The New York Times Report on SimplyThick Neonatal Intensive Care Practices

John L. Holahan— 2013 SimplyThick® Necrotizing Enterocolitis Risk Update

SimplyThick® president John L. Holahan is currently advising that:

WARNING - [SimpyThick] NOT intended for use with preterm or infants under 12 months of age. Or children under the age of 12 years with a history of NEC [necrotizing enterocolitis].

Although no definitive link between NEC and SimplyThick® brand products has been found or established, in an abundance of caution, anyone at risk for or with a significant risk factor for developing NEC should not use SimplyThick® products.

SimplyThick® Disclaimer

Although information provided is believed to be true and accurate, SimplyThick, LLC (ST) cannot anticipate all actual situations and/or conditions of use. ST cannot assure the suitability of SimplyThick® products for any particular situation or that SimplyThick® products will work in every situation.

The Food and Drug Administration has not evaluated nor approved any food thickener as a swallowing aid. Do not self-diagnose or self-treat swallowing problems, also commonly termed dysphagia.

Swallowing problems and/or dysphagia can be a serious medical condition that should only be treated with proper medical supervision. If you have any questions about use of SimplyThick® products, consult your doctor or physician.

SimplyThick® Infant Formula Prescription

The New York Times has determined that speech pathologists were responsible for SimplyThick® usage in neonatal intensive care units.

Julie Mueller who's daughter Addison died after being prescribed SimplyThick® told The Times, "I was astounded how a hospital and manufacturer was gearing this toward newborns when they never had to prove it would be safe for them. Basically we just did a research trial for the [SimplyThick®] manufacturer.”

The New York Times SimplyThick® article is as follows.

Warning Too Late for Some Babies
Catherine Saint Louis— February 5, 2013

Addison Mueller, about a week old, with her siblings. She was fed milk with SimplyThick to prevent choking, and died soon after.

Six weeks after Jack Mahoney was born prematurely on Feb. 3, 2011, the neonatal staff at WakeMed Hospital in Raleigh, N.C., noticed that his heart rate slowed slightly when he ate. They figured he was having difficulty feeding, and they added a thickener to help.

When Jack was discharged, his parents were given the thickener, SimplyThick, to mix into his formula. Two weeks later, Jack was back in the hospital, with a swollen belly and in inconsolable pain. By then, most of his small intestine had stopped working. He died soon after, at 66 days old.

A month later, the Food and Drug Administration issued a caution that SimplyThick should not be fed to premature infants because it may cause necrotizing enterocolitis, or NEC, a life-threatening condition that damages intestinal tissue.

Experts do not know how the product may be linked to the condition, but Jack is not the only child to die after receiving SimplyThick. An F.D.A. investigation of 84 cases, published in The Journal of Pediatrics in 2012, found a “distinct illness pattern” in 22 instances that suggested a possible link between SimplyThick and NEC. Seven deaths were cited; 14 infants required surgery.

Last September, after more adverse events were reported, the F.D.A. warned that the thickener should not be given to any infants. But the fact that SimplyThick was widely used at all in neonatal intensive care units has spawned a spate of lawsuits and raised questions about regulatory oversight of food additives for infants.

SimplyThick is made from xanthan gum, a widely-used food additive on the F.D.A.’s list of substances “generally recognized as safe.” SimplyThick is classified as a food and the F.D.A. did not assess it for safety.

John Holahan, president of SimplyThick, which is based in St. Louis, acknowledged that the company marketed the product to speech language pathologists who in turn recommended it to infants. The patent touted its effectiveness in breast milk.

However, Mr. Holahan said, “There was no need to conduct studies, as the use of thickeners overall was already well established. In addition, the safety of xanthan gum was already well established.”

Since 2001, SimplyThick has been widely used by adults with swallowing difficulties. A liquid thickened to about the consistency of honey allows the drinker more time to close his airway and prevent aspiration.

Doctors in newborn intensive care units often ask non-physician colleagues like speech pathologists to determine whether an infant has a swallowing problem. And those auxiliary feeding specialists often recommended SimplyThick for neonates with swallowing troubles or acid reflux.

The thickener became popular because it was easy to mix, could be used with breast milk, and maintained its consistency, unlike alternatives like rice cereal.

“It was word of mouth, then neonatologists got used to using it. It became adopted,” said Dr. Steven Abrams, a neonatologist at Texas Children’s Hospital in Houston. “At any given time, several babies in our nursery — and in any neonatal unit — would be on it.”

But in early 2011, Dr. Benson Silverman, the director of the F.D.A.’s infant formula section, was alerted to an online forum where doctors had reported 15 cases of NEC among infants given SimplyThick. The agency issued its first warning about its use in babies that May. “We can only do something with the information we are provided with,” he said. “If information is not provided, how would we know?”

Most infants who took SimplyThick did not fall ill, and NEC is not uncommon in premature infants. But most who develop NEC do so while still in the hospital. Some premature infants given SimplyThick developed NEC later than usual, a few after they went home, a pattern the F.D.A. found unusually worrisome.

Even now it is not known how the thickener might have contributed to the infant deaths. One possibility is that xanthan gum itself is not suitable for the fragile digestive systems of newborns. The intestines of premature babies are “much more likely to have bacterial overgrowth” than adults’, said Dr. Jeffrey Pietz, the chief of newborn medicine at Children’s Hospital Central California in Madera.

“You try not to put anything in a baby’s intestine that’s not natural.” If you do, he added, “you’ve got to have a good reason.”

A second possibility is that batches of the thickener were contaminated with harmful bacteria. In late May 2011, the F.D.A. inspected the plants that make SimplyThick and found violations at one in Stone Mountain, Ga., including a failure to “thermally process” the product to destroy bacteria of a “public health significance.”

The company, Thermo Pac, voluntarily withdrew certain batches. But it appears some children may have ingested potentially contaminated batches.

The parents of Jaden Santos, a preemie who died of NEC while on SimplyThick, still have unused packets of recalled lots, according to their lawyer, Joe Taraska.

The authors of the F.D.A. report theorized that the infants’ intestinal membranes could have been damaged by bacteria breaking down the xanthan gum into too many toxic byproducts.

Dr. Qing Yang, a neonatologist at Wake Forest University, is a co-author of a case series in the Journal of Perinatology about three premature infants who took SimplyThick, developed NEC and were treated. The paper speculates that NEC was “most likely caused by the stimulation of the immature gut by xanthan gum.”

Dr. Yang said she only belatedly realized “there’s a lack of data” on xanthan gum’s use in preemies. “The lesson I learned is not to be totally dependent on the speech pathologist.”

Julie Mueller’s daughter Addison was born full-term and given SimplyThick after a swallow test showed she was at risk of choking. It was recommended by a speech pathologist at the hospital.

Less than a month later, Addison was dead with multiple holes in her small intestine. “It was a nightmare,” said Ms. Mueller, who has filed a lawsuit against SimplyThick. “I was astounded how a hospital and manufacturer was gearing this toward newborns when they never had to prove it would be safe for them. Basically we just did a research trial for the manufacturer.”

Xanthomonas Campestris—Gram-Negative Bacteria—Xanthan Gum Endotoxins

Xanthomonas campestris, a plant-causing-disease bacterium, is the food thickener/pharmaceutical lubricating source of xanthan gum. The viscous properties of xanthan gum are also applicable for oil and gas drilling endeavors. To obtain the xanthan gum biopolymer powder, Xanthomonas campestris microorganisms are fermented in nutrient-rich (generally corn derivative) broths and extracted by alcohol precipitation.

Because xanthomonas campestris is a gram-negative bacteria, the conversion to xanthan-gum process releases lipopolysaccarides (endotoxins). As explained by former Monsanto researcher, John L. Holahan et al. (1999) 14 grams of Keltrol T xanthan gum dissolved in 2 liters of water will produce in excess of one million eu (endotoxin units) per gram of dry unpurified xanthan gum.

Pharmaceutical grade xanthan gum should be free of endotoxins but this goal is generally not achievable. The level of endotoxins present in food-grade xanthan gum i. e. SimplyThick® is not known.

SimplyThick® "Word of Mouth" Marketing

It is concerning that the SimplyThick® product entered the elder/infant health care market without FDA evaluation or approval and now, according to Mr. Holahan, poses a greater risk to specified patients. 

SimplyThick® was exported to Canada, Puerto Rico, Guatemala, Ecuador, Panama, Barbados, Cayman Islands, and Italy. Health Canada has linked the SimplyThick®
product to infant necrotizing enterocolitis disease.

For further information re SimplyThick® please refer to the following reports.

SimplyThick Neonatal Intensive Care Practices 

FDA "SimplyThick" Infant Health Risk Warnings are Complicated

Thermo Pac, LLC—SimplyThick— Processing Deficiencies

 Infant— SimplyThick—Alert: Health Canada October 18, 2012

John L. Holahan—SimplyThick—Xanthan Gum—Necrotizing Enterocolitis

John L. Holahan: Burdock Group SimplyThick Safe for Infant Formula Approval 2001

SimplyThick Infant Formula Experiment

DHASCO®/ARASCO® Oils: Generally Recognized as Safe Infant Formula Additives

FDA Concerns re DHASCO®/ARASCO® Infant Formula Additives

In 2001 Martek Biosciences, Inc. petitioned the FDA to recognize the company's self-certified Generally Recognized as Safe (GRAS) status for its ARA fungal oil (ARASCO®) and DHA algal oil (DHASCO®) infant formula ingredients.

The Generally Recognized as Safe designation is a U.S. industry devised mechanism to avoid due diligence.  Additives, classified generally recognized as safe, enter consumer products without premarket approval and independent testing.

Some researchers are of the opinion that the ARASCO®/DHASCO® products, which contain long-chain polyunsaturated fatty acids (LCPUFAs), are infant health risks.

The FDA agreed to accept the Martek Biosciences, generally recognized as safe, claims but countered that further DHASCO®/ARASCO®, testing was warranted because:

... some studies have reported unexpected deaths among infants who consumed formula supplemented with LCPUFAs. These unexpected deaths were attributed to Sudden Infant Death Syndrome (SIDS), sepsis or necrotizing enterocolitis. Also, some studies have reported adverse events and other morbidities including diarrhea, flatulence, jaundice, and apnea in infants fed LCPUFAs.

Diethylene Glycol Deaths Prompt Regulatory Action

In September 1937 the S. E. Massengill Company began marketing an antibiotic product called elixir sulfanilamide. The medication contained the dissolving agent Diethylene glycol, a known toxic substance.

Elixir Sulfanilamide was responsible for 100 deaths, many of them children.  Dr. Samuel E. Massengill pleaded guilty to the federal charges of adulteration/misbranding of the company's product and paid fines.

Following the "Taste of Raspberries, Taste of Death" poisoning Congress expediently passed the 1938 Food, Drug, and Cosmetic Act.

Congressional actions twenty years later compromised the intent of the 1938 legislation and the ability of the Federal Drug Administration to protect consumers from injurious products.

The 1958 pro-industry Food Additives Amendment, aka "The GRAS Law" permits financially-positioned entities to establish the safety and suitability of their products by way of industry-sponsored trials and selected approval panels.

Martek Biosciences Response to FDA: Supplemental DHASCO®/ARASCO® Safety Studies "Would not be Productive"

Martek Biosciences informed the FDA that further DHASCO®/ARASCO®, safety studies "would not be productive":

As such it is doubtful that convening a group of experts to answer purely hypothetical concerns would be scientifically productive, but such a step would certainly and unnecessarily further delay the availability of the proven clinical benefits of Arasco/Dhasco-supplementation to preterm and term infants of American families.

The Agency and the courts have long held that GRAS determination requires neither unanimity nor the absence of a conflict in the scientific community.

ARASCO and DHASCO pose unique testing problems because it can be difficult to distinguish whether an observed effect related to the test material is a normal physiological response to the high dietary load of that particular macronutrient, a dietary deficiency that is related to presence of a large amount of the test material in the diet, or a toxicological effect.

...studies conducted in term and preterm infants with balanced addition of ARASCO and DHASCO as sources of both bioactive fatty acids showed no difference in deaths between treatment and control groups.

...some studies have reported changes attributed to possible effects on the kidney. Martek presents an analysis of these studies and concludes that there are no consistent treatment related effects of DHASCO and ARASCO, either alone or in combination, with respect to kidney weight, kidney function or kidney histopathology.

The question of whether the DHASCO® and ARASCO® oils are benign/beneficial infant formula additives remains unknown because Martek Biosciences would not support the FDA's position that:

any evaluation that a use of a food ingredient is safe is a time-dependent judgment that is based on general scientific knowledge as well as specific data and information about the ingredient.

Wyeth-Ayerst 1998 Notice of Claim to the FDA for ARASCO/DHASCO Oils' Exemption from Premarket Approval

In its FDA waiver request letter, Wyeth-Ayerst affirmed that the products:

...conditions of use are such that ARASCO and DHASCO will comprise less than 3.5% of an infant formula fat blend, their use does not meaningfully affect the overall content of heavy metals, pesticides, trans fatty acids, residual extraction solvent, or non-saponifiables in the infant formulas in which they are used.

Wythe-Ayerst initiated research trials found that (US/Canada) infant study groups supplied with ARASCO/DHASCO enhanced formula "grew significantly better than the human milk fed group." The Wythe-Ayerst claim is not supportable.

As a result of its and other industry-funded animal/infant research projects, Wythe concludes that "the safety and tolerance of the of the Arasco and Dhasco-supplemented formula" is well documented and needs no further inquiry.

Martek Biosciences DHASCO® ARASCO® Business Matters

Bloomberg Businessweek advised interested parties— "A Growing Boost for Baby Formula"—that Martek's first-mover DHASCO/ARASCO status and the company's 15-24 year contracted partnerships with 14 infant formula producers were favorable investment factors.

A federal anti-trust lawsuit was filed against Martek Biosciences, Inc. in 2011. The plaintiff, BNLfoods, claimed that Martek Biosciences had achieved a U.S. infant formula ARA fungal oil/DHA algal oil additives monopoly.

DHASCO®/ARASCO® Oils Classified Organic

It is instructive to consider the Martek Biosciences organic certification revenue strategy:

If our oils are unable to be used in organic food and beverage products, the opportunity for sales of our oils into the food and beverage market will be limited to non-organic products.

The fifteen member National Organic Standards Board determined during their fall 2011 Savannah meeting that Martek Biosciences DHA algal and ARA fungal oils should be included on the National List as organic substances. This recommendation was made in spite of the fact the ARASCO® and DHASCO® additives (Formulaid®) are:

derived from genetically mutated algae and soil fungus, are processed with petrochemical solvents, grown in genetically engineered corn, and formulated for use in infant formula, dairy and other products with a myriad of other unreviewed synthetic ingredients.

Reference: The Organic Watergate—Cornucopia Institute

Martek Biosciences 2010 Petition to the National Organic Standards Board for Organic Certification

Martek Bioscience, Inc. notified the National Organic Standards Board in its 2010 request that the inclusion of negative DHA algal/ANA fungal oil information was unjustified:

Martek also is concerned that by quoting the Cornucopia report, the TAP (Technical Advisory Panel) could be creating the unintentional impression that it has reviewed the underlying data and believes that there is some legitimacy to the positions advanced by Cornucopia.

International Formula Council Complaints

The May 2012 International Formula Council's letter to the National Organic Standards Board warned that unfavorable findings on the part of the Board re infant formula product substances such as choline, inositol, carrageenan, and arachididontic acid might result in market disruption and force manufacturers to reconsider whether to continue in the organic baby formula business.

International Formula Council members: Abbott Nutrition, Mead Johnson Nutrition, Nestlé Infant Nutrition, PBM Products, LLC, A Perrigo Company, and Pfizer Nutrition are of the opinion that hexane-extracted ingredients are suitable for inclusion on the National Organic List.

For a historic perspective on harmful industry marketing concepts please read the 1981 NYT report: "The Controversy Over Infant Formula." In summary: The World Health Organization agreed by a vote of 118 to l that infant-formula advertising should be restricted. The U.S. was the lone opponent.

Is the U.S.D.A. certified-organic label meaningless?  Evidence supplied by The New York Times and others indicate that the National Organic Standards Board is and has been unduly influenced by financial interests.

National Organic Standards Board May 25, 2012 recommendations: add synthetic ingredients, choline and inositol to the National Organic List. Carrageenan, another synthetic product, was allowed to remain on the National Organic List but is considered unsuitable for use in infant, under six months, formula. The World Health Organization advises that carrageenan should not be added to infant formulas. Some studies referenced by WHO suggest that degraded carrageenan may be a "possible human carcinogen."  Carrageenan is present in food products, pet food and pharmaceuticals. Carrageenan's primary production site is the Philippines.