease.
You are welcome to call our toll-free number [phone number removed] at any time, I can be reached there directly or you can speak with any of our customer service representatives.
This product is not intended to diagnose, treat, cure or prevent disease.
We are thrilled that so many people across the country have been able to improve their health and quality of life through our products.
This product is not intended to diagnose, treat, cure or prevent disease.
Best,
Dave

[the sensible celiac]

Sorry Dave, but I'm calling bullshit on this one.  You say that "Many people suffer from gluten intolerance symptoms that range from mild to severe. Obviously, most of these people do not have celiac disease, but may often have a sensitivity to gluten. For these people, GlutenEase has  been very helpful."

I'm saying that is marketing bullshit. Can you refer me to a scientific study that shows that "Obviously most of these people do not have celiac disease"?  No?  I didn't think so.  The reality of it is that people who are said to have Gluten Intolerance are in fact suffering from celiac disease and it is a medical necessity for them to follow a gluten free diet for the rest of their lives.

According to the Gluten Intolerance Group, a resource for people with celiac disease Celiac Disease and Gluten Intolerance are simply different names for the exact same autoimmune disorder.

According to the US Government National Institute of Health "Other names for celiac disease are celiac sprue and gluten intolerance."  Now this is an organization that employs real scientists that use the scientific method to produce actual scientific facts, not woo woo marketing designed to confuse gullible and uninformed victims.

Can you refer me to a scientific study that shows that your specific product produces the results that you claim, imply, or hope that people will infer it does?  No? I did not think so.

I love the way that you dance around the scientifically supported medical fact that people with celiac disease absolutely MUST avoid foods containing gluten.  Once a person has adopted a gluten free diet they have no need of any woo woo enzyme products that claim to help with the gluten free diet, because their need for dietary modifications has already been met.

Can you explain to me why it is that your company uses Google AdSense ads that are targeted to appear in web pages that include the word celiac if, as you admit, it is not a cure for celiac disease?  I have configured my Google AdSense account to block ads for your companies products from appearing on any of my websites.  That will not be changing just because you posted some FUD in this forum.

I am aware of the real, actual science that is being conducted at Stanford about the possibility of using an enzyme approach to treating celiac disease, but I see no reason to confuse this scientific research with your profit-making commercial product that has not been tested or approved as a treatment for celiac disease.   You can refer to the science at Stanford all you want to, but that will not confuse me into believing that your woo woo magic product is useful in a medical fashion. 

You say " GlutenEase was formulated as both a "safety net" of sorts for events when people do not control the preparation of their foods, and thus the possibility of gluten contamination exists; as well as a product to help those just with gluten intolerance (but are not diagnosed as having a specific disease). "  This is distinctly different from saying that your product has been tested using a double blind controlled study according to scientific protocols and found, by way of scientific testing, to produce some effect other than increasing your income.

Dave, you say "we have positioned GlutenEase as a digestive supplement" that is clearly the kind of a sentence that would be written by a marketing person, not by a scientist. Scientists do not position products, they deal in facts. You say that you are a "technical advisor", is that different in some way from a member of the marketing team?

Sorry Dave, but I strongly urge all users of this forum to take the money they might otherwise use to buy your products and use it instead to buy some nice gluten free pasta, it will have the same medical benefit, but more nutritional value.  I expect it would also cost about 1% as much as your product on a per unit weight basis.

Buy GF pasta folks!  Ignore this woo woo.

Hello,

My name is David Barton, and I'm a technical adviser at Enzymedica. I came across this discussion, and I wanted to address some of the concerns you have shared about GlutenEase and clarify its use and intent.
 
At Enzymedica, we have positioned GlutenEase as a digestive supplement that's supportive of those with gluten intolerance, not as a cure for celiac disease. GlutenEase was formulated as both a "safety net" of sorts for events when people do not control the preparation of their foods, and thus the possibility of gluten contamination exists; as well as a product to help those just with gluten intolerance (but are not diagnosed as having a specific disease). GlutenEase was launched as a component to addressing  gluten intolerance, in conjunction with good judgment and a thorough knowledge of one's own digestive and bodily limits.
 
Many people suffer from gluten intolerance symptoms that range from mild to severe. Obviously, most of these people do not have celiac disease, but may often have a sensitivity to gluten. For these people, GlutenEase has  been very helpful.
 
GlutenEase's primary role is to break down gluten into its individual amino acids, ideally resulting in no damage to the gut or food sensitivity issues. A key component to the product is a protease enzyme with a high amount of DDP-IV, along with amylase and Glucoamylase, to break down carbohydrates, and thus we would recommend GlutenEase in conjunction with gluten-free, casein-free diets. A digestion supplements such as GlutenEase has been shown to help those who simultaneously incorporate the supplement along with their diet.

Please accept our apology for any confusion about GlutenEase being used to “cure” celiac disease  or other gluten intolerance conditions. I welcome the  continuation of an open discussion about our products, and I along with Enzymedica's team, will continue to monitor our messaging to avoid potential health issues that arise from considering our product a cure for any disease.
 
We have an active educational process where we work to inform retailers that carry our products about what they can and cannot do. This very topic was the focus of a lengthy interview I just conducted with a top  health industry retail publication, Vitamin Retailer (Nov. 2007). In that interview I discussed how  GlutenEase is to be used, the fact it is not a cure for diseases such as celiac, as well as how and why it works. Understanding how difficult health conditions like celiac disease can make everyday life, it’s exciting to see that at some point, enzymes may have a role in improving symptoms. I would encourage you to read the Journal of the American Medical Association Aug. 14, 2006 issue that included the article “Enzymes Might Cut Celiac Symptoms.” The article discusses how Stanford University  doctors “presented evidence that suggests that a cocktail of enzymes might be a useful therapy for celiac disease.”
 
You are welcome to call our toll-free number (removed)  at any time, I can be reached there directly or you can speak with any of our customer service representatives.

We are thrilled that so many people across the country have been able to improve their health and quality of life through our products.

Best,
Dave

[the sensible celiac]

Here is a link to an article about Enzymedica from the Charlotte Sun, you be the judge.

Here is a link to a blog post about Enzymedica, you be the judge.

[the sensible celiac]

Here is a thread on another forum about Glutenease.  Notice that exactly one hour after someone expressed doubts about the product, a new user created an account there and posted a message that includes, verbatim, some of rthe marketing woo used by this company.

You be the judge.

And another post about Glutenease. You be the judge.

[the sensible celiac]

Here is another message about Glutenease.

In all of my research so far, I find nothing at all to suggest that there is any reason why a person with celiac disease, which is exactly the same thing as gluten intolerance, should waste their money on a product that absolutely, positively has no science whatsoever to back up the claims they do not exactly make, but hope you will think they make.

[the sensible celiac]

We have an active educational process where we work to inform retailers that carry our products about what they can and cannot do.

I believe what Dave is telling us here is that their legal department works closely with their resellers to make sure they only imply that this product is useful for people that must avoid gluten.  I'm sure Dave does not want any of the resellers of these untested, unverified, unstudied, undocumented products to be arrested or taken to court for making claims that actually cross over the line into illegality.

There are some companies that use recognizable methods of deception to sell their products.  One method that can be used to confuse people that are not paying close attention is to talk about one thing, then talk about something else.  In this type of case the reader is left to make the false connection.

I'll give you two examples.

1) During the marketing phase of the Iraq war, before the actual invasion, whenever George W Bush mentioned the attacks of 9/11, he would immediately mention Saddam Hussein.  He did this every single time.  Eventually just because of his use of this marketing technique many Americans thought that Saddam Hussein was involved in some way with the attacks of 9/11.

2) In his earlier post in this thread Dave mentioned that the product he wants you to buy contains enzymes. Then he mentioned that Stanford University is doing research involving enzymes.  Dave did not say that the enzymes in the product he is selling contains enzymes that Stanford University has found to be effective as a cure for celiac disease.  Dave did not say that.  He just says that Stanford University is doing research on enzymes.

I wonder, if you chose to jump to the conclusion that the product Dave is selling is based on the research being done at Stanford would Dave correct your misunderstanding?  Or would he gladly take your money?

You be the judge.

[the sensible celiac]

Here is some information found on the enzymedica website. This information comes directly from the company that is marketing this product.  Please note that I do not claim that enzymedica manufactures glutenease, and from what I have seen on their website they do not seem to claim that they manufacture whatever is inside the capsules they sell for $28.98 for a package of 60 capsules.

Here is their obviously ridiculous claim about the effectiveness of the gluten free diet: "Though effective in the short term, removing foods does not provide an ultimate solution. Once those foods are reintroduced to the diet, the symptoms return."

Now we will make a few changes, and we will compare the statement made by enzymedica on their own website to a similar statement we will make about quitting the habit of smoking cigarettes "Though effective in the short term, giving up cigarettes does not provide an ultimate solution. Once a person starts smoking again, they start coughing a lot again."  Does that sound stupid?  We think so.

So, according to enzymedica, the gluten free diet is not a solution, because if you eat gluten your symptoms will come back.

I wonder if there is any other way to address this chronic shortcoming that enzymedica has identified in the gluten free diet, and which they would apparently like you to believe is a good reason for buying their capsules, which are not intended to diagnose, treat, cure or prevent disease.

What if a person went on a gluten free diet, and then after they went on the gluten free diet they did not eat any gluten. I wonder if the symptoms would still return in that case?  The gluten free diet IS intended to treat a disease, it is used to treat a disease that is sometimes called gluten intolerance or celiac disease.

So, you can not eat gluten for $0, and not get sick, or you can go off the gluten free diet, buy these capsules for $28.98, still get sick, then buy more of these capsules for $28.98, and still get sick, then buy other products that they "also recommend" and which, coincidentally, they also sell, and still get sick.

Or you can go on the gluten free diet, not go off the gluten free diet, not get sick, and not buy these capsules.

Recommended Usage (from enzymedica):
Take 1 capsule with any meal containing gluten or casein.

Recommended Usage (from the Sensible Celiac):
Do not eat meals with gluten.  If casein bothers you, do not eat meals with casein. Do not take these capsules.  Do not buy these capsules.  Do not take medical advice from somebody that wants to sell you something unless that person is a licensed pharmacist or other medical professional.

Other Uses for Glutenease

In addition to not using Glutenease from Enzymedica to treat gluten intolerance, which is also known as celiac disease, the Sensible Celiac also recommends that you do not use Glutenease from Enzymedica  to treat hemorrhoids, hangnails, Parkinsons disease, or cardiomyopathy.  While we imagine that it is possible that Glutenease from Enzymedica could help people with these medical problems digest proteins, it is not the standard, scientifically supported treatment for any of the medical conditions discussed in this thread, none of them.

The amount of scientific evidence that indicates Glutenease from Enzymedica  can be used to treat hemorrhoids, hangnails, Parkinsons disease, or cardiomyopathy is exactly the same as it is for gluten intolerance, which is also called celiac disease.

[the sensible celiac]

After further consideration, we realized there was a better analogy that might be used to expose the logical flaw that seems to be intentionally present in the marketing literature used everywhere that Glutenease by Enzymedica is sold.

Lets take the Enzymedica statement that appears in the Glutenease  advertisements and examine it again in the light of rational thought, we'll be comparing it to accidental suicide by way of a handgun.

Glutenease by Enzymedica Marketing Statement
"Though effective in the short term, removing foods does not provide an ultimate solution. Once those foods are reintroduced to the diet, the symptoms return. "

Now imagine a person who is drunk, or high, or drunk and high playing Russian Roulette, and then suddenly realizing it is not a very smart thing to do:

Russian Roullette Claim Using Similar Logic
"Though effective in the short term, putting the gun down does not provide an ultimate solution. Once the gun is reinserted in the mouth, the person could die".

We do not recommend that people with celiac disease, which is sometimes called gluten intolerance, should play Russian Roulette with their health.

[GwenRN]

I must also strongly discourage those with celiac disease (which is another NAME for gluten intolerance) from using this product. It is being marketed as a "digestive enzyme", similar to lactaid for lactose intolerance. The problem with this deceptive marketing is that the causes of these two intolerances are quite different.

People with lactose intolerance lack the enzyme needed to properly digest lactose. Replacing this enzyme goes to the root cause of their discomfort.

People with gluten intolerance (aka, celiac disease) produce antibodies in response to gluten which can cause severe damage to the villi of the small intestine, resulting in many serious health effects. Enzymes have NOT been proven to prevent any of these damaging antibodies from being formed.

Let's take this claim, and examine it:

"Understanding how difficult health conditions like celiac disease can make everyday life, it’s exciting to see that at some point, enzymes may have a role in improving symptoms. I would encourage you to read the Journal of the American Medical Association Aug. 14, 2006 issue that included the article “Enzymes Might Cut Celiac Symptoms.” The article discusses how Stanford University  doctors “presented evidence that suggests that a cocktail of enzymes might be a useful therapy for celiac disease.”

Even under the guise of "medical research" all they can claim is that enzymes (but not neccesarily THEIR enzymes) MIGHT show some REDUCTION in symptoms"

So, those with celiac have two options:

Follow the scientifically proven diet which can effectively eliminate 100% of their symptoms
or
Pay money for a product which may possibly have a chance at reducing some of their symptoms, and put themselves at risk for long-term damage to multiple body systems.

Seems like an easy choice to me, no?

[CarolM]

Alba Therapeutics is presently doing extensive research to develop a treatment that safely prevents the intestinal damage caused by ingesting gluten.  Phht - all they had to do was ask Enzymedica.   

If Enzymedica truly had a product that made a discernable difference in what happens when a celiac patient ingests gluten, they'd have held a huge press conference and you'd hear people shouting praises from the rooftops in every city in the US, Canada and Europe.  There's no reason (due to lack of scientific evidence) to believe that this product in any way alters the auto-immune response in the gut when gluten is present.  If you accidentally ingest gluten, you will suffer some degree of damage.  Even if this pill mitigates your physical sensations (pain, bloating, etc.), which I doubt, it will do nothing to protect you from the real damage inflicted on your GI tract.  And, that discomfort is how many celiacs spot those well-hidden sources of gluten and know to avoid them in the future.  It's wrong and irresponsible for this company to imply in any way that this product can help celiac patients/gluten intolerance patients to ingest gluten without consequence.

As much as I'd love to believe in this product (along with Santa Claus, the Easter Bunny, and the Thing That Lives Under The Stairs) the reality is that at this point in time there is only one known cure/treatment for Celiac Disease - a strict gluten free diet.

As Walter Cronkite used to say, "And that's the way it is."

[acjeff]

I was on HIGH doses of Viokase (prescription pancreatic digestive enzyme) when I did my gluten challenge. Biopsy confirmed celiac. My daily dose of protease was something like 25 times what they recommend with that product.
I have chronic pancreatitis, thus the high dose digestive enzymes.
Which obviously did not do a single thing to prevent intestinal damage caused by gluten.

[CarolM]

acjeff,

Thanks for sharing your information on this important subject.

Carol