Thursday, June 27, 2013

The Xanthan Gum Enigma

SimplyThick is Xanthan Gum

SimplyThick, a previously-prescribed neonatal intensive care xanthan gum formula supplement, is the presumed cause of infant necrotizing enterocolitis deaths and injuries in North Carolina, Florida, New York, New Mexico, Texas, Colorado, Wisconsin, Indiana and Canada.  Nine infant deaths have been linked to SimplyThick. The number of intestinal-impairing injuries will likely never be known.

There is no information as to whether FDA officials have queried health authorities in Puerto Rico, Guatemala, Ecuador, Panama, Barbados, Cayman Islands and Italy for SimplyThick adverse event reports.

Research on the part of news organizations indicates that the SimplyThick xanthan gum product was inducing infant necrotizing enterocolitis as early as 2004.

SimplyThick investigative articles:

Huffington Post— June 2013—"FDA Links Baby Deaths to SimplyThick Infant Formula
St. Louis Magazine—June 2013—"Simply Thick: A Tragedy No One Saw Coming
Courthouse News Service— June 2013—"Babies' Deaths Blamed on 'Simply Thick'"
The New York Times—February 2013—"Warning Too Late for Some Babies"
St. Louis Business Journal— February 2013—"SimplyThick faces issues with product safety"

provide additional information on the subject.

If processed to the Code of Federal Regulation specifications, xanthan gum should be innocuous but as referenced by the FDA, "xanthan gum is the primary source of bacterial endotoxin."

Because xanthan gum is ubiquitous in food and present in pharmaceutical/cosmetic supplies, tracing product usage to harmful medical events is quixotic.

The St. Louis Magazine advises that in spite of manufacturer's and FDA online warnings, SimplyThick remains in the infant formula market.

Xanthomonas campestris pathovar campestris

Xanthomonas campestris pathovar campestris [Xcc], a gram-negative bacterium, is the source of xanthan gum and the cause of necrotic plant disease.

Fermentation [lysis] of the Xcc organism in U.S., Chinese, French, and Austrian bacterial factories produce xanthan gum. Absent bacterial filtration, xanthan gum contains significant lipopolysaccharide impurities. Scientifically the term lipopolysaccharides is synonymous with endotoxins.

Patent applications illustrate that xanthan gum endotoxin-reduction methods are demanding.

KELTROL T [Kelco Biopolymers] xanthan gum, for instance, contains more than one million endotoxin units per gram.

"Removing these exceedingly high loads of endotoxin from the biopolymer in a commercially efficient manner can be particularly challenging." state inventors: William S. Bousman, George T. Colegrove, Robert Raczkowski, Monica A. Garcia and John L. Holahan, III.

As a consequence, xanthan gum comprised consumer products contain an undisclosed level of endotoxins. Whether these pathogens are responsible for the SimplyThick infant necrotizing enterocolitis incidents is yet to be determined.

Xanthan Gum Cosmetic Applications

In addition to food and pharmaceutical products, xanthan gum is present in 3,470 adult/infant cosmetic items.

Injury reports are submitted to the FDA by way of the Voluntary Cosmetic Registration Program (VCRP). VCRP is utilized by the industry-funded Cosmetic Ingredient Review panel to address product safety.

Cosmetic ingredients are not regulated by the FDA. Access to the VCRP adverse event reporting database is subject to Freedom of Information Act filings.

Safety Assessment of Microbial Polysaccharide Gums as Used in Cosmetics

Xanthan Gum Cosmetics Ingredient Review September 2012

Some of the microbial polysaccharide gums under scrutiny:
are reported to be used on baby skin, to be applied to the eye area or mucous membranes, or could possibly be ingested...or inhaled [dehydroxanthan gum].
Twenty-nine infant products contain xanthan gum.

Q&A: Matters before the Cosmetics Ingredient Review Panel

Individuals quoted: Bart Heldreth, Ph.D. - Chemist (CIR Staff)
Daniel C. Lieber, Ph.D., Ronald C. Shank, Ph.D., James G. Marks, Jr., M.D., Donald V. Belsito, M.D.-Expert CIR Panel Members

Dr. Shank:
The title might have an association with microbial lipopolysaccharides which are well known to be high biological activity in toxicity, so rather than make that association, change polysaccharides to gums.
Dr. Lieber:
I agree with your point on lipopolysaccharide. You don't want to get people thinking the wrong thing.
Dr. Lieber:
Any other comments? Okay, good. Next is the microbial polysaccharides. I actually really like the title, because I was wondering how the heck did you get that? It sounded like it could be something that I didn't want to put on my skin. But any rate, this is our first review.
Dr. Shank:
That's better -- well, at least toxicologically when you say microbial polysaccharides some of those -- the lipo polysaccharides are quite toxic. So, I'd like to avoid that association, if we can. Gum sounds pretty good to me.
Mr. Heldreth:
I mean, you never know what people [manufacturers] are doing to make their stuff.
Dr. Marks:
So, the only -- let's go on page 48. That should be Panel Book -- I looked in there, see if I have my thinking correct here. I said that the xanthan gum -- and that's the most commonly used -- 5 percent was irritating to the rabbit, and it's used up to 6 percent in cosmetics. So, let's see.
So, I was a little bit concerned if it's irritating the rabbit at 5 percent, what would it do to a human if it were put on at a 6 percent? But where do I -- yeah, there it is. If you go up -- actually it's page 47 under Table 10. Xanthan gum rabbits, 5 percent aqueous, they had a localized irritation with bleeding and cracking. That was daily application.
So, that was a bit of an alert for me that if we have it at 6 percent in leave-on products, what's the -- I'd like to see an RIPT not so much for sensitization but for irritation. And I wasn't able to find in the data something that would reassure me about this study on rabbits with 5 percent aqueous.
Dr. Belsito:
I'm sure there is probably some hard data, but there is certainly a good amount of soft data. How many complaints has the FDA received about cosmetic products containing xanthan gum, and if there are 3,400 out there, one would expect that if it was an issue they'd get a lot.

Financial Considerations Versus Public Safety

Post marketing adverse-usage complaints are often held in abeyance.

The John L. Holahan, III patented, SimplyThick,  product may be a case in point.

The SimplyThick®/necrotizing enterocolitis incidence link was raised in 2005 by a neonatal intensive care nurse who asked this online question:
Does anyone else use Simply Thick in NICU? We have been using it for about a year and a half and coincidentally it seemd to be the year of NEC now.
The FDA states that the agency did not learn until early 2011 that the SimplyThick product was substantively linked to infant NEC episodes.

When informed of the potential SimplyThick/xanthan gum medical problem, Dr. Benson Silverman, the director of the F.D.A.’s infant formula section, responded “We can only do something with the information we are provided with. If information is not provided, how would we know?”

Thursday, June 13, 2013

The SimplyThick Mackenna Cope Necrotizing Enterocolitis Case History

SimplyThick is Xanthan Gum

SimplyThick investigative reports: St. Louis Magazine—June 2013—"Simply Thick: A Tragedy No One Saw Coming," Courthouse News Service— June 2013—"Babies' Deaths Blamed on 'Simply Thick' "— The New York Times—February 2013— "Warning Too Late for Some Babies" provide additional information on the subject.

Xanthan gum is classified a benign substance but according to the FDA, "xanthan gum is the primary source of bacterial endotoxin." In spite of manufacturer's and FDA online warnings, SimplyThick remains a recommended infant product.

An unknown number of infants have died or were gravely injured after being prescribed SimplyThick. Mackenna Cope was one of those infants.

"Local Baby May Have Died From Formula Additive"

KKTV—May 2011—David Nancarrow
The Food and Drug Administration has the medical files of a little girl named Mackenna Cope. Her name may be added to a list of two deaths potentially linked to an additive called SimplyThick, which the FDA is telling hospitals and health-care providers not to give premature babies.

The treatment is used at Memorial Hospital as well as in hospitals across the nation and is being investigated as contributing to a deadly condition known as necrotizing enterocolitis.

The only home Mackenna Cope ever knew was the neo-natal intensive care unit. She was born early at 33-and-a-half weeks.

"I never thought, at 26, I would be burying my daughter," said Stacy Cope.

Two years after Mckenna's death, Stacy Cope took a call she never thought she'd get from the doctor who cared for her daughter at Memorial Hospital.

"The doctor said when the FDA's warning came out, the doctor said it alerted him," she said.

The FDA has issued a warning for the use of SimplyThick, an additive used in many cases, including among premature babies who have trouble swallowing, or keeping down food. The product is now under investigation for possibly causing the type of intestinal failure that killed Mackenna a week before she could have gone home.

"At five o'clock that evening she'd been rushed in for emergency surgery, but her intestines were already dead,” Stacy said. “There was nothing they could do."
Two years has brought some peace to Stacy and her family, who originally thought they'd never know what, exactly, caused Mackenna to get so sick.

"Now to know it may be because of something someone put in her bottles is kind of unnerving," Stacy said.

Her thoughts now are for every other parent of a premature baby.

"Make sure you're aware what people are giving your children," she said.

The FDA has not determined what specifically in SimplyThick could be causing the deadly condition.

FDA officials urge care givers to not give SimplyThick to premature babies. Symptoms necrotizing enterocolitis include bloating, as well as greenish tinged bile and vomiting. Parents who have questions or concerns about the product should call their healthcare providers.
11 News has learned Memorial Hospital has referred four cases to the FDA. Parkview Medical Center in Pueblo tells 11 News that they have never used SimplyThick. A spokeswoman with the hospital said that they use rice cereal, because "it's always need to change."

11 News has placed a call with Penrose; the hospital is now looking into whether any cases involving SimplyThick have been reported.